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 April 2 through April 4, 2012 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.
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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 review of patient records the facility failed to ensure that functions that were delegated to the physician assistant or certified registered nurse practitioner by the medical director had properly countersigned records by the medical director or a narcotic treatment physician.
The findings include:
Fourteen patient records were reviewed on April 2 through April 4, 2012. The medical director delegated functions to the physician assistant or certified registered nurse practitioner. According to the regulation, all functions that were delegated to the physician assistant or certified register nurse practitioner must be properly 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 two of three records reviewed, specifically record # 3 and 5.
Patient record # 3 was admitted on March 9, 2012. The history and physical examination was conducted and documented by the Physician Assistant on 3/9/2012. The medical director or narcotic treatment physician failed to countersign the history and physical examination in the patient record.
Patient record # 5 was admitted on February 17, 2012. The history and physical examination was conducted and documented by the Physician Assistant on 2/17/12. The medical director or narcotic treatment physician failed to countersign the history and physical examination in the patient record.
This is a repeat citation from the monitoring visit conducted on March 29 through March 30, 2012.
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Plan of Correction
1. The Medical Director will ensure that all History and Physical Evauations performed by any Physician's Assistant is counter-signed.
2. The Medical Records Coordinator, who is responsible for medical records of Chemical Dependency patients, will audit all discharged MMT charts on a monthly basis to ensure compliance with the requirement that History and Physical Examinations conducted by Physician's Assistants are counter-signed.
3. Results of the audits will be reported monthly to the Executive Committee, internally called Dashboard, for four months for oversight and monitoring.
4. The Medical Director will remain responsible for ensuring that all History and Physical Evaluations conducted by Physician's Assistants are counter-signed.
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715.9(a)(1) 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:
(1) Verify that the individual has reached 18 years of age.
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Observations
Based on the review of patient records, the facility failed to document verification of eligibility in one of thirteen patient records.
The findings include:
Fourteen patient records were reviewed April 2 through April 4, 2012. Thirteen patient records were reviewed for documentation of verification of eligibility for services. The facility failed to verify that the individual had reached the age of 18 years of age in patient record # 12.
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Plan of Correction
1. The Clinical Compliance Director, in collaboration with the supervisors of Admissions, will develop a policy and procedure governing the verification of age of a patient prior to the administration of Methadone.
2. In addition to a state-issued identification, such as a driver's license, the verification of age will include, but will not be limited to, access cards, birth certificates, baptismal certificates, high school diplomas, etc.
3. Once developed, the policy and procedure will be reviewed by the Forms Committee for implementation.
4. Following approval, the Project Director will notify the facility's main referral sources that proof of age will be required prior to the adminsitration of Methadone. In addition, the facility's main payors --including, but not limited to, Community Behavioral Health, Behavioral Health Services Initiative of Philadelphia and Magellan Behavioral Health -- will be notified of the eligibility requirement as well.
5. Staff of the Admissions Department will be trained in the policy and procedure by the Admissions supervisor, who will be responsible for ensuring that the age eligibility requirement is met. |
715.9(a)(2) LICENSURE Intake
(a) Prior to administration of an agent, a narcotic treatment program shall screen each individual to determine eligibility for admission. The narcotic treatment program shall:
(2) Verify the individual 's identity, including name, address, date of birth, emergency contact and other identifying data.
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Observations
Based on the review of patient records, the facility failed to verify the identity of the patient prior to the administration of an agent in one of thirteen patient records.
The findings include:
Fourteen patient records were reviewed on April 2 through April 4, 2012. Thirteen patient records were specifically reviewed for patient identity information. Based on the facility's policy, the admissions coordinator will make a copy of the state issued photo identification for the record. Patient record #12 did not contain a copy of the patient's state issued photo identification.
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Plan of Correction
1. The Clinical Compliance Director, in collaboration with the supervisors of Admissions, will develop a policy and procedure governing the verification of the identity of a patient prior to the administration of Methadone. 2. In addition to a state-issued identification, such as a driver's license, the verification of identity will include, but will not be limited to, access cards, birth certificates, baptismal certificates, high school diplomas, etc. 3. Once developed, the policy and procedure will be reviewed by the Forms Committee for implementation. 4. Following approval, the Project Director will notify the facility's main referral sources that proof of identity will be required prior to the adminsitration of Methadone. In addition, the facility's main payors --including, but not limited to, Community Behavioral Health, Behavioral Health Services Initiative of Philadelphia and Magellan Behavioral Health -- will be notified of the eligibility requirement as well. 5. Staff of the Admissions Department will be trained in the policy and procedure by the Admissions supervisor, who will be responsible for ensuring that the age eligibility requirement is met.
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715.9(c) LICENSURE Intake
(c) If a patient was previously discharged from treatment at another narcotic treatment program, the admitting narcotic treatment program, with patient consent, shall contact the previous facility for the treatment history.
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Observations
Based on the review of patient records, the facility failed to contact the previous narcotic treatment facility for the patient's treatment history in one of one patient records reviewed.
The findings include:
Fourteen patient records were reviewed April 2 through April 4, 2012. One patient record 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 record #8.
Patient # 8 was admitted on February 26, 2012. The record contained documentation that the patient had received narcotic treatment services previously at other narcotic treatment programs. The record did not contain documentation of any attempt to obtain the patient's prior treatment history from the previously attended narcotic treatment facilities.
This is a repeat citation from the monitoring visit conducted on March 29 through March 30, 2012.
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Plan of Correction
1. The Clinical Director, who supervises the Methadone Coordinator, will develop a form to be used for any patient who is "guest dosed" by the facility or who will be inducted in Methadone Maintenance.
2. The form will seek information from previous narcotic treatment program providers, including the current provider, about the individual patient's treatment history at that facility. In addition, each patient will be asked to complete a release of information for the previous treatment providers.
3. Once developed and in place, an audit of 10 percent of closed applicable charts will be completed each month for four months to determine compliance with the requirement that information is requested from previous narcotic treatment programs.
4. Results of the audits will be provided monthly for four 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 the review of patient records, the facility failed to document a consultation with the physician assistant that documented the examination prior to the first dose in one of six patient records.
The findings include:
Fourteen patient records were reviewed on April 2, 2012 through April 4, 2012. Six patient records were reviewed for physician's documentation of the patient's initial and subsequent dose and schedule.
Patient # 3 was admitted on March 9, 2012. The patient record contained a document titled "Intake Physical Examination" that was written by the physician assistant and signed off by the narcotic treatment physician on 3/9/2012. This form did not contain documentation of a consultation between the physician assistant and the narcotic treatment physician.
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Plan of Correction
1. The Medical Director will retrain fellow practitioners -- including Medical Doctors, Physician's Assistants and Certified Registered Nurse Practitioners -- that the Narcotic Treatment Physician conducting the initial evaluation must complete the Intake Physical Examination prior to the first-dose administration of Methadone.
2. The training will include a prohibition against the use of the Intake Physical Examination form by non-MDs.
3. The Medical Director will be responsible for monitoring compliance with the requirement. |
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 a review of the facility's policy and procedures for medication control, the facility failed to ensure that the narcotic treatment physician was the only person that is permitted to determine the proper dosage level for a patient.
The findings include:
The facility's policy titled, " Medication Control- Methadone" was reviewed on April 2, 2012. The facility's policy stated, " Only a licensed physician, certified registered nurse practitioners, or physician's assistant may prescribe Methadone to patients within the detoxification and rehabilitation programs. Each medication order and dosage change will be written, signed and dated by the Narcotic Treatment Physician (NTP) or the CRNP or Physician's Assistant."
An interview with the Medical Director and Project Director confirmed that, on rare occasions, someone other than the narcotic treatment physician has prescribed methadone.
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Plan of Correction
1. The facility will revised its policy governing medication administration to ensure that only Medical Doctors are permitted to adjust any dosage of Methadone. Previously, the facility permitted adjustments to Methadone by Physician's Assistants and Certified Register Nurse Practitioners.
2. The policy will be revised to state not only that only the Narcotic Treatment Physician may adjust doses of Methadone, but also that such adjustments may not be completed by either Physician's Assistants or Certified Registered Nurse Practitioners.
3. The revised policy will be presented to both the Pharmacy and Therapeutics Committee and the Forms Committee for review and approval.
4. Once approved, the policy will be disseminated to staff.
5. On the day following the conclusion of the site visit, the facility's Director of Medical Services, a Medical Doctor who supervises the Physician's Assistant and Certified Registered Nurse Practitioner, informed both that they may no longer adjust doses of Methadone. |
715.17(c)(2) 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:
(2) Drug storage areas. A narcotic treatment program shall develop and implement written policies and procedures regarding storage of medications and access to the medication storage area. Agents shall be stored in a locked safe that has been approved by the DEA under 21 CFR 1301.72 and 1301.74 (relating to physical security controls; and other security controls).
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Observations
Based on the review of the facility's policy and procedures and observation during the inspection of the nurse's stations, the facility failed provide individual storage of methadone in accordance with DEA regulations as well as their policy and procedure.
The findings include:
The facility's policy and procedure titled, "Medication Control" was reviewed on April 2, 2012. According to the facility's policy, "All units dispensing Methadone will store inventory in separate lock boxes that will be inventoried separately from other controlled substances." The facility failed to follow their policy. Other narcotic medications were observed to be in the methadone storage safes, located in nurse's stations.
This finding was confirmed by the Quality Assurance staff and nurses.
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Plan of Correction
1. The facility has purchased additional locking medication storage boxes so that Methadone is stored separately from other narcotics.
2. The facility presently has two safes in its medication storage areas, one for Methadone and the other for all other narcotics.
3. The second, non-Methadone storage boxes will be distributed to each of the facility's five medication rooms. Methadone will continue to be stored in a locked safe that is bolted to the wall. The non-Methadone storage boxes, which will contain a lock, will be stored in locking cabinets within the medication rooms. The medication rooms themselves are locked when not occupied by a nurse.
4. The requirement that Methadone and non-Methadone narcotics be stored separately will be verified by the Infection Control Nurse/Nurse Educator during routine medication room inspections, which occur at least quarterly.
5. The quarterly Medication Room inspections are reported to the Pharmacy and Therapeutics Committee. |
709.32(b) LICENSURE Medication Control
709.32. Medication control.
(b) Verbal medication orders may be accepted but shall be put in writing and signed within 24 hours thereafter by the prescribing physician.
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Observations
Based on a review of the facility's policy and procedures and patient records, the facility failed to ensure that verbal medication orders were put in writing and signed within 24 hours thereafter by the prescribing physician, as required by regulation, in four of four patient records. Also, the facility's policy on verbal orders did not meet the regulation.
The findings include:
Fourteen patient records were reviewed on April 2 through April 4, 2012. According to the facility's policy, verbal orders for all medications may be accepted by the the Registered Nurse or Licensed Nurse Practitioner. The policy states, "Verbal orders are ordered by physicians and must be reviewed, signed, timed, and dated by the attending doctor within 24 hours." The policy does not meet the regulation requirement of having verbal orders signed by the prescribing physician within 24 hours.
Patient records # 1, 3, 4 and 6 contained documentation of a verbal medication order that was not signed by the prescribing physician within 24 hours.
Patient #1 was admitted on March 21, 2012. Verbal orders contained in the patient record dated March 26, 2012 were signed and dated by the prescribing physician assistant, however, she did not follow the facility's policy and document the time that the order was signed off.
Patient # 3 was admitted on March 9, 2012. Verbal orders contained in the patient record dated March 10, 2012 were signed off by the prescribing physician assistant on March 12, 2012. However, it was not signed within 24 hours.
Patient # 4 was admitted on March 3, 2012. Verbal orders contained in the patient record dated March 9, 2012 were signed off by the prescribing certified registered nurse practitioner, however, she failed to date and sign her signature. It could not be determined if the orders were signed off within 24 hours. The record also contained verbal orders on March 10, 2012 at 2400 hours and March 11, 2012. These orders were not signed off by the prescribing certified registered nurse practitioner.
Patient # 6 was admitted February 22, 2012. A verbal order dated February 24, 2012 was not signed off by the prescribing certified registered nurse practitioner.
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Plan of Correction
1. The facility will revise its policy and procedure governing the authentication of verbal orders.
2. The policy revision will ensure that only those practitioners issuing verbal orders will be the practitioner authenticating the verbal order. Previously, the Attending Physician in a case was permitted to authenticate verbal orders issued by another Licensed Independent Practitioner.
3. The policy and procedures change will be reviewed by the Pharmacy and Therapeutics Committee for approval. Once approved, all Licensed Independent Practitioners will be trained in the new requirements on May 10, 2012.
4. The Medical Records Department, which conducted audits of all closed charts, also will be trained in the new requirements. Authentication of verbal orders is tracked by Medical Records Coordinators during routine monthly audits. |