Federal Register / Vol. 80, No. 59 / Friday, March 27, 2015 / Notices 16395 

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1

21 CFR section Number of 

respondents 

Number of 

responses per 

respondent 

Total 

annual 

responses 

Average 

burden per 

response 

Total hours 

610.2 Lot Release Information Submission .................................... 76 84 .54 6,197 3 18,591 

660.6(b) Lot Release Information Submission ................................ 2 9 18 5 90 

660.36(a)(2) and (b) Lot Release Information Submission ............. 1 1 1 6 6 

660.46(b) Lot Release Information Submission .............................. 1 1 1 5 5 

Total ............................................................................................ 80 .......................... 6,217 .................... 18,692 

1There are no capital costs or operating and maintenance costs associated with this collection of information. 

Dated: March 23, 2015. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2015–07008 Filed 3–26–15; 8:45 am] 

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DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

[CMS–3313–N] 

Announcement of the Re-Approval of 

the College of American Pathologists 

(CAP) as an Accreditation Organization 

Under the Clinical Laboratory 

Improvement Amendments of 1988 

AGENCY: Centers for Medicare & 

Medicaid Services (CMS), HHS. 

ACTION: Notice. 

SUMMARY: This notice announces the 

application of the College of American 

Pathologists (CAP) for approval as an 

accreditation organization for clinical 

laboratories under the Clinical 

Laboratory Improvement Amendments 

of 1988 (CLIA) program. We have 

determined that the CAP meets or 

exceeds the applicable CLIA 

requirements. In this notice, we 

announce the approval and grant CAP 

deeming authority for a period of 6 

years. 

DATES: This notice is effective from 

March 27, 2015, until March 27, 2021. 

FOR FURTHER INFORMATION CONTACT: 

Melissa Singer, 410–786–0365. 

SUPPLEMENTARY INFORMATION: 

I. Background and Legislative 

Authority 

On October 31, 1988, the Congress 

enacted the Clinical Laboratory 

Improvement Amendments of 1988 

(CLIA) (Pub. L. 100–578). CLIA 

amended section 353 of the Public 

Health Service Act. We issued a final 

rule implementing the accreditation 

provisions of CLIA on July 31, 1992 (57 

FR 33992). Under these provisions, we 

may grant deeming authority to an 

accreditation organization if its 

requirements for laboratories accredited 

under its program are equal to or more 

stringent than the applicable CLIA 

program requirements in 42 CFR part 

493 (Laboratory Requirements). Subpart 

E of part 493 (Accreditation by a Private, 

Nonprofit Accreditation Organization or 

Exemption under an Approved State 

Laboratory Program) specifies the 

requirements an accreditation 

organization must meet to be approved 

by CMS as an accreditation organization 

under CLIA. 

II. Notice of Approval of CAP as an 

Accreditation Organization 

In this notice, we approve the College 

of American Pathologists (CAP) as an 

organization that may accredit 

laboratories for purposes of establishing 

their compliance with CLIA 

requirements in all specialties and 

subspecialties. We have examined the 

initial CAP application and all 

subsequent submissions to determine its 

accreditation program’s equivalency 

with the requirements for approval of an 

accreditation organization under 

subpart E of part 493. We have 

determined that the CAP meets or 

exceeds the applicable CLIA 

requirements. We have also determined 

that the CAP will ensure that its 

accredited laboratories will meet or 

exceed the applicable requirements in 

subparts H, I, J, K, M, Q, and the 

applicable sections of R. Therefore, we 

grant the CAP approval as an 

accreditation organization under 

subpart E of part 493, for the period 

stated in the DATES section of this notice 

for all specialties and subspecialties 

areas under CLIA. As a result of this 

determination, any laboratory that is 

accredited by the CAP during the time 

period stated in the DATES section of this 

notice will be deemed to meet the CLIA 

requirements for the listed specialties 

and subspecialties, and therefore, will 

generally not be subject to routine 

inspections by a state survey agency to 

determine its compliance with CLIA 

requirements. The accredited laboratory, 

however, is subject to validation and 

complaint investigation surveys 

performed by CMS, or its agent(s). 

III. Evaluation of the CAP Request for 

Approval as an Accreditation 

Organization Under CLIA 

The following describes the process 

used to determine that the CAP 

accreditation program meets the 

necessary requirements to be approved 

by CMS as an accreditation program 

with deeming authority under the CLIA 

program. The CAP formally applied to 

CMS for approval as an accreditation 

organization under CLIA for all 

specialties and subspecialties. In 

reviewing these materials, we reached 

the following determinations for each 

applicable part of the CLIA regulations: 

A. Subpart E—Accreditation by a 

Private, Nonprofit Accreditation 

Organization or Exemption Under an 

Approved State Laboratory Program 

The CAP submitted its mechanism for 

monitoring compliance with all 

requirements equivalent to conditionlevel requirements, a list of all its 

current laboratories and the expiration 

date of their accreditation, and a 

detailed comparison of the individual 

accreditation requirements with the 

comparable condition-level 

requirements. We have determined that 

the CAP’s policies and procedures for 

oversight of laboratories performing all 

laboratory testing covered by CLIA are 

equivalent to those required by our 

CLIA regulations in the matters of 

inspection, monitoring proficiency 

testing (PT) performance, investigating 

complaints, and making PT information 

available. The CAP submitted 

documentation regarding its 

requirements for monitoring and 

inspecting laboratories, and describing 

its own standards regarding 

accreditation removal or withdrawal of 

accreditation, notification requirements, 

and accreditation organization 

resources. We have determined that the 

requirements of the accreditation 

program submitted for approval are 

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16396 Federal Register / Vol. 80, No. 59 / Friday, March 27, 2015 / Notices 

equal to or more stringent than the 

requirements of the CLIA regulations. 

B. Subpart H—Participation in 

Proficiency Testing for Laboratories 

Performing Nonwaived Testing and 

Listing of Analytes Requiring PT From 

Subpart I 

We have determined that the CAP’s 

requirements are equal to or more 

stringent than the CLIA requirements at 

§ 493.801 through § 493.865. Like CLIA, 

all of the CAP’s accredited laboratories 

are required to participate in an HHSapproved PT program for tests listed in 

Subpart I. CLIA exempts waived testing 

from PT, whereas the CAP requires its 

accredited laboratories to participate in 

a CMS-approved PT program for test 

systems waived under CLIA. 

C. Subpart J—Facility Administration 

for Non-Waived Testing 

The CAP requirements are equal to or 

more stringent than the CLIA 

requirements at § 493.1100 through 

§ 493.1105. CAP is more stringent than 

CLIA in its specific requirements for the 

Laboratory Information System that 

include requirements for computer 

facility, hardware and software, system 

security, patient data, auto verification, 

data retrieval and preservation, 

interfaces, and telepathology. 

D. Subpart K—Quality System for 

Nonwaived Testing 

We have determined that the QC 

requirements of CAP are more stringent 

than the CLIA requirements at 

§ 493.1200 through § 493.1299. The CAP 

lists extensive requirements for the 

methodologies of clinical biochemical 

genetics, molecular pathology and flow 

cytometry, which are presented in 

separate checklists. The CAP’s control 

procedure requirements for molecular 

testing and histocompatibility are more 

specific and detailed than the CLIA 

requirements for control procedures. 

CAP laboratories performing waived 

testing must follow the same 

requirements that apply to non-waived 

testing for procedure manuals, specimen 

handling, results reporting, instruments, 

and equipment. Under CLIA, the 

Subpart K Quality System requirements 

do not apply to waived testing. 

E. Subpart M—Personnel for Nonwaived 

Testing 

We have determined that the CAP 

requirements are equal to or more 

stringent than the CLIA requirements at 

§ 493.1403 through § 493.1495 for 

laboratories that perform moderate and 

high complexity testing. For certain 

types of testing, such as molecular 

testing, the experience requirements for 

General Supervisor are more closely 

related to the specific testing technology 

than the CLIA requirements. The CAP 

also applies personnel requirements to 

waived testing. CLIA regulations do not 

contain personnel requirements for 

waived testing. 

F. Subpart Q—Inspection 

We have determined that the CAP 

inspection requirements are equal to or 

more stringent than the CLIA 

requirements at § 493.1771 through 

§ 493.1780. CAP will continue to 

conduct biennial onsite inspections. 

During the onsite inspection, CAP 

requires that the inspector meet with the 

hospital administrator or medical staff 

to obtain their feedback on the 

laboratory service. The CAP also 

requires a mid-cycle self-inspection of 

all accredited laboratories. CLIA 

regulations do not contain these 

requirements. 

G. Subpart R—Enforcement Procedures 

We have determined that the CAP 

meets the requirements of subpart R to 

the extent that such requirements are 

utilized by accreditation organizations. 

CAP policy sets forth the actions the 

organization takes when laboratories it 

accredits do not comply with its 

requirements and standards for 

accreditation. When appropriate, the 

CAP will deny, suspend, or revoke 

accreditation in a laboratory accredited 

by the CAP and report that action to us 

within 30 days. The CAP also provides 

an appeals process for laboratories that 

have had accreditation denied, 

suspended, or revoked. 

We have determined that the CAP’s 

laboratory enforcement and appeal 

policies are equal to or more stringent 

than the requirements of part 492 

subpart R as they apply to accreditation 

organizations. 

IV. Federal Validation Inspections and 

Continuing Oversight 

The federal validation inspections of 

laboratories accredited by the CAP may 

be conducted on a representative 

sample basis or in response to 

substantial allegations of 

noncompliance (that is, complaint 

inspections). The outcome of those 

validation inspections, performed by 

CMS or our agents, or the state survey 

agencies, will be our principal means 

for verifying that the laboratories 

accredited by CAP remain in 

compliance with CLIA requirements. 

This federal monitoring is an ongoing 

process. 

V. Removal of Approval as an 

Accrediting Organization 

Our regulations provide that we may 

rescind the approval of an accreditation 

organization, such as that of the CAP, 

for cause, before the end of the effective 

date of approval. If we determine that 

the CAP has failed to adopt, maintain 

and enforce requirements that are equal 

to, or more stringent than, the CLIA 

requirements, or that systemic problems 

exist in its monitoring, inspection or 

enforcement processes, we may impose 

a probationary period, not to exceed 1 

year, in which the CAP would be 

allowed to address any identified issues. 

Should the CAP be unable to address 

the identified issues within that 

timeframe, CMS may, in accordance 

with the applicable regulations, revoke 

the CAP’s deeming authority under 

CLIA. 

Should circumstances result in our 

withdrawal of the CAP’s approval, we 

will publish a notice in the Federal 

Register explaining the basis for 

removing its approval. 

VI. Collection of Information 

Requirements 

This notice does not impose any 

information collection and record 

keeping requirements subject to the 

Paperwork Reduction Act (PRA). 

Consequently, it does not need to be 

reviewed by the Office of Management 

and Budget (OMB) under the authority 

of the PRA. The requirements associated 

with the accreditation process for 

clinical laboratories under the Clinical 

Laboratory Improvement Amendments 

of 1988 (CLIA) program, and the 

implementing regulations in 42 CFR 

part 493, subpart E, are currently 

approved under OMB control number 

0938–0686. 

Dated: March 9, 2015. 

Andrew M. Slavitt, 

Acting Administrator, Centers for Medicare 

& Medicaid Services. 

[FR Doc. 2015–07111 Filed 3–26–15; 8:45 am] 

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