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Based on document review and interviews with key personnel on January 24 -26, 2011, it was determined that The Aroostook Medical Center did not have an effective governing body.
Findings include:

1. The Medical Staff did not have an effective, data driven quality improvement program designed to improve patient outcomes and decrease medical errors. Foe further information see Tags A-0338 and A-0263, ?482.21.

2. The minutes of the governing body meetings held during 2010 were reviewed. The governing body received reports from the President of the Medical Staff, and reviewed and accepted the minutes of the Medical Staff Executive Committee. These minutes and reports did not contain evidence of medical performance improvement projects.

3. The 2010 Governing Board Meeting minutes reflect a regular agenda item labeled " Quality - Service Excellence " . There was no discussion of medical staff performance improvement projects under this agenda item.

4. The Governing Body regularly received and approved the minutes of the Quality & Professional Affairs Committee. The Quality & Professional Affairs Committee reviewed minutes from the meetings of the Medical Quality Review Committee, the Medical Staff Executive Committee, the Medicine Department, Surgery Department and Department of Emergency Medicine.

5. The 2010 minutes of the Quality & Professional Affairs Committee do not contain discussion of, or reference to, medical performance improvement activities by the medical staff, nor medical staff projects designed to increase patient safety or reduce medical errors.

6. There was no item in the Governing Body's 2010 meeting minutes requesting a report of medical staff performance improvement activities, or of activities designed to improve patient safety or reduce medical errors.

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

Based on a review of the Medical Staff Bylaws, including the "Medical Staff and AHP [Allied Health Professional] Staff Performance Improvement Plan", the minutes of the Medical Staff Executive Committee, and the minutes of the Departments of Medicine, Surgery, and Emergency, and the Medical Quality Review Committee, held from January 2010 through December 2010, and interviews with key staff on January 24-26, 2011, it was determined that The Aroostook Medical Center did not have an effective hospital-wide, data driven, performance improvement program involving the Medical Staff that reflected the complexity of the hospital's services.

Findings include:

1. Chapter Four of the Medical Staff Bylaws contains the "Medical Staff And AHP [Allied Health Professional] Staff Performance Improvement Plan" and the "MQRC [Medical Quality Review Committee] PI Indicators Frequency & Threshold " .

2. The indicators in this document describe criteria by which the MQRC selects cases for retrospective review.

3. According to this document, " Indicators/criteria will be divided into three types:These are: (1) Type I - A rule, standard, generally recognized professional guideline or law that should nearly always be performed, i.e. see "Rules for Content of the Medical Record" . (2) Type II -Indicators that require analysis by peers in order to determine cause, effect and severity. (3) Type III - Indicators that are rated per practitioner, service or department. No records are evaluated by MQRC. "

4. There were no clinical performance indicators with specific targets for improvement described in the Medical Staff PI Plan. The plan did not contain any measurable goals related to improving medical care, increasing patient safety or improving outcomes from current levels of performance.

5. During an interview on January 26, 2011, the Chief Medical Officer confirmed that the plan contains criteria for retrospective chart review only.

6. A review of the minutes demonstrates that the Chief Medical Officer reports on CMS Core Measure performance at the MQRC and Executive Committee meetings, as well as other departments and committees. There was no evidence in these minutes that these reports were other than informational.

7. In a meeting on January 26, 2011, the Chief Medical Officer stated that the Core Measures were generally at their targets and no significant work was being done other than monitoring performance.

8. During the same meeting the Chief Medical Information Officer and Chair of the MQRC stated that the hospitalist service, which treats the majority of non-surgical inpatients, was working on medication reconciliation. He said that there was an implied target of 100% compliance, but that the Medical Staff was not aware of this target, and there had been no measurement of actual compliance.

9. At the same meeting the Chief Medical Officer stated that the Medical Staff had not established clinical performance improvement goals and that, " nothing had been written down. "

10. The Lead Certified Registered Nurse Anesthetist (CRNA) who manages the Anesthesia Service stated that the hospital performs surgery in several specialties, including: Oral and Maxillofacial Surgery, Otolaryngology, Urological Surgery, Obstetrics and Gynecology, Ophthalmology, Podiatric Surgery and Orthopedic Surgery, and endoscopic procedures.

11. The Chief Medical Officer confirmed that there are no clinical performance improvement activities for these surgical specialties.

12. The Chief Medical Officer stated that the Physiatrists are members of the Medical Staff, and confirmed that there were no clinical performance improvement initiatives for the Physiatrists.

13. During the same meeting, the President of the Medical Staff, an Emergency Physician, and the Chief Medical Information Officer, and the immediate past Chief of the Emergency Department, confirmed that the Emergency Department was measuring emergency department operational efficiency. They confirmed that this initiative did not involve clinical performance improvement by the emergency physicians.

14. The minutes of the Medical Quality Review Committee did not contain discussion of prospective, data driven, performance improvement initiatives to improve patient outcomes and prevent similar errors by other members of the Medical Staff. The minutes did not reflect evidence that there was discussion of problem prevention, nor analysis of performance improvement opportunities arising from the case discussion in order to improve safety, prevent errors, or improve outcomes.

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

Based on a review of the minutes of the Medical Quality Review Committee, (MQRC), and interviews with key staff on January 24-26, 2011, it was determined that the hospital did not have a process that effectively tracked the causes of medical errors and adverse patient events, analyze their causes, nor implement preventive actions or mechanisms for feedback and learning throughout the hospital.

Findings include:

1. The minutes of the MQRC ( Medical Quality Review Committee) from January 2010 through November 2010, which comprise the meetings of calendar year 2010, were reviewed. Chart review was performed and cases were assigned to three categories, " Care appropriate " , Care controversial " and " Care inappropriate ".

2. When a case was determined to be, "care inappropriate" , the minutes of the MQRC describe that the practitioner was notified and that a letter was put in the physician's peer review file.

3. The minutes did not contain documentation that the issues that contributed to the error or adverse outcome were discussed, nor evidence that there was analysis of the causes, nor evidence that there were actions to prevent future occurrences by other practitioners.

4. These MQRC minutes were discussed during a meeting on January 26, 2011, with the Chief Medical Officer, the Chief Medical Information Officer, the Director of Quality and the President of the Medical Staff. The Chief Medical Officer described "care controversial" as care that some providers might disagree with, but was otherwise appropriate. "Care inappropriate" was described as incorrect care.

5. The Chief Medical Officer reported that in 2010, twelve, (12) cases were described as "care inappropriate" .

6. The Chief Medical Information Officer said that the number of, "care inappropriate cases" might be misleading. He gave as an example, a case of a pediatric patient seen in the Emergency Department (ED), who was given antibiotics using an out-of-date dosing scale. The case was deemed "care inappropriate," and he discussed the updated dosing schedule with the provider. When asked if this information had been shared with other members of the Emergency Department, he said no, but no other problems with pediatric dosing had been found on random chart review by the MQRC.

7. The Chief Medical Information Officer conceded that the MQRC process did not ensure that all ED providers would know about, or use, the newer dosing schedule, and that the MQRC process did not ensure that this potential problem would be prevented in the future.

Based on a review of documents and interviews with key personnel on January 24-26, 2011, it was determined that The Aroostook Medical Center Medical Staff was not responsible for the quality of medical care provided to patients.

Findings include:

1. Chapter Four of the Medical Staff Bylaws contains the "Medical Staff And AHP [Allied Health Professional] Staff Performance Improvement Plan " and the " MQRC [Medical Quality Review Committee] PI Indicators Frequency & Threshold " .

2. The indicators in this document describe criteria by which the MQRC selects cases for retrospective review.

3. According to this document, " Indicators/criteria will be divided into three types: These are: (1) Type I - A rule, standard, generally recognized professional guideline or law that should nearly always be performed, i.e. see " Rules for Content of the Medical Record ". (2) Type II -Indicators that require analysis by peers in order to determine cause, effect and severity. (3) Type III - Indicators that are rated per practitioner, service or department. No records are evaluated by MQRC. "

4. There were no clinical performance indicators with specific targets for improvement described in this plan. The Medical Staff PI Plan did not contain any measurable goals related to improving medical care, increasing patient safety or improving outcomes from current levels of performance.

5. During an interview on January 26, 2011, the Chief Medical Officer confirmed that the plan contains criteria for retrospective chart review only.

6. A review of the minutes demonstrates that the Chief Medical Officer reports on CMS Core Measure performance at the MQRC and Executive Committee meetings, as well as other departments and committees. There was no evidence in these minutes that these reports were other than informational.

7. During an interview on January 26, 2011, the Chief Medical Officer stated that the Core Measures were generally at their targets and no significant work was being done other than monitoring performance.

8. During an interview on January 26, 2011, the Chief Medical Information Officer and Chair of the MQRC stated that the hospitalist service, which treats the majority of non-surgical inpatients, was working on medication reconciliation. He said that there was an implied target of 100% compliance, but that the Medical Staff was not aware of this target, and there had been no measurement of actual compliance.

9. During an interview on January 26, 2011, the Chief Medical Officer stated that the Medical Staff had not established clinical performance improvement goals and that, " nothing had been written down. "

10. The Lead CRNA (Certified Registered Nurse Anesthetist) who manages the Anesthesia Service stated that the hospital performs surgery in several specialties, including: Oral and Maxillofacial Surgery, Otolaryngology, Urological Surgery, Obstetrics and Gynecology, Ophthalmology, Podiatric Surgery and Orthopedic Surgery, and endoscopic procedures.

11. The Chief Medical Officer confirmed that there are no clinical performance improvement activities for these surgical specialties.

12. During an interview on January 26, 2011, the Chief Medical Officer stated that the Physiatrists were members of the Medical Staff, and confirmed that there were no clinical performance improvement initiatives for the Physiatrists.

13. During an interview on January 26, 2011, the President of the Medical Staff, an Emergency Physician, and the Chief Medical Information Officer, and the immediate past Chief of the Emergency Department, confirmed that the Emergency Department was measuring emergency department operational efficiency. They confirmed that this initiative did not involve clinical performance improvement by the emergency physicians.

14. The 2010 minutes of the MQRC did not contain discussion of prospective, data driven, performance improvement initiatives to improve patient outcomes and prevent similar errors by other members of the medical staff. The minutes did not reflect evidence that there was discussion of problem prevention, nor analysis of performance improvement opportunities arising from the case discussion in order to improve safety, prevent errors, or improve outcomes.

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

Based on interview with the Medical Assistant and review of pharmacy policy "Drug Samples Policy" and a tour of the OB/GYN & Midwifery Services area on January 25, 2011, it was determined that the pharmacy or drug storage areas failed to be maintained in accordance with accepted professional principles, including secure storage of medications and dispensing of medications by appropriately licensed practitioners.

The findings are as follows:

1. A tour of the drug storage areas in the out patient OB/GYN & Midwifery Services contained signage directing drug sales representatives to "enter medications into the Log book ." Upon interview with the Medical Assistant, it was determined that unsupervised access is given to each drug representative to place their medications in the Outpatient medication closet without supervision.

2. MSR title 32, Chapter 117 :The Maine Pharmacy Act 32 subset 13731 .1 states " It is unlawful for any person to engage in the practice of pharmacy unless licensed to practice under this Act; provided that physicians.....of the healing arts who are licensed under the laws of this State may dispense and administer perscription drugs to thier patients in the practice...." It was determined, in an interview with the Medical Assistant (M.A.), that sample medications were dispensed from these medication closets by the M.A. instead of by the practicing physicians.