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 and buprenorphine, in the treatment of narcotic addiction. This inspection was conducted on December 19, 2011 through December 21, 2011 by staff from the Division of Drug and Alcohol Program Licensure. Based on the findings of the on-site inspection, New Directions Treatment Services, 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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715.8(1)(vi) LICENSURE Psychosocial Staffing
A narcotic treatment program shall comply with the following staffing ratios as established in Chapter 704 (relating to staffing requirements for drug and alcohol treatment activities):
(vi) Outpatients. The counseling caseload for one FTE counselor in an outpatient narcotic treatment program may not exceed 35 active patients.
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Observations
Based on the review of administrative documentation, the facility failed to maintain counselor caseloads to no more than 35 to 1.The findings include:Administrative documentation that included counselor caseloads was reviewed and discussed with the Facility Director on December 19, 2011. Counselor # 1 had a caseload of 36:1 which exceeded the permitted 35:1 caseload. Counselor # 1 had 43 patients on their caseload. Fifteen clients were on a reduced counseling schedule that was permitted by a facility exception. (43-15 =28 patients, 15/2 = 7.5 patients on reduced counseling, 28+7.5=35.5 or 36 to 1 ratio)The Facility Director confirmed this finding.
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Plan of Correction
This issue arises from cases being assigned or transferred onto caseloads that are already almost full. The two people in our office who are responsible for assigning or transferring cases have been instructed to always run an already existing report that lists all of the caseloads with their actual and equivalent number of cases, before adding a case to any caseload. The clinical supervisor will insure that this procedure is followed consistently and that cases are not assigned in excess of the maximum allowed by this standard. This is currently in effect. |
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 facility for the patient's treatment history in one of one patient records reviewed.The findings include:Thirty-one patient records were reviewed December 19-21, 2011. One patient record required contacting the prior treatment facility for the patient's treatment history from a previously attended facility. Patient record # 3, did provide documentation of any attempt to obtain the patient's prior treatment history from previously attended treatment facilities.This is a repeat citation from the methadone monitoring inspection conducted on December 6-8, 2011.
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Plan of Correction
Our intake interview form will be amended to include documentation to indicate that such a request has been made, when appropriate. The fax form that is used to make the request, and the accompanying consent form, will be attached to the intake interview form and inserted into the patient chart. An administrative assistant, who checks admission documentation for completeness, will check to insure that this documentation is included. This person will report to the facility director any failure to document this process. The facility director will insure that this procedure is established and monitor ongoing implementation. This will be in place by 2/13/2012. |
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 patient records, the facility failed to document that the narcotic treatment physician reviewed the dosage levels at least twice a year, with each review occurring at least 2 months apart in two of eight patient records.The findings include:Thirty-one patient records were reviewed on December 19-21, 2011. Eight records were reviewed for documentation that the narcotic treatment physician reviewed the dosage levels at least twice a year. The facility failed to document semi-annual dose reviews in patient records # 11 and 12.Patient # 11 was admitted on 11/20/2006. The last dose review for this patient was documented on June 3, 2011. Patient # 12 was admitted on October 6, 2010. The last dose review for this patient was documented on March 1, 2011. The finding was confirmed by the facility director.
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Plan of Correction
The facility director will instruct the nursing supervisor to generate an already available report weekly that lists all patients who have not had a dose review in the past 160 days. The nursing supervisor will present all such cases to the program physician for review. The physician will document in the patient record that the dosage has been reviewed and found to be appropriate or adjusted as needed. The nursing supervisor will report the successful completion of this to the facility director who will be responsible to insure that it is done consistently. This procedure will be in place by 2/13/2012. |
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 the review of patient records, the facility failed to ensure the physician documented in the patient record the rationale for granting take home medication in five of nine patient records.The findings include:Thirty-one patient records were reviewed on December 19-21, 2011. Nine patient records were reviewed for take home medication documentation. Patient records # 7, 11, 16, 26, and 30 did not have the physician's rationale for granting the take home medication. The reasons documented for granting take-homes were "gained a takeout." Patient # 7 received six take-home medication bottles. The reason documented in the patient's record did not include the narcotic treatment physician's rationale. The reasons documented in the record for take-homes being granted were "gained a take out and client earned sixth take out."Patient # 11 received two take-home medication bottles. The reason documented in the patient's record did not include the narcotic treatment physician's rationale. The reason documented in the record for take-homes being granted was "gained a take out."Patient # 16 was unsuccessfully discharged from the program on 4/12/2011. This patient was provided seven take home medication bottles. The narcotic treatment physician failed to document an order for these take-home medication bottles, therefore, there was no rationale documented for granting these take-home medications. Patient # 26 had received one take-home bottle on June 18, 2011. The narcotic treatment physician failed to document an order for this take-home, and there was no rationale documented for granting the take-home medication. There was an order signed on August 24, 2011, that stated "lost takeout," however, an original order for the take-home medication to be rescinded was not documented. Patient # 30 received six take-home medication bottles. The reason documented in the patient's record did not include the narcotic treatment physician's rationale. The reasons documented in the record for take-homes being granted was "gained a take out."The facility director confirmed this finding during interviews on December 20, 2011 and December 21, 2011.
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Plan of Correction
The program will immediately cease the practice of providing any take home medication doses to patients who are being terminated involuntarily for threats or acts of violence. The documentation of the rationale for take outs will in the future clearly indicate that the granting of take outs has been done in a manner consistent with the requirements of both these standards and program policies. The nursing supervisor will insure that this is being done consistently. The plan to address the documentation portion of this citation will be fully implemented by 2/13/2012. |
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, the facility granted take home privileges despite the fact that the narcotic treatment physician did not evaluate the patients to determine if they met the eight point criteria required to receive take-home medications in three of nine records.The findings include:Thirty-one patient records were reviewed on December 19-21, 2011. The narcotic treatment physician failed to ensure by exercising reasonable clinical judgment, that the patient was responsible for handling narcotic drugs in patient records # 12, 16, and 26. Patient # 12 was admitted on October 6, 2010. This patient received four take-home medication bottles a week. The record indicated that the patient had received a citation for driving under the influence in October of 2011. The record also revealed that the patient's significant other was abusing alcohol with no intentions to discontinue the usage. The patient repeatedly expressed frustrations surrounding his home life in counseling sessions. Patient # 16 was admitted on January 26, 2011 and discharged for violence on April 12, 2011. This patient was provided seven take-home bottles at the time of his discharge. The record failed to include documentation from the narcotic treatment physician justifying the take-home medications.Patient # 26 received one take-home bottle on June 18, 2011. The record failed to include a written order for this take-home medication, and the record did not include documentation from the narcotic treatment physician justifying the take-home medication.An interview with the facility director confirmed these findings.
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Plan of Correction
The documentation of the rationale for take outs will in the future clearly indicate that the granting of take outs has been done in a manner consistent with the requirements of both these standards and program policies, including a review, conducted by the program physician in consultation with other pertinent staff members, of the patients compliance with the provisions of this standard. The nursing supervisor will insure that this is being done consistently. The plan to address the documentation portion of this citation will be fully implemented by 2/13/2012. |
715.16(f) LICENSURE Take-home priveleges
(f) An exception granted under subsection (d) shall continue only for as long as the temporary disability or exceptional circumstance exists. When a patient is permanently disabled, that case shall be reviewed at least annually to determine whether the need for the exception still exists.
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Observations
Based on the review of patient records and a review of administrative documentation, the facility failed to annually review each case to determine whether the need for the exception for 13-day take-home still existed in two of three patient records.The findings include:Thirty-one patient records were reviewed on December 19-21, 2011. The Methadone Monitoring Questionnaire documented that twenty patients at the facility had 13-day take home privileges due to permanent physical disability. Three records were reviewed for annual documentation of the need for the 13-day take home exception. Two of three records failed to include documentation that the justification for 13-day take homes still existed, specifically in patient records # 8 and 28. An interview with the facility director confirmed that the documentation for annual review was not completed. This is a repeat citation from the December 6, 2010 through December 8, 2010 methadone monitoring inspection.
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Plan of Correction
All patients who are currently being granted this exception due to disability will be reviewed during the month of February, 2012 to determine whether the need for the exception still exists. In the future any patient who qualifies for such an exception will be informed at the time the exception is granted that such a review will take place and that continuation of the exception will be contingent on a review done annually to determine that the need still exists. The nursing supervisor will insure that the reviews of patients with current exceptions are conducted as indicated and that the documentation is complete, and will monitor that this protocol is adhered to consistently in the future. This procedure will be fully implemented by 2/28/2012. |
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 that verbal orders were signed off by the prescribing physician within 24-hours as required in three of five patient records reviewed.The findings include:Thirty-one patient records were reviewed on December 19-21, 2011. Five records were reviewed for verbal orders being signed off by the prescribing physician within 24-hours. The facility failed to document authentication within 24-hours in patient records # 7, 12, and 29. Patient record # 7 provided documentation of a verbal order issued on May 13, 2011, that stated the patient "gained a take out." The narcotic treatment physician signed off on this order on May 16, 2011. Patient record # 12 provided documentation of a verbal order written on January 22, 2011, that stated, "permitted take-home medication as a result of compliance with state requirements and facility policies." The narcotic treatment physician signed off on this order on January 24, 2011. Patient # 29 provided documentation of a verbal order on March 17, 2011, issued by narcotic treatment physician A. A second narcotic treatment physician, physician B, signed off on the verbal order on March 18, 2011. This order was signed off within 24-hours, however, it failed to be signed by the prescribing narcotic treatment physician.
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Plan of Correction
All program physicians will be reminded of the necessity of signing all medication orders within 24 hours . Generally this can be done on the next business day. In cases where it is not practical to do so, e.g. a patient released from the hospital on a Saturday, the physicians will be given remote access so that they confirm verbal orders in accord with this standard. The nursing supervisor will insure that orders are signed in compliance with this standard, by verifying daily that there are no outstanding verbal orders. Any instances will be reported to the facility director for follow up. This procedure will be in place by 2/13/2012.
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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 the review of patient records, the facility failed to complete the annual physical with a re-evaluation by the narcotic treatment physician in eight of sixteen patient records reviewed. Additionally, the facility failed to document an annual physical in one of sixteen patient records. The findings include:Thirty-one patient records were reviewed on December 19-21, 2011. Sixteen patient records were reviewed for annual physical examinations. The facility failed to document a physical examination that had an annual reevaluation by the narcotic treatment physician in patient records # 5, 6, 8, 10, 12, 27, 28, and 29. Additionally, the facility failed to document an annual physical in patient record # 31.Patient # 5 was admitted 6-10-09. The annual physical exam was completed on 6-6-11 by the Certified Registered Nurse Practitioner (CRNP). The annual physical exam did not include a re-evaluation by the narcotic treatment physician. Patient # 6 was admitted 2-28-2007. The annual physical exam was completed on 2-24-2011 by the Certified Registered Nurse Practitioner (CRNP). The annual physical exam did not include a re-evaluation by the narcotic treatment physician. Patient # 8 was admitted 11-29-2004. The annual physical exam was completed on 11-29-2011 by the Certified Registered Nurse Practitioner (CRNP). The annual physical exam did not include a re-evaluation by the narcotic treatment physician. Patient # 10 was admitted 4-8-2010. The annual physical exam was completed on 4-21-2011 by the Certified Registered Nurse Practitioner (CRNP). The annual physical exam was not signed by the narcotic treatment physician and therefore did not include a re-evaluation by the narcotic treatment physician. Patient # 12 was admitted 10-6-2010. The annual physical exam was completed on 10-17-2011 by the Certified Registered Nurse Practitioner (CRNP). The annual physical exam did not include a re-evaluation by the narcotic treatment physician. Patient # 27 was admitted 6-21-2010. The annual physical exam was completed on 6-13-2011 by the Certified Registered Nurse Practitioner (CRNP). The annual physical exam did not include a re-evaluation by the narcotic treatment physician. Patient # 28 was admitted 8-01-2007. The annual physical exam was completed on 8-29-2011 by the Certified Registered Nurse Practitioner (CRNP). The annual physical exam did not include a re-evaluation by the narcotic treatment physician. Patient # 29 was admitted 10-25-2010. The annual physical exam was completed on 10-3-2011 by the Certified Registered Nurse Practitioner (CRNP). The annual physical exam did not include a re-evaluation by the narcotic treatment physician. The findings were confirmed by the facility director..
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Plan of Correction
This citation was the result primarily of a new annual physical examination form that was used in the cited records that did not contain provisions for the physician's reevaluation. This form has already been replaced by one that does make that provision. In cases where the annual physical examination is done by the CRNP, she will file these for the physician to do the reevaluation. A member of the nursing staff has been assigned to verify that the reevaluations are done and signed on a timely basis. The nursing supervisor will insure that this procedure is followed consistently. The other issue involved a physical examination that was apparently misfiled. Medical personnel have been advised that in the future access to records can either be in the form of copies that are made by them or at their request, or if a medical chart is removed from the filing cabinet where it is stored, it must be signed out and back in upon its return. No documents are permitted to leave the chart except to make a copy. This process is already implemented. |
715.23(c)(1-7) LICENSURE Patient records
(c) An annual evaluation of each patient 's status shall be completed by the patient 's counselor and shall be reviewed, dated and signed by the medical director. The annual evaluation period shall start on the date of the patient 's admission to a narcotic treatment program and shall address the following areas:
(1) Employment, education and training.
(2) Legal standing.
(3) Substance abuse.
(4) Financial management abilities.
(5) Physical and emotional health.
(6) Fulfillment of treatment objectives.
(7) Family and community supports.
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Observations
Based on a review of the patient records, the facility failed to document an annual evaluation that was completed by the patient's counselor and reviewed, dated and signed by the medical director in five of the sixteen records reviewed.The findings include:Thirty-one patient records were reviewed on December 19-21, 2011. Sixteen of the thirty-one patient records were required to include an annual evaluation. One of the sixteen records failed to include the medical director's signature on the annual evaluation, specifically record # 8. One of the sixteen records had the annual evaluation completed three months early, specifically record # 11. Three of the sixteen records did not document an annual evaluation in the patient record, specifically records # 6, 29, and 30. Patient record # 8 was admitted to treatment on November 29, 2004. The annual evaluation was completed on November 29, 2011. The evaluation was not signed by the medical director as required.Patient # 11 was admitted on May 24, 2010. The annual evaluation was documented on February 15, 2011. This evaluation was completed three months early.Patient # 6 was admitted on February 28, 2007. The last documented annual evaluation was on February 18, 2010. The facility failed to document an annual evaluation for 2011 as of the date of the review.Patient # 29 was admitted on October 25, 2010. The annual evaluation was due on October 25, 2011. The facility failed to document an annual evaluation for 2011 as of the date of the review.Patient # 30 was admitted on August 25, 2008. The last annual evaluation was documented on September 27, 2010. The facility failed to document an annual evaluation for 2011 as of the date of the review.The findings were confirmed by the facility director.
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Plan of Correction
The clinical supervisor will generate a list at the beginning of each month of all the annual reviews that are due in that month. She will monitor their completion during the course of the month and insure that all are completed and signed by the medical director by the end of the month. She will report to the facility director at the end of each month any annual reviews that are not completed and signed. The facility director will follow up to insure that any remaining reviews are completed and signed and that the counselor is aware of the requirement for timely submission and intends to abide by it in the future. Ths process is in place now. |
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 the review of facility documentation that included incident reports, the facility failed to provide documentation of unusual incident reports to the Department that involved incidents with potential for negative community reaction or which the facility director believed may lead to community concern and drug related hospitalization of a patient.The findings include:During the December 19, 20, and 21, 2011 methadone monitoring, the facility provided documentation of incident reports that identified a patient being hospitalized due to a possible drug overdose. Also, on several occasions the facility documented that emergency treatment was sought onsite and ambulance services were contacted to transport patients to the local hospital. Documentation included incidents of law enforcement involvement on the facility grounds. The facility failed to provide the Department with written reports of the account of the incidents that occurred at the facility.A discussion with the facility director confirmed that the facility was not submitting incident reports as required.
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Plan of Correction
The procedure for written reporting of all incidents, unusual or otherwise, has already been changed to require a review by the Facility Director, who will sign off to indicate that an assessment of has been made of the incident to determine if it meets the criteria for reporting under this standard. If it does, a dated signature on the form indicates that an "Unusual Incident Report" form has been completed and faxed to DOH. All staff has already been notified that all deaths of active patients, regardless of circumstances, must generate an incident report. The patient's primary counselor has been assigned the task of generating the report. The counselors have been instructed to include information about the cause of death, if it is known, as well as the source of such information. They have also been instructed to include the same information in a closing note in the patients file. This note may include some additional information that may was not available at the time the Unusual Incident Report was submitted. Additionally, all incident reports are now being scanned into electronic documents to insure easy access and future availability.
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