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Based on interviews, record reviews, and a review of policies and procedures, it was determined the facility failed to have in place an effective quality assessment and performance improvement (QAPI) program.

The facility developed a policy related to Quality Improvement that indicated "anyone" could refer concerns related to adverse patient events to the medical staff Quality Improvement Committee. However, the facility failed to establish a system for the reporting of adverse patient events to ensure an effective, ongoing, data-driven quality assurance program was maintained. In addition, the facility failed to maintain/demonstrate evidence of an effective QAPI program.

Refer to A0267.

Based on interviews, record reviews, and a review of policies and procedures, it was determined the facility failed to implement and maintain an effective ongoing hospitalwide data-driven quality assessment and performance improvement (QAPI) program.

The facility failed to ensure the process for the referral of adverse patient events was effective and/or that all adverse patient events were measured, analyzed, or tracked for two of seven patients selected for review (patients #1 and #3).

The findings include:

A review of the facility's Quality Assurance/Performance Improvement (QAPI) Program Policy entitled "Medical Staff Quality Improvement Committee (MSQIC): Peer Review and Ongoing Professional Practice Evaluation" policy (effective date April 27, 2010) revealed "anyone could refer a case for review to the Medical Staff Coordinator, the Quality Improvement Quality Coordinator, the Director of QI department or any member of the MSQIC committee." The QAPI Program policy revealed the facility defined 47 clinical indicators for review by the MSQIC (QAPI Committee). However, of the 47 indicators defined, only five of the clinical indicators were required to be reviewed at 100 percent. According to the policy, cases regarding the remaining 45 clinical indicators would only be reviewed if referred to the MSQIC. The following clinical indicators were included in the listing of cases to be reviewed by referral only: unanticipated readmissions of patients within a defined timeframe (14 days) following discharge for problems related to the initial medical condition or surgical complication, incidents of delay in treatment/consultation resulting in significant deterioration in a patient's condition, and incidents of unavailability of physicians on the on-call list for the Emergency Department (ED).

Interview with the Quality and Risk Management Director on May 25, 2011, at 2:15 p.m., revealed the hospital's QAPI Committee reviewed 100 percent of mortality, unanticipated cardiac or respiratory arrests outside of the Intensive Care Unit, Post-Anesthesia Care Unit, or Operating Room. In addition, major peri-operative complications of patients undergoing anesthesia, possible permanent or serious infant intrapartum injury, and risk management referrals for significant clinical concerns not otherwise classified were reviewed by the Committee. All other clinical quality department indicators were reviewed by referral only.

Interview with the Clinical Coordinator on May 25, 2011, at 2:15 p.m., revealed most referrals were documented, but the Clinical Coordinator was not sure if all referrals for the QAPI Committee were documented. The interview also revealed the indicators listed in the policy were only reviewed if a referral was made and, as a result, it was possible that all of the indicators would not be reviewed.

Interview with the Chairperson of the QAPI Committee on May 24, 2011, at 9:15 a.m., revealed that all clinical indicators listed in the policy were reviewed by the QAPI Committee. However, the Chairperson was not aware of the process staff was to utilize to make referrals of concerns related to adverse patient events to the QAPI Committee.

Interview with physician #1 on May 24, 2011, at 2:00 p.m., revealed that he was a member of the QAPI Committee and stated the QAPI Committee reviewed all indicators listed in the policy. According to physician #1, if there was a concern not listed as an indicator for review, the facility staff/physician would need to make a referral to the Committee. Physician #1 also stated there was not a referral form for staff to use to notify the Committee of a concern and staff would need to "just call the quality director."

Additional interviews were conducted on May 24, 2011, and included staff member #12 at 9:55 a.m.; staff member #2 at 10:40 a.m.; staff member #4 at 11:05 a.m.; staff member #5 at 11:15 a.m.; staff member #6 at 11:20 a.m.; staff member #13 at 11:45 a.m.; staff member #17 at 3:30 p.m.; and staff member #11 on May 25, 2011, at 3:05 p.m. Staff members interviewed were unaware of a referral system to report occurrences to the QAPI Committee that could be a quality/care issue. Staff members stated if they had a concern they would tell their immediate supervisor.

As a result of the facility's failure to have a referral process in place, the following patient cases which met the clinical indicators for review were not referred to the QAPI Committee:

1. A review of patient #1's medical record revealed the patient was triaged in the ED on September 21, 2010, at 11:33 p.m. The triage assessment revealed patient #1's blood pressure was 101/56 (normal range 100-140/60-90), the patient's pulse rate was 107 (normal range 60-100), and the patient's respiratory rate was 33 (normal range 12-20). The patient also complained of dizziness, hypoventilation, "feet numb," and shortness of breath. The triage documentation revealed the patient had undergone a surgical procedure on September 21, 2010, at 2:30 p.m., the same day the patient presented to the ED. Registered Nurse (RN) #5 conducted a nursing assessment of patient #1 on September 21, 2010, at 11:37 p.m.; patient #1 was anxious, cool, pale, and tachycardiac (rapid pulse rate). The nurse also noted patient #1 had abdominal tenderness with guarding. The nurse documented the patient stated he/she was "Hurting all over, up in left (L) arm, can't breathe."

A review of the Emergency Department (ED) physician's assessment of patient #1, dated September 22, 2010, at 12:46 a.m., revealed the patient complained of dizziness and abdominal pain. The ED physician documented the patient had undergone a surgical procedure "today" (September 21, 2010) and presented to the ED with complaints of difficulty breathing, abdominal pain, and right (R) shoulder pain. The physician's assessment revealed patient #1 was anxious, short of breath, and was having abdominal pain.

Documentation revealed patient #1's medical condition worsened throughout the patient's admission to the ED and the ED physician contacted the on-call physician on three different occasions from 2:30 a.m. until 6:50 a.m. on September 22, 2010. The on-call physician presented to the facility at 7:10 a.m. on September 22, 2010, and patient #1 was taken to the Operating Room for a surgical procedure at 7:35 a.m.

An interview conducted on May 25, 2011, at 9:40 a.m., with RN #5 revealed patient #1 had complained of pain initially but the patient's pain and medical condition had worsened while the patient was in the ED. According to RN #5, the patient became pale, "tachycardiac," and received IV fluids and a blood transfusion while in the ED.

An interview conducted on May 24, 2011, at 2:25 p.m., with the ED physician revealed the on-call physician was telephoned several times related to patient #1's condition. The ED physician stated, "I felt [the patient] needed treatment when I called him; that is why I called him." The ED physician stated patient #1 became hypotensive and intravenous (IV) fluids were administered. In addition, according to the ED physician, the patient's Hemoglobin and Hematocrit dropped and the patient received a blood transfusion. The ED physician stated due to the on-call physician's prolonged response time, patient #1 experienced a delay in treatment and "suffered a negative outcome."

A review of the facility's physician on-call list for the ED revealed the on-call physician was the only physician on-call for that specialty service on September 21, 2010, for consultation and/or to further manage the care of patients that presented to the ED with complaints related to that particular specialty area. A review of the facility's "Physician On-Call Coverage in Lieu of Availability of On-Call Physician Services" policy (effective date March 2011) revealed the on-call physician had a legal obligation under the Emergency Medical Treatment and Labor Act (EMTALA) to come to the facility to provide emergency stabilizing treatment for a patient when requested by the Emergency Room physician. The review revealed the on-call physician was to respond by phone to the initial call within 30 minutes. The policy further revealed when an ED physician requested an on-call physician to provide stabilizing medical care, the on-call physician must physically respond within a reasonable timeframe which, according to the policy, was 30 minutes unless a more immediate response was appropriate as determined by the ED physician.

An interview conducted on May 24, 2011, at 1:45 p.m., with the on-call physician, revealed patient #1 had undergone a surgical procedure earlier in the day on September 22, 2010, and had reportedly presented to the ED due to dizziness and pain. The on-call physician stated patient #1's Hemoglobin and Hematocrit (H & H) were slightly low upon admission and this was not unusual post surgical procedure. The interview revealed the ED physician had contacted the on-call physician a second time to report the patient's Hemoglobin and Hematocrit had decreased and the on-call physician requested for the patient to receive a blood transfusion. The on-call physician reported patient #1 had received a CT scan of the pelvis/abdomen that had been incorrectly interpreted as normal. The on-call physician stated he was misled by the incorrect results of the CT scan and, as a result, this led to the delay in treatment.

A review of patient #1's preliminary report dated September 22, 2010, at 6:05 a.m., of the CT scan revealed there was no apparent acute enteric, hepatobiliary, pancreatic, splenic, renal, or adrenal abnormalities noted. However, the Radiology report of the same CT scan read a second time on September 22, 2010, at 8:22 a.m., revealed a large amount of fluid present within patient #1's abdomen. In addition, the report revealed the fluid density was noted to be greater than simple fluid, and there was high "attenuation" in the left anterior abdomen near the umbilicus consistent with active hemorrhage and a mesenteric mass that could have been a large hematoma.

An interview conducted on May 24, 2011, at 4:15 p.m., with the Emergency Department Medical Director (EDMD) revealed the MSQIC (QAPI Committee) had reviewed the medical record of patient #1 initially due to concerns raised by the facility's radiologist of the misinterpretation of the patient's CT scan. However, according to the EDMD, it was discovered during the review that the on-call physician's response time to the ED physician's contact regarding patient #1 had been inappropriate. The EDMD stated the Committee determined the on-call physician should have presented to the ED when initially contacted by the ED physician regarding patient #1's complaints, and should have intervened when the patient's condition worsened and the on-call physician was contacted a second time. The interview revealed the Committee determined the on-call physician had failed to respond when contacted by the ED physician in a timely manner. As noted previously in the review of the facility policy, all incidents of delay in treatment/consultation resulting in significant deterioration in a patient's condition and all incidents of the unavailability for ED call by a physician on the on-call list were to be reviewed by the QAPI Committee.

A review of a copy of a letter to the on-call physician dated March 3, 2011, from the QAPI Committee, revealed the Committee found the on-call physician's overall care related to patient #1 to be inappropriate. The Committee determined the on-call physician should have conducted a more timely evaluation of a post-operative patient with symptoms of hypotensive shock. The on-call physician appealed these findings and on March 22, 2011, the Medical Executive Committee overruled the QAPI Committee's determination that the on-call physician's care had been inappropriate and determined the care was controversial.

2. A review of patient #3's record revealed that the patient was admitted to the facility on April 27, 2010, with a diagnosis of fetal demise. On April 28, 2010, dilation with suction evacuation was performed in Surgery by physician #8. Patient #3 was re-admitted on May 10, 2010, 13 days after initial admission, with a diagnosis of pelvic pain, incomplete abortion, and endometritis. On May 11, 2010, patient #3 returned to Surgery and physician #5 performed a second dilation and curettage. A review of the Quality Review meeting notes revealed no evidence this case was reviewed as per the QAPI policy indicators.

An interview with physician #8 on May 24, 2011, at 3:15 p.m., regarding patient #3 revealed that though "it isn't expected, it is not unheard of or very common to return a patient to surgery for a second D and C procedure." Although the case involving patient #3 met the clinical indicators for review by the QAPI Committee, the physician did not refer this case to the Quality Review Committee.

An interview with physician #5 on May 24, 2011, at 3:40 p.m., regarding patient #3 revealed that it is not common for a patient to be returned to the Operating Room for a second D and C procedure. Although the case involving patient #3 met the clinical indicators for review by the QAPI Committee, the physician did not refer this case to the Quality Review Committee.