INITIAL COMMENTS
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This report is a result of an on-site complaint investigation conducted on July 22, 2008 by staff from the Division of Drug and Alcohol Program Licensure. Based on the findings of the on-site complaint investigation, Parkside Recovery was found not to be in compliance with the applicable chapters of 28 PA Code which pertain to the facility. The following deficiencies were identified during this investigation and a plan of correction is due on September 5, 2008.
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Plan of Correction
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715.7(b) LICENSURE Dispensing or Administering Staffing
(b) Dispensing time shall be prorated for patient census. There shall be sufficient dispensing staff to ensure that all patients are medicated within 15 minutes of arrival at the dispensing area.
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Observations
Based on observation and discussion with a clinical supervisor on July 22, 2008, the narcotic treatment program failed to prorate the dispensing time for patient census.
Findings:
At approximately 12:20 PM, it was observed by the Licensing Specialists that the waiting room dispensing area was full of patients. The clinical supervisor escorting the Licensing Specialists was unable to determine which patients were waiting to be dosed as some patients were "just hanging out." The clinical supervisor confirmed the dispensing area closes at 12:30 PM for nursing changes and maintenance.
At approximately 12:45 PM, the Licensing Specialists, along with the Nurse Manager, went into the dispensing area to speak with another nurse. At this time, the dispensing area was still open and several patients in the waiting room were still waiting to receive their methadone dose. These patients were not medicated within 15 minutes of their arrival at the dispensing area.
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Plan of Correction
To ensure our continued compliance with regulation 715.7 (b) Parkside Recovery will take the following steps:
- The nurse manager will schedule sufficient nurses on a daily basis to ensure that there will be sufficient dispensing staff to ensure that all patients are medicated within 15 minutes of arrival the dispensing area.
- All nurses will be instructed to utilize and monitor the security camera that observes the medication line to ensure clients are medicated within 15 minutes
- Security will be instructed to monitor the progress of the dispensing line and report to management immediately any deficiency. Management will contact nurse manager to immediately correct the problem.
- The program Director will collect random security tapes of the dispensing area during peak medication hours and audit them for compliance. Any non-compliance will be immediately addressed with a plan of correction. A log will be maintained of all security tapes that are audited.
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715.14(d) LICENSURE Urine testing
(d) A narcotic treatment program shall ensure that a laboratory that performs the testing required under this section shall be in compliance with applicable Federal requirements, specifically the Clinical Laboratory Improvement Amendments of 1998 (42 U.S.C.A. §§ 201 note, 263 and 263a notes), and State requirements, specifically the Pennsylvania Clinical Laboratory Act (35 P.S. §§ 2151-2165) and Chapter 5 (relating to clinical laboratories).
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Observations
Based on interviews with nursing staff and the facility director on July 22, 2008, the narcotic treatment program failed to ensure that a laboratory that performs testing required under this section shall be in compliance with applicable Federal requirements, specifically the Clinical Laboratory Improvement Amendments (CLIA) of 1998 and State requirements, specifically the Pennsylvania Clinical Laboratory Act and Chapter 5.
Findings:
The nursing staff and facility director confirmed that oral fluid tests returned to the contracted laboratory for re-testing are sent to Forensic Fluids in Kalamazoo, Michigan. No documentation was presented demonstrating this laboratory is in compliance with Federal, State and Chapter 5 requirements.
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Plan of Correction
Parkside Recovery will collect all CLIA waived certifications yearly from Parkway Clinical Laboratory and all other outside laboratories used by Parkway Clinical laboratory.
The following steps will be taken to ensure this deficiency does not recur.
- Prior to any inspection all certifications will be re-confirmed by the Program Director.
- Parkway Clinical will fax or e-mail CLIA certification once they receive their annual renewal certificate.
- To be included in a new agreement, Parkway Clinical Laboratory will be required to monitor the CLIA certifications of Laboratories they use on an ongoing basis and inform Parkside Recovery of any changes and/or renewals of certificates.
- All CLIA certificates will be kept on file at Parkside Recovery.
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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 12 patient records on July 22, 2008, one of twelve records was required to have documentation of the narcotic treatment physician's determination whether, in exercising reasonable clinical judgment, the patient would be responsible in handling narcotic drugs.
Findings:
Patient record #135 revealed the patient had a complete annual history and physical examination on October 1, 2007. The documents had been completed by the narcotic treatment physician. It was noted, by the physician, that the patient was alcohol dependent. Additional documents in the patient records revealed the patient had poor support systems, was unemployed and had multiple environmental stressors. A progress note dated October 3, 2007 indicated that during the individual therapy session, the patient stated that "...she has been getting seizures, which she says is from alcohol withdraw and since no longer drinking has seen a decrease in number of seizures." The documented plan for the patient was "...to abstain from drinking alcohol because of recent seizures and begin to attend AA/NA again so that she can have the necessary support needed in her recovery. Based on the documentation in the patient record, the patient was not abstinent from recent abuse of drugs, specifically alcohol. The patient did not have a stable home environment and social relationships. There was no documentation to support whether the rehabilitative benefit to the patient derived from decreasing the frequency of attendance outweighs the potential risks of drug diversion. A document titled "Take Home/Reduced Schedule Case Conference" dated July 2, 2007, indicated the patient met all the required criteria for take-homes. The documentation indicated permanent take-homes for Saturdays and Sundays. The patient was receiving two consecutive take home doses up to her death on or about November 2, 2007 per dosing records reviewed in the record. It was not clear that the physician considered the 8 point criteria above when approving the take-home privileges.
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Plan of Correction
To ensure the 8 criteria are used to determine whether a client is responsible in handling narcotic drugs, Parkside Recovery has taken the following steps:
- The take home form has been modified to include detailed information under each of the 8 criteria
- The counselor will assess whether the client meets the 8 criteria and document this on the take home form. The supervisor will review and approve for completion.
- The patient will then will be seen in a face to face visit with the physician, at which time the 8 criteria will be reviewed by the physician before final approval is given.
- At the 180 day medication review the physician will again review the 8 criteria with clients who have take homes. The 180 day medication review and the annual review forms have been modified to include the 8 criteria for the physician's review.
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715.18(a)(4) LICENSURE Rehabilitative services
a) A narcotic treatment program shall provide, either onsite or through referral agreements, a full range of rehabilitative services. Rehabilitative services shall include:
(4) Behavioral health services
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Observations
Based on a review of 12 patient records on July 22, 2008, the narcotic treatment program failed to provide, either onsite or through referral agreements, behavioral health services in four of the patient records where such services were required.
Findings:
Patient record #7432 revealed the patient died of an apparent drug overdose. Documentation indicated the patient was "to go to Parkside for emergency start of methadone monitoring treatment." The patient was referred from an inpatient facility where he had been admitted due to suicidal ideations. The record contained no documentation indicating that the patient received ongoing behavioral health services relative to the suicidal ideation either onsite or through a referral agreement.
Patient record #6316 revealed the patient had a history of mental health issues. Progress notes indicated the patient was struggling with his alcoholism and was increasingly depressed. On April 23, 2008, the patient expressed suicidal ideations in group therapy. According to documentation provided, the police were called due to the patient's violence, they were informed by facility staff that the patient was suicidal. It was reported that the police initiated involuntary commitment proceeding against the patient. Urine drug screen and breathalyzer results confirmed the patient had an ongoing history of alcohol and benzodiazapine use. The record contained no documentation indicating that the patient was receiving ongoing behavioral health services relative to the alcoholism and depression either onsite or through a referral agreement.
Patient record #7150 revealed that a mental health intake screening was completed on January 11, 2008. The screen indicated that the patient's ups and downs were considered normal. The patient denied any history of previous psychiatric treatment. The patient was transferred to a new counselor four months after admission for methadone treatment. Documentation revealed the counselor requested a psychiatric referral as the patient reported issues with depression. The appointment was scheduled for June 9, 2008 at 2:00 PM. No psychiatric report was documented in the patient's record. On May 1, 2008, the therapist requested the patient be transferred to a new counselor. This was granted on May 6, 2008. The therapist reasoned that the patient had "...frequent outbursts in group which required intervention by security." On June 18, 2008, the patient attended an individual therapy session. The therapist wrote that " he complained mostly at first, claiming he can't focus, but eventually did the task (not that well), but with help got enough done to meet his treatment needs for today... He was rushed, anxious, restless, careless and was reminded that he needs to put his issues 'on a shelf ' so that he can work on treatment goals in his sessions." Three days later on June 21, 2008, the patient was reported dead due to an apparent drug overdose. The record contained no documentation indicating that the patient had been receiving ongoing behavioral health services either onsite or through a referral agreement.
Patient record #5339 revealed that during the intake interview, the patient acknowledged previous psychiatric treatment. The patient was diagnosed with Borderline Personality Disorder, Depression and Anxiety. Documentation indicated the patient was prescribed Klonopin, Seroquel, Remeron and Trazodone. The patient admitted, during the history and assessment session, having a history of suicidal ideations, self-mutilating ideations and destructive behaviors that resulted in four previous attempts of suicide. Documentation revealed that the patient was admitted to Albert Einstein Healthcare Network for a suicide attempt on August 7, 2007 and discharged on August 14, 2007. The patient's diagnosis was Bipolar Disorder and Opioid Dependence. A physician note dated September 7, 2007 indicated the patient was seen for follow-up post reinstatement for OD/suicide attempt. Documentation revealed the patient had been at the program for four years and had made little progress. The physician stated that the patient was advised that if some progress was not made with treatment goals and abstinence from illicit drug use, that patient could be placed on a behavioral contract and possibly discharged from the program. Documentation dated September 12, 2007, indicated the patient was admitted to Frankford Hospital due to suicide ideations/attempt. The patient was released from the hospital on September 20, 2008. A document labeled " Parkside Recovery Philadelphia- Client Deaths: July 2007- July 2008 revealed that "...client was scheduled to meet with the treatment team to attempt to transfer the client to a higher level of care. Client committed suicide on the day before his appointment." No other documentation was found in the patient's record to suggest that this appointment was scheduled.
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Plan of Correction
The deficiency report states that Parkside Recovery failed to utilize necessary referrals for clients where services were required. To improve client referrals for in house services or the utilization of outside referrals, Parkside Recovery will re- train clinical staff on the referral process and its importance to quality client care. This training will take place on September 15, 2008. Parkside Recovery will utilize the charts cited in this deficiency as a tool for this training. The Program Director will be responsible for seeing that this training occurs. Clinical Supervisors will be responsible for reviewing records and making sure the proper referral occur as needed. |
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 a review of incident reports and 12 patient records on July 22, 2008, the facility failed to file a written Unusual Incident Report with the Department within 48 hours following an unusual incident.
Findings:
In 11 of 12 patient records reviewed, specifically #128, 6745, 5339, 135, 6113, 124, 7364, 7432, 6316, 7150 and 5619, where incidents had occurred and a report was required, no Unusual Incident Reports were filed with the Division.
An interview with the Chairperson for the Morbidity and Mortality Subcommittee of the facility, who is responsible for investigating and reporting on unusual incidents, revealed that the narcotic treatment program did not file Unusual Incident Reports with the Division for 11 of the 12 patients mentioned above.
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Plan of Correction
In order to ensure compliance with Regulation 715.28, Parkside Recovery will implement the following incident management protocol:
- Program Managers and staff will be trained on responsibility for reporting and responding to incidents including implementation of corrective actions (10-17- 08)
- All incident reports will be submitted to the Program Director and Clinical Supervisor within 24 hours of the incident.
- The Program Director will have the responsibility for all external reporting including reporting to the DOH and will report all unusual incidents within 48 hours.
- The Program Director will forward copies of external reports to the Incident Manager
- Compliance with external reporting will be monitored by Incident Manager, who will receive all internal reports from program staff.
- The Incident Manager will maintain a log of all incidents and review weekly with the Program Director to ensure all external reporting requirements are met.
- The Incident Manager will facilitate incident review at the monthly CQI meeting in order to ensure the effectiveness of incident management system and develop system improvements if needed.
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709.15(b) LICENSURE Subchapter B.Licensing Procedures.Right to en
709.15. Right to enter and inspect.
(b) The authorized Department representative shall have full and free access to the records of the facility and its clients.
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Observations
Based on an interview with administrative personnel, the facility failed to provide copies of requested sections in specific patient records to the Licensing Specialists during the complaint investigation on July 22, 2008.
Findings:
The Licensing Specialists identified a specific and limited amount of patient-related information to be copied and taken back to the Division for further review and were prepared to sign a confidentiality agreement in order to obtain the information. Facility administrators refused to allow for the copying and removal of those records, denying full and free access at that time.
The Division mailed an Intent to Issue an Order to Show Cause why the license should not be revoked on July 25, 2008 for failure to provide for full and free access to the client records. On August 1, 2008, the patient records of 12 patients were hand delivered to the Division by an employee of the facility.
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Plan of Correction
Parkside Recovery has implemented the following protocol to comply with 709.15 (b)
- Full and free access to the records will be given to the Department of Health Representative. If records need to be copied it will be given to the Department of Health Representative with the signed consent according to 42 CFR, subpart D, subpart 2.53.
- The DOH authorization form will be kept on file at Parkside Recovery to be used when copies of clinical records are requested by the Department of Health Representative.
When copies of records are removed from Parkside Recovery, a medical record
Clerk will inform Health Information Mgmt Specialist from the Office of Corporate Accountability.
- To ensure the deficiency does not reoccur the Health Information Mgmt Specialist
From the Office of Corporate Accountability (formerly Compliance Department) will assist Parkside Staff to expedite and complete the request for the specific records.
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