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 9, 2012, to May 11, 2012 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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715.17(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:
Twelve patient records were reviewed. One patient record reviewed required documentation of the patient's induction into methadone maintenance. Patient # 12 was admitted December 14, 2011. The physician then wrote a standing order for the initial dose of 30 milligrams to be administered December 15, 2011, 40 milligrams to be administered December 18, 2011 and follow up with physician on December 20, 2011.
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
All doctors have been re-trained by the Medical Director as of 6/1/2012 and advised again that standing orders are prohibited to comply with best practice guidelines and to ensure that this deficiency does not re-occur again. Person responsible - Dr. Laura Murray. How will it be monitored? This will be addressed in monthly supervisions with program physicians by Medical Director to ensure that all doctors continue to be aware that this is prohibited and to ensure that this deficiency does not re-occur. |
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 the Notification of Program Termination form, the facility failed to restrict the reasons for involuntary termination to those reasons allowed by regulation.
The findings include:
Twelve patient records were reviewed including five discharge records. Two patient records were reviewed for involuntary discharge. One patient record contained documentation of the patient being discharged for reasons other than those listed by regulation.
Patient # 3 was admitted on March 24, 2011 and discharged on November 11, 2011. The reason for discharge was possession of a controlled substance. A Notification of Program Termination on October 19, 2011, also listed the patient had consistently positive urine screens and refused the recommended treatment.
The Notification of Program Termination form included multiple reasons for termination outside of the scope of the regulation. The reasons for discharge included excessive absences, failure to seek employment, training or education, and when determined to be appropriate by medical and psychiatric staff.
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Plan of Correction
Facility's "Notice of termination Form was revised by the Program Director during the site visit and the revised form was looked at by the onsite reviewer.The revised form has been in use since the date of approval.Proper use of the form will be reviewed during monthly chart reviews by the Program Director and /or the Clinical Supervisor. |
715.23(b)(5) LICENSURE Patient records
(b) Each patient file shall include the following information:
(5) The results of all annual physical examinations given by the narcotic treatment program which includes an annual reevaluation by the narcotic treatment physician.
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Observations
Based on the review of patient records, the facility failed to complete the annual physical with a re-evaluation by the physician in two of three patient records reviewed.
The findings include:
Twelve patient records were reviewed. Three records were reviewed for annual physicals. One record failed to document an annual physical, # 2, and a second record documented a late annual physical, # 8.
Patient # 2 was admitted February 16, 2011 and discharged on March 30, 2012. The annual physical exam was not documented as of the date of discharge.
Patient # 8 was admitted April 16, 2007. The annual physical exam was documented late on May 10, 2012.
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Plan of Correction
On March 26,2012, the facility was upgraded from a manual dispense, to an automated dispensing system. This system allows us to print an annual physical report, which will be done every six weeks, to ensure physicals are completed in accordance with regulations. This will be monitored by the nurse supervisor and/or the Director of Nursing monthly. |
704.7(b) LICENSURE Counselor Qualifications
704.7. Qualifications for the position of counselor.
(a) Drug and alcohol treatment projects shall be staffed by counselors proportionate to the staff/client and counselor/client ratios listed in 704.12 (relating to full-time equivalent (FTE) maximum client/staff and client/counselor ratios).
(b) Each counselor shall meet at least one of the following groups of qualifications:
(1) Current licensure in this Commonwealth as a physician.
(2) A Master's Degree or above from an accredited college with a major in chemical dependency, psychology, social work, counseling, nursing (with a clinical specialty in the human services) or other related field which includes a practicum in a health or human service agency, preferably in a drug and alcohol setting. If the practicum did not take place in a drug and alcohol setting, the individual's written training plan shall specifically address a plan to achieve counseling competency in chemical dependency issues.
(3) A Bachelor's Degree from an accredited college with a major in chemical dependency, psychology, social work, counseling, nursing (with a clinical specialty in the human services) or other related field and 1 year of clinical experience (a minimum of 1,820 hours) in a health or human service agency, preferably in a drug and alcohol setting. If a person's experience did not take place in a drug and alcohol setting, the individual's written training plan shall specifically address a plan to achieve counseling competency in chemical dependency issues.
(4) An Associate Degree from an accredited college with a major in chemical dependency, psychology, social work, counseling, nursing (with a clinical specialty in the human services) or other related field and 2 years of clinical experience (a minimum of 3,640 hours) in a health or human service agency, preferably in a drug and alcohol setting. If a person's experience was not in a drug and alcohol setting, the individual's written training plan shall specifically address a plan to achieve counseling competency in chemical dependency issues.
(5) Current licensure in this Commonwealth as a registered nurse and a degree from an accredited school of nursing and 1 year of counseling experience (a minimum of 1,820 hours) in a health or human service agency, preferably in a drug and alcohol setting. If a person's experience was not in a drug and alcohol setting, the individual's written training plan shall specifically address a plan to achieve counseling competency in chemical dependency issues.
(6) Full certification as an addictions counselor by a statewide certification body which is a member of a National certification body or certification by another state government's substance abuse counseling certification board.
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Observations
Based on a review of personnel records, the facility failed to ensure that each counselor met the qualifications for the position in one of two records.
Findings:
Three personnel records were reviewed on May 9, 2012. In personnel record # 3, the counselor did not meet the qualifications for the position of counselor based on an unverified Bachelor's Degree in Business Management. In addition, a review of the employee's application noted the pursuit of a CADC that was not confirmed.
An interview with the Facility Director confirmed the the findings.
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Plan of Correction
As of May 9, 2012 the counselor referred to in the finding has been re-assigned to counselor assistant. Since May 9, 2012 all his group and individual sessions have been monitored by the Program Director, Clinical Supervisor or Lead Counselor. This will continue as long as this counselor assistant carries a caseload or until he meets the qualifications for Counselor. A supervision plan has been developed requiring the individual to complete all necessary requirements to achieve certification by July 15, 2012. If the training plan is not completed by that date the individual not be able to work with clients.In the future all potential hires will not only have all credentials verified by the NHS Credentialing Department but all required documentation needed to meet the requirements of the position hiring for will need to be presented by the canidate at time of initial interview so the Program Director can verify they meet all BDAP required stffing standards. |