36C10G20R0018 0001_1.docx
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- Solicitation number
- 36C10G20R0018
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| 36C10G20R0018 0002_1.docx | DOCX document | |
| 36C10G20R0018 A0002.pdf | ||
| 36C10G20R0018 Solictiation for Laboraty Accreditation Services.pdf | ||
| 36C10G20R0018_1.docx | DOCX document | |
| Technical Exhibit A 617.xlsx | XLSX spreadsheet |
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AMENDMENT 0001
SUBJECT: QUESTIONS/ANSWERS
RFP No: 36C10G20R0018 Laboratory Accreditation Services Page 22 of 22
5. PROJECT NUMBER (if applicable)
CODE
7. ADMINISTERED BY
2. AMENDMENT/MODIFICATION NUMBER
CODE
6. ISSUED BY
8. NAME AND ADDRESS OF CONTRACTOR
4. REQUISITION/PURCHASE REQ. NUMBER
3. EFFECTIVE DATE
9A. AMENDMENT OF SOLICITATION NUMBER
9B. DATED
PAGE OF PAGES
10A. MODIFICATION OF CONTRACT/ORDER NUMBER
10B. DATED
BPA NO.
1. CONTRACT ID CODE
FACILITY CODE
CODE
Offers must acknowledge receipt of this amendment prior to the hour and date specified in the solicitation or as amended, by one of the following methods:
The above numbered solicitation is amended as set forth in Item 14. The hour and date specified for receipt of Offers
E. IMPORTANT:
is extended,
(a) By completing Items 8 and 15, and returning __________ copies of the amendment; (b) By acknowledging receipt of this amendment on each copy of the offer submitted; or (c) By separate letter or electronic communication which includes a reference to the solicitation and amendment numbers. FAILURE OF YOUR ACKNOWLEDGMENT TO BE RECEIVED AT THE PLACE DESIGNATED FOR THE RECEIPT OF OFFERS PRIOR TO THE HOUR AND DATE SPECIFIED MAY is not extended.
12. ACCOUNTING AND APPROPRIATION DATA
(REV. 11/2016)
is required to sign this document and return ___________ copies to the issuing office.
is not, A. THIS CHANGE ORDER IS ISSUED PURSUANT TO: (Specify authority) THE CHANGES SET FORTH IN ITEM 14 ARE MADE IN THE CONTRACT ORDER NO. IN ITEM 10A.
15C. DATE SIGNED
B. THE ABOVE NUMBERED CONTRACT/ORDER IS MODIFIED TO REFLECT THE ADMINISTRATIVE CHANGES SET FORTH IN ITEM 14, PURSUANT TO THE AUTHORITY OF FAR 43.103(b).
RESULT IN REJECTION OF YOUR OFFER. If by virtue of this amendment you desire to change an offer already submitted, such change may be made by letter or electronic communication, provided each letter or electronic communication makes reference to the solicitation and this amendment, and is received prior to the opening hour and date specified.
C. THIS SUPPLEMENTAL AGREEMENT IS ENTERED INTO PURSUANT TO AUTHORITY OF:
D. OTHER
Contractor
16C. DATE SIGNED
14. DESCRIPTION OF AMENDMENT/MODIFICATION
16B. UNITED STATES OF AMERICA
Except as provided herein, all terms and conditions of the document referenced in Item 9A or 10A, as heretofore changed, remains unchanged and in full force and effect.
15A. NAME AND TITLE OF SIGNER
16A. NAME AND TITLE OF CONTRACTING OFFICER
15B. CONTRACTOR/OFFEROR
STANDARD FORM 30
PREVIOUS EDITION NOT USABLE
Prescribed by GSA - FAR (48 CFR) 53.243 (Type or print) (Type or print) (Organized by UCF section headings, including solicitation/contract subject matter where feasible.)
(Number, street, county, State and ZIP Code) (If other than Item 6) (Specify type of modification and authority) (such as changes in paying office, appropriation date, etc.)
(If required)
(SEE ITEM 11)
(SEE ITEM 13)
(X)
CHECK
ONE
13. THIS ITEM APPLIES ONLY TO MODIFICATIONS OF CONTRACTS/ORDERS,
IT MODIFIES THE CONTRACT/ORDER NO. AS DESCRIBED IN ITEM 14.
11. THIS ITEM ONLY APPLIES TO AMENDMENTS OF SOLICITATIONS
AMENDMENT OF SOLICITATION/MODIFICATION OF CONTRACT
(Signature of person authorized to sign) (Signature of Contracting Officer) None 36C10G U.S. Department of Veterans Affairs OPAL | Strategic Acquisition Center 10300 Spotsylvania Ave | STE 400 Fredericksburg VA 22408-2697 36C10G U.S. Department of Veterans Affairs OPAL | Strategic Acquisition Center 10300 Spotsylvania Ave | STE 400 Fredericksburg VA 22408-2697 To all Offerors/Bidders
36C10G20R0018
X X X
X The Purpose of this Amendment is to answer questions provided by the deadline for questions on the RFQ.
See the Continuation Pages for the questions and answers.
2. The other purpose is to correct the Contract administration Data section Page 29 of 83, para 3 “INVOICES” from “ Invoices shall be submitted monthly ” to “ Invoices shall be submitted quarterly
See Continuation Pages
MAURICIO VAZQUEZ
Chief, Acquisition Services Division 4A Warrant # SAC 13L3-4576 Page 1 of
| Question # |
| Section |
| Page # |
| Question / Clarification |
| Answer / Clarification |
RFQ;
SECURITY REQUIREMENTS
| Do these requirements apply only to the security of the necessary viewing of electronic protected health information (PHI) during the course of an inspection, or do these requirements also preclude the viewing of electronic standard operating procedures (SOP), policies, and other laboratory documents and records that do not contain PHI? |
| If logging into the VA network is required for electronic viewing, then it must be monitored by a VA staff member. Any electronic documentation that is on a public domain or provided to the vendor outside of the VA network and does not include PHI can be viewed without oversight. |
SECURITY REQUIREMENTS
| With the safety of both laboratory staff and inspectors in mind due to the COVID-19 pandemic, we are strongly encouraging a 2-step inspection process that includes an off-site review of electronic SOP, policies and other laboratory documents and records (as individual laboratories have these documents and records electronically available) prior to the on-site inspection to facilitate a reduced number of inspectors needed for the on-site inspection and to reduce the amount of time needed on-site. Do the security requirements listed on page 6 preclude the off-site review of laboratory documents and records that do not contain PHI from being electronically reviewed prior to the on-site portion of the inspection? |
| Electronic documentation that does not contain PHI including records like SOP, policies and other documents can be provided through email or fax to the contractor in advance of an on-site visit. |
| Question # |
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| Question / Clarification |
| Answer / Clarification |
PLACE OF PAST PERFORMANCE
This includes the phrase “and at the Contractor facilities”. Is the reference to contractor facilities referring to activities such as continuous monitoring and post inspection review? If not, please elaborate on the meaning of the reference.
Yes, since work will be needed in addition to the on-site inspections these activities are expected to take place at the contractor facilities.
section 2.12
SUB-CONTRACTOR
| For the statement requiring Contractor recognition of the AABB and the American Society of Histocompatibility and Immunogenetics, how does the VHA define “recognition” of the subcontractors, and how does the VHA envision orchestration of such recognition? |
| There is no expectation that the contractor has responsibility for other entity accreditations but will acknowledge other entity accreditation decisions and communicate accreditation issues within the scope of the other entity’s purview. |
SEE NEXT PAGE FOR CONTINUATION OF QUESTIONS/ANSWERS
| Question # |
| Section |
| Page # |
| Question / Clarification |
| Answer / Clarification |
section 2.12
SUB-CONTRACTOR
| Does the VHA envision separation of transfusion medicine and histocompatibility departments within a VHA institution by CLIA number and/or department director for accreditation decision purposes, or will the VHA require the Contractor formally recognize the other entities? |
| It is the expectation that the contractor will issue accreditation decisions for the specialties and subspecialties it monitors and inspects. AABB will be issuing accreditation decisions for transfusion medicine/histocompatibility and it is the VA’s responsibility to ensure a laboratory holds current accreditation for all areas before issuing a CLIA certificate. |
section 2.12
SUB-CONTRACTOR
We understand this to mean the Contractor will recognize the other entities accreditation but will not be responsible for their performance. Please inform us if the VHA concurs with our understanding?
Yes, there is no expectation that the contractor has responsibility for other entity accreditations.
| Question # |
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| Page # |
| Question / Clarification |
| Answer / Clarification |
4.1 PERFORMANCE / QUALITY CONTROL PLAN
| This item states “The entire plan shall be submitted at award.” Does this mean that something less than the entire plan is acceptable for the response to the RFP? If not, what is this wording intended to mean? |
| See Page 60 on page limits as it indicates |
Volume III Performance / Quality Control Plan (outline/portions)
See also page 62
VOLUME III – PERFORMANCE / QUALITY CONTROL PLAN
Section 1 – Quality
The Offeror, at a minimum, shall provide detailed information on their Performance / Quality Control Plan and provide an outline and limited portions of their plan… item 3.
INVOICES
Invoices shall be submitted monthly. Does the request for monthly invoicing apply to all activities on a monthly basis, or just the inspection activities that occur in that month?
This is an error. Invoices will be submitted quarterly after 90 days of rendered services. change is hereby incorporated into the solicitation.
| Question # |
| Section |
| Page # |
| Question / Clarification |
| Answer / Clarification |
item 3.
INVOICES
If the monthly invoicing includes continuous monitoring how will this be calculated, based on an annual basis, or a 3-month, 6- month or 9-month basis?
Invoices will be submitted quarterly after 90 days of rendered services.
item 3.
INVOICES
| What type of documentation will be required for this? |
| The accrediting decision documentation received within the 3-month billing period for high/moderate complexity on-site inspections will indicate the completion of the activity and a quarterly list of laboratories monitored within the 3-month period will also be required. |
item 3.
INVOICES
| And when would service start for the 3-, 6-, and 9-month periods? |
| When issued a task order. Orders will be issued for the 3, 6, and 9 month periods to coincide with the 12 month order / period of performance |
item 3.
INVOICES
| Is the intent of monitoring for various monthly periods to align with the annual billing? |
| Annual billing will be done quarterly after 90 days of rendered services to align with the annual period of performance. |
| Question # |
| Section |
| Page # |
| Question / Clarification |
| Answer / Clarification |
RFP;
52.216-18 ORDERING
The statement “Any supplies and services to be furnished under this contract shall be ordered by issuance of delivery orders or task orders by the individuals or activities designated in the Schedule. Such orders may be issued from through.” It appears the underlined section of this sentence is missing content?
“through the SAC only.” Orders will be issued centrally by the SAC. No other individuals or activities shall be authorized to order on this contract.
VAAR 852.219-74 LIMITATIONS ON SUBCONTRACTING MONITORING AND COMPLIANCE
| We understand that neither this clause nor FAR 52.219-4 applies to indefinite delivery contracts. Do you concur, if not, why not? |
| The Government reserves the right under VAAR 852.219-74. However, there are no known contractors under FAR 52.219-4 for any set aside for this acquisition. |
(h) MULTIPLE AWARDS
If the VHA decides to issue multiple awards, may this decision be based on a separation of activities?
No, it would be based on Laboratory complexities.
(h) MULTIPLE AWARDS
Or perhaps this is an inadvertent editing error, given the VHA’s intention to award one contract, please clarify.
The Government Reserves the right to award multiple awards
(h) MULTIPLE AWARDS
Would the VHA potentially request the contractor only supply Inspection and not include Continuous Monitoring in the contract?
No
| Question # |
| Section |
| Page # |
| Question / Clarification |
| Answer / Clarification |
(h) MULTIPLE AWARDS
If so, would the VHA provide a method of ongoing communication with the contractor to provide input into the accreditation process, such as in a case that PT monitoring identifies an issue with results that would be applicable to the laboratories next inspection?
Not Applicable; see answer to question 17.
(h) MULTIPLE AWARDS
How does the VHA envision these communications to occur during the monitoring process?
Not Applicable; see answer to question 17.
52.212-2 EVALUATION
It appears there may be a conflict in descriptions of the government’s evaluation priorities: On page 1, “The Government will award a single vendor lowest price technically acceptable indefinite delivery/indefinite quantity (ID/IQ) fixed price contract” On page 63, “Specifically, the Government may first evaluate the total proposed price of all Offerors. Thereafter, the Government will evaluate the technical capability of the proposal of the lowest priced Offeror only. If the lowest priced Offeror’s technical capability is determined to be rated as Acceptable, the Government may make award to that Offeror without further evaluation of the remaining Offerors’ technical
The award will be made to the offeror who’s technical is acceptable and who’s price is lowest. Per FAR 52.212-2 Evaluation of Commercial Items, the Government is required to provide the how technical and other factors are in relation to the price factor for all offerors to understand the importance of the factors in relation to price. You must be found technically acceptable and have the lowest price to be awarded the contract.
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20 Continued
52.212-2 EVALUATION
capabilities. If the lowest priced Offeror’s technical capability is determined to be rated as Unacceptable, then the Government may evaluate the next lowest priced technical proposal, and so forth and so on, until the Government reaches the lowest priced technical proposal that is determined to be rated as Acceptable.”
However, on page 57, the VHA indicates that “Technical and past performance, when combined, are Approximately equal to cost or price.” This appears to imply that a higher technical review result combined with past performance could outweigh price as the primary driver for selection. Please explain the apparent contradiction in evaluation criteria. In addition, please clarify whether the proposals must include a section on past performance and if so, what is the VHA seeking in this regard?
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| Answer / Clarification |
INTRODUCTION
“Contractors are encouraged to review and ensure that sufficient bandwidth is available on their end of the transmission. Finally, due to VA email file size restrictions, contractors may need to logically separate their Offer into separate emails. If this is necessary, contractors should attempt to contain a complete volume within single email transmissions (and not split volumes).” What are your system restrictions that will prevent your receipt of our submission, or prevent your ability to open our submission documents? Certain document types, specific file size limitation?
It is recommended that file sizes not exceed 20 megabits. It is recommended that zip files not be used or limited due to version limitations. If zip files are used there should be a list of documents identified in the email on what documents are contained in the zip file in order to verify all documents have been received.
RFP ;
Volume V.
“a. Contract Administration Data–Acknowledgement of Amendments, if any.” What is this intended to cover?
Any amendments that are issued during the open timeframe of the combined synopsis solicitation. Further instructions shall be provided upon issuance of any amendment.
| Question # |
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| Question / Clarification |
| Answer / Clarification |
RFP
4. PRICE EVALUATION APPROACH
64-65 Is the purpose of having multiple Continuous Monitoring periods (3, 6, and 9 months) to enable the addition and or deletion of laboratories and to charge applicable fees? If not, please elaborate on the need for the multiple Continuous Monitoring periods identified.
Yes
RFP
Need for a non-routine inspection or re-inspection due
| If the VHA decides to issue multiple awards, may this decision be based on a separation of activities? Or perhaps this is an inadvertent editing error, given the VHA’s intention to award one contract, please clarify. |
| Non-routine or re-inspections at the VA request would be billable using the established costs of the high or moderates on-site inspection line items but follow-up inspections due to accreditation recommendations should be included in the high/moderate on-site inspection estimates. |
| Question # |
| Section |
| Page # |
| Question / Clarification |
| Answer / Clarification |
CONTRACTOR ACCREDITATION TERMS
CONTRACTOR ACCREDITATION TERMS. The Contractor Terms of Accreditation require the laboratory director to sign off to indicate a clear understanding and acknowledgement of associated requirements of the accreditation program. As long as the Contractor Terms of Accreditation requiring laboratory director signature adhere to the VHA applicable requirements outlined in the PWS, we believe it would be best for the VHA allow the contractor the ability to have the lab director sign off and acknowledge the Contractor Terms of Accreditation to insure understanding and compliance to associated requirements.
Any documentation provided to laboratories that the contractor wants signed must be reviewed by the Contracting Officer and COR before distributing to laboratories to ensure that the wording coincides/is in accordance with the terms and conditions of the contract.
///////////////////////////////////////////////LAST LINE / END OF DOCUMENT////////////////////////////////////////////////
The Purpose of this Amendment is to answer questions provided by the deadline for questions on the RFQ.
Contract Opportunity Amendment to a Previous Combined Solicitation
PRODUCT SERVICE CODE
SUBJECT
CONTRACTING OFFICE'S
ZIP-CODE
SOLICITATION NUMBER
BASE NOTICE TYPE
RESPONSE DATE/TIME/ZONE
ARCHIVE
DAYS AFTER THE RESPONSE DATE
RECOVERY ACT FUNDS
SET-ASIDE
NAICS CODE
CONTRACTING OFFICE
ADDRESS
POINT OF CONTACT
(POC Information Automatically Filled from User Profile Unless Entered)
DESCRIPTION
See Attachment
AGENCY'S URL
URL DESCRIPTION
AGENCY CONTACT'S EMAIL
ADDRESS
EMAIL DESCRIPTION
ADDRESS
POSTAL CODE
COUNTRY
ADDITIONAL INFORMATION
GENERAL INFORMATION
PLACE OF PERFORMANCE
* = Required Field Contract Opportunity Amendment to a Previous Combined Solicitation R420 Laboratory Accreditation Services (VA-20-00048095) 22408-2697 36C10G20R0018 07-16-2020 14:00
EASTERN TIME, NEW YORK, USA
N 813920 U.S. Department of Veterans Affairs OPAL | Strategic Acquisition Center 10300 Spotsylvania Ave | STE 400 Fredericksburg VA 22408-2697 Contract Specialist Matthew Cron Matthew.Cron@va.gov (240)215-0588 https://www.va.gov/Opal VA | Strategic Acquisition Center
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