INITIAL COMMENTS
|
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 March 9-11, 2010 by staff from the Division of Drug and Alcohol Program Licensure. Based on the findings of the on-site inspection, Habit Opco, Inc. - Allentown 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 and a plan of correction is due on April 8, 2010.
|
Plan of Correction
|
715.11 LICENSURE Confidentiality of patient records
A narcotic treatment program shall physically secure and maintain the confidentiality of all patient records in accordance with 42 CFR 2.22 (relating to notice to patients of Federal confidentiality requirements) and § 709.28 (relating to confidentiality).
|
Observations
Based on observations of client and counselor interactions in common areas and review of patient records, the facility failed to maintain patient confidentiality in accordance with state and federal regulations.
The findings include:
Observation of the flow of patients waiting to be dosed was conducted on March 10, 2010. While sitting in the waiting room at about 10:30 AM, it was noted that several staff were having patient related conversations with the patients in the waiting room. On March 11, 2010, while going to the water dispensing machine at about 11:25 AM, this writer observed several interactions with staff and patients in common areas of the building. One patient was confronted by the counselor for not showing up to group and everyone in the waiting room was able to hear this confrontation, including another visitor. At the reception desk, within the hearing range of others, another patient was being asked to sign a notice of intent to terminate his treatment.
Twelve patient records were reviewed March 9-10, 2010. Three patient records were reviewed for consents to release information content. Two patient records contained consents to release information that exceeded the limitations imposed at 4 PA Code 255.5(b).
Patient record # 1 contained a consent to release STD/TB results, but failed to state who would be the recipient of the information or why. There was no witness signature.
Patient record # 12 contained consents to release information to Office of Vocation Rehabilitation (OVR) and the probation officer, allowing the release of urine drug screen results which exceeds the limitations imposed at 4 Pa. Code Subsection 255.5(b).
|
Plan of Correction
The Program Director and Clinical Director reviewed the Habit OPCO policies, state and federal regulations pertaining to confidentiality at the counselor's weekly group supervision. In addition a special staff meeting was held on March 22,2010 for all staff, specifically to discuss the confidentiality issues in the waiting room and the correct procedure for completing consent forms.
The Program Director and Clinical Director will review and monitor compliance on a weekly basis for one month, and then monthly for six months, a total of seven months. An in-service training that addresses proper completion of consents to release information will be scheduled within four months.
The Clinical Director will conduct random chart reviews and submit a written report every three months, on an ongoing basis, which will address the completion of consents to release information within the limits of state regulations. |
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.
|
Observations
Based on a review of administrative documentation and patient records, the facility failed to complete urine drug screens according to regulation and program policy in four of twelve patient records.
The findings include:
Policy and procedure for urine drug screens was reviewed on March 9, 2010. The policy for collecting urine drug screens state that each patient will be required to submit two random urine specimens a month for the first three months of their treatment. Twelve patient records were reviewed March 9-10, 2010. Patients # 2, 6, 8 and 12 did not have two urine drug screens (UDS) per month for the first three months of their treatment.
.
Patient # 1 did not have a urine drug screen completed in July 2009.
Patient # 2 did not have a urine drug screen completed in April and June 2009.
Patient # 3 did not have a urine drug screen completed in June 2009.
Patient # 11 did not have a urine drug screen completed in August 2009.
|
Plan of Correction
The Program Director and the Nurse Manager consulted with the Information Technology staff of Habit OPCO, as well as the software developer to address the deficiency. The Information Technology staff has provided instruction to the Nurse Manager and the Program Director for the proper scheduling of urine drug screens per Habit OPCO policy and state regulation. The Nurse Manager will meet with staff nurses individually to review the necessary changes to procedure.
The Nurse Manager will review and monitor compliance on a weekly basis for one month, and then monthly for six months, for a total of seven months.
The Program Director and Nurse Manager will meet quarterly to review the scheduling of urine drug screens to ensure compliance has been attained. |
715.16(a)(3) LICENSURE Take-home privileges
(a) A narcotic treatment program shall determine whether a patient may be provided take-home medications.
(3) The narcotic treatment physician shall document in the patient record the rationale for permitting take-home medication.
|
Observations
Based on the review of patient record documentation, the facility failed to ensure that the physician documented in the patient record the rationale for granting take home medication in two of three patient records and a change in the take home status of the third patient was not matched by the physician's rationale for that change.
The findings include:
Twelve patient records were reviewed March 9-10, 2010. Three records were required to include documentation of takehome privileges and were reviewed for take home medication documentation.
Patient records # 5 and 8 did not include documentation of the physician's rationale for granting the take home medication.
Patient # 10 was admitted 11-17-2008 with 5 take home bottle privileges. The patient was granted a 6th bottle, but there was no corresponding documentation of the physician's rationale for the change in status.
|
Plan of Correction
The Program Director reviewed the deficiencies with the Medical Director on March 12, 2010 and provided him with copies of the relevant state regulations. The standard form for requesting take-home medication has been revised to allow space for the rationale for recommending take homes. Files will be reviewed by the Program Director on a weekly basis for one month, and then on a monthly basis for three months, for a total of four months.
The Clinical Director will review the forms as part of random chart reviews every quarter to ensure proper documentation. The Clinical Director will submit a written report each quarter pertaining to the proper documentation of the rationale for take homes. |
715.16(b)(1-8) LICENSURE Take-home privileges
(b) The narcotic treatment physician shall consider the following in determining whether, in exercising reasonable clinical judgment, a patient is responsible in handling narcotic drugs:
(1) Absence of recent abuse of drugs (narcotic or non-narcotic), including alcohol.
(2) Regular narcotic treatment program attendance.
(3) Absence of serious behavioral problems at the narcotic treatment program.
(4) Absence of known recent criminal activity.
(5) Stability of the patient 's home environment and social relationships.
(6) Length of time in comprehensive maintenance treatment.
(7) Assurance that take-home medication can be safely stored within the patient 's home.
(8) Whether the rehabilitative benefit to the patient derived from decreasing the frequency of attendance outweighs the potential risks of drug diversion.
|
Observations
Based on the review of patient records, the facility failed to address the criteria for granting take home medication in the physician's written rationale in three of three patient records.
The findings include:
Twelve patient records were reviewed March 9-10, 2010. Three patient records were reviewed for documentation granting take home privileges.
Patient record # 5 contained clinical documentation of instability of the patient's environment due to other's using drugs and alcohol. There was also documentation of an abusive relationship with another clinic patient. There was no documentation of what rehabilitative benefit would be derived from decreasing the frequency of attendance and how that would outweigh the potential risks of drug diversion.
Patient record # 8 had no documentation of how the rehabilitative benefit derived from decreasing the frequency of attendance would outweigh the potential risks of drug diversion.
Patient record # 10 had no documentation of how the rehabilitative benefit derived from decreasing the frequency of attendance would outweigh the potential risks of drug diversion.
|
Plan of Correction
The Program Director reviewed the deficiencies with the Medical Director on March 12, 2010 and provided him with copies of the relevant state regulations. The standard form for requesting take-home medication has been revised to allow space for the rationale for recommending take homes. Files will be reviewed by the Program Director on a weekly basis for one month, and then on a monthly basis for three months, for a total of four months. The Clinical Director will review the forms as part of random chart reviews every quarter to ensure proper documentation. The Clinical Director will submit a written report each quarter pertaining to the proper documentation of the rationale for take homes.
In addition the Program Director and Clinical Director met with the clinical staff on March 22, 2010 to discuss the need for clinicians to clearly and directly communicate to the Medical Director any information regarding the patient's appropriateness for take home medication based on the eight state and federal criteria. The clinical staff was instructed to provide any and all relevant information on the Take Home Application form.
|
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.
|
Observations
Based on the review of patient records and discussion with staff, the facility failed to ensure the physician signed verbal orders according to regulations in two of two patient records reviewed.
The findings include:
Twelve patient records were reviewed March 9-10, 2010. Two patient records contained documentation of a physician's verbal orders.
Patient record # 6 contained a documented verbal order for take home privileges on 2-9-10 and had a physician signature dated 2-12-10. There was another verbal order dated 2-17-10, signed 2-19, 10 and a verbal order 2-19-10 and signed 2-21-10.
Patient record # 8 contained a verbal order written by the narcotic treatment physician on 10-8-09 and signed by the medical director on 10-12-2009.
Patient record # 11 contained a documented verbal order on 9-4-2009 that was signed on 9-9-09. Another verbal order was documented on 9-14-09 and signed 9-17-09, more than 24 hours as required by regulation.
|
Plan of Correction
The Program Director consulted with the Information Technology staff of Habit OPCO regarding the deficiency and the procedure for obtaining physician's signature within 24 hours of a verbal order. The Information Technology staff provided the physician with access to software to be installed on the physician's home computer that will allow him to submit a digital signature when issuing a verbal order. If any problems arise with the use of the home computer, the physician understands that he will need to come into the facility to hand-sign verbal orders within 24 hours.
The Nurse Manager will review and monitor compliance on a bi-weekly basis for two months, and then on a montthly basis for four months, for a total of six months. Any issues of lateness will be reported to the Program Director immediately, and the Program Director will address these with the physician within 48 hours. |
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.
|
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:
Twelve patient records were reviewed March 9-10, 2010. Two records were reviewed for involuntary termination documentation. The patient handbook was reviewed March 9, 2010.
Patient # 2 was involuntarily terminated for attendance reasons. The program policy is to terminate for 5 consecutive days absence. While this patient had absences from treatment, they were not more than 2 days consecutive.
|
Plan of Correction
The Program Director, the Clinical Director and the Nurse Manager met to discuss the procedures for involuntary termination. The existing policies on involuntary termination were reviewed. The Program Director, the Clinical Director and the Nurse Manager will review the policies on termination from treatment, including involuntary termination, at the monthly staff meeting that occurs on the first Wednesday of the month.
The Clinical Director will review and monitor compliance on a biweekly basis for two months, and then quarterly as part of random chart reviews. The Clinical Director will submit a written report of the results on a quarterly basis. This quarterly report will be completed on an ongoing basis. |
715.22(c) LICENSURE Patient grievance procedures
(c) Penalties may not be initiated prior to final resolution with the exception that penalties may be initiated against patients who have committed acts of physical violence or who have threatened to commit acts of physical violence in or around the narcotic treatment program premises.
|
Observations
Based on a review of patient records, the facility failed to withhold the start of an involuntary detoxification in one of two patient records.
The findings include:
Twelve patient records were reviewed March 9-10, 2010. Two patient records included documentation showing the facility was required to wait until the final resolution of an appeal of the termination notice before initiating penalties against the patient.
Patient # 1 was given a written notice of involuntary termination on 1-21-10 and the detoxification order was placed on 1-21-10. The detoxification was started on 1-22-10 before the 2 day opportunity to appeal was expired.
|
Plan of Correction
The Program Director reviewed the Habit OPCO and state regulations with the Nurse Manager on March 12, 2010. The Nurse Manager has met with all dispensing staff individually to clarify the procedures for initiating a detoxification and involuntary termination. The Program Director will review the procedures at the monthly staff meeting on the first Wednesday of the month. If the Medical Director is unable to attend the scheduled staff meeting, the Program Director will meet with him separately on that date and review the deficiency and the appropriate state policy as well as facility procedures. This will specifically address the need to wait for the appeal process to be completed prior to initiating a detox order. The Program Director will track all involuntary detoxifications for the next six months to ensure compliance with regulations.
The Clinical Director will also review and monitor compliance on a monthly basis for three months, and then quarterly for one year. The results of the review will be included in the quarterly report on chart reviews. The Nurse Manager will also monitor compliance on a monthly basis for three months. The Program Director will maintain records of each patient's involuntary detoxification on an ongoing basis to ensure compliance. |
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.
|
Observations
Based on the review of patient records, the narcotic treatment program failed to document the results of annual re-evaluations by the narcotic treatment physician in two of two patient records.
The findings include:
Twelve patient records were reviewed on March 9-10, 2010. Annual re-evaluations by the narcotic treatment physician were required in two patient records. The narcotic treatment program failed to document the results of the annual re-evaluation by the narcotic treatment physician in patient records # 9 and 10.
|
Plan of Correction
The Program Directo reviewed the Habit OPCO policies and state regulations regarding annual re-evaluations with the Medical Director on March 12, 2010, and provided him with copies of the relevant state regulations.
The Program Director will monitor and review the results of the annual re-evaluations on a monthly basis for three months, and then quarterly thereafter for one year. The Clinical Director will also review the physician's documentation of the annual re-evaluation as part of the random chart review process, and will bring any deficiencies to the attention of the Program Director immediately should they occur. |
715.23(b)(23) LICENSURE Patient records
(b) Each patient file shall include the following information:
(23) Discharge summary.
|
Observations
Based on a review of patient records, the facility failed to document all of the required information on the discharge summaries or to complete the discharge summaries within seven days in four of four patient records.
The findings include:
Twelve patient records were reviewed March 9-10, 2010. Four patient records were required to include documentation of discharge summaries.
Patient records # 1, 2, 3 and 4 did not include documentation on the discharge summaries of all services offered to the patients during the course of their treatment. The discharge summaries did not include documentation of the patients' status at the time of discharge.
|
Plan of Correction
The Clinical Director reviewed the deficiencies with the clinical staff at the weekly group supervision meeting. The Discharge Summary form has been revised to include a listing of all the services offered to the patients of Habit OPCO, and the counselors will indicate which of these services have been utilized by the patient upon completing the form. The form was also revised to include a space for documentation of the patients' status at the time of discharge. The counselors have been instructed on the proper use of the revised form.
The Clinical Director, Program Director and Medical Director will monitor and review the forms as they are submitted for signature at the time of discharge. The Clinical Director will note any further issues with proper completion of the form and will report this to the management team at the weekly meeting for three months. |