CHAPTER 555. MEDICAL STAFF

§ 555.1. Principle.

 There shall be an organized medical staff which is accountable to the governing body and which has responsibility for the quality of medical care provided to patients and for the ethical conduct and professional practice of its members and other practitioners who have been granted clinical privileges in the ASF.

 A member of the medical staff shall be qualified for membership and the exercise of clinical privileges granted to him. The governing body of the ASF, after considering the recommendations of the medical staff, may grant clinical privileges to qualified, licensed practitioners in accordance with their training, experience and demonstrated competence and judgment. Members of the medical staff and others granted clinical privileges shall currently hold licenses to practice in this Commonwealth.

 (a)  To receive favorable recommendation for appointment, or reappointment, members of the medical staff shall always act in a manner consistent with the highest ethical standards and levels of professional competence.

 (b)  Privileges granted shall reflect the results of peer review or utilization review programs, or both, specific to ambulatory surgery.

 (c)  Privileges granted shall be commensurate with an individual’s qualifications, experience and present capabilities.

 (d)  Granting of clinical privileges shall follow established policies and procedures in the bylaws or similar rules and regulations. The procedures shall provide the following:

   (1)  A written record of the application, which includes the scope of privileges sought and granted. The delineation ‘‘clinical privileges’’ shall address the administration of anesthesia.

   (2)  A review, summarized on record with appropriate documentation, of the qualifications of the applicant.

 (e)  Reappraisal and reappointment shall be required of every member of the medical staff at regular intervals no longer than every 2 years.

 (f)  The governing body shall request and consider reports from the National Practitioner Data Bank on each practitioner who requests privileges.

   The provisions of this §  555.3 amended October 22, 1999, effective November 22, 1999, 29 Pa.B. 5583. Immediately preceding text appears at serial page (256562).

 (a)  If the ASF assigns patient care responsibilities to physician assistants and nurse practitioners, the medical staff shall have established policies and procedures approved by the governing body, for overseeing and evaluating their clinical activities. The training, experience and demonstrated current competence of physician assistants and nurse practitioners shall be commensurate with their duties and responsibilities.

 (b)  Physician assistants shall perform within the limits established by the medical staff and consistent with the Medical Practice Act of 1985 (63 P. S. § §  422.1—422.45) and the Osteopathic Medical Practice Act (63 P. S. § §  261—271). Certified registered nurse practitioners shall perform within the limits established by the medical staff and consistent with the Professional Nursing Law (63 P. S. § §  211—225.5) and the joint regulations of the State Boards of Medicine and Nursing.

 (c)  Physician assistants and nurse practitioners shall be licensed or certified as applicable.

   The provisions of this §  555.4 amended October 22, 1999, effective November 22, 1999, 29 Pa.B. 5583. Immediately preceding text appears at serial page (256563).

MEDICAL ORDERS

§ 555.11. Written orders.

 (a)  Medication or treatment shall be administered by authorized persons to administer drugs and medications only upon written and signed orders of a practitioner acting within the scope of the practitioner’s license.

 (b)  Physician assistants and certified registered nurse practitioners may write orders for medication or treatment in accordance with their legally authorized scope of practice and policies and procedures of the ASF.

 (c)  Written orders may be issued by facsimile transmission.

 Oral orders for medication or treatment shall be accepted only under urgent circumstances when it is impractical for the orders to be given in written manner by the responsible practitioner. Oral orders shall be administered in accordance with §  555.13 (relating to administration of drugs) only by personnel qualified by their professional license or certification issued by the Commonwealth and according to medical staff bylaws or rules, who shall document the orders in the proper place in the medical record of the patient. The order shall include the date, time and full signature of the person taking the order and shall be countersigned by a practitioner within 48 hours of the order. If the practitioner is not the attending physician, the practitioner shall be authorized by the attending physician and shall be knowledgeable about the patient’s condition. Countersignatures may be received by facsimile transmission.

 Drugs shall be administered only upon the proper order of a practitioner acting within the scope of the practitioner’s license and authorized according to medical staff bylaws, rules and regulations. Drugs shall be administered directly by a practitioner qualified according to medical staff bylaws, rules and regulations or by a professional nurse or by a licensed practical nurse with pharmacy training. Physician assistants and certified registered nurse practitioners shall be permitted to administer drugs within their authorized scope of practice. Further policies on the administration of drugs shall be established by the medical staff in conjunction with pharmaceutical services or personnel.

   The provisions of this §  555.13 adopted October 22, 1999, effective November 22, 1999, 29 Pa.B. 5583.

SURGICAL SERVICES

§ 555.21. Surgical procedures.

 Procedures performed in the ASF are limited to procedures that are approved by the governing body, upon the recommendation of the medical staff and congruent with ASF classification as stated on its ASF license.

 (a)  Pertinent medical histories and physical examinations, and supplemental information regarding drug sensitivities shall be documented the day of surgery or one of the following:

   (1)  If medical evaluation, examination and referral are made from a private practitioner’s office, hospital or clinic, pertinent records thereof shall be available and made part of the patient’s clinical record at the time the patient is registered and admitted to the ASF. This information is considered valid only if the evaluation was performed no more than 30 days prior to date of surgery.

   (2)  A practitioner shall examine the patient immediately before surgery to evaluate the risk of anesthesia and of the procedure to be performed. The information shall be clearly documented in the medical record.

 (b)  A written statement indicating informed consent, obtained by the practitioner, and signed by the patient, or responsible person, for the performance of the specific procedures shall be procured and made part of the patient’s clinical record. It shall contain a statement which evidences the appropriateness of the proposed surgery, as well as any alternative treatments discussed with the patient. It shall also identify any practitioner who will participate in the surgery.

 (c)  Written instructions for preoperative procedures, which have been approved by the medical staff, shall be given to the patient or responsible person, and shall include:

   (1)  Applicable restrictions upon food and drink before surgery.

   (2)  Special preparations to be made by the patient.

   (3)  The required proximity of the patient to the ASF for a specific time following surgery, if applicable.

   (4)  An understanding that the patient may require admission to the hospital in the event of medical need.

   (5)  Upon discharge of a patient who has received sedation or general anesthesia, a responsible person shall be available to escort the patient home. With respect to patients who receive local or regional anesthesia, a medical decision shall be made regarding whether these patients require a responsible person to escort them home.

 (d)  Preoperative diagnostic studies, if performed, shall be evaluated, annotated, signed and entered into the patient’s medical record before surgery.

 (e)  Prior to the administration of anesthesia, it is the responsibility of the primary operating surgeon and the person administering anesthesia to properly identify the patient and the procedure to be performed and to document this identification in the patient’s medical record. This procedure shall be in written policies designating the mechanism to be used to identify each surgical patient.

   The provisions of this §  555.22 amended October 22, 1999, effective November 22, 1999, 29 Pa.B. 5583. Immediately preceding text appears at serial pages (256563) to (256564).

 (a)  Approved surgical procedures shall be performed only by a qualified physician, dentist or podiatrist within the limits of the practitioner’s defined specific practice privileges. Physician assistants and certified registered nurse practitioners may be permitted to assist in the performance of surgical procedures in accordance with their legally authorized scope of practice and the policies and procedures of the ASF.

 (b)  Tissues and exudates removed during a surgical procedure shall be properly labeled and sent to a laboratory for examination by a pathologist. The specimen shall be accompanied by pertinent clinical information, including its source and the preoperative and postoperative surgical diagnosis. The pathologist’s signed report of the examination shall be made a part of the patient’s medical record. Certain tissues and exudates may be exempt from laboratory examination. The exemptions shall be those that are consistent with current medical practices and are in writing and approved by the governing body.

 (c)  An ASF shall be prepared to initiate immediate onsite resuscitation or other appropriate response to an emergency which may be associated with procedures performed there.

 (d)  The ASF shall have an effective procedure for the immediate transfer to a hospital of patients requiring emergency medical care beyond the capabilities of the ASF.

 (e)  The ASF shall have a written transfer agreement with a hospital which has emergency and surgical services available, or physicians performing surgery in the ASF shall have admitting privileges at a hospital in close proximity to the ASF, to which patients may be transferred.

 (f)  There shall be a written agreement in effect with an ambulance service staffed by certified EMT personnel, for the safe transfer of a patient to a hospital in an emergency situation, or as the need arises.

 (a)  The findings and techniques of an operation shall be accurately and completely written or dictated immediately after the procedure by the practitioner medical staff member who performed the operation. If a physician assistant or certified registered nurse practitioner performed part of the operation, the findings and techniques of the procedure shall be accurately recorded and the report shall be countersigned by the medical staff member. This description shall become a part of the patient’s medical record.

 (b)  A patient who has received anesthesia shall be observed in the facility by a registered nurse, physician assistant or a practitioner for a period of time which is sufficient to ensure that no immediate postoperative complications are present.

 (c)  Patients in whom a complication is known or suspected to have occurred during or after the performance of a surgical procedure shall be informed of the condition and arrangements made for treatment of the complication. In the event of admission to an inpatient facility, a summary of care given in the ASF concerning the suspected complication shall accompany the patient.

 (d)  A medical professional certified in advanced cardiac life support shall be present until patients operated on that day have been discharged from the facility. If a patient receives general anesthesia, regional anesthesia or IV sedation, an anesthetist shall remain present until that patient has been discharged from the facility.

 (e)  Patients shall be discharged in the company of a responsible person, if one is deemed to be necessary under §  555.22(c)(5) (relating to preoperative care).

 (f)  Protocols approved by the medical staff shall be established for instructing patients in self-care after surgery including written instructions which, at a minimum, include the following:

   (1)  The symptoms of complications associated with procedures performed.

   (2)  An explanation of prescribed drug regime including directions for use of medications.

   (3)  The limitations and restrictions on activities of the patient, if necessary.

   (4)  A specific telephone number to be used by the patient, if a complication or question arises.

   (5)  A date for follow-up or return visit after the performance of the surgical procedure.

   (6)  Instructions on the care of dressing and wounds.

   (7)  Instructions on dietary limitations.

 (g)  Patients shall be discharged only on the written signed order of a practitioner.

   The provisions of this §  555.24 amended October 22, 1999, effective November 22, 1999, 29 Pa.B. 5583. Immediately preceding text appears at serial page (256565).

   This section cited in 28 Pa. Code §  553.21 (relating to principle).

ANESTHESIA SERVICES

§ 555.31. Principle.

 (a)  Anesthesia services provided in the facility are limited to those techniques that are approved by the governing body upon the recommendation of qualified medical staff. They shall be limited to those techniques appropriate to the assigned classification per ASF license.

 (b)  The governing body shall define the degree of supervision required and the scope of responsibilities delegated to anesthesiologists, certified registered nurse anesthetists and dentist anesthetists, as well as the corresponding responsibilities of supervising physicians.

 (a)  Anesthetics shall be administered by anesthesiologists and certified registered nurse anesthetists and dentist anesthetists, or practitioners as defined in §  551.3 (relating to definitions).

 (b)  If a nonphysician administers the anesthesia, the anesthetist shall be under the overall direction of an anesthesiologist or a physician or dentist who is present in the ASF.

 (c)  The Director of Anesthesia Services shall be responsible for designating the physician or dentist who will be responsible for the overall direction of the anesthetist.

 (a)  In ASFs where an anesthesiologist is present, the anesthesiologist shall be designated the Director of Anesthesia Services and shall be responsible for directing the anesthesia services and establishing the general policies and procedures for the administration of anesthesia in the ASF which shall be approved by the governing body.

 (b)  In ASFs where there is no anesthesiologist, the governing body shall designate a physician or dentist to function as the Director of Anesthesia Services, who shall be responsible for directing the anesthesia services and establishing the general policies and procedures for the administration of anesthesia in the ASF which shall be approved by the governing body.

 (c)  Policies and procedures shall be developed for anesthesia services and shall include the following:

   (1)  Education, training and supervision of personnel.

   (2)  Responsibilities of nonphysician anesthetists.

   (3)  Responsibilities of supervising physicians or dentists.

 (d)  Anesthesia procedures shall provide at least the following:

   (1)  A patient requiring anesthesia shall have a pre-anesthesia evaluation by a practitioner, with appropriate documentation of pertinent information regarding the choice of anesthesia.

   (2)  A review and documentation shall be made of the condition of the patient immediately prior to induction of anesthesia, including pertinent laboratory findings, time of administration and dosage of preanesthesia medications.

   (3)  Prior to beginning the administration of anesthesia, the anesthetist shall check equipment to be used in administration of anesthetic agents. An anesthetic gas machine in anesthetising areas shall have a pin-index safety system.

   (4)  Following the procedure for which anesthesia was administered, the anesthetist shall remain with the patient as long as necessary to insure safe transport to the recovery area and shall advise personnel responsible for postanesthetic care of the condition of the patient.

   (5)  A patient receiving anesthesia shall have an anesthetic record maintained. This shall include a record of vital signs and all events taking place during the induction of, maintenance of and emergence from anesthesia, including the dosage and duration of anesthetic agents, other drugs and intravenous fluids.

   (6)  Intraoperative physiologic monitoring shall include the following at a minimum:

     (i)   The use of oxygen saturation by pulse oximetry.

     (ii)   The use of End Tidal CO₂ monitoring during endotracheal anesthesia.

     (iii)   The use of EKG monitoring.

     (iv)   The use of blood pressure monitoring.

   (7)  A patient may not receive general anesthesia unless one or more additional health care professionals besides the one performing the surgery, are present, one of whom is trained in the administration of anesthesia.

   (8)  Before discharge from the ASF, a patient shall be evaluated for proper anesthesia recovery by an anesthetist, the operating room surgeon, anesthesiologist or dentist. Depending on the type of anesthesia and length of surgery, the postoperative check shall include at least the following:

     (i)   Level of activity.

     (ii)   Respirations.

     (iii)   Blood pressure.

     (iv)   Level of consciousness.

     (v)   Oxygen saturation by pulse oximetry.

 (a)  Appropriate precautions shall be taken to ensure the safe administration of anesthetic and other medical gas agents, in accordance with the latest edition of NFPA Code 56G, and other applicable NFPA Codes as required.

 (b)  The machines used for anesthesia shall have at least one annual function testing by technicians with appropriate training and a log of this testing and outcomes shall be maintained.

   The provisions of this §  555.35 amended October 22, 1999, effective November 22, 1999, 29 Pa.B. 5583. Immediately preceding text appears at serial page (256567).