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 September 26-29, 2011 by staff from the Division of Drug and Alcohol Program Licensure. Based on the findings of the on-site inspection, The Consortium 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.
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Plan of Correction
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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 patient records, the facility failed to obtain an informed and voluntary consent from the patient prior to the disclosure of information in five of seven patient records.
The findings include:
Fifteen patient records were reviewed on September 27-29, 2011. Seven patient records were reviewed for the proper execution of an informed and voluntary consent from the patient prior to the disclosure of information. Five of the seven patient records, # 5, 6, 7, 13 and 14 did not include consents consistent with the regulations for providing information with patient consent.
Patient record # 5 contained five signed blank consents to release information. There was also a signed consent to release information that did not contain documentation of what information was being released and another that did not specify who would be receiving the information to be released.
Patient # 6 had documentation that most of the patient's record was released to Social Security Administration, a government agency that is restricted to 4 PA Code 255.5. There was also a signed consent to the patient's primary care physician (PCP) that did not specify what information was being released. There were two signed consents that failed to include who was going to receive the information.
Patient record # 7 contained a signed consent to release information that did not specify what specific information was going to be released. There were seven consents in this record that did not demonstrate a copy had been offered to the patient as required.
Patient record # 13 included consents to release that did not include what specific information was being released as "other" was checked without the information being identified. There was also a blank consent to release signed by the patient and the witness.
Patient record # 14 contained a signed consent to the patient's primary care physician (PCP) that did not specify what information was being released.
This is a repeat deficiency from the methadone monitoring dated March 31 2011.
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Plan of Correction
Responsible Party(s):
Clinical Staff, including Clinical Supervisors, Intake staff, and Clinical Counseling staff, are responsible for ensuring that patient files maintain confidentiality and contain valid consents to release patient information.
Medical Records staff is responsible for completing all requests for information from the Social Security Administrataion.
Time Frame for Completion:
Clinical Supervisors will be responsible for ensuring that all Clinical staff,Medical Records Staff and intake staff, is trained on the proper and full completion of consents to release information.
This training will take place by November 15, 2011.
All identified deficiencies with consents to release information in records # 5, 6, 7, 13 and 14 will be corrected by November 18, 2011.
Monitoring:
Clinical Supervisors, and Clinical Counseling staff will review client files during monthly supervision to ensure compliance with this standard.
The Facility Director will review requests fulfilled to the Social Security Adminstration prior to information being released to ensure compliance with this standard.
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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.
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Observations
Based on the review of patient records and administrative documentation, the facility failed to ensure the physician signed verbal orders in accordance with Federal and State statutes and regulations.
The findings include:
Fifteen patient records were reviewed September 27-29, 2011. Patient # 15 was admitted August 3, 2011 as a transfer from another narcotic treatment program. The record contained documentation stating "begin MMTP per Dr.xxx". There was no signature of the physician who issued the verbal order, but someone else signed and failed to date the signature.
In addition, there was no documented face to face until August 15, 2011.
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Plan of Correction
Responsible Party(s): The Medical Director, Physicians and Nursing Dept. are responsible for ensuring that all verbal orders are signed and dated by the ordering physician.
Time Frame for Completion: Identifed charts deficient in this area during inspection will be signed by the prescribing physician, but will be dated for the current date of change.
Moving forward,verbal orders will only be requested to be done by the physician that is scheduled to be on site within the next 24 hours, so as to ensure that the prescribing physician will be available to sign the order.
The Medical Director and the on site physician will be trained by the Facility Director to ensure that all verbal orders are signed and dated by the prescribing physician within 24 hours of the approved verbal order by 11/18/11.
Monitoring: The Nursing Supervisor will be responsible for review of all verbal orders to ensure compliance with this standard.
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715.17(c)(5) LICENSURE Medication control
(c) A narcotic treatment program shall develop and implement written policies and procedures regarding the medications used by patients which shall include, at a minimum:
(5) Security of all substances. A narcotic treatment program shall develop and implement written policies and procedures to minimize the likelihood of loss, theft or misuse of an agent or another controlled substance as well as a plan of action if a loss, theft or misuse does occur. In the event of loss, theft or misuse, the Federal and State statutes and regulations regarding reporting shall be followed.
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Observations
Based on observation, the facility failed to ensure the security of the controlled substance, increasing the risk of loss, theft or misuse of the controlled substance.
The findings include:
On September 29, 2011 at about 9:30 AM, a physical plant inspection of the medication area was conducted. This included the dosing area, which contains the safe containing the controlled substance prescribed for dosing.
The door leading from the main hallway in which the patients line up to be dosed was found unlocked. There is a sign posted on the door stating the door is to be kept locked at all times. The director of nursing, when asked about the sign, stated that door is never locked. In addition, the door to the actual medication room was left open, making it vulnerable to anyone walking into that area, putting the controlled substance stored there at risk.
This was discussed with the director of nursing who reported the door was left open due to the oppressive heat and humidity from not having sufficient air flow.
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Plan of Correction
Responsible Party(s): The Facilities Director, Nursing Supervisor, and Facility Director are responsible for ensuring that the dosing area, which contains a controlled substance prescribed for dosing purposes is kept locked and closed at all times.
Time Frame for Completion: The Facilities Department will be contacted by the Facility Director by 11/1/11 to ensure that the heating and air conditioning system is repaired and in working order at all times. The repairs will help to further ensure that the dosing area will be locked and secured as required by state and federal mandates.
During the course of repairs, and at all other times, the door to the dispensing area will be locked.
Fans will be utilized to ensure proper air flow, during times when having the door unlocked, become uncomfortable.
The Facilities Department will be responsible for all repairs to the system by 12/31/11.
Monitoring: The Maintenance Department will complete daily rounds of the dosing area to ensure that the dosing area is kept locked and secured at all times. The Maintenance Dept and the Facility Director will also be repsonsible for ensuring that all repairs are reported immediately to the Facilities Department.
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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 review of patient records, the facility failed to ensure all efforts had been initiated to retain the patient prior to the involuntary termination.
The findings include:
Patient # 3 was admitted December 16, 2010 and involuntarily terminated August 29, 2011 for non-compliance. The patient was discharged because "he didn't show any progress in group". There were no treatment contracts or treatment plan goals addressing patient's attendance. In addition, the documentation by the clinician showed groups were contraindicated for this patient at this time, and individual counseling would have been more suited to the needs of the patient.
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Plan of Correction
Responsible Party(s):
The Facility Director, Clinical Supervisors and assigned Clinical Counseling Staff are are responsible for ensuring that involuntary terminations are only considered for those infractions identified by state regulations.
Timeframe for Completion: The Clinical Supevisors and Clinical Counseling staff will recieve training by 11/30/11 to ensure that all staff are aware on offenses that can be considered for involuntary termination.
The staff will also be trained on clinical interventions that must be utilized, and documented, prior to placing a person in an involuntary termination status.
Training will take place by 11/30/11.
Monitoring:
The Facility Director and Clinical Supervisors will review all requests for involuntary termination to ensure that there are documented interventions that have been utilized and documented prior to terminating a person's treatment services. |
715.21(1)(i-iv) LICENSURE Patient termination
A narcotic treatment program shall develop and implement policies and procedures regarding involuntary terminations. Involuntary terminations shall be initiated only when all other efforts to retain the patient in the program have failed.
(1) A narcotic treatment program may involuntarily terminate a patient from the narcotic treatment program if it deems that the termination would be in the best interests of the health or safety of the patient and others, or the program finds any of the following conditions to exist:
(i) The patient has committed or threatened to commit acts of physical violence in or around the narcotic treatment program premises.
(ii) The patient possessed a controlled substance without a prescription or sold or distributed a controlled substance, in or around the narcotic treatment program premises.
(iii) The patient has been absent from the narcotic treatment program for 3 consecutive days or longer without cause.
(iv) The patient has failed to follow treatment plan objectives.
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Observations
Based on the review of patient records, the facility failed to restrict the reasons for involuntary termination to those reasons allowed by regulation in three of five patient records.
The findings include:
Fifteen patient records were reviewed September 27-29. 2011. Five patient records were reviewed for involuntary, or therapeutic, discharge. Three patient records contained documentation of the patient being discharged for reasons other than those listed by regulation.
Patient # 3 was admitted December 16, 2010 and involuntarily terminated August 29, 2011 for non-compliance. The patient was discharged because "he didn't show any progress in group". There were no treatment contracts or treatment plan goals addressing patient's attendance.
Patient # 8 was admitted July 14, 2010 and involuntarily terminated August 5, 2011 for non-compliance. The documentation stated the patient failed to attend groups and continued to use illicit substances. These areas were not addressed through treatment plan goals or in individual counseling sessions.
Patient # 10 was admitted February 9, 2011 and involuntarily terminated July 24, 2011 for non-compliance. Patient was given a 21 day detoxification for non-attendance. The clinical documentation indicated the patient never stabilized and continued to use opiates. The clinician documented a goal for the patient to "fill out an increase" form, but the patient's dose never went above 45 milligrams despite continuous positive for opiate urine drug screens. The patient record revealed that the patient did miss dosing/ clinic attendance, but only one period of missing three days; the record indicated the patient was reinstated following the three day absence.
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Plan of Correction
Responsible Party(s): The Facility Director, Clinical Supervisors, and Clinical Counseling staff are responsible for ensuring that only those offenses outlined in state regulations are considered for possible involuntary termination.
Timeframe for Completion: The Clinical Supervisors and Clinical Counseling staff will be training on state identified infractions that can be considered for involuntarily terminating a person from treatment.
This training will be conducted by the Facility Director no later than 11/30/11.
Monitoring: The Facility Director and Clinical Supervisors will review all cases for involuntary termination to ensure that the infraction is outlined in the state regulation.
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715.23(a) LICENSURE Patient records
(a) A narcotic treatment program shall maintain patient records in conformance with 42 CFR 2.16 and 2.22 (relating to security for written records; and notice to patients of Federal confidentiality requirements) and State statutes and regulations. A narcotic treatment program shall maintain a complete file on the premises for each present and former patient of the narcotic treatment program for at least 4 years after the patient has completed treatment or treatment has been terminated. Files shall be updated regularly so that the information is current.
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Observations
Based on the review of patient records, the facility failed to ensure the patient records were complete and updated regularly with current information in eleven of fifteen patient records reviewed.
The findings include:
Fifteen patient records were reviewed September 27-29, 2011. Fifteen patient records were required to have complete and current information.
Patient records # 3, 5, 6, 7 and 9 did not have the required case consultations.
Patient records # 9 and 12 did not have current progress notes.
Patient records # 6 and 9 did not have an annual evaluation as required.
Patient record # 4 did not have an aftercare plan as required.
Patient records # 5, 7 and 9 did not have a documented discharge as required.
Patient records # 1, 2, 4 and 5 did not have documented follow up contact attempt as required.
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Plan of Correction
Responsible Party(s):
The Clinical Supervisors, Clinical Counseling Staff and Medical Records Staff are responsible for ensuring that patient records are complete and updated regulary with curent patient information.
Timeframe for Completion:
Clinical Counseling Staff will be trained by the Clinical Supervisors and the Facility Director regarding the timelines for completion of documentation as well as the importance of maintaining a complete and updated patient record. Training will be completed by 11/30/11.
Medical Records staff will training and receive documented supervision regarding the timelines for filing current documentation in the patient record by 11/30/11.
Records:# 3, 5, 6, 7 and 9 will have and updated case consultation completed by 11/18/11.
Records # 9 and 12 will have all current progress notes filed by 11/18/11.
Records # 6 and 9 will have an annual evaluation completed by 11/18/11.
Record # 4 did will have an aftercare plan completed by 11/18/11.
Records # 5, 7 and 9 will have a documented discharge as required by 11/18/11.
Records # 1, 2, 4 and 5 will have documented follow up contact attempts as required by 11/18/11.
Monitoring:
The Facility Director will provide weekly to bi-weekly supervision with the Medical Records Staff to review the status of filing and to ensure that all patient records have complete and current information.
The Clinical Supervisor will provide bi-weekly to monthly supervision with Clinical Counseling Staff to monitor the completion of required documentation and to ensure the smooth transition of the documentation from the Counselor of Record to the Medical Records office.
The Facility Director and the Clinical Supervisors will conduct monthly patient record reviews to ensure that all required documentation is fully completed and filed into the clinical record.
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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, the facility failed to submit documentation of all unusual incidents to the Department as required.
The findings include:
Unusual incident logs were reviewed September 26, 2011.
An incident of aggressive behaviors on the grounds of the facility, on July 7, 2011 resulted in a 911 call to the police. The police did arrive. This was not reported to the Department as an incident with potential for negative community reaction.
On August 17, 2011, a 911 call was placed for a drug-related transport to the emergency room of the local hospital. This report was not forwarded to the Department.
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Plan of Correction
Responsible Party(s):
All program staff who are employed by the agency are responsible for ensuring that all unusual incidents are documented within 24 hours of the incident and submitted to the Clinical Supervisor and/or Facility Director.
The Facility Director and Clinical Supervisors are responsible for ensuring that all unusual incidents that are identified in 715.28(c) (1-5) are documented and filed with the Department within 48 hours of the unusual incident
Timeframe:
The Facility Director will train the Clinical Supervisors by 11/18/11, in regards to the documentation of unusual incident reports and submission of the reports to the Department within 48 hours of the unusual incident.
Monitoring:
The Facility Director will retain copies of all unusual incident reports in the Director's office.
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