Laboratory Compliance Evaluator

2 weeks ago

Hillsboro, United States State of Oregon Full time
Position Overview:

The State of Oregon is seeking a dedicated Laboratory Compliance Evaluator to oversee inspections related to clinical laboratory operations, including non-medical substance testing and health screening permits.

This is a full-time, permanent position that is part of a unionized workforce. The recruitment process may be utilized to create a pool of qualified candidates for current and future openings.

Key Responsibilities:

As a Laboratory Compliance Evaluator, your primary duties will include conducting assessments and supporting the administration of the Clinical Laboratory Improvement Amendments (CLIA) program within the Laboratory Compliance team of the Regulatory Section. You will independently manage and monitor all clinical laboratory inspections to ensure timely execution and address any complaints regarding clinical, drug testing, and health screening laboratories. Your role will involve:

  • Performing thorough inspections for clinical laboratory testing, non-medical substance abuse testing, and health screening permit evaluations.
  • Assessing whether deficiencies present an immediate risk to public safety and taking necessary actions, which may include halting laboratory testing until compliance is confirmed.
  • Determining the level of deficiencies, whether they warrant standard or conditional citations, or if they pose immediate and serious risks to patient outcomes.
  • Evaluating the adequacy of laboratories' claims of compliance or corrective action plans to address identified deficiencies.

Qualifications:

To be considered for this role, candidates must possess:

  • A bachelor's degree in chemical, physical, biological science, medical technology, or a related discipline AND four years of relevant laboratory training and experience in high complexity testing, along with the ability to analyze facts for compliance recommendations.
  • Alternatively, a master's degree in the aforementioned fields AND two years of relevant laboratory training and experience.

Preferred Skills:

  • In-depth knowledge of clinical laboratory testing and familiarity with state and federal laboratory regulations.
  • Compliance with CMS requirements for clinical laboratory surveyors.
  • Experience as a technical supervisor under CLIA, with clinical laboratory experience across various specialties.
  • Certification from ASCP or AMT is advantageous.
  • Understanding of potential biological and chemical threat agents.
  • Proficiency in surveying, interpreting, and applying complex regulations, including documenting findings and preparing investigative reports.
  • Ability to articulate deficiency citations clearly, ensuring compliance issues are understandable in legal contexts.
  • Experience fostering a culturally competent and diverse work environment.

Benefits:

The State of Oregon offers a supportive work environment with a commitment to health equity and diversity. Benefits include:

  • Comprehensive health insurance with minimal out-of-pocket expenses.
  • Generous paid leave, including holidays, personal business days, sick leave, and vacation.
  • Retirement plan options after a specified period of service.
  • Opportunities for student loan forgiveness through qualifying programs.
  • Additional optional benefits, including disability insurance and flexible spending accounts.
  • Continuous professional development opportunities.

Work Environment:

This position supports a hybrid work model, allowing for both in-office and remote work. On-site presence is required for a portion of the week, with the flexibility to work remotely on designated days. Travel across the state is necessary, with potential overnight stays.

Application Process:
Interested candidates should complete the online application and submit a resume and cover letter detailing their qualifications and experiences relevant to this position.

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