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Tag No.: A0043
Based on review medical record review, document review and staff interview, it was determined that the governing body failed to ensure that surgical care was provided in a safe manner consistent with standards of practice. As a result, a patient sustained injuries during a procedure, including "accidental" removal of a vital organ. This was found in one (1) of one (1) medical record reviewed (Patient #1).
This failure to provide oversight of the activities of the Department of Surgery places patients who have surgery at risk for errors and potential harm.
Findings include:
See Tag A 0951
Tag No.: A0145
Based on document review and staff interview, the facility failed to ensure that: 1) patients are free from all forms of abuses or harassment when complaints are investigated: and 2) grievance procedures specify how patients will be protected and free from abuses, harassment, and reprisals when they voiced complaints. This was identified in one (1) of one (1) grievance investigation reports reviewed.
Findings include:
1) Review of facility ' s document titled: " Patient/Customer Contact Summary, " dated 6/13/16, noted that a grievance was received on 6/10/16. The allegation stated that the surgeon went to patient ' s bedside and stated to the patient: " Your --- called the Department of Health and now I ' ll probably lose my license " .
During phone interview with Staff A, the Chief Nursing Officer, on 6/15/16 at 3:30 PM, Staff A verified that the grievance was received.
2) The facility ' s procedure did not specify how patients are protected from reprisal when complaints are filed. Review of the following facility policies and procedures related to how complaints are handled by the facility failed to address how patients will be protected during a complaint investigation:
1) Patient Grievance Mechanism Policy #1102 B.
2) Behaviors that Undermine a Culture of Safety: Medical Staff Policy #3309
3) Patient Bill of Rights policy #1102.
Tag No.: A0940
Based on medical record review, document review and staff interview, the facility failed to provide surgery consistent with acceptable standards of practice for one (1) of one (1) patient, which resulted in harm.
This failed practice placed patients at increased risk for adverse surgical outcomes.
See Tag A 0951
Findings include:
Review of medical record for Patient #1 revealed that the patient was admitted on 5/12/16 with a complaint of shortness of breath (SOB) and referral from her private physician for low hemoglobin. Upon arrival at the hospital and testing of her hemoglobin level at 4:46 PM, the patient's hemoglobin level was 5.2 mg/dl (10-12 mg/dl normal range).
The physician decided to perform a colonoscopy to see if the source of bleeding was lower down in the gastrointestinal tract and the surgeon performed the colonoscopy on 5/16/16.
On 5/17/16 the patient was noted with episode of extreme dizziness, diaphoresis and severe left sided abdominal pain and her blood pressure was 85/56 normal (120/70). Rapid response team was called; the patient was returned to the Operating Room. An emergency splenectomy (removal of the spleen) was performed. During the surgery, the patient's left kidney was removed, along with the spleen.
The patient displayed a lack of improvement from the date of surgery and on 5/25/16, prior to a planned discharge, and with continued complaint of severe abdominal pain, an abdominal CT scan was done, which showed the presence of a lap pad.
On 5/25/16 the patient was returned to the operating room at 8:59 AM. The surgeon documented an operation report in the progress note that he removed a foreign body (retained lap pad) from the patient's abdominal cavity.
On 5/26/16 the surgeon documented that during the surgical procedure, a gastric ulcer was perforated and was returned to OR to have it repaired.
During interviews, with the Medical Director of Surgery on 5/27/16 at 2:48 PM, and the physician on 6/1/16 at 3:00 PM, it was stated that "the removal of the patient's kidney was an accident."
Tag No.: A0951
Based on medical record review, document review and staff interview, the surgical department failed to ensure that (a) facility staff followed facility policy and procedure for performing surgical counts and procedures, (b) the environment of the different Operating Rooms (OR) were not maintained at recommended humidity, (c) incidents related to surgical procedures are tracked and trended.
This was identified in the review of seven (7) of seven (7) medical records reviewed. (Patient #1, #2, #3, #4, #5, #6, and #7) .
Findings Include:
(a) Review of medical record of Patient #1 revealed that on 5/17/16 at 3:00 AM, the patient had surgery performed.
A review of the medical record revealed that there was no documentation in the medical record of the surgical counts performed.
During interview with Staff V, Circulating Nurse on 5/31/16 at 12:57 PM, and Staff K, Scrub Nurse on 6/1/16 at 11:00AM, it was stated that they counted the lap pads used and the counts were reconciled with the amount of lap pads brought to the sterile field for the surgeon's use.
It was stated by both the circulating nurse and the scrub nurse that a lot of pads were used and a count was maintained on the white board as was facility practice. At the end of the surgical procedure, they both counted again and recorded the information on the board which was wiped off when the OR was cleaned.
During interview with Staff N, Nurse Operating Room Director, on 6/2/16 at 11:50 AM, it was verified that count of soft goods is not recorded in the medical record.
Similar findings were noted in medical records for Patient #2, #3, #4, #5, #6, and #7, where there were no documentation of the surgical counts performed.
A review of facility policy titled "Prevention of Retained Surgical Items (counts)," effective 10/07/15, states in step #11 that all counts (sponges, sharps, instruments, and miscellaneous items) should be performed and recorded for all surgical procedures.
The policy did not specify where to record this information.
The policy further stated the times when a count should be performed. Per policy, counts should have been performed at least 4 times. Both the scrub nurse and the circulating nurse stated that they counted only 2 times during the procedure. This is not in compliance with facility policy.
Review of the facility incident report dated September 2015 noted a similar surgical case involving gauze sponge counts and retained foreign body. Recommendations included documenting each "soft good count."
Staff continued the practice of recording the counts on the white board which is wiped off at the end of the surgical procedures. It was identified that the policy was not updated at that time to include specifically, where staff should document the count.
(b) Review of temperature and humidity logs from May 2016 to June 2016 identified that there were instances when the humidity in the OR fell outside the required range (30-60%).
On 6/1/16 the humidity for C.V.O.R was recorded as 67%.
On 5/17/16 the humidity in OR #9 was recorded as 22%.
On 5/21/16 the humidity in OR #8 was 72%.
During interview on 6/2/16 at 10:35 AM the Temperature and Humidity logs were reviewed with Staff Y, the Director of Engineering who verified the findings.
(c) A review of Quality Assurance and Performance Improvement (QAPI) Meeting Minutes from June 2015 to May 2016 showed during a period of one (1) year between 6/10/15 to 5/27/16, the facility listed four (4) cases of patients being returned to OR (Unplanned Return to OR cases). There were four (4) cases of retained foreign bodies during the same period, two (2) of the four (4) cases were near misses. These cases were not tracked and trended.
A review of the incidents and accidents from May 2015 to June 2016 revealed that the facility failed to analyze, track and trend incidents related to surgical procedures. During the review, a log of incidents and accidents including surgical staff errors was noted but there were no analysis, tracking or trending.
There was no documented evidence that the surgical incidents and accidents were being discussed, analyzed, tracked, and trended to identify patterns and areas for improvement in the delivery of safe surgical services.