| Regulation | LIS Non-Compliance Area | Correction Required | Plans of Correction | Correction Date | POC Status |
| 6400.141(a) | Individual #1 had an annual physical examination on 7/16/19 and not again until 9/15/20. | An individual shall have a physical examination within 12 months prior to admission and annually thereafter. | The individual in question in non-verbal and has been diagnosed with Autism. She usually cooperatives during appointments at the PCPs office if the appointment does not last for a long time. She is not able to tolerate longer appointments. She had an appointment on 7/20/20 to complete a physical examination as well as to be medically cleared for a procedure under sedation. According to the staff who accompanied her for the appointment, the PCP was able to assess and clear the individual for the procedure under sedation. However, the individual did not allow for an extensive physical examination to be conducted. Another appointment was thus scheduled for 9/15/20 during which the annual physical examination was completed. Greater Hearts has a tracker (see attachment #: 2) that residential supervisors use to track and schedule annual appointments. Supervisors will continue to use this tracker and program specialist will review the tracker periodically during the Wednesday supervisory meetings to ensure that all annual appointments are scheduled and attended timely. Also, supervisors will send outlook calendar invite to all staff members responsible for each appointment to ensure that staff members are aware of the date and time for all appointments. |
01/22/2021
| Implemented |
| 6400.141(c)(7) | Individual #1 has not had a gynecological exam since being admitted to Greater Hearts on 7/6/18. | The physical examination shall include: A gynecological examination including a breast examination and a Pap test for women 18 years of age or older, unless there is documentation from a licensed physician recommending no or less frequent gynecological examinations. | The individual in question did not have a gynecological exam because her PCP had indicated otherwise. It is also worth mentioning that the individual prior to moving into Greater Hearts had refused all gynecological examination when she lived at her old placement.
Individual #1 moved into Greater Hearts on 7/6/18. In August 2018, she had an appointment with her new PCP to establish care. During that appointment, Greater Hearts staff asked about a possible referral to a gynecologist. The PA-C who saw the individual indicated that because of the individuals autism diagnosis and difficulty in cooperating with procedures involving excessive touching, there was the need to discuss sedated PAP for cervical cancer screening. As part of the appointment summary, the attending PA-C wrote that the discussion about PAP smear would be done during the next appointment in 6-months (see page 6 of attachment # 3). The individual had the follow up appointment on 1/07/19 to get immunization and to specifically discuss the pap test / gynecology referral. Her PCP stated that referral to the gynecologist was not indicated and that pap test will cause the individual psychological trauma (see attachments #: 4 and #5). Staff was asked to follow up with the PCP in the event of any gynecological concerns. The individuals PCP continued to prescribe her birth control medications. During her annual examination in 2020, the PCP again indicated N/A on the section for gynecological examination meaning it was still not needed. The individuals PCP was contacted on 11/30/2020 because staff noticed that during the individuals menstrual cycle, she spotted longer than usual. Upon the insistence of Greater Hearts staff, the individual was given a referral to the gynecologist during the appointment on 11/30/20. After a search for a gynecologist who takes the individuals insurance and one willing to consider examination under sedation, a gynecologist was identified, and an appointment has been scheduled for 2/12/21 which is the earliest possible date available. |
02/12/2021
| Implemented |
| 6400.144 | Individual #1 was seen at dentist on 9/28/20. The dentist was unable to perform examination on that date due to Individual #1 needing sedation. The dentist needed POA/or Individual responsible for making medical decisions to sign off on the procedure. As of the date of inspection, this examination has yet to occur. On 11/30/20, Individual #1's PCP recommended Individual #1 see a gynecologist. As of 1/22/21, the appointments are not yet scheduled. | Health services, such as medical, nursing, pharmaceutical, dental, dietary and psychological services that are planned or prescribed for the individual shall be arranged for or provided.
| Individual #1 had a dental examination under sedation on 1.24.2020. She had a follow up appointment with her dentist on 02.10.20. At that appointment, the dentist indicated the need for a follow up in 2021. However, in July 2020 the individual was informed that she could no longer be seen at the Dental Center. A new dentist was thus identified for the individual. On 9/28/20, individual #1 had an appointment to establish care with the newly identified dentist. At the appointment, the individual did not cooperate for the dentist to examine her. The dentist then recommended a sedated dental examination. The individual in question is non-verbal and does not write or sign. As such the consent of a POA was needed for this procedure. Since moving into Greater Hearts, her mother had been the one responsible for given consent for medical procedures. So, the individuals mother was contacted through her county support coordinator regarding the recommendation for a sedated dental examination. It is worth mentioning that in December 2019, an attempt was made for a sedated dental examination. However, the individual did not cooperate for the anesthesia to be administered by the providers at St. Joseph Hospital in Reading PA. In January 2020, after several attempts, the individual had a successful dental procedure under sedation and in July 2020 the individual had an auditory procedure under sedation. Considering the difficulty, the individual goes through when receiving general anesthesia and the fact that the individual had completed 2 procedures under sedation in 2020, her mother indicated she would prefer for the sedated dental examination to be done in 2021. A dental appointment was scheduled for 3/4/2021.
Upon insistence of Greater Hearts staff, individual #1 was given a gynecology referral on 11/30/20. Once the referral was made, the PCPs office and Greater Hearts staff searched for a gynecologist who accepts the individuals insurance as well as was willing to consider an examination under sedation. As of 1/23/21, the only gynecologist identified could see the individual on 2/12/21 and an appointment has been made.
Greater Hearts was of the view that when an individual is not able to give consent for medical procedure (as in the case of individual #1), the persons family assumes that responsibility; hence the involvement of individual #1s mother in making medical decisions. To help clarify this confusion, Greater Hearts requested a meeting with ODP together with the support coordinator for the individual. At the meeting held on 1/26/21, Greater Hearts was informed that since the individual cannot give consent and she reside in the care of the agency, it is the responsibility of Greater Hearts to provide the consent for medical procedures until the individuals mother becomes a legal guardian. Following this meeting, it has been decided that for individuals who are not able to give consent and has no court appointed legal guardian or advocate, Greater Hearts CEO and/or COO will give consent for recommended medical procedure or treatment to avoid delays in the individual getting the recommended treatment. |
03/04/2021
| Implemented |
| 6400.181(e)(6) | Individual #1's ability to use or avoid poisonous material was not addressed in her assessment. | The assessment must include the following information: The individual's ability to safely use or avoid poisonous materials, when in the presence of poisonous materials. | Since moving into Greater Hearts on 7/6/18, three assessments have been completed for the individual. Included in each assessment was the assessors view of the individuals ability to avoid poisonous material. Copies of the individuals assessment for 2019 and 2020 were uploaded on the One drive folder used for the inspection. On page 7 of the 2020 assessment dated 4.21.20 (see attachment # 6), there is a question regarding the individuals ability to use or avoid poisonous material. The assessors comment in this section of the assessment also indicates the current practice at the individuals home regarding poisonous materials.
Greater Hearts will continue to use an assessment tool that addresses an individuals ability to use or avoid poisonous material. When necessary, program specialist and personnels responsible for completing the assessment will be trained to provide an accurate assessment of this ability as well as provide an updated assessment when the individuals ability changes. |
02/08/2021
| Implemented |
| 6400.181(e)(9) | Individual #1's disability and medical limits were not addressed in her assessment. | The assessment must include the following information: Documentation of the individual's disability, including functional and medical limitations. | Since moving into Greater Hearts on 7/6/18, three assessments have been completed for the individual. In each of the assessments, the individuals disability and medical limits were address. Copies of the individuals assessment for 2019 and 2020 were uploaded on the drive used for the inspection. On page 14 and 15 of the 2020 assessment dated 4.21.20 (see attachment # 6), the individual¿s disability and medical limits were addressed to some extent.
Greater Hearts will continue to use an assessment tool that addresses an individuals disability and medical limits in order to be in compliance with the required regulations. The program team at Greater Hearts (assistant program director, program specialist and supervisors) and / or a consultant knowledgeable in matters pertaining to ODP regulations will review and when necessary update the current assessment tool to ensure that the current tool conforms to the dictates of 55 PA Code Chapter 6400.181 regarding assessments. Perhaps, the questions on the assessment tool will be rearranged in the order in which they are addressed in the 6400 regulations for easy reference during inspection or compliance audit. The program specialist and personnels responsible for completing the assessment will be trained on the outcome of the assessment tool review and new assessments maybe completed for all individuals when necessary. The initial meeting for the review of the current assessment tool will be on 2/15/21. |
02/15/2021
| Implemented |
| 6400.211(b)(3) | Individual #1's record does not document who to contact for emergency medical treatment. | Emergency information for each individual shall include the following: The name, address and telephone number of the person able to give consent for emergency medical treatment, if applicable.
| Everyone served by Greater Hearts has a fact sheet as well as an emergency medical plan. The plan for individual #1 (see attachment #7) was made available during the inspection and it included the name of the person able to give consent for emergency medical treatment. The information was however missing on the fact sheet. As of 1/22/20, the fact sheet has been updated and is now known as Emergency Information Sheet and it contains the name and contact of the person able to give medical consent and all other information as specified in 55 PA Code Chapter 6400.211 (see attachment #8). This will be updated to reflect the discussion taken after Greater Hearts met with Brandi Repress from ODP regarding who is responsible for making medical discussion since the individual is not able to do so. Also, the program specialist will ensure that the fact sheet for everyone supported by Greater Hearts will be updated to the new format - Emergency Information Sheet by 2.28.21. |
02/28/2021
| Implemented |
| 6400.165(g) | The medication reviews that were completed for Individual #1 do not include the reason for prescribing each medication as required. | If a medication is prescribed to treat symptoms of a psychiatric illness, there shall be a review by a licensed physician at least every 3 months that includes to document the reason for prescribing the medication, the need to continue the medication and the necessary dosage. | The current psychiatric medication review form used by Greater Hearts did not include the reason for which each psychotropic medication was prescribed. To prevent this error in future, the program specialist has updated the form as of 2/2/21 to include the items required by 55 PA Code Chapter 6400.165(g). The updated form (see attachment # 9) is currently being reviewed by Greater Hearts program team and Chief Operating Officer. Upon their approval, the new form will be used for all psychiatric medication review appointments. Between 2/15/21 and 3/1/21, training will be provided on the use of the new form for all residential supervisors and DSPs involved in psychiatric medication review appointments. |
02/02/2021
| Implemented |
| 6400.166(a)(2) | The PRN medications on Individual #1's Medication Administration Records do not include the name of the prescribing physician. | A medication record shall be kept, including the following for each individual for whom a prescription medication is administered: Name of the prescriber. | The MAR as issued by PDC pharmacy included the name of the prescribing physician for each medication listed at the time the MAR was printed. However, medications that were handwritten on the MAR by staff did not include the name of the prescribing physician. The program specialist has taken notice of this and has trained residential supervisors on how medications should be entered on the MAR with emphasis on the need to include the name of the prescribing physician for each medication as of 2/4/21 (See attachment #10). During the monthly house meetings for February 2021 and March 2021, DSPs will receive similar training as well. Program specialist and residential supervisors are reviewing all MARS at each home run by Greater Hearts to ensure that each medication listed on the current MARs include the name of the prescribing physician. As a preventative measure, residential supervisors will review all MARs as part of their routine weekly checks at each house to ensure that they are in compliance with 55 PA Code Chapter 6400.166(a)(2) and additional monthly review will also be conducted by the program specialist. |
02/04/2021
| Implemented |
| 6400.166(a)(11) | On Individual #1's Medication Administration Records,The following medications did not include the purpose for taking the medication: Aquaphor, Gabapentin, Miralax, Temazepam, Risperidone, Hydocort, and Lorazepam. | A medication record shall be kept, including the following for each individual for whom a prescription medication is administered: Diagnosis or purpose for the medication, including pro re nata. | PDC the pharmacy that serves the individuals supported by Greater Hearts has been contacted regarding the need to include the diagnosis or purpose for each medication on the MAR. However, it appears that the actual prescriptions from the prescribers might have been the cause of this error since some of them were silent on the purpose or diagnosis. To help rectify this, letters (see attachment #11 for sample) have been written to the prescribers for the medications identified for individual #1 to indicate the purpose as part of the script. Once the pharmacy receives the new scripts from the prescribers, they would be able to update the MAR accordingly. Cognizant of this violation, the program specialist and residential supervisors are reviewing the current MARs for everyone supported and when necessary, prescribers will be contacted to update the script to include the purposes or diagnosis. Going forward, program specialist and residential supervisors in reviewing new scripts will take the necessary steps to ensure compliance with 55 PA Code Chapter 6400.166(a)(11). |
03/01/2021
| Implemented |
| 6400.167(a)(3) | Individual #1 received double dose of Risperidone on 8/20/20 and double dose of Temazepam on 8/19/20. She also received double dose of Cetirizine 10mg on 12/16/20. | Medication errors include the following: Administration of the wrong dose of medication. | The two staff members involved in the medication error were relatively new to Greater Hearts at the time the error occurred. Both are no longer employed at Greater Hearts. This notwithstanding, Greater Hearts acknowledges the gravity of medication errors and the potential risks associated. Upon the companys own review during the 2020 calendar year, it was identified that not having an in-house medication administration trainer was a contributing factor. Acting on this, the assistant director for Greater Hearts Human Services has completed the required training as of 07/21/20 and currently serves as the in-house trainer for the company. To help provide adequate monitoring and coaching for both new and old DSPs who administer medications, the COO and the companys certified medication administration trainer will ensure that all current residential supervisors and program specialists are trained as Practicum Observers by April 15th, 2021. Going forward, newly employed supervisors will be required to pass their practicum observer training during their probation period (first 90 days of employment).
Also, inattentiveness and complacency on the part of DSPs can partly be blamed as possible causes of the medication errors. To tackle this, all Greater Hearts DSPs will be mandated (beginning 2021 calendar year) to complete a refresher course as part of the annual medication administration recertification process. This training will be in addition to the number of medication observations and MAR reviews required by ODP for recertification. This refresher course may or may not be the full medication administration training course. However, its content will include a review of the medication administration process, staff role and a discussion of common errors as well as how to prevent them.
To help prevent medication errors, Greater Hearts has contracted with PDC Pharmacy which is more experienced in serving individuals living in 6400 regulated homes. With the help of PDC pharmacy, the company has changed how medications are packaged and delivered to each house. Currently, PDC pharmacy supplies only four weeks worth of medications during a delivery cycle. The medication on each blister pack is labeled according to the week and day on which it is to be administered (see attachment #12 for sample). Staff members have been trained to only administer medication that correspond to a day on which the administration is taken place. During April 2021, Greater Hearts management will evaluate and make the necessary changes to ensure that the current system is serving the purpose for which it was initiated to reduce medication error-. |
04/15/2021
| Implemented |
| 6400.169(a) | Staff person #2 had initial medication administration training 2/6/18. He did not complete medication training in 2019. On 2/6/20, he did have medication training. However, the medication training document was not correctly filled out in that the trainer did not sign and date that staff person #2 was recertified. This medication training document is not valid. He was successfully retrained on 12/9/20.
Staff person #5 had initial medication administration training on 2/11/18. He had recertification on 2/11/19 and then again on 2/11/20. However, the trainings completed in 2019 and 2020 were not correctly filled out in that the trainer did not sign and date when staff person #5 was recertified. The medication training documents are not valid. | A staff person who has successfully completed a Department-approved medications administration course, including the course renewal requirements may administer medications, injections, procedures and treatments as specified in § 6400.162 (relating to medication administration). | Not having an in-house medication administration trainer was a contributing factor for this violation. As described above in the corrective action for 55 PA Code Chapter 6400.167(a)(3), the assistant program director for the company has completed the required training as of July 21st, 2020 and is certified as a medication administration trainer. All staff members hired after her certification date have been trained and appropriate documentation have been duly completed. To recertify the error related to the medication training document not correctly filled, staff persons #2 and #5 will be retrained by the current trainer. Both started their retraining process on 1/27/2021. A review of the medication training records of all staff members will be completed by the end of February 2021 and all staff members whose records are like that of #2 or #5 and hence are deemed not valid will be required to be retrained by the current trainer. |
02/26/2021
| Implemented |
| 6400.213(1)(i) | Individual #1's record does not address her religion. Her record indicates her religion is unknown. | Each individual's record must include the following information: Personal information, including: (i) The name, sex, admission date, birthdate and Social Security number and religious affiliation. | Individual #1 is non-verbal and is not able to write or sign. During her admission to Greater Hearts, there were no information from her mother or in her ISP or records from her previous placement - with regards to her religious preference, hence the indication of Unknown. Upon communication with the inspectors during the inspection process, individual #1s record has been updated to state that religious preference has not been indicated (see attachment #8). This will be updated should available information in future suggest otherwise. As of 2/2/21, the program specialist has inspected the Emergency Information sheet (previously known as fact sheet) for all individuals to ensure that their religious preference is duly recorded. |
02/02/2021
| Implemented |