INITIAL COMMENTS
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This report identifies the findings of an on-site complaint investigation conducted on May 17, 2007 by staff of the Division of Drug and Alcohol Licensure in conjunction with two representatives of the Philadelphia Diversion Unit of the U.S. Department of Justice, Drug Enforcement Administration office. On that date, the project/facility director, two physicians and the office manager were interviewed. At approximately 3:00 PM, a physical plant walk through was conducted. The following deficiencies were identified during this investigation and a plan of correction is due on June 15, 2007.
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Plan of Correction
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705.28 (b) (1) LICENSURE Fire safety.
705.28. Fire safety.
(b) Smoke detectors and fire alarms. The nonresidential facility shall:
(1) Maintain a minimum of one operable automatic smoke detector on each floor, including the basement and attic.
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Observations
The facility failed to install smoke detectors in the basement and in the attic.
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Plan of Correction
There will be a special smoke detector ordered that is not extra sensitive to change in temperature in the attic area. This special detector was installed in the attic on June 9th, 2007 and was interconnected to the overall detection system. A smoke detector will be installed in the basement and will be interconnected to the building detection and alarm system. This task will be accomplished by June 15th, 2007. Both of these tasks are the prime responsibility of the Assistant Director |
709.28(b) LICENSURE Confidentiality
709.28. Confidentiality.
(b) The project shall secure client records within locked storage containers.
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Observations
Client records were stored in open boxes and unlocked file cabinets in an unlocked room in the basement of the facility. The door to the area contained a sign stating not to lock the door.
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Plan of Correction
The Assistant Director will co-ordinate and oversee the transfer of all the archived files to a different room in the basement area. this room is not accessed by unauthorized staff and is used only for storage of records. A more secure lock will be installed on the door to this room to further assure the security of the archived records. This undertaking is the prime responsibility of the Assistant Director and will be completed by June 30th, 2007. |
709.30 LICENSURE Client Rights
709.30. Client rights.
The project director shall develop written policies and procedures on client rights and shall demonstrate efforts toward informing clients of the following:
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Observations
The facility failed to demonstrate that clients were informed of their rights in seven of seven client records reviewed.
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Plan of Correction
The medical director will review New Insights' current client handout on client's rights and make any appropriate revisions by June 27th, 2007. The medical director will review with the clinical staff at the staff meeting on July 11th, 2007 New Insights policy to give the client bill of rights handout to all clients at the time of admission. The clients are to sign in the chart that they have recieved their client bill of rights. The medical director will review all charts within one week of admission to confirm compliance with this policy. |
709.31(b) LICENSURE Uniform Data Collection System
709.31. Uniform Data Collection System.
(b) A data collection and record-keeping system shall be developed that allows for the efficient retrieval of data needed to measure the project's performance in relationship to its stated goals and objectives.
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Observations
The facility failed to present a record keeping system that allowed for the efficient retrieval of data. Facility staff indicated that they could not present a list of all active clients until the following workday. The facility failed to produce a list of the active clients. The facility also was unable to produce a list of the clients for whom buprenorphine had been prescribed.
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Plan of Correction
The Billing Supervisor will design a report in a seperate field within our current billing software program. The field will accommodate an entry of "A" for active (or) "I" for inactive for each client in our system. This will allow for a census report of active (or) inactive clients to be generated upon request. This task will be the prime responsibility of the Billing Supervisor. The target date for completion is July 15th, 2007. |
709.32(c)(1) LICENSURE Medication Control
709.32. Medication control.
(c) The project shall have a written policy regarding all medications used by clients which shall include, but not be limited to:
(1) Administration of medication.
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Observations
The policy states that medications will not be stored, administered or prescribed at this facility. However, contrary to the project's own policy, New Insights' clients were prescribed Suboxone (buprenorphine) by on-site physicians under contract with New Insights. The clients took their prescriptions to a local pharmacy and had them filled. The clients then returned to the facility and took the Suboxone under staff supervision.
Chapter 715. Standards For Approval of Narcotic Treatment Program.
715.1. General provisions
(a) An entity within this Commonwealth which uses agents for maintenance or detoxification of persons shall obtain the approval of the Department to operate a narcotic treatment program. (An agent is defined as, "A Commonwealth approved opioid pharmacotherapy substance." 28 Pa. Code 701.1 Definitions)
This Regulation is not met as evidenced by:
Documentation in seven client records demonstrated that New Insights' contracted physicians had prescribed Suboxone (buprenorphine) at New Insights for detoxification and maintenance as part of the client's treatment regimen since May 23, 2006. On March 22, 2006, New Insights formally requested approval to become a Modified Narcotic Treatment Program using buprenorphine. On May 4, 2006, that request was denied by the Division of Drug and Alcohol Program Licensure due to legal actions by the Department of State and the Department of Public Welfare Office of Medical Assistance Programs against the physicians' licenses. The prescribing of buprenorphine following the Division's denial was done with the full knowledge that the Department of Health, Division of Drug and Alcohol Program Licensure needed to approve the facility as a Modified Narcotic Treatment Program prior to initiating treatment with the agent buprenorphine.
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Plan of Correction
The medical director and executive director has already met with the prescribing physician, Rodney Hough, MD and informed him of the need to immediately terminate the prescribing and suprevised administration of Buprenorphine. The medical director will review with Rodney Hough, MD the state licensing requirements for a facility to have a MNTP license for the prescribing and administration of Buprenorphine on June 18th, 2007 during his next clinical supervision. The medical director will meet with Rodney Hough, MD every two weeks to confirm that no further Buprenorphine prescriptions have been written. Clinical charts will be randomly reviewed by the medical director quarterly to monitor for compliance. |
709.91(b)(1) LICENSURE Intake and admission
709.91. Intake and admission.
(b) Intake procedures shall include documentation of:
(1) Disclosure to the client of criteria for admission, treatment, completion and discharge.
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Observations
The facility failed to demonstrate that clients were informed of the criteria for admission, treatment, completion, and discharge in seven of seven client records reviewed.
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Plan of Correction
The medical director for New Insights will develop a client handout that will explain criteria for admission into drug and alcohol treatment at New Insights, type and level of treatment including group and individual sessions, and criteria for successful completion and discharge from treatment. The medical director will complete this client handout and review it with the executive director by June 27th, 2007. The clinical staff will be oriented to this client handout at the staff meeting of July 11th, 2007. Every client who has completed their initial drug and alcohol evaluation and is being recommended for treatment, will be given this handout by the evaluating clinician. The clinician will review the handout with the client and the client will sign that they have received it. The medical director will review the charts of all new admissions within one week of admission to confirm compliance. |
709.91(b)(2)(i) LICENSURE Intake and admission
709.91. Intake and admission.
(b) Intake procedures shall include documentation of:
(2) Client orientation to the project which shall include, but is not limited to, a familiarization with the following:
(i) Project policies.
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Observations
The facility failed to demonstrate that clients were oriented to the project's policies in seven of seven client records reviewed.
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Plan of Correction
The medical director for New Insights will develop a client handout explaining New Insights rules, and policies for all clients in treatment. This will be completed and reviewed with the executive director by June 27th, 2007. The clinical staff and office staff will be oriented to this client handout at the staff meeting of July 11th, 2007. This will be given to all new clients at the time that they present to the office for their initial evaluation as part of an orientation package. The front office staff will be responsible to give it to the client at the time they check in for their initial appointment. Through regular contact with the office staff at staff meetings, the medical director will monitor the office staff's understanding and compliance with this policy. |
709.91(b)(4) LICENSURE Intake and admission
709.91. Intake and admission.
(b) Intake procedures shall include documentation of:
(4) Consent to treatment.
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Observations
The records of seven clients who received treatment using the agent buprenorphine were reviewed. A separate consent to treatment is required by 28 Pa. Code 715. 12 when an agent (buprenorphine) is used for maintenance or detoxification. A consent to treatment was not signed by clients in four of seven client records reviewed, #1, 4, 5, and 6.
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Plan of Correction
New Insights currently has all its clients receiving drug and alcohol counseling sign a consent to treat form. A consent to treat form that is specific to Buprenorphine has also been developed and is in all blank medical charts. The clinical supervisor has made the physician prescribing Buprenorphine aware of the unsigned consents and aware of 28 Pa. code 715.12. If New Insights pursues and obtains a MNTP license, all future medical charts will be reviewed regularly by the clinical supervisor to assure consents to treat are signed prior to any medical services. |
709.92(b) LICENSURE Treatment and rehabilitation services
709.92. Treatment and rehabilitation services.
(b) Treatment and rehabilitation plans shall be reviewed and updated at least every 60 days.
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Observations
Treatment plan updates were not completed in one of one client record reviewed, #3.
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Plan of Correction
The clinical supervisor has reviewed all the clinical charts. On the one clinical chart that the treatment plan update that was not done in the 60 day time frame, the counselor was made aware of the deficiency. The clinical supervisor will review all the active clinical charts for that counselor to assure treatment plans and treatment plan updates are done in the proper time intervals. The counselor was also made aware of the treatment management form which had previously been developed as an aid for the counselors to track when treatment plans and case consults are due. |
709.93(a) LICENSURE Client records
709.93. Client records.
(a) There shall be a complete client record on an individual which includes information relative to the client's involvement with the project. This shall include, but not be limited to, the following:
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Observations
There was documentation that client #3 was admitted to New Insights for treatment on May 23, 2006. This client was provided medical services that included a prescription for Suboxone on an ongoing and regular basis. A clinical record for this client was not opened until October 16, 2006.
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Plan of Correction
After the date that client #3 began medical services, and then being admitted for counseling service, New Insights changed its policy to avoid medication prescribing prior to being admitted to drug and alcohol counseling. All clients were then to be sene for a drug and alcohol evaluation by a counselor, and admitted into treatment, before bing referred for medical services. By doing it in this order, all clients will have an active clinical chart with all admission papers signed before being referred for medical services. Clients will not be able to self refer to the physician, but must have been seen and referred by the counselor doing the intake. |
709.93(a)(8) LICENSURE Client records
709.93. Client records.
(a) There shall be a complete client record on an individual which includes information relative to the client's involvement with the project. This shall include, but not be limited to, the following:
(8) Case consultation notes.
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Observations
Case consultations were missing in three of three client records reviewed, # 3, 4, and 6.
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Plan of Correction
All the clinical charts were reviewed by the clinical supervisor. The counselor whose charts that were delinquent in the 90 day case consults were already made aware of the deficiencies. The clinical supervisor will review all the active charts for those counselors to assure case consults are being done in the proper 90 day time frames. The counselors were also made aware of the treatment management form which had previously bene developed as an aid for the counselors to track when treatment plans and case consults are due. |
709.17(a)(1) LICENSURE Subchapter B.Licensing Procedures.Refusal/rev
709.17. Refusal or revocation of license.
(a) The Department may revoke or refuse to issue a license for any of the following reasons:
(1) Failure to comply with a directive issued by the Department.
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Observations
On May 4, 2006, a letter was sent to the New Insights, Inc. project/facility director denying the application to use the agent buprenorphine for detoxification or maintenance. Buprenorphine is approved for the treatment of narcotic addiction and is available in two different tablets sold under the trade names of Subutex and Suboxone. New Insights used the Suboxone form of buprenorphine. The facility, with disregard to the written notification from the Department, proceeded to provide Suboxone treatment to clients, thus violating the requirements of this standard and those under Chapter 715, Standards For Approval of Narcotic Treatment Programs.
715.1. (a) General provisions
715.1. General provisions
(a) An entity within this Commonwealth which uses agents for maintenance or detoxification of persons shall obtain the approval of the Department to operate a narcotic treatment program.
This Regulation is not met as evidenced by:
On May 4, 2006, a letter was sent to the New Insights, Inc. project/facility director denying the application to use the agent buprenorphine for detoxification or maintenance. There was documentation in seven client records demonstrating that the facility had been using buprenorphine without Department approval for detoxification and maintenance as part of the treatment regimen since May 23, 2006.
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Plan of Correction
I would like to respond to the initial comment that referenced the use of Buprenorphine without department approval. I did not intentionally violate the Department of Health regulations. The letter from your department stated that you were unable to process our application for approval of a modified narcotic treatment program. I was disappointed because I then became aware that we would not be able to bill insurance for medical services, nor access public funds. However, I thought it would be legitimate if the prescribing physician, who maintains his primary practice address in Carlisle, would be able to provide prescriptions for Suboxone on a self-pay basis by renting space at the New Insights facility in Lemoyne. On May 21, 2007 I notified your office of our agency's cessation of the administration of all medications immediately. In the near future, we plan to resubmit information to request a modified narcotic treatment program license. In the Interim, we arranged the transition of the total of 6 active clients who are currently taking Suboxone. All six current clients taking Suboxone were transferred to another buprenorphine certified physician. Whom currently has only (1) Suboxone client and was more than willing to accommodate the aforementioned clients. I apologize for this oversight, but realize my negligence and ultimate responsibility. I firmly believe in the value of Buprenorphine administration when coupled with quality care. We hope to provide this service in the future within the guidelines set forth by the Division of Drug and Alcohol Program Licensure. |
709.17(a)(2) LICENSURE Subchapter B.Licensing Procedures.Refusal/rev
709.17. Refusal or revocation of license.
(a) The Department may revoke or refuse to issue a license for any of the following reasons:
(2) Violation of, or noncompliance with, this chapter.
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Observations
The facility is licensed to provide services as a drug free outpatient and partial hospitalization program only. The facility is in violation of this chapter by to providing buprenorphine maintenance and detoxification treatment to clients at this facility.
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Plan of Correction
Upon our staff psychiatrist obtaining his certification for buprenorphine administraion, the medical director will resubmit policy's and procdeures for approval of a narcotic treatment program. The goal for this plan is July 15th, 2007. |
709.17(a)(4) LICENSURE Subchapter B.Licensing Procedures.Refusal/rev
709.17. Refusal or revocation of license.
(a) The Department may revoke or refuse to issue a license for any of the following reasons:
(4) Gross incompetence, negligence or misconduct in the operation of the facility.
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Observations
The facility has exhibited gross misconduct by providing services which they are not approved to provide as required per Chapter 715. Standards For Approval of Narcotic Treatment Programs.
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Plan of Correction
On May 21, 2007 I notified your office of our agency's cessation of the administration of all medications immediately. In the near future, we plan to resubmit information to request a modified narcotic treatment program license. In the interim, we arranged the transition of the total of 6 active clients who are currently taking Suboxone. All six current clients taking Suboxone were transferred to another buprenorphine certified physician. |