[29 Pa.B. 3999]
[Continued from previous Web Page] Section 205.4. Building plans.
This section sets forth the requirements for both preliminary and final architectural plan approval. Only one set of plans will now be required. The Department has incorporated the preliminary plan criteria in former subsection (f), in subsection (e), former subsection (h) which addresses the final plan submission.
Although the PANPHA supports the Department's effort to streamline the physical plant section and to permit providers more flexibility, it suggested that the Department continue to require a preliminary and final plan approval process, as the two-step process was helpful to providers in that it identified many necessary changes needed in the architectural, mechanical and electrical plans. The Department will continue to work with providers and will review plans prior to final submission if requested to do so. The final submission of plans may also be revised if the review finds that there are necessary changes to be made.
The Department adopted a recommendation from PANPHA that the reference to preliminary plans be deleted from former subsection (c), now subsection (b).
Section 205.5. Number of building plans to be prepared.
This section, which required preliminary plans to be filed in duplicate, has been repealed.
Section 205.7. Basement or cellar.
The Department has deleted subsection (a).
Section 205.8. Ceiling heights.
Subsections (a) and (b) have been deleted, permitting ceiling heights except in boiler rooms to be 7 feet, 6 inches.
Section 205.9. Corridors.
The Department has deleted former subsections (a) and (b) and added a prohibition that corridors may not be used for storage. One commentator asked the Department to clarify the section to permit the temporary storage of equipment while serving residents. The Department has decided not to do so as it does not want to raise issues of what is temporary, or permit the temporary storage of items such as geri-chairs and IV equipment.
Section 205.14. Locks.
Although the Department did not propose any substantive changes to this section, the PANPHA requested that protocols for special locking arrangements (SLAs) be included in the regulations. The Department has decided not to issue standard protocols at this time. Instead, it feels that it is important to look at each individual request for an SLA on a case-by-case basis to ensure residents subject to these exceptions are provided with sufficient therapeutic activities and that staffing will not decrease as a result of an exception being issued. However, the Department is accepting IRRC's recommendation that the issue be studied and, if necessary, addressed in future rulemaking.
Section 205.20. Resident bedrooms.
This section is amended to require only a flat amount of square footage for single and multibed rooms and to delete additional minimum space requirements within the square footage requirement. For example, a single-bed 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. It wants to provide facilities with the flexibility to arrange rooms in various ways. The PANPHA commended the Department's decision to delete the specific spacial requirements within the minimum square footage.
Section 205.21. Special care room.
The PANPHA pointed out that the special care room should be required to have negative pressure and that this should be reflected in § 205.66 (relating to special ventilation requirements for new construction) which sets forth special ventilation requirements. This section has been amended to require ventilation as specified in § 205.66.
Section 205.24. Dining room.
The Department has deleted former sections (a) and (b) which addressed the space requirements when a facility combined a dining room and a recreation area. Former subsection (c) is now subsection (a). A new subsection (b) is added which requires tables and space to accommodate wheelchairs. St. Mary's Home of Erie inquired as to whether the Department will make exceptions for facilities which do not provide tables and space to accommodate wheelchairs. As with all requests for exceptions, the Department will review requests individually under § 51.33 (pertaining to requests for exceptions) which requires the publication of the request as well as the determination in the Pennsylvania Bulletin.
The PACAH commented that the requirement that adaptive devices be provided to facilitate the eating of meals was not included in this section, but supported its deletion as it is covered by Federal requirements. This language appeared instead in § 211.6(h) (relating to dietary services) and has been deleted.
Section 205.25. Kitchen.
The PACAH suggested that the entire section be deleted as it felt it was overly prescriptive. Most of the requirements for a kitchen have been deleted with the exception of subsection (a), which requires that there be a kitchen, and former subsection (d), now subsection (b), which requires a service pantry on each unit.
Section 205.27. Lounge and recreation rooms.
The Department deleted former subsections (b) and (c) and retained the text of subsection (a) with a minor amendment. A comment was received from a nursing home administrator regarding former subsection (a), that lounges should not be required on each floor. The requirement is for lounges on each floor rather than each unit. The Department believes it is important that residents not have to go to another floor, to visit the lounge area, which could require the negotiation of stairs.
Section 205.31. Storage.
The Department has retained the text of subsection (a). This provision requires that for each bed there be a minimum of 10 square feet of storage space provided for items, including residents' possessions. A couple comments were received suggesting that former subsections (c) and (d), pertaining to storage of residents belongings and indoor recreation equipment, be deleted. These subsections have been deleted as had been proposed.
Section 205.33. Utility room.
The Department has added a new subsection (b), which requires separate bedpan flushers to be provided in soiled workrooms unless a facility has them in residents' bathrooms. Also, a new subsection (c) has been added which requires hand-washing facilities in soiled and clean utility rooms. Former subsections (b) and (c) were deleted.
Section 205.34. Treatment room or examining room.
This section has been deleted.
Section 205.35. Telephone.
This section has been deleted. The Federal regulations which are being adopted require that residents have access to a telephone.
Sections 205.36. Bathing facilities, 205.37. Equipment for bathrooms, 205.38. Toilet facilities, 205.39. Toilet room equipment, and 205.40. Lavatory facilities.
These sections address bathrooms, toilet rooms and lavatories. The Department has deleted requirements as to the size of tubs and shower stalls while retaining the requirement of a minimum clearance around bathtubs in § 205.36(h).
Subsections (c) and (d) were originally proposed to be deleted in § 205.37. The Department received a recommendation from an administrator and a facility that subsection (d)'s requirement of a dressing area next to the shower be deleted. However, in light of past incidents involving resident injury while bathing, the Department has determined that the entire section should remain and that additional language should be added to subsection (c) to require appropriate supervision of and assistance for residents being bathed. The Department believes subsection (d)'s requirement of a dressing area next to the shower will help to prevent resident falls.
A new subsection (e), which requires that bath water temperature be tested before a resident is bathed, has also been added to this section. One commentator suggested requiring comfortable air temperature as well, but the Department considers this matter to be adequately covered in Federal regulations which require a comfortable environment.
In § 205.38, the Department proposed to delete subsections (b)--(e) while keeping subsection (a) and subsection (f), now designated as subsection (e), which requires a minimum ratio of 1 toilet per 4 residents. After reviewing comments received, the Department decided to keep subsection (b), which requires no less than 3 1/2 feet of space from the front of the toilet to the wall, and the first sentence of subsection (c), which requires at least one toilet on each floor to accommodate residents in wheelchairs. The specific spatial requirements which were previously listed were deleted in response to a question from the PANPHA as to whether or not the dimensions were adequate to accommodate wheelchairs and other assistive devices. The Department also decided to keep former subsection (g), now designated as subsection (f), which requires separate toilets and lavatories for use by visitors.
Sections 205.61. Heating requirements for existing and new construction, 205.62. Special heating requirements for new construction, 205.63. Plumbing and piping systems required for existing and new construction, and 205.64. Special plumbing and piping systems for new construction.
The Department has deleted 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 (relating to application of the Life Safety Code).
Although § 205.61(a) was proposed to be deleted, the Department has rethought this proposal. It has determined that it should retain a reference to local and State building codes and continue to require that the most stringent apply.
Section 205.66. 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). Criteria for the special care room have been added in response to a comment from the PANPHA. The provisions for exam and treatment rooms have been deleted to reflect that former § 205.34, pertaining to exam and treatment rooms, has been deleted.
Section 205.67. Electric requirements for existing and new construction.
In response to a comment from the PANPHA, the Department has deleted the reference to lighting which is satisfactory for sewing as well as the reference to 200 footcandles. It has also revised the section to simply require lighting which is satisfactory for resident activities.
Sections 205.71. Bed and furnishings and 205.72. Furniture.
Most of the provisions in these two sections have been deleted. However, the Department is retaining the requirement in § 205.71, that a bed be equipped with an appropriately sized mattress, and in § 205.72, 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. Much of former § 205.72(j) is retained, however, the former exception to the requirement of a drawer or cabinet in former subsection (j) has been deleted. It is important that every resident have a locked drawer or cabinet in which to store personal possessions.
Sections 205.73. Sterilization.
This section, pertaining to sterilization requirements, has been repealed. Sterilization is covered under the general infection control provisions in the Federal regulations at 42 CFR 483.65.
Section 205.74. Linen.
This section, which requires a sufficient quantity of linen, was proposed to be deleted in its entirety, as the Federal regulations require that facilities have bedding which is appropriate to the climate. The Department agrees with a comment from the PANPHA that the Federal requirement alone is not sufficient. Therefore, the text of former subsection (a), requiring sufficient linen, has been retained, although the specific requirement of three daily changes of linen per resident has been deleted.
Section 205.75. Supplies.
The PACAH suggested that the Department delete this section arguing that it is repetitive of Federal and State regulations. The Department is retaining the section as there is no direct Federal regulation generally requiring adequate supplies.
Chapter 207. Housekeeping and Maintenance Standards for Long-Term Care Nursing Facilities
Sections 207.1. Environmental safety and 207.3. Housekeeping.
These sections address environmental safety, housekeeping and maintenance. The Department is repealing them in light of the general requirement in § 207.2(a) (relating to administrator's responsibility) that the administrator be responsible for the satisfactory housekeeping and maintenance of the buildings and grounds.
Section 207.2. Administrator's responsibility.
The provision in subsection (b) which required a full-time employe to be responsible for housekeeping and maintenance and for the training of personnel has been deleted. The Department has also deleted former subsection (c) which specifically stated that the administrator is responsible for ensuring contract services meet the requirements of the chapter. It was concluded that this did not have to be specifically stated, as the administrator is responsible for ensuring that the licensure requirements are met whether they are performed by employes or contracted out.
Section 207.4. Ice containers and storage.
Former subsections (b)--(d) have been deleted. The Department retained the general provision in former subsection (a), which requires the sanitary handling of the ice storage container.
Section 207.5. Maintenance of equipment and building.
This section has been repealed. Its provisions are adequately addressed in § 207.2(a) (relating to administrator's responsibility), which provides that the administrator is responsible for the satisfactory housekeeping and maintenance of the facility.
Chapter 209. Fire Protection and Safety Programs for Long-Term Care Nursing Facilities
Section 209.1. Fire department service.
In response to a comment from the Department of Aging, the reference to the fire department in this section has been changed to emergency services to reflect the fact that most areas are covered by an emergency notification system.
Section 209.2. Hazardous areas.
In response to a comment by the PACAH, this former section, which addressed requirements for pipes and radiators in residents' rooms, has been repealed, as these matters are addressed in § 205.61 (relating to heating requirements for existing and new construction).
Section 209.3. Smoking.
The Department proposed to retain only subsection (a), which provides that the facility must have smoking policies, and subsection (b), which requires the facility to take safeguards against smoking related fire hazards. Subsections (c)--(g), which mandate certain smoking precautions, were to appear as guidelines to the regulation.
The PACAH commented that it agreed with the retention of subsection (b), but did not agree with the proposed deletion of subsections (c)--(f). In response to a smoking related incident, as well as the PACAH's comment, the Department concluded that it was important to retain the entire section and to reword subsection (c) to require adequate supervision for smoking residents who require it. Although subsections (e)--(g) are addressed in the Life Safety Code, the Department determined that it was important to also specifically retain them in the licensure regulations.
Both the PACAH and the University of Pennsylvania Medical Center's Institute on Aging, commented on this section. The PACAH urged the Department to address in subsection (a) the rights of smoking residents as well as nonsmoking residents, and to require that the policies be reviewed upon admission. The rights of smoking residents are already addressed in this section. The Department will review any complaints by smoking residents on a case by case basis.
The Institute on Aging and PACAH stated that they would like the Department to address the protection of employes by adopting regulations banning smoking entirely in facilities. The Department believes that this is an issue to be negotiated between the employes and each individual facility, and that a specific disposition should not be dictated by regulation.
Sections 209.4. Fire extinguishers, 209.5. Emergency lighting system and 209.6. Fire alarm.
These sections are being repealed, as the matters they address are already addressed in the NFPA 101 Life Safety Code. The Department has moved former § 209.6(b), requiring personnel to be instructed in the use of fire extinguishers, to a new § 209.7(c) (relating to disaster preparedness).
Section 209.7. Disaster preparedness.
This section has been revised by deleting former subsection (a) and incorporating its requirement that the facility have a comprehensive written disaster plan into former subsection (b), now subsection (a). Also, the requirement that had been included in § 209.6 (relating to fire alarm), requiring all employes to be instructed in the use of fire extinguishers, is added in subsection (c). The PANPHA asked whether all employes must be instructed in the use of the fire extinguishers. Recognizing the potential for disaster which a fire in a long-term care nursing facility could have, the Department feels it is necessary that all employes be instructed in the use of the fire extinguishers and has clarified § 209.7(c) accordingly.
There are a limited number of types of extinguishers which facilities would use and local fire companies and departments are often willing to assist in this type of instruction.
Chapter 211. Program Standards for Long-Term Care Nursing Facilities
Section 211.1. Reportable diseases.
This section which was titled ''Infection control,'' has been amended and is now titled ''Reportable diseases.'' The list of reportable has been updated. A new subsection (c) has been added to require facilities to report cases of resistant bacterial infections such as Methicillin Resistant Staphyloccus Aureus (MRSA), Vancomycin-Resistant Enterococci (VRE) and Vancomycin-Resistant Staphylococcus Epidermidis (VRSE) to the local field office for the Division of Nursing Care Facilities.
Cedarbrook and Lehigh County Home asked whether the Department was requiring the reporting of individual cases of MRSA or only nosocomial outbreaks. HAP, PHCA, PACAH and St. Mary's Home of Erie felt that reporting individual cases was cumbersome and unnecessary, and urged the Department to limit the reporting requirement for MRSA to nosocomial outbreaks. The Department has reconsidered the usefulness of this information reported on an individual basis and has revised the subsection to require reporting of only nosocomial outbreaks of the resistant bacterial infections such as MRSA.
The PANPHA suggested that the Department define ''nosocomial outbreak,'' however, such a determination could vary depending on the size of the facility. The Department instead revised the regulation to require the determination of a nosocomial outbreak for reporting purposes to be made by the facility's medical director.
Section 211.2. Physician services.
The Department had proposed to amend this section by retaining subsection (e), which states that the attending physician is responsible for the medical evaluation of a resident and for prescribing appropriate care. The Department had also proposed to retain former subsection (l)(2) and (4). These provisions provided 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. As proposed, the remainder of the paragraphs of former subsection (l) were 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) (relating to physician services; and administration).
Good Shepherd suggested the Department retain former subsection (a), which stated that the facility shall have a physician responsible for the needs of the residents. The Department believes this is adequately addressed in the Federal regulations. The commentator, along with Quest Diagnostics and the PANPHA, agreed with the Department's proposed deletion of former subsections (g) and (h), which prescribed various admission and periodic testing of residents and recognized that physicians now have the flexibility to order only those tests they feel are necessary in individual situations.
The PANPHA questioned the requirement of former subsection (e), now subsection (a), that the physician is responsible for the medical evaluation of the resident, as the physician is only part of an interdisciplinary team. The Department is retaining this requirement. Although the team has input into the resident's care plan, the physician has the final responsibility for the resident's medical evaluation.
The Department proposed to delete former subsection (f) in its entirety. This subsection stated that the facility shall have current medical information at admission, and information on the rehabilitation potential with a summary of the prior course of treatment within 48 hours. The University of Pennsylvania Health System's Institute on Aging commented that 48 hours was too short a time for the facility to assess the resident, but felt the Federal requirement of 30 days was too long for the initial physician visit.
The Federal regulation in 42 CFR 483.20 provides that the facility have physician orders at the time of admission and that an assessment be within 14 days of admission. Therefore, the Department deleted the portion of former subsection (f), now subsection (b), which provided for the summary of the rehabilitation potential and prior course of treatment within 48 hours of admission, and is instead requiring that the medical assessment include this information and be conducted no later than 14 days after admission.
Several commentators were confusing the medical assessment required by this subsection with the MDS's functional assessment. One commentator suggested that the Department define ''medical assessment''; however, the Department believes that is within the realm of the practice of medicine and therefore a decision to be made by the practitioner.
The University of Pennsylvania Health System's Institute on Aging, the PMS, the Pennsylvania Medical Directors Association (PDMA) and IRRC objected to the proposed deletion of former subsection (k), which states that a facility must have a medical director licensed in this Commonwealth. The Department agrees that the Federal requirement of a medical director in 42 CFR 483.75(i) would not cover the requirement of a Pennsylvania license. Therefore, the subsection has been retained as new subsection (c).
Section 211.3. Oral and telephone orders.
Subsection (b) provides that a physician must countersign oral orders for care and treatments within 7 days of receipt of the order. Former § 211.9(h), now subsection (c), provides that physicians countersign oral orders for medications within 48 hours. However, the Department received comments from the PACAH, PHCA and PANPHA that countersignatures for both medications and treatments should be 7 days. St. Mary's Home of Erie noted the problems facilities face with weekend orders. The Department is concerned that there is more of a likelihood that a mistake could be made with oral orders for medications than for treatments, as many medications sound similar and there could be mistakes regarding the dosage. Therefore, the 48 hour time limit is kept for countersignatures to medication orders. In light of the fact that facsimile transmissions are permitted, the Department believes that the 48 hour time limit is not unreasonable and best protects the health and safety of residents.
Both the PNA and IRRC commented that subsection (a) should be amended to reflect that only registered nurses and not licensed nurses may take oral orders. The subsection has been amended to reflect this. IRRC suggested that a section be added providing that licensed practical nurses may accept oral orders only in emergency situations under 49 Pa. Code § 21.145(b) (relating to functions of the LPN). As this is already the scope of practice set forth in the nurse board's regulations, the Department does not feel it is necessary to repeat the regulation here.
In response to a suggestion by the PANPHA, the Department moved former § 211.9(f) (relating to pharmaceutical services) with minor revisions to this section and redesignated it as subsection (c).
Subsections (d) and (e) have been added. They provide that initial written orders and countersignatures may be by facsimile transmission. They also require facilities to have policies and protocols for the taking and transcribing of oral orders. Subsection (d) provides that oral orders shall only be accepted in situations where it is ''impractical'' for the practitioner to issue a written order. Although the Department recognizes the subjective nature of the term ''impractical,'' subsection (e) requires facilities to identify, through written policies, those types of situations where oral orders would be acceptable. Therefore, the facility will be required to have written policies to follow which the Department will review as part of the survey process.
Section 211.4. Procedure in event of death.
Subsections (a)--(c) are deleted. These subsections required a facility to notify a resident's treating physician upon the resident's death and to document the death in the resident's medical record. They 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. Clinical records.
The Department has changed the term ''medical records'' to ''clinical records'' to be consistent with Federal terminology. It has also deleted former subsections (b), (d)--(g) and (o). Subsection (o) outlined what had to be included in nurses' notes. It is not necessary to include that information in a specific licensure regulation as the information should be included in nurses' notes using standard protocol. The other subsections, which addressed resident requests for copies of records and maintenance of medical record facilities, are adequately covered by Federal regulations in 42 CFR 483.75(l).
The Department proposed to delete the term ''medical record practitioner'' and amend former subsection (n), now subsection (i), to require that the supervisory responsibility for the medical record service be performed by ''personnel competent to carry out the functions of the medical record service.'' The PACAH agreed with the proposed deletion of the term and related requirements, as it felt the requirement added an unnecessary expense. However, IRRC, the PHCA, PANPHA and two accredited record technicians (ARTs), urged the Department to expressly set forth basic requirements for qualifications of medical records personnel. The Department has amended subsection (i) to require the medical records service to be assigned to a medical records practitioner and it has included a definition of ''medical records practitioner'' in § 201.3 (relating to definitions).
Several commentators, including the PANPHA and PHCA, expressed concern that the proposed language prohibited the use of medical records consultants. Therefore, the Department has added specific language to subsection (i) which permits a facility to contract with a medical records practitioner to act as a consultant, but that still requires overall supervisory responsibility of the clinical record service be by a medical records practitioner. The facility which uses a consultant for this purpose must ensure that the consultant devotes a sufficient number of hours to adequately supervise the clinical record service.
Section 211.6. Dietary services.
The Department has eliminated former subsections (a), (b), (e)--(j), (l), (n)--(q) and (s). These subsections address adequate staffing, frequency of meals, substitutions and sanitary conditions and are covered by the Federal regulations in 42 CFR 483.35. The remaining provisions have been recodified in subsections (a)--(f).
In response to a comment by the PHCA that hand washing does not guarantee a food service worker will be free of communicable diseases, the Department deleted language in subsection (f) which suggested that result. The subsection now simply requires that dietary personnel practice hygienic food handling techniques.
Section 211.7. Physician assistants and certified registered nurse practitioners.
The last sentence in subsection (a), which stated that physician assistants and certified registered nurse practitioners (CRNPs) could not be used in lieu of physicians, was deleted as it referenced former § 211.2(b) and (c) (relating medical services), which was deleted as well. The PACAH agreed with the section as written. The University of Pennsylvania Health System's Institute on Aging argued that the section should reflect the fact that CRNPs may prescribe drugs. As subsection (a) states that CRNPs may be utilized in accordance with the requirements of their licensing statute and regulations governing their scope of practice, the Department does not believe it is necessary to specifically grant them the right to prescribe in facility licensure regulations.
Section 211.8. Restraints.
The Department added drug restraints to subsection (d), which requires a physician's order for the use of a restraint, and deleted former subsection (f), which did not require an order for a geriatric chair. Both amendments are consistent with Federal regulations. New subsection (f) requires an interdisciplinary team to reevaluate the need for all restraints ordered by physicians. As proposed, subsection (e) would have required the physician to review the necessity for the continued restraint every 30 days. In response to a comment by the PANPHA, the Department has revised the section by deleting that requirement in subsection (e) and adding a requirement to subsection (f) that the interdisciplinary team shall reevaluate the use of all restraints every 30 days or sooner if necessary. This section ties into § 211.11(b) (relating to resident care plan), which requires the individual charged with coordinating the resident care plan to be part of the interdisciplinary team. The review may be sooner than every 30 days based on the interdisciplinary team's assessment of the resident.
Both Good Shepherd and Lehigh County Home commented that the Federal requirement of quarterly reports by the interdisciplinary team would be sufficient. The Department wants to encourage restraint reduction. It believes that a more frequent periodic review by the interdisciplinary team will assist facilities with this initiative.
St Mary's Home of Erie questioned whether the physician would have to attend the interdisciplinary team meeting. It is not mandatory that the physician attend the meetings, however, as an essential member of the team, the physician must have input into and review the team report and any recommendations therein to discontinue restraint usage.
The Philadelphia Geriatric Center questioned what the Department meant by a chemical restraint in subsection (d) as proposed. The Department has included a revised definition that specifically includes chemical restraints in § 201.3 (relating to definitions), and deleted the words ''physical or chemical'' in subsection (d). Instead, it included the word ''drug'' along with the list of physical restraints which require a physician's order. One commentator suggested the Department clarify that the use of a drug be for purposes of restraint in subsection (d). The Department has not done so as it believes that the wording is clear.
Lehigh County Home also commented that the pharmacist rather than the interdisciplinary team was the expert on chemical restraints and should review these orders instead of the interdisciplinary team. The Department believes that the pharmacist should have input in these situations and should either consult with or be a part of the interdisciplinary team.
A nursing home administrator suggested that the regulations permit the use of side rails and not consider them a restraint, because families often request them. The Department recognizes that families may request side rails, but the Department views side rails as a potential restraint and has not exempted them in these regulations. Facilities need to communicate to families the potential effect that the use of side rails or any restraint may have on the resident. The HCFA considers side rails to be a restraint as well.
Section 211.9. Pharmacy services.
The Department has eliminated the provisions in subsection (a) which provided that the facility have written policies and procedures for ensuring the identity of the resident and recording of medication administration. 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. PANPHA suggested that subsection (a) (1) and (2), which requires the facility to ensure the identity of the resident prior to administering the medication and to record the dosage and time given, be retained as a safeguard. The Department rejected this recommendation. It believes that this is standard protocol and covered by the broad general wording of the Federal regulation. The Department incorporated a suggestion from HAP that the words ''regarding medication administration'' be added to former subsection (a)(3), now subsection (a)(1).
That part of subsection (e) which required a 30 or 60 day review of physician's orders for intermediate or skilled care residents has been deleted to reflect the elimination of the references to skilled and intermediate care. Former subsections (f) and (g), which addressed automatic stop orders and the recording of any medications not given, as well as former subsection (i), which specified the information which needed to appear on a prescription container, have also been deleted as the Department believes these matters are adequately covered by the Federal regulations which address labeling requirements, require the accurate ''acquiring, receiving, dispensing, and administering'' of all pharmaceuticals, and specifically address labeling of drugs.
Former subsection (h), which addressed oral orders for medications, has been moved to § 211.3 (relating to oral and telephone orders) as suggested by the PANPHA.
The Department added the provisions of provider Bulletin No. 53, issued in January 1998, to former subsection (j), now subsection (f), which permits a resident to use an outside pharmacy as long as the pharmacy complies with applicable regulations and facility policies. Subsections (f)(1)--(4), which address the facility's responsibilities when residents choose outside pharmacies, have been added to the proposed language.
The Department proposed to delete former subsection (k), now subsection (g), which addressed the labeling and handling of over-the-counter drugs. The Department agrees with a suggestion from Good Shephard that this subsection be retained.
The Department has revised former subsection (m), now subsection (i), to require the return of outdated or deteriorated medications to the issuing pharmacy on at least a quarterly basis. St. Mary's Home of Erie suggested the requirement that these drugs be returned to the issuing pharmacy be eliminated. However, the Department feels this is the proper means of disposing and accounting for these medications.
Former subsection (o), which required the facility to have policies regarding the pharmacist's duties and the pharmaceutical committee's role, has been deleted as well, since the Federal regulation addresses service consultation and the role of the pharmacist in the facility.
Former subsection (p), which addressed experimental use of drugs, has been deleted as the subsection simply referenced a Federal regulation addressing experimental use of drugs. Former subsection (q) has been deleted, as its requirements for storage of drugs and biologicals is dealt with in 42 CFR 483.60(e).
The Department has amended former subsection (r), now subsection (k), which outlined the duties of the pharmaceutical services committee. The subsection provides that the oversight of the pharmaceutical services in the facility is the responsibility of the quality assurance committee. Good Shephard and the Pennsylvania Long-Term Pharmacists Coalition were concerned that this amendment could be interpreted as eliminating the pharmacist's role in reviewing drug regimens and the pharmacy committee's role in the oversight of pharmaceutical services in the facility. This was not the Department's intent. Facilities are encouraged to appoint a pharmacist to the quality assurance committee. New language has been added to subsection (k) which requires that the quality assurance committee seek input from the pharmacist in developing written procedures for administration and control of drugs, and in overseeing the pharmaceutical services within the facility. Facilities may continue to operate pharmaceutical services committees which may function separately or as an integral part of the quality assurance committee. Further, the Federal language in 42 CFR 483.60(c) specifically provides that each resident's drug regimen is to be reviewed monthly by a licensed pharmacist.
Section 211.10. Resident care policies and 211.11. Resident care plan.
The Department has deleted former subsections (a), (b) and (d)--(f) of § 211.10, which required a facility to have resident care policies and former subsections (d) and (e) of § 211.11, which provided that resident care plans are to be interdisciplinary and are to set goals to be utilized by the care team. Federal regulations in 42 CFR 483.20(d) address the requirements of resident care plans and the role of the interdisciplinary care team. The portion of § 211.10(c) which addressed what specifics must be included in resident care policies has been deleted as well.
The Department has revised subsections (a)--(c) of § 211.11. Subsection (a) had required a registered nurse (RN) to develop the care plan. The amended language does not limit facilities to using an RN, but states that the facility shall designate an individual to be responsible for the coordination and implementation of the care plan. Subsection (b) requires the individual to be a member of the interdisciplinary team.
The PNA objected to the proposed amendment to subsection (a) and urged the Department to retain the RN requirement. The Department felt that the facility should still have the flexibility to use an individual other than an RN as an overall coordinator, but added specific language to subsection (c) which provides that the RN is responsible for developing the nursing assessment portion of the resident care plan. This is consistent with 42 CFR 483.20(c)(1)(ii), which states that an RN is responsible for signing and certifying the information on the resident assessment instrument used to develop the care plan.
Although the Department proposed to delete former subsection (g), which provides that the resident shall participate in the development and review of the resident's care plan, it has reconsidered the matter and is retaining the subsection as subsection (e).
Section 211.12. Nursing services.
The Department has amended subsection (a), which required nursing services to meet the needs of residents, to reflect the Federal language in 42 CFR 483.30(a) which requires nursing services to meet the needs of residents on a 24-hour basis. The PNA suggested that nursing care be under the direction of an RN at all times. Although new subsection (f)(1) permits a facility to use an LPN on the night tour of duty in facilities having a census of 59 or less, subsection (f)(2) requires a registered nurse to be on call and proximate to the facility in such a situation.
Former subsection (d), which required that if a director of nursing has institutional responsibilities other than nursing an RN shall serve as an assistant, has been deleted. The PACAH objected to the proposed deletion as it feels an assistant is necessary to ensure that someone will be serving as a director of nursing at all times. The Department believes that the requirement of a full time director of nursing is clearly set forth in subsection (b) and implied by the other provisions of this section which describe the director of nursing's responsibility and accountability. Facilities may hire registered nurses to assist the director of nursing if necessary.
Former subsection (g), now subsection (e), required that a facility designate a ''charge nurse'' to supervise all nursing activities. In response to a comment from a facility that the term ''charge nurse'' should be ''supervisor,'' the Department has changed the wording to state that the facility shall designate an RN to oversee nursing activities on all tours of duty. The PHCA questioned whether this would still permit the use of an LPN as charge nurse on the night tour of duty in facilities of 59 or less. This is still permitted as long as the RN is available as set forth in subsection (f)(2).
Former subsection (e), now subsection (d), is amended to delete former requirements that the director of nursing be responsible for nursing service objectives, job descriptions, scheduling rounds and staff development. The Department did not feel it had to mandate that these particular assignments be performed by the director of nursing only. The director of nursing is still responsible for standards of accepted nursing practice, written job descriptions for nursing personnel, coordination of nursing services with other resident services, recommendations for staffing levels and general supervision of nursing services. The PNA's comments reflect that it agrees with continuing to designate these delineated duties being assigned to the director of nursing.
Former subsections (f) and (i) have been deleted. They addressed supervision of nursing services and minimum staffing ratios through July 1, 1988.
The Department has amended the general number of nursing hours in former subsection (n), now subsection (i), 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. This subsection implements this statement of policy as revised. This is a minimum requirement. Any quality of care deficiencies will be cited even if facilities meet the minimum staffing ratio.
Many commentators, including IRRC, Senator Kukovich and former Senator Williams, Representatives Casorio and Veon, PNA, PANPHA, the Pennsylvania AFL/CIO, United Church of Christ Homes, the Lehigh County Home, St. Mary's Home of Erie, SEIU and the Pennsylvania Health Law Project, expressed their belief that the 2.3 minimum number of hours was too low. The commentaters felt that acuity levels have been rising in long-term care nursing facilities as individuals are spending less time in acute care settings before being released to a nursing home and that the minimum nurse staffing levels should reflect this. The majority of the stakeholders who commented on this provision argued that the level should be 2.7. The Department has reconsidered the issue and has revised the minimum nursing staff level to 2.7 hours of direct care for each resident.
The PACAH and the Pennsylvania AFL/CIO oppose any flat minimum rate for nursing hours. Although the Department recognizes that a flat minimum rate does not guarantee positive outcomes, it believes that it is important to set a minimum staffing level which is simply a floor that a facility may not go below. Obviously, quality is determined by many factors, but a minimum staffing level can not hurt facilities which are staffed at or above that level. The minimum level will likely help facilities which are not meeting that staffing level to avoid deficiency situations which may result from insufficient staffing.
One commentator suggested that the term ''nursing unit'' in new subsection (k), which requires weekly time schedules to reflect personnel by unit, be defined. The Department is reluctant to do so. It chooses to provide licensees with the flexibility to determine what constitutes a nursing unit for their own individual facility.
Subsections (r) and (s) are deleted, as nutritional needs and restorative care are addressed in the comprehensive resident assessments required by the Federal regulations in 42 CFR 483.25(d), (i) and (j).
Section 211.13. Rehabilitative services.
The Department has repealed this section, as this subject matter is covered by the Federal regulation in 42 CFR 483.45.
Section 211.14. Diagnostic services.
This section is deleted, as the subject is addressed in the Federal regulation in 42 CFR 483.75(j) and (k).
Section 211.15. Dental services.
The Department is deleting subsections (b)--(d) from this section as the subject matter addressed in those subsections are covered in the Federal regulation in 42 CFR 483.55. Subsection (a) is amended to require that facilities assist residents in obtaining routine and emergency dental care.
Section 211.16. Social services.
The Department had proposed to delete this section as the subject matter is covered in the Federal regulation in 42 CFR 483.15(g). However, the Federal requirement mandates only that social services be provided and that a social worker be employed by facilities with a census of more than 120 residents. The Department deleted the majority of the section, but added language that requires facilities with 120 beds or less that do not employ a social worker to obtain consultation with a qualified social worker.
Section 211.17. Pet therapy.
The Department deleted all subsections from this section addressing resident activities, except for former subsection (f) which sets forth requirements for facilities using pet therapy. Resident activities are addressed in the Federal regulation in 42 CFR 483.15(f). In response to a comment from St. Mary's Home of Erie that dining rooms are sometimes used as all purpose rooms and animals should be permitted there, the Department revised subsection (1) to prohibit animals in the dining room only when meals are being served.
Fiscal Impact
The final rulemaking incorporates most of the Federal certification regulations for long-term care nursing facilities. It retains only those State licensure requirements which are either not addressed by the Federal regulations or are stricter than the Federal standards but important to keep to ensure high quality of care for the citizens of this Commonwealth. The final rulemaking will not impose additional costs on the great majority of long-term care nursing facilities, which are already certified to participate in the Federal Medicare Program and therefore already need to comply with the Federal regulations that have been incorporated by reference.
The few facilities which do not participate in Medicare or MA may incur minor costs in heightened educational and training requirements for nurse aides. The adoption of 2.7 hours of direct nursing care per resident for long-term care nursing facilities should not impose an additional financial burden on these providers. The Department's statistics indicate that currently almost 90% of long-term care providers either meet or exceed this standard.
The final-form regulations eliminate the requirement that facilities file two sets of construction plans for new construction or renovation and, instead, require only one set of plans to be filed. This will save facilities time and money. Although the final-form regulations keep a basic square footage requirement for rooms, they remove many of the specific spacial dimension requirements inside those rooms. This will permit flexibility in design for new construction or renovations and thereby result in potential savings for providers.
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