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Based on a review of documents and interviews with relevant personnel on April 26-27, 2011, it was determined that Cary Medical Center did not have an effective governing body responsible for the conduct of the institution.

Findings include:

1. The hospital failed to develop, implement, and maintain an effective, ongoing, hospital-wide quality assessment and performance improvement program (for more details refer to Tag A-0263).

2. The hospital failed to have an organized medical staff that was responsible for the quality of medical care provided to patients by the hospital (for more details refer to Tags A-0338 and A-0347).

The cumulative effect of these deficient practices result in the Condition of Participation being out of compliance.

Based on a review of relevant documents and interviews with key hospital personnel on April 26-27, 2011, it was determined that the medical staff failed to document or perform case review as required in the Quality Plan, failed to recognize failures in peer review case finding, failed to have peer review in physicians' credentialing files, failed to consider or take action regarding adverse information presented at the time of credentialing, and failed to involve the emergency physicians in improving patient outcomes.

Findings include:

1. During a complaint investigation, a patient was found to have seventy-nine (79) Cary Hospital Emergency Department (ED) visits during a thirteen month period, from August 2009 through August 2010. On fifty-one (51) occasions, the patient had an unscheduled return to the ED within seventy-two hours. On at least two occasions, the patient had an unscheduled return to the ED and was admitted to the hospital.

2. During an interview on April 26, 2011, the Chief Operating Officer stated that this patient's care was not subject to peer review since it did not meet the criteria for peer review. During the same interview, the Chief Operating Officer stated that the Peer Review criteria for the ED was to review unscheduled returns to the ED within 72 hours only if they are admitted to the hospital.

3. The Cary Hospital Peer Review form lists review criteria as "Unscheduled return to the ED within 72 hours."

4. During an interview on April 27, 2011 with the Chief of Emergency Medicine and the President of the Medical Staff, this patient's unscheduled returns were discussed. The Chief of Emergency Medicine stated that there must be a systems failure since this patient should have been identified for peer review. The Chief of Emergency Medicine further stated that peer review was generally performed informally without written documentation.

5. The Hospital-Wide Quality Management & Patient Safety Plan states, "Trending for Peer Review by the Medical Staff will include: ...Unscheduled ER revisits within 72 hours ..." The Chief Operating Officer and the Medical Staff Services Manager stated, during meetings on April 26 and 27, 2011, all peer review would be found within individual physicians' quality files.

6. The Emergency Medicine Quality Management Plan for 2010 stated, "The summary of chart reviews is reported in the minutes of the monthly department meetings. Charts with deficiencies and a minimum of one chart per reviewer will be discussed in detail with discussion included in the department meeting minutes. Deficiencies and other issues involving other departments of the Medical Staff or hospital will be referred appropriately. Additionally, results of individual reviews will be organized in a provider-specific manner and forwarded to the Medical Staff Coordinator for use in credentialing."

7. The Emergency Physicians meeting minutes from September 2009 through December 2010 were reviewed. In September 2009, the minutes stated, "Peer review was completed following the meeting." There were no minutes of these discussions, nor a record of the cases reviewed. In the remainder of the minutes, there was no evidence of case review, nor was there "detail with discussion included in the department meeting minutes."

8. A review of the Emergency Department meeting minutes from September 2009 through December 2010 did not contain evidence that "results of individual reviews will be organized in a provider-specific manner and forwarded to the Medical Staff Coordinator for use in credentialing," as there was no evidence of case review.

9. The ED/Inpatient Nurse Manager stated, during a meeting on April 26, 2011, that minutes are not kept of physician chart reviews and that any records of chart review would be found in physicians' credentialing files. This was confirmed by the Chief Operating Officer at the same meeting. It was similarly confirmed by the Chief of Emergency Medicine, during a meeting on April 27, 2011, that "our case review is informal and we don't take minutes."

10. The credentialing quality files for all emergency physicians providing coverage at the Cary Emergency Department during 2009 and 2010 were reviewed. During this time period, the Chief Executive Officer stated in a meeting on April 27, 2011, that the ED saw 28,000 patients: 14,000 in 2009 and 14,000 in 2010. Twenty-four (24) quality files were examined. There were only thirteen (13) peer reviews performed in this time period. Only seven (7) physicians' files contained peer review. The remaining seventeen (17) physicians had no case review performed during this time period.

11. During a review of credentialing files, there was documentation that a physician disclosed that since his previous appointment there had been a malpractice claim made against him. The malpractice claim was related to his care of a patient in the ED of Cary Medical Center. In the same re-appointment application, a reference hospital reported "issues working within the ED team." The minutes of the Emergency Physicians regarding this re-appointment application read, "Reappointment - MD, DISCUSSION: ..., MD (Emergency Medicine); the complete reappointment application and physician profile of [ED physician] was reviewed. There was one new claim and one negative hospital verification. The report from the National Practitioner's Data Bank contained no reports. ACTION: A motion was made to recommend reappointment of [ED physician] to the Courtesy Medical Staff with privileges as requested through December 31, 2012. The motion was seconded and so VOTED unanimously to recommend reappointment. This recommendation will be forwarded to the Medical Staff Executive Committee." The minutes of the Medical Staff Executive Committee meeting were identical except that the recommendation would be forwarded to the Board of Directors. There was no discussion in the minutes regarding the negative hospital evaluation or malpractice suit, or whether any issues had been noted at Cary Medical Center.

12. The physician disclosed a malpractice claim arising out of the care at Cary Hospital in his re-appointment application. A review of this physician's quality file did not contain evidence of peer review of that case, nor was there any evidence of peer review for this physician during the entire period 2009 and 2010.

13. The Medical Staff Services Manager, in a meeting on April 27, 2011, stated that the Emergency Physicians' performance improvement indicator for 2009 and 2010 was to ensure that EKG's were performed within ten (10) minutes of arrival for patients with chest pain. This was confirmed by the Chief of Emergency Medicine and the President of the Medical Staff in a separate meeting on the same day.

14. The Chief of Emergency Medicine stated physicians do not perform the EKG; the nurses perform it. He continued that this was a relevant physician indicator because, "physicians are the captain of the ship." The Chief of Emergency Medicine confirmed that there were standing orders for nurses to perform EKG's. Both the Chief of Emergency Medicine and the Medical Staff Services Manager acknowledged, during meetings on April 27, 2011, this performance indicator did not measure physician response times to interpretation of the EKG.

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

Based on a review of relevant documents and interviews with key hospital personnel on April 26-27, 2011, it was determined that the medical staff failed to document or perform case review as required in the Quality Plan, failed to recognize failures in peer review case finding, failed to have peer review in physicians' credentialing files, failed to consider or take action regarding adverse information presented at the time of credentialing, and failed to involve the emergency physicians in improving patient outcomes.

Findings include:

1. During a complaint investigation, a patient was found to have seventy-nine (79) Cary Hospital Emergency Department (ED) visits during a thirteen month period, from August 2009 through August 2010. On fifty-one (51) occasions, the patient had an unscheduled return to the ED within seventy-two hours. On at least two occasions, the patient had an unscheduled return to the ED and was admitted to the hospital.

2. During an interview on April 26, 2011, the Chief Operating Officer stated that this patient's care was not subject to peer review since it did not meet the criteria for peer review. During the same interview, the Chief Operating Officer stated that the Peer Review criteria for the ED was to review unscheduled returns to the ED within 72 hours only if they are admitted to the hospital.

3. The Cary Hospital Peer Review form lists review criteria as "Unscheduled return to the ED within 72 hours."

4. During an interview on April 27, 2011 with the Chief of Emergency Medicine and the President of the Medical Staff, this patient's unscheduled returns were discussed. The Chief of Emergency Medicine stated that there must be a systems failure since this patient should have been identified for peer review. The Chief of Emergency Medicine further stated that peer review was generally performed informally without written documentation.

5. The Hospital-Wide Quality Management & Patient Safety Plan states, "Trending for Peer Review by the Medical Staff will include: ...Unscheduled ER revisits within 72 hours ..." The Chief Operating Officer and the Medical Staff Services Manager stated, during meetings on April 26 and 27, 2011, all peer review would be found within individual physicians' quality files.

6. The Emergency Medicine Quality Management Plan for 2010 stated, "The summary of chart reviews is reported in the minutes of the monthly department meetings. Charts with deficiencies and a minimum of one chart per reviewer will be discussed in detail with discussion included in the department meeting minutes. Deficiencies and other issues involving other departments of the Medical Staff or hospital will be referred appropriately. Additionally, results of individual reviews will be organized in a provider-specific manner and forwarded to the Medical Staff Coordinator for use in credentialing."

7. The Emergency Physicians meeting minutes from September 2009 through December 2010 were reviewed. In September 2009, the minutes stated, "Peer review was completed following the meeting." There were no minutes of these discussions, nor a record of the cases reviewed. In the remainder of the minutes, there was no evidence of case review, nor was there "detail with discussion included in the department meeting minutes."

8. A review of the Emergency Department meeting minutes from September 2009 through December 2010 did not contain evidence that "results of individual reviews will be organized in a provider-specific manner and forwarded to the Medical Staff Coordinator for use in credentialing," as there was no evidence of case review.

9. The ED/Inpatient Nurse Manager stated, during a meeting on April 26, 2011, that minutes are not kept of physician chart reviews and that any records of chart review would be found in physicians' credentialing files. This was confirmed by the Chief Operating Officer at the same meeting. It was similarly confirmed by the Chief of Emergency Medicine, during a meeting on April 27, 2011, that "our case review is informal and we don't take minutes."

10. The credentialing quality files for all emergency physicians providing coverage at the Cary Emergency Department during 2009 and 2010 were reviewed. During this time period, the Chief Executive Officer stated in a meeting on April 27, 2011, that the ED saw 28,000 patients: 14,000 in 2009 and 14,000 in 2010. Twenty-four (24) quality files were examined. There were only thirteen (13) peer reviews performed in this time period. Only seven (7) physicians' files contained peer review. The remaining seventeen (17) physicians had no case review performed during this time period.

11. During a review of credentialing files, there was documentation that a physician disclosed that since his previous appointment there had been a malpractice claim made against him. The malpractice claim was related to his care of a patient in the ED of Cary Medical Center. In the same re-appointment application, a reference hospital reported "issues working within the ED team." The minutes of the Emergency Physicians regarding this re-appointment application read, "Reappointment - MD, DISCUSSION: ..., MD (Emergency Medicine); the complete reappointment application and physician profile of [ED physician] was reviewed. There was one new claim and one negative hospital verification. The report from the National Practitioner's Data Bank contained no reports. ACTION: A motion was made to recommend reappointment of [ED physician] to the Courtesy Medical Staff with privileges as requested through December 31, 2012. The motion was seconded and so VOTED unanimously to recommend reappointment. This recommendation will be forwarded to the Medical Staff Executive Committee." The minutes of the Medical Staff Executive Committee meeting were identical except that the recommendation would be forwarded to the Board of Directors. There was no discussion in the minutes regarding the negative hospital evaluation or malpractice suit, or whether any issues had been noted at Cary Medical Center.

12. The physician disclosed a malpractice claim arising out of the care at Cary Hospital in his re-appointment application. A review of this physician's quality file did not contain evidence of peer review of that case, nor was there any evidence of peer review for this physician during the entire period 2009 and 2010.

13. The Medical Staff Services Manager, in a meeting on April 27, 2011, stated that the Emergency Physicians' performance improvement indicator for 2009 and 2010 was to ensure that EKG's were performed within ten (10) minutes of arrival for patients with chest pain. This was confirmed by the Chief of Emergency Medicine and the President of the Medical Staff in a separate meeting on the same day.

14. The Chief of Emergency Medicine stated physicians do not perform the EKG; the nurses perform it. He continued that this was a relevant physician indicator because, "physicians are the captain of the ship." The Chief of Emergency Medicine confirmed that there were standing orders for nurses to perform EKG's. Both the Chief of Emergency Medicine and the Medical Staff Services Manager acknowledged, during meetings on April 27, 2011, this performance indicator did not measure physician response times to interpretation of the EKG.

15. The medical staff failed to be responsible for the quality of care provided to patients. For further information see Tag A -0347

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

Based on document review and interview with key personnel on April 26-27, 2010, it was determined that the hospital failed to coordinate care with the primary care practitioner, failed to document deviations from a narcotic withdrawal plan, failed to consider alternatives to narcotic analgesics in the face of a withdrawal regimen, failed to document appropriate informed consent or refusal, and failed to perform expected neurological assessments.

Findings include:

1. On April 26-27, 2011, a review was conducted of the medical record of a patient who received care and services in the Cary Medical Center Emergency Department between August 1, 2009 and August 31, 2010. There were seventy-nine (79), emergency department visits to the Cary Emergency Department from August 1, 2009 through August 31, 2010.

2. The medical record revealed that the patient presented with multiple complaints of pain due to migraine headaches, dental pain, musculoskeletal pain, abdominal pain and chest pain. The patient was administered schedule II narcotics during thirty-three (33) visits. She was administered non-schedule narcotics at twenty-seven (27) Emergency Department visits.

3. According to the medical record, the patient's primary care practitioner was called only once during this time period to discuss the patient's pain management.

4. On April 11, 2010, the Chief of Emergency Medicine treated the patient. The Emergency Department Physician's record states, "The patient has recently been seen and was taken off all her opiates at home for this headache. She is on low dose methadone (2.5 mg/day). She has been told to avoid opiates ... I have, however, tonight in view of her level of discomfort given her Demerol 100 mg. ... "

5. The record did not contain evidence of discussion with the patient, or the patient's primary care practitioner regarding the decision to modify the patient's pain management regimen.

6. The April 11, 2010 record did not contain documentation that the physician considered alternative regimens consistent with the patient's headache management plan nor avoided additional narcotics, such as the Demerol that was administered. There was no documentation that the physician performed a neurological examination. There was no description of the patient's pain, nor an assessment of the patient's degree of pain.

7. During a meeting on April 27, 2011, at approximately 3:00 p.m, the Chief of Emergency Medicine stated, "I never called [the patient ' s Primary care giver] to discuss [the patients] care, it's just not operational .... "

8. At the same meeting, the Chief of Emergency Medicine reported that he did not recall giving [the patient] Demerol on April 11, 2010, while the patient was receiving Methadone.

9. The Chief of Emergency Medicine further stated that he did not query the Maine Prescription Monitoring Program database. "I didn't use it. I know that it is available. I didn't use it for [this patient]."

10. The Chief of Emergency Medicine was asked if it was his expectation that both a neurological examination and a pain assessment would be conducted on a patient presenting to the Emergency Department with the Chief Complaint of "headache." He stated, "Yes, it's the expectation that they be documented. I know that you will find times that it's not done."

11. The President of the Cary Medical Staff was interviewed at the meeting with the Chief of Emergency Medicine on April 27, 2011. Additionally, she was an Emergency Physician who treated this patient on multiple occasions. The President of the Medical Staff stated that she did not query the Maine Prescription Monitoring Program database for this
patient, nor had she consulted with the patient's primary care practitioner.

12. During interviews on April 27, 2011, the Chief of Emergency Medicine and the President of the Medical Staff both stated that no review had been performed of this patient's care.

13. The potential impact of these deficient practices, including not coordinating with the primary care practitioner and not adhering to a narcotic withdrawal regimen, and the failure to appropriately use the Maine Prescription Monitoring Program was that the patient may have been placed at risk for disability by continuing narcotic addiction or dependency. The potential impact of the failure to perform appropriate neurological examinations when the patient presented with headache was that the patient may have been placed at risk for having a potentially life threatening condition which might not have been diagnosed without an appropriate physical examination.