PROPOSED RULEMAKING
DEPARTMENT OF HEALTH
[28 PA. CODE CHS. 201, 203, 205, 207, 209, 211, 551, 553, 555, 557, 559, 561, 563, 565, 567, 569, 571 AND 573]
Health Facility Licensure
[27 Pa.B. 3609] The Department of Health (Department) proposes to amend Part IV (relating to health facilities) by amending Chapters 201, 203, 205, 207, 209, 211 551, 553, 555, 557, 559, 561, 563, 565, 567, 569, 571 and 573 to read as set forth in Annex A.
Purpose of the Amendments
The amendments propose to amend the standards for the licensing and operation of long term care facilities and ambulatory surgical facilities (ASF).
On December 18, 1996, those provisions of the Health Care Facilities Act (act) (35 P. S. §§ 448.101--448.904), relevant to the Certificate of Need (CON) Program terminated. See 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 long term care and ambulatory surgery should begin to meet immediately. This was due to the need to address as quickly as possible any potential 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 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 long term care and ambulatory surgery work groups were comprised of representatives from the Department, the Department of Public Welfare (DPW), the Pennsylvania Medical Society (PMS), the Pennsylvania Nurses Association (PNA), the Hospital Association of Pennsylvania (HAP), the Health Law Project of the Public Interest Law Center, Legislative staff and other persons with expertise regarding these services. In addition, representatives from the Pennsylvania Association of Non-Profit Homes for the Aging (PANPHA), the Pennsylvania Health Care Association (PHCA), the Pennsylvania Association of Rehabilitation Facilities (PARF), the Pennsylvania Association of County Affiliated Homes (PACAH) and Pennsylvania Protection and Advocacy (PP&A) served on the long term care work group. The ambulatory surgery work group included representation from the Ambulatory Surgical Association, as well as input from several physicians and dentists.
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 recommendation of the work group that reviewed the long term care chapter of the SHSP (Chapter 14, Long Term Care), was that there was no perceivable gap between the long term care chapter of the SHSP and the current licensure regulations with regard to quality of care. However, the Department had already commenced a review of its long term care regulations for purposes of updating and to consider the effect of recently adopted Federal certification regulations. Due to this factor and the likelihood that any changes to the regulations would impact the area of quality assurance, the work group further recommended that it review the draft proposed long term care regulations. The work group met with program personnel on five separate occasions in January and February, 1997 and provided comments to the Department on the draft set of proposed amendments. The Department then revised the proposed amendments based on that input.
Similarly, the Department had published notice on December 7, 1996, in the Pennsylvania Bulletin that it would commence a review of the regulations pertaining to ASFs on January 10, 1997. See 26 Pa.B. 5913 (December 7, 1996). The work group which was convened in January 1997 considered amendments necessitated by changes in the delivery of care in ASFs since the enactment of the regulations and reviewed the quality assurance criteria contained in the SHSP (Chapter 5, ''Surgical Services'') applicable to ambulatory surgical care. The work group determined that there were gaps in quality assurance and recommended incorporating much of the criteria contained in the SHSP into the licensure regulations.
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.
After reviewing the recommendations and the public comments, the Department concludes that the current long term care facilities and ambulatory surgical facilities regulations should be amended, in order to reflect changes which have occurred since their enactment and to address any gaps in the area of quality assurance which may be present due to the sunset of CON.
Summary
Subpart C: Long Term Care Facilities The Department was in the process of revising its long term care licensure regulations prior to the sunset of CON Legislation on December 18, 1996. Proposed amendments had been prepared adopting the Federal certification regulations at 42 CFR 483.1--483.75. Facilities which participate in the Medicare and Medical Assistance Programs must comply with these regulations in addition to the state licensure regulations. The great majority of Pennsylvania long term care nursing facilities participate in Medicare and Medical Assistance and are subject to both Federal and State quality assurance regulations. In many instances, the State regulations are duplicative and in a few cases, the two conflict.
The draft set of proposed licensure regulations which the Department prepared, deleted those State regulations which were either overly prescriptive or duplicative of the Federal certification regulations.
The Department felt it necessary to keep certain State licensure regulations which are not addressed in the Federal certification regulations. For example, there is no Federal counterpart to the State licensure regulation in § 211.1 (relating to reportable diseases), requiring the reporting of specific diseases or to § 201.22 (relating to prevention, control and surveillance of tuberculosis (TB)), pertaining to the protocols for tuberculosis control. There are a few proposed amendments to current regulations which are stricter in some respects than the corresponding Federal regulations. For example, the Federal regulation in 42 CFR 483.13(a), states that a restraint may not be applied for discipline or convenience. The State licensure regulation pertaining to restraints in § 211.8 (relating to use of restraints), has always been more specific than the Federal regulation and the Department now proposes to add a requirement that the need for a restraint be reviewed every 30 days by an interdisciplinary team as defined in § 201.3 (relating to definitions). Another proposed amendment in § 201.3, revises the definition of ''restraint'' to include chemical as well as physical restraints. This follows the Federal regulations which address chemical as well as physical restraints.
The State licensure regulation in § 201.14 (relating to responsibility of license) lists various incidents that must be reported to the appropriate Division of Nursing Care Facility's field office. The proposed amendments add deaths due to sepsis and require notification within 24 hours. Although both State and Federal regulations provide transfers and discharges in appropriate circumstances and only after adequate prior notice. However, the proposed amendment in § 201.29(d) (relating to resident rights) specifically places the responsibility for appropriate placement on the facility.
As part of the appointment of work groups to review the 21 chapters of the SHSP, a work group was assigned to look at the long term care chapter of the plan. The recommendation of the work group that reviewed the long term care chapter of the SHSP was that there was no perceivable gap between the long term care chapter of the SHSP and the current licensure regulations with regard to quality of care. However, the work group further recommended that it review the draft proposed long term care regulations. The work group met with program personnel on five separate dates in January and February 1997 and provided comments to the Department on the draft set of proposed amendments. The Department then revised the proposed amendments based on that input.
Chapter 201. General Provisions
The addition of Chapter 51 (relating to general information) covering general provisions which are common to all health care facilities necessitates the elimination of these sections which are currently located in Chapter 201. Specifically, the provisions of § 201.2 (relating to requirements) pertaining to exceptions to the long term care nursing facility licensure regulations are now addressed in §§ 51.31--51.34 (relating to exceptions). Section 205.3 is now addressed in § 51.5 (relating to building occupancy). Section 201.16, pertaining to change of ownership is now located at § 51.4 (relating to change in ownership; change in management). Section 201.28 pertaining to nondiscrimination policy is now located at §§ 51.11--51.13 (relating to civil rights).
Section 201.3 is amended to include a new definition of ''abuse.'' The definition is taken from the guidelines to the Federal regulations. This is also the definition of ''abuse'' which is used by the Department when hearing appeals of nurse aides who have had a finding of abuse entered against them in the nurse aide registry. The Department kept that portion of the former definition which now appears under the subheading of ''neglect.''
The requirements for a charge nurse, dietician and a social worker, have been revised. The definition of ''dietician'' and ''social worker'' now reflects the Federal requirements for social workers.
The term ''clinical records'' is now defined and includes a resident's medical record as well as social and financial records.
The term ''resident'' has been added to the definitions. ''Resident'' replaces the term ''patient'' throughout the regulations. This change has been made to be consistent with Federal terminology.
A definition is now included for the term ''interdisciplinary team.'' This definition has been taken from the Federal regulation at 42 CFR 483.20(d)(2)(ii), which lists the professionals who must take part in the preparation of residents' care plans.
The definition of ''restraint'' has been revised in accordance with the guidelines to the Federal regulations and now specifically includes chemical restraints. Further, the definition used to refer to a device which was applied to a resident but now includes devices which are adjacent to a resident which depending on the situation, could include side rails. This is also consistent with the Federal view of what constitutes a restraint.
The definitions of ''intermediate care'' and ''skilled care'' have been combined and a long term care nursing facility is defined as a facility providing both skilled and intermediate care. This is in keeping with the trend toward elimination of the distinction between these two levels of care. By statement of policy dated February 17, 1996, the Department eliminated the distinction between the two levels for calculating requisite nursing hours. The new definition reflects a range of care rather than two separate levels to be provided in a long term care nursing facility.
Section 201.2
In § 201.2, the Department proposes to incorporate the Federal certification regulations at 42 CFR 483.1--483.75, pertaining to quality assurance, with the exception of various subsections listed. The subsections which the Department does not propose to incorporate primarily reference the Medicare and Medicaid Programs and are thus applicable to the facilities which participate in those programs only and not suitable as general licensure regulations.
Section 201.12 (relating to application for license)
Subsection (b), requiring the issuance of a CON as a condition of licensure, has been deleted.
Section 201.13 (relating to issuance of license)
This section sets forth licensure fees and has been revised to reflect the statutory increase in fees which have been in effect since 1992, following amendments to the act.
Section 201.14 (relating to responsibility of license)
The Department proposes to amend subsection (c) and to add a new subsection (d) which will now require the reporting of serious incidents within 24 hours. It is proposed that reports of accidents and death due to sepsis be added to the list of reportable incidents.
Section 201.15 (relating to restrictions on license)
The reference to the former Health Care Facility Hearing Board as the appellate body to hear final licensure decisions, has been revised to reflect an amendment to The Administrative Code of 1929 (71 P. S. § 2102 (n)), in 1996, which transferred the duties of that Board to the Health Policy Board.
Section 201.16
The Department proposes to delete this section concerning change in ownership, structure or name. This requirement will now be covered under proposed § 51.4 which provides general information on change of ownership applicable to all health care facilities.
Section 201.22
The Department proposes to delete this section which requires the facility to notify the resident's attending physician and responsible person of a change in the resident's condition as this is required under the Federal regulations.
The Department proposes to add a new § 201.22 which addresses the testing of residents and staff for tuberculosis. The proposed criteria are based on CDC protocols.
Sections 201.24 and 201.25
These sections dealing with admission and discharge policies are being deleted. A new § 201.29(c) and (d) (relating to resident rights) has been proposed which sets forth the facility's responsibilities with regard to transfer and discharge of residents. The new language clarifies that 30 days advance notice must be given prior to discharge and that the facility is responsible for assuring that the resident is appropriately placed.
Chapter 203: Application of Life Safety Code for Long Term Care Nursing Facilities Section 203.2 presently requires long term care facilities to comply with certain Life Safety Code standards. As all long term care facilities are currently required to meet Life Safety Code construction and sprinkler requirements, this section is duplicative and the Department proposes its deletion from the regulations.
Chapter 205: Physical Plant and Equipment Standards for Long Term Care Nursing Facilities Section 205.4 (relating to building plans)
The Department proposes to amend this section which sets forth the requirements for both preliminary and final architectural plan approval. Only one set of final plans will now be required. Section 205.5 which requires preliminary plans to be filed in duplicate will be deleted.
Section 205.20 (relating to resident bedrooms)
Section 205.20 is amended to only require a flat amount of square footage for single and multibedrooms and to delete all further instructions regarding minimum space requirements. For example, a single bedroom must still have a minimum room area clearance of 100 feet but requirements that there be a minimum of 3 feet between the bed and the adjacent wall and 4 feet between the foot of the bed and the opposing wall or furniture have been deleted.
The Department had received reports that these requirements sometimes mandated bed placements which were contrary to a resident's preference.
Section 205.24 (relating to dining room)
The Department proposes to delete that portion of this section which addressed the space requirements when a facility combined a dining room and a recreation area. A new subsection (b) is added which requires tables and space to accommodate wheelchairs.
Section 205.25 (relating to kitchen)
Most of this section on requirements for a kitchen have been deleted as overly prescriptive with the exception of subsection (d), proposed (b), which requires a service pantry on each unit.
Section 205.31 (relating to storage)
The only subsection which the Department proposes to keep in this section on storage is the requirement that a minimum of 10 square feet per bed of storage space be provided for items including residents' possessions.
Section 205.33 (relating to utility room)
The Department proposes to add a new subsection (b) which requires separate bedpan flushers be provided in soiled workrooms unless a facility has them in residents' bathrooms.
Sections 205.34 and 205.35
The Department proposes to delete these regulations which require a treatment room and a telephone for resident use. The Federal regulations which are to be adopted require residents have access to a telephone.
Sections 205.36--205.40
These sections address bathrooms, toilet rooms and lavatories. The Department proposes to delete requirements as to the size of tubs and shower stalls while retaining the requirement of a minimum clearance around bathtubs in § 205.36 (relating to bathing facilities). In § 205.38 (relating to toilet facilities), the only subsection which the Department feels is necessary to keep as a licensure regulation is (a) which requires a minimum ratio of 1/4 toilets per residents.
Sections 205.61--205.64
The Department proposes to delete several subsections from these sections which address heating requirements and plumbing and piping systems since these are for the most part covered in the NFPA 101 Life Safety Code which is already incorporated by reference in § 203.1.
Section 205.66 (relating to special ventilation requirements for new construction)
This section sets forth special ventilation requirements for new construction. Amendments have been made to the chart contained in subsection (a).
Sections 205.71 and 205.72 (relating to bed and furnishings; and futniture)
These sections address beds and furniture. The only requirement which the Department proposes to keep is that a bed be equipped with an appropriately sized mattress and that each resident have a bedside drawer or cabinet which can be locked. References to all other types of furniture such as bedside chairs, overbed tables and footstools have been deleted.
Sections 205.73 and 205.74
Sections 205.73 pertaining to sterilization requirements and § 205.74 which requires a sufficient quantity of linen are proposed to be deleted. Sterilization is covered under the general infection control provisions in the Federal regulations at 42 CFR 483.65 and § 205.75 (relating to supplies) requires that the facility have adequate supplies which would include linen.
Chapter 207: Housekeeping and Maintenance Standards for Long Term Care Nursing Facilities Sections 207.1, 207.3 and 207.5
These sections address environmental safety, housekeeping and maintenance. The Department proposes to delete them in their entirety in light of the general requirement that the administrator be responsible for the satisfactory housekeeping and maintenance of the buildings and grounds in § 207.2(a) (relating to administrator's responsibility).
Chapter 209: Fire Protection and Safety Programs for Long Term Care Nursing Facilities Section 209.3 (relating to smoking)
The Department proposes to keep only subsection (a) which provides that the facility must have smoking policies. The current provisions found at subsections (c)-- (h), which mandate certain smoking precautions, may subsequently appear as guidelines to the regulation.
Sections 209.4, 209.5 and 209.6
These sections on fire extinguishers, the emergency lighting system and the fire alarm are being deleted as they are already addressed in the NFPA 101 Life Safety Code. The Department proposes to move subsection (f) of § 209.6, requiring personnel be instructed in the use of fire extinguishers, to a new subsection (c) in § 209.7 (relating to disaster preparedness) dealing with disaster preparedness.
Chapter 211: Program Standards for Long Term Care Nursing Facilities Section 211.1 (relating to reportable diseases)
This section which was titled Infection Control has been amended and is now titled Reportable Diseases. The list of reportable diseases still remains but has been updated. A new subsection (c) has been added to require facilities to report cases of Methicillin Resistant S. Aureus (MRSA) to the local field office for the Division of Nursing Care Facilities.
Section 211.2 (relating to physician services)
The Department proposes to amend this section on physician services by retaining subsection (e) which states that the attending physician is responsible for the medical evaluation of a resident and for prescribing appropriate care. Subsection (l)(2) and (4) is also retained. These subsections provide that a medical director's duties include review of incidents and accidents which occur in the facility and the development of policies delineating physician responsibilities. The remainder of the paragraphs are deleted in light of the adoption of the Federal regulation on physician services and responsibilities of the medical director at 42 CFR 483.40 and 483.75(i).
Section 211.4 (relating to procedure in event of death)
Subsections (a)--(c) are proposed to be deleted. These subsections required a facility to notify a resident's treating physician upon the resident's death, to document the death in the resident's medical record and also required the physician to complete and sign the death certificate under Article V of the Vital Statistics Law of 1953 (35 P. S. §§ 450.501--450.506). The Department does not believe it is necessary to include these items in licensure regulations as they reflect standard protocol and existing law.
Section 211.5 (relating to clinical records)
The Department proposes to change the term ''medical records'' to ''clinical records'' and to delete subsections (b), (d)--(g) and (o). These subsections outlined what had to be included in nurses' notes and are not considered to be needed in a specific licensure regulation as the information should be included in nurses' notes using standard protocol. The other subsections address providing copies of records to residents upon request and maintenance of medical record facilities.
Section 211.6 (relating to dietary services)
The Department proposes to eliminate subsections (a), (b), (e)--(q) and (s). These subsections address adequate staffing, frequency of meals, substitutions and sanitary conditions. These sections are covered by the Federal regulations. The concept of a dietary services supervisor is deleted to correspond to the Federal regulation in 42 CFR 483.35(a) which requires a facility to have a qualified dietician.
Section 211.8 (relating to use of restraints)
The Department proposes to add chemical restraints to subsection (d) which requires a physician's order for the use of a restraint and to delete subsection (f) which did not require an order for a geriatric chair. Both these amendments are consistent with Federal regulations. New subsection (f) requires an interdisciplinary team to reevaluate the need for all restraints ordered by physicians.
Section 211.9 (relating to pharmacy services)
The Department proposes to eliminate the majority of subsection (a) which provides that the facility have written policies and procedures for ensuring the identity of the resident and recording of administration as these requirements are covered by the Federal regulation in 42 CFR 483.60(a) which states that the facility must assure accurate administration of all drugs.
Sections 211.10 and 211.11 (relating to resident care policies; and resident care plan)
The Department proposes to delete subsections (a) and (b) and (d)--(f) of § 211.10, pertaining to resident care policies and subsections (a)--(e) and (g) of § 211.11 pertaining to resident care plans. Federal regulations in 42 CFR 483.20, thoroughly address resident care plans. The Department intends to keep subsection (f) which specifically requires that the resident's care plan be available to staff caring for the resident's needs.
Section 211.12 (relating to nursing services)
Subsection (e) is amended to add a specific requirement that the director of nursing be responsible for nursing service objectives, job descriptions, scheduling rounds and staff development.
The Department proposes to amend the general number of nursing hours in subsection (n) to eliminate the distinctions between skilled and intermediate care. By statement of policy dated February 17, 1996, the Department set the requirement at 2.3 hours of nursing care per resident in a 24-hour period. It is now amending the regulations to reflect this policy.
Subsections (r) and (s) are proposed to be deleted as nutritional needs and restorative care are covered in the comprehensive resident assessments required by the Federal regulations in 42 CFR 483.20(b).
Section 211.13
The Department proposes to delete this section addressing rehabilitative services in its entirety as this subject is covered by the Federal regulation in 42 CFR 483.45.
Section 211.14
This section pertaining to diagnostic services is to be deleted in its entirety as the subject is addressed in the Federal regulation in 42 CFR 483.75(j) and (k).
Section 211.15 (relating to dental services)
The Department is deleting subsections (b)--(d) from this section on dental services as these are covered in the Federal regulation in 42 CFR 483.55.
Section 211.16
The Department is deleting this section addressing social services in its entirety as the subject is covered in the Federal regulation in 42 CFR 483.15(g).
Section 211.17 (relating to pet therapy)
The Department proposes to delete all subsections from this section addressing patient activities, except for subsection (f) which sets forth requirements for facilities using pet therapy. Patient activities are addressed in the Federal regulation in 42 CFR 483.15.
Subpart F: Ambulatory Surgical Facilities. On December 7, 1996, the Department published notice in the Pennsylvania Bulletin that it would commence a review of the regulations pertaining to ASF on January 10, 1997. See 26 Pa.B. 5913. This review was accomplished through the convening of a work group which not only considered appropriate amendments to the ASF regulations due to the passage of time since enactment, but also, in light of the termination of the CON Program, considered the quality criteria contained in the SHSP relevant to ASFs.
The work group recommended that the ASF regulations should apply to all freestanding or office based facilities which perform outpatient surgery on patients not requiring hospitalization, but who still need constant medical supervision for a limited period of time following the surgery. The work group recommended that the Department recognize three levels of ASFs and that these levels be distinguished by the level of anesthesia administered and by patient acuity. Class A ASFs need not be licensed but do need accreditation to be recognized as ASFs. Class B (office based) and Class C (freestanding) facilities require licensure. Operative times of up to four hours are permitted in ASFs and a recovery time of the same period is also permitted. The work group recommended that the Department be permitted to use outside National accreditating agencies to perform some or all aspects of licensure surveys. The following contains the highlights of changes proposed to the chapters discussing ASFs.
Chapter 551: General Information Section 551.2 (relating to affected institutions) states that only facilities licensed under this subpart can provide ambulatory surgery.
Section 551.3 (relating to definitions) defines ambulatory surgery as that surgery which is performed on an outpatient basis in a facility which is not located in a hospital and upon patients who do not require hospitalization, but who do require constant medical supervision following the surgical procedure. An ''ASF'' is defined as a facility or portion thereof not located upon the premises of a hospital which provides specialty or multispecialty outpatient surgical treatment. These provisions clearly distinguish outpatient surgery performed in a hospital from ambulatory surgery performed at an ASF. Additionally, the definitions State that ambulatory surgery does not include individual or group practice offices of private physicians or dentists, unless these offices have a distinct part used solely for outpatient surgical treatment on a regular and organized basis. Thus, a physician's office will not generally be considered as an ASF, unless it meets the specific requirements of this subpart.
The definition divides ASFs into three classifications:
Class A--A private or group practice office of practitioners where procedures performed are limited to those requiring administration of either local or topical anesthesia or no anesthesia. Class A ASFs must receive accreditation from a Nationally recognized accrediting body such as the Accreditation Association for Ambulatory Health Care (AAAHC) or the Joint Commission on the Accreditation of Health Care Organizations (JCAHO) in order to be identified as providing ambulatory surgery.
Class B--Single or multiple specialty facilities with a distinct part used solely for ambulatory surgical treatments involving administration of sedation analgesia or dissociative drugs wherein reflexes may be obtunded.
Class C--Single or multiple specialty facilities used exclusively for the purpose of providing ambulatory surgical treatments which involve the use of any anesthetic agents, including general anesthesia.
This classification system is based upon the types of procedures performed, the status of the patient receiving the surgery and the level of anesthesia which is used.
The patient status is covered under the definition of ''physical status classification.'' These classifications involve an evaluation of the patient's overall health as it would influence the conduct and outcome of surgery. Five types of patient classifications are established:
Class 1--No organic, physiologic, biochemical, metabolic or psychiatric disturbance.
Class 2--These patients have a systemic disturbance which may be of mild to moderate degree but which is either controlled or has not changed in its severity for some time.
Class 3--These patients suffer from significant systemic disturbance, although the degree to which it limits the patient's functioning or causes disability may not be quantifiable.
Class 4--These patients suffer from severe systemic diseases that are already life threatening and may or may not be correctable by surgery.
Class 5--These patients are moribund and are not expected to survive without surgery.
Under the three types of ASFs, Classes A--C, the following patients may be treated: Class B ASFs may treat patients in Class 1 or 2, unless the patient's physical classification status would not be adversely affected by the surgery. Class C ASFs may treat patients in Classes 1--3 as long as the ASF complies with the regulations on anesthesia and recovery time (See § 551.21).
The classification of ASFs under Classes A--C reflects the system used under the June 17, 1994, amendments to Chapter 5 (Outpatient Surgery) of the SHSP. The patient classifications under Classes 1--5 are those established by the American Society of Anesthesiologists (ASA). Under these classifications, those entities which are the most equipped and capable of performing ambulatory surgery, will perform those surgeries requiring the higher levels of anesthesia on the more medically complex patients.
Due to the proposed addition of a general information chapter (Chapter 51) which will cover administrative matters which apply to all health care facilities, the provisions at §§ 551.11--551.13 concerning the exceptions process are proposed for deletion, as they will now be covered under §§ 51.31--51.34.
Section 551.21 (relating to criteria for ambulatory surgery) sets forth in detail the criteria for ambulatory surgery. Section 551.21(a)(1) and (2) states that ambulatory surgical procedures do not generally exceed a total of 4 hours of operating time and a total of 4 hours of directly supervised recovery. This replaces the prior limitation of 90 minutes operating time and retains the recovery time of 4 hours. Section 551.21(b)(1) and (2) states that if the surgical procedures to be performed in an ASF require anesthesia, the anesthesia must be either local or regional or general anesthesia if it is of 4 hours or less duration. Section 551.21(c)(1)--(5) states that certain types of surgical procedures may not be performed in an ASF, regardless of the classification. These surgeries are those generally associated with the risk of extreme blood loss, those which require major or prolonged invasion of body cavities, those which directly involve major blood vessels, those which are generally emergency or life threatening in nature and those surgeries which are performed on patients younger than 6 months of age or on low birth weight babies up to 1 year of age.
Section 551.31 (relating to licensure) sets forth the procedure for licensure and States that all Class B and Class C ASFs must obtain a license. The license issued by the Department will designate the facility as either Class B or Class C. For the Department to determine the appropriate classification, the applicant must provide: a list of operative procedures proposed to be performed at the facility, the highest level of anesthetic proposed to be used and highest patient classification level proposed to receive ambulatory surgery at the facility. ASFs which are classified as Class B and wish to be reclassified as Class C may not provide services to patients in Class 3 until the ASF has requested and obtained a license as a Class C ASF.
Section 551.32 discusses surveys and inspections which must be conducted by the Department prior to occupancy of the building housing the ASF. As previously stated, Chapter 51 will now address general administrative matters. Section 51.5 discusses building occupancy, thus § 551.32 is duplicative and is proposed to be deleted.
Section 551.33 (relating to survey) maintains the Department's ability to conduct onsite surveys, but adds language that the Department may designate Nationally recognized accrediting agencies to perform some or all aspects of these licensure surveys.
Section 551.34 (relating to licensure process) increases the ASF licensure fee from $50 to $250.
Sections 551.41 and 551.82 (relating to policy; and regular license) increase the period of licensure from 1 year to 2 years.
Section 551.91(b)(10) (relating to grounds) adds as a ground for refusal to renew, suspend or revoke a license a finding that the licensee is providing services exceeding the scope of the classification assigned in the license.
Sections 551.93(b) and 551.111 (relating to notice; and hearings relating to licensure) transfer the jurisdiction of hearings relating to licensure from the State Health Facilities Hearing Board to the Health Policy Board. This section tracks the statutory amendment under The Administrative Code of 1929 (71 P. S. § 2102(n)).
Sections 551.121--551.123 discuss civil rights compliance. These issues will now be covered under the general administrative chapter in §§ 51.11-- 51.13. As a result, the Department proposes to delete §§ 551.121--551.123 as they are duplicative.
Chapter 553: Ownership, Governance and Management Section 553.2(c) (relating to ownership) would be amended to define an owner of an ASF as any person who has a direct or indirect equity interest in the facility equal to or greater than 5%. Section 553.2(d) will be amended to require the ASF to notify the Department in writing within 30 days of any change in management, ownership, officers or directors. Change in ownership is specifically defined to mean any change involving 5% or more of the equity of the ASF. Change in ownership also includes the death, retirement or incapacitation of any shareholder, partner or other equity owner of an ASF. These changes are made to assure that, regardless of the corporate form of the ASF, the Department will receive the same information alerting it as to the ownership of the ASF and any change which may occur in that ownership.
Section 553.3(8)(iv) (relating to governing body responsibilities) requires the governing body of the ASF to assure compliance with the universal precautions for prevention of transmission of diseases promulgated by OSHA. Similarly, § 553.3(8)(vi) requires the ASF to comply with all applicable Federal and State regulations, including the Americans with Disabilities Act (ADA).
Section 553.4(h) (relating to other functions) adds a requirement that the governing body appoint a medical director who shall be certified by a board recognized by the American Board of Medical Specialties or the dental, podiatric or osteopathic equivalent. The presence of a qualified medical director will assist in the functioning of the ASF and provide a medically trained individual who can deal with whatever issues might arise.
Section 553.25 (relating to discharge criteria) establishes specific physical status criteria which must be met before an individual is discharged from an ASF. The categories which must be checked are: vital signs (blood pressure, heart rate temperature and respiratory rate are within the normal range for the patient's age or at preoperative levels), activity (patient has regained preoperative mobility without assistance), mental status (patient is awake, alert or functioning at preoperative status), pain (patient's pain can be effectively controlled with medication), bleeding (patient's bleeding is controlled and consistent with that expected from the surgical procedure) and nausea/vomiting (minimal nausea or vomiting is controlled and consistent with that expected from the surgical procedure).
Chapter 555: Medical Staff Section 555.12 (relating to oral orders) would be amended to note that oral orders for medication or treatment shall be accepted only under urgent circumstances and the relevant information must be transcribed in the patient's medical record at the time of administration and countersigned by the practitioner within 24 hours.
Section 555.13 (relating to administration of drugs) is new and requires that drugs shall be administered only upon the appropriate order of a practitioner acting within the scope of his license and according to medical staff bylaws, rules and regulations. Drugs may be administered only by: 1) the practitioner; 2) a registered professional nurse; or 3) a licensed practical nurse with pharmacy training.
Section 555.24(d) (relating to postoperative care) would be amended so as to delete the requirement that a physician be present until the patient is discharged, but requires the presence of a medical professional certified in advanced cardiac life support (ACLS). However, if general anesthesia has been administered during the operation, the anesthesiologist or anesthetist must remain present until the patient has been discharged.
Section 555.32(a) (relating to administration of anesthesia) would be amended to allow the administration of anesthetics by: 1) anesthesiologists; 2) certified registered nurse anesthetists; 3) dentist anesthetists; or 4) qualified practitioners as listed in § 551.3.
Section 555.33(c) (relating to anesthesia policies and procedures) would be amended to require that policies and procedures shall be developed by the governing body of the ASF and shall include: education, training and supervision of personnel, responsibilities of nonphysician anesthetists and responsibility of the supervising physician or dentist. Section 555.33(d)(6) and (7) would be amended to provide that certain types of intraoperative physiologic monitoring must be available and that no patient shall receive general anesthesia unless at least one other health care professional is present in addition to the professional performing the surgery.
Section 555.35 (relating to safety regulations) would be amended to add a requirement that all machines used for anesthesia shall receive at least one annual functioning test, by appropriately trained technicians.
Chapter 557: Quality Assurance and Improvement It is proposed that the title of this section be amended to read: ''quality assurance and improvement,'' to reflect the interest and concerns in this area. The Department expects that facilities will not only assure the quality of care delivered, but will actively seek methods to improve that quality.
Section 557.3(a) (relating to the quality assurances and improvement program) would be amended to require that the quality assurance and improvement program to monitor and evaluate specific data, including medical records, incident reports, infection control records and patient complaints. Several other areas which should be evaluated under this program are also added to this section. These additional areas reflect the standards for quality assurance and improvement programs established by the American Association for Ambulatory Health Care (AAAHC).
Chapter 559: Nursing Personnel The only proposed changes to this chapter are in § 559.3 (relating to nursing personnel). Specifically, § 559.3(a) would be amended to provide that an adequate number of unlicensed personnel shall be present at the ASF. This section presently uses the terminology of ancillary personnel. The terminology of unlicensed personnel is a more precise description of this type of personnel. Section 559.3(b) would be amended so as to provide that at least one registered professional nurse shall be in attendance when patients are present. The current provision requires a registered professional nurse to be present at all times the facility is open, regardless if any patients are being treated. Section 559.3(c) would be amended to require that any registered professional nurse or licensed practical nurse who practices at the ASF must be appropriately licensed to practice in this Commonwealth. The current provision only requires those nurses who are employed by the ASF to be licensed.
Chapter 561: Pharmaceutical Services Section 561.2 (relating to pharmaceutical service) would be amended to reflect National standards for ASF pharmacies. Under § 561.2(a), pharmaceutical services shall be supervised by a physician or dentist who is qualified to assume responsibility for the quality of services rendered. Section 561.2(b) would state that a pharmacy which is owned and operated by an ASF shall be supervised by a licensed pharmacist. Finally, § 561.2(c) permits the ASF to contract with a pharmacy but requires that those contracted pharmaceutical services shall be provided in accordance with the same ethical and professional practices and legal requirements that would be required if these services were provided directly by the ASF.
Section 561.21 (relating to principle) would be amended to add a sentence providing that the ASF may use drugs for experimental purposes, but the use must be approved or review waived by an Institutional Review Board (IRB).
Section 561.23 currently titled ''Use of dangerous drugs'' would be retitled ''Use of controlled substances and other drugs.'' The section would be amended to provide that policies and procedures must be developed and approved by the medical staff which govern the use of controlled substances and other drugs, including sedatives, anticoagulants, antibiotics, oxytoxics and corticosteroids.
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