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 April 23-24, 2013 by staff from the Division of Drug and Alcohol Program Licensure. Based on the findings of the on-site inspection, Habit OPCO, 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.
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Plan of Correction
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715.10(a)(1) LICENSURE Pregnant patients
(a) A narcotic treatment program may place a pregnant patient, regardless of age, who has had a documented narcotic dependency in the past and who may return to narcotic dependency, on a comprehensive maintenance regime.
(1) For these patients, evidence of current physiological dependence on narcotic drugs is not needed if a narcotic treatment physician certifies the pregnancy and, exercising reasonable clinical judgment, finds treatment to be medically justified.
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Observations
Based on the review of patient records, the facility failed to document the criteria under which the patient was being admitted in two of four patient records reviewed.
The findings include:
Twelve patient records were reviewed April 23-24, 2013. Four patient records were reviewed for the documentation of the physician's determination of physical dependency and pregnancy.
Patient # 7 was admitted March 1, 2013. The physician completed a document for determining current and one year dependency. The physician documented the patient had less than one year dependency based on his exam but also documented patient self-reported more than one year dependency. There was no documentation that clarified the physician's justification of the treatment being medically justified. There was no documentation by the physician that he had determined to admit the patient based on the pregnancy. The only documentation pertained to the patient's positive urine screen.
Patient # 8 was admitted May 5, 2013. The physician completed a document for determining one year and current dependency. The physician documented the patient had less than one year dependency based on his exam. There was no documentation that clarified the physician's justification of the patient being admitted for narcotic treatment being medically justified. There was no documentation by the physician that he had determined to admit the patient based on the pregnancy. The only documentation pertained to the patient's positive urine screen.
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Plan of Correction
The Interim Medical Director's training plan will be modified to include the need to document pregnancy as the primary reason for admission, especially in cases where 1 year of opioid dependence is not documented and/or verified (by 5/25/13). The Program Director will also provide this information to the Interim Medical Director in writing (by 05/25/2013). The nurse manager or designee will review the admission notes of pregnant patients to ensure compliance (ongoing). |
715.10(c) LICENSURE Pregnant patients
(c) Counseling records and other appropriate patients records shall reflect the nature of prenatal support provided by the narcotic treatment program.
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Observations
Based on the review of patient records, the facility failed to document pre-natal support in three of four patient records reviewed.
The findings include:
Twelve patient records were reviewed April 23-24, 2013. Four patient records were reviewed for documentation reflecting the nature of the prenatal support provided by the narcotic treatment program.
Patient # 2 was admitted January 19, 2013. The patient was pregnant upon admission. Despite a significant amount of medical documentation, there was no documentation of the prenatal support or even documentation of the birth.
Patient # 6 was admitted March 29, 2013. The patient was pregnant upon admission. There was medical documentation of the prenatal care being received, there was no documentation reflecting any prenatal support being offered in the counseling records.
Patient # 7 was admitted March 1, 2013. The patient was pregnant upon admission. There was medical documentation of the prenatal care being received, there was no documentation reflecting any prenatal support being offered in the counseling records.
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Plan of Correction
Clinicians will be provided training on the documentation of prenatal support (including documenting when patients refuse prenatal medical care) at the next general staff meeting (05/30/2013). Each clinician will also be made aware of this requirement in their individual weekly supervision sessions. The nurse manager will ensure that all pregnant patients are discussed at each MDT meeting (ongoing). This will ensure that supports are discussed in a multi-disciplinary environment (ongoing). |
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 maintain confidentiality of patient records in accordance with 42 CFR 2.22 and in seven of seven patient records.
The findings include:
Twelve patient records were reviewed April 23-24, 2013. Seven patient records were reviewed for an informed and voluntary consent from the patient prior to the disclosure of information.
Patient record # 1 included releases of information to various sources that did not include the specific information to be disclosed. The specific information section on the release of information forms were blank. The release of information form completed for the funding source stated the psychosocial evaluation was to be released to the funding source.
Patient record # 2 included releases of information to various sources that did not include the specific information to be disclosed. The specific information section on the release of information forms were blank. The release of information form completed for the funding source stated the psychosocial evaluation was to be released to the funding source.
Patient record # 3 included releases of information to various sources that did not include the specific information to be disclosed. The specific information section on the release of information forms were blank. The release of information form completed for the funding source stated the psychosocial evaluation was to be released to the funding source.
Patient record # 4 included releases of information to various sources that did not include the specific information to be disclosed. The specific information section on the release of information forms were blank. The release of information form completed for the funding source stated the psychosocial evaluation was to be released to the funding source.
Patient record # 5 included releases of information to various sources that did not include the specific information to be disclosed. The specific information section on the release of information forms were blank.
Patient record # 7 contained a release of information form for the funding source stating the psychosocial evaluation was to be released to the funding source.
Patient record # 8 contained a release of information form for the funding source stating the psychosocial evaluation was to be released to the funding source.
The consents to release information were all identified as being "two-way" consents. The federal regulations only have provisions for authorization to disclose information. A consent to obtain information is not consistent with the federal confidentiality regulations found at 42 C.F.R. nor does it authorize a program to disclose information.
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Plan of Correction
All Watsontown staff members were provided with a confidentiality training by our Corporate Chief Compliance Officer on 04/29/2013. A narrated powerpoint presentation has been placed on the intranet and all new hires will be required to review this as a component of their orientation. Refresher courses will be offered by the Chief Compliance Officer annually. The Clinical Director will conduct random chart audits on a monthly basis to verify compliance (Ongoing). |
715.16(a)(3) LICENSURE Take-home privileges
(a) A narcotic treatment program shall determine whether a patient may be provided take-home medications.
(3) The narcotic treatment physician shall document in the patient record the rationale for permitting take-home medication.
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Observations
Based on a review of patient records, the facility failed to ensure the physician document a rationale for permitting take home medication in two of two patient records reviewed.
The findings include:
Twelve patient records were reviewed April 23-24, 2013. Two patient records were reviewed for take home medication.
Patient # 1 was admitted October 10, 2012. The patient was dosing on site three days per week, receiving two consecutive take home medication doses twice weekly. The physician failed to document a rationale for granting the take home medication privileges.
Patient # 5 was admitted December 3, 2012 as a transfer from another narcotic treatment program. The patient was receiving take home privileges upon admission and the facility continued the same take home privilege without the physician documenting the rationale. In addition, the patient was granted an increase of the number of take home medication bottles per week and the physician failed to document the rationale for increasing the number of take home bottles on April 3, 2013.
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Plan of Correction
The Interim Medical Director's training plan will be modified to include the need to document the rationale for permitting takehome medications (by 5/25/13). The Program Director will also provide this information to the Interim Medical Director in writing (by 05/25/2013). The nurse manager or designee will review the take home orders to verify compliance (ongoing). |
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
Based on the review of patient records, the facility failed to ensure the physician signed verbal orders within 24 hours as required in one of three patient records reviewed.
The findings include:
Twelve patient records were reviewed April 23-24, 2013. Three patient records reviewed contained documentation of verbal orders by the physician.
Patient # 6 was admitted March 29, 2013. Verbal orders were documented on three different occasions.
The physician issued a verbal order on April 8, 2013. The verbal order was signed and dated by the physician on April 10, 2013.
The physician issued a verbal order on April 11, 2013. The verbal order was signed and dated by the physician on April 13, 2013.
The physician issued a verbal order on April 14, 2013. The verbal order was signed and dated by the physician on April 16, 2013.
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Plan of Correction
The Facility Director will circulate information regarding the requirement to all physicians working at the Watsontown facility. Physicians in Watsontown have been provided with remote access to the EHR. The Nurse Manager will conduct quarterly audits on the patient records to verify that patient verbal orders are signed within 24 hours. |
715.23(b)(23) LICENSURE Patient records
(b) Each patient file shall include the following information:
(23) Discharge summary.
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Observations
Based on the review of patient records, the facility failed to ensure a discharge was completed as required in two of three patient records reviewed.
The findings include:
Twelve patient records were reviewed April 23-24, 2013. Three patient records were reviewed for documentation of a discharge summary. Two patient records failed to have documentation of completed discharge summaries as required.
Patient # 11 was admitted in October 2012 and discharged March 11, 2013. A discharge summary was not completed at the time of the inspection.
Patient # 12 was admitted in November 2012 and discharged January 15, 2013. While a discharge summary was documented as being done, it was dated March 4, 2013. A discharge summary is to be completed within 7 days of discharge according to regulation and according to the facility's policy and procedure. In addition, the documentation provided failed to include a reason for the admission into treatment, what services were offered or the status of the patient upon discharge.
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Plan of Correction
Clinicians will be provided training on the documentation of discharge ? specifically the completion of discharge summaries - at the next general staff meeting (05/30/2013). Each clinician will also be made aware of this requirement in their individual weekly supervision sessions. The Facility Director (or designee) will verify compliance through quarterly chart audits (ongoing). |