INITIAL COMMENTS
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This report is a result of an on-site licensure renewal inspection conducted on July 23 - 25, 2013 by staff from the Division of Drug and Alcohol Program Licensure. Based on the findings of the on-site inspection, Fayette County Drug and Alcohol Commission, Inc. was found not to be in compliance with the applicable chapters of 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(a)(1) LICENSURE Intake
(a) Prior to administration of an agent, a narcotic treatment program shall screen each individual to determine eligibility for admission. The narcotic treatment program shall:
(1) Verify that the individual has reached 18 years of age.
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Observations
Based on a review of patient records, the facility failed to verify that the individual had reached 18 years of age prior to the administration of a narcotic agent in two of five patient records.
The findings include:
Twenty client records were reviewed on July 24 - 25, 2013. Five records pertained to patients who were prescribed Suboxone and required verification that the individual had reached 18 years of age prior to the administration of the Suboxone. The facility failed to verify that the individual had reached 18 years of age prior to the administration of Suboxone in patient records # 3 and 10.
Patient # 3 was admitted into treatment on March 20, 2013. Patient # 3 was prescribed 8 mg/2 mg Suboxone daily on April 4, 2013, prior to verifying that the individual had reached 18 years of age.
Patient # 10 was admitted into treatment on November 14, 2012. Patient # 10 was prescribed 8 mg/2 mg Suboxone daily on November 15, 2012, prior to verifying that the individual had reached 18 years of age.
The clinical supervisor was interviewed throughout the licensing inspection and confirmed the findings.
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Plan of Correction
The Clinical Supervisor will develop a written policy for the narcotic detoxification treatment program by 9/1/13. This plan will indicate that all clients receiving outpatient narcotic detoxification must provide proof of age, verifying that they have reached 18 years of age prior to the prescription of a narcotic agent. It will be the responsibility of the Clinical Supervisor to issue a "memo" notifying FCDAC staff and prescribing physician that narcotic agents cannot be prescribed unless verification of age is obtained. The Clinical Supervisor will address the "memo" in a staff meeting to ensure staff understanding. The Clinical Supervisor will ensure that the policy is being followed by reviewing clinical records and providing ongoing clinical supervision with staff. |
715.9(a)(2) LICENSURE Intake
(a) Prior to administration of an agent, a narcotic treatment program shall screen each individual to determine eligibility for admission. The narcotic treatment program shall:
(2) Verify the individual 's identity, including name, address, date of birth, emergency contact and other identifying data.
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Observations
Based on a review of patient records, the facility failed to verify the individual's identity, including the name, address and date of birth and emergency contact prior to the administration of a narcotic agent in three of three patient records.
The findings include:
Twenty client records were reviewed on July 24 - 25, 2013. Five records pertained to patients who were prescribed Suboxone and required verification of the individual's identity, including name, address, date of birth and emergency contact prior to the administration of Suboxone. The facility failed to verify the individual's identity, including the name, address, date of birth and emergency contact prior to the administration of Suboxone in patient records # 2, 9 and 10.
Patient # 2 was admitted into treatment on March 19, 2013. Patient # 2 was prescribed 8 mg/2 mg Suboxone daily on March 21, 2013, prior to verifying the individual's identity including the name, address and date of birth.
Patient # 9 was admitted into treatment on February 27, 2013. Patient # 9 was prescribed 8 mg/2 mg Suboxone daily on February 28, 2013, prior to verifying the individual's identity including the emergency contact.
Patient # 10 was admitted into treatment on November 14, 2012. Patient # 10 was prescribed 8 mg/2 mg Suboxone daily on November 15, 2012, prior to verifying the individual's identity including the name, address and date of birth.
The clinical supervisor was interviewed throughout the licensing inspection and confirmed the findings.
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Plan of Correction
The Clinical Supervisor will develop a written policy for the outpatient narcotic detoxification treatment program by 9/1/13 to ensure that prior to administration of an agent, that each individual will be screened to determine eligibility into the program. This plan will indicate the need to collect and verify the individual's identifying data, including name, address, date of birth, emergency contact and any other relevant information. An emergency consent was developed and instituted on 8/2/13 in order to comply with regulations. It shall be the responsibility of the Clinical Supervisor to issue a "memo" notifying FCDAC staff and prescribing physician that narcotic agents cannot be prescribed unless prior verification is obtained. The Clinical Supervisor will address the "memo" in a staff meeting to ensure staff understanding. The Clinical Supervisor will ensure that the policy is being followed by reviewing clinical records and providing ongoing clinical supervision with staff. |
715.9(a)(4) LICENSURE Intake
(a) Prior to administration of an agent, a narcotic treatment program shall screen each individual to determine eligibility for admission. The narcotic treatment program shall:
(4) Have a narcotic treatment physician make a face-to-face determination of whether an individual is currently physiologically dependent upon a narcotic drug and has been physiologically dependent for at least 1 year prior to admission for maintenance treatment. The narcotic treatment physician shall document in the patient 's record the basis for the determination of current dependency and evidence of a 1 year history of addiction.
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Observations
Based on a review of patient records, the facility's physician failed to document in the patient's record the basis for the determination of current dependency prior to the administration of a narcotic agent in five of five patient records.
The findings include:
Twenty client records were reviewed on July 24 - 25, 2013. Five patients were prescribed Suboxone. These patient records were reviewed for documentation that the physician made a face-to-face determination of whether the individual was currently physiologically dependent upon a narcotic drug prior to admission for outpatient detoxification treatment and the basis for this determination. The physician failed to document in the patient's record the basis for determination of current dependency prior to administration of a narcotic agency in patient records # 2, 3, 4, 9 and 10.
Patient # 2 was admitted into treatment on March 19, 2013. The physician conducted a face-to-face visit with patient # 2 on March 21, 2013 and prescribed 8 mg/2 mg Suboxone daily. The physician failed to document whether patient # 2 was currently physiologically dependent upon a narcotic drug prior to admission for outpatient detoxification treatment and the basis for the determination.
Patient # 3 was admitted into treatment on March 20, 2013. The physician conducted a face-to-face visit with patient # 3 on April 4, 2013 and prescribed 8 mg/2 mg Suboxone daily. The physician failed to document whether patient # 3 was currently physiologically dependent upon a narcotic drug prior to admission for outpatient detoxification treatment and the basis for the determination.
Patient # 4 was admitted into treatment on February 5, 2013. The physician conducted a face-to-face visit with patient # 4 on February 7, 2013 and prescribed 8 mg/2 mg Suboxone, 1/4 film three times per day. The physician failed to document whether patient # 4 was currently physiologically dependent upon a narcotic drug prior to admission for outpatient detoxification treatment and the basis for the determination.
Patient # 9 was admitted into treatment on February 27, 2013. The physician conducted a face-to-face visit with patient # 9 on February 28, 2013 and prescribed 8 mg/2 mg Suboxone daily. The physician failed to document whether patient # 9 was currently physiologically dependent upon a narcotic drug prior to admission for outpatient detoxification treatment and the basis for the determination.
Patient # 10 was admitted into treatment on November 14, 2012. The physician conducted a face-to-face visit with patient # 10 on November 15, 2012 and prescribed 8 mg/2 mg Suboxone daily. The physician failed to document whether patient # 10 was currently physiologically dependent upon a narcotic drug prior to admission for outpatient detoxification treatment and the basis for the determination.
The clinical supervisor was interviewed throughout the licensing inspection and confirmed the findings.
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Plan of Correction
The Clinical Supervisor has met with the Medical Director on 8/5/13 and informed him that when completing the initial face to face Psychiatric Diagnostic Interview, he must document in the client's record the basis for the determination of current physiological dependence upon a narcotic drug. Individuals who do not indicate a prior history of use will not be eligible for admission into the outpatient narcotic detoxification program. Clinical Supervisor will ensure ongoing compliance with this regulation through weekly clinical supervision with related staff and review of admissions with Facility Medical Director. |
715.13(b) LICENSURE Patient identification
(b) A narcotic treatment program shall maintain onsite a photograph of each patient which includes the patient 's name and birth date. The narcotic treatment program shall update the photograph every 3 years.
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Observations
Based on a review of patient records, the facility failed to maintain onsite a photograph of each patient which includes the patient's name and birth date in one of five patient records.
The findings include:
Twenty client records were reviewed on July 24 - 25, 2013. Five records pertained to patients who were prescribed Suboxone and required documentation of a photograph including the patient's name and date of birth. The facility failed to maintain onsite a photograph of each patient which includes that patient's name and birth date in patient record # 2.
Patient # 2 was admitted into treatment on March 19, 2013. Patient # 2 was prescribed 8 mg/2 mg Suboxone daily on March 21, 2013. The facility failed to maintain onsite a photograph of patient # 6 which includes their name and birth date.
The clinical supervisor was interviewed throughout the licensing inspection and confirmed the findings.
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Plan of Correction
By 9/1/13, the Clinical supervisor will develop a system for verifying the identity of the individual seeking treatment prior to admission to the outpatient narcotic detoxification program. This system will include a photograph of the individual, as well as the individual's name and birth date and will be maintained in the client's record. The Clinical Supervisor will ensure that the policy is being followed by reviewing clinical records and providing ongoing clinical supervision with staff. |
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 a review of patient records, the facility failed to complete an initial drug screening urinalysis for each prospective patient and a random urinalysis at least monthly thereafter in four of five patient records.
The findings include:
Twenty client records were reviewed on July 24 - 25, 2013. Five patients were prescribed Suboxone and were required to complete an initial drug screening urinalysis and a monthly random drug screening urinalysis thereafter. The facility failed to completed an initial drug screening urinalysis and a monthly random drug screening urinalysis in patient records # 2, 3, 4 and 10.
Patient # 2 was admitted into treatment on March 19, 2013. Patient # 2 was prescribed 8 mg/2 mg Suboxone daily on March 21, 2013, prior to the completion of an initial drug screening urinalysis. The initial drug screening urinalysis was not completed until March 26, 2013, after the Suboxone was prescribed to patient # 2. Patient record # 2 did not include documentation of a random drug screening urinalysis for the month of April 2013.
Patient # 3 was admitted into treatment on March 20, 2013. Patient # 3 was prescribed 8 mg/2 mg Suboxone daily on April 4, 2013, prior to the completion of an initial drug screening urinalysis. The initial drug screening urinalysis was not completed until April 5, 2013, after the Suboxone was prescribed to patient # 3. Patient record # 3 did not include documentation of a random drug screening urinalysis for the month of June 2013.
Patient # 4 was admitted into treatment on February 5, 2013. Patient # 4 was prescribed 8 mg/2 mg Suboxone, 1/4 film three times per day on February 7, 2013, prior to the completion of an initial drug screening urinalysis. The initial drug screening urinalysis was not completed until March 6, 2013, after the Suboxone was prescribed to patient # 4.
Patient # 10 was admitted into treatment on November 14, 2012. Patient # 10 was prescribed Suboxone on November 15, 2012. Patient # 10 had a drug screening urinalysis on November 14, 2012, March 7 and March 9, 2013. Patient record # 10 did not include documentation of a random drug screening urinalysis for the following months: November 2012, December 2012, January 2013 and February 2013.
The clinical supervisor was interviewed throughout the licensing inspection and did not dispute the findings.
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Plan of Correction
By 9/1/13, the Clinical Supervisor will develop a written policy regarding initial urinalysis drug screening and subsequent monthly drug screening that will be conducted for prospective and active individuals seeking outpatient narcotic detoxification program. As part of the initial intake interview for the narcotic detoxification treatment, an initial "Dip Stick" urinalysis drug screen will be conducted by the treatment staff. The results of the urinalysis will be reviewed by the medical director prior to the initial prescription of a narcotic agent. It shall be the responsibility of the Clinical Supervisor to issue a "memo" notifying FCDAC staff and prescribing physician of the policy regarding urinalysis drug screenings. The Clinical Supervisor will address the "memo" in a staff meeting to ensure staff understanding. Clinical Supervisor will ensure ongoing compliance with this regulation through weekly clinical supervision and review of admissions with Facility Medical Director. |
715.15(b) LICENSURE Medication dosage
(b) The narcotic treatment physician shall determine the proper dosage level for a patient, except as otherwise provided in this section. If the narcotic treatment physician determining the initial dose is not the narcotic treatment physician who conducted the patient examination, the narcotic treatment physician shall consult with the narcotic treatment physician who performed the examination before determining the patient 's initial dose and schedule.
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Observations
Based on a review of patient records, the facility's physician failed to adhere to the dosing protocol listed on the medication by ordering that single dose Suboxone film be halved, quartered and cut into eighths in four of five patient records. The medication packaging identifies this as a single dose medication.
The findings include:
The physician prescribed Suboxone 8 mg/2 mg SL film, 4 mg daily (1/2 film daily) for patient # 2 on May 9, 2013. The physician also prescribed Suboxone 8 mg/2 mg SL film, 1 mg daily (1/8 film daily) on July 5, 2013.
The physician prescribed Suboxone 8 mg/2 mg SL film, 6 mg daily (3/4 film daily) for patient # 3 on May 2, 2013. The physician also prescribed Suboxone 8 mg/2 mg SL film, 4 mg daily (1/2 film daily) on May 30, 2013.
The physician prescribed Suboxone 8 mg/2 mg SL film, 1/4 film three times per day for patient # 4 on February 7, 2013. The physician also prescribed Suboxone 8 mg/2 mg SL film, 4 mg daily (1/2 film daily) on February 21, 2013. The physician prescribed Suboxone 8 mg/2 mg SL film, 2 mg daily (1/4 film daily) for patient # 4 on March 28, 2013.
The physician prescribed Suboxone 8 mg/2 mg SL film, 6 mg daily (3/4 film daily) for patient # 10 on December 6, 2012. The physician also prescribed Suboxone 8 mg/2 mg SL film, 4 mg daily (1/2 film daily) on December 27, 2012. The physician prescribed Suboxone 8 mg/2 mg SL film, 3 mg daily (3/8 film daily) for patient # 10 on January 24, 2013. The physician also prescribed Suboxone 8 mg/2 mg SL film, 2 mg daily (1/4 film daily) on March 7, 2013.
Suboxone film is not formulated to be cut into smaller doses. Prescriptions need to be for the manufactured quantities of 12 mg/3 mg, 8 mg/2 mg, 4 mg/1 mg or 2 mg/.5 mg doses.
The clinical supervisor was interviewed throughout the licensing inspection and confirmed the findings.
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Plan of Correction
The Project Director, Facility Director and Clinical Supervisor have discussed and reviewed with the Fayette County Drug and Alcohol Commission's (FCDAC) Medical Director that the Suboxone film is not formulated to be cut into smaller doses. Therefore, any Suboxone prescriptions that the Fayette County Drug and Alcohol Commission physician issues can only be written following the manufactured quantities of 8mg, 4mg or 2mg. The Clinical Supervisor, or their designee will ensure that the FCDAC physician is adhering to the manufacturer's recommendations by conducting Quality Assurance checks on all written prescriptions during the medication visits prior to the client leaving FCDAC. |
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 a review of patient records, the facility failed to document the involuntary termination of a patient from the narcotic treatment program was in the best interests of the health or safety of the patient and others in one of one patient record.
The findings included:
Twenty patient records were reviewed on July 24 - 25, 2013. One patient record pertained to an involuntary termination. The facility failed to document the involuntary termination of a patient from the narcotic treatment program was in the best interests of the health or safety of the patient and others in patient record # 19.
Patient # 19 was admitted into treatment on November 13, 2012 and involuntarily terminated on February 8, 2013. A termination notice dated February 8, 2013 stated the client was being involuntarily terminated from treatment as the "client was verbally abusive towards staff and others at the agency". A review of the discharge summary and progress note from February 8, 2013 indicated the client had yelled at the counselor and used profanity. The reasons for discharge documented in the record of patient # 19 failed to demonstrate the involuntary termination was in the best interests of the health or safety of the patient and others. The facility failed to restrict the involuntary termination of client # 19 to the reasons permitted by regulation.
The clinical supervisor was interviewed throughout the licensing inspection and did not dispute the findings.
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Plan of Correction
By 9/1/13, the Clinical Supervisor will develop a written policy for individuals attending the narcotic detoxification treatment program regarding involuntary terminations. The policy will include but is not limited to the following reasons for involuntary termination of individuals attending the narcotic detoxification program; committing or threatening to commit acts of physical violence in or around the narcotic detoxification program premises, possession of a controlled substance without a prescription, distributing or selling a controlled substance in or around the narcotic detoxification program premises, being absent from the narcotic treatment program for at least 3 consecutive days without cause, and failure to follow the treatment plan objectives. Upon policy completion, it shall be the responsibility of the Clinical Supervisor to issue a "memo" notifying FCDAC staff and prescribing physician of the changes. The Clinical Supervisor will address the "memo" in a staff meeting to ensure staff understanding. Clinical Supervisor will ensure ongoing compliance with this regulation through ongoing clinical supervision and review of admissions with Facility Medical Director. |
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 a review of patient records, the facility failed to provide an opportunity for a patient terminated involuntarily to receive a detoxification of at least 7 days in one of one patient record.
The findings included:
Twenty patient records were reviewed on July 24 - 25, 2013. One patient record pertained to an involuntary termination The facility failed to provide an opportunity for a patient terminated involuntarily to receive a 7 day detoxification in patient record # 19.
Patient # 19 was admitted into treatment on November 13, 2012 and involuntarily terminated on February 8, 2013. The facility failed to provide patient # 19 an opportunity to receive a detoxification of at least 7 days. Patient # 19 did not commit or threat to commit an act of violence and should have been afforded the opportunity of a 7 day detoxification.
The clinical supervisor was interviewed throughout the licensing inspection and did not dispute the findings.
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Plan of Correction
By 9/1/13, the Clinical Supervisor will develop a written policy for individuals who are involuntarily terminated from the narcotic detoxification treatment program. This policy shall afford the individual the opportunity to receive a rapid detoxification for at least 7 days at FCDAC prior to discharge. Individuals who commit or threaten acts of violence will be exempt from participating and will be discharged involuntarily without a rapid detoxification protocol. Upon policy completion, it shall be the responsibility of the Clinical Supervisor to issue a "memo" notifying FCDAC staff and prescribing physician of the changes. The Clinical Supervisor will address the "memo" in a staff meeting to ensure staff understanding. Clinical Supervisor will ensure ongoing compliance with this regulation through weekly clinical supervision and review of admissions with Facility Medical Director. |
715.28(a)(1-10) LICENSURE Unusual incidents
(a) A narcotic treatment program shall develop and implement policies and procedures to respond to the following unusual incidents:
(1) Physical assault by a patient.
(2) Inappropriate behavior by a patient causing disruption to the narcotic treatment program.
(3) Selling of drugs on the premises.
(4) Complaints of patient abuse (physical, verbal, sexual and emotional).
(5) Death or serious injury due to trauma, suicide, medication error or unusual circumstances.
(6) Significant disruption of services due to disaster such as fire, storm, flood or other occurrence.
(7) Incident with potential for negative community reaction or which the facility director believes may lead to community concern.
(8) Theft, burglary, break-in or similar incident at the facility.
(9) Drug related hospitalization of a patient.
(10) Other unusual incidents the narcotic treatment program believes should be documented.
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Observations
Based on a review of the facility's policy manual, the facility failed to document policies and procedures to respond to unusual incidents.
The findings included:
The facility's policy manual was reviewed on July 23, 2013. The facility failed to document any policies and procedures to respond to unusual incidents.
The clinical supervisor was interviewed throughout the licensing inspection and confirmed the findings.
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Plan of Correction
By 9/1/13, the Clinical Supervisor will develop a written policy to respond to unusual incidents that occur with clients who are involved in FCDAC's narcotic detoxification treatment program. This policy will include, but not be limited to the regulations set forth in 715.28(a)(1-10). Upon policy completion, it shall be the responsibility of the Clinical Supervisor to issue a "memo" notifying FCDAC staff and prescribing physician of the changes. The Clinical Supervisor will address the "memo" in a staff meeting to ensure staff understanding. Clinical Supervisor will ensure ongoing compliance with this regulation through ongoing clinical supervision and review of admissions with Facility Medical Director. |