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 March 16- 17, 2015 by staff from the Division of Drug and Alcohol Program Licensure. Based on the findings of the on-site inspection, Tadiso, 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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715.6(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 timesheets, the facility failed to provide physician services, at least one hour per week for every ten patients, for eight of seventeen weeks reviewed.
The findings include:
Physician time sheets for the months of November and December 2014 as well as January and February 2015 were reviewed on March 16-17, 2015. Seven weeks provided insufficient onsite physician hours during November 2014, December 2014, January 2015 and February 2015.
During the week of November 2-8, 2014, the patient census was 717. The facility was required to provide at least 71.7 physician hours. There were 62.58 physician hours documented.
During the week of November 23-29, 2014, the patient census was 724. The facility was required to provide at least 72.4 physician hours. There were 25.52 physician hours documented.
During the week of December 7-13, 2014, the patient census was 712. The facility was required to provide at least 71.2 physician hours. There were 41.31 physician hours documented.
During the week of December 21-27, 2014, the patient census was 723. The facility was required to provide at least 72.3 physician hours. There were 33.31 physician hours documented.
During the week of December 28, 2014 - January 3, 2015, the patient census was 722. The facility was required to provide at least 72.2 physician hours. There were 8.28 physician hours documented.
During the week of January 18 - 24, 2015, the patient census was 723. The facility was required to provide at least 72.3 physician hours. There were 66.01 physician hours documented.
During the week of February 8 -14, 2015, the patient census was 714. The facility was required to provide at least 71.4 physician hours. There were 64.57 physician hours documented.
These findings were reviewed with facility staff during the licensing process.
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Plan of Correction
Background: The time sheets that were reviewed were for the period of the year that contained 7 of the 11 holidays observed by the clinic. In addition, the physician utilized 14 vacation days during this time period. Action: To cover for the physician time needed when the medical director or physician assistant are not available (at training, on vacation or incapacitated) Tadiso will use a temporary agency to secure the needed medical coverage. The Executive Assistant who serves as the human resources manager, has contacted a temp agency to schedule personnel for needed time periods. She is responsible for ensuring that this does not happened again. She is responsible for auditing all time records on a monthly basis so she will monitor this issues for compliance. |
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 a review of patient records, the facility failed to document that a physician assistant may perform functions of a narcotic treatment physician in a narcotic treatment program if the records are properly countersigned by the medical director or a narcotic treatment physician in five of nine patient records.
The findings include:
Fourteen patient records were reviewed on March 16 - 17 , 2015. Nine of the patient records included physical examinations performed by the physician's assistant and required the narcotic treatment physician's countersignature, within three days, as per the state licensing body. Patient records # 3, 4, 5, 8 and 14 did not include a physician's countersignature within three days.
Patient #3 was admitted on November 7, 2014 and the physician assistant performed a physical on November 7, 2014. A physician countersignature was due by November 10, 2014. The physician countersigned the document on November 13, 2014.
Patient #4 was admitted on February 9, 2015 and the physician assistant performed a physical on January 30, 2015. A physician countersignature was due by February 2, 2015. The physician countersigned the document on February 3, 2015.
Patient #5 was admitted on August 14, 2013 and the physician assistant performed a physical on August 27, 2014. A physician countersignature was due by August 30, 2014. The physician countersigned the document on September 2, 2014.
Patient #8 was admitted on January 12, 2012 and the physician assistant performed a physical on February 27, 2015. A physician countersignature was due by February 2, 2015. The physician countersigned the document on March 3, 2015.
Patient #14 was admitted on October 16, 2014 and the physician assistant performed a physical on October 16, 2014. A physician countersignature was due by October 19, 2014. The physician countersigned the document on October 20, 2014.
These findings were reviewed with facility staff during the licensing process.
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Plan of Correction
To insure that all physicals that may be performed by the physician assistant are countersigned within the required 3 day time frame, the physician assistant and medical director will meet at the end of each day to review all of the activities of the physician assistant and secure all required countersignatures. The medical director also has computer access that allows him to daily review all of the physician assistants documentation even when the medical director is not at the agency. The Operations Director is responsible for monitoring this issue and ensuring that it does not happen again. The Quality Improvement Coordinator will complete periodic audits. |
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 a review of patient records, the facility failed to document that the narcotic treatment physician made 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 one year prior to admission for maintenance treatment in two of five patient records.
The findings include:
Fourteen patient records were reviewed on March 16 - 17, 2015. The physician's face-to-face determination of current and one year dependance was reviewed in five patient records. The facility failed to document a face-to-face determination of current and one year dependence by the narcotic treatment physician prior to admission to maintenance treatment in patient records # 1 and 4.
Patient #1 was admitted to treatment on November 25, 2014 and was given the initial dose on November 26, 2014. There was no initial physical documented in patient record #1 and the current / one year history of dependance form was signed by the physician on December 8, 2014.
Patient #4 was admitted to treatment on February 9, 2015 and was given the initial dose on February 9, 2015. There initial physical was performed by the physician assistant on January 30, 2015. The current / one year history of dependance form was signed by the physician on February 10, 2015.
These findings were reviewed with facility staff during the licensing process.
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Plan of Correction
The medical director will meet with all new admissions on the day that they are scheduled to begin treatment at which time he will review all of the information from the medical exam, the psychosocial interview as well as any records from previous treatment and will document the evidence that supports the one year or more physical dependence upon opioids and document evidence of current dependency. This meeting will take place upon receipt of the intake urine drug screen and prior to the patient receiving any methadone. The Operations Director will be responsible for ensuring this corrective action is implemented. In addition, the Quality Improvement Coordinator will periodically monitor this deficiency for compliance. |
715.14(a) LICENSURE Urine testing
(a) A narcotic treatment program shall complete an initial drug-screening urinalysis for each prospective patient and a random urinalysis at least monthly thereafter.
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Observations
Based on a review of the patient records, the facility failed to obtain a complete drug screen urinalysis prior to the administration of methadone, a narcotic agent, in two of five patient records. A complete drug screen includes receiving the results from the CLIA and Department of Health approved laboratory.
The findings include:
Fourteen patient records were reviewed on March 16 - 17, 2015. Five patient records were required to include a complete drug screen urinalysis prior to the administration of methadone, a narcotic agent. A complete urine drug screen includes receiving the results from the CLIA and Department of Health approved laboratory. The facility failed to obtain a complete drug screen urinalysis prior to the administration of methadone, a narcotic agent in patient records # 1 and 3.
Patient #1 was admitted on November 25, 2014 and received their first dose of methadone on November 26, 2014. The facility did not receive the results of the urinalysis until November 28, 2014, after the initial dose was given.
Patient #3 was admitted on November 7, 2014 and received their first dose of methadone on November 10, 2014. The facility did not receive the results of the urinalysis until November 13, 2014, after the initial dose was given.
These findings were reviewed with facility staff during the licensing process.
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Plan of Correction
The laboratory results of the intake urine drug screens that are faxed to the agency will be scanned into the electronic record and will indicate the time the fax was received. If a faxed result is not available the lab will be contacted by phone to see if a result is available and if so have it faxed prior to the patient being medicated. If no result is available, the patient will be rescheduled to return to the clinic the following day for the first day of medication. The Operations Director is responsible for implementing this corrective action. To monitor this issue and prevent it from re-occurring, the Quality Improvement Coordinator will audit the files for compliance. |
715.15(b) LICENSURE Medication dosage
(b) The narcotic treatment physician shall determine the proper dosage level for a patient, except as otherwise provided in this section. If the narcotic treatment physician determining the initial dose is not the narcotic treatment physician who conducted the patient examination, the narcotic treatment physician shall consult with the narcotic treatment physician who performed the examination before determining the patient 's initial dose and schedule.
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Observations
Based on a review of patient records, the facility failed to document that the narcotic treatment physician determined the proper dosage level for the patient in five of fourteen patient records.
The findings include:
Fourteen patient records were reviewed on March 16 - 17, 2015. The narcotic treatment physician is required to determine the proper dosage level for the patient in all patient records. The narcotic treatment physician did not document the proper dosage level for the patient in patient records # 1, 2, 3, 7 and 14.
Patient #1 was admitted on November 25, 2014. The initial order was written by the physician's assistant on November 26, 2014 at 13:35. The patient's first dose was on November 26, 2014 at 13:40. The physician did not sign the order until November 26th at 21:59, after the patient had already dosed. The physician assistant assistant wrote a dosage increase order on December 2, 2014 at 11:29. The patient was dosed at the increased dosage on December 2nd at 12:02. The physician did not sign this order until December 4, 2014 at 8:16, after the patient had already dosed. The physician assistant wrote a dosage decrease order on March 11, 2015 at 6:41 and the patient dosed at the decreased dosage on March 11, 2015 at 13:26. The physician did not sign the order until March 13, 2015, after the patient had already dosed.
Patient #2 was admitted on January 5, 2015. The initial order was written by the physician's assistant on January 7, 2015 at 13:47. The patient's first dose was on January 7, 2015 at 13:52. The physician did not sign the order until January 7, 2015 at 14:08, after the patient had already dosed. The physician assistant assistant wrote a dosage increase order on March 11, 2015 at 10:38. The patient was dosed at the increased dosage on March 11, 2015 at 10:40. The physician did not sign this order until March 13, 2015 at 6:50, after the patient had already dosed.
Patient #3 was admitted on November 7, 2014. The physician assistant assistant wrote a dosage increase order on January 6, 2015 at 13:20. The patient was dosed at the increased dosage on January 6, 2015 at 13:22. The physician did not sign this order until January 7, 2015 at 14:08, after the patient had already dosed.
Patient #7 was admitted on June 10, 2009. The physician assistant assistant wrote a dosage increase order on March 13, 2015 at 10:24. The patient was dosed at the increased dosage on March 13, 2015 at 10:40. The physician did not sign this order until March 16, 2015 that 9:05, after the patient had already dosed.
Patient #14 was admitted on October 16, 2014 and discharged December 22, 2014. A 10 day detox order was written by the physician's assistant on December 3, 2014 at 11:13. The physician signed the order on December 4, 2014. The taper did not start until December 12, 2012; however, the physician's assistant wrote the order and determined the dosage levels.
It was confirmed throughout the course of the inspection that none of these orders were verbal orders, as the physician works full - time.
These findings were reviewed with facility staff during the licensing process.
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Plan of Correction
The physician assistant will review any recommended dosage levels with the medical director who will sign all orders prior to the patient receiving any change in dosage level. The physician assistant no longer has the authorization to change a dose until the medical director approves it. The Operations Director and the Nursing Supervisor are responsible for implementing this plan of correction. The Nursing Supervisor will review all changes and the Quality Improvement Coordinator add this to her list of items to review during periodic internal audits. |
715.16(a)(1) LICENSURE Take-home privileges
(a) A narcotic treatment program shall determine whether a patient may be provided take-home medications.
(1) A narcotic treatment program may give take-home medications only to a patient who the narcotic treatment physician has determined is responsible and able to handle narcotic drugs outside the narcotic treatment program.
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Observations
Based on a review of patient records, the facility failed to document that the facility gave take-home medications only to patients who the narcotic physician has determined is responsible and able to handle narcotic drugs outside the narcotic treatment program in two of four patient records.
The findings include:
Fourteen patient records were reviewed on March 16 - 17, 2015. Four of the patients reviewed had take-home privileges. The narcotic treatment physician is required to determine a person responsible enough to handle narcotic drugs in all patient records. The narcotic treatment physician did not determine patients responsible to handle narcotic drugs outside the narcotic treatment program in patient records # 8 and 9.
Patient #8 was admitted on January 12, 2012. Bi-weekly privileges were ordered by the physician's assistant on February 23, 2015 and subsequent bottles were dispensed that same day. The physician singed the order on February 25, 2015, after the order had already been put into effect.
Patient #9 was admitted on December 12, 2012. Tri-weekly privileges were ordered by the physician's assistant on October 14, 2014 and subsequent bottles were dispensed that same day. The physician singed the order on October 15, 2014 after the order had already been put into effect.
These findings were reviewed with facility staff during the licensing process.
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Plan of Correction
Any recommendations for take-home privileges from case conference or from the physician assistant will be reviewed by the medical director who will enter the order prior to the patient receiving any change in dosing schedule. The medical director will review all such recommendations to insure that the patient is deemed responsible and able to handle narcotic drugs outside the treatment program. The Operations Director is responsible for monitoring this issue and ensuring that it does not happen again. The Quality Improvement Coordinator will complete periodic audits for this issue. |
715.16(a)(2) LICENSURE Take-home privileges
(a) A narcotic treatment program shall determine whether a patient may be provided take-home medications.
(2) The narcotic treatment physician shall make this determination after consultations with staff involved in the patient's care.
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Observations
Based on a review of patient records, the facility failed to document that the physician made the determination to grant take-home medications after consultations with staff involved in the patient's care in two of four patient records.
The findings include:
Fourteen patient records were reviewed on March 16 - 17, 2015. Four of the patients reviewed had take-home privileges. The narcotic treatment physician is required to make the determination to grant take-home medications after consultations with staff involved in the patient's care in all patient records. The narcotic treatment physician did not determine patients responsible to handle narcotic drugs after consultations with staff in patient records # 8 and 9.
Patient #8 was admitted on January 12, 2012. Bi-weekly privileges were ordered by the physician's assistant on February 23, 2015 and subsequent bottles were dispensed that same day. The physician singed the order on February 25, 2015, after the order had already been put into effect.
Patient #9 was admitted on December 12, 2012. Tri-weekly privileges were ordered by the physician's assistant on October 14, 2014 and subsequent bottles were dispensed that same day. The physician singed the order on October 15, 2014 after the order had already been put into effect.
These findings were reviewed with facility staff during the licensing process.
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Plan of Correction
Prior to any take-home orders being entered the medical director will consult with the physician assistant and clinical supervisors who may have reviewed the patient's request in case conference. No change in dosing schedule will be entered until reviewed by the medical director. The Operations Director is responsible for monitoring this issue and ensuring that it does not happen again. The Quality Improvement Coordinator will complete periodic audits for compliance. |
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 have the physician document the rationale for permitting take-home medication in the patient record in two of four patient records.
The findings include:
Fourteen patient records were reviewed on March 16 - 17, 2015. Four of the patients reviewed had take-home privileges. The narcotic treatment physician is required to document the rationale for permitting take-home medication in the patient record in all patient records. The narcotic treatment physician did not document the rationale for permitting take-home medication in the patient record in patient records # 8 and 9.
Patient #8 was admitted on January 12, 2012. The rationale for take-home medications and bi-weekly privileges were ordered by the physician's assistant on February 23, 2015 and subsequent bottles were dispensed that same day. The physician singed the order on February 25, 2015, after the order had already been put into effect.
Patient #9 was admitted on December 12, 2012. The rationale for take-home medications and tri-weekly privileges were ordered by the physician's assistant on October 14, 2014 and subsequent bottles were dispensed that same day. The physician singed the order on October 15, 2014, after the order had already been put into effect.
These findings were reviewed with facility staff during the licensing process.
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Plan of Correction
The medical director will review with the physician assistant any recommendations for take-home privileges that may have been made in case conference. The medical director will then document in the patient record the rationale for granting the take-home medication. The Operations Director is responsible for monitoring this issue and ensuring that it does not happen again. The Quality Improvement Coordinator will complete periodic audits for compliance. |
715.16(a)(4) LICENSURE Take-home privileges
(a) A narcotic treatment program shall determine whether a patient may be provided take-home medications.
(4) A narcotic treatment physician may rescind take-home medication privileges.
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Observations
Based on a review of patient records, the facility failed to document that the narcotic treatment physician rescinded take-home medication privileges in two of two patient records.
The findings include:
Fourteen patient records were reviewed on March 16 -17, 2015. Two of the patients reviewed had take-home privileges rescinded. The narcotic treatment physician is required to document the rescinding of privileges in all patient records. The physician did not document the rescinding of privileges in patient records #6 and 11.
Patient #6 was admitted on October 25, 2011. The physician's assistant wrote an order to rescind take-home privileges on October 10, 2014 and the order was put into effect immediately. The physician co-signed the order on October 15, 2014.
Patient #11 was admitted on June 18, 2013. The physician's assistant wrote an order to rescind take-home privileges on October 8, 2014 and the order was put into effect immediately. The physician co-signed the order on October 15, 2014.
These findings were reviewed with facility staff during the licensing process.
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Plan of Correction
The medical director will document in the order the rationale for rescinding any take-home privileges. The medical director will also document in a MD note the action taken and the rationale for the action. The Operations Director is responsible for monitoring this issue and ensuring that it does not happen again. The Quality Improvement Coordinator will complete periodic audits for compliance. |
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 a review of patient records, the facility failed to document that the narcotic treatment physician wrote and signed all medication orders and determined the patient's initial and subsequent dose and schedule in five of fourteen patient records.
The findings include:
Fourteen patient records were reviewed on March 16 - 17, 2015. The narcotic treatment physician is required to write and sign all patient medication orders as well as the patient's initial and subsequent dose and schedule in all patient records. The narcotic treatment physician did not write the medication order and / or document the patient's initial and subsequent dose and schedule in patient records # 1, 2, 3, 7 and 14.
Patient #1 was admitted on November 25, 2014. The initial order was written by the physician's assistant on November 26, 2014 at 13:35. The patient's first dose was on November 26, 2014 at 13:40. The physician did not sign the order until November 26, 2014 at 21:59, after the patient had already dosed. The physician assistant assistant wrote a dosage increase order on December 2, 2014 at 11:29. The patient was dosed at the increased dosage on December 2, 2014 at 12:02. The physician did not sign this order until December 4, 2014 at 8:16, after the patient had already dosed. The physician assistant wrote a dosage decrease order on March 11, 2015 at 6:41 and the patient dosed at the decreased dosage on March 11, 2015 at 13:26. The physician did not sign the order until March 13, 2015, after the patient had already dosed.
Patient #2 was admitted on January 5, 2015. The initial order was written by the physician's assistant on January 7, 2015 at 13:47. The patient's first dose was on January 7, 2015 at 13:52. The physician did not sign the order until January 7, 2015 at 14:08, after the patient had already dosed. The physician assistant assistant wrote a dosage increase order on March 11, 2015 at 10:38. The patient was dosed at the increased dosage on March 11, 2015 at 10:40. The physician did not sign this order until March 13, 2015 at 6:50, after the patient had already dosed.
Patient #3 was admitted on November 7, 2014. The physician assistant assistant wrote a dosage increase order on January 6, 2015 at 13:20. The patient was dosed at the increased dosage on January 6, 2015 at 13:22. The physician did not sign this order until January 7, 2015 at 14:08, after the patient had already dosed.
Patient #7 was admitted on June 10, 2009. The physician assistant assistant wrote a dosage increase order on March 13, 2015 at 10:24. The patient was dosed at the increased dosage on March 13th at 10:40. The physician did not sign this order until March 16, 2015 at 9:05, after the patient had already dosed.
Patient #14 was admitted on October 16, 2014 and discharged December 22, 2014. A 10 day detox order was written by the physician's assistant on December 3, 2014 at 11:13. The physician signed the order on December 4, 2014. The taper did not start until December 12, 2014; however, the physician's assistant wrote the order and determined the dosage levels.
It was confirmed throughout the course of the inspection that none of these orders were verbal orders, as the physician works full - time.
These findings were reviewed with facility staff during the licensing process.
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Plan of Correction
The medical director will first document that he has determined the patient's initial and subsequent dose in a MD note and will then sign the medication order for the patient. The Operations Director is responsible for monitoring this issue and ensuring that it does not happen again. The Quality Improvement Coordinator will complete periodic audits for compliance. |
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 facility failed to document that the results of all annual physical examinations included an annual reevaluation by the narcotic treatment physician in six of nine patient records.
The findings include:
Fourteen patient records were reviewed on March 16 - 17, 2015. Nine patient records included an annual physical examination. The results of all annual physical examinations are to include an annual reevaluation by the narcotic treatment physician. Patient records # 5, 6, 8, 9, 10 and 12 did not include an annual evaluation by the narcotic treatment physician.
Patient #5 was admitted on August 14, 2013. An annual physical examination was conducted by the physician's assistant on August 27, 2014. The physician co-signed the document on September 2, 2014; however, there was no annual reevaluation documented by the narcotic treatment physician.
Patient #6 was admitted on October 25, 2011. An annual physical examination was conducted by the physician's assistant on October 21, 2014. The physician co-signed the document on October 21, 2014; however, there was no annual reevaluation documented by the narcotic treatment physician.
Patient #8 was admitted on January 12, 2012. An annual physical examination was conducted by the physician's assistant on February 27, 2015. The physician co-signed the document on March 3, 2015; however, there was no annual reevaluation documented by the narcotic treatment physician.
Patient #9 was admitted on December 14, 2012 and discharged on January 30, 2015. An annual physical examination was conducted by the physician's assistant on December 11, 2014. The physician co-signed the document on December 11, 2014; however, there was no annual reevaluation documented by the narcotic treatment physician.
Patient #10 was admitted on June 25, 2012 and discharged on February 5, 2015. An annual physical examination was conducted by the physician's assistant on September 5, 2014. The physician co-signed the document on September 8, 2014; however, there was no annual reevaluation documented by the narcotic treatment physician.
Patient #12 was admitted on June 23, 2011 and discharged on February 10, 2015. An annual physical examination was conducted by the physician's assistant on July 7, 2014. The physician co-signed the document on July 9, 2014; however, there was no annual reevaluation documented by the narcotic treatment physician.
These findings were reviewed with facility staff during the licensing process.
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Plan of Correction
The medical director will review all annual physical exams conducted by the physician assistant and the medical director will document his evaluation of the patient based on the exam conducted by the physician assistant as well as the medical director's own interaction with the patient. The Operations Director is responsible for monitoring this issue and ensuring that it does not happen again. The Quality Improvement Coordinator will complete periodic audits for compliance. |