Lab Director SOW 7-15-25.pdf

FMC LEXINGTON

LAB DIRECTOR SERVICES

STATEMENT OF WORK

Subject

The Federal Bureau of Prisons, Lexington, Kentucky intends to make a single award of a firm fixed price requirements type contract to a responsible entity for the provision of a Laboratory Director Services for the College of American Pathologist (CAP) Accredited Clinical Laboratory at the Federal Medical Center (FMC) located in Lexington, Kentucky. Services provided under this contract will include on-site consulting services of a Laboratory Director as defined by CAP.

Background

The FMC Lexington is a Federal Bureau of Prisons facility that provides a medical mission for federal inmates. In meeting the medical needs of a growing inmate population, FMC Lexington provides essential medical care which includes laboratory services. Any testing not performed by FMC Lexington is referred to a Reference Laboratory. The Lab Director will not have onsite responsibilities to perform evaluation of cytology or pathology specimens.

FMC Lexington intends to make a single award to a responsible entity for the provision of a contract Laboratory Director as set forth in this solicitation/contract. In evaluating offers, the Government will evaluate the qualifications for a Lab Director as defined by CAP.

Schedule

The schedule for the Laboratory Director will normally consist of 12 visits per year, executed as one visit per month. A visit will last approximately one to two hours in duration, depending on the volume of items to review. Generally, visits will be scheduled between the hours of 7:00 am and 3:00 pm, Monday through Friday, excluding Federal Holidays. In the event the Laboratory Director is unable to provide a monthly visit, a covering Laboratory Director will provide coverage. If the contractor fails to provide coverage, the Government may seek contractual remedy.

The Contractor Employee is responsible for completing and maintaining the Session-Based Invoice Verification (SBIV) for each visit.

The SBIV form must include:

Contractor/Service details Contract Number Date and verification of time-in and time-out for each day services are provided.

Signature of Health Services Administrator or designee verifying times.

Place of Performance

The Laboratory Director will provide monthly in-house visits to the FMC Laboratory located at the main institution, FMC Lexington, 3301 Leestown Rd., Lexington, Kentucky 40511. Per

CAP, if the activities are routinely conducted remotely, periodic on-site visits must occur to ensure delegated duties and laboratory practices are performed in an effective manner.

Description of Duties

The contractor will provide a Laboratory Director (as defined by CAP) for the FMC Lexington Laboratory. The Contractor will maintain medical liability insurance, in an amount which is not less than the amount normally prevailing in the community of Lexington, Kentucky, for these services. A copy of their Insurance Binder must be provided prior to contract award. The Laboratory Director will provide monthly consultation to the laboratory of approximately one to two hours in duration. The purpose of these visits will include, but is not limited to the following duties and responsibilities:

Be accessible to the laboratory for consultations, as needed, regarding the ordering of appropriate tests and the medical significance of laboratory data

Ensure the laboratory is providing appropriate educational activities to the technologists Ensure the laboratory has sufficient number of personnel with appropriate qualifications Ensure the laboratory is a safe environment in compliance with good practice and applicable regulations As a New Director review policies and procedures within three months and then routinely every two years to meet CAP requirement Ensure the performance specifications for new tests, instruments, and methods introduced to the laboratory have been properly validated or verified prior to being used for patient testing

Oversight/Review of all aspects of the laboratory’s Quality Management Plan Review/Sign proficiency testing for completeness, record of investigation and corrective action, if applicable be involved when problems directly affect patient care Review/Sign Quality Control Data, ensure QC procedures are sufficient for the extent of testing performed in the laboratory; if applicable be involved when problems directly affect patient care

Coordinate resolution of laboratory based problems after investigation Oversee CAP or other accrediting agency inspections as indicated Review and approve Interim Self-inspection performed and ensure all deficiencies are corrected in a timely manner Review of Annual and Biennial items required for CAP accreditation to include Lab

Information System changes and test report communication Review any potential problem areas within the laboratory and ensure proper corrective action Review/Sign Monthly Consulting Meeting Summary

Qualifications/Credentialing

The contract Laboratory Director must possess:

MD, DO, or DPM licensed to practice (if required) in the jurisdiction where the laboratory is located, and have one of the following:

i. Certification in anatomic or clinical pathology, or both, by the American Board of Pathology or American Osteopathic Board of Pathology, or possess qualifications equivalent to those required for certification; or

ii. Have at least one year of laboratory training during residency; or

iii. Have at least two years of experience supervising high complexity testing;

OR

Doctoral degree in a chemical, physical, biological, or clinical laboratory science from an accredited institution, and have current certification by a board approved by HHS

OR

MD, DO or DPM, licensed to practice in the jurisdiction where the laboratory is located (if required) and have one of the following:

i. At least 20 hours of continuing medical education credit hours in laboratory medicine; or

ii. Equivalent training during medical residency; or

iii. At least one year of experience supervising nonwaived laboratory testing

OR

Doctoral degree with one of the following:

i. At least one-year of experience supervising nonwaived laboratory testing; or

ii. Certified by a board approved by HHS

The contractor shall provide the name of the candidate(s) that will be providing services for FMC Lexington and photocopies of documents evidencing their own and their candidate(s)’ ability to meet qualifications to perform required services as stated in this statement of work.

Examples of evidence include a copy of license or permit, diplomas, internship/residency certifications, letters of recommendation, resumes, etc.

Attire

The Contractor must wear appropriate and professional attire at all times. The Contractor is prohibited from wearing khaki or green clothing of any type as this is the color clothing the inmate population wears.

Non-Personal Services/Common Law Employee Information

The service is a contractual arrangement and not a personnel appointment. Payment is based on the provision of an end product or the accomplishment of a specific result. The service does not constitute an employer/employee relationship. The contractor will not be subject to Government supervision, except for security related matters. However, contractor performance shall be monitored.

If the resulting contract is made to an individual(s), the provision of these services has been determined to meet certain criteria for creating common law employee relationship. Therefore, the BOP is responsible for the payment of FICA taxes (7.65%) and the withholding of the individual’s taxes. These responsibilities apply only when award of this solicitation is made to an individual. It does not apply to companies or individuals who are incorporated. For evaluation purposes, an additional 7.65% will be added to the price submitted by individuals who are not incorporated.

Health Requirements

The contractor shall ensure their employee is free of communicable diseases. Any individual who subsequently develops a medical condition which might reasonably be expected to place other workers, inmates, or the public at risk shall be immediately removed from affected activities. In any such case, the contractor shall be responsible, at no additional cost to the institution, for securing the services of any replacement personnel required to perform this contract.

The contract employee may be required to submit to testing for/or provide evidence acceptable to the clinical director of recent testing for tuberculosis of other communicable diseases. Failure to submit to testing for or providing acceptable evidence of recent testing for or immunity to selected communicable diseases shall be grounds for denying access to the institution and inmates. The contract employee shall immediately inform, in writing to the Contract Officer’s Representative (COR) and Administrative Contracting Officer, adverse action taken by any regulatory body involving certification. This includes, but is not limited to, suspensions, revocations, restrictions on the contract employee licensure.

Inmate Management

Provision of services will not require frequent and unsupervised contact with inmates. The contract employee shall not be responsible for the management of any inmates, other than to ensure inmates involved within the contract’s scope of work abide by all rules to ensure their safety and well-being. The Lab Director shall complete Contractor Orientation prior to assuming institution involvement. Reimbursement to the contract employee (Lab Director) for the time spent in the institution orientation or other specific security related training will be at the contract rate, prorated hourly. The contract employee may, at any time, be removed from the institution at the discretion of the CEO. The contract employee is to constantly be aware of security and maintain a professional relationship with inmates at all times. Any violation of the institution rules and regulations are to be brought immediately to the attention of any Government employee employed at the institution. The Contract employee will report any infractions of rules and regulations by any inmate to the Laboratory Supervisor, Health Services Administrator or the Contracting Officer’s Representative (COR).

Institution Security

The contractor/contract employees shall agree to all regulations prescribed by the institution for the safety, custody, and conduct of inmates. The contract employee will be required to operate a system of records as identified for medical treatment documentation, and will require adherence to the Privacy Act of 1974. The contract employee will be required to sign in and out of the institution for accountability purposes. A badge will be issued and worn at all times for proper Identification.

Pricing

The contract rate for Laboratory Director shall be on a per visit basis. Visit lengths are defined as approximately one to two hours in duration. Services shall be provided in accordance with commercial practices.

Additional Information

This is a contractual agreement and not an appointment. All duties outlined in the Statement of Work shall be performed in accordance with the standards and methods generally accepted with the Contractor’s field of expertise.

Payment shall be based on an end product or the accomplishment of specific results, and the results to be obtained shall be entirely within the contractor’s own unsupervised determination.

In order to ensure accurate records of billing, the contractor must supply a monthly invoice/statement of service rendered to include the required Session-Based Invoice Verification

(SBIV).

Special Considerations

The contractor shall immediately inform the Contract Officer’s Technical Representative (COR) in writing of any adverse action taken by any local, state, federal, or accrediting agency which affects the contractor’s licenses or certifications.

In the event of the contractor’s choice to seek dissolution of this contract agreement, the contractor will give preferably a six month notice to the COR so solicitation of a new lab director service can occur to prevent loss of accreditation and laboratory testing services at FMC Lexington.