[35 Pa.B. 2499]
[Continued from previous Web Page] § 2600.106. Swimming areas
Three commentators suggested deleting this section and deferring to State regulations for swimming pools. Four commentators suggested adding that staff certified as Red Cross life saving staff must be present when residents are using the pool or another body of water and that all pools and ponds shall be fenced and have automatic latched gate.
Response
The Department clarified that applicable laws and regulations will govern the construction, safety and sanitation of swimming pools. Specific requirements for life saving staff, fencing and latched gates were not included, but are examples of requirements that may be applied by other State or local authorities.
§ 2600.107(a) and (b). Internal and external disasters (redesignated as Emergency preparedness)
IRRC asked whether qualified fire, safety and local emergency management offices were intended to be the same as a fire safety expert. IRRC recommended that the Department describe who is ''qualified'' to make these judgments. Sixteen commentators suggested requiring approval by qualified local emergency management offices.
Response
Subsection (a) was revised to require the home to have a copy and be familiar with the local municipal emergency preparedness plan. Subsection (b) was revised to clarify what is included in the written emergency procedures. In accordance with § 2600.107(d), the emergency plan and procedures must be submitted to the local emergency management agency, instead of having the plans or procedures developed and approved by qualified fire, safety and local emergency management offices. The local emergency management agency supports the community in civil defense, disaster mitigation and preparedness, planning and response to and recovery from man-made or natural disasters.
§ 2600.107(c). Internal and external disasters (redesignated as Emergency preparedness)
IRRC asked for clarification of the term ''contact names'' and whether it is intended to be the resident's designated person. Fourteen commentators requested clarification of the requirement for an alternate means of utilities. Sixteen commentators suggested that the disaster plan include a plan to obtain nonperishable food and drinking water. Four commentators requested deletion the requirement to maintain a supply of medications, since the personal care home does not supply the medication and the availability of medication is determined by the resident's physician, pharmacist and insurance plan. Twenty commentators suggested requiring a plan for emergency medication delivery.
Response
This section was revised and clarified based on public comment and relocated to subsection (b). The requirement to maintain a 3-day supply of medications was deleted in response to comment.
§ 2600.108. General health and safety
The Department deleted this section as it is not necessary based on all the other requirements of this chapter.
§ 2600.109. Firearms and weapons (redesignated as § 2600.108)
Eighteen commentators requested clarification of weapons.
Response
The dictionary definition of ''weapon'' applies.
§ 2600.109. Pets (new section)
A section was added to address whether pets are permitted by the home, the health condition of the pet as it relates to the health and safety of the residents and the additional charge for pets, if applicable.
FIRE SAFETY
§ 2600.121. Unobstructed egress
Seven commentators requested clarification of the purpose and permissibility of locking exit doors, how to provide security for residents if exit doors cannot be locked from the outside and how to provide unimpeded evacuation route in an emergency. Commentators noted that the Department should defer fire safety approval to occupancy and fire safety authorities.
Response
Fire safety is a key concern as many residents have died in fires. The intent of the section is to permit residents to quickly exit the building in the event of a fire. Doors may be locked from the outside to provide security to the residents. The Department clarified that a home is permitted to use special emergency locking devices on exit doors if they have a written approval from the Department of Labor and Industry, the Department of Health or the appropriate local building authority. IRRC submitted no comments.
§ 2600.122. Exits
Eight commentators noted that the Department should defer fire safety approval to occupancy and fire safety authorities. Commentators suggested requiring this provision only to new construction or significant renovation, or both. Commentators requested clarification of the term ''accessible'' and expressed concern about the cost of retrofitting personal care homes for exits. IRRC submitted no comments.
Response
The Department included a provision in the order to this final-form rulemaking to give existing homes 18 months after the effective date of this final-form rulemaking to comply. The requirement for two independent and accessible fire safety exits per floor is a one-time cost for an existing home that does not have two exits. This requirement is critical to provide for safe evacuation in the event of a fire. In many cases of an actual fire, the interior stairwell may be blocked by fire or smoke making egress impossible. A second exit is often necessary to escape the fire. A second exit may be an interior stairwell. For a multistory home installation of a fire escape may be required. The fire escape may be of any sturdy construction material, including wood. The cost of installing a new fire door and fire escape is estimated at $5,000. The benefit of providing an alternate escape route for resident in the event of a fire outweighs the cost.
§ 2600.123. Emergency evacuation
Commentators suggested requiring this provision only to new construction or significant renovation, or both. Nine commentators noted that occupancy requirements should be the purview of occupancy and fire safety authorities. Commentators expressed concerns about the cost and availability of 24-hour monitoring systems. Four commentators recommended that all homes be connected to a 24-hour monitoring system or have provide additional staff. One commentator suggested deletion of subsection (b), as it duplicates § 2600.87 and § 2600.121 (relating to unobstructed egress). Four commentators noted that subsection (c) conflicts with section on secured dementia care units. IRRC asked for clarification of the emergency evacuation plan in subsection (d).
Response
These requirements are critical for residents and staff persons to be alerted in the event of a fire. Although some of these requirements are regulated by the Department of Labor and Industry or other local fire safety authorities, it is critical that the Department complete an inspection of these requirements during its annual inspection, since fire safety authorities do not conduct regular inspections. An exemption for existing homes was not added since these requirements are critical for the protection of the residents in the event of a fire.
The requirement to have the home's fire system connected to the local fire department was deleted, since it is addressed in § 2600.130(i).
The Department deleted proposed subsection (b) since, as the commentator suggests, it duplicates other requirements of this chapter.
For a secure dementia unit, special locking devices may be used on exit doors if the home has a written approval from the Department of Labor and Industry, the Department of Health or the appropriate local building authority.
The term ''emergency evacuation plan'' was deleted from subsection (d) and was replaced with emergency procedures which are defined in § 2600.107 (relating to emergency preparedness).
The Department exempted small homes from the requirement to post an emergency evacuation diagram. An emergency diagram is not needed in a small home where exits are well known and visible. The Department added a subsection to clarify that if the home chooses to serve residents with mobility needs above or below the grade level of the home, there must be a fire safe area to which the residents may safely evacuate.
§ 2600.125. Flammable and combustible materials
Two commentators requested clarification of combustible materials.
Response
The Department clarified the references to flammable and combustible.
§ 2600.126. Furnaces
Twelve commentators suggested revising that furnaces be inspected and cleaned annually or as often as recommended by manufacturer. Fourteen commentators expressed concern about cost.
Response
This change was not made. The annual furnace inspection and cleaning may be conducted by a trained home maintenance person at no cost to the home. An annual furnace inspection and cleaning is important to prevent fires or other dangerous conditions.
§ 2600.128. Supplemental heating sources
The Department clarified language in this section and added that wood and coal burning stoves must be screened or otherwise equipped so that residents are not burned by contact with the stove.
§ 2600.129. Fireplaces
Eight commentators recommended requiring cleaning only of fireplaces that are regularly used, due to cost. Two commentators recommended allowing residents to sit by the fire in subsection (c).
Response
Subsection (b) was amended to state that cleanings need to occur when there is an accumulation of creosote. This will reduce the cost to the homes as a cleaning is no longer required annually. Subsection (c) was deleted. Nothing in this section precludes a resident from sitting by the fireplace.
§ 2600.130(a). Smoke detectors and fire alarms
Commentators suggested requiring this provision only to new construction or significant renovation, or both. Forty commentators noted that occupancy requirements should be the purview of occupancy and fire safety authorities.
Response
This requirement is critical for residents and staff persons to be alerted in the event of a fire. Although the smoke detectors are regulated by the Department of Labor and Industry or other local fire safety authorities, it is critical that the Department complete an inspection of the smoke detectors during its annual inspection, since fire safety authorities do not conduct regular inspections. An exemption for existing homes was not added since this is critical for the protection of the residents in the event of a fire.
§ 2600.130(d). Smoke detectors and fire alarms
In response to fiscal concerns of small homes, the Department added an exemption for a small home serving eight or fewer residents. A large home must continue to meet this existing requirement so that residents and staff persons are able to hear the smoke detector or fire alarm no matter where they are in the home. This requirement is already required by the Department of Labor and Industry for a home serving nine or more residents.
§ 2600.130(e). Smoke detectors and fire alarms
Commentators suggested requiring this provision only to new construction or significant renovation, or both. Commentators noted that occupancy requirements should be the purview of occupancy and fire safety authorities. Forty-one commentators stated that these requirements are cost prohibitive. IRRC asked whether the Department considered allowing alternatives to subsection (e), such as permitting a home to install a fire alarm for an individual with a hearing impairment only in areas that would be utilized by that person.
Response
A resident or staff person with a hearing impairment must be alerted in the event of a fire. This applies to all homes regardless of size. The required signaling device is required only in areas that would be utilized by that individual. The estimated cost of installing a full strobe light and bed vibrator system is $170 per person. The bed vibrator system would of course be required only for a resident with a hearing impairment. The Department revised this requirement to allow the use of a personal body device that is portable and the possession of the individual. The benefit of providing equal fire protection for a person with a hearing impairment outweighs the cost.
§ 2600.130(i). Smoke detectors and fire alarms
Nine commentators expressed concern about cost for a 24-hour monitoring system. See comments received in § 2600.123.
Response
In response to comments, the Department added the clarification that a fire connection service or 24-hour monitoring service is required only if it is available in the community.
§ 2600.131. Fire extinguishers
Commentators suggested requiring this provision only to new construction or significant renovation, or both. Commentators noted that occupancy requirements should be the purview of occupancy and fire safety authorities. Six commentators recommended deleting requirement for locked fire extinguishers at subsection (e), which could pose a safety hazard in an emergency.
Response
These requirements are critical for residents and staff persons in the event of a fire. Although some of these requirements are regulated by the Department of Labor and Industry or other local fire safety authorities, it is critical that the Department complete an inspection of these requirements during its annual inspection, since fire safety authorities do not conduct regular inspections. An exemption for existing homes was not added since these requirements are critical for the protection of the residents in the event of a fire.
Locking of fire extinguishers is required in subsection (e) only if access to the extinguisher could cause a safety risk to the resident. If extinguishers are locked, staff must be able to open them in an emergency.
§ 2600.132(a). Fire drills
Four commentators suggested not requiring unannounced fire drills, as this may upset residents.
Response
This change was not made. Unannounced fire drills are necessary to provide a realistic scenario for residents and staff persons to practice how they will respond in the event of an actual fire.
§ 2600.132(d). Fire drills
Thirty-five commentators recommended that fire safety authorities should decide evacuation times, based on building construction, fire suppression equipment, staff and evacuation plans. Commentators asked for consideration that sometimes residents are not evacuated from the building, but are evacuated to fire-safe zones within the building. Commentators also noted that evacuating residents completely out of the building in certain weather conditions could also lead to injuries and stress. Commentators suggested different evacuation times for small versus large homes.
IRRC recommended maintaining the current 5-minute standard. IRRC noted that the regulations for fire drills in long-term care facilities in 28 Pa. Code § 209.8 (relating to fire drills) do not require complete evacuation of the facility. IRRC asked for clarification of whether the fire safe area could be a location within the home.
Response
The requirement to evacuate the home within 2 1/2 minutes was deleted from the final-form rulemaking. Instead, as suggested by commentators, the evacuation time will be established by a fire safety expert. A fire safe area may be within the home, such as an approved fire tower or area.
A comparison to long-term care nursing facilities is not appropriate since long-term care nursing facilities must comply with a more stringent fire safety occupancy code than most personal care homes.
§ 2600.132(e). Fire drills
Thirteen commentators recommended not requiring fire drills at night and to follow simulated fire drills that nursing care facilities conduct for night shift. Commentators recommended requiring fire drills during sleeping hours only once a year.
Response
The intent of subsection (e) is to ensure that residents have practiced a fire drill during different times of the day and night, such as at meal time, during various activities and while sleeping. Since most fire deaths occur at night while people are sleeping and since reaction time is slower and people are disoriented when waking abruptly, fire drills during sleeping are critical to protect the residents in the event of an actual fire.
§ 2600.132(h) and (j). Fire drills
Seven commentators suggested adding an exemption during inclement weather for resident protection.
Response
The home may select a day of each month when the weather is suitable for the fire drill. Even during winter months, there are usually a few days during which evacuation is possible.
§ 2600.133. Exit signs
The Department revised this section to exempt small homes since the exit paths in a small home are likely well known and visible.
RESIDENT HEALTH
§ 2600.141(a). Resident health exam and medical care (redesignated as Resident medical evaluation and health care)
IRRC indicated that the section should identify who is responsible for paying for the health examination. IRRC noted that residents may have health coverage plans that pay for health examinations, and would not want to pay higher rates for a different health care provider or a home's doctor. IRRC notes that section 1057.3(a)(2) of the Public Welfare Code (62 P. S. § 1057.3(a)(2)) allows a 30-day period for obtaining an examination after admission, but does not set a time period for examinations before admission. IRRC requested clarification of the 60-day period for examinations before admission.
Twenty-nine commentators support using a standard form, including the MA-51 form. IRRC asked whether the ''standardized form'' referenced in subsection (a) is the same as the current MA-51 form, and suggested referencing the specific form. Commentators recommended updating the medical evaluation every 6 months or when there is a significant change in the resident's medical condition.
IRRC noted that commentators recommended deletion of the requirements for body positioning, health status, communicable disease and mobility assessment. IRRC requested clarification of the need for communicable disease precautions and two commentators expressed concern that this violates resident confidentiality. IRRC and one commentator recommended rewording of subsection (a)(11).
Response
The intent of the section is not to make residents or prospective residents have a medical exam by the home's physician. The section does not state that the home determines who conducts the exam. Subsection (a) was reworded to clarify that the exam should be documented on a form specified by the Department. Although the MA-51 form is acceptable, the Department does not want to specify the MA-51 as this form may change or stop being used. The time frame of the 60 calendar days before admission was to give the prospective resident more flexibility in scheduling the medical exam. In addition, if a resident had a medical exam within the 2 months prior to admission this prevents them from paying for a repeat medical exam.
The change to require an updated medical evaluation when there is a significant change in the resident's medical condition was made to subsection (b)(2).
The requirements for body positioning and health status were kept since they are important to provide appropriate medical and personal care services to the resident. The requirement regarding communicable disease was deleted since the home must be trained in and apply universal precautions. As noted by the commentators, confidentiality of some specific types of communicable disease is protected by applicable laws.
The Department made the suggested clarification regarding mobility assessment.
§ 2600.141(b). Resident health exam and medical care (redesignated as Resident medical evaluation and health care)
IRRC requested clarification of the intent of this subsection. Sixteen commentators suggested adding that the home should assist residents in accessing medical, dental and psychiatric care. Commentators had concerns that this subsection makes the home responsible for ensuring access to medical, dental and psychiatric care, when the home can only assist in arranging appointments.
Response
This subsection is intended to clarify the frequency and conditions under which a new medical evaluation is required. In response to public comment, a change to require an updated medical evaluation when there is a significant change in the resident's medical condition was made.
In response to comment, a requirement was added in § 2600.142(a) (relating to assistance with health care) to require the home to assist the resident in securing access to medical care if the resident's health declines.
§ 2600.142. Physical and behavioral health (redesignated as Assistance with health care)
Thirty-three commentators expressed concern about the home's responsibility to convince residents to access medical or dental care. IRRC recommended either moving subsection (a) to § 2600.227 or cross-referencing § 2600.227. IRRC recommended requiring the home to discuss health care services with the resident or the resident's responsible person and documenting the services in the support plan. IRRC recommended that the resident's physician determine the necessity of health care services. IRRC suggested that the section direct the home to work with the responsible authorities for health care services, such as a case manager from a mental health service provider, to make decisions and referrals.
IRRC suggested identifying the party responsible to educate and inform the resident. IRRC recommended clarifying who is responsible for making reasonable efforts to obtain consent. If the administrator has this responsibility, IRRC suggested requiring documentation of these efforts in the resident's record. IRRC requested clarification of the applicable laws.
Response
The home is not responsible to convince a resident to seek medical or dental care, but to educate and inform the resident and to document the refusal.
As suggested, proposed subsection (a) was relocated to § 2600.227. Subsections (a) and (d) were added in response to comments to addresses the efforts made to obtain care if the resident's health status declines and to obtain preventive medical, dental, vision and behavioral health care.
Documentation of medical services is required in the support plan in § 2600.227. The requirement for the home to discuss health care services with the resident is addressed in subsection (b). The Department clarified that the home must educate and inform the resident about the need for health care. The Department did not require the resident's physician to determine the necessity of health care services or direct the home to work with the responsible authorities for health care services. These duties are beyond the scope of the home's responsibilities.
The Department did not specify the staff person at the home who is responsible to train the resident about the need for health care or to make efforts to obtain consent. This is unnecessary and overly prescriptive. The reference to applicable laws was deleted as unnecessary.
§ 2600.143(a). Emergency medical plan
Seventeen commentators recommended requiring staff to be aware of emergency plan and applicable laws for mental health emergencies. IRRC noted that there are many factors beyond the control of a home that affects the availability of emergency care. IRRC requested clarification of the Department's intent or deletion of this subsection.
Response
Staff training should include training in the emergency medical plan. This subsection was revised to clarify the intent for the home have a plan to follow if a resident has a health emergency. Specific components of the plan are relocated from subsection (c).
§ 2600.143(d). Emergency medical plan (redesignated as § 2600.143(b))
Several commentators suggested that confidentiality of medical information be provided. Four commentators requested deletion of the resident's age. Three commentators suggested adding ''and other diagnosis'' in subsection (d)(3). Twelve commentators suggested adding health care proxy in subsection (d)(9). IRRC noted commentator suggestions for clarification of subsection (d)(9), including ''if applicable'' in the event that a resident may not have a designated power of attorney. Two commentators suggested adding ''if applicable'' in subsection (d)(10). Six commentators recommended adding ''if applicable'' in subsection (d)(11). IRRC requested clarification of subsection (d)(9), (10) and (12).
Response
Confidentiality restrictions at the emergency medical site are the responsibility of the medical treatment facility. The resident's date of birth will be requested upon emergency medical treatment. Medical diagnosis is intended to be broadly interpreted to include behavioral diagnoses. This section was clarified to add ''if applicable'' at several of the locations suggested. Health care proxy was added. Several paragraphs were revised and clarified as requested.
§ 2600.143(e). Emergency medical plan
IRRC and one commentator recommended a review of the Health Insurance Portability and Accountability Act of 1996 (Pub. L. No. 104-191, 110 Stat. 1936) to ensure that subsection (e) does not conflict.
Response
Subsection (e) was deleted as it is unnecessary to call out transfer to a long-term care facility for purposes of this section on emergency care.
§ 2600.144. Use of tobacco and tobacco-related products (redesignated as Use of tobacco).
IRRC and seven commentators recommended requiring disclosure of smoking policies to prospective residents at admission. IRRC recommended indicating what specific steps a home should implement to protect nonsmoking residents. IRRC requested clarification of the need for subsections (d) and (e).
One commentator requested clarification of subsections (f) and (g). IRRC recommended deleting subsection (g) or incorporating it into subsection (f). IRRC requested clarification of how the designated smoking area is to be addressed in the fire safety procedures in subsection (f).
Response
This section was revised to require that the home rules specify whether the home permits smoking on the grounds of the building. Subsection (c) includes provisions to protect nonsmokers from second hand smoke. Subsections (d) and (e) are retained but revised and relocated. These provisions are important to prohibit smoking during transportation and outside of the smoking room. Subsections (f) and (g) are deleted as unclear and unnecessary.
§ 2600.145. Supervised care (deleted on final-form)
Commentators suggested including a reference to the resident's physician. IRRC and commentators recommended identifying the types of assessment agencies to which a resident is to be referred. PANPHA noted, for example, that the area agency on aging is the appropriate assessment agency for elderly persons who receive public funding.
Response
This section was deleted, as it duplicates information from other sections.
NUTRITION
§ 2600.161(a) and (b). Nutritional adequacy
Six commentators supported requiring nutritionally balanced meals. Seven commentators recommended allowing for family style meals and requiring at least two daily snacks. IRRC recommended using the word ''offered'' in subsections (a) and (b) since residents may choose to dine out.
Response
This section was clarified by changing subsection (a) to state meals shall meet the recommended dietary allowances established by the United States Department of Agriculture (USDA), as the USDA is National authority on the topic of nutrition. As suggested by IRRC, in subsection (b) ''provided'' was replaced by ''offered.'' Two daily snacks were not added as this would be cost prohibitive for the home. Family style meals are permitted, but not required.
§ 2600.161(b)--(d). Nutritional adequacy
Commentators suggested requiring nutritionally balanced meals, following dietary restrictions and deleting reference to food groups. IRRC requested clarification of the need for subsection (d).
Response
As suggested by IRRC and commentators, subsection (d) was deleted since the revised requirement for meals to meet the USDA recommended dietary allowances in subsection (a) is appropriate. Based on comments, the Department added a requirement to ensure that a resident's special dietary needs as prescribed by a physician, physician's assistant, certified registered nurse practitioner or dietitian must be met.
§ 2600.161(d) and (e). Nutritional adequacy
Two commentators suggested reasonable accommodation for a resident with personal dietary preferences. Seven commentators requested deletion of the requirement to provide dietary alternatives based on special health needs, religious beliefs and vegetarian preferences, due to cost. IRRC indicated that subsection (e), which requires dietary alternatives, conflicts with subsection (d), which requires items from all four food groups. IRRC noted that many commentators remarked that many homes do not have the resources available to offer alternative diets. IRRC suggested requiring that a home discuss food preferences or dietary requirements with prospective residents and inform them of whether the home can meet their dietary needs.
Response
The Department appreciates the cost and food service issues for a home to provide for a variety of food alternatives to meet the preferences of each resident. The Department agrees that the issue of food service should be discussed up front with the resident prior to admission. In response to comment, the Department has revised the section to eliminate the requirement to honor vegetarian preferences and require the home to make available dietary alternatives only for special health needs such as food allergies and religious beliefs.
As discussed previously, subsection (d) was added to ensure that a resident's special dietary needs as prescribed by a physician, physician's assistant, certified registered nurse practitioner or dietitian will be met. If the home cannot accommodate a resident's special dietary needs, the resident will be referred to the appropriate assessment agency or to a more appropriate level of care.
§ 2600.161(f). Nutritional adequacy
Twenty commentators requested deleting this requirement as not every home can offer therapeutic diets, due to cost and lack of staff dietitian. IRRC noted that in homes where most residents are SSI recipients, providing therapeutic diets may be cost prohibitive. IRRC recommended deleting subsection (f) or amending to apply only to homes which offer this type of service. IRRC recommended requiring homes that do not offer therapeutic diets to disclose this information to prospective residents, agencies or parties seeking to place an individual at a home.
Response
In response to comment, this proposed requirement was deleted.
§ 2600.161(g). Nutritional adequacy
Many commentators found this requirement expensive and unnecessary, as many residents are capable of getting their own beverages. Commentators suggested making drinking water available at all times, and making other beverages available upon request during waking hours and at resident cost. IRRC recommended deleting subsection (g) or justifying its need.
Response
In response to comment, this proposed requirement was deleted.
§ 2600.162(a) and (b). Meal preparation (eliminated on final-form)
One commentator indicated that requiring the preparation of foods in a consistency that meets resident needs would be costly for a home serving SSI recipients. IRRC suggested that the availability or lack of this type of service should be disclosed to prospective residents before they move in and included in the contract.
Response
In response to comment, this proposed requirement regarding food consistency was deleted. The requirement in proposed subsection (b) regarding uneaten foods was relocated to § 2600.103(e) (relating to food service).
§ 2600.162(c). Meal preparation (redesignated as § 2600.162(a). Meals)
Commentators observed that this requirement would allow a home to serve the evening meal at 8 p.m. and wait until 12 p.m. the next day to serve breakfast. Eight commentators suggested adjusting the time frame to 12 to 14 hours, or requiring an evening snack. IRRC suggested reducing the time period to 14 hours or require a snack be offered between the evening meal and breakfast.
Response
In response to comment, this requirement was changed to 15 hours, to allow for a 5 p.m. supper and an 8 a.m. breakfast. The Department also clarified that there may not be more than 6 hours between breakfast and lunch and lunch and supper.
§ 2600.162(d). Meal preparation (eliminated on final-form)
Five commentators were concerned that this would prohibit home grown vegetables, and requested clarification of ''sources approved or considered satisfactory.'' IRRC requested clarification of ''satisfactory'' and which agencies are included in ''Federal, state or local authorities.''
Response
In response to comment, the proposed requirement for Federal, State or local approval was deleted. The requirement regarding spoiled foods was relocated to § 2600.103(i).
§ 2600.162(e). Meal preparation (redesignated as § 2600.162(b). Meals)
Commentators indicated this requirement is unreasonable and impractical for many homes. Eleven commentators recommended adding ''when a resident misses a meal for an unavoidable reason'' and recommended that resident notify the home if he will be missing meal time. IRRC suggested that instead of mandating substitute food, that all homes be required to inform residents of their policies concerning missed meals.
Response
The intent of the subsection is to ensure that a resident who misses a meal is offered food that meets daily nutritional requirements. A resident may miss a meal because of delayed transportation or a lengthy medical appointment. A resident on a low income, such as an SSI recipient, who misses a meal may not be able to afford to use part of his monthly personal needs allowance to buy additional food. A resident with mobility needs may not be able to access a substitute meal. For a resident with health concerns, missing a meal may pose a health risk.
§ 2600.162(f) and (g). Meal preparation (eliminated on final-form)
Twelve commentators and IRRC recommended amending proposed subsection (f) to allow menu adjustments for hot and cold foods based on resident preferences.
Response
In response to comment, proposed subsection (f) was deleted. The Department also eliminated proposed subsection (g) as unnecessary.
§ 2600.162(h) and (i). Meal preparation (eliminated on final-form)
Six commentators recommended deletion of subsection (h) or adding that residents may be charged for adaptive equipment. IRRC found that subsection (h) is duplicative of § 2600.104(d) (relating to dining room). IRRC recommended moving the words ''and utensils'' to § 2600.104(d) and deleting § 2600.162(h). One commentator recommended deleting subsection (i).
Response
In response to comment, the proposed subsections were deleted.
§ 2600.163. Personal hygiene for food service workers
Seven commentators requested clarification of the differences between subsections (a) and (b). Thirteen commentators indicated that subsection (d) may be too costly to enforce.
Response
Subsection (a) relates to hand washing and (b) relates to sanitary practices, such as not serving food that has dropped on the floor and using a separate, clean cutting surface for the preparation of meats and vegetables. Subsection (d) must be enforced to protect the health of the residents.
§ 2600.164. Withholding or forcing of food prohibited
One commentator recommended adding a requirement that if a home has a resident with a cognitive impairment that affects his ability to eat and drink adequate amounts of food and water, the staff must provide proper cueing and feeding techniques. Three commentators recommended requiring appropriate cueing to encourage and remind residents to eat and drink. IRRC indicated that if staff cannot do this, referrals to medical personnel and transfer to an appropriate facility should be done. One commentator suggested allowing that food or drink may be withheld when necessary due to scheduled medical or dental procedures.
One commentator noted that it would be very difficult to verify that all residents in a large independent living facility are eating, because residents are free to come and go, and may go out for meals. Nine commentators requested recognition of the resident's right to fast for religious reasons. Commentators recommended requiring reporting of unexplained weight loss to the resident's physician. IRRC recommended that the Department determine whether it needs to include observations of other symptoms to include situations when the staff is unable to observe a resident at each meal.
Response
The allowance to withhold food or drink in accordance with prescribed medical or dental procedures was added at subsection (a). The addition relates to encouraging and reminding a resident to eat and drink was made in new subsection (d). In accordance with subsection (c), if the resident refuses to eat or drink for 24 hours, the home must immediately notify the resident's primary care physician and resident's designated person.
TRANSPORTATION
§ 2600.171. Transportation
IRRC recommended instructing homes to utilize the Medical Assistance Transportation Program (MATP) for SSI recipients. IRRC also suggested that the Department assist homes in linking SSI recipients with the MATP. IRRC requested clarification of subsection (a)(1). IRRC recommended considering existing staff in subsection (a)(5).
Response
This change was not made. The MATP is an entitlement program for eligible residents who do not have other transportation options available to them. Residents should not be required to use the program if they choose not to.
Subsection (a)(1) applies only to transportation provided by staff persons or the home's volunteers.
The suggested change regarding existing staff was not made. If a staff person has completed the required training, this meets the intent of this section.
To assure the safe transportation of the residents, the Department added a requirement for an assistant to be present when necessary.
MEDICATIONS
§ 2600.181(b) and (c). Self-administration
Eight commentators recommended that the resident's medical exam indicate the ability to self-administer medications. IRRC recommended amending subsection (c) to recognize that the resident's physician determines whether the resident can self-administer medications.
Response
Proposed subsection (b) was revised and relocated to § 2600.182 (relating to medication administration). New subsection (b) clarifies that if a resident needs assistance with his medication schedule, staff persons shall remind him of the prescribed schedule.
In response to comment, subsection (c) was revised to require an assessment for self-administration by the resident's physician. Also in response to comment, § 2600.141(a)(7) (relating to resident medical evaluation and health care) was amended to add the requirement for the physician to assess the resident's ability to self-administer medications as part of the medical evaluation.
§ 2600.181(e). Self-administration
Fifteen commentators requested deletion of this subsection, as many independent individuals who live alone would not be classified as capable of self-administration of medications under this stringent definition. IRRC requested clarification that the ability of a person to self-administer medication is determined based on the clinical experience, observations and judgment of a health care professional, such as a physician or certified nurse practitioner, not by home staff persons.
Response
This section was revised to address the comments and clarify in lay terms the three key components of knowledge for self-administration.
Subsection (f) was added to require a record of all medications for a resident who self-administers his medication.
§ 2600.182. Medication administration (added on final-form)
Forty-three commentators requested the development of a program to permit, and properly train, personal care home staff persons to administer prescription medications. Many commentators noted the existence of medication administration training programs for staff persons in other Departmental licensed residential settings and suggested that these programs be used as models for a medications training program for personal care home staff. IRRC recommended the development of a medications administration program modeled after programs used in other residential settings. IRRC recommended an amendment to the final-form rulemaking to include medication administration training and certification of home staff persons.
Response
In response to overwhelming recommendations from many public commentators and IRRC, the Department added a subsection to address medication administration provided by the home. Medication administration is an optional service that may be provided by the home. If the home does not provide medication administration and a resident develops the need for medication administration, the home must refer the resident to an appropriate assessment agency.
New subsection (b)(4) permits medication administration of oral and topical prescription medications by trained staff persons. The injection of insulin for diabetes and epinephrine for insect bites and other allergies is also permitted by trained staff persons. The new requirement is consistent with the regulations for medications administration training for community homes for individuals with mental retardation under § 6400.168 (relating to medication administration training) and child residential facilities under § 3800.188 (relating to medications administration training). The Department has developed a medications training program similar to the program used in these two residential programs.
The State Board of Nursing regulation in 49 Pa. Code § 21.14 (relating to administration of drugs), published at 33 Pa.B. 6219 (December 20, 2003), no longer limits drug administration to a licensed registered nurse, thereby eliminating any uncertainty about this matter.
Proposed subsection (b), regarding the list of medical professionals who may administer medications, was relocated to this section. In addition to medical personnel listed in proposed subsection (b), two additional nurse trainee program options were added to subsection (b)(2) and (3).
In subsection (c), the Department has clarified the activities included in medication administration.
§ 2600.182(a) and (b). Storage and disposal of medications and medical supplies (redesignated as § 2600.183(a) and (b))
Seven commentators suggested that complementary and alternative medications (CAM) do not need to be kept in their original containers or in locked areas.
Response
No change was made to this subsection. Storage of CAM is important since some CAM, if taken improperly, may cause illness or death.
§ 2600.182(d). Storage and disposal of medications and medical supplies (redesignated as § 2600.183(d))
Commentators noted that because medications are packaged separately, storing prescription, over the counter (OTC) medications and CAM in separate areas is problematic. Several commentators noted that it is safer and more efficient to store medications for the same resident together.
Response
The Department agrees and has deleted this requirement. A new requirement that the home may keep only current medications for individuals living in the home was added.
§ 2600.182(f). Storage and disposal of medications and medical supplies (redesignated as § 2600.183(f))
Five commentators requested deleting ''medications shall be given to the resident'' and inserting ''shall be offered their medications upon discharge.''
Response
This change was not made. The medications belong to the resident and must be returned to the resident upon departure.
§ 2600.182(g) and (e). Storage and disposal of medications and medical supplies (deleted on final-form)
Six commentators requested revision of proposed subsection (g), commenting that hospitals and nursing homes do not require storing antiseptics and external use medications separately. Seven commentators suggested requiring storage as directed by a pharmacy.
Response
These proposed subsections were deleted. The Department agrees with the commentator that there is no need for separate storage. Subsections (a)--(c) and (e) regulate storage of medications, making subsection (h) unnecessary.
§ 2600.183. Labeling of medications (redesignated as § 2600.184)
One commentator asked if the use ''bubble packs'' provided by pharmacies is allowed. Six commentators suggested deleting the requirement for labeling of CAM and sample medications. Commentators questioned the need to identify sample medications to a particular resident's use and accompany with a physician's order. Commentators noted that many residents receive sample medications from physicians outside of the home, who do not always inform the home of the reasons for these sample medications. IRRC requested clarification of the application of subsection (d) for residents who administer their own medications and store their medications in their rooms. IRRC suggested taking into consideration that not all residents receive assistance from the home in arranging medical care.
Response
Bubble packs are allowed. Bubble packs are considered the same as the original container as long as the bubble pack is labeled in accordance with this section.
The Department clarified the content required on the medication label. These items are consistent with the content found on a pharmacy label.
Proposed subsection (b) was deleted, however the requirement for labeling of CAM remains in § 2600.183(a) (relating to storage and disposal of medications and medical supplies). Proper labeling is necessary since inappropriate use of CAM may cause adverse reaction with the resident's other medications, or may cause medications to be less effective.
The Department clarified that subsection (d) only applies to sample prescription medications. Sample prescription medications must include the items identified in subsection (a) to protect the resident and other residents from misadministration.
§ 2600.184. Accountability of medication and controlled substances (redesignated as § 2600.185)
Five commentators suggested requiring homes to obtain medications for residents and to keep an adequate supply of medications on hand at all times. Four commentators requested requiring storage of controlled substances to be locked with limited access.
Response
The Department clarified the meaning of ''safekeeping'' and added reference to medical equipment in subsection (a).
The Department did not require a home to keep a supply of medication on hand since the supply of prescription medication is governed by the resident's physician and pharmacist.
The Department did not add a specific requirement to lock controlled substances, since all medications must be kept locked. In subsection (b)(1), the policies of the home must address the receipt of controlled substances.
The Department added a provision to document the administration of medications for residents who are non-self-administering and for those residents for whom assistance with medications administration is provided.
§ 2600.185. Use of medications (redesignated as § 2600.186. Prescription medications)
Three commentators requested deletion of subsection (a) as repetitive. Eight commentators requested clarification in subsection (b) of the word ''help'' and deletion of ''OTC'' and ''CAM.'' IRRC asked that the section be amended to allow for flexibility in emergency situations. Three commentators and IRRC asked for an amendment that requires the administration of medication only to the resident for whom the medication was prescribed. Three commentators asked for deletion of subsection (c), as the original prescriber may be unavailable, and common practice is for oral changes to be made by any practitioner licensed to prescribe medications.
Response
In response to comment, proposed subsections (a) and (b) were deleted. In response to comment, the Department added that prescription medications must be prescribed by an authorized prescriber and that they be used only by the resident for whom the medication was prescribed. Subsection (c) was revised to allow emergency changes by an alternate prescriber. The Department clarified that a home staff person may not take oral orders from a physician. In accordance with medical practice, only written orders from the prescriber are permitted. Under certain circumstances as regulated by the Department of State, a registered nurse is permitted to take oral orders from a prescriber.
§ 2600.186. Medication records (redesignated as § 2600.187)
IRRC asked for clarification of what types of medications are covered in subsection (a), and how subsection (a) is consistent with the storage requirements in proposed § 2600.182. Thirty-eight commentators requested deletion of subsection (b)(2) and (3) and suggested use of a drug reference book instead. Three commentators suggested deletion of subsection (b)(6) because the information is available in the resident file and on the emergency transfer sheet. Nine commentators opposed subsection (b)(7) because it conflicts with the definition of ''self-administration.'' Twenty-four commentators suggested replacing ''by the end of the shift'' with ''within reasonable time'' in subsection (d). IRRC questioned whether the home is responsible for the proper storage of medications that a resident keeps in his room.
Response
The Department revised subsection (a) to apply only to medications administered by the home and to clarify the content of the medication record. This includes prescription medications, OTC medications and CAM.
In response to comment, proposed subsection (b) was deleted.
In response to comment, the Department deleted ''by the end of the shift'' to ''within 24 hours unless other wise instructed by the prescriber.''
The Department added subsection (d) to require the home to follow the instructions of the prescriber.
In response to IRRC's question, if the resident does not need assistance with medication, medication may be locked in a resident's room for self-administration.
§ 2600.187. Medication errors (redesignated as § 2600.188)
Four commentators requested deletion of this section, stating that residents have the right to refuse medication and treatment. Fifteen commentators requested deletion of subsection (a), stating that resident refusal of medication should not be considered a medication error, and suggested that documentation occur at the end of the shift. Eight commentators suggested requiring a system in place to identify and document prescriptions not filled.
Response
The Department agrees that a resident has the right to refuse medication and treatment. This provision was added in § 2600.191 (relating to resident education). In accordance with § 2600.187(c) (relating to medication records), refusals will be reported to the prescriber within 24 hours, unless otherwise instructed by the prescriber. Refusal of medication is not considered a medication error. The Department clarified the definition of ''medication error'' in subsection (a).
In subsection (b), the Department clarified that a medication error must be immediately reported to the resident, the resident's designated person and the prescriber. New subsection (c) was added to require the home to keep documentation of errors and the prescriber's response.
§ 2600.190. Medication administration training (new section on final-form)
Forty-three commentators requested the development of a program to permit, and properly train, personal care home staff persons to administer prescription medications. Many commentators noted the existence of medication administration training programs for staff persons in other Departmental licensed residential settings, and suggested that these programs be used as models for a medications training program for personal care home staff. IRRC recommended the development of a medications administration program modeled after programs used in other residential settings. IRRC recommended an amendment to the final-form rulemaking to include medication administration training and certification of home staff persons.
Response
In response to overwhelming recommendations from many public commentators and IRRC, the Department has added a section to address medication administration provided by the home. Medications administration is an optional service that may be provided by the home. If the home does not provide medication administration and a resident develops the need for medication administration, the home must refer the resident to an appropriate assessment agency.
The new section permits medications administration of oral and topical prescription medications by trained staff persons. The injection of insulin for diabetes and epinephrine for insect bites and other allergies is also permitted by trained staff persons. The new requirement is consistent with the regulations for medications administration training for community homes for individuals with mental retardation under § 6400.168 and child residential facilities under § 3800.188. The Department will develop a medications training program similar to the program used in these other two residential programs.
§ 2600.191. Resident education
The Department added a requirement regarding resident education and refusal of a medication in response to discussions with the State Board of Nursing.
SAFE MANAGEMENT TECHNIQUES
§ 2600.201. Safe management techniques
Forty-five commentators requested deletion of this section, stating that residents whose behavior endangers others belong in treatment centers, not personal care homes.
Response
The Department concurs that a resident whose behavior endangers himself or others should receive appropriate supports and treatment in a living situation other than a personal care home. This does not negate the need for a home to have effective positive behavior approaches in place to respond appropriately to unanticipated, rare incidents.
§ 2600.202. Prohibition on the use of seclusion and restraints (redesignated as Prohibitions).
Four commentators requested deletion of this section, stating that it duplicates resident right that prohibits the use of restraints. Four commentators requested clarification of aversive conditioning. Five commentators suggested that drugs ordered by a physician and part of a resident's ongoing support plan to treat symptoms of a specific mental, emotional or behavioral condition should be construed as a chemical restraint. One commentator requested clarifying the difference between a mechanical and a manual restraint.
Response
This section was maintained and clarified. A drug ordered by a licensed physician or dentist as part of ongoing medical treatment, or as pretreatment prior to a medical or dental examination or treatment, is not a chemical restraint. When a physician orders a drug that is part of the resident's ongoing support plan, and has documented as such for treating the symptoms of mental, emotional or behavioral condition, the drug is not considered as a chemical restraint. This is necessary to allow a physician to effectively treat behavioral health conditions. The differences between a manual and mechanical restraint was defined.
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