HospitalInspections.org

Based on review of Governing Board meeting minutes, review of Quality Improvement meeting minutes, review of the Pharmacy schedules for July and August 2010, review of the hospital-wide Quality Indicators 2010, review of the hospital-wide Quality Improvement Plan and interviews with the Chief Executive Officer, the Chief Operating Office, the Director of Human Resources, the Director of Quality, the Director of Pharmacy and Pharmacy Technicians on November 8 and 9, 2010 and January 3-6, 2010, it was determined that the hospital failed to have an effective governing body legally responsible for the conduct of the hospital as an institution as evidenced by:

1. The governing body failed to ensure that the Quality Improvement Plan followed its mission and objectives consistently (Tag A0264);

2. The governing body failed to participate in the investigation related to the problems identified in Pharmaceutical Services (Tag A0277);

3. The governing body failed to ensure that processes and systems within the hospital related to Pharmaceutical Services were adequate to maintain patient safety (Tags A0265 and A0267);

4. The governing body failed to ensure adequate personnel resources within Pharmaceutical Services to promote staff and patient safety (Tag A0317);

5. The governing body failed to be totally responsible for the operations of the hospital (Tags A0283, A0285 and A0309):

6. The governing body failed to ensure that the hospital identified project improvement projects in 2010 (Tags A0297, A0298, A0299, A0300, A0301, A0302, and A0303);

7. The governing body failed to ensure that all medical staff requirments were met (Tag A0044);

8. The governing body failed to hold the medical staff accountable for the quality of care provided to patients (Tag A0049);

9. The governig body failed to take action through the hospital's quality program to identify quality and performance problems (Tag A0083);

10. The governing body failed to ensure that the services provided under contracts were provided in a safe a effective manner (Tag A0084);

11. The governing body failed to ensure that the emergency service requirements were all met (Tag A0091);and

12. The governing body failed to ensure that the hospital was in complaince with the Condition of Participation: Emergency Services (Tag A0092).


The cumulative effects of these deficient practices resulted in this Condition of Participation being out of compliance.

Based on review of Northern Maine Medical Center ' s Quality Improvement Plan, review of Northern Maine Medical Center ' s Quality Indicators for 2010, review of Northern Maine Medical Center ' s Performance Improvement Committee meeting minutes of May 2010 and interviews with the Director of Pharmacy, the Director of Human Resources and the Director of Quality on November 8 and 9, 2010 and January 3-6, 2011, it was determined that the hospital failed to develop, implement and maintain an effective, ongoing hospital-wide, data driven quality assessment and performance improvement program that focused on indicators related to improving processes and systems as evidenced by:

1. The hospital failed to ensure that the scope of the hospital-wide Quality Improvement Program ' s requirements were met (Tag A0264);

2. The hospital failed to identify system and process problems within the Department of Pharmacy in a timely manner (Tag A0266);

3. The hospital failed to develop quality indicators to measure and analyze aspects of performance that assessed processes related to drug and biological security within Pharmaceutical Services (Tags A0265 and A0267);

4. The hospital failed to identify opportunities for improvement and changes that would lead to improvements within Pharmaceutical Services based on data collected (Tag A0276);

5. The hospital failed to involve the governing body to determine the frequency and detail of data collection necessary to make improvements regarding drugs and biologicals within the Pharmaceutical Services (Tag A0277);

6. The hospital failed to ensure that the hospital-wide Quality Improvement Plan ' s program activities were consistently met (Tag A0283);

7. The hospital failed to set priorities for its performance improvement activities focused on high-risk, problem prone areas that affected patient safety and quality of care within Pharmaceutical Services (Tag A0285);

8. The hospital failed to take immediate action aimed at performance improvement related to drugs and biologicals within Pharmaceutical Services (Tag A0289);

9. The hospital failed to ensure that the hospital ' s governing body was responsible and accountable for ensuring full legal responsibility for the performance improvement program (Tag A0309);

10. The hospital failed to ensure that the governing body was responsible to see that an ongoing program for quality was implemented and maintained (Tag A0310);

11. The hospital failed to maintain a performance improvement program that addressed priorities for improvement and patient safety and that actions related to these were evaluated (Tag A0313);

12. The hospital failed to establish clear expectations related to safety within Pharmaceutical Services (Tag A0314); and

13. The hospital failed to allocate adequate resources within Pharmaceutical Services to reduce risk to patients (Tag A0317).



The cumulative effects of these deficient practices resulted in this Condition of Participation being out of compliance.

Based on review of the hospital-wide Quality Improvement Plan, information provided and interviews with key staff on November 8-9, 2010 and January 3-6, 2011, it was determined that the hospital failed to maintain documented evidence that all the program scope requirements were met.

Findings include:

1. The Northern Maine Medical Center Quality Improvement Plan was reviewed on November 9, 2010. The plan stated, " I. MISSION STATEMENT: The mission of Northern Maine Medical Center is to provide, coordinate and/or support access to high quality, affordable health care and to positively impact our communities ' quality of life by improving health status. Quality in health care is defined as doing the right thing consistently to ensure: The best possible clinical outcomes for patients while supporting innovation and continual improvement of the quality of our service ... ...II. OBJECTIVES: ...B. To utilize internally as well as externally designated standards such as evidence-based practices to measure and improve performance. C. To design effective mechanisms for identifying, assessing, improving, and measuring professional practice and outcomes ... ....I. Assurance of effective communication systems for reporting quality activities to the Medical Staff, Administration and Governing Body. ....III. PURPOSE: The purpose of the Quality Improvement Plan is to ensure the quality, appropriateness and necessity of patient care and professional practice. This will be done by establishing structure, process and outcome indicators. ....Process measures encompass all components of clinical care, the way that the care is provided, and the non-medical activities that support clinical operations. This criterion will be used to prospectively, concurrently and/or retrospectively monitor, evaluate, and improve known or suspected problems that influence the patient care system. "

2. The Northern Maine Medical Center ' s Quality Indicators for 2010 were reviewed on November 9, 2010. There were no indicators documented for Pharmaceutical Services.

3. The Northern Maine Medical Center ' s Performance Improvement Committee meeting minutes for May 2010 were reviewed. The documentation included a review of the year 2009 for Pharmacy. The performance measures documented were: individualized drug dosing; clear and complete orders; adverse drug reaction reporting and blood by-product usage. No measures were documented regarding preventing drug diversion.

4. During an interview with the Director of Pharmacy on November 8, 2010, he stated, " I have not put any new indicators in place. "

5. During an interview with the Director of Quality on November 8, 2010, she stated, " I was not involved in the investigation of the drug diversion..I did know about the investigation and we did not do a Root Cause Analysis. "

6. In spite of the fact that no new quality indicators were initiatated by Pharmaceutical Services related to the drug diversion, that the Director of Quality Improvement was not involved in the investigation related to the drug diversion, that there was no evidence that the Governing Body was aware and/or involved in the drug diversion investigation, during an interview with the Chief Executive Officer on November 9, 2010, he stated, " I guess we could have done a Root Cause Analysis but I think we did a thorough investigation and we took it very seriously."

7. A review of the hospital-wide performance impreovement indicators on January 3-6, 2011, revealed no indicators for the departments of

8. A review of the Performance Improvrment Plan for 2010, on January 4, 2011 revealed no reference to the need to identify and list performance improvement projects annually.

9. During an interview with the Director of Quality on January 5 and 6, 2011, she stated that she really didn't understand what a "project" was. She did confirm that there had been no projects documented for 2010.

10. The Northern Maine Medical Center's Quality Indicator Tracking Log with hospital-wide performance improvement indicators was reviewed January 4-6, 2011. This review revealed that there were no identified indicators for Obstetrics that had not reached the identified threshold of 100% for over two (2) quarters.

11. The Peerformance Improvement indicators for Emergency Services were reviewed on January 4-6, 2011. There was no data for the 1st and 2nd quarter Of 2010 for all but one (1) indicator. The one indicator had data from the 1st quarter only.


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Based on review of clinical contracts and interviews with the Quality Director on January 5, 2011, it was determined that the governing body failed to ensure that the quality program reflected the complexity of the hospital's organization and services; involved all hospital departments and services (including those services furnished under contract or arrangement).

Findings include:

1. A review of five (5) clinical contracts on January 05, 2011, revealed that three (3) of the five (5) contracts were not included in the hospital-wide quality assessment and performance improvement program. This was verified during interviews with the Director of Nursing and the Quality Director on January 05, 2011.

2. A review of five (5) clinical contracts on January 05,2011 revealed that none of the five (5) contracts contained a written requirement that the contractee be involved in the hospital-wide quality assessment and performance improvement program. This was verified during interviews with the Quality Director on January 05, 2011.

3. This was a repeat deficiency from the June 7-10, 2010, Federal
Validation Survey at this hospital. This deficiency and findings were addressed
in the facility ' s Plan of Correction for this survey. The corrective action plan
was to review and revise all patient related contracts to include the requirement that the contractee be involved in the hospital wide quality assessment and performance improvement program. The completion date was to be completed by September 30, 2010 by the Quality Director.

4. In an interview on January 5, 2011, with the Quality Director at 2:10 p.m.,
she stated that this had been an "oversite" on her part.

Based on review of information provided and interviews with key staff on November 8 and 9, 2010, it was determined that the hospital Quality Indicators for 2010 did not include any indicators related to Pharmaceutical Services and therefore no measureable improvements were able to be reviewed.

Findings include:

Please see Tags A0263, A0264, A0338, for additional information regarding the measureable improvement identified for indicators.

Based on review of policies and procedures, Quality Indicators and interviews with key staff on November 8 and 9, 2010, it was determined that the hospital ' s Quality Improvement Plan did not include Pharmaceutical Services indicators.

Findings include:

1. During an interview with the Director of Pharmacy on November 8, 2010, he stated that he had reached his goals for the indicators that he had chosen for 2009 and had not added any new indicators in 2010.

2. During an interview with the Director of Quality on November 8, 2010, she stated that she did not know of any new indicators that Pharmaceutical Services had developed.

3. During an interview with the Director of Pharmacy on November 9, 2010, he stated that if he had had more things in place related to quality checks on processes and systems, that probably the drug diversion could have been avoided. Additionally, he stated that he thought it was alright for the off-site pharmacists to provide supervision for Pharmacy Technicians on weekends the past summer.

4. The potential impact of not identifying quality indicators with measurable goals was that problems within Pharmaceutical Services could have been and were undetected for several years.

5. Please see Tag A0338 for additional information regarding identifying and reducing medical errors.

Based on review of information provided and interviews with key staff on November 8 and 9, 2010 and January 4-6, 2011, it was determined that there was no documented evidence that the hospital developed indicators related to preventing the diversion of drugs and biologicals and did not institute measures to provide supervision of Pharmacy technicians on weekends consistently.

Findings include:

1. Please see Tags A0264, A0266 and A0277 for additional information regarding the lack of quality indicators related to Pharmaceutical Services.

2.

Based on review of information provided and interviews with key staff on November 8 and 9, 2010, it was determined that there was no documented evidence that the hospital identified opportunities to improve the process and systems within Pharmaceutical Services related to drugs and biologicals.

Findings include:

Please see Tags A0264, A0266 and A0277 regarding the lack of sufficent data by which to set priorities.

Based on review of the Governing Board meeting minutes for 2010, and interviews with key staff on November 8 and 9, 2010, it was determined that there was no documented evidence that the Governing Body was aware of the problems identified within Pharmaceutical Services.

Findings include:

1. DEA [Drug Enforcement Agency] 106 Forms were reviewed on November 8 and 9, 2010. These forms were submitted by the hospital on October 6 and an amendment to that form on November 9, 2010. The form included a list of the missing medications. Those medications included: Hydrocodone - APAP 10-325 Tablets - 8,742 tablets lost; Hydrocodone -APAP 10-325 Tablets - 400 tablets lost and Lorazepam 1 MG [milligram] Tablets - 241 tablets lost.

2. The record keeping system of Scheduled III drugs that would follow the flow of these medications from their entry through dispensation was reviewed on November 8 and 9, 2010. The Director of Pharmacy stated on November 8, 2010 that he did not review this log regularly and did not compare what was ordered to what was used by patients.

3. During an interview with the Director of Pharmacy on November 8 and 9, 2010, he stated, " I was working with a technician on the weekend and she told me that the Hydrocodone bin was empty again. I really had no formal tracking system in place. I asked myself what did we have. I can see how the diversion could be missed. "

4. The Governing Board meeting minutes were review on November 9, 2010. The last documented meeting was held in October 2010, prior to the drug diversion being discovered. There was no documentation that any other meetings of the Board had been held.

5. During an interview with the Director of Quality on November 8, 2010, she stated that she did not know if the Board was aware of the drug diversion occurrence.

Based on review of meeting minutes, review of the hospital-wide Quality Improvement Plan and interviews with key staff on November 8 and 9, 2010, it was determined that the program requirements as outlined in the plan were not consistently met.

Findings include:

Please see Tags A0264, A0266 and A0277 for additional information regarding the specifics of the Quality Plan and how the plan was not followed consistently.

Based on review of meeting minutes, review of information provided and interviews with key staff on November 8 and 9, 2010, it was determined that there was no documented evidence that the hospital had set as a priority through the Quality Program to focus on the problem-prone Pharmaceutical Services.

Findings include:

Please see Tags A0264, A0266 and A0277 for additional information regarding the hospital's quality program.

Based on review of information provided and interviews with key staff on November 8 and 9, 2010, it was determined that there was no documented evidence that the hospital took immediate action via the Quality Improvement Plan related to the drug diversion, unauthorized access to medications and lack of supervision for the Pharmacy Technicians on weekends in July and August 2010.

Findings include:

Please see Tags A0264, A0266 and A0277 for additional information regarding the lack of action by the hospital related to Pharmaceutical Services.

Based on review of meeting minutes and interviews with key staff on November 8 and 9, 2010, it was determined that there was no documented evidence that the Governing Body had taken full responsibility for the hospital-wide Quality Improvement Plan and its scope.

Findings include:

Please see Tag A0264 for additioanl information regarding the role of the governing body.

Based on review of information provided and interviews with key staff on November 8 and 9, 2010, it was determined that there was no documented evidence that the Quality Improvement Program was implemented for the issues identified within Pharmaceutical Services.

Findings include:

Please see Tags A0264, A0266 and A0277 regarding the implementation of quality indicators with Pharmaceutical Services.

Based on review of information provided and interviews with key staff on November 8 and 9, 2010, it was determined that there was no documented evidence that the hospital quality assessment and performance improvement efforts addressed the priorities for improvement and patient safety in Pharmaceutical Services.

Findings include:

Please see Tags A0264, A0266 and A0277 for additional information regarding the efforts of the quality program to address priorities.

Based on review of information provided and interviews with key staff on November 8 and 9, 2010, it was determined that there was no documented evidence that clear expectations for safety within Pharmaceutical Services had been developed.

Findings include:

Please see Tags A0264, A0266 and A0277 for additional information related to the establishment of safety expectation in Pharmaceutical Services.

Based on review of Pharmacy schedules for July and August 2010, review of policies and procedures, review of an email and interviews with key staff on November 8 and 9, 2010, it was determined that there was no documented evidence that adequate resources had been allocated for the Department of Pharmacy to ensure safety of patients and to prevent drug diversion.

Findings include:

Please see Tags A0264, A0266 and A0277 for additional information regarding adequate personnel to meet the needs of Pharmaceutical Services.

Based on review of policies and procedures, review of job descriptions, review of DEA 106 Forms, review of pharmacist scheduling, review of the Pharmacy floor plan, review of job descriptions and interviews with the Chief Executive Officer, the Chief Operating Officer, the Director of Quality, the Director of Pharmacy, the Director of Human Resources and Pharmacy Technicians on November 8 and 9, 2010, it was determined that the hospital failed to maintain their pharmaceutical services utilizing systems and processes that would ensure compliance with acceptable standards of practice as evidenced by:

1. The hospital failed to ensure the maintenance of the pharmacy in accordance with accepted professional principles (See Tag A0491);

2. The hospital failed to require the Director of Pharmacy to be actively involved in establishing medication-related policies and procedures (See Tag A0492);

3. The hospital failed to employ a sufficient number of pharmacists to respond to the pharmaceutical needs of the patient (See Tag A0493);

4. The hospital failed to ensure that all records of the receipt and disposition of scheduled drugs were accurate (See Tag A0494);

5. The hospital failed to maintain a system that would ensure that drugs and biologicals were controlled and distributed in accordance with applicable standards of practice (See Tag A0500);

6. The hospital failed to have effective processes that would ensure that dispensing of drugs and biologicals was consistently under the supervision of a pharmacist (See Tag A0501);

7. The hospital failed to keep all drugs and biologicals stored securely to prevent access by unauthorized individuals (See Tag A0502);

8. The hospital failed to keep drugs listed in Schedules II, III, IV and V within a secure area (See Tag A0503);

9. The hospital failed to have processes and systems in place to prevent access to locked areas by unauthorized personnel (See Tag A0504);

10. The hospital failed to assure that when a pharmacist was not available on-site that drugs and biologicals were not removed by Pharmacy Technicians (See Tag A0506); and

11. The hospital failed to develop systems to recognize abuses and losses of controlled substances in a timely manner (See Tag A0509).

The cumulative effects of these deficient practices resulted in this Condition of Participation being out of compliance.

Based on review of policies and procedures, review of information provided and interviews with key staff on November 8 and 9, 2010, it was determined that the pharmacy was not being administered to ensure the safe and appropriate use of medications.

Findings include:

1. DEA [Drug Enforcement Agency] 106 Forms were reviewed on November 8 and 9, 2010. These forms were submitted by the hospital on October 6 and an amendment to that form on November 9, 2010. The form included a list of the missing medications. Those medications included: Hydrocodone - APAP 10-325 Tablets - 8,742 tablets lost; Hydrocodone -APAP 10-325 Tablets - 400 tablets lost and Lorazepam 1 MG [milligram] Tablets - 241 tablets lost.

2. The record keeping system of Scheduled III drugs that would follow the flow of these medications from their entry through dispensation was reviewed on November 8 and 9, 2010. The Director of Pharmacy stated on November 8, 2010 that he did not review this log regularly and did not compare what was ordered to what was used by patients.

3. Four (4) Pharmacy Technicians were interviewed on November 9, 2010. All the technicians stated that because they all rotate their responsibilities such as ordering medications, it was difficult to notice if any medication had been ordered more frequently than patient use would dictate.

4. During an interview with Technician A on November 9, 2010, she stated that she had begun to question the ordering of a medication ' Hydrocodone ' one weekend that she was working. She stated that she remembered putting the order away on October 6, 2010, and it was time to order more because there were only ten (10) pills left. She stated that she knew they would not use ninety (90) pills in two (2) weeks. She stated that the Pharmacy Registered Nurse was the one who had consistently ordered the medication and wondered if he had a prescription for himself and had filled it there. She continued by stating that she had checked and the Pharmacy Registered Nurse did not have a prescription there. She stated it was that weekend that she brought her concerns to the Director of Pharmacy who was working with her.

5. Four (4) Pharmacy Technicians were interviewed on November 9, 2010. They were asked if they worked weekends and if there was ever a time that they were working in the Pharmacy with no pharmacist present. Several of the technicians answered ' yes ' . They explained that an off-site pharmacist was available by telephone.

6. During an interview with the Director of Pharmacy on November 8 and 9, 2010, he stated, " I was working with a technician on the weekend and she told me that the Hydrocodone bin was empty again. I really had no formal tracking system in place. I asked myself what did we have. I can see how the diversion could be missed. "

7. During another interview with the Director of Pharmacy on November 9, 2010, when asked if he had ever dispensed medication to staff without proof of a prescription, he stated, " Yes..there was a nurse who needed seizure medication and a physician who needed medication that he had forgotten at home. " Additionally, when asked if Pharmacy staff ever helped themselves to medication in the Pharmacy, he stated, " Yes ....probably Tylenol or something like that. " The Director was asked if he checked to see which medications the staff took, he stated, " No..I trusted them but that process has stopped now. "

8. During yet another interview with the Director of Pharmacy on November 9, 2010, he was asked if he was aware that Pharmacy Technicians were not allowed to work independently in the Pharmacy without a pharmacist present, he stated. " Well, there was a pharmacist on the other end of the telephone. "

9. During an interview with the Director of Pharmacy on November 9, 2010, when asked if he had ever suggested a medication for the Pharmacy Registered Nurse to take, he stated, " I suggested an over the counter medication but the nurse said that didn ' t work so I think I might have said try Darvocet. "

10. During an interview with the Director of Pharmacy on November 8 and 9, 2010, when asked if he had developed any new policies and procedures after the diversion incident, he stated, " No..not yet..but I have put new practices in place. "

11. An email dated August 6, 2010 from the Pharmacy Registered Nurse was reviewed on November 9, 2010. The email included an attachment that described what need to be done on the weekends with off-site Pharmacy coverage. The Director of Pharmacy was asked on November 9, 2010 if he had helped develop and approve this process. He stated. " No..I did not ....but I was aware of it. "

12. The potential impact of no systems and processes to ensure that Pharmaceutical Services were delivered in a safe and appropriate manner was that medications could have been and were diverted by staff working in the Pharmacy.

13. The potential impact of dispensing medications to staff with no verification of a prescription was that staff could receive medications that had not been prescribed for them and their particular medical needs.

14. The potential impact of staff being able to help themselves to any medications within the Pharmacy and not identifing which medications they took was that there would be no record of the name of the medication or the amount of medication used.

15. The potential impact of Pharmacy Technicians working independently (and outside their scope of practice) in the Pharmacy with no Pharmacist onsite was that patients could receive the wrong medications, the wrong dose of the medications and/or the wrong patient could receive medications.

Based on review of policies and procedures and interviews with the Director of Pharmacy and pharmacy technicians on November 8 and 9, 2010, it was determined that the Director of Pharmacy (full time pharmacist) was not responsible for all activities within the department.

Findings include:

1. An email dated August 6, 2010 from the Pharmacy Registered Nurse was reviewed on November 9, 2010. The email included an attachment that described what need to be done on the weekends with off-site Pharmacy coverage. The Director of Pharmacy was asked on November 9, 2010 if he had helped develop and approve this process. He stated. " No..I did not ....but I was aware of it. "

2. During an interview with the Director of Pharmacy on November 8, 2001, when asked if new policies and/or procedures had been developed recently, he stated, " No, not yet, but I have changed practice. "

3. The Pharmacy and Therapeutics Committee meeting minutes from February 2010 through October 19, 2010, were reviewed on November 9, 2010. There was no documentation in the October 19, 2010 meeting minutes that the diversion of drugs was discussed nor was there any reference to revision of existing policies and/or new policies being developed related to the diversion.

4. The job description for the Director of Pharmacy was reviewed on November 9, 2010. It stated, " ESSENTIAL FUNCTIONS: 10. Maintains established procedures concerning quality control, security of controlled substances ....13. Delivers pharmaceutical services in accordance with the hospital and pharmacy ' s mission policy and applicable laws. "

5. See Tag A0491 for additional information.

Based on review of information provided, review of the Pharmacy Schedules for June, July, and August 2010 and interviews with the Director of Pharmacy and pharmacy technicians on November 8 and 9, 2010, it was determined that there was documented evidence that there was not sufficient staffing in the Pharmacy to ensure that quality pharmaceutical services were consistently provided.

Findings include:

1. A review of the Pharmacy Schedules for June, July and August 2010 was conducted on November 9, 2010. This schedule revealed that on July 24, 25 and 31, and August 7, 8, and 14, there was no pharmacist on-site at the hospital. This finding was confirmed with the Director of Pharmacy and pharmacy technicians on November 9, 2010.

2. During another interview with the Director of Pharmacy on November 9, 2010, he was asked if he was aware that pharmacy technicians were not allowed to work independently in the Pharmacy without a pharmacist present, he stated, " Well, there was a pharmacist on the other end of the telephone. "

2. Four (4) Pharmacy Technicians were interviewed on November 9, 2010. They were asked if they worked weekends and if there was ever a time that they were working in the Pharmacy with no pharmacist present. Several of the technicians answered ' yes ' . They confirmed that an off-site pharmacist was available by telephone.

3. Please see Tag A0491 for additional information.

Based on review of policies and procedures, review of ordering logs and interviews with the Director of Pharmacy and pharmacy technicians on November 9, 2010, it was determined that there was no documented evidence that the accountability procedures to ensure control of distribution, use and disposition of all scheduled drugs were consistently working and thus discouraging diversion of medications.

Findings include:

1. DEA [Drug Enforcement Agency] 106 Forms were reviewed on November 8 and 9, 2010. These forms were submitted by the hospital on October 6 and an amendment to that form on November 9, 2010. The form included a list of the missing medications. Those medications included: Hydrocodone - APAP 10-325 Tablets - 8,742 tablets lost; Hydrocodone -APAP 10-325 Tablets - 400 tablets lost and Lorazepam 1 MG [milligram] Tablets - 241 tablets lost.

2. A review of the Pharmacy ordering log revealed that Hydrocodone had been ordered on May 9, 10, September 21, 26, October 5, 2010. Additionally, there were fifteen (15) other times, with no dates that Hydrocodone had been ordered between April and September 2010. Lorazepam was ordered on September 21, 2010 and three (3) other times, with no dates, from April to September 2010.

3. During an interview with the Director of Human Resources on November 8 and 9, 2010, she stated that the Pharmacy Registered Nurse had admitted to her that he had taken the majority of the Hydrocodone from the hospital pharmacy but had not taken all of them.

4. During an interview with the Director of Human Resources on November 8 and 9, 2010 she stated that one (1) of the pharmacy technicians told her that the Director of Pharmacy allowed the pharmacy staff to take medications off the shelf if they needed ' flexaril, estrogen and pain medication ' .

5. Pharmacy Technician C was interviewed on November 9, 2010. She confirmed that Pharmacy staff were allowed to self medicate and that the medications that were taken were not recorded anywhere and no one would know what had been taken.

6. The Director of Pharmacy was interviewed on November 8 and 9, 2010 and he stated that ' yes ' , he did allow his staff to take medications if they needed it and ' no ' he never did check to see what the staff took because he trusted them.

7. The potential impact of dispensing medications to staff with no verification of a prescription was that staff could receive medications that had not been prescribed for them and their particular medical needs.

8. The potential impact of staff being able to help themselves to any medications within the Pharmacy and not identifing which medications they took was that there would be no record of the name of the medication or the amount of medication used.

Based on review of policies and procedures, review of information provided and interviews with the Director of Pharmacy, the Director of Human Resources and Pharmacy Technicians on November 8 and 9, 2010, it was determined that the system to ensure that drugs and biologicals were controlled and distributed, in order to provide patient safety, was not consistent with acceptable standards of practice.

Findings include:

1. MRSA? title 32, Chapter 117: Maine Pharmacy Act, 32 13731, Unlawful Practice: Penalties: Injunctions 1. Applicability. states, "It is unlawful for any person to engage in the practice under the Act; provided that physicians, dentists, veterinarians or other practitioners of the healing arts who are licensed under the laws of this State may dispense and administer prescription drugs to their patients in the practice of their respective professions where specifically authorized to do so by law."

2. The record keeping system of Scheduled III drugs that would follow the flow of these medications from their entry through dispensation was reviewed on November 8 and 9, 2010. The Director of Pharmacy stated on November 8, 2010 that he did not review this log regularly and did not compare what was ordered to what was used by patients.

3. The Northern Maine Medical Center titled ' Controlled Drugs Distribution ' stated, " The purchase, storage, distribution and accounting of controlled drugs will be done in accordance with all federal and state laws and standards of professional practice. The Pharmaceutical Service department is responsible for compliance with this policy. "

4. During an interview with the Director of Human Resources on November 8 and 9, 2010, she stated that the Pharmacy Registered Nurse had admitted to her that he had taken the majority of the Hydrocodone from the hospital pharmacy but had not taken all of them.

5. DEA [Drug Enforcement Agency] 106 Forms were reviewed on November 8 and 9, 2010. These forms were submitted by the hospital on October 6 and an amendment to that form on November 9, 2010. The form included a list of the missing medications. Those medications included: Hydrocodone - APAP 10-325 Tablets - 8,742 tablets lost; Hydrocodone -APAP 10-325 Tablets - 400 tablets lost and Lorazepam 1 MG [milligram] Tablets - 241 tablets lost.

6. During an interview with the Director of Human Resources on November 8 and 9, 2010 she stated that one (1) of the pharmacy technicians told her that the Director of Pharmacy allowed the pharmacy staff to take medications off the shelf if they needed ' flexeril, estrogen and pain medication ' . She further stated that this technician did not feel that it was right for self medication to occur with no prescription.

7. Pharmacy Technician C was interviewed on November 9, 2010. She confirmed that Pharmacy staff were allowed to self medicate.

8. The Director of Pharmacy was interviewed on November 8 and 9, 2010 and he stated that ' yes ' , he did allow his staff to take medications if they needed it and ' no ' he never did check to see what the staff took because he trusted them.

9. DEA [Drug Enforcement Agency] 106 Forms were reviewed on November 8 and 9, 2010. These forms were submitted by the hospital on October 6 and an amendment to that form on November 9, 2010. The form included a list of the missing medications. Those medications included: Hydrocodone - APAP 10-325 Tablets - 8,742 tablets lost; Hydrocodone -APAP 10-325 Tablets - 400 tablets lost and Lorazepam 1 MG [milligram] Tablets - 241 tablets lost.

10. The potential impact of no systems and processes to ensure that Pharmaceutical Services were delivered in a safe and appropriate manner was that medications could have been and were diverted by staff working in the Pharmacy.

11. The potential impact of dispensing medications to staff with no verification of a prescription was that staff could receive medications that had not been prescribed for them and their particular medical needs.

13. The potential impact of staff being able to help themselves to any medications within the Pharmacy and not identifing which medications they took was that there would be no record of the name of the medication or the amount of medication used.

14. The potential impact of Pharmacy Technicians working independently (and outside their scope of practice) in the Pharmacy with no Pharmacist onsite was that patients could receive the wrong medications, the wrong dose of the medications and the wrong patient could receive medications.

Based on review of Pharmacy schedules, review of information provided and interviews with key staff on November 8 and 9, 2010, it was determined that all compounding, packaging and dispensing of drugs and biologicals was not always under the supervision of a pharmacist.

Findings include:

1. Chapter 117: MAINE PHARMACY ACT HEADING: PL 1987, C. 710, ?5 (NEW)
Subchapter 1: TITLE AND DEFINITIONS HEADING: PL 1987, C. 710, ?5 (NEW)

9. Dispense or dispensing. "Dispense" or "dispensing" means the preparation and delivery of a prescription drug in a suitable container appropriately labeled for subsequent administration to or use by a patient or other individual entitled to receive the prescription drug pursuant to a lawful order of a practitioner.

25. Pharmacy technician. "Pharmacy technician" means a person employed by a pharmacy who works in a supportive role to, and under the direct supervision of, a licensed pharmacist.

2. An email generated by the Pharmacy Registered Nurse was reviewed on November 9, 2010. The email included an attachment with instructions with what needed to be done on the weekends with off-site coverage. The attachment stated, " Weekend Pharmacy Routine with use of Offsite Pharmacist on Duty: 1. Narcotics are to be dispensed as requested or needed by the Omnicell. Leave request slips/Omnicell fill lists with the Narcotic book and pharmacist will cosign on Monday am. All narcotic dispenses will be cosigned by both techs, as a double check, then followed by pharmacist ... ...5. Remind staff that we do have a pharmacist on duty, and contact number to reach them. "

3. The Pharmacy schedules from July 18 - 31 and August 1 - 14, 2010 were reviewed on November 8 and 9, 2010. It was documented that on July 24, 25 and 31, 2010 there was no pharmacist on-site but rather off-site. It was also documented that on August 7, 8 and 14, 2010 the Pharmacy coverage by a pharmacist was off-site.

4. Four (4) pharmacy technicians were interviewed on November 9, 2010. They were asked if they worked weekends and if there was ever a time that they were working in the Pharmacy with no pharmacist present. Several of the technicians answered ' yes ' . They confirmed that an off-site pharmacist was available by telephone but there was no Pharmacist on-site..

5. During another interview with the Director of Pharmacy on November 9, 2010, he was asked if he was aware that pharmacy technicians were not allowed to work independently in the Pharmacy without a pharmacist present, he stated, " Well, there was a pharmacist on the other end of the telephone. "

6. The potential impact of Pharmacy Technicians working independently (and outside their scope of practice) in the Pharmacy with no Pharmacist onsite was that patients could receive the wrong medications, the wrong dose of the medications and the wrong patient could receive medications.

Based on review of policies and procedures, review of information provided and interviews with key staff on November 8 and 9, 2010, it was determined that all drugs and biologicals were not being stored securely.

Findings include:


1. The record keeping system of Scheduled III drugs that would follow the flow of these medications from their entry through dispensation was reviewed on November 8 and 9, 2010. The Director of Pharmacy stated on November 8, 2010 that he did not review this log regularly and did not compare what was ordered to what was used by patients.

2. The Northern Maine Medical Center titled ' Controlled Drugs Distribution ' stated, " The purchase, storage, distribution and accounting of controlled drugs will be done in accordance with all federal and state laws and standards of professional practice. The Pharmaceutical Service department is responsible for compliance with this policy. "

3. During another interview with the Director of Pharmacy on November
9, 2010, when asked if he had ever dispensed medication to staff without proof of a prescription, he stated, " Yes..there was a nurse who needed seizure medication and a physician who needed medication that he had forgotten at home. " Additionally, when asked if Pharmacy staff ever helped themselves to medication in the Pharmacy, he stated, " Yes ....probably Tylenol or something like that. " The Director was asked if he checked to see which medications the staff took, he stated, " No..I trusted them but that process has stopped now. "

4.The record keeping system of Scheduled III drugs that would follow the flow of these medications from their entry through dispensation was reviewed on November 8 and 9, 2010. The Director of Pharmacy stated on November 8, 2010 that he did not review this log regularly and did not compare what was ordered to what was used by patients.

5.Please see Tags A0491, A0492 and A0493 for additional information.

Based on review of information provided and interviews with key staff on November 8 and 9, 2010, it was determined that drugs listed in Schedules II, II, IV and V of the Comprehensive Drug Abuse Prevention and Control Act of 1970 were not all kept in a secure area.

Findings include:

Please see Tag A0502 for additional information regarding the security of scheduled medications.

Based on review of information provided and interviews with key staff on November 8 and 9, 2010, it was determined that unauthorized individuals had access to secure areas.

Findings include:

Please see TAGS A0491, A0492, A0493, A0494, A0500, A0501, A502 and A0503 for additional information related to personnel access to locked areas.