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 July 18, 19 and 20, 2012 by staff from the Division of Drug and Alcohol Program Licensure. Based on the findings of the on-site inspection, RHD Montgomery County Methadone Center 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.
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Plan of Correction
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715.9(c) LICENSURE Intake
(c) If a patient was previously discharged from treatment at another narcotic treatment program, the admitting narcotic treatment program, with patient consent, shall contact the previous facility for the treatment history.
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Observations
Based on the review of patient records, the facility failed to contact the previous narcotic treatment facility for the patient's treatment history in two of three patient records reviewed.
The findings include:
Twenty patient records were reviewed July 18 to 20, 2012. The review of patient records revealed that three patients possessed prior narcotic treatment experiences that required the facility to contact the prior narcotic treatment program for treatment histories. Patient records # 3 and 15 both contained documentation of previous narcotic treatment involvement but neither record provided documentation of any efforts to obtain prior treatment histories.
The findings were reviewed with the Facility Director and Clinical Supervisor.
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Plan of Correction
A meeting was held by the Program Director with the Intake Coordinator and Intake Worker to review the needed documentation and releases of patients that have had previous treatment at an NTP to contact the NTP for treatment histories. Intake Coordinator will monitor this for compliance and Program Director will oversee this compliance. Completion Date: 8/14/12 |
715.9(e) LICENSURE Intake
(e) A narcotic treatment program shall secure a personal history from the patient within the first week of admission. The personal history shall be made a part of the patient record.
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Observations
Based on a review of patient records, the facility failed to document that a personal history of the patient was completed within the first week of admission in one of five patient records.
The findings include:
Twenty patient records were reviewed July 18 to 20, 2012. Five of the patient records reviewed documented an admission date in the applicable timeframe and required the documentation of a personal history completed within one week of admission. The facility did not document the personal history within the first week of admission in patient record # 15.
Patient #15 was admitted on May 3, 2012. The personal history was not dated and therefore it could not be determined that the personal history had been completed within the first week of admission.
The findings were reviewed with the Facility Director and Clinical Supervisor.
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Plan of Correction
A meeting was held by the Program Director with the Intake Coordinator and the Intake worker to review that need for documentation of the client's personal history within the first week of admission and to be sure to sign and date this history. Intake Coordinator will monitor this compliance and Program Director will oversee this compliance. Completion Dtae: 8/14/12 |
715.17(b) LICENSURE Medication control
(b) A narcotic treatment program shall develop policies and procedures regarding verbal medication orders, including the issuing and receiving of orders, identifying circumstances when orders are appropriate and documenting orders, in accordance with applicable Federal and State statutes and regulations.
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Observations
Based on the review of patient records, the facility failed to ensure the physician signed and dated within 24 hours after submitting a verbal order in one of one patient record reviewed.
The findings include:
Twenty patient records were reviewed July 18 to 20, 2012. One record contained documentation of a physician's verbal order, #3. The physician signed a Medication Order Request on March 28, 2012, for the patient to start on 30 mg of methadone for induction. The section of the form "Doctor verbally ordered:" identified the patient to start on 30 mg on March 29, 2012 at 11:30 a.m. with the "Order received by:" the Director of Nursing. The physician did not sign or date this verbal order.
The findings were reviewed with the Facility Director and Clinical Supervisor.
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Plan of Correction
A meeting has been held by the Program Director with the Medical Director and The Charge Nurse to address Verbal Orders and the Medical Director's need to sign and date such orders upon the Medical Director's next arrival to MCMC. Provisions for Doctor to give verbal Orders has also been added to Medical Director Job Description and has been signed and dated by the PD and MD. Charge Nurse will present Verbal Orders to MD for signature and PD will oversee this issue for compliance. Completed 8/15/12 |
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 the review of patient records, the facility failed to ensure that the narcotic treatment physician determined the proper dosage level in two of six patients. Additionally, the narcotic treatment physician must document orders in accordance with applicable Federal and State regulations and statutes.
The findings include:
Twenty patient records were reviewed on July 18 to 20, 2012. Six patient records were reviewed for written orders by the narcotic treatment physician that determined the patient's initial dose and subsequent dosing orders. The review of records indicated that the narcotic treatment physician failed to determine the proper dosage in accordance with applicable Federal and State regulations and statutes in patient records # 13 and 15.
In patient record # 13, the pregnant patient was administered 20 mg of methadone on admission on April 4, 2012. On this same date, there was an order written to increase the dose to 30 mg per day in one day.
In patient record # 15, the patient was administered 30 mg of methadone on admission on May 4, 2012. On May 8, 2012, there was an order written to increase the dose by 10 mg on that date. On this same date, there was an order written to increase the dose by 5 mg for the next day based on symptoms of withdrawal.
On September 4, 2007, all narcotic treatment programs were issued a letter regarding methadone dose orders, especially during the induction phase, by the Department of Health & Human Services, Substance Abuse and Mental Health Services Administration: (SAMHSA)
In part, the following is excerpted from the letter:
"Because methadone overdose deaths have occurred in early treatment due to the drug's
cumulative effects of the first several days, it is also important to be cautious when
adjusting the dose. According to the drug labeling, the peak respiratory depressant
effects of methadone typically occur later and persist longer than its peak analgesic effects, which can contribute to cases of iatrogenic overdose, particularly during treatment initiation and dose titration. With repeated dosing, "methadone may be retained in the liver and released slowly, prolonging the duration of action despite low plasma concentrations." The drug labeling also states that "steady-state concentrations are not usually attained until 3 to 5 days of dosing," and that doses "will 'hold' for a longer period of time as tissue stores of methadone accumulate." Therefore, patients should be closely monitored during the induction phase, and the increase in dose should be under the close supervision of a physician as stated in 42 CFR 8.12 (h)(4), ' Dosing and administration decisions shall be made by a program physician familiar with the most up-to-date product labeling'. "
The findings were reviewed with the facility director and the clinical supervisor.
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Plan of Correction
A meeting has been held between the Medical Director and the Program Director to address the Medical Director's need to determine the patient's proper dosing in accordance with applicable Federal and State regulations and to ensure that patients are monitored closely during the induction phase and increases in doses should be closely supervised by the doctor. Program Director will monitor for compliance. Completed 8/15/12 |
715.17(c)(7) 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:
(7) Drug reactions and medication errors. A narcotic treatment program shall report any adverse drug reaction or medication error to a narcotic treatment physician immediately and initiate corrective action. The narcotic treatment program shall record the reaction or error in the drug administration record and the clinical chart, and shall inform each person who is authorized to administer medication or supervise self-medication of the reaction or error.
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Observations
Based on a review of administrative documentation, the facility failed to document that the Narcotic Treatment Physician was notified of a medication error in one of one records.
The findings include:
Twenty patient records and administrative documentation were reviewed on July 18 to 20, 2012. One complaint of June 19, 2012, identified that a patient had concerns with take home bottles. The facility failed to document notification of the physician. The facility also failed to initiate any corrective action prior to the onsite monitoring inspection. The complaint had a handwritten note of "Resolved 6/29/2012 with patient, nurse, counselor and director."
The findings were reviewed with the Facility Director and Clinical Supervisor.
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Plan of Correction
A meeting has been held between the Progam Director and the Charge Nurse to review the process of labeling of THB's and to implement the process of labeling each bottle individually by printing label individually after each pour. Charge nurse will instruct all other dispensing staff of this process and will oversee for compliance. Program Director will make sure this is happening and thatin the future all medication errors will be reported in the form of an incident report and submitted to Medical Director as well as other supervisory authorities. Completed 8/15/12 |
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 prepare a treatment plan within the time frames of the facility in two of five patient records reviewed.
The findings include:
Twenty patient records were reviewed on July 18 to 20, 2012. Five patient records were reviewed for treatment plans. The review of records indicated that the facility did not prepare treatment plans within 30 days from admission in patient records # 13 and 14.
Patient # 13 was admitted on April 4, 2012. A treatment plan was due on or before May 4, 2012. The treatment plan was dated May 10, 2012, by staff signatures. Although the patient signed the plan, the signature was not dated to confirm the time frame.
Patient # 14 was admitted on April 13, 2012. A treatment plan was due on or before May 13, 2012. The treatment plan was dated May 11, 2012, by staff and patient signatures. This patient was incarcerated from April 20, 2012, until they returned to the program on May 17, 2012. The patient was not available for signature on May 11, 2012. It is unclear if the goals were mutually acceptable to the patient as the patient was not attending the program at the time of the signature dates.
The findings were reviewed with the Facility Director and Clinical Supervisor.
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Plan of Correction
A meeting has been held by the Program Director with the Intake Coordinator and Intake Worker to review guidelines for creating an initial treatment plan within the first 30 days of admission to include appropriate time frames, signing and dating as well as to establish mutual goals documented for patient treatment. Intake Coordinator will monitor this complaince and Program Director will oversee compliance. Completed 8/15/12 |
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 of administrative documentation, the facility failed to provide documentation of incident reports involving complaints of drug related hospitalization of a patient to the Department.
The findings include:
Administrative documentation that included the unusual incident reports was reviewed July 20, 2012. It was noted the facility had documentation of an incident on July 12, 2012, of a patient who became difficult to rouse after reporting illicit substance use. An emergency call was placed and the patient was transported to a local hospital. This unusual incident was not reported to the Department as required.
This was discussed with facility director and clinical supervisor who acknowledged it was not sent.
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Plan of Correction
Program Director will be responsible to make sure that all future administrative documentation of unusual incidents are sent to the appropriate sources including DOH Licensing. Asst Director will also be responsible for this compliance in the absence of the Program Director. |