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 May 12, 13, 14, and 15, 2008 by staff from the Division of Drug and Alcohol Program Licensure. Based on the findings of the on-site inspection, Health Masters, Inc. was found not to be in compliance with the applicable chapters of 28 PA Code which pertain to the facility. Deficiencies were identified during this inspection and plan of correction is due on June 10, 2008.
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Plan of Correction
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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 32 patient records, the facility failed to document that the physician reviewed methadone dose levels for the patients at least twice a year. Specifically, the patient records contained documentation that the certified registered nurse practitioner had performed dose reviews for patients # 5, 6, 11, and 18. Only the physician may perform the dose reviews.
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Plan of Correction
Health Masters will employ an adjusted form for the documentation of dose reviews that will reflect that the physician only is determining the dosage of patients. To ensure compliance with this standard, Project Director will monitor dose reviews performed monthly for physician input only. Compliance with standard effective 7/1/2008. |
715.16(b)(1-8) LICENSURE Take-home privileges
(b) The narcotic treatment physician shall consider the following in determining whether, in exercising reasonable clinical judgment, a patient is responsible in handling narcotic drugs:
(1) Absence of recent abuse of drugs (narcotic or non-narcotic), including alcohol.
(2) Regular narcotic treatment program attendance.
(3) Absence of serious behavioral problems at the narcotic treatment program.
(4) Absence of known recent criminal activity.
(5) Stability of the patient 's home environment and social relationships.
(6) Length of time in comprehensive maintenance treatment.
(7) Assurance that take-home medication can be safely stored within the patient 's home.
(8) Whether the rehabilitative benefit to the patient derived from decreasing the frequency of attendance outweighs the potential risks of drug diversion.
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Observations
Based upon a review of facility policy and procedure regarding take-home privileges and the record review of 32 patient records, 19 of which were reviewed for take-home privilege content, the facility failed to follow their policy and procedure in the determination of patients' take-home status. Specifically, patient # 28 returned two take-home bottles in a metal container that did not lock (locked containers are required); patient # 17 continued to have six day take-home status although record documentation indicated that the patient's attendance at the facility was not on a regular basis as scheduled; and patients # 2 and 20 received tri-weekly take-home privileges when they did not adhere to the facility policy or the requirements of the regulations for take-home privileges.
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Plan of Correction
Nursing personnel have been instructed by Facility Director to not allow any take home medication to leave facility unless a locked container is provided by patient in compliance with Health Masters policy.
Patients have been issued reminder notes by nursing personnel as to policy enforcement. Lock boxes and locks have been purchased by facility for use by patients, and are available at front desk. Nursing Supervisor will be responsible to ensure compliance by randomly checking dosing area and actions of dosing personnel. Compliance with standard and policy effective 7/1/2008.
All take home privilege changes are to be discussed during interdepartmental meeting, as per policy, with physician making final determination of any and all changes. Facility Director will instruct staff, both clinical and medical, of the proper procedure for initiating all changes regarding granting, rescinding, and reinstating take home privilege status of patient. Eight point criteria and Health Masters take home privilege form will be utilized to document changes, as well as case consult form. Facility Director will ensure compliance with policy and standards effective 7/15/08
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715.16(c) 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:
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Observations
Of the review of 32 patients, 19 patient records were reviewed for take-home privilege content. The facility failed to submit a thirteen day take-home exception request to the Department for the one applicable record. Specifically, the facility granted patient # 8 thirteen take-home doses for a vacation without submitting an exception request to the Department nor obtaining Department approval.
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Plan of Correction
Project Director will be responsible for instructing all clinical staff as to the criteria regarding take home exception doses. Department standards, as well as Health Master's policy and procedure will be reviewed as an in house training to ensure that staff is aware of the proper use of exception forms regarding take home medications. Facility Director will forward all exception requests to physican for review and determination of appropriateness. Compliance with standard effective 7/15/2008. |
715.17(b) LICENSURE Medication control
(b) A narcotic treatment program shall develop policies and procedures regarding verbal medication orders, including the issuing and receiving of orders, identifying circumstances when orders are appropriate and documenting orders, in accordance with applicable Federal and State statutes and regulations.
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Observations
Of the 32 patient records reviewed, 19 records were reviewed for medication orders along with a review of the facility policy and procedure on medication orders. The facility failed to have the physician sign the verbal order within 24 hours in 19 records reviewed.
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Plan of Correction
Verbal orders issued by physician will be signed within the required 24 hours by
physician while on-site or by fax when off-site within that time frame.
Physician is available 7 days/week to ensure compliance with regulation. Project Director will be made aware of all verbal orders accepted for the day, and
Project Director will be responsible for ensuring that physician will be on-site to
sign for orders in acceptable time frame or sign the order while off site and fax it to the site. Compliance by 7/1/08.
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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
Of the 32 patient records reviewed, 19 patient records were reviewed to determine compliance of the physician's medication orders. The facility failed to have the physician sign the initial dosing orders prior to the patient's first dose of methadone in nine patient records, # 1, 2, 3, 4, 20, 22, 24, 25, and 26.
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Plan of Correction
Effective 7/15/2008, Health Masters intake policy will reflect the practice of the narcotic treatment physician signing and dating the initial dose order for a patient immediately following physical exam and prior to patient receiving initial dose of medication. Nurse Practitioner and Facility Director will review intake documentation to ensure that initial dose orders are manually written by physician and entered into patient's chart prior to receiving initial dose of medication. Compliance with standard effective 7/15/2008. |
715.17(c)(3)(i-v) 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:
(3) Inspection of storage areas. A narcotic treatment program shall inspect all drug storage areas and the dispensing station at least quarterly to ensure that the areas are maintained in compliance with Federal, State and local laws and regulations. A narcotic treatment program shall develop and implement written policies and procedures regarding who performs the inspections, how often, and in what manner the inspections are to be documented. The policies and procedures shall include the following:
(i) Disinfectants and drugs for external use shall be stored separately from oral and injectable drugs.
(ii) Drugs requiring special conditions for storage to insure stability shall be properly stored.
(iii) Outdated and contaminated drugs shall be removed and destroyed according to Federal and State regulations.
(iv) Administration of controlled substances shall be documented.
(v) Controlled substances and other abusable drugs shall be stored in accordance with Federal and State regulations.
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Observations
Based on a review of policy and procedure and facility documentation, the quarterly inspection of the medication areas did not comply with the requirements of the standards and facility policy. Specifically, the quarterly inspections listed only inventories of current supplies and did not include information regarding the storage of disinfectants, drugs for external use, and drugs requiring special storage conditions nor did the documentation include removal and destruction of outdated and contaminated drugs.
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Plan of Correction
Nursing personnel have created an inspection list and form that accounts for the inventories, storage, removal and destruction of materials and drugs required by standard. Nursing personnel had previously utilized an inventory method that was exhaustive but not complete by the standard. Nursing personnel will be responsible for completing inventory monthly according to policy and presenting to CRNP for approval. Compliance effective for month of July, beginning 7/1/08. |
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 provide each patient with the minimal requirement of an average of 2.5 hours of psychotherapy per month during the patient's first 2 years of treatment in 6 of 19 records (# 7, 19, 21, 26, 29, and 32) reviewed for content.
Patient # 7 received 1.5 hours of psychotherapy in January 2008, 2.5 hours in February 2008, and 1.25 hours in March 2008; an average of 1.75 hours.
Patient # 19 received 2.25 hours of psychotherapy in February 2008, 2.5 hours in March 2008, and 2.5 hours in April 2008; an average of 2.4 hours.
Patient # 21 received 1.25 hours of psychotherapy in February 2008, 1.75 hours in March 2008, and 2.25 hours in April 2008; an average of 1.75 hours.
Patient # 26 received 3 hours of psychotherapy in February 2008, 2.75 hours in March 2008, and 1.25 hours in April 2008; an average of 2.3 hours.
Patient # 29 received 2.5 hours of psychotherapy in February 2008 and .75 hours in March and April 2008; an average of 1.3 hours.
Patient # 32 received 2.5 hours recorded in February and April 2008 and 1.25 in March 2008; an average of 2.0 hours.
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Plan of Correction
Project Director will continue to review service provided with counselors during weekly supervision. Counseling staff will provide to Director a schedule that includes all patients and necessary counseling times. Patients will be given a copy of group meeting calendar at the onset of each month. Front desk personnel and counseling staff will enforce counseling attendance on scheduled dates prior patients receiving medication. Any patient noncompliant with counseling requirements for a given month will be discussed during interdepartmental meeting for consideration of placement on a "behavior contract". These patients will be required to attend additional counseling in order to obtain the required monthly average counseling time. Project Director will be responsible for generating services provided reports weekly and to address caseload compliance with individual counselors. Compliance with standard effective 8/1/08. |
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 a review of patient records, the physician failed to date the results of the patient's physical reevaluation in 6 of 13 patient records reviewed for content, specifically, patients # 21, 23, 25, 27, 31, and 32. The timeliness of undated material cannot be determined.
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Plan of Correction
Project Director will be responsible for reviewing with physician the standards addressing patient records and the required information. Physician will be responsible for to affix a date to signature as appropriate on all documentation required in patient record. CRNP and Project Director will be responsible for processing patient record information and reviewing for all properly dated signatures. Compliance with standard by 7/15/08 |
715.23(b)(15) LICENSURE Patient records
(b) Each patient file shall include the following information:
(15) Psychosocial evaluations of the patient.
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Observations
Of the 32 patient records that were reviewed, 11 were reviewed for the content of the psychosocial evaluation. The facility failed to provide an evaluative assessment of the patient history obtained by clinical staff that included the counselor's clinical analysis of the patient's problems/needs, assets/strengths, support systems, coping mechanisms, negative factors, patient's attitude toward treatment and overall impressions. Instead, the psychosocial evaluations of the patient consisted primarily of the repetition of the history and statements reported by the patient in 4 of 11 records reviewed for content, patient records # 20, 22, 24, and 30.
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Plan of Correction
Project Director will be responsible for reviewing all completed evaluative assessments by clinical staff and ensure that the clinician has applied an analysis of patient problems and needs based on reported and documented information. Project Director will address assessment needs via an in-house training and present the components of the assessment to clinical staff. Additional trainings will also be made available to staff through various providers, based on availability, such as Greenbriar Treatment Center, Pyramid Services, Gateway Rehabilitation Center, BDAP. Project Director will continue to attempt to obtain resource materials as instructional aids for staff to assist in improving clinical assessment skills. Compliance with standard ongoing, with in-house training by 8/1/08, and additional trainings throughout year 2008. |
715.23(d) LICENSURE Patient records
(d) A narcotic treatment program shall prepare a treatment plan that outlines realistic short and long-term treatment goals which are mutually acceptable to the patient and the narcotic treatment program.
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Observations
Of the 32 patient records reviewed, 24 records were reviewed for the content of the treatment plan. The treatment plans contained global and non-specific goals; the contents did not address patient specific needs and goals as identified in patients' personal histories and psychosocial evaluations in 13 records, specifically, patient records # 9, 16, 20, 21, 22, 23, 24, 25, 26, 29, 30, 31, and 32.
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Plan of Correction
Health Masters will continue to provide Counseling staff training regarding effective treatment plan formation. The Greenbriar Treatment Center provides information which will be made available to entire staff at an in-house training by Project Director. Resource material will also be obtained for each counselor. Project Director and physician will be responsible for reviewing content of individual treatment plans to ensure relevancy to identified patient needs in history. Compliance by 8/1/08.
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715.23(d)(1) LICENSURE Patient records
(d) A narcotic treatment program shall prepare a treatment plan that outlines realistic short and long-term treatment goals which are mutually acceptable to the patient and the narcotic treatment program.
(1) The treatment plan shall identify the behavioral tasks a patient shall perform to complete each short-term goal.
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Observations
Of the 32 patient records, 24 patient records were reviewed for treatment plan content. Twelve patient records, specifically # 9, 16, 20, 21, 22, 23, 24, 25, 26, 29, 30, 31, and 32, contained vague, non-specific steps to reach their goals and the time frames were generalized rather than realistically specific to the action step. Further, the treatment plans did not include support services.
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Plan of Correction
Health Masters will continue to provide Counseling staff training regarding effective treatment plan formation. The Greenbriar Treatment Center provides information which will be made available to entire staff at an in-house training by Project Director. Resource material will also be obtained for each counselor. Project Director will be responsible for reviewing content of individual treatment plans to ensure relevancy to identified patient needs in history. Compliance by 7/1/08. |
715.23(d)(2) LICENSURE Patient records
(d) A narcotic treatment program shall prepare a treatment plan that outlines realistic short and long-term treatment goals which are mutually acceptable to the patient and the narcotic treatment program.
(2) The narcotic treatment physician or the patient 's counselor shall review, reevaluate, modify and update each patient 's treatment plan as required by Chapters 157, 709 and 711 (relating to drug and alcohol services general provisions; standards for licensure of freestanding treatment activities; and standards for certification of treatment activities which are a part of a health care facility).
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Observations
Of the 32 patient records, 23 records were reviewed for the content of the treatment plan update. The facility failed to document the progress or lack of progress in achieving the goals from the prior treatment plan in 7 of 23 patient records, specifically, patients # 16, 21, 23, 29, 30, 31, and 32.
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Plan of Correction
Health Masters will continue to provide Counseling staff training regarding effective treatment plan formation. The Greenbriar Treatment Center provides information which will be made available to entire staff at an in-house training by Project Director. Resource material will also be obtained for each counselor. Project Director will be responsible for reviewing content of individual treatment plans to ensure relevancy to identified patient needs in history. Compliance by 7/1/08. |
715.28(b)(1-4) LICENSURE Unusual incidents
(b) These policies and procedures shall include the following:
(1) Documentation of the unusual incident.
(2) Prompt review and investigation.
(3) Implementation of a timely and appropriate corrective action plan, when indicated.
(4) Ongoing monitoring of the corrective action plan.
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Observations
Based on a review of policy and procedure and record review, the facility failed to follow policy as there was no incident report developed following the death of patient # 10.
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Plan of Correction
Facility Director will be responsible for acknowledging all incidents and ensuring that incident reports are completed in timely manner. Facility Director will be responsible for reporting occurrence of incidents to Compliance Officer, as well as to Department. Entire staff will be issued copy of policy listing unusual incidents that require reporting to Director and Compliance Officer, as well as to the Department. Compliance with standard effective 7/1/2008. |
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 review of administrative documentation provided during the inspection and staff interviews, the facility failed to submit documentation of unusual incidents to the Department as required; specifically, the facility failed to notify the Department of the death of patient # 10.
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Plan of Correction
Facility Director will be responsible for acknowledging all incidents and ensuring that incident reports are completed in timely manner. Facility Director will be responsible for reporting occurrence of incidents to Compliance Officer, as well as to Department. Entire staff will be issued copy of policy listing unusual incidents that require reporting to Director and Compliance Officer, as well as to the Department. Compliance with standard effective 7/1/2008. |