Alternate Quality Assessment Survey

Forms and Documents

Document Name	Status

No forms / supporting documents in this ICR. Check IC Document Collections.

IC Document Collections

IC ID	Document Title	Status
8226	Alternate Quality Assessment Survey Form	Migrated

ICR Details

OMB Control No: 0938-0650	ICR Reference No: 199511-0938-004
Status: Historical Active	Previous ICR Reference No: 199508-0938-001
Agency/Subagency: HHS/CMS	Agency Tracking No:
Title: Alternate Quality Assessment Survey
Type of Information Collection: Reinstatement with change of a previously approved collection	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved without change	Conclusion Date: 02/06/1996
	Date Received in OIRA: 11/13/1995
Terms of Clearance: Approved for use through 2/98 under the following conditions: 1) no later than 2/13/96, HCFA discusses with OMB its amendments in response to public comment and rationales for accepting or rejecting public comment. OMB may request amendments to the instrument pursuant to this discussion; 2) HCFA submits a more detailed phase-in plan and agrees to meet with OMB at an agreed milestone to assess adherence to the plan and laboratory experience; 3) HCFA amends its burden estimate for CLIA regulations to reflect implementation of this alternative enforcement approach; 4) the next submission for OMB review: a) further explores opportunities for amending the survey instrument and eligibility criteria so they are more outcome-based; and b) considers the feasibility of pre-printing laboratory-specific data on the forms before sending them to eligible laboratories; 6) HCFA consults with OMB regarding any future plans or approaches to revising the CLIA fee schedule that would reflect enforcement alternatives offered to laboratories and the related costs; and 7) HCFA briefs OMB on its plans to incorporate the AQAS data into the OSCAR/CLIA data base and efforts to evaluate the cost- effectiveness of the AQAS as an enforcement tool.

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	02/28/1998	02/28/1998
Responses	4,000	0	0
Time Burden (Hours)	12,000	0	0
Cost Burden (Dollars)	0	0	0

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Abstract: Used in lieu of an onsite survey for those CLIA laboratories with good performance determined on last onsite survey. Revised to reflect CLIA's streamlined inspection process, reduce burden, and improve CLIA system by rewarding good performance. Designed to determine current compliance, as well as prepare laboratories for future onsite surveys.

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Authorizing Statute(s): None

Citations for New Statutory Requirements: None

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Associated Rulemaking Information
RIN:	Stage of Rulemaking:	Federal Register Citation:	Date:

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Federal Register Notices & Comments

Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 1

IC Title	Form No.	Form Name
Alternate Quality Assessment Survey	HCFA-667

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ICR Summary of Burden

	Total Approved	Previously Approved	Change Due to New Statute	Change Due to Agency Discretion	Change Due to Adjustment in Estimate	Change Due to Potential Violation of the PRA
Annual Number of Responses	4,000	0	0	4,000	0	0
Annual Time Burden (Hours)	12,000	0	0	12,000	0	0
Annual Cost Burden (Dollars)	0	0	0	0	0	0

Burden increases because of Program Change due to Agency Discretion: Yes

Burden Increase Due to:

Burden decreases because of Program Change due to Agency Discretion: No

Burden Reduction Due to:

Short Statement:

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Annual Cost to Federal Government: $0

Does this IC contain surveys, censuses, or employ statistical methods? No

Is the Supporting Statement intended to be a Privacy Impact Assessment required by the E-Government Act of 2002? No

Is this ICR related to the Affordable Care Act [Pub. L. 111-148 & 111-152]? Uncollected

Is this ICR related to the Dodd-Frank Wall Street Reform and Consumer Protection Act, [Pub. L. 111-203]? Uncollected

Is this ICR related to the American Recovery and Reinvestment Act of 2009 (ARRA)? Uncollected

Is this ICR related to the Pandemic Response? Uncollected

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Common Form ICR:  No

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On behalf of this Federal agency, I certify that the collection of information encompassed by this request complies with 5 CFR 1320.9 and the related provisions of 5 CFR 1320.8(b)(3).

The following is a summary of the topics, regarding the proposed collection of information, that the certification covers:

(a) It is necessary for the proper performance of agency functions;

(b) It avoids unnecessary duplication;

(c) It reduces burden on small entities;

(d) It uses plain, coherent, and unambiguous language that is understandable to respondents;

(e) Its implementation will be consistent and compatible with current reporting and recordkeeping practices;

(f) It indicates the retention periods for recordkeeping requirements;

(g) It informs respondents of the information called for under 5 CFR 1320.8 (b)(3) about:

(i) Why the information is being collected;

(ii) Use of information;

(iii) Burden estimate;

(iv) Nature of response (voluntary, required for a benefit, or mandatory);

(v) Nature and extent of confidentiality; and

(vi) Need to display currently valid OMB control number;

(h) It was developed by an office that has planned and allocated resources for the efficient and effective management and use of the information to be collected.

(i) It uses effective and efficient statistical survey methodology (if applicable); and

(j) It makes appropriate use of information technology.

If you are unable to certify compliance with any of these provisions, identify the item by leaving the box unchecked and explain the reason in the Supporting Statement.

Certification Date: 11/13/1995

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