STATEMENT_OF_NEED_FOR_ANNUAL_LAB_ACCREDITATION.docx

Statement of Need Pathology and Laboratory Accreditation

PART 1. SCOPE OF WORK:

This is a requirement for non-personal service 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 Orlando VAMC. All testing sites that perform laboratory test for patient care within the VHA must be in compliance with CFR Part 493 and must maintain accreditation by a nationally recognized, and VA designated laboratory accrediting agency/program with deemed status from 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, supervision, and other items and non-personal services necessary to perform Accreditation of Laboratory Services as defined in this statement of work. 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.

1.2 Background: Department of Veterans Affairs (VA) Laboratories have been accredited for over 35 years. The laboratory accreditation process is a complex system of related and dependent activities. It includes pre-inspection/review activities (e.g., education on accreditation process, application); 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 and monitoring activities (e.g., ongoing communication; 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 Joint Commission (TJC) accreditation

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

1.3 Objectives: The objective of this requirement is to supply accreditation services for specified Orlando VA clinical laboratories with minimal complexity (see Technical Exhibit A) located in 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 certain standards of quality and safety, and confers deemed compliance with healthcare quality standards of payors, both public (e.g., Medicare) and commercial.

1.4 Scope: This requirement includes inspection, quality assessment and laboratory accreditation services for Orlando VHA laboratories specified under Technical Exhibit A, 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) that fall under this requirement include:

• Point of Care Testing, Urinalysis, and Chemistry (see Technical Exhibit B) Currently there are one major clinical laboratory for hospital, two clinical outpatient laboratories and five CBOCs) that utilize inspection, quality assessment, and laboratory accreditation services. Three are high complexity, and five are minimum complexity as categorized by FDA. The five minimum complexity laboratories are the only laboratories included in this requirement. Complexity testing is determined by the needs of each site and can change. During this contract's period of performance, the total number of inspection, quality assessment, and laboratory accreditation sites is not expected to change more than 10% if the facilities needs comply with the testing complexity defined by FDA. In the performance of the tasks associated with this Performance Work Statement, the Contractor shall comply with the following:

See Technical Exhibit A for Laboratory Name, Location, Accreditation Expiration Date, CLIA Number, and Complexity Level and Facility type. See Technical Exhibit B for Laboratory Specialty/Sub-specialty with Annual Volume.

1.5 Period of Performance: The period of performance shall be for one base period. The Period of Performance reads as follows:

Base Year March 1, 2019 – March 31, 2020

Option Year 1 March 1, 2020 – March 31, 2021

Option Year 2 March 1, 2021 - March 31, 2022

Option Year 3 March 1, 2022 - March 31, 2023

Option Year 4 March 1, 2023 - March 31, 2024

1.6 Recognized Holidays: The contractor is not required to perform services on the following Federal holidays.

1.7 Hours of Operation: The Contractor is responsible for conducting business between the hours of 08:00 - 16:30 (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.

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

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

PART 2. DEFINITIONS:

2.1.1. On Cycle Inspection, Quality Assessment, and Laboratory Accreditation services: Contractor provides Accreditation support services with quality oversight program/standards for Orlando 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 re-accredit or revoke accreditation (which must be provided to the Government no more than 90 calendar days from date of on-site inspection).

2.1.2. Out of Cycle Inspection, Quality Assessment, and Laboratory Accreditation services: Contractor provided Accreditation support services with quality oversight program/standards for Orlando 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 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).

2.1.3. Initial Inspection, Quality Assessment, and Laboratory Accreditation services: Contractor provides Accreditation support services with quality oversight program/standards for any new Orlando VHA laboratory or any Orlando 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).

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

2.1.5. 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.

2.1.6. 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).

2.1.7. 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 if 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).

2.1.8. 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.

2.1.9. 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 Orlando Veterans Affair Medical Centers "VAMC" sites and 2) all testing sites performing Anatomic Pathology services. All other inspection team personnel shall meet one of the following criteria:

· 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 hat 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.

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

2.1.11. 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.

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

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

2.1.14. WORK DAY. The number of hours per day the Contractor provides services in accordance with the contract.

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

PART 3. SUMMARY OF REQUIREMENTS:

3.1 Description of Duties. The Contractor shall when needed:

3.1.1. 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. 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.

vii. Method for providing electronic deliverables in a Microsoft Word and/or Access compatible format (i.e., XML), as applicable.

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.

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.

3.1.2. Perform ON CYCLE INSPECTION, QUALITY ASSESSMENT, AND LABORATORY ACCREDITATION SERVICES, defined under 2.1.1 prior to the accreditation expiration date provided by the Government (Technical Exhibit A) utilizing INSPECTION TEAM assembled in accordance with criteria defined under 2.1.9.

3.1.3. Perform OUT OF CYCLE INSPECTION, QUALITY ASSESMENT, AND LABORATORY ACCREDITATION SERVICES, defined under 2.1.2 within 6 months of Government request.

3.1.4. Perform INITIAL INSPECTION, QUALITY ASSESMENT, AND LABORATORY ACCREDITATION SERVICES, defined under 2.1.3, within 6 months of Government request utilizing INSPECTION TEAM assembled in accordance with criteria defined under 2.1.10.

3.1.5. 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.

3.1.6. Deliverables

A. One Time

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

ii. Provide master copies of laboratory accreditation material to each VHA laboratory or CBOC 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 no more than 90 calendar days from date of onsite inspection.

ii. Provide information regarding new standards, revised, or updated accreditation information within 30 days of contractor's publication.

ii. Provide master copies of laboratory accreditation material to each Orlando VHA laboratory or within 60 days of contract award.

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

PART 4: OPERATING CONSTRAINTS

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

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

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

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

4.5 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.

PART 5: GOVERNMENT FURNISHED EQUIPMENT

A. Request for Initial Inspection, Quality Assessment, and Laboratory Accreditation Services.

B. Laboratory Information for Accreditation Application per facility.

Technical Exhibit A

Ste. 41-47 Deltona, FL 32725

Orlando, FL 32803

Technical Exhibit B