CLIA Lab Director

Role: CLIA Lab Director (Waived Testing Only)

Location: Hybrid; Remote with monthly on site visits in Hanover, PA 17331

Start date: Asap

Hours: Flexible, available for guidance as necessary on a weekly basis

Pay: $500/month

CLIA Lab Director Responsibilities

• Be responsible for and actively involved in the overall operation and administration of the Lab, collaborating closely with onsite Nurse Practitioners or Physician Assistants and providing expert guidance and consultation on laboratory results to ensure they have the necessary insights to make informed clinical decisions when necessary.
• Be available to the Lab and its personnel to provide onsite, telephone, or electronic consultation as needed; on-site requirements limited to monthly visits with documentation of supervision
• Ensure that the Lab is in compliance with all applicable federal, state and local laws, rules, regulations, and professional standards, including without limitation, CLIA and all CLIA Regulations applicable to a laboratory performing waived testing
• Ensure that the Lab: (1) develops and implements policies, processes, and procedures and use the resources necessary to provide consistent, high quality waived testing services; (2) uses a quality system to approach to laboratory services testing that provides accurate, reliable, and timely patient test results
• Ongoing monitoring of each testing process used in the Lab in order to identify errors or potential problems that could result in errors;
• Taking corrective action; and
• Evaluating the corrective actions taken, to make sure that they were effective and prevent recurrence;
• Ensure the Lab is enrolled and participates in an HHS-approved proficiency testing program that meets the applicable criteria for the testing performed at the Lab, and that all conditions for enrollment and testing of samples required by the CLIA Regulations are met, including, without limitation, those set forth in subpart H of the CLIA Regulations;
• Ensure the Lab’s physical and environmental conditions are adequate and appropriate for the testing performed
• Ensure that new test procedures are reviewed, included in the procedure manual of the Lab, and followed by Lab personnel;

CLIA Lab Director Requirements

• Must be qualified to a manage and direct the laboratory personnel and performance of CLIA-waived tests and must be eligible to be an operator of a laboratory within the requirements of CLIA regulations, including 42 C.F.R. §493.1443
• Must possess a current license as a laboratory director issued by the State of Pennsylvania
• Demonstrated working knowledge and competency within a laboratory environment
• Must possess excellent written and oral communication skills
• Demonstrated competency using computer hardware, lab information systems and automated test instruments
• Demonstrated skills prioritizing and organizing workload
• Superb attention to detail; ability to follow processes and procedures from beginning to end within established timelines
• Ability to handle discreet, confidential information
• Desire to work as part of an interdisciplinary team to meet the needs of health center customers

Archive Background

Working with a range of healthcare providers, such as nurse practitioners, doctors, psychotherapists and nutritionists, Archive operates onsite healthcare clinics across America and Mexico. Our vision is to create beautiful healthcare spaces, run by compassionate, insightful professionals dedicated to helping people flourish mentally and physically.