HospitalInspections.org

Based on a review of documents and interviews with relevant personnel on June 27 - 30, 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 Tag A-0338).

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 personnel as described below, it was determined that Cary Medical Center did not have an effective quality assessment and performance improvement program focused on improved health outcomes, reducing or preventing medical errors, and involving all hospital departments and services.

Findings include:

1. 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 Tag A-0338).

2. The Cary Medical Center "Dashboard of Clinical Quality, Service Excellence, Financial Vitality and Workforce Excellence" was reviewed. The 2010 Medical Staff performance improvement indicators for Anesthesiology, Pathology, and Pediatrics were at, or exceeded, their performance targets during all measurement periods. The 2011 indicators for these specialties were also at their targets during the first calendar quarter, the only measurement period available at the time of the survey. These indicators could not demonstrate improvements in health outcomes as they were already at, or above their targets.

3. The only 2011 Emergency Physician clinical quality indicator was, " Room to evaluation time for psychiatric patients within 10 minutes " . During a meeting with medical staff leaders on June 29, 2011, the President of the Medical Staff, an Emergency Physician said this was a " high risk indicator " . During the same meeting, the President of the Medical Staff stated that she considered the, " Room to evaluation time for psychiatric patients within 10 minutes " , to be a high volume indicator as well as high risk.

4. According to numbers supplied by the Chief Executive Officer and the Manager of Medical Staff Services at the time of the survey, 79 patients had been screened by this indicator from January 1, 2011 through May 2011. At the same time, there were 6050 patients seen by the Emergency Physicians. This represents only 1.3% of the volume seen by the Emergency Physicians.

5. In an e-mail dated June 30, 2011, the Manager of Medical Staff Services Stated, " No, it [the psychiatric indicator] does not include [Emergency Department] walkin. This is a physician indicator not a mid-level. Our walkin providers would not see patients who present for psychiatric reasons". In an e-mail dated July 1, 2011, the Manager of Medical Staff Services supplied 2011 volumes for the Emergency Department Walk-In-Center, staffed by Physician Assistants and Nurse Practitioners. The Walk-In-Center volume is approximately 5900 patients annually.

6. The Cary Medical Center "Dashboard of Clinical Quality, Service Excellence, Financial Vitality and Workforce Excellence" was reviewed. The only 2010 and 2011 Walk-In-Center quality initiative was " Patient length of stay < 60 minutes by provider (from the time pt arrives in pt room to discharge) " . There were no clinical quality initiatives for the Walk-In-Center, staffed by Physician Assistants and Nurse Practitioners, for 2010 or 2011 focused on improved health outcomes or safety.

7. The Cary Medical Center "Dashboard of Clinical Quality, Service Excellence, Financial Vitality and Workforce Excellence" was reviewed. The 2010 Department of Medicine quality improvement indicators were, "Completion of Medication Reconciliation at Discharge, and, " Verbal Orders Signed, Dated, and Timed within 48 hours " . For 2011, this was modified to " dating, and timing all entries in the progress notes."

8. The indicator for medication reconciliation had a target of " 100% completion at discharge " . The results during the four quarters of 2010 were, 86%, 86%, 85%, and 73%. The Department of Medicine meeting minutes from May 2010 through June 2011, did not contain discussion of the lower than expected, and declining, results on this indicator. For each report, the minutes stated, " ACTION: Informational. "

9. The Cary Medical Center "Dashboard of Clinical Quality, Service Excellence, Financial Vitality and Workforce Excellence" was reviewed. The 2010 Surgical indicator was, " Communication between surgeon and patient/family post op " . The target was 100%. During 2010 the performance of this indicator was, 51%, 82%, 97%, 86%, 68%, 61%, and 68%. This indicator was not continued into 2011, despite the failure to achieve or sustain the goal of 100% any time during 2010. The minutes of the Department of Surgery from May 2010 through May 2011 did not contain discussion as to why this indicator was discontinued despite the failure to achieve the target or demonstrate sustained improvement.

10. The minutes of the Department of Surgery were reviewed from May 2010 through May 2011. For each period in which the Surgical Quality Indicators were discussed, the minutes read, " The Surgery Quality Indicator Reports for [month(s)] were distributed and reviewed. ACTION: Informational " . The minutes did not contain any indication that discussion occurred, or measures taken, to improve this quality indicator.

11. According to the November 2010 Departmental Meeting minutes, the Department of Surgery adopted " VTE [venous [thromboembolism] prophylaxis " >70% " , " Numerator: VTE Protocol initiated, Denominator: All surgical procedures " , as an indicator for 2011. As of the time of the survey, June 27-30, 2011, the hospital was unable to provide results for progress against this indicator. The May 2011, Department of Surgery meeting minutes state, " The CEO reported the OR Nurse Manager has generated reports that show the usage of SCD ' s by provider, the compliance with the usage of SCD ' s is very good. The majority of cases are gynecology procedures and general surgery. As of April 1st the Thrombosis Risk Assessment form is being placed on all records. A discussion ensued regarding confusion among staff if these are considered orders. ACTION: The CEO will pull a group together to discuss the assessment form. An update will be provided at the next meeting. "

12. Surgeons at the hospital perform approximately 850 GI endoscopic procedures per year, according to a July 8, 2011 e-mail from the CEO " YTD 2011 - Colonoscopies - 288 and EGD ' s - 136 " . In the same communication, the CEO ' s stated, " Endoscopic procedures are not part of the VTE Protocol, last year Colonoscopies were reviewed using the Interqual SIMS criteria. "

13. In an e-mail communication dated July 13, 2011, the CEO stated, " Interqual SIM criteria is a tool to determine appropriateness of surgical or invasive procedures whether or not confirmatory tissue was obtained during the procedure. Information is obtained from the patient ' s record and compared to the indications listed. I have attached the Colonoscopy SIM reference. The surgeons decide which procedures will be reviewed each year, last year colonoscopy was one of the procedures chosen. " The attachment is entitled " SIM plus (Trademark) Specialized Procedures Colonoscopy " . The copyright notice identifies it as a product of the McKesson Corporation " . This document does not contain results or data.

14. The minutes from the Department of Surgery from May 2010 through May 2011 did not contain discussion of endoscopic quality. The minutes of the Medical Executive Committee from May 2010 through June 2011 did not contain discussion of endoscopic quality. The 2010 and 2011 Cary Medical Center Dashboards did not include endoscopic indicators or results from Interqual SIM plus (Trademark) data.

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 personnel during the survey on June 27-30, 2011, it was determined that the Medical Staff could not demonstrate that it was responsible for the quality of medical care, failed to comply with the Medical Staff Bylaws by not documenting discussion of case review, failed to examine the quality of care in certain physician specialties, failed to review adverse patient outcomes, failed to consider or take action regarding adverse information presented at the time of credentialing, and failed to perform meaningful case review in order to find opportunities for improving health outcomes.

Findings include:

1. The Medical Staff 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 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."

3. A review of the Emergency Department meeting minutes from May 2010 through May 2011 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 documentation of the discussion of case review.

4. The peer review files covering the current appointment period, for the twenty-eight, (28), active members of the medical staff in Anesthesia, Surgery and surgical subspecialties, Obstetrics, Pediatrics, Internal Medicine, Family Medicine, and Emergency Medicine, were reviewed on June 29, 2011. A total of ninety-nine, (99) peer review worksheets were present in these files. All of the cases reviewed were felt to be " appropriate " .

5. The December 2010 Medical Executive Committee minutes state, " The Chief of Staff suggested the current peer review process be examined for improvement. ACTION: The committee members shall research means of improving the peer review process and discuss at the next Medical Staff Executive Committee meeting " . The January 2011 minutes state, " The Chief of Staff requested the departments review a few charts at each department meeting. If this process proves unsuccessful it will be brought back to this committee to determine an alternative process. There was concern not enough Surgery and Emergency Medicine files are being flagged for review. "

6. The March Medical Executive Committee minutes state, " The Department Chiefs reported peer review was completed at all meetings this month. It will be documented in the minutes if peer review was completed either prior to or following the department meeting. ACTION: Informational. "

7. The meeting of the Surgery Department that followed the March 2011 Medical Executive Committee occurred on May 9, 2011. There was no evidence that the department " ...review a few charts at each department meeting " as described in the January 2011 Medical Executive Committee meeting. Furthermore, the minutes did not contain any notation that peer review occurred either before or following the meeting.

8. The Cary Medical Staff Bylaws, Article XI, Section 4, d, states, " Each department shall analyze and review, on a peer group basis, the clinical work of the department... " and Article XI, Section 4, e 3 states, " Once peer review cases are assigned to a reviewer, results will be reported and analyzed at the appropriate departmental meeting " . Article XI, Section 4, c, states, " Each department shall ... maintain accurate minutes of such meetings, and forward such minutes to the Executive Committee " .

9. The minutes of the Departments of Medicine, Surgery, and Emergency Medicine from May 2010 through May 2011 were reviewed. The only entry regarding case review was, " Peer review was completed prior to, [or following], the meeting " . There was no evidence that these departments were in compliance with the Medical Staff Bylaws to, " analyze and review, on a peer group basis, the clinical work of the department " , nor, " Once peer review cases are assigned to a reviewer, results will be reported and analyzed at the appropriate departmental meeting " , nor, " maintain accurate minutes of such meetings " , since there were no minutes regarding the case review, case discussion, trending or analysis of the quality of care, or recommendations for improvement of future care.

10. On June 29, 2011 the quality files for the Active Medical staff were examined. This review covered their current two-year appointment. There were only two, (2) cases reviewed from General Surgeons, one, (1) Orthopedic case review, one, (1) Otolaryngology review, three, (3) Urological reviews, and none, (0), Ophthalmological cases reviewed. Of the three Obstetricians, one physician had one (1) case reviewed, another had four, (4) cases reviewed, and a third had twelve, (12) cases reviewed.

11. Minutes of the Maternal Child Review Committee from June 2010 through June 2011 and the minutes of the Department of Surgery from July 2010 through May 2011 did not contain evidence, or analysis of, Obstetrical case review as described in the Medical Staff Bylaws. There was no discussion or analysis regarding the discrepancies in number of Obstetrical peer review cases and whether this represented a quality issue.


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

Based on a review of the Cary Hospital Anesthesia Record, and confirmed during interviews with the Chief of Anesthesia and the Lead CRNA on June 29, 2011, it was determined that the CRNA ' s at Cary Hospital were not under the appropriate supervision of the operating practitioner as defined in State Regulation.

Findings include:

1. During an interview on June 29, 2011, the Lead CRNA described the anesthesia form as a continuous record with the first side containing the anesthesia plan, and the next side containing the anesthesia record. The Lead CRNA said that the front side of this form has entries for nurses, who sign the form. The section containing the anesthesia plan was completed and signed by a CRNA and an anesthesiologist, prior to surgery.

2. Additionally, the Lead CRNA reported that the anesthesia record was completed by the CRNA in the operating room during the procedure. The medications administered during the operative procedure, their dose, route of administration, and any adjuncts used, were recorded on the anesthesia record.


3. Also during the same interview, the Lead CRNA agreed that the anesthesia plan does not list adjunct medications to be used, nor does it list medications, doses or route of administration that may have been administered in the operating room that were not originally part of the plan. The Lead CRNA said that the operative record is signed by the CRNA, but is not signed by a physician. The name of the anesthesiologist was handwritten in the space reserved for that signature.

4. The State of Maine Board of Nursing Rules and Regulations Chapter 8, C, (3) states: " adjustments and corrective actions as indicated. For aspects of anesthesia practice that require execution of the medical regimen, the certified registered nurse anesthetist shall be responsible and accountable to a physician or dentist. Without limitation, coordination and appropriate communication shall be deemed to have occurred if the prescribing physician or dentist shall have signed the patient's anesthesia record. "