OMB.report

Federal forms, ICRs, and supporting documents

Information Collection Request

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

ICR 201305-0920-011 · OMB 0920-0961 · Historical Active

Forms and Documents
DocumentTypeStatusAvailability
Proficiency Testing in US Clinical Laboratories: Perception, Practices and Potential for Expanded Utility Form and Instruction Modified Repair queued
Attachment 4_Crosswalk for Proposed Change to Advertisement for OMB 0920_0961.docx Supplementary Document Uploaded 2013-05-22 Repair queued
Attachment 3_Proposed advertisement for OMB 0920_0961.docx Supplementary Document Uploaded 2013-05-22 Repair queued
Attachment 2_Previous advertisement for OMB 0920_0961.docx Supplementary Document Uploaded 2013-05-22 Available
Attachment 1_Proposed change to advertisement for OMB 0920_0961 5PM.docx Justification for No Material/Nonsubstantive Change Uploaded 2013-05-22 Repair queued
Attachment J_Language used to advertise survey_2013.docx Supplementary Document Uploaded 2013-02-11 Available
Attachment I_Postcard Follow-up.pdf Supplementary Document Uploaded 2013-02-11 Available
Attachment H_Survey Invitation Letter.docx Supplementary Document Uploaded 2013-02-11 Repair queued
IC Document Collections
IC IDCollectionTypeStatusForm
205793 Proficiency Testing in US Clinical Laboratories: Perception, Practices and Potential for Expanded Utility Form and Instruction Modified
ICR Details
0920-0961 201305-0920-011
Historical Active 201302-0920-011
HHS/CDC 19666
Proficiency Testing in US Clinical Laboratories: Perception, Practices and Potential for Expanded Utility
No material or nonsubstantive change to a currently approved collection   No
Regular
Approved without change 05/30/2013
Retrieve Notice of Action (NOA) 05/28/2013
  Inventory as of this Action Requested Previously Approved
04/30/2015 04/30/2015 04/30/2015
29,840 0 29,840
9,947 0 9,947
0 0 0
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.
US Code: 42 USC 241 Name of Law: The Public Health land Welfare
  
None
Not associated with rulemaking
No
  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 29,840 0 0 0 0
Annual Time Burden (Hours) 9,947 9,947 0 0 0 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0
No
No
$54,032
Yes Part B of Supporting Statement
No
No
No
No
Uncollected
Petunia Gissendaner 4046390164
  No
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:
 
 
 
 
 
 
 
    (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;
 
 
 
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.
05/28/2013