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 August 5- 8, 2008 by staff from the Division of Drug and Alcohol Program Licensure. Based on the findings of the on-site inspection, The Family Center of Thomas Jefferson University (MATER) was found not to be in compliance with the applicable chapters of 28 PA Code which pertain to the facility. Deficiencies were identified during this inspection and plan of correction is due on September 12, 2008.
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Plan of Correction
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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 16 patient records on August 6 through 8, 2008, four were required to have documentation verifying the individuals's identity. The narcotic treatment program failed to verify the individual's identity in one of four patient records.
Findings:
Patient record #8 was missing the individual's identification.
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Plan of Correction
Patient was a transfer from another NTP. However, photo identification was not provided by the transferring clinic.
POC: Intake Clinic Coordinator will review, with the Clinical Supervisor, prior to admission, all transfer documentation to ensure photo identification is included. Transfers will not be accepted without this piece of documentation.
Timeframe for completion: Immediate.
Person(s) responsible: Clinical Supervisor and Intake Clinic Coordinator.
Our primary source of referral is from Thomas Jefferson Hospital. After a 3-day medical stabilizsation period during which the TJUH Social Worker and the Family Center Nurse Coordinator have met the patient, the patients, upon discharge, will present at Family Center for MAT. At a minimum,all patients must present with hospital identification bracelet.
Addendum -
Timeframe for completion: Permanent identification will be obtained within the 30 days maximum allowable time permitted by the DOH. Any impeding obstacles in meeting this requirement, that are beyond the control of the clinic, will be documented in the patient's chart, by the Case Manager, with a concrete plan to achieve compliance.
Person(s) responsible: Clinical Supervisor and Intake Clinic Coordinator.
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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 a review of 16 patient records on August 6 through 8, 2008, one was required, with patient consent, to contact the previous facility for the patient's treatment history. The narcotic treatment program failed to document the attempt to obtain the patient's treatment history in one of one patient records where required.
Findings:
Patient record #4 was missing documentation that the narcotic treatment program attempted to obtain the patient's consent to contact the previous facility for the treatment history.
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Plan of Correction
Administrative Clinic Coordinator will obtain a release of information, based on the patient's reported past treatment experience, to obtain past treatment histories. All possible transfer admissions will be reviewed with the Clinical Supervisor
Person(s) Responsible: Administrative Clinic Coordinator and Clinicl Supervisor
Timeframe: Immediate |
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).
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Observations
Based on a review of the policies and procedures manual and patient records from August 6 through August 8, 2008, the narcotic treatment program failed to secure and maintain the confidentiality of all patient records in accordance with 42 CFR Part 2, Subpart B, Subsections 2.31 and 2.32 and 28 Pa. Code Subsection 709.28(c). Sixteen of 16 patient records were required to have consent to release information forms. The facility failed to provide for the confidentiality of patients directly in 3 of 16 patient records and failed to provide for the privacy of counseling based on observed events during the inspection.
Findings:
The narcotic treatment program's policies and procedures manual indicated that individuals between the ages of 16 through 18 years old were required to have the parent/guardian sign the consent for methadone treatment form, a violation of state law at 71 P. S. Subsection 1690.112.
Observation made on August 7 through 8, 2008 revealed that sensitive conversations between program personnel and patients were taking place in the hallways of the program.
Doors were left open to offices occupied by counselors and patients in private conversation.
One counseling office overlooking the Atrium contains a wall of windows from ceiling to floor. Two-thirds of the windows are covered with blinds. The lower one-third of the windows have no coverage. Individuals in the elevator have direct view of the office and all individuals in the office.
In patient record #8, information was released without a consent to release information form signed by the patient.
In patient record #7, the consent to release information form was missing what information was to be released.
In patient record #12, the consent to release information form was illegible.
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Plan of Correction
Addendum: The Clinical Supervisor is conducting complete chart audits, which includes all clinical, non-clinical documentation, and legibility of chart documents. If any charts are missing documentation, the Clinical Supervisor and the staff responsible will correct the deficit, along with identifying the reasons for the deficit.
The manual has been edited with language that is in compliance with 71 P.S. Subsection 1690.112.
This issue was addressed with the "temp" counselor; (5) white sound machines have been purchased and are currently utilized; screening has been placed on the atrium windows
Supervisory trainings are being held weekly for all staff and the non-compliance chart issues are being addressed at this time.
Person(s) responsible: Clinical Supervisor
Timeframe for completion: Immediate for all consents; immediate for screening of windows; immediate for white sound machines; immediate for confidentiality issues. |
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 16 patient records on August 6 through 8, 2008, two were required to have completed a weekly random urinalysis for pregnant patients per the narcotic treatment program's policies and procedures manual. The narcotic treatment program failed to conduct weekly random urinalysis tests in two of two patient records, #4 and 13.
Findings:
Record #4 revealed the patient to be pregnant and was missing a weekly urinalysis from May 29, 2008 through August 5, 2008. Documentation in the patient's record confirmed that only three urinalysis tests were conducted during that time period.
Record #13 revealed the patient to be pregnant upon admission to the narcotic treatment program on March 18, 2008. A review of urinalysis tests from May 1, 2008 through August 5, 2008 confirmed that only four urinalysis tests were conducted during that time period, or only one per month.
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Plan of Correction
POC: A system will be reinstated that closely monitors all random urine screenings for pregnant patients. This system will be monitored on a weekly basis and discussed during the weekly Patient Status meeting.
Person(s) responsible: Clinical Supervisor and Primary Counselor
Timeframe for completion: Two week |
715.15(a) LICENSURE Medication Dosage
(a) The narcotic treatment physician shall review the dosage levels at least twice a year, with each review occurring at least 2 months apart, to determine a patient 's therapeutic dosage.
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Observations
Based on a review of 16 patient records on August 6 through 8, 2008, nine were required to have documentation that the narcotic treatment physician reviewed the dosage levels at least twice a year, with each review occurring at least 2 months apart. The narcotic treatment program failed to document the physician's dosage review in two of nine patient records, #2 and 11.
Findings:
Patient record #2 revealed that the narcotic treatment physician last conducted a dosage review in September 2007.
Patient record #11 revealed that the narcotic treatment physician last conducted a dosage review in December 2007.
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Plan of Correction
The Clinical Supervisor is conducting complete chart audits. This audit includes reviewing for timeliness of dosage reviews. This review will be included in the auditing grid to ensure compliance. All upcoming dosage level reviews will be submitted and completed by the physician within the timeframe.
Person(s) responsible: Clinical Supervisor, Nurse Manager, Primary Counselor, and Medical Director
Timeframe for completion: Two weeks |
715.16(a)(1) LICENSURE Take-home privileges
(a) A narcotic treatment program shall determine whether a patient may be provided take-home medications.
(1) A narcotic treatment program may give take-home medications only to a patient who the narcotic treatment physician has determined is responsible and able to handle narcotic drugs outside the narcotic treatment program.
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Observations
Based on a review of 16 patient records on August 6 through 8, 2008, four were required to have documentation of the narcotic treatment physician's determination that the patient is responsible and able to handle narcotic drugs outside the narcotic treatment program. The narcotic treatment program failed to document the narcotic treatment physician's determination in four of four records, #1, 2, 11 and 13.
Findings:
Record #1 was missing the required documentation of the narcotic treatment physician's determination.
Record #2 was missing the required documentation of the narcotic treatment physician's determination.
Record #11 was missing the required documentation of the narcotic treatment physician's determination.
Record #13 was missing the required documentation of the narcotic treatment physician's determination.
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Plan of Correction
All charts have been reviewed and any missing documentation has been corrected. All future NTP physicians's determination will be recorderd in the weekly OutPatient Treatment team meeting and become part of the clinical chart.
Person(s) responsible: Medical Direcotr, Primary Counselor, and Clinical Supervisor
Timeframe for completion: Immediate |
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.
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Observations
Based on a review of 16 patient records on August 6 through 8, 2008, four were required to have documentation of the narcotic treatment physician's rationale for permitting take-home medication. The narcotic treatment program failed to document the narcotic treatment physician's rationale in four of four records, #1, 2, 11 and 13.
Findings:
Record #1 was missing the required documentation of the narcotic treatment physician's rationale.
Record #2 was missing the required documentation of the narcotic treatment physician's rationale.
Record #11 was missing the required documentation of the narcotic treatment physician's rationale.
Record #13 was missing the required documentation of the narcotic treatment physician's rationale.
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Plan of Correction
All THB applications, physician's rationale, DOH applications, prescriptions requesting dosing schedules will be reviewed by the Clinical Supervisor to ensure all documentation has been properly completed and is in compliance with regulations. Any missing or incomplete documents will be returned so that missing information is documented. Clinical Supervisor will track returned documents for timely submission.
Person(s) responsible: Medical Direcotr, Clinical Supervisor, and Primary Counslor
Timeframe for completion: Immediate
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715.16(d)(1-3) LICENSURE Take-home privileges
(d) A narcotic treatment program may make exceptions to the requirements in subsection (c) relating to the length of time of satisfactory adherence to narcotic treatment program rules and number of days of take-home medication when, in the reasonable clinical judgment of the narcotic treatment physician, which is documented in the patient record:
(1) A patient has a permanent physical disability.
(2) A patient has a temporary disability.
(3) A patient has an exceptional circumstance such as illness, personal or family crisis, or travel which interferes with the patient 's ability to conform to the applicable mandatory attendance schedules. In all cases, the patient shall demonstrate an ability to responsibly handle narcotic drugs.
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Observations
Based on interviews with staff and the review of 16 patient records on August 6 through 8, 2008, four patient records were required to have documentation of the narcotic treatment physician's reasonable clinical judgement for granting the take homes as an exception. The facility failed to include physician documentation of an exception for the take home bottles in four of four patient records where required.
Findings:
Record #1 was missing physician documentation of an exception for the 27 take home bottles.
Record #2 was missing physician documentation of an exception for the the 13 take home bottles.
Record #11 was missing physician documentation of an exception for the 13 take home bottles.
Record #13 was missing physician documentation of an exception for the 13 take home bottles.
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Plan of Correction
All exceptions have been resubmitted to the DOH and all 13-days schedules were reduced pending DOH approval. Prescription forms will be required to have "DOH approval" attached to ensure compliance. All future 13-day THB requests will be monitored for documentation compliance by the Clinical Supervisor. Any missing documentation will be returned for completion and the submitted to the DOH for approval. Physicians rationale is included on prescription.
Person(s) repsonsible: Primary Counselor, Pharmacy Dispensing Nurse, and Clinical Supervisor
Timeframe for completion: Immediate |
715.16(e) LICENSURE Take-home priveleges
(e) With an exception granted under subsection (d), a narcotic treatment program may not permit a patient to receive more than a 2-week take-home supply of medication.
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Observations
Based on a review of 16 patient records on August 6 through 8, 2008, four were required to receive no more than 13 take home bottles. The facility failed to restrict one patient to 13 take home bottles.
Findings:
Record #1 contained documentation that the patient was receiving 27 take home bottles every two weeks with more than 100 Mgs in each bottle. The patient was on split dosing, though there was no explanation found in the record to state the reason. In addition, the documentation showed the patient to be receiving prescriptions for OxyContin and Percocet for "back pain."
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Plan of Correction
The POC includes the following steps:
1) All 6 or more THB requests must be submitted on the required Criteria Form which clearly states the DOH requirements. No 6 or more THB requests will be approved without the Medical Director's signature. All THB requests are discussed, on a weekly basis, with the multi-dicplinary team.
2) Once the internal document has been approved, the DOH Request form will be completed by the counselor, submitted to the Medical Director for approval, and the faxed to the DOH for approval.
3) No changes in the patient's THB schedule will occur without the approved DOH Request form attached to the revised presciption form which requires an indication (check box) that the approved form is attached.
4) Completed documentation will be filed in the patient's clinical chart and any medical documentation (split dose based on a P &T) will be in the patient's medical chart
5) Weekly supervisor will monitor all THB's and Callbacks
Person(s) responsible: Medical Director, Clinical Supervisor, Counselor, and Dispensing Nurses.
Timeframe for completion: Immediate |
715.16(f) LICENSURE Take-home priveleges
(f) An exception granted under subsection (d) shall continue only for as long as the temporary disability or exceptional circumstance exists. When a patient is permanently disabled, that case shall be reviewed at least annually to determine whether the need for the exception still exists.
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Observations
Based on staff interviews and a review of 16 patient records on August 6 through 8, 2008, four patient records were required to have an exception documented for the take home bottles they received. The facility failed to document an exceptional circumstance and/or temporary or permanent disability before granting the take home schedules for four of four patient records where required.
Findings:
Record #1 was missing documentation of exceptional circumstance, temporary or permanent disability.
Record #2 was missing documentation of exceptional circumstance, temporary or permanent disability.
Record #11 was missing documentation of exceptional circumstance, temporary or permanent disability.
Record #13 was missing documentation of exceptional circumstance, temporary or permanent disability.
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Plan of Correction
THB requests have been resubmitted with exceptional circumstances and/or temporary or permanent disability included.
Again this submission, pendind DOH approval, prescription change, phyisican's rationale will be monitored by the Clinical Supervisor.
Any additional DOH requests will be completed by the Clinical Supervisor.
Person(s) responsible: Clinical Supervisor, Primary Counselor, and Medical Director
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715.20(4) LICENSURE Patient transfers
A narcotic treatment program shall develop written transfer policies and procedures which shall require that the narcotic treatment program transfer a patient to another narcotic treatment program for continued maintenance, detoxification or another treatment activity within 7 days of the request of the patient.
(4) The receiving narcotic treatment program shall document in writing that it notified the transferring narcotic treatment program of the admission of the patient and the date of the initial dose given to the patient by the receiving narcotic treatment program.
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Observations
Based on a review of 16 patient records on August 6 through 8, 2008, two were required to have documentation of notification to the transferring facility of admission to the program.
The facility failed to document notification to the transferring facility of the patient's admission.
Findings:
Record #8 was missing documentation of notification to the transferring facility of the admission and date of first dose.
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Plan of Correction
The Administrative Clinic Coordinator will, if the notification information to the transferring NTP is faxed, will print out a transmittal sheet. If sent through regualr US mail, the envelope will be copied. Notice verification will be filed in patient's clinic chart.
Person(s) responsible: Administrative Clinic Coordinator
Timeframe for completion: Immediate
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715.23(b)(11) LICENSURE Patient records
(b) Each patient file shall include the following information:
(11) Counselor notes regarding patient progress and status.
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Observations
Based on a review of 16 patient records on August 6 through 8, 2008, five were reviewed for progress notes. The facility failed to demonstrate patient progress and status in the notes reviewed in four of five patient records where required.
Findings:
Record # 9 had four consecutive, individual treatment progress notes which contained identical language.
Record #10 had group progress notes on a standardized form which utilized a check list to "assess" the individual in the group setting. The check list was not consistently completed for the group notes reviewed. In addition, the check list contained language which described observations rather than assessments.
Record #12 had missing group notes. The check list was not consistently completed for the group notes reviewed. In addition, the check list contained language which described observations rather than assessments.
Record #13 had missing individual treatment notes for the month of July 2008.
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Plan of Correction
1) The treatment plans for patients exceeds the minimum 2.5 hours required by the State. The goal is 5 - 9 hours weekly, which includes psycho-educational groups facilitated by non-clinical staff.
2) Training has been provded by the Clinical Supervisor to reinforce completing an assessment of the observed behaviors for non-clinical staff
3) The Clinical Supervisor has reviewed, via training with all clinical staff: timeliness of all clinical documents, content, assessments, and plans.
4) The Clinical Supervisor is doing chart reviews, using the clinical grid, in weekly supervision.
Person(s) responsible: Clinical Supervisor, Therapist, and Support Staff.
Timeframe for completion: Immediate
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715.23(b)(15) LICENSURE Patient records
(b) Each patient file shall include the following information:
(15) Psychosocial evaluations of the patient.
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Observations
Based on a review of 16 patient records on August 6 through 8, 2008, four were reviewed for psychosocial evaluations. The facility failed to ensure the evaluations were completed timely and contained clinical impressions of the historical data in three of four patient records where required.
Findings:
The psychosocial evaluation in patient record #4 was a reiteration of the historical data rather than an evaluation of the data collected during the assessment process.
The psychosocial evaluation in patient record record #8 was completed 2 months after the data was collected and three months after the patient was admitted, exceeding the time frame established in facility policy and procedure.
The psychosocial evaluation in patient record #12 was a reiteration of the historical data rather than an evaluation of the data collected during the assessment process.
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Plan of Correction
#4 & #12 -Clinical Supervisor and Program Director will provide training regarding assessments versus data for psychosocials. Clinical Supervisor will review all PSH for evaluative assessments during weekly supervision.
#8 - Highly non-compliant patient. Clinical Supervisor will monitor all late PSH and discuss barriers to completed within the timeframe, as well as progress notes that indicate all efforts, and strategies used, to engage the patient into treatment. New admission patients will be monitored weekly in supervision.
Person(s) responsible: Program Director and Clinical Supervisor: assessment/evaluation training
Timeframe: 30 days
Person(s) responsible: Clinical Supervisor: Weekly supervision to monitor PSH completion, as per policies and procedures.
Timeframe: 30 days
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715.23(d) LICENSURE Patient records
(d) A narcotic treatment program shall prepare a treatment plan that outlines realistic short and long-term treatment goals which are mutually acceptable to the patient and the narcotic treatment program.
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Observations
Based on a review of 16 patient records on August 6 through 8, 2008, three were reviewed for comprehensive treatment plans. The facility failed to ensure the treatment plans were individualized and based on the evaluation in 2 of 3 patient records.
Findings:
Record #8 contained a treatment plan that was general and not related to the needs identified in the evaluation.
Record #12 contained a treatment plan that was general and not related to the needs identified in the evaluation.
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Plan of Correction
Clinical Supervisor will provide formal, and supervisory training, for all clinical staff regarding how to write an individual treatment plan based on previous goals, achieved goals, and new goals. This training will be monitored and reinforced in weekly supervisory sessions and documented.
Person(s) responsible: Clinical Supervisor and Primary Counselor
Timeframe: 30 days
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715.23(d)(1) LICENSURE Patient records
(d) A narcotic treatment program shall prepare a treatment plan that outlines realistic short and long-term treatment goals which are mutually acceptable to the patient and the narcotic treatment program.
(1) The treatment plan shall identify the behavioral tasks a patient shall perform to complete each short-term goal.
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Observations
Based on a review of 16 patient records on August 6 through 8, 2008, three were reviewed for comprehensive treatment plans. The facility failed to include behavioral tasks to complete the identified short term goals in 2 of 3 patient records where required.
Findings:
Record # 8 was missing measurable action steps for the patient to accomplish to meet the short term goals.
Record #12 was missing measurable action steps for the patient to accomplish to meet the short term goals.
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Plan of Correction
the Clinical Supervisor will be conducting treatment plan trainings that address how to identify, and include, short term treatment planning. and measureable action to accomplish same.
Training will be mandatory and documented. All training issues will be reinforced and monitored in weekly supervisory sessions.
Person(s) responsible: Clinical Supervisor
Timeframe for completion: 30 days |
715.23(d)(2) LICENSURE Patient records
(d) A narcotic treatment program shall prepare a treatment plan that outlines realistic short and long-term treatment goals which are mutually acceptable to the patient and the narcotic treatment program.
(2) The narcotic treatment physician or the patient 's counselor shall review, reevaluate, modify and update each patient 's treatment plan as required by Chapters 157, 709 and 711 (relating to drug and alcohol services general provisions; standards for licensure of freestanding treatment activities; and standards for certification of treatment activities which are a part of a health care facility).
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Observations
Based on a review of 16 patient records on August 6 through 8, 2008, seven were reviewed for treatment plan updates. The facility failed to re-evaluate, modify and/or update the treatment plans in five of seven patient records where required.
Findings:
Record #8 contained generalized progress statements that did not reflect the stated goals or the patient's progress. Prior goal resolution was missing.
Record #10 contained generalized progress statements that did not reflect the stated goals.
Record #11 contained updates that were repetitive from update to update without documentation of an explanation. Prior goal resolution was missing.
Record #12 contained documentation that did not specifically address the stated goals.
Record #13 contained generalized progress statements that did not specifically address the identified goals.
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Plan of Correction
The Clinical Supervisor will be conducting mandated and documented trainings on all aspects of treatment planning. All treatment plans will be reviewed by the Clinical Supervisor for signature and content. Additional support will be provided each primary counselor during weekly supervisory sessions.
Person(s) responsible: Clincal Supervisor
Timeframe for completion: one month |
715.29(5) LICENSURE Exceptions
A narcotic treatment program is permitted, at the time of application or any time thereafter, to request an exception from a specific regulation.
(5) If the exception relates to a specific patient, the narcotic treatment program shall maintain documentation of the exception in the patient 's record.
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Observations
Based on a review of 16 patient records on August 6 through 8, 2008, four were required to document quarterly callbacks and reviews of the take home medications. The facility failed to conduct and document quarterly callbacks and reviews for patients with 13 day take home bottles.
Findings:
Record #1 was missing documentation of a quarterly review and did not have a quarterly callback conducted by April 2008 as required.
Record #2 was missing documentation of a quarterly review and did not have a quarterly callback by July 2008 as required.
Record #11 was missing documentation of a quarterly review and did not have a call back documented since October 2007.
Record #13 was missing documentation of a quarterly review and had not had a call back documented in the record since January 2008.
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Plan of Correction
1) The Clinical Supervisor has implemented a monitoring grid which will include THB's and quarterly call backs, when indicated.
2) Chart audits will be done during weekly supervisory sessions by the Clinical Supervisor.
3) This grid will address all scheduled call backs and eliminate missed callbacks.
4) Callback schedule will be monitored by the Clinical Supervisor.
5) Also, quarterly call backs will continue to be addressed, monitored, and documented in weekly Patient Status meeting. The Medical Director is present at these meetings.
Person(s) responsible: Clinical Supervisor and Primary Counselor
Timeframe for completion: Immediate
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