36C10G20R0018 Solictiation for Laboraty Accreditation Services.pdf

COMBINED SYNOPSIS/SOLICITATION 36C10G20R0018 Page 1 of 83

COMBINED SYNOPSIS/SOLICITATION FOR COMMERCIAL ITEMS

General Information

Document Type: Combined Solicitation/Synopsis

Solicitation Number: 36C10G20R0018

Posted Date: June 17, 2020

Original Response Date: July 16, 2020

Current Response Date: July 16, 2020

Product or Service Code: R420

Set Aside: None

NAICS Code: 813920

Contracting Office Address

Office of Procurement, Acquisition and Logistics (OPAL) Strategic Acquisition Center (SAC) 10300 Spotsylvania Ave, Suite 400 Fredericksburg, VA 22408

Description This is a combined synopsis/solicitation for commercial items prepared in accordance with the format in Federal Acquisition Regulation (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 document will not be issued.

The associated North American Industrial Classification System (NAICS) code for this procurement is 813920, with a small business size standard of $16.5M.

This solicitation is a Request For Proposals (RFP). The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular FAC 2020-06, effective date 06-05-2020.

Type of Contract:

The Government will award a single vendor lowest price technically acceptable indefinite delivery/indefinite quantity (ID/IQ) fixed price contract. Task Orders will be placed during the period of performance for required services.

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Number of Contracts to be Awarded:

The Government intends to select one contractor for this acquisition. However, the Government reserves the right not to award a contract at all, depending on the quality of the proposals and prices submitted and the availability of funds.

Minimum and Maximum Quantity of Services:

The total minimum quantity of services the Government will acquire under the contract is 241 continuous monitoring labs. The total maximum quantity of services the Government will acquire under the contract per performance period are: 120 high complexity, 32 moderate complexity, and 270 continuous monitoring labs. The total maximum quantity of services the Government will acquire under the contract are: 600 high complexity, 160 moderate complexity, and 1350 continuous monitoring labs.

Task Orders:

Task Orders shall be issued by the SAC Contracting Officer(s) as requirements for additional number of lab accreditation services are required within the current period of performance. No oral orders are authorized.

Not all Contract Line Items Number(s) (CLIN) are required to be ordered on any given Task Order. CLINs will be identified on every order and the quantity being ordered. For the minimum and maximum order limitations, reference Section C:

Contract Clauses:

C.3 52.216-18 ORDERING

C.4 52.216-19 ORDER LIMITATIONS

Acquisition Office:

The Office of Procurement, Acquisition and Logistics, Strategic Acquisition Center, 10300 Spotsylvania Ave, Suite 400, Fredericksburg, VA 22408, is seeking to purchase laboratory accreditation services, which include continuous monitoring.

All interested companies shall provide proposal for the following Services:

PERFORMANCE WORK STATEMENT (PWS)

Part 1. Scope of Work

Description of Services/Introduction:

The Department of Veterans Affairs (VA), Veterans Health Administration (VHA) has a requirement for non-personal services to provide laboratory accreditation services. The laboratory accreditation services include the continuous monitoring and on-site inspection with pre and post inspection activity.

These services must be performed by contractors identified by the Centers for Medicare and Medicaid Services (CMS) as a “deemed” 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.

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Background:

VHA Laboratory Accreditation Service have been provided by a contractor for VHA clinical laboratories and community-based outpatient centers (CBOCs) for over 40 years.

Maintaining laboratory accreditation is directed by:

• VHA Handbook 1100.16 which establishes policy and responsibilities in obtaining and retaining hospital accreditation

• VHA Handbook 1106.01 which establishes policy and responsibilities for

P&LMS

Objectives:

The objectives of this requirement are to have on-site inspection and continuous monitoring services for accreditation for specified VHA clinical laboratories and CBOCs. Bi-annual on-site inspections are a requirement of maintaining laboratory accreditation required by CLIA and TJC Hospital accreditation agreement. Laboratory accreditation aligns with one of P&LMS National Enforcement Office (NEO) strategies under quality improvement. Laboratory accreditation confers recognition that a laboratory meets certain standards of quality and safety, and confers compliance with healthcare quality standards of payors, both public (e.g., Medicare) and commercial.

Scope:

The contractor shall perform all services. The contractor shall provide all qualified personnel, equipment, supplies, facilities, transportation, travel, tools, materials, supervision, and other items and non-personal services necessary to successfully perform the services as defined in this Performance Work Statement except for those items specified as Government furnished property and services. Reciprocal inspection services shall not be a part of this acquisition and no agreements in support of this acquisition shall be entered into by the Government with the vendor, its subsidiaries, or its subcontractors. No Government employee shall be used for reciprocal inspections. Task Orders shall be placed during the current period of performance to indicate services requested to be rendered.

This requirement includes inspection services for the defined Food and Drug Administration (FDA) complexity levels of high and moderate, at specified VHA laboratories and CBOCs, where patient testing is performed. Quality measures and specialties/subspecialties (in language/terms referenced on CMS, Clinical and Laboratory Standards Institute (CLSI)) that fall under this requirement may include but are not limited to:

Specialties:

1. Chemistry

2. Clinical Cytogenetics

3. Diagnostic Immunology

4. Hematology

5. Histocompatibility

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6. Microbiology

7. Pathology

8. Serology

9. Radiobioassay

Subspecialties:

1. Autopsy Pathology

1. Bacteriology

2. Blood Gas

3. Body Fluid Analysis

4. Coagulation

5. Cytology

6. Endocrinology

7. Flow Cytometry

8. General Immunology

9. Genetic testing

10. Gynecologic Cytopathology

11. Hematopoietic Progenitor Cell Services Histocompatibility

12. Histopathology

13. Electron Microscopy

14. Immunohistochemistry

15. In Situ Hybridization

16. Intraoperative Consultation/MOHS

17. Molecular Biology

18. Molecular Microbiology

19. Molecular Pathology

20. Mycobacteriology

21. Mycology

22. Oral Pathology

23. Parasitology

24. Point of Care Testing – Waived

25. Point of Care Testing – Non Waived

26. Point of Care Testing – Provider Performed

27. Routine Chemistry

28. Special Chemistry

29. Syphilis Serology

30. Surgical Pathology

31. Mohs Surgery

32. Toxicology

33. Urinalysis

34. Virology

Quality Measure Inspection Areas:

1. Safety

2. Specimen Collection

3. Laboratory Computer Services

4. Telepathology

5. Environment

6. Communications

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7. Laboratory Director Responsibilities

8. Quality Improvement

9. Complaint Review

The contractor shall have a formal process to update and modernize their accreditation material to maintain standards/checklists that correlate with accepted industry standard laboratory practices and emerging technologies.

There are approximately 241 VHA patient testing sites (clinical laboratories and CBOCs) that utilize accreditation service under this requirement. Based on FDA categorization, 205 sites are considered high complexity, and 36 are considered moderate complexity. VHA patient testing sites are currently located in the contiguous 48 states as well as Alaska, Hawaii, Philippines, and Puerto Rico. This laboratory site volume is not expected to change by more than 10%.

See Technical Exhibit A for Laboratory Name, Location, Inspection Month, CLIA Number, Complexity Level, Facility type, Facility affiliations, Specialty/Sub-specialty and Annual Volume.

NOTE: Blood bank/Transfusion service inspection is not a requirement of this acquisition.

Period of Performance:

The period of performance shall be for one base period and four, 12-month option periods. Option periods are exercised as a required and are not guaranteed. The Period of Performance reads as follows:

• Base Period: 9/15/2020 – 9/14/2021

• Option Period 1: 9/15/2021 – 9/14/2022

• Option Period 2: 9/15/2022 – 9/14/2023

• Option Period 3: 9/15/2023 – 9/14/2024

• Option Period 4: 9/15/2024 – 9/14/2025

Recognized Holidays:

The contractor is not required to perform services on the following Federal holidays.

New Year’s Day Labor Day Martin Luther King Jr.’s Birthday Columbus Day President’s Day Veteran’s Day Memorial Day Thanksgiving Day Independence Day Christmas Day

Hours of Operation:

The Contractor is responsible for conducting business between the hours of 08:00 – 4:30 (local time for the facility being inspected), 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.

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Place of Performance:

The work to be performed under the resulting contract will be performed at VHA facilities requiring inspection as set forth on Technical Exhibit A and at the Contractor facilities, as required per each Task Order.

Security Requirements:

A business associate agreement (BAA) between VHA and the contractor must be in place within 45 days and before on-site inspection activity occurs, as viewing VHA information may occur in the process of performing this requirement. A contractor may request physical review of VHA information and VHA information systems only while at inspection location sites listed in Technical Exhibit A and to the extent necessary to perform the services specified in the requirement. A contractor may review electronic records from the VHA computer system only by observing a VHA staff person who is reviewing the electronic record at the inspector’s request as part of the requirement process.

The C&A requirements do not apply, and that a Security Accreditation Package is not required. The contractor representatives will not be left alone with VA sensitive information. No VA sensitive information will leave the site of contract performance.

Corrective action response information submitted to contractor for inspection finding resolution will be de-identified of protective health information.

NOTE: This requirement does not require a contractor to have an account or ongoing access to the VHA computer system. A contractor is not allowed to connect their computer equipment to the VHA system.

Physical Security:

The Contractor shall be responsible for safeguarding government equipment, information, and property provided for contractor use. Any Government equipment provided to the contractor shall be handled and safeguarded per the Federal Acquisition Regulation (FAR) 45.104(a), Responsibility and Liability for Government Property and FAR 24.103 Procedures (Protection of Individual Privacy).

Post Award Conference/Periodic Progress Meetings:

The Contractor agrees to attend post award conference convened by the contracting activity or contract administration office in accordance with FAR Subpart 42.5. The contractor also agrees to participate in electronic contract progress meetings at the request of the P&LMS NEO. The contractor also agrees to participate in P&LMS annual meeting if invited by P&LMS NEO. This may be in person or through electronic methods, not to exceed one time per contract period.

Contracting Officer Representative (COR):

The COR will be identified by separate letter. The COR monitors technical aspects of the contract and assists in contract administration, per the contractor provided Performance / Quality Control Plan for quality monitoring.

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 regarding changes

COMBINED SYNOPSIS/SOLICITATION 36C10G20R0018 Page 7 of 83 in cost or price, or in estimates or changes in delivery dates. The COR is not authorized to change the terms and conditions of the resulting order.

Identification of Contractor Employees:

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 shall also ensure that documents or reports produced by contractors are suitably marked as contractor products or that contractor participation is appropriately disclosed. Contractor employees will wear name badges identifying them as employees of the contractor when on Government facilities.

Travel:

The Government anticipates contractor will be expected to travel to perform the tasks associated with the requirement.

VHA employees will not be expected to travel to support this accreditation requirement.

Contractor Accreditation Terms The Government will not be bound by contractor inspection or accreditation terms.

Terms of agreement for accreditation, inspection and/or continuous monitoring are outlined in this PWS.

Part 2. Definitions and Supplementary Requirements Definitions and information related to this acquisition can be referenced below and/or per FAR 2.101.

2.1 Continuous Monitoring

Monitoring activities that occur throughout a laboratory registration with the contractor outside of Inspection activity. This may include off-cycle activity/self-inspection, proficiency testing ordering checks, inspection follow up, and educational activities.

2.2 Deliverables

Deliverables may be physically or electronically delivered. Deliverables that are not separately priced (NSP) shall be included in the laboratory inspection and/or monitoring service cost. Deliverables that are not electronically provided shall be shipped Freight of Board (FOB) destination.

2.3 Education Opportunities

Training or educational offerings by the contractor on various laboratory functions.

This may include webinars, live trainings, in-person trainings, printed materials/papers, formal continuing education opportunities, and website tools.

2.4 Inspection/Audit/Survey/Assessment

Review of laboratory practices and quality measures through contractor provided

COMBINED SYNOPSIS/SOLICITATION 36C10G20R0018 Page 8 of 83 inspection activity with established standards. This service shall include pre-inspection, on-site physical inspection, and post-inspection follow up activities.

Routine inspections shall occur in the date range outlined in Technical Exhibit A and shall occur within the same range biennially thereafter throughout the contract performance period, as designated per Task Order.

On demand inspections shall occur within 6 months of Government request or date mutually agreed upon between contractor and COR for laboratories included in contract, within the limits of a Task Order.

2.5 Inspection Follow up

Tracking and monitoring of follow up activity for laboratories that warrant additional documentation be submitted after post-inspection activity is complete.

2.6 Inspection Team

The contractor team that perform the on-site inspection. Inspection teams shall meet the CMS personnel standards for use in “deemed” status accreditation inspections and have knowledge in the specialties/sub-specialties identified by a laboratory.

The inspection team shall include a licensed pathologist certified by the American Board of Pathology for sites designated as Veteran Affair Medical Centers (VAMC) and testing sites performing Anatomic Pathology services including intraoperative consult/Mohs testing.

Inspection team personnel shall have documented inspection training and qualifications to ensure consistency of inspections across the VHA laboratories.

Documentation of inspection team member qualifications or education shall be provided to P&LMS NEO upon request.

2.7 Off-Cycle Activity/Self Inspection

Activity that occurs in the year other than when the on-site inspection occurs. A contractor midcycle program shall be in place to ensure that laboratories continue to comply with contractor regulatory requirements throughout accreditation cycle.

The midcycle activity may include a laboratory review of the inspection checklist/standards, checking proficiency testing ordering, and/or verifying laboratory information on file with the contractor.

2.8 On-site Inspection Activity

Physical on-site review of laboratory practices and quality measures by contractor inspection team using predetermined standards and checklists. Inspection activity shall not disrupt or impede laboratory activity.

2.9 Proficiency Testing Ordering Check

Process to crosscheck individual laboratory proficiency testing (PT) ordering with test activity menu in specialties/subspecialties to the analyte level. This check

COMBINED SYNOPSIS/SOLICITATION 36C10G20R0018 Page 9 of 83 shall be done semi-annually to ensure all required PT is being performed for each laboratory.

2.10 Pre-Inspection Activity

Activity that takes place before on-site inspection or accreditation process. This includes activity such as laboratory registration into contractor electronic web portals, access to inspection checklist or standards, education on accreditation process, registration for inspection into vendor system, access to inspection checklist or standards, P&LMS NEO notification of inspection dates and ongoing notification of new or revised standards.

2.11 Post-inspection Activity

Activity that occurs after on-site inspection. Written document identifying inspection findings, instructions to laboratories on how to submit corrective action responses, follow up by contractor to evaluate corrective action responses, written documentation of inspection outcome and recommended follow up action. This activity shall be completed within 90 days of on-site inspection.

2.12 Subcontractor

A company or person that enters into a contract with a prime contractor to perform a specific task as part of an overall project. The Government does not have privity of contract with the subcontractor. Subcontractors are under the responsibility of the primary contractor and must meet the same requirements outlined in the PWS.

The Contractor will recognize accreditation by the American Association of Blood Banks and American Society for Histocompatibility and Immunogenetics.

PART 3. Summary of Requirements/Outcomes The Contractor shall be identified by Centers for Medicare and Medicaid Services (CMS) as a “deemed” 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 Contractor will recognize accreditation by the American Association of Blood Banks and American Society for Histocompatibility and Immunogenetics.

The requirement shall include supporting services and a Performance / Quality Control Plan for meeting the requirements outlined for the laboratories listed in Technical Exhibit A. Accreditation activity is required on this acquisition and includes several phases of activity including pre-inspection, on-site inspection, post-inspection activities and continuous monitoring. The Contractor shall perform the following per laboratory as identified by the COR for each Task Order during the current performance period:

3.1 Supporting Services

3.1.1 Assign a contract account manager (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 acquisition. The name and contact information for the contract account manager (and alternate) shall be designated in writing to the Contracting Officer and

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COR. Liaison shall be available during normal business hours.

Contract account manager shall assist P&LMS NEO with troubleshooting and resolving concerns to the daily performance of this contract.

3.1.2 Provide information regarding the contractor’s laboratory accreditation program or topic of P&LMS NEO choosing at the P&LMS annual conference if extended an invitation by the government.

3.1.3 Provide a method for VHA general laboratory staff to receive live (not automated) technical support and/or customer service from the contractor for inspection of checklists or standards and web site portal issues during normal business hours.

3.1.4 Provide an electronic method (i.e., secure website, fax, email) for receipt of VHA furnished correspondence.

3.1.5 Provide one, non-electronic, master hardcopy of laboratory inspection material to the COR each time the checklists/standards are changed within 30 days.

3.1.6 Electronically provide laboratory data for quality measures upon

P&LMS NEO request. This may include individual sites or P&LMS NEO determined sub-section of laboratories. Data requests may include top cited inspection findings, percent of findings overturned, corrective action submissions and/or other findings statistics for VHA laboratories.

3.1.7 The contractor shall meet with the P&LMS NEO post-award and periodically upon Government request.

3.1.8 Provide P&LMS NEO staff with grouped electronic access to inspection checklist/standards, inspection reports, individual lab test menu and other accreditation data within P&LMS NEO defined groups for laboratories awarded to contractor.

3.2 Pre-Inspection Activity

3.2.1 Provide a method for individual or affiliated laboratories listed in

Technical Exhibit A to create an electronic account with the contractor such as a contractor hosted web server. This account shall be used to electronically track, reproduce and submit inspection related materials. Access to this account shall include individual laboratories and P&LMS NEO staff and shall allow staff to access/obtain VHA laboratory account information during and outside of normal business hours.

3.2.2 Provide standardized checklists/standards by which VHA laboratories included in contract are required to be inspected by (regardless of

COMBINED SYNOPSIS/SOLICITATION 36C10G20R0018 Page 11 of 83 complexity). Access to these checklists/standards will be given to laboratories awarded to the contractor for the contract duration.

3.2.3 Provide new standards and revised, or updated inspection information as it becomes available to the laboratory director/manager, and P&LMS NEO in writing (mailed or electronic) within 10 business days of the modification/change.

3.2.4 Provide accreditation education to VHA laboratories included in contract about phases of the inspection process. This education can be accomplished through educational handouts, webinar trainings, recorded topical presentations, live meetings, or other agreed upon training method.

3.2.5 The COR will designate the inspection window for the laboratories included in the Task Order and the contractor shall provide the actual inspection dates as a deliverable spreadsheet in a format agreed upon by P&LM NEO.

NOTE: This information is used for P&LMS NEO management and oversight and not disclosed to laboratory sites.

3.2.6 Provide a method for laboratories to submit accreditation required information to the contractor within 6 months before inspection date occurs per Task Order. This submission shall allow for laboratories to select up to 5 days within the designated inspection window that inspection cannot occur (blackout dates).

3.3 On-Site Inspection

3.3.1 Provide a physical on-site review of laboratory practices and quality measures by contractor inspection team using predetermined standards and checklists. This inspection shall be performed within the time frame of the Task Order, indicated by the COR. The accreditation date for laboratories shall be set as the last day of inspection time frame indicated in Technical Exhibit A.

3.3.2 Laboratory testing menus are subject to change and the pre-inspection laboratory submitted inspection information shall be used to determine the specialties/sub-specialties included at an individual laboratory site inspection. The inspection team must meet the requirements listed in section 2.6 for the specialties/sub-specialties identified.

3.4 Post Inspection Activity

3.4.1 At the close of the on-site inspection, contractor shall provide written document to the laboratory identifying findings or preliminary deficiency report as a result of the on-site inspection.

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3.4.2 Provide instructions to laboratories on how to submit corrective action responses. This includes documentation required, timeline for submission, findings protest process, and standardized forms for submission.

3.4.3 Provide consistent follow up for the evaluation of corrective action responses and issuing feedback to the laboratory. A copy of corrective action responses submitted by VHA laboratories shall be forwarded to P&LMS NEO office, if requested.

3.4.4 Provide written documentation, on contractor letterhead or certificate of the inspection outcome or accreditation recommendation to the laboratory and P&LMS NEO within 90 days of on-site inspections. If post-inspection activity is not complete within 90 days of on-site inspection or inspection finding determine additional action is needed, then documentation related to post-inspection process must be provided to P&LMS NEO with recommended follow up action at 90 days.

3.5 Continuous Monitoring

3.5.1 Provide Off-Cycle Activity/Self Inspection activity that is monitored, reviewed and coordinated by the contractor.

3.5.2 Verify bi-annually a laboratory’s proficiency testing ordering or alternate assessment is correct for all analytes and methods used in the laboratory. Notification shall be generated to the laboratory in the event of an incompatibility. Reports of proficiency testing ordering check activity shall be made available to P&LMS NEO if requested.

3.5.3 Provide communication about the educational webinars and tools that are available to the laboratories and P&LMS NEO office.

Changes to the accreditation process must also be communicated within 10 days of change.

3.5.4 Provide a process to track and monitor documentation provided to the contractor after post-inspection activity is complete based on inspection findings outcome. Contractor will notify laboratory and P&LMS NEO when full contractor accreditation status has been satisfied.

3.6 Implementation Plan

Provide an Implementation Plan detailing how laboratories register into contractor such as web portal, how to submit pre-inspection information, provide training for laboratories on accreditation process and access for inspection checklists / standards. Laboratories should have at least three months of inspection checklist/standards access before inspection occurs. Registration of the laboratories and access to inspection checklist/standards must be complete within 45 days of contract award.

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3.7 Deliverables

3.7.1 One Time

3.7.1.1 Provide contact information for contractor account manager

(and alternate) within 30 days of contract award.

3.7.1.2 Provide an electronic method for VHA to furnish

correspondence (i.e., secure website, fax, email) within 30 days of contract award.

3.7.1.3 Provide a method for individual or affiliated laboratories included on this contract to create an electronic account with the contractor such as a contractor hosted web server within 45 days of contract award.

3.7.2 Recurring

3.7.2.1 Provide contractor staff, annually, to present at P&LMS conference if invitation is extended on date specified by the P&LMS NEO. P&LMS NEO will identify those requested to attend.

3.7.2.2 Provide one, non-electronic, master hardcopy of laboratory inspection material to COR with each checklists/standards revision within 30 days of award or change.

3.7.2.3 Provide laboratory data for quality measures upon P&LMS

NEO request, up to 2 requests per contract year. This may include individual sites or P&LMS NEO determined sub-section of laboratories. Data requests may include top cited inspection findings, percent of findings overturned, corrective action submissions, off cycle activity reports, and/or other statistic findings for VHA laboratories. This information shall be provided to P&LMS NEO as a hard copy or electronically within 20 days of request.

3.7.2.4 Provide master copies of laboratory accreditation material to each VHA laboratory or CBOC within 45 days of Task Order award. This information shall be available as a hard copy or electronically upon request.

3.7.2.5 Provide notification of standards and revised, or updated inspection information as it becomes available to the laboratory director/manager, and P&LMS NEO in writing (mailed or electronic) within 10 business days of the modification.

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3.7.2.6 Provide accreditation education to VHA laboratories included in contract about phases of the inspection process to laboratories and P&LMS NEO at least 30 days before scheduled inspection dates.

3.7.2.7 Provide electronic monthly report of inspection activity to

P&LMS NEO in Excel (.XML) format. Reports shall include all laboratory sites, be in standardized format agreed upon by P&LMS NEO and contractor to include required information such as:

1. CLIA ID Number

2. Identifying unique accreditation number

3. Laboratory Name

4. Scheduled Inspection Date

5. Actual Inspection Date

6. Inspection Type

7. Inspection Status

8. Inspection Due Date

9. Post-Inspection Activity Complete Date

3.7.2.8 Provide P&LMS NEO documented evidence for the board-

certified pathologist and other inspection team evaluations, as applicable, within 10 working days of request by P&LMS NEO. This requirement is described in section 2.6 above.

3.7.2.9 Provide electronic quarterly report of labs with inspection findings and labs 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 such as:

VHA No Findings Inspection Summary Report:

1. CLIA ID

2. Site Identifying number

3. Laboratory Name

4. City

5. State

6. Inspection Date

VHA Findings Inspection Summary Report:

1. Requirement (ID)/Standard

2. Checklist Edition

3. Checklist /Section

4. Subject Header/Chapter

5. Section Unit

6. Inspection Date

7. Phase/Safer placement

8. Requirement Text / Standard Text

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9. Site Identifying number

10. CLIA Number

3.7.2.10 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 shall identify, at minimum, the laboratory’s name and address, laboratories CLIA number, the contractor’s assigned laboratory identifier, and date inspection occurred.

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

3.7.2.12 Provide notification to the laboratory and P&LMS NEO within 10 days of full contractor accreditation status has been satisfied.

3.7.2.13 Provide P&LMS NEO electronic notification of an event in which contractor receives reports regarding quality of services performed by the contractor under this requirement. 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.

3.7.2.14 Provide P&LMS NEO with quarterly documented customer satisfaction results that are submitted by VHA staff in response to inspection activity to the Contractor.

Part 4: Quality

4.1 Performance / Quality Control Plan

The contractor shall provide a Performance / Quality Control Plan on how the contractor shall effectively produce, manage and ensure their work complies with the requirement of the PWS and each task order. The contractor, at a minimum, shall provide detailed information on their Performance / Quality Control Plan identifying, addressing, indicating, and/or referencing Management, Quality Control, services to be performed in accordance with the PWS, communication with the Government / customer, and standard / checklist process with accepted industry laboratory practices and emerging technologies. Additions to performance / quality control plans can be presented to illustrate and meet areas not previously identified in the plan and shall need to be part of the proposal.

The entire plan shall be submitted at award. Any updates to the plan effecting any area of the PWS shall be provided to the Government once finalized. The contractor is responsible for management and quality control of the performance quality control plan. Any updates to the plan effecting any area of the PWS shall be

COMBINED SYNOPSIS/SOLICITATION 36C10G20R0018 Page 16 of 83 provided to the Government once finalized. The contractor is responsible for management and quality control of the Performance / Quality Control Plan.

4.3 Customer Service Surveys

The Contractor shall provide the Government customer satisfaction survey results that are submitted by VHA staff to the contractor, quarterly. The reviews shall be focused on identifying improvement opportunities in Contractor inspection activities.

Part 5 Operating Constraints.

5.1 Business Associate Agreement (BAA)

The contractor shall have a BAA with VHA for inspection activity by 45 days after contract award and/or before first on-site inspection.

5.2 Federal Holidays

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

5.3 Avoid Dates

The Contractor shall allow each VHA facility to select 5 avoid dates in addition to those mandated by federal law such as holidays.

5.4 Network Access

The Contractor shall have no direct unsupervised access to the VHA computer network.

5.5 CLIA Deemed Status

The Contractor shall be identified by Centers for Medicare and Medicaid Services (CMS) as a deemed status accrediting agency under the Clinical Laboratories Improvement Amendment (CLIA)

5.6 Cooperative Agreement

Contractor identified by The Joint Commission (TJC) as having a comparative agreement pursuant to the Cooperative Accreditation Initiative. This is due to VHA facilities being TCJ hospital accredited and TJC will honor the inspections performed under this contract if organization has agreement. Contractor agrees to recognize accreditation by the American Association of Blood Banks and American Society for Histocompatibility and Immunogenetics

5.7 Inspection Specialties/ Subspecialties/ Quality Measures

The Contractor shall have the capability of providing accreditation services for laboratories that contractor submits a bid, based on complexity levels (defined by FDA) in the following:

Specialties:

1. Chemistry

2. Clinical Cytogenetics

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3. Diagnostic Immunology

4. Hematology

5. Histocompatibility

6. Microbiology

7. Pathology

8. Serology

9. Radiobioassay

Subspecialties:

1. Autopsy Pathology

2. Bacteriology

3. Blood Gas

4. Body Fluid Analysis

5. Coagulation

6. Cytology

7. Endocrinology

8. Flow Cytometry

9. General Immunology

10. Genetic testing

11. Gynecologic Cytopathology

12. Hematopoietic Progenitor Cell Services Histocompatibility

13. Histopathology

14. Electron Microscopy

15. Immunohistochemistry

16. In Situ Hybridization

17. Intraoperative Consultation/MOHS

18. Molecular Biology

19. Molecular Microbiology

20. Molecular Pathology

21. Mycobacteriology

22. Mycology

23. Oral Pathology

24. Parasitology

25. Point of Care Testing – Waived

26. Point of Care Testing – Non Waived

27. Point of Care Testing – Provider Performed

28. Routine Chemistry

29. Special Chemistry

30. Syphilis Serology

31. Surgical Pathology

32. Mohs surgery

33. Toxicology

34. Urinalysis

35. Virology

COMBINED SYNOPSIS/SOLICITATION 36C10G20R0018 Page 18 of 83

Part 6 VHA Furnished Information This information is provided by the Government for the contractor’s situational awareness and/or informational purposes only. It is not a requirement under the PWS for the contractor

6.1 Laboratory Information

(Technical Exhibit A) to include, CLIA number, FDA complexity, facility name, facility address, facility type, affiliations, site volume, and specialties/subspecialties (as of Apr 2020).

6.2 Changes to laboratory Information

Changes to laboratory information and/or addition/subtractions of laboratory facility inspection needs within 30 days of change. This includes director, test menu, location or other changes that are reported to P&LMS NEO for CLIA certificate issue.

6.3 Corrective Action Response Information

Corrective Action Response Information submitted to contractor for inspection finding resolution will be de-identified of protective health information.

6.4 Information Required by Contractor

Information Required by contractor for laboratory inspection per facility.

6.5 Proficiency Testing Ordering Data

Proficiency Testing ordering data for laboratories, if requested.

6.6 Schedule of Inspection

Schedule of inspection requirement dates

THIS SECTION INTENTIONALLY LEFT BLANK

COMBINED SYNOPSIS/SOLICITATION 36C10G20R0018 Page 19 of 83

PRICE/COST SCHEDULE

ITEM INFORMATION

ITEM

NUMBER

DESCRIPTION OF

SUPPLIES/SERVICES QUANTITY UNIT UNIT PRICE

0001 High Complexity Inspection:

Laboratory (Lab) identified as High in Complexity.

All requirements for pre-inspection, on-site physical inspection, and post-inspection follow up activities for each Lab.

Contract Period: Base POP Begin: 9/15/2020 POP End: 9/14/2021

1 EA $

0002 Moderate Complexity Inspection:

Laboratory (Lab) identified as Moderate in Complexity.

All requirements for pre-inspection, on-site physical inspection, and post-inspection follow up activities for each Lab.

Contract Period: Base

0003 Continuous Monitoring:

Laboratory (Lab) monitoring for three

(3) Months.

All requirements for monitoring activities occurring throughout a Lab registration outside of Inspection activity (Include off-cycle activity/self-inspection, proficiency testing ordering checks, inspection follow up, and educational activities) for each Lab.

(ONLY USED FOR NEW LAB)

Contract Period: Base

COMBINED SYNOPSIS/SOLICITATION 36C10G20R0018 Page 20 of 83

ITEM

NUMBER

DESCRIPTION OF

SUPPLIES/SERVICES QUANTITY UNIT UNIT PRICE

0004 Continuous Monitoring:

Laboratory (Lab) monitoring for six (6) Months

All requirements for monitoring activities occurring throughout a Lab registration outside of Inspection activity (Include off-cycle activity/self-inspection, proficiency testing ordering checks, inspection follow up, and educational activities) for each Lab.

(ONLY USED FOR NEW LAB)

Contract Period: Base

0005 Continuous Monitoring:

Laboratory (Lab) monitoring for nine

(9) Months

All requirements for Monitoring activities that occur throughout a Lab registration outside of Inspection activity. Include off-cycle activity/self-inspection, proficiency testing ordering checks, inspection follow up, and educational activities for each Lab.

(ONLY USED FOR NEW LAB)

Contract Period: Base

0006 Continuous Monitoring Laboratory (Lab) monitoring for twelve

(12) Months; entire contract period.

All requirements for Monitoring activities that occur throughout a Lab registration outside of Inspection activity. Include off-cycle activity/self-inspection, proficiency testing ordering checks, inspection follow up, and educational activities for each Lab.

Contract Period: Base

COMBINED SYNOPSIS/SOLICITATION 36C10G20R0018 Page 21 of 83

NUMBER

DESCRIPTION OF

SUPPLIES/SERVICES QUANTITY UNIT UNIT PRICE

1001 High Complexity Inspection:

Laboratory (Lab) identified as High in Complexity.

All requirements for pre-inspection, on-site physical inspection, and post-inspection follow up activities for each Lab.

Contract Period: Option 1 POP Begin: 9/15/2021 POP End: 9/14/2022

1002 Moderate Complexity Inspection:

Laboratory (Lab) identified as Moderate in Complexity.

All requirements for pre-inspection, on-site physical inspection, and post-inspection follow up activities for each Lab.

Contract Period: Option 1

1003 Continuous Monitoring:

Laboratory (Lab) monitoring for three

(3) Months.

All requirements for monitoring activities occurring throughout a Lab registration outside of Inspection activity (Include off-cycle activity/self-inspection, proficiency testing ordering checks, inspection follow up, and educational activities) for each Lab.

(ONLY USED FOR NEW LAB)

Contract Period: Option 1

COMBINED SYNOPSIS/SOLICITATION 36C10G20R0018 Page 22 of 83

NUMBER

DESCRIPTION OF

SUPPLIES/SERVICES QUANTITY UNIT UNIT PRICE

1004 Continuous Monitoring:

Laboratory (Lab) monitoring for six (6) Months

All requirements for monitoring activities occurring throughout a Lab registration outside of Inspection activity (Include off-cycle activity/self-inspection, proficiency testing ordering checks, inspection follow up, and educational activities) for each Lab.

(ONLY USED FOR NEW LAB)

Contract Period: Option 1

1005 Continuous Monitoring:

Laboratory (Lab) monitoring for nine

(9) Months

All requirements for Monitoring activities that occur throughout a Lab registration outside of Inspection activity. Include off-cycle activity/self-inspection, proficiency testing ordering checks, inspection follow up, and educational activities for each Lab.

(ONLY USED FOR NEW LAB)

Contract Period: Option 1

1006 Continuous Monitoring Laboratory (Lab) monitoring for twelve

(12) Months; entire contract period.

All requirements for Monitoring activities that occur throughout a Lab registration outside of Inspection activity. Include off-cycle activity/self-inspection, proficiency testing ordering checks, inspection follow up, and educational activities for each Lab.

Contract Period: Option 1

COMBINED SYNOPSIS/SOLICITATION 36C10G20R0018 Page 23 of 83

NUMBER

DESCRIPTION OF

SUPPLIES/SERVICES QUANTITY UNIT UNIT PRICE

2001 High Complexity Inspection:

Laboratory (Lab) identified as High in Complexity.

All requirements for pre-inspection, on-site physical inspection, and post-inspection follow up activities for each Lab.

Contract Period: Option 2 POP Begin: 9/15/2022 POP End: 9/14/2023

2002 Moderate Complexity Inspection:

Laboratory (Lab) identified as Moderate in Complexity.

All requirements for pre-inspection, on-site physical inspection, and post-inspection follow up activities for each Lab.

Contract Period: Option 2

2003 Continuous Monitoring:

Laboratory (Lab) monitoring for three

(3) Months.

All requirements for monitoring activities occurring throughout a Lab registration outside of Inspection activity (Include off-cycle activity/self-inspection, proficiency testing ordering checks, inspection follow up, and educational activities) for each Lab.

(ONLY USED FOR NEW LAB)

Contract Period: Option 2

COMBINED SYNOPSIS/SOLICITATION 36C10G20R0018 Page 24 of 83

NUMBER

DESCRIPTION OF

SUPPLIES/SERVICES QUANTITY UNIT UNIT PRICE

2004 Continuous Monitoring:

Laboratory (Lab) monitoring for six (6) Months

All requirements for monitoring activities occurring throughout a Lab registration outside of Inspection activity (Include off-cycle activity/self-inspection, proficiency testing ordering checks, inspection follow up, and educational activities) for each Lab.

(ONLY USED FOR NEW LAB)

Contract Period: Option 2

2005 Continuous Monitoring:

Laboratory (Lab) monitoring for nine

(9) Months

All requirements for Monitoring activities that occur throughout a Lab registration outside of Inspection activity. Include off-cycle activity/self-inspection, proficiency testing ordering checks, inspection follow up, and educational activities for each Lab.

(ONLY USED FOR NEW LAB)

Contract Period: Base

2006 Continuous Monitoring Laboratory (Lab) monitoring for twelve

(12) Months; entire contract period.

All requirements for Monitoring activities that occur throughout a Lab registration outside of Inspection activity. Include off-cycle activity/self-inspection, proficiency testing ordering checks, inspection follow up, and educational activities for each Lab.

Contract Period: Base

COMBINED SYNOPSIS/SOLICITATION 36C10G20R0018 Page 25 of 83

NUMBER

DESCRIPTION OF

SUPPLIES/SERVICES QUANTITY UNIT UNIT PRICE

3001 High Complexity Inspection:

Laboratory (Lab) identified as High in Complexity.

All requirements for pre-inspection, on-site physical inspection, and post-inspection follow up activities for each Lab.

Contract Period: Option 3 POP Begin: 9/15/2023 POP End: 9/14/2024

3002 Moderate Complexity Inspection:

Laboratory (Lab) identified as Moderate in Complexity.

All requirements for pre-inspection, on-site physical inspection, and post-inspection follow up activities for each Lab.

Contract Period: Option 3

3003 Continuous Monitoring:

Laboratory (Lab) monitoring for three

(3) Months.

All requirements for monitoring activities occurring throughout a Lab registration outside of Inspection activity (Include off-cycle activity/self-inspection, proficiency testing ordering checks, inspection follow up, and educational activities) for each Lab.

(ONLY USED FOR NEW LAB)

Contract Period: Option 3

COMBINED SYNOPSIS/SOLICITATION 36C10G20R0018 Page 26 of 83

NUMBER

DESCRIPTION OF

SUPPLIES/SERVICES QUANTITY UNIT UNIT PRICE

3004 Continuous Monitoring:

Laboratory (Lab) monitoring for six (6) Months

All requirements for monitoring activities occurring throughout a Lab registration outside of Inspection activity (Include off-cycle activity/self-inspection, proficiency testing ordering checks, inspection follow up, and educational activities) for each Lab.

(ONLY USED FOR NEW LAB)

Contract Period: Option 3

3005 Continuous Monitoring:

Laboratory (Lab) monitoring for nine

(9) Months

All requirements for Monitoring activities that occur throughout a Lab registration outside of Inspection activity. Include off-cycle activity/self-inspection, proficiency testing ordering checks, inspection follow up, and educational activities for each Lab.

(ONLY USED FOR NEW LAB)

Contract Period: Option 3

3006 Continuous Monitoring Laboratory (Lab) monitoring for twelve

(12) Months; entire contract period.

All requirements for Monitoring activities that occur throughout a Lab registration outside of Inspection activity. Include off-cycle activity/self-inspection, proficiency testing ordering checks, inspection follow up, and educational activities for each Lab.

Contract Period: Option 3

COMBINED SYNOPSIS/SOLICITATION 36C10G20R0018 Page 27 of 83

NUMBER

DESCRIPTION OF

SUPPLIES/SERVICES QUANTITY UNIT UNIT PRICE

4001 High Complexity Inspection:

Laboratory (Lab) identified as High in Complexity.

All requirements for pre-inspection, on-site physical inspection, and post-inspection follow up activities for each Lab.

Contract Period: Option 4 POP Begin: 9/15/2024 POP End: 9/14/2025

4002 Moderate Complexity Inspection:

Laboratory (Lab) identified as Moderate in Complexity.

All requirements for pre-inspection, on-site physical inspection, and post-inspection follow up activities for each Lab.

Contract Period: Option 4

4003 Continuous Monitoring:

Laboratory (Lab) monitoring for three

(3) Months.

All requirements for monitoring activities occurring throughout a Lab registration outside of Inspection activity (Include off-cycle activity/self-inspection, proficiency testing ordering checks, inspection follow up, and educational activities) for each Lab.

(ONLY USED FOR NEW LAB)

Contract Period: Option 4

COMBINED SYNOPSIS/SOLICITATION 36C10G20R0018 Page 28 of 83

NUMBER

DESCRIPTION OF

SUPPLIES/SERVICES QUANTITY UNIT UNIT PRICE

4004 Continuous Monitoring:

Laboratory (Lab) monitoring for nine

(9) Months

All requirements for Monitoring activities that occur throughout a Lab registration outside of Inspection activity. Include off-cycle activity/self-inspection, proficiency testing ordering checks, inspection follow up, and educational activities for each Lab.

(ONLY USED FOR NEW LAB)

Contract Period: Option 4

4005 Continuous Monitoring:

Laboratory (Lab) monitoring for nine

(9) Months

All requirements for Monitoring activities that occur throughout a Lab registration outside of Inspection activity. Include off-cycle activity/self-inspection, proficiency testing ordering checks, inspection follow up, and educational activities for each Lab.

(ONLY USED FOR NEW LAB)

Contract Period: Option 4

4006 Continuous Monitoring Laboratory (Lab) monitoring for twelve

(12) Months; entire contract period.

All requirements for Monitoring activities that occur throughout a Lab registration outside of Inspection activity. Include off-cycle activity/self-inspection, proficiency testing ordering checks, inspection follow up, and educational activities for each Lab.

Contract Period: Option 4

COMBINED SYNOPSIS/SOLICITATION 36C10G20R0018 Page 29 of 83

CONTRACT ADMINISTRATION DATA

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

a. CONTRACTOR:

Contractor Name Point of Contact/Title:

Telephone Number:

Fax Number:

Email:

DUNS Number:

Tax Identification Number (TIN):

b. GOVERNMENT: Contracting Officer 36C10G

Primary: Mauricio Vazquez, Mauricio.Vazquez@va.gov Alternate: Twillie L. Curry III, Twillie.Curry@va.gov

Contact Specialist 36C10G Primary: Marlon Nibbs, Marlon.Nibbs@va.gov Alternate: Matthew Cron, Matthew.Cron@va.gov

U.S. Department of Veterans Affairs OPAL | Strategic Acquisition Center 10300 Spotsylvania Ave | STE 400 Fredericksburg VA 22408-2697

2. CONTRACTOR REMITTANCE…