36C25720Q1295_1.docx

36C25720Q1295

PAGE 1 OF

1. REQUISITION NO.

2. CONTRACT NO.

3. AWARD/EFFECTIVE DATE

4. ORDER NO.

5. SOLICITATION NUMBER

6. SOLICITATION ISSUE DATE

a. NAME

b. TELEPHONE NO. (No Collect Calls)

8. OFFER DUE DATE/LOCAL

TIME

9. ISSUED BY

CODE

10. THIS ACQUISITION IS

UNRESTRICTED OR

SET ASIDE:

% FOR:

SMALL BUSINESS

HUBZONE SMALL

BUSINESS

SERVICE-DISABLED

VETERAN-OWNED

SMALL BUSINESS

WOMEN-OWNED SMALL BUSINESS

(WOSB) ELIGIBLE UNDER THE WOMEN-OWNED

SMALL BUSINESS PROGRAM

EDWOSB

8(A)

NAICS:

SIZE STANDARD:

11. DELIVERY FOR FOB DESTINA-

TION UNLESS BLOCK IS

MARKED

SEE SCHEDULE

12. DISCOUNT TERMS

13a. THIS CONTRACT IS A

RATED ORDER UNDER

DPAS (15 CFR 700)

13b. RATING

14. METHOD OF SOLICITATION

RFQ

IFB

RFP

15. DELIVER TO

CODE

16. ADMINISTERED BY

CODE

17a. CONTRACTOR/OFFEROR

CODE

FACILITY CODE

18a. PAYMENT WILL BE MADE BY

CODE

TELEPHONE NO.

DUNS:

DUNS+4:

PHONE:

FAX:

17b. CHECK IF REMITTANCE IS DIFFERENT AND PUT SUCH ADDRESS IN OFFER 18b. SUBMIT INVOICES TO ADDRESS SHOWN IN BLOCK 18a UNLESS BLOCK BELOW IS CHECKED

SEE ADDENDUM

19.

20.

21.

22.

23.

24.

ITEM NO.

SCHEDULE OF SUPPLIES/SERVICES

QUANTITY

UNIT

UNIT PRICE

AMOUNT

(Use Reverse and/or Attach Additional Sheets as Necessary)

25. ACCOUNTING AND APPROPRIATION DATA

26. TOTAL AWARD AMOUNT (For Govt. Use Only) 27a. SOLICITATION INCORPORATES BY REFERENCE FAR 52.212-1, 52.212-4. FAR 52.212-3 AND 52.212-5 ARE ATTACHED. ADDENDA

ARE

ARE NOT ATTACHED.

27b. CONTRACT/PURCHASE ORDER INCORPORATES BY REFERENCE FAR 52.212-4. FAR 52.212-5 IS ATTACHED. ADDENDA

ARE

ARE NOT ATTACHED

28. CONTRACTOR IS REQUIRED TO SIGN THIS DOCUMENT AND RETURN _______________

29. AWARD OF CONTRACT: REF. ___________________________________ OFFER

COPIES TO ISSUING OFFICE. CONTRACTOR AGREES TO FURNISH AND

DATED ________________________________. YOUR OFFER ON SOLICITATION

DELIVER ALL ITEMS SET FORTH OR OTHERWISE IDENTIFIED ABOVE AND ON ANY

(BLOCK 5), INCLUDING ANY ADDITIONS OR CHANGES WHICH ARE

ADDITIONAL SHEETS SUBJECT TO THE TERMS AND CONDITIONS SPECIFIED

SET FORTH HEREIN IS ACCEPTED AS TO ITEMS:

30a. SIGNATURE OF OFFEROR/CONTRACTOR 31a. UNITED STATES OF AMERICA (SIGNATURE OF CONTRACTING OFFICER) 30b. NAME AND TITLE OF SIGNER (TYPE OR PRINT) 30c. DATE SIGNED 31b. NAME OF CONTRACTING OFFICER (TYPE OR PRINT) 31c. DATE SIGNED

AUTHORIZED FOR LOCAL REPRODUCTION

(REV. 2/2012)

PREVIOUS EDITION IS NOT USABLE

Prescribed by GSA - FAR (48 CFR) 53.212

7. FOR SOLICITATION

INFORMATION CALL:

STANDARD FORM 1449

OFFEROR TO COMPLETE BLOCKS 12, 17, 23, 24, & 30

SOLICITATION/CONTRACT/ORDER FOR COMMERCIAL ITEMS

671-21-1-121-0030 36C25720Q1295 09-01-2020 Ronalda Ohio 210-694-6245 09-11-2020

2:00 PM

00504 00504 Department of Veterans Affairs Contracting Section 7201 I-40 West Suite 100 Amarillo

TX

79106 X 813920 $16.5 Million N/A X Department of Veterans Affairs PLMS Section 7400 Merton Minter Blvd San Antonio

TX

78229 00504 Department of Veterans Affairs Contracting Section 7201 I-40 West Suite 100 Amarillo

TX

79106

This is accomplished through the Tungsten Network located at:

http:www.fsc.va.gov/einvoice.asp This is mandatory and the sole method for submitting invoices

TX

(877) 353-9791

(512) 460-5540 See CONTINUATION Page See Section B for Statement of Work and Price/Cost Schedule.

**NOTE: All questions must be submitted in writing to the Contracting Officer Ronalda Ohio at ronalda.ohio@va.gov by COB September 8, 2020.

See the provision at 52.212-2 for evaluation criteria. The attached pricing sheet must be completed and returned with proposals. Should offerors wish to include different prices for option years, separate price lists should be included with proposals.

See CONTINUATION Page X X X Contracting Officer Table of Contents

SECTION B - CONTINUATION OF SF 1449 BLOCKS

B.1 CONTRACT ADMINISTRATION DATA

1. Contract Administration: All contract administration matters will be handled by the following individuals:

a. CONTRACTOR:

b. GOVERNMENT: Contracting Officer 36C257 00504 Department of Veterans Affairs Contracting Section 7201 I-40 West Suite 100 Amarillo TX 79106

2. CONTRACTOR REMITTANCE ADDRESS: All payments by the Government to the contractor will be made in accordance with:

3. INVOICES: Invoices shall be submitted in arrears:

4. GOVERNMENT INVOICE ADDRESS: All Invoices from the contractor shall be submitted electronically in accordance with VAAR Clause 852.232-72 Electronic Submission of Payment Requests.

This is accomplished through the Tungsten Network located at:

http:www.fsc.va.gov/einvoice.asp This is mandatory and the sole method for submitting invoices TX ACKNOWLEDGMENT OF AMENDMENTS: The offeror acknowledges receipt of amendments to the Solicitation numbered and dated as follows:

Statement of Work Pathology and Laboratory Accreditation

Section 1. SCOPE OF WORK:

This is a requirement for non-personal services to provide Accreditation of Laboratory Services for all CLIA (Clinical Laboratories Improvement Amendment) certified, and FDA defined complexity levels (high, moderate, waived) testing sites identified for the STVHCS.

All testing sites that perform laboratory tests for patient care within the VHA must be in compliance with CFR Part 493 and must maintain accreditation by a nationally recognized, a VA designated laboratory accrediting agency/program with deemed status fromn the Center for Medicare and Medicaid Services (CMS).

1.1 Description of Services/Introduction:

The Contractor shall provide all personnel, equipment, supplies, facilities, transportation, tools, materials, and other items and non-personal necessary to perform Accreditation of Laboratory Services as defined in this Statement of Work (SOW).

The Contractor must be identified by Centers for Medicare and Medicaid Services (CMS) as an accrediting agency under the Clinical Laboratories Improvement Amendment (CLIA) and identified by The Joint Commission (TJC) as having a comparative agreement pursuant to the Cooperative Accreditation Initiative.

The laboratory accreditation process is a complex system of related and dependent activities. It includes pre-inspection/review activities (e.g., on-site inspection/reviews, inspection/review notification to Laboratory Director/Chief and VA National Enforcement Office (NEO) Representative, inspection/review validation/notification process); post-inspection/review report(s) in an exportable format (access compatible); data measurement, complaint management program and reporting requirements and data submissions.

Maintaining laboratory accreditation is directed by:

Veterans’ Health Administration (VHA) Handbook 1100.16 which establishes policy and responsibilities in obtaining and retaining The Join Commission (TJC) accreditation.

VHA Handbook 1106.01 which establishes policy and responsibilities for Pathology and Laboratory Medicine Service (P&LMS).

1.2 Objectives: The objective of this requirement is to supply accreditation services for specified STVHCS clinical laboratories and community-based outpatient centers (CBOCs). Maintaining laboratory accreditation is consistent with one of Pathology and Laboratory Medicine Services (P&LMS) strategies under quality improvement. Laboratory accreditation confers recognition that a laboratory meets firm standards of quality and safety and confers deemed compliance with healthcare quality standards of payors, both public (e.g., Medicare) and commercial.

Annual Lab Accreditation

1.2 Scope:

This requirement includes inspection, quality assessment and laboratory accreditation services for all FDA defined complexity levels (high, moderate, waived), at specified STVHCS VHA laboratories and CBOCs, where patient testing is performed. Specialties/subspecialties (in language/terms reference on CMS, Clinical and Laboratory Standards Institute (CLSI), and Good Laboratory Practices (GLP) public websites) that fall under this requirement include:

· Specialties – Chemistry, Hematology, Immunohematology (Blood Bank), Microbiology, Anatomic Pathology, Point-of-Care Testing,

· Subspecialties – Transfusion Medicine, Toxicology, Coagulation, Immunology, Urinalysis, Histology, Cytopathology, Molecular Pathology, Bacteriology, Blood Gas, Cytology, Histopathology, General Immunology, Immunochemistry, Molecular Microbiology, Mycobacteriology, Mycology, Point-of-Care Testing, Routine Chemistry, Syphilis Serology

· Quality Oversight – Lab General, Team Leader Assessment of Director & Quality, All Common, Safety, Specimen Collection, Laboratory Computer Services, Environment, Communications, Laboratory Director Responsibilities; Quality Improvement, Complaint Review, and Autopsy

Technical Requirements:

In the performance of the tasks associated with the Statement of work (SOW), the Contractor must comply with the following:

· Contractor must be able to meet all requirement listed in the Statement of Work (SOW).

· This inspection must include the following: quality assessment and laboratory accreditation services for the defined FDA complexity levels (high), at specified VHA laboratories and CBOCs, where patient testing is performed. Specialties/subspecialties (in language/terms referenced on CMS, Clinical and Laboratory Standards Institute (CLSI), and Good Laboratory Practice (GLP) public websites). Must provide inspection teams that are specialized in that discipline and accreditation checklists for the following specialties:

· Specialties – Chemistry, Clinical Cytogenetics, Diagnostic Immunology, Hematology, Histocompatibility, Immunohematology, Microbiology, Pathology, and Radio bioassay, Blood Bank

· Subspecialties - Bacteriology, Blood Gas, Coagulation, Cytology, Donor Specimen, Endocrinology, Flow Cytometry, General Immunology, Genetic testing, Hematology, Histocompatibility, Histopathology, Electron Microscopy, Immunohematology, Immunohistochemistry, Molecular Biology, Molecular Microbiology, Mycobacteriology, Mycology, Oral Pathology, Parasitology, Point of Care Testing, Routine (Chemistry), Syphilis Serology, Toxicology, Urinalysis, and Virology

· Quality Oversight -Safety, Specimen Collection, Laboratory Computer Services, Telepathology, Environment, Communications, Laboratory Director Responsibilities; Quality Improvement, Complaint Review, and Autopsy

· The contractor must be able to offer a coordinated American Association of Blood Banks (AABB) Inspection.

· The accreditation programs accreditation standards must be translated into a detailed checklist requirement. Checklists may be downloaded in three different electronic formats:

· 1. PDF

· 2. Word/XML

· 3. Excel – provides a useful tool for cross-referencing a laboratory’s own policies and procedures with checklist requirements

· The accreditation program must have inspection teams use the checklists as a guide to assess the laboratory's overall management and operation.

· The inspection shall consist of the following:

· The inspection team leader must be a board-certified pathologist who has received training and has participated in several inspections as a team member.

· Inspection team members are other pathologists, doctoral scientists, supervisory-level medical technologists, pathology residents and fellows, and other individuals who have been trained in inspection requirements and have expertise in the area of the laboratory that they inspect.

· Inspectors must examine at minimum: preanalytic, analytic, and post analytic aspects of quality management (QM) in the laboratory, performance and monitoring of general quality control (QC); test methodologies and specifications; reagents, controls, and media; equipment; specimen handling, test reporting and internal performance assessment; and external proficiency testing. In addition, personnel requirements, safety, document management, and other administrative practices must be included in the inspection process.

· The inspection must be onsite and offered as follows:

· Initial Inspection, Quality Assessment, and Laboratory Accreditation services Contractor provided Accreditation support services with quality oversight program/standards for any new VHA laboratory or any VHA laboratory whose complexity increases from waived to non-waived during the contract Period of Performance. This service includes one on-site inspection (which may be announced and must occur within 6 months of government request) followed by written notification of contractor decision to accredit or deny accreditation (which must be provided to the government no more than 90 calendar days from date of on-site inspection).

· On Cycle Inspection, Quality Assessment, and Laboratory Accreditation services: Contractor provided Accreditation support services with quality oversight program/standards for VHA laboratories whose current accreditation expires during the contract Period of Performance. This service includes one unannounced on-site inspection (which must occur prior to current expiration date) followed by written notification of contractor decision to reaccredit or revoke accreditation (which must be provided to the Government no more than 90 calendar days from date of on-site inspection).

· Out of Cycle Inspection, Quality Assessment, and Laboratory Accreditation services: Contractor provided Accreditation support services with quality oversight program/standards for VHA laboratories identified as requiring additional on-site inspection(s) during the contract Period of Performance. This service includes one on-site inspection, in addition to a routine on-cycle inspection, (which may be announced and must occur within 6 months of government request or date mutually agreed upon between contractor and COR/STVHCS P&LMS liaison) followed by written notification of contractor decision to (re)accredit, revoke, or deny accreditation (which must be provided to the government no more than 90 calendar days from date of on-site inspection).

· Contractor must offer a detailed inspection report of findings and offer a Summary Conference to review any deficiencies or concerns.

· Contractor must offer Post Inspection follow up and guidance on any deficiencies or concerns.

· Contractor must provide a clear guideline of how to maintain Accreditation with their program.

1.4 Period of Performance: The period of performance shall be for one (1) base period with four (4) Option Years.

1.5 Recognized Holidays: The contractor is not required to perform services on the following Federal Holidays:

1.6 Hours of Operation: The Contractor is responsible for conducting business between the hours of 07:30 – 4:00 (ET - standard local time for the facility being accredited), Monday thru Friday, except Federal Holidays or when the Government facility is closed due to local or national emergencies, administrative closings, or similar Government directed facility closings.

1.7 Place of Performance: The work to be performed under the resulting contract will be performed at VHA facilities requiring accreditation as set forth on Technical Exhibit A and at the contractor facilities.

Complexity testing is determined by the needs of each site and can change. During this contract’s period of performance, the total number of inspections, quality assessments, and laboratory accreditation sites is not expected to change more than 10%, as long as the facilities needs comply with the testing complexity defined by the FDA.

1.8 Type of Contract: The government will award a Firm Fixed Price Contract.

1.9 Physical Security: The Contractor shall be responsible for safeguarding any government equipment, information and property provided for contractor use.

1.10 Post Award Conference/Periodic Progress Meetings: The Contractor agrees to attend any post award conference convened by the contracting activity or contract administration office in accordance with Federal Acquisition Regulation Subpart 42.5.

1.11 Contracting Officer Representative (COR): The (COR) will be identified by separate letter. The COR monitors all technical aspects of the contract and assists in contract administration. The COR is authorized to perform the following functions: ensure that the Contractor performs the technical requirements of the contract: perform inspections necessary in connection with contract performance: maintain written and oral communications with the Contractor concerning technical aspects of the contract: issue written interpretations of technical requirements, including Government drawings, designs, specifications: monitor Contractor's performance and notifies both the Contracting Officer and Contractor of any deficiencies; coordinate availability of government furnished property, and provide site entry of Contractor personnel. A letter of designation issued to the COR, a copy of which is sent to the Contractor, states the responsibilities and limitations of the COR, especially with regard to changes in cost or price, estimates or changes in delivery dates. The COR is not authorized to change any of the terms and conditions of the resulting order.

1.12 Identification of Contractor Employees: All contract personnel attending meetings, answering Government telephones, and working in other situations where their contractor status is not obvious to third parties are required to identify themselves as such to avoid creating an impression in the minds of members of the public that they are Government officials. They must also ensure that all documents or reports produced by contractors are suitably marked as contractor products or that contractor participation is appropriately disclosed. All contractor employees will wear name badges identifying them as employees of the contractor.

1.13 Contractor Travel: The Government anticipates travel to perform the tasks associated with the effort, as well as to attend an annual program-related conference or provide training for Auditors during the period of performance. Include all estimated travel costs in your firm-fixed price line items.

1.14 Organizational Conflict of Interest: Contractor personnel performing work under this requirement may receive, have access to, or participate in the development of proprietary or source selection information (e.g., cost or pricing information, budget information or analyses, specifications or work statements, etc.) or perform evaluation services which may create a current or subsequent Organizational Conflict of Interests (OCI) as defined in FAR Subpart 9.5. The Contractor shall notify the Contracting Officer immediately whenever it becomes aware that such access or participation may result in any actual or potential OCI and shall promptly submit a plan to the Contracting Officer to avoid or mitigate any such OCI. The Contractor’s mitigation plan will be determined to be acceptable solely at the discretion of the Contracting Officer and in the event the Contracting Officer unilaterally determines that any such OCI cannot be satisfactorily avoided or mitigated, the Contracting Officer may affect other remedies as he or she deems necessary, including prohibiting the Contractor from participation in subsequent contracted requirements which may be affected by the OCI.

Section 2 Description of Duties.

The Contractor shall when needed:

2.1 Provide Laboratory Accreditation Program Services. The program shall include supporting services and a contractor developed quality oversight program or contractor CAP Annual Lab Accreditation.

A. Supporting Services shall include:

i. A contact for contractor who shall have ability to act for the contractor (i.e., resolve disputes, sign documents, etc.) on all matters relating to this contract which includes overseeing the performance of the contract. The name and contact information shall be designated in writing to the Contracting Officer and COR. Contact shall be available during normal business hours.

ii. Providing a method for VHA general laboratory staff to receive live (not automated) technical support and/or customer service from the contractor, during normal business hours.

iii. Providing a method for VHA general laboratory staff to access/obtain contractor-published laboratory accreditation material, documents, forms, educational opportunities during and outside of normal business hours.

iv. Providing a method for the contractor to notify the laboratory director/manager, regional medical technologists in writing (mailed or electronic) if any new standards, revised, or updated accreditation information become available.

v. Providing an electronic method (i.e., secure website, fax, email) for receipt of VA furnished correspondence.

B. Quality Oversight/Quality Standards shall include:

i. Processes equivalent to those submitted to and approved by CMS for which contractor obtained laboratory accreditation "granting" authority.

ii. Hard (non-electronic) master copies of laboratory accreditation material provided by the contractor and electronic master copies in Microsoft Word compatible format.

iii. Standardized written document identifying any deficient finding for any (identified) standard or requirement for all on-site inspections.

iv. Standardized documents serving as written notification of contractor's decision to accredit (a laboratory). The document must identify, at minimum, the laboratory's name and address, the contractor's assigned laboratory identifier, and the laboratory's accreditation expiration date.

v. Standardized written formats (for VHA specialties/subspecialties) for laboratory accreditation materials provided by the contractor. This includes language used and general/common laboratory requirements (i.e., safety, laboratory automation and informatics, quality management, method evaluation, personnel, equipment).

vi. Method to obtain and resolve concerns initiated by STVHCS general laboratory staff regarding quality of services performed by the contractor and/or quality of services/testing performed in any specialty/subspecialty of the laboratory where patient testing is performed during the period of performance.

vii. Method for providing electronic deliverables.

viii. Process to maintain, query, analyze, and/or generate reports for any work performed or any (facility) information/data furnished by the government under this requirement.

2.2. Perform ON CYCLE INSPECTION, QUALITY ASSESSMENT, AND LABORATORY ACCREDITATION SERVICES, prior to the accreditation expiration date provided by the Government (current listing provided in Technical Exhibit B) utilizing INSPECTION TEAM assembled in accordance with established criteria.

2.3. Provide a transition plan sufficient to provide continuous accreditation and service and to ensure all laboratories are inspected for accreditation prior to their current accreditation expiration date. The plan must include a transition process for immediate remediation in the even a laboratory may have been identified as an at-risk laboratory during the transition.

Section 3: OPERATING CONSTRAINTS.

3.1. The contractor shall have a Business Associate Agreement (BAA) with VHA.

3.2. The Contractor shall allow each VA facility to select 10 avoid dates in addition to those mandated by federal law such as holidays.

3.3. Scheduling of an inspections/reviews shall avoid all Federal holidays, including Veterans Day.

3.4. The Contractor shall have no access to the VA computer network.

3.5 The Contractor shall be identified by Centers for Medicare and Medicaid Services (CMS) as an accrediting agency under the Clinical Laboratories Improvement Amendment (CLIA) and identified by The Joint Commission (TJC) as having a comparative agreement pursuant to the Cooperative Accreditation Initiative.

3.6 Definitions:

3.6.1. On Cycle Inspection, Quality Assessment, and Laboratory Accreditation services: Contractor provided Accreditation support services with quality oversight program/standards for VHA laboratories whose current accreditation expires during the contract Period of Performance. This service includes one unannounced on-site inspection (which must occur prior to current expiration date) followed by written notification of contractor decision to reaccredit or revoke accreditation (which must be provided to the Government no more than 90 calendar days from date of on-site inspection).

3.6.2. Out of Cycle Inspection, Quality Assessment, and Laboratory Accreditation services: Contractor provided Accreditation support services with quality oversight program/standards for VHA laboratories identified as requiring additional on-site inspection(s) during the contract Period of Performance. This service includes one on-site inspection, in addition to a routine on-cycle inspection, (which may be announced and must occur within 6 months of government request or date mutually agreed upon between contractor and COR/STVHCS P&LMS liaison) followed by written notification of contractor decision to (re)accredit, revoke, or deny accreditation (which must be provided to the government no more than 90 calendar days from date of on-site inspection).

3.6.3 Initial Inspection, Quality Assessment, and Laboratory Accreditation services Contractor provided Accreditation support services with quality oversight program/standards for any new VHA laboratory or any VHA laboratory whose complexity increases from waived to non-waived during the contract Period of Performance. This service includes one on-site inspection (which may be announced and must occur within 6 months of government request) followed by written notification of contractor decision to accredit or deny accreditation (which must be provided to the government no more than 90 calendar days from date of on-site inspection).

3.6.4 ON-SITE INSPECTION. A physical review of laboratory practices performed by the contractor’s inspection team.

3.6.6 CONTRACTOR. A supplier or vendor awarded a contract to provide specific supplies or service to the government. The term used in this contract refers to the prime contractor.

3.6.7. CONTRACTING OFFICER. A person with authority to enter into, administer, and or terminate contracts, and make related determinations and findings on behalf of the government. Note: The only individual who can legally bind the government. See Federal Acquisition Regulation 2.101(b).

3.6.8. CONTRACTING OFFICER'S REPRESENTATIVE (COR). An employee of the U.S. Government appointed by the contracting officer to administer the contract. Such appointment shall be in writing and shall state the scope of authority and limitations. This individual has authority to provide technical direction to the Contractor as long as that direction is within the scope of the contract, does not constitute a change, and has no funding implications. This individual does NOT have authority to change the terms and conditions of the contract. See Federal Acquisition Regulation 2.101(b).

3.6.9. DELIVERABLE. Anything that can be physically or electronically delivered. Deliverables that are not separately priced (NSP) shall be included shall be included in the Laboratory Accreditation service cost. Deliverables shall be shipped Freight of Board (FOB) destination.

3.6.10. INSPECTION TEAM. A group used by the contractor to perform on-site inspections. Must include a licensed pathologist certified by the American Board of Pathology for 1) all Veteran Affair Medical Centers “VAMC” and 2) all testing sites performing Anatomic Pathology services. All inspection team personnel shall meet one of the following criteria and be verified by the contractor. Documentation of evaluation of inspection team members shall be provided to PLMS upon request.

· Currently performing patient testing duties in an accredited laboratory that provides services in the specialties/subspecialties they inspect; or

· Board certified by a nationally recognized organization for the specialties/subspecialties they inspect and have a minimum of 1-year previous working experience in an accredited laboratory that provided services in the specialties/subspecialties; or

· Meet CLIA test personnel requirements for the specialties/subspecialties they inspect and have a minimum of 3 years previous working experience in an accredited laboratory that provided services in the specialties/subspecialties; or

· Have a minimum of 5 years of experience providing inspection, quality assessment, and laboratory accreditation services for a CMS approved accrediting organization that provides inspection, quality assessment, and laboratory accreditation services in the specialties/subspecialties they inspect

3.6.11 NORMAL BUSINESS HOURS: 8:00 AM to 5:00 PM EST Monday through Friday, except on Federal Holidays.

3.6.12. INSPECTOR TRAINING. Training provided to government staff, by the contractor, that is consistent with training provided to contractor’s inspectors, as evidenced by contractor generated inspector training certificate or letter. Training shall occur at the contractor’s facility, the trainee’s duty location, or electronically (i.e., web-based training module). Contractor shall provide successful trainees documented evidence of contractor’s certification for laboratory accreditation inspector training within 30 days of completing training.

3.6.13. QUALITY ASSURANCE. The government procedures to verify that services being performed by the Contractor are performed according to acceptable standards.

3.6.14. QUALITY CONTROL PLAN. All necessary measures taken by the Contractor to ensure that the quality of an end product or service shall meet contract requirements.

3.6.15. SUBCONTRACTOR. One that enters into a contract with a prime contractor. The Government does not have privity of contract with the subcontractor.

3.6.16. WORKDAY. The number of hours per day the Contractor provides services in accordance with the contract.

3.6.17. WORK WEEK. Monday through Friday, unless specified otherwise.

Section 4: Summary of Requirements:

4.1 Description of Duties. The Contractor shall:

4.1.1. Provide Laboratory Accreditation Program Services. The program shall include supporting services and a contractor developed quality oversight program or contractor developed quality standards for all specialties/subspecialties (Technical Exhibit B) offered at any VHA laboratory or CBOCs (Technical Exhibit A) where patient testing is performed during the period of performance.

A. Supporting Services shall include:

i. Assigning a senior level liaison (and alternate) who shall have full authority to act for the contractor (i.e., resolve disputes, sign documents, etc.) on all matters relating to this contract which includes overseeing the performance of the contract account manager. The name and contact information for the senior level liaison (and alternate) shall be designated in writing to the Contracting Officer and COR. Liaison shall be available during normal business hours.

ii. Assigning a contract manager (and alternate) who shall assist STVHCS P&LMS staff with troubleshooting and resolving any concerns relating to the daily performance of this contract. The name and contact information for the Contract Manager (and alternate) shall be designated in writing to the Contracting Officer and COR. Liaison shall be available during normal business hours.

iii. Providing one contractor personnel to present current information regarding the contractor’s inspection, quality assessment, and laboratory accreditation program at the STVHCS P&LMS annual conference if extended an invitation by the government.

iv. Providing a method for VHA general laboratory staff to receive live (not automated) technical support and/or customer service from the contractor, during normal business hours.

v. Providing a method for VHA general laboratory staff to access/obtain contractor-published laboratory accreditation material, documents, forms, educational opportunities during and outside of normal business hours.

vi. Providing a method for STVHCS P&LMS staff to access/obtain VHA laboratory account information during and outside of normal business hours.

vii. Providing a method for the contractor to notify the laboratory director/manager, regional medical technologists, and STVHCS P&LMS staff in writing (mailed or electronic) if any new standards, revised, or updated accreditation information become available.

viii. Providing an electronic method (i.e., secure website, fax, email) for receipt of VA furnished correspondence.

ix. Providing standardized checklists/standards by which all VHA laboratories are required to be inspected by (regardless of complexity) for consistency across laboratories.

B. Quality Oversight/Quality Standards shall include:

i. Processes equivalent to those submitted to and approved by CMS for which contractor obtained laboratory accreditation “granting” authority.

ii. A Quality Control Plan (QCP) as described in Part 5.

iii. Hard (non-electronic) master copies of laboratory accreditation material provided by the contractor and electronic master copies in Microsoft Word compatible format.

iv. Standardized written document identifying any deficient finding for any (identified) standard or requirement for all on-site inspections.

v. Standardized documents serving as written notification of contractor’s decision to accredit (a laboratory). The document must identify, at minimum, the laboratory’s name and address, the contractor’s assigned laboratory identifier, and the laboratory’s accreditation expiration date.

vi. Standardized written formats (for VHA specialties/subspecialties) for laboratory accreditation materials provided by the contractor. This includes language used and general/common laboratory requirements (i.e., safety, laboratory automation and informatics, quality management, method evaluation, personnel, equipment).

vii. Method to obtain and resolve concerns initiated by VHA general laboratory staff regarding quality of services performed by the contractor and/or quality of services/testing performed in any specialty/subspecialty of the laboratory where patient testing is performed during the period of performance.

viii. Method for providing electronic deliverables to STVHCS P&LMS staff in a Microsoft Word and/or Access compatible format (i.e., XML), as applicable.

ix. Process to ensure that only STVHCS P&LMS staff are notified of the scheduled date for unannounced or announced on-site inspections (i.e., date of unannounced inspection remains confidential).

x. Process to maintain, query, analyze, and/or generate reports for any work performed or any (facility) information/data furnished by the government under this requirement.

See Technical Exhibit A which lists the facilities’ CLIA number and complexity level. See Technical Exhibit B which lists the facility’s specialty, subspecialty and annual test volumes

4.1.4. Perform INITIAL INSPECTION, QUALITY ASSESMENT, AND LABORATORY ACCREDITATION SERVICES, defined under 3.1.3, within 6 months of Government request utilizing INSPECTION TEAM assembled in accordance with criteria defined under 3.1.10.

4.1.5 Provide Inspector training, as needed, for a minimum of 10 STVHCS P&LMS staff. Training shall be consistent with training provided to contractor inspectors. Training should be provided by the contractor upon request.

4.1.6. Provide a transition plan sufficient to provide continuous accreditation and service and to ensure all laboratories are inspected for accreditation prior to their current accreditation expiration date. The plan must include a transition process for immediate remediation in the event a laboratory may have been identified as an at-risk laboratory during the transition.

4.1.7. Deliverables

A. One Time

i. Provide contact information for senior level liaison and contractor account manager (and alternate) within 30 days of contract award.

ii. Provide contractor’s quality control plan for this requirement. Plan must be approved by Contracting Officer within 30 days of contract award.

iii. Provide contract staff to present at annual STVHCS P&LMS conference if invitation is extended on date specified by the STVHCS.

iv. Provide master copies of laboratory accreditation material to each VHA laboratory or CBOC and the STVHCS within 60 days of contract award.

B. Recurrent

i. Provide written notification (contractor letterhead document or certificate, etc.) of contractor decision to (re)accredit, revoke, or deny accreditation to the inspected laboratory and STVHCS no more than 90 calendar days from date of on-site inspection. This information should also be available to STVHCS P&LMS in Access compatible format (i.e., XML).

ii. Provide STVHCS P&LMS information regarding new standards, revised, or updated accreditation information within 30 days of contractor’s publication. This information should be available as a hard copy or electronically upon request.

iii. Provide master copies of laboratory accreditation material to each VHA laboratory or CBOC and STVHCS P&LMS within 60 days of contract award. This information should be available as a hard copy or electronically upon request.

iv. Provide written document identifying any deficient finding for any (identified) standard or requirement to the inspected laboratory and STVHCS P&LMS within 30 days of on-site inspections.

v. Provide STVHCS P&LMS electronic notification of any event in which contractor receives reports regarding quality of services performed by the contractor under this requirement and/or quality of services/testing performed in any specialty/subspecialty of VHA laboratories within 10 working days of receipt of information.

vi. Provide the scheduled date for all unannounced on-site inspections to the STVHCS P&LMS liaison in confidentiality within 10 working days of scheduling the date. These should be provided to STVHCS P&LMS in Access compatible format (i.e., XML).

vii. Provide STVHCS P&LMS documented evidence for the board-certified pathologist and other inspection team evaluations, as applicable, within 10 working days of request by STVHCS P&LMS. This requirement is described in 3.6.10 above.

viii. Provide STVHCS P&LMS documented evidence for all other inspection team personnel, as applicable, within 10 working days of request by STVHCS P&LMS. This requirement is described in 3.6.10 above

ix. Provide inspector trainee and COR documented evidence of contractor’s certification for laboratory accreditation inspector training within 30 days of successful completion of training.

x. Provide queried data and/or summary reports to STVHCS P&LMS within 30 days of request. This information should be available as a hard copy or electronically upon request.

xi. Provide electronic monthly report of upcoming inspections to NEO in Access compatible format (i.e., XML). Reports in must be in standardized format and include information such as:

a. CLIA ID Number

b. Identifying unique accreditation number

c. Laboratory Name

d. Scheduled Inspection Date

e. Actual Inspection Date

f. Inspection Type

g. Inspection Status

h. Inspection due date

i. Accreditation Status

j. Accreditation End Date

k. Complexity Points

l. Accreditation Fee

m. Inspector Summation Report Available Date

n. Post-Inspection Activity Complete Date

xii. Provide electronic quarterly report of laboratory sites included in award with inspection findings or with no inspection findings to P&LMS NEO in Excel (.XML) format. Reports must be in standardized format agreed upon by P&LM NEO and contractor to include required information:

VHA No Findings Inspection Summary Report:

A. CLIA ID

B. Site Identifying number C. Laboratory Name D. City E. State F. Inspection Date VHA Findings Inspection Summary Report:

a. Requirement (ID)/Standard

b. Checklist Edition

c. Checklist /Section

d. Subject Header/Chapter

e. Section Unit

f. Inspection Date

g. Phase/Safer placement

h. Requirement Text / Standard Text

i. Site Identifying number

j. CLIA Number

xiii. Provide written documentation, on contractor letterhead or certificate, the inspection or accreditation outcome to P&LMS NEO within 90 days of on-site inspections. The document must identify, at minimum, the laboratory’s name and address, laboratories CLIA number, the contractor’s assigned laboratory identifier, and date inspection occurred.

xiv. Provide post-inspection documentation to P&LMS NEO if post-inspection process is not complete within 90 days.

xv. Provide P&LMS NEO electronic notification of an event in which contractor receives reports of quality concerns related to services/testing performed by a VHA laboratory within 5 working days of receipt of information.

xvi. P&LMS NEO point of contact – Jill Hancock, National Enforcement Coordinator, Jill.Hancock@va.gov, 202-549-4592 Section 5: Quality Control Plan.

B.2 PRICE/COST SCHEDULE

ITEM INFORMATION

SERVICE ACCREDITATION FOR LABORATORY FOR THE SOUTH TEXAS VETERANS HEALTH CARE SYSTEM, 7400 MERTON MINTER BLVD., SAN ANTONIO, TX 78229-4404. CAP #2143201 Planning UID: VA-20-00074681 COR: KRISTEN DELGADO-WILLIAMS, QUALITY MANAGEMENT, 210-617-5300 EXT. 5135. SERVICE: LABORATORY ACCREDITATION Contract Period: Base POP Begin: 11-01-2020 POP End: 10-31-2021

LOCAL STOCK NUMBER: 2143201

SERVICE ACCREDITATION FOR LABORATORY FOR THE KERRVILLE DIVISION PATHOLOGY AND LABORATORY MEDICINE SERVICE, 3600 MEMORIAL BLVD., KERRVILLE, TX 78028-5768. CAP #2134501 COR: KRISTEN DELGADO-WILLIAMS, QUALITY MANAGEMENT, 210-617-5300 EXT. 5135. SERVICE: LABORATORY ACCREDITATION Contract Period: Base POP Begin: 11-01-2020 POP End: 10-31-2021

SERVICE ACCREDITATION FOR LABORATORY FOR THE SOUTH TEXAS VETERANS HEALTH CARE SYSTEM, 7400 MERTON MINTER BLVD., SAN ANTONIO, TX 78229-4404. CAP #2143201 Planning UID: VA-20-00074681 COR: KRISTEN DELGADO-WILLIAMS, QUALITY MANAGEMENT, 210-617-5300 EXT. 5135. SERVICE: LABORATORY ACCREDITATION Contract Period: Option 1 POP Begin: 11-01-2021 POP End: 10-31-2022

SERVICE ACCREDITATION FOR LABORATORY FOR THE KERRVILLE DIVISION PATHOLOGY AND LABORATORY MEDICINE SERVICE, 3600 MEMORIAL BLVD., KERRVILLE, TX 78028-5768. CAP #2134501 COR: KRISTEN DELGADO-WILLIAMS, QUALITY MANAGEMENT, 210-617-5300 EXT. 5135. SERVICE: LABORATORY ACCREDITATION Contract Period: Option 1 POP Begin: 11-01-2021 POP End: 10-31-2022

SERVICE ACCREDITATION FOR LABORATORY FOR THE SOUTH TEXAS VETERANS HEALTH CARE SYSTEM, 7400 MERTON MINTER BLVD., SAN ANTONIO, TX 78229-4404. CAP #2143201 Planning UID: VA-20-00074681 COR: KRISTEN DELGADO-WILLIAMS, QUALITY MANAGEMENT, 210-617-5300 EXT. 5135. SERVICE: LABORATORY ACCREDITATION Contract Period: Option 2 POP Begin: 11-01-2022 POP End: 10-31-2023

SERVICE ACCREDITATION FOR LABORATORY FOR THE KERRVILLE DIVISION PATHOLOGY AND LABORATORY MEDICINE SERVICE, 3600 MEMORIAL BLVD., KERRVILLE, TX 78028-5768. CAP #2134501 COR: KRISTEN DELGADO-WILLIAMS, QUALITY MANAGEMENT, 210-617-5300 EXT. 5135. SERVICE: LABORATORY ACCREDITATION Contract Period: Option 2 POP Begin: 11-01-2022 POP End: 10-31-2023

SERVICE ACCREDITATION FOR LABORATORY FOR THE SOUTH TEXAS VETERANS HEALTH CARE SYSTEM, 7400 MERTON MINTER BLVD., SAN ANTONIO, TX 78229-4404. CAP #2143201 Planning UID: VA-20-00074681 COR: KRISTEN DELGADO-WILLIAMS, QUALITY MANAGEMENT, 210-617-5300 EXT. 5135. SERVICE: LABORATORY ACCREDITATION Contract Period: Option 3 POP Begin: 11-01-2023 POP End: 10-31-2024

SERVICE ACCREDITATION FOR LABORATORY FOR THE KERRVILLE DIVISION PATHOLOGY AND LABORATORY MEDICINE SERVICE, 3600 MEMORIAL BLVD., KERRVILLE, TX 78028-5768. CAP #2134501 COR: KRISTEN DELGADO-WILLIAMS, QUALITY MANAGEMENT, 210-617-5300 EXT. 5135. SERVICE: LABORATORY ACCREDITATION Contract Period: Option 3 POP Begin: 11-01-2023 POP End: 10-31-2024

SERVICE ACCREDITATION FOR LABORATORY FOR THE SOUTH TEXAS VETERANS HEALTH CARE SYSTEM, 7400 MERTON MINTER BLVD., SAN ANTONIO, TX 78229-4404. CAP #2143201 Planning UID: VA-20-00074681 COR: KRISTEN DELGADO-WILLIAMS, QUALITY MANAGEMENT, 210-617-5300 EXT. 5135. SERVICE: LABORATORY ACCREDITATION Contract Period: Option 4 POP Begin: 11-01-2024 POP End: 10-31-2025

SERVICE ACCREDITATION FOR LABORATORY FOR THE KERRVILLE DIVISION PATHOLOGY AND LABORATORY MEDICINE SERVICE, 3600 MEMORIAL BLVD., KERRVILLE, TX 78028-5768. CAP #2134501 COR: KRISTEN DELGADO-WILLIAMS, QUALITY MANAGEMENT, 210-617-5300 EXT. 5135. SERVICE: LABORATORY ACCREDITATION Contract Period: Option 4 POP Begin: 11-01-2024 POP End: 10-31-2025

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SECTION C - CONTRACT CLAUSES

C.1 52.212-4 CONTRACT TERMS AND CONDITIONS—COMMERCIAL ITEMS (OCT 2018)

(a) Inspection/Acceptance. The Contractor shall only tender for acceptance those items that conform to the requirements of this contract. The Government reserves the right to inspect or test any supplies or services that have been tendered for acceptance. The Government may require repair or replacement of nonconforming supplies or reperformance of nonconforming services at no increase in contract price. If repair/replacement or reperformance will not correct the defects or is not possible, the Government may seek an equitable price reduction or adequate consideration for acceptance of nonconforming supplies or services. The Government must exercise its post-acceptance rights—

(1) Within a reasonable time after the defect was discovered or should have been discovered; and

(2) Before any substantial change occurs in the condition of the item, unless the change is due to the defect in the item.

(b) Assignment. The Contractor or its assignee may assign its rights to receive payment due as a result of performance of this contract to a bank, trust company, or other financing institution, including any Federal lending agency in accordance with the Assignment of Claims Act (31 U.S.C. 3727). However, when a third party makes payment (e.g., use of the Governmentwide commercial purchase card), the Contractor may not assign its rights to receive payment under this contract.

(c) Changes. Changes in the terms and conditions of this contract may be made only by written agreement of the parties.

(d) Disputes. This contract is subject to 41 U.S.C. chapter 71, Contract Disputes. Failure of the parties to this contract to reach agreement on any request for equitable adjustment, claim, appeal or action arising under or relating to this contract shall be a dispute to be resolved in accordance with the clause at FAR 52.233-1, Disputes, which is incorporated herein by reference. The Contractor shall proceed diligently with performance of this contract, pending final resolution of any dispute arising under the contract.

(e) Definitions. The clause at FAR 52.202-1, Definitions, is incorporated herein by reference.

(f) Excusable delays. The Contractor shall be liable for default unless nonperformance is caused by an occurrence beyond the…