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 March 29 through 31, 2 011 by staff from the Division of Drug and Alcohol Program Licensure. Based on the findings of the on-site inspection, Kirkbride Center was found not to be in compliance with the applicable chapters of 4 PA Code and 28 PA Code which pertain to the facility. The following deficiencies were identified during this inspection and a plan of correction is due on April 30, 2011.
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Plan of Correction
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715.6(e) LICENSURE Physician Staffing
(e) A physician assistant or certified registered nurse practitioner may perform functions of a narcotic treatment physician in a narcotic treatment program if authorized by Federal, State and local laws and regulations, and if these functions are delegated to the physician assistant or certified registered nurse practitioner by the medical director, and records are properly countersigned by the medical director or a narcotic treatment physician. One-third of all required narcotic treatment physician time shall be provided by a narcotic treatment physician. Time provided by a physician assistant or certified registered nurse practitioner may not exceed two-thirds of the required narcotic treatment physician time.
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Observations
Based on a review of patient records, the facility failed to ensure that functions that were assigned to the physician assistant or certified registered nurse practitioner by the medical director, had been properly countersigned by the medical director or a narcotic treatment physician.
The findings include:
Patient records were reviewed on March 29 through 31, 2011. The medical director assigned functions to the physician assistant or certified registered nurse practitioner, specifically patient records # 1, 3, 4, 6, 7, 10 and 14. According to the regulation, functions that are delegated to the physician assistant or certified register nurse practitioner must be countersigned by the medical director or narcotic treatment physician. History and Physical Examinations were delegated to the physician assistant or certified registered nurse practitioner by the medical director. The medical director failed to countersign the history and physical examination in seven out of fourteen records reviewed. Specifically, patient records # 1, 3, 4, 6, 7, 10 and 14.
Patient # 1 was admitted on 11/ 29/10. The history and physical examination was conducted and documented by the certified registered nurse practitioner on 11/29/10. The medical director or narcotic treatment physician failed to countersign the history and physical examination in the patient record.
Patient # 3 was admitted on 2/8/11. The history and physical examination was conducted and documented by the certified registered nurse practitioner on 2/8/11. The medical director or narcotic treatment physician failed to countersign the history and physical examination in the patient record.
Patient # 4 was admitted on 3/15/11. The history and physical examination was conducted and documented by the certified registered nurse practitioner on 3/7/11. The medical director or narcotic treatment physician failed to countersign the history and physical examination in the patient record.
Patient # 6 was admitted on 2/14/11. The history and physical examination was conducted and documented by the certified registered nurse practitioner on 2/14/11. The medical director or narcotic treatment physician failed to countersign the history and physical examination in the patient record.
Patient # 7 was admitted on 11/ 12/10. The history and physical examination was conducted and documented by the certified registered nurse practitioner on 11/12/2010. The medical director or narcotic treatment physician failed to countersign the history and physical examination in the patient record.
Patient # 10 was admitted on 3/4/11. The history and physical examination was conducted and documented by the certified registered nurse practitioner on 3/4/11. The medical director or narcotic treatment physician failed to countersign the history and physical examination in the patient record.
Patient # 14 was admitted on 2/24/11. The history and physical examination was conducted and documented by the certified registered nurse practitioner on 2/24/11. The medical director or narcotic treatment physician failed to countersign the history and physical examination in the patient record.
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Plan of Correction
1. The Intake Physical Examination is completed in conjunction with the Physician's Documentation of Opiate Addiction and is an abbreviated version of the History and Physical Examination that is completed within 24 hours of Admission.
3. The Intake Physical Examination is completed upon admission and includes both vital signs and a Review of Systems.
3. Effective immediately, only a Medical Doctor will complete the Intake Physical Examination. In rare cases when a so-called physician extender -- Physician's Assistant or Nurse Practitioner -- completes the Intake Physical Examination, a Medical Doctor will sign off on the review following consultation and in collaboration with the Licensed Independent Practitioner completing the examination. The Medical Doctor signing off will document the consultation.
4. Periodic chart audits by the Executive Director or his designee will certify that the state standards are being met. |
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 fourteen patient records on March 29 through March 31, the narcotic treatment program failed to have a narcotic treatment physician make the determination and document in the patient's record the basis for the assessment of an individual's physiological dependence upon a narcotic drug and current dependency in 5 of 14 records, as required.
Findings:
In the review of patient record documentation, it was determined that the writing on the "Physician's Documentation of Opiate Addiction" form was documented by the Certified Registered Nurse Practitioner (CRNP), not the physician. The purpose of this form was to document the client's criteria for physiologic addiction and that they have been addicted to heroin or other opiate drugs for a period of at least one year prior to the date of intake. In accordance with regulation, this determination and the document of same must be completed by a physician.
The medical director or narcotic treatment physician did countersign this document; however, the determination must by documented by the narcotic treatment physician. An interview with the medical director confirmed that the Physician's Documentation of Opiate Addiction form was prepared by the CRNP, not the physician. The medical director or narcotic treatment physician countersigned paperwork documented by the CRNP in patient records # 1, 2, 3, 13, and 14.
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Plan of Correction
1. Effective immediately, only a Medical Doctor will complete the Physician's Documentation of Opiate Addiction following assessment of the patient.
2. Period chart audits by the Executive Director or his designee will confirm compliance with the state standard. |
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 the review of patient records and an interview with the Clinical Supervisor, the facility failed to contact the previous narcotic treatment facility for the patient's treatment history in two of five patient records reviewed.
The findings include:
Fourteen patient records were reviewed March 29 through March 31, 2011. Five patient records required contacting the prior narcotic treatment facility for the patient's previous treatment history. The facility failed to document that a patient's previous treatment facility was contacted for the patient's treatment history, specifically patient records #1 and 13.
Patient records # 1 and 13 contained documentation that the patients had received narcotic treatment services previously at other narcotic treatment programs. Records # 1 and 13 did not contain documentation of any attempt to obtain the patient's prior treatment history from the previously attended narcotic treatment facilities.
An interview with the clinical supervisor on March 31, 2011 at 11:20 a.m. confirmed that the facility did not contact the previous narcotic treatment facility for the patient's treatment history in patient records # 1 and 13.
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Plan of Correction
1. The facility is in the process of hiring of a Methadone Coordinator, who will administratively coordinate the treatmetn of Methadone patients from admission through to discharge to a Methadone clinic.
2. The Methadone Coordinator, or in his/her absence, the Clinical Operations Supervisor, will contact previous treatment providers self-reported by the patient or available through collateral information supplied to the Kirkbride Center to obtain information about previous treatment experiences.
3. The Kirkbride Center will seek information about treatment experiences provided the patient signs a release of information consent to do so. The agencies that will be contacted for collateral information mostly likely will be based upon self-report by the agencies.
4. A form will be developed to indicate what treatment provider(s) have been contacted and the result of the contact. Efforts will be made to obtain as much information as possible about the patient's previous narcotics treatment experience and will be documented in the patient's medical record.
5. Information sent by previous providers will be stored in the collateral/miscellaneious section of the individual patient record. |
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 patient records and an interview with the project director and the facility director, the facility failed to ensure that the facility received the laboratory results of the patient's urine drug screen prior to initially dosing the patient in three of eight records. In addition, rapid drug testing was being used as an initial urine test for illicit drug usage in the three records.
The findings include:
Fourteen patient records were reviewed on March 29 through March 31, 2011. Eight patient records required laboratory results of drug screen urinalysis prior to the patient's initial dose. The facility failed to document the completion of a drug screen urinalysis prior to dosing in three patient records, specifically records # 7, 11, and 13.
Patient # 7 was admitted to treatment on November 12, 2010. Patient # 7 received a dose of 25 mg on November 12, 2010; the urinalysis results were not received by the facility until November 16, 2010. In patient record # 7, there is documentation of on-site drug testing that the facility utilized prior to dosing. This practice does not meet the regulations as the testing is not Clinical Laboratory Improvement Amendments of 1998 (CLIA) approved.
Patient #11 was admitted to treatment on February 16, 2011. Patient #11 received a dose of 30 mg on February 17, 2011; the urinalysis results were not received by the facility until February 18, 2011. In patient record # 11, there is documentation of on-site drug testing that the facility utilized prior to dosing. This practice does not meet the regulations as the testing is not Clinical Laboratory Improvement Amendments of 1998 (CLIA) approved.
Patient #13 was admitted to treatment on March 3, 2011. Patient #13 received a dose of 30 mg on March 4, 2011; the urinalysis results were not received by the facility until March 5, 2011. In patient record # 13, there is documentation of on-site drug testing that the facility utilized prior to dosing. This practice does not meet the regulations as the testing is not Clinical Laboratory Improvement Amendments of 1998 (CLIA) approved.
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Plan of Correction
1. The Admissions Department will be instructed to obtain -- when available -- drug screen results from sending referral organizations.
2. This will include outpatient Methadone Clinics, crisis centers and Emergency Rooms.
3. In cases in which patients currently participating in Methadone Maintenance are referred by an outpatient clinic, last-dose verification will be utilized prior to the administration of the narcotic agent.
4. Drug screen results from clinics, crisis centers and emergency rooms will be obtained prior to the administration of Methadone. This will include the administration of Methadone for both tapers and titrations.
5. If no drug screen is available, the facility will delay administration of Methadone until it has secured a drug screen result from its laboratory, Atlantic Diagnostic Laboratories.
6. The facility will continue to administer on-site drug screens, which will be used for validation purposes only.
7. Referral sources, including Managed Care Organizations, will be notified in a letter about this practice.
8. Upon implementation, the Clinical Compliance Director will monitor closed charts for a four-month period to ensure the practice is being followed. Results will be reported monthly for months to the Executive Committee, internally called Dashboard, for oversight and monitoring. |
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 a review of patient records, the narcotic treatment program failed to document the consultation between the narcotic treatment physician determining the initial dose and the narcotic treatment physician performing the physical examination in 9 of 14 patient records.
The findings include:
Fourteen patient records were reviewed on March 29 through March 31,2 011. Nine of fourteen patient records required documentation of a consult between the narcotic treatment physician determining the initial dose and the narcotic treatment physician performing the physical examination, specifically patient records # 1, 3, 4, 6, 7, 11, 12, 13, and 14.
Record #1 - Patient was admitted on 11/29/10. The Certified Registered Nurse Practitioner (CRNP) completed the physical examination on 11/29/10. The narcotic treatment physician determined the initial dose on 11/30/10, but failed to document a consultation with the Certified Registered Nurse Practitioner who completed the physical examination.
Record #3 - Patient was admitted on 2/18/11. The Certified Registered Nurse Practitioner (CRNP) completed the physical examination on 2/8/11. The narcotic treatment physician determined the initial dose on 2/9/11, but failed to document a consultation with the Certified Registered Nurse Practitioner who completed the physical examination.
Record #4 - Patient was admitted on 3/15/11. The Certified Registered Nurse Practitioner (CRNP) completed the physical examination on 3/7/11. The narcotic treatment physician determined the initial dose on 3/15/11, but failed to document a consultation with the Certified Registered Nurse Practitioner who completed the physical examination.
Record #6 - Patient was admitted on 2/14/11. The Certified Registered Nurse Practitioner (CRNP) completed the physical examination on 2/14/11. The narcotic treatment physician determined the initial dose on 2/15/11, but failed to document a consultation with the Certified Registered Nurse Practitioner who completed the physical examination.
Record #7 - Patient was admitted on 11/12/10. The Certified Registered Nurse Practitioner (CRNP) completed the physical examination on 11/12/10. The narcotic treatment physician determined the initial dose on 11/12/10, but failed to document a consultation with the Certified Registered Nurse Practitioner who completed the physical examination.
Record #11 - Patient was admitted on 2/16/11. The Certified Registered Nurse Practitioner (CRNP) completed the physical examination on 2/16/11. The narcotic treatment physician determined the initial dose on 2/17/11, but failed to document a consultation with the Certified Registered Nurse Practitioner who completed the physical examination.
Record #12 - Patient was admitted on 2/28/11. The Certified Registered Nurse Practitioner (CRNP) completed the physical examination on 3/1/11. The narcotic treatment physician determined the initial dose on 2/28/11, but failed to document a consultation with the Certified Registered Nurse Practitioner who completed the physical examination.
Record #13 - Patient was admitted on 3/3/11. The Certified Registered Nurse Practitioner (CRNP) completed the physical examination on 3/3/11. The narcotic treatment physician determined the initial dose on 3/4/11, but failed to document a consultation with the Certified Registered Nurse Practitioner who completed the physical examination.
Record #14 - Patient was admitted on 2/24/11. The Certified Registered Nurse Practitioner (CRNP) completed the physical examination on 2/24/11. The narcotic treatment physician determined the initial dose on 2/25/11, but failed to document a consultation with the Certified Registered Nurse Practitioner who completed the physical examination.
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Plan of Correction
1. The Intake Physical Examination is completed in conjunction with the Physician's Documentation of Opiate Addiction and is an abbreviated version of the History and Physical Examination that is completed within 24 hours of Admission. 3. The Intake Physical Examination is completed upon admission and includes both vital signs and a Review of Systems. 3. Effective immediately, only a Medical Doctor will complete the Intake Physical Examination. In rare cases when a so-called physician extender -- Physician's Assistant or Nurse Practitioner -- completes the Intake Physical Examination, a Medical Doctor will sign off on the review following consultation and in collaboration with the Licensed Independent Practitioner completing the examination. The Medical Doctor signing off will document the consultation. 4. Periodic chart audits by the Executive Director or his designee will certify that the state standards are being met. |
715.17(c)(1)(i-vi)) 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:
(1) Administration of medication.
(i) A narcotic treatment physician shall determine the patient 's initial and subsequent dose and schedule. The physician shall communicate the initial and subsequent dose and schedule to the person responsible for the administration of medication. Each medication order and dosage change shall be written and signed by the narcotic treatment physician.
(ii) An agent shall be administered or dispensed only by a practitioner licensed under the appropriate Federal and State laws to dispense agents to patients.
(iii) Only authorized staff and patients who are receiving medication shall be permitted in the dispensing area.
(iv) There shall be only one patient permitted at a dispensing station at any given time.
(v) Each patient shall be observed when ingesting the agent.
(vi) Administering and dispensing shall be conducted in a manner that protects the patient from disruption or annoyance from other individuals.
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Observations
Based on the review of patient records and an interview with the Medical Director, the facility failed to ensure that the narcotic treatment physician determined the proper dosage level in six patient records. Additionally, the narcotic treatment physician must document orders in accordance with applicable Federal and State Statues and regulations.
The findings include:
Fourteen patient records were reviewed on March 29 through March 31, 2011. Eight patient records were reviewed for the physician's documentation in determining the proper dose. Six of eight patient records, specifically, # 3, 4, 11, 12, 13,and 14 had standing orders documented for determining the patient's dose.
Patient # 3 received an initial dose of 30 mg. Documented in the patient record # 3 was a standing order:
2/09/10 30 mg 2/11/10 45 mg
2/10/10 40 mg 2/12/10 50 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 # 4 received an initial dose of 25 mg. Documented in the patient record # 4 was a standing order:
3/16/11 25 mg 3/18/11 35 mg 3/20/11 45 mg
3/17/11 30 mg 3/19/11 40 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 the patient record # 11 was a standing order:
3/17/11 30 mg 3/19/11 40 mg 3/21/11 50 mg
3/18/11 35 mg 3/20/11 45 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 # 12 received an initial dose of 20 mg. Documented in the patient record #12 was a standing order:
2/28/11 20 mg 3/02/11 40 mg, daily 45 mg
3/01/11 35 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 the patient record # 13 was a standing order:
3/04/11 30 mg 3/06/11 40 mg 3/08/11 50 mg
3/05/11 35 mg 3/07/11 45 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 the patient record # 14 was a standing order:
2/25/11 30 mg 2/27/11 45 mg
2/26/11 40 mg 50 daily
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 was conducted with the medical director and confirmed that the physician did not assess the patient each day prior to the patient getting their dose increased during the induction phase of methadone.
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Plan of Correction
1. All orders for both Methadone tapers and titrations are individually determined by the Narcotic Treatment Physician; the facility does not utilize standing protocols for the titration of Methadone.
2. The facility will initiate an induction monitoring form that will be utilized for any patient who is undergoing a titration in their dose of Methadone.
3. The induction monitoring form will be completed by the charge nurse on the unit once the Narcotic Treatment Physician notifies nursing that a patient is undergoing induction with Methadone.
4. The induction monitoring form will be an enhanced vital signs record.
5. Once in place, nurses will be trained by the Director of Nursing in the application of the induction monitoring form.
6. The Induction Monitoring Form will be provided to the narcotic Treatment Physician for review in making determinations about the appropriate dosing and titration/taper for each patient. The Narcotic Treatment Physician will make an adjustment in the Methadone dosing only following a face-to-face assessment of the patient.
7. Periodic chart audits by the Executive Director will determine compliance with completion of the induction monitoring form. |
715.23(b)(24) LICENSURE Patient records
(b) Each patient file shall include the following information:
(24) Follow-up information regarding the patient.
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Observations
Based on the review of the facility policy and procedure manual, patient records, and an interview with the facility director and clinical supervisor, the facility failed to document follow-up in four of six discharged records.
The findings include:
The facility policy and procedure was reviewed on March 29, 2011. The policy stated that follow-up will be conducted within seven days of the patient being discharged from the program. Follow-up was not documented in four out of six discharged records, specifically patient records # 1,2,3, and 7.
Patient # 1 was discharged 1/19/2011. The patient transferred to another clinic. The facility documented follow-up; however, there was no way to determine if the follow-up was conducted within the required seven days since the therapist failed to date their signature.
Patient # 2 was discharged 1/26/2011. The patient transferred to another clinic. The facility documented follow-up; however, there was no way to determine if the follow-up was conducted within the required seven days since the therapist failed to date their signature.
Patient # 3 was discharged 3/15/2011. The patient transferred to another clinic. The facility documented follow-up; however, there was no way to determine if the follow-up was conducted within the required seven days since the therapist failed to date their signature.
Patient # 7 was discharged 12/22/2010. The patient transferred to another clinic. The facility documented follow-up; however, there was no way to determine if the follow-up was conducted within the required seven days since the therapist failed to date their signature.
The facility director and clinical supervisor were interviewed and confirmed this finding.
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Plan of Correction
1. The Follow-Up form has been revised to require not only the signature of the Primary Therapist verifying the patinet's follow-up efforts, but also the date on which the follow-up was initiated.
2. Periodic chart audits by the Clinical Operations Supervisor will ensure compliance with the state standard. |
715.23(e) LICENSURE Patient records
(e) Patient file records, information and documentation shall be legible, accurate, complete, written in English and maintained on standardized forms or electronically.
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Observations
Based on the review of patient records and a discussion with the project director and facility director, the facility failed to provide patient files that contained information and documentation that was legible.
The findings include:
Fourteen patient records were reviewed March 29 through March 31, 2011. All records contained signatures and dates that were illegible. Additionally, in records # 7, 11, and 12, there was handwriting from clinical and medical staff that were illegible. A discussion with the project director and facility director confirmed these findings.
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Plan of Correction
1. The Facility Director, the Clinical Director and the Clinical Operations Supervisor will intiate a legibility test for all Primary Therapists and Behavioral-Health Technicians.
2. Based upon the subjective findings of that survey, a determination will made as to which staff members will be required to print all entries in the medical records and which staff members will be permitted to handwrite their entries.
3. Name stamps have been purchased for all Primary Therapists to be used above their signatures in entries in the medical records.
4. On a monthly basis for four months, the Facility Director will review a sample of the documentation of those required to print to determine subjectively whether legibility has improved. The review will consist of medical records of all Primary Therapists required to print.
5. Results will be reported to the Executive Committee, internally called Dashboard, for oversight and monitoring. |