[27 Pa.B. 2703]
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PROGRAM, SERVICE, PERSONNEL AND AGREEMENT REQUIREMENTS § 138.11. Director.
The director of the cardiac catheterization service shall be Board certified in cardiology or pediatric cardiology.
§ 138.12. Medical staff.
(a) There shall be at least two physicians staffing the cardiac catheterization laboratory to perform angiographies.
(b) These physicians shall have graduated from an accredited training program in cardiac catheterization or have demonstrated training and experience acceptable to the credentialling committee of the hospital.
§ 138.13. Nursing staff.
(a) There shall be at least one registered nurse assigned to the cardiac catheterization laboratory at all times who shall have intensive care or coronary care experience and knowledge of cardiovascular medications, and experience with cardiac catheterization. In pediatric units, this nurse shall also have experience in pediatric cardiac surgery units.
(b) Other nursing personnel shall include nurses with specialized education which includes theory, advanced technical skills and supervised experience in a cardiac catheterization service before assuming primary responsibility for the nursing care of cardiac catheterization patients.
(c) There shall be nursing service goals and objectives, standards of nursing practice, procedure manuals and written job descriptions for each level of personnel which includes the following:
(1) A means for assessing the nursing care needs of the patients and determining adequate staffing to meet those needs.
(2) Staffing patterns that are adequate to meet the nursing goals, standards of practice and the needs of the patients.
(3) An adequate number of licensed and unlicensed assistive personnel to assure that staffing levels meet the total nursing needs of the patient.
(4) Nursing personnel assigned to duties consistent with their training, experience and scope of practice, where applicable.
§ 138.14. Programs and services.
(a) To perform cardiac catheterizations a hospital shall be an acute care facility that:
(1) Has inpatient medical and surgical services onsite.
(2) Has a coronary care unit onsite with 24-hour per day monitoring capability.
(3) Has a peripheral vascular surgical program available.
(4) Provides noninvasive cardiac diagnostic modalities including exercise and pharmacologic stress testing, echo cardiography and nuclear cardiology.
(5) Has a setting in which ambulatory cardiac catheterization patients can be observed for 4 to 6 hours after the procedure.
(6) Has adequate physician coverage to manage postprocedure complications.
(b) Outpatient diagnostic cardiac catheterization services shall be performed if care is exercised in selecting only appropriate low risk patients as defined in this chapter.
(c) To allow for continuity of care, mobile cardiac catheterization laboratories may be utilized onsite at a hospital which is already providing cardiac catheterization services while the existing, fixed cardiac catheterization laboratory is being renovated or its equipment upgraded.
§ 138.15. High-risk cardiac catheterizations.
A hospital may perform high-risk cardiac catheterizations only if it has an open heart surgical program onsite.
§ 138.16. Transfer agreements for low-risk cardiac catheterization hospitals.
(a) A hospital that does not have an open heart surgical program onsite may perform low-risk cardiac catheterizations if the hospital has protocols for distinguishing between low and high-risk cardiac catheterization patients and a formal written agreement with at least one hospital that does have an open heart surgical program onsite, which agreement includes the following:
(1) Protocols addressing indications, contraindications and other criteria for the emergency transfer of patients in a timely manner.
(2) Assurance of transfer of patients to an open heart surgery program and initiation of open heart surgery in a timely manner.
(3) Provision for semiannual data exchange on performance between the hospitals party to the agreement.
(4) Specification of mechanisms for continued substantive communication between the hospital's party to the agreement, and between their sending and receiving physicians.
(5) A provision prohibiting the hospital receiving the transferred patient from duplicating the diagnostic cardiac catheterization unless clinically appropriate.
(b) The agreement shall remain continuously in effect and be reviewed at least annually.
§ 138.17. PTCA.
(a) In a hospital in which elective PTCA is performed, each physician performing PTCAs shall have graduated from an accredited training program in PTCA or have demonstrated training and experience acceptable to the credentialling committee of the hospital.
(b) A rigorous mechanism for valid peer review shall be established and ongoing in any hospital offering PTCA services.
(c) If a hospital that does not have an open heart surgery program onsite performs an emergency PTCA, the hospital shall report the circumstances to the Department in writing within 72 hours.
§ 138.18. EPS.
(a) In a hospital in which EPS is performed, each physician performing EPS shall have graduated from an accredited training program in electrophysiology or have demonstrated training and experience acceptable to the credentialling committee of the hospital.
(b) Therapeutic electrophysiology, including ablation and the implantation of automatic implantable cardiovertor defibrillators shall be performed in a hospital with an open heart surgery program, and not in any other facility. Implantation of routine permanent pacemakers may be performed in hospitals that do not have an open heart surgery program onsite. Pediatric diagnostic electro- physiology procedures also shall only be performed at a hospital with onsite pediatric cardiovascular surgery.
§ 138.19. Pediatric cardiac catheterizations.
A hospital may perform pediatric cardiac catheterizations only if:
(1) It has a pediatric heart surgical program onsite.
(2) The physicians and other staff who participate in the pediatric cardiac catheterizations are trained and experienced in the care of the pediatric cardiac patient.
(3) The equipment used for pediatric cardiac catheterizations is appropriate to meet the needs of the pediatric patient. Bi-plane cineangiography shall be readily available 24 hours per day, and laboratories (both catheterization and general chemical) shall be equipped for small volume samples.
§ 138.20. Quality management and improvement.
(a) A hospital providing cardiac catheterization services shall maintain patient data on the following:
(1) Mortality/morbidity.
(2) Infections and complications (stroke rate, rate of myocardial infarction, vascular complications, length of stay, rate of emergency bypass surgery for PTCA, and the like).
(3) Patient risk factors (age, medical history, and the like).
(4) Volume of procedures performed (including separate volumes for diagnostic visualizations, PTCA and electrophysiology procedures).
(b) The hospital shall provide this information to the Department on a quarterly basis, on a form prescribed by the Department. This data shall be integrated into the hospital's quality assurance program and used to ensure necessary corrections to improve outcomes.
(c) The Department will review the information submitted by the hospital and other relevant information which is available to assess the qualitative performance of the hospital's cardiac catheterization program. The Department will publish, by statement of policy, the values or standards, or both, for each of the factors reported to the Department.
(d) If the Department's review of this information raises concerns with the quality of care in a cardiac catheterization program, the Department will undertake a review of that program to determine if these concerns are valid. The hospital shall cooperate with the Department in this review.
CHAPTER 139. [NEWBORN] NEONATAL SERVICES
GENERAL PROVISIONS § 139.1. Principle.
When a hospital provides [newborn] neonatal services, they shall be provided in [such] a manner [as to meet] that meets the medical needs of the newborns.
§ 139.2. Scope.
This chapter applies to hospitals which provide obstetrical or [newborn] neonatal infant care, or both. The Department recognizes the following levels of neonatal care:
(1) Level I. (Normal Neonatal).
(2) Level II. (Neonatal Intermediate/Intensive Care).
(3) Level III. (Neonatal Intensive Care).
§ 139.2a. Definitions.
The following words and terms, when used in this chapter, have the following meaning, unless the context clearly indicates otherwise:
Board certified--A physician licensed to practice medicine in this Commonwealth who has successfully passed an examination and has maintained certification in the relevant medical specialty area or subspecialty area, or both, offered by one of the following groups:
(i) The American Board of Medical Specialists.
(ii) The American Osteopathic Association.
(iii) The foreign equivalent of either group listed in subparagraph (i) or (ii).
Board eligibility or board eligible--A physician licensed to practice medicine in this Commonwealth who has completed the preliminary requirements necessary to take an examination by the American Board of Medical Specialists, the American Osteopathic Association or the foreign equivalent of either group and who is presently eligibile to take the examination and is within 3 years of attaining eligibility.
Guidelines--The term refers to the current Guidelines for Perinatal Care issued by the American Academy of Pediatrics and the American College of Obstetricians and Gynecologists.
NICU--Neonatal intensive care unit--The term refers to a unit which is specifically equipped and staffed for the care and treatment of high-risk infants and those infants otherwise in need of intensive care.
§ 139.3. Director.
A member of the medical staff shall be appointed director of [newborn] neonatal services. [He] The director shall be certified by the American Board of Pediatrics or an equivalent board, eligible for Board certification or have successfully completed an approved residency in pediatrics.
§ 139.4. Nursing services.
(a) [Newborn] Neonatal nursing services shall be provided in accordance with Chapter 109 (relating to nursing services) and [the provisions of] this section.
(b) A registered professional nurse, especially trained and experienced in the care of normal and high-risk infants,[ shall be designated as the nursing supervisor of the nurseries. At least one registered professional nurse shall be on duty in at least one nursery at all times when any nursery is occupied] shall be responsible for the neonatal care unit at all times when the unit is occupied. No [occupied nursery] newborn shall be left unattended.
(c) [All nursery personnel shall have education and nursing skills which are appropriate to their duties and assignments] Licensed nursing personnel shall be assigned to duties consistent with their legal scope of practice. Unlicensed assistive personnel shall be assigned duties consistent with standardized training and competency evaluation.
(d) [A sufficient number of nursing personnel shall be on duty at all times to provide adequate infant care in all nurseries.] Staffing shall be adequate to meet nursing care goals, standards of nursing practice and nursing care needs of patients. The appropriate number of staff necessary to accomplish these goals, standards and needs shall be established in the written policies of the [newborn] neonatal service and shall be [based on current recommendations of the American Academy of Pediatrics] consistent with the Guidelines.
FACILITIES § 139.11. Facilities and equipment.
The maternity and [newborn] neonatal services shall be separate and apart from other hospital services and especially from potential sources of infection. Access to each [nursery] neonatal care unit shall be controlled to insure security and safety of all infants.
§ 139.12. [Nursery] Neonatal care units.
(a) [All hospitals] Hospitals with maternity services shall provide [well infant nurseries] neonatal care units with areas for newborn recovery, observation[,] and isolation and provisions or arrangements for the care of high-risk infants in a [''special care nursery,''] neonatal intensive care unit either at the facility of birth or at a transfer site. Space allocation and total number of bassinets [should conform to the current recommendation of the American Academy of Pediatrics] shall be consistent with the Guidelines.
[(b) Well newborn infants delivered within the hospital may be admitted directly to the infant nursery. The term ''well infant nursery'' shall mean a nursery for the care of well newborn infants.
(c)] (b) There should be an isolation area for the reception and care of infants exposed to potential sources of infection and infants suspected of or having any communicable disease. Infants may be housed and nursed in the isolation area pending diagnosis, disposition[,] or completion of treatment. This isolation area should be served by [nursery] nursing personnel and shall meet the standards established in the Guidelines for this type of care.
[(d)] (c) A [special care nursery] neonatal intensive care unit is one which is specifically equipped and staffed for the care and treatment of high-risk infants and those otherwise in need of intensive care. The neonatal intensive care unit shall meet the standards established in the Guidelines for this type of care. If such a service is not provided at the facility of birth, arrangements [must] shall be made with [a ''transfer nursery''] an existing neonatal intensive care unit in the area of appropriate referral. The judgment of the attending physician and the policies of the hospital's Neonatal Services department shall determine the need for consultation with and referral to the hospital with an existing neonatal intensive care unit. The term ''high risk infant'' means any infant who, on the basis of socioeconomic, genetic[,] or patho-physiologic history prior to delivery or on the basis of findings in the newborn period, manifests or is likely to manifest persistent and significant signs of distress. This [includes but is not limited to the following] may include:
* * * * * [(e) A ''transfer nursery,'' as used in subsection (d), is a special care nursery staffed and equipped to receive and provide appropriate care to infants transferred from the facility of birth for specialized diagnostic and treatment services. All requirements in this chapter for special care nurseries also apply to transfer nurseries.]
§ 139.13. [Nursery equipment] Equipment and supplies.
(a) Required equipment and supplies shall be in accordance with this section, the Guidelines for Design and Construction of Hospital and Health Care Facilities issued by the American Institute of Architects and with written policies of the [newborn] neonatal service which shall be [based upon current recommendations of the American Academy of Pediatrics] consistent with the Guidelines.
(b) An individual bassinet and equipment for the exclusive use of the infant to whom it is assigned shall be provided for each infant. All necessary supplies shall be stored in covered containers to permit individualized infant care and minimize risk of infection.
(c) Each [nursery] neonatal care unit shall have its own wash basin with hot and cold running water equipped with foot, knee[,] or elbow control so that hand contact with the sink is avoided. A sufficient supply of an antiseptic cleansing agent and disposable towels shall be readily available. Where paper towels are used, a dispenser shall be provided.
(d) [Special care nurseries] Neonatal intensive care units shall be equipped with all equipment and supplies required for other [nurseries] care units.
§ 139.14. Oxygen control.
Oxygen shall be administered only with proper apparatus for its safe administration and control of concentration. Concentration of oxygen should not exceed a safe level commensurate with current concepts of oxygen therapy as recommended by the [American Academy of Pediatrics] Guidelines.
§ 139.15. Temperature control.
A stable year-round temperature and humidity shall be maintained in all [nurseries] neonatal care units in accordance with written newborn service policies consistent with [current recommendations of the American Academy of Pediatrics] the Guidelines.
§ 139.16. Housekeeping and maintenance.
The [nursery service] neonatal care unit shall be maintained in a clean and sanitary manner at all times. An environmental services room shall be provided for the exclusive use of the neonatal unit and shall be directly accessible from the unit.
§ 139.17. [Special care nurseries] Neonatal intensive care units (Levels II and III).
In addition to the general requirements for the equipment of [nurseries] neonatal care units, the following provisions shall be required for all new construction, renovation or expansion of [special care nurseries] neonatal intensive care units and [should] shall be available to all present [special care nurseries] neonatal intensive care units:
(1) The construction and arrangement of the [special care nursery] neonatal intensive care unit shall permit personnel to observe the infants and have immediate access to them. Total [nursery] neonatal care unit space, exclusive of anteroom, shall provide adequate floor space consistent with the [current recommendations of the American Academy of Pediatrics] the Guidelines.
(2) Each infant requiring heat or air control, or both, shall have [his own] a separate incubator or other warming device and [ his own] an individual environment with individualized heat, oxygen, suction[,] and air turnover controls, as appropriate. Any infant whose condition permits may be placed in a bassinet.
* * * * * (4) A double-grounded electrical outlet shall be provided for each incubator or radiant warmer. Sufficient extra outlets should be provided for other electronic patient care equipment. Some electrical outlets in the[ nursery] unit shall be on the emergency electrical circuit of the hospital and shall be so marked.
(5) Resuscitation equipment [must] shall be available within the [nursery] neonatal intensive care unit. An effective method for preventing heat loss by the infant shall be available while [he] the infant is undergoing any treatment.
(6) Air within [special care nurseries shall] neonatal intensive care units may not be recirculated and shall be frequently turned over each hour.
POLICIES § 139.21. Policies and procedures.
The director of [newborn] neonatal services shall be responsible for developing written policies and procedures for [nursery] the provision of medical services within the neonatal care unit which shall be available to the medical and nursing staff. The policies and procedures shall be reviewed by the director once a year and revised as necessary, and dated to indicate the time of last review. They shall provide specifications to conform to [the requirements of] §§ 139.22--139.29 [of this title (relating to policies)].
§ 139.22. Physicians' services.
(a) [A physician on-call schedule shall be posted in the nursery to ensure that] There shall be a physician [is] available at all times. This physician shall be certified by the American Board of Pediatrics or an equivalent board, eligible for Board certification, or have successfully completed an approved residency in pediatrics.
(b) [All newborn] Newborn infants shall have a complete physical examination [by a physician or his authorized delegate in the delivery room and also within 24 hours after admission to the nursery], at or near the time of delivery consistent with the recommendations contained in the Guidelines and the results of the examinations shall be recorded in the infant's medical record.
* * * * * (e) There shall be a method for the proper identification of each infant and his mother or other responsible person at the time of discharge from the hospital. Infants discharged or transferred to another [nursery] neonatal care unit or hospital shall be carefully identified.
§ 139.23. Delivery suite services.
* * * * * (b) The director of obstetrics and the director of [newborn] neonatal services shall formulate policies and procedures for delivery room care of infants [ which are consistent with the recommendations of the nursery committee]. These policies and procedures shall be written and shall include provisions for:
(1) Notification of the physician in charge of the infant and the nurse [in charge of the nursery] responsible for the provision of nursing services in the neonatal care unit when the delivery of a potentially high-risk infant is expected.
* * * * * (8) A carefully planned procedure to be instituted for the transportation of newborn infants to the [nursery] neonatal care unit from the delivery room to insure maximum protection of the infant. Transfer of distressed infants to the [nursery] unit shall be done in [such] a manner [as to minimize] that minimizes heat loss and to insure adequate oxygenation.
(9) The record of the newborn infant to accompany [him] the infant from the place of delivery to the [nursery] neonatal care unit and be immediately available to [nursery] unit personnel. This record shall include information concerning prenatal history, course of labor, delivery, drug administration to mother and infant, Apgar score, relevant conditions of the mother, procedures performed on the infant in the delivery room, complications of any type, and other facts and observations.
§ 139.24. [Special care nurseries] Neonatal intensive care units (Levels II and III).
(a) In hospitals with [special care nurseries] neonatal intensive care units, the director of the [newborn] neonatal services [and the nursery committee] shall develop written policies and procedures regarding admission of infants to [special care nurseries] neonatal intensive care units.
(b) Policies for [special care nurseries shall] neonatal intensive care units include:
(1) [requirements] Requirements, in accordance with the [current recommendations of the Academy of Pediatrics] Guidelines, for staffing of [special care nurseries] neonatal intensive care units. In addition, [transfer and special care nurseries] these units shall be staffed on every shift by at least one registered professional nurse who has special training, experience[,] and interest in infants requiring special care and who is assigned no other responsibilities.
(2) [a] A requirement that a pediatrician designated by the director of the [newborn] neonatal services shall be on call 24 hours a day.
(3) [a] A provision that private physicians or specialists may care for their patients in [special care nurseries] neonatal intensive care units. However, the final authority for policy in [special care nurseries] neonatal intensive care units shall reside with the director of [the newborn] neonatal services.
(4) [a] A requirement that ancillary [nursery] personnel employed to meet the needs of infants shall have appropriate, specified skills and training.
(5) [provisions] Provisions for physicians, nurses, and social service staff to assist parents of special care infants to become acquainted with their infant and [his] any problems during [his] the infant's hospitalization.
(6) [a] A definite written policy, developed by the [nursery committee] director of neonatal services, which provides for the unique problems involved in the total care of infants in [special care nurseries] neonatal intensive care units to be met, by making arrangements with the hospital nursing and social service departments and community health and social agencies, and by specifying what provisions will be made for continuing care, follow-up[,] and home assistance.
§ 139.25. Control of infection.
(a) The director of [newborn] neonatal services [and the nursery committee] through the hospital's infection control program shall establish procedures for the control of infection, governing [such] mat- ters such as [nursery] appropriate attire, isolation, and cleaning of equipment in the neonatal care unit. Infection control procedures for [newborn] neonatal services may be included among the responsibilities of the committee established [pursuant to § 147.21 (relating to infection control)] under other licensure regulations. These procedures shall be written, reviewed at least annually[,] and dated to indicate the date of last review.
(b) Infection control procedures shall do the following:
(1) [prohibit] Prohibit common or group carriers for transporting infants to their mothers[; and].
(2) [require] Require and specify procedures for scrupulous hand cleansing by all [nursery] neonatal care unit personnel and visitors before and after each infant contact.
(c) [Consideration shall be given to the current recommendations of the American Academy of Pediatrics] The infection control standards shall be consistent with the current Guidelines.
§ 139.26. Care given by parents.
(a) The [maternity] obstetrical and [nursery] neonatal care departments of any hospital which provides rooming-in services shall have written policies governing [such] the services. These procedures shall be designed to prevent cross contamination.
* * * * * § 139.27. Laboratory services and radiological services.
* * * * * (d) A hospital in which a [special care nursery] neonatal intensive care unit is located shall have a licensed blood bank, available or on call to the [nursery] unit on a 24-hour-a-day, [seven] 7-day-a-week basis.
§ 139.28. Patient medical records.
Patient medical records shall be maintained in accordance with Chapter 115 (relating to medical records services). The following information shall also be included in the [newborn] neonatal record if the entire maternal records are not maintained as the [newborn] neonatal records [as set forth] in § 115.23(b) (relating to preservation of medical records):
* * * * * (9) Condition of infant at birth, including the [one] 1-and [five] 5-minute Apgar Score or its equivalent, resuscitation, time of sustained respirations, details of physical abnormalities, pathological states observed and treatments given before transfer to the [nursery] neonatal care unit.
* * * * * § 139.29. Infant nursing records.
Upon admission to a [nursery] neonatal care unit, nurses shall initiate and maintain records on all infants as to weight, type[,] and volume of feedings; time of first voiding; time of passage of first stool; number, color[,] and consistency of stools; and temperature. If abnormalities are suspected or recognized, nurses shall also make notations on respiratory rate, dyspnea, color, cyanosis, jaundice, pallor, lethargy, twitching, motor activity, skin and buttocks, vomiting, condition of the eyes and umbilical cord, and other relevant factors as indicated and warranted by the condition of the infant. Treatments, medication[,] and special procedures ordered by a physician should also be recorded with time, date[,] and the name and title of the individual who administers them.
[FORMULA] NUTRITIONAL SERVICES § 139.31. Policies and procedures.
Written policies and procedures for infant feeding [and formula preparation, if appropriate,] shall be established and shall be available to the medical and nursing staffs.
§ 139.32. Commercial formula.
Precautions [must] shall be taken to prevent the contamination and expiration of commercial formulas.
§ 139.33. Formula preparation.
(a) A [professional] registered professional nurse or dietitian shall be in charge of formula preparation.
* * * * * § 139.34. Breastfeeding.
Management of breastfeeding mothers and infants shall be [in accordance with current recommendations of the American Academy of Pediatrics] consistent with the Guidelines.
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