44896 Federal Register / Vol. 87, No. 142 / Tuesday, July 26, 2022 / Proposed Rules 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

42 CFR Part 493 

[CMS–3326–P] 

RIN 0938–AT47 

Clinical Laboratory Improvement 

Amendments of 1988 (CLIA) Fees; 

Histocompatibility, Personnel, and 

Alternative Sanctions for Certificate of 

Waiver Laboratories 

AGENCY: Centers for Medicare & 

Medicaid Services (CMS) and Centers 

for Disease Control and Prevention 

(CDC), Department of Health and 

Human Services (HHS). 

ACTION: Proposed rule. 

SUMMARY: This proposed rule would 

update the Clinical Laboratory 

Improvement Amendments of 1988 

(CLIA) fees and clarify the CLIA fee 

regulations. This proposed rule includes 

a proposal to provide sustainable 

funding for the CLIA program through a 

biennial two-part increase of CLIA fees. 

We are proposing to incorporate 

limited/specific laboratory fees, 

including fees for follow-up surveys, 

substantiated complaint surveys, and 

revised certificates. We are also 

proposing to distribute the 

administrative overhead costs of test 

complexity determination for waived 

tests and test systems with a nominal 

increase in Certificate of Waiver (CoW) 

fees. In addition, we are proposing to 

clarify the methodology used to 

determine program compliance fees. 

This proposed rule would ensure the 

continuing quality and safety of 

laboratory testing for the public. This 

proposed rule would also amend 

histocompatibility and personnel 

regulations under CLIA to address 

obsolete regulations and update the 

regulations to incorporate technological 

changes. In addition, this proposed rule 

would amend the provisions governing 

alternative sanctions (including civil 

money penalties, a directed plan of 

correction, a directed portion of a plan 

of correction, and onsite state 

monitoring) to allow for the imposition 

of such sanctions on CoW laboratories. 

DATES: To be assured consideration, 

comments must be received at one of 

the addresses provided below, no later 

than 5 p.m. on August 25, 2022. 

ADDRESSES: In commenting, please refer 

to file code CMS–3326–P. 

Comments, including mass comment 

submissions, must be submitted in one 

of the following three ways (please 

choose only one of the ways listed): 

1. Electronically. You may submit 

electronic comments on this regulation 

to https://www.regulations.gov. Follow 

the ‘‘Submit a comment’’ instructions. 

2. By regular mail. You may mail 

written comments to the following 

address ONLY: Centers for Medicare & 

Medicaid Services, Department of 

Health and Human Services, Attention: 

CMS–3326–P, P.O. Box 8016, Baltimore, 

MD 21244–8016. 

Please allow sufficient time for mailed 

comments to be received before the 

close of the comment period. 

3. By express or overnight mail. You 

may send written comments to the 

following address ONLY: Centers for 

Medicare & Medicaid Services, 

Department of Health and Human 

Services, Attention: CMS–3326–P, Mail 

Stop C4–26–05, 7500 Security 

Boulevard, Baltimore, MD 21244–1850. 

For information on viewing public 

comments, see the beginning of the 

SUPPLEMENTARY INFORMATION section. 

FOR FURTHER INFORMATION CONTACT: 

Kimberly Weaver, CMS, (410) 786–3531, 

and Jessica Wright, CMS, (410) 786– 

3838, for general information on CLIA 

fees. 

Jeffrey Pleines, CMS, (410) 786–0684, 

for the budget and financial impact on 

CLIA fees. 

Sarah Bennett or Cindy Flacks, CMS, 

(410) 786–3531, for personnel issues. 

Penny Keller, CMS, (410) 786–3531, 

or Jelani Sanaa, CMS, (410) 786–1139, 

for histocompatibility issues. 

Sarah Bennett, CMS, (410) 786–3531, 

for alternative sanctions for CoW 

laboratories issues. 

Nancy Anderson, CDC, (404) 498– 

2741, for personnel and 

histocompatibility issues. 

SUPPLEMENTARY INFORMATION:

Inspection of Public Comments: All 

comments received before the close of 

the comment period are available for 

viewing by the public, including any 

personally identifiable or confidential 

business information that is included in 

a comment. We post all comments 

received before the close of the 

comment period on the following 

website as soon as possible after they 

have been received: https://

www.regulations.gov. Follow the search 

instructions on that website to view 

public comments. CMS will not post on 

Regulations.gov public comments that 

make threats to individuals or 

institutions or suggest that the 

individual will take actions to harm the 

individual. CMS continues to encourage 

individuals not to submit duplicative 

comments. We will post acceptable 

comments from multiple unique 

commenters even if the content is 

identical or nearly identical to other 

comments. 

I. Background 

A. Clinical Laboratory Improvement 

Amendments of 1988 (CLIA) Fees 

On October 31, 1988, Congress 

enacted the Clinical Laboratory 

Improvement Amendments of 1988 

(CLIA) (Pub. L. 100–578), which 

replaced in its entirety section 353 of 

the Public Health Service Act (PHSA). 

Section 353(m) of the PHSA requires the 

Secretary to impose two separate types 

of fees: ‘‘certificate fees’’ and 

‘‘additional fees.’’ Certificate fees are 

imposed for the issuance and renewal of 

certificates and must be sufficient to 

cover the general costs of administering 

the CLIA program, including evaluating 

and monitoring approved proficiency 

testing (PT) programs and accrediting 

bodies and implementing and 

monitoring compliance with program 

requirements. Additional fees are 

imposed for inspections of 

nonaccredited laboratories and for the 

cost of evaluating accredited 

laboratories to determine overall if an 

accreditation organization’s standards 

and inspection process are equivalent to 

the CLIA program. These evaluations 

are referred to as validation inspections. 

The additional fees must be sufficient to 

cover, among other things, the cost of 

carrying out such inspections. 

Certificate and additional fees vary by 

group or classification of laboratory, 

based on such considerations as the 

Secretary determines relevant, which 

may include the total test volume and 

scope of the testing being performed by 

the laboratories, and only a nominal fee 

may be required for the issuance and 

renewal of Certificates of Waiver 

(CoWs). 

In January 2018, we published the 

‘‘Request for Information: Revisions to 

Personnel Regulations, Proficiency 

Testing Referral, Histocompatibility 

Regulations and Fee Regulations under 

the Clinical Laboratory Improvement 

Amendments (CLIA) of 1988’’ (83 FR 

1004). As part of the general solicitation 

for comments related to the CLIA fees, 

more than a few commenters noted that 

the CLIA compliance and additional 

fees have not been updated since 1997 

and supported increasing the fees. Some 

of these commenters suggested that the 

CLIA fees be reviewed annually and 

updated as needed to cover the program 

costs of performing biennial surveys. 

Based on stakeholder comments from 

the Request for Information (RFI), in the 

December 31, 2018 Federal Register, we 


khammond on DSKJM1Z7X2PROD with PROPOSALS3
Federal Register / Vol. 87, No. 142 / Tuesday, July 26, 2022 / Proposed Rules 44897 

1https://www.cms.gov/Regulations-andGuidance/Legislation/CLIA/Index. 

issued a notice with comment period 

(83 FR 67723 through 67728) 

(hereinafter referred to as the December 

31, 2018 notice). The December 31, 2018 

notice increased fees for laboratories 

certified under CLIA. The December 31, 

2018 notice increased CLIA fees by 20 

percent to help ensure the CLIA 

program could continue to be selfsustaining, as required by law. The 2018 

increase was intended to give CMS time 

to propose a process through 

rulemaking to allow for ongoing changes 

to the CLIA fees. The changes being 

proposed in this rule would result in a 

continuous level of funding that would 

increase as the obligations to the CLIA 

program increase and keep the program 

adequately funded over time. 

In September 2020, we released new 

tools to reduce burdensome paperwork 

and authorization delays for laboratories 

seeking CLIA certification. Laboratories 

now have the option to pay CLIA 

certification fees on the CMS CLIA 

program website. Online payments are 

processed overnight, which is 

substantially faster than hard-copy 

checks.1

This proposed rule would make 

changes to the methodology for 

determining the amount of the CLIA 

fees as described in the February 28, 

1992 final rule with comment period (57 

FR 7002) (hereinafter referred to as the 

February 1992 final rule) and codified 

in 42 CFR part 493, subpart F—General 

Administration. The fees for the CoW, 

Certificate for Provider Performed 

Microscopy (PPM), and the provisional 

certificate that we refer to as the 

Certificate of Registration (CoR) were 

based on the cost of issuing the 

certificates. The Certificate of 

Accreditation (CoA) and Certificate of 

Compliance (CoC) fees were based on 

the annual test volume and scope of 

testing that separated the laboratories 

into schedules or groups of laboratories. 

Except where described below, we are 

generally proposing to continue 

determining these fees in the same 

manner as in the February 1992 final 

rule, with the exception of a change in 

the amount of the CoW fee. 

As one such change, we propose to 

allocate, directly from the CoW fees, the 

administrative overhead costs of the 

Food and Drug Administration (FDA) 

process to categorize clinical laboratory 

tests as waived as described in the 

memorandum of understanding (MOU) 

between CMS and FDA (IA19–23). We 

believe this is appropriate because the 

functions of the FDA under the MOU 

are to provide administrative support to 

the CLIA program, specifically by 

categorizing tests as waived. 

In addition, we propose implementing 

certificate fees for the issuance of 

replacement and revised certificates. We 

receive numerous requests daily for 

replacements of lost and misplaced 

certificates and for revised copies of 

certificates after demographic, 

laboratory director, and/or specialty/ 

subspecialty changes. As a result, 

thousands of replacement and revised 

certificates have been generated and 

mailed annually. We believe this 

additional certificate fee will encourage 

laboratories to better manage their 

certificates, provide accurate 

information when applying for or 

updating a CLIA certificate, and cover 

the costs of producing duplicate or 

revised documents. 

The February 1992 final rule also 

stated at § 493.645(b)(1) that laboratories 

issued a CoA would be assessed a fee to 

cover the cost of evaluating the 

individual laboratories to determine 

whether an accreditation program’s 

standards and inspection policies are 

equivalent to the Federal program. The 

February 1992 final rule explained that 

there would be a random sample of 5 

percent of all accredited laboratories 

inspected by HHS, and the findings 

compared to the findings of the 

Accreditation Organizations (AOs). The 

February 1992 final rule stated that all 

accredited laboratories would share the 

cost of this activity and that the fees 

would be the same as for inspections by 

nonaccredited laboratories. We propose 

new § 493.645(a)(1) to clarify that all 

accredited laboratories share in the 

validation inspections cost. Under 

§ 493.645(b)(1), the accredited 

laboratories currently pay a fee even 

though HHS inspects only 5 percent of 

them annually. The fee is 5 percent of 

what the inspection cost of an 

equivalent nonaccredited CoC 

laboratory would pay based on the test 

volume and scope (that is, the schedule 

or group) of the laboratories. 

In the February 1992 final rule, the 

inspection fees for laboratories holding 

a CoC were based on estimates of the 

length of time required to perform a 

laboratory survey in the different 

schedules multiplied by the estimated 

hourly rate of three different entities 

that perform surveys. As outlined in the 

February 1992 final rule, we believe this 

methodology was a starting point 

intended to allow the methodology to be 

adjusted as historical data and 

experience were gained. The three 

inspection entities mentioned in the 

February 1992 final rule were the state 

agency, contracted surveyors, and 

Federal surveyors. Of these three 

entities, an hourly rate was established 

solely for the state agencies, as any 

contracted surveyors’ salaries are paid 

by their contractual amount. The 

Federal surveyors perform their surveys 

in conjunction with non-survey work 

plus actual costs for travel to those 

surveys. Given this diversity of costs, it 

is not feasible to determine a Federal 

hourly rate for just the survey activities. 

Due to these difficulties, we propose 

to cease using the hourly rate outlined 

in current regulations as the basis for 

determining compliance inspection fees 

for laboratories holding a CoC and 

replace it with the methodology 

proposed in this rule. We propose to 

keep inspection fees separated by the 

schedules as previously determined. 

The additional fees allowed for in 

section 353(m) of the PHSA are fees for 

determining compliance with the CLIA 

regulations. Some of these fees were 

previously included in subpart F but 

were not implemented due to technical 

limitations. However, a new data system 

that can implement these requirements 

is under development, with an expected 

startup date of October 2022. Therefore, 

we propose to implement the collection 

of additional fees as outlined in the 

February 1992 final rule, to be effective 

October 2022, as well as the others in 

this proposed rule, which would be 

effective 30 days after the publication of 

the final rule. We believe the collection 

of these additional fees will help bridge 

the shortfall between program 

expenditures and collections as 

discussed in section I.A.1.b. of this 

proposed rule. 

The February 1992 final rule 

provisions codified at 42 CFR part 493, 

subpart F—General Administration was 

numbered too close together to allow 

new provisions or the separation of 

existing provisions, for clarification, to 

stay in numerical order. Therefore, we 

propose to redesignate and renumber 

some provisions so that the flow of this 

section is easier to follow. For example, 

we are proposing to redesignate current 

§ 493.645(a) as § 493.649(a) and remove 

the current regulatory text at § 493.649. 

In addition, we propose redesignating 

current § 493.646 as new § 493.655 to 

maintain thematic order in that 

§ 493.655, which outlines the payment 

of fees, is better placed after the 

provisions discussing the different types 

of fees. Each such change, including this 

example, is explained in full at its 

designated provision within section II. 

of this proposed rule. 

Upon the final rule effective date, 

which would be 30 days following 

publication, we propose implementing 

fee increases as described above. We 

expect the fee increase to be larger than 


khammond on DSKJM1Z7X2PROD with PROPOSALS3
44898 Federal Register / Vol. 87, No. 142 / Tuesday, July 26, 2022 / Proposed Rules 

subsequent fee increases and include an 

across-the-board increase of twenty 

percent and an inflation factor (CPI–U) 

of 1.047. We utilized the CPI–U factors 

promulgated by OMB as part of their 

economic assumptions for budgetary 

estimates. To calculate the 4.7 percent 

compound factor for the two-year 

increase, we multiplied together factors 

for each of the two years as follows: 

Factor Year 1 (Budgeted Rate for Fiscal 

Year (FY) 2022) = 1.023 

Factor Year 2 (Budgeted Rate for 

FY2023) = 1.023 

The compounded factor = 1.023 × 

1.023 = 1.047. 

The 20 percent across-the-board 

(ATB) increase was determined as the 

amount that, including newly charged 

fees and inflation, is the difference 

necessary to fund in total annual 

projected program obligations and allow 

for the gradual accumulation of 6 

months’ worth of obligations as an 

operating margin at the start of the year. 

We have calculated that the one-time 20 

percent across-the-board increase would 

generate approximately 12.7 million 

dollars annually while the inflation 

factor would generate approximately 3.1 

million dollars. The other proposed fees 

would generate approximately 6.7 

million dollars for a total of 

approximately 22.5 million dollars per 

year. We believe this would stabilize the 

CLIA program and allow us to use the 

inflation factor for future biennial 

increases. The actual across-the-board 

percentage may change based on any 

new information that becomes available 

or updated assumptions. The revised 

certificate fee found at proposed 

§ 493.639(a); the replacement certificate 

fee found at proposed § 493.639(b); the 

follow-up surveys, substantiated 

complaint surveys, and unsuccessful PT 

on CoC laboratories found at proposed 

§ 493.643(d)(1) through (4); follow-up 

surveys on CoA laboratories found at 

proposed § 493.645(a)(2); and 

substantiated complaint surveys on 

CoW, PPM, or CoA laboratories found at 

proposed § 493.645(b) would be 

implemented on the effective date of the 

final rule. However, the collection of the 

fees is dependent on the new data 

system being online. 

1. CLIA Budget Process 

Table 1 provides a summary of 

projected user fee collections, program 

obligations, and carryover balances 

through the end of FY 2025. Start of 

year carryover balances plus anticipated 

collections at current rates, net of 

sequester, equals budgetary resources 

available for obligation, or spending, in 

a given fiscal year. This amount, less 

projected program obligations, equals 

end-of-year carryover. The continued 

decrease in the projected end-of-year 

carryover shows financial obligations 

for the CLIA program continue to 

significantly outpace user fee 

collections at current rates. This 

proposed rule would create sustainable 

funding in a few different ways. 

a. Two-Part Periodic Increase 

First, establishing a two-part periodic 

increase could be easily implemented 

and would provide an understandable 

calculation of fee increases. CMS will 

publish future fee increases in a notice 

in the Federal Register. CMS will not 

publish a notice in the Federal Register 

if no fee increases are required. Every 2 

years, in preparation for the biennial fee 

increase, we would calculate the 

inflation adjustment using the 

Consumer Price Index for all Urban 

Consumers (CPI–U). At that time, CMS 

would look back over the previous 2 

years and determine if the calculated 

CPI–U inflation adjustment would be 

sufficient to cover actual program 

obligations. If the total fee amounts, 

including any increase applied, do not 

match or exceed actual program 

obligations based on a review of the 

obligations of the previous 2 years, CMS 

will apply an additional across-theboard increase to each laboratory’s fees 

by calculating the difference between 

the total fee amounts and actual 

program obligations. If CMS determines 

that the inflation adjustment is not 

enough to cover the program 

obligations, an additional across-theboard amount would be added to the 

adjustment to ensure that the fee 

increase is spread equally across all fees 

in a flat percentage amount, which 

would cover CLIA obligations. The 

adjusted fees would become part of the 

baseline for the next biennial increase. 

If the level of collections was found to 

be sufficient to cover program 

obligations, CMS would not implement 

a biennial inflation adjustment or an 

across-the-board fee increase. With any 

fee increase, the amount of the increase 

and a summary of CLIA obligations 

along with the calculations of the 

increase using the CPI–U and any 

determined shortfall would be 

published in a notice in the Federal 

Register. 

Table 2 shows a representation of the 

change in national average laboratory 

fees if the two-part increase was 4 

percent over the current fees. 

BILLING CODE 4120–01–P 


khammond on DSKJM1Z7X2PROD with PROPOSALS3EP26JY22.126</GPH>

TABLE 1 : CMSP ro1ec . f ions t or CLIA Ohr 12a f ions an dF ee C 0 II ec f IODS 

FY2021 FY2022 FY2023 FY2024 FY2025 

Available Carryover $37,971,994 $29,503,205 $14,362,115 ($2,493,627) ($21,103,458) (SOY)* 

New collections $69,874,000 $63,000,000 $63,000,000 $63,000,000 $63,000,000 

Sequester ( 5. 7%) ($3,982,818) ($3,591,000) ($3,591,000) ($3,591,000) ($3,591,000) 

Available Budgetuy $103,863,176 $88,912,205 $73,771,115 $56,915,373 $38,805,542 Resources** 

Obligations $74,359,971 $74,550,090 $76,264,742 $78,018,831 $79,813,264 

Carryover (EOY)* $29,503,205 $14,362,115 ($2,493,627) ($21,103,458) ($41,507,722) 

*SOY= Start of Year, EOY = End of Year 

** Budgetuy resources mean amounts available to be obligated. In this instance it means the sum of available 

carryover+ new user fee collections less projected sequestration. 

EP26JY22.127</GPH>khammond on DSKJM1Z7X2PROD with PROPOSALS3

TABLE 2: Examples, Two-part Increase per Certificate Type• 

National Average CoC compliance fee/CoA Validation Sunrey fee 

Laboratory Example, Biennial Increase of classification Current average 

(schedule) 4% 

Certificate of 

Compliance (CoC) 

& Certificate of eoc CoA Coe CoA 

Accreditation 

(CoA) 

LVA** $360 $18 $374.40 $18.72 

A $1,192 $60 $1.239.68 $62.40 

B $1,591 $80 $1.654.64 $83.20 

C $1.988 $99 $2.067.52 $102.96 

D $2,336 $117 $2.429.44 $121.68 

E $2,684 $134 $2.791.36 $139.36 

F $3.032 $152 $3.153.28 $158.08 

G $3,380 $169 $3.515.20 $175.76 

H $3,728 $186 $3.877.12 $193.44 

I $4.076 $204 $4.239.04 $212.16 

J $4.408 $220 $4.584.32 $228.80 

Not annlicable - - - -

*Note: The Certificate of Registration (CoR) fee would increase from the $100 to $104. 

**LVA "SL:hedule A, Low Volume". 

CLIA Biennial Certificate 

Current average Example, 

CoC/CoA cow PPM CoC/CoA 

$180 - - $187.20 

$180 - - $187.20 $180 - - $187.20 $516 - - $536.64 $528 - - $549.12 $780 - - $811.20 

$1.320 - - $1372.80 $1,860 - - $1934.40 $2,448 - - $2 545.92 $7.464 - - $7 762.56 $9.528 - - $9 909.12 

- $180 $240 - 
44900 Federal Register / Vol. 87, No. 142 / Tuesday, July 26, 2022 / Proposed Rules 

b. Collection of Other Authorized Fees 

The CLIA regulations also authorize 

the collection of other fees; however, the 

program has historically not exercised 

its authority in collecting these fees due 

to technical difficulties. CMS believes 

this has been a missed opportunity. 

With the improvement in technology 

since 1992, we will be enforcing 

existing regulatory authority in the 

collection of these fees as well as 

clarifying circumstances when such fees 

are applicable. If finalized, this 

proposed rule would implement 

collection of these other fees, which are 

laboratory specific and provide an 

incentive for laboratories to remain 

compliant with all provisions of the 

CLIA regulations. 

The fees include: 

• A fee for follow-up surveys to 

determine correction of the deficient 

practices found in either a CoC survey 

or a CoA validation survey; 

• An addition of a specialties survey 

fee when it is necessary to determine 

compliance of testing in one or more 

additional specialties outside of the CoC 

survey cycle; 

• A substantiated complaint survey 

fee; 

• A fee for a desk review of 

unsuccessful PT performance; 

• A fee for a replacement certificate 

when a laboratory loses or destroys a 

CLIA certificate and requests a 

replacement certificate; and 

• A fee for issuing a revised 

certificate when the laboratory changes 

the laboratory director or other 

information found on a certificate and 

requests a new certificate to reflect the 

changes. 

Table 3 represents a national average 

per incident of the amount that would 

have been collected had these fees been 

implemented in FY2019. We totaled the 

number of follow-up surveys, 

substantiated complaints, and 

unsuccessful PT events and multiplied 

them by the national average number of 

hours recorded by the state survey 

agencies for these activities and then 

multiplied that by the national average 

unit cost, which was $72.06 in 2019. 

The amounts for the revised certificates 

and replacement certificates are the fee 

amount as discussed in section II.C. of 

this proposed rule, specifically at 

§ 493.639(a). 

BILLING CODE 4120–01–C 

2. CoW Fee Increase 

This proposed rule would authorize a 

fee increase for the CoW. A CoW 

laboratory is limited to performing tests 

categorized by FDA as waived, which 

are simple laboratory examinations and 

procedures that have an insignificant 

risk of an erroneous result, including 

those that employ methodologies that 

are so simple and accurate as to render 

the likelihood of erroneous results by 

the user negligible, or the Secretary has 

determined pose no unreasonable risk of 

harm to the patient even if performed 

incorrectly. Some examples of waived 

tests include tests for blood glucose or 

cholesterol. As part of our financial 

obligations to administer the CLIA 

program, we compensate FDA for its 

role in determining if tests and test 

systems meet criteria to be categorized 

as waived tests/test systems. This 

proposed rule would implement a 

nominal increase for CoW fees which 

would offset program obligations to 

FDA for its role under the CMS–FDA 

MOU (IA19–23) in categorizing tests 

and test systems as waived. The 

obligation to CLIA, defined by the MOU 

and calculated against the number of 

CoW laboratories, is approximately $25 

per laboratory to cover the FDA 

obligation. The additional $25.00 would 

increase the current $180.00 biennial 

CoW fee to $205.00. Due to the public 

health emergency for COVID–19 and the 

number of smaller laboratories that hold 

a Certificate of Waiver, we are proposing 

to delay the implementation of the onetime $25 fee increase until the Secretary 

terminates the declaration or allows it to 

expire. 

B. CLIA Requirements for 

Histocompatibility, Personnel, and 

Alternative Sanctions for CoW 

Laboratories 

CLIA requires any laboratory that 

examines human specimens for the 

purpose of providing information for the 

diagnosis, prevention, or treatment of 

any disease or impairment of, or the 

assessment of health, of human beings 

to be certified by the Secretary for the 

categories of examinations or 

procedures performed by the laboratory. 

The implementing regulations at 42 CFR 

part 493 specify the conditions and 

standards that must be met to achieve 

and maintain CLIA certification. These 

conditions and standards strengthen 

Federal oversight of clinical laboratories 

and help ensure the accuracy and 

reliability of patient test results. 

CMS is always looking for ways to 

improve our programs and better serve 


khammond on DSKJM1Z7X2PROD with PROPOSALS3EP26JY22.128</GPH>

TABLE 3: Projection of other Authorized Fees per Certificate Type 

Projected National Average Other Authorized fees 

Follow-up surveys Unsuccessful 

(including those for Substantiated Proficiency 

the addition of Complaint Testing (PT) Replacement Revised 

Certificate type specialties) Surveys event Certificates Certificates 

Certificate of Compliance $329 $1,879 $517 $75 $150 (CoC) 

Certificate of $329 $5,0ll $517 $75 $95 Accreditation (CoA) 

Certificate of Registration $329 $2,802 $517 $75 $150 (CoR) 

Certificate of Waiver n/a $1,364 n/a $75 $95 (CoW) 

Certificate of Provider 

Performed Microscopy n/a $2,556 n/a $75 $150 

(PPM) 
Federal Register / Vol. 87, No. 142 / Tuesday, July 26, 2022 / Proposed Rules 44901 

2See the ‘‘Medicare, Medicaid and CLIA 

Programs; Regulations Implementing the Clinical 

Laboratory Improvement Amendments of 1988 

(CLIA)’’ final rule with comment period (57 FR 

7002) that published in the February 28, 1992 

Federal Register (hereinafter referred to as the 

‘‘1992 final rule with comment period’’). 

3See the ‘‘Medicare, Medicaid, and CLIA 

Programs; Laboratory Requirements Relating to 

Quality Systems and Certain Personnel 

Qualifications’’ final rule (68 FR 3640) that 

published in the January 24, 2003 Federal Register 

(hereinafter referred to as the ‘‘2003 final rule’’). 

4See the 1992 final rule with comment period. 

5See the ‘‘Request for Information: Revisions to 

Personnel Regulations, Proficiency Testing Referral, 

Histocompatibility Regulations and Fee Regulations 

Under the Clinical Laboratory Improvement 

Amendments of 1988 (CLIA)’’ RFI (83 FR 1004) that 

published in the January 9, 2018 Federal Register 

(hereinafter referred to as the ‘‘2018 RFI’’). 

6https://www.cdc.gov/cliac/docs/summary/ 

cliac1114_summary.pdf. 

our beneficiaries. Concerning laboratory 

oversight, HHS endeavors to improve 

consistency in the application of 

laboratory standards, coordination, 

collaboration, and communication in 

both routine and emergent situations, 

thereby further improving laboratory 

oversight and, ultimately, patient care. 

The regulations related to CLIA 

histocompatibility and personnel 

requirements have not been updated 

since 1992 2 and 2003,3 and the 

regulations for CoW laboratory 

alternative sanctions have not been 

updated since 1992.4 HHS believes it is 

time to update these regulations to 

reflect the current state of the American 

health care system and new advances in 

technology. 

HHS sought expert advice to inform 

our decision-making on the regulatory 

updates proposed in this rule. We 

solicited advice on several topics 

addressed in this rule from the Clinical 

Laboratory Improvement Advisory 

Committee (CLIAC), the official Federal 

advisory committee charged with 

advising HHS regarding appropriate 

regulatory standards for ensuring 

accuracy, reliability, and timeliness of 

laboratory testing. On January 9, 2018, 

we also issued a Request for 

Information 5 (RFI) that solicited input 

from the public on issues related to 

CLIA personnel and histocompatibility 

requirements, and alternative sanctions 

for CoW laboratories. We received 

approximately 8,700 total comments in 

response to the 2018 RFI. The CLIAC 

recommendations and information 

received in response to the 2018 RFI 

helped us determine the policies 

proposed in this proposed rule. 

This proposed rule would amend 

histocompatibility and personnel 

regulations to address obsolete 

regulations and update the regulations 

to incorporate changes in technology. 

This proposed rule would also amend 

§ 493.1804(c) to allow alternative 

sanctions to be imposed on CoW 

laboratories. 

1. Histocompatibility 

The CLIA regulations include 

requirements specific to certain 

laboratory specialties such as 

microbiology and subspecialties such as 

endocrinology. Histocompatibility is a 

type of laboratory testing performed on 

the tissue of different individuals to 

determine if one person can accept 

cells, tissue, or organs from another 

person. The CLIA regulatory 

requirements for the specialty of 

histocompatibility at § 493.1278, 

including the crossmatching 

requirements, address laboratory testing 

associated with organ transplantation 

and transfusion and testing on 

prospective donors and recipients. As of 

October 2019, 218 CLIA-certified 

laboratories perform testing in this 

specialty. The current specialty 

regulations were published in the 1992 

final rule with comment period, and 

additional changes were made in the 

2003 final rule. Specifically, the 2003 

final rule changed the regulations to 

decrease the number of specialty/ 

subspecialty-specific quality control 

(QC) regulations in instances where 

general QC requirements would apply. 

The specialty of histocompatibility has 

not yet been similarly updated. Many of 

the changes proposed in this rule would 

remove histocompatibility-specific 

requirements from § 493.1278 that we 

have determined are addressed by the 

general QC requirements at §§ 493.1230 

through 493.1256 and 493.1281 through 

493.1299. We believe that removing 

specific requirements for obsolete 

methods and practices and eliminating 

redundant requirements will decrease 

the burden on laboratories performing 

histocompatibility testing. We have 

heard from our stakeholders, 

particularly the transplantation 

community, that physical crossmatches 

are a barrier to modernized decisionmaking approaches on organ 

acceptability based on risk assessment. 

For the crossmatching regulations that 

this proposed rule would amend, HHS 

requested input from CLIAC on the 

acceptability and application of newer 

crossmatching techniques in lieu of 

physical crossmatching. The CLIAC 

gathered information on the 

acceptability and application of newer 

crossmatching techniques for 

transplantation because there have been 

advances in the field of transplantation 

since 1992. These advances have made 

the physical crossmatch less significant 

in non-sensitized patients. The CLIAC 

stated that histocompatibility testing has 

evolved from cell-based assays to 

molecular typing and solid-phase 

platforms for antibody detection, 

improving accuracy and sensitivity. 

Significant changes have occurred in the 

clinical practice of transplantation 

(immunosuppression, desensitization 

practices), and improvements in antirejection therapies have led to improved 

outcomes and mitigation of risk due to 

human leukocyte antigen (HLA) 

antibodies. At its November 2014 

meeting, CLIAC made the following 

recommendations 6 for CMS to explore: 

• Regulatory changes or guidance(s) 

that would allow virtual crossmatching 

to replace physical crossmatching as a 

pre-requisite for organ transplant. 

• Appropriate criteria and decision 

algorithms, based on CLIAC deliberation 

of the Virtual Crossmatch Workgroup 

input, under which virtual 

crossmatching would be an appropriate 

substitute for physical crossmatching. 

The determination of appropriate 

criteria and decision algorithms should 

involve a process that includes an open 

comment period. 

In the 2018 RFI (83 FR 1005 through 

1006, 1008), we requested comments 

and information related to 

histocompatibility and crossmatching 

requirements that may have become 

outdated and requested suggestions for 

updating these requirements to align 

with current laboratory practice. The 

comments we received in response to 

the 2018 RFI recommended updating 

the current histocompatibility and 

crossmatching requirements to align 

with current laboratory practices. Both 

the CLIAC recommendations and the 

comments on the 2018 RFI informed the 

changes proposed in this rule. 

2. Personnel 

The CLIA regulations related to 

personnel requirements were updated 

with minor changes to the doctoral high 

complexity laboratory director (LD) 

qualifications in the 2003 final rule (68 

FR 3713) but otherwise have remained 

unchanged since we published the 1992 

final rule with comment period (57 FR 

7002). In the 2018 RFI (83 FR 1005 

through 1006, 1008), we sought public 

comment and information related to 

CLIA personnel requirements in the 

following areas: nursing degrees; 

physical science degrees; personnel 

competency assessment (CA); personnel 

training and experience; and nontraditional degrees. As we explained in 

the 2018 RFI, these are areas that the 

CDC, CMS, stakeholders, and state 

agency surveyors identified as relevant 

to our efforts to update the CLIA 


khammond on DSKJM1Z7X2PROD with PROPOSALS3
44902 Federal Register / Vol. 87, No. 142 / Tuesday, July 26, 2022 / Proposed Rules 

7https://www.cdc.gov/cliac/docs/summary/ 

cliac0419_summary.pdf. 

personnel requirements to better reflect 

current knowledge, changes in the 

academic context, and advancements in 

laboratory testing. 

We received approximately 8,700 

comments in response to the 2018 RFI. 

In response to our questions about 

nursing degrees, the majority of 

commenters did not concur that nursing 

degrees were equivalent to a biological 

or chemical sciences degree. However, 

some stakeholders suggested nursing 

degrees could be used as a separate 

qualifying degree for nonwaived testing 

personnel (TP). In response to our 

questions about physical science 

degrees as well as non-traditional 

degrees, stakeholders commented that a 

physical science degree was hard to 

define. In considering how to evaluate 

physical science and other nontraditional degrees, some commenters 

recommended that we evaluate 

coursework taken using a semester-hour 

educational algorithm to qualify 

individuals for CLIA personnel 

positions. If an individual has the 

appropriate coursework without the 

traditional chemical or biological 

degree, the individual’s educational 

coursework should be considered when 

determining whether that individual 

meets the educational requirements 

under CLIA. In response to the 

questions about CA, many commenters 

stated that individuals with an 

applicable associate’s degree should be 

permitted to perform CA on moderate 

complexity TP. Some commenters 

stated that required training should 

depend on the complexity of the testing 

to be performed and that all nonwaived 

testing should require training related to 

the individual’s laboratory 

responsibilities. Several commenters 

also stated that any required training 

and experience should be in a CLIAcertified laboratory. Many commenters 

agreed that all training and experience 

should be documented; many noted that 

documentation from a former employer 

should be acceptable, assuming it 

provided specific details about the 

individual’s job, training, and CA. 

In addition to the 2018 RFI, we 

requested input from CLIAC for 

recommended changes to the CLIA 

personnel requirements found in 

subpart M—Personnel for Nonwaived 

Testing, §§ 493.1351 through 493.1495. 

In response, CLIAC established a 

workgroup that included laboratory 

experts, representatives from 

accreditation organizations (AOs), and 

government. The CLIAC Personnel 

Regulations Workgroup provided 

information and data to CLIAC for their 

deliberation in recommending to HHS 

to updating the personnel regulations.7

CLIAC made 12 recommendations at the 

April 2019 meeting to improve CLIA 

personnel regulations, including: (1) 

making biological science degrees 

acceptable for laboratory personnel and 

considering candidates with other 

degree backgrounds based on 

coursework; (2) removing the degree in 

physical science from the CLIA 

regulations due to its broadness; and (3) 

requiring personnel to have training and 

experience in their areas of 

responsibility. 

After the April 2019 CLIAC meeting, 

CMS and the Centers for Disease Control 

and Prevention (CDC) met to review and 

consider the recommendations along 

with the information provided in 

response to the 2018 RFI. The following 

CLIAC recommendations support 

proposals included in this proposed 

rule: 

• Coursework should be considered 

in meeting CLIA personnel 

requirements; 

• Degree in physical science should 

be removed from CLIA regulations; 

• All personnel should have 

appropriate training and experience; 

• Remove the statement ‘‘possess 

qualification that are equivalent to those 

required for such certification’’, as 

applicable; 

• Laboratory experience should be 

clinical in nature; 

• 20 credit hours should be required 

for all LDs except those certified by the 

American Board of Pathology, American 

Board of Osteopathic Pathology, and 

American Board of Dermatology; 

• Laboratory directors should make at 

least two reasonably spaced onsite visits 

to the laboratories they direct annually. 

These visits should be documented; 

• Modify CLIA requirements for 

technical consultants (TC) to include an 

associate degree and training and 

experience; and 

• Modify the definition of mid-level 

practitioner to include registered nurse 

anesthetists and clinical nurse 

specialists. 

Following this, CMS and CDC 

collaborated to develop a list of 

personnel regulation updates proposed 

in this rule. 

3. Alternative Sanctions for CoW 

Laboratories 

In section III.C. of this proposed rule, 

we are proposing to amend 

§ 493.1804(c)(1) to allow CMS to impose 

alternative sanctions on CoW 

laboratories, as appropriate. CoW 

laboratories are laboratories that only 

perform waived tests, that is, simple 

laboratory examinations and procedures 

that have an insignificant risk of an 

erroneous result. For example, a urine 

dipstick pregnancy test is a waived test. 

The current regulations state that we do 

not impose alternative sanctions on 

CoW laboratories because those 

laboratories are not inspected for 

compliance with condition-level 

requirements (§ 493.1804(c)(1)). 

However, while not subject to the 

biennial routine surveys, CoW 

laboratories are surveyed as a result of 

a complaint, and based on the 

complaint survey, may be found to be 

out of compliance with a conditionlevel requirement. In the absence of 

alternative sanctions, our only recourse 

in cases of compliance issues found at 

CoW laboratories is to apply principal 

sanctions (that is, revocation, 

suspension, or limitation of the CLIA 

certificate). We believe the ability to 

levy alternative sanctions (that is, civil 

money penalties, a directed plan of 

correction, a directed portion of a plan 

of correction, and onsite state 

monitoring) on CoW laboratories helps 

CMS ensure appropriate sanctions are 

applied to CoW laboratories, as in the 

case of other certificate types (certificate 

of PPM, CoR, CoC, CoA). 

In addition, we believe that this 

proposed change, if finalized, would 

reduce burden on CoW laboratories. The 

ability to impose alternative sanctions 

would be particularly useful in 

instances in which we find PT referral 

violations. PT is the testing of unknown 

samples sent to a laboratory by an HHSapproved PT program to check the 

laboratory’s ability to determine the 

correct testing results. This proposed 

rule would amend the CoW regulations 

at § 493.1804(c)(1) to allow for the 

application of alternative sanctions 

where warranted, in addition to or in 

lieu of principal sanctions. 

We note that while the regulatory text 

at § 493.1804(c)(1) currently specifies 

that CMS will not impose alternative 

sanctions on laboratories that have 

CoWs because those laboratories are not 

inspected for compliance with 

condition-level requirements aligns 

with the statute, this distinction is not 

required by the applicable statute at 42 

U.S.C. 263a(h). Therefore, in section 

III.C. of this proposed rule, we are 

proposing to remove the parenthetical 

‘‘(CMS does not impose alternative 

sanctions on laboratories that have 

certificates of waiver because those 

laboratories are not inspected for 

compliance with condition-level 

requirements.)’’ from § 483.1804(c). 

In responses received from the 2018 

RFI, commenters noted that alternative 


khammond on DSKJM1Z7X2PROD with PROPOSALS3
Federal Register / Vol. 87, No. 142 / Tuesday, July 26, 2022 / Proposed Rules 44903 

sanctions instead of principal sanctions 

should be an option to create parity for 

all certificate types, especially in cases 

of PT referral. Further, commenters also 

stated that CoW laboratories should be 

held to the same standards and level of 

compliance as those that perform 

moderate complexity and/or high 

complexity testing. 

II. Provisions of the Proposed 

Regulations for CLIA Fees 

This section provides an overview of 

the proposed revisions to the CLIA fee 

requirements established by the 

February 1992 final rule. 

A. Proposed Definitions of 

‘‘Replacement Certificate’’ and ‘‘Revised 

Certificate’’ (§ 493.2) 

At § 493.2, we are proposing to add 

definitions for ‘‘Replacement 

certificates’’ and ‘‘Revised certificates.’’ 

After several years of experience and 

data analysis, it has been determined 

that the number of reissued certificates 

continues to be remarkable. Reissued 

certificates fall into two different 

categories: revised and replacement 

certificates. For further discussion 

please refer to section II.C. of this 

proposed rule. We are proposing that 

these definitions be added to § 493.2 

with the other definitions listed to allow 

clarity in the regulations where fees for 

replacement and revised certificates are 

being proposed. 

B. Proposed Changes to Certificate Fees 

(§ 493.638) 

At § 493.638(a), we are proposing to 

amend the regulatory language to clarify 

when a laboratory is required to pay a 

certificate fee and when the certificate is 

issued. We removed the listing of the 

individual certificates in the first 

paragraph of this section as all 

certificates go through the same process. 

The current regulation text specifies 

when a certificate fee is required, but we 

wish to clarify with more specific 

wording. The certificate fee is currently 

incurred when the original certificate is 

issued; when the certificate is 

subsequently renewed; if there is a 

change in certificate type requiring a 

new certificate to be issued; or if a 

lapsed certificate is reactivated with a 

gap in service and therefore reissued. 

The intent of the regulation is not 

changing. We believe adding this 

clarification would improve 

transparency concerning the 

requirement to pay certificate fees. 

Specifically, at § 493.638(a)(1) for 

registration certificates, we are 

proposing to remove the reference to the 

CoC because we believe the flat fee 

charged for a CoR and the temporary 

nature of the certificate require a 

separate section. We are proposing to 

redesignate the fees associated with a 

CoC to a new provision at 

§ 493.638(a)(5) to keep fee information 

relevant to the different certificate types 

separate, rather than referencing the 

certificate types together. 

At § 493.638(a)(2) for CoW, we are 

proposing to add the costs incurred by 

FDA to determine whether a test system 

meets the criteria for waived status, as 

specified at § 493.15(d). A CMS 

representative reviews an application 

for a CoW to determine whether the 

applicant has requested a CLIA 

certificate that covers the testing they 

have listed on the application that they 

will be performing. The cost of such a 

review is already part of the CoW fee. 

However, FDA must expend resources 

reviewing tests, procedures, and 

examinations to determine whether a 

test meets the criteria to be designated 

as waived. This expense is not currently 

captured in the fee for a CoW, and we 

propose that it should be. HHS had 

delegated the responsibility to FDA for 

the review of test systems and 

assignment of complexity, including 

what is required by § 493.15(d). CMS 

compensates FDA out of the CLIA funds 

for this determination under the CMS– 

FDA MOU (IA19–23). CoW laboratories 

are restricted to using waived tests. We 

believe that the regulatory restrictions of 

test systems for the CoW laboratories 

and the CMS requirement to determine 

what tests can be performed in a CoW 

laboratory under § 493.15(d) require us 

to place this fee on the CoW laboratories 

alone. We believe the predicted increase 

in CoW laboratories will offset expected 

increases in the obligation to FDA for 

the continued process of review and 

categorization of tests as waived. 

We are proposing to make editorial 

changes to clarify the current provision 

§ 493.638(b) that describes certificate fee 

amounts. We are separating this section 

into four shorter paragraphs designated 

as § 493.638(b)(1) through (4). Proposed 

§ 493.638(b)(1) states that CMS will 

publish a notice in the Federal Register 

when assessed fees are adjusted in 

accordance with § 493.680. This section 

also includes a brief discussion of the 

basis for certificate fees as set forth in 

§ 493.638(c). Proposed § 493.638(b)(2) 

states that certificate fees would be 

collected at least biennially. Certificate 

fees may be assessed more frequently 

than every 2 years if the laboratory 

changes its certificate type. Proposed 

§ 493.638(b)(3) states how fees would be 

determined and proposed 

§ 493.638(b)(4) states that CMS would 

notify the laboratories when the fees are 

due and the fee amount. This currently 

takes place in the form of a fee coupon 

sent through U.S. Mail by the Billing 

and Certificate Issuance contractor. 

We are also proposing to move the 

regulatory text currently found at 

§ 493.643(c)(1) through (3) to a new 

provision at § 493.638(c) to align the 

provisions more closely for laboratory 

schedules and specialties with the 

related provisions concerning certificate 

fees. Our intent is to refer back to this 

provision when the compliance fees are 

discussed. In addition to redesignating 

this regulatory text, we propose making 

minor changes to clarify the regulatory 

text related to specialties of service 

before those specialties are explained at 

§ 493.643(c)(3). 

At the proposed new § 493.638(c)(3), 

we are proposing to redesignate the 

regulatory text currently at 

§ 493.643(c)(1) with changes. We believe 

that the separation of Schedule A into 

two parts at § 493.643(c)(1)(i)(A) and (B) 

was confusing, and we propose listing 

them as separate schedules. The 

proposed text in the new provision 

§ 493.638(c)(3) now includes 

§ 493.638(c)(3)(i) through (xi). At 

§ 493.638(c)(3)(i), we propose describing 

the low volume schedule as Schedule V 

to differentiate it from Schedule A, now 

proposed at § 493.638(c)(3)(ii). Current 

data processing system requirements 

have been built to refer to the low 

volume A schedule laboratories as 

Schedule V and will continue with the 

new data system. 

C. Proposed Changes to Fees for Revised 

and Replacement Certificates 

(§ 493.639) 

At § 493.639, we are proposing to 

revise the current section heading (‘‘Fee 

for revised certificate’’) to read as ‘‘Fee 

for revised and replacement certificates’’ 

to match the contents of the section as 

amended to include both revised 

certificates and replacement certificates. 

We are proposing to define and explain 

revised and replacement certificates in 

section II.A. of this proposed rule. In 

this proposed provision at § 493.639 we 

would further explain the fees 

associated with each type. 

At § 493.639(a), we are proposing to 

remove the reference to registration 

certificates as the section applies to all 

CLIA certificate types under the 

statutes. We are also proposing to 

amend the circumstances in which a 

laboratory may request a revised 

certificate to include changes to 

laboratory name and location, laboratory 

director, or services offered (specialties 

and subspecialties). We are proposing 

the fee be based on the national average 

cost to issue the revised certificate. 

However, due to differing amounts of 


khammond on DSKJM1Z7X2PROD with PROPOSALS3
44904 Federal Register / Vol. 87, No. 142 / Tuesday, July 26, 2022 / Proposed Rules 

work required per certificate type, the 

fee is not a single amount. Please see 

Table 4. 

We determined the time and 

resources required to enter changes to 

laboratory demographics, review of 

specialties and subspecialties, and 

review of laboratory director 

qualifications using an average of the 

state survey agencies’ calculated unit 

hourly cost. The state unit hourly cost 

is determined by the CLIA budget office 

and is based on a formula of total state 

costs divided by the total staff years. 

The total state costs are reported to CMS 

by the state survey agencies and include 

staff salaries as determined by each 

state’s civil service pay scale, fringe 

benefits, travel costs, and other costs 

such as office supplies, computers 

containing software required to perform 

and report a CLIA survey, etc. The total 

staff year hours are determined by 

multiplying the number of full-time 

employees (FTE) by 1600 hours, 

representing the productive work year. 

The time and resources for state 

agencies to enter demographic changes 

are less than those where the 

qualifications of the laboratory director 

or services need to be reviewed to 

ensure CLIA personnel requirements are 

met. Review of laboratory director 

qualifications applies to laboratories 

holding a CoC, a certificate of PPM, or 

CoR. 

AOs are responsible for reviewing 

CoA laboratory director qualifications, 

and the AO is also responsible for 

reviewing the addition of specialties 

and subspecialties for the CoA 

laboratory. As such, state agency staff 

are not responsible for reviewing 

laboratory director qualifications or 

changes in specialties/subspecialties for 

laboratories with a CoA; however, they 

are responsible for processing the other 

demographic change requests for CoA 

laboratories. Therefore, a revised 

certificate for a CoA laboratory does not 

include the cost to review the 

qualifications of laboratory directors, 

nor does it include the adding or 

deleting of specialties or subspecialties. 

For a CoC, a change in services 

(adding or deleting a specialty or 

subspecialty) does not include review to 

determine compliance with the 

regulations for services added; however, 

the entry or deletion of specialty or 

subspecialty changes requires state 

agency personnel time and resources. 

CLIA personnel requirements are not 

required for laboratories with a CoW, 

nor are there specialty or subspecialty 

requirements. Therefore, the time and 

resources required to enter requested 

demographic changes for CoW 

laboratories are less than for other 

certificate types. Please see the section 

below for the calculations used to 

determine these fee amounts. 

We are proposing the following fees 

for issuing revised certificates: 

The revised certificate fee would be 

paid prior to the issuance of the revised 

certificate. Nonpayment of this fee 

would not result in the revocation of the 

laboratory’s certificate; however, a 

revised certificate would not be issued. 

At § 493.639(a)(1), we are proposing a 

new provision explaining that the 

addition of services (that is, specialties/ 

subspecialties) for laboratories with a 

CoC may result in an additional fee for 

purposes of determination of 

compliance if added services require an 

inspection. That addition of the 

specialties inspection fee is described in 

a new provision at § 493.643(d)(2). 

We are proposing to delete the current 

provisions at § 493.639(b)(1) and (2), 

which provide information on fees for 

issuing a revised certificate and 

scenarios that describe changes that may 

require a change in certificate. We 

propose to replace them with a new 

provision at § 493.639(b) that outlines 

fees for issuing a replacement 

certificate. We believe the current 

provisions are confusing as written and 

where the provisions are located in the 

regulations. 

At the new provision § 493.639(b), we 

are proposing a fee for issuance of 

replacement certificates as discussed in 

section II.A. of this proposed rule. This 

proposed requirement must account for 

the time and resources required to issue 

a replacement certificate when 

requested. Historically, replacement 

certificates have been issued without 

additional fees when a laboratory loses 

or destroys its current certificate. We 

have determined that the actual cost of 

issuing a replacement certificate is 

$75.00. A replacement certificate is one 

where no changes are being requested. 

The fee would be paid prior to the 

issuance of the replacement certificate. 

Nonpayment of this fee would not result 

in the revocation of the laboratory’s 

certificate; however, a replacement 

certificate would not be issued. 

The calculations used to determine 

the proposed fee amounts for 

replacement certificates, and revised 

certificates were based on the time, and 

the average state unit costs for 2019 

when these fees were set. When these 

calculations were made, the national 

average unit hourly cost in 2019 was 

$72.06. It was determined that it took 

state agency personnel approximately 

45 minutes to receive, review, and enter 

a request for a replacement certificate 

and another 15 minutes to print and 

mail the certificate. The cost of the 

replacement certificate is calculated to 

cost the CLIA program $75.00. This cost 

is rounded up ($72.06 to $75.00) to 

adjust for the time period needed to 

finalize the rule. 

Furthermore, CMS determined that 

additional state agency resources are 

expended when issuing revised 

certificates as follows: 

• An additional 20 minutes to review 

and enter requested demographic 

changes or $20.00 for revised CoWs and 

CoAs. 

• An additional 45 minutes to review 

and enter requested laboratory director 

changes or specialty changes for $55.00 

for revised CoRs and CoCs. 

These additional costs are therefore 

reflected in the proposed fees for issuing 

revised certificates. (See Table 4) 

D. Proposed Changes to Fees Applicable 

to Laboratories Issued a CoC (§ 493.643) 

At § 493.643, we are proposing to 

rename the section heading ‘‘Fee for 


khammond on DSKJM1Z7X2PROD with PROPOSALS3EP26JY22.129</GPH>

TABLE 4: CMS Proposed Fee for Issuance of Revised Certificate 

Certificate Type Fee 

cow $95.00 

CoA $95.00 

CoR $150.00 

CoC $150.00 

PPM $150.00 
Federal Register / Vol. 87, No. 142 / Tuesday, July 26, 2022 / Proposed Rules 44905 

8https://www.cms.gov/Regulations-andGuidance/Guidance/Manuals/Downloads/ 

som107ap_c_lab.pdf. 

determination of program compliance’’ 

to ‘‘Additional fees applicable to 

laboratories issued a certificate of 

compliance’’ for clarification. 

We are proposing to add language at 

§ 493.643(b) to describe the costs 

included in the fee for routine 

inspections to increase transparency. 

We are proposing to delete the second 

sentence of § 493.643(b) in 

consideration of a two-part biennial fee 

increase as discussed under section II.H. 

(§ 493.680) of this proposed rule. For 

clarity, we are proposing to redesignate 

the third sentence of the current 

provision at § 493.643(b) as § 493.643(c). 

At the new provision § 493.643(c)(1), 

we are proposing that the inspection fee 

will be based on the schedules of the 

laboratories as defined in the new 

provision under § 493.638(c)(3). The fee 

amounts assigned to the schedules in 

the February 1992 final rule were based 

on an estimated number of hours to 

perform a survey of a laboratory with 

the scope and volume associated with 

each schedule multiplied by an 

estimated 1992 hourly rate for a 

surveyor of $35.00. The established 

hourly rate of $35.00 was intended to be 

used as a baseline and then revised after 

actual data were collected and 

experience gained (57 FR 7193). In 1992 

it was anticipated that the universe of 

regulated laboratories would be much 

greater than those regulated prior to the 

implementation of CLIA ‘88. 

The hourly rate for performing 

laboratory surveys is recalculated by 

CMS for each state annually to 

determine the CLIA obligation to 

support the state survey agencies but 

has not been used to increase CLIA fees 

on an ongoing basis. The national 

average hourly rate in 2019 was $72.06. 

A description of the national average 

hourly rate calculation is provided in 

section II.C. of this proposed rule. 

Extensive data collected over time 

now enables us to better estimate the 

number of hours it takes for a surveyor 

to perform an inspection of a laboratory 

within each schedule. Such estimates 

are primarily driven by the scope and 

volume of tests run by the laboratory 

and the laboratory’s compliance with 

the CLIA regulations. A laboratory with 

a high-test volume and multiple 

specialties may have processes and 

practices that allow it to meet and 

exceed CLIA regulations as they operate 

with a high degree of quality and 

efficiency while ensuring reported 

results are accurate and timely to 

provide optimum patient care. The 

surveyor will likely spend less time on 

inspecting that laboratory. In contrast, if 

a laboratory with a small test volume 

and few specialties does not have 

processes and practices that allow it to 

operate with the same high degree of 

quality and efficiency, such a laboratory 

is likely not to meet the CLIA 

requirements. Such laboratories may be 

reporting test results that may not be 

accurate and reliable. While the test 

volume may be low, the surveyor will 

likely spend additional time surveying 

such laboratories due to the less-thanoptimal operations and processes. 

Conversely, the number of hours 

needed to survey a large laboratory with 

poor compliance history could be quite 

large. The surveyor would spend more 

time in this laboratory, given the size 

and poor compliance history, the 

surveyor would review the prior survey 

deficiencies to ensure the laboratory’s 

monitors put into place have corrected 

the deficiency. In contrast, a surveyor 

may not need to spend as many hours 

to survey a laboratory with lower test 

volume and specialties but a favorable 

compliance history. Taking each 

scenario into account, we believe the 

average number of hours a surveyor 

spends in each laboratory reflects the 

universe of laboratories within each 

schedule. Thus, we will not be changing 

the differences between the amounts of 

the fees within the compliance fee 

schedules relative to each other. They 

will remain in their relative amounts 

and be increased across the board by the 

same percentage in the proposed twopart fee increase (section II.H. 

(§ 493.680) of this proposed rule). 

Table 5 illustrates the different 

scenarios mentioned previously in this 

proposed rule and how the number of 

hours spent on the survey vary based on 

both the size (the schedule) of the 

laboratory and poor compliance with 

the CLIA regulations. Poor compliance 

is being defined for this illustration as 

a laboratory with at least one conditionlevel deficiency cited during a survey. 

For information about condition-level 

deficiencies, please see the CLIA 

website for the Interpretive Guidelines 

for Laboratories, Appendix C: 

Interpretive Guidelines.8


khammond on DSKJM1Z7X2PROD with PROPOSALS3
44906 Federal Register / Vol. 87, No. 142 / Tuesday, July 26, 2022 / Proposed Rules 

For example, a large laboratory with 

good compliance in the column titled 

Condition Level Deficiencies not cited 

and row J. Additionally, for a mediumsized laboratory (schedules D–E) with 

no condition level deficiencies cited is 

15 hours and ranging to 79 hours. In 

contrast, the average number of hours 

spent on survey in small (schedules V– 

A) laboratories with condition level 

deficiencies was 18 and ranged to a high 

of 143 hours. In the largest (schedule J) 

laboratories, survey hours differed from 

an average of 32 hours spent in 

laboratories without condition level 

deficiencies compared to 75 hours in 

those laboratories that had condition 

level deficiencies cited. 

The February 1992 final rule did not 

consider other costs involved in the 

inspection process, such as continuous 

training of the state surveyors and 

monitoring of the state agency program 

processes by the CMS Locations 

(Regional Offices). The CLIA program 

has created and continuously updates 

periodic training for surveyors through 

online training modules, onsite 

meetings, and conference calls. 

The surveyors are individually 

monitored with a Federal Monitoring 

Survey (FMS) process where CMS 

location (Regional Office) Federal 

surveyors observe the individual state 

surveyor on a survey or perform a 

survey of the same laboratory after the 

state surveyor has completed their 

survey to confirm that the state surveyor 

is competent and following the 

prescribed survey process. The CMS 

locations (Regional Offices) also perform 

an annual State Agency Performance 

Review (SAPR) for each state survey 

agency, including a review of the state 

survey agency’s training processes and 

monitoring processes for their state 

surveyors. This includes a review of the 

deficiency reports state surveyors have 

sent to laboratories to determine that the 

surveyor is following the program’s 

principles of documentation and the 

proper survey process. 

There are also costs to the program to 

maintain a computerized system for 

entering inspection findings and 

compliance monitoring, including 

proficiency testing. The computer 

system also allows the CMS locations to 

run reports to monitor the inspections 

entered by the state surveyors. 

The compliance fees have historically 

been based on the costs to the CLIA 

program for the State agencies. These 

aforementioned activities are obligations 

outside of the state survey agency 

annual budgets. We are therefore 

proposing that the determination of 

inspection fees for laboratories in each 

schedule and state will no longer be 

determined solely by the estimated 

hours spent on a survey of a laboratory 

within each schedule nor by the 

surveyor hourly rate of $35.00 

established in 1992. 

We believe that the compliance fees 

currently set within the schedules 

should continue to be used but that 

additional fees, as previously described, 

should be added to the regulatory 

scheme. All fees would be increased 

biennially following the biennial twopart fee increase as proposed in this rule 

in § 493.680. 

We believe we are authorized to base 

these fees per laboratory schedule (or 

group) even though the fees will no 

longer be determined solely by the 

estimated hours spent on a survey of a 

laboratory within each schedule nor by 

the 1992 surveyor hourly rate of $35.00 

based on section 353(m)(3)(C) of the 

PHSA, which states that, fees shall vary 

by group or classification of laboratory, 

based on such considerations as the 

Secretary determines are relevant, 

which may include the dollar volume 

and scope of the testing being performed 

by the laboratories. We believe our 

proposals are within the bounds of our 

authority under the PHSA. 

At § 493.643(c)(2), we are proposing 

to redesignate language from the current 

§ 493.643(b) which states the fees are 

assessed and payable biennially. We 

believe this will support the two-part 

fee increase proposed in this rule and 

described in § 493.680. 

At the new provision § 493.643(c)(3), 

we are proposing that the fee amount 

would be the amount applicable to a 

given laboratory increase listed in the 

most recent published CLIA fee increase 

notice in the Federal Register. 

We are proposing to redesignate 

current § 493.643(d)(1) and (2) where 

additional fees for CoC laboratories are 

discussed at § 493.643(d)(2) and (3) and 

redesignate the fourth and fifth 

sentences of current provision 

§ 493.643(b) where an additional fee for 

a follow-up survey on a CoC laboratory 

is discussed as a new provision at 

§ 493.643(d)(1). We believe the 

discussion of additional fees for CoC 

laboratories should be grouped together. 

We are proposing to move the current 

regulatory text at § 493.643(d)(2) to 

§ 493.643(d)(3) with no changes. Current 

regulation allows additional fees to be 

assessed for substantiated complaints; 

however, this has not been 

implemented. This proposed rule would 


khammond on DSKJM1Z7X2PROD with PROPOSALS3EP26JY22.130</GPH>

TABLE 5: Survey Hours with Condition Level Deficiencies Cited vs. Not Cited by 

Schedule Code 

Condition Level Deficiencies not cited Condition Level Deficiencies cited 

Schedule code Range of hours Range of hours required 

of Number of required to perform Number of to perform the 

laboratories laboratories** the individual surveys laboratories** individual surveys and 

that were and the average (avg) the average (avg) 

surveyed* number hours** number of hours** 

V-A 3,446 4 - 69 (avg: 12) 661 5 - 143 (avg: 18) 

B-C 1,328 4 - 69 (avg: 13) 320 7 - 123 (avg: 19) 

D-E 972 4 - 79 (avg: 15) 261 6 - 201 (avg: 23) 

F-G 727 5 - 165 (avg: 18) 192 6 - 378 (avg: 30) 

H-1 935 5 - 284 (avg: 21) 279 7 - 497 (avg: 41) 

J 110 8 - 213 (avg: 32) 23 8 - 378 (avg: 75) 

*For a descnptlon of the schedules see the sect10n of this docwnent with the proposed amendments to 42 CFR chapter IV, 

specifically provision § 493.638( c ). The schedules have been grouped as two schedules together to keep the size of the table 

to a minimwn. We are not proposing to change the schedules this way. 

**The data comes from the SAS Viya system for surveys completed between 10-01-2017 and 09-30-2019 with condition level 

deficiencies not cited versus condition level deficiencies cited and separated by schedule codes. 
Federal Register / Vol. 87, No. 142 / Tuesday, July 26, 2022 / Proposed Rules 44907 

implement fees for substantiated 

complaints, meaning those complaints 

where the allegations against the 

laboratory were found to be true by 

CMS. We believe implementing the fee 

for substantiated complaints would 

cover the costs required to perform such 

a survey, including documenting the 

deficiencies found to be violated, 

preparing a report for the laboratory, 

and review of the laboratory’s plan of 

correction and monitoring their 

correction. The fee is proposed to be 

limited to the cost of the actual time and 

resources required for these activities. 

At new provision § 493.643(d)(4), we 

are proposing to establish an additional 

fee for certificates of compliance that are 

found to have unsuccessful PT through 

a PT desk review. Current policy 

requires the review of PT performance 

every 30–45 days for each laboratory 

with a CoC that performs testing and is 

enrolled in PT for an analyte or test 

included in subpart I. Cases of 

unsuccessful PT performance require a 

PT desk review to confirm. Upon 

confirmation, the laboratory is notified 

of its regulatory requirement to 

investigate and correct the unsuccessful 

PT performance. Currently, such PT 

desk reviews do not generate an 

additional fee; however, conducting the 

desk review requires surveyor time and 

resources. We believe this new fee 

would cover the costs of the desk 

review, including documenting the 

deficiencies found to be violated, 

preparing a report for the laboratory, 

and reviewing the laboratory’s plan of 

correction and monitoring their 

correction. The fee is proposed to be 

limited to the cost of the actual time and 

resources required for these activities. 

As with the other fees listed in this 

section, only laboratories with 

unsuccessful PT performance would be 

impacted if this rule is finalized. The 

fees in this section must be paid, or 

HHS will revoke the laboratory’s CoC. 

E. Proposed Changes to Additional Fees 

Applicable to Laboratories Issued a 

CoA, CoW, or Certificate for PPM 

Procedures (§ 493.645) 

At § 493.645, we are proposing to 

change the current section heading 

(‘‘Additional fee(s) applicable to 

approved State laboratory programs and 

laboratories issued a certificate of 

accreditation, certificate of waiver, or 

certificate for PPM procedures’’) to 

clarify the contents of the section as 

amended. The proposed title would be 

‘‘Additional fees applicable to 

laboratories issued a certificate of 

accreditation, certificate of waiver, or 

certificate for PPM procedures.’’ 

We are proposing to move in its 

entirety the regulatory text regarding 

fees for CLIA-exempt laboratory fees by 

state laboratory programs in 

§ 493.645(a)(1) through (3) to 

§ 493.649(a)(1) through (3). We believe 

the fees for approved state laboratory 

programs should be listed separately 

from the other CLIA-certified 

laboratories in the regulations. A state 

laboratory program is a laboratory 

program that HHS approves as exempt 

due to the state requirements being 

equal to or more stringent than the CLIA 

requirements. Under such programs, the 

state provides regulatory oversight of its 

laboratories in lieu of such laboratories 

regulated by HHS. HHS approves and 

monitors such state laboratory programs 

to ensure standards of the state 

laboratory programs are and remain at 

least as stringent as the CLIA 

regulations. HHS does not issue fees to 

laboratories covered by these programs 

but charges a fee to the program as 

described in the new provision at 

§ 493.646. 

We are also proposing to make 

editorial corrections to the references of 

§§ 493.645(a) and 493.646 noted in 

§§ 493.557(b)(4) and 493.575(i) and 

replacing those references with 

§§ 493.649(a) and 493.655(b). The 

requirements previously included at 

§§ 493.645(a) and 493.646(b) governing 

applicable fees are proposed to be 

redesignated as § 493.649(a) and new 

§ 493.655(b). 

We are further proposing to 

redesignate current § 493.645(b)(1) and 

(2) regarding the payment of inspection 

fees as new § 493.645(a)(1) and (2). We 

are proposing new § 493.645(a)(1) to 

clarify the amount accredited 

laboratories pay for their inspection 

(validation survey) fees by removing the 

last sentence of the current regulatory 

text, which reads that these costs are the 

same as those that are incurred when 

inspecting nonaccredited laboratories. 

We believe this does not fully explain 

how the fee is determined. This fee is 

based on fees that CoC laboratories pay 

for compliance inspections; however, an 

accredited laboratory is only assessed 5 

percent of the fee a CoC laboratory pays 

because only 5 percent of CoA 

laboratories are inspected (undergo a 

validation survey) annually. For 

example, a CoC laboratory classified as 

‘‘schedule D’’ pays an average biennial 

compliance fee of $2,336.00. The 

accredited laboratory classified as 

‘‘schedule D’’ would pay an average 

biennial inspection (validation survey) 

fee of $117.00. 

At new § 493.645(a)(2), we are 

proposing to redesignate the provision 

from current § 493.645(b)(2), with no 

changes. This provision established an 

additional fee if a laboratory issued a 

CoA were to be inspected and follow-up 

visits were necessary because of 

identified deficiencies. Historically this 

fee had not been implemented due to 

technical difficulties described 

previously in this rule. We are 

proposing that it be implemented 

through this proposed rule. As stated in 

the current regulatory text, the 

additional fee to cover the cost of these 

follow-up visits would be based on the 

actual resources and time necessary to 

perform the follow-up visits. Also, as 

stated in the regulatory text, HHS would 

revoke the laboratory’s CoA for failure 

to pay the fee. 

At new § 493.645(b), we are proposing 

to redesignate the provision from 

current § 493.645(c). This provision 

established a fee for substantiated 

complaint surveys, those in which the 

allegations against the laboratory were 

found to be true, on CoA, CoW, or 

certificate for PPM procedures 

laboratories. Historically, this fee has 

not been implemented. We believe 

implementing the fee for substantiated 

complaints would cover the costs 

required to perform such a survey, 

including documenting the deficiencies 

found to be violated, preparing a report 

for the laboratory, and review of the 

laboratory’s plan of correction and 

monitoring their correction. The fee is 

limited to the actual time and resources 

required for these activities. 

F. Proposed Changes to Additional Fees 

Applicable to Approved State 

Laboratory Programs (§ 493.649) 

At § 493.649, we are proposing to 

delete the current language in its 

entirety and replace it with language 

from § 493.645(a)(1) through (3). The 

current provision at § 493.649 would no 

longer be needed as the methodology for 

determining inspection fees in this 

proposed rule is no longer based on a 

surveyor hourly rate. At new § 493.649, 

we are proposing to revise the current 

section heading (‘‘Methodology for 

determining fee amount’’) to give a clear 

meaning of the contents of the section 

as amended. The proposed title is 

‘‘Additional fees applicable to approved 

State laboratory programs.’’ We are 

proposing to replace the current 

language with current provisions 

§ 493.645(a)(1) through (3) with minor 

changes (removing ‘‘costs of’’ from 

current 493.469(a)(3)). The provisions at 

§ 493.645(a)(1) through (3) outline the 

fees applicable to approved state 

laboratory programs and have been 

comingled with the provision that 

outlines the fees for accredited PPM and 

CoW laboratories. We believe separating 


khammond on DSKJM1Z7X2PROD with PROPOSALS3
44908 Federal Register / Vol. 87, No. 142 / Tuesday, July 26, 2022 / Proposed Rules 

9 60 FR 20047, April 24, 1995 (https://

www.govinfo.gov/content/pkg/FR-1995-04-24/pdf/ 

95-9953.pdf#page=13). 

10 68 FR 3640, January 24, 2003 (https://

www.govinfo.gov/content/pkg/FR-2003-01-24/pdf/ 

03-1230.pdf). 

this provision from the other laboratory 

certificate types will allow for improved 

readability and understanding. 

G. Proposed Changes to Payment of Fees 

(§§ 493.646 and 493.655) 

At § 493.646, we are proposing to 

redesignate the current provision with 

minor changes corresponding to the 

validation survey cost as new § 493.655 

and including a reference to § 493.563 

that contains the validation inspection 

information. We believe this provision 

which outlines the payment of fees, is 

better placed after discussions of the 

different types of fees. 

We are proposing to redesignate 

§ 493.646(a) and (b) where the payment 

of fees is discussed to new provisions at 

§ 493.655(a) and (b) with a minor 

change referencing approved state 

laboratory programs instead of stateexempt laboratories. The state program 

pays CMS, not the individual 

laboratories. 

H. Proposed Methodology for 

Determining the Biennial Fee Increase 

(§ 493.680) 

At new provision § 493.680, we are 

proposing the biennial two-part fee 

increase, which would be calculated as 

described in section I.B. of this 

proposed rule and published as a notice 

with a comment period at least 

biennially. Should the off-year of the 

biennial increase result in unexpected 

program obligations, CMS may need to 

calculate an interim fee increase based 

on either the CPI–U or difference in 

obligations and total collected fees or a 

combination of both. All fees, existing 

and proposed, mentioned in this 

proposed rule would also be subject to 

the biennial two-part fee increase. 

III. Provisions of the Proposed 

Regulations for CLIA Requirements for 

Histocompatibility, Personnel, and 

Alternative Sanctions for CoW 

Laboratories 

This section provides an overview of 

the proposed revisions to the CLIA 

requirements for histocompatibility and 

personnel and application of alternative 

sanctions for CoW laboratories 

originally established by the 1992 final 

rule with comment period (57 FR 7002), 

subsequently modified in 1995 9 and 

2003,10 and currently specified in 

subpart A—General Provisions, subpart 

K—Quality System for Nonwaived 

Testing, subpart M—Personnel for 

Nonwaived Testing, and subpart R— 

Enforcement Procedures. 

A. Proposed Changes to 

Histocompatibility Requirements 

1. General, Human Leukocyte Antigen 

(HLA) Typing, Disease-Associated 

Studies, and Antibody Screening and 

Identification (§ 493.1278(a) Through 

(d)) 

At § 493.1278(a)(1), we are proposing 

to amend the requirement by changing 

‘‘an audible alarms system’’ to ‘‘a 

continuous monitoring and alert 

system’’ because this allows the 

laboratories more flexibility in 

determining the best way to monitor 

refrigerator temperatures. It is very 

important to monitor temperatures 

continuously, so that recipient and 

donor specimens and reagents are stored 

at the appropriate temperature to ensure 

accurate and reliable testing. 

At § 493.1278(a)(2), we are proposing 

to modify the requirement by expanding 

the regulatory language to include that 

the laboratory must establish and follow 

written policies and procedures for the 

storage and retention of patient 

specimens based on the specific type of 

specimen because the type and duration 

of specimen storage are equally 

important as ease of retrieval. We are 

retaining the requirement that stored 

specimens must be easily retrievable. 

At § 493.1278(a)(3), we are proposing 

to delete the labeling requirement for inhouse prepared typing sera reagent 

requirement. If a laboratory is 

performing histocompatibility testing, 

this requirement under the general 

reagent labeling requirements for all test 

systems must be met under 

§ 493.1252(c) and, therefore, is 

duplicative. 

At § 493.1278(a)(4), we are proposing 

to revise this requirement by removing 

the examples (that is, antibodies, 

antibody-coated particles, or 

complement) to clarify that these 

technologies, as well as current and 

future technologies, are allowed for the 

isolation of lymphocytes or lymphocyte 

subsets. We are also proposing to clarify 

the requirement by adding 

‘‘identification’’ of lymphocytes, or 

lymphocyte subsets. In this type of 

testing, lymphocytes can be isolated, but 

the subsets (B-cells and T-cells) are 

identified rather than isolated. Due to 

these proposed changes, 

§ 493.1278(a)(4) would be under the 

proposed revision at § 493.1278(a)(3). 

The current requirement at 

§ 493.1278(a)(5) would be redesignated 

as § 493.1278(a)(4). This requirement 

remains unchanged. At § 493.1278(b)(1) 

through (3), we are proposing to delete 

these requirements pertaining to 

establishing HLA typing procedures. 

The requirement that the laboratory 

must establish and have written 

procedures that ensure quality test 

results are already addressed by the 

general requirements for all test systems 

under current § 493.1445(e)(1) and 

(e)(3)(i) and proposed change at 

§ 493.1278(f), respectively, and 

therefore, are duplicative. 

At § 493.1278(b), we are proposing to 

redesignate the provisions at paragraph 

(b)(4) to paragraph (b)(1). At newly 

redesignated paragraph (b)(1), we are 

proposing to delete the language that 

states potential new antigens not yet 

approved by this committee must have 

a designation that cannot be confused 

with WHO terminology because new 

alleles are approved monthly, which 

makes this requirement obsolete. 

At § 493.1278(b)(5)(i) through (iv), we 

are proposing to delete the requirements 

for preparation of cells or cellular 

extracts, selecting typing reagents, 

ensuring that reagents used for typing 

are adequate, and assignment of HLA 

antigens as they are already addressed 

by the general requirements for all test 

systems under §§ 493.1445(e)(1) and 

(e)(3)(i), 493.1251, and 493.1252, and 

therefore, are duplicative. 

At § 493.1278(b)(5)(v), we are 

proposing to modify the requirement to 

add ‘‘allele’’ and delete the ‘‘re’’ prefix 

in the word ‘‘retyping’’ in this 

paragraph. We propose inserting 

‘‘allele’’ because the regulation only has 

antigen typing, but there is typing done 

at the allele level. We are removing 

redundancy by deleting the ‘‘re’’ prefix 

since CLIA already requires the 

laboratory to define frequency and 

criteria for performing typing under the 

proposed revision at § 493.1278(b)(2). 

At § 493.1278(b)(6)(i) through (iii), we 

are proposing to delete requirements 

procedures for HLA typing control 

materials procedures as they are 

addressed by the general requirements 

regarding quality control materials and 

procedures for all test systems under 

§ 493.1256(a) through (d) and (f) through 

(h), and therefore, are duplicative. 

At § 493.1278(c), we are proposing to 

delete this requirement for control 

procedures and materials regarding 

disease related studies because this is 

addressed by the general requirements 

for all test systems under §§ 493.1256(d) 

and 493.1451(b)(4), and therefore, is 

duplicative. 

At § 493.1278(d), we are proposing to 

change the name of this section from 

‘‘Antibody Screening’’ to ‘‘Antibody 

Screening and Identification’’ for 

clarification as both processes apply to 

histocompatibility testing. The 


khammond on DSKJM1Z7X2PROD with PROPOSALS3
Federal Register / Vol. 87, No. 142 / Tuesday, July 26, 2022 / Proposed Rules 44909 

provisions covered under this section 

apply to both screening and 

identification. The proposed change at 

§ 493.1278(a)(4) would be under our 

proposed § 493.1278(c). 

At § 493.1278(d)(1) through (3) and (5) 

through (7), we are proposing to delete 

these requirements for antibody 

screening laboratory procedures as they 

are addressed by the general 

requirements for all test systems under 

§§ 493.1445(e)(1) and (e)(3)(i), 493.1251, 

493.1252, and 493.1256, and therefore, 

are duplicative. 

2. Crossmatching and Transplantation 

(§ 493.1278(e) and (f)) 

At § 493.1278(e)(1) through (3), we are 

proposing to remove these three 

requirements regarding the laboratory 

having crossmatch procedures and 

controls as we believe the provisions to 

be removed are addressed by the general 

requirements for all test systems under 

§§ 493.1445(e)(1), 493.1251, 493.1256, 

and 493.1451(b)(4), and therefore, are 

duplicative. 

Since 1992, there have been important 

advances in the field of transplantation 

and histocompatibility. Based on 

comments received in response to the 

2018 RFI and stakeholder and CLIAC 

input, we understand the current 

regulations at § 493.1278 do not reflect 

the standard practice for laboratories 

performing testing in the specialty of 

histocompatibility and are viewed by 

the transplantation community as a 

barrier to modernized decision making 

approaches for organ acceptability. 

Additionally, we understand that the 

use of risk assessment and alternative 

immunologic assessment procedures are 

currently the standard practice for 

laboratories performing testing in the 

specialty of histocompatibility. 

Therefore, we are proposing to add the 

requirements summarized below, at 

§ 493.1278(d), to increase flexibility in 

the regulations and remove perceived 

barriers. These requirements include: 

• Defining donor and recipient HLA 

antigens, alleles, and antibodies to be 

tested; 

• Defining the criteria necessary to 

assess a recipient’s alloantibody status; 

• Assessing recipient antibody 

presence or absence on an ongoing 

basis; 

• Typing the donor at the serological 

level, to include those HLA antigens to 

which antibodies have been identified 

in the potential recipient, as applicable; 

• Describing the circumstances in 

which a pre- and post-transplant 

confirmation testing of donor and 

recipient specimens is required; 

• Making available all applicable and 

donor and recipient test results to 

transplant team; 

• Ensuring immunologic assessments 

are based on the test report results 

obtained from a test report from CLIA 

certified testing laboratory(ies); 

• Defining time limits between 

recipient testing and the performance of 

crossmatch; and 

• Requiring that the test report must 

specify what type of crossmatch was 

performed. 

At § 493.1278(f), we are proposing to 

change the words ‘‘transfusion’’ and 

‘‘transfused’’ to ‘‘infusion’’ and 

‘‘infused’’, respectively. The relevance 

of HLA testing and the decisions of the 

extent of testing in both a transplant and 

transfusion setting are critical to both 

organ and cell acceptance in the host 

recipient. The use of the word 

‘‘transfusion’’ is inappropriate given 

that the product itself is the transfusion 

but the action of introducing the 

product is the process of infusion. 

Transfusion is more specific to 

immunohematology. There are specific 

transfusion regulations in the 

immunohematology section at 

§ 493.1271 that should not be confused 

with histocompatibility requirements. 

Since histocompatibility addresses 

materials that are not always blood 

products, we believe the term 

‘‘infusion’’ would be more appropriate. 

This proposed change at § 493.1278(f) 

would be under the proposed revision at 

§ 493.1278(e). 

At § 493.1278(f)(1), we are proposing 

to revise this requirement to state that 

laboratories performing 

histocompatibility testing must establish 

and have written policies and 

procedures specifying the types of 

histocompatibility testing under the 

proposed regulation at § 493.1278(e). In 

addition, we are proposing to add 

‘‘identification’’ after ‘‘antibody 

screening’’ under our proposed revision 

at § 493.1278(c), as identification is an 

important part of the process for 

crossmatching. Finally, we are 

proposing to remove ‘‘compatibility 

testing’’ at § 493.1278(f)(1) because this 

activity is specific to 

immunohematology, and crossmatching 

is a more appropriate description of 

what we understand is the current 

histocompatibility procedure used by 

laboratories. The proposed change at 

§ 493.1278(f)(1) would be under our 

proposed § 493.1278(e). 

At § 493.1278(f)(1), we are further 

proposing to modify the current general 

requirement to specify that the 

laboratory must establish and follow 

written policies and procedures that 

address the transplant type (organ, 

tissue, cell) donor type (living, 

deceased, or paired) and recipient type 

(high risk vs. non-sensitized). The 

following terminologies were also 

updated to reflect current practices: 

‘‘cadaver donor’’ is replaced by 

‘‘deceased donor,’’ ‘‘transfused’’ is 

replaced by ‘‘infused,’’ and ‘‘combined’’ 

is replaced by ‘‘paired.’’ In addition, we 

believe that clarifying the current 

regulatory language allows the 

laboratories to make decisions based on 

existing technologies and practices for 

determining what testing is applicable 

for those transplant programs they 

serve. The proposed changes at 

§ 493.1278(f)(1) would be under the 

proposed revision at § 493.1278(e)(1). 

At § 493.1278(f)(2) through (3), we are 

proposing to remove these requirements 

for renal and nonrenal transplantation 

crossmatch procedures which are 

perceived as obstacles to current 

practices by the transplant community 

and would allow for alternative 

immunologic assessment procedures to 

be used in the designated specialty of 

histocompatibility. The requirement 

that the laboratory must establish and 

follow written policies and procedures 

test procedures are already addressed in 

the general requirements for all test 

systems under §§ 493.1445(e)(1) and 

(e)(3)(i), 493.1251, 493.1256(c) through 

(h), and 493.1451(b)(4) and therefore, 

are duplicative. In addition, we are 

adding a new requirement for pretransplant recipient specimens under 

the proposed § 493.1278(e)(3). Under 

this new proposed requirement, the 

laboratory must have written policies 

and procedures to obtain a recipient 

specimen for a crossmatch, or to 

document its efforts to obtain a recipient 

specimen, collected on the day of 

transplant. We recognize that the 

laboratory may not be able to obtain a 

recipient specimen collected on the day 

of a transplant since this collection 

process depends upon the physician 

obtaining the specimen and submitting 

it to the laboratory. 

At § 493.1278(f)(1)(ii), we are 

proposing to modify this requirement 

for laboratory policies and procedures 

as it would be included in the amended 

protocol requirements under the 

proposed regulation at 

§ 493.1278(e)(1)(i) and (iii), and 

therefore, would be duplicative. The 

proposed revised requirement reflects 

current practices in the 

histocompatibility community. 

At § 493.1278(f)(1)(iii), we are 

proposing to replace ‘‘the level of’’ with 

‘‘type and frequency’’ to clarify this 

revised requirement refers to the type 

and frequency of testing practice to 

support the clinical transplant 


khammond on DSKJM1Z7X2PROD with PROPOSALS3
44910 Federal Register / Vol. 87, No. 142 / Tuesday, July 26, 2022 / Proposed Rules 

protocols. We are also proposing to 

remove the examples of antigen and 

allele level in the regulation as these 

examples may not be all-inclusive and 

generally are reflected in guidance 

rather than regulatory text. The 

proposed change at § 493.1278(f)(1)(iii) 

would be under our proposed 

§ 493.1278(e)(2). 

The requirement at § 493.1278(g) 

would be redesignated as § 493.1278(f). 

This requirement remains unchanged. 

B. Proposed Changes to Personnel 

Requirements 

CMS recognizes that the COVID–19 

public health emergency (PHE) requires 

flexibility, and we are committed to 

taking critical steps to ensure America’s 

clinical laboratories can respond during 

a PHE to provide reliable testing while 

ensuring patient health and safety. As 

such, we request that the public provide 

comments regarding how the CLIA 

personnel requirements have affected 

the health system’s response to the 

COVID–19 PHE and any potential 

opportunities for improvement to such 

requirements. We welcome suggestions 

regarding potential improvements that 

may be specific to a pandemic or public 

health emergency context, as well as 

broader recommendations. 

1. Definitions (§ 493.2) 

a. Midlevel Practitioner 

At § 493.2, we are proposing to amend 

the definition of midlevel practitioner 

by adding a nurse anesthetist and 

clinical nurse specialist to the 

definition. CLIA currently defines a 

midlevel practitioner as a nurse 

midwife, nurse practitioner, or 

physician assistant. We agree with 

CLIAC’s recommendation to include 

nurse anesthetists and clinical nurse 

specialists in the definition of midlevel 

practitioner. We believe including nurse 

anesthetists and clinical nurse 

specialists in the definition will be 

inclusive of current types of mid-level 

practitioners. For example, the 

American Association of Nurse 

Anesthetists (https://www.aana.com/) 

scope of practice states that the practice 

may include performing point-of-care 

testing. If the regulations are too 

specific, some individuals may not 

qualify when they would have prior to 

the proposed change. 

b. Continuing Education (CE) Credit 

Hours 

At § 493.2, we are also proposing to 

add a definition for ‘‘Continuing 

education (CE) credit hours’’ to state 

that it means either continuing medical 

education (CME) or continuing 

education (CE) units. Generally, CME 

refers to continuing education credits 

earned by physicians (by which we 

mean doctors of medicine, osteopathy, 

or podiatric medicine). We propose that 

CE would be a broader term used for 

individuals seeking to qualify as 

laboratory directors who are not 

physicians. In the current CLIA 

regulations at § 493.1405(b)(2)(i), CME is 

considered as acceptable training or 

experience for individuals to qualify as 

a LD overseeing moderate complexity 

testing. 

As we are proposing in section III.B. 

of this proposed rule to require all 

individuals seeking to qualify as LD for 

both moderate and high complexity 

testing to have 20 CE credit hours, we 

believe we need to establish a more 

general term for purposes of the 

proposed requirement. As described 

below, the CE credit hours would cover 

all of the LD responsibilities defined in 

the applicable regulations and must be 

obtained prior to qualifying as a LD. For 

example, under proposed 

§ 493.1405(b)(2)(ii)(B), the 20 CE credit 

hours would be required to cover all of 

the LD responsibilities defined in 

§ 493.1407 (moderate complexity 

testing). 

The term CME was originally used 

because it was only required at 

§ 493.1405(b)(2)(i), which is a provision 

specifically related to doctors of 

medicine, osteopathy, or podiatry. We 

believe that including a definition for 

CE credit hours in the CLIA regulations 

will respect that historic use, afford a 

means of referring to a broader range of 

professionals, and alleviate confusion 

between the terms. 

c. Doctoral Degree 

At § 493.2, we are proposing to add a 

definition for ‘‘doctoral degree’’ to state 

that it means an earned postbaccalaureate degree with at least 3 

years of graduate-level study that 

includes research related to clinical 

laboratory testing or advanced study in 

clinical laboratory science or medical 

technology. Originally, degrees were 

given in medical technology; however, 

the naming convention for medical 

technology degrees has changed since 

the regulations were first published in 

the 1992 final rule with comment 

period. The degree is now referred to as 

clinical laboratory science. A clinical 

laboratory science degree is 

synonymous with a medical technology 

degree. For purposes of 42 CFR part 493, 

doctoral degrees would not include 

doctors of medicine (MD), doctors of 

osteopathy (DO), doctors of podiatry, 

doctors of veterinary medicine (DVM), 

or honorary degrees. 

We are proposing this modification to 

CLIA regulations to clarify what we 

mean by the term ‘‘doctoral degree.’’ It 

seems this general term has created 

confusion as various stakeholders have 

asked us the following questions. 

• Are doctors of medicine degrees 

considered to be a type of doctoral 

degree? 

• Does a doctoral degree include 

traditional (for example, Doctor of 

Philosophy (Ph.D.), doctorate in science 

(DSc)) and professional (for example, 

Doctorate in Clinical Laboratory Science 

(DCLS)) degrees or does doctoral degree 

only mean a Ph.D.? 

The CLIA regulations for personnel 

qualifications separate doctors of 

medicine, osteopathy, and podiatry 

from other non-medical doctoral degrees 

by including specific qualification 

requirements for these three types of 

degrees. MD and DO degrees pertain to 

post-graduate level education, 

specifically in medicine, and are 

associated with treating illnesses and 

medical conditions. In contrast, doctoral 

degrees can be obtained in various fields 

like biology and chemistry. Historically, 

we intended a doctoral degree to mean 

a Ph.D. in a science field related to 

laboratory work. However, we have 

come to understand that our doctoral 

degrees could be interpreted more 

broadly to include both traditional and 

professional doctoral degrees. Doctoral 

degree is a general term used to describe 

post-graduate level education for 

various non-medical specific degrees 

and includes both traditional (for 

example, Ph.D., DSc) and professional 

(for example, DCLS) degrees. A 

traditional earned doctoral degree is 

generally focused on research and may 

include academic coursework and 

professional development. In contrast, a 

professional earned doctoral degree 

emphasizes specific skills and 

knowledge for success in a particular 

profession without a concentrated focus 

on research. For example, the DCLS is 

an advanced professional doctorate 

designed for practicing clinical 

laboratory scientists (CLSs) or medical 

technologists (MTs) who have at least a 

bachelor’s degree and wish to further 

their level of clinical expertise and 

develop leadership and management 

skills. Individuals with a DCLS are 

experts in clinical laboratory testing. 

Individuals must have a bachelor’s 

degree in medical technology or clinical 

laboratory science and the requisite 

experience in order to be admitted to a 

DCLS graduate program. The DCLS 

contributes to increasing laboratory 

efficiency and improves timely access to 

accurate and appropriate laboratory 

information. A graduate of a DCLS 


khammond on DSKJM1Z7X2PROD with PROPOSALS3
Federal Register / Vol. 87, No. 142 / Tuesday, July 26, 2022 / Proposed Rules 44911 

11https://www.cms.gov/regulations-andguidance/guidance/manuals/downloads/ 

som107c06pdf.pdf. 

program will be able to: provide 

appropriate test selection and 

interpretation of test results; monitor 

laboratory data and testing processes; 

improve the quality, efficiency, and 

safety of the overall diagnostic testing 

process; and direct laboratory 

operations to comply with all state and 

Federal laws and regulations. We would 

consider a DCLS an acceptable doctoral 

degree. 

For the purposes of qualifying under 

the CLIA personnel regulations, we do 

not consider a MD or DO to be the same 

as a non-medical doctoral degree. 

Therefore, these individuals must 

continue to qualify under the applicable 

CLIA personnel regulations, that is, MDs 

and DOs must qualify under doctors of 

medicine or osteopathy requirements. 

Those individuals with non-medical 

doctoral degrees as outline above must 

qualify under the doctoral degree 

requirements. If finalized, the State 

Operations Manual (SOM) 11 will be 

updated accordingly. 

The CLIA regulations aim to ensure 

accurate and reliable testing on 

specimens derived from the human 

body for the purposes of providing 

information for the diagnosis, 

prevention, or treatment of any disease 

or impairment of, or the assessment of 

health of human beings. Therefore, we 

believe that DVM should be removed 

from the qualifying doctoral degrees as 

it is not relevant to testing on specimens 

derived from the human body. We 

understand many of the methodologies 

may be the same; however, testing on 

human specimens is clearly specified in 

the statutory language and regulatory 

definition of a laboratory under CLIA. 

Therefore, testing of animal specimens 

does not meet the intent of the CLIA 

regulations. Of the nine boards 

approved by HHS for qualification of 

applicants with doctoral degrees, only 

one allows individuals with DVMs to sit 

for board certification. Since 1965, 

American Board of Medical 

Microbiology has granted certification to 

four individuals. Individuals who have 

previously qualified under a provision 

requiring a doctoral degree will 

continue to qualify under the new rule, 

if finalized. If finalized, we would 

remove the reference to DVMs in the 

SOM, Chapter 6 (that is, Interpretive 

Guidelines) under § 493.1443(b)(3) (page 

353). 

Finally, as discussed above, we are 

proposing that a doctoral degree must be 

an earned post-baccalaureate degree 

with at least three years of graduatelevel study that includes research 

related to clinical laboratory testing or 

advanced study in clinical laboratory 

science or medical technology. As such, 

honorary degrees do not meet the intent 

of a qualifying doctoral degree as an 

individual has not completed the 

necessary course and laboratory work 

required for the post-baccalaureate 

degree or necessary to ensure quality 

testing, for example, accurate and 

reliable results. We believe that 

qualifying individuals who hold only 

honorary degrees is not consistent with 

the public health purposes of the CLIA 

statute. Furthermore, we believe that 

this would impede CMS’ ability to 

ensure health and safety of the public 

and individuals served by CLIAcertified laboratories. 

d. Training and Experience 

At § 493.2, we are proposing to add a 

definition for ‘‘Laboratory training or 

experience’’ to state that it means that 

the training or experience must be 

obtained in a facility that meets the 

definition of a laboratory under § 493.2 

and is not excepted from CLIA under 

§ 493.3(b). Laboratory subject to CLIA 

would mean the laboratory meets the 

definition of a ‘‘laboratory’’ under 

§ 493.2. Training and experience 

obtained in a research laboratory that 

only reports aggregate results or a 

forensic laboratory does not meet this 

definition. These types of facilities are 

exempt from CLIA under § 493.3(b), and 

as such, training and experience 

acquired in these facilities is not 

applicable to CLIA laboratories. 

In all situations, an individual is 

required to meet training and/or 

experience requirements in addition to 

the educational requirements to 

competently perform their regulatory 

responsibilities. Because the CLIA 

personnel requirements for nonwaived 

testing are based on the complexity of 

testing performed (moderate versus 

high), we conclude that appropriate 

training and experience is necessary. 

Comments from the 2018 RFI support 

this proposal. Comments received from 

the 2018 RFI include the following: 

• Training and or experience should 

be in a CLIA certified laboratory. 

• Research experience is not 

equivalent to clinical experience. 

• Dependent on complexity level of 

testing, minimum standards should 

increase as the complexity level 

increases. 

Further, commenters stated that 

documentation from a former employer 

would be acceptable, provided it 

included specific details of the 

individual’s job description, training 

and CA for areas of testing performed. 

This documentation could be from an 

LD, manager or supervisor. 

We concur with the CLIAC 

recommendation that all personnel 

should have training and experience in 

their areas of responsibility as listed in 

CLIA for the appropriate test complexity 

as shown in Table 6. which shows the 

specific personnel categories that have a 

provision requiring training or 

experience, or both, or require 

experience directing or supervising, or 

both. 


khammond on DSKJM1Z7X2PROD with PROPOSALS3EP26JY22.131</GPH>

TABLE 6: Personnel Requirements by Test Complexity for Proposed Personnel 

Changes that Require Training or Experience, or Both 

CLIASection Role Com lexit 

Laborato director Moderate 

Technical consultant Moderate 

Moderate 

493.1451 

493.1495 
44912 Federal Register / Vol. 87, No. 142 / Tuesday, July 26, 2022 / Proposed Rules 

12https://www.cms.gov/Regulations-andGuidance/Legislation/CLIA/Downloads/ResearchTesting-and-CLIA.pdf. 

This means personnel should have 

training or experience examining and 

performing tests on human specimens 

for the purpose of providing information 

that is used in diagnosing, treating, and 

monitoring an individual’s condition. 

Each individual must have 

documentation of training or experience 

applicable to the types and complexity 

of testing performed. This training 

should be such that the individual can 

demonstrate that he or she has the skills 

required for proper performance of preanalytic, analytic, and post-analytic 

phases of testing. For example, if the 

individual performs blood gas testing on 

a nonwaived point-of-care device, 

demonstration of skills should include, 

but is not limited to, the following: 

• Proper specimen collection, 

handling and labelling; 

• Proper test performance according 

to the laboratory’s policies and 

manufacturer’s instructions; 

• Verification of performance 

specifications; 

• Calibration and preventive 

maintenance; 

• Proficiency testing; and 

• Proper reporting of patient test 

results. 

Training may include, but is not 

limited to, attendance at: 

• Seminars given by experts in the 

field; 

• On-site or off-site instrument 

trainings given by a manufacturer; 

• Technical training sessions, 

workshops, or conferences given by a 

professional laboratory organization; or 

• A formal laboratory training 

program. 

Documentation may consist of, but is 

not limited to: 

• Letters from training programs or 

employers. 

• Attestation statements of an 

individual’s training and experience by 

the LD. 

• Log sheet(s) initialed by the 

attendees indicating attendance at a 

training session or in-service. 

• Certificates from organizations 

providing the training session, 

workshop, conference, specialty course. 

We expect all documentation 

supporting an individual’s education, 

training and experience to be 

independently generated, that is, not 

authored by the individual who is trying 

to meet CLIA personnel qualification 

requirements. For example, a 

curriculum vitae (CV) is not acceptable 

verification, in and of itself, to 

document an individual’s education, 

training or experience. Letters on 

letterhead from previous employment, 

competency assessment, and 

comprehensive list of job 

responsibilities may be examples of 

acceptable documentation. 

Laboratory testing of non-human 

specimens is not acceptable experience, 

for example, environmental, animal 

testing, as it is not used for the purpose 

of providing information used in the 

diagnosis, prevention, or treatment of 

any disease or impairment of, or the 

assessment of the health of, human 

beings. 

Many comments received on the 2018 

RFI stated that experience from a 

research laboratory should not be 

accepted. Depending on the 

circumstances, research testing can be 

either exempt from CLIA or subject to 

CLIA. Specifically, research laboratories 

that test human specimens but do not 

report patient specific results for the 

diagnosis, prevention or treatment of 

any disease or impairment of, or the 

assessment of the health of individual 

patients are excepted from the CLIA 

regulations at § 493.3(b)(2). In 

accordance with that regulation, only 

those facilities performing research 

testing on human specimens that do not 

report patient-specific results may 

qualify to be exempt from CLIA 

certification.12 An example of a 

nonpatient-specific result would be ‘‘10 

out of 30 participants were positive for 

gene X.’’ The result in this example is 

a summary of the group data, and is not 

indicative of an individual’s health. An 

example of a patient- specific result 

would be ‘‘participant A was positive 

for gene X’’ in which the result is 

specific to participant A. In cases where 

patient-specific test results are 

maintained by a statistical research 

center for possible use by investigators 

in which the results are not reported out 

as patient-specific and could not be 

used ‘‘for the diagnosis, prevention, or 

treatment of any disease or impairment 

of, or the assessment of the health of, 

human beings,’’ CLIA would not apply. 

Research testing where patientspecific results are reported from the 

laboratory, and those results will be or 

could be used ‘‘for the diagnosis, 

prevention, or treatment of any disease 

or impairment of, or the assessment of 

the health of, human beings’’ are subject 

to CLIA. Therefore, we would consider 

research experience related to reporting 

patient-specific results as applicable 

experience to meet the CLIA personnel 

requirements; however, if the research 

experience only includes aggregate 

reporting of results, we would not 

consider this acceptable experience to 

meet CLIA personnel requirements as 

this type of research testing is exempt 

from CLIA (§ 493.3(b)(2)). 

CLIA regulations at § 493.3(b)(1) 

specifically exempt facilities or 

components of facilities that only 

perform testing for forensic purposes are 

not subject to CLIA requirements. This 

was addressed in a Survey and 

Certification policy memo (S&C–08–35) 

published on September 5, 2008 

(https://www.cms.gov/Medicare/ 

Provider-Enrollment-and-Certification/ 

SurveyCertificationGenInfo/Policy-andMemos-to-States-and-Regions.html). 

(See the preamble to the 1992 final rule 

with comment period for an important 

discussion concerning this subject (57 

FR 7014).) 

In summary, laboratory results 

generated purely for the purpose of 

detecting illegal substances or illegal 

amounts of certain substances in the 

body may be relevant to legal 

proceedings. However, there is no 

concern in such testing for developing 

accurate and reliable data for use by 

health care professionals for the purpose 

of diagnosis or treatment. The 

determining factor is not the test itself, 

but the purpose for which the test is 

conducted. 

In addition, based on the CLIA law 

and its legislative history, forensic 

testing is excluded under CLIA since 

forensic testing is conducted to 

determine if there has been a violation 

of the law and is not done for the 

purpose for providing diagnosis, 

treatment or assessment of health. 

Therefore, we do not consider 

forensic testing to be acceptable 

experience or training as a means to 

meet CLIA personnel requirements as 

this type of testing is exempt from CLIA 

(§ 493.3(b)(3)). 

e. Experience Directing or Supervising 

At § 493.2, we are proposing to add a 

definition for ‘‘Experience directing or 

supervising’’ to state that it means that 

the director or supervisory experience 

must be obtained in a facility that meets 

the definition of a laboratory under 

§ 493.2 and is not excepted under 

§ 493.3(b). Experience directing or 

supervising a research laboratory that 

tests human specimens but does not 

report patient-specific results for the 

diagnosis, prevention, or treatment of 

any disease or impairment of, or the 

assessment of the health of individual 

patients would not meet this definition 

(for example, reporting of aggregate 

results). Experience directing or 

supervising any facility or component of 

a facility that only performs testing for 

forensic purposes also would not meet 

this definition. The ordering of tests and 

interpreting and applying the results of 


khammond on DSKJM1Z7X2PROD with PROPOSALS3
Federal Register / Vol. 87, No. 142 / Tuesday, July 26, 2022 / Proposed Rules 44913 

these tests in diagnosing and treating an 

individual’s illness would not meet this 

definition because it is not related to the 

performance of clinical laboratory 

testing. Ordering of tests and 

interpreting and applying of results falls 

under the practice of medicine and are 

not related to the performance of 

clinical laboratory testing. Teaching 

experience directly related to a medical 

technology or clinical laboratory 

sciences program, or a clinical 

laboratory section of a residency 

program, would be considered 

acceptable experience because we 

understand that such experience from 

teaching related to a medical technology 

or clinical laboratory sciences program 

would include all aspects of the entire 

testing process (pre-analytic, analytic 

and post-analytic), as well as quality 

control and quality assessment. These 

are critical responsibilities of a 

laboratory director as defined by CLIA. 

See discussion on proposed definition 

of ‘‘Laboratory training or experience’’ 

for more information on proposed 

treatment of research laboratories and 

forensic testing experience. 

2. PPM Laboratory Director 

Responsibilities (§ 493.1359) 

At § 493.1359, we are proposing to 

clarify the CA requirements for PPM 

laboratories in the Standard for PPM LD 

responsibilities, as this testing is 

moderate complexity per § 493.19(b)(2) 

and subject to CA. Based on the fact the 

regulations do not have a requirement 

for a TC for PPM laboratories, we 

believe that it is currently unclear in the 

regulation how CA applies to these 

types of laboratories. The SOM, 

Appendix C (that is, Interpretive 

Guidelines) on page 151 (https://

www.cms.gov/Regulations-andGuidance/Guidance/Manuals/ 

Downloads/som107ap_c_lab.pdf) 

discusses CA for PPM laboratories. 

Therefore, we are proposing to clarify, 

via modifications to this LD 

responsibilities section of the 

regulations, the CA requirement for 

PPM laboratories. We are proposing that 

the competency of all TP would be 

evaluated to ensure that the staff 

maintains their competency to perform 

test procedures and report test results 

promptly, accurately, and proficiently. 

This would include the following: 

• Direct observations of routine 

patient test performance, including 

patient preparation, if applicable, 

specimen handling, processing, and 

testing; 

• Monitoring the recording and 

reporting of test results; 

• Review of test results or 

worksheets; 

• Assessment of test performance 

through testing internal blind testing 

samples or external proficiency testing 

samples; and 

• Assessment of problem solving 

skills. 

Generally, these requirements mirror 

the CA provisions for moderate and 

high complexity testing at 

§§ 493.1413(b)(8) (TC responsibilities) 

and 493.1451(b)(8) (TS responsibilities). 

We are not proposing to include ‘‘Direct 

observation of performance of 

instrument maintenance and function 

checks’’ as the only equipment required 

for PPM testing is limited to bright-field 

and phase-contrast microscopy. 

Typically, TP do not perform these 

activities for PPM testing; rather, they 

are performed by third-party entities. 

In addition, we are proposing at 

§ 493.1359(d) the same CA intervals as 

in §§ 493.1413(b)(8) and 493.1451(b)(8) 

apply to mid-level practitioners for 

consistency. That is, evaluating and 

documenting the performance of 

individuals responsible for PPM testing 

at least semiannually during the first 

year the individual tests patient 

specimens. Thereafter, evaluations must 

be performed at least annually. 

3. Laboratory Director Qualifications 

(§ 493.1405) 

At §§ 493.1405(b)(1)(ii), 

493.1411(b)(1)(ii), 493.1443(b)(1)(ii), 

and 493.1449, we are proposing to 

remove ‘‘or possess qualifications that 

are equivalent to those required for such 

certification.’’ In making this proposal, 

we acknowledge that there are limited 

timeframes for an individual to sit for 

the boards, however, by allowing any 

such ‘‘eligible’’ individual to qualify 

under our regulations, we have found 

that some individuals may never sit for 

exams, or may even fail the exams. Such 

individuals were not who we intended 

to be eligible under these provisions. 

Further, even if we were to ban such 

individuals by carving them out of those 

we considered to hold ‘‘qualifications 

that are equivalent to those required for 

certification,’’ it would be difficult to 

identify those individuals and remove 

them from their LD roles. In making this 

proposal, we acknowledge having 

historically accepted letters from 

individuals that have documented proof 

from the American Board of Pathology 

or American Board of Osteopathic 

Pathology that they are eligible to sit for 

the boards based on SOM guidance 

(https://www.cms.gov/Regulations-andGuidance/Guidance/Manuals/ 

Downloads/som107ap_c_lab.pdf, page 

351, D6078). In addition, we propose to 

eliminate the equivalency standard, as 

we do not have a means to evaluate 

equivalency to other boards for 

equivalency to American Board of 

Pathology or American Board of 

Osteopathic Pathology as it would be up 

to the Board to make a determination of 

equivalency, and we do not believe in 

retrospect it would be appropriate to 

expect those entities to conduct such 

analyses. Furthermore, we had 

requested that CLIAC consider what 

‘‘possessing qualifications that are 

equivalent to board certification’’ 

should mean. CLIAC recommended that 

this verbiage be removed from relevant 

sections of subpart M because it was 

confusing, and we have no mechanism 

to determine when qualifications are 

‘‘equivalent to board certification.’’ We 

concur with the CLIAC 

recommendation. Further, we believe 

that individuals who historically may 

have qualified under this provision 

would still qualify through alternative 

routes, thus not disadvantaging 

individuals seeking to qualify as LDs. If 

finalized, we further propose that an 

individual who qualified under the 

predecessor regulations and is currently 

employed as a LD may continue to serve 

in that capacity so long as there is no 

break in service. For example, an 

individual who is serving as the LD of 

a CLIA-certified laboratory at the date of 

the publication of the final rule, and 

continues to serve as a LD of CLIAcertified laboratory that performs 

nonwaived testing, would continue to 

qualify. However, an individual who 

does not continue as LD of a CLIAcertified laboratory after the date of 

implementation of the final rule would 

need to requalify under the new 

provisions. 

At § 493.1405(b)(2)(ii)(A), we are 

proposing to change the ‘‘or’’ to an 

‘‘and’’ to include directing or 

supervising nonwaived laboratory 

testing in the provision. In addition, we 

are proposing to remove ‘‘Beginning 

September 1, 1993’’ from 

§ 493.1405(b)(2)(ii)(B) and continue to 

retain the provision for 20 hours of CE 

credit hours for moderate complexity 

LDs who are seeking to qualify without 

certification by the American Board of 

Pathology and the American Board of 

Osteopathic Pathology. We believe by 

requiring the 20 CE credit hours, the 

LDs would have a better understanding 

of their responsibilities in the overall 

management and direction of 

laboratories, which would result in 

improved overall compliance. 

Historically, LD citations are among the 

top 10 condition-level deficiencies cited 

by surveyors. We believe that this 

would also improve the ability of 

laboratories to report accurate and 


khammond on DSKJM1Z7X2PROD with PROPOSALS3
44914 Federal Register / Vol. 87, No. 142 / Tuesday, July 26, 2022 / Proposed Rules 

reliable test results, thus helping to 

protect the health and safety of the 

public. 

At §§ 493.1405(b)(2)(ii)(C) and 

493.1443(b)(2)(i), we are proposing to 

remove the residency provision for the 

following reasons. First, the residency 

requirement causes confusion with 

board certification for doctoral degrees 

(for example, American Board of 

Internal Medicine). It is also challenging 

for these individuals to qualify under 

this provision as the medical 

residencies as generally do not include 

the type of laboratory training or require 

the 1 year of laboratory training that we 

would expect to see related to laboratory 

administration and operation for which 

the LD is responsible. We would expect 

the residency program to provide the 

director the knowledge in principles 

and theories of laboratory practice, 

including: quality control and quality 

assessment; proficiency testing; the 

phases of the total process (that is, preanalytic, analytic, and post-analytic), as 

well as general laboratory systems; 

facility administration; and 

development and implementation of 

personnel policy and procedure 

manuals. This training should also 

include hands-on laboratory testing. 

However, a typical residency does not 

include performing laboratory training 

for a year (defined in interpretive 

guidelines as 2,080 hours of laboratory 

training) nor does it include knowledge 

in principles and theories of laboratory 

practice. We have observed, and AOs 

have noted to us, that very few 

individuals qualify through the medical 

residency route. The onus for providing 

the documentation related to clinical 

laboratory experience during residency 

is on the applicant (that is, it must be 

documentation of the individual’s 

clinical laboratory experience during 

residency). 

CLIAC recommended that we clarify 

the residency requirements by 

emphasizing the requisite laboratory 

training must be ‘‘clinical laboratory 

training,’’ meaning ‘‘have at least one 

year of clinical laboratory training 

during medical residency or 

fellowship.’’ However, we believe that 1 

year of laboratory training is vague. We 

also believe that after removing the 

residency requirement, there would be 

several alternative routes for individuals 

to qualify as LDs. Individuals seeking to 

qualify as a moderate complexity LD 

may still qualify under § 493.1405(b)(3) 

through (5) without a medical 

residency. We would continue to accept 

residency experience as counting 

toward the requirement of 2 years of 

laboratory experience directing or 

supervising high complexity testing for 

doctors of medicine, doctors of 

osteopathy, or doctors of podiatry. We 

would also accept experience directing 

or supervising high complexity testing 

from a medical fellowship program 

toward the requirements outlined in the 

regulations. Generally, a fellowship 

program follows a residency program 

and is for those individuals who choose 

to pursue additional training in their 

specialty. Section 493.1443(b)(2)(ii) is 

the current requirement that allows 

individuals with at least 2 years of 

experience directing or supervising high 

complexity testing to qualify under 

paragraph (b)(2). 

At § 493.1405(b)(3), we are proposing 

to revise paragraph (b)(3)(ii) to include 

an educational option that includes a 

qualification algorithm for an individual 

that does not have an earned doctoral 

degree in a chemical, biological, or 

clinical laboratory science or medical 

technology (see section I.D.1.a of this 

proposed rule). We are also proposing to 

add paragraph (b)(3)(iii) to include the 

addition of 20 CE credit hours for 

doctoral degrees, as well as the current 

paragraphs (b)(3)(i) through (ii). This 

would include the requirement to be 

certified by an applicable board and 

continue to be certified and have at least 

1 year of experience directing or 

supervising nonwaived testing. 

The current CLIA regulations at 

§§ 493.1405, 493.1411, 493.1423, 

493.1441, 493.1449, 494.1461, and 

493.1489 indicate acceptable degrees for 

personnel as those in a chemical, 

physical, biological, or clinical 

laboratory science or medical 

technology. Degree names and types 

have changed since the CLIA 

regulations were first published in 1992. 

As a result, in some cases, there are 

degrees for which the area of study may 

not be clear based on the name of the 

degree given. This makes it challenging 

for CMS, state agencies, Exempt States 

(ES), and AOs to determine what types 

of degrees are considered acceptable 

degrees in order to qualify CLIA 

personnel. At the time the CLIA 

regulations were published, individuals 

typically received a degree in the areas 

of biology, chemistry, medical 

technology, or clinical laboratory 

science. Today, we often must perform 

an evaluation of transcripts to determine 

if the individuals meet CLIA personnel 

requirements. 

We believe it is important that 

individuals lacking a traditional degree 

in chemical, biological, or clinical 

laboratory science or medical 

technology should be considered if they 

have completed the coursework that is 

equivalent to the aforementioned 

traditional degrees and acquired 

documentation of the equivalent 

educational coursework. In addition to 

the educational requirements discussed 

in this section, CLIA also has experience 

and training requirements (see our 

proposed updates to §§ 493.1405, 

493.1411, and 493.1423), but they will 

not be addressed in this educational 

discussion. 

We believe degrees should be in a 

science that deals in the kind of clinical 

laboratory testing, that is, that which is 

related to testing of human specimens as 

the definition of a ‘‘laboratory,’’ which 

is defined in terms of the examination 

of materials from the human body for 

the purposes of providing information 

for the diagnosis, prevention, or 

treatment of any disease or impairment 

of, or the assessment of the health of 

human beings (see § 493.2). In some 

cases, it is clear that a degree would 

meet these standards. For example, 

degrees in microbiology, genetics, 

molecular biology, biochemistry, and 

organic chemistry would be considered 

appropriate degrees. In other instances, 

it is not apparent whether the degree 

would meet such requirements. 

Environmental sciences, biotechnology, 

and marine biology are examples of 

degrees that would not appear in 

keeping with the scope of the CLIA 

program. At face value, we do not 

believe these types of degrees should 

qualify an individual under the 

requirements in subpart M because they 

are not related to clinical laboratory 

testing. Environmental science degrees 

may cover such areas as ecosystem 

management, the impact of 

industrialization on the environment, 

and natural resource management. 

Biotechnology degrees focus on 

developing technologies and products 

related to medical, environmental, and 

industrial areas. Marine biology focuses 

on studying marine organisms, their 

behaviors, and interactions with the 

environment. We would not consider 

these to be appropriate degrees under 

the CLIA program because these degrees 

do not generally appear to be focused on 

clinical laboratory testing or focused on 

the testing of human specimens, which 

is the scope of the CLIA regulations. 

However, in this proposed rule, we are 

proposing an option for an educational 

algorithm based on semester hours as an 

alternative qualification mechanism. 

Individuals with degrees that are not 

clearly biological or chemical in nature 

may be evaluated using this algorithm if 

finalized and may qualify for CLIA 

personnel positions in subpart M. 

In developing the proposed algorithm, 

we explored the required courses for 

bachelor’s, master’s, and doctoral 

degrees in the major studies of biology, 


khammond on DSKJM1Z7X2PROD with PROPOSALS3
Federal Register / Vol. 87, No. 142 / Tuesday, July 26, 2022 / Proposed Rules 44915 

chemistry, and medical technology. For 

purposes of this discussion, only 

degrees in biology and chemistry will be 

addressed, as degrees in medical 

technology and clinical laboratory 

science do not need to be evaluated for 

equivalency. Multiple sections of the 

CLIA regulations specify that 

educational degrees in ‘‘chemical, 

physical or biological science or 

medical laboratory technology from an 

accredited institution’’ constitute 

appropriate education to qualify for 

laboratory roles in the noted complexity 

and laboratory specialty areas. In all 

situations, the educational requirement 

is based on the laboratory individual 

having a sufficient educational 

background (coursework) to be qualified 

to gain the subsequent training and 

experience to competently perform their 

roles. 

Three levels (small, medium, and 

large) of both public and private 

accredited universities and colleges 

were reviewed. For purposes of this 

research, small institutions were 

defined as less than 5,000 students, 

medium as 5,000 to 15,000 students, 

and large as greater than 15,000 

students. Seven colleges and 

universities were evaluated for all three 

defined types. Table 7 describes the 

number of semester hours (SH) required 

across all three sizes of colleges and 

universities for both a bachelor’s in 

Biology and a bachelor’s in Chemistry. 

In general, accredited colleges and 

universities require general biology, 

molecular biology or genetics, general 

chemistry, organic chemistry, and 

biochemistry. We are proposing a 

specific coursework algorithm to qualify 

candidates, in lieu of a qualifying 

degree, for all testing levels. At present, 

only § 493.1489(b)(2)(ii) specifies 

specific coursework required. This is for 

an associate degree individual to 

perform high complexity testing. 

Specifying coursework requirements 

will allow CMS, state agencies, AOs, 

and ES to consistently evaluate 

educational qualifications. 

For both the doctoral degree and 

master’s degree curricula, there were no 

consistent coursework thesis or research 

requirements for Biology and Chemistry 

majors of study. For example, 

evaluation of the master’s degree 

requirements revealed three tracks that 

included: 

• Coursework; 

• Coursework and thesis; and 

• Coursework, thesis, and research. 

For doctoral degrees, we will propose 

the following educational algorithm for 

those individuals who have a doctoral 

degree that is not clearly in a chemical 

or biological science. We would expect 

those individuals to: 

• Meet master’s degree equivalency; 

and 

• At least 16 SH of additional 

doctoral-level coursework in biology, 

chemistry, medical technology, or 

clinical laboratory science; and 

• A thesis or research project in 

biology, chemistry, medical technology, 

or clinical laboratory science related to 

laboratory testing for the diagnosis, 

prevention, or treatment of any disease 

or impairment of or the assessment of 

the health of human beings. 

CLIAC recommended that other 

degrees (such as those in the 

humanities, physical sciences, and 

others) may not have the requisite 

science coursework, and candidates for 

positions should be considered based on 

a minimum number of hours of courses 

with laboratory components with 

relevance to clinical laboratory testing 

(which could also come from postdegree curricular work). We concur with 

CLIAC’s recommendation that relevant 

science and laboratory coursework 

should be considered when evaluating 

an individual’s education qualifications. 

The educational algorithm may allow 

individuals without a traditional 

chemical or biological degree to meet 

the CLIA personnel education 

requirements based on their 

coursework. Individuals who may have 

the appropriate coursework would not 

be disadvantaged by having a degree 

that is not considered chemical or 

biological in nature. Please note that the 

requirements for the applicable 

laboratory training or experience, or 

both, found in subpart M (and discussed 

previously), are required in addition to 

the educational requirement. 

At § 493.1405(b)(4), we are proposing 

to redesignate current paragraphs 

(b)(4)(ii) and (iii) as paragraphs (b)(4)(iv) 

and (v), respectively. We are proposing 

new paragraphs (b)(4)(ii) and (iii) as 

additional educational options that 

include a qualification algorithm for an 

individual that does not have a master’s 

degree in a chemical, biological, or 

clinical laboratory science or medical 

technology (see section I.D.1.c. of this 

proposed rule). We are proposing to add 

a new requirement at paragraph 

(b)(4)(vi) to include the addition of 20 

CE credit hours. 

As a result of the above discussion, 

we are proposing that individuals meet 

either of the following two options for 

use as educational algorithms: 

• Option 1 

++ Meet bachelor’s degree 

equivalency; and 

++ At least 16 SH of additional 

graduate level coursework in biology, 

chemistry, medical technology, or 

clinical laboratory science; or 

• Option 2 

++ Meet bachelor’s degree 

equivalency; and 

++ At least 16 SH, which may 

include a combination of graduate level 

coursework in biology, chemistry, 

medical technology, or clinical 

laboratory science and a thesis or 

research project related to laboratory 

testing for the diagnosis, prevention, or 

treatment of any disease or impairment 

of, or the assessment of the health of, 

human beings. 


khammond on DSKJM1Z7X2PROD with PROPOSALS3EP26JY22.132</GPH>

TABLE 7: Average Required Semester Hours (SH)* for Bachelor's Degrees in 

Biology and Chemistry 

Semeste Bachelor's Biolo Bachelor's Chemist 

Bio 20-49 

8-20 25-56 

Other 7-28 11-42 

* Quarter hours may be converted to semester hours by multiplying the semester hours by 1.5. For 

example, 3 semester hours is equivalent to 4.5 quarter hours. 

**The majority of colleges and universities did not break out the biology SH, but instead grouped 

them in "Other''. 
44916 Federal Register / Vol. 87, No. 142 / Tuesday, July 26, 2022 / Proposed Rules 

13https://www.cms.gov/Regulations-andGuidance/Legislation/CLIA/Downloads/ 

CLIAtopten.pdf. 

At § 493.1405(b)(5), we propose to 

redesignate current paragraphs (b)(5)(ii) 

and (iii) to paragraphs (b)(5)(iii) and (iv), 

respectively. In addition, we are 

proposing a new paragraph (b)(5)(ii) 

with an educational option that 

includes a qualification algorithm for an 

individual that does not have a 

bachelor’s degree in a chemical, 

biological, or clinical laboratory science 

or medical technology (see section 

I.D.1.c. of this proposed rule). We are 

also proposing to add a new 

requirement at paragraph (b)(5)(v) to 

include the addition of 20 CE credit 

hours. 

In general, an associate degree 

requires the completion of 60 semesters, 

and a bachelor’s degree requires the 

completion of 120 semester hours. In 

the case of bachelor’s degrees, for this 

reason, we are proposing that the 

equivalent educational requirements for 

associate degrees at § 493.1489(b)(2)(ii) 

should be doubled. That is, an 

individual must have at least 120 SH, or 

equivalent, from an accredited 

institution that, at a minimum, include 

either 48 SH of medical laboratory 

technology or clinical laboratory science 

courses; or 48 SH of science courses that 

include: 12 SH of chemistry, which 

must include general chemistry and 

biochemistry or organic chemistry; 12 

SH of biology, which must include 

general biology and molecular biology, 

cell biology or genetics; and 24 SH of 

chemistry, biology, or medical 

laboratory technology or clinical 

laboratory science in any combination. 

Note: We are not proposing to amend 

the education SH requirements at 

§ 493.1489(b)(2)(ii) in this proposed 

rule, as there is no need to amend. 

In addition to the degrees discussed 

above, we are proposing a new 

framework for evaluating nontraditional degrees, a part of the 

educational algorithm described 

previously. One example of a nontraditional degree may be a Regents 

Bachelor of Arts (RBA), which is a 

baccalaureate degree program designed 

for adult students. The basic principle 

of an RBA is that credit is awarded for 

what students know regardless of how 

that knowledge was obtained. In other 

words, students may earn collegeequivalent credit for work and life 

experiences that can be equated to 

college courses. It is designed to provide 

students with a comprehensive general 

education. Many times, no specific 

courses are required for graduation, 

allowing students to design their own 

programs of study. This degree is 

usually awarded by a Board of Regents. 

It is a general education degree without 

the designation of a major. Many of 

these individuals have an associate 

degree in medical laboratory technology 

(MLT), but not an appropriate bachelor’s 

degree that would make them eligible to 

qualify under the provisions in CLIA 

personnel requirements that require 

minimum of a bachelor’s degree. This 

becomes problematic because there is 

no designation of a major, and CLIA 

qualifies individuals with the highest 

academic degree applicable to CLIA. 

Generally, in these cases, we have seen 

that these individuals have an associate 

degree (AA) degree in MLT and have 

many years of clinical laboratory 

experience. Currently, these individuals 

cannot meet CLIA personnel 

qualifications in subpart M that require 

a minimum of a bachelor’s degree. We 

believe that their education and 

experience should qualify them to be 

TCs as long as their AA is in medical 

laboratory technology or laboratory 

science. Public feedback from the 2018 

RFI supported that a non-traditional 

degree should be considered as a means 

to meet CLIA requirements for the TC 

and TP for moderate complexity testing, 

providing a minimum number of 

semester hours were obtained in 

chemistry, biology, and laboratory 

sciences. We believe a non-traditional 

degree can be a means to qualify as TC 

and TP, providing an adequate number 

of biology, chemistry or medical 

laboratory, or clinical laboratory science 

courses is part of the curriculum in 

addition to meeting the training or 

experience requirements. 

At § 493.1405(b)(6) through (7), we are 

proposing to remove the ‘‘grandfather’’ 

provisions as these requirements had to 

have been met by February 28, 1992. 

Individuals can no longer qualify under 

these provisions. A grandfather is a 

provision in which a previous rule 

would continue to apply to individuals 

already qualified and employed in the 

given personnel capacity upon 

implementing a new rule. The new rule 

will apply to all individuals seeking to 

qualify after the implementation of said 

rule. We propose to revise paragraph 

(b)(6) with a new grandfather provision 

for all individuals who qualified under 

this provision, as well as § 493.1406 

prior to the date of the final rule. We 

intend to allow individuals already 

qualified and employed in the given 

personnel capacity as of the date of the 

final rule to continue to be qualified 

under the new provisions (that is, 

grandfathered). However, we intend to 

require all individuals becoming 

employed by a laboratory or changing 

assignments within a laboratory after 

the final rule’s effective date to qualify 

under the new provisions. This includes 

those individuals who may have been 

previously employed in a given position 

prior to the effective date but took a 

break or a leave of absence and came 

back after the date of the final rule. 

4. Laboratory Director Qualifications on 

or Before February 28, 1992 (§ 493.1406) 

At § 493.1406, we are proposing to 

remove the grandfather provision for 

these requirements as they had to have 

been met by February 28, 1992. 

Individuals can no longer qualify under 

these provisions. We plan to grandfather 

all individuals qualified under this 

provision prior to the date of the final 

rule under § 493.1405(6). All 

individuals qualifying after the date of 

the final rule will be required to qualify 

under the new provisions. 

5. Laboratory Director Responsibilities 

(§ 493.1407) 

At §§ 493.1407(c) and 493.1445(c), we 

are proposing to revise the requirements 

so that the LD must be on-site at the 

laboratory at least once every 6 months, 

with at least a 4-month interval between 

the two on-site visits. However, 

laboratory directors may elect to be onsite more frequently. The laboratory 

must provide documentation of these 

visits, including evidence of performing 

activities that are part of the LD 

responsibilities. We concur with 

CLIAC’s recommendation that LDs 

should make at least two (reasonably 

spaced) on-site visits to each laboratory 

they direct per year. We would expect 

the on-site visits to be once every 6 

months with an interval of at least 4 

months between the two on-site visits. 

We will continue to require that the LD 

is accessible to the laboratory to provide 

telephone or electronic consultation as 

needed. Based on a review of 

information provided by state agencies, 

AOs, and ESs, onsite LD on-site visits 

are required as follows: 

• 18 percent (n=9 of 49) of states 

require on-site visits and one territory; 

• 71 percent (n=3 of 7) AOs; and 

• 100 percent (n=1 of 2) ES. 

CLIA statistics show that LD citations 

are consistently among the top 10 

condition-level deficiencies cited by 

surveyors.13 Feedback from the states, 

AOs, and ES indicated that the number 

of deficiencies cited at the time of the 

survey was less when the LD was onsite full-time or made regular on-site 

visits. Based on anecdotal information 

from the state agencies, ES, and AOs, 

the laboratories that did not have a LD 

who made regular visits to the 


khammond on DSKJM1Z7X2PROD with PROPOSALS3
Federal Register / Vol. 87, No. 142 / Tuesday, July 26, 2022 / Proposed Rules 44917 

laboratory tended to have an increased 

number of citations related to overall 

noncompliance with laboratory 

requirements. Some states currently 

require on-site laboratory directors to 

visit their laboratory at prescribed 

intervals, while others do not (see Table 

8 for a complete list of states and 

territories). Feedback from states and 

AOs that did not have such a 

requirement for on-site visits, generally 

supported the addition a requirement 

for on-site visits. Further, on-site visits 

are meant to supplement regular 

interactions between off-site directors 

and the lab (for example, by telephone 

or other telepresence). We concur with 

CLIAC’s recommendations that clear 

documentation of LD on-site visits 

should demonstrate the laboratory is in 

continuous compliance with current 

laws and regulations, including but not 

limited to the assessment of the physical 

environment for safe laboratory testing. 

The on-site LD visits cannot be 

delegated. We believe adding the on-site 

requirement supports increased 

compliance for laboratories. 

BILLING CODE 4120–01–P 


khammond on DSKJM1Z7X2PROD with PROPOSALS3
44918 Federal Register / Vol. 87, No. 142 / Tuesday, July 26, 2022 / Proposed Rules 

BILLING CODE 4120–01–C 

6. Technical Consultant Qualifications 

(§ 493.1411) 

As discussed in section II.B.3. of this 

proposed rule, we are proposing to 

amend § 493.1411(b)(1)(ii) by removing 

‘‘or possess qualifications that are 

equivalent to those required for such 

certification.’’ 

As discussed in section II.B.16. of this 

proposed rule, we are proposing to 

amend § 493.1411(b)(3)(i) by removing 

an earned doctoral, master’s, or 

bachelor’s degree in ‘‘physical science’’ 

as a means to qualify. We further 

propose to redesignate current 

paragraph (b)(3)(ii) as paragraph 

(b)(3)(iii). Then, we propose to revise 

paragraph (b)(3)(i) by changing the 

‘‘and’’ to an ‘‘or’’ and to add a 

requirement at new paragraph (b)(3)(ii) 

to meet either § 493.1405(b)(3)(ii) or 

(b)(4)(ii) or (iii) to allow individuals 


khammond on DSKJM1Z7X2PROD with PROPOSALS3EP26JY22.133</GPH>

TABLE 8: State and Territorial Requirements for On-site Laboratory Directors Every 6 

Months 

Requirement for On-site Laboratory Directors Do not Require On-site Laboratory Directors 

Everv 6 Months Once Everv 6 Months 

Georgia Alabama 

Hawaii Alaska 

Maine American Samoa (territory) 

Maryland Arkansas 

Nevada Arizona 

New York California 

Oklahoma Colorado 

Pennsylvania Connecticut 

Rhode Island Delaware 

Tennessee District of Columbia 

Puerto Rico (territory) Florida 

Guam (territory) 

Idaho 

Illinois 

Indiana 

Iowa 

Kansas 

Kentucky 

Louisiana 

Massachusetts 

Michigan 

Minnesota 

Mississippi 

Missouri 

Montana 

North Carolina 

North Dakota 

Nebraska 

New Hampshire 

New Jersey 

New Mexico 

Ohio 

Oregon 

Saipan (territory) 

South Carolina 

South Dakota 

Texas 

Utah 

Vermont 

Virginia 

Virgin Islands (territory) 

Washington 

West Virginia 

Wisconsin 

Wyoming 

N=lO states+ 1 US territorv N=40 states 4 US territories + District of Columbia 
Federal Register / Vol. 87, No. 142 / Tuesday, July 26, 2022 / Proposed Rules 44919 

14https://www.cms.gov/Medicare/ProviderEnrollment-and-Certification/ 

SurveyCertificationGenInfo/Policy-and-Memos-toStates-and-Regions-Items/Survey-and-Cert-Letter16-18.html?DLPage=1&DLEntries=10&DLFilter=16- 

18&DLSort=3&DLSortDir=descending. 

who do not have a chemical, biological, 

or clinical laboratory science or medical 

technology degree to be eligible to 

qualify as a TC using the educational 

algorithm. 

As discussed in section II.B.16. of this 

proposed rule, we are proposing to 

revise § 493.1411(b)(4)(i) by removing a 

doctoral, master’s, or bachelor’s degree 

in ‘‘physical science’’ as a means to 

qualify, and adding an earned doctoral, 

master’s, or bachelor’s degree in 

‘‘clinical laboratory science’’ as a means 

to qualify. At § 493.1411(b)(4), we are 

proposing to change the ‘‘and’’ to an 

‘‘or’’ in paragraph (b)(4)(i). We are also 

proposing to redesignate current 

paragraph (b)(4)(ii) as paragraph 

(b)(4)(iii) and to add new paragraph 

(b)(4)(ii) to state that the individual 

must meet the criteria in 

§ 493.1405(b)(5)(ii) to allow individuals 

who do not have a chemical, biological, 

or clinical laboratory science or medical 

technology degree to be eligible to 

qualify as a TC using the educational 

algorithm. We would also redesignate 

current paragraph (b)(5)(ii) as paragraph 

(b)(5)(iii) with the addition of ‘‘or.’’ 

At § 493.1411(b), we are proposing to 

add a requirement at paragraph (b)(5) to 

allow individuals with an associate 

degree in medical laboratory technology 

or clinical laboratory science and at 

least 4 years of laboratory training or 

experience, or both, in nonwaived 

testing and the designated specialty or 

subspecialty areas of service for which 

the TC is responsible for qualifying as 

TCs. As discussed in section I.B. of this 

proposed rule, CLIAC recommended 

that we modify CLIA requirements to 

add the option for individuals with an 

associate degree to qualify as TCs. We 

concur with the CLIAC 

recommendation. In general, this will 

allow individuals who may have an 

applicable associate degree in addition 

to required training or experience, or 

both, to qualify as TCs. We recognize 

that the current personnel qualifications 

for general supervisors (GS) for high 

complexity testing may be less stringent 

than those of TCs for moderate 

complexity testing. The current CLIA 

regulations allow an individual with an 

associate degree (§ 493.1461) to perform 

CA on high complexity TP (see 

§§ 493.1461(c)(2), 493.1489(b)(2)(i)). The 

regulations under moderate complexity 

state that the TC is responsible for CA 

and does not allow delegation of this 

responsibility to any individual. The 

high complexity regulations allow the 

LD or TS to delegate the CA to the GS. 

However, the same individual cannot 

perform CA on TP for moderate 

complexity testing unless they can 

qualify as a TC. Therefore, if a 

laboratory performs both moderate and 

high complexity testing, a GS can only 

perform CA on moderate complexity TP 

if they can meet the regulatory 

requirements of a TC. This proposed 

change would allow individuals with 

applicable associate degrees to assess 

competency in laboratories that perform 

both moderate and high complexity 

testing and bring parity to who performs 

CA for all nonwaived laboratories while 

maintaining the laboratory’s ability to 

produce accurate and reliable testing. 

At § 493.1411(b), we are proposing to 

add a requirement at paragraph (b)(6) to 

allow individuals who are qualified 

under § 493.1411(b)(1), (2), (3), or (4) or 

have earned a bachelor’s degree in 

respiratory therapy or cardiovascular 

technology from an accredited 

institution and have at least 2 years of 

laboratory training or experience, or 

both, in blood gas analysis to qualify as 

TC for blood gas testing only. Most 

blood gas testing was categorized as 

high complexity when the original 

regulations were finalized in the 1992 

final rule with comment period. Due to 

improved technology, most routine 

blood gas testing is now categorized as 

moderate complexity. We are proposing 

this change because we believe that it 

would provide adequate oversight of 

moderate complexity blood gas testing. 

Adding this provision specific to TCs in 

the area of blood gas testing would 

allow individuals to qualify as a TC in 

this specific area of expertise. Please 

note that we will still not consider a 

degree in respiratory therapy or 

cardiovascular technology to be 

equivalent to a biological or chemical 

science degree. An individual with 

these qualifications should be able to 

oversee the testing and CA of personnel 

performing blood gas testing. 

At § 493.1411(b)(7), we are proposing 

to add a grandfather provision to 

include those already qualified prior to 

the date of the final rule, including 

nurses. 

7. Testing Personnel Qualifications 

(§ 493.1423) 

We are proposing to redesignate 

§ 493.1423(b)(2), (3), and (4) as 

§ 493.1423(b)(4), (5), (6), respectively. 

We are also proposing to separate 

current paragraph (b)(1) into two 

separate provisions. Revised paragraph 

(b)(1) would include the current 

requirement of a doctor of medicine or 

doctor of osteopathy licensed to practice 

medicine or osteopathy in the state in 

which the laboratory is located. New 

paragraph (b)(2) would include the 

requirement of an earned doctoral, 

master’s, or bachelor’s degree in a 

chemical, biological, or clinical 

laboratory science or medical 

technology from an accredited 

institution. As discussed in section 

II.B.16. of this proposed rule, we are 

proposing to remove an earned doctoral, 

master’s, or bachelor’s degree in 

‘‘physical science’’ as a means to 

qualify. In addition, we are proposing to 

add an earned doctoral, master’s, or 

bachelor’s degree in nursing as a means 

to qualify. In Survey and Certification 

memo 16–18–CLIA,14 we stated that ‘‘a 

bachelor’s in nursing meets the 

requirement of having earned a 

bachelor’s degree in a biological science 

for high complexity TP’’ and that ‘‘an 

associate’s degree in nursing meets the 

requirement of having earned an 

associate’s degree in a biological science 

for moderate complexity TP.’’ We 

appreciate all comments received in 

response to the 2018 RFI and agree that 

a nursing degree is not equivalent to a 

biological or chemical science degree. 

We also concur with some commenters’ 

recommendation that nursing degrees be 

used as a separate qualifying degree for 

TP. As testing practices and 

technologies have evolved, point of care 

testing has become a standard of 

practice in many health care systems, 

allowing laboratory results to be 

delivered to the treating health care 

provider as rapidly as possible. We 

recognize that in many health care 

systems, nurses perform the majority of 

the point of care testing in many 

different scenarios (for example, 

bedside, surgery centers, end-stage renal 

disease facilities). We do not have any 

reason to believe that nurses would be 

unable to accurately and reliably 

perform moderate and high complexity 

testing with appropriate training and 

demonstration of competency. 

We are proposing to add new 

paragraph (b)(3) to include the 

requirement that the individual must 

meet the criteria in § 493.1405(b)(3)(ii) 

or (b)(4)(ii) or (iii) or (b)(5)(ii) to allow 

individuals who do not have a 

chemical, biological, or clinical 

laboratory science or medical 

technology degree to be eligible to 

qualify as a TP using the educational 

algorithm. See discussion in section 

II.B.3. of this proposed rule. 

In addition, we are proposing to add 

at paragraph (b)(7) a requirement to 

allow individuals for blood gas testing 

to be qualified under § 493.1423(b)(1) 

through (4) or have earned a bachelor’s 

degree in RT or cardiovascular 


khammond on DSKJM1Z7X2PROD with PROPOSALS3
44920 Federal Register / Vol. 87, No. 142 / Tuesday, July 26, 2022 / Proposed Rules 

15https://www.ascp.org/content/docs/defaultsource/boc-pdfs/exam-content-outlines/ascp-bocus-procedures-book-web.pdf. 

technology from an accredited 

institution or have an AA related to 

pulmonary function and have at least 2 

years training or experience or both in 

blood gas analysis. We are proposing 

this addition so that parity can exist 

with high complexity TP requirements 

for blood gas testing at § 493.1489(b)(6). 

See previous discussion at 

§ 493.1411(b). 

8. Laboratory Director Qualifications 

(§ 493.1443) 

As discussed in section II.B.3. of this 

proposed rule, we are proposing to 

amend § 493.1443(b)(1)(ii) by removing 

‘‘or possess qualifications that are 

equivalent to those required for such 

certification.’’ As discussed in the above 

section of this proposed rule, we are 

proposing to amend § 493.1443(b)(2) by 

removing the residency requirement at 

paragraph (b)(2)(i) as a means to qualify 

and redesignating paragraph (b)(2)(ii) 

(which requires the individual to have 

at least 2 years of experience directing 

or supervising high complexity testing) 

as paragraph (b)(2)(i). As discussed in 

section II.B.3. of this proposed rule, we 

are also proposing to add new paragraph 

(b)(2)(ii) to require 20 CE credit hours. 

We are also proposing to redesignate 

current paragraph (b)(3)(i) as new 

paragraph (b)(3)(iii) and to redesignate 

the provisions of paragraphs (b)(2)(ii)(A) 

and (B) as new paragraph (b)(3)(iv). 

As discussed in section II.B.16. of this 

proposed rule, we are proposing to 

redesignate the introductory text of 

paragraph (b)(3) as new paragraph 

(b)(3)(i) to revise this paragraph by 

removing an earned doctoral, master’s, 

or bachelor’s degree in ‘‘physical 

science’’ as a means to qualify. As 

discussed in section II.B.3. of this 

proposed rule, we would revise newly 

redesignated paragraph (b)(3)(i) by 

adding an earned doctoral, master’s, or 

bachelor’s degree in ‘‘medical 

technology’’ as a means to qualify. 

As discussed in section I.D.1.c. of this 

proposed rule, we are proposing to add 

an educational requirement at new 

paragraph (b)(3)(ii) that includes a 

qualification algorithm for an individual 

that does not have an earned doctoral 

degree in a chemical, biological, or 

clinical laboratory science or medical 

technology. 

At paragraphs (b)(3)(ii) and (b)(4) and 

(5), we are proposing to delete these 

paragraphs to remove the grandfather 

provisions as these requirements had to 

have been met by February 24, 2003, 

March 14, 1990, and February 28, 1992, 

respectively, and individuals can no 

longer qualify under these provisions. 

We are proposing to add new paragraph 

(b)(4) to specify the new grandfather 

provision. We are also proposing to 

redesignate paragraph (b)(6) as new 

paragraph (b)(5). 

Finally, as discussed in section II.B.3. 

of this proposed rule, we are proposing 

to add a 20 CE credit hour requirement 

at new paragraph (b)(3)(v). 

9. Laboratory Director Responsibilities 

(§ 493.1445) 

For proposals related to § 493.1445, 

please see the discussion at II.B.5. of 

this proposed rule. 

10. Technical Supervisor Qualifications 

(§ 493.1449) 

At § 493.1449, we are proposing to 

combine the provisions of paragraphs 

(c) through (g) into new paragraph (c) 

and combine paragraphs (h) through (j), 

(n), and (q) into new paragraph (d). We 

are also proposing to redesignate 

paragraphs (k), (l), (m), (o), and (p) as 

paragraphs (e), (f), (g), (h), and (i), 

respectively. We propose to make these 

changes to simplify the regulations by 

reducing confusion and grouping 

identical TS requirements into a 

combined provision. We are also 

proposing to insert the education 

algorithm at paragraph (c)(4)(i)(B). 

At newly redesignated paragraph 

(e)(1)(ii)(B) (formerly paragraph 

(k)(1)(ii)(B)), we are proposing to 

remove and reserve this paragraph since 

the American Society of Cytology has 

not provided certification for cytology 

since 1998; certification is provided by 

American Board of Pathology and 

American Board of Osteopathic 

Pathology. 

At newly redesignated paragraph (d) 

(formerly paragraph (q)), we are 

proposing to amend the 

immunohematology requirement for the 

TS requirement to align with other TS 

qualifications and allow individuals 

with doctoral, master’s, and bachelor’s 

degrees with appropriate training and 

experience to qualify as a TS for 

immunohematology. This provision will 

be included in § 493.1449(d). The 

current regulation requires that the TS 

for immunohematology be a doctor of 

medicine or osteopathy. Fulfilling the 

CA requirements (for example, direct 

observation) can be challenging in rural 

facilities as the TS may not be onsite as 

the individual(s) may cover a large 

geographic area. Often a MT/CLS with 

a SBB (Specialist in Blood Bank) from 

ASCP (American Society for Clinical 

Pathology) 15 is on-site to oversee the 

day-to-day operations of the blood bank. 

By allowing qualified individuals with 

doctoral, master’s, or bachelor’s degrees, 

to qualify as TSs, the personnel 

responsibilities will align with the 

current practices in laboratories without 

affecting the ability of the laboratory to 

provide accurate and reliable results. 

Further, this proposed change may help 

alleviate a shortage of physicians in 

rural areas and does not constitute a risk 

to public health or the individuals 

served by the laboratory. 

As discussed in section II. B.16. of 

this proposed rule, we are proposing at 

§ 493.1449 to remove an earned 

doctoral, master’s, or bachelor’s degree 

in ‘‘physical science’’ as a means to 

qualify. 

11. General Supervisor Qualifications 

(§ 493.1461) 

As discussed in section II. B.16. of 

this proposed rule, we are proposing at 

§ 493.1461(c)(1)(i) to remove an earned 

doctoral, master’s, or bachelor’s degree 

in ‘‘physical science’’ as a means to 

qualify. At § 493.1461(c)(3) through (5), 

we are proposing to delete the 

grandfather provisions as these 

requirements had to have been met by 

February 28, 1992, April 24, 1995, and 

September 1, 1992, respectively, and 

individuals can no longer qualify under 

these provisions. We plan to grandfather 

all individuals qualified under this 

provision. We are also proposing to add 

new paragraph (c)(3) to specify a new 

grandfather provision for those 

individuals who had qualified prior to 

the publication of the final rule. 

12. General Supervisor Qualifications 

on or Before February 28, 1992 

(§ 493.1462) 

At § 493.1462, we are proposing to 

remove the grandfather provision as this 

requirement must have been met by 

February 28, 1992. These individuals 

would be included in the grandfather 

provision for § 493.1461(c)(3) through 

(5). 

13. General Supervisor Responsibilities 

(§ 493.1463) 

At § 493.1463(b)(4), we are proposing 

to revise the language stating the need 

to annually evaluate and document the 

performance of all testing personnel to 

now require the evaluation and 

documentation of the competency of all 

testing personnel. Historically, CLIA has 

allowed the TS to delegate all CA to the 

GS. However, the current regulations 

only speak to the ability of the GS to 

perform annual CA. We are clarifying 

that the GS may be delegated both the 

semi-annual and the annual CA. 


khammond on DSKJM1Z7X2PROD with PROPOSALS3
Federal Register / Vol. 87, No. 142 / Tuesday, July 26, 2022 / Proposed Rules 44921 

14. Cytotechnologist Qualifications 

(§ 493.1483) 

At §§ 493.1483(b)(2) and 

493.1489(b)(2)(ii)(B)(1), we are 

proposing to replace ‘‘CAHEA’’ with 

CAAHEP (Commission on Accreditation 

of Allied Health Education Programs) 

and to remove, ‘‘or other organization 

approved by HHS.’’ In October 1992, the 

American Medical Association (AMA) 

announced its intent to support the 

establishment of a new and independent 

agency to assume the accreditation 

responsibilities of the Commission on 

Allied Health Education Accreditation 

(CAHEA), which is CAAHEP. HHS has 

no approval process for programs not 

approved or accredited by the 

Accrediting Bureau of Health Education 

Schools (ABHES) or CAAHEP. 

At § 493.1483(b)(3) through (5), we are 

proposing to remove the grandfather 

provisions as these requirements had to 

have been met by September 1, 1992, or 

September 1, 1994, as individuals can 

no longer qualify under these 

provisions. We plan to grandfather all 

individuals qualified under this 

provision prior to the date of the final 

rule. These individuals would be 

included in the new grandfather 

provision at § 493.1483(b)(3). 

15. Testing Personnel Qualifications 

(§ 493.1489) 

We are proposing to remove 

paragraph (b)(3) as the February 28, 

1992 grandfather provision must have 

been met by February 28, 1992. We are 

also proposing to redesignate 

paragraphs (b)(2)(i) and (ii) to 

paragraphs (b)(3)(i) and (ii), 

respectively. As noted, at 

§ 493.1489(b)(2)(ii)(B)(1), we are 

proposing to replace ‘‘CAHEA’’ with 

‘‘CAAHEP’’ and to remove ‘‘or other 

organization approved by HHS.’’ 

In addition, we are proposing to 

revise paragraph (b)(1) to separate the 

provisions into two paragraphs (that is, 

paragraph (b)(1) and new paragraph 

(b)(2)(i)). New paragraph (b)(1) would 

include the current requirement of a 

doctor of medicine or doctor of 

osteopathy licensed to practice 

medicine or osteopathy in the state in 

which the laboratory is located. New 

paragraph (b)(2)(i) would include an 

earned doctoral, master’s, or bachelor’s 

degree in a chemical, biological, or 

clinical laboratory science or medical 

technology from an accredited 

institution. As discussed in section 

II.B.16. of this proposed rule, we are 

proposing to remove an earned doctoral, 

master’s, or bachelor’s degree in 

‘‘physical science’’ as a means to 

qualify. We are also proposing to add an 

earned doctoral, master’s, or bachelor’s 

degree in nursing as a means to qualify 

(see discussion at § 493.142 in section 

II.B.7. of this proposed rule). In 

addition, we are proposing to add new 

paragraph (b)(2)(ii) to state who may be 

qualified under § 493.1443(b)(3) or 

§ 493.1449(c)(4) or (5) to allow 

individuals who do not have a 

chemical, biological, or clinical science 

or medical technology or clinical 

laboratory science degree to be eligible 

to qualify as a TC using the educational 

algorithm. 

At § 493.1489(b)(4), we are proposing 

to amend this requirement by moving 

the military provision out of the April 

24, 1995, grandfather provision and 

make it a mechanism that individuals 

will be able to qualify to be equivalent 

to the already existing provision in 

moderate complexity testing 

(§ 493.1423(b)(3)). We believe these 

individuals have the requisite 

educational background to meet the 

requirements to perform laboratory 

testing under CLIA. In addition, we are 

proposing to remove paragraph (b)(4) 

introductory text and paragraph (b)(4)(i) 

[the text that currently states ‘‘On or 

before’’ through ‘‘graduated from a [ML] 

or [CL] training program approved or 

accredited by ABHES, CAHEA, or other 

organizations approved by HHS’’] per 

the discussion under § 493.1483(b)(2). 

As a result, the current military 

requirement at paragraph (b)(4)(ii) 

would be redesignated as paragraph 

(b)(4). 

16. Technologist Qualifications on or 

Before February 28, 1992 (§ 493.1491) 

The current language at 

§ 493.1491(b)(6) is being included in the 

grandfather at § 493.1489(b)(5). We are 

proposing to remove § 493.1491 as 

individuals can no longer qualify under 

this provision. 

17. Proposed Removal of Earned Degree 

in Physical Science as an Educational 

Requirement 

At §§ 493.1405, 493.1411, 493.1423, 

493.1443, 493.1449, 493.1461, and 

493.1489, we are proposing to remove 

‘‘physical science’’ and add a new 

educational requirement for the ability 

to qualify based on semester hours. We 

concur with CLIAC’s recommendation 

that a degree in physical science should 

be removed from the CLIA regulations 

as it is too broad and may not include 

relevant laboratory science coursework. 

It is a broad discipline often described 

as the study of nonliving systems, such 

as astronomy, physics, and earth 

sciences. Generally, these types of 

degrees are not related to clinical 

laboratory testing. Due to variation in 

usage and the absence of universally 

accepted definitions, a ‘‘physical 

science degree’’ is difficult to define for 

regulatory purposes. We believe that the 

proposed semester algorithm will allow 

individuals to qualify in the absence of 

a traditional chemical, biological, or 

clinical laboratory science or medical 

technology degree. An individual 

graduating with a physical science 

degree may or may not have sufficient 

course experience to meet the 

educational requirement, so the degree 

alone should not be listed among those 

that satisfy the educational requirement. 

We note that in some instances, 

individuals with these types of degrees 

have been able to qualify as high 

complexity TP under § 493.1489 and 

GSs under § 493.1461(b)(2) as long as 

they have the applicable training or 

experience (see section I.D.1.c. of this 

proposed rule). 

18. Clinical Laboratory Science and 

Medical Technology 

At §§ 493.1405(b)(3) and (b)(5)(i), 

493.1411(b)(4) and (6), 493.1443(b)(3)(i), 

and 493.1449(c)(3)(i), (c)(5)(i), (d)(3)(i), 

(d)(5)(i), (h)(2)(i), and (i)(2)(i), we are 

proposing to remove any text referring 

to ‘‘medical technology’’ degrees and 

replace such text with references to 

degrees in ‘‘clinical laboratory science 

and medical technology’’ so that the 

latter phrase appears consistently 

throughout subpart M. Originally, 

degrees were given in medical 

technology, however; the naming 

convention for medical technology 

degrees has changed since the 

regulations were first published in the 

1992 final rule with comment period. 

The degree is now referred to as clinical 

laboratory science. A clinical laboratory 

science degree is synonymous with a 

medical technology degree. 

C. Proposed Change to CLIA 

Requirements for Alternative Sanctions 

for CoW Laboratories 

As discussed in section I.C. of this 

proposed rule, we are proposing to 

amend § 493.1804(c)(1) by removing the 

phrase ‘‘(CMS does not impose 

alternative sanctions on laboratories that 

have certificates of waiver because those 

laboratories are not inspected for 

compliance with condition-level 

requirements.)’’. 

IV. Collection of Information 

Requirements 

Under the Paperwork Reduction Act 

of 1995 (PRA), we are required to 

publish a 60-day notice in the Federal 

Register and solicit public comment 

before a collection of information 

requirement is submitted to the Office of 


khammond on DSKJM1Z7X2PROD with PROPOSALS3
44922 Federal Register / Vol. 87, No. 142 / Tuesday, July 26, 2022 / Proposed Rules 

16https://www.bls.gov/oes/tables.htm. 

17https://www.bls.gov/oes/tables.htm. 

18https://www.bls.gov/oes/tables.htm. 

19https://www.bls.gov/oes/current/oes_nat.htm. 

Management and Budget (OMB) for 

review and approval. 

To fairly evaluate whether an 

information collection should be 

approved by OMB, PRA section 

3506(c)(2)(A) of the PRA requires that 

we solicit comment on the following 

issues: 

• The need for the information 

collection and its usefulness in carrying 

out the proper functions of our agency. 

• The accuracy of our burden 

estimates. 

• The quality, utility, and clarity of 

the information to be collected. 

• Our effort to minimize the 

information collection burden on the 

affected public, including the use of 

automated collection techniques. 

We are soliciting public comment on 

each of the section 3506(c)(2)(A) 

required issues for the following 

information collection requirements 

(ICRs). 

The requirements and burden will be 

submitted to OMB under OMB Control 

Number 0938–0612, which expires 

January 31, 2024. The information 

collection will be revised to account for 

the burden. 

A. CLIA Fees 

This document does not impose 

information collection requirements, 

that is, reporting, recordkeeping, or 

third-party disclosure requirements. 

Consequently, there is no need for 

review by the Office of Management and 

Budget under the authority of the 

Paperwork Reduction Act of 1995 (44 

U.S.C. 3501 et seq.). 

B. Histocompatibility, Personnel, and 

Alternative Sanctions 

1. Laboratory Costs To Update Policies 

and Procedures 

If this rule is finalized, we expect that 

the 34,082 CoC and CoA laboratories 

would incur costs for the time needed 

to review the revised personnel 

regulations and update their policies 

and procedures to be in compliance. 

The total one-time burden per 

laboratory to review and update affected 

policies and procedures is 5 to 7 hours. 

A management level employee (11– 

9111) would perform this task at an 

hourly wage of $557.61 per hour as 

published by the 2021 Bureau of Labor 

Statistics.16 The wage rate would be 

$115.22 to include overhead and fringe 

benefits. The total cost would range 

from $19,634,640 to $27,488,496 (34,082 

laboratories × 5- or 7-hours × $115.22). 

Similarly, we expect that the 31,982 

PPM laboratories would incur costs for 

the time needed to review and update 

the one change clarifying the 

requirement for CAs in PPM 

laboratories. We assume a one-time 

burden of 0.25 to 0.5 hours per 

laboratory for this task (31,982 × 0.25 or 

0.5 hours). A management level 

employee (11–9111) would perform this 

task at an hourly wage of $57.61 per 

hour as published by the 2021 Bureau 

of Labor Statistics.17 The wage rate 

would be $115.22 to include overhead 

and fringe benefits. The total cost would 

range from would range from $921 to 

$1,842,483 (31,982 laboratories × 0.25- 

or 0.5-hours × $115.22). 

If finalized, the changes to the 

histocompatibility requirements would 

affect approximately 218 laboratories 

that perform testing in this specialty. 

The laboratories may need to make 

additional changes to their policies and 

procedures for the histocompatibility 

updates. We assume a one-time cost of 

1 to 2 hours per laboratory for this task 

(218 × 1 or 2). A management level 

employee (11–9111) would perform this 

task at an hourly wage of $57.61 per 

hour as published by the 2021 Bureau 

of Labor Statistics.18 The wage rate 

would be $115.22 to include overhead 

and fringe benefits. The total cost would 

range from would range from $25,118 to 

$50,236 (218 laboratories × 1- or 2-hours 

× $115.22). 

2. Accreditation Organization and 

Exempt State Costs To Update Policies 

and Procedures 

If the proposed changes are finalized, 

seven approved accrediting 

organizations and two exempt states 

would have to review their policies and 

procedures, provide updates and submit 

the changes to CMS for approval (9 

organizations/exempt states × 10 or 15 

hours). We assume a one-time cost of 10 

to 15 hours to identify the applicable 

legal obligations and to develop the 

policies and procedures needed to 

reflect the new requirements for 

personnel and histocompatibility. A 

management level employee (11–9111) 

would perform this task at an hourly 

wage of $57.61 per hour as published by 

the 2021 Bureau of Labor Statistics.19

The wage rate would be $115.22 to 

include overhead and fringe benefits. 

The total cost would range from would 

range from $10,370 to $17,283 (9 × 10- 

or 15 hours × $115.22). 

Table 9 reflects the total burden and 

associated costs for the provisions 

included in this proposed rule. 


khammond on DSKJM1Z7X2PROD with PROPOSALS3EP26JY22.134</GPH>

TABLE 9: Summary of All Costs for Collection of Information in this Proposed 

Rule 

Burden Hours 

Information Collection Requests* Increase/Decrease ( +!-) * Cost(+/-)* 

A. Laboratorv Costs to Update Policies and Procedures 

CoC/CoA +7 $27,488,496 

PPM +0.5 $728,185 

Histocompatibilitv +2 $50,236 

B. Accreditation Organization and Exempt State Costs to 

Update Policies and Procedures +15 $17,283 

TOTAL +24.5 +28,284,200 

* All costs reflected in this table are one-time only costs. There are no ongoing costs. 
Federal Register / Vol. 87, No. 142 / Tuesday, July 26, 2022 / Proposed Rules 44923 

V. Response to Comments 

Because of the large number of public 

comments we normally receive on 

Federal Register documents; we are not 

able to acknowledge or respond to them 

individually. We will consider all 

comments we receive by the date and 

time specified in the DATES section of 

this preamble, and, when we proceed 

with a subsequent document, we will 

respond to the comments in the 

preamble to that document. 

VI. Regulatory Impact Analysis 

A. Statement of Need 

1. CLIA Fees 

As discussed in section I. of this 

proposed rule, when CLIA was enacted 

and its implementing regulations were 

finalized in 1992, CLIA fees were 

established based on estimates as to the 

average time a survey would take, cost 

of the surveyor salary per hour, as well 

as the size of the laboratory (schedules 

A, B, etc.). As discussed in section II. of 

this proposed rule, we are proposing to 

increase certain CLIA fees, add new 

CLIA fees, and institute a biennial fee 

increase based on our analysis of the 

overall level of collections relative to 

the costs of maintaining the CLIA 

program, which project a shortfall 

beginning in calendar year 2023. 

2. Histocompatibility, Personnel, 

Alternative Sanctions 

This rule also proposes to update the 

CLIA regulations concerning 

histocompatibility (§ 493.1278), 

personnel (§§ 493.1351 through 

493.1495), and alternative sanctions for 

laboratories operating under a CoW 

(§ 493.1804). With few exceptions, no 

changes have been made to the 

requirements listed above since the 

CLIA regulations were finalized in the 

1992 final rule with comment period (57 

FR 7002). Many changes have occurred 

in the practice of laboratory medicine 

since that time, and other parts of the 

regulations have since been updated to 

eliminate redundancies and streamline 

requirements. HHS assessed the need to 

update the sections addressed in this 

proposed rule and solicited public input 

via the 2018 RFI (83 FR 1004) and 

advice from the CLIAC (www.cdc.gov/ 

cliac/past-meetings.html) before making 

decisions about the changes to propose. 

Because the specialty of 

histocompatibility is an evolving area of 

the clinical laboratory, several changes 

were made to update and clarify the 

histocompatibility requirements 

finalized in the 2003 final rule (68 FR 

3640). Since then, there have continued 

to be advancements in 

histocompatibility testing. As a result, 

some requirements have become 

obsolete and may preclude using 

current, improved methods and 

practices. As already mentioned, there 

have been updates to other parts of the 

CLIA regulations to eliminate 

redundancy with general quality system 

requirements. However, changes to 

eliminate redundancy have not 

previously been made in the 

histocompatibility specialty, which we 

believe would simplify and streamline 

the regulations. Thus, we propose 

eliminating redundant 

histocompatibility specialty regulations 

in this proposed rule. 

Provisions to end a phase-in period, 

previously included in subpart M, that 

allowed individuals with an earned 

doctoral degree in a chemical, physical, 

biological, or clinical laboratory science 

to meet the qualification requirements 

for LD of high complexity testing prior 

to obtaining board certification, were 

finalized in the 2003 final rule (68 FR 

3640). This rule also revised and 

expanded the qualifications required for 

such individuals to direct a laboratory 

performing high complexity testing. No 

other changes have been made to clarify 

or update subpart M since 1992, even 

though the top 10 laboratory 

deficiencies have historically continued 

to include qualification requirements 

and responsibilities for moderate and 

high complexity LD. These high 

numbers of deficiencies may be due, in 

part, to the redundancy throughout 

subpart M or to requirements that are 

unclear, both of which may be an 

ongoing source of confusion for 

laboratories and individuals seeking to 

determine their qualification status. The 

number of deficiencies may also be due 

to laboratories whose directors are onsite infrequently or not at all. 

The CLIA requirements at § 493.1804 

describe general considerations for the 

imposition of sanctions under the CLIA 

program. This includes principal or 

alternative sanctions as described in 

§ 493.1804(c). This section specifies that 

alternative sanctions are not imposed on 

laboratories issued a CoW, but 

discretion is permitted in applying 

principal or alternative sanctions to 

laboratories issued other certificate 

types. Since the CLIA statute at 42 

U.S.C. 263a(h) does not make this 

distinction concerning alternative 

sanctions, we found that § 493.1804(c) 

can be updated to reflect CMS’ belief 

that alternative sanctions instead of 

principal sanctions should be an option 

to create parity for all certificate types. 

In some cases, we believe the 

imposition of principal sanctions on 

CoW laboratories is not appropriate and 

could create an undue burden on these 

laboratories that do not currently have 

the option of receiving alternative 

sanctions, if appropriate, as laboratories 

with other certificate types. 

In summary, we based our decision to 

update our regulations at § 493.1278 

related to histocompatibility on changes 

in practice, advice from the CLIAC, and 

responses to the 2018 RFI. We based our 

decision to update the personnel 

requirements in subpart M, §§ 493.1351 

through 493.1495, and propose changes 

in this rule to delete obsolete and 

redundant regulations and to clarify this 

subpart specifying personnel 

qualifications and responsibilities on 

advice from CLIAC, common questions 

we have received, and responses to the 

2018 RFI. We based our decision to 

update our regulation at § 493.1804(c) to 

allow for alternative sanctions to be 

imposed on CoW laboratories on 

responses received to the 2018 RFI. 

B. Overall Impact 

We have examined the potential 

impacts of this rule as required by 

Executive Order 12866 on Regulatory 

Planning and Review (September 30, 

1993), Executive Order 13563 on 

Improving Regulation and Regulatory 

Review (January 18, 2011), the 

Regulatory Flexibility Act (RFA) 

(September 19, 1980, Pub. L. 96–354), 

section 1102(b) of the Social Security 

Act, section 202 of the Unfunded 

Mandates Reform Act of 1995 (March 

22, 1995; Pub. L. 104–4), Executive 

Order 13132 on Federalism (August 4, 

1999), the Congressional Review Act (5 

U.S.C. 804(2)). 

Executive Orders 12866 and 13563 

direct agencies to assess all costs and 

benefits of available regulatory 

alternatives and, if regulation is 

necessary, to select regulatory 

approaches that maximize net benefits 

(including potential economic, 

environmental, public health, and safety 

effects, distributive impacts, and 

equity). Section 3(f) of Executive Order 

12866 defines a ‘‘significant regulatory 

action’’ as an action that is likely to 

result in a rule: (1) (having an annual 

effect on the economy of $100 million 

or more in any 1 year, or adversely and 

materially affecting a sector of the 

economy, productivity, competition, 

jobs, the environment, public health or 

safety, or state, local or tribal 

governments or communities (also 

referred to as ‘‘economically 

significant’’); (2) creating a serious 

inconsistency or otherwise interfering 

with an action taken or planned by 

another agency; (3) materially altering 

the budgetary impacts of entitlement 

grants, user fees, or loan programs or the 


khammond on DSKJM1Z7X2PROD with PROPOSALS3
44924 Federal Register / Vol. 87, No. 142 / Tuesday, July 26, 2022 / Proposed Rules 

rights and obligations of recipients 

thereof; or (4) raising novel legal or 

policy issues arising out of legal 

mandates, the President’s priorities, or 

the principles set forth in the Executive 

Order. 

A regulatory impact analysis (RIA) 

must be prepared for major rules with 

significant regulatory actions and/or 

economically significant effects ($100 

million or more in any one year). The 

regulation is not economically 

significant within the meaning of 

section 3(f)(1) of the Executive order 

since neither the low estimate: 

$28,145,841 nor the high estimate: 

$57,528,591 exceeds the $100 million 

annual threshold. 

This proposed rule increases certain 

CLIA Fee requirements and will affect 

approximately 265,335 clinical 

laboratories, resulting in some budget 

implications. However, since 

laboratories, accrediting organizations, 

and exempt states will need to make 

changes to comply with the Federal 

regulatory changes, we have provided 

an assessment of the impact of 

estimated costs of these changes in 

Table 14. 

The Regulatory Flexibility Act (RFA) 

requires agencies to analyze options for 

regulatory relief of small entities if a 

rule has a significant impact on a 

substantial number of small entities. For 

purposes of the RFA, we estimate that 

the great majority of clinical laboratories 

and AOs are small entities, either by 

being nonprofit organizations or by 

meeting the Small Business 

Administration definition of a small 

business (having revenues of less than 

$8.0 million to $41.5 million in any 1 

year). For purposes of the RFA, 

approximately 82 percent of clinical 

laboratories qualify as small entities 

based on their nonprofit status as 

reported in the American Hospital 

Association Fast Fact Sheet, updated 

January 2021 (https://www.aha.org/ 

statistics/fast-facts-us-hospitals), and 

100 percent of the AOs are nonprofit 

organizations. Individuals and states are 

not included in the definition of a small 

entity. While a significant number of 

clinical laboratories and accrediting 

agencies are affected by this rule, the 

impact is not economically significant. 

It is anticipated that the benefits 

obtained by ensuring quality laboratory 

testing will outweigh the costs. See 

Table 10. Therefore, the Secretary has 

certified that this proposed rule will not 

have a significant economic impact on 

a substantial number of small entities. 

We are voluntarily preparing a 

Regulatory Impact Analysis, including 

both a qualitative and quantitative 

analysis, and are requesting public 

comments on the impacts to assist us in 

making this determination in the final 

rule. 

In addition, section 1102(b) of the Act 

requires us to prepare a regulatory 

impact analysis if a rule may have a 

significant impact on the operations of 

a substantial number of small rural 

hospitals. This analysis must conform to 

the provisions of section 603 of the 

RFA. For purposes of section 1102(b) of 

the Act, we define a small rural hospital 

as a hospital located outside a 

metropolitan statistical area with fewer 

than 100 beds. There are approximately 

905 small rural hospitals in the U.S. 

Such hospitals often provide limited 

laboratory services or may refer all their 

testing to larger facilities. We are unable 

to estimate the number of laboratories 

that support small rural hospitals and 

do not expect that the rule will have a 

significant impact on small rural 

hospitals. Therefore, the Secretary has 

certified that this proposed rule will not 

have a significant impact on the 

operations of a substantial number of 

small rural hospitals. 

Section 202 of the Unfunded 

Mandates Reform Act of 1995 (UMRA) 

also requires that agencies assess 

anticipated costs and benefits before 

issuing any rule whose mandates 

require spending in any 1 year of $100 

million in 1995 dollars, updated 

annually for inflation. In 2021, that 

threshold was approximately $158 

million. We do not anticipate this 

proposed rule would impose an 

unfunded mandate on states, tribal 

governments, and the private sector of 

more than $158 million annually. We 

request comments from states, tribal 

governments, and the private sector on 

this assumption. 

Executive Order 13132 establishes 

certain requirements that an agency 

must meet when it promulgates a 

proposed rule that imposes substantial 

direct requirement costs on state and 

local governments, preempts state law, 

or otherwise has federalism 

implications. Two states have exempt 

status, which means we have 

determined that the state has enacted 

laws relating to the laboratory 

requirements that are equal to or more 

stringent than CLIA requirements, and 

the state licensure program has been 

approved by us. If this rule is finalized, 

the two states, New York and 

Washington, would need to update their 

policies and procedures to maintain 

their exempt status but would otherwise 

not incur additional costs. Therefore, 

this proposed rule would not have a 

substantial direct effect on state or local 

governments, preempt states, or 

otherwise have a federalism 

implication, and there is no change in 

the distribution of power and 

responsibilities among the various 

levels of government. 

C. Anticipated Effects 

Tables 10 and 11 reflect the estimated 

impact for the provisions included in 

this proposed rule. 


khammond on DSKJM1Z7X2PROD with PROPOSALS3EP26JY22.135</GPH>

. TABLE 10 . S ummaryo fE s f 1ma t d e m I Jae t ti or p ropose dR e2u If a 10ns 

Proposed Chan2e Low estimate Hil!h estimate 

Laboratories updating policies and procedures related to $20,524,180 $29,279,200 personnel and histocompatibilitv 

Accrediting organizations and exempt states updating 

policies and procedures related to personnel, $10,370 17,283 

histocomoatibilitv. and laboratorv director site visit 

Travel for site visits-Driving $150,800 $678 745 

Travel for site visits-Flving $478.400 $956 800 

Total Increased cost $21,163,750 $31,034 043 
Federal Register / Vol. 87, No. 142 / Tuesday, July 26, 2022 / Proposed Rules 44925 

1. Fees 

This proposed rule impacts 

approximately 265,335 CLIA certified 

laboratories. Certificate of Waiver (CoW) 

= 201,767; Certificate of Provider 

Performed Microscopy (PPM) = 29,988; 

Certificate of Registration (CoR) = 2,826; 

Certificate of Compliance (CoC) = 

17,799; Certificate of Accreditation 

(CoA) = 15,781. (Data from Quality, 

Certification and Oversight Reports 

(QCOR) as of September 27, 2020) 

a. Two-Part Biennial Survey Fees 

(1) CoC Laboratories Compliance Survey 

Fees 

Table 12 reflects the national average 

of compliance fees for each 

classification of laboratories (schedules) 

that requires inspection. Specifically, 

Table 12 represents the national average 

for each schedule for the current 

Compliance Survey Fees (noted with a 

‘‘c’’) as paid biennially by laboratories 

that hold a CoC and the national average 

for each schedule for the new 

Compliance Survey Fees (noted with a 

‘‘n’’) that will be paid after the first 

biennial two-part fee increase 

(estimating a 5 percent increase as a low 

estimate and a 20 percent increase as a 

high estimate) by laboratories that hold 

a CoC. As discussed in section II. of this 

proposed rule, Table 12 shows 

estimated increases for CoC laboratories 

subject to the biennial fee increase. 

(2) CoA Laboratories Validation Survey 

Fees 

Table 13 shows the national average 

of the Validation Survey Fee for each 

schedule of accredited laboratory. 

Specifically, Table 13 represents the 

national average fees for each schedule 

for the current Validation Survey Fee 

(noted with a ‘‘c’’) as paid biennially by 

laboratories that hold a CoA and the 

national average for the new Validation 

Survey Fee (noted with an ‘‘n’’) that will 

be paid the first biennial two-part fee 

increase (estimating a 5 percent increase 

as a low estimate and a 20 percent 

increase as a high estimate) by 

laboratories that hold a CoA. As 

discussed in section II. of this proposed 

rule, Table 13 shows estimated 

increases for CoA laboratories subject to 

the biennial fee increase. 


khammond on DSKJM1Z7X2PROD with PROPOSALS3EP26JY22.136</GPH> EP26JY22.137</GPH>

Low estimate timate 

CLIAFeeRe $9,144,894 $29,661,467 

$9,144,894 $29,661,467 

TABLE 12: Two-part fee for CoC Survey Fees* 

Laboratory Current New average New Number of Number of 

classification average (c) (n) average Laboratories per Laboratories 

(schedules) Low increase (n) schedule* per schedule 

=5% High divided by 2•• 

increase= 

20% 

V $360 $378 $432 6,462 3231 

A $1,192 $1,251.60 $1,430 4,054 2027 

B $1,591 $1,670.55 $1,909 147 73.5 

C $1,988 $2,087.40 $2,386 2.032 1.016 

D $2,336 $2,452.80 $2,803 176 88 

E $2,684 $2,818.20 $3,221 1,427 713.5 

F $3,032 $3,183.60 $3,638 815 407.5 

G $3,380 $3,549 $4,056 517 258.5 

H $3,728 $3,914.40 $4,474 1,733 866.5 

I $4,076 $4,279.80 $4,891 195 97.5 

J $4,408 $4,628.40 $5,290 189 94.5 

*Number of CoC labs by laboratory classification (schedules) (Data from Certification and 

Survey Provider Enhanced Reporting (CASPER) 0086S CLIA Laboratories Schedule Counts) Includes CoR labs 

of application type CoC. 

**The fees are biennial; therefore, approximately half the CoC laboratories are affected ammally. 
44926 Federal Register / Vol. 87, No. 142 / Tuesday, July 26, 2022 / Proposed Rules 

(3) Certificate of Waiver (CoW) Waived 

Test Categorization Certificate Fee 

Table 14 shows the additional fee to 

be added to Certificates of Waiver (CoW) 

to offset program obligations to FDA for 

its role in the categorization of tests and 

test systems as waived. Specifically, 

Table 14 represents the certificate fee 

(noted with a ‘‘c’’) as paid biennially by 

laboratories that hold a CoW and the 

new certificate Fee (noted with an ‘‘n’’) 

that will be paid by laboratories that 

hold a CoW using the current number of 

CoW labs for the low estimate and the 

current number plus 10,000 new CoW 

for the high estimate. As discussed in 

section II. of this proposed rule, Table 

14 reflects a total increase of $25 as each 

laboratory’s part of the Waived test 

categorization fee. 

(4) Two-Part Biennial Certificate Fees 

Table 15 shows the national average 

of the certificate fee for each schedule 

for the CoC and CoA laboratories and 

shows the CoW, PPM, and CoR 

certificate fees. Specifically, Table 15 

represents the national average fees for 

each schedule for the CoC and CoA 

Certificate Fee and the CoW, PPM, and 

CoR (noted with a ‘‘c’’) as paid 

biennially by laboratories that hold a 

CoC, CoA, CoW, PPM, or CoR and the 

national average fees for each schedule 

for the new CoC and CoA Certificate Fee 

and the CoW, PPM, and CoR (noted 

with an ‘‘n’’) that will be paid after the 

first biennial two-part fee increase 

(using 5 percent to arrive at a low 

estimate and 20 percent to arrive at a 

high estimate) by laboratories that hold 

a CoC, CoA, CoW, PPM, or CoR. As 

discussed in section II. of this proposed 

rule, Table 15 reflects estimated 

increases for all laboratory types subject 

to the biennial fee increase. 


khammond on DSKJM1Z7X2PROD with PROPOSALS3EP26JY22.138</GPH> EP26JY22.139</GPH>

TABLE 13: Two-part fee for Certificate of Accreditation (CoA) Validation Survey Fees* 

Laboratory Current New average New Number of Number of 

classification average (c) (n) average laboratories per Laboratories 

(schedules) 5% (n) schedule* per schedule 

20% divided by 2** 

V $18 $18.9 21.6 2,108 1054 

A $60 $63 72 2,522 1261 

B $80 $84 96 135 67.5 

C $99 $103.95 118.8 1,739 869.5 

D $117 $122.85 140.4 189 94.5 

E $134 $140.7 160.8 1,524 762 

F $152 $159.6 182.4 900 450 

G $169 $177.45 202.8 612 306 

H $186 $195.3 223.2 3,043 1521.5 

I $204 $214.2 244.8 1,098 549 

J $220 $231 264 1,914 957 

*Number of CoA labs by laboratory classification (schedules) (Data from CASPER 0086S CLIA Laboratories 

Schedule 

Counts) Includes CoR labs of application type CoA. 

**The fees are biennial; therefore, approximately half the CoA laboratories are affected annually. 

TABLE 14: Certificate of Waiver (CoW) Waived Test Categorization Fee* 

Type of CLIA certificate Current New Fee (n) based on current number 

Fee (c) ofCoWlabs 

Certificate of Waiver $180 $205 (CoW) 

*Total CoW labs as of9-27-2020 = 201,767 / 2 = 100,883.50 (data from QCOR) for 

the low estimate. Addition of 10,000 new CoW labs 211,767/2 = 105,883.50 for the 

high estimate. The fees are biennial; therefore, approximately half the CoW 

laboratories are affected annually. 
Federal Register / Vol. 87, No. 142 / Tuesday, July 26, 2022 / Proposed Rules 44927 

b. Proposed New Replacement and 

Revised Fees 

Table 16 shows the cost of the 

replacement and revised certificate fees 

for each certificate type. These fees have 

not been charged prior to this proposed 

rule. A low estimate used the current 

number of laboratories and a high 

estimate used the number of labs plus 

half again that amount. 

c. New Additional Fees 

Table 17 shows the cost of the 

additional fees added by this proposed 

rule. These fees are only paid by 

laboratories with substantiated 

complaint surveys, unsuccessful 

performance of PT, or follow-up surveys 

for the determination of correction of 

deficiencies found on an original 

survey. 


khammond on DSKJM1Z7X2PROD with PROPOSALS3EP26JY22.140</GPH> EP26JY22.141</GPH>

TABLE 15: Two-part Biennial Certificate Fee 

TypeofCLIA Laboratory Current New fee New fee (n) 

Certificate schedule fee (c) (n) using using20% 

5%forthe for the high 

low estimate 

estimate 

Certificate of Waiver (CoW) Not $205.00 $215.25 246.00 

annlicable 

Certificate of Provider Performed Not $240.00 $252.00 288.00 

Microscopy (PPM) applicable 

Certificate of Compliance (CoC) V $180.00 $189.00 216.00 

and Certificate of Accreditation 

(CoA) 

CoCandCoA A 180.00 189.00 216.00 

CoCandCoA B 180.00 189.00 216.00 

CoCandCoA C 516.00 541.80 619.20 

CoCandCoA D 528.00 554.40 633.60 

CoCandCoA E 780.00 819.00 936.00 

CoCandCoA F 1 320.00 1 386.00 1 584.00 

CoCandCoA G 1860.00 1953.00 2 232.00 

CoCand CoA H 2 448.00 2 570.40 2 937.60 

CoCandCoA I 7 464.00 7 837.20 8 956.80 

Coe andCoA J 9,528.00 10,004.40 11,433.60 

Certificate of Registration (CoR) Not $100 $105 120.00 

annlicable 

*Number of laboratories from QCOR and CASPER 0086S CLIA Laboratories Schedule Counts. 

**The fees are biennial; therefore, approximately half the CoA laboratories are affected annually. 

Number of 

laboratories* 

201,767 

29,988 

Coe CoA 

6,462 2,108 

4,054 2,522 

147 135 

2.032 1 739 

176 189 

1,427 1524 

815 900 

517 612 

1.733 3 043 

195 1098 

189 1,914 

2,826 

TABLE 16: CLIA Replacement and Revised Certificates FY2019* 

Certificate Number of Replacement Cost of Number of Revised 

Number of 

Laboratories 

divided by 2** 

100,883.5 

14,994 

Coe CoA 

3231 1054 

2027 1261 

73.5 67.5 

1.016 869.5 

88 94.5 

713.5 762 

407.5 450 

258.5 306 

866.5 1521.5 

97.5 549 

94.5 957 

1,413 

Cost of 

type Certificates issued in Replacement Certificates issued in Revised 

FY2019 Certificate FY2019 

CoC 259 $75 515 

cow 2,824 $75 6,985 

CoA 496 $75 505 

PPM 525 $75 984 

Total: 4104 $75 8989 

• Number of Replacement and Revised Certificates FY2019 (Data from CASPER 0 104D CLIA 

116 Activity report). 

Certificate 

$150 

$95 

$150 

$95 

$150 
44928 Federal Register / Vol. 87, No. 142 / Tuesday, July 26, 2022 / Proposed Rules 

d. Histocompatibility, Personnel, and 

Alternative Sanctions for CoW 

Laboratories 

This proposed rule, if finalized, could 

impact all of the 271,399 CLIA-certified 

laboratories (accessed from the CMS 

Quality Improvement Evaluation 

System (QIES) database October 4, 2019) 

to some extent. The changes to the 

personnel requirements would impact 

34,082 CoC and CoA laboratories, as 

well as 31,982 PPM Certificate 

laboratories. The histocompatibility 

changes would impact 218 CoC and 

CoA laboratories certified for this 

specialty; and the allowance for 

alternative sanctions could impact 

201,767 CoW laboratories only if they 

are found to be out of compliance with 

CLIA and subject to sanctions. The 

proposed rule, if finalized, would also 

impact the seven CLIA-approved AOs 

and two exempt states. Although 

complete data are not available to 

calculate all estimated costs and 

benefits that would result from the 

changes proposed in this rule, we are 

providing an analysis of the potential 

impact based on available information 

and certain assumptions. 

Implementation of these proposed 

requirements in a final rule would result 

in changes that are anticipated to have 

both quantifiable and non-quantifiable 

impacts on laboratories, AOs, and 

exempt states, as specified above. In 

estimating the quantifiable impacts, we 

include costs to CoC, CoA, and PPM 

laboratories that could result from the 

need to update policies and procedures. 

We also estimate costs for travel 

expenses that laboratories may incur to 

meet the proposed requirement to have 

an LD on-site at least once every 6 

months. For quantifiable impacts on 

AOs and exempt states, we estimate the 

costs for updating their policies and 

procedures to reflect the new 

requirements, if finalized, for personnel 

and histocompatibility. 

2. Quantifiable Impacts 

a. Laboratory Costs To Update Policies 

and Procedures 

If this rule is finalized, we expect that 

the 33,580 CoC and CoA laboratories 

would incur costs for the time needed 

to review the revised personnel 

regulations and update their policies 

and procedures to be in compliance 

with them. We assume a one-time 

burden of 5 to 7 hours per laboratory to 

review and update affected policies and 

procedures, and we assume the person 

performing this task would be a 

management level employee paid 

$115.22 per hour (wages, salary and 

benefits; www.bls.gov/news.release/ 

ecec.t02.htm). Therefore, we estimate 

the one-time costs for CoC and CoA 

laboratories to update policies and 

procedures to comply with the revised 

personnel requirements would range 

from $19,634,640 to $27,488,496 (see 

Table 18). 

Similarly, we expect that the 29,998 

PPM laboratories would incur costs for 

the time needed to review and update 

the one change clarifying the 

requirement for CAs in PPM 

laboratories. We assume a one-time 

burden of 0.25 to 0.5 hours per 

laboratory for this task, also to be 

performed by a management level 

employee paid $115.22 per hour (wages, 

salary and benefits). Therefore, we 

estimate the one-time costs for PPM 

laboratories to update the single revised 

policy and procedure to comply with 

the personnel requirements would range 

from $864,092 to $1,728,185 (see Table 

18). 

If finalized, the changes to the 

histocompatibility requirements would 

affect approximately 218 laboratories 

that perform testing in this specialty 

(QIES database October 4, 2019). While 

these laboratories are included in the 

calculations above, they may need to 

make additional changes to their 

policies and procedures for the 

histocompatibility updates, if the 

proposed rule is finalized. We assume a 


khammond on DSKJM1Z7X2PROD with PROPOSALS3EP26JY22.142</GPH>

TABLE 17: New Additional Fees 

Affected Total Range of Cost Estimate for 

Proposed CLIA Number of Hourly Hours Proposed new fees per 

Fees Certificate Affected Cost Occupation incident 

type(s) Laboratories Low High Low High Estimate * Estimate 

Substantiated All Laboratory $150.22 13-1041 

Complaints types 56 1 43-1011 5.00 184.75 $751.10 $27,753.15 

43-9199 

Unsuccessful Certificate of 13-1041 

Proficiency Compliance 1,308 $150.22 43-1011 1.25 32.25 $187.78 $4,844.60 

Testing (PT) (CoC) 43-9199 laboratories 

Certificate of 

Compliance 

Follow-up (CoC) & 13-1041 

Surveys2 Certificate of 225 $150.22 43-1011 8.65 19.08 $1,299.40 $2,866.20 

Accreditation 43-9199 

(CoA) 

laboratories 

Total $2,238.30 $35,463.95 Estimated Cost 

*Total number of affected laboratories is based on actual numbers from FY2019; Data from CASPER reporting system. 

1$75.11 hourly rate includes $27.79 (13-1041: Compliance Officer)+ $28.91 (43-1011: First-Line Supervisors of Office and 

Administrative Support Workers)+ $18.41 (43-9199: Office and Administrative Support Workers, All Other). The wage rate 

would be doubled to $150 .22 to include overhead and fringe benefits. Data from the Department of Labor. 

2lncludes Follow-up surveys on CoC and CoA laboratories and for Addition of Specialties. 
Federal Register / Vol. 87, No. 142 / Tuesday, July 26, 2022 / Proposed Rules 44929 

one-time burden of one to two hours per 

laboratory for this task, as described 

above. Therefore, the laboratory costs 

for updating policies and procedures 

related to histocompatibility would 

range from $25,118 to $50,236 (see 

Table 18). 

b. Accreditation Organization and 

Exempt State Costs To Update Policies 

and Procedures 

If the proposed changes are finalized, 

seven approved accrediting 

organizations and two exempt states 

would have to review their policies and 

procedures, provide updates and submit 

the changes to us for approval. We 

estimate a one-time burden of 10 to 15 

hours to identify the applicable legal 

obligations and to develop the policies 

and procedures needed to reflect the 

new requirements for personnel and 

histocompatibility. We assume the 

person performing this review will be a 

management level employee paid 

$115.22 per hour (wages, salary and 

benefits). Therefore, we estimate the 

costs for accrediting organizations and 

exempt states to update their policies 

and procedures would range from 

$10,370 to $17,283 (see Table 18). 

c. Laboratory Costs for On-Site 

Laboratory Director Requirement 

Estimating the potential travel costs 

for LD to meet the on-site requirement 

is complex, due to wide variation in the 

numbers of individuals who might incur 

travel costs, variation in the distances 

traveled and modes of transportation 

used, and variation among already 

existing state and accreditation 

requirements for LD to be on-site at 

some frequency. In addition, we had 

limited available data on which to base 

our assumptions. Therefore, we used an 

approach in calculating our estimates 

such that the estimates described below 

may be higher than actual costs that 

would be incurred if the proposed 

change is finalized. We are requesting 

public comments and data to assist us 

in estimating this impact in the final 

rule. 

In general, 11 states, one territory, and 

three out of seven AOs currently have 

some requirement for on-site visits by 

LD, although the required frequencies 

vary. Ten states, including the exempt 

state of New York, (Supplemental Table) 

plus the territory of Puerto Rico 

currently have requirements that are as 

stringent or more stringent than the 

proposed provision that requires a LD to 

be on-site at least once every 6 months. 

Therefore, we have not counted CoC 

laboratories in these 10 states or in 

Puerto Rico among those that would be 

impacted if the proposed requirement 

for on-site LD visits was finalized. One 

accrediting organization (AABB) now 

requires on-site LD visits at least once 

a quarter. However, AABB only 

accredits 265 laboratories, or 

approximately 1.6 percent, of all 

accredited laboratories (QIES database, 

October 4, 2019). Some of these 

laboratories are part of a hospital or 

other health care system that has 

laboratory specialties accredited for 

CLIA purposes by one or more of the 

other accrediting organizations, and 

therefore, would be impacted by the 

proposed requirement for on-site LD 

visits. Since we do not have data to 

determine the number of such 

laboratories that are only accredited by 

AABB and already be meeting this 

proposed requirement, and the number 

is likely to be relatively small, we are 

not adjusting the number of impacted 

laboratories based on AABB 

accreditation. 

In the 40 states, four territories, and 

the District of Columbia, where the LD 

is not required to be on-site at least 

twice per year, 26,007 CoC and CoA 

laboratories (QIES, October 4, 2019) may 

not meet this new requirement, if 

finalized, and may incur travel costs. 

We have not adjusted this number 

where the proposed provision was 

partially met, since no frequency was 

specified for CoC laboratories in three 

additional states, CoA laboratories 

under two additional accrediting 

organizations, or laboratories in the 

exempt State of Washington. 

We assume that in most instances, the 

LD is on-site daily or otherwise more 

frequently than twice per year. Based on 

a review of state and AO information, 

discussed earlier in the preamble for 

this proposed rule, we assume that 

between 5 percent (1300) and 20 percent 

(5201) of the CoC and CoA laboratories 

would need their LD to travel to the 

laboratory twice a year to meet this 

requirement. For our estimate, we 

assumed this travel would include a 

combination of two modes of 

transportation, driving, and flying. For 

the low estimate, we assumed that 1 

percent of the 26,007 laboratories, or 


khammond on DSKJM1Z7X2PROD with PROPOSALS3EP26JY22.143</GPH>

TABLE 18: Estimated Costs to Update Policies and Procedures 

Proposed Total Range of Cost Estimate for 

Regulation Affected Group Number of Hourly Hours Personnel and Histocompatibility 

Affected Cost Proposed Chan2es Change Groups Low Hi2h Low Estimate Hi2h Estimate 

Personnel CoC&CoA 33,580 $115.22 5 7 $19,634,640 $27,488,496 Laboratories 

PPM 29,988 $115.22 0.25 0.50 $864,092 $1,728,185 Laboratories 

Histocompatibility CoC&CoA 218 $115.22 1 2 $25,118 $50,236 Laboratories 

Accrediting 

Personnel, Organizations 9 $115.22 10 15 $10,370 $17,283 Histocompatibility and Exempt 

States 

Total Increased Cost $20,534,220 $29,284,500 
44930 Federal Register / Vol. 87, No. 142 / Tuesday, July 26, 2022 / Proposed Rules 

260, would compensate their directors 

for flights while 4 percent, or 1,040 

laboratories, would compensate them 

for their mileage to drive. For the high 

estimate, we assumed that, at most, 2 

percent of the 26,007 laboratories, or 

520, would compensate their LD for 

flying, and the other 18 percent, or 

4,681 laboratories, would compensate 

for driving. 

• Driving: We believe most LD would 

drive fewer than 250 miles round trip to 

reach the laboratories they direct. We 

assume these LD would drive to the 

location, conduct business, and return 

home the same day. We base our 

calculations for driving on the 

maximum estimated distance of 250 

miles at $0.58 cents per mile 

(Government travel reimbursement rates 

for mileage (https://www.gsa.gov/travelresources)) for a maximum cost of 

$145.00 per trip. This may be an 

overestimate since we believe not all the 

individuals who drive would travel 250 

miles round trip. Based on the low 

estimate of 1,040 laboratories incurring 

costs for driving and our high estimate 

of 4,681 laboratories incurring costs for 

driving, our calculated cost for driving 

is estimated to range from $150,800 to 

$678,745 (see Table 19). 

• Flying: Our estimates for the cost of 

flying assume that travel to a remote site 

would be necessary in these cases. We 

believe basing it on travel to a remote 

site will over-estimate the cost since in 

many locations, although the LD may fly 

to reach their destination, they would 

not travel to remote locations, and the 

travel costs would be less. However, we 

do not know the specific circumstances 

for which flying would be required. We 

estimated the maximum airfare for this 

travel to be $1500 and lodging costs to 

average $170.00 per night (based on the 

average of 100 hotel rates throughout 

the U.S. in 2019 (https://

www.businesstravelnews.com/ 

uploadedFiles/9._Microsites/Corporate_

Travel_Index/Corporate_Travel_Index_

2019/US_Diem/4-5_USHotelDetail.pdf)). 

We assumed lodging for two nights 

would be needed. Therefore, the 

estimated cost for one trip would be 

$1500 flight + $340.00 lodging or 

$1840.00 per trip. Based on the low 

estimate of 260 laboratories incurring 

costs for remote travel and our high 

estimate of 520 laboratories incurring 

costs for remote travel, the range for 

laboratory costs for flying to on-site 

visits would be between $478,400 and 

$956,800 (see Table 19). 

Based on these assumptions for both 

driving and flying, if this proposed rule 

is finalized, we estimate the total cost 

for laboratories to compensate for LD 

travel would range from $629,200 to 

$1,635,545. 

d. Results 

We estimate that the overall impact of 

adding requirements for the proposed 

changes in personnel, 

histocompatibility, and travel for LD onsite visits will range from $11,421,708 to 

$16,983,208 in the first year (see Tables 

18 and 19) if these proposed changes are 

finalized. 

For each of the changes, Table 20 

shows the projected range of cost 

estimates annually for 5 years starting in 

2020. We assume costs for updating 

policies and procedures will be onetime costs only incurred in 2021. We 

presume the travel costs will be ongoing 

and will not change significantly over 

the 5-year period. The maximum cost 

estimate of approximately $16.1 million 

for the first year based on 2020 costs 

and approximately $1.6 million for 

subsequent years is not considered a 

significant economic impact. This 

proposed rule does not reach the 

economic threshold and thus is not 

considered a major rule. We request 

comments and additional data to assist 

us in making a more thorough and 

accurate prediction of impact of the 

final rule. 

BILLING CODE 4120–01–P 


khammond on DSKJM1Z7X2PROD with PROPOSALS3EP26JY22.144</GPH>

TABLE 19: Estimated Travel Costs to Meet On-site Laboratory Director Requirement 

Proposed Airfare Hotel Driving Cost Total Low Impact for 

Affected Total Number of Cost Personnel and Regulation Group Affected Group Cost ($170/2 ($0.58/mile*250 Histocompatibility Change ($1,500) niehts) miles) Re!!lllation Chanees 

CoAand Low High Low High On-Site CoC 

Laboratory Laboratories Estimate Estimate estimate estimate 

Director Drivine 1.040(4%) 4 681(18%) NA NA $145 $150 800 $678 745 

Flvin2 260 (1%) 520(2%) $1500 $340 NIA $478 400 $956 800 

Total Increased Cost $629 200 $1635 545 

EP26JY22.145</GPH>khammond on DSKJM1Z7X2PROD with PROPOSALS3

TABLE 20: Five-Year Projection for Total Estimated Annual Costs for Proposed Histocompatib

Reeulaf 

Proposed Change 2023 2024 2025 2026 

Low Bi11:h Low Bi!!h Low Bi!!h Low Bi11:h 

Laboratories updating 

policies and procedures $10,787,073 $15,339,510 $0 $0 $0 $0 $0 $0 

related to personnel and histocomoatibilitv 

Accrediting 

organizations and 

exempt states updating 

policies and procedures $5,435 $8,153 $0 $0 $0 $0 $0 $0 

related to personnel, 

histocompatibility, and 

laboratory director site 

visit 

Travel-Driving $150 800 $678,745 $150,800 $678,745 $150 800 $678 745 $150 800 $678 74

Travel-Flying $478 400 $956,800 $478,400 $956,800 $478 400 $956 800 $478 400 $956 80

Total Increased cost $11,421.708 $16.983,208 $629.200 $1,635.545 $629.200 $1.635,545 $629,200 $1,635.5

* Low/high estimates represent the sum of estimates in Table 17 to update policies and Table 18 to estimate travel costs. 
44932 Federal Register / Vol. 87, No. 142 / Tuesday, July 26, 2022 / Proposed Rules 

BILLING CODE 4120–01–C 

e. Non-Quantifiable Impacts and 

Benefits 

(1) CLIA Fees 

CMS has limited knowledge of the 

non-quantifiable impacts and benefits 

and is seeking public comment on this 

topic. 

(2) Histocompatibility, Personnel, 

Alternative Sanctions 

If the changes proposed in this rule 

for histocompatibility, personnel, and 

alternative sanctions are finalized, 

several non-quantifiable impacts, most 

of which are considered benefits, will 

result for laboratories, accrediting 

organizations, and exempt states 

concerning changes in the requirements 

for personnel, histocompatibility, and 

alternative sanctions for CoW 

laboratories. We solicit comments and 

data to determine quantifiable estimates 

for these non-quantifiable impacts in the 

final rule. 

Many personnel changes proposed in 

this rule would decrease the burden and 

provide greater flexibility for 

laboratories by increasing the number of 

eligible candidates for some personnel 

categories by expanding and clarifying 

the qualifying degrees. Examples of 

these proposed changes that would 

increase the number of qualified 

candidates for personnel categories 

include the addition of: clinical nurse 

specialists and certified registered nurse 

anesthetists in the definition of midlevel 

practitioners, a bachelor’s degree in 

respiratory therapy as a possible 

qualifying degree as a TC and TP for 

moderate and high complexity blood gas 

testing, an associate or bachelor of 

nursing degree as a qualifying degree for 

moderate complexity TP, and a bachelor 

of nursing degree as a qualifying degree 

for high complexity TP. Adding these 

options as qualifying degrees does not 

preclude the need for individuals to 

meet clinical laboratory training and 

experience requirements. Another 

proposed personnel change that would 

decrease burden, increase flexibility for 

laboratories, and streamline regulations 

is aligning the technical supervisor 

qualifications for laboratories 

performing immunohematology with 

those of other specialties such as 

hematology. Instead of limiting those 

qualified to serve as a technical 

supervisor in immunohematology to 

individuals with a doctor of medicine or 

doctor of osteopathy degree and 

appropriate certification and 

experience, if this proposed rule is 

finalized, individuals may also qualify 

with a doctoral, master’s, or bachelor’s 

degree in a chemical, biological, or 

clinical laboratory science or medical 

technology and 1, 2, or 4 years 

applicable experience, respectively. All 

of these proposed changes, if finalized, 

would streamline the regulations and 

could increase a laboratory’s ability to 

find qualified personnel, especially in 

rural areas. As it is not possible to 

predict the pathway a laboratory would 

use to qualify individuals when hiring 

personnel, we cannot quantify the 

impacts that would result. However, we 

request comments and data to assist us 

in estimating these impacts in the final 

rule. 

If the rule is finalized, several other 

changes being proposed in this rule will 

impact laboratories and their personnel. 

However, we do not have data to 

quantify the impact. One proposed 

change is the qualification requirement 

for 20 CE credit hours, as defined, to 

cover LD responsibilities as defined in 

the regulations prior to serving as an LD. 

This requirement would apply to LD for 

both moderate and high complexity 

testing except for those doctors of 

medicine, osteopathy, or podiatry who 

are certified by the American Board of 

Pathology, the American Osteopathic 

Board of Pathology, or other boards 

approved by HHS. Although there 

would be costs associated with 

obtaining these credits, currently 

employed LD, at the effective date of the 

final rule, will not be required to obtain 

the 20 CE credit hours to retain their 

employment status. In the future, we 

cannot predict the number of 

laboratories that would choose to hire a 

LD through the qualification route that 

would require the 20 CE credit hours. 

Another proposed change that could 

impact laboratories that cannot be 

quantified is the removal of physical 

science degrees as qualifying degrees for 

any personnel categories. As stated 

above, we cannot predict the number of 

laboratories that may have otherwise 

chosen to hire personnel with a physical 

science degree. Currently, employed 

laboratory personnel, at the effective 

date of the final rule, will not be 

disqualified. We request comments and 

data to assist us in more accurately 

estimating these impacts in the final 

rule. 

The changes to the histocompatibility 

requirements proposed in this rule 

would impact laboratories, accrediting 

organizations, and exempt states if 

finalized. This proposed rule would 

streamline the histocompatibility 

requirements and remove those that are 

no longer relevant based on current 

testing practices, adding flexibility for 

laboratories and removing perceived 

barriers to current practices. It would 

remove specific requirements that are 

redundant with those covered in general 

under §§ 493.1251, 493.1252, 493.1256, 

and 493.1445, simplifying the 

requirements related to procedure 

manuals; test systems, equipment, 

instruments, reagents, materials, and 

supplies; control procedures; and LD 

responsibilities. We believe these 

impacts would decrease the burden and 

positively affect laboratories certified to 

perform testing in this specialty, as well 

as health care providers and patients. 

We request comments and data to assist 

us in more accurately estimating the 

impact of these histocompatibility 

changes in the final rule. 

Last, concerning the alternative 

sanctions provision being proposed in 

this rule, when finalized, the rule would 

allow us discretion in imposing 

alternative sanctions (that is, civil 

money penalties (CMP), directed plan of 

correction, directed portion of a plan of 

correction, and on-site state 

monitoring), rather than only being able 

to impose principal sanctions (that is, 

revocation, suspension, limitation of the 

CLIA certificate), in CoW laboratories, if 

appropriate. We believe this change 

would increase flexibility, decrease 

potential burden while moving those 

laboratories toward compliance, and 

have no added economic impact on 

CoW laboratories. As previously 

described, an example of when this 

proposed regulatory change could 

decrease the burden would be in the 

case of sanctions imposed for improper 

proficiency testing referral. Although we 

have no data indicating that principal 

sanctions have been imposed on CoW 

laboratories for this reason in the past, 

if it occurred in the future, the ability to 

impose alternative sanctions, if 

appropriate, would be less punitive and 

potentially decrease any quantifiable 

economic impact. At this time, we 

cannot quantify what that impact would 

be. 

D. Alternatives Considered 

1. CLIA Fees 

We considered multiple options prior 

to this proposed rule, including limiting 

across-the- board increase to varying 

percentages and timeframes required to 

achieve reasonable carryover targets for 

the CLIA program as a whole. We 

discussed multiple options in the notice 

with comment period (NC), including 

limiting the increase to varying 

percentages and timeframes across a 

single fee type, specifically Compliance 

Fees. When preparing the NPRM, we 

reviewed the alternatives in the NC to 

see if they were viable moving forward. 

The approach proposed here was the 

best scenario for longevity for 


khammond on DSKJM1Z7X2PROD with PROPOSALS3
Federal Register / Vol. 87, No. 142 / Tuesday, July 26, 2022 / Proposed Rules 44933 

20 83 FR 67723, December 31, 2018 (https://

www.govinfo.gov/content/pkg/FR-2018-12-31/pdf/ 

2018-28359.pdf). 

maintaining the fiscal solvency of the 

user-funded CLIA program. We have 

determined that 2 quarters worth of 

obligations were a reasonable carryover 

target based on program funding 

requirements and the time to 

accumulate and make available current 

year fee collections. We have also 

decided to build up to the carryover 

target over a 3-year period to avoid 

either overcharging or undercharging. 

For example, we considered the 

following options: 

• Setting various one-time dollar 

level fee increases for Certificate of 

Waiver laboratories. 

• Setting various percentage increases 

for the one-time across-the-board 

increase. 

Public comments received from the 

2018 notice with comment period 

(Medicare Program; Clinical Laboratory 

Improvement Amendments of 1988 

(CLIA) Fees) 20 were considered during 

rulemaking. We are also seeking public 

input on additional alternatives to 

consider. 

2. Histocompatibility, Personnel, 

Alternative Sanctions 

Several alternatives were considered 

in developing these proposed changes to 

the histocompatibility, personnel, and 

alternative sanctions requirements 

under CLIA. In all cases, one option 

would be to leave the regulations as 

written. However, because many of the 

changes being proposed for 

histocompatibility and personnel 

resulted from public input via the 2018 

RFI and recommendations made by 

CLIAC and would add flexibility, 

remove redundant or obsolete 

requirements, clarify and streamline the 

regulations, and decrease burden while 

maintaining laboratory quality, we 

perceived that not making these changes 

would not be preferable. Also, the 

proposed change to allow alternative 

sanctions to be imposed on CoW 

laboratories aligns the regulations with 

the CLIA statute; therefore, no other 

options were considered. 

Regarding the histocompatibility 

requirements, we initially considered 

only removing the crossmatch 

regulatory requirement at 

§ 493.1278(f)(2) which was perceived as 

a barrier to current practice with kidney 

transplantation. However, we decided to 

obtain input from stakeholders to 

identify any concerns regarding 

crossmatching and other current 

regulatory requirement under the 

histocompatibility specialty. Our 

purpose for seeking stakeholder input 

through CLIAC and the 2018 RFI was to 

obtain information on whether the 

current histocompatibility requirements, 

including requirements for 

crossmatching, needed to be revised 

from when CLIA was published in 1998 

and 2003 to reflect the current practice. 

Our proposed revision reflects our 

attempt to address the inputs from the 

stakeholders and are intended to reflect 

the current practices as provided to 

CMS by the stakeholders through the 

2018 RFI and CLIAC. 

One of the personnel requirements 

being proposed is to require that LD of 

moderate and high complexity testing, 

who are qualified through an 

educational pathway other than being a 

certified anatomic or clinical 

pathologist, have at least 20 CE credit 

hours related to their LD 

responsibilities. We considered 

requiring this of all LD. However, since 

pathologists obtain this education as 

part of their education and training, it 

would be redundant and could increase 

costs to require this, although we do not 

have data to estimate what those costs 

would be since we do not know how 

many LD would qualify using this 

pathway. We believe it is appropriate to 

propose this requirement for other LD 

qualification routes. This information is 

critical for fulfilling LD responsibilities 

and is not always included in education 

and training for alternative qualification 

pathways. 

Another LD requirement proposed in 

this rule is on-site visits to the 

laboratory at least once every 6 months, 

with at least a 4-month interval between 

on-site visits. We considered requiring 

these visits at a different frequency or 

not adding this requirement. However, 

surveyors reported that laboratories in 

which the director is not on-site tend to 

have more issues and citations when 

inspected, and ten states, the territory of 

Puerto Rico, and one of the CLIAapproved AOs already require LD to be 

on-site at least once every 6 months. As 

a result, CLIAC recommended that LD 

make and document at least two 

reasonably spaced on-site visits per year 

to supplement other interactions with 

staff and verify that the laboratory 

complies with laws and regulations. We 

agree with the CLIAC recommendation 

that two on-site visits per year is an 

appropriate frequency to achieve the 

intended improvement in laboratory 

compliance without adding a significant 

burden to laboratories. We will monitor 

this impact if the proposal is finalized. 

Requiring these visits at a greater 

frequency and keeping all other factors 

the same would increase total projected 

costs for each on-site visit added per 

year. While requiring on-site visits only 

once per year would reduce estimated 

costs, it could delay the potential time 

it takes to identify laboratory issues that 

could ultimately result in patient harm. 

A third personnel requirement proposed 

in this rule for which we considered 

various options is the expansion of the 

definition of midlevel practitioners to 

include certified registered anesthetists, 

and clinical nurse specialists as 

personnel qualified to serve as a LD or 

TP in PPM laboratories. Currently, this 

definition is limited to nurse midwives, 

nurse practitioners, or physician 

assistants, licensed by the state where 

the individual practices, if required in 

the state where the laboratory is located. 

We considered not expanding this 

definition or expanding it to include 

only one of the proposed categories. 

However, certified registered 

anesthetists and clinical nurse 

specialists are both considered 

advanced practice registered nurses, as 

are certified nurse midwives and nurse 

practitioners. All four categories require 

at least a master’s degree in nursing, and 

all may play a role in providing primary 

and preventive care services to the 

public. This may include performing the 

microscopic examinations required 

under PPM. As there is no expected 

cost-increasing impact of adding either 

of these nursing categories to the 

midlevel practitioner definition, and the 

change would increase flexibility and 

access to PPM testing, we are proposing 

it in this rule. We are requesting public 

comments related to alternative changes 

to be considered to assist us in 

finalizing this rule. 

E. Conclusion 

1. CLIA Fees 

Although the effect of the changes 

will increase laboratory costs, 

implementation of these changes would 

be negligible in terms of workload for 

laboratories as these fee increases are 

operational and technical in nature and 

do not require additional time to be 

spent by laboratory employees. 

2. Histocompatibility, Personnel, 

Alternative Sanctions 

We estimate that the cost to 

laboratories, accrediting organizations, 

and exempt states to comply with the 

changes proposed in this rule would 

range between $11,421,708 and 

$16,983,208 in 2020 dollars for the first 

year and between $629,200 and 

$1,635,545 in subsequent years. 

Although the proposed changes will 

increase laboratory costs, 

implementation of these changes, if 

finalized, streamline and simplify 


khammond on DSKJM1Z7X2PROD with PROPOSALS3
44934 Federal Register / Vol. 87, No. 142 / Tuesday, July 26, 2022 / Proposed Rules 

regulations, add flexibility in laboratory 

hiring practices, ensure that the LD is 

on-site at least twice per year, and align 

histocompatibility testing with current 

methods and practices. These changes 

will also allow alternative sanctions to 

be imposed on CoW laboratories. 

In accordance with the provisions of 

Executive Order 12866, this regulation 

was reviewed by the Office of 

Management and Budget. 

Chiquita Brooks-LaSure, Administrator 

of the Centers for Medicare & 

Medicaid Services, approved this 

document on July 6, 2022. 

Rochelle P. Walensky, MD, MPH, 

Director of the Centers for Disease 

Control and Prevention, approved this 

document on July 1, 2022. 

List of Subjects in 42 CFR Part 493 

Administrative practice and 

procedure, Grant programs-health, 

Health facilities, Laboratories, Medicaid, 

Medicare, Penalties, Reporting and 

recordkeeping requirements. 

For the reasons set forth in the 

preamble, the Centers for Medicare & 

Medicaid Services proposes to amend 

42 CFR chapter IV as set forth below: 

PART 493—LABORATORY 

REQUIREMENTS 

■ 1. The authority citation for part 493 

continues to read as follows: 

Authority: 42 U.S.C. 263a, 1302, 1395x(e), 

the sentence following 1395x(s)(11) through 

1395x(s)(16). 

■ 2. Amend § 493.2 by— 

■ a. Adding the definitions of 

‘‘Continuing education (CE) credit 

hours’’, ‘‘Doctoral degree’’, ‘‘Experience 

directing or supervising’’, and 

‘‘Laboratory training or experience’’ in 

alphabetical order; 

■ b. Revising the definition of ‘‘Midlevel 

practitioner’’; and 

■ c. Adding the definitions of 

‘‘Replacement certificate’’ and ‘‘Revised 

certificate’’ in alphabetical order. 

The additions and revision read as 

follows: 

§ 493.2 Definitions. 

* * * * * 

Continuing education (CE) credit 

hours means either continuing medical 

education (CME) or continuing 

education units (CEUs). The CE credit 

hours must cover the applicable 

laboratory director responsibilities and 

be obtained prior to qualifying as a 

laboratory director. 

* * * * * 

Doctoral degree means an earned 

post-baccalaureate degree with at least 

three years of graduate level study that 

includes research related to clinical 

laboratory testing or advanced study in 

clinical laboratory science or medical 

technology. For purposes of this part, 

doctoral degrees do not include doctors 

of medicine (MD), doctors of osteopathy 

(DO), doctors of podiatry, doctors of 

veterinary medicine (DVM) degrees, or 

honorary degrees. 

* * * * * 

Experience directing or supervising 

means that the director or supervisory 

experience must be obtained in a facility 

that meets the definition of a laboratory 

under this section and is not excepted 

under § 493.3(b). 

* * * * * 

Laboratory training or experience 

means that the training or experience 

must be obtained in a facility that meets 

the definition of a laboratory under this 

section and is not excepted under 

§ 493.3(b). 

Midlevel practitioner means a nurse 

midwife, nurse practitioner, nurse 

anesthetist, clinical nurse specialist, or 

physician assistant licensed by the State 

within which the individual practices, if 

such licensing is required in the State in 

which the laboratory is located. 

* * * * * 

Replacement certificate means an 

active CLIA certificate that is reissued 

with no changes made. 

* * * * * 

Revised certificate means an active 

CLIA certificate that is reissued with 

changes to one or more fields displayed 

on the certificate, such as the 

laboratory’s name, address, laboratory 

director, or approved specialties/ 

subspecialties. For purposes of this part, 

revised certificates do not include the 

issuance, renewal, change in certificate 

type, or reinstatement of a terminated 

certificate with a gap in service. 

* * * * * 

§ 493.557 [Amended] 

■ 3. Amend § 493.557 in paragraph 

(b)(4) by removing the reference 

‘‘§§ 493.645(a) and 493.646(b)’’ and 

adding in its place the reference 

‘‘§§ 493.649(a) and 493.655(b)’’. 

§ 493.575 [Amended] 

■ 4. Amend § 493.575 in paragraph (i) 

by removing the reference 

‘‘§§ 493.645(a) and 493.646(b)’’ and 

adding in its place the reference 

‘‘§§ 493.649(a) and 493.655(b)’’. 

■ 5. Section 493.638 is revised to read 

as follows: 

§ 493.638 Certificate fees. 

(a) Basic rule. Laboratories must pay 

a fee that covers the costs incurred for 

the issuance, renewal, change in 

certificate type, or reinstatement of a 

terminated certificate with a gap in 

service, and other direct administrative 

costs, as applicable. The total of fees 

collected by HHS under the laboratory 

program must be sufficient to cover the 

general costs of administering the 

laboratory certification program under 

section 353 of the PHS Act. 

(1) For registration certificates, the fee 

is a flat fee that includes the costs for 

issuing the certificates, collecting the 

fees, and evaluating whether the 

procedures, tests, or examinations listed 

on the application fall within the testing 

allowed for the requested certificate. 

(2) For a certificate of waiver, the fee 

includes the costs for issuing the 

certificate; collecting the fees; 

evaluating whether the procedures, 

tests, or examinations listed on the 

application fall within the testing 

appropriate for the requested certificate; 

and determining whether a laboratory 

test meets the criteria for a waived test. 

(3) For a certificate for PPM 

procedures, the fee includes the costs 

for issuing the certificate, collecting the 

fees; and evaluating whether the 

procedures, tests, or examinations listed 

on the application meet the criteria for 

inclusion in the subcategory of PPM 

procedures. 

(4) For a certificate of accreditation, 

the fee includes the costs for issuing the 

certificate, collecting the fees, 

evaluating the programs of accrediting 

bodies, and evaluating whether the 

procedures, tests, or examinations listed 

on the application fall within the testing 

appropriate for the requested certificate. 

(5) For a certificate of compliance, the 

fee includes the costs for issuing the 

certificates, collecting the fees, 

evaluating and monitoring proficiency 

testing programs, and evaluating 

whether the procedures, tests or 

examinations listed on the application 

fall within the testing appropriate for 

the requested certificate. 

(b) Fee amount. (1) The certificate fee 

amount is set biennially by HHS. CMS 

will publish a notice in the Federal 

Register biennially with any 

adjustments to the fee amounts, 

including any adjustments due to 

inflation, in accordance with § 493.680. 

For certificates of waiver and certificates 

of PPM, the certificate fee amount is 

based on the category of test complexity 

performed by the laboratory. For all 

other certificate types, the fee amount is 

based on the category of test complexity 

performed by the laboratory and 

schedules or ranges of annual laboratory 

test volume (excluding waived tests and 

tests performed for quality control, 

quality assurance, or proficiency testing 

purposes) and specialties tested, with 


khammond on DSKJM1Z7X2PROD with PROPOSALS3
Federal Register / Vol. 87, No. 142 / Tuesday, July 26, 2022 / Proposed Rules 44935 

the amounts of the fees in each schedule 

being a function of the costs for all 

aspects of general administration of 

CLIA as set forth in paragraph (c) of this 

section. 

(2) Certificate fees are assessed and 

payable at least biennially. 

(3) The amount of the fee payable by 

the laboratory is the amount listed in 

the most recent notice published in the 

Federal Register at the time the 

application, renewal, change in 

certificate type, or reinstatement is 

processed by HHS or its designee. 

(4) After processing an application for 

an issuance, renewal, change in 

certificate type, or reinstatement of a 

terminated certificate with a gap in 

service, HHS or its designee notifies the 

laboratory of the applicable fee amount. 

(c) Classification of laboratories for 

purposes of determining the fee amount 

for certificate types other than 

certificates of waiver or certificates of 

PPM. (1) For purposes of determining a 

laboratory’s classification under this 

section, a test is a procedure or 

examination for a single analyte. (Tests 

performed for quality control, quality 

assessment, and proficiency testing are 

excluded from the laboratory’s total 

annual volume.) Each profile (that is, 

group of tests) is counted as the number 

of separate procedures or examinations; 

for example, a chemistry profile 

consisting of 18 tests is counted as 18 

separate procedures or tests. 

(2) For purposes of determining a 

laboratory’s classification under this 

section, the specialties and 

subspecialties of service for inclusion 

are: 

(i) The specialty of Microbiology, 

which includes one or more of the 

following subspecialties: 

(A) Bacteriology. 

(B) Mycobacteriology. 

(C) Mycology. 

(D) Parasitology. 

(E) Virology. 

(ii) The specialty of Serology, which 

includes one or more of the following 

subspecialties: 

(A) Syphilis Serology. 

(B) General immunology. 

(iii) The specialty of Chemistry, 

which includes one or more of the 

following subspecialties: 

(A) Routine chemistry. 

(B) Endocrinology. 

(C) Toxicology. 

(D) Urinalysis. 

(iv) The specialty of Hematology. 

(v) The specialty of 

Immunohematology, which includes 

one or more of the following 

subspecialties: 

(A) ABO grouping and Rh typing. 

(B) Unexpected antibody detection. 

(C) Compatibility testing. 

(D) Unexpected antibody 

identification. 

(vi) The specialty of Pathology, which 

includes the following subspecialties: 

(A) Cytology. 

(B) Histopathology. 

(C) Oral pathology. 

(vii) The specialty of Radiobioassay. 

(viii) The specialty of 

Histocompatibility. 

(ix) The specialty of Clinical 

Cytogenetics. 

(3) There are 11 schedules of 

laboratories for the purpose of 

determining the fee amount a laboratory 

is assessed. Each laboratory is placed 

into one of the 11 schedules in 

paragraphs (c)(3)(i) through (xi) of this 

section based on the laboratory’s scope 

and volume of testing: 

(i) Schedule V. The laboratory 

performs not more than 2,000 laboratory 

tests annually. 

(ii) Schedule A. The laboratory 

performs tests in no more than three 

specialties of service with a total annual 

volume of more than 2,000 but not more 

than 10,000 laboratory tests. 

(iii) Schedule B. The laboratory 

performs tests in at least four specialties 

of service with a total annual volume of 

not more than 10,000 laboratory tests. 

(iv) Schedule C. The laboratory 

performs tests in no more three 

specialties of service with a total annual 

volume of more than 10,000 but not 

more than 25,000 laboratory tests. 

(v) Schedule D. The laboratory 

performs tests in at least four specialties 

with a total annual volume of more than 

10,000 but not more than 25,000 

laboratory tests. 

(vi) Schedule E. The laboratory 

performs more than 25,000 but not more 

than 50,000 laboratory tests annually. 

(vii) Schedule F. The laboratory 

performs more than 50,000 but not more 

than 75,000 laboratory tests annually. 

(viii) Schedule G. The laboratory 

performs more than 75,000 but not more 

than 100,000 laboratory tests annually. 

(ix) Schedule H. The laboratory 

performs more than 100,000 but not 

more than 500,000 laboratory tests 

annually. 

(x) Schedule I. The laboratory 

performs more than 500,000 but not 

more than 1,000,000 laboratory tests 

annually. 

(xi) Schedule J. The laboratory 

performs more than 1,000,000 

laboratory tests annually. 

■ 6. Section 493.639 is revised to read 

as follows: 

§ 493.639 Fees for revised and 

replacement certificates. 

(a) If, after a laboratory is issued a 

certificate, it requests a revised 

certificate, the laboratory must pay a fee 

to cover the cost of issuing a revised 

certificate. The fee for a revised 

certificate is based on the cost to issue 

the revised certificate to the laboratory. 

The fee must be paid in full before the 

revised certificate will be issued. 

(1) If laboratory services are added to 

a certificate of compliance, the 

laboratory must pay an additional fee if 

required under § 493.643(d)(2). 

(2) [Reserved] 

(b) If, after a laboratory is issued a 

certificate, it requests a replacement 

certificate, the laboratory must pay a fee 

to cover the cost of issuing a 

replacement certificate. The fee for a 

replacement certificate is based on the 

cost of issuing the replacement 

certificate to the laboratory. The fee 

must be paid in full before issuing the 

replacement certificate. 

■ 7. Section 493.643 is revised to read 

as follows: 

§ 493.643 Additional fees applicable to 

laboratories issued a certificate of 

compliance. 

(a) Fee requirement. In addition to the 

fee required under § 493.638, a 

laboratory subject to routine inspections 

must pay a fee to cover the cost of 

determining program compliance. 

Laboratories issued a certificate for PPM 

procedures, certificate of waiver, or a 

certificate of accreditation are not 

subject to this fee for routine 

inspections. 

(b) Costs included in the fee. Included 

in the fee for determining program 

compliance are costs for evaluating 

qualifications of laboratory personnel; 

monitoring laboratory proficiency 

testing; and conducting onsite 

inspections of laboratories including: 

documenting deficiencies, evaluating 

laboratories’ plans to correct 

deficiencies, creating training programs, 

training surveyors, and necessary 

administrative costs. 

(c) Fee amount. The amount of the fee 

for determining program compliance is 

set biennially by HHS. 

(1) The fee is based on the category of 

test complexity and schedules or ranges 

of annual laboratory test volume and 

specialties tested, with the amounts of 

the fees in each schedule being a 

function of the costs for all aspects of 

determining program compliance as set 

forth in § 493.638(c). 

(2) The fee is assessed and payable 

biennially. 

(3) The amount of the program 

compliance fee is the amount applicable 

to the laboratory listed in the most 

recent notice published in the Federal 

Register at the time that the fee is 

generated. 


khammond on DSKJM1Z7X2PROD with PROPOSALS3
44936 Federal Register / Vol. 87, No. 142 / Tuesday, July 26, 2022 / Proposed Rules 

(d) Additional fees. (1) If a laboratory 

issued a certificate of compliance has 

been inspected and follow-up visits are 

necessary because of identified 

deficiencies, HHS assesses the 

laboratory a fee to cover the cost of these 

visits. The fee is based on the actual 

resources and time necessary to perform 

the follow-up visits. HHS revokes the 

laboratory’s certificate of compliance for 

failure to pay the assessed fee. 

(2) If, after a certificate of compliance 

is issued, a laboratory adds services and 

requests that its certificate be upgraded, 

the laboratory must pay an additional 

fee if, to determine compliance with 

additional requirements, it is necessary 

to conduct an inspection, evaluate 

personnel, or monitor proficiency 

testing performance. The additional fee 

is based on the actual resources and 

time necessary to perform the activities. 

HHS revokes the laboratory’s certificate 

for failure to pay the compliance 

determination fee. 

(3) If it is necessary to conduct a 

complaint investigation, impose 

sanctions, or conduct a hearing, HHS 

assesses the laboratory holding a 

certificate of compliance a fee to cover 

the cost of these activities. If a 

complaint investigation results in a 

complaint being unsubstantiated, or if 

an HHS adverse action is overturned at 

the conclusion of the administrative 

appeals process, the Government’s costs 

of these activities are not imposed upon 

the laboratory. Costs for these activities 

are based on the actual resources and 

time necessary to perform the activities 

and are not assessed until after the 

laboratory concedes the existence of 

deficiencies or an ALJ rules in favor of 

HHS. HHS revokes the laboratory’s 

certificate of compliance for failure to 

pay the assessed costs. 

(4) Laboratories with a certificate of 

compliance must pay a fee if the 

laboratory fails to perform successfully 

in proficiency testing for one or more 

specialties, subspecialties, analytes, or 

tests specified in subpart I of this part, 

and it is necessary to conduct a desk 

review of the unsuccessful performance. 

The additional fee is based on the actual 

resources and time necessary to perform 

the desk review. HHS revokes the 

laboratory’s certificate of compliance for 

failure to pay the assessed costs. 

■ 8. Amend § 493.645— 

■ a. By revising the section heading; 

■ b. By removing paragraph (a); 

■ c. By redesignating paragraphs (b) and 

(c) as paragraphs (a) and (b); 

■ d. By revising newly redesignated 

paragraph (a); and 

■ e. In newly redesignated paragraph (b) 

by adding a paragraph heading. 

The revisions and addition read as 

follows: 

§ 493.645 Additional fees applicable to 

laboratories issued a certificate of 

accreditation, certificate of waiver, or 

certificate for PPM procedures. 

(a) Accredited laboratories. (1) A 

laboratory that is issued a certificate of 

accreditation is assessed an additional 

fee to cover the cost of performing 

validation inspections described at 

§ 493.563. All accredited laboratories 

share in the cost of these inspections. 

These costs are five percent of the same 

costs as those that are incurred when 

inspecting nonaccredited laboratories of 

the same schedule (or range) and are 

paid biennially by each accredited 

laboratory whether the accredited 

laboratory has a validation inspection or 

not. HHS revokes the laboratory’s 

certificate of accreditation for failure to 

pay the fee. 

(2) If a laboratory issued a certificate 

of accreditation has been inspected and 

follow-up visits are necessary because of 

identified deficiencies, HHS assesses 

the laboratory an additional fee to cover 

the cost of these visits. The fee is based 

on the actual resources and time 

necessary to perform the follow-up 

visits. HHS revokes the laboratory’s 

certificate of accreditation for failure to 

pay the fee. 

(b) Complaint surveys. * * * 

§ 493.646 [Removed] 

■ 9. Section 493.646 is removed. 

■ 10. Section 493.649 is revised to read 

as follows: 

§ 493.649 Additional fees applicable to 

approved State laboratory programs. 

(a) Approved State laboratory 

programs. State laboratory programs 

approved by HHS are assessed a fee for 

the following: 

(1) Costs of Federal inspections of 

laboratories in that State (that is, CLIAexempt laboratories) to verify that 

standards are being enforced in an 

appropriate manner. 

(2) Costs incurred for investigations of 

complaints against the State’s CLIAexempt laboratories if the complaint is 

substantiated. 

(3) The State’s pro rata share of 

general overhead to administer the 

laboratory certification program under 

section 353 of the PHS Act. 

(b) [Reserved] 

■ 11. Section 493.655 is added to read 

as follows: 

§ 493.655 Payment of fees. 

(a) Except for laboratories covered by 

approved State laboratory programs, all 

laboratories are notified in writing by 

HHS or its designee of the appropriate 

fee(s) and instructions for submitting 

the fee(s), including the due date for 

payment and where to make payment. 

The appropriate certificate is not issued 

until the applicable fees have been paid. 

(b) For approved State laboratory 

programs, HHS estimates the cost of 

conducting validation inspections as 

described at § 493.563 within the State 

on at least a biennial period. HHS or its 

designee notifies the State by mail of the 

appropriate fees, including the due date 

for payment and the address of the 

United States Department of Treasury 

designated commercial bank to which 

payment must be made. In addition, if 

complaint investigations are conducted 

in laboratories within these States and 

are substantiated, HHS bills the State(s) 

the costs of the complaint 

investigations. 

■ 12. Section 493.680 is added to read 

as follows: 

§ 493.680 Methodology for determining the 

biennial fee increase. 

(a) General rule. Except for fees 

assessed to State laboratory programs 

approved by HHS, the fee amounts 

described in this subpart are subject to 

a biennial increase based on a two-part 

calculation of the Consumer Price 

Index-Urban (CPI–U) inflation 

adjustment and, if applicable, an 

additional increase as follows: 

(1) CMS calculates the inflation rate 

using the compounded CPI–U over 2 

years and, provided that the calculated 

rate is greater than zero, applies an 

increase to all fee amounts equal to the 

calculated rate. 

(2) If the total fee amounts, including 

any increase applied under paragraph 

(a)(1) of this section, do not match or 

exceed actual program obligations based 

on a review of the previous 2 years’ 

obligations, CMS applies an additional 

across the board increase to each 

laboratory’s fees by calculating the 

difference between the total fee amounts 

and actual program obligations. 

(b) Baseline. Any increase applied 

under paragraph (a) of this section is 

incorporated into the baseline fee 

amounts for any subsequent biennial 

increase. 

(c) Publication. Any increase applied 

under paragraph (a) of this section, 

including the calculation thereof, will 

be published as a notice in the Federal 

Register. 

■ 13. Section 493.1278 is amended by— 

■ a. Revising paragraphs (a)(1) and (2); 

■ b. Removing paragraph (a)(3); 

■ c. Redesignating paragraphs (a)(4) and 

(5) as paragraphs (a)(3) and (4), 

respectively; 

■ d. Revising newly redesignated 

paragraph (a)(3); 


khammond on DSKJM1Z7X2PROD with PROPOSALS3
Federal Register / Vol. 87, No. 142 / Tuesday, July 26, 2022 / Proposed Rules 44937 

■ e. Removing paragraphs (b)(1), (2), 

and (3); 

■ f. Redesignating paragraphs (b)(4) and 

(5) as paragraphs (b)(1) and (2), 

respectively; 

■ g. In newly redesignated paragraph 

(b)(1), removing the phrase ‘‘latest 

report of the’’ and the second sentence; 

■ h. Revising newly redesignated 

paragraph (b)(2); 

■ i. Removing paragraph (b)(6). 

■ j. Revising paragraphs (c), (d), (e), and 

(f); and 

■ k. Removing paragraph (g). 

The revisions read as follows: 

§ 493.1278 Standard: Histocompatibility. 

(a) * * * 

(1) Use a continuous monitoring 

system and alert system to monitor the 

storage temperature of specimens (donor 

and recipient) and reagents and notify 

laboratory personnel when temperature 

limits are exceeded. 

(2) Establish and follow written 

policies and procedures for the storage 

and retention of specimens based on the 

specific type of specimen. All 

specimens must be easily retrievable. 

The laboratory must have an emergency 

plan for alternate storage. 

(3) If the laboratory uses immunologic 

reagents to facilitate or enhance the 

isolation or identification of 

lymphocytes or lymphocyte subsets, the 

efficacy of the methods must be 

monitored with appropriate quality 

control procedures. 

* * * * * 

(b) * * * 

(2) Have available and follow written 

criteria for determining when antigen 

and allele typing are required. 

(c) Antibody screening and 

identification. The laboratory must 

make a reasonable effort to have 

available monthly serum specimens for 

all potential transplant recipients for 

periodic antibody screening, 

identification, and crossmatch. 

(d) Crossmatching. For each type of 

crossmatch that a laboratory performs, 

the laboratory must do the following, as 

applicable: 

(1) Establish and follow written 

policies and procedures for performing 

a crossmatch. 

(2) Have available and follow written 

criteria for the following: 

(i) Defining donor and recipient 

human leukocyte antigen (HLA) 

antigens, alleles, and antibodies to be 

tested; 

(ii) Defining the criteria necessary to 

assess a recipient’s alloantibody status; 

(iii) Assessing recipient antibody 

presence or absence on an ongoing 

basis; 

(iv) Typing the donor at the serologic 

level to include those HLA antigens to 

which antibodies have been identified 

in the potential recipient, as applicable; 

(v) Describing the circumstances in 

which pre- and post-transplant 

confirmation testing of donor and 

recipient specimens is required; 

(vi) Making available all applicable 

donor and recipient test results to the 

transplant team; 

(vii) Ensuring immunologic 

assessments are based on test results 

obtained from a test report from a CLIAcertified laboratory; and 

(viii) Defining time limits between 

recipient testing and the performance of 

a crossmatch. 

(3) The test report must specify the 

type of crossmatch performed. 

(e) Transplantation. Laboratories 

performing histocompatibility testing 

for infusion and transplantation 

purposes must establish and follow 

written policies and procedures 

specifying the histocompatibility testing 

(that is, HLA typing, antibody screening 

and identification, and crossmatching) 

to be performed for each type of cell, 

tissue, or organ to be infused or 

transplanted. The laboratory’s policies 

and procedures must include, as 

applicable— 

(1) Testing protocols that address: 

(i) Transplant type (organ, tissue, 

cell); 

(ii) Donor (living, deceased, or 

paired); and 

(iii) Recipient (high risk vs. 

unsensitized); 

(2) Type and frequency of testing 

required to support clinical transplant 

protocols; and 

(3) Process to obtain a recipient 

specimen, if possible, for crossmatch 

that is collected on the day of the 

transplant. If the laboratory is unable to 

obtain a recipient specimen on the day 

of the transplant, the laboratory must 

have a process to document its efforts to 

obtain the specimen. 

(f) Documentation. The laboratory 

must document all control procedures 

performed, as specified in this section. 

■ 14. Amend § 493.1359: 

■ a. In paragraph (a) by removing the 

word ‘‘and’’; 

■ b. By revising paragraph (b)(2); and 

■ c. By adding paragraphs (c) and (d). 

The revision and additions read as 

follows: 

§ 493.1359 Standard; PPM laboratory 

director responsibilities. 

* * * * * 

(b) * * * 

(2) Is performed in accordance with 

applicable requirements in this subpart 

and subparts H, J, and K of this part; 

(c) Evaluate the competency of all 

testing personnel and ensure that the 

staff maintains their competency to 

perform test procedures and report test 

results promptly, accurately, and 

proficiently. The procedures for 

evaluation of the competency of the staff 

must include, but are not limited to— 

(1) Direct observations of routine 

patient test performance, including, if 

applicable, specimen handling, 

processing, and testing; 

(2) Monitoring the recording and 

reporting of test results; 

(3) Review of test results or 

worksheets; 

(4) Assessment of test performance 

through testing internal blind testing 

samples or external proficiency testing 

samples; and 

(5) Assessment of problem solving 

skills; and 

(d) Evaluating and documenting the 

performance of individuals responsible 

for PPM testing at least semiannually 

during the first year the individual tests 

patient specimens. Thereafter, 

evaluations and documentation must be 

performed at least annually. 

■ 15. Amend § 493.1405 by revising 

paragraph (b) to read as follows: 

§ 493.1405 Standard; Laboratory director 

qualifications. 

* * * * * 

(b) The laboratory director must— 

(1)(i) Be a doctor of medicine or 

doctor of osteopathy licensed to practice 

medicine or osteopathy in the State in 

which the laboratory is located; and 

(ii) Be certified in anatomic or clinical 

pathology, or both, by the American 

Board of Pathology or the American 

Osteopathic Board of Pathology; or 

(2)(i) Be a doctor of medicine, doctor 

of osteopathy, or doctor of podiatric 

medicine licensed to practice medicine, 

osteopathy, or podiatry in the State in 

which the laboratory is located; and 

(ii) Have had laboratory training or 

experience consisting of: 

(A) At least 1 year directing or 

supervising nonwaived laboratory 

testing; and 

(B) Have at least 20 CE credit hours 

in laboratory practice that cover the 

laboratory director responsibilities 

defined in § 493.1407; or 

(3)(i) Hold an earned doctoral degree 

in a chemical, biological, or clinical 

laboratory science or medical 

technology from an accredited 

institution; or 

(ii)(A) Meet master’s equivalency; and 

(B) Have at least 16 semester hours of 

additional doctoral level coursework in 

biology, chemistry, medical technology 

(MT), or clinical laboratory science 

(CLS); or 

(C) A thesis or research project in 

biology/chemistry/MT/CLS related to 


khammond on DSKJM1Z7X2PROD with PROPOSALS3
44938 Federal Register / Vol. 87, No. 142 / Tuesday, July 26, 2022 / Proposed Rules 

laboratory testing for the diagnosis, 

prevention, or treatment of any disease 

or impairment of, or the assessment of 

the health of, human beings; and 

(iii) Have at least 20 CE credit hours 

in laboratory practice that cover the 

laboratory director responsibilities 

defined in § 493.1407; and 

(A) Be certified and continue to be 

certified by a board approved by HHS; 

and 

(B) Have had at least 1 year of 

experience directing or supervising 

nonwaived laboratory testing; or 

(4)(i) Have earned a master’s degree in 

a chemical, biological, or clinical 

laboratory science or medical 

technology from an accredited 

institution; or 

(ii)(A) Meet bachelor’s degree 

equivalency; and 

(B) Have at least 16 semester hours of 

additional graduate-level coursework in 

biology, chemistry, medical technology, 

or clinical laboratory science; or 

(iii)(A) Meet bachelor’s degree 

equivalency; and 

(B) Have at least 16 semester hours, 

which may include a combination of 

graduate-level coursework in biology, 

chemistry, medical technology, or 

clinical laboratory science and a thesis 

or research project related to laboratory 

testing for the diagnosis, prevention, or 

treatment of any disease or impairment 

of, or the assessment of the health of, 

human beings; and 

(iv) Have at least 1 year of laboratory 

training or experience, or both, in 

nonwaived testing; and 

(v) Have at least 1 year of supervisory 

laboratory experience in nonwaived 

testing; and 

(vi) Have at least 20 CE credit hours 

in laboratory practice that cover the 

director responsibilities defined in 

§ 493.1407; or 

(5)(i) Have earned a bachelor’s degree 

in a chemical, biological, or clinical 

laboratory science or medical 

technology from an accredited 

institution; or 

(ii) At least 120 semester hours, or 

equivalent, from an accredited 

institution that, at a minimum, includes 

either— 

(A) 48 semester hours of medical 

laboratory technology courses; or 

(B) 48 semester hours of science 

courses that include— 

(1) 12 semester hours of chemistry, 

which must include general chemistry 

and biochemistry or organic chemistry; 

(2) 12 semester hours of biology, 

which must include general biology and 

molecular biology, cell biology or 

genetics; and 

(3) 24 semester hours of chemistry, 

biology, or medical laboratory 

technology in any combination; and 

(iii) Have at least 2 years of laboratory 

training or experience, or both, in 

nonwaived testing; and 

(iv) Have at least 2 years of 

supervisory laboratory experience in 

nonwaived testing; and 

(v) Have at least 20 CE credit hours in 

laboratory practice that cover the 

director responsibilities defined in 

§ 493.1407. 

(6) Notwithstanding any other 

provision of this section, an individual 

is considered qualified as a laboratory 

director of moderate complexity testing 

under this section if they were qualified 

and serving as a laboratory director of 

moderate complexity testing in a CLIAcertified laboratory as of [effective date 

of the final rule], and have done so 

continuously since [effective date of the 

final rule]. 

§ 493.1406 [Removed] 

■ 16. Section 493.1406 is removed. 

■ 17. Amend § 493.1407 by revising 

paragraph (c) to read as follows: 

§ 493.1407 Standard; Laboratory director 

responsibilities. 

* * * * * 

(c) The laboratory director must: 

(1) Be onsite at least once every 6 

months, with at least 4 months between 

the minimum two on-site visits. 

Laboratory directors may elect to be onsite more frequently and must continue 

to be accessible to the laboratory to 

provide telephone or electronic 

consultation as needed; and 

(2) Provide documentation of these 

visits, including evidence of performing 

activities that are part of the laboratory 

director responsibilities. 

* * * * * 

■ 18. Amend § 493.1411 by revising 

paragraph (b) to read as follows: 

§ 493.1411 Standard; Technical consultant 

qualifications. 

* * * * * 

(b) The technical consultant must— 

(1)(i) Be a doctor of medicine or 

doctor of osteopathy licensed to practice 

medicine or osteopathy in the State in 

which the laboratory is located; and 

(ii) Be certified in anatomic or clinical 

pathology, or both, by the American 

Board of Pathology or the American 

Osteopathic Board of Pathology; or 

(2)(i) Be a doctor of medicine, doctor 

of osteopathy, or doctor of podiatric 

medicine licensed to practice medicine, 

osteopathy, or podiatry in the State in 

which the laboratory is located; and 

(ii) Have at least 1 year of laboratory 

training or experience, or both, in 

nonwaived testing, in the designated 

specialty or subspecialty areas of service 

for which the technical consultant is 

responsible (for example, physicians 

certified either in hematology or 

hematology and medical oncology by 

the American Board of Internal 

Medicine are qualified to serve as the 

technical consultant in hematology); or 

(3)(i) Hold an earned doctoral or 

master’s degree in a chemical, 

biological, or clinical laboratory science 

or medical technology from an 

accredited institution; or 

(ii) Meet either requirements in 

§ 493.1405(b)(3)(ii) or (b)(4)(ii) or (iii); 

and 

(iii) Have at least 1 year of laboratory 

training or experience, or both, in 

nonwaived testing, in the designated 

specialty or subspecialty areas of service 

for which the technical consultant is 

responsible; or 

(4)(i) Have earned a bachelor’s degree 

in a chemical, biological, or clinical 

laboratory science or medical 

technology from an accredited 

institution; or 

(ii) Meet § 493.1405(b)(5)(ii); and 

(iii) Have at least 2 years of laboratory 

training or experience, or both, in 

nonwaived testing, in the designated 

specialty or subspecialty areas of service 

for which the technical consultant is 

responsible; or 

(5)(i) Have earned an associate’s 

degree in medical laboratory technology 

or clinical laboratory science; and 

(ii) Have at least 4 years of laboratory 

training or experience, or both, in 

nonwaived testing, in the designated 

specialty or subspecialty areas of service 

for which the technical consultant is 

responsible. 

(6) For blood gas analysis, the 

individual must— 

(i) Be qualified under paragraph 

(b)(1), (2), (3), or (4) of this section; or 

(ii)(A) Have earned a bachelor’s 

degree in respiratory therapy or 

cardiovascular technology from an 

accredited institution; and 

(B) Have at least 2 years of laboratory 

training or experience, or both, in blood 

gas analysis; or 

(7) Notwithstanding any other 

provision of this section, an individual 

is considered qualified as a technical 

consultant under this section if they 

were qualified and serving as a 

technical consultant for moderate 

complexity testing in a CLIA-certified 

laboratory as of [effective date of the 

final rule], and have done so 

continuously since [effective date of the 

final rule]. 

Note 1 to paragraph (b): The technical 

consultant requirements for ‘‘laboratory 

training or experience, or both’’ in each 

specialty or subspecialty may be acquired 

concurrently in more than one of the 

specialties or subspecialties of service, 


khammond on DSKJM1Z7X2PROD with PROPOSALS3
Federal Register / Vol. 87, No. 142 / Tuesday, July 26, 2022 / Proposed Rules 44939 

excluding waived tests. For example, an 

individual who has a bachelor’s degree in 

biology and additionally has documentation 

of 2 years of work experience performing 

tests of moderate complexity in all specialties 

and subspecialties of service, would be 

qualified as a technical consultant in a 

laboratory performing moderate complexity 

testing in all specialties and subspecialties of 

service. 

■ 19. Amend § 493.1423 by revising 

paragraph (b) to read as follows: 

§ 493.1423 Standard; Testing personnel 

qualifications. 

* * * * * 

(b) Meet one of the following 

requirements: 

(1) Be a doctor of medicine or doctor 

of osteopathy licensed to practice 

medicine or osteopathy in the State in 

which the laboratory is located; or 

(2) Have earned a doctoral, master’s, 

or bachelor’s degree in a chemical, 

biological, or clinical laboratory science 

or medical technology, or nursing from 

an accredited institution; or 

(3) Meet the requirements in 

§ 493.1405(b)(3)(ii), (b)(4)(ii) and (iii), or 

(b)(5)(ii); or 

(4) Have earned an associate’s degree 

in a chemical, biological science or 

medical laboratory technology or 

nursing from an accredited institution; 

or 

(5) Be a high school graduate or 

equivalent and have successfully 

completed an official military medical 

laboratory procedures course of at least 

a duration of 50 weeks and have held 

the military enlisted occupational 

specialty of Medical Laboratory 

Specialist (Laboratory Technician); or 

(6)(i) Have earned a high school 

diploma or equivalent; and 

(ii) Have documentation of training 

appropriate for the testing performed 

prior to analyzing patient specimens. 

Such training must ensure that the 

individual has— 

(A) The skills required for proper 

specimen collection, including patient 

preparation, if applicable, labeling, 

handling, preservation or fixation, 

processing or preparation, 

transportation, and storage of 

specimens; 

(B) The skills required for 

implementing all standard laboratory 

procedures; 

(C) The skills required for performing 

each test method and for proper 

instrument use; 

(D) The skills required for performing 

preventive maintenance, 

troubleshooting, and calibration 

procedures related to each test 

performed; 

(E) A working knowledge of reagent 

stability and storage; 

(F) The skills required to implement 

the quality control policies and 

procedures of the laboratory; 

(G) An awareness of the factors that 

influence test results; and 

(H) The skills required to assess and 

verify the validity of patient test results 

through the evaluation of quality control 

sample values prior to reporting patient 

test results. 

(7) For blood gas analysis, the 

individual must— 

(i) Be qualified under paragraph 

(b)(1), (2), (3), or (4) of this section; or 

(ii)(A) Have earned a bachelor’s 

degree in respiratory therapy or 

cardiovascular technology from an 

accredited institution; and 

(B) Have at least 1 year of laboratory 

training or experience, or both, in blood 

gas analysis; or 

(C)(1) Have earned an associate’s 

degree related to pulmonary function 

from an accredited institution; and 

(2) Have at least 2 years of training or 

experience, or both, in blood gas 

analysis. 

■ 20. Amend § 493.1443 by revising 

paragraph (b) to read as follows: 

§ 493.1443 Standard: Laboratory director 

qualifications. 

* * * * * 

(b) The laboratory director must— 

(1)(i) Be a doctor of medicine or 

doctor of osteopathy licensed to practice 

medicine or osteopathy in the State in 

which the laboratory is located; and 

(ii) Be certified in anatomic or clinical 

pathology, or both, by the American 

Board of Pathology or the American 

Osteopathic Board of Pathology; or 

(2) Be a doctor of medicine, a doctor 

of osteopathy, or doctor of podiatric 

medicine licensed to practice medicine, 

osteopathy, or podiatry in the State in 

which the laboratory is located; and 

(i) Have at least 2 years of experience 

directing or supervising high 

complexity testing; and 

(ii) Have at least 20 CE credit hours 

in laboratory practice that cover the 

director responsibilities defined in 

§ 493.1445; or 

(3)(i) Hold an earned doctoral degree 

in a chemical, biological, or clinical 

laboratory science or medical 

technology from an accredited 

institution; or 

(ii)(A) Meet master’s equivalency; and 

(B) Have at least 16 semester hours of 

additional doctoral level coursework in 

biology, chemistry, medical technology, 

or clinical laboratory science; or 

(C) A thesis or research project in 

biology, chemistry, medical technology, 

or clinical laboratory science related to 

laboratory testing for the diagnosis, 

prevention, or treatment of any disease 

or impairment of, or the assessment of 

the health of, human beings; and 

(iii) Be certified and continue to be 

certified by a board approved by HHS; 

and 

(iv) Have at least 2 years of: 

(A) Laboratory training or experience, 

or both: and 

(B) Laboratory experience directing or 

supervising high complexity testing; 

and 

(v) Have at least 20 CE credit hours in 

laboratory practice that cover the 

director responsibilities defined in 

§ 493.1445; or 

(4) Notwithstanding any other 

provision of this section, an individual 

is considered qualified as a laboratory 

director of high complexity testing 

under this section if they were qualified 

and serving as a laboratory director of 

high complexity testing in a CLIAcertified laboratory as of [effective date 

of the final rule], and have done so 

continuously since [effective date of the 

final rule]. 

(5) For the subspecialty of oral 

pathology, be certified by the American 

Board of Oral Pathology, American 

Board of Pathology, or the American 

Osteopathic Board of Pathology. 

■ 21. Amend § 493.1445 by revising 

paragraph (c) to read as follows: 

§ 493.1445 Standard; Laboratory director 

responsibilities. 

* * * * * 

(c) The laboratory director must: 

(1) Be onsite at least once every 6 

months, with at least 4 months between 

the minimum two on-site visits. 

Laboratory directors may elect to be onsite more frequently and must continue 

to be accessible to the laboratory to 

provide telephone or electronic 

consultation as needed; and 

(2) Provide documentation of these 

visits, including evidence of performing 

activities that are part of the laboratory 

director responsibilities. 

* * * * * 

■ 22. Section 493.1449 is revised to read 

as follows: 

§ 493.1449 Standard; Technical supervisor 

qualifications. 

The laboratory must employ one or 

more individuals who are qualified by 

education and either training or 

experience to provide technical 

supervision for each of the specialties 

and subspecialties of service in which 

the laboratory performs high complexity 

tests or procedures. The director of a 

laboratory performing high complexity 

testing may function as the technical 

supervisor provided he or she meets the 

qualifications specified in this section. 

(a) The technical supervisor must 

possess a current license issued by the 


khammond on DSKJM1Z7X2PROD with PROPOSALS3
44940 Federal Register / Vol. 87, No. 142 / Tuesday, July 26, 2022 / Proposed Rules 

State in which the laboratory is located, 

if such licensing is required; and 

(b) The laboratory may perform 

anatomic and clinical laboratory 

procedures and tests in all specialties 

and subspecialties of services except 

histocompatibility and clinical 

cytogenetics services provided the 

individual functioning as the technical 

supervisor— 

(1) Is a doctor of medicine or doctor 

of osteopathy licensed to practice 

medicine or osteopathy in the State in 

which the laboratory is located; and 

(2) Is certified in both anatomic and 

clinical pathology by the American 

Board of Pathology or the American 

Osteopathic Board of Pathology. 

(c) If the requirements of paragraph 

(b) of this section are not met and the 

laboratory performs tests in the 

subspecialty of bacteriology, 

mycobacteriology, mycology, 

parasitology, or virology, the individual 

functioning as the technical supervisor 

must— 

(1)(i) Be a doctor of medicine or 

doctor of osteopathy licensed to practice 

medicine or osteopathy in the State in 

which the laboratory is located; and 

(ii) Be certified in clinical pathology 

by the American Board of Pathology or 

the American Osteopathic Board of 

Pathology; or 

(2)(i) Be a doctor of medicine, doctor 

of osteopathy, or doctor of podiatric 

medicine licensed to practice medicine, 

osteopathy, or podiatry in the State in 

which the laboratory is located; and 

(ii) Have at least 1 year of laboratory 

training or experience, or both, in high 

complexity testing within the specialty 

of microbiology with a minimum of 6 

months of experience in high 

complexity testing within the applicable 

microbiology subspecialty; or 

(3)(i) Have an earned doctoral degree 

in a chemical, biological, or clinical 

laboratory science or medical 

technology from an accredited 

institution; or 

(ii)(A) Meet the requirements in 

§ 493.1443(b)(3)(ii); and 

(B) [Reserved] 

(iii) Have at least 1 year of laboratory 

training or experience, or both, in high 

complexity testing within the specialty 

of microbiology with a minimum of 6 

months of experience in high 

complexity testing within the applicable 

subspecialty; or 

(4)(i) Have earned a master’s degree in 

a chemical, biological, or clinical 

laboratory science or medical 

technology from an accredited 

institution; or 

(ii)(A) Meet bachelor’s degree 

equivalency; and 

(B) Have at least 16 semester hours of 

additional graduate level coursework in 

chemical, biological, or clinical 

laboratory science or medical 

technology; or 

(iii)(A) Meet bachelor’s degree 

equivalency; and 

(B) Have at least 16 semester hours, 

which may include a combination of 

graduate level coursework in biology, 

chemistry, medical technology, or 

clinical laboratory science and a thesis 

or research project related to laboratory 

testing for the diagnosis, prevention, or 

treatment of any disease or impairment 

of, or the assessment of the health of, 

human beings; and 

(iv) Have at least 2 years of laboratory 

training or experience, or both, in high 

complexity testing within the specialty 

of microbiology with a minimum of 6 

months of experience in high 

complexity testing within the applicable 

subspecialty; or 

(5)(i) Have earned a bachelor’s degree 

in a chemical or biological science or 

clinical laboratory science or medical 

technology from an accredited 

institution; or 

(ii) Have at least 120 semester hours, 

or equivalent, from an accredited 

institution that, at a minimum, includes 

either— 

(A) 48 semester hours of medical 

laboratory technology courses; or 

(B) 48 semester hours of science 

courses that include— 

(1) 12 semester hours of chemistry, 

which must include general chemistry 

and biochemistry or organic chemistry; 

(2) 12 semester hours of biology, 

which must include general biology and 

molecular biology, cell biology or 

genetics; and 

(3) 24 semester hours of chemistry, 

biology, or medical laboratory 

technology in any combination; and 

(iii) Have at least 4 years of laboratory 

training or experience, or both, in high 

complexity testing within the specialty 

of microbiology with a minimum of 6 

months of experience in high 

complexity testing within the applicable 

subspecialty. 

(d) If the requirements of paragraph 

(b) of this section are not met and the 

laboratory performs tests in the 

specialty of diagnostic immunology, 

chemistry, hematology, radiobioassay, 

or immunohematology, the individual 

functioning as the technical supervisor 

must— 

(1)(i) Be a doctor of medicine or a 

doctor of osteopathy licensed to practice 

medicine or osteopathy in the State in 

which the laboratory is located; and 

(ii) Be certified in clinical pathology 

by the American Board of Pathology or 

the American Osteopathic Board of 

Pathology; or 

(2)(i) Be a doctor of medicine, doctor 

of osteopathy, or doctor of podiatric 

medicine licensed to practice medicine, 

osteopathy, or podiatry in the State in 

which the laboratory is located; and 

(ii) Have at least 1 year of laboratory 

training or experience, or both, in high 

complexity testing for the applicable 

specialty; or 

(3)(i) Have an earned doctoral degree 

in a chemical, biological, or clinical 

laboratory science or medical 

technology from an accredited 

institution; or 

(ii) Meet the education requirement at 

§ 493.1443(b)(3)(ii); and 

(iii) Have at least 1 year of laboratory 

training or experience, or both, in high 

complexity testing within the applicable 

specialty; or 

(4)(i) Have earned a master’s degree in 

a chemical, biological, or clinical 

laboratory science or medical 

technology from an accredited 

institution; or 

(ii) Meet the education requirement at 

paragraphs (c)(4)(ii) and (iii) of this 

section; and 

(iii) Have at least 2 years of laboratory 

training or experience, or both, in high 

complexity testing for the applicable 

specialty; or 

(5)(i) Have earned a bachelor’s degree 

in a chemical or biological science or 

clinical laboratory science or medical 

technology from an accredited 

institution; or 

(ii) Meet the education requirement at 

paragraph (c)(5)(ii) of this section; and 

(iii) Have at least 4 years of laboratory 

training or experience, or both, in high 

complexity testing for the applicable 

specialty. 

(e)(1) If the requirements of paragraph 

(b) of this section are not met and the 

laboratory performs tests in the 

subspecialty of cytology, the individual 

functioning as the technical supervisor 

must— 

(i) Be a doctor of medicine or a doctor 

of osteopathy licensed to practice 

medicine or osteopathy in the State in 

which the laboratory is located; and 

(ii) Be certified in anatomic pathology 

by the American Board of Pathology or 

the American Osteopathic Board of 

Pathology. 

(2) An individual qualified under 

paragraph (b) or (d)(1) of this section 

may delegate some of the cytology 

technical supervisor responsibilities to 

an individual who is in the final year of 

full-time training leading to certification 

specified in paragraph (b) or (k)(1)(ii) of 

this section provided the technical 

supervisor qualified under paragraph (b) 

or (e)(1) of this section remains 


khammond on DSKJM1Z7X2PROD with PROPOSALS3
Federal Register / Vol. 87, No. 142 / Tuesday, July 26, 2022 / Proposed Rules 44941 

ultimately responsible for ensuring that 

all of the responsibilities of the cytology 

technical supervisor are met. 

(f) If the requirements of paragraph (b) 

of this section are not met and the 

laboratory performs tests in the 

subspecialty of histopathology, the 

individual functioning as the technical 

supervisor must— 

(1) Meet one of the following 

requirements: 

(i)(A) Be a doctor of medicine or a 

doctor of osteopathy licensed to practice 

medicine or osteopathy in the State in 

which the laboratory is located; and 

(B) Be certified in anatomic pathology 

by the American Board of Pathology or 

the American Osteopathic Board of 

Pathology; or 

(ii) An individual qualified under 

paragraph (b) or (f)(1) of this section 

may delegate to an individual who is a 

resident in a training program leading to 

certification specified in paragraph (b) 

or (l)(1)(i)(B) of this section, the 

responsibility for examination and 

interpretation of histopathology 

specimens. 

(2) For tests in dermatopathology, 

meet one of the following requirements: 

(i)(A) Be a doctor of medicine or 

doctor of osteopathy licensed to practice 

medicine or osteopathy in the State in 

which the laboratory is located; and 

(B) Meet one of the following 

requirements: 

(1) Be certified in anatomic pathology 

by the American Board of Pathology or 

the American Osteopathic Board of 

Pathology; or 

(2) Be certified in dermatopathology 

by the American Board of Dermatology 

and the American Board of Pathology; 

or 

(3) Be certified in dermatology by the 

American Board of Dermatology; or 

(ii) An individual qualified under 

paragraph (b) or (f)(2)(i) of this section 

may delegate to an individual who is a 

resident in a training program leading to 

certification specified in paragraph (b) 

or (l)(2)(i)(B) of this section, the 

responsibility for examination and 

interpretation of dermatopathology 

specimens. 

(3) For tests in ophthalmic pathology, 

meet one of the following requirements: 

(i)(A) Be a doctor of medicine or 

doctor of osteopathy licensed to practice 

medicine or osteopathy in the State in 

which the laboratory is located; and 

(B) Must meet one of the following 

requirements: 

(1) Be certified in anatomic pathology 

by the American Board of Pathology or 

the American Osteopathic Board of 

Pathology; or 

(2) Be certified by the American Board 

of Ophthalmology and have successfully 

completed at least 1 year of formal postresidency fellowship training in 

ophthalmic pathology; or 

(ii) An individual qualified under 

paragraph (b) or (f)(3)(i) of this section 

may delegate to an individual who is a 

resident in a training program leading to 

certification specified in paragraph (b) 

or (f)(3)(i)(B)(2) of this section, the 

responsibility for examination and 

interpretation of ophthalmic specimens; 

or 

(g) If the requirements of paragraph 

(b) of this section are not met and the 

laboratory performs tests in the 

subspecialty of oral pathology, the 

individual functioning as the technical 

supervisor must meet one of the 

following requirements: 

(1)(i) Be a doctor of medicine or a 

doctor of osteopathy licensed to practice 

medicine or osteopathy in the State in 

which the laboratory is located; and 

(ii) Be certified in anatomic pathology 

by the American Board of Pathology or 

the American Osteopathic Board of 

Pathology; or 

(2) Be certified in oral pathology by 

the American Board of Oral Pathology; 

or 

(3) An individual qualified under 

paragraph (b) or (g)(1) or (2) of this 

section may delegate to an individual 

who is a resident in a training program 

leading to certification specified in 

paragraph (b) or (m)(1) or (2) of this 

section, the responsibility for 

examination and interpretation of oral 

pathology specimens. 

(h) If the laboratory performs tests in 

the specialty of histocompatibility, the 

individual functioning as the technical 

supervisor must either— 

(1)(i) Be a doctor of medicine, doctor 

of osteopathy, or doctor of podiatric 

medicine licensed to practice medicine, 

osteopathy, or podiatry in the State in 

which the laboratory is located; and 

(ii) Have training or experience that 

meets one of the following 

requirements: 

(A) Have 4 years of laboratory training 

or experience, or both, within the 

specialty of histocompatibility; or 

(B)(1) Have 2 years of laboratory 

training or experience, or both, in the 

specialty of general immunology; and 

(2) Have 2 years of laboratory training 

or experience, or both, in the specialty 

of histocompatibility; or 

(i) Have an earned doctoral degree in 

a biological or clinical laboratory 

science or medical technology from an 

accredited institution; or 

(ii) Meet the education requirement at 

§ 493.1443(b)(3)(ii); and 

(iii) Have training or experience that 

meets one of the following 

requirements: 

(A) Have 4 years of laboratory training 

or experience, or both, within the 

specialty of histocompatibility; or 

(B)(1) Have 2 years of laboratory 

training or experience, or both, in the 

specialty of general immunology; and 

(2) Have 2 years of laboratory training 

or experience, or both, in the specialty 

of histocompatibility. 

Note 1 to paragraph (h): The technical 

supervisor requirements for ‘‘laboratory 

training or experience, or both’’ in each 

specialty or subspecialty may be acquired 

concurrently in more than one of the 

specialties or subspecialties of service. For 

example, an individual, who has a doctoral 

degree in chemistry and additionally has 

documentation of 1 year of laboratory 

experience working concurrently in high 

complexity testing in the specialties of 

microbiology and chemistry and 6 months of 

that work experience included high 

complexity testing in bacteriology, mycology, 

and mycobacteriology, would qualify as the 

technical supervisor for the specialty of 

chemistry and the subspecialties of 

bacteriology, mycology, and 

mycobacteriology. 

(i) If the laboratory performs tests in 

the specialty of clinical cytogenetics, the 

individual functioning as the technical 

supervisor must— 

(1)(i) Be a doctor of medicine, doctor 

of osteopathy, or doctor of podiatric 

medicine licensed to practice medicine, 

osteopathy, or podiatry in the State in 

which the laboratory is located; and 

(ii) Have 4 years of training or 

experience, or both, in genetics, 2 of 

which have been in clinical 

cytogenetics; or 

(2)(i) Hold an earned doctoral degree 

in a biological science, including 

biochemistry, or clinical laboratory 

science or medical technology from an 

accredited institution; 

(ii) Meet the education requirement at 

§ 493.1443(b)(3)(ii); and 

(ii) Have 4 years of training or 

experience, or both, in genetics, 2 of 

which have been in clinical 

cytogenetics. 

■ 23. Amend § 493.1461 by revising 

paragraphs (c), (d)(3)(i), and (e)(1) and 

(4) to read as follows: 

§ 493.1461 Standard: General supervisor 

qualifications. 

* * * * * 

(c) If the requirements of paragraph 

(b)(1) or (2) of this section are not met, 

the individual functioning as the 

general supervisor must— 

(1)(i) Be a doctor of medicine, doctor 

of osteopathy, or doctor of podiatric 

medicine licensed to practice medicine, 

osteopathy, or podiatry in the State in 

which the laboratory is located or have 

earned a doctoral, master’s, or 

bachelor’s degree in a chemical, 


khammond on DSKJM1Z7X2PROD with PROPOSALS3
44942 Federal Register / Vol. 87, No. 142 / Tuesday, July 26, 2022 / Proposed Rules 

biological, or clinical laboratory science 

or medical technology from an 

accredited institution; and 

(ii) Have at least 1 year of laboratory 

training or experience, or both, in high 

complexity testing; or 

(2)(i) Qualify as testing personnel 

under § 493.1489(b)(3); and 

(ii) Have at least 2 years of laboratory 

training or experience, or both, in high 

complexity testing; or 

(3) Meet the requirements at 

§ 493.1443(b)(3) or § 493.1449(c)(4) or 

(5); or 

(4) Notwithstanding any other 

provision of this section, an individual 

is considered qualified as a general 

supervisor under this section if they 

were qualified and serving as a general 

supervisor in a CLIA-certified laboratory 

as of [effective date of the final rule], 

and have done so continuously since 

[effective date of the final rule]. 

(d) * * * 

(3)(i) Have earned an associate’s 

degree related to pulmonary function 

from an accredited institution; and 

* * * * * 

(e) * * * 

(1) In histopathology, by an 

individual who is qualified as a 

technical supervisor under 

§ 493.1449(b) or (f)(1); 

* * * * * 

(4) In oral pathology, by an individual 

who is qualified as a technical 

supervisor under § 493.1449(b) or (g). 

§ 493.1462 [Removed] 

■ 24. Section 493.1462 is removed. 

■ 25. Amend § 493.1463 by revising 

paragraph (b)(4) to read as follows: 

§ 493.1463 Standard: General supervisor 

responsibilities. 

* * * * * 

(b) * * * 

(4) Evaluating and documenting the 

competency of all testing personnel. 

* * * * * 

■ 26. Amend § 493.1483 by revising 

paragraph (b) to read as follows: 

§ 493.1483 Standard: Cytotechnologist 

qualifications. 

* * * * * 

(b) Meet one of the following 

requirements: 

(1) Have graduated from a school of 

cytotechnology accredited by the 

Commission on Accreditation of Allied 

Health Education Programs (CAAHEP); 

or 

(2) Be certified in cytotechnology by 

a certifying agency approved by HHS; or 

(3) Notwithstanding any other 

provision of this section, an individual 

is considered qualified as a 

cytotechnologist under this section if 

they were qualified and serving as a 

cytotechnologist in a CLIA-certified 

laboratory as of [effective date of the 

final rule], and have done so 

continuously since [effective date of the 

final rule]. 

■ 27. Amend § 493.1489 by revising 

paragraph (b) to read as follows: 

§ 493.1489 Standard; Testing personnel 

qualifications. 

* * * * * 

(b) Meet one of the following 

requirements: 

(1) Be a doctor of medicine, doctor of 

osteopathy, or doctor of podiatric 

medicine licensed to practice medicine, 

osteopathy, or podiatry in the State in 

which the laboratory is located; or 

(2)(i) Have earned a doctoral, master’s, 

or bachelor’s degree in a chemical, 

biological, or clinical laboratory science 

or medical technology or nursing from 

an accredited institution; 

(ii) Be qualified under the 

requirements of § 493.1443(b)(3) or 

§ 493.1449(c)(4) or (5); or 

(3)(i) Have earned an associate’s 

degree in a laboratory science or 

medical laboratory technology from an 

accredited institution or— 

(ii) Have education and training 

equivalent to that specified in paragraph 

(b)(2)(i) of this section that includes— 

(A) At least 60 semester hours, or 

equivalent, from an accredited 

institution that, at a minimum, includes 

either— 

(1) 24 semester hours of medical 

laboratory technology courses; or 

(2) 24 semester hours of science 

courses that include— 

(i) 6 semester hours of chemistry; 

(ii) 6 semester hours of biology; and 

(iii) 12 semester hours of chemistry, 

biology, or medical laboratory 

technology in any combination; and 

(B) Have laboratory training that 

includes: 

(1) Completion of a clinical laboratory 

training program approved or accredited 

by the ABHES or the CAAHEP (this 

training may be included in the 60 

semester hours listed in paragraph 

(b)(3)(ii)(A) of this section); or 

(2) At least 3 months documented 

laboratory training in each specialty in 

which the individual performs high 

complexity testing; or 

(4) Successful completion of an 

official U.S. military medical laboratory 

procedures training course of at least 50 

weeks duration and having held the 

military enlisted occupational specialty 

of Medical Laboratory Specialist 

(Laboratory Technician); or 

(5) Notwithstanding any other 

provision of this section, an individual 

is considered qualified as a high 

complexity testing personnel under this 

section if they were qualified and 

serving as a high complexity testing 

personnel in a CLIA-certified laboratory 

as of [effective date of the final rule], 

and have done so continuously since 

[effective date of the final rule]. 

(6) For blood gas analysis— 

(i) Be qualified under paragraph 

(b)(1), (2), (3), (4), or (5) of this section; 

(ii) Have earned a bachelor’s degree in 

respiratory therapy or cardiovascular 

technology from an accredited 

institution; or 

(iii) Have earned an associate’s degree 

related to pulmonary function from an 

accredited institution; or 

(7) For histopathology, meet the 

qualifications of § 493.1449(b) or (l) to 

perform tissue examinations. 

§ 493.1491 [Removed] 

■ 28. Section 493.1491 is removed. 

■ 29. Amend § 493.1804 by revising 

paragraph (c)(1) to read as follows: 

§ 493.1804 General considerations. 

* * * * * 

(c) * * * 

(1) CMS may impose alternative 

sanctions in lieu of, or in addition to, 

principal sanctions. 

* * * * * 

Dated: July 13, 2022. 

Xavier Becerra, 

Secretary, Department of Health and Human 

Services. 

[FR Doc. 2022–15300 Filed 7–22–22; 4:15 pm] 

BILLING CODE 4120–01–P 


khammond on DSKJM1Z7X2PROD with PROPOSALS3