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 October 25-27, 2011 by staff from the Division of Drug and Alcohol Program Licensure. Based on the findings of the on-site inspection, Parkside Recovery 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 two patient records reviewed.
The findings include:
Twenty six patient records were reviewed October 25-127, 2011. The review of patient records revealed that two patients possessed prior narcotic treatment experiences that required the facility to contact the prior narcotic treatment program for treatment histories. Patient records # 11 and 4 both contained documentation of previous narcotic treatment involvement but neither record provided documentation of any efforts to obtain prior treatment histories.
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Plan of Correction
Effective 10/28/2011 intake staff have been retrained to obtain signed consent to contact previous treatment facilities and to document outreach efforts and outcomes in the progress note.The same process is adhered to by counselors completing biopsychosocial assessments and obtaining additonal treatment history. The clinical supervisor is reviewing all intakes and biopsychosocial assessments for treatment history confirmation. |
715.16(a)(5) LICENSURE Take-home privileges
(a) A narcotic treatment program shall determine whether a patient may be provided take-home medications.
(5) A narcotic treatment program shall develop written policies and procedures relating to granting and rescinding take-home medication privileges.
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Observations
Based on a review of administrative documentation and discussion with facility staff, the facility failed to update the policy and procedure to reflect the facility's updated practice related to the granting and rescinding of take home medication privileges.
The findings include:
The facility's policy and procedures were reviewed October 25, 2011. The policy related to the granting and rescinding take home medication privileges stated the counselors complete the "take home reduced schedule form" and submit to the clinical supervisor. It is then reviewed by the program physician for determination of any changes with take-home medication. The medical director and the project director reported on October 25, 2011 that the facility now has implemented a take home committee that includes staff from the various disciplines involved in patient care at the facility. The take home committee reviews the patient's adherence to the criteria and makes recommendations to the medical director who then makes the decision. This current procedure is not the stated policy and procedure.
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Plan of Correction
The policy was updated as of 11/29/2011 to reflect the current practices related to the granting and rescinding take home medication privileges stated the counselors complete the "take home reduced schedule form" and submit to the clinical supervisor. It is then reviewed by the program physician for determination of any changes with take-home medication. The medical director and the project director reported on October 25, 2011 that the facility now has implemented a take home committee that includes staff from the various disciplines involved in patient care at the facility. The take home committee reviews the patient's adherence to the criteria and makes recommendations to the medical director who then makes the decision. |
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 the physician completed a written dosage change in one of one patient records reviewed.
The findings include:
Twenty five patient records were reviewed October 25-27, 2011. One patient record reviewed required documentation of the patient's induction into methadone maintenance. Patient # 14 was admitted July 13, 2011. The physician wrote a standing order for the initial dose of 30 milligrams to be administered July 14, 2011, 40 milligrams to be administered July 16, 2011 and 60 milligrams to be administered July 18, 2011. The patient, according to patient record documentation, met with the physician 7 days after the initial dose was administered.
This issue of standing orders was addressed September 4, 2007 when the DEPARTMENT OF HEALTH & HUMAN SERVICES Substance Abuse and Mental Health Services Administration addressed all narcotic treatment facilities, stating in part the following:
"In determining the initial dose for each individual patient, the
physician should consider factors such as body weight, size, other substance use and
abuse, diet, co-occurring disorders (check for prescribed SSRIs, benzodiazepines, HIV
medications, anti-seizure medication, etc.) and medical diseases, genetic factors, and
tolerance. The drug labeling states that "methadone's pharmacokinetic properties,
coupled with high inter-patient variability in its absorption, metabolism, and relative
analgesic potency, necessitate a cautious and highly individualized approach to
prescribing." Even though the Treatment Improvement Protocol (TIP #43) and drug
labeling state that a typical first dose of methadone for a patient actively abusing opioids
is 20 to 30 milligrams, some patients may require a much lower dose. According to 42
CFR 8.12 (h) (3) (ii), "...the initial dose of methadone shall not exceed 30 milligrams
and the total dose for the first day shall not exceed 40 milligrams.. .." (emphasis added).
The initial methadone dose should be appropriate for the individual patient, with the
maximum initial dose being 30 mg. Clearly, a 30-mg dose should not be the initial dose
for all patients.
Of note, there has been a rapid increase in the abuse of the opioid-type pain relieving
medications. Typically, hydrocodone and oxycodone are the drugs of choice, and the
resulting addiction is treated by the OTPs. These are short-acting opioids with a half-life
of 2 to 4 hours. However, methadone has an elimination half-life that can vary from 8 to
59 hours depending on the individual being treated. Thus, methadone induction must be
approached cautiously.
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' ."
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Plan of Correction
Effective 10/28/2011 the Medical Director re-educated the physicians to no longer provide standing orders for methadone inductions. The physician responsible for the one standing order no longer works for Parkside Recovery Germantown. |
715.17(c)(3)(i-v) 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:
(3) Inspection of storage areas. A narcotic treatment program shall inspect all drug storage areas and the dispensing station at least quarterly to ensure that the areas are maintained in compliance with Federal, State and local laws and regulations. A narcotic treatment program shall develop and implement written policies and procedures regarding who performs the inspections, how often, and in what manner the inspections are to be documented. The policies and procedures shall include the following:
(i) Disinfectants and drugs for external use shall be stored separately from oral and injectable drugs.
(ii) Drugs requiring special conditions for storage to insure stability shall be properly stored.
(iii) Outdated and contaminated drugs shall be removed and destroyed according to Federal and State regulations.
(iv) Administration of controlled substances shall be documented.
(v) Controlled substances and other abusable drugs shall be stored in accordance with Federal and State regulations.
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Observations
Based on the review of administrative documentation and discussion with facility staff, the facility failed to follow their policy regarding drug storage areas and the dispensing station.
The findings include;
The facility's policies and procedures were reviewed October 25, 2011. The policy related to the frequency of inspecting the drug storage and dispensing station stated the inspections were to be conducted on a monthly basis.
The documentation pertaining to these monthly inspections was reviewed October 26, 2011. The documentation failed to include monthly inspections, as required per facility policy, for the months of March and April 2011.
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Plan of Correction
Effective 10/28/2011 the Nurse Supervisor reviewed the policy with nursing staff at staff meeting. The monthly inspection log was added to the calendar with the nurse supervisor identified as the point person and one staff person as a backup to complete the storage area inspection at least monthly. |
715.21 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.
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Observations
Based on a review of administrative documentation, the facility failed to develop and implement a specific policy regarding involuntary terminations.
The findings include:
The facility's policies and procedures were reviewed October 25, 2011. The policy and procedure manual contained two different policies regarding involuntary terminations. One policy documented reasons for involuntary discharge that were consistent with the regulations while the second policy included additional reasons for involuntary terminations. These additional reasons include excessive absences, consistent abnormal urine drug screens and failing to seek employment or training when the treatment team deemed the patient was ready to work.
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Plan of Correction
Effective 10/28/2011 the outdated policy was removed from the policy and procedure manual by the program director. The current policy was reviewed with staff on 10/28/2011. |
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 and administrative documentation, the facility failed to restrict the reasons for involuntary termination to those reasons allowed by regulation.
The findings include:
Twenty six patient records were reviewed October 25-27, 2011. Seven patient records were reviewed for having received written notice of involuntary termination. Two of seven patient records revealed documentation that patients # 20 and 22 were given written notice of termination for reasons not identified as a reason for termination in the regulations.
Patient # 20 was given written notice of termination for excessive absences.
Patient # 22 had initially requested a 21 day voluntary detoxification, but was then given written notice of involuntary termination for being five minutes to dose.
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Plan of Correction
Effective 10/28/2011 the clinical staff was re-educated at staff meeting by the clinical supervisor regarding the Department allowable reasons for involuntary terminations. The clinical supervisor will review all involuntary terminations prior to discharge. |
715.21(2) 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.
(2) A patient terminated involuntarily, except a patient who commits or threatens to commit acts of physical violence, shall be afforded the opportunity to receive detoxification of at least 7 days. The detoxification may take place at the facility or the patient may be referred to another narcotic treatment program or hospital licensed and approved by the Department for detoxification.
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Observations
Based on the review of patient records, the facility failed to restrict immediate involuntary terminations to the commission of /or threats of physical violence.
The findings include:
Twenty six patient records were reviewed October 25-27, 2011. Patient # 15 was given an immediate termination for a failure to sign a consent to release form that would have allowed for the coordination of care between the facility and the patient's physician.
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Plan of Correction
Effective 10/28/2011 the clinical staff was retrained by the clinical supervisor on documentation of clinical interventions and actions related to client safety prior to any termination. The clinical supervisor will review all immediate terminations in collaboration with the on-site physician and/or medical director. |
715.23(b)(14) LICENSURE Patient records
(b) Each patient file shall include the following information:
(14) Case consultation notes regarding the patient.
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Observations
Based on the review of patient records, the facility failed to complete case consultations as required in eight of twenty patient records reviewed.
The findings include:
Twenty six patient records were reviewed on October 25-27, 2011. Twenty patient records were reviewed for case consultations. Five patient records, # 1, 15, 16, 18 and 21, did not include documentation of required case consultations. Three patient records, # 7, 17 and 23 had case consultations that contained the identical dispositions despite life changes documented within the patient's progress notes.
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Plan of Correction
Effective 10/28/2011 the clinical staff was re-educated to the timely and clinical accuracy needed to effectively complete case consultations. The clinical supervisor will review the case consultations from the documentation tracker and monthly chart audits to ensure compliance with this standard. |
715.23(b)(24) LICENSURE Patient records
(b) Each patient file shall include the following information:
(24) Follow-up information regarding the patient.
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Observations
Based on the review of patient records, the facility failed to document the attempt or completion of patient follow up contact in three of seven patient records reviewed.
The findings include:
Twenty six patient records were reviewed October 25-27, 2011. Seven patient records required documentation of an attempt or completion of a follow up contact.
Patient # 16 was admitted June 19, 2007. The patient was discharged on September 6, 2011. The follow up contact was required to have been attempted within thirty days of the patient's discharge. The 30 day follow up was not documented as completed.
Patient # 26 was admitted July 20, 2009. The patient was discharged on May 13, 2011. The follow up contact was required to have been attempted within thirty days of the patient's discharge. The 30 day follow up was not documented as completed.
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Plan of Correction
Effective 10/28/2011 the medical records staff was re-trained to document the date the outreach letter is sent onto the discharge packet. The clinical supervisor or program director will review the discharge pakets to ensure documentation is completed. |
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, the facility failed to file written unusual incident reports within 48 hours as required.
The findings include:
The facility provided their documentation of unusual incidents. On August 1, 2011, an incident report regarding the appearance of a bed bug on the floor of a group room was completed. This was not forwarded to the Department as required.
There were multiple reports of the facility having called the police onsite; these were not forwarded to the Department as required.
There was an incident report of a patient who died while in treatment. Patient # 13 was admitted August 6, 2010. The patient was discharged as deceased on October 24, 2011. There was no documentation that an incident report of the patient's death was reported to the Department.
Facility staff verified verbally on October 27, 2011 that these incidents were not forwarded to the Department as required.
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Plan of Correction
Effective 10/28/2011 the incident reporting policy and standard was reviewed with the Lead Clinical Supervisor reponsible for incident reporting. All incident reports will be sent to the Department as required and supporting fax confirmation included in the incident log report.The incident log will be reviewed and reconciled at monthly incident management meetings by the Lead Clinical Supervisor and the Incident Management representative. |