Newborn Screening CLIA Director, HYBRID/Part-Time

Newborn Screening CLIA Director - Part Time/Hybrid

About Us:

Our mission at the Ohio Department of Health (ODH) is advancing the health and well-being of all Ohioans. Our agency is committed to building a modern, vibrant public health system that creates the conditions where all Ohioans flourish.

The Ohio Department of Health supports a hybrid teleworking model. This position may work a hybrid schedule at the discretion of the manager or supervisor, which will require occasional attendance in the office for training, meetings and other operational needs. Employees must reside within a reasonable distance to their assigned headquarters for compliance with workplace reporting requirements.

The ODH Public Health Laboratory assists the agency, local health departments, and clinicians across Ohio in disease outbreak investigations, public health emergencies, and identification of disease causes to aid in treatment and prevention. Our services include screening for diseases of public health interest, reference support for confirmation of low incidence infectious agents, laboratory investigation to determine epidemiological patterns, and oversight of the state's alcohol breath testing program. Samples received annually to exceed 1,000,000, tests performed (e.g., newborn screening, microbiology, serology, virology).

The ODH Public Health Laboratory performs routine testing of patient and environmental samples for a multitude of tests. These testing requirements include, but are not limited to:

A. Newborn Screening

B. Microbiology

C. Serology

D. Virology

To be able to legally perform this testing, the laboratory must hold a Certificate of Compliance issued by the Centers for Medicare and Medicaid Services (CMS) under the Clinical Laboratory Improvement Amendments (CLIA).

CLIA regulations require a high complexity laboratory to have a Laboratory Director available to oversee the overall operation and administration of the laboratory. This is to ensure that personnel are competent to perform test procedures, and record and report test results promptly, accurately, and proficiently and for assuring compliance with the applicable regulations.

What You'll Do:

As the CLIA Public Health Lab Administrator (Newborn Screening), you will plan, direct and manage the Bureau of Public Health Laboratory in all activities related to Microbiology testing to include proper testing, reporting results, test interpretation, development of test methodologies, setting of standards & certification of tests meeting CLIA/CAP certification requirements &/or other state & federal guidelines.

* Supervises supervisory personnel (e.g., microbiology supervisors)

* Develops laboratory budget & monitors expenditures

* Participates in developing new programs, methodologies & tests

* Develops, implements & enforces laboratory policies, procedures & performance standards affecting wide range of entities (e.g., local health departments, agency institutions, hospitals, physicians)

* Oversees all laboratory testing & research activities and provides scientific expertise to staff for all human related specimens (Newborn Screening and Radiation Chemistry, if applicable)

* Provides continuous feedback and training; ensures that staff is qualified and cross-train ODH newborn screening staff to provide consistent and timely services

* Provides assistance and guidance to the ODH laboratory staff as an alternate Responsible Official for the Select Agent Program

* Ensures regulations, policies, and procedures related to maintaining the Ohio Public Health Laboratory's CLIA license are followed

* Reviews and approve all laboratory procedures, safety manuals, and proficiency testing results (before submission to vendor and upon receipt of evaluation report)

* Submits an annual review of training and competency files and corrective action plans/reports

* Develops strategic planning initiatives

* Ensures timely review and approval of all laboratory procedure and safety manuals, review and approval of all proficiency testing results (before submission to vendor and upon receipt of evaluation report) demonstrated by comments, signature/date

* Ensures an annual review of training and competency files and corrective action plans/reports demonstrated by comments, signature/date

What's in it for you:

At the State of Ohio, we take care of the team that cares for Ohioans. We provide a variety of quality, competitive benefits to eligible full-time and part-time employees. For a list of all the State of Ohio Benefits, visit our Total Rewards website! Our benefits package includes:

Medical Coverage

* Quality, affordable, and competitive medical benefits are offered through the Ohio Med PPO plan.

Dental, Vision and Basic Life Insurance

* Dental, vision and basic life insurance premiums are free after one year of continuous service.

Time Away From Work and Work/Life Balance

* Paid time off, including vacation, personal, and sick leave

* 11 paid holidays per year

* Childbirth/Adoption leave

Ohio Public Employees Retirement System

* OPERS is the retirement system for State of Ohio employees. The employee contributes 10% of their salary towards their retirement. The employer contributes an amount equal to 14% of the employee's salary. Visit the OPERS website for more information.

Deferred Compensation

* The Ohio Deferred Compensation program is a 457(b) voluntary retirement savings plan. Visit the Ohio Deferred Compensation website for more information.

Ohio is a Disability Inclusion State and strives to be a Model Employer of Individuals with disabilities. The State of Ohio is committed to providing access and inclusion and reasonable accommodation in its services, activities, programs and employment opportunities in accordance with the Americans with Disabilities Act (ADA) and other applicable laws.

This position is unclassified in accordance with ORC 124.11 (A) (9)

THIS POSITION FALLS WITHIN THE UNCLASSIFIED CIVIL SERVICE STATUS. EMPLOYEES IN THE UNCLASSIFIED CIVIL SERVICE OF THE STATE OF OHIO SERVE AT THE PLEASURE OF THE APPOINTING AUTHORITY AND MAY BE REMOVED FROM THEIR UNCLASSIFIED POSITION AT ANY TIME FOR ANY LEGAL REASON.

Qualifications as outlined by Code of Federal Regulations 493.1443 Standard;

The CLIA laboratory director must be qualified to manage and direct the laboratory personnel and performance of high complexity tests and must be eligible to be an operator of a laboratory. Below are 6 qualification options to meet this requirement:

(1) Be a doctor of medicine or doctor of osteopathy licensed to practice medicine or osteopathy in the State in which the laboratory is located; and Be certified in anatomic or clinical pathology, or both, by the American Board of Pathology or the American Osteopathic Board of Pathology or possess qualifications that are equivalent to those required for such certification; OR

(2) Be a doctor of medicine, a doctor of osteopathy or doctor of podiatric medicine licensed to practice medicine, osteopathy or podiatry in the State in which the laboratory is located; and have at least one year of laboratory training during medical residency (for example, physicians certified either in hematology or hematology and medical oncology by the American Board of Internal Medicine); or have at least 2 years of experience directing or supervising high complexity testing; OR

(3) Hold an earned doctoral degree in a chemical, physical, biological, or clinical laboratory science from an accredited institution and o Be certified and continue to be certified by a board approved by HHS; or o Before February 24, 2003, must have served or be serving as a director of a laboratory performing high complexity testing and must have at least: (A) Two years of laboratory training or experience, or both; and (B) Two years of laboratory experience directing or supervising high complexity testing. OR

(4) Be serving as a laboratory director and must have previously qualified or could have qualified as a laboratory director under regulations at 42 CFR 493.1415, published March 14, 1990 at 55 FR 9538, on or before February 28, 1992; OR

(5) On or before February 28, 1992, be qualified under State law to direct a laboratory in the State in which the laboratory is located; OR

(6) For the subspecialty of oral pathology, be certified by the American Board of Oral Pathology, American Board of Pathology, the American Osteopathic Board of Pathology, or possess qualifications that are equivalent to those required for certification.

And in addition, certificate to practice medicine in state of Ohio as issued by State Medical Board pursuant to Section 4731.14 & 4731.281 of Revised Code is required for criteria in which licensure is noted.

Job Skills: Public Health

Technical Skills: Executive Leadership, Laboratory, Public Health

Professional Skills: Attention to Detail, Decision Making, Developing Others, Strategic Thinking, Written Communication