INITIAL COMMENTS
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This report identifies the findings of an on-site complaint investigation conducted at March 28, 2007 by staff from the Division of Drug and Alcohol Program Licensure. The following activities were conducted as part of this investigation:
- Observation and inspection of the medication dispensing area.
- Interviews with staff including counselors, clinical supervisors, facility director, nurse, and program coordinator.
- Review of patient records.
- Review of initial dosing protocol.
- Review of physician coverage.
- Review of intake screening and assessment process and timeframes.
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Plan of Correction
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709.24(a)(4) LICENSURE Treatment/Rehabilitation Management
709.24. Treatment/rehabilitation management.
(a) The governing body shall adopt a written plan for the coordination of client treatment and rehabilitation services which includes, but is not limited to:
(4) Written procedures for referral outlining cooperation with other service providers.
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Observations
The facility's policy and procedure require an intake appointment be held within 7 days of patient contact. By facility report, Bucks County Drug and Alcohol Commission requires that an IV opioid drug user be engaged in treatment within 14 days. The assessment for an IV drug user must occur within 24 hours and for patients who are snorting or swallowing opioids, the assessment must be completed within 72 hours. Aldie must provide interim services within 48 hours of patient contact pending formal admission.
In patient file numbers 1, it appears the assessment for the incoming referral was completed in a timely manner. However, the delay between assessment and actual admission to treatment exceeding the timeframe. The patient record contained no information to explain the almost three week lag between assessment and treatment commencement.
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Plan of Correction
L 0161 - Aldie's Access to Care policy stipulates that if the patient is not able to have an intake session within one week of the assessment, then a referral should be made to Mobile Engagement (i.e., interim) Services. The patient received preadmission medical services at Aldie eight days after the assessment, but there is no documented explanation as to why this patient's intake appointment was 16 days after the assessment or that a referral was made to MES. [Note: The SCA's requirement and Aldie's policy regarding providing interim services within 48 hours, only applies to IV drug users or pregnant women; but patient #1 was neither.]
Aldie is currently in compliance with its Access to Care policies and procedures and SCA requirements. The Pharmacotherapy and Outpatient Program coordinators are responsible for ensuring adherence to the applicable timeframes, including referrals to Mobile Engagement Services and other interim services as warranted, and that any variances to this procedure are adequately documented in the patient's record.
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709.32(c)(1) LICENSURE Medication Control
709.32. Medication control.
(c) The project shall have a written policy regarding all medications used by clients which shall include, but not be limited to:
(1) Administration of medication.
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Observations
Aldie Foundation is governed by both Chapter 709 and 715 concerning medication management. The following deficiencies were identified:
The urine specimens collected from the patient are placed on the same window shelf in the dispensing area that the cup containing methadone is placed on for the patient to pick up for consumption. The shelf was not sanitized between the different uses.
28 Pa. Code 715.6(d)- A narcotic treatment program shall provide narcotic treatment physician services at least one hour per week onsite for every ten patients.
The patient census in June 2006 was 186 patients enrolled in the narcotic treatment program. 18.6 weekly physician service hours were required. The combined physician time for June 2006 for the two narcotic treatment physicians was 49.25 hours or 11.50 hours per week. The facility needed an additional 7.1 hours per week. Only the physician time dedicated to the narcotic treatment program may be included in computing the time to meet this regulation.
28 Pa. Code 715.9(a)(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.
Documentation of current dependency for patient number 1 was based on the results of an urinalysis completed 20 days prior to admission. This cannot be used to determine current dependency.
28 Pa. Code 715.14(b) A narcotic treatment program shall develop and implement policies and procedures to ensure that urine collected from patients is unadulterated. These policies and procedures shall include random observation which shall be conducted professionally, ethically and in a manner which respects patient privacy.
Patients are handed the urine collection container by the receptionist located on the first floor. Patients then proceed unescorted to the lower level bathroom where the specimen is collected. Although the receptionist announces that a patient is going downstairs, this is not always audible to the nurse on the lower level.
The lower level bathroom is equipped with a closed circuit camera and the monitor is in the nurses station. There is baby changing table in the bathroom. When patients face the changing table, their backs are to the camera. Therefore, the nurse is unable to determine if any adulteration took place with the urine sample.
28 Pa. Code 715.14(b) A narcotic treatment program shall develop and implement policies and procedures to minimize misidentification of urine specimens and to ensure that the tested specimens can be traced to the donor.
Patients are required to carry the urine sample to the nursing station window. The patient and urine sample are unobserved from the time they leave the bathroom until they are admitted to the secure dispensing area.
28 Pa. Code 715.16(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.
(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:
Patient number 3 was placed on a six-day take-home schedule at a time when his/her urine drug screen was positive for continued opiate use. The patient did not meet the criteria for take-home privileges.
715.17(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.
(iii)Only authorized staff and patients who are receiving medication shall be permitted in the dispensing area.
When Division staff were observing the methadone dispensing, the staff person unlocked the dispensing room door when the courier arrived to pick up the laboratory samples. Dispensing was in process and neither the daily bottle of methadone nor the safe was secure. The dispensing room needs to secure at all times when the safe is not locked.
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Plan of Correction
L 0319 - 709.32(c)(1) - A divider was installed on the window shelf, and each side has been clearly labeled, in order to separate the specimen containers and the medication dispensing area.
The dispensing staff shall ensure that patients are using the shelf areas correctly, and will sanitize the areas if a container is misplaced on the dispensing side of the barrier.
715.6(d) - Aldie previous calculations for this Standard included the total number of hours that a physician was onsite at Aldie and available to provide physician services to patients if needed. However, the physician was also available to provide some services to outpatient drug-free patients during the hours onsite.
Aldie has subsequently increased the number of onsite hours that the program physician is dedicated to the NTP, and is currently in compliance with this Standard. The program coordinator is assigned the ongoing responsibility to ensure that there are sufficient dedicated physician service-hours onsite for the number of patients in the NTP.
715.9(a)(4) - During the initial intake physical examination the program physician noted several indicators (including current withdrawal symptoms) in determining that patient #1 was currently physiologically dependent upon a narcotic drug, one of which was the results of a urinalysis from a specimen that was obtained 20 days before. This test result should not have been included in the documentation of current indicators.
Aldie has now adopted the practice of only using urinalysis test results that are no more than three days old as one of the factors used to determine current dependency. The program coordinator shall arrange urine testing to occur within this timeframe when scheduling intake physical exam appointments. The program physician shall monitor compliance with this practice.
715.14(b) - The receptionist staff have been instructed to wait for a response from the nurse confirming the announcement, or repeat the announcement until a confirmation is received from the nurse. The office manager shall ensure that the receptionists comply with this procedure.
The baby changing table was removed from the monitored bathroom and placed in a portioned-off area in the adjacent waiting room. A mirror will be installed by June 30, 2007, on the wall opposite of the camera to improve the visibility of patients' actions. The program coordinator shall make sure that no other vision obstructing objects are place in the bathroom used for monitoring patients giving urine samples.
715.14(b) - At the time of this inspection, patients and their urine samples were (and still are) observable by the dispensing nurse from the time they proceed down the steps and enter the bathroom, while they are in the bathroom providing the urine sample, when they leave the bathroom and proceed to the dispensing waiting room less than four feet away, while they are in the waiting room, and until they are admitted to the secure dispensing area where they hand the specimen bottle to the nurse. This is accomplished because there are closed circuit cameras in the hallway outside of the bathroom as well as in the bathroom which are monitored in the nurses' station. The dispensing room door has a large 7"x19" window that allows the nurse to see all patients in the waiting room area prior to admitting them into the secure dispensing area; therefore, patients can be observed by the nurse between the time they leave the bathroom and are admitted to the secure dispensing area. However, Aldie's office manager will also explore the feasibility of installing a mirror in the hallway outside of the bathroom and waiting room if it will be able to provide the nurse with an additional means of observing the patient with a urine sample container as he/she proceeds from the bathroom to the waiting room area. If such a mirror would be effective, it will be installed by June 30, 2007.
715.16 (b)&(c) - Patient #3's urine drug screen was positive for continued opiate use because the patient was taking prescribed pain medication, and not because he was abusing narcotic drugs. Therefore, since the patient also met the other criteria for take-home privileges, the patient was appropriately placed on a six-day take-home schedule. The clinical record of patient 3 contained documentation by the program nurse that the patient brought in a prescription for Hydroco/APAP that was to be taken as needed. The urine test lab report, that showed the opiate use, was received on 3/27/07 (a day before this onsite investigation occurred) and was reviewed by the physician on 3/29/07, the next day that the physician was onsite. The physician noted on the report that the opiate was the prescription medication and that it was discussed. This patient record includes significant documentation of the patient's extensive medical problems and the patient suffers significant pain, for which the patient occasionally takes the prescribed pain medication as needed. The last time the patient's urine indicated positive for opiates was 5/23/06, which shows that the patient is not likely to be abusing or inappropriately using the "prn" pain meds.
Aldie's NTP has recently created a new "Take-home Medication Privilege Change Request" form, and eliminated the use of a previous multi-purpose form, in order to improve the documentation of the criteria used in making take-home medication decisions. Use of this new form in patient records will prevent the appearance of a possible violation of this Standard in the future. The program physician shall insure that this new form is properly completed prior to writing orders for any changes in take-home medication privileges.
715.17(c)(1)(iii) - From the dispensing nurse's perspective, she did maintain the security of the dispensing room when she momentarily unlocked and opened the door to give collected urine samples to the laboratory courier. The nurse is required to insure that the patient urine samples are secured, and therefore she keeps them in the dispensing room until the courier can take them. The door was not left unlocked or unattended while the methadone bottle was out of the safe during dispensing. However, the bottle was not properly secured in the dispensing cabinet, nor was the safe locked at that time.
As a result, the nurse manager will be responsible for instructing and monitoring the dispensing staff regarding the following medication security procedures. The safe is to remain locked except when removing or depositing a methadone bottle, and that the bottle attached to the dispensing machine is to be secured in the adjacent locked holding container. All bottles containing methadone are to be kept in the safe except for the one being used during dosing. The dispensing nurse shall not unlock the door to the nursing station at any time that the safe is open or a bottle is not yet secured in the dispensing cabinet. Aldie's medication control policy will be revised by 6/30/07 to specifically include these procedures for securing methadone bottles during dosing.
As an additional security measure, the nurse manager has subsequently made a request to the courier to plan the arrival time to pick up the urine samples to be after the regular dosing hours. However, since the timeframe on most days between the end of dosing and when the nurse leaves for the day (i.e., alarming the dispensing area) is only an hour or less, the courier may not always be able to delay arriving until after dosing. On the occasions when this occurs, the dispensing nurse shall be responsible for insuring that only authorized persons are able to gain access into the dispensing room.
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709.91(b)(2)(iv) LICENSURE Intake and admission
709.91. Intake and admission.
(b) Intake procedures shall include documentation of:
(2) Client orientation to the project which shall include, but is not limited to, a familiarization with the following:
(iv) Services provided.
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Observations
Patient number 2 disclosed at intake both past and current use of drugs and alcohol including use of narcotics. Patient was initially assessed as needing intensive drug and alcohol outpatient treatment. There is no indication that the patient who was diagnosed as opioid dependent was made aware of the narcotic treatment services offered by Aldie Foundation.
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Plan of Correction
L 1859 - The assessment process covers explaining to the patient the various services that are available. The clinical record of Patient 2 includes the signed "Client Letter of Understanding" which was completed with the patient at the time of the assessment. This form lists all of the programs offered by Aldie. By signing this form, the patient indicated agreement that the indicated treatment modality was appropriate for him. Therefore there was an indication in the patient's record that he was made aware of all the services offered by Aldie.
In order to clarify for record reviewers that the patient has become familiarized with the services provided by Aldie, including narcotic treatment services, the "Client Letter of Understanding" form has be edited to add wording (before the statement that the patient agrees that he/she is appropriate for the indicated service modality) that specifies that all of the services provided by Aldie were explained to the patient. The Pharmacotherapy and Outpatient Program coordinators shall insure that this form is completed as part of the assessment paperwork packet.
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