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 September 5 and 6, 2012, by staff from the Division of Drug and Alcohol Program Licensure. Based on the findings of the on-site inspection, Habit OPCO -Watsontown, was found not to be in compliance with the applicable chapters of 4 PA Code and 28 PA Code which pertain to the facility. The following deficiencies were identified during this inspection.
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Plan of Correction
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715.6(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 a review of personnel records and administrative documentation, the facility failed to identify all of the responsibilities of a narcotic treatment physician.
The findings include:
Nine personnel records and the policy and procedure manual were reviewed on September 5, 2012. The medical director's personnel record was reviewed for documentation of responsibilities. The record contained a job description that was not signed.
The finding was reviewed with the Facility Director, nurse and administrative assistant and were not disputed.
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Plan of Correction
Habit OPCO will ensure that the Watsontown physician is notified, in writing, that all work is to be completed in accordance with the requirements identified in §715.6(b) (to include: Performing a medical history and physical exam, determining diagnosis and determining narcotic dependence, reviewing treatment plans, determining dosage and all changes in doses, ordering take-home privileges, discussing cases with the treatment team, issuing verbal orders pertaining to patient care, assessing coexisting medical and psychiatric disorders, treating or making appropriate referrals for treatment of these disorders). The Director of PA Operations will draft the notification in an email format, and distribute it to all Habit OPCO physicians who are employed or contracted for PA programs. The notification and dissemination will occur no later than
Monday, October 1, 2012.
Additionally, to prevent a recurrence of this deficiency, the "Attachment A: Statement of Work" of the physician agreement for Pennsylvania Phsyicians will be modified to include this language. This modification will occur prior to any additional physician hirings in PA.
The Company president (who is also in-house counsel) will prepare the contract and disseminate to physician for signature. Upon return of the executed document, the HR Director will place the signed contract in the physicians HR file. |
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 administrative documentation, the facility failed to provide at least one hour of physician time a week, on site, for every ten patients for one of the six weeks reviewed.
The findings include:
The physician time sheets were reviewed for the months of August and September, 2012. Six weeks were reviewed along with the average census for those weeks. One week provided insufficient onsite physician hours.
During the week of August 22-28, 2012, the patient census was 3. The facility was required to provide at least 1 onsite physician hour. The physician hours documented were by "telephone coverage only." The amount of physician hours documented did not meet the required hours. Physician services are required to be provided on site.
The findings were reviewed with the Facility Director, nurse and administrative assistant and were not disputed.
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Plan of Correction
Habit OPCO acknwledges the need for one (1) hour of physician coverage for every ten (10) patients on the active census.
In situations where there are vacations and/or unforseen absences, Habit OPCO will make arrangements for on-site covering physician time.
The nursing staff will monitor physician scheduling to ensure compliance with this standard.
PDA: October 1, 2012 |
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 clinical documentation, the facility failed to document the basis for determining current and one year history of dependency in two of four patient records.
The findings include:
Four patient records were reviewed September 6, 2012. All patient records were reviewed for physician documentation of the basis for determining current and one year history of dependency. Patients # 1 and 2 were transfers from another narcotic treatment program. Patients # 3 and 4 were new admissions.
Patient # 3 was admitted on August 15, 2012. The documentation by the physician for determining current dependency and at least one year history of dependence was a medical note that indicated a prior six month history of outpatient treatment and the assessment of patient withdrawal symptoms.
Patient # 4 was admitted on August 29, 2012. The documentation by the physician for determining current dependency and at least one year history of dependence was a medical note that indicated prior inpatient treatment 1 month ago and the assessment of patient withdrawal symptoms. Additionally, the form addressing the length of opiate dependency was incomplete.
The findings were reviewed with the Facility Director, nurse and administrative assistant and were not disputed. Documentation as provided in patient records # 3 and 4 failed to specify a year history of addiction.
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Plan of Correction
Habit OPCO acknowledges the need to document a one (1) year opiate dependency for new admissions as required by §715.9 (a) (4).
The Watsontown physician will receive training from Chief Medical Officer regarding appropriate documentation of current dependence and a one year history of dependence.
Ongoing compliance will be monitored by the Physician, the charge nurse, and the Facility Director through random monthly chart audits.
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715.9(c) LICENSURE Intake
(c) If a patient was previously discharged from treatment at another narcotic treatment program, the admitting narcotic treatment program, with patient consent, shall contact the previous facility for the treatment history.
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Observations
Based on the review of patient records, the facility failed to contact the previous narcotic treatment facility for the patient's treatment history in one of one patient records reviewed.
The findings include:
Four patient records were reviewed September 6, 2012. One patient record required contacting the prior narcotic treatment facility for the previous treatment history that was reported by the patient.
Patient record # 1 contained documentation that the patient had received narcotic treatment services previously at another narcotic treatment program. The facility failed to document any attempt to obtain the patient's prior treatment history from the previously attended narcotic treatment facility.
The findings were reviewed with the Facility Director, nurse and administrative assistant and were not disputed.
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Plan of Correction
While Habit OPCO had obtained medical records from the NTP that the pt was transferring from, Habit OPCO failed to obtain records from an additional previously attended NTP.
Habit OPCO will document attempts to procure medical and treatment records from all prior treatment at NTP's regardless of the time that has lapsed since admission or discharge.
This will be achieved by clincians and will be reviewed and monitored by the Facility Director during random monthly chart audits. |
715.11 LICENSURE Confidentiality of patient records
A narcotic treatment program shall physically secure and maintain the confidentiality of all patient records in accordance with 42 CFR 2.22 (relating to notice to patients of Federal confidentiality requirements) and § 709.28 (relating to confidentiality).
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Observations
Based on a review of patient records, the facility failed to obtain an informed and voluntary consent from the patient prior to the disclosure of information in four of four patient records.
The findings include:
Four patient records were reviewed on September 6, 2012. All patient records were reviewed for the requirement to include an informed and voluntary consent from the patient prior to the disclosure of information.
Patient record # 1 included a consent to release information to a funding source care manager that allowed for the release of the psychosocial evaluation, medical evaluation, length of Rx data, Rx modality, HIV/AIDS information, last methadone/suboxone dose, prescription verification, lab results, discharge summary, dose, impairment and significant incidents. Additionally, the patient record contained a Pennsylvania Client Placement Criteria form that disclosed the name of the medication, the number of take home bottles and the dose of the medication. Both of these documents exceeded the parameters permitted within 4 Pa. Code 255.5. Consents to release information to the emergency contact and to the funding verification source did not include a witness signature nor documented whether the patient received a copy. A consent to release information to the "Massachusetts Department of Public Health" failed to document whether the patient received a copy.
Patient record # 2 documented contact with a funding verification source on August 7, 2012. A consent to release information to the funding verification source was signed on August 9, 2012, and failed to include a witness signature and did not document whether the patient received a copy. A consent to release information to a treatment provider failed to include the purpose of the disclosure and listed the specific information to be disclosed as emergency contact. Additionally, the patient record contained a Pennsylvania Client Placement Criteria form that disclosed the name of the medication which exceeded the parameters permitted within 4 Pa. Code 255.5. A consent to release information to the "Massachusetts Department of Public Health" failed to document whether the patient received a copy.
Patient record # 3 included consents to release information to a funding verification source, to an emergency contact and to the "Massachusetts Department of Public Health" which failed to include a witness signature and did not document whether the patient received a copy. A consent to release information to a medical facility listed the information to be disclosed as "need more information can't only say 304.00 Opioid Dependence."
Patient record # 4 contained a consent to release information to an emergency contact that did not include a witness signature nor document whether the patient received a copy. A consent to release information to a funding verification source was signed on August 29, 2012. Contact with the funding verification source was documented on August 24, 2012. A consent to release information to the "Massachusetts Department of Public Health" failed to document whether the patient received a copy. Consents to release information to two different medical facilities signed on August 29, 2012, failed to include the information to be disclosed.
The findings were reviewed with the Facility Director, nurse and administrative assistant and were not disputed.
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Plan of Correction
Upon review, it was determined that one staff member was responsible for these errors. That staff member will be trained on the completion of Consent Forms to include training on Federal Regulations (42 CFR) and information pertaining to 4 PA Code 255.5.
The "Massachussets Department of Public Health" form, which was incorrectly included with new intake paperwork, has been removed from the intake packet originals.
Patient confidentiality forms will be reviewed by the Facility Director for completeness and accuracy through random monthly chart reviews.
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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 on the review of patient records and administrative documentation, the facility failed to ensure granted take home privileges are determined by the narcotic treatment physician.
The findings include:
Four patient records were reviewed on September 6, 2012. One patient record was reviewed for take home status. Patient # 1 was admitted on August 8, 2012. The patient was granted take home privileges on September 5, 2012. An Application for Take Home Medication was signed by the patient on September 5, 2012. This form included the results of the last two drug tests dated August 8, 2012, and June 26, 2012, provided by the previous narcotic treatment program. The form was signed with approval by the clinician and take home committee. The medical director signed without documenting approval. The narcotic treatment physician did not document the rationale for permitting the take home medication.
The findings were reviewed with the Facility Director, nurse and administrative assistant and were not disputed.
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Plan of Correction
The Physician will be trained by the Chief Medical Officer, the Facility Director, and the Nurse Manager on the proper completion of the "Take Home" committee form.
Compliance with the training objectives regarding the wirtten approval and justification will be monitored by the Facility Director via random monthly chart audits. |
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 the review of administrative documentation, the facility failed to limit only authorized staff and patients who are receiving medication to be permitted in the dispensing area.
The findings include:
The policy and procedure manual were reviewed on September 5, 2012. The administration of medication policy stated "the nurse will allow a pre-school aged child to accompany a patient to the dispensary window only if there is no other caregiver available and the child is restrained and held away from the window."
The findings were reviewed with the Facility Director, nurse and administrative assistant and were not disputed.
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Plan of Correction
The policy in question will be updated to read:
It is understood that in order for some patients to meet all of their treatment responsibilities they may need to bring their child/children to the program on occasion. This policy is intended to assist these patients and provide a safe environment for the patient, the child and the program. Habit OPCO intends to provide a safe environment for individuals receiving medication.
Procedure:
1. Staff will identify areas where children can safely wait for their parents.
2. Children under 8 years of age are to be accompanied by a parent or guardian at all times.
3. Children are not allowed at the dosing window.
The policy will be updated by the Facility Director by 10/09/2012, and will be disseminated to all HOI staff members. The policy will also be placed on the company intranet. |
715.21 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.
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Observations
Based on a review of the facility policy and procedure manual and the patient handbook, the facility failed to restrict their policy and procedure on involuntary terminations to those areas specified in the regulations.
The findings include:
A review of the facility policy and procedure manual on September 5, 2012, revealed that patients could be terminated for reasons other that those specified by regulations. According to the facility policy and procedure manual, patients could be terminated for reasons such as loitering, illicit drug use, non-compliance with program rules and nonpayment for treatment services. Additionally, the patient handbook states an emergency termination notice can be issued when the Program Director reasonably determines the need to terminate a patient's treatment.
The Facility Director, nurse and administrative assistant were informed of the plan for review of the findings.
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Plan of Correction
715.21 indicates that involuntary termination from the program may be initiated if the program deems that the termination would be in the best interests of the health or safety of the patient and others, or if the program finds any of the following conditions exist:
(i) the patient has committed acts of physical violence in or around the narcotic treatment program premesis.
(ii) the patient possessed a controlled substance without a prescription or sold or distributed a controlled substance, in or around the narcotic treatment program premesis.
(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.
Additionally, 715.21 indicates that "a patient terminated involuntarily, except a patient who commits or threatens to commit acts of physical violence, shall be afforded the opportunity to receive detoxification of at least seven days. The detoxification may take place at the facility..."
Habit OPCO will ensure that discharge recommendations are compliant with 715.21 by providing current staff members, existing patients and incoming patients with a copy of the specific language of the regulation.
Current staff members and patients will be required to sign off on an acknowledgement of this regulation.Future patients will be provided with this information as an addendum to the patient handbook.
Ongoing compliance will be monitored by the Facility Director through monthly random chart audits.
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709.32(b) LICENSURE Medication Control
709.32. Medication control.
(b) Verbal medication orders may be accepted but shall be put in writing and signed within 24 hours thereafter by the prescribing physician.
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Observations
Based on a review of patient records and the facility's policy and procedures, the facility failed to ensure that verbal medication orders were put in writing and signed with 24 hours thereafter by the prescribing physician, as required by regulation and facility policy and procedure, in one of one patient record.
The findings include:
Four patient records were reviewed on September 6, 2012. All verbal medication orders were required to be signed within 24 hours by the prescribing physician. Patient record # 3 contained documentation of verbal medication orders that were not signed by the prescribing physician within 24 hours.
Patient # 3 was admitted on August 15, 2012. Verbal orders contained in the patient record dated August 19, 2012; August 23, 2012; and August 27, 2012 were all signed by the narcotic treatment physician on August 29, 2012. A verbal order contained in the patient record dated August 31, 2012, was dated September 5, 2012.
The findings were reviewed with the Facility Director, nurse and administrative assistant and were not disputed.
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Plan of Correction
The physician has been forwarded, via USPS, a CD-Rom that contains the script/code to allow remote access to the electronic health record system. By providing this access to the physician, the physician should be able to review and approve all verbal orders within 24 hours as required by policy.
The CD-Rom was forwarded to the physician prior to the submission of this corrective action plan.
Ongoing compliance will be monitored through random monthly chart audits by the Facility Director. |