PROPOSED RULEMAKING
DEPARTMENT OF HEALTH
[28 PA. CODE CHS. 51, 136, 138, 139 AND 158]]
Health Facility Licensure
[27 Pa.B. 2703] The Department of Health (Department) proposes to amend Part IV (relating to health facilities) by adding Chapters 51, 136, 138, 158 and amending Chapter 139 to read as set forth in Annex A.
Purpose and Procedure
This proposed rulemaking amends the standards a hospital needs to satisfy to secure authorization to perform open heart surgery, cardiac catheterizations, organ transplantation surgery and to provide services to newborns under its hospital license. They also would prohibit open heart surgery, cardiac catheterizations and organ transplantation surgery from being performed at nonhospital locations. Finally, the Department proposes to add a general information chapter which would set forth regulations which are applicable to all health care facilities.
On December 18, 1996, those provisions of the Health Care Facilities Act (act) (35 P. S. §§ 448.101--448.904b), relevant to the Certificate of Need (CON) Program terminated. See section 904(a) of the act (35 P. S. § 448.904(a)). On December 14, 1996, the Department published notice that it would undertake a review of those clinically related health services covered under the CON Program. See 26 Pa.B. 6029 (December 14, 1996).
This review involved the formation of 14 work groups to review the 23 clinically related health services which were previously reviewed under the CON Program. The members of the work groups, in addition to representatives from the Department's CON licensure and legal staff, were chosen for their expertise and knowledge of the particular service. Each work group included a physician who practiced the particular specialty under review. Additionally, representatives of Statewide organizations in the health care arena were invited to participate in the work groups. The work groups were chaired by either a Deputy Secretary or the Department's Chief Counsel.
The 14 work groups were organized to review the following services: (1) ambulatory surgical care; (2) cardiac catheterization; (3) long-term care; (4) neonatal care; (5) open heart surgery; (6) vital organ transplantation; (7) comprehensive medical rehabilitation--inpatient; (8) drug and alcohol rehabilitation--inpatient; (9) emergency department; (10) intermediate care facility/mentally retarded (ICF/MR); (11) lithotripsy--biliary and renal; (12) magnetic resonance imaging (MRI) and positron emission tomography (PET); (13) medical surgery and inpatient surgery; and (14) psychiatric inpatient--adult, child and adolescent.
The Department determined that the work groups on open heart surgical services, organ transplantation surgical services, cardiac catheterization services and neonatal services should begin to meet immediately. This was due to the need to address as quickly as possible any quality assurance gaps which could be present for these high risk health services.
The work groups met during the months of January and February, 1997. Their assigned task was to examine the criteria contained in the State Health Services Plan (SHSP) and determine if any of the criteria contained therein discussing quality assurance and patient safety should be added to existing regulations of the Department regarding licensure of health care facilities. The act provides that, in order to be issued a license, a health care provider must show that: (1) it is a responsible person; (2) the place to be used as a health care facility is adequately constructed, equipped and maintained and safely and efficiently operated; (3) it will provide safe and efficient services adequate for the care and treatment of patients or residents; and (4) it is in substantial compliance with the rules and regulations of the Department. See section 808(a) of the act (35 P. S. § 448.808(a)). Therefore, with the termination of the CON Program, the Department's focus is on the quality of care provided at the health care facilities which it licenses in this Commonwealth.
The open heart surgery, cardiac catheterization, vital organ transplantation surgery and neonatal services work groups were comprised of representatives from the Department, the Pennsylvania Medical Society (PMS), the Pennsylvania Nurses Association (PNA), the Hospital Association of Pennsylvania (HAP), Legislative staff and other persons with expertise regarding these services. The following specialists were active members of their respective work groups: cardiac surgeon (open heart surgical services), cardiologist (cardiac catheterization), transplant surgeon (organ transplant work group) and neonatologist (neonatal). These four work groups were chaired by a Deputy Secretary of the Department. The four work groups submitted to the Secretary of Health (Secretary) a report and draft regulations. Those materials were then made available to the general public and public hearings were conducted. Before the amendments in Annex A were decided upon, the written and verbal comments received during the hearing process were considered by the Secretary and Department staff. Additional input regarding the merits of recommendations contained in the comments was also solicited from persons with relevant expertise.
At the conclusion of their review and discussion of relevant material regarding these various health care services, the work groups drafted proposed recommendations to the Secretary. The recommendations of the work groups differed depending on the service being reviewed. The work groups on open heart surgery, cardiac catheterization and vital organ transplantation surgery recommended that the Department draft new regulations to address quality assurance aspects of these services. The work group on neonatal care recommended that the Department amend its current regulations so as to assure compliance with the Nationally recognized standards of neonatal care. The work groups agreed that the Department should address, in a general information chapter, the notification requirements for health care facilities that intend to offer these services.
On February 1, 1997, the Department published notice that six work group recommendations were available and that a public meeting would be held on February 11, 1997. See 27 Pa.B. 621 (February 1, 1997). These six work groups reviewed the following services: cardiac catheterization, intermediate or skilled nursing care inpatient services, ambulatory surgical care, neonatal care, open heart surgery and vital organ transplantation services. Approximately seven individuals presented testimony at the public meeting on February 11. In addition, written comments were received from various individuals and institutions.
The existing hospital licensure regulations do not address or include any specific requirements that focus upon the provision of open heart surgical, cardiac catheterization services and organ transplantation surgery. The Department has concluded that the current regulations do not impose quality standards necessary to protect the health, safety and welfare of potential candidates for these services and that the regulatory deficiency requires remedy through the addition of regulations addressing these specific services and the relevant quality assurance requirements. Under CON, hospitals which planned to offer these services needed to meet quality standards in the SHSP. In the absence of quality standards, the health, safety and welfare of the patients who need these services are at risk.
Following the sunset of CON, hospitals that had not received a CON to provide open heart surgery, cardiac catheterization services, organ transplantation services and neonatal services have been able to provide those services without first demonstrating to the Department satisfaction of important quality standards. To date, the Department is aware of six hospitals that have started or intend to start to provide open heart surgery since the termination of CON. The Department has also been notified that six new cardiac catheterization laboratories are commencing to provide services and that one hospital is starting to provide transplantation surgery. Each of these services constitutes a surgical procedure involving invasion of a vital organ, and life threatening circumstances.
Similarly, while Chapter 139 (relating to newborn services) of the Department's present regulations discuss newborn services, the Department believes that the chapter is not consistent with the current standards and technology for the treatment of newborns and infants and needs to be updated. The Department is aware of at least one hospital that has opened a neonatal intensive care unit (NICU) since the termination of CON. These units provide intensive care to newborns and infants who suffer from low birth weight, respiratory distress, congenital anomalies, seizures, infections or serious feeding difficulties which pose an immediate threat to neonatal survival. The Department is concerned that NICU units meet all of the current quality assurance standards. The proposed amendments will address these issues, by adopting the current Guidelines for Perinatal Care issued by the American Academy of Pediatrics and the American College of Obstetrics and Gynecology and by setting forth other updated standards relating to quality assurance matters.
Finally, the Department agrees with the work groups that a general information chapter should be added to the regulations to address notification requirements for the addition of services at health care facilities. The Department also proposes to address other issues in this chapter which are common to all health care facilities.
Summary
Subpart A. General Provisions.
Chapter 51. General Information Subpart A and Chapter 51 are proposed new additions to the licensure regulations. This subpart will contain those provisions which are applicable to all health care facilities. Chapter 51 contains general information which must be followed by all health care facilities.
Section 51.1 (relating to legal base and scope) would provide that this chapter is applicable to all health care facilities.
Section 51.2 (relating to licensed facilities) would identify the types of health care facilities which are licensed by the Department.
Section 51.3(a) (relating to notification) would provide that when health care facilities wish to add new health care services, they must first notify the Department of their intent to do so and cannot add these services until the Department has informed them of their compliance with all licensure requirements. With the termination of CON, the licensure process becomes the chief mechanism by which the Department can assess compliance with quality assurance and patient safety criteria. Section 51.3(b) provides a similar notification requirement for the addition of beds to a health care facility. This language already appeared in the regulations for general and special hospitals and long term care facilities, but now will be applicable to all health care facilities. Under § 51.3(h), a health care facility may not provide a new health care service or add beds until it has been informed by the Department that it is in compliance with the licensure regulations.
Section 51.3(c) would provide that a health care facility must provide written notice to the Department at least 30 days before the date it intends to cease the provision of an existing health care service or to decrease its bed complement. Unlike § 51.3(a) and (b), the health care facility may cease these services or decrease the number of beds after the passage of 30 days from the date of notification to the Department, even if the Department has not responded to the health care facility.
Section 51.3(d) would provide that a health care facility must provide written notice to the Department at least 30 days prior to the initiation of any design phase for new construction, alteration or renovation of the facility. By requiring this notice, the Department will be apprised as soon as possible of a health care facility's construction plans and will be able to provide advice and assistance to the health care facility at an early juncture, which could lead to a cost savings for the facility if it finds at this beginning phase that its construction plans need to be modified in order to comply with the Department's regulations.
Section 51.3(e) and (f) would provide that if a health care facility becomes aware that it is in noncompliance with the Department's regulations or is aware of the occurrence of an event at the facility or a situation at the facility which could compromise the quality of care or patient safety, the facility must immediately notify the Department of this fact and the steps which it will take to bring the facility into compliance with the regulations or rectify the situation. These sections reflect the Department's concern that it be aware of any situations at licensed health care facilities which could pose a threat to the quality of care being provided and the safety of the patients or residents in that facility. By requiring immediate notification, the Department can assure that it will learn of these matters as soon as possible and can take steps, including working with the facility in question, to ensure that the matter is corrected before any further problems occur.
Section 51.4 (relating to change in ownership; change in management) would require that health care facilities inform the Department when a change of ownership or a transfer of more than 5% of the stock or equity occurs.
Section 51.5 (relating to building occupancy) would require that all health care facilities must undergo occupancy surveys at least 2 weeks prior to the expected commencement of the occupancy of new or remodeled facilities.
Sections 51.11--51.13 (relating to civil rights) would provide the civil rights compliance expected from all health care facilities.
Under §§ 51.21--51.24 (relating to restriction of provision of health care services) restrictions would be placed on the location of the provision of certain health care services. These restrictions grew out of the recommendations of the work groups that certain services should only be performed in hospitals or in appropriately equipped ambulatory surgical facilities. Under § 51.21, surgery may only be performed in an acute care hospital or in a licensed ambulatory surgical facility. Section 51.22 would limit the performance of cardiac catheterization services to acute care hospitals. Section 51.23 provides that PET may be provided only in a hospital which complies with the Department's regulations governing nuclear medicine and radiology. Section 51.24 provides that lithotripsy services may only be provided in a hospital or in an ambulatory surgical facility which is authorized to provide anesthesia. These restrictions were believed to be appropriate to assure quality of care and patient safety.
Sections 51.31--51.34 (relating to exceptions) provide for an exceptions process, wherein any health care facility may request that the Department waive the applicability of certain regulations.
The proposed addition of Chapter 51 will necessitate the future deletion of duplicative requirements elsewhere in the regulations, particularly in the general hospital, long term care facility and ambulatory surgical facility regulations.
Subpart B. General and Special Hospitals
Chapter 136. Open Heart Surgical Services The work group that considered the provisions of the SHSP on open heart surgical services included all of the representatives of the various entities set forth previously.
After an exhaustive review of the criteria contained in the SHSP, the current regulations, National standards and the approaches taken by other states, the work group recommended that the Department promulgate new regulations addressing this service. Existing regulations do not address qualitative criteria for an open heart surgery program. Due to the complexity and life threatening aspects of this surgery, the Department agrees that specific regulations are necessary to ensure quality of care and patient safety.
Section 136.1 (relating to principle) would require that all adult open heart surgical services and all pediatric open and closed heart surgical services must be performed in hospitals and at no other location. This continues the requirement previously contained in Chapter 6 of the SHSP and is in accordance with current medical practice.
Section 136.2 (relating to definitions) would contain definitions for the various terminology associated with this service. Most of these definitions appeared in the SHSP. The terms ''board certified'' and ''board eligible'' have been defined precisely so as to indicate that a physician must maintain board certification and that board eligibility does not last indefinitely. The inclusion of both open and closed heart procedures in the definition of ''pediatric heart surgery'' is in accordance with current medical practice. The age requirement contained therein was arrived at after consultation with several cardiologists.
Section 136.11 (relating to director) would require that the director of the open heart surgery program shall be a board certified surgeon whose training emphasized cardiac surgery. This requirement was contained in the SHSP.
Section 136.12 (relating to medical staff) would specify minimum qualifications for the physicians staffing the service and includes standards to ensure adequate physician staffing of the service at all times. These requirements were also contained in the SHSP.
Section 136.13 (relating to nursing staff) would address the minimum qualifications of nurses staffing the service, including the nurse who directs and supervises the nursing staff, and specifies nursing practice and procedure issues that are to be addressed and the mechanisms for doing so. These requirements reflect those contained in the SHSP.
Section 136.14 (relating to support team in the operating room) would address requirements for the operating room support team, with particular focus on requirements for perfusionists and extracorporeal pump oxygenators to enable operation of the service at all times. These requirements are consistent with those found in the SHSP.
Section 136.15 (relating to other support services) would identify supportive services which are to be available at all times, and specifies which of those services are to be available on site. As set forth in the definition section (§ 136.2), ''onsite'' means that the service is located in the physical structure in which the open heart surgical services are being offered or in an adjoining structure. While these proposed requirements are consistent with those contained in the SHSP, the work group carefully evaluated the need for each of them and whether the particular support service needed to be on site or simply available. This section also addresses size and equipment requirements for operating rooms. The standards for operating room size and equipment are to be consistent with the requirements of the Inter-Society Commission on Heart Disease (ICD) and the Guidelines and Indications for Coronary Artery Bypass Graft Surgery issued in 1991 by the American College of Cardiology/American Heart Association (ACC/AHA Guidelines).
Section 136.16 (relating to rapid mobilization) would require rapid mobilization capability and support team availability for emergency procedures at all times, and require physician on-call schedules to be posted. These requirements were contained in the SHSP. The on-call schedule must be posted at each area where cardiac surgical patients are present so that the physicians can be contacted immediately.
Section 136.17 (relating to observation of patients) would require that a cardiac surgical care service have the ability to maintain visual observation of all patients. The cardiac surgical care service is referenced instead of the open heart surgical service because the former incorporates the latter and patient observation capabilities need not be separately addressed at the open heart surgical service level. This requirement is consistent with that contained in the SHSP. The work group strongly felt that capability of the medical and nursing staff to have direct visual observation of the cardiac patients was necessary so that immediate response could occur if the patient developed problems.
Section 136.18 (relating to post-operative care) would require that an intensive surgical care service be available to the open heart surgery patient immediately following surgery, and specifies that the cardiac surgical service shall be responsible for the postoperative care of the patient and be involved in discharge planning. These requirements are consistent with those suggested in the ACC/AHA Guidelines.
Section 136.19 would address the training and education the staff of the open heart surgical program are to secure and provide. These requirements are consistent with those found in the SHSP.
Section 136.20 (relating to pediatric open heart surgery--supplementary criteria) would specify standards a hospital needs to satisfy, in addition to other standards contained in the chapter, to offer a pediatric open heart surgical program. These requirements are consistent with those found in the SHSP.
Section 136.21 (relating to quality management and improvement) would require a hospital that performs open heart surgery to maintain statistics on outcomes of its open heart surgery program, including morbidity and mortality data; to integrate that data in its quality assurance program; and to participate in the Department's collection and review of outcome data.
The quality of all open heart surgery programs will be monitored on an ongoing basis through a quality assessment process. Quality indicators such as morbidity, mortality and infection data will be used to select hospitals for a vigorous assessment of whether they are meeting quality standards. Based upon the findings, the Department will determine whether any remedial or corrective action is necessary.
The use of a quality assessment process will enable the Department to determine whether acceptable quality standards are being met based upon evolving technology and changing standards in clinical practice as embraced by the medical community. Review of services in this manner enables the Department to consider practice changes embraced in the current medical literature and avoid adopting regulations detailing precise standards of practice which may become rapidly outdated.
The work group spent a considerable amount of time on this issue and looked at the approaches taken by other states, including New York and New Jersey. The proposal will assure that the Department is able to monitor the quality assurance of each open heart surgery program without placing an undue burden on the hospitals, as most of the data requested is readily available and may already be included in reports sent to other entities. The Department intends to adopt a mechanism to implement this requirement through a statement of policy. This will allow the Department to alter the policy if other, less burdensome mechanisms can be used in the reporting of this data.
Chapter 138. Cardiac Catheterization Services The work group that considered the provisions of the SHSP on cardiac catheterization services included all of the representatives of the various entities set forth under Purpose and Procedure. In addition to a cardiologist who attended the meetings, several additional cardiologists were also contacted and their suggestions and input were considered by the work group and the Department.
After an exhaustive review of the criteria contained in Chapter 7 of the SHSP, the current regulations, National standards and the approaches taken by other states, the work group recommended that the Department promulgate new regulations addressing this service. Existing regulations do not address qualitative criteria for cardiac catheterization services. Due to the complexity and life threatening aspects of this service, the Department agrees that specific regulations are necessary to ensure quality of care and patient safety.
Section 138.1 (relating to principle) would require that all cardiac catheterizations be performed in hospitals in accordance with accepted and prevailing standards of medical practice. Although there has been discussion about freestanding and mobile cardiac catheterization labs, these laboratories were not permitted under the SHSP. In reviewing this area, the work group agreed that the current standard of practice is that cardiac catheterizations are performed in hospitals, due to the availability of the support services. The procedure involves the insertion of a catheter in a blood vessel of the arm or leg and manipulating that catheter into the veins and arteries of the heart. This procedure can only be performed where immediate treatment is available if a problem should occur. The potentiality of life-threatening complications necessitates that the staff, equipment and services of a hospital be immediately available.
Section 138.2 (relating to definitions) contains definitions for the various terminology associated with this service. Most of these definitions appeared in the SHSP. The term ''board certified'' has been defined precisely so as to indicate that a physician must maintain board certification. The distinction between ''high-risk'' and ''low risk'' cardiac catheterizations is important as only hospitals that also perform open heart surgery may also perform high-risk cardiac catheterizations. The definition of high-risk cardiac catheterization contains those type of catheterizations which present a significant risk of cardiac complication. These include certain diagnostic catheterizations, all percutaneous transluminal coronary angioplasties (PTCA) and pediatric catheterizations, and most therapeutic electrophysiology procedures. The current standards of medical practice indicate that these procedures are, or have the potential to be, in the high-risk category. The cardiologists consulted by the Department agreed that these types of catheterizations were appropriately classified as high-risk. The definition of ''pediatric cardiac catheterization'' was arrived at after consultation with several cardiologists. Although there is no universally agreed upon definition of when a pediatric patient becomes an adult patient, reference to the patient's physical development appears to be an appropriate measure.
Section 138.11 (relating to director) would prescribe the qualifications for the director of a cardiac catheterization program. The requirement that the director be Board certified in cardiology or pediatric cardiology is consistent with the standards established in the Guidelines for Cardiac Catheterization and Cardiac Catheterization Laboratories issued by the American College of Cardiology/American Heart Association (ACC/AHA Guidelines) in 1991.
Section 138.12 (relating to medical staff) would specify minimum qualifications for the physicians staffing the service. The requirement that two physicians must staff the cardiac catheterization laboratory does not mean that two physicians must be present when catheterizations are performed. The laboratory must utilize the services of at least two physicians but only one physician has to be present for the actual catheterization. These requirements are consistent with those contained in the SHSP.
Section 138.13 (relating to nursing staff) would specify the minimum qualifications for the nurses staffing the service, and identifies nursing practice and procedure issues that are to be addressed and the mechanisms for doing so. Although not explicitly set forth in the SHSP, this section is consistent with general nursing staff requirements.
Section 138.14 (relating to programs and services) would specify the services that are to be onsite or available for a hospital to perform cardiac catheterization services. ''Onsite'' is defined as being in the same physical structure in which the cardiac catheterization services are being offered or in an adjoining structure. It also addresses requirements for performing outpatient diagnostic cardiac catheterization and the circumstances under which a mobile cardiac catheterization laboratory may be utilized on site on a temporary basis. Outpatient cardiac catheterizations are only permitted on low risk patients if a physician determines that treatment on an outpatient basis is appropriate. As stated previously, freestanding or mobile cardiac catheterization laboratories are not permitted. However, the work group recognized that a hospital may be undergoing renovation of its fixed catheterization laboratory and may need to utilize a mobile facility while the renovation is occurring. As long as all other quality standards are adhered to, this usage would be permitted.
Section 138.15 (relating to high-risk cardiac catheterizations) would require that high-risk cardiac catheterizations be performed only at a hospital that has an open heart surgical program onsite. As previously discussed, this reflects the requirements in the SHSP and the standards of current medical practice, as set forth in the ACC/AHA Guidelines.
Section 138.16 (relating to transfer agreements for low-risk cardiac catheterization hospital) would permit a hospital that does not have an open heart surgical program onsite to perform low-risk cardiac catheterizations if it has protocols for distinguishing between low and high-risk cardiac catheterization patients and an agreement which addresses designated items with at least one hospital that does have an open heart surgical program. The section also requires that an agreement be in effect at all times and reviewed at least annually. This is consistent with the requirements in the SHSP.
Section 138.17 (relating to PTCA) would establish specific physician and peer review requirements for hospitals in which elective PTCAs are performed. It also makes an exception for emergent PTCAs from the requirement that high-risk cardiac catheterizations be performed only at a hospital with an open heart surgical program onsite. It treats an emergent PTCA as an extraordinary occurrence and requires the hospital to report the circumstances to the Department within 72 hours. The Department's assessment of the propriety of performing each PTCA performed at a hospital that does not have an open heart surgical program onsite will be made by assessing the appropriateness of the hospital's protocols and its adherence to those protocols. These requirements are consistent with those found in the SHSP.
Section 138.18 (relating to EPS) would prescribe the standards that need to be met by a physician who performs EPS. It also addresses where certain types of therapeutic electrophysiology may be conducted. These standards were reviewed with several cardiologists and are consistent with current medical practice.
Section 138.19 (relating to pediatric cardiac catheterizations) would prescribe requirements in addition or alternative to other requirements contained in the chapter that need to be satisfied for a hospital to perform pediatric cardiac catheterizations. These requirements are consistent with the standards contained in the ACC/AHA Guidelines.
Section 138.20 (relating to quality management and improvement) would require a hospital that performs cardiac catheterizations to maintain statistics on outcomes of its cardiac catheterization patients, including morbidity and mortality data; to integrate that data in its quality assurance program; and to participate in the Department's collection and review of outcome data.
The quality of all cardiac catheterization programs would be monitored on an ongoing basis through a quality assessment process in a manner similar to the manner in which the quality of open heart surgical programs will be monitored. (See previous discussion at § 136.21.)
Chapter 139. Newborn Services The work group assigned to review the quality criteria for neonatal care and for neonatal intensive care units which appears in the SHSP found that the existing regulations basically addressed those issues. However, the work group did recommend that the regulations be amended to incorporate the Guidelines for Perinatal Care issued by the American Academy of Pediatrics and the American College of Obstetrics and Gynecology (Guidelines). Additionally, the work group recommended that, throughout the regulations, the term ''newborn'' be replaced with ''neonatal,'' as this reflects current usage and terminology.
Under the proposed amendments, the regulations distinguish between the levels and types of care provided in ''neonatal care units'' and ''neonatal intensive care units.'' Under § 139.12 (relating to neonatal care units), all hospitals that provide maternity services must also have a neonatal care unit with areas for newborn recovery, observation and isolation. Hospitals must follow the Guidelines in determination of the appropriate standards applicable for staffing, equipment and other areas for neonatal care units.
The term ''neonatal intensive care unit'' replaces the former designation of ''special care nursery'' to describe those areas in hospitals which are specifically equipped and staffed for the care and treatment of high-risk infants and those neonatals otherwise in need of intensive care. Under present § 139.12(d) (proposed as new subsection (c)), neonatal intensive care units must meet the standards established in the Guidelines for these types of units. Those hospitals which provide maternity services but do not have a neonatal intensive care unit, must have arrangements for referrals with a hospital which does possess a unit.
Section 139.3 (relating to director) provides that all neonatal care units must have a medical director who is either board eligible or board certified. Section 139.22 (relating to physicians' services) requires that a board eligible or board certified physician must be available at all times. Under § 139.2a (relating to definitions), ''Board certified'' is defined as a licensed physician who has passed an examination and maintained certification in the relevant medical specialty area and/or subspecialty area offered by a medical specialty board recognized by either the American Board of Medical Specialties, the American Osteopathic Association or a foreign equivalent. ''Board eligible'' is defined as a licensed physician who has completed the necessary requirements to take the examination recognized by one of the aforementioned organizations and who is within 3 years of attaining eligibility. The work group added these definitions to ensure that the medical director and physicians on call possessed the appropriate skills necessary for the treatment of neonatals.
Chapter 158. Vital Organ Transplantation Services The work group which reviewed the quality criteria contained in the SHSP found that there was a gap between those criteria and those in the present licensure regulations. Although organ transplantation surgical services are subject to the general hospital regulations, there are no regulations which discuss the specific quality criteria which must be followed by such a program. The work group believed that it was necessary to address these specific quality criteria in the regulations.
The work group noted that organ transplantation is unique in the surgical field in that any program that wishes to obtain organs must participate in the procurement system established by the Organ Procurement and Transplantation Network (OPTN). This network was created for the express purpose of procuring and allocating organs for transplantation. See 42 U.S.C.A. § 274. In addition to this function, the OPTN also establishes membership and medical criteria which must be met by every transplantation program in the United States. The Work Group reviewed the present membership/medical criteria of the OPTN and found it to be detailed and geared to quality assurance and patient safety. The work group recommended that the OPTN standards be incorporated into the Department's regulations.
The work group concluded that a chapter addressing specific quality criteria should be added to the licensure regulations. As current standards of medical practice establish that organ transplantation can be performed safely only in a hospital setting, the work group proposed to add a chapter to the regulations pertaining to general and special hospitals.
The work group also noted that this chapter would only apply to certain organs defined as ''vital organs,'' that is, heart, lung, liver, kidney, pancreas, small bowel. Transplantation issues regarding bone, bone marrow, tissue and eye are not covered by this proposed chapter. The work group recommended that the Department review these types of transplantations and determine if any additional regulations are necessary.
Section 158.1 (relating to principle) would set forth the requirement that all transplantation services shall be provided in hospitals. The work group found that the services, staff and programs immediately available in a hospital are crucial to a transplantation program and that performance of transplantations in hospitals is the prevailing medical practice.
Section 158.2 (relating to definitions) would set forth definitions of terminology used in the proposed amendments. Of primary importance is the distinction between ''transplantation center'' and ''transplantation program.'' A transplantation center is the entire unit of a hospital which is devoted to the performance of organ transplantations. A transplantation program is the actual surgical program established for the operation of organ transplantation. Each type of organ transplanted constitutes a separate transplantation program.
Section 158.3(b) (relating to scope) would require that each transplantation program shall be a participating member of the OPTN and shall comply with its standards, guidelines and bylaws. This section also requires hospitals that provide transplantation services to make a commitment of resources and planning. Section 158.3(a)(1)--(9) lists a variety of areas in which this commitment must be shown including an identifiable and stable transplant team, adequate support staff and appropriate mechanisms for selection of the patients who will receive transplantations.
Section 158.11 (relating to medical director) would require that the hospital appoint a medical director of transplantation who shall be either a transplantation surgeon or a transplantation physician and who is either certified or eligible for certification by the American Board of Surgery, the American Board of Internal Medicine or an equivalent board. Board eligibility must have been attained within the 3 years previous to appointment to the position of medical director. These requirements will assure that an individual with appropriate knowledge, skills and experience is in charge of the various transplantation programs at a hospital.
Section 158.12 (relating to transplantation) would require that each hospital also employ a transplantation coordinator who shall be certified by the American Board of Transplant Coordinators. This individual will assure that all of the transplantation programs are operating appropriately and will work with the OPTN and other health care facilities in the organ procurement process.
Section 158.13 (relating to medical staff) would establish the requirements for the medical staff. Section 158.13(a) requires that each transplantation program have at least one transplantation surgeon and one transplantation physician on staff. These physicians must meet OPTN standards also. Section 158.13(b) requires that certain supporting medical staff at the transplantation center be available at all times. These include nephrologists, pathologists, anesthesiologists, radiologists, internists and psychiatrists. After some discussion as to whether all of these specialists were needed for every type of transplantation program, the work group agreed that any transplantation program involving a vital organ could require the services of any one or more of these specialties.
Section 158.14 (relating to laboratories) would require that laboratory services shall be on site or immediately accessible. The requirements set forth in this section reflect those present in the current OPTN standards.
Section 158.15 (relating to support services) would require that the hospital maintain or have access to certain support services, including rehabilitation services, social services and counseling. The hospital must also maintain adequately equipped operating rooms, adequate equipment and supplies, intensive care facilities capable of maintaining transplant patients and facilities for acute hemodialysis. Many of these criteria were contained in the SHSP. The work group believed that all of these support services were necessary regardless of the type of organ being transplanted.
Section 158.16 (relating to selection criteria) would require that each transplantation program establish written procedures for selecting transplantation candidates and distributing organs in a fair and equitable manner. The section requires the program to comply with the OPTN criteria. The criteria established by OPTN are detailed and set forth specific qualifications for patient eligibility and selection. This section reinforces the necessity of establishing written patient selection criteria which must take into account the relevant ethical and medical considerations.
Section 158.17 (relating to referrals, hours of operation) would require a transplantation center to accept referrals from all physicians, ensuring that all individuals have an opportunity to be evaluated as a transplantation candidate. This section further provides that all transplantation services must be available at all times. This is of particular importance as an organ which can be transplanted may become available at any time and the organ must be transplanted within a limited period of time to retain its viability.
Section 158.18 (relating to volume of procedures) would address the number of procedures which must be performed by each program. The SHSP set a minimum number of procedures for each type of transplantation program. The standards currently adopted by the OPTN do not require a minimum number of procedures for any transplantation program. Rather, the OPTN looks at the ''survivability rate'' of each program. By use of a formula accounting for patient mix, severity of medical condition upon occurrence of transplantation and other relevant factors, the OPTN reviews each program to determine if it deviates significantly from the expected survival rate. If a program does deviate in this manner and it cannot be explained through some unique clinical aspect, it will be considered for probation by the OPTN. The Health Care Finance Administration (HCFA), which provides reimbursement for some types of transplantation surgery, does require a minimum number of transplant surgeries for certain types of organs (heart:12 transplants per year; liver: 12 transplants per year; lung: 10 transplants per year) for each transplantation program which attempts to obtain reimbursement from the Medicare program.
After extensive discussion of this issue, the work group believed that the review conducted by the OPTN was probably the best method of analyzing the success of a transplantation program. However, the work group also felt that the minimum procedures established by HCFA were not unreasonable. Therefore, § 158.18(a) provides that each transplantation program must perform an adequate number of procedures to maximize quality. Section 158.18(b) provides that a program must perform the number of procedures required by either HCFA or OPTN where those standards exist. Thus, a HCFA participant is expected to perform the minimum number of transplantations established by that agency. Finally, § 158.18(c) provides that failure to meet the standards set forth in subsection (c) shall cause the Department to review the transplantation program and determine its compliance with other quality assurance criteria. These provisions will provide the Department with the flexibility of reviewing a program: (1) at any time if there are concerns that the low number of transplantations performed is negatively affecting quality outcomes; and (2) if the program fails to meet the HCFA minimums or the OPTN survivability rate.
Section 158.19 (relating to post-transplantation care) would require that the hospital maintain an extensive post-transplantation care program which shall last throughout the recipient's life. This standard is adopted from the OPTN and is a recognition that transplantation recipients require constant and extensive follow-up monitoring and treatment. It is the responsibility of the program that performed the transplantation to assure that this treatment is provided.
Sections 158.31--158.35 would set forth supplementary criteria for the various transplantation programs. Each of these sections addresses a transplantation program for a specific vital organ (§ 158.31=kidney, § 158.32=heart, § 158.33=liver, § 158.34=lung, heart/lung, § 158.35=pancreas). Each of these sections contains criteria relating to specific staffing or support services which must be present on site in order for the hospital to maintain one of these transplantation programs.
Section 158.36 (relating to other organs) states that any transplantation program involving organs not covered in §§ 158.31--158.35, must comply with specific criteria of the OPTN applicable to these organs.
Finally, § 158.37 (relating to pediatric transplantation programs) would set forth supplementary criteria which apply to any pediatric transplantation program. Section 158.37(b) provides that where the pediatric transplantation criteria differ from the general transplantation criteria, any hospital which provides pediatric transplantation must follow the pediatric criteria when transplants are performed on infants and children. The remainder of Section 158.37 details the specific staff and support services necessary for a pediatric transplantation program. The common element of these criteria is that certification or training is required in treating pediatric patients. This reflects the concern of the Work Group that children be considered as a group requiring individualized and specialized treatment, and not simply as ''little adults.''
Fiscal Impact
These proposed amendments, to ensure the quality of services being provided at licensed health care facilities, will result in some additional costs to the Department. Increased staffing may be necessary to implement the expanded quality assessment process. These resources would be needed to review submitted documentation supporting the licensure requests, to conduct onsite surveys of health care facilities and process licensure applications. Additional costs may also include stipends/fees or expenses for persons not part of the Department staff who may assist the Department in the licensure and quality assurance assessment process.
The proposed amendments to the Department's licensure regulations will impose additional costs on health care providers to some degree. Most of the proposed regulations require that medical directors of particular health care services in hospitals must now receive certification from a specialty board. The employment of these individuals could increase the cost of these services. Additionally, costs may be incurred for some minor construction/renovation, equipment or supply costs to meet new requirements. However, in most instances, the standards being adopted are those which the Department expects that the vast majority of health care facilities to already be meeting if they provide these services.
In reviewing the fiscal impact, it should be remembered that the reason for many of these amendments is the sunset of the CON Program. Most of the amendments which are being proposed cover health care services or health care facilities which previously had to undergo CON review prior to commencement of their activity. This review involved expenses for the Department in the employment of an entire division to process and review CON applications. For CON applicants, the actual costs involved the preparation of the application, hiring health care consultants to assist with the CON process, a fee to the Department which could be as much as $20,000 and the time and resources of the facility's staff. Indirect costs included the time which the facility had to wait until its application went through the often lengthy CON process. Although these proposed amendments will not eliminate all of the costs which health care facilities experienced under CON, the overall effect should be a reduced fiscal impact.
Paperwork Requirements
The Department will experience some increase in paperwork related to reviews in processing licensure requests and additional regulatory requirements. Particularly in the areas of cardiac catheterization and open heart surgical services, Department staff will be reviewing additional data, not currently collected, from providers of these services, in order to generate reports which will be used to assess quality.
In general, there will not be a significant paperwork burden on providers to comply with the expanded licensure requirements. There will also be additional reporting responsibilities for providers of cardiac catheterization and open heart surgical services, to submit data on outcomes to the Department. Options are being explored to implement the least burdensome reporting process possible consistent with obtaining the data needed to assess quality performance.
As with fiscal impact, most of these paperwork requirements should be compared with those previously required under the CON Program. Applicants were required to submit detailed applications which, depending on the health care service proposed to be offered, could be quite lengthy and require extensive documentation.
Effective Date/Sunset Date
The proposed amendments will become effective upon final publication in the Pennsylvania Bulletin.
Statutory Authority
Section 803(2) of the act (35 P. S. § 448.803(2)) authorizes the Department to promulgate, after consultation with the Health Policy Board, regulations necessary to carry out the purposes and provisions of the act. Section 801.1 of the act (35 P. S. § 448.801a) provides that a purpose of the act is to promote the public health and welfare through the establishment of regulations setting minimum standards for the operation of health care facilities. The same section provides that the minimum standards are to assure safe, adequate and efficient facilities and services, and are also to promote the health, safety and adequate care of patients or residents of these facilities.
These provisions, in combination with the Department's express authority under the definition of ''health care facility'' in section 802.1 of the act to employ regulations to create new categories of health care facilities as may be required due to the emergence of new modes of health care, confer upon the Department the necessarily implied authority to employ regulations to restrict certain modes of health care services to specified health care facilities to ensure the health, safety and adequate care of patients.
Regulatory Review
Under section 5(a) of the Regulatory Review Act (71 P. S. § 745.5(a)), on May 21, 1997, a copy of the proposed amendments was submitted to the Independent Regulatory Review Commission (IRRC) and to the Chairpersons of the House Committee on Health and Human Services and the Senate Committee on Public Health and Welfare. In addition to submitting the proposed amendments, the Department has provided IRRC and the Committees with a copy of a detailed Regulatory Analysis Form prepared by the Department in compliance with Executive Order 1996-1, ''Regulatory Review and Promulgation.'' A copy of this material is available to the public upon request.
If IRRC has objections to any portion of the proposed amendments, it will notify the Department within 30 days of the close of the public comment period. The notification shall specify the regulatory review criteria which have not been met by that portion. The Regulatory Review Act specifies detailed procedures for review prior to final publication of the regulation, by the Department, the General Assembly and the Governor, of objections raised.
Contact Person
Interested persons are invited to submit written comments, suggestions or objections to or regarding the proposed regulations within 30 days of the date of publication of this notice in the Pennsylvania Bulletin. These comments should be directed to: James T. Steele, Jr., Assistant Counsel, Department of Health, P.O. Box 90, Harrisburg, PA 17108-0090, (717) 783-2500. If you are a person with a disability, comments, suggestions or objections regarding the proposed regulations may also be submitted to Mr. Steele in alternative formats, such as by audio tape, braille or by using TDD: (717) 783-6514. If you are a person with a disability and require an alternative format of this document (that is, large print, audio tape, braille) please contact Mr. Steele so that he can make the necessary arrangements.
DANIEL F. HOFFMAN,
SecretaryFiscal Note: 10-148. (1) General Fund;
(GGO) Revenue Increased Loss Cost (2) Implementing Year 1996-97 is $750,000 $10,000; (3) 1st Suceeding Year 1997-98 is $750,000 $10,000; 2nd Succeeding Year 1998-99 is $750,000 $10,000; 3rd Succeeding Year 1999-00 is $750,000 $10,000; 4th Succeeding Year 2000-01 is $750,000 $10,000; 5th Succeeding Year 2001-02 is $750,000 $10,000; (4) Fiscal Year 1995-96 $1.9 million; Fiscal Year 1994-95 $1.5 million; Fiscal Year 1993-94 $1.2 million; (7) General Government Operations; (8) recommends adoption.
(Editor's Note: Chapters 51, 136, 138 and 159 are new. They have printed in regular type to enhance readability. Chapter 139 exists and appears with brackets and bold face to show changes.)
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