Proficiency Testing in US Clinical Laboratories: Perception, Practices and Potential for Expanded Utility

Forms and Documents

Document Name	Status
Proficiency Testing in US Clinical Laboratories: Perception, Practices and Potential for Expanded Utility Form and Instruction	New
OMB Supporting Statement B.docx Supporting Statement B	2013-02-11
Attachment J_Language used to advertise survey_2013.docx Supplementary Document	2013-02-11
Attachment I_Postcard Follow-up.pdf Supplementary Document	2013-02-11
Attachment H_Survey Invitation Letter.docx Supplementary Document	2013-02-11
OMB Supporting Statement A_revised 1.24.2013.doc Supporting Statement A	2013-02-11

IC Document Collections

IC ID	Document Title	Status
205793	Proficiency Testing in US Clinical Laboratories: Perception, Practices and Potential for Expanded Utility Form and Instruction	New

ICR Details

OMB Control No: 0920-0961	ICR Reference No: 201302-0920-011
Status: Historical Active	Previous ICR Reference No:
Agency/Subagency: HHS/CDC	Agency Tracking No: 18796
Title: Proficiency Testing in US Clinical Laboratories: Perception, Practices and Potential for Expanded Utility
Type of Information Collection: New collection (Request for a new OMB Control Number)	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved without change	Conclusion Date: 04/01/2013
	Date Received in OIRA: 02/14/2013
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	04/30/2015	18 Months From Approved
Responses	29,840	0	0
Time Burden (Hours)	9,947	0	0
Cost Burden (Dollars)	0	0	0

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Abstract: This project is part of a cooperative agreement between the Centers for Disease Control and Prevention (CDC) and the Association of Public Health Laboratories (APHL). The primary focus is to conduct a systematic analysis to understand which types of laboratories follow proficiency testing (PT) good laboratory practices (GLPs) and to identify which kinds of laboratories could be targeted to promote PT GLPs. Based upon prior work conducted by APHL and CDC, it appears that many of these laboratories use their PT results internally for quality improvement. Since laboratories already pay for PT materials to meet regulatory requirements, the use of PT for quality improvement purposes has the potential to further improve laboratory quality at no additional cost to US clinical laboratories. In addition, by conducting this analysis APHL and CDC hope to learn more about the types of laboratories that do not comply with the Clinical Laboratory Improvement Amendments of 1988 (CLIA) PT requirements. The survey population frame is 20,500 Certificate of Compliance laboratories and 16,800 Certificate of Accreditation laboratories. All of these laboratories are required to perform PT in accordance with CLIA.

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Authorizing Statute(s): US Code: 42 USC 241 Name of Law: The Public Health land Welfare
  

Citations for New Statutory Requirements: None

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Associated Rulemaking Information
RIN:	Stage of Rulemaking:	Federal Register Citation:	Date:
	Not associated with rulemaking

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Federal Register Notices & Comments
60-day Notice:	Federal Register Citation:	Citation Date:
	77 FR 47075	08/07/2012
30-day Notice:	Federal Register Citation:	Citation Date:
	78 FR 9699	02/11/2013
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
Proficiency Testing in US Clinical Laboratories: Perception, Practices and Potential for Expanded Utility	None	Proficiency Testing in US Clinical Laboratories: Perception, Practices and Potential for Expanded Utility

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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	29,840	0	0	29,840	0	0
Annual Time Burden (Hours)	9,947	0	0	9,947	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: Miscellaneous Actions

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

Burden Reduction Due to:

Short Statement: This is a new Information Collection Request.

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Annual Cost to Federal Government: $54,032

Does this IC contain surveys, censuses, or employ statistical methods? Yes Part B of Supporting Statement

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]? No

Is this ICR related to the Dodd-Frank Wall Street Reform and Consumer Protection Act, [Pub. L. 111-203]? No

Is this ICR related to the American Recovery and Reinvestment Act of 2009 (ARRA)? No

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: 02/14/2013

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