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 25, 2010 and August 26, 2010 by staff from the Division of Drug and Alcohol Program Licensure. Based on the findings of the on-site inspection, Pyramid Healthcare York Pharmacotherapy Services, 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
September 22, 2010.
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Plan of Correction
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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 8 patient records and an interview with the Facility Director and Director of Narcotic Treatment Program Services, the narcotic treatment program failed to have a narcotic treatment physician document whether an individual is currently physiologically dependent upon a narcotic drug for at least one year prior to admission in 4 of 8 records.
Findings:
Seventeen patient records were reviewed during the monitoring visit. Eight patient records required documentation of a determination of dependency by the physician. There was no documentation that verified that the narcotic treatment physician made a determination of the patient's physiological dependence upon a narcotic drug in patient records # 5, 11, 15, and 16. The documentation that was presented during the inspection utilized the DSM IV criteria for dependency rather than the documentation of an individualized assessment of current dependency and a one year history of dependence upon a narcotic drug. An interview with the Facility Director and Director of Narcotic Treatment Program Services at 12:00 p.m. on August 26, 2010 confirmed this issue.
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Plan of Correction
The program physicians will discontinue the use of the DSM IV form which did not adequately address all necessary and requested criteria and return to the use of the Determination of Opiate Dependency form which specifically addresses current physiological dependence and identifies one year history.
The completed form will be maintained in the client's medical chart and medical chart audits will occur monthly conducted by the nursing staff.
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715.9(b)(2) LICENSURE Intake
(b) Exceptions to the requirements in subsection (a) are:
(2) Upon readmitting a patient who has been out of a narcotic treatment program for 6 months or less after a voluntary termination, the narcotic treatment program shall update the information in and review the patient 's file to show current opiate narcotic dependency, but need not conduct a physical examination and applicable laboratory tests. Privileges earned during the previous treatment may be reinstated at the discretion of the narcotic treatment physician.
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Observations
Based on the review of patient records, the facility failed to update the patient record to show current opiate dependency in one of one patient records.
The findings include:
Seventeen patient records were reviewed on August 25 and 26, 2010. One patient record was reviewed for readmission. Patient record # 11 was re-admitted and dosed on February 19, 2010 without medical documentation of current dependency. A urine drug screen test was conducted on February 19, 2010, and the results were not available until after the patient was provided their first methadone dose. The drug history had not been updated since August 19, 2009. A psychosocial evaluation was not completed at the time of readmission; the previous evaluation was completed August 19, 2009. An interview with the Facility director confirmed this issue on August 26, 2010.
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Plan of Correction
The noted readmission occurred before new readmission procedures were put into place. The program director will ensure that all readmissions follow the intake policy, which include submission to a urine screen and the completion of an evaluation if absence has been greater than 6 months.
Compliance will be monitored through monthly chart audits completed by the program director and weekly peer audits completed by the counselors.
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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 the review of patient records and an interview with the Facility Director, Director of Narcotic Treatment Program Services and the Nurse, the facility failed to ensure that the narcotic treatment physician shall determine the proper dosage level in for six of six patients.
The findings include:
Seventeen patient records were reviewed on August 25, 2010 and August 26, 2010. Six patient records were reviewed for the physician's documentation in determining the initial dose. Six out of six patient records, specifically, 5, 11, 13, 14, 15 and 16 had standing orders documented for their initial dose.
Patient # 5 received an initial dose of 30 mg. Documented in patient record # 5 was an order by the physician that included a standing order to increase by 5 mg every three days until the patient reached 60 mg. There was no documentation that the narcotic treatment physician continued to assess the patient to determine if an increase in the patient's dose was needed.
Patient # 11 received an initial dose of 30 mg. Documented in patient record # 11 was an order by the physician that included a standing order to increase by 5 mg every three days until the patient reached 60 mg. There was no documentation that the narcotic treatment physician continued to assess the patient to determine if an increase in the patient's dose was needed.
Patient # 13 received an initial dose of 30 mg. Documented in patient record # 13 was an order by the physician that included a standing order to increase by 5 mg every two days until the patient reached 60 mg. There was no documentation that the narcotic treatment physician continued to assess the patient to determine if an increase in the patient's dose was needed.
Patient # 14 received an initial dose of 30 mg. Documented in patient record # 14 was an order by the physician that included a standing order to increase by 5 mg until the patient reached 60 mg. There was no documentation that the narcotic treatment physician continued to assess the patient to determine if an increase in the patient's dose was needed.
Patient # 15 received an initial dose of 30 mg. Documented in patient record # 15 was an order by the physician that included a standing order to increase by 5 mg until the patient reached 60 mg. There was no documentation that the narcotic treatment physician continued to assess the patient to determine if an increase in the patient's dose was needed
Patient # 16 received an initial dose of 30 mg. Documented in patient record # 16 was an order by the physician that included a standing order to increase by 5 mg until the patient reached 60 mg. There was no documentation that the narcotic treatment physician continued to assess the patient to determine if an increase in the patient's dose was needed
An interview with the Facility Director, Director of Narcotic Treatment Program Services and the Nurse took place on August 26, 2010 at approximately 12:15 p.m. and confirmed that the standing orders were documented in the patient records.
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Plan of Correction
The program physicians will determine the appropriate dosage level for the induction of a new client. The client will remain at this dose until completing a dose assessment form and requesting an increase.
Upon receiving request, the program physicians, through assessment, will adjust dosage according to determined need.
Compliance will be monitored by random monthly medical chart audits conducted by the program director
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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 17 patient records on August 25 and 26, 2010, the narcotic treatment program failed to document the narcotic treatment physician's rationale in three of three records reviewed.
The findings include:
The narcotic treatment physician failed to document the rationale for permitting take-home medication in client records # 6, 10, and 12. In patient records # 6, 10, and 12, the facility utilized a document that was signed by staff and included their recommendations. The physician signed the document but did not include comments or a rationale for granting the take-home privileges.
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Plan of Correction
The program physicians will complete the section indicating their reasoning for granting or denying take-homes for all submitted take-home requests.
The change in process was reviewed with the program physicians by the program director.
Compliance will be ensured through monthly chart audits completed by the nursing staff.
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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.
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Observations
Based on a review of patient records and staff interviews, the facility failed to consider the criteria for take-home privileges in two of three records reviewed.
The findings include:
Based on a review of 17 patient records on August 25 and 26, 2010, three records were required to contain documentation that the narcotic treatment physician considered the eight point criteria to determine whether a patient was responsible in handling narcotic drugs. Per regulation, the facility failed to consider the criteria for take-home privileges in patient record # 10.
Patient record # 10 contained documentation that indicated the patient was not in a stable home environment and the patient identified that verbal abuse existed in the home. Additionally, the record indicated that the patient reported a stressful environment with a newborn and having 22 days of school left to attend. Further, a review of the patient's treatment plan indicated that the patient had not completed treatment goals due to personal stressors that included funding issues and a chaotic living situation.
An interview with the patient's therapist and the Facility Director took place on August 25, 2010 and confirmed that this information was not taken into consideration or presented to the medical director for reassessment of take-home privileges.
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Plan of Correction
Case consults on clients will be forwarded to the program physicians for review before granting take-homes, to ensure they have all information needed to verify that the client meets 8 point criteria.
Counselors will document any exceptions or changes on the take home request form.
Review of this information will be conducted at weekly staff meeting.
Compliance will be ensured by the program director through monthly chart audits and weekly peer reviews conducted by counselors.
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715.21 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.
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Observations
Based on the review of patient records and an interview with the facility director, the narcotic treatment program failed to document all efforts to retain the patient in the program prior to initiating an involuntary termination in three of three patient records.
The findings include:
Seventeen patient records were reviewed on August 25-26, 2010. Documentation that an involuntary termination was initiated only when all other efforts to retain the patient in the program had failed was required in three patient records. The facility did not document the efforts made to retain the patient in patient records # 1, 2, and 4. The records indicated in all three cases that the clients were provided the notification of termination on the date of discharge and indicated that the "patient refused to sign" the notification. Documentation in the patient records failed to contain any information that addressed efforts to maintain each patient in treatment. Additionally, an interview with the facility director took place on August 26, 2010 and confirmed there were issues with the patient termination documentation.
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Plan of Correction
Counselors will date the Involuntary Discharge form for the day they meet with the client to discuss involuntary termination.
A corresponding DAP note will be included to discuss outcomes, any steps taken to avoid discharge, and review of the appeal process.
This process will be added to the discharge file checklist and staff will be trained to the new process by the program director.
Compliance will be ensured by the program director through monthly chart audits and weekly peer reviews conducted by counselors.
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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.
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Observations
Based on the review of the grievance file and an interview with the facility director, the facility failed to provide adequate notification that a patient was going to be terminated from the program prior to penalties being initiated in one of one patient records.
The findings include:
The grievance file was reviewed on August 26, 2010. Patient # 17 filed a grievance that he was not properly notified of his termination from the program prior to his methadone taper beginning. The patient reported to the dosing window and was informed that he was going to begin a taper. Client was not notified prior to the penalties being initiated. The grievance documented that the patient concerns were validated. Additionally, an interview with the facility director confirmed that proper notification was not given in this incident.
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Plan of Correction
Appropriate administrative follow-up occurred with the staff person involved to include retraining on involuntary discharge procedures. This training occurred 8.9.10.
Subsequently, all staff were retrained on involuntary discharge procedures on 8.11.10. The training was conducted by the program director.
Compliance will be monitored through chart audits conducted by the program director of all involuntary discharged clients.
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715.23(b)(12) LICENSURE Patient records
(b) Each patient file shall include the following information:
(12) Applicable consent forms.
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Observations
Based on the review of patient records, the consent to release information forms to the funding sources exceeded the limitations imposed at 4 Pa. Code Subsection 255.5(b) and 4 Pa. Code Subsection 255.5(a)(6) in three of twelve client records. Additionally, four of twelve records failed to have a complete consent form and four of twelve failed to have a consent form for the emergency contact.
The findings include:
Seventeen patient records were reviewed on August 25-26, 2010. Twelve records were reviewed for consent to release information forms. Based on the review of client records, the facility failed to ensure that the information disclosed to the funding source did not exceed 4 Pa Code Subsection 255.5 (b) in records # 8, 14, and 15. Additionally, records # 10, 11, 13, and 16 failed to have a complete consent form. Patient records # 10, 12, 14, and 15 failed to have a consent form for the emergency contact.
Patient record # 8 exceeded 255.5 (b) by allowing the patient history and physical to be released to the probation officer and the consent for the insurance company allowed the release of treatment plans.
Patient records # 10, 11, 13 and 16 failed to document what was being released to the insurance company.
In patient records # 14 and 15, the consent exceeded 255.5 (b) by allowing the discharge summary, aftercare plan, treatment plan and medication records to be released to the insurance company.
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Plan of Correction
All staff will participate in a training conducted by the corporate clinical director or designee on completing releases and confidentiality by 10-15-10.
New templates for releases were provided to all staff on 9-1-10.
Releases will be reviewed for accuracy during weekly peer reviews conducted by counselors and monthly chart audits conducted by the program director.
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715.23(b)(23) LICENSURE Patient records
(b) Each patient file shall include the following information:
(23) Discharge summary.
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Observations
Based on review of the facility policy and procedure manual and an interview with the facility director, the policy failed to include the correct timeframe in which a discharge summary should be completed.
The findings include:
The policy and procedure manual was reviewed on August 25-26, 2010. The facility policy on discharge summaries indicated that the discharge summary will be completed within 30 days of discharge. The facility procedure exceeded the licensure guidelines 709.93 (a) (10), as a discharge summary must be completed within one week of the client's discharge from the program. An interview with the facility director on August 26, 2010, confirmed that the policy and procedure manual does indicate that the discharge summary policy states it will be completed within 30 days of discharge.
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Plan of Correction
The program was following the correct timeframe for discharge summaries, however, the policy read incorrectly. The policy was corrected and now states that discharge summaries will be completed within 7 days of discharge. |
715.28(c)(1-5) LICENSURE Unusual incidents
(c) A narcotic treatment program shall file a written Unusual Incident Report with the Department within 48 hours following an unusual incident including the following:
(1) Complaints of patient abuse (physical, verbal, sexual and emotional).
(2) Death or serious injury due to trauma, suicide, medication error or unusual circumstances.
(3) Significant disruption of services due to a disaster such as a fire, storm, flood or other occurrence.
(4) Incidents with potential for negative community reaction or which the facility director believes may lead to community concern.
(5) Drug related hospitalization of a patient.
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Observations
Based on review of administrative documentation provided during the inspection and staff interviews, the facility failed to submit documentation of unusual incidents to the Department as required.
The findings include:
The administrative incident report log was reviewed on August 26, 2010. The facility failed to notify the Department within 48 hours of an unusual incident on three occasions in the past eight months.
On January 6, 2010, there was an incident involving four police cars on the grounds of the facility. A patient was apprehended for questioning. The facility failed to notify the Department of this event.
On April 27, 2010 and May 1, 2010, there was documentation of medication spills in the dosing area that were not reported to the Department.
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Plan of Correction
The program will comply with DOH regulation regarding the submission of unusual incident reports. The program director will maintain copies of fax confirmation sheets for all submitted unusual reports sent to the Department. |