Accreditation Program for Clinical Laboratories-Follow on

Added: Feb 25, 2015 3:16 pm Modified: Mar 04, 2015 4:42 pmTrack Changes 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.

o VHA 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.

Added: Feb 25, 2015 3:16 pm COMBINED SYNOPSIS/SOLICITATION

This is a Combined Synopsis/Solicitation for Commercial Items prepared in accordance with the format in FAR Subpart 12.6 - Streamlined Procedures for Evaluation and Solicitation for commercial items, as supplemented with additional information included in this notice. This announcement constitutes the only solicitation; proposals are being requested and a written solicitation will not be issued. Solicitation number VA119-15-R-0081 is issued for this combined synopsis/solicitation; this solicitation is being issued as a Request for Proposal (RFP). This combined synopsis/solicitation incorporates provisions and clauses in effect through Federal Acquisition Circular (FAC) 05-78, dated 26 Dec 2014. The associated North American Industrial Classification System (NAICS) code for this procurement is 813920. This procurement action is unrestricted. The Department of Veterans Affairs (VA) intends to award a Firm Fixed Price contract, in accordance with FAR Part 16.202, with one (5-month) base period and four (4) one-year option periods in support of the VA Office of Pathology and Laboratory Services Office. The purpose of this contract is to fulfill a requirement that all laboratory testing undergo an onsite inspection and be accredited by a nationally-recognized Center for Medicare and Medicaid Services (CMS)-deemed accreditation body. All work shall be performed within U.S. facilities and U.S. territories.

1. Contract Line Item Numbers (CLINs) are provided in Schedule B: Price Schedule attached hereto.

2. Statement of Work is provided in Attachment 1 - Performance Work Statement with Technical Exhibit A: Lab Name, Location, Accreditation Expiration Date, CLIA Number, and Complexity Level and Technical Exhibit B for Lab Specialty/Sub-specialty with Annual Volume.

3. Additional Instructions are found in Attachment 2 - Addendum to Instructions to Offerors and Evaluation Approach

4. Clauses and Provisions are found in Attachment 3 - Contract Administration Data, Contract Clauses, and Solicitation Provisions

5. Attachment 4 - Contractor's Rules of Behavior

Proposals are due March 23, 2015 at 5:00pm Eastern time. LATE OFFERS MAY NOT BE CONSIDERED FOR EVALUATION. Please reference the solicitation number on your offer email(s).

Please submit offers by following the instructions included in Attachment 2, paragraph D. Proposal Submission.