CHAPTER 135. SURGICAL SERVICES

§ 135.1. Principle.

 When a hospital provides surgical services, they shall be provided in a manner sufficient to meet the medical needs of the patients.

 The director of the surgical services shall be a member of the medical staff who is certified by the American Board of Surgery or an equivalent board or who is eligible for Board certification or has successfully completed an approved residency training program in surgery.

 A roster of physicians, dentists and podiatrists with a delineation of the surgical privileges of each shall be maintained in the surgical suite and available to the surgical nurse supervisor.

 An operating room register shall be provided and maintained on a current basis. The operating room log or register shall contain date of the operation, name and number of patient, names of surgeons and surgical assistants, names of anesthetists, type of anesthesia given, pre- and postoperative diagnosis, type of surgical procedure, and the presence or absence of complications in surgery. This information may also be maintained in an accession file of copies of the operating room record.

 There shall be an on-call schedule of physicians established and posted at each patient unit or other area where surgical patients are admitted or the communications center of the hospital to ensure that there is 24-hour emergency care or postoperative followup care, or both, available.

   The provisions of this §  135.5 adopted December 9, 1977, effective December 10, 1977, 7 Pa.B. 3631.

POLICIES

§ 135.11. Policies and procedures.

 (a)  The surgical division of the medical staff, shall develop written policies and procedures for surgical services. These policies shall be made available to the medical staff and surgical nursing personnel.

 (b)  The policies and procedures of the surgical services shall establish:

   (1)  Appointment procedures which will fairly evaluate the quality and competence of each surgeon seeking appointment to the surgical staff.

   (2)  Reappointment procedures which provide for the periodic reappraisal of the qualifications and competence of each surgeon.

   (3)  Criteria to determine what circumstances require an assistant present at surgery and to determine whether the assistant should be a physician, a professional, or nonprofessional personnel.

   (4)  Surgical specimens that are exempt from pathological review in §  135.15 (relating to surgical specimens).

   The provisions of this §  135.11 amended under sections 801.1 and 803 of the Health Care Facilities Act (35 P. S. § §  448.801a and 448.803).

 The medical staff shall establish procedures to ensure that preoperative and postoperative medical records are completed in a timely and accurate manner.

 (a)  The record of surgery shall be maintained in accordance with § §  115.31—115.33 (relating to patient medical records; contents; and entries).

 (b)  After the patient has been placed on the operating table, it is the responsibility of the primary operating surgeon and the person administering anesthesia to properly identify the patient and to document this identification in the patient’s medical record. This procedure shall be set forth in written policies designating the mechanism to be used to identify each surgical patient.

 (c)  Procedures shall be established to ensure that, except in emergencies, at least the following data are recorded in the medical record of the patient prior to surgery:

   (1)  Verification of identity of patient.

   (2)  Medical history and supplemental information regarding drug sensitivities and other pertinent facts.

   (3)  General physical examination, details of significant abnormalities, and evaluation of the capacity of the patient to withstand anesthesia and surgery.

   (4)  Provisional diagnosis.

   (5)  Laboratory test results.

   (6)  Consultation reports.

   (7)  Signed informed consent obtained by the surgeon.

   (8)  X-ray reports.

   (9)  Dental X-ray reports if applicable.

   The provisions of this §  135.13 amended under section 2102(g) of The Administrative Code of 1929 (71 P. S. §  532(g)); and section 803 of the Health Care Facilties Act (35 P. S. §  448.803).

 Responsibilities of nursing personnel in the surgical recovery room shall be established.

 Tissues or exudates removed during a surgical procedure shall be properly labeled and sent to the laboratory for examination by the pathologist, who shall determine the extent of examination necessary for diagnosis except as provided in this section. The specimen shall be accompanied by pertinent clinical information, including its source and the preoperative and postoperative surgical diagnosis. A hospital may elect not to send the following categories of specimens to the laboratory for pathologic examination, as set forth in its written policies and procedures:

   (1)  Specimens that by nature or condition do not permit fruitful examination, such as a cataract, orthopedic appliance, calculi, foreign body or a portion of rib removed only to enhance operative exposure.

   (2)  Therapeutic radioactive sources, the removal of which shall be guided by radiation safety requirements.

   (3)  Traumatically injured members that have been amputated and for which examination for either medical or legal reasons is not deemed necessary.

   (4)  Specimens known to rarely, if ever, show pathological change, and removal of which is highly visible postoperatively, such as the foreskin from the circumcision of a newborn infant.

   (5)  Placentas that are grossly normal and have been removed in the course of operative and nonoperative obstetrics.

   (6)  Teeth, if the number, including fragments, is recorded in the medical record.

   The provisions of this §  135.15 amended under sections 801.1 and 803 of the Health Care Facilities Act (35 P. S. § §  448.801a and 448.803).

   The provisions of this §  135.15 adopted December 9, 1977, effective December 10, 1977, 7 Pa.B. 3631; amended June 9, 1989, effective June 10, 1989, 19 Pa.B. 2445. Immediately preceding text appears at serial page (77286).

 A competent adult may authorize any surgical procedure to be performed upon his body, and the consent of no other person is required.

   The provisions of this §  135.16 adopted December 9, 1977, effective December 10, 1977, 7 Pa.B. 3631.

SURGICAL NURSING SERVICES

§ 135.21. Surgical suite nursing administration.

 Surgical suite nursing service shall be under the direction and supervision of a professional registered nurse who is qualified by training and experience in operating room management and techniques.

 When surgical services are provided, professional or nonprofessional personnel, or both, who are trained and experienced in postoperative care shall be provided on a 24-hour basis.

 At least one professional registered nurse shall be on duty in the recovery room whenever the room is occupied. Additional personnel shall be provided to meet the needs of each patient.

 If surgical nursing is a distinct and separate service, the following conditions shall be met, in addition to those governing nursing services generally:

   (1)  The surgical nursing service shall be under the direction and supervision of a professional registered nurse who is qualified by training and experience in the field of surgical nursing.

   (2)  A patient care unit with patients requiring skilled nursing care shall have professional registered nurse supervision on each tour of duty, and the skilled care shall be administered by professional registered nurses.

   (3)  A patient care unit with patients requiring moderate or minimal nursing care, or both, shall have supervision by either a professional registered nurse or a licensed practical nurse on each tour of duty. If the person so assigned is a licensed practical nurse, he shall work under the direction and supervision of a professional registered nurse.

   The provisions of this §  135.24 adopted December 9, 1977, effective December 10, 1977, 7 Pa.B. 3631.