INITIAL COMMENTS |
This report is a result of an on-site inspection conducted for the approval to use a narcotic agent, specifically methadone, in the treatment of narcotic addiction. This inspection was conducted on June 18-19, 2013 by staff from the Program Licensure Division. Based on the findings of the on-site inspection, Pennsylvania Associates LLC d/b/a Mount Pocono Medical was found not to be in compliance with the applicable chapters of 4 PA Code and 28 PA Code which pertain to the facility. The following deficiencies were identified during this inspection. |
Plan of Correction
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715.12(1-5) LICENSURE Informed patient consent
A narcotic treatment program shall obtain an informed, voluntary, written consent before an agent may be administered to the patient for either maintenance or detoxification treatment. The following shall appear on the patient consent form:
(1) That methadone and LAAM are narcotic drugs which can be harmful if taken without medical supervision.
(2) That methadone and LAAM are addictive medications and may, like other drugs used in medical practices, produce adverse results.
(3) That alternative methods of treatment exist.
(4) That the possible risks and complications of treatment have been explained to the patient.
(5) That methadone is transmitted to the unborn child and will cause physical dependence.
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Observations Based on a review of patient records, the facility failed to obtain an informed, voluntary, written consent prior to the administration of a narcotic agent for maintenance treatment.
The findings include:
Fifteen patient records were reviewed on June 18-19, 2013. Eight patient records were reviewed for the completion of an informed, voluntary, written consent prior to the administration of a narcotic agent. The facility failed to document the completion of an informed, voluntary, written consent prior to the administration of a narcotic agent in patient records # 11 and 12.
Patient # 11 was readmitted to the program on November 1, 2012. The patient received their initial dose of methadone on November 1, 2012. The informed consent in the patient record was from the prior treatment episode and was dated May 1, 2012. The facility failed to obtain the patient's informed, voluntary, written consent prior to the administration of a narcotic agent upon readmission to the program.
Patient # 12 was readmitted on December 4, 2012. The patient received their first dose of methadone on December 6, 2012. The informed consent in the patient record was from the prior treatment episode and was dated May 17, 2011. The facility failed to obtain the patient's informed, voluntary, written consent prior to the administration of a narcotic agent upon their readmission to the program.
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Plan of Correction The clinic director has reviewed the standard 715.12(1-5)and will ensure that the lead counselor will conduct an inservice by 7/31/13 on "informed patient consent"; in addition, the charts will be reviewed by the lead counselor to ensure future compliance |
715.14(a) LICENSURE Urine testing
(a) A narcotic treatment program shall complete an initial drug-screening urinalysis for each prospective patient and a random urinalysis at least monthly thereafter.
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Observations Based on review of the patient records, the facility failed to obtain a complete drug screen urinalysis prior to the administration of Methadone, a narcotic agent in two of six records reviewed. A complete drug screen includes receiving the results from the CLIA and Department of Health approved laboratory.
The findings include:
Fifteen patient records were reviewed on June 18-19, 2013. Six patient records were reviewed for documentation of the completion of a drug screen urinalysis prior to the administration of Methadone, a narcotic agent. A complete drug screen includes receiving the results from the CLIA and Department of Health approved laboratory. The facility failed to obtain a complete drug screen urinalysis prior to the administration of Methadone, a narcotic agent in two of six records reviewed.
Patient #10 was admitted on May 7, 2013. The urine screen results were not reported until May 9, 2013. The initial dose of Methadone was given on May 7, 2013. The facility did document an instant drug test on May 7, 2013. The facility does not have approval from the Department to use instant drug tests. Instant drug tests are not from the CLIA and Department of Health approved laboratory. The facility failed to document a complete drug screen urinalysis prior to the administration of Methadone, a narcotic agent, for this patient.
Patient # 11 was admitted on November 1, 2012. This patient was transferred from another narcotic treatment facility due to the continued use of illicit benzodiazepines. The transferring facility sent the patient's last urine drug screen that was completed on October 4, 2012 and it was positive for benzodiazepines. The initial dose of Methadone was given on November 1, 2012. The urine screen results were not reported until November 3, 2012. The patient's urine screen was positive for benzodiazepines, marijuana, opiates, and oxycodone. The facility failed to document a complete drug screen urinalysis prior to the administration of Methadone, a narcotic agent, for this patient.
These findings were discussed with the facility director and were not disputed.
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Plan of Correction The clinic director has reviewed the standard 715.14(a) and will ensure that the medical department will conduct an inservice by 7/31/13 to re educate the staff on 715.14. In addition the clinic will not accept UA results from transferring clinics. The medical department/Nursing will review all charts before they are accepted to check for compliance. |
715.23(c)(1-7) LICENSURE Patient records
(c) An annual evaluation of each patient 's status shall be completed by the patient 's counselor and shall be reviewed, dated and signed by the medical director. The annual evaluation period shall start on the date of the patient 's admission to a narcotic treatment program and shall address the following areas:
(1) Employment, education and training.
(2) Legal standing.
(3) Substance abuse.
(4) Financial management abilities.
(5) Physical and emotional health.
(6) Fulfillment of treatment objectives.
(7) Family and community supports.
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Observations Based on the review of patient records, the facility failed to complete annual evaluations in accordance with the regulations in three of eight patient records reviewed.
The findings included:
Fifteen patient records were reviewed June 18-19, 2013. Eight patient records required documentation of an annual evaluation.
Patient # 5 was admitted on April 12, 2011. The annual evaluation was due April 12, 2012, however, it was not documented until July 12, 2012. As of the date of the inspection, the annual evaluation that was due in April 2013 was not documented in the patient record.
Patient # 6 was admitted March 1, 2011. The last annual evaluation was documented on March 12, 2012. As of the date of the inspection, the annual evaluation that was due in March 2013 was not documented in the patient record.
Patient # 7 was admitted on February 22, 2011. The annual evaluation was due February 22, 2012, however, it was not documented until July 15, 2012. As of the date of the inspection, the annual evaluation that was due in February 2013 was not documented in the patient record.
These findings were discussed with the facility director and were not disputed.
This is a repeat citation from the methadone monitoring inspection conducted on May 1-2, 2012.
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Plan of Correction The clinic director has reviewed the standard 715.23(c)(1-7) and will ensure that the lead counselor will instruct the staff to use the clinic software as a reminder "tool" to show when annual evaluations are due so they may completed by the due date. |
715.28(c)(1-5) LICENSURE Unusual incidents
(c) A narcotic treatment program shall file a written Unusual Incident Report with the Department within 48 hours following an unusual incident including the following:
(1) Complaints of patient abuse (physical, verbal, sexual and emotional).
(2) Death or serious injury due to trauma, suicide, medication error or unusual circumstances.
(3) Significant disruption of services due to a disaster such as a fire, storm, flood or other occurrence.
(4) Incidents with potential for negative community reaction or which the facility director believes may lead to community concern.
(5) Drug related hospitalization of a patient.
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Observations Based on the review facility documentation that included incident reports, patient records and staff discussions, the facility failed to provide documentation of incident reports involving death, drug related hospitalization of a patient and incidents with potential for negative community reaction to the Department.
The findings include:
During the June 18-19, 2013 methadone monitoring inspection, patient record reviews and administrative documentation revealed reportable incidents were not sent into the Department.
Patient # 8 was admitted on November 26, 2011. A review of this patient record revealed the patient was hospitalized on March 21, 2013 as a result of a drug overdose and was in the intensive care unit at the hospital. The facility failed to provide the Department with a written report that provided an account of this patient's hospitalization. This patient also died on April 9, 2013 while still a patient at the clinic. The facility failed to provide the Department with written report that provided an account of the patient's death.
A review of administrative documentation revealed that the facility was left unsecured from Saturday January 12, 2013 until Sunday morning January 13, 2013. The facility documented that the counselor on duty on January 12, 2013 failed to secure the facility. When the staff arrived to work on January 13, 2013 an alarm was sounding and the building was unsecured. The security videos were reviewed by the facility director. Review of the video showed a man entering the facility on Saturday January 12, 2013 at 10:50 a.m. This was after the facility had been vacated by staff. At 11:00 a.m. three police officers entered the building and completed a search and left the building. The local alarm company did not have an updated call list and the staff were not contacted when the alarm was tripped. The facility failed to provide the Department with a report that provided an account of this incident that could be a potential community concern.
A review of incident reports revealed Patient # 16 was arrested at the facility. The documentation alleged this patient was involved in a possible overdose of an unidentified female. The patient had told several other patients about this and a patient contacted the police. The police arrived at the facility and were provided details about the client by facility staff. The patient returned to the facility and was apprehended by the police. The facility failed to provide the Department with a report that provided an account of this incident that could be a potential community concern.
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Plan of Correction The clinic director has reviewed the standard 715.28(c)(1-5)and the facility failed to comply with said regualation. Going forward the facility director will ensure that all reports that are recorded will be sent to the DOH within 48 hours. |
705.2 (2) LICENSURE Building exterior and grounds.
705.2. Building exterior and grounds.
The residential facility shall:
(2) Keep the grounds of the facility clean, safe, sanitary and in good repair at all times for the safety and well-being of residents, employees and visitors. The exterior of the building and the building grounds or yard shall be free of hazards.
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Observations Based on observation, the facility failed to keep the grounds of the facility safe and in good repair at all times for the safety and well-being of residents, employees and visitors.
The findings include:
Upon arrival to the facility on June 18, 2013 at approximately 8:30 AM it was observed that the employee and visitors' parking lot was unsafe and in poor condition.
The parking lot was unsafe due to the asphalt being uneven and having many potholes. Because of the size and number of potholes, it was hazardous to walk in the parking lot, and it would have been difficult if not impossible for drivers to avoid the potholes when driving in the parking lot.
The findings were confirmed by the facility director on June 19, 2013 and were not disputed.
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Plan of Correction On 7/17/2013 the potholes and uneven asphalt were corrected to provide safe entry, existing, and walking within the parking lot for all consumers, visitors, and employees. The maintenance and upkeep of the parking lot will be monitored one time per month by the facility director to ensure that the parking lot is kept in a safe condition for all consumers, visitors and employees. All noted issues found upon monthly inspection will be addressed by the facility director within 24 hours. The protocol will be to notify PTC corporate office and the landlord within 24 hours of noted issues. |