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PARK NICOLLET METHODIST HOSPITAL 6500 EXCELSIOR BLVD SAINT LOUIS PARK, MN 55426 April 6, 2018
VIOLATION: ADMINISTRATION OF DRUGS Tag No: A0405
Based on interview and document review, the hospital failed to ensure patients received medications as prescribed by the medical provider, for 1 of 8 patients reviewed (P1), who did not receive all doses of an antibiotic during post-operative care.

Findings include:

P1's surgical record indicated that P1 underwent a planned surgical procedure on 02/12/18, for a diagnostic laparoscopy with right cystectomy. P1's post-operative diagnosis was removal of a dermoid right ovarian cyst. P1 was discharged to home the next day on 02/13/18, at 10:48 a.m.

A day after hospital discharge, P1 came to the emergency department on 02/14/18, with severe abdominal pain. A CT scan showed P1 had a bowel obstruction and needed emergency surgery. At 10:04 p.m., on 02/14/18, P1 was taken to the operating room for emergent repair of a herniation through the surgical site.

P1's operating room note, dated 02/14/18, at 11:41 p.m., indicated P1 underwent an exploratory laparoscopy, incisional hernia repair, removal of foreign body, and repair of small bowel injury. After surgery, P1 went to the PACU (post anesthesia care unit) and received an intravenous (IV) antibiotic, Cefoxitin 1 gm, shortly before 1:00 a.m., on 02/15/18. P1 was transferred to an inpatient medical unit for ongoing care, shortly before 2:00 a.m., on 02/15/18.

P1's post-operative physician's orders, dated 02/15/18, at 1:56 a.m., indicated P1 was to receive three additional doses of Cefoxitin 1 gm IV every six hours. The doses were scheduled for administration at 6:00 a.m., 12:00 p.m., and 6:00 p.m., on 02/15/18.

P1's medication administration record for 02/15/18, showed P1 did not receive the 6:00 a.m., dose of IV Cefoxitin 1 gm. P1 received only two of the three ordered doses of IV Cefoxitin, which were administered at 12:00 p.m., and 6:00 p.m., on 02/15/18.

Registered Nurse (RN)-C was interviewed on 04/04/18, at 4:05 p.m. RN-C was assigned to P1's care after P1 transferred from the PACU to the medical unit during the night of 02/15/18. P1 had standard post-operative orders, including IV antibiotics. RN-C could not recall if any of P1's antibiotic doses were scheduled to be given during that night shift of 02/15/18. RN-C was never told she omitted P1's 6:00 a.m., dose of IV Cefoxitin or made a medication error.

RN-A was interviewed on 04/05/18, at 10:25 a.m. RN-A was assigned to P1's care on the medical unit during the day shift of 02/15/18. P1 was scheduled to receive IV Cefoxitin 1 gm at 12:00 p.m. and again at 6:00 p.m. When RN-A went to P1's bedside to administer the 12:00 p.m. dose of IV Cefoxitin, RN-A found P1's 6:00 a.m. dose of IV Cefoxitin hanging on the IV pole, completely full and not infused. RN-C had hung the 6:00 a.m., dose but didn't open the regulator for infusion. RN-A administered the 12:00 p.m. Cefoxitin and then notified the medical provider that P1 missed the 6:00 a.m., dose of Cefoxitin. The medical provider said P1's antibiotics were prophylactic and the missed dose did not need to be replaced. RN-A made a notation on P1's medication administration record that P1's 6:00 a.m., dose was not given. RN-A was aware that a missed dose of medication constituted a medication error, which required completion of a medication error report. RN-A did not complete a medication error report regarding the discovery of P1's missed dose of IV antibiotic.

The hospital's policy Nursing Medication Administration (undated) indicated "In the event of an adverse drug reaction or medication error, the following needs to be completed: a. Notify managing clinician or primary clinician. b. Take appropriate measures to treat the patient and document the patient's response in the EMR. c. Enter into BEST Care Reporting System."

The hospital's policy Near Miss, Unexpected, Sentinel, and Adverse Health Event Reporting (undated) indicated "All employees are responsible for identifying and reporting events of concern by utilizing the BEST Care Reporting System. When a near miss or unexpected event or variation in the expected outcome or delivery of care occurs, the individual identifying the event will report the event to the appropriate leader(s) and enter into BEST Care Reporting System." The policy specified that the purpose of the BEST Care Reporting System was "To provide for uniform and timely investigation and evaluation of unexpected and critical events; to identify opportunities for systems and process improvements; to have a positive impact on improving patient care processes and outcomes, treatment and services through the mitigation of risk."

RN-A was interviewed on 04/05/18, at 2:45 p.m. RN-A stated leadership staff were unaware of P1's medication error, until the error was identified by surveyors, because RN-C failed to enter the event in the hospital's BEST Care Reporting System which tracks, trends, and initiates necessary remedies. During the survey, nursing leadership planned follow-up learning for RN-A and RN-C regarding the correct procedure for medication administration, medication errors, and standardized patient care hand-off. RN-A explained that the standardized patient care hand-off at the change of shift was not thorough between RN-A and RN-C on 02/15/18; the hand-off should have included a bedside assessment of P1's care needs, which would have trapped the medication error.
VIOLATION: SURGICAL SERVICES Tag No: A0940
Based on observation, interview, and document review, the hospital failed to maintain safe fire safety practice in the operating room, which had the potential to affect all patients undergoing surgical procedures where heat devices are used. This resulted in an immediate jeopardy to the health and safety of operating room patients.

The immediate jeopardy began on 04/05/18, at 12:40 p.m., when a surgeon was observed disregarding operating room fire safety; during a patient's laparoscopic cholecystectomy, the surgeon failed to properly holster the cautery device when it was not in use and instead, placed the cautery device on top of the patient's surgical drape over the patient's chest. The surgeon stated he does not use the cautery holster during surgeries because the holster does not stay in place. The surgeon's practice was contrary to hospital policy that required surgeons to holster cautery devices when not in use during surgical procedures.

The immediate jeopardy was removed on 04/06/18, at 12:20 p.m., when an acceptable removal plan was implemented to protect the health and safety of surgical patients.

Based on observation, interview and document review, the hospital failed to maintain appropriate standards of medical practice during surgical procedures, for 1 of 9 patients reviewed (P1), who required a second surgery due to a surgeon's error during the first surgery.

The hospital's failure to meet the surgical needs of patients in a safe setting and maintain acceptable standards of surgical practice resulted in the hospital's inability to meet the Condition of Participation of Surgical Services at 42 CFR 482.51.
VIOLATION: OPERATING ROOM POLICIES Tag No: A0951
Based on observation, interview, and document review, the hospital failed to maintain safe fire safety practice in the operating room, which had the potential to affect all patients undergoing surgical procedures where heat devices are used. The hospital failed to maintain appropriate standards of medical practice during surgical procedures, for 1 of 9 patients reviewed (P1), who required a second surgery due to a surgeon's error during the first surgery.

Findings include:

Operating room observations on 04/05/18, at 12:40 p.m., established that during P1's laparoscopic cholecystectomy, Surgeon (S)-K placed the cautery device, after use in surgery, on top of the drape, over P1's chest. When queried about why S-K placed the device on the drape and not in a cautery holster device, S-K stated he tried using holster devices on previous occasions, but they did not stay positioned where he wanted them, so he no longer used a holster for cautery device placement when it was not in use during surgery. S-K's unsafe practice with the cautery device placed the hospital in immediate jeopardy status regarding operating room fire risk. S-K was trialing a new type of laparoscopic specimen bag system to replace the endocatch bag.

The hospital's policy On Fire Safety for Surgical Services (undated) indicated "Standard precautions for all cases (Fire Risk Assessment 0-4) to prevent OR fires include: Must place electrosurgical (cautery), active electrode in holster when not in use."

Observations on 04/05/18, at 11:34 a.m., established that the hospital's surgeons use a disposable specimen bag system/endocatch that is designed for use as a receptacle for the collection and extraction of tissue, organs, and calculi during laparoscopic surgical procedures. The endocatch instrument is inserted through a 10 mm laparoscopic opening. A specimen collection bag is then deployed from the instrument and the specimen is scooped into the bag. The specimen bag is then tied closed. The bag is pulled back through the 10 mm opening with the specimen inside the bag.

P1's pre-operative history and physical, dated 02/09/18, indicated that P1 needed surgery to remove an ovarian cyst that was causing significant pelvic pain. P1's surgery was scheduled for 02/12/18, and did not require an overnight stay.

P1's surgical record indicated that P1 was admitted to the surgery center at 9:29 a.m., on 02/12/18, for a diagnostic laparoscopy with right cystectomy. Surgery began at 11:05 a.m., and ended at 1:27 p.m. P1's post-operative diagnosis was removal of a dermoid right ovarian cyst. The operative note indicated that S-I encountered a problem retrieving the endocatch bag through the 10 mm surgical opening. S-I made several attempts with ring forceps, but was not successful to remove the endocatch bag. S-I extended the 10 mm surgical opening with a scalpel and scissors. S-I then attempted to pull the endocatch bag through the surgical opening and the bag broke into pieces when it was removed from P1's abdomen.

P1's post-operative progress notes, dated 02/12/18, at 5:30 p.m., indicated P1 did not meet the criteria for discharge, due to incisional pain and nausea. P1 was kept overnight in observation status. P1 was discharged to home the next day on 02/13/18, at 10:48 a.m.

P1's clinic record on 02/14/18, indicated P1 presented to the clinic at 4:00 p.m., with severe abdominal pain. P1's incision was red and inflamed. P1 was sent to the emergency room .

P1's emergency department (ED) record, dated 02/14/18, indicated P1 presented to the ED at 5:15 p.m., with significant abdominal pain. A CT scan of the abdomen and pelvis showed P1 had a bowel obstruction secondary to a spigelian hernia containing multiple loops of small bowel. At 10:04 p.m., P1 was taken to the operating room for herniation through the surgical site.

P1's operating room note, dated 02/14/18, at 11:41 p.m., indicated P1 underwent an exploratory laparoscopy, incisional hernia repair, removal of foreign body, and repair of small bowel injury. S-J noted that the retained foreign body was approximately one-third of the endocatch bag, which was found in the lower abdomen. After surgery, P1 was admitted to an inpatient medical unit for ongoing care, including intravenous antibiotics. P1 remained hospitalized until 02/19/18, when she was discharged home.

S-J was interviewed on 04/05/18, at 12:40 p.m. S-J stated he was the surgeon on-call on 02/14/18, and was notified that P1 required emergent surgery for acute port-side incisional hernia that had been confirmed by CT scan. S-J performed P1's second surgery and corrected the herniation, which was a significant loop of bowel exiting the abdominal incision caused by incorrect closure during P1's first surgery. S-J had to snip a mis-placed suture that attached P1's bowel to the lap closure; S-J was then able to return the bowel to its cavity. S-J recovered a piece of the endocatch bag from P1's first surgery, which S-J removed right below P1's first surgical site. The fragment was approximately one-third of the endocatch bag or 2 inches by 2 inches in size, which was an incidental finding, as all of P1's emergent symptoms were due to P1's herniated bowel obstruction.

S-I was interviewed on 04/04/18, at 3:10 p.m. S-I stated he performed P1's first surgery on 02/12/18, when he removed P1's ovarian cyst via laparoscopy. P1's procedure was going fine until S-I started to retrieve the specimen in the endocatch bag. The bag would not fit through the 10 mm surgical opening. S-I first tried to manually pull the bag through the surgical opening. S-I tugged and pulled on the bag without success. S-I next tried to use forceps rings to remove the bag, which didn't work. S-I then cut and extended the tissue at the surgical site. S-I still had to tug and wiggle the bag to get it out, which shredded during retrieval. S-I reconstructed the bag fragments and thought he had all of the bag pieces, but S-I did not compare the reconstructed bag to an intact endocatch bag nor did S-I reconcile the reconstructed bag fragments with any of the other surgical staff. As a result of making a wider and deeper port to retrieve the specimen bag, S-I closed the surgical site with a running lock stitch to bring the fascia together. P1's body habitus made suturing challenging and S-I inadvertently placed one suture through P1's bowel, affixing it to the lap closure.

Chief Medical Officer (CMO)-G was interviewed on 04/04/18, at 11:40 a.m. CMO-G stated the hospital conducted a root cause analysis (RCA) of P1's surgical complication. The hospital determined the event constituted both a practice issue and a product issue. The practice issue concerning S-I's surgical technique was immediately reviewed by the department medical director and then forwarded to the appropriate physician committees for peer review regarding the technical aspects of P1's procedure. The hospital reviewed the endocatch bag product; a retrospective review of surgical cases showed zero incidents of bag breakage since 2014. The hospital's action plan included the implementation of a reconciliation protocol for the reconstruction of any breaches in instrument integrity by two operating room staff who visualize, compare, and verify that all pieces of the instrument are accounted for. The hospital is trialing a new type of laparoscopic specimen bag system from another vendor.

Medical Director (MD)-H was interviewed on 04/05/18, at 11:30 a.m. MD-H verified he reviewed the elements of P1's procedure with S-I on 02/15/18, and then directed the matter through the formal peer review process. MD-H met with P1 prior to P1's discharge and provided full disclosure about the surgical complication.

P1 declined an interview during the investigation.