INITIAL COMMENTS
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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 May 20-21, 2014 by staff from the Division of Drug and Alcohol Program Licensure. Based on the findings of the on-site inspection, Northeast Family Health Care, LLC was found not to be in compliance with the applicable chapters of 4 PA Code and 28 PA Code which pertain to the facility.
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Plan of Correction
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715.11 LICENSURE Confidentiality of patient records
A narcotic treatment program shall physically secure and maintain the confidentiality of all patient records in accordance with 42 CFR 2.22 (relating to notice to patients of Federal confidentiality requirements) and § 709.28 (relating to confidentiality).
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Observations
Based on administrative documentation reviewed and discussion with facility staff, the facility failed to maintain the confidentiality of all patients.
The findings include:
An incident report describing the police entering into the facility asking for a specific patient who had just entered the building. According to the documentation presented, the staff admitted the patient was in fact there and had gone into the restroom. While the patient was in the restroom, another staff stood outside yelling for the patient to come out of the bathroom. When the patient came out the two police officers were right there and asked her name, then arrested, cuffed and removed the patient from the facility. This was discussed with one staff person involved who did acknowledge the patient's presence was announced to the police officers. The officers were also free to identify any patients that were in the waiting area as well.
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Plan of Correction
Facility director will conduct a training within the next 30 days on confidentiality within the clinic, and also educate the staff, specifically the front desk staff on the state requirements of what information can be disclosed to police or any other legal authorities upon entrance into the building.
Facility director has a scheduled appointment with the local police within the next 7 days to educate and work with them on learning the regulations that OTP facilities must abide by when entering. |
715.16(a)(3) LICENSURE Take-home privileges
(a) A narcotic treatment program shall determine whether a patient may be provided take-home medications.
(3) The narcotic treatment physician shall document in the patient record the rationale for permitting take-home medication.
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Observations
Based on the review of patient record documentation, the facility failed to ensure the physician document in the patient record the rationale for granting take home medication in two of three patient records.
The findings include:
Thirteen patient records were reviewed May 20-21, 2014. Three records were reviewed for take home medication documentation. Patient records # 3 and 4 did not have the physician's rationale for granting the take home medication.
Patient # 3 was admitted July 31, 2013. The patient entered as a transfer from another narcotic treatment program and had 6 take home bottles at the time. The take home bottles were continued per dosing records, but there was no documentation of a rationale. In addition, there was no rationale for take home privileges dated 12-18-13 and 1-15-14.
Patient # 4 was admitted as a transfer from another narcotic treatment program. The patient was receiving 6 take home bottles from the referring facility. There was no indication the receiving physician reviewed the documentation sent by the transferring facility nor was there documented a rationale for continuing the 6 take home bottles. The nursing department documented a verbal order from the physician that the 6 take home bottles were to be continued.
This was discussed with the facility director 5-21-14.
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Plan of Correction
Facility reviewed the deficiencies and reviewed specified charts. Upon the absence of the doctor's rationale, the facility director will meet with both physicians in the facility within the next 7 days( by 6/24/14) and review the need for specific rationale when granting take home bottles.
Additionally, the facility director reviewed the deficiency regarding patient #4 - director will continue to have a dialogue with the clinic physicians by 6/24/14 to encourage and integrate nursing and medical communication in regards to transferred patients as well as conduct monthly medical chart review audits to ensure that rationales are documented correctly. |
715.16(b)(1-8) LICENSURE Take-home privileges
(b) The narcotic treatment physician shall consider the following in determining whether, in exercising reasonable clinical judgment, a patient is responsible in handling narcotic drugs:
(1) Absence of recent abuse of drugs (narcotic or non-narcotic), including alcohol.
(2) Regular narcotic treatment program attendance.
(3) Absence of serious behavioral problems at the narcotic treatment program.
(4) Absence of known recent criminal activity.
(5) Stability of the patient 's home environment and social relationships.
(6) Length of time in comprehensive maintenance treatment.
(7) Assurance that take-home medication can be safely stored within the patient 's home.
(8) Whether the rehabilitative benefit to the patient derived from decreasing the frequency of attendance outweighs the potential risks of drug diversion.
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Observations
Based on a review of patient records and discussion with facility staff, the facility failed to consider all eight points prior to granting take home privileges in one of two take home exception records reviewed.
The findings include:
Thirteen patient records were reviewed May 20-21, 2014. Two patient records were reviewed for documentation of take homes for exceptional circumstances.
Patient # 2 was admitted October 29, 2013. A note dated 12/4/13 and signed by the physician stated patient was eligible for a "hardship" take home bottle one day a week because he had a stand at a flea market on Sundays. It was noted he had been missing his dosing on Sundays to attend to his stand at the flea market. Further documentation reported he was using illicit benzodiazepine drugs. This patient did meet the requirements for take home medication.
This was discussed with the facility director 5-21-14.
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Plan of Correction
Facility director reviewed the deficiencies - for patient #2, director reviewed the chart and the request for takehomes did not meet criteria for exception bottles nor takehome per the state requirements.
Within 7 days, the patient's take home was taken, as it was reviewed by the clinical and medical team. Patient #2 was provided with a treatment plan, which included goals of how to obtain take homes such as providing clean UDS, and also complying with treatment.
A clinical staffing was held within 7 days to review the state requirements for take home bottles and continued bi weekly clinical supervision will also cover the requirements of take homes for all clients. |
715.17(c)(1)(i-vi)) LICENSURE Medication control
(c) A narcotic treatment program shall develop and implement written policies and procedures regarding the medications used by patients which shall include, at a minimum:
(1) Administration of medication.
(i) A narcotic treatment physician shall determine the patient 's initial and subsequent dose and schedule. The physician shall communicate the initial and subsequent dose and schedule to the person responsible for the administration of medication. Each medication order and dosage change shall be written and signed by the narcotic treatment physician.
(ii) An agent shall be administered or dispensed only by a practitioner licensed under the appropriate Federal and State laws to dispense agents to patients.
(iii) Only authorized staff and patients who are receiving medication shall be permitted in the dispensing area.
(iv) There shall be only one patient permitted at a dispensing station at any given time.
(v) Each patient shall be observed when ingesting the agent.
(vi) Administering and dispensing shall be conducted in a manner that protects the patient from disruption or annoyance from other individuals.
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Observations
Based on a review of patient records, the facility failed to ensure the narcotic treatment physician determined the initial and subsequent dosage and schedules for all patients reviewed.
The findings include:
Thirteen patient record were reviewed May 20-21, 2014. Thirteen patient records required the physician make the dose and schedule determination.
Patient # 3 was admitted July 31, 2013. There were multiple documents discussing consultations with the nursing and clinical staff related to the patient's take home schedules and dosing without including that the determination was being made by the physician.
This was discussed with the facility director 5-21-14.
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Plan of Correction
The facility director reviewed the deficiencies as they were discussed.
Patient #3: after the chart was reviewed facility director instructed all consultations to occur with the presence of the nursing and physician staff in order to ensure that the case consult was reviewed with a team approach.
Facility director met with the physicians within 7 days of the state visit to review the requirements of the physician rationale.
Facility director also has organized scheduling to accommodate the physician's scheduling so he/she is attending all case consults and THB meetings. Staff was educated that the physician will make the final decision on any dosing changes, with no exceptions to support the best interest of the client/consumer and their treatment. |
715.21(1)(i-iv) LICENSURE Patient termination
A narcotic treatment program shall develop and implement policies and procedures regarding involuntary terminations. Involuntary terminations shall be initiated only when all other efforts to retain the patient in the program have failed.
(1) A narcotic treatment program may involuntarily terminate a patient from the narcotic treatment program if it deems that the termination would be in the best interests of the health or safety of the patient and others, or the program finds any of the following conditions to exist:
(i) The patient has committed or threatened to commit acts of physical violence in or around the narcotic treatment program premises.
(ii) The patient possessed a controlled substance without a prescription or sold or distributed a controlled substance, in or around the narcotic treatment program premises.
(iii) The patient has been absent from the narcotic treatment program for 3 consecutive days or longer without cause.
(iv) The patient has failed to follow treatment plan objectives.
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Observations
Based on the review of patient records, the facility failed to restrict the reasons for involuntary termination to those reasons allowed by regulation in two of four patient records reviewed.
The findings include:
Thirteen patient records were reviewed May 20-21, 2014. Four patient records were reviewed for involuntary, or administrative, discharge documentation. Two patient records contained documentation of the patient being discharged for reasons other than those listed by regulation.
Patient # 3 was in process of transferring to another narcotic treatment program at the time of the inspection for non-compliance. The patient was given written notice of intent to terminate stating the reason as the patient had had a verbal altercation with another patient. There was no documentation this was a threatening verbal altercation. Discussion with the clinical staff confirmed there were no threats made.
Patient # 9 was listed as having been involuntarily terminated for "non-compliance with treatment plan", but was in reality being detoxified involuntarily for falling behind with payments. On February 6, 2014, the clinical note stated the patient offered to pay a significant amount of what was owed and the clinician agreed to ask if that would be acceptable. This offer by the patient was rejected; the patient was informed she must pay in full or the involuntary detoxification would proceed.
This was discussed with the facility director 5-21-14.
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Plan of Correction
Facility director reviewed the charts that were pulled for the state visit.
Patient #3: Facility director reviewed the chart and during biweekly clinical supervision reviewed the state requirements of a discharge, and also will provide a training within 30 days during the supervision to review with clinicians the importance of documentation specifically when an altercation occurs.
Patient #9: Facility director reviewed the deficiency and chart. Director will provide a training within 30 days with all clinicians to review the state criterion for an administrative discharge, which does not include financial. Facility director and lead counselor will continue to review during biweekly clinical supervision, all clients who are noncompliant with their treatment to ensure discharges are within the state requirements.
In regards to administrative detox due to financial noncompliance, facility director will also provide training and education to therapists within the next 30 days, to provide them with treatment plan interventions to assist the clients in meeting their financial requirements, but provide therapeutic support clinically. |
715.23(d) LICENSURE Patient records
(d) A narcotic treatment program shall prepare a treatment plan that outlines realistic short and long-term treatment goals which are mutually acceptable to the patient and the narcotic treatment program.
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Observations
Based on the review of patient records, the facility failed to ensure a treatment plan was prepared in two of four patient records reviewed.
The findings include:
Thirteen patient records were reviewed May 20-21, 2014. Four records were reviewed for a prepared treatment plan.
Patient # 10 was admitted October 8, 2013. A preliminary treatment plan for the first 30 days was signed October 15, 2013. The patient was discharged March 28, 2014. There was no comprehensive treatment plan in the patient record at the time of the inspection.
Patient # 11 was admitted September 13, 2013. A preliminary treatment plan for the first 30 days was signed September 13, 2013. The patient was discharged April 15, 2014. There was no comprehensive treatment plan in the patient record at the time of the inspection.
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Plan of Correction
Facility director reviewed the state deficiencies.
Director and lead counselor conduct monthly chart review audits to determine that treatment plans are being completed.
Additionally, the director and lead counselor will continue to facilitate bi weekly supervision to therapists and train them on time management and completion of treatment plans within the allotted time to remain in compliance with the state.
In order to adhere to the 30 day completion requirement for the initial treatment plan, facility director will provide an inservice training for all counselors reviewing initial treatment plans and the compliance of completion. |
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 a review of administrative documentation and discussion with administrative staff, the facility failed to file unusual incidents with a potential for community concern on two separate occasions.
The findings include:
Administrative documentation was reviewed May 20, 2014 which included an incident report describing the police entering into the facility asking for a specific patient who had just entered the building. According to the documentation presented, the staff admitted the patient was in fact there and had gone into the restroom. While the patient was in the restroom, another staff stood outside yelling for the patient to come out of the bathroom. When the patient came out the two police officers were right there and asked her name, then arrested, cuffed and removed the patient from the facility.
On May 20, 2014, the facility director described an incident that had recently occurred in the front parking area of the facility where staff observed two patients "sleeping" in a closed and locked car. The facility director stated she and other staff attempted to arouse the "sleeping" patients, which was very difficult to do. Emergency response personnel were contacted through 911 and took the patient's to the emergency room for evaluation. A written incident report was requested, but not received.
This was discussed with and confirmed by the facility director May 21, 2014.
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Plan of Correction
Facility director will conduct a training within the next 30 days on confidentiality within the clinic, and also educate the staff, specifically the front desk staff on the state requirements of what information can be disclosed to police or any other legal authorities upon entrance into the building.
Facility director has a scheduled appointment with the local police within the next 7 days to educate and work with them on learning the regulations that OTP facilities must abide by when entering.
Facility director will obtain the correct form, and send an unusual incident report within the state requirement time frame of 48 hours in order to stay in compliance with the state requirements.
In regards to the second incident, the facility director will continue to identify appropriate protocol and continue to train nursing and other staff to respond appropriately, as well as file the correct unusual incident reporting form within 47 hours to remain in compliance with the state requirements. |