Federal Register / Vol. 60, No. 78 / Monday, April 24, 1995 / Rules and Regulations 20035

DEPARTMENT OF VETERANS

AFFAIRS

38 CFR Part 21

RIN 2900–AH25

Veterans Education: Establishing

Eligibility Under the Montgomery GI

Bill—Active Duty

AGENCY: Department of Veterans Affairs.

ACTION: Final rule.

SUMMARY: This document amends the

Vocational Rehabilitation and Education

regulations to reflect the statutory

requirement that individuals seeking to

establish eligibility for educational

assistance under the Montgomery GI

Bill—Active Duty through a

combination of active duty service and

service in the Selected Reserve must

enter the Selected Reserve within one

year of discharge from active duty.

EFFECTIVE DATE: December 18, 1989, the

date this requirement became effective.

FOR FURTHER INFORMATION CONTACT: June

C. Schaeffer, Assistant Director for

Policy and Program Administration,

Education Service, Veterans Benefits

Administration (202) 273–7187.

SUPPLEMENTARY INFORMATION: The

Secretary of Veterans Affairs hereby

certifies that this final rule will not have

a significant economic impact on a

substantial number of small entities as

they are defined in the Regulatory

Flexibility Act (RFA), 5 U.S.C. 601–612.

Pursuant to 5 U.S.C. 605(b), the

amended regulations, therefore, are

exempt from the initial and final

regulatory flexibility analyses

requirements of sections 603 and 604.

This final rule merely reflects statutory

requirements. Further, the final rule

affects only individuals, and does not

directly affect small entities.

List of Subjects in 38 CFR Part 21

Civil rights, Claims, Education, Grant

programs—education, Loan programs—

education, Reporting and recordkeeping

requirements, Schools, Veterans,

Vocational education, Vocational

rehabilitation.

Approved: March 21, 1995.

Jesse Brown,

Secretary of Veterans Affairs.

For the reasons set out in the

preamble, 38 CFR part 21, subpart K is

amended as set forth below.

PART 21—VOCATIONAL

REHABILITATION AND EDUCATION

Subpart K—All Volunteer Force

Educational Assistance Program (New

GI Bill)

1. The authority citation for part 21,

subpart K continues to read as follows:

Authority: 38 U.S.C. chapter 30, Pub. L.

98–525, 38 U.S.C. 510(a).

2. In § 21.7042 paragraph (b)(4) and its

authority citation are revised to read as

follows:

§ 21.7042 Basic eligibility requirements.

* * * * *

(b) * * *

(4) Except as provided in paragraph

(b)(7) of this section, after completion of

active duty service, the individual must

serve at least four continuous years of

service in the Selected Reserve. An

individual whose release from active

duty service occurs after December 17,

1989, must begin this service in the

Selected Reserve within one year from

the date of his or her release from active

duty. During this period of service in

the Selected Reserve the individual

must satisfactorily participate in

training as prescribed by the Secretary

concerned.

(Authority: 38 U.S.C. 3012(a)(1); Pub. L. 100–

689, Pub. L. 101–237)

* * * * *

[FR Doc. 95–9990 Filed 4–21–95; 8:45 am]

BILLING CODE 8320–01–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Health Care Financing Administration

42 CFR Part 493

[HSQ–216–FC]

RIN 0938–AG71

CLIA Program; Categorization of Tests

and Personnel Modifications

AGENCY: Health Care Financing

Administration (HCFA) and Public

Health Service (PHS), HHS.

ACTION: Final rule with comment period.

SUMMARY: In this rule we are responding

to some of the comments on

categorization of tests and personnel

requirements received in response to

rules published on February 28, 1992

and January 19, 1993. (In a future rule,

we will be responding to the remaining

comments.) We are revising our

regulations to: Allow dentists and

midlevel practitioners to perform tests

in the ‘‘physician-performed’’

microscopy (PPM) subcategory of

moderate complexity procedures (we

now call the subcategory ‘‘providerperformed’’); include three additional

tests in PPM; and expand provisions

relating to general supervisor and high

complexity testing personnel.

DATES: Effective date: These regulations

are effective April 24, 1995.

Comment date: Comments on the

addition of three PPM tests will be

considered if we receive them at the

appropriate address, as provided under

ADDRESSES, no later than 5 p.m. on June

23, 1995.

ADDRESSES: Mail written comments (1

original and 3 copies) to the following

address: Health Care Financing

Administration, Department of Health

and Human Services, Attention: HSQ–

216–FC, P.O. Box 26676, Baltimore, MD

21207.

If you prefer, you may deliver your

written comments (1 original and 3

copies) to one of the following

addresses:

Room 309–G, Hubert H. Humphrey

Building, 200 Independence Avenue,

SW., Washington, DC 20201,

or

Room 132, East High Rise Building,

6325 Security Boulevard, Baltimore,

MD 21207.

Because of staffing and resource

limitations, we cannot accept comments

by facsimile (FAX) transmission. In

commenting, please refer to file code

HSQ–216–FC. Comments received

timely will be available for public

inspection as they are received,

generally beginning approximately 3

weeks after publication of a document,

in Room 309–G of the Department’s

offices at 200 Independence Avenue,

SW., Washington, DC, on Monday

through Friday of each week from 8:30

a.m. to 5 p.m. (phone: (202) 690–7890).

For comments that relate to

information collection requirements,

mail a copy of comments to: Office of

Information and Regulatory Affairs,

Office of Management and Budget,

Room 10235, New Executive Office

Building, Washington, DC 20503, Attn:

Allison Herron Eydt, HCFA Desk

Officer.

Copies: To order copies of the Federal

Register containing this document, send

your request to: New Orders,

Superintendent of Documents, P.O. Box

371954, Pittsburgh, PA 15250–7954.

Specify the date of the issue requested

and enclose a check or money order

payable to the Superintendent of

Documents, or enclose your Visa or

Master Card number and expiration

date. Credit card orders can also be

placed by calling the order desk at (202)
20036 Federal Register / Vol. 60, No. 78 / Monday, April 24, 1995 / Rules and Regulations

783–3238 or by faxing to (202) 275–

6802. The cost for each copy is $8.00.

As an alternative, you can view and

photocopy the Federal Register

document at most libraries designated

as Federal Depository Libraries and at

many other public and academic

libraries throughout the country that

receive the Federal Register.

FOR FURTHER INFORMATION CONTACT:

Rosemary Bakes-Martin, (404) 488–

7655, for questions regarding the

addition of the three PPM tests; Rhonda

S. Whalen, (404) 488–7655, for

questions regarding personnel; and Judy

Yost, (410) 597–5907, for certificate, fee,

and inspection issues.

SUPPLEMENTARY INFORMATION:

I. Background

Under section 353 of the Public

Health Service Act (42 U.S.C. 263a), as

amended by the Clinical Laboratory

Improvement Amendments of 1988

(CLIA), all laboratories that examine

human specimens for the diagnosis,

prevention or treatment of any disease

or impairment of, or the assessment of

the health of, human beings must meet

certain requirements to perform the

examination. Many of the requirements

are based on the complexity of the tests

performed. There are currently three test

categories: Waived, moderate

complexity, including the subcategory

of physician-performed microscopy, and

high complexity.

Following the publication on

February 28, 1992 (57 FR 7002) of the

initial regulations implementing CLIA,

HHS established a Clinical Laboratory

Improvement Advisory Committee

(CLIAC) to advise and make

recommendations on technical and

scientific aspects of the regulations. The

CLIAC is composed of individuals

involved in the provision of laboratory

services, use of laboratory services,

development of laboratory testing

devices or methodologies, and others as

approved by HHS. In addition, HHS has

designated the following four CLIAC

subcommittees: cytology; personnel;

proficiency testing, quality control and

quality assurance; and test

categorization.

The CLIAC meets as needed, but not

less than once a year. So far, the CLIAC

has met in October, 1992, February,

May, August, and December, 1993, and

March and September, 1994. The

subcommittee on test categorization has

met in January and June, 1993; the

subcommittee on cytology has met in

December, 1993; and the subcommittee

on proficiency testing, quality control,

and quality assurance has met in March

and September, 1994.

Following publication of the February

28, 1992 regulations, we received

approximately 16,000 letters from

professional organizations and

individuals that provided around 71,000

comments. In response to public

comments received concerning certain

physician performed microscopy

procedures, we requested the CLIAC to

evaluate the categorization of these

tests. As a result, we developed a new

subcategory of moderate complexity

testing, called physician-performed

microscopy (PPM) procedures, and

published the requirements concerning

the subcategory in a rule on January 19,

1993 (58 FR 5215).

In this rule, we address the comments

we received concerning the application

of certain personnel requirements and

comments concerning categorization of

PPM tests. One area of commenter

concern was that currently employed

supervisors and high complexity testing

personnel continue to be qualified.

Another area of concern was that our

requirements would diminish access to

services, particularly in rural and

underserved areas, leading to

recommendations that we expand the

PPM procedures subcategory to include

dentists and midlevel practitioners.

II. Responses to Comments

A. Categorization: Physician-Performed

Microscopy Procedures

As stated earlier, we established a

new subcategory of moderate

complexity testing called ‘‘physicianperformed microscopy (PPM)

procedures’’ in revisions to the CLIA

regulations, published in the Federal

Register on January 19, 1993. In

response to the regulation establishing

PPM, we received approximately 2,200

comments from professional

organizations and individuals. A

significant number of these comments

addressed the tests categorized as PPM

procedures, including requests that

some of these tests be waived, or that

additional tests be added to the list of

PPM procedures. Some commenters

asked that PPM be expanded to include

specific tests related to a particular

medical specialty or practice.

Conversely, other commenters were

opposed to adding additional tests or

criteria to PPM, and felt that this

subcategory should remain very limited.

Comments and Responses

Comment: A number of commenters

stated that PPM is too restrictive, and

that all of the PPM procedures should

be categorized as waived tests. Some

commenters specifically stated that wet

mounts and urine sediment

examinations should not be in PPM but

should be waived tests.

Response: Tests included in PPM are

moderate complexity microscopic

examinations that do not meet the

criteria for waiver because they are not

simple procedures; they require training

and specific skills for test performance.

Personnel performing these tests must

be proficient in the use of a microscope

and must be able to detect and identify

cellular elements present in a specimen,

both of which require substantial

training, experience, and specific

knowledge to be accurately performed.

To differentiate significant elements in

a specimen from debris or artifacts

requires a high level of interpretive

skills. In fact, personnel requirements

for this subcategory of moderate

complexity testing are more stringent

than for other moderate complexity

testing due to the nature of testing in

PPM. Examinations of wet mount

preparations and urine sediment were

included in PPM because they meet the

PPM criteria. These microscopic

examinations are performed during a

patient’s physical examination on

specimens that are labile or not

appropriate to send to another

laboratory for analysis. In addition,

controls are generally not available to

monitor the complete testing process for

these procedures. Therefore, only

limited activities are suitable for

inspection.

Comment: Several commenters

expressed confusion as to which

examinations are considered ‘‘wet

mount examinations’’.

Response: We are revising the

description of ‘‘wet mount

examinations’’ at § 493.19(c)(1)

(formerly § 493.16(c)(1)), to clarify what

we mean by wet mount preparations.

Although we provided the examples of

vaginal, cervical or skin specimens as

part of the wet mount definition, we

never intended to limit wet mount

examinations to only these specimens.

By revising the definition of this test, we

are not making any changes in what was

originally intended for this group of

examinations. They are moderate

complexity microscopic examinations

performed on any direct specimen that

may be suspended in a drop of water or

saline. They are performed using a

microscope, which is limited to brightfield or phase-contrast, in order to

recognize the presence or absence of

bacteria, fungi, parasites, and human

cellular elements (including red and

white blood cells, epithelial cells, etc.)

and to differentiate these from artifacts.

They are not procedures in which

definitive identification or enumeration

is made or any staining is performed.
Federal Register / Vol. 60, No. 78 / Monday, April 24, 1995 / Rules and Regulations 20037

Comment: A number of commenters

requested that additional tests be added

to PPM. Microscopic tests that were

suggested include synovial fluid

analysis, qualitative and quantitative

semen analysis, nasal smears or sputum

for eosinophils or basophils, wet mount

examination of prostatic fluid or

secretions, stools for leukocytes, scabies

examinations, Gram stain, Tzanck

preparations, white blood cell counts

and leukocyte differentials, microscopic

examinations of hair morphology, darkfield examinations and molluscum

smears. A number of non-microscopic

procedures were also requested,

including microbiology cultures, serum

glucose and BUN levels, qualitative

drug screens, a variety of serologic tests,

and miscellaneous tests performed

using hand-held or elementary

instrumentation.

Other organizations and professionals

were opposed to adding tests or criteria

to PPM. Two organizations suggested

explicit language to limit procedures

included in PPM to specific microscopic

examinations and exclude any testing

that involves automated

instrumentation or biochemical

reactions.

Response: Tests in PPM are limited to

specific microscopic examinations that

are moderately complex procedures and

meet the criteria for PPM. Most of the

tests named by commenters for addition

to PPM do not meet these established

criteria. However, nasal smear

examinations for granulocytes, fecal

leukocyte examinations, and qualitative

semen analysis (limited to the presence

or absence of sperm and detection of

motility) do meet the criteria for

inclusion in PPM. They are all moderate

complexity microscopic examinations

that are performed during the course of

a patient examination. They are

performed on labile specimens, require

very limited specimen processing and

handling, and controls are not available

to monitor the entire testing process.

Fecal leukocyte examinations and

qualitative semen analyses are actually

forms of wet mount examinations. The

CLIAC recommended that these three

examinations be included in PPM, and

HHS agrees with CLIAC that these

procedures meet the PPM criteria. The

other examination that the CLIAC

recommended be added to PPM, the wet

mount examination of expressed

prostatic secretions, is now included in

PPM because it meets the clarified

definition of wet mounts in

§ 493.19(c)(1). Tests that the CLIAC

reviewed, and recommended not be

included in PPM, are the Gram stain,

quantitative semen analysis,

histodermatology slides, white blood

cell (WBC) differential, and polarization

of synovial fluid for crystals. These

examinations do not meet the criteria

for inclusion in the PPM subcategory.

The quantitative semen analysis,

histodermatology slides, and

polarization of synovial fluid for

crystals are all high complexity

procedures. Although some Gram stains

and WBC differentials are categorized as

moderate complexity, these

examinations do not meet the additional

criteria required for inclusion in PPM.

They are not performed on labile

specimens, and quality control materials

are readily available for Gram stains and

WBC differentials. Both of these

examinations are performed on

specimen preparations that must be

stained in order to differentiate and

identify cellular elements. These

staining procedures require multiple,

critical steps. Therefore, HHS concurs

with the CLIAC recommendations that

these tests not be included in the PPM

subcategory, and has not added these

tests to the list of PPM examinations.

Comment: Several organizations

requested that tests relevant to specific

medical specialties, including

pediatrics, internal medicine, family

practice, rheumatology, and infectious

disease, be added to PPM for physicians

with appropriate training.

Response: The CLIAC considered a

proposal by HHS to expand PPM to

include additional medical specialtyspecific microscopic examinations

when performed by physicians with

specialty training. The CLIAC

recommended that PPM not be

expanded to include medical specialtyspecific procedures, due to the difficulty

in establishing a mechanism to assure

adequate training and competency in

performing each of these specialized

procedures. HHS agrees with this

recommendation and we have not

added medical specialty-specific

procedures to PPM; however,

physicians may continue to perform

these procedures in accordance with the

applicable requirements for the level of

complexity in which the test is

categorized.

Comment: One organization stated

that, in order to contain costs,

physicians should be able to perform

essential laboratory tests in their offices

without restrictions and recommended

that a free-standing physician category

be established with the range of tests

performed in each laboratory based on

the physician’s specialty, training and

experience. The organization indicated

that there should be no specific test list;

any testing other than cytopathology

would be included in this category.

Testing could be performed by the

physician, or by other personnel under

the direction and control of the

physician. Quality control and

proficiency testing would be required,

and laboratories would be subject to onsite inspections if it was suspected that

they were not in compliance with the

regulations.

Response: The CLIA regulations were

developed in an effort to ensure the

quality of laboratory services in every

testing situation and assure that

accurate and reliable testing is available

to all patients. To do this, minimum

requirements were established for

laboratory testing that, in accordance

with the law, depend on the complexity

of the procedures being performed and

are independent of the testing location.

As test procedures become more

complex, more stringent testing

requirements are imposed. PPM

contains a unique group of microscopic

procedures that are routinely performed

in the course of a patient examination.

They are tests for which it is difficult to

enforce regulatory requirements because

biological controls that monitor the

entire testing process are not readily

available and because the inspection

process would interfere with a patient

examination. The PPM subcategory was

established to exempt physicians (and,

as discussed below, mid-level

practitioners and dentists are now

included) from the requirement for

routine inspections if the PPM

procedures are the only tests, in

addition to waived tests, that they

perform. Physicians, mid-level

practitioners, and dentists are not

prohibited from performing other

laboratory procedures in their offices or

clinics. However, for procedures that

can be regulated through an inspection

process, routine inspections are

required, since this is one mechanism to

assure that the quality of testing is

maintained.

Changes to the Regulations

In this regulation, we have moved the

PPM subcategory, formerly located at

§ 493.16, to a new § 493.19.

In the list of PPM procedures now

located at § 493.19(c), we are changing

the description of wet mounts at

§ 493.19 (c)(1) to clarify the types of

examinations that are included in this

procedure. Also, to the list of PPM

procedures, we are adding three tests:

nasal smears for granulocytes, fecal

leukocyte examinations, and qualitative

semen analysis (limited to the presence

or absence of sperm and detection of

motility).
20038 Federal Register / Vol. 60, No. 78 / Monday, April 24, 1995 / Rules and Regulations

Other Revisions to the Regulations

Currently, PPM procedures are

subsumed in the category of moderate

complexity, with changes made to

moderate complexity testing

requirements as needed. To aid readers

in finding requirements pertinent to

their needs, we have created a discrete

subcategory of requirements for PPM

procedures, by breaking out the

requirements for PPM as necessary.

Currently, a laboratory that meets the

requirements to perform high or

moderate complexity tests is issued a

‘‘certificate’’. We also have certificates

for PPM procedures. For clarity, to

distinguish between the generic use of

the word certificate and the type of

certificate issued to a laboratory that

performs tests of moderate or high

complexity, or both, we are changing

‘‘certificate’’ (for tests of moderate or

high complexity, or both) to ‘‘certificate

of compliance.’’ This is the certificate

that will be issued following the

determination of successful compliance

with the CLIA regulations for testing

that includes moderate and/or high

complexity. Where necessary, we make

revisions concerning each specific

certificate and/or subcategory (including

waived tests). We are changing, as

required, references to specific

certificates to refer to ‘‘appropriate’’

certificates.

We make these technical changes in

the following existing sections and

headings: §§ 493.2, definition of

‘‘certificate’’ under ‘‘CLIA certificate’’;

493.3(a)(1); 493.5(a)(2) and (c) (formerly

493.10); 493.20(a) and (b); 493.25(c)

(formerly 493.25(d)); subpart C heading;

493.43 heading and paragraph (a);

493.45 introductory paragraph and

paragraphs (a)(1), (2) and (3) (the last is

deleted) and (d) and (f); 493.49; 493.51

heading, introductory paragraph, and

paragraphs (b) and (c); 493.55(a); 493.57

introductory paragraph and

subparagraph (b)(1)(ii); 493.511(h);

493.521(j); 493.602; 493.638; 493.639(b);

493.643(d); 493.645 heading and

paragraph (c) (redesignated from

paragraph (a)(2)); 493.646(a); 493.649(a)

and (b); subpart H heading; 493.803(a);

493.807 heading; subheading preceding

493.821; subpart I heading; subpart J

heading; 493.1101, including the

heading; subpart K heading; 493.1201

heading; subpart M heading; subpart P

heading; 493.1701, including heading;

493.1777 heading, introductory

paragraph and paragraphs (a) and (g);

493.1814(b)(3); 493.1834(b) and

(f)(2)(iii); 493.1836(c)(2) and (3); and

493.2001.

B. Personnel

1. Physician-Performed Microscopy

Procedures

Comment: Approximately 68 percent

of the 2,200 comments received in

response to the regulation establishing

PPM addressed personnel requirements,

especially expansion of the PPM

subcategory to include other health care

practitioners. The comments were

divided between individuals who

suggested expansion of PPM to include

other health care professionals and

those commenters who believed that

PPM should be limited to physicians.

While national laboratory organizations

and individual laboratory professionals

commented that PPM should be limited

to physicians, professional

organizations representing physicians

and midlevel health care practitioners

stated that PPM should be expanded to

include other health care providers. We

also received comments requesting that

dentists be included in PPM to allow

them to perform wet mount

examinations as part of their dental

evaluations.

Several commenters representing

physicians and midlevel health care

practitioners included information and

responded to questions posed in the

preamble to the January 19, 1993,

Federal Register rule creating the PPM

subcategory. In that publication, we

specifically asked commenters to

comment on the type of health care

professionals who usually perform the

PPM tests as part of a physical

examination, how often the tests are

performed, and the quality, access and

cost implications in establishing the

PPM subcategory.

The commenters who responded to

these questions stated that depending

on the type of health care setting,

physicians, or quite often nurse

practitioners, nurse midwives, or

physician assistants, perform physical

examinations and the laboratory tests

related to these examinations. In some

cases, State laws authorize these

midlevel practitioners to practice

independently. These commenters

added that, because of the variety of

settings, it is impossible to estimate the

percentage of testing done by each

group of health professionals. However,

they did say that many midlevel

practitioners perform patient

examinations and certain microscopic

tests on a daily basis and in equal or

greater numbers than physicians in

some places. They also said that

midlevel practitioners receive the

training needed to perform these tests

and the quality of their test results is at

least equivalent to testing performed by

physicians. Commenters indicated that,

in addition to the physicians and the

midlevel practitioners listed above,

emergency personnel, registered nurses,

licensed practical nurses, and medical

assistants perform PPM tests.

Commenters indicated that although the

cost of testing might vary, this was not

related to who performed the test.

Lastly, the commenters stressed that

the quality, cost and access implications

of not including midlevel practitioners

under the certificate for the PPM

subcategory were extensive, especially

in rural areas, among low-income

populations, and in other areas where

there is a shortage of physicians. In

some of these settings, midlevel

practitioners are the only available

health care providers. Excluding these

professionals from obtaining a

certificate for the PPM subcategory has

substantial cost implications. Since

laboratories that have a certificate for

the PPM subcategory are not subject to

fees for routine inspections, the cost of

providing services under the PPM

certificate is lower than under a

certificate of compliance. If facilities

cannot afford to provide testing under a

certificate of compliance, patient access

to health care would be limited.

Response: In considering these

comments, we sought the advice of the

CLIAC. In an effort to provide an

opportunity for public discussion and

consideration of these issues, we

scheduled two CLIAC meetings on the

PPM subcategory. Presentations were

made by HHS, and the public was

invited to comment and provide

information. The CLIAC recommended

that individuals and organizations

representing practitioners seeking to be

included in the PPM subcategory submit

documentation concerning the specific

course work and the amount of training

such individuals receive in the

performance of microscopic

examinations. Over 100 individuals and

organizations responded to the request

for information, with many of the

commenters providing documentation

of specific training curricula in

microscopic procedures. The CLIAC

asked CDC to evaluate the materials

submitted. In reviewing the training

programs of nurse midwives, nurse

practitioners and physician assistants,

CDC concluded that these practitioners,

like physicians, perform the procedures

currently included in the PPM

subcategory in conjunction with patient

evaluations, and the training they

receive in microscopic examinations is

comparable to that of physicians. The

CLIAC considered this information and

recommended that midlevel

practitioners, defined as nurse
Federal Register / Vol. 60, No. 78 / Monday, April 24, 1995 / Rules and Regulations 20039

practitioners, nurse midwives, and

physician assistants, be included in the

PPM subcategory. The CLIAC suggested

that these midlevel practitioners be

permitted to perform PPM procedures

under the supervision of a physician or

to function independently in States that

authorize individual practice.

In view of the CLIAC

recommendation and the CDC

evaluation that nurse midwives, nurse

practitioners and physician assistants

receive sufficient training to properly

perform and interpret the microscopic

examinations currently included in the

PPM subcategory, we are adding

midlevel practitioners to the PPM

subcategory. We define them in § 493.2

as nurse practitioners, nurse midwives

and physician assistants, licensed by a

State if such licensing is required.

As a result of the comments received,

we also considered the inclusion of

dentists in the PPM subcategory. After

evaluating the education and training

that dentists receive in clinical

laboratory procedures, we concluded

that dentists, with either a Doctor of

Dental Medicine (DDM) or Doctor of

Dental Surgery (DDS) degree, are

qualified to perform the examinations in

the PPM subcategory and we are adding

dentists as persons who may perform

PPM procedures.

Upon evaluation of the education and

training of emergency personnel,

registered nurses, licensed practical

nurses, and medical assistants, we

determined that these practitioners do

not receive sufficient training to

properly perform and interpret the

microscopic examinations currently

included in the PPM subcategory. For

this reason, we are not adding them as

persons who may perform PPM

procedures.

Changes to the Regulations

To accommodate the above additions,

we are changing the name from

‘‘physician-performed microscopy

procedures’’ to ‘‘provider-performed

microscopy procedures.’’

To be consistent with other personnel

requirements, we are moving the

personnel requirements for the PPM

subcategory, formerly located at

§ 493.16(e)(2) (§ 493.16(e)(3) is

redesignated as § 493.19(e)(2)), to

subpart M. At § 493.1355, we are

specifying the condition requirements

for laboratory director of PPM

procedures, with director qualification

requirements located at § 493.1357 and

director responsibilities at § 493.1359.

To the director responsibility

requirements, we are adding the

requirement limiting the number of

laboratories that an individual can

direct to five, which was inadvertently

not included in previous regulations;

currently, directors of laboratories

performing other moderate complexity

testing may only direct five. The

condition requirements for testing

personnel performing PPM procedures

are now located at § 493.1361, while

testing personnel qualifications are

located at § 493.1363 and

responsibilities are at § 493.1365.

We are also making numerous

conforming changes to part 493 to

accommodate the revision to include

midlevel practitioners and dentists. We

are revising the following additional

sections and headings: §§ 493.2—

definition of ‘‘CLIA certificate—

certificate for physician-performed

microscopy procedures’’ by adding

‘‘dentist’’ and ‘‘midlevel practitioner’’,

and revising ‘‘physician’’ (for

consistency to include doctors of

osteopathy and to require the physician

to be licensed in the State in which the

laboratory is located); 493.20(b);

493.25(c) (redesignated from 493.25(d));

heading for subpart C; 493.43 heading;

493.45(a)(2); 493.47; 493.49(a)(3); 493.53

heading and introductory paragraph;

493.638; 493.639(b); 493.643(a);

493.646(a); 493.1776 heading and

paragraphs (a) (3) and (4) and (b);

493.1814(b)(3); 493.1834(b) and

(f)(2)(iii); and 493.1836(c) (2) and (3).

2. General Discussion of General

Supervisor and High Complexity

Testing Personnel Comments

In response to the personnel

requirements contained in the final

regulations published February 28,

1992, we received approximately 55,000

comments from individuals and

organizations. The qualification

requirements for general supervisor and

high complexity testing personnel

received the most extensive comments.

Approximately 8,000 comments

concerned general supervisor, 14,000

comments related to high complexity

testing personnel and more than 10,000

comments pertained to testing

personnel, with the complexity of

testing not specified. Some commenters

indicated that the regulations were too

stringent, while others thought the

requirements were too lenient. Among

the commenters who thought that the

minimum qualifications should be

raised, there was a general consensus

that the increase in requirements should

be prospective and that the regulations

should include alternative qualifying

pathways to avoid affecting currently

employed individuals adversely. Many

commenters were concerned that the

regulations would eliminate the jobs of

many laboratory employees who possess

extensive work experience but lack the

requisite degree or formal laboratory

training. This would particularly

exacerbate the shortage of qualified

laboratory personnel in rural and

underserved areas and limit patient

access to testing.

In evaluating the many comments, we

sought advice from the CLIAC

concerning whether changes were

needed in the regulations pertaining to

general supervisor and high complexity

testing personnel. Many individuals and

organizations provided detailed

information and suggestions to CLIAC

about the qualifications that should be

required for supervision and

performance of high complexity testing.

The CLIAC recommended revising the

regulations to recognize currently

employed individuals who do not meet

the qualifications contained in the final

regulations but who have clinical

laboratory training and extensive

laboratory experience.

We acknowledge that extensive

experience can qualify individuals to

competently perform these functions.

Therefore, in response to the comments

provided to the regulations published

February 28, 1992, and to the CLIAC

advice, and to mitigate the impact of the

regulations on currently employed

people, especially those in rural and

underserved areas, we are making in

this regulation the changes necessary to

provide alternative qualification

pathways.

We are revising the general supervisor

(§ 493.1461) and high complexity testing

personnel (§ 493.1489) requirements to:

qualify individuals currently performing

high complexity testing and those

currently employed general supervisors

if they have the requisite laboratory

training or experience; recognize 50-

week U.S. military medical laboratory

training programs and accredited

laboratory training programs; and

establish equivalent requirements for

the associate degree. More specific

comments and responses concerning

revisions to the regulations to create

alternative qualifications for general

supervisor and high complexity testing

personnel follow.

We also are making conforming crossreference changes to §§ 493.1463 and

493.1495.

3. Specific Comments and Responses

General Supervisor Qualifications

Comment: Although many

commenters agreed that the minimum

requirement for general supervisor

should be an associate degree in clinical

laboratory science or medical laboratory

technology, others indicated that the
20040 Federal Register / Vol. 60, No. 78 / Monday, April 24, 1995 / Rules and Regulations

requirement should be an associate

degree with area of study not specified.

Some commenters said that

requirements equivalent to the associate

degree should be established. Several

commenters indicated that individuals

having a bachelor of arts or education

degree with a specified number of

science courses should be qualified.

Response: We agree with the

commenters who suggested the

establishment of requirements

equivalent to the associate degree with

appropriate study in the sciences

because we believe individuals who

have completed the requisite courses

and training are qualified to supervise

high complexity testing. In this

regulation, we are defining the

following as equivalent to the academic

requirements for an associate degree: 60

semester hours, which must include

either 24 semester hours of medical

laboratory technology courses or 24

semester hours of science courses that

include six semester hours of chemistry,

six semester hours of biology, and

twelve semester hours of courses in

chemistry, biology or medical laboratory

technology, or any combination. In

addition, individuals must have

completed either an accredited clinical

laboratory or medical laboratory training

program (which may be included in the

60 semester hours specified above) or

three months of documented training in

each specialty in which the individual

performs high complexity testing. We

are specifying the equivalent

requirements for the associate degree

under high complexity testing

personnel, which are adopted by crossreference to the general supervisor

requirements. Therefore, individuals

who do not have a degree or who have

a bachelor’s degree that is not in a

science can now qualify as a general

supervisor if they meet the equivalency

requirements for an associate degree and

have at least two additional years of

laboratory training or experience in high

complexity testing.

Comment: Many commenters

recommended qualifying medical

laboratory technicians without an

associate degree to serve as general

supervisor. Some commenters

recommended qualifying individuals,

including certified laboratory assistants,

who received training in an accredited

hospital or approved technical school

training program. Other commenters

recommended qualifying individuals

with military training.

Response: We agree with the

commenters that the regulations should

recognize individuals who were serving

as a general supervisor of high

complexity testing on or before

September 1, 1992 (the effective date of

the CLIA personnel regulations) but do

not have an associate degree, or

equivalent, provided they have

completed an accredited clinical

laboratory training program. We believe

individuals having this training and

experience have the appropriate

qualifications to serve as a general

supervisor. Therefore, we are adding a

provision to the general supervisor

qualification requirements to qualify

individuals who, on or before

September 1, 1992, were serving as a

general supervisor of high complexity

testing. The individual must on or

before April 24, 1995, have completed a

50-week U.S. military medical

laboratory training program or have

graduated from a medical laboratory or

clinical laboratory training program

accredited by the Accrediting Bureau of

Health Education Schools, Commission

on Allied Health Education

Accreditation or other organization

approved by HHS. To help assure

equivalency to other qualification

pathways, individuals having this type

of training are required to have two

additional years of laboratory training or

experience in high complexity testing in

order to qualify as general supervisor.

This additional training or experience

may be acquired before or after

completing the accredited or U.S.

military medical laboratory training

program.

Comment: Several commenters

misread the regulations and thought that

individuals qualified under regulations

published March 14, 1990 (55 FR 9576)

were required to obtain an associate

degree.

Response: Individuals who qualified

as general supervisors under the

previous Federal regulations are

qualified under these regulations and

are not required to obtain an associate

degree.

Comment: Some commenters

recommended that all laboratory

personnel currently employed as

general supervisors be qualified through

a ‘‘grandfather’’ provision.

Response: We agree with the

commenters and the CLIAC

recommendation that regulations should

include provisions to allow currently

employed supervisors who have

pertinent laboratory experience to

continue their employment. We are

adding a provision to the general

supervisor requirements to qualify high

school graduates, or equivalent, who, on

or before September 1, 1992, were

serving as a general supervisor and have

at least ten years of laboratory training

or experience in high complexity

testing, including at least 6 years of

supervisory experience in high

complexity testing within the last 10

years because we believe this amount of

experience is appropriate to qualify

individuals as general supervisors and

is commensurate with the general

supervisor responsibility requirements.

Comment: A few commenters agreed

with the responsibilities for general

supervisor, while a few commenters

disagreed. Most of the commenters who

disagreed with the responsibilities were

opposed to requiring the general

supervisor to be onsite when high

complexity tests are performed by

personnel who do not have at least an

associate degree. Conversely, many

commenters indicated that an

individual with an associate degree

should be allowed to perform high

complexity testing only when a

technologist or supervisor is onsite.

Response: In the revised regulation

published in the Federal Register on

January 19, 1993, we changed the

requirement for onsite supervision to

require 24-hour review of any high

complexity testing performed by

personnel who do not have at a

minimum an associate degree and were

performing high complexity testing on

or before January 19, 1993. However, in

the January 19, 1993 regulation, we

retained the onsite supervision

requirement for those high school

graduates, or equivalent, who began

performing high complexity testing after

January 19, 1993. In this regulation, we

are not changing the requirements for

onsite supervision or 24-hour review.

However, we believe individuals who

have completed accredited or 50-week

U.S. military medical laboratory training

programs or have academic

qualifications equivalent to the associate

degree are qualified to perform high

complexity testing. Therefore, we are

revising the regulations to qualify as

high complexity testing personnel

individuals having these qualifications.

Individuals who qualify under these

new provisions may perform high

complexity testing without onsite

supervision or 24-hour review.

We do not agree with the commenters

that onsite supervision should be

required for high complexity testing

performed by individuals having an

associate degree; such a requirement

would be unnecessarily burdensome

and could exacerbate personnel

shortages and limit patient access to

testing. It should be emphasized that

these are minimum requirements that

do not restrict laboratories from

establishing their own policies requiring

higher personnel qualifications. In all

cases, the laboratory director is

responsible for ensuring that all testing
Federal Register / Vol. 60, No. 78 / Monday, April 24, 1995 / Rules and Regulations 20041

personnel have the necessary education

and training or experience required for

test performance.

Testing Personnel Qualifications (High

Complexity)

Comment: Numerous commenters

believed an associate degree in

laboratory science or medical laboratory

technology should be the minimum

education requirement. Several

commenters suggested recognizing

associate degrees in fields other than

clinical laboratory science or medical

laboratory technology, with others

suggesting equivalent requirements be

established for the associate degree.

Response: Currently, the qualification

requirements for high complexity

testing personnel contain provisions

that prospectively require high school

graduates to obtain an associate degree.

As mentioned above, in evaluating the

comments received concerning high

complexity testing personnel, we sought

the advice of the CLIAC about the

appropriateness of the qualifications

required. The CLIAC recommended that

the associate degree be established as

the minimum education requirement

and, in addition, that equivalent

academic requirements be established

for the associate degree. In this

regulation, we are adding a provision to

qualify individuals who have completed

specific college courses but do not have

an associate degree or who have an

associate degree that is not in medical

laboratory technology or a laboratory

science. As previously mentioned, we

have defined requirements equivalent to

the associate degree (60 semester hours

that must include 24 semester hours of

medical laboratory technology courses

or 24 semester hours of science courses

that include six semester hours of

chemistry, six semester hours of biology

and twelve semester hours of courses in

chemistry, biology or medical laboratory

technology, or any combination);

individuals qualifying under the

equivalency provisions also must have

completed either an accredited clinical

laboratory or medical laboratory training

program (which may be included in the

60 semester hours) or three months of

documented training in each specialty

in which the individual performs high

complexity testing. The laboratory

training may be acquired before, during

or after completing the academic

requirements.

Comment: Many commenters

recommended recognizing medical

laboratory technicians without an

associate degree. Commenters also

recommended qualifying individuals,

including certified laboratory assistants,

who received training in an accredited

hospital or technical school training

program. A large number of commenters

suggested qualifying individuals with

military training.

Response: We agree with the

commenters that, in addition to the

revisions made to the general supervisor

requirements, revisions are needed in

the qualification requirements for high

complexity testing personnel to

recognize individuals who have

completed a nondegree clinical

laboratory training program and,

therefore, have equivalent training.

Therefore, we are adding to the high

complexity testing personnel

requirements, a provision to qualify

individuals who, on or before April 24,

1995 have completed a 50-week U.S.

military medical laboratory training

program or have graduated from a

medical laboratory or clinical laboratory

training program accredited by the

Accrediting Bureau of Health Education

Schools, Commission on Allied Health

Education Accreditation or other

organization approved by HHS.

Comment: A number of commenters

recommended that the regulations be

revised to qualify all currently

employed high complexity testing

personnel. Other commenters said

currently employed high school

graduates, who were trained on the job,

should be allowed to continue

performing high complexity testing but

only under supervision.

Response: We agree with the CLIAC

recommendation that the regulations

should be revised to alleviate the impact

on currently employed personnel. We

also believe that high school graduates

with appropriate training, who were

performing high complexity testing on

or before April 24, 1995 have obtained

sufficient work experience to allow

them to continue performing testing

with supervisory oversight. Therefore,

we are revising the regulations to allow

these individuals to continue

performing high complexity testing even

after September 1, 1997 (the current

limit) and do not require that they

obtain additional training or education.

However, performance of any high

complexity testing by these individuals

must be in accordance with the

supervision requirements discussed

below.

Comment: A few commenters agreed

with the responsibility requirements for

high complexity testing personnel,

while numerous commenters disagreed.

The majority of the commenters who

disagreed were opposed to requiring

onsite supervision when individuals

who do not have an associate degree

perform high complexity testing.

Response: As previously mentioned

above under the discussion of

qualifications of the general supervisor,

in the regulation published in the

Federal Register on January 19, 1993,

we changed the requirement for onsite

supervision to only require 24-hour

review of any high complexity testing

performed by personnel who do not

have an associate degree and who were

performing high complexity testing on

or before January 19, 1993. The onsite

supervision requirement was retained

only for those high school graduates, or

equivalent, who began performing high

complexity testing after January 19,

1993. In this regulation, we are not

changing the requirements for onsite

supervision or 24-hour review.

However, we believe individuals who

have completed accredited or U.S.

military laboratory training programs or

have qualifications equivalent to the

associate degree and have appropriate

laboratory training are qualified to

perform high complexity testing without

supervision. Therefore, we are revising

the qualification requirements for high

complexity testing personnel to allow

individuals having these qualifications

to perform high complexity testing

without onsite supervision or 24-hour

review.

III. Other Revisions

We are making the following

technical changes in addition to those

discussed above:

• We are making minor editorial

changes to improve clarity and remove

redundancies. This includes removing

§§ 493.610, 493.614, 493.618, 493.622,

493.626, 493.629, 493.630, 493.631,

493.632, 493.633 and 493.634.

• We are revising the definition of

‘‘certificate of registration’’ in § 493.2 to

exclude reference to laboratories that are

exempt from CLIA requirements

because they are licensed by a HCFAapproved laboratory licensure program:

these laboratories are not required to

obtain a registration certificate.

• From the definition of ‘‘physician’’

in § 493.2 we are deleting the phrase ‘‘or

equivalent degree’’ as there are no

degrees equivalent to doctor of

medicine, osteopathy or podiatric

medicine.

• To §§ 493.35(d)(2) and 493.37(b)(2)

we are adding a requirement that a

laboratory seeking a certificate of waiver

must permit announced inspections by

HHS (as well as unannounced) because

it was inadvertently omitted from the

January 19, 1993 rule.

• In §§ 493.35(d)(2)(iv),

493.49(b)(2)(iv), 493.1776(a)(4) and

493.1776(b)(4)(iv), we indicate that we

will collect information during
20042 Federal Register / Vol. 60, No. 78 / Monday, April 24, 1995 / Rules and Regulations

inspections to determine the

‘‘appropriateness’’ of tests, rather than

their ‘‘addition, deletion or continued

inclusion’’.

• In § 493.602 we clarify Federal

validation survey activity to include

accredited laboratories and change

‘‘State-exempt’’ to ‘‘CLIA exempt’’ to

agree with references that were changed

in previous regulations.

• In §§ 493.638, 493.639, and

493.645(c), we revise the text so that it

more accurately reflects what costs fees

do and do not cover; for example, they

do cover the cost of categorizing tests.

• In the title of § 493.645 and

paragraph (a) we are changing the word

‘‘licensure’’ to ‘‘laboratory’’ and, in

paragraph (a), ‘‘State-exempt’’ to ‘‘CLIAexempt’’ to conform to changes made in

previous regulations.

IV. Waiver of Delay in Effective Date

We find good cause to waive the usual

30-day delay in effective date for most

of the revisions. Those persons who

become qualified under the revised

regulations are no less qualified now

than they will be in 30 days. Hence, it

serves no purpose to delay our

regulations. Other revisions are very

technical in nature and to delay their

effective date is also unnecessary. Also,

under the provisions of the current

regulations, revisions of the list of PPM

tests may be done outside of a

rulemaking process through publication

of a Federal Register notice that does

not require a 30 day delay. As indicated

earlier, we also will consider comments

received on the addition of three new

PPM procedures. Therefore, we find

good cause to waive the delay in

effective date of this rule.

V. Response to Comments

Because of the large number of items

of correspondence we normally receive

on Federal Register documents

published for comment, 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, if we proceed with

a subsequent document, we will

respond to the comments in the

preamble to that document.

VI. Collection of Information

Requirements

The portions of §§ 493.7, 493.35,

493.39, 493.43, 493.53, 493.55, and

493.57 of this document that have been

revised contain information collection

and recordkeeping requirements that are

subject to review by the Office of

Management and Budget (OMB) under

the Paperwork Reduction Act of 1980

(44 U.S.C. 3501 et seq.). These reporting

and recordkeeping requirements are not

effective until a notice of OMB’s

approval is published in the Federal

Register. The information collection

requirements concern the performance

of recordkeeping. The respondents who

will provide the information include

any entity performing laboratory testing

used for assessment, diagnostic or

treatment purposes. Public reporting

burden for this collection of information

is estimated to be 61 hours per

laboratory per year.

Organizations and individuals

desiring to submit comments on the

information collection and

recordkeeping requirements should

direct them to the OMB official whose

name appears in the ADDRESSES section

of this preamble.

VII. Regulatory Impact Statement

Background

We generally prepare a regulatory

flexibility analysis that is consistent

with the Regulatory Flexibility Act

(RFA) (5 U.S.C. 601 through 612) unless

the Secretary certifies that a rule will

not have a significant economic impact

on a substantial number of small

entities. For purposes of the RFA, all

laboratories are considered to be small

entities. Individuals and States are not

included in the definition of a small

entity.

Also, section 1102(b) of the Act

requires the Secretary 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 604

of the RFA. For purposes of section

1102(b) of the Act, we define a small

rural hospital as a hospital that is

located outside of a Metropolitan

Statistical Area and has fewer than 50

beds.

General

This rule modifies CLIA regulations

published February 28, 1992 and

January 19, 1993. There are

approximately 157,000 entities enrolled

under CLIA that may be affected by the

provisions of this rule. The significance

of the effect will vary depending on the

volume and complexity of tests

performed; whether the entity employs

midlevel practitioners to perform

provider-performed microscopy (PPM)

procedures; and whether employees

meet the personnel requirements

contained in the February 28, 1992

regulations. While we cannot estimate

the number of entities that may make

changes in their laboratory testing

practices as a result of this rule, we

believe the modifications to the CLIA

program will benefit the affected entities

in several ways. This rule will help to

ease implementation of the CLIA

program at no loss to public health and

safety by offering alternative

qualification standards for laboratory

employees who would be adversely

affected by the original personnel

requirements. It also increases patient

access to laboratory services, especially

in rural and underserved areas, by

expanding the list of personnel qualified

to conduct certain laboratory tests. In

addition, it reduces the regulatory

burden for laboratories by enabling

them to provide an expanded menu of

tests under a PPM certificate without

incurring the costs associated with

obtaining a certificate of compliance.

Categorization of Tests

Expanding the list of PPM procedures

may affect a laboratory’s choice of

certificate. Laboratories with certificates

for PPM are not subject to costs

associated with the routine inspections

required under a certificate of

compliance. Therefore, laboratories

holding a certificate of compliance that

change to a certificate for PPM will have

a decrease in compliance costs and the

number of inspections. Certificate of

waiver laboratories choosing to expand

their test menu to include PPM

procedures and obtain a certificate of

PPM will have increased certificate fees,

as well as additional costs inherent in

meeting applicable requirements, such

as personnel and proficiency testing.

The current biennial fee for a certificate

of waiver is $100, as compared to $150

for a certificate for PPM. Although the

cost of obtaining a certificate for PPM is

more than for a certificate of waiver, it

is less than the cost associated with a

certificate of compliance.

Provider-Performed Microscopy

Procedures

All providers performing microscopy

examinations in conjunction with

patient evaluations may be affected by

the expansion of the subcategory of

microscopy procedures to include

midlevel health care practitioners and

dentists. Many midlevel practitioners

routinely perform patient examinations

and associated laboratory testing, and in

some States, are authorized to practice

independently. Because there is such a

wide variety of settings in which these

services are offered, we cannot quantify

the percentage of tests done by each

type of health professional. However,

there are no data to indicate that the

quality of their tests results is not at

least equivalent to the tests performed
Federal Register / Vol. 60, No. 78 / Monday, April 24, 1995 / Rules and Regulations 20043

by physicians. As a result of this

expansion, patient access to care and

services will increase, particularly in

rural and underserved areas where there

are shortages of physicians and, as many

commenters pointed out, midlevel

practitioners are the only health care

providers available.

Personnel Requirements

As a result of our evaluation of the

32,000 comments received on the

general supervisor and testing personnel

requirements contained in the February

28, 1992 regulations, and after

consultation with the CLIAC, we are

revising the regulations to mitigate the

impact of the regulations on currently

employed individuals. Adding

alternative qualification standards to the

general supervisor and high complexity

testing personnel requirements enables

currently employed individuals with

equivalent training and experience to

continue to qualify for these positions.

As stated in the impact analysis that

accompanied the February 28, 1992

regulations, we recognize that flexibility

is needed by the laboratory industry to

effectively take advantage of the

personnel resources available to it, and

it was not our intention to

disenfranchise anyone currently

employed. By providing equivalent

qualification standards, we will increase

the available pool of qualified laboratory

personnel which will enable

laboratories to meet the certification

requirements without compromising the

health and safety of patients. We expect

many laboratories to benefit from this

revision to the regulations, especially

those in rural and underserved areas

who are experiencing personnel

shortages and the resultant limited

patient access to laboratory services.

In accordance with the provisions of

Executive Order 12866, this regulation

was reviewed by the Office of

Management and Budget.

List of Subjects in 42 CFR Part 493

Grant programs—health, Health

facilities, Laboratories, Medicaid,

Medicare, Reporting and recordkeeping

requirements.

42 CFR part 493 is amended as set

forth below:

PART 493—LABORATORY

PROCEDURES

1. The authority citation for part 493

is revised to read as follows:

Authority: Sec. 353 of the Public Health

Service Act, secs. 1102, 1861(e), the sentence

following 1861(s)(11), 1861(s)(12),

1861(s)(13), 1861(s)(14), 1861(s)(15), and

1861(s)(16) of the Social Security Act (42

U.S.C. 263a, 1302, 1395x(e), the sentence

following 1395x(s)(11), 1395x(s)(12),

1395x(s)(13), 1395x(s)(14), 1395x(s)(15), and

1395x(s)(16)).

2. Section 493.2 is amended by

revising the definition of ‘‘CLIA

certificate’’ and ‘‘physician’’ and adding

in alphabetical order definitions of

‘‘Dentist’’ and ‘‘Midlevel practitioner’’

to read as follows:

§ 493.2 Definitions.

* * * * *

CLIA certificate means any of the

following types of certificates issued by

HCFA or its agent:

(1) Certificate of compliance means a

certificate issued to a laboratory after an

inspection that finds the laboratory to be

in compliance with all applicable

condition level requirements, or

reissued before the expiration date,

pending an appeal, in accordance with

§ 493.49, when an inspection has found

the laboratory to be out of compliance

with one or more condition level

requirements.

(2) Certificate for provider-performed

microscopy (PPM) procedures means a

certificate issued or reissued before the

expiration date, pending an appeal, in

accordance with § 493.47, to a

laboratory in which a physician,

midlevel practitioner or dentist

performs no tests other than PPM

procedures and, if desired, waived tests

listed in § 493.15(c).

(3) Certificate of accreditation means

a certificate issued on the basis of the

laboratory’s accreditation by an

accreditation organization approved by

HCFA (indicating that the laboratory is

deemed to meet applicable CLIA

requirements) or reissued before the

expiration date, pending an appeal, in

accordance with § 493.61, when a

validation or complaint survey has

found the laboratory to be noncompliant

with one or more CLIA conditions.

(4) Certificate of registration or

registration certificate means a

certificate issued or reissued before the

expiration date, pending an appeal, in

accordance with § 493.45, that enables

the entity to conduct moderate or high

complexity laboratory testing or both

until the entity is determined to be in

compliance through a survey by HCFA

or its agent; or in accordance with

§ 493.57 to an entity that is accredited

by an approved accreditation

organization.

(5) Certificate of waiver means a

certificate issued or reissued before the

expiration date, pending an appeal, in

accordance with § 493.37, to a

laboratory to perform only the waived

tests listed at § 493.15(c).

* * * * *

Dentist means a doctor of dental

medicine or doctor of dental surgery

licensed by the State to practice

dentistry within the State in which the

laboratory is located.

* * * * *

Midlevel practitioner means a nurse

midwife, nurse practitioner, 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.

* * * * *

Physician means an individual with a

doctor of medicine, doctor of

osteopathy, or doctor of podiatric

medicine degree who is licensed by the

State to practice medicine, osteopathy,

or podiatry within the State in which

the laboratory is located.

* * * * *

3. In § 493.3, the introductory text of

paragraph (a) is republished and

paragraph (a)(1) is revised to read as

follows:

§ 493.3 Applicability.

(a) Basic rule. Except as specified in

paragraph (b) of this section, a

laboratory will be cited as out of

compliance with section 353 of the

Public Health Service Act unless it—

(1) Has a current, unrevoked or

unsuspended certificate of waiver,

registration certificate, certificate of

compliance, certificate for PPM

procedures, or certificate of

accreditation issued by HHS applicable

to the category of examinations or

procedures performed by the laboratory;

or

* * * * *

4. A new § 493.5 is added to read as

follows:

§ 493.5 Categories of tests by complexity.

(a) Laboratory tests are categorized as

one of the following:

(1) Waived tests.

(2) Tests of moderate complexity,

including the subcategory of PPM

procedures.

(3) Tests of high complexity.

(b) A laboratory may perform only

waived tests, only tests of moderate

complexity, only PPM procedures, only

tests of high complexity or any

combination of these tests.

(c) Each laboratory must be either

CLIA-exempt or possess one of the

following CLIA certificates, as defined

in § 493.2:

(1) Certificate of registration or

registration certificate.

(2) Certificate of waiver.

(3) Certificate for PPM procedures.

(4) Certificate of compliance.
20044 Federal Register / Vol. 60, No. 78 / Monday, April 24, 1995 / Rules and Regulations

(5) Certificate of accreditation.

§ 493.10 [Removed]

5. Section 493.10 is removed.

§ 493.16 [Redesignated as § 493.19]

6. Section 493.16 is redesignated as

§ 493.19 and is revised to read as

follows:

§ 493.19 Provider-performed microscopy

(PPM) procedures.

(a) Requirement. To be categorized as

a PPM procedure, the procedure must

meet the criteria specified in paragraph

(b) of this section.

(b) Criteria. Procedures must meet the

following specifications:

(1) The examination must be

personally performed by one of the

following practitioners:

(i) A physician during the patient’s

visit on a specimen obtained from his or

her own patient or from a patient of a

group medical practice of which the

physician is a member or an employee.

(ii) A midlevel practitioner, under the

supervision of a physician or in

independent practice only if authorized

by the State, during the patient’s visit on

a specimen obtained from his or her

own patient or from a patient of a clinic,

group medical practice, or other health

care provider of which the midlevel

practitioner is a member or an

employee.

(iii) A dentist during the patient’s

visit on a specimen obtained from his or

her own patient or from a patient of a

group dental practice of which the

dentist is a member or an employee.

(2) The procedure must be categorized

as moderately complex.

(3) The primary instrument for

performing the test is the microscope,

limited to bright-field or phase-contrast

microscopy.

(4) The specimen is labile or delay in

performing the test could compromise

the accuracy of the test result.

(5) Control materials are not available

to monitor the entire testing process.

(6) Limited specimen handling or

processing is required.

(c) Provider-performed microscopy

(PPM) examinations. A laboratory may

qualify to perform tests under this

section if it restricts PPM examinations

to one or more of the following

procedures (or additional procedures

added to this list as provided under

paragraph (d) of this section), waived

tests and no others:

(1) All direct wet mount preparations

for the presence or absence of bacteria,

fungi, parasites, and human cellular

elements.

(2) All potassium hydroxide (KOH)

preparations.

(3) Pinworm examinations.

(4) Fern tests.

(5) Post-coital direct, qualitative

examinations of vaginal or cervical

mucous.

(6) Urine sediment examinations.

(7) Nasal smears for granulocytes.

(8) Fecal leukocyte examinations.

(9) Qualitative semen analysis

(limited to the presence or absence of

sperm and detection of motility).

(d) Revisions to criteria and the list of

PPM procedures.

(1) The CLIAC conducts reviews upon

HHS’ request and recommends to HHS

revisions to the criteria for

categorization of procedures.

(2) HHS determines whether a

laboratory procedure meets the criteria

listed under paragraph (b) of this section

for a PPM procedure. Revisions to the

list of PPM procedures proposed by

HHS are published in the Federal

Register as a notice with an opportunity

for public comment.

(e) Laboratory requirements.

Laboratories eligible to perform PPM

examinations must—

(1) Meet the applicable requirements

in subpart C or subpart D, and subparts

F, H, J, K, M, and P of this part.

(2) Be subject to inspection as

specified under subpart Q of this part.

7. Section 493.20 is revised to read as

follows:

§ 493.20 Laboratories performing tests of

moderate complexity.

(a) A laboratory may qualify for a

certificate to perform tests of moderate

complexity provided that it restricts its

test performance to waived tests or

examinations and one or more tests or

examinations meeting criteria for tests

of moderate complexity including the

subcategory of PPM procedures.

(b) A laboratory that performs tests or

examinations of moderate complexity

must meet the applicable requirements

in subpart C or subpart D, and subparts

F, H, J, K, M, P, and Q of this part.

Under a registration certificate or

certificate of compliance, laboratories

also performing PPM procedures must

meet the inspection requirements at

§ 493.1777.

(c) If the laboratory also performs

waived tests, compliance with subparts

H, J, K, M, and P of this part is not

applicable to the waived tests. However,

the laboratory must comply with the

requirements in §§ 493.15(e) and

493.1775.

8. In § 493.25, paragraphs (c) and (d)

are redesignated as (d) and (c),

respectively, and paragraphs (b), (c) and

(d) are revised to read as follows:

§ 493.25 Laboratories performing tests of

high complexity.

* * * * *

(b) A laboratory performing one or

more tests of high complexity must meet

the applicable requirements of subpart C

or subpart D, and subparts F, H, J, K, M,

P, and Q of this part.

(c) If the laboratory also performs tests

of moderate complexity, the applicable

requirements of subparts H, J, K, M, P,

and Q of this part must be met. Under

a registration certificate or certificate of

compliance, PPM procedures must meet

the inspection requirements at

§ 493.1777.

(d) If the laboratory also performs

waived tests, the requirements of

subparts H, J, K, M, and P are not

applicable to the waived tests. However,

the laboratory must comply with the

requirements in §§ 493.15(e) and

493.1775.

9. In § 493.35, paragraphs (a) and (d)

are revised to read as follows:

§ 493.35 Application for a certificate of

waiver.

(a) Filing of application. Except as

specified in paragraph (b) of this

section, a laboratory performing only

one or more waived tests listed in

§ 493.15 must file a separate application

for each laboratory location.

* * * * *

(d) Access requirements. Laboratories

that perform one or more waived tests

listed in § 493.15(c) and no other tests

must meet the following conditions:

(1) Make records available and submit

reports to HHS as HHS may reasonably

require to determine compliance with

this section and § 493.15(e);

(2) Agree to permit announced and

unannounced inspections by HHS in

accordance with subpart Q of this part

under the following circumstances:

(i) When HHS has substantive reason

to believe that the laboratory is being

operated in a manner that constitutes an

imminent and serious risk to human

health.

(ii) To evaluate complaints from the

public.

(iii) On a random basis to determine

whether the laboratory is performing

tests not listed in § 493.15.

(iv) To collect information regarding

the appropriateness of waiver of tests

listed in § 493.15.

* * * * *

10. In § 493.37, the introductory text

of paragraph (b) is republished and

paragraphs (b)(2) and (g) are revised to

read as follows:

§ 493.37 Requirements for a certificate of

waiver.

* * * * *
Federal Register / Vol. 60, No. 78 / Monday, April 24, 1995 / Rules and Regulations 20045

(b) Laboratories issued a certificate of

waiver—

* * * * *

(2) Must permit announced or

unannounced inspections by HHS in

accordance with subpart Q of this part.

* * * * *

(g) A laboratory with a certificate of

waiver that wishes to perform

examinations or tests not listed in the

waiver test category must meet the

requirements set forth in subpart C or

subpart D of this part, as applicable.

11. In § 493.39, the introductory

paragraph is republished and paragraph

(a) is revised to read as follows:

§ 493.39 Notification requirements for

laboratories issued a certificate of waiver.

Laboratories performing one or more

tests listed in § 493.15 and no others

must notify HHS or its designee—

(a) Before performing and reporting

results for any test or examination that

is not specified under § 493.15 for

which the laboratory does not have the

appropriate certificate as required in

subpart C or subpart D of this part, as

applicable; and

* * * * *

12. The heading of subpart C is

revised to read as follows:

Subpart C—Registration Certificate,

Certificate for Provider-performed

Microscopy Procedures, and

Certificate of Compliance

13. In § 493.43, the heading and

paragraph (a) are revised to read as

follows:

§ 493.43 Application for registration

certificate, certificate for providerperformed microscopy (PPM) procedures,

and certificate of compliance.

(a) Filing of application. Except as

specified in paragraph (b) of this

section, all laboratories performing tests

of moderate complexity (including the

subcategory) or high complexity, or any

combination of these tests, must file a

separate application for each laboratory

location.

* * * * *

14. In § 493.45, a new introductory

paragraph is added, the introductory

paragraph (a) is republished, paragraph

(a)(3) is removed, and paragraphs (a)(1),

(a)(2), (d), and (f) are revised to read as

follows:

§ 493.45 Requirements for a registration

certificate.

Laboratories performing only waived

tests, PPM procedures, or any

combination of these tests, are not

required to obtain a registration

certificate.

(a) A registration certificate is

required—(1) Initially for all

laboratories performing test procedures

of moderate complexity (other than the

subcategory of PPM procedures) or high

complexity, or both; and

(2) For all laboratories that have been

issued a certificate of waiver or

certificate for PPM procedures that

intend to perform tests of moderate or

high complexity, or both, in addition to

those tests listed in § 493.15(c) or

specified as PPM procedures.

* * * * *

(d) In accordance with subpart R of

this part, HHS will initiate suspension

or revocation of a laboratory’s

registration certificate and will deny the

laboratory’s application for a certificate

of compliance for failure to comply with

the requirements set forth in this

subpart. HHS may also impose certain

alternative sanctions. In addition,

failure to meet the requirements of this

subpart will result in suspension of

payments under Medicare and Medicaid

as specified in subpart R of this part.

* * * * *

(f) In the event of a noncompliance

determination resulting in an HHS

denial of a laboratory’s certificate of

compliance application, HHS will

provide the laboratory with a statement

of grounds on which the noncompliance

determination is based and offer an

opportunity for appeal as provided in

subpart R.

* * * * *

15. In § 493.47, the heading,

paragraph (a), the introductory text of

paragraphs (b) and (c), paragraph (c)(2),

and paragraphs (d) and (e) are revised to

read as follows:

§ 493.47 Requirements for a certificate for

provider-performed microscopy (PPM)

procedures.

(a) A certificate for PPM procedures is

required—

(1) Initially for all laboratories

performing test procedures specified as

PPM procedures; and

(2) For all certificate of waiver

laboratories that intend to perform only

test procedures specified as PPM

procedures in addition to those tests

listed in § 493.15(c).

(b) HHS will issue a certificate for

PPM procedures if the laboratory—

* * * * *

(c) Laboratories issued a certificate for

PPM procedures are subject to—

* * * * *

(2) The applicable requirements of

this subpart and subparts H, J, K, M, and

P of this part; and

* * * * *

(d) In accordance with subpart R of

this part, HHS will initiate suspension,

limitation, or revocation of a

laboratory’s certificate for PPM

procedures for failure to comply with

the applicable requirements set forth in

this subpart. HHS may also impose

certain alternative sanctions. In

addition, failure to meet the

requirements of this subpart may result

in suspension of all or part of payments

under Medicare and Medicaid, as

specified in subpart R of this part.

(e) A certificate for PPM procedures is

valid for a period of no more than 2

years.

16. Section 493.49 is revised to read

as follows:

§ 493.49 Requirements for a certificate of

compliance.

A certificate of compliance may

include any combination of tests

categorized as high complexity or

moderate complexity or listed in

§ 493.15(c) as waived tests. Moderate

complexity tests may include those

specified as PPM procedures.

(a) HHS will issue a certificate of

compliance to a laboratory only if the

laboratory—

(1) Meets the requirements of

§§ 493.43 and 493.45;

(2) Remits the certificate fee specified

in subpart F of this part; and

(3) Meets the applicable requirements

of this subpart and subparts H, J, K, M,

P, and Q of this part.

(b) Laboratories issued a certificate of

compliance—

(1) Are subject to the notification

requirements of § 493.51; and

(2) Must permit announced or

unannounced inspections by HHS in

accordance with subpart Q of this part—

(i) To determine compliance with the

applicable requirements of this part;

(ii) To evaluate complaints;

(iii) When HHS has substantive

reason to believe that tests are being

performed, or the laboratory is being

operated in a manner that constitutes an

imminent and serious risk to human

health; and

(iv) To collect information regarding

the appropriateness of tests listed in

§ 493.15 or tests categorized as moderate

complexity (including the subcategory)

or high complexity.

(c) Failure to comply with the

requirements of this subpart will result

in—

(1) Suspension, revocation or

limitation of a laboratory’s certificate of

compliance in accordance with subpart

R of this part; and

(2) Suspension or denial of payments

under Medicare and Medicaid in

accordance with subpart R of this part.
20046 Federal Register / Vol. 60, No. 78 / Monday, April 24, 1995 / Rules and Regulations

(d) A certificate of compliance issued

under this subpart is valid for no more

than 2 years.

(e) In the event of a noncompliance

determination resulting in an HHS

action to revoke, suspend or limit the

laboratory’s certificate of compliance,

HHS will—

(1) Provide the laboratory with a

statement of grounds on which the

determination of noncompliance is

based; and

(2) Offer an opportunity for appeal as

provided in subpart R of this part. If the

laboratory requests a hearing within 60

days of the notice of sanction, it retains

its certificate of compliance or reissued

certificate of compliance until a

decision is made by an administrative

law judge (ALJ) as provided in subpart

R of this part, except when HHS finds

that conditions at the laboratory pose an

imminent and serious risk to human

health or when the criteria at

§ 493.1840(a) (4) and (5) are met.

(f) For laboratories receiving payment

from the Medicare or Medicaid program,

such payments will be suspended on

the effective date specified in the notice

to the laboratory of a noncompliance

determination even if there has been no

appeals decision issued.

(g) A laboratory seeking to renew its

certificate of compliance must—

(1) Complete and return the renewal

application to HHS 9 to 12 months prior

to the expiration of the certificate of

compliance; and

(2) Meet the requirements of § 493.43

and paragraphs (a)(2) and (b)(2) of this

section.

(h) If HHS determines that the

application for the renewal of a

certificate of compliance must be denied

or limited, HHS will notify the

laboratory in writing of the—

(1) Basis for denial of the application;

and

(2) Opportunity for appeal as

provided in subpart R of this part.

(i) If the laboratory requests a hearing

within the time period specified by

HHS, the laboratory retains its

certificate of compliance or reissued

certificate of compliance until a

decision is made by an ALJ as provided

in subpart R, except when HHS finds

that conditions at the laboratory pose an

imminent and serious risk to human

health.

(j) For laboratories receiving payment

from the Medicare or Medicaid program,

such payments will be suspended on

the effective date specified in the notice

to the laboratory of nonrenewal of the

certificate of compliance even if there

has been no appeals decision issued.

17. In § 493.51, the introductory

paragraph of paragraph (a) is

republished and the heading, the

section’s introductory paragraph and

paragraphs (a)(5), (b) and (c) are revised

to read as follows:

§ 493.51 Notification requirements for

laboratories issued a certificate of

compliance.

Laboratories issued a certificate of

compliance must meet the following

conditions:

(a) Notify HHS or its designee within

30 days of any change in—

* * * * *

(5) Technical supervisor (laboratories

performing high complexity only).

(b) Notify HHS no later than 6 months

after performing any test or examination

within a specialty or subspecialty area

that is not included on the laboratory’s

certificate of compliance, so that

compliance with requirements can be

determined.

(c) Notify HHS no later than 6 months

after any deletions or changes in test

methodologies for any test or

examination included in a specialty or

subspecialty, or both, for which the

laboratory has been issued a certificate

of compliance.

18. In § 493.53, the heading, the

introductory paragraph, and paragraph

(a) are revised to read as follows:

§ 493.53 Notification requirements for

laboratories issued a certificate for

provider-performed microscopy (PPM)

procedures.

Laboratories issued a certificate for

PPM procedures must notify HHS or its

designee—

(a) Before performing and reporting

results for any test of moderate or high

complexity, or both, in addition to tests

specified as PPM procedures or any test

or examination that is not specified

under § 493.15(c), for which it does not

have a registration certificate as required

in subpart C or subpart D, as applicable,

of this part; and

* * * * *

19. The introductory text of

§ 493.55(a) is revised to read as follows:

§ 493.55 Application for registration

certificate and certificate of accreditation.

(a) Filing of application. A laboratory

may be issued a certificate of

accreditation in lieu of the applicable

certificate specified in subpart B or

subpart C of this part provided the

laboratory—

* * * * *

20. In § 493.57, the introductory

paragraph and paragraph (b) are revised

to read as follows:

§ 493.57 Requirements for a registration

certificate.

A registration certificate is required

for all laboratories seeking a certificate

of accreditation, unless the laboratory

holds a valid certificate of compliance

issued by HHS.

* * * * *

(b)(1) The laboratory must provide

HHS with proof of accreditation by an

approved accreditation program—

(i) Within 11 months of issuance of

the registration certificate; or

(ii) Prior to the expiration of the

certificate of compliance.

(2) If such proof of accreditation is not

supplied within this timeframe, the

laboratory must meet, or continue to

meet, the requirements of § 493.49.

* * * * *

21. In § 493.511, paragraph (h) is

revised to read as follows:

§ 493.511 Removal of deeming authority

and final determination review.

* * * * *

(h) After HCFA withdraws approval of

an accreditation organization’s deeming

authority, the certificates of

accreditation of all affected laboratories

continue in effect for 60 days after the

laboratory receives notification of the

withdrawal of approval. HCFA may

extend the period for an additional 60

days for a laboratory if it determines

that the laboratory submitted an

application for inspection to another

approved accreditation organization or

an application for the appropriate

certificate to HCFA, the State agency, or

other HCFA agent before the initial 60-

day period ends.

* * * * *

22. Paragraph (j) of § 493.521 is

revised to read as follows:

§ 493.521 Removal of CLIA exemption and

final determination review.

* * * * *

(j) After HCFA withdraws approval of

a State laboratory licensure program, the

exempt status of licensed or approved

laboratories in the State continues in

effect for 60 days after the laboratory

receives notification from the State of

the withdrawal of HCFA’s approval of

the program. HCFA may extend this

period for an additional 60 days for a

laboratory if it determines that the

laboratory submitted an application for

accreditation to an approved

accreditation organization or an

application to HCFA for the appropriate

certificate before the initial 60-day

period ends.

* * * * *

23. Section 493.602 is revised to read

as follows:
Federal Register / Vol. 60, No. 78 / Monday, April 24, 1995 / Rules and Regulations 20047

§ 493.602 Scope of subpart.

This subpart sets forth the

methodology for determining the

amount of the fees for issuing the

appropriate certificate, and for

determining compliance with the

applicable standards of the Public

Health Service Act (the PHS Act) and

the Federal validation of accredited

laboratories and of CLIA-exempt

laboratories.

§§ 493.610, 493.614, 493.618, 493.622,

493.626, 493.629, 493.630, 493.631, 493.632,

493.633 and 493.634 [Removed]

24. Sections 493.610, 493.614,

493.618, 493.622, 493.626, 493.629,

493.630, 493.631, 493.632, 493.633 and

493.634 are removed.

25. Section 493.638 is revised to read

as follows:

§ 493.638 Certificate fees.

(a) Basic rule. Laboratories must pay

a fee for the issuance of a registration

certificate, certificate for PPM

procedures, certificate of waiver,

certificate of accreditation, or a

certificate of compliance, as applicable.

Laboratories must also pay a fee to

reapply for a certificate for PPM

procedures, certificate of waiver,

certificate of accreditation, or a

certificate of compliance. 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 and

certificates of compliance, the costs

include issuing the certificates,

collecting the fees, evaluating and

monitoring proficiency testing

programs, evaluating which procedures,

tests or examinations meet the criteria

for inclusion in the appropriate

complexity category, and implementing

section 353 of the PHS Act.

(2) For a certificate of waiver, the

costs include issuing the certificate,

collecting the fees, determining if a

certificate of waiver should be issued,

evaluating which tests qualify for

inclusion in the waived category, and

other direct administrative costs.

(3) For a certificate for PPM

procedures, the costs include issuing

the certificate, collecting the fees,

determining if a certificate for PPM

procedures should be issued, evaluating

which procedures meet the criteria for

inclusion in the subcategory of PPM

procedures, and other direct

administrative costs.

(4) For a certificate of accreditation,

the costs include issuing the certificate,

collecting the fees, evaluating the

programs of accrediting bodies, and

other direct administrative costs.

(b) Fee amount. The fee amount is set

annually by HHS on a calendar year

basis and is based on the category of test

complexity, or on the category of test

complexity and schedules or ranges of

annual laboratory test volume

(excluding waived tests and tests

performed for quality control, quality

assurance, and proficiency testing

purposes) and specialties tested, with

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 § 493.649 (b) and

(c). This fee is assessed and payable at

least biennially. The methodology used

to determine the amount of the fee is

found in § 493.649. The amount of the

fee applicable to the issuance of the

registration certificate or the issuance or

renewal of the certificate for PPM

procedures, certificate of waiver,

certificate of accreditation, or certificate

of compliance is the amount in effect at

the time the application is received.

Upon receipt of an application for a

certificate, HHS or its designee notifies

the laboratory of the amount of the

required fee for the requested certificate.

26. Section 493.639(b) is revised to

read as follows:

§ 493.639 Fee for revised certificate.

* * * * *

(b) A laboratory must pay a fee to

cover the cost of issuing a revised

certificate in any of the following

circumstances:

(1) The fee for issuing an appropriate

revised certificate is based on the cost

to issue the revised certificate to the

laboratory as follows:

(i) If a laboratory with a certificate of

waiver wishes to perform tests in

addition to those listed in § 493.15(c) as

waived tests, it must, as set forth in

§ 493.638, pay an additional fee for the

appropriate certificate to cover the

additional testing.

(ii) If a laboratory with a certificate for

PPM procedures wishes to perform tests

in addition to those specified as PPM

procedures or listed in § 493.15(c) as

waived tests, it must, as set forth in

§ 493.638, pay an additional fee for the

appropriate certificate to cover the

additional testing.

(2) A laboratory must pay a fee to

cover the cost of issuing a revised

certificate when—

(i) A laboratory changes its name,

location, or its director; or

(ii) A laboratory deletes services or

wishes to add services and requests that

its certificate be changed. (An additional

fee is also required under § 493.643(d) if

it is necessary to determine compliance

with additional requirements.)

27. In § 493.643, paragraphs (a) and

(d) are revised to read as follows:

§ 493.643 Fee for determination of

program 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.

* * * * *

(d) Additional fees. (1) 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,

in order 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.

(2) 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.

28. Section 493.645 is revised to read

as follows:

§ 493.645 Additional fee(s) applicable to

approved State laboratory programs and

laboratories issued a certificate of

accreditation, certificate of waiver, or

certificate for PPM procedures.

(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
20048 Federal Register / Vol. 60, No. 78 / Monday, April 24, 1995 / Rules and Regulations

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) Costs of the State’s prorata share

of general overhead to develop and

implement CLIA.

(b) Accredited laboratories. (1) In

addition to the certificate fee, a

laboratory that is issued a certificate of

accreditation is also assessed a fee to

cover the cost of evaluating individual

laboratories to determine overall

whether an accreditation organization’s

standards and inspection policies are

equivalent to the Federal program. All

accredited laboratories share in the cost

of these inspections. These costs are the

same as those that are incurred when

inspecting nonaccredited laboratories.

(2) If a laboratory issued a certificate

of accreditation has been inspected and

followup 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 followup visits. HHS

revokes the laboratory’s certificate of

accreditation for failure to pay the

assessed fee.

(c) If, in the case of a laboratory that

has been issued a certificate of

accreditation, certificate of waiver, or

certificate for PPM procedures, it is

necessary to conduct a complaint

investigation, impose sanctions, or

conduct a hearing, HHS assesses that

laboratory a fee to cover the cost of these

activities. Costs 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 for failure to pay

the assessed costs. 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 costs of these activities are

not imposed upon the laboratory.

29. Section 493.646(a) is revised to

read as follows:

§ 493.646 Payment of fees.

(a) Except for CLIA-exempt

laboratories, 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.

* * * * *

30. In § 493.649, paragraph (a) and the

introductory paragraph of paragraph (b)

are revised to read as follows:

§ 493.649 Methodology for determining fee

amount.

(a) General rule. The amount of the

fee in each schedule for compliance

determination inspections is based on

the average hourly rate (which includes

the costs to perform the required

activities and necessary administration

costs) multiplied by the average number

of hours required or, if activities are

performed by more than one of the

entities listed in paragraph (b) of this

section, the sum of the products of the

applicable hourly rates multiplied by

the average number of hours required by

the entity to perform the activity. The

fee for issuance of the registration

certificate or certificate of compliance is

based on the laboratory’s scope and

volume of testing.

(b) Determining average hourly rates

used in fee schedules. Three different

entities perform activities related to the

issuance or reissuance of any certificate.

HHS determines the average hourly

rates for the activities of each of these

entities.

* * * * *

31. The heading of subpart H is

revised to read as follows:

Subpart H—Participation in Proficiency

Testing for Laboratories Performing

Tests of Moderate Complexity

(Including the Subcategory), High

Complexity, or Any Combination of

These Tests

32. Section 493.803(a) is revised to

read as follows:

§ 493.803 Condition: Successful

participation.

(a) Each laboratory performing tests of

moderate complexity (including the

subcategory) and/or high complexity

must successfully participate in a

proficiency testing program approved by

HCFA, if applicable, as described in

subpart I of this part for each specialty,

subspecialty, and analyte or test in

which the laboratory is certified under

CLIA.

* * * * *

33. The heading of § 493.807 is

revised to read as follows:

§ 493.807 Condition: Reinstatement of

laboratories performing tests of moderate

complexity (including the subcategory),

high complexity, or any combination of

these tests, after failure to participate

successfully.

* * * * *

34. The undesignated center heading

immediately preceding § 493.821 is

revised to read as follows:

Proficiency Testing by Specialty and

Subspecialty for Laboratories

Performing Tests of Moderate

Complexity (Including the

Subcategory), High Complexity, or Any

Combination of These Tests

35. The heading to subpart I is revised

to read as follows:

Subpart I—Proficiency Testing

Programs for Tests of Moderate

Complexity (Including the

Subcategory), High Complexity, or Any

Combination of These Tests

36. The heading for subpart J is

revised to read as follows:

Subpart J—Patient Test Management

for Moderate Complexity (Including the

Subcategory), High Complexity, or Any

Combination of These Tests

37. Section 493.1101 is revised to read

as follows:

§ 493.1101 Condition: Patient test

management; moderate complexity

(including the subcategory), or high

complexity testing, or any combination of

these tests.

Each laboratory performing moderate

complexity (including the subcategory)

or high complexity testing, or any

combination of these tests, must employ

and maintain a system that provides for

proper patient preparation; proper

specimen collection, identification,

preservation, transportation, and

processing; and accurate result

reporting. This system must assure

optimum patient specimen integrity and

positive identification throughout the

preanalytic (pre-testing), analytic

(testing), and postanalytic (post-testing)

processes and must meet the standards

as they apply to the testing performed.

38. The heading to subpart K is

revised to read as follows:

Subpart K—Quality Control for Tests

of Moderate Complexity (Including the

Subcategory), High Complexity, or Any

Combination of These Tests

39. The heading to § 493.1201 is

revised to read as follows:

§ 493.1201 Condition: General quality

control; moderate complexity (including the

subcategory) or high complexity testing, or

any combination of these tests.

40. The heading to subpart M is

revised to read as follows:
Federal Register / Vol. 60, No. 78 / Monday, April 24, 1995 / Rules and Regulations 20049

Subpart M—Personnel for Moderate

Complexity (Including the

Subcategory) and High Complexity

Testing

41. New § 493.1351 is added to

subpart M to read as follows:

§ 493.1351 General.

This subpart consists of the personnel

requirements that must be met by

laboratories performing moderate

complexity testing, PPM procedures,

high complexity testing, or any

combination of these tests.

42. Following § 493.1351, a new

undesignated center heading and new

§§ 493.1353, 493.1355, 493.1357,

493.1359, 493.1361, 493.1363, and

493.1365 are added to subpart M to read

as follows:

Laboratories Performing ProviderPerformed Microscopy (PPM)

Procedures

§ 493.1353 Scope.

In accordance with § 493.19(b), the

moderate complexity procedures

specified as PPM procedures are

considered such only when personally

performed by a health care provider

during a patient visit in the context of

a physical examination. PPM

procedures are subject to the personnel

requirements in §§ 493.1355 through

493.1365.

§ 493.1355 Condition: Laboratories

performing PPM procedures; laboratory

director.

The laboratory must have a director

who meets the qualification

requirements of § 493.1357 and provides

overall management and direction in

accordance with § 493.1359.

§ 493.1357 Standard; laboratory director

qualifications.

The laboratory director must be

qualified to manage and direct the

laboratory personnel and the

performance of PPM procedures as

specified in § 493.19(c) and must be

eligible to be an operator of a laboratory

within the requirements of subpart R of

this part.

(a) The laboratory director must

possess a current license as a laboratory

director issued by the State in which the

laboratory is located, if the licensing is

required.

(b) The laboratory director must meet

one of the following requirements:

(1) Be a physician, as defined in

§ 493.2.

(2) Be a midlevel practitioner, as

defined in § 493.2, authorized by a State

to practice independently in the State in

which the laboratory is located.

(3) Be a dentist, as defined in § 493.2.

§ 493.1359 Standard; PPM laboratory

director responsibilities.

The laboratory director is responsible

for the overall operation and

administration of the laboratory,

including the prompt, accurate, and

proficient reporting of test results. The

laboratory director must—

(a) Direct no more than five

laboratories; and

(b) Ensure that any procedure listed

under § 493.19(c)—

(1) Is personally performed by an

individual who meets the qualification

requirements in § 493.1363; and

(2) Is performed in accordance with

applicable requirements in subparts H,

J, K, M, and P of this part.

§ 493.1361 Condition: Laboratories

performing PPM procedures; testing

personnel.

The laboratory must have a sufficient

number of individuals who meet the

qualification requirements of § 493.1363

to perform the functions specified in

§ 493.1365 for the volume and

complexity of testing performed.

§ 493.1363 Standard: PPM testing

personnel qualifications.

Each individual performing PPM

procedures must—

(a) Possess a current license issued by

the State in which the laboratory is

located if the licensing is required; and

(b) Meet one of the following

requirements:

(1) Be a physician, as defined in

§ 493.2.

(2) Be a midlevel practitioner, as

defined in § 493.2, under the

supervision of a physician or in

independent practice if authorized by

the State in which the laboratory is

located.

(3) Be a dentist as defined in § 493.2

of this part.

§ 493.1365 Standard; PPM testing

personnel responsibilities.

The testing personnel are responsible

for specimen processing, test

performance, and for reporting test

results. Any PPM procedure must be—

(a) Personally performed by one of the

following practitioners:

(1) A physician during the patient’s

visit on a specimen obtained from his or

her own patient or from a patient of a

group medical practice of which the

physician is a member or employee.

(2) A midlevel practitioner, under the

supervision of a physician or in

independent practice if authorized by

the State in which the laboratory is

located, during the patient’s visit on a

specimen obtained from his or her own

patient or from the patient of a clinic,

group medical practice, or other health

care provider, in which the midlevel

practitioner is a member or an

employee.

(3) A dentist during the patient’s visit

on a specimen obtained from his or her

own patient or from a patient of a group

dental practice of which the dentist is

a member or an employee; and

(b) Performed using a microscope

limited to a brightfield or a phase/

contrast microscope.

§ 493.1401 [Removed]

43. Section 493.1401 is removed.

44. In § 493.1461, the introductory

text of paragraph (c) and paragraph

(c)(2) is revised, and new paragraphs

(c)(4) and (c)(5) are added to read as

follows:

§ 493.1461 Standard; General supervisor

qualifications.

* * * * *

(c) If the requirements of paragraph

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

are not met, the individual functioning

as the general supervisor must—

* * * * *

(2)(i) Qualify as testing personnel

under § 493.1489(b)(2); and

(ii) Have at least 2 years of laboratory

training or experience, or both, in high

complexity testing; or

* * * * *

(4) On or before September 1, 1992,

have served as a general supervisor of

high complexity testing and as of April

24, 1995—

(i) Meet one of the following

requirements:

(A) Have graduated from a medical

laboratory or clinical laboratory training

program approved or accredited by the

Accrediting Bureau of Health Education

Schools (ABHES), the Commission on

Allied Health Education Accreditation

(CAHEA), or other organization

approved by HHS.

(B) Be a high school graduate or

equivalent and have successfully

completed an official U.S. military

medical laboratory procedures course of

at least 50 weeks duration and have

held the military enlisted occupational

specialty of Medical Laboratory

Specialist (Laboratory Technician).

(ii) Have at least 2 years of clinical

laboratory training, or experience, or

both, in high complexity testing; or

(5) On or before September 1, 1992,

have served as a general supervisor of

high complexity testing and—

(i) Be a high school graduate or

equivalent; and

(ii) Have had at least 10 years of

laboratory training or experience, or

both, in high complexity testing,

including at least 6 years of supervisory
20050 Federal Register / Vol. 60, No. 78 / Monday, April 24, 1995 / Rules and Regulations

experience between September 1, 1982

and September 1, 1992.

* * * * *

§ 493.1463 [Amended]

45. In § 493.1463, all references to

‘‘§ 493.1489(b)(4)’’ are amended to read

‘‘§ 493.1489(b)(5).’’

46. In § 493.1489, the introductory

text to the section and to paragraph (b)

are republished, paragraphs (b)(2) and

(b)(4) through (b)(6) are revised, and

paragraph (b)(7) is added to read as

follows:

§ 493.1489 Standard; Testing personnel

qualifications.

Each individual performing high

complexity testing must—

* * * * *

(b) Meet one of the following

requirements:

* * * * *

(2)(i) Have earned an associate 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, include

either—

(1) 24 semester hours of medical

laboratory technology courses; or

(2) 24 semester hours of science

courses that include—

(i) Six semester hours of chemistry;

(ii) Six semester hours of biology; and

(iii) Twelve semester hours of

chemistry, biology, or medical

laboratory technology in any

combination; and

(B) Have laboratory training that

includes either of the following:

(1) Completion of a clinical laboratory

training program approved or accredited

by the ABHES, the CAHEA, or other

organization approved by HHS. (This

training may be included in the 60

semester hours listed in paragraph

(b)(2)(ii)(A) of this section.)

(2) At least 3 months documented

laboratory training in each specialty in

which the individual performs high

complexity testing.

* * * * *

(4) On or before April 24, 1995 be a

high school graduate or equivalent and

have either—

(i) Graduated from a medical

laboratory or clinical laboratory training

program approved or accredited by

ABHES, CAHEA, or other organization

approved by HHS; or

(ii) Successfully completed an official

U.S. military medical laboratory

procedures training course of at least 50

weeks duration and have held the

military enlisted occupational specialty

of Medical Laboratory Specialist

(Laboratory Technician);

(5)(i) Until September 1, 1997—

(A) Have earned a high school

diploma or equivalent; and

(B) Have documentation of training

appropriate for the testing performed

before analyzing patient specimens.

Such training must ensure that the

individual has—

(1) 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;

(2) The skills required for

implementing all standard laboratory

procedures;

(3) The skills required for performing

each test method and for proper

instrument use;

(4) The skills required for performing

preventive maintenance,

troubleshooting, and calibration

procedures related to each test

performed;

(5) A working knowledge of reagent

stability and storage;

(6) The skills required to implement

the quality control policies and

procedures of the laboratory;

(7) An awareness of the factors that

influence test results; and

(8) The skills required to assess and

verify the validity of patient test results

through the evaluation of quality control

values before reporting patient test

results; and

(ii) As of September 1, 1997, be

qualified under § 493.1489(b)(1), (b)(2),

or (b)(4), except for those individuals

qualified under paragraph (b)(5)(i) of

this section who were performing high

complexity testing on or before April 24,

1995;

(6) For blood gas analysis—

(i) Be qualified under

§ 493.1489(b)(1), (b)(2), (b)(3), (b)(4), or

(b)(5);

(ii) Have earned a bachelor’s degree in

respiratory therapy or cardiovascular

technology from an accredited

institution; or

(iii) Have earned an associate 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.

§ 493.1495 [Amended]

47. In § 493.1495, all references to

‘‘§ 493.1489(b)(4)’’ are amended to read

‘‘§ 493.1489(b)(5).’’

48. The heading to subpart P is

revised to read as follows:

Subpart P—Quality Assurance for

Moderate Complexity (Including the

Subcategory) or High Complexity

Testing, or Any Combination of These

Tests

49. Section 493.1701 is revised to read

as follows:

§ 493.1701 Condition: Quality assurance;

moderate complexity (including the

subcategory) or high complexity testing, or

any combination of these tests.

Each laboratory performing moderate

complexity (including the subcategory)

or high complexity testing, or any

combination of these tests, must

establish and follow written policies

and procedures for a comprehensive

quality assurance program that is

designed to monitor and evaluate the

ongoing and overall quality of the total

testing process (preanalytic, analytic,

postanalytic). The laboratory’s quality

assurance program must evaluate the

effectiveness of its policies and

procedures; identify and correct

problems; assure the accurate, reliable

and prompt reporting of test results; and

assure the adequacy and competency of

the staff. As necessary, the laboratory

must revise policies and procedures

based upon the results of those

evaluations. The laboratory must meet

the standards as they apply to the

services offered, complexity of testing

performed and test results reported, and

the unique practices of each testing

entity. All quality assurance activities

must be documented.

50. In § 493.1776, the introductory

text of paragraphs (a), (b), and (b)(4) are

republished and the heading and

paragraphs (a)(3), (a)(4), (b)(1), (b)(4)(iii)

and (b)(4)(iv) are revised to read as

follows:

§ 493.1776 Condition: Inspection of

laboratories issued a certificate for PPM

procedures.

(a) HHS or its designee will conduct

announced or unannounced inspections

of any laboratory at any time during its

hours of operation to—

* * * * *

(3) Determine whether the laboratory

is performing tests in addition to

procedures specified as PPM

procedures; and

(4) Collect information regarding the

appropriateness of tests specified as

PPM procedures.

(b) The laboratory may be required, as

part of this inspection, to—(1) Permit

HHS or its designee to interview all

employees of the laboratory concerning

the laboratory’s compliance with the

applicable requirements of part 493.

Requirements for the purposes of this

section are located in subpart C or
Federal Register / Vol. 60, No. 78 / Monday, April 24, 1995 / Rules and Regulations 20051

subpart D, if applicable, and subparts H,

J, K, M, and P of this part;

* * * * *

(4) Permit HHS or its designee upon

request to review all information and

data necessary to—

* * * * *

(iii) Determine whether the laboratory

is performing tests in addition to

procedures specified as PPM

procedures; (iv) Collect information

regarding the appropriateness of tests

specified as PPM procedures; and

* * * * *

51. In § 493.1777, introductory text to

the section is added and the heading

and paragraphs (a) and (g) are revised to

read as follows:

§ 493.1777 Condition: Inspection of

laboratories requesting or issued a

certificate of compliance.

Laboratories requesting or issued a

certificate of compliance must permit an

inspection to assess compliance with

part 493 of this chapter. Testing in the

subcategory of PPM procedures, may be

included in the laboratory’s routine or

complaint inspection. PPM procedures

are assessed for compliance with only

the applicable requirements specific to

the subcategory of testing.

(a) HHS or its designee may conduct

unannounced or announced inspections

on at least a biennial basis of any

laboratory at any time during its hours

of operation. To assess compliance with

the requirements of part 493, HHS will

inspect a laboratory possessing a

registration certificate before issuance of

a certificate of compliance.

* * * * *

(g) Failure to permit an inspection

under this subsection will result in the

suspension of Medicare and Medicaid

payments to the laboratory, or

termination of the laboratory’s

participation in Medicare and Medicaid

for payment, and suspension of or

action to revoke the laboratory’s CLIA

certificate of compliance in accordance

with subpart R of this part.

§ 493.1804 [Amended]

52. In § 493.1804(b)(2), the word

‘‘ore’’ is revised to read ‘‘or’’.

53. In § 493.1814, the introductory

text of paragraph (b) is republished and

paragraph (b)(3) is revised to read as

follows:

§ 493.1814 Action when deficiencies are at

the condition level but do not pose

immediate jeopardy.

* * * * *

(b) Failure to correct condition level

deficiencies. If HCFA imposes

alternative sanctions for condition level

deficiencies that do not pose immediate

jeopardy, and the laboratory does not

correct the condition level deficiencies

within 12 months after the last day of

inspection, HCFA—

* * * * *

(3) May impose (or continue, if

already imposed) any alternative

sanctions that do not pertain to

Medicare payments. (Sanctions imposed

under the authority of section 353 of the

PHS Act may continue for more than 12

months from the last date of inspection,

while a hearing on the proposed

suspension, limitation, or revocation of

the certificate of compliance,

registration certificate, certificate of

accreditation, or certificate for PPM

procedures is pending.)

* * * * *

54. In § 493.1834, the heading and

introductory text of paragraph (f)(2) are

republished and paragraphs (b) and

(f)(2)(iii) are revised to read as follows:

§ 493.1834 Civil money penalty.

* * * * *

(b) Scope. This section sets forth the

procedures that HCFA follows to

impose a civil money penalty in lieu of,

or in addition to, suspending, limiting,

or revoking the certificate of

compliance, registration certificate,

certificate of accreditation, or certificate

for PPM procedures of a laboratory that

is found to have condition level

deficiencies.

* * * * *

(f) Accrual and duration of penalty—

* * * * *

(2) Duration of penalty. The civil

money penalty continues to accrue until

the earliest of the following occurs:

* * * * *

(iii) HCFA suspends, limits, or

revokes the laboratory’s certificate of

compliance, registration certificate,

certificate of accreditation, or certificate

for PPM procedures.

* * * * *

55. In § 493.1836, the heading of

paragraph (c) is republished and

paragraphs (c)(2) and (c)(3) are revised

to read as follows:

§ 493.1836 State onsite monitoring.

* * * * *

(c) Duration of sanction.

* * * * *

(2) If the laboratory does not correct

all deficiencies within 12 months, and

a revisit indicates that deficiencies

remain, HCFA cancels the laboratory’s

approval for Medicare payment for its

services and notifies the laboratory of its

intent to suspend, limit, or revoke the

laboratory’s certificate of compliance,

registration certificate, certificate of

accreditation, or certificate for PPM

procedures.

(3) If the laboratory still does not

correct its deficiencies, the Medicare

sanction continues until the suspension,

limitation, or revocation of the

laboratory’s certificate of compliance,

registration certificate, certificate of

accreditation, or certificate for PPM

procedures is effective.

56. In § 493.2001, paragraph (e) and

paragraph (e)(1) are revised to read as

follows:

§ 493.2001 Establishment and function of

the Clinical Laboratory Improvement

Advisory Committee.

* * * * *

(e) The Clinical Laboratory

Improvement Advisory Committee or

subcommittee, at the request of HHS,

will review and make recommendations

concerning:

(1) Criteria for categorizing tests and

examinations of moderate complexity

(including the subcategory) and high

complexity;

* * * * *

(Catalog of Federal Domestic Assistance

Program No. 93.778, Medical Assistance;

Program No. 93.773, Medicare—Hospital

Insurance; and Program No. 93.774,

Medicare—Supplementary Medical

Insurance Program)

Dated: December 23, 1994.

Philip R. Lee,

Assistant Secretary for Health.

Bruce C. Vladeck,

Administrator, Health Care Financing

Administration.

Dated: December 27, 1994.

Donna E. Shalala,

Secretary.

[FR Doc. 95–9953 Filed 4–21–95; 8:45 am]

BILLING CODE 4120–01–P

FEDERAL COMMUNICATIONS

COMMISSION

47 CFR Part 61

[CC Docket No. 93–179, FCC 95–133]

Price Cap Rules for Local Exchange

Carriers

AGENCY: Federal Communications

Commission.

ACTION: Final rule.

SUMMARY: This action is taken to

incorporate explicitly the ‘‘add-back’’

adjustment into the local exchange

carrier (LEC) price cap rules. The

explicit add-back rule will first be

applied when the LECs file their 1995

access tariffs. It is intended that the

explicit add-back rule will ensure that