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 and buprenorphine, in the treatment of narcotic addiction. This inspection was conducted on February 21, 2012 through February 23, 2012 by staff from the Division of Drug and Alcohol Program Licensure. Based on the findings of the on-site inspection, A.R.S. of Lancaster, L.P. 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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715.9(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 patient records, the narcotic treatment program failed to have a narcotic treatment physician make a face-to face determination and document in the patient's record the basis for determining an individual's physiological dependence upon a narcotic drug in one of twelve records reviewed.
The findings include:
Twenty-Eight patient records were reviewed on February 21, 2012 through February 23, 2012. Twelve records were reviewed for documentation that the narcotic treatment physician made a face-to-face determination of the patient's physiological dependence upon a narcotic drug. There was no documentation verifying that the narcotic treatment physician made a face-to-face determination of the patient's physiological dependence upon a narcotic drug in patient record # 14.
Patient # 14 was readmitted to the program on December 20, 2011. The narcotic treatment physician failed to document a face-to-face determination of the patient's physiological dependence upon a narcotic drug. The documentation did not include the determination of current dependency and evidence of a one year history of addiction.
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Plan of Correction
Going forward the narcotic treatment physician will ensure that the face to face determination of physiological opioid dependency and evidence of one year history of addiction is properly documented for all admissions and readmissions through the use of the history and physical form which is completed prior to the admission induction dose.
The medical director and director of nursing retrained all medical staff on the procedure to complete a full history and physical assessment prior to admission and readmission on 2/29/12.
The Director of Nursing or Charge Nurse will ensure that the narcotic treatment physician face to face and basis for determination of current dependency and evidence of a 1 year addiction history is documented for all admissions and readmissions by reviewing this information through the existing chart audit procedure that takes place prior to the patient receiving his/her first dose of methadone.
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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 record reviewed.
The findings include:
Twenty-eight patient records were reviewed February 21-23, 2012. One patient record required contacting the prior narcotic treatment facility for previous treatment history.
Patient record # 7 contained documentation that indicated the patient had received narcotic treatment services at another narcotic treatment program. The facility failed to document an attempt to obtain the patient's treatment history from the previously attended narcotic treatment facility.
An interview with the facility director confirmed the finding.
This is a repeat citation from the methadone monitoring inspection conducted on January 10-13, 2011.
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Plan of Correction
The Facility Director and Clinical Supervisor developed a letter that will be utilized to contact all previous narcotic treatment facilities from which an admission reports receiving treatment. When an admission reports receiving treatment in the past from a narcotic treatment facility, ARS staff will obtain a release of information from the admission so that the letter can be sent requesting previous treatment history. The Facility Director and Clinical Supervisor conducted a meeting with the clinical staff on 2/27/2012 to train on this procedure. Compliance with this procedure will be monitored on an ongoing basis through the existing audits of patient records of newly admitted patients that are completed by the Clinical Supervisor. |
715.15(a) LICENSURE Medication Dosage
(a) The narcotic treatment physician shall review the dosage levels at least twice a year, with each review occurring at least 2 months apart, to determine a patient 's therapeutic dosage.
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Observations
Based on a review of patient records, the facility failed to ensure the narcotic treatment physician reviewed the dosage levels at least twice a year, with each review occurring at least 2 months apart in three of nine records reviewed.
The findings include:
Twenty-eight records were reviewed on February 21 - 23, 2012. Nine patient records required the narcotic treatment physician document a review of the dosage levels at least twice a year. The facility failed to document a dosage review in patient records # 3, 17, and 23.
Patient #3 was admitted on November 13, 2007. A review of the patient record revealed that the narcotic treatment physician failed to conduct a dose review in 2011.
Patient # 17 was admitted on August 30, 3007. A review of the patient record revealed that the narcotic treatment physician failed to conduct two dosage reviews in 2011. The narcotic treatment physician conducted one dosage review on December 23, 2011.
Patient # 23 was admitted on January 11, 2007. A review of the patient record revealed that the narcotic treatment physician failed to conduct two dosage reviews in 2011. The narcotic treatment physician conducted one dosage review in April 2011.
Interview with the physician assistant confirmed this finding.
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Plan of Correction
ARS Medical Director/Physician will review dosage levels for all patients at least twice per year, with each review occurring at least 2 months apart, to determine a patients therapeutic dosage. The ARS Medical Director/Physician will utilize the Automated Dispensing System to schedule and track the review of dosage levels to ensure that the reviews occur according to the requirement. Compliance with this procedure will be monitored by the physician extender through a quarterly review of the schedule report in conjunction with patient records to ensure that the dosage reviews have occurred and have been documented accordingly. |
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 facility failed to ensure that the narcotic treatment physician documented clearly written orders that determined the patient 's initial dose and schedule in two of six patient records.
The findings include:
Twenty-eight patient records were reviewed on February 21-23, 2012. Six patient records were reviewed for written orders by the narcotic treatment physician that determined the patient's initial dose and schedule. The review of records did not indicate that standard orders were being used, however, the narcotic treatment physician failed to document clear induction orders in patient records # 12 and 14.
Patient #12 was admitted on February 21, 2012. The initial medication order was documented on February 21, 2012. The order written by the narcotic treatment physician indicated a, "range of 20-60 mg- 30 mg today, reevaluate each day for continued withdrawal signs and symptoms, hold for any dose sedation." The range indicated on the order was not clear and the order provided opportunity for interpretation by the medical staff who were reading the order.
Patient #14 was admitted on December 20, 2011. The initial medication order was documented on December 20, 2011. The order written by the narcotic treatment physician indicated, "range of 20-60 mg, 30 mg today. call for orders beyond this dose." The range indicated on the order was not clear and the order provided opportunity for interpretation by the medical staff who were reading the order.
The narcotic treatment physician was interviewed and confirmed this documentation.
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Plan of Correction
The Facility Director met with the ARS Medical Director, Narcotic Treatment Physician, and Director of Nursing to train them on the expectation that the wording described in this citation be stopped effective 3/1/12. All future admission orders will only include dosing instructions for the initial dose to eliminate the possibility of interpretation by the medical staff reading the order. The Director of Nursing has met with all nursing staff to train them on the requirements of the initial dosing orders. On- going compliance with this procedure will be monitored through the existing audits of all admission charts that are conducted by the Director of Nursing or Charge Nurse before the patient receives his/her first dose of methadone. |
715.16(a)(3) LICENSURE Take-home privileges
(a) A narcotic treatment program shall determine whether a patient may be provided take-home medications.
(3) The narcotic treatment physician shall document in the patient record the rationale for permitting take-home medication.
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Observations
Based on the review of patient records, the facility failed to ensure the physician documented the rationale for granting take home medication in three of three patient records.
The findings include:
Twenty-eight patient records were reviewed on February 21-23, 2012. Three records were reviewed for take home medication documentation. Patient records # 1, 13 and 21 did not have the physician's rationale for granting the take home medication.
Patient # 1 was granted take home medication on June 28, 2011. The doctor's reason for granting take homes was, "Phase 0 to phase 2." On August 23, 2011, the patient was granted additional take homes. The reason documented by the narcotic treatment physician was, " Phase 2 to phase 4." The narcotic treatment physician failed to document in the patient record the rationale for permitting take-home medication.
Patient # 13 was granted take home medication on March 29, 2011. The physician's documented reason for granting take homes was documented, "Phase 0 to phase 2." The patient was granted additional take homes on May 5, 2011. The physician's documented reason for granting take homes was, "Phase 2 to phase 4." Additional take homes were granted on August 12, 2011. The doctor's reason for granting take homes was, "Restore to phase 6, getting sixth take home." On August 23, 2011, the patient was granted additional take homes. The reason documented by the narcotic treatment physician was, " Phase 2 to phase 4." The narcotic treatment physician failed to document in the patient record the rationale for permitting take-home medication.
Patient # 21 was granted take home medication on September 27, 2011. The physician's documented reason for granting take homes was, "Phase 0 to phase 2." The narcotic treatment physician failed to document in the patient record the rationale for permitting take-home medication.
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Plan of Correction
The narcotic treatment physician will document the rationale for justification of all take home orders in the reason section of the physician order. The Facility Director and Medical Director met with the Director of Nursing and Physician Assistant on 2/28/12 to train on this procedure. The Director of Nursing trained all nursing staff on 2/29/12 on this procedure.
On an ongoing basis, the director of nursing will review all orders for take homes to ensure that the rationale for granting take homes is documented within the physician order prior to the patient receiving takehome medication.
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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 direct observation of the medication area, the facility failed to follow their policy and procedures not allowing children/infants in the dispensing area under any circumstances. The facility also failed to conduct administering and dispensing in a manner that protects the patient from disruption or annoyance from other individuals.
The findings include:
As part of methadone monitoring the dispensing area was directly observed. During direct observation of the medication area on February 21, 2012, at about 9:45 a.m., three patients presented to the dosing window with their children.
The first patient informed their child to move to the end of the hallway to wait for the completion of dosing. The second patient informed their child to move to the wall behind them to await completion of dosing. The third patient was informed by nursing staff of the need to have the child wait along the wall behind them for completion of dosing.
Each patient had to monitor their child during their period of dosing. This did not provide protection of the patient from disruption during dosing.
During the onsite monitoring visit on February 23, 2012, at about 9 a.m., the monitor observed an individual holding a child in the waiting room area. When the child was put down, the child immediately began running toward the open hallway dispensing area. This would be a distraction to anyone dosing at the time.
The findings were reviewed with the Program Director, Facility Director, Clinical Supervisor, and Director of Nursing and were not disputed.
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Plan of Correction
To ensure children are kept away from the medication area, the administrative staff will be enhancing the portion of the lobby set aside for children to make the area more appealing to children. This area is within view of ARS staff members and is within view of the medication area to ensure that children can be appropriately monitored.
All staff have been retrained on the policy of not allowing children in the medication area and training on this policy will be incorporated into new hire orientation.
Patients will be given proper notice of the enforcement of the no children at dosing window policy. Patients will be told that they will not be medicated if their child is with them at the dosing window.
The medical staff will be responsible for ensuring compliance with this policy through monitoring the medication area. Patients attempting to bring children to the medication area, will not be medicated. Instead, Nursing Staff will instruct the patient to accompany the children back to the lobby to either have the children wait in the lobby or have someone monitor their child while they medicate.
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715.17(c)(4)(i-viii) 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:
(4) Method for control and accountability of drugs. A narcotic treatment program shall develop and implement written policies and procedures regarding who is authorized to remove drugs from the storage area and the method for accounting for all stored drugs. An agent or other drug prescribed or administered shall be documented on an individual medication record or sheet in a manner sufficient to maintain an accurate accounting of medication at all times and shall include:
(i) The name of the medication.
(ii) The date prescribed.
(iii) The dosage.
(iv) The frequency.
(v) The route of administration.
(vi) The date and time administered.
(vii) The name of the person administering the medication.
(viii) The take-home schedule, if applicable.
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Observations
Based on the review of the policy and procedure manual, the facility failed to update their policy for the method for control and accountability of drugs.
The findings include:
The policy and procedure manual was reviewed on February 21, 2012. The policy on the method for control and accountability of drugs had the former director of nursing listed as the power of attorney as the person who can accept deliveries of narcotic medications. The facility failed to update the policy to reflect current personnel.
This finding was reviewed with the director of nursing and the facility director and was not disputed.
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Plan of Correction
The facility director updated the methadone policy procedures on 2/23/2012 to amend the policy and procedure concerning the methods for control and accountability of drugs to include only the title/position of the staff member authorized as the power of attorney and as the person who can accept deliveries of narcotic medications which is the director of nursing. |
715.19(1) LICENSURE Psychotherapy services
A narcotic treatment program shall provide individualized psychotherapy services and shall meet the following requirements:
(1) A narcotic treatment program shall provide each patient an average of 2.5 hours of psychotherapy per month during the patient 's first 2 years, 1 hour of which shall be individual psychotherapy. Additional psychotherapy shall be provided as dictated by ongoing assessment of the patient.
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Observations
Based on a review of patient records, the facility failed to document an average of 2.5 hours of psychotherapy per month during the patient's first two years, in five of sixteen patient records, as required.
The findings include:
Twenty-eight patient records were reviewed on February 21 - 23, 2012. Sixteen patient records were reviewed for the completion of an average of 2.5 psychotherapy hours per month. The facility failed to document an average of 2.5 hours of psychotherapy per month in patient records # 1, 6, 11, 15, and 25.
Patient #1 was admitted into treatment on November 4, 2010. The patient attended 1 hour of psychotherapy in November, 2011, 1 hour of psychotherapy in December, 2011 and 1 hour of psychotherapy in January, 2012. Patient # 1 attended an average of 1 hour of psychotherapy per month.
Patient # 6 was admitted into treatment on May 19, 2010 and was discharged January 27, 2011. The patient attended 2.5 hours of psychotherapy in October, 2010, 2.5 hours of psychotherapy in November, 2010, and 1.25 hours of psychotherapy in December, 2010. Patient # 6 attended an average of 2.08 hours of psychotherapy per month.
Patient # 11 was admitted into treatment on February 17, 2011. The patient attended 1 hour of psychotherapy in November, 2011, 3 hours of psychotherapy in December, 2011, and 3 hours of psychotherapy in January , 2012. Patient # 11 attended an average of 2.33 hours of psychotherapy per month.
Patient # 15 was admitted into treatment on September 7, 2010 and discharged October 4, 2011. The patient attended 1.5 hours of psychotherapy in July, 2011, 1.25 hours of psychotherapy in August, 2011, and .50 hours of psychotherapy in September, 2011. Patient # 15 attended an average of 1.08 hours of psychotherapy per month.
Patient # 25 was admitted into treatment on February 23, 2010 and discharged October 24, 2011. The patient attended 1 hour of psychotherapy in July, 2011, 1 hour of psychotherapy in August, 2011, and 0 hours of psychotherapy in September, 2011. Patient # 25 attended an average of .66 hours of psychotherapy per month
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Plan of Correction
ARS Counselors have been trained on 3/12/12 to place stops on patients the last two weeks of the month using the automated dispensing system to ensure all patients who are non compliant with counseling hours are met with and complete their requirements for the month. All missed counseling appointments will be documented within the patient record. Patients with repeated missed appointments will be staffed utilizing case consultation.
To ensure compliance, for the next 6 months, the Clinical Supervisor, will review with each counselor monthly their entire caseload and ensure that each patient received and it is documented in their patient chart a minimum of 2.5 hours of psychotherapy per month, during the patient's first 2 years in treatment. Additionally, the facility director will conduct monthly random chart audits to ensure compliance is met.
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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 review of patient records, the facility failed to ensure all efforts had been initiated to retain the patient prior to the involuntary termination in one of three records.
The findings include:
Twenty-eight patient records were reviewed on February 21-23, 2013. Three patient records documented an involuntarily termination from the program.
Patient # 25, was admitted on February 23, 2010 and involuntarily terminated on October 24, 2011 for financial reasons and missing counseling sessions. While financial responsibility was addressed by the Executive Director, the facility did not document sufficient attempts to work with this patient in order to retain them in treatment.
This is a repeat citation from the January 10-12, 2011 methadone monitoring inspection.
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Plan of Correction
On 3/12/2012, the clinical supervisor reviewed the procedures to document the efforts made to work with patients and how the documentation should be reflected within the patient treatment plans with all clinical staff before a patient is presented with an involuntary discharge. All potential discharges will be reviewed by Executive Director, Clinical Supervisor and Medical Director prior to presentation to team to ensure that documentation reflects the efforts made to engage and work with patients. 100 percent of involuntary discharges will be monitored by the Executive Director for compliance ongoing. |
715.23(b)(5) LICENSURE Patient records
(b) Each patient file shall include the following information:
(5) The results of all annual physical examinations given by the narcotic treatment program which includes an annual reevaluation by the narcotic treatment physician.
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Observations
Based on the review of patient records, the facility failed to complete an annual physical with a re-evaluation by the physician in six of six patient records reviewed.
The findings include:
Twenty-eight patient records were reviewed on February 21-23, 2012. Six patient records were reviewed for documentation of an annual physical examination given by the narcotic treatment program which included an annual reevaluation by the narcotic treatment physician. The narcotic treatment physician failed to document a reevaluation in patient records # 1, 3, 9, 13, 15 and 23.
Patient # 1 was admitted 11-4-2010. The annual physical exam was completed on 11-21-2011 by the Certified Physician Assistant (PAc), but did not include a re-evaluation by the physician. The narcotic treatment physician circled "yes" next to a pre-typed standardized statement that said, "the patient continues to be appropriate for MMT."
Patient # 3 was admitted 11-13-2007. The annual physical exam was completed on 11-4-2011 by the Certified Physician Assistant (PAc), but did not include a re-evaluation by the physician. The narcotic treatment physician circled "yes" next to a pre-typed standardized statement that said, "the patient continues to be appropriate for MMT."
Patient # 9 was admitted 12-14-2010. The annual physical exam was completed on 12-6-2011 by the Certified Physician Assistant (PAc), but did not include a re-evaluation by the physician. The narcotic treatment physician circled "yes" next to a pre-typed standardized statement that said, "the patient continues to be appropriate for MMT."
Patient # 13 was admitted 5-6-2008. The annual physical exam was completed on 5-3-2011 by the Certified Physician Assistant (PAc), but did not include a re-evaluation by the physician. The narcotic treatment physician circled "yes" next to a pre-typed standardized statement that said, "the patient continues to be appropriate for MMT."
Patient # 15 was admitted 9-7-2010. The annual physical exam was completed on 9-9-2011 by the Certified Physician Assistant (PAc), but did not include a re-evaluation by the physician. The narcotic treatment physician circled "yes" next to a pre-typed standardized statement that said, "the patient continues to be appropriate for MMT."
Patient # 23 was admitted 1-11-2007. The annual physical exam was completed on 1-13-2011 by the Certified Physician Assistant (PAc), but did not include a re-evaluation by the physician. The narcotic treatment physician circled "yes" next to a pre-typed standardized statement that said, "the patient continues to be appropriate for MMT."
The narcotic treatment physician was interviewed and confirmed that his reevaluation of the patient was by circling the "yes" next to the pre-typed statement on the annual physical completed by the physician's assistant.
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Plan of Correction
The annual physical form has been changed to provide a space where the physician will document his annual reevaluation of the patient. All standardized statements have been removed from the form. The Medical Director will train all medical staff by 3/14/12 on the changes made to this form to ensure ongoing compliance. Compliance with this procedure will continue to be monitored on an ongoing basis through the existing chart audits conducted by the Facility Director and Clinical Supervisor. |
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 the review of administrative documentation, the facility failed to provide documentation of incident reports involving complaints of patient abuse (physical, verbal, sexual , and emotional) to the Department. Additionally, there were two incidents that could have caused potential negative community reaction which need to be reported to the Department.
The findings include:
Administrative documentation that included the unusual incident reports was reviewed February 22, 2012. Patient records were reviewed on February 21-23, 2012 Patient record # 19 documented that she revealed information to her counselor regarding treatment by another provider of services. There was no documentation that this unusual incident was reported to the Department, as required.
On June 11, 2011, there was an incident with a patient that required the facility staff to summon police to the clinic. This incident was not reported to the Department, as required.
On November 21, 2011 an ambulance was called to the facility to assist a patient that fell on a bus at the clinic. This incident involved a patient being transported to the emergency room for evaluation. This incident was not reported to the Department, as required.
This was discussed with facility staff who acknowledged these incident reports were not sent to our Department.
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Plan of Correction
Going forward, the Facility Director will complete all unusual incident reports within 48 hours of an incident. In the event that the Facility Director is not able to submit the report within 48 hours due to being out of the facility, the Project Director will complete and submit the report. Both the Facility and Project Directors have reviewed the regulations regarding unusual incident reporting to ensure that all future qualifying events are reported as required. |