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Commonwealth of Pennsylvania |
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POSITION DESCRIPTION FOR JOB POSTING |
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Position Number: 00025973 |
Description Activated On: 7/15/2024 12:17:27 PM |
Position Purpose: Describe the primary purpose of this position and how it contributes to the organization’s objectives. Example: Provides clerical and office support within the Division to ensure its operations are conducted efficiently and effectively. This position in the Bureau of Laboratories, Division of Laboratory Improvement, supports the organization’s mission of licensing and regulating clinical laboratories within the Commonwealth by performing on-site inspections of laboratories and other activities to ensure the laboratories’ compliance with applicable state regulations and federal requirements. |
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Description of Duties: Describe in detail the duties and responsibilities assigned to this position. Descriptions should include the major end result of the task. Example: Types correspondence, reports, and other various documents from handwritten drafts for review and signature of the supervisor. This position requires frequent travel throughout the Commonwealth to conduct on-site inspections of clinical laboratories. Performs on-site evaluations of all areas of the clinical laboratory to review records of the complexity of testing, laboratory personnel qualifications, instrumentation, quality assurance, laboratory management practices and other factors to ensure compliance with the State’s Clinical Laboratory Act and the Federal Clinical Laboratory Improvement Amendments of 1988 (CLIA ’88) and Food and Drug Administration (FDA) Blood Bank Regulations. Prepares either a letter of compliance, deficiency or adverse action to the laboratory director based upon the on-site visit and evaluates the plan of correction received in response to a letter of deficiency, including supportive documents furnished and recommends for or against state licensure, or CLIA ’88 certification to ensure that the laboratory is aware of its licensure/certification status. Reviews and evaluates data from alternative laboratory monitoring protocols to ensure the laboratory’s compliance with applicable state regulations and federal requirements. Provides technical training and direction to public health and private laboratory personnel of varying backgrounds in regulated laboratories concerning laboratory procedures and tests of wide-ranging complexity as the needs are identified during the on-site or through repeated proficiency testing failures to ensure that laboratories have the needed information to produce quality laboratory test results. Provides consultation in response to requests for state and federal regulatory, technical and reimbursement information to keep laboratories informed about state regulations and federal requirements. Performs investigative visits to laboratories in response to a complaint against a facility originating from governmental or law enforcement agencies, reimbursement agencies and the general public relating to improper quality assurance practices, inaccurate results, unqualified personnel and/or fraud to ensure the protection of the health and welfare of the citizens of the Commonwealth. Schedules monthly activity, including one road trip in overnight status, by selecting from a geographically-based list of laboratories identified by the section supervisor as requiring on-site visits to ensure effective use of state/federal funds and resources. Reviews records of previous laboratory visits, including personnel evaluations, proficiency testing results and correspondence, in order to prepare for the on-site evaluation of a laboratory facility and to identify potential problem areas that must be addressed during the on-site visit to ensure that a thorough review is conducted with the least amount of disruption to the laboratory operations. Acts as a team leader coordinating the activities of a team when the size of the facility dictates a team approach to ensure that a complete and thorough review is conducted. Assists and participates in planning and conducting formal workshops, seminars, in-service programs and conferences pertaining to the state and federal clinical laboratory regulations to provide laboratories with up-to-date information for compliance. Accesses a federal database to retrieve information to determine if a laboratory is due for a survey and enters data from the survey to ensure that the laboratory maintains current federal certification. Works with the Section Supervisor to assist with evaluating and monitoring the performance of clinical laboratories enrolled in external proficiency testing programs to ensure that laboratories are producing quality results. Monitors results of external proficiency testing (PT) programs to determine competency of all licensed laboratories in the Commonwealth for all categories of licensure both by manual and electronic methods to ensure that laboratories are producing quality results. Evaluates plans of corrections submitted by laboratories cited for repeat unsatisfactory proficiency performance and responds appropriately, including drafting technical responses to ensure that laboratories are addressing unsatisfactory performance appropriately. Works with the Section Supervisor to assist with evaluating and monitoring aspects of section activities as required for the CLIA ‘88 State Agency Performance Review (SAPR) to ensure compliance with performance requirements so that CLIA funding is maintained. Sends post clinical laboratory survey questionnaires and summarizes the findings of responses received to facilitate improvement of the on-site survey process. Appears as a witness in court proceeding or as a specialized witness to defend survey findings. Makes up shortfall in clerical support by performing related clerical duties to ensure that the Division operates as required. Adheres to safety policies as described in the Bureau of Laboratories Policy Manual, Chemical Hygiene Plan, and Bloodborne Pathogens Plan to ensure personal safety and the safety of others within the Bureau. Follows Bureau quality control and quality assurance policies to ensure accurate results and outstanding customer service. Shares with colleagues the information gained from external training opportunities to ensure that all staff has current up-to-date information. Public Health Emergency Response - this position may be given an assignment to support the public health emergency response of the Department of Health. Emergency assignments could at times be received with little or no advance notice, and may continue for any period of time - ranging from a few hours to several weeks, depending on the nature of the circumstance. The emergency assignments may at times be performed under adverse conditions and may require travel to another site other than the employee's assigned headquarters for periods of time. Demonstrates awareness of the vulnerable populations the organization serves by identifying, providing, and advocating for resources, services, communication methods, and policies that would help those populations achieve health equity Performs other related duties as required. |
Decision Making: Describe the types of decisions made by the incumbent of this position and the types of decisions referred to others. Identify the problems or issues that can be resolved at the level of this position, versus those that must be referred to the supervisor. Example: In response to a customer inquiry, this work involves researching the status of an activity and preparing a formal response for the supervisor’s signature. Decision making is made based on defined standards or the proper professional/technical discipline. The position determines compliance with state regulations and federal requirements and makes independent decisions to license/certify or deny licensure/certification for a laboratory. The supervisor periodically reviews on-going work progress and results of some assignments. New assignments are performed independently based on knowledge of standards and procedures. The position advises outside of its work unit, serving as an independent representative of the PA Department of Health regarding federal certification and state licensure of laboratory surveys. |
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Requirements Profile: Identify any specific experience or requirements, such as a licensure, registration, or certification, which may be necessary to perform the functions of the position. Position-specific requirements should be consistent with a Special Requirement or other criteria identified in the classification specification covering this position. Example: Experience using Java; Professional Engineer License Experience: Licenses, registrations, or certifications: 1. N/A 2. N/A 3. N/A 4. 5. 6. |
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Essential Functions: Provide a list of essential functions for this position. Example: Transports boxes weighing up to 60 pounds.
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