Federal Register / Vol. 87, No. 44 / Monday, March 7, 2022 / Notices 12711 

Interpersonal Violence Impacting 

Children and Youth: March 8, 2022. 

The meeting is closed to the public. 

FOR FURTHER INFORMATION CONTACT: 

Aisha L. Wilkes, M.P.H., Scientific 

Review Officer, National Center for 

Injury Prevention and Control, CDC, 

4770 Buford Highway NE, Mailstop 

S106–9, Atlanta, Georgia 30341, 

Telephone (404) 639–6473, AWilkes@

cdc.gov. 

The Director, Strategic Business 

Initiatives Unit, Office of the Chief 

Operating Officer, Centers for Disease 

Control and Prevention, has been 

delegated the authority to sign Federal 

Register notices pertaining to 

announcements of meetings and other 

committee management activities, for 

both the Centers for Disease Control and 

Prevention and the Agency for Toxic 

Substances and Disease Registry. 

Kalwant Smagh, 

Director, Strategic Business Initiatives Unit, 

Office of the Chief Operating Officer, Centers 

for Disease Control and Prevention. 

[FR Doc. 2022–04680 Filed 3–4–22; 8:45 am] 

BILLING CODE 4163–18–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

[CMS–3425–N] 

Announcement of the Approval of 

COLA as an Accreditation 

Organization for the Specialty of 

Pathology To Include Histopathology, 

Cytology and Oral Pathology Under the 

Clinical Laboratory Improvement 

Amendments of 1988 

AGENCY: Centers for Medicare & 

Medicaid Services (CMS), HHS. 

ACTION: Notice. 

SUMMARY: This notice announces the 

application of COLA for approval as an 

accreditation organization for clinical 

laboratories under the Clinical 

Laboratory Improvement Amendments 

of 1988 (CLIA) program for the specialty 

of Pathology to include Histopathology, 

Cytology and Oral Pathology. We have 

determined that COLA meets or exceeds 

the applicable CLIA requirements. In 

this notice, we announce the approval 

and grant COLA deeming authority for 

the specialty of Pathology to include 

Histopathology, Cytology and Oral 

Pathology for a period of 2 years. 

DATES: This notice is effective from 

March 7, 2022 to March 7, 2024. 

FOR FURTHER INFORMATION CONTACT: 

Raelene Perfetto (410) 786–6876. 

SUPPLEMENTARY INFORMATION: 

I. Background and Legislative 

Authority 

On October 31, 1988, the Congress 

enacted the Clinical Laboratory 

Improvement Amendments of 1988 

(CLIA) (Pub. L. 100–578). CLIA 

amended section 353 of the Public 

Health Service Act. We issued a final 

rule implementing the accreditation 

provisions of CLIA on July 31, 1992 (57 

FR 33992). Under those provisions, 

CMS may grant deeming authority to an 

accreditation organization if its 

requirements for laboratories accredited 

under its program are equal to or more 

stringent than the applicable CLIA 

program requirements in 42 CFR part 

493 (Laboratory Requirements). Subpart 

E of part 493 (Accreditation by a Private, 

Nonprofit Accreditation Organization or 

Exemption Under an Approved State 

Laboratory Program) specifies the 

requirements an accreditation 

organization must meet to be approved 

by CMS as an accreditation organization 

under CLIA. 

II. Notice of Approval of COLA for the 

Specialty of Pathology To Include 

Histopathology, Cytology and Oral 

Pathology as an Accreditation 

Organization 

In this notice, we approve COLA as an 

organization that may accredit 

laboratories for purposes of establishing 

their compliance with CLIA 

requirements for the specialty of 

Pathology to include Histopathology, 

Cytology and Oral Pathology. We have 

examined the initial COLA application 

and all subsequent submissions to 

determine its accreditation program’s 

equivalency with the requirements for 

approval of an accreditation 

organization under subpart E of part 

493. We have determined that COLA 

meets or exceeds the applicable CLIA 

requirements. We have also determined 

that COLA will ensure that its 

accredited laboratories will meet or 

exceed the applicable requirements in 

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

applicable sections of R. Therefore, we 

grant COLA approval as an accreditation 

organization under subpart E of part 

493, for the period stated in the DATES

section of this notice for the specialty of 

Pathology and the subspecialties of 

Histopathology, Cytology and Oral 

Pathology. As a result of this 

determination, any laboratory that is 

accredited by COLA during the time 

period stated in the DATES section of this 

notice will be deemed to meet the CLIA 

requirements for the specialty of 

Pathology to include Histopathology, 

Cytology and Oral Pathology, and 

therefore, will generally not be subject 

to routine inspections by a State survey 

agency to determine its compliance with 

CLIA requirements. The accredited 

laboratory, however, is subject to 

validation and complaint investigation 

surveys performed by CMS, or its 

agent(s). 

III. Evaluation of COLA’s Request for 

Approval as an Accreditation 

Organization Under CLIA for the 

Specialty of Pathology To Include 

Histopathology, Cytology and Oral 

Pathology 

The following describes the process 

used to determine that COLA 

accreditation program meets the 

necessary requirements to be approved 

by CMS and that, as such, CMS may 

approve COLA as an accreditation 

program with deeming authority under 

the CLIA program. In reviewing these 

materials, we reached the following 

determinations for each applicable part 

of the CLIA regulations: 

A. Subpart E—Accreditation by a 

Private, Nonprofit Accreditation 

Organization or Exemption Under an 

Approved State Laboratory Program 

COLA submitted its mechanism for 

monitoring compliance with all 

requirements equivalent to conditionlevel requirements, a list of all its 

current laboratories and the expiration 

date of their accreditation, and a 

detailed comparison of the individual 

accreditation requirements with the 

comparable condition-level 

requirements. We have determined that 

COLA policies and procedures for 

oversight of laboratories performing 

laboratory testing for the specialty of 

Pathology to include Histopathology, 

Cytology and Oral Pathology are 

equivalent to those required under the 

CLIA regulations in the matters of 

inspection, monitoring proficiency 

testing (PT) performance, investigating 

complaints, and making PT information 

available. COLA submitted 

documentation regarding its 

requirements for monitoring and 

inspecting laboratories and describing 

its standards regarding data 

management, the inspection process, 

procedures for removal or withdrawal of 

accreditation, notification requirements 

for laboratories out of compliance, and 

accreditation organization resources. We 

have determined that COLA’s 

requirements for monitoring and 

inspecting laboratories are equivalent to 

those required under our regulations for 

laboratories in the areas of data 

management, the inspection process, 

procedures for removal or withdrawal of 

accreditation, notification requirements 


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12712 Federal Register / Vol. 87, No. 44 / Monday, March 7, 2022 / Notices 

for laboratories out of compliance, and 

accreditation organization resources. 

Therefore, we have determined that the 

requirements of the accreditation 

program submitted for approval are 

equal to or more stringent than the 

requirements of the CLIA regulations. 

B. Subpart H—Participation in 

Proficiency Testing for Laboratories 

Performing Nonwaived Testing 

We have determined that COLA’s 

requirements are equal to or more 

stringent than the CLIA requirements at 

§§ 493.801 through 493.865. 

C. Subpart J—Facility Administration 

for Nonwaived Testing 

We have determined that COLA’s 

requirements for the specialty of 

Pathology to include Histopathology, 

Cytology and Oral Pathology are equal 

to or more stringent than the CLIA 

requirements at §§ 493.1100 through 

493.1105. 

D. Subpart K—Quality System for 

Nonwaived Testing 

We have determined that COLA’s 

requirements for the specialty of 

Pathology to include Histopathology, 

Cytology and Oral Pathology are equal 

to or more stringent than the CLIA 

requirements at §§ 493.1200 through 

493.1299. 

E. Subpart M—Personnel for Nonwaived 

Testing 

We have determined that COLA’s 

requirements for the specialty of 

Pathology to include Histopathology, 

Cytology and Oral Pathology are equal 

to or more stringent than the CLIA 

requirements at §§ 493.1403 through 

493.1495 for laboratories that perform 

moderate and high complexity testing. 

F. Subpart Q—Inspection 

We have determined that COLA’s 

requirements for the specialty of 

Pathology to include Histopathology, 

Cytology and Oral Pathology are equal 

to or more stringent than the CLIA 

requirements at §§ 493.1771 through 

493.1780. 

G. Subpart R—Enforcement Procedures 

We have determined that COLA’s 

requirements for the specialty of 

Pathology to include Histopathology, 

Cytology and Oral Pathology meet the 

requirements of subpart R to the extent 

that it applies to accreditation 

organizations. COLA policy sets forth 

the actions the organization takes when 

laboratories it accredits do not comply 

with its requirements and standards for 

accreditation. When appropriate, COLA 

will deny, suspend, or revoke 

accreditation in a laboratory accredited 

by COLA and report that action to us 

within 30 days. COLA also provides an 

appeal process for laboratories that have 

had accreditation denied, suspended, or 

revoked. 

We have determined that COLA’s 

laboratory enforcement and appeal 

policies are equal to or more stringent 

than the requirements of part 493 

subpart R as they apply to accreditation 

organizations. 

IV. Federal Validation Inspections and 

Continuing Oversight 

The Federal validation inspections of 

laboratories accredited by COLA may be 

conducted on a representative sample 

basis or in response to substantial 

allegations of noncompliance (that is, 

complaint inspections). The outcome of 

those validation inspections, performed 

by CMS or our agents, or the State 

survey agencies, will be our principal 

means for verifying that the laboratories 

accredited by COLA remain in 

compliance with CLIA requirements. 

This Federal monitoring is an ongoing 

process. 

V. Removal of Approval as an 

Accrediting Organization 

CLIA regulations at § 493.575 provide 

that we may rescind the approval of an 

accreditation organization, such as that 

of COLA, before the end of the effective 

date of approval in certain 

circumstances. For example, If we 

determine that COLA has failed to 

adopt, maintain and enforce 

requirements that are equal to, or more 

stringent than, the CLIA requirements, 

or that systemic problems exist in its 

monitoring, inspection or enforcement 

processes, we may impose a 

probationary period, not to exceed 1 

year, in which COLA would be allowed 

to address any identified issues. Should 

COLA be unable to address the 

identified issues within that timeframe, 

CMS may, in accordance with the 

applicable regulations, revoke COLA’s 

deeming authority under CLIA. 

Should circumstances result in our 

withdrawal of COLA’s approval, we will 

publish a notice in the Federal Register 

explaining the basis for removing its 

approval. 

VI. Collection of Information 

Requirements 

This document does not impose 

information collection requirements, 

that is, reporting, record keeping or 

third-party disclosure requirements. 

Consequently, there is no need for 

review by the Office of Management and 

Budget (OMB) under the authority of the 

Paperwork Reduction Act of 1995 (44 

U.S.C. Chapter 35). The requirements 

associated with the accreditation 

process for clinical laboratories under 

the CLIA program, codified in 42 CFR 

part 493 subpart E, are currently 

approved by OMB under OMB control 

number 0938–0686. 

VII. Executive Order 12866 Statement 

In accordance with the provisions of 

Executive Order 12866, this notice was 

not reviewed by the Office of 

Management and Budget. 

The Administrator of the Centers for 

Medicare & Medicaid Services (CMS), 

Chiquita Brooks-LaSure, having 

reviewed and approved this document, 

authorizes Lynette Wilson, who is the 

Federal Register Liaison, to 

electronically sign this document for 

purposes of publication in the Federal 

Register. 

Lynette Wilson, 

Federal Register Liaison, Centers for Medicare 

& Medicaid Services. 

[FR Doc. 2022–04770 Filed 3–4–22; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Impact of Health Misinformation in the 

Digital Information Environment in the 

United States Throughout the COVID– 

19 Pandemic Request for Information 

(RFI) 

AGENCY: Office of the Surgeon General, 

Department of Health and Human 

Services. 

ACTION: Request for information (RFI). 

SUMMARY: The Office of the Surgeon 

General requests input from interested 

parties on the impact and prevalence of 

health misinformation in the digital 

information environment during the 

COVID–19 pandemic. The purpose of 

this RFI is to understand the impact of 

COVID–19 misinformation on 

healthcare infrastructure and public 

health more broadly during the 

pandemic including (but not limited to) 

quality of care, health decisions and 

outcomes, direct and indirect costs, 

trust in the healthcare system and 

providers, and healthcare worker morale 

and safety, understand the unique role 

the information environment played in 

the societal response to the COVID–19 

pandemic and implications for future 

public health emergencies, understand 

the impact of exposure to health 

misinformation and how access to 

trusted and credible health information, 

particularly during a public health 

emergency, impacts lifesaving health 

decisions such as an individual’s 


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