DOCUMENT
Q -- Amendment 0001 Accreditation Program for Clinical Laboratories-Follow on - Attachment
- Notice Date
- 3/4/2015
- Notice Type
- Attachment
- NAICS
- 813920
— Professional Organizations
- Contracting Office
- U.S. Department of Veterans Affairs;Strategic Acquisition Center;10300 Spotsylvania Ave;Suite 400;Fredericksburg VA 22408
- ZIP Code
- 22408
- Solicitation Number
- VA11915R0081
- Response Due
- 3/23/2015
- Archive Date
- 5/22/2015
- Point of Contact
- debbie.frankovich@va.gov
- E-Mail Address
-
debbie.frankovich@va.gov
(debbie.frankovich@va.gov)
- Small Business Set-Aside
- N/A
- Description
- Amendment 0001 Accreditation of Laboratories, Request for Proposal (RFQ) VA119-15-R-0081 Response to Industry Questions Below is the list of questions submitted in response to the Accreditation of Laboratories RFQ as of 03 March 2015 and the corresponding Government responses. Q1: The Exhibit B that is attached does not have the Laboratory Specialty/subspecialty and annual volumes as indicated in the PWS section 1.4, it looks like the list of VA's in Alaska and Alabama. A1: The Technical Exhibit B posted as Attachment "VA119-15-R-0081-004" is an Excerpt of the full version. The file indicates that interested vendors must "Contact the Contracting Officer for detailed information." Vendors can request a copy of the full version of Technical Exhibit B by submitting an email to the following POC: Debbie Frankovich at Debbie.frankovich@va.gov. Q2: Regarding the statement in 1.2 Background of the PWS bullet point 1 " Maintaining laboratory accreditation is directed by: o Veterans Health Administration (VHA) Handbook 1100.16 which establishes policy and responsibilities in obtaining and retaining The Joint Commission (TJC) accreditation. oVHA Handbook 1106.01 which establishes policy and responsibilities for Pathology and Laboratory Medicine Services (P&LMS)" The highlighted text refers to obtaining The Joint Commission accreditation. Does this refer to Hospital accreditation or Laboratory accreditation? If this refers to laboratory accreditation reference to TJC should be removed A2: The Joint Commission (TJC) holds the national hospital accreditation contract for the Veterans Health Administration (VHA). That agreement requires that all VA laboratories obtain laboratory accreditation using a source with whom TJC has a Comparative Agreement. Q3: Has a contractor performed similar work to this for the government in the past? If available, please provide the incumbent contract number. A3: Yes, The College of American Pathologist is the incumbent for this requirement Contract No. VA101(049A3)-P-0320. Q4: Please define what is meant by a comparative agreement (PWS 6.5). A4: TJC holds the national hospital accreditation contract for VHA. That agreement requires that all VA laboratories obtain laboratory accreditation using a source with whom TJC has a Comparative Agreement. Additional information regarding TJCs Comparative Agreement may be found on The Joint Commission's website: http://www.jointcommission.org/facts_about_the_cooperative_accreditation_initiative/ Q5: If this contract is awarded to a new accrediting body, how soon must an accrediting decision be rendered by the new contractor for those facilities with upcoming expiration dates in May and June? A5: If this contract is awarded to a new accrediting body, an accrediting decision must be rendered by the new contractor in accordance with technical capability provided in their proposal for facilities with upcoming expiration dates in May and June. Reference PWS 4.1.6 and 4.1.7.B.i Q6: PWS 1.4 Scope-The total number of sites expected to change is not more than 10%. a.Would the government require projected pricing (in this offer) for the potential increased number of sites? A6a: No, the Government does not require projected pricing for the potential increase. b.Would this fixed fee contract allow for a modification to any additional sites? A6b: Yes, a modification will be required if additional sites need to be added to the contract. Q7: Would the government be able to provide the quantity and number of specialty and sub-specialty locations? A7: Yes. A detailed version (VA sensitive data) of Exhibit B will be provided by VA contracting office upon offeror's request. Q8: Will waived testing locations be included in the laboratory survey? A8: Waived testing location(s) shall be included in the laboratory survey if the waived testing location is identified as section of the surveyed laboratory and that information is provided to the contractor prior to the laboratory survey. Q9: As directed in document VA119-15-R-0081-004, we request the following detailed information for each laboratory subject to the RFP: a. CLIA Specialty i. Laboratory testing specialty and subspecialties (as defined by CMS) Ai: A detailed version (VA sensitive data) of Exhibit B will be provided by VA contracting office upon offeror request. ii. Annual test volume A: A detailed version (VA sensitive data) of Exhibit B will be provided by VA contracting office upon offeror request. b. CLSI Standard Ab: CLSI Standards are not intentionally cited in the PWS. Due to public law, the VHA does not fall under the authority of CMS, but instead has established the VA National Enforcement Office to manage and oversee testing within the VHA. Therefore in some areas the VHA has established their own testing categorization/terminology and identification of testing and testing specialties is not always consistent with the CMS defined specialties. (i.e., the VA identifies the testing classification of point of care or ancillary testing) The test categorization information provided in the PWS and on the Exhibits was obtained from the VHA databases according to established processes the VHA has for collection, storing, and utilizing data. In order to provide clarification on the terminology utilized, VA has referenced general terminology commonly found in CLSI literature. c. Good Laboratory Practices Ac: Good Laboratory Practices are not intentionally cited in the PWS. Due to public law, the VHA does not fall under the authority of CMS, but instead has established the VA National Enforcement Office to manage and oversee testing within the VHA. Therefore in some areas the VHA has established their own testing categorization/terminology and identification of testing and testing specialties is not always consistent with the CMS defined specialties. (i.e., the VA identifies the testing classification of point of care or ancillary testing). The test categorization information provided in the PWS and on the Exhibits was obtained from the VHA databases according to established processes the VHA has for collection, storing, and utilizing data. In order to provide clarification on the terminology utilized, VA has referenced general terminology commonly found in good laboratory practice literature. Q10: The VA website lists over 700 CBOCs; the RFP lists approximately 120 CBOCs. Would you explain the difference? Are the 580 CBOCs not listed in the RFP not performing testing? A10. All CBOCs do not require laboratory accreditation/inspection under this requirement. Exhibits A and B provide a current listing of all CBOCs requiring laboratory accreditation/inspection under this requirement.
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- File Name: VA119-15-R-0081 VA119-15-R-0081_1.docx (https://www.vendorportal.ecms.va.gov/FBODocumentServer/DocumentServer.aspx?DocumentId=1898693&FileName=VA119-15-R-0081-008.docx)
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- File Name: VA119-15-R-0081 VA119-15-R-0081_1.docx (https://www.vendorportal.ecms.va.gov/FBODocumentServer/DocumentServer.aspx?DocumentId=1898693&FileName=VA119-15-R-0081-008.docx)
- Record
- SN03658140-W 20150306/150304234717-148570916874dd53f110ba34b22236ed (fbodaily.com)
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