CHAPTER 557. QUALITY ASSURANCE AND IMPROVEMENT

 The ASF, with active participation of the medical and nursing staff, shall conduct an ongoing quality assurance and improvement program designed to objectively and systematically monitor and evaluate the quality and appropriateness of patient care, pursue opportunities to improve patient care and resolve identified problems.

 (a)  The ASF shall have a written plan for the quality assurance and improvement program that describes the program’s objectives, organization, scope and mechanisms for overseeing the effectiveness of monitoring, evaluation and problem solving activities.

 (b)  The written plan shall be endorsed by the governing body and the medical director who are responsible for establishment and direction of the program and which indicates the staff person responsible for implementation of the program.

 (c)  The plan shall emphasize the ongoing nature of the quality assurance program and the comprehensiveness of the scope of the program which shall include monitoring and evaluation of the following:

   (1)  Medical staff functions including:

     (i)   Peer-based review of clinical performance of individuals with clinical privileges.

     (ii)   Surgical case and tissue review.

   (2)  Anesthesia services.

   (3)  Nursing services.

   (4)  Pharmaceutical services.

   (5)  Pathology and radiology services.

   (6)  Infection control procedures.

   (7)  Procedures performed in the ASF and their necessity.

   (8)  Reports of accidents, injuries and safety hazards.

 (d)  The plan shall include participation of practitioners and other health care personnel.

 (a)  The quality assurance program shall include monitoring and evaluation of data collected, based on defined criteria that reflect current knowledge and clinical experience and relate to the care provided by the service. Sources of data include the medical records, incident reports, infection control records and patient complaints. The medical record shall contain sufficient data to support the diagnosis and determine that the procedures are appropriate to the diagnosis. Facilities that treat pediatric patients shall segregate data regarding these patients.

 (b)  The quality assurance program shall provide for the identification of problems and actions taken—through the monitoring and evaluation process—which improve the quality of patient care.

 (c)  The frequency, severity and source of suspected problems or concerns are evaluated by practitioners and nurses.

 (d)  Measures shall be implemented to resolve important problems or concerns identified. The results of these corrective measures shall be monitored to assure that the problem has been satisfactorily resolved. Measures which may be taken include:

   (1)  Changes in policies and procedures.

   (2)  Staffing and assignment changes.

   (3)  Appropriate education and training.

   (4)  Adjustments in clinical privileges.

   (5)  Changes in equipment or physical plant.

 (e)  The program shall include a mechanism to assure that activities are documented and reports of the quality assurance activities are brought to the attention of the governing body. There shall be a periodic reappraisal of the program.

 (f)  The quality assurance program shall include the establishment of a quality assurance committee.

 (a)  The Committee shall consist of the following:

   (1)  A practitioner who is not an owner.

   (2)  A representative of administration.

   (3)  A registered nurse.

   (4)  Other health care personnel, as appropriate.

 (b)  Committee functions shall include:

   (1)  Evaluating data submitted as part of the quality assurance program.

   (2)  Reviewing credentials.

   (3)  Reviewing tissue examination reports.

   (4)  Reviewing infection control program.

   (5)  Reviewing the standards of practice in all specific areas of the ASF.

 (c)  Committee records of the activities shall include:

   (1)  Reports made to the governing body.

   (2)  Minutes of committee meetings including date, time, persons attending, description and results of cases reviewed and recommendations made by the committee.

   (3)  Corrective actions taken including appropriate orientation, training or education programs necessary to correct deficiencies which are uncovered as a result of the quality assurance program.

   The provisions of this §  557.4 amended October 22, 1999, effective November 22, 1999, 29 Pa.B. 5583. Immediately preceding text appears at serial pages (256570) to (256571).