Lab Director - Fractional/Part Time

Job Description

Dash is seeking a qualified, board-certified Laboratory Director on a fractional (contract) basis to direct the laboratory through initial CLIA certification (COC) and maintain compliance thereafter for the High Complexity work completed by the Dash team.. The Director will hold overall responsibility for the laboratory's operation and administration under 42 CFR Part 493, Subpart M, and will be named as Laboratory Director on the CMS-116 application.The Director will delegate specific duties in writing to qualified personnel but remains accountable for every delegated function.

Key Responsibilities

Duties follow the director standards in 42 CFR 493.1445 (high complexity).

Certification phase (pre-inspection)

1. Review and sign the CMS-116 application; serve as the named Laboratory Director with the State Agency or accrediting organization (CAP, COLA, or The Joint Commission).
2. Confirm test menu and complexity categorization; identify the specialties and subspecialties to be listed.
3. Approve the laboratory's physical plant, environmental conditions, and safety program as appropriate for the testing performed.
4. Establish and approve the procedure manual, including the written policy for director on-site visits and how each visit is documented.
5. Approve method verification (moderate-complexity FDA-cleared tests) or full validation (modified tests and LDTs) before any patient testing begins.
6. Enroll the laboratory in HHS-approved proficiency testing for every regulated analyte.
7. Verify personnel qualifications; appoint technical consultant/supervisor, clinical consultant, general supervisor, and testing personnel in writing with defined duties.
8. Approve training and initial competency assessment for all testing personnel.
9. Lead the laboratory through the initial survey and sign the plan of correction for any cited deficiencies.

Ongoing compliance (post-certification)

1. Be on-site at least once every 6 months, with at least 4 months between the two minimum visits, and document each visit with evidence of director activities performed.
2. Remain accessible by phone or electronic means to provide consultation as needed.
3. Oversee the quality control and quality assessment programs; review QC, calibration, and corrective actions.
4. Review proficiency testing results and attestations; direct investigation and corrective action for unsatisfactory results.
5. Ensure competency assessment is performed semiannually in the first year and annually thereafter for each testing employee.
6. Ensure test reports contain required information and that results are reported promptly and accurately.
7. Review and sign new or revised procedures, and complete periodic procedure reviews.
8. Ensure the laboratory is prepared for biennial inspections and maintains records for required retention periods.
9. Provide clinical consultation to ordering providers on test selection and result interpretation, directly or through a qualified clinical consultant.

Duties may be delegated in writing to qualified personnel; the Director remains responsible for their proper performance. A director may direct no more than five non-waived laboratories.

Qualifications

Candidates must hold a current state license in the state of Massachusetts and meet at least one pathway below for the laboratory's complexity level, under the personnel rules effective December 28, 2024. 

All experience and training must have been obtained in a CLIA-certified laboratory. Director Continuing Education must cover the director responsibilities and be completed before qualifying.

Accepted HHS-approved boards for doctoral-level directors include ABB, ABCC, ABMM, ABMLI, ABMGG, ACHI, ASCP BOC, and doctoral-level ABFT or NRCC certifications.

Candidates must also:

• Currently direct no more than four other non-waived laboratories, so this role does not exceed the five-laboratory limit.
• Hold an active, unrestricted medical license in Massachusetts 
• Have no CLIA sanctions or exclusions, including the two-year prohibition after directing a laboratory whose certificate was revoked.

Time Commitment

The Director will be reachable by phone or email during testing hours, with a response time of 3 business days for routine issues and <1 business day for critical issues such as failed QC or PT.