Federal Register / Vol. 78, No. 36 / Friday, February 22, 2013 / Notices 12323 

laws passed since the previous 

collection document was approved. 

While the OMB control number for this 

proposed collection will remain the 

same as the previously approved 

collection, this proposed collection will 

be given a new CMS Form Number. 

Form Number: CMS–10430 (OCN: 

0938–0702); Frequency: Annually; 

Occasionally; Affected Public: Private 

Sector; Business or other for-profits and 

Not-for-profit institutions, and State, 

Local, or Tribal Governments; Number 

of Respondents: 8,716; Total Annual 

Responses: 39,831,442; Total Annual 

Hours: 3,760,422 hours. (For policy 

questions regarding this collection 

contact Lisa Campbell at 301–492–4114. 

For all other issues call 410–786–1326.) 

2. Type of Information Collection 

Request: Reinstatement with a change of 

a previously approved collection; Title: 

Medicare Electronic Data Interchange 

(EDI) Registration and Electronic Data 

Interchange (EDI) Enrollment Form; 

Use: The purpose of this collection is to 

obtain information that will be 

subsequently used during transaction 

exchange for identification of Medicare 

providers/suppliers and authorization of 

requested Electronic Data Interface (EDI) 

functions. The EDI Enrollment and the 

Medicare Registration Forms are 

completed by Medicare providers, 

suppliers, or both suppliers and 

submitted to Medicare contractors. 

Authorization is needed for providers 

and suppliers to send and receive 

HIPAA standard transactions directly 

(or through a designated 3rd party) to 

and from Medicare contractors. 

Medicare contractors would use the 

information for initial set-up and 

maintenance of the access privileges. 

The use of the standard form provides 

an efficient uniform means by which 

Medicare captures information 

necessary to drive Medicare EDI 

security and EDI access privileges. All 

EDI providers will complete and sign 

the EDI Enrollment Form along with the 

Medicare EDI Registration Form. They 

will also reconfirm their access 

privileges annually. 

The information collected will be 

uploaded into Medicare contractor 

computer systems. Medicare contractors 

will store this information in a database 

accessed at the time of provider 

connection to the Medicare Data 

Contractor Network (MDCN). When 

authentication is successful and 

connectivity is established, transactions 

may be exchanged. The information will 

be stored in a computer data base and 

used to authenticate the user on day-today electronic commerce, support the 

submitter and password administration 

function, and validate access 

relationships between providers/ 

suppliers and their designated EDI 

submitter/receiver on a per transaction 

basis. Form Number: CMS–10164 (OCN: 

0938–0983); Frequency: Once; Affected 

Public: Private Sector—Business or 

other for-profits, Not for-profit 

institutions; Number of Respondents: 

240,000; Total Annual Responses: 

240,000; Total Annual Hours: 80,000. 

(For policy questions regarding this 

collection contact Claudette Sikora at 

410–786–5618. For all other issues call 

410–786–1326.) 

3. Type of Information Collection 

Request: Reinstatement without change 

of a previously approved collection. 

Title of Information Collection: 

Medicare Credit Balance Reporting 

Requirements and Supporting 

Regulations in 42 CFR 405.371, 405.378 

and 413.20; Use: Section 1815(a) of the 

Social Security Act authorizes the 

Secretary to request information from 

providers which is necessary to 

properly administer the Medicare 

program. Quarterly credit balance 

reporting is needed to monitor and 

control the identification and timely 

collection of improper payments. The 

information obtained from Medicare 

credit balance reports will be used by 

the contractors to identify and recover 

outstanding Medicare credit balances 

and by Federal enforcement agencies to 

protect Federal funds. The information 

will also be used to identify the causes 

of credit balances and to take corrective 

action. Form Number: CMS–838 (OCN: 

0938–0600); Frequency: Yearly; Affected 

Public: Private sector—Business or other 

for-profits; Number of Respondents: 

45,838; Total Annual Responses: 

183,352; Total Annual Hours: 550,056. 

(For policy questions regarding this 

collection contact Milton Jacobson at 

410–786–7553. For all other issues call 

410–786–1326.) 

To obtain copies of the supporting 

statement and any related forms for the 

proposed paperwork collections 

referenced above, access CMS’ Web Site 

address at http://www.cms.hhs.gov/ 

PaperworkReductionActof1995, or 

Email your request, including your 

address, and phone number as well the 

OMB number, and CMS document 

identifier, to Paperwork@cms.hhs.gov, 

or call the Reports Clearance Office on 

(410) 786–1326. 

To be assured consideration, 

comments and recommendations for the 

proposed information collections must 

be received by the OMB desk officer at 

the address below, no later than 5 p.m. 

on March 25, 2013. 

OMB, Office of Information and 

Regulatory Affairs, Attention: CMS 

Desk Officer, Fax Number: (202) 395– 

6974, Email: 

OIRA_submission@omb.eop.gov. 

Dated: February 19, 2013. 

Martique Jones, 

Deputy Director, Regulations Development 

Group, Office of Strategic Operations and 

Regulatory Affairs. 

[FR Doc. 2013–04135 Filed 2–21–13; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

[CMS–3279–N] 

Announcement of the Re-Approval of 

the Commission on Office Laboratory 

Accreditation (COLA) as an 

Accreditation Organization Under the 

Clinical Laboratory Improvement 

Amendments of 1988 

AGENCY: Centers for Medicare & 

Medicaid Services (CMS), HHS. 

ACTION: Notice. 

SUMMARY: This notice announces the 

application of the Commission on Office 

Laboratory Accreditation (COLA) for 

approval as an accreditation 

organization for clinical laboratories 

under the Clinical Laboratory 

Improvement Amendments of 1988 

(CLIA) program. 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 a 

period of 6 years. 

DATES: Effective Date: This notice is 

effective from February 22, 2013 to 

February 22, 2019. 

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 


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12324 Federal Register / Vol. 78, No. 36 / Friday, February 22, 2013 / Notices 

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 Commission 

on Office Laboratory Accreditation 

(COLA) 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 following specialty 

and subspecialty areas under CLIA: 

• Microbiology, including 

Bacteriology, Mycobacteriology, 

Mycology, Parasitology, Virology. 

• Diagnostic Immunology, including 

Syphilis Serology, General Immunology. 

• Chemistry, including Routine 

Chemistry, Urinalysis, Endocrinology, 

Toxicology. 

• Hematology. 

• Immunohematology, including 

ABO Group & Rh Group, Antibody 

Detection, Antibody Identification, 

Compatibility Testing. 

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 submitted specialty and 

subspecialty areas under CLIA. 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 listed subspecialties and 

specialties, and therefore, will generally 

not be subject to routine inspections by 

a state survey agency to determine its 

compliance with CLIA requirements. 

The accredited laboratory, however, is 

subject to validation and complaint 

investigation surveys performed by 

CMS, or its agent(s). 

III. Evaluation of the COLA Request for 

Approval as an Accreditation 

Organization Under CLIA 

The following describes the process 

used to determine that the 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. COLA formally 

applied to CMS for approval as an 

accreditation organization under CLIA 

for the following specialties and 

subspecialties: 

• Microbiology, including 

Bacteriology, Mycobacteriology, 

Mycology, Parasitology, Virology. 

• Diagnostic Immunology, including 

Syphilis Serology, General Immunology. 

• Chemistry, including Routine 

Chemistry, Urinalysis, Endocrinology, 

Toxicology. 

• Hematology. 

• Immunohematology, including 

ABO Group & Rh Group, Antibody 

Detection, Antibody Identification, 

Compatibility Testing. 

In reviewing these materials, we 

reached the following determinations 

for each applicable part of the CLIA 

regulations: 

A. Subpart E—Accreditation by a 

Private, Nonprofit Accreditation 

Organization or Exemption Under an 

Approved State Laboratory Program 

The 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. The COLA policies and 

procedures for oversight of laboratories 

performing laboratory testing for the 

submitted CLIA specialties and 

subspecialties are equivalent to those of 

CLIA in the matters of inspection, 

monitoring proficiency testing (PT) 

performance, investigating complaints, 

and making PT information available. 

The COLA submitted requirements for 

monitoring and inspecting laboratories 

in the areas of accreditation 

organization, data management, the 

inspection process, procedures for 

removal or withdrawal of accreditation, 

notification requirements, and 

accreditation organization resources. 

The requirements of the accreditation 

programs submitted for approval are 

equal to or more stringent than the 

requirements of the CLIA regulations. 

Our evaluation identified the COLA 

requirements pertaining to waived 

testing that are more stringent than 

CLIA requirements. The COLA requires 

the laboratory director to review quality 

control results for waived tests monthly 

and also requires that competency be 

assessed and documented for personnel 

performing waived testing. The CLIA 

requirements at § 493.15(e) require 

eligible laboratories to follow the 

manufacturer’s instructions for 

performing tests and obtain a certificate 

of waiver as outlined in part 493, 

subpart B. 

B. Subpart H—Participation in 

Proficiency Testing for Laboratories 

Performing Nonwaived Testing 

The COLA’s requirements are equal to 

the CLIA requirements at § 493.801 

through § 493.865. Like CLIA, all of the 

COLA’s accredited laboratories are 

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

subpart I. The COLA also encourages its 

accredited laboratories to participate in 

PT for tests that are waived under CLIA. 

C. Subpart J—Facility Administration 

for Nonwaived Testing 

The COLA’s requirements are equal to 

the CLIA requirements at § 493.1100 

through § 493.1105. 

D. Subpart K—Quality System for 

Nonwaived Testing 

The COLA requirements are equal to 

or more stringent than the CLIA 

requirements at § 493.1200 through 

§ 493.1299. For instance, when a 

laboratory establishes performance 

specifications for a test not approved by 

the Food and Drug Administration 

(FDA) or a test that has been approved 

by the FDA but modified, the COLA 

requires its accredited laboratories to 

submit all data obtained for review and 

approval by the COLA prior to adding 

the test to the laboratory’s menu. 

E. Subpart M—Personnel for Nonwaived 

Testing 

We have determined that the COLA 

requirements are equal to the CLIA 

requirements at § 493.1403 through 

§ 493.1495 for laboratories that perform 

moderate and high complexity testing. 

F. Subpart Q—Inspections 

We have determined that the COLA 

requirements are equal to the CLIA 

requirements at § 493.1771 through 

§ 493.1780. The COLA will continue to 

conduct biennial onsite inspections. An 

unannounced inspection would be 

performed when a complaint, lodged 

against a laboratory accredited by the 

COLA, indicates that problems may 

exist within the laboratory that may 


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Federal Register / Vol. 78, No. 36 / Friday, February 22, 2013 / Notices 12325 

have a serious or immediate impact on 

patient care. 

G. Subpart R—Enforcement Procedures 

The COLA meets the requirements of 

subpart R to the extent that it applies to 

accreditation organizations. The 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, the 

COLA will deny, suspend, or revoke 

accreditation in a laboratory accredited 

by the COLA and report that action to 

us within 30 days. The COLA also 

provides an appeals process for 

laboratories that have had accreditation 

denied, suspended, or revoked. 

We have determined that the 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 the 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 the COLA remain in 

compliance with CLIA requirements. 

This federal monitoring is an ongoing 

process. 

V. Removal of Approval as an 

Accrediting Organization 

Our regulations provide that we may 

rescind the approval of an accreditation 

organization, such as that of the COLA, 

for cause, before the end of the effective 

date of approval. If we determine that 

the 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 the COLA would be 

allowed to address any identified issues. 

Should the 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 the 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 notice does not impose any 

information collection and record 

keeping requirements subject to the 

Paperwork Reduction Act (PRA). 

Consequently, it does not need to be 

reviewed by the Office of Management 

and Budget (OMB) under the authority 

of the PRA. The requirements associated 

with the accreditation process for 

clinical laboratories under the CLIA 

program, codified in 42 CFR part 493 

subpart E, are currently approved by 

OMB under OMB approval 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. 

Authority: Section 353 of the Public 

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

Dated: February 8, 2013. 

Marilyn Tavenner, 

Acting Administrator, Centers for Medicare 

& Medicaid Services. 

[FR Doc. 2013–03927 Filed 2–21–13; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

[CMS–3280–PN] 

Medicare and Medicaid Programs; 

Application From the Center for 

Improvement in Healthcare Quality 

(CIHQ) for CMS-Approval of Its 

Hospital Accreditation Program 

AGENCY: Centers for Medicare & 

Medicaid Services, HHS. 

ACTION: Proposed notice. 

SUMMARY: This proposed notice with 

comment period acknowledges the 

receipt of an application from the Center 

for Improvement in Healthcare Quality 

(CIHQ) for recognition as a national 

accrediting organization for hospitals 

that wish to participate in the Medicare 

or Medicaid programs. 

DATES: To be assured consideration, 

comments must be received at one of 

the addresses provided below, no later 

than 5 p.m. on March 25, 2013. 

ADDRESSES: In commenting, refer to file 

code (CMS–3280–PN). Because of staff 

and resource limitations, we cannot 

accept comments by facsimile (FAX) 

transmission. 

You may submit comments in one of 

four ways (choose only one of the ways 

listed): 

1. Electronically. You may submit 

electronic comments on specific issues 

in this regulation to http:// 

www.regulations.gov. Follow the 

‘‘Submit a comment’’ instructions. 

2. By regular mail. You may mail 

written comments to the following 

address ONLY: Centers for Medicare & 

Medicaid Services, Department of 

Health and Human Services, Attention: 

CMS–3280–PN, P.O. Box 8016, 

Baltimore, MD 21244–8010. 

Please allow sufficient time for mailed 

comments to be received before the 

close of the comment period. 

3. By express or overnight mail. You 

may send written comments to the 

following address ONLY: Centers for 

Medicare & Medicaid Services, 

Department of Health and Human 

Services, Attention: CMS–3280–PN, 

Mail Stop C4–26–05, 7500 Security 

Boulevard, Baltimore, MD 21244–1850. 

4. By hand or courier. Alternatively, 

you may deliver (by hand or courier) 

your written ONLY to the following 

addresses. 

a. For delivery in Washington, DC— 

Centers for Medicare & Medicaid 

Services, Department of Health and 

Human Services, Room 445–G, Hubert 

H Humphrey Building, 200 

Independence Avenue SW., 

Washington, DC 20201. 

(Because access to the interior of the 

Hubert H. Humphrey Building is not 

readily available to persons without 

Federal Government identification, 

commenters are encouraged to leave 

their comments in the CMS drop slots 

located in the main lobby of the 

building. A stamp-in clock is available 

for persons wishing to retain a proof of 

filing by stamping in and retaining an 

extra copy of the comments being filed.) 

b. For delivery in Baltimore, MD— 

Centers for Medicare & Medicaid 

Services, Department of Health and 

Human Services, 7500 Security 

Boulevard, Baltimore, MD 21244–1850. 

If you intend to deliver your 

comments to the Baltimore address, call 

telephone number (410) 786–9994 in 

advance to schedule your arrival with 

one of our staff members. 

Comments erroneously mailed to the 

addresses indicated as appropriate for 

hand or courier delivery may be delayed 

and received after the comment period. 

For information on viewing public 

comments, see the beginning of the 

SUPPLEMENTARY INFORMATION section. 

FOR FURTHER INFORMATION CONTACT: 

Cindy Melanson, (410) 786–0310. 

Patricia Chmielewski, (410) 786–6899. 

Monda Shaver, (410) 786–3410. 


sroberts on DSK5SPTVN1PROD with NOTICES