Lab Director

Location:

Hanover, Maryland Reports to:

Medical Director Compensation:

$150,000 - $200,000 annually, commensurate with experience and education Position Summary Maryland Primary Care Physicians, LLC (MPCP) is the largest physician-owned primary care group in Maryland, serving families across Central Maryland for nearly 30 years through ten offices. As part of our commitment to convenient, coordinated care, MPCP operates an on-site clinical laboratory performing moderate complexity testing under a CLIA Certificate of Compliance and COLA accreditation. The laboratory processes over 3 million tests annually and is supported by a team of 18 laboratory staff members. We are seeking a qualified Laboratory Director to provide overall direction and oversight of the laboratory, ensuring the accuracy, reliability, and timeliness of all patient test results and full compliance with CLIA regulations (42 CFR Part 493) and COLA accreditation standards. The Laboratory Director is responsible for the management of the laboratory across the pre-analytic, analytic, and post-analytic phases of testing. The director may delegate specific duties in writing but retains ultimate responsibility for the laboratory's compliance and quality. Key Responsibilities

• Provide overall management and direction of the laboratory and its personnel.
• Ensure the physical and environmental conditions of the laboratory are adequate and safe.
• Ensure testing systems provide quality results appropriate for patient care, including verification of test method performance specifications before use.
• Employ a sufficient number of qualified personnel and ensure each is appropriately trained, with documented competency assessed at required intervals.
• Ensure enrollment and successful participation in an approved proficiency testing (PT) program, with PT results reviewed and corrective action taken as needed.
• Establish and maintain quality control and quality assessment programs, and ensure problems are identified and corrected.
• Ensure reported results include pertinent reference intervals and that a system is in place for reporting and addressing critical and imminently life-threatening values.
• Specify, in writing, the responsibilities and duties of each consultant and each person performing testing, including the level of supervision required.
• Ensure policies and procedures are established, reviewed, approved, and followed, and that the procedure manual is current and available to staff.
• Serve as, or designate qualified individuals to serve as, the Technical Consultant and Clinical Consultant as required for moderate complexity testing.
• Maintain compliance with CLIA, COLA, state, and applicable federal requirements, and serve as the laboratory's point of contact during inspections and surveys.
• Manage laboratory budgets, procurement of supplies, and vendor relationships.
• Plan for testing and equipment enhancements to allow the laboratory to stay current with clinical practice.

Minimum Qualifications (CLIA-Qualifying Pathways) The Laboratory Director must satisfy one of the following CLIA pathways for a moderate complexity laboratory director under 42 CFR 493.1405, along with the corresponding Maryland personnel qualifications under

COMAR 10.10.07.04C

Pathway 1 — Pathologist (preferred)

• A licensed MD or DO, and
• Board certified in anatomic and/or clinical pathology by the American Board of Pathology or the American Osteopathic Board of Pathology. Pathway 2 — Doctoral Scientist
• An earned doctoral degree (e.g., PhD) in a chemical, biological, clinical/medical laboratory science, or medical technology field, and
• Board certification by an HHS-approved certifying board, and
• At least 1 year of experience directing or supervising non-waived testing, and 20 CE credit hours covering director responsibilities. Pathway 3 — Master's Degree
• A master's degree in a chemical, biological, clinical/medical laboratory science, or medical technology field, and
• At least 1 year of laboratory training or experience, and 1 year of supervisory experience in non-waived testing, and 20 CE credit hours covering director responsibilities. Pathway 4 — Bachelor's Degree
• A bachelor's degree in a chemical, biological, clinical/medical laboratory science, or medical technology field, and
• At least 2 years of laboratory training or experience, and 2 years of supervisory experience in non-waived testing, and 20 CE credit hours covering director responsibilities.

OR Individuals qualified as a moderate complexity laboratory director and serving as a moderate or high complexity testing laboratory director in a CLIA-certified laboratory as of December 28, 2024 and have done so continuously since December 28, 2024. Preferred Qualifications

• Prior experience as a CLIA laboratory director or technical consultant in a physician office laboratory or comparable multi-site outpatient setting.
• Working knowledge of COLA accreditation standards and survey processes.
• Experience with relevant testing specialties (e.g., chemistry, hematology, urinalysis, immunoassay)
• Familiarity with the laboratory information system(s) LabDaq and Epic used at MPCP.
• Strong understanding of quality management systems and

CLIA/COLA

documentation practices.

• Strong analytical and problem-solving abilities.
• Excellent leadership, organizational, and communication skills.
• Experience supporting a high-volume laboratory operation and supervising a multi-member laboratory team.

MMR and Flu vaccinations required (Unless approved for a medical or religious exemption) PPD Background Check and Drug Test required