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| Regulation | LIS Non-Compliance Area | Correction Required | Plans of Correction | Correction Date | POC Status |
| 6400.144 | REPEAT from 10/16/19 annual inspection: Health services such as medical, pharmaceutical, dental, etc. that are planned for or prescribed to the individual shall be completed as prescribed. Also described in 6400.165(c) of this report, there were occasions throughout the year where medications were not administered as ordered. Some instances of this included:
· Individual #1's Clotrimazole, prescribed to take twice a day for 14 days, was available to him in the home on 3/9/2020. However, the medication wasn't administered to him until 8PM on 3/10/2020; two omitted doses.
· Individual #1 did not receive his final dose the 14-day prescription of Clotrimazole (medication described above) on 3/24/20.
· Staff documented that Individual #1's 75mg of Sertraline was not administered at 8AM on 6/8/02020 as prescribed but administered late, at 9:39am, due to computer technical issues. Medications administered late due to staff working on computer issues is not an applicable reason for administering medications late. There is no evidence that an order to administer the medication late was obtained from the individual's prescribing physician.
· Individual #1 did not receive his 75mg dose of Sertraline at 8AM on 6/19/20, as prescribed.
· On 6/29/20, the individual's Quetiapine 25 mg was discontinued. However, Individual #1 was administered 25mg of Quetiapine on 6/29/20 and 6/30/20.
· On 7/8/20, Individual #1 did not receive his prescribed 75mg of Sertraline as prescribed. Staff person #3 documented her initials on the individual's mar as if she administered the medication. However, the agency determined that this medication wasn't administered due to the dose still being available at the home at 8AM on 7/9/2020.
· On 10/17/20 Individual #1 did not receive his prescribed 25mg dose of Quetiapine.
· Individual #1's prescribed 75mg of Sertraline was not administered on 10/26/20.
· Individual #1 did not receive any Quetiapine from 10/27/20 to 10/31/20, despite being prescribed Quetiapine.
· From 10/29/20 through 10/31/20, Individual #1 did not receive his prescribed 100 mg of Sertraline daily.
· On 10/26/20, Individual #1's Psychiatrist increased the individual's dose of Quetiapine to 50mg daily. This was not administered as prescribed until 8PM on 11/2/20, despite having the medication available in the home since 7:45PM on 10/30/20. The individual's prescribing physician was contacted on 10/27/20 to inform them that the new order of Quetiapine was not delivered from pharmacy. There is no evidence that the agency attempted obtain the medication until 2 days later, when the home contacted the pharmacy on 10/29/20. There is no evidence that the individual's prescribing physician was notified after 10/27/20 of the delay of obtaining the current order of medication or how to proceed with medication management to the individual of their Quetiapine medication. | 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.
| January 11, 2021- All program specialists were trained on their responsibilities that health services such as medical, pharmaceutical, dental, dietary, and physical services that are planned or prescribed for the individual shall be arranged for or provided.
A training record was signed indicating their attendance and understanding. (Attachment #1)
Program specialists will continue to ensure that 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.
Program specialists reviewed and verified that 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's Clotrimazole, prescribed to take twice a day for 14 days, was available to him in the home on 3/9/2020. However, the medication wasn't administered to him until 8PM on 3/10/2020; two omitted doses.
January 11, 2021- A med error was entered into EIM for the two omitted doses. (Attachment # 22)
- Individual #1 did not receive his final dose the 14-day prescription of Clotrimazole (medication described above) on 3/24/20.
January 11, 2021- A med error was entered into EIM for the omitted dose. (Attachment # 23)
- Staff documented that Individual #1's 75mg of Sertraline was not administered at 8AM on 6/8/02020 as prescribed but administered late, at 9:39am, due to computer technical issues. Medications administered late due to staff working on computer issues is not an applicable reason for administering medications late. There is no evidence that an order to administer the medication late was obtained from the individual's prescribing physician.
January 11, 2021- A med error was entered into EIM for the late administration. (Attachment # 24)
- Individual #1 did not receive his 75mg dose of Sertraline at 8AM on 6/19/20, as prescribed.
January 11, 2021- A med error was entered into EIM for the omission. (Attachment # 25)
- On 6/29/20, the individual's Quetiapine 25 mg was discontinued. However, Individual #1 was administered 25mg of Quetiapine on 6/29/20 and 6/30/20.
January 11, 2021- A med error was entered into EIM for wrong medication, gave discontinued medication. (Attachment # 26)
- On 7/8/20, Individual #1 did not receive his prescribed 75mg of Sertraline as prescribed. Staff person #3 documented her initials on the individual's mar as if she administered the medication. However, the agency determined that this medication wasn't administered due to the dose still being available at the home at 8AM on 7/9/2020.
July 9, 2020- The med error was reported into EIM. (# 8761733) This was documented on the MAR as an omission. (Attachment # 27)
- On 10/17/20 Individual #1 did not receive his prescribed 25mg dose of Quetiapine.
October 17, 2020- Individual #1 was away from the program at the time of the administration. (Attachment # 28)
- Individual #1's prescribed 75mg of Sertraline was not administered on 10/26/20.
October 26, 2020- Individual #1¿s 75mg of Sertraline was administered correctly on 10/26/2020. (Attachment # 29)
- Individual #1 did not receive any Quetiapine from 10/27/20 to 10/31/20, despite being prescribed Quetiapine.
January 11, 2020- The correct dose should have been 50mg. A review of the MAR indicated that he received 25mg of Quetiapine from 10/27/20-11/1/20. A med error was entered into EIM for the wrong dose. (Attachment # 30)
- From 10/29/20 through 10/31/20, Individual #1 did not receive his prescribed 100 mg of Sertraline daily.
October 29-31, 2020- A review of the MAR indicated that he received 100mg of Sertraline as prescribed from 10/29-10/31/20. (Attachment # 31)
- On 10/26/20, Individual #1's Psychiatrist increased the individual's dose of Quetiapine to 50mg daily. This was not administered as prescribed until 8PM on 11/2/20, despite having the medication available in the home since 7:45PM on 10/30/20. The individual's prescribing physician was contacted on 10/27/20 to inform them that the new order of Quetiapine was not delivered from pharmacy. There is no evidence that the agency attempted obtain the medication until 2 days later, when the home contacted the pharmacy on 10/29/20. There is no evidence that the individual's prescribing physician was notified after 10/27/20 of the delay of obtaining the current order of medication or how to proceed with medication management to the individual of their Quetiapine medication.
January 11, 2021- A med error was entered into EIM for the wrong dose from 10/27/20-11/1/20. (Attachment # 32)
January 2021- A Monthly Supervisory Documentation Review form will be completed by each program specialist documenting that 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. |
02/15/2021
| Implemented |
| 6400.18(b)(2) | Individual #1 wasn't administered his medications as prescribed on a few occasions throughout the year. The home failed to report the following medication errors through the Department's information management system or on a form specified by the Department.
· Individual #1's Clotrimazole, prescribed to take twice a day for 14 days, was available to him in the home on 3/9/2020. However, the medication wasn't administered to him until 8PM on 3/10/2020; two omitted doses, the evening on 3/9/2020 and the morning on 3/10/2020.
· Individual #1 did not receive his final dose the 14-day prescription of Clotrimazole (medication described above) on 3/24/20.
· Staff documented that Individual #1's 75mg of Sertraline was not administered at 8AM on 6/8/02020 as prescribed but administered late, at 9:39am, due to computer technical issues. There is no evidence that an order to administer the medication late was obtained from the individual's prescribing physician.
· Individual #1 did not receive his 75mg dose of Sertraline at 8AM on 6/19/20, as prescribed.
· On 10/17/20 Individual #1 did not receive his prescribed 25mg dose of Quetiapine. | The home shall report the following incidents, alleged incidents and suspected incidents through the Department's information management system or on a form specified by the Department within 72 hours of discovery by a staff person:
A medication error as specified in § 6400.166 (relating to medication errors), if the medication was ordered by a health care practitioner. | January 11, 2021- All program specialists were trained on their responsibilities that the home shall report the following incidents, alleged incidents and suspected incidents through the Department's information management system or on a form specified by the Department within 72 hours of discovery by a staff person: A medication error as specified in § 6400.166 (relating to medication errors), if the medication was ordered by a health care practitioner.
A training record was signed indicating their attendance and understanding. (Attachment #1)
Program specialists reviewed and verified the home shall report the following incidents, alleged incidents and suspected incidents through the Department's information management system or on a form specified by the Department within 72 hours of discovery by a staff person: A medication error as specified in § 6400.166 (relating to medication errors), if the medication was ordered by a health care practitioner.
Program specialists will continue to ensure that the home shall report the following incidents, alleged incidents and suspected incidents through the Department's information management system or on a form specified by the Department within 72 hours of discovery by a staff person: A medication error as specified in § 6400.166 (relating to medication errors), if the medication was ordered by a health care practitioner.
- Individual #1's Clotrimazole, prescribed to take twice a day for 14 days, was available to him in the home on 3/9/2020. However, the medication wasn't administered to him until 8PM on 3/10/2020; two omitted doses.
January 11, 2021- A med error was entered into EIM for the two omitted doses. (Attachment # 22)
- Individual #1 did not receive his final dose the 14-day prescription of Clotrimazole (medication described above) on 3/24/20.
January 11, 2021- A med error was entered into EIM for the omitted dose. (Attachment # 23)
- Staff documented that Individual #1's 75mg of Sertraline was not administered at 8AM on 6/8/02020 as prescribed but administered late, at 9:39am, due to computer technical issues. Medications administered late due to staff working on computer issues is not an applicable reason for administering medications late. There is no evidence that an order to administer the medication late was obtained from the individual's prescribing physician.
January 11, 2021- A med error was entered into EIM for the late administration. (Attachment # 24)
- Individual #1 did not receive his 75mg dose of Sertraline at 8AM on 6/19/20, as prescribed.
January 11, 2021- A med error was entered into EIM for the missed dose. (Attachment # 25)
- On 10/17/20 Individual #1 did not receive his prescribed 25mg dose of Quetiapine.
October 2020- MAR indicated that individual #1 was away with family at the time of administration. (Attachment # 28)
January 2021- A Monthly Supervisory Documentation Review form will be completed by each program specialist documenting that the home shall report the following incidents, alleged incidents and suspected incidents through the Department's information management system or on a form specified by the Department within 72 hours of discovery by a staff person: A medication error as specified in § 6400.166 (relating to medication errors), if the medication was ordered by a health care practitioner. |
02/15/2021
| Implemented |
| 6400.165(c) | REPEAT from 10/16/19 annual inspection: There were a few occasions throughout the year when Individual #1 was not administered his medications as prescribed. Examples of when this occurred include the following:
· Individual #1's Clotrimazole, prescribed to take twice a day for 14 days, was available to him in the home on 3/9/2020. However, the medication wasn't administered to him until 8PM on 3/10/2020; two omitted doses.
· Individual #1 did not receive his final dose the 14 day prescription of Clotrimazole (medication described above) on 3/24/20.
· Staff documented that Individual #1's 75mg of Sertraline was not administered at 8AM on 6/8/02020 as prescribed but administered late, at 9:39am, due to computer technical issues. Medications administered late due to staff working on computer issues is not an applicable reason for administering medications late. There is no evidence that a order to administer the medication late was obtained from the individual's prescribing physician.
· Individual #1 did not receive his 75mg dose of Sertraline at 8AM on 6/19/20, as prescribed.
· On 7/8/20, Individual #1 did not receive his prescribed 75mg of Sertraline as prescribed. Staff person #3 documented her initials on the individual's mar as if she administered the medication. However, the agency determined that this medication wasn't administered due to the dose still being available at the home at 8AM on 7/9/2020.
· On 10/17/20 Individual #1 did not receive his prescribed 25mg dose of Quetiapine.
· Individual #1's prescribed 75mg of Sertraline was not administered on 10/26/20.
· On 10/26/20, Individual #1's Psychiatrist increased the individual's dose of Quetiapine to 50mg daily. This was not administered as prescribed until 8PM on 11/2/20, despite having the medication available in the home since 7:45PM on 10/30/20.
· From 10/29/20 through 10/31/20, Individual #1 did not receive his prescribed 100 mg of Sertraline daily. | A prescription medication shall be administered as prescribed. | January 11, 2021- All program specialists were trained on their responsibilities that prescription medication shall be administered as prescribed.
A training record was signed indicating their attendance and understanding. (Attachment #1)
Program specialists will continue to ensure a prescription medication shall be administered as prescribed.
Program specialists reviewed and verified that medications were administered as prescribed.
- Individual #1's Clotrimazole, prescribed to take twice a day for 14 days, was available to him in the home on 3/9/2020. However, the medication wasn't administered to him until 8PM on 3/10/2020; two omitted doses.
January 11, 2021- A med error was entered into EIM for two omitted doses. (Attachment # 22)
- Individual #1 did not receive his final dose the 14 day prescription of Clotrimazole (medication described above) on 3/24/20.
January 11, 2021- A med error was entered into EIM for the omitted dose. (Attachment # 23)
- Staff documented that Individual #1's 75mg of Sertraline was not administered at 8AM on 6/8/02020 as prescribed but administered late, at 9:39am, due to computer technical issues. Medications administered late due to staff working on computer issues is not an applicable reason for administering medications late. There is no evidence that an order to administer the medication late was obtained from the individual's prescribing physician.
January 11, 2021- A med error was entered into EIM for the late administration. (Attachment # 24)
- Individual #1 did not receive his 75mg dose of Sertraline at 8AM on 6/19/20, as prescribed.
January 11, 2021- A med error was entered into EIM for the missed dose. (Attachment # 25)
- On 7/8/20, Individual #1 did not receive his prescribed 75mg of Sertraline as prescribed. Staff person #3 documented her initials on the individual's mar as if she administered the medication. However, the agency determined that this medication wasn't administered due to the dose still being available at the home at 8AM on 7/9/2020.
July 9, 2020- A med error was reported into EIM (#8761733). January 13, 2021- The med error was documented on the MAR. (Attachment # 27)
- On 10/17/20 Individual #1 did not receive his prescribed 25mg dose of Quetiapine.
October 17, 2020- Individual #1 was away from the program with family at the time of administration. (Attachment # 28)
- Individual #1's prescribed 75mg of Sertraline was not administered on 10/26/20
October 26, 2020- Individual #1¿s 75mg of Sertraline was administered correctly on 10/26/2020. (Attachment # 29)
- On 10/26/20, Individual #1's Psychiatrist increased the individual's dose of Quetiapine to 50mg daily. This was not administered as prescribed until 8PM on 11/2/20, despite having the medication available in the home since 7:45PM on 10/30/20.
January 11, 2021- A med error was entered into EIM for the Quetiapine, wrong dose from 10/27/20-11/1/20. (Attachment # 32)
- From 10/29/20 through 10/31/20, Individual #1 did not receive his prescribed 100 mg of Sertraline daily.
October 29-31, 2020- A review of the MAR indicated that individual #1 received 100mg of Sertraline as prescribed from 10/29-10/31/2020. (Attachment # 31)
January 2021- A Monthly Supervisory Documentation Review form will be completed by each program specialist documenting a prescription medication shall be administered as prescribed. |
02/15/2021
| Implemented |
| 6400.166(a)(12) | REPEAT from 10/16/19 annual inspection: The agency provided two medication administration records (mars) for Individual #1 that documented medications administered to him, by staff, in March 2020. The mars listed daily and as needed medication administrations. However, the mars themselves did not contain the month or the year (date) of the administration. | A medication record shall be kept, including the following for each individual for whom a prescription medication is administered: Date and time of medication administration. | January 11. 2021- All program specialists were trained on their responsibilities that the date and time of medication administration shall be recorded on the medication record at the time the medication is administered.
A training record was signed indicating attendance and understanding. (Attachment # 1)
Program specialists will continue to ensure that the date and time of medication administration will be recorded on the medication record at the time the medication is administered.
Program specialists have reviewed and verified that the date and time of medication administration has been recorded at the time the medication is administered.
- The agency provided two medication administration records (MARS) for Individual #1 that documented medications administered to him, by staff, in March 2020. The mars listed daily and as needed medication administrations. However, the MARS themselves did not contain the month or the year (date) of the administration.
June 2020- SFI began using an electronic record system in 2020. The system was instituted at individual #1s home starting June 2020. The electronic MAR has safeguards set up to include automatically pre-populating the months and year on the MARS.
SFI has just completed its first year of using the electronic MAR system to document med administration. As we continue to learn this system, we will meet with Thompsons Pharmacy in Altoona to review these concerns and how we can address them as we move forward. This is in process of being scheduled. SFI staff will receive additional training on the electronic MAR system to ensure accuracy during the medication administration process.
In addition, a Monthly Supervisory Documentation Review form will be completed by each program specialist to review all meds are documented correctly including documentation of the date and time of medication administration. |
02/15/2021
| Implemented |
| 6400.166(b) | REPEAT from 10/16/19 annual inspection:
On 5/13/20, at 8am Staff #4 administered Sertraline HCL 50 mg to Individual #1. Staff #4 did not log that she had administered the medication. On the MAR for June 2020 for Individual #1 under the comments section it indicates Individual #1 received Sertraline 50 mg correctly on 6/24/20; but that it was not documented on the MAR. The box for 6/24/20 for Sertraline 50mg is blank. | The information in subsection (a)(12) and (13) shall be recorded in the medication record at the time the medication is administered. | January 11, 2021- All program specialists were trained on their responsibilities that the information in subsection (a)(12) date and time of administration and (13) name and initials of the person administering the medication, shall be recorded in the medication record at the time the medication is administered.
A training record was signed indicating their attendance and understanding. (Attachment # 1)
Program specialists will continue to ensure that information in subsection (a)(12) and (13) shall be recorded in the medication record at the time the medication is administered.
Program specialists reviewed and verified the information in subsection (a)(12) and (13) were recorded in the medication record at the time the medications were administered.
- On 5/13/20 at 8am staff #4 administered Sertraline HCL 50 mg to Individual #1. Staff #4 did not log that she had administered the medication. On the MAR for June 2020 for Individual #1 under the comments section it indicates Individual #1 received Sertraline 50 mg correctly on 6/24/20; but that it was not documented on the MAR. The box for 6/24/20 for Sertraline 50mg is blank.
June 2020- SFI began using an electronic administration record system. This system was instituted at individual #1¿s home starting June 2020. The electronic MAR system will automatically record the staff¿s initials on the MAR once the staff indicates that the administration is complete.
SFI has just completed its first year of using the electronic MAR system to document med administration. As we continue to learn this system, we will meet with Thompsons Pharmacy in Altoona to review these concerns and how we can specifically address them as we move forward. This meeting is in the process of being scheduled.
SFI staff will receive additional training on the electronic MAR system to ensure accuracy during the medication administration process.
In addition, a Monthly Supervisory Documentation Review form will be completed by each program specialist to review all meds are documented correctly including the date and time of administration and name and initials of the person administering the medication is recorded in the medication record at the time the medications are administered. |
02/15/2021
| Implemented |
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