Center Medical Director - Requires active Medical License in NJ

Job Description

Job Description

Classification : Part-time Independent Contractor (Glassboro & Cherry Hill Locations)

Reports to : Director of Operations

PURPOSE

General Requirements – Adhere to all Standard Operating Procedures, Current Good Manufacturing Practices, and Company Policies. Ensure the facility is in compliance with all applicable state, federal, consignees, and ABO designated regulations. Ensure donor suitability, product integrity, and continued good health of donors through the center’s compliance with the Food and Drug Administration (FDA) regulations, state regulations, the Standard Operating Procedure Manual guidelines of the Company, and any other applicable regulatory standards.

ESSENTIAL RESPONSIBILITIES & DUTIES

CENTER MEDICAL DIRECTOR :

• Perform History and Physical Exams on Applicant Donors.
• Perform Repeat History and Physical exams on an annual basis on qualified donors.
• Explain process of Plasmapheresis.
• Obtain signed consent for Plasmapheresis.
• Explain all risks involved in Plasmapheresis.
• Monitor all reception area personnel in regard to donor acceptability and Total Protein requirements.
• Counsel donors with positive test results.
• Review SPE results.
• Monitor Physician Substitute(s) if applicable.
• Perform Monthly Reviews of Physician Substitutes (observe physical examination).
• Review applicable Donor Records of Physical Examinations and Laboratory tests approved by Physician Substitutes.
• Review all Abnormal SPE results.
• Review all donor adverse reactions.
• Review and approve all new and revised SOP procedures prior to release.
• Help establish Emergency procedures for the center.
• Available (on call) to provide assistance if center staff have questions or need guidance in handling of emergencies.
• Responsible for the continuous application of the Quality Assurance procedures to determine

donor suitability and collection of whole blood (if applicable) and plasmapheresis within the facility.

LABORATORY DIRECTOR :

The laboratory director is responsible for the overall operation and administration of the laboratory, including the employment of personnel who are competent to perform test procedures, and record and report test results promptly, accurately, and proficiently and for assuring compliance with the applicable regulations.

a) The laboratory director, if qualified, may perform the duties of the technical

b) consultant, clinical consultant, and testing personnel, or delegate these

c) responsibilities to personnel meeting the qualifications of §§ 493.1409, 493.1415,

d) and 493.1421, respectively.

e) If the laboratory director reapportions performance of his or her

f) responsibilities, he or she remains responsible for ensuring that all duties are

g) properly performed.

h) The laboratory director must be accessible to the laboratory to provide onsite,

i) telephone or electronic consultation as needed.

j) Each individual may direct no more than five laboratories.

k) The laboratory director must—

1. Ensure that testing systems developed and used for each of the tests performed in

the laboratory provide quality laboratory services for all aspects of test performance, which

includes the preanalytic, analytic, and post-analytic phases of testing;

2. Ensure that the physical plant and environmental conditions of the laboratory are appropriate

for the testing performed and provide a safe environment in which employees are protected

from physical, chemical, and biological hazards;

3. Ensure that—

i) The test methodologies selected have the capability of providing the quality of results required for patient care;

ii) Verification procedures used are adequate to determine the accuracy, precision, and other pertinent performance characteristics of the method; and

iii) Laboratory personnel are performing the test methods as required for accurate and reliable results;

4. Ensure that the laboratory is enrolled in an HHS-approved proficiency testing program for the testing performed and that—

i) The proficiency testing samples are tested as required under subpart H of this part;

ii) The results are returned within the timeframes established by the proficiency testing program;

iii) All proficiency testing reports received are reviewed by the appropriate staff to evaluate the laboratory's performance and to identify any problems that require corrective action; and

iv) An approved corrective action plan is followed when any proficiency testing results are found to be unacceptable or unsatisfactory;

5. Ensure that the quality control and quality assessment programs are established and maintained to assure the quality of laboratory services provided and to identify failures in quality as they occur;

6. Ensure the establishment and maintenance of acceptable levels of analytical performance for each test system;

7. Ensure that all necessary remedial actions are taken and documented whenever significant deviations from the laboratory’s established performance specifications are identified, and that patient test results are reported only when the system is functioning properly;

8. Ensure that reports of test results include pertinent information required for interpretation;

9. Ensure that consultation is available to the laboratory's clients on matters relating to the quality of the test results reported and their interpretation concerning specific patient conditions;

10. Employ a sufficient number of laboratory personnel with the appropriate education and either experience or training to provide appropriate consultation, properly supervise, and accurately perform tests and report test results in accordance with the personnel's responsibilities described in this subpart;

11. Ensure that prior to testing patients' specimens, all personnel have the appropriate education and experience, receive the appropriate training for the type and complexity of the services offered, and have demonstrated that they can perform all testing operations reliably to provide and report accurate results;

12. Ensure that policies and procedures are established for monitoring individuals who conduct preanalytical, analytical, and post-analytical phases of testing to ensure that they are competent and maintain their competency to process specimens, perform test procedures, and report test results promptly and proficiently, and whenever necessary, identify needs for remedial training or continuing education to improve skills;

13. Ensure that an approved procedure manual is available to all personnel responsible for any aspect of the testing process; and

14. Specify, in writing, the responsibilities and duties of each consultant and each person, engaged in the performance of the preanalytic, analytic, and post-analytic phases of testing, that identifies which examinations and procedures each individual is authorized to perform, whether supervision is required for specimen processing, test performance or results reporting, and whether consultant or director review is required prior to reporting patient test results.

REQUIREMENTS

PHYSICAL DEMANDS

Performing the responsibilities of the job requires regular use of hands to finger, handle, or feel objects, tools, or controls, and to reach with the hands and arms. Frequently required to stand, walk, climb, or balance; and to stoop, kneel or crouch. May be required to walk and stand for short periods of time. Ability to read and type while sitting in front of a computer. Physically able to use and operate equipment used in assessing donor suitability. Ability to lift tug and pull up to 25 pounds.

WORK ENVIRONMENT

This job operates in a professional office environment. This role routinely uses standard office equipment such as computers, phones, photocopiers, filing cabinets, and fax machines. May be exposed to bloodborne pathogens and other conditions common to a donor center. Personal protective equipment is required such as eyewear, lab coats, and gloves.