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 August 18-20, 2009 by staff from the Division of Drug and Alcohol Program Licensure. Based on the findings of the on-site inspection, Discovery House, Inc. 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 September 24, 2009.
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Plan of Correction
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715.6(b)(1-9) LICENSURE Physician Staffing
(b) A narcotic treatment program may employ narcotic treatment physicians to assist the medical director. A narcotic treatment physician 's responsibilities include:
(1) Performing a medical history and physical exam.
(2) Determining diagnosis and determining narcotic dependence.
(3) Reviewing treatment plans.
(4) Determining dosage and all changes in doses.
(5) Ordering take-home privileges.
(6) Discussing cases with the treatment team.
(7) Issuing verbal orders pertaining to patient care.
(8) Assessing coexisting medical and psychiatric disorders.
(9) Treating or making appropriate referrals for treatment of these disorders.
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Observations
Based on the review of administrative documentation, the facility failed to include all of the required responsibilities of the narcotic treatment physician.
The findings include:
The policy and procedure manual and physician job description were both reviewed on August 18, 2009. The physician's job description did not include issuing verbal orders pertaining to patient care, assessing coexisting medical and psychiatric disorders or treating/referring for treatment of these disorders. The policy and procedure manual specifically stated on page 130 that the program does not provide any medical treatment for physical and/or mental health conditions. It also states that the program does not evaluate for these disorders, prescribe, dispense or administer meds other than opiate agonists medications.
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Plan of Correction
The corporate office will amend the physician job description, and the policy and procedure manual to include issuing verbal orders pertaining to pt care, assessing coexisting medical and psychiatric disorders, and treating/referring for treatment of these disorders as a physician's job duty. The medical director will be trained by the corporate medical director on these tasks by 10/15/09. |
715.6(d) LICENSURE Physician Staffing
(d) A narcotic treatment program shall provide narcotic treatment physician services at least 1 hour per week onsite for every ten patients
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Observations
Based on the review of physician's time sheets and a discussion with the facility director, the facility failed to provide the required physician hours for the census being served.
The findings include:
A review of the physicians' time sheets was conducted on August 18, 2009 revealing that the former medical director discontinued employment with the facility as of June 29, 2009 and the new medical director began his employment with the facility on July 8, 2009. The facility was without a medical director for a period of eight days. This was confirmed by the facility director.
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Plan of Correction
The facility will ensure that the required physician hours for the census being served is met by obtaining a back up physician in case the current medical director terminates his employment, needs vacation leave or sick time, or leaves for any other reason by 11/1/09. |
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 the review of the certified registered nurse practitioner (CRNP) job description, the facility failed to restrict the functions of the CRNP to those allowed by regulation.
The findings include:
The job description for the CRNP was reviewed for content on August 18, 2009. The job description was signed on July 7, 2009 and allowed for the CRNP to prescribe medication and insure appropriate dose, exceeding what state regulations allow.
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Plan of Correction
The corporate office will amend the CRNP job description for the state of Pennsylvania to not include prescribing and insuring appropriate dose as a job duty by 10/15/09. The Director on-site will do monthly chart audits to ensure that the CRNP is not prescribing medication. |
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 the review of patient records, the facility failed to have the physician document the basis for the determination of current dependency and one year history of addiction prior to the administration of the narcotic agent in three of five patient records.
The findings include:
Twenty five patient records were reviewed on August 18-20, 2009. Five records were reviewed for physician documentation of dependency.
Patient record # 8 was administered a narcotic agent on June 9, 2009. The documentation of dependency was completed on June 11, 2009.
Patient record # 12 was administered a narcotic agent on August 10, 2009. The documentation of dependency form was signed on August 19, 2009, but there was no information entered for the basis of the determination.
Patient record # 19 was administered a narcotic agent on August 5, 2009. The documentation of dependency was completed on August 19, 2009.
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Plan of Correction
The corporate medical director will train the medical director on how to properly and efficiently document determination of current dependency and one year history of addiction on new admissions in the patient charts by 10/15/09. The Director on-site will collaborate with the corporate medical director on conducting monthly chart audits to ensure this deficiency does not recur. |
715.9(b)(2) LICENSURE Intake
(b) Exceptions to the requirements in subsection (a) are:
(2) Upon readmitting a patient who has been out of a narcotic treatment program for 6 months or less after a voluntary termination, the narcotic treatment program shall update the information in and review the patient 's file to show current opiate narcotic dependency, but need not conduct a physical examination and applicable laboratory tests. Privileges earned during the previous treatment may be reinstated at the discretion of the narcotic treatment physician.
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Observations
Based on the review of patient records, the facility failed to show current dependency for a re-admitted patient in one of two patient records.
The findings include:
Twenty five patient records were reviewed on August 18-20, 2009. Two records were reviewed for documentation of a readmitted patient who had been out of treatment for less than 6 months after a voluntary termination.
Patient record # 12 demonstrated a voluntary termination date of 4-20-2009 and a re-admission date of 8-10-2009. The patient had an intake urine drug screen on July 28, 2009, with the results returned on July 30, 2009. The patient had a positive for methadone result. There was no documentation as to where the patient was getting the methadone. The physician met with the patient on 8-10-2009 and completed a physical exam in which he documented the sign of current dependency as "yawning" without any further detail. The documentation of current and one year addiction history was not signed by the physician until 8-19-2009 and failed to include any information determining whether the patient had a current dependency.
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Plan of Correction
The corporate medical director will train the medical director on properly documenting current dependency for readmissions by 10/15/09. The medical director will commence with proper documentation of current dependency. The corporate medical director, along with the on-site director, will conduct monthly chart audits to ensure this deficency does not recur. |
715.10(b) LICENSURE Pregnant patients
(b) A narcotic treatment program shall give pregnant patients the opportunity for prenatal care either by the narcotic treatment program or by referral to appropriate health-care providers.
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Observations
Based on the review of patient records, the facility failed document that pregnant patients were given the opportunity for prenatal care either by the narcotic treatment program or by referral to appropriate health-care providers in one of two patient records reviewed.
The findings include:
Twenty five patient records were reviewed on August 18-20, 2009. Two patient records were reviewed for documentation of prenatal care. Patient record # 20 contained documentation by the clinician that the patient would see the facility physician, but there was no supporting documentation the patient was receiving prenatal care at the facility or anywhere else.
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Plan of Correction
The facility director will instruct the nursing manager to schedule all pregnant patients to meet with the medical director on a monthly basis as soon as the patient is determined to be pregnant by 10/15/09. The medical director will be trained on how to make referrals to appropriate health-care providers by the corporate medical director by 10/15/09. The on-site director will ensure that the medical director is documenting proper referrals by conducting monthly chart audits and noting whether or not this plan of correction has been implemented by the medical director. |
715.10(d) LICENSURE Pregnant patients
(d) Within 3 months after termination of pregnancy, the narcotic treatment physician shall enter an evaluation of the patient 's treatment status into her record and state whether she should remain in comprehensive maintenance treatment or receive detoxification treatment.
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Observations
Based on the review of patient records, the narcotic treatment program failed to document, within three months after the termination of pregnancy, whether or not the patient should continue maintenance or receive detoxification treatment in one of one patient record.
The findings include:
Twenty five patient records were reviewed August 18-20, 2009. Two patient records were reviewed for documentation pertaining to pregnancy care. An evaluation of the patient's treatment status within three months after termination of pregnancy was required in one patient record. The narcotic treatment program, specifically the physician, did not document this evaluation that was due by August 19, 2009 based on the patient's termination of pregnancy on May 19, 2009 in patient record # 21.
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Plan of Correction
The corporate medical director will train the medical director on the necessity of meeting with all patients who have terminated pregnancies within three months of the termination of pregnancy by 10/15/09. The facility director will train the nursing manager on how to schedule the medical director to meet with all patient who have terminated pregnancies within three months of the termination by 10/15/09. The nursing manager will keep a list of patients that need to meet with the medical director for this issues, and the director on-site will audit those charts to ensure the patient has met with the medical director in a timely manner. |
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 the review of patient records, the facility failed to ensure that the narcotic treatment physician completed the dose reviews in three of four patient records.
The findings include:
Twenty five patient records were reviewed on August 18-20, 2009. Four patient records were reviewed for the required semi-annual dose review by the narcotic treatment physician. Three patient records contained documentation of the Certified Registered Nurse Ratione (CRNP) completing the semi-annual dose review.
Patient record # 10 had a documented dose review by the CRNP in July 2009.
Patient record # 13 had a documented dose review by the CRNP in August 2009.
Patient record # 20 had a documented dose review by the CRNP in July 2009.
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Plan of Correction
The corporate medical director will be conducting a training to instruct the CRNP and the medical director on the limitations of requirements of the CRNP position. The facility director will ensure that only the medical director is assessing patients for semi-annual dose reviews, instead of the CRNP by 10/15/09. The Director will audit random charts every 2 months to attest to this. |
715.15(f) LICENSURE Medication dosage
(f) The narcotic treatment program shall develop written policies and procedures relating to narcotic treatment medication dosage which includes the requirements of subsections (a)--(e).
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Observations
Based on the review of the facilities policy and procedure manual on August 18, 2009 the facility failed to restrict the reviewing the dosage levels to the physician only in their policy and procedure .
Findings:
The policy and procedure manual contained language allowing the physician to assign a designee to review patient dosage levels. The policy for dose adjustments allows the clinician/nurse or clinical team to consult with the Discovery House physician for dose adjustments. Dose adjustments will receive final approval by physician OR DESIGNEE.
This was a repeat deficiency from the last methadone monitoring review.
In addition, on page 137 of the manual, it states that a solid form of the medication may be given to those with more then one-week status and it MAY be prepared and dispensed in a single child-proof medication box. And the solid form may be scored for the patient to halve or quarter, based on the dosing instructions
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Plan of Correction
The corporate office will revise the policy and procedure to reflect that only the physician (and no designee) can review the dosage levels of patients by 9/21/09. Random chart audits every two months will be conducted by the on-site director to ensure this corrective action is being implemented. |
715.16(a)(5) LICENSURE Take-home privileges
(a) A narcotic treatment program shall determine whether a patient may be provided take-home medications.
(5) A narcotic treatment program shall develop written policies and procedures relating to granting and rescinding take-home medication privileges.
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Observations
Based on the review of the facility's policy and procedures and patient records, the facility failed to establish policy and procedure compliant with the regulations in granting take-home medication privileges.
The findings include:
The policy and procedure manual was reviewed on August 18, 2009. Patient records were reviewed August 18-20, 2009. The policy and procedure manual uses the Department's previously issued criteria guidelines as their policy to grant take-home medication privileges to patients with time less than required in the regulations. The patient records revealed the practice of the program is consistent with the criteria guidelines that are more liberal than the regulations require.
Patient record # 13 was admitted 8-24-2007 and was given 6 take-home bottles since 4-3-2009.
Patient record # 18 was admitted 7-29-2008 and was given bi-weekly take home status on 6-25-2009. This patient comes into dose 2 days per week, receiving take home medication bottles for 3 days and 2 days. To be eligible for 3 day take home bottles, a patient is required to be in treatment for at least 2 years. In addition, this patient is receiving split doses.
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Plan of Correction
The corporate compliance officer at the corporate office will ammend the policy to reflect the PA Dept. of Health's criteria for take home privileges. |
715.16(c)(2)(i-iv) LICENSURE Take-home previliges
(c) A narcotic treatment program shall require a patient to come to the narcotic treatment program for observation daily or at least 6 days a week for comprehensive maintenance treatment, unless a patient is permitted to receive take-home medication as follows:
(2) A narcotic treatment program may permit a patient to reduce attendance at the narcotic treatment program for observation to two times weekly and receive no more than a 3-day take-home supply of medication when in the reasonable clinical judgment of the narcotic treatment physician, which is documented in the patient record:
(i) A patient demonstrates satisfactory adherence to narcotic treatment program rules for at least 2 years.
(ii) A patient demonstrates substantial progress in rehabilitation.
(iii) A patient demonstrates responsibility in handling narcotic drugs.
(iv) A patient demonstrates that rehabilitation progress would improve by decreasing the frequency of attendance for observation.
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Observations
Based on a review of patient records, the facility failed to adhere to the requirements for granting take-home medication privileges to one of one patient records.
The findings include:
Twenty five patient records were reviewed on August 18-20, 2009. Six patient records were reviewed for compliance to take home privilege regulations. One of the 6 records was reviewed for compliance to receiving no more than a 3-day take home supply. Patient record # 18 was admitted 7-29-2008 and was given bi-weekly take home status on 6-25-2009. The patient attends 2 non-consecutive days per week, receiving take home medication bottles for 3 days and then 2 days. To be eligible for 3 day take home bottles, a patient is required to be in treatment for at least 2 years. In addition, this patient is receiving split doses.
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Plan of Correction
The corporate compliance officer at the corporate office will ammend the policy to reflect the PA Dept. of Health's criteria for take home privileges. |
715.16(c)(3)(i-viii) LICENSURE Take-home privileges
(c) A narcotic treatment program shall require a patient to come to the narcotic treatment program for observation daily or at least 6 days a week for comprehensive maintenance treatment, unless a patient is permitted to receive take-home medication as follows:
(3) A narcotic treatment program may permit a patient to reduce attendance at the narcotic treatment program for observation to one time weekly and receive no more than a 6-day take-home supply of medication when in the reasonable clinical judgment of the narcotic treatment physician, which is documented in the patient record:
(i) A patient demonstrates satisfactory adherence to narcotic treatment program rules for at least 3 years.
(ii) A patient demonstrates substantial progress in rehabilitation.
(iii) A patient demonstrates responsibility in handling narcotic drugs.
(iv) A patient demonstrates that rehabilitation progress would improve by decreasing the frequency of attendance for observation.
(v) A patient demonstrates no major behavioral problems.
(vi) A patient is employed, is actively seeking employment, attends school, is a homemaker or is considered unemployable for mental or physical reasons.
(vii) A patient is not known to have abused alcohol or other drugs within the previous year.
(viii) A patient is not known to have engaged in any criminal activity within the previous year.
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Observations
Based on a review of patient records, the facility failed to adhere to the requirements for granting take-home medication privileges in one of five patient records.
The findings include:
Twenty five patient records were reviewed on August 18-20, 2009. Six patient records were reviewed for compliance to take home privilege regulations. Five of the six records were reviewed for compliance to the receiving of a 6-day take-home supply of the medication. One of the five records reviewed was granted a 6-day take-home supply as of 4-3-2009. Patient record # 13 was admitted 8-24-2007. A patient must demonstrate satisfactory adherence to narcotic treatment program rules for at least 3 years.
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Plan of Correction
The corporate compliance officer at the corporate office will ammend the policy to reflect the PA Dept. of Health's criteria for take home privileges. |
715.17(c)(6)(i-iv) 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:
(6) Inventories. A narcotic treatment program shall conduct monthly inventories of agents and other controlled substances stored. Each inventory record shall include:
(i) The date the inventory was conducted.
(ii) The time of day it was conducted.
(iii) The name and amount of each product on hand at the time of the inventory.
(iv) The name of the individual conducting the inventory.
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Observations
Based on the review of administrative documentation and staff interviews, the facility failed to complete the inventory of agents and other controlled substances on a monthly basis for one of the past 12 months reviewed.
The findings include:
The binder of the documented monthly inventories was reviewed on August 20, 2009. There was no documented inventory for the month of July 2009. The nurse responsible reported the July inventory was given to the director. The director denied having a copy of the July inventory, acknowledging it had not been completed as required.
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Plan of Correction
The medical director will request documentation of the inventory of agents and other controlled substances from the facility's nursing manager at the end of every month and for the month that was missed. The documentation will be given to the facility's director and retained in both the dispensary and a binder in the director's office effective 10/1/09. The director and nurse manager will ensure that the corrective action is implemented. |
715.21(1)(i-iv) LICENSURE Patient termination
A narcotic treatment program shall develop and implement policies and procedures regarding involuntary terminations. Involuntary terminations shall be initiated only when all other efforts to retain the patient in the program have failed.
(1) A narcotic treatment program may involuntarily terminate a patient from the narcotic treatment program if it deems that the termination would be in the best interests of the health or safety of the patient and others, or the program finds any of the following conditions to exist:
(i) The patient has committed or threatened to commit acts of physical violence in or around the narcotic treatment program premises.
(ii) The patient possessed a controlled substance without a prescription or sold or distributed a controlled substance, in or around the narcotic treatment program premises.
(iii) The patient has been absent from the narcotic treatment program for 3 consecutive days or longer without cause.
(iv) The patient has failed to follow treatment plan objectives.
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Observations
Based on the review of administrative documentation, the facility failed to restrict the reasons for involuntary termination to those areas allowed by regulation.
The findings include:
The policy and procedure manual was reviewed on August 18, 2009.
The manual includes examples for immediate discharge that includes revealing a weapon of any kind.
The patient handbook was reviewed on August 18, 2009. Involuntary administrative termination was discussed on page 20. The reasons the facility could involuntarily terminate a patient included a statement "you violate the program rules" without being specific. On page 21 and 22 there was a discussion of what the program rules were. These rules exceeded what the regulations allow for involuntary termination, including having weapons on the property, wearing hats or sunglasses at the dosing window, loitering, and paying the fee on time.
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Plan of Correction
The corporate office will amend the policy and procedure manual, as well as the patient handbook, to reflect the Pennsylvania Department of Health's regulations regarding reasons for involuntary termination by 10/15/09. The director on-site will train all employees in an in-service training on the regulations for involuntary termination. All staff will report any involuntary termination to the corporate clinical supervisor. The Clinical Service Coordinator will ensure that the corrective action is being implemented at the clinic. |
715.23(b)(14) LICENSURE Patient records
(b) Each patient file shall include the following information:
(14) Case consultation notes regarding the patient.
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Observations
Based on the review of patient records, the facility failed to document case consultations listing the names and discipline of all staff involved in the case consultations in three of five patient records.
The findings include:
Twenty five patient records were reviewed on August 18-20, 2009. Five patient records were reviewed for case consultations. Three of the patient records, # 1, 5 and 10, failed to include what staff were consulted and the discipline of each.
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Plan of Correction
The facility's clinical supervisor will conduct an in-service training for all clinical staff regarding correctly documenting names and disciplines of all staff involved in case consultations by 10/15/09. The clinical supervisor will ensure that all case consultations are being documented correctly beginning on 10/15/09 by having all case consultations submitted to her to review as they are due. |