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Based on observation, interview and document review, the hospital failed to ensure conflicting health care directives were clarified for 1 of 2 patients (P12) reviewed who required an interpreter and whose code status was not clarified upon admission.

Findings include:

P12's Admission Default Flowsheet Data printed 7/10/18, identified P12 had an advanced healthcare directive, and it was scanned into the medical record with dictation, "Current Scanned."

During observation on 7/10/18, at 9:19 a.m. P12 was laying in the bed in her assigned room. Registered nurse (RN)-A was in the room and prepared, then administered an intravenous (IV) preparation of Invanz (an antibiotic). P12 was unable to communicate with RN-A in English, so an interpreter was present and translating for P12 during the interaction.

P12's most recent POLST (Physician Orders for Life-Sustaining Treatment) dated 3/12/18, identified P12 had orders to be a Do Not Resuscitate/Do Not Intubate (DNR/DNI) with "Comfort-Focused Treatment" being selected. Further, the POLST identified P12 had orders to have no artificial nutrition via tube and no antibiotics. No additional POLSTs were located in the medical record since 3/12/18.

P12's current physician orders signed 7/6/18, identified P12 was admitted to the hospital as an inpatient, with a code status listed "Full Code." Further, P12's history and physical (H&P) dated 7/6/18, identified P12 admitted to the hospital with presumptive osteomyelitis (inflammation of the bone, typically due to infection). P12 was prescribed steroid medication along with several antibiotics. A section labeled, "Code:" was listed with dictation, "has been DNR/DNI but will leave full code [all resuscitation attempts made] d/t [due to] pending procedure and need to discuss with pt [patient] when interpreter available."

Immediately following the observation of P12 receiving IV antibiotic medication, on 7/10/18, at 9:19 a.m. P12's medical record was reviewed with RN-B. The record lacked any scanned health care directive, nor any dictated or evidence clarification of the conflicting physician orders for life sustaining care and treatment which could be required and/or necessary to ensure P12's wishes were implemented correctly in an emergent situation. RN-B identified she would look for clarification of the advanced directive.

On 7/10/18, at 1:55 p.m. RN-B was interviewed and verified the medical record lacked any signed copy of P12's health care directive; nor clarification of P12's POLST (signed 3/6/18) directing comfort-focused measures and her current orders for a full code. RN-B went with the provider and an interpreter after the discrepancies were identified, and P12 clarified she wished to have the antibiotic therapy, however, did not want to be a full code. P12 wished for DNR/DNI. RN-B stated P12 did not have a health care directive either, despite it being recorded on admission she did. RN-B stated P12's admission documents, "Probably weren't reviewed very well," which lead to it being recorded incorrectly. Further, RN-B stated P12's life sustaining orders should have been clarified to, "Fulfill the patient wishes" and provide patient safety.

A hospital provided Advance Directives/Advance Care Planning: System Policy dated 1/2018, identified a purpose to respect the rights of adult patients and honor "...to the fullest extent possible, their treatment choices as documented in a properly executed Advance Directive or POLST/Resuscitation Guideline order." A procedure was listed which directed staff to document the presence of an Advance Directive in the medical record, and validating the Directive in writing with the patient signing it, and being witnessed by two adults. The policy lacked any direction or guidance pertaining to ensuring these steps are completed if the patient required an interpreter, nor a process or procedure to ensure conflicting sources of data or orders are clarified.

Based on interview and document review, the hospital failed to ensure every inpatient was asked whom should be notified (family member or representative) of their admission to the hospital. This had the potential to affect all inpatients of the facility.

Findings include:

During interview on 7/12/18, at 11:19 a.m. the director of regulatory and compliance (DRC) stated the hospital did not have a policy regarding the patient's right to have a family member/representative or their physician notified promptly of their admission to the hospital. The DRC stated she did not think there was a procedure in place for this to occur, nor had they implemented this process.

On 7/12/18, at 11:25 a.m. the DRC and the director of nursing for critical care and specialty services (DON-CC/SS) stated notification of a family member and physician was only completed if the patient requested it. The DON-CC/SS stated they do not routinely ask patients if there was anyone they wanted notified of their admission. The DON-CC/SS did not think there was a policy regarding admission notification, and confirmed the facility was not completing this process.

A policy on admission notification was requested and not provided from the facility.

Based on observation, interview, and document review, the facility failed to ensure the 3C unit, a subacute inpatient adolescent psychiatric unit, was free of ligature risk in their environment. This had the potential to affect all 6 patients currently in the 14 bed unit.

Findings include:

A ligature risk (point) is defined as anything which could be used to attach a cord, rope, or other material for the purpose of hanging or strangulation

On 7/10/18, at 9:30 a.m. during a tour of the 3C Adolescent Crisis Stabilization Program, room F345, a double room, was observed to have closet handles with openings behind, window shades with hanging metal cords, a clock and a sound machine with electrical cords, and an entry door with exposed hinges, internal to the room. Shower room F349A, was observed to have 3 grab bars with openings, and an attached shower rod with a shower curtain that did not pull away. The entry door also had exposed hinges internal to the room. Patient room F374, was also observed to have internal exposed hinges, a window shade with a metal cord, and a clock with an electrical cord.

On 7/10/18, at 9:40 a.m. registered nurse (RN)-H confirmed the above observations, and confirmed patients on the unit were able to be alone in their bedrooms or shower room. RN-H stated patients were on 30 minute checks. RN-H stated patients were admitted from emergency departments and county crisis teams with diagnoses of depression, and in, "high stress." RN-H stated these patients often have suicidal ideation or suicidal ideation behaviors. RN-H stated patients have thoughts of harming themselves including cutting, and attempts to take their own life. RN-H stated they interview patients and their care givers, and closely screen patients prior to and during admission to the 3C unit. RN-H stated patients have verbally contracted with staff to keep themselves safe while participating in the 5-7 day program on the unit. The patients are screened at least twice a day for suicidal risk, and the hospital has transferred patients from the 3C unit to acute psychiatric units for self harm. RN-H stated they have not had any suicidal attempts on the 3C due to the ligature risks observed on the tour.

On 7/10/18, at approximately 10:00 a.m. P9 stated she had been on another psychiatric unit, 7A, prior to being on 3C, and stated there was more freedom on 3C. P9 stated she was admitted because she cut herself on her leg, and confirmed she still had thought about suicide, but talked with staff about it instead of acting upon it.

During a unit tour on 7/11/18, at 2:10 p.m., the following observations were made and confirmed by RN-H and the patient relations manager (PRM).

Ligature risks in room F345 were measured at:
-Clock cord: 65 inches.
-Sound machine cord: 71 inches.
-Window shade cord; 83 inches.
In addition, there were 2 closet handles that protruded, and 2 grab bars in the bathroom that protruded from the wall.
Shower room F349A was again observed to have 3 grab bars that protruded from the wall, an attached shower curtain rod, a shower curtain that did not pull away, and a door with internal exposed hinges.

Single room F374 was observed to have 3 protruding grab bars in the bathroom, one protruding closet door handle, and:
-Clock cord: 60 inches.
-Window shade cord: 83 inches.

The unit day room was observed to have 5 windows, all with shades with the same cords as observed in F374 and F345. The unit kitchen was observed to have a 4 slotted toaster and a toaster oven.

During the tour, RN-H stated patients had free access to the kitchen area, but staff were in the adjoining nurses station and day room. RN-H stated there was always staff present in the day room when patients were there. RN-H stated the unit opened in 2004, and they have not had any patients attempt suicide, although they have had patients exhibit self-harm behaviors such as cutting. RN-H stated if patients were not able to stay safe on the unit, they were moved to one of the more acute psychiatric units.

On 7/11/18, at 3:00 p.m. the director of regulatory and compliance (DRC) stated all psychiatric inpatient units were assessed for ligature risk in August, 2017, and a mitigation plan was developed and implemented. The DRC stated 3C mitigation was clinical in nature, and the facility did not have plans for environmental mitigation of ligature risk for the 3C unit, even though it was an inpatient psychiatric unit.

On 7/11/18, at 3:10 p.m. the hospital's regulatory and safety director (FSRD) stated the clinical mitigation plan was the end point of the mitigation discussion for the 3C unit. The FSRD stated the facility decision was based on input from many internal clinical perspectives and outside input as well. The FSRD also stated the thought process was similar to that of providing psychiatric care in an outpatient unit: due to the nature of the patients, mitigation could be clinical in nature.

On 7/12/18, at 8:30 a.m. the DRC stated a Joint Commission surveyor had indicated ligature risk did not apply to the 3C unit because the services were "out of scope."

On 7/12/18, at 8:35 a.m. medical doctor (MD)-G stated the 3C unit was never used as overflow for other, potentially more acute psychiatric patients. MD-G stated the unit was relatively full during the school year, but less during the summer months. MD-G confirmed that many staff were included in the decision to make clinical mitigation the focus for 3C and several staff had toured other units in the Twin Cities area.

On 7/12/18, at 8:45 a.m. the DRC confirmed the 3C unit was an inpatient psychiatric unit, and there were six patients currently on the unit.

Review of the hospital's 8/31/17, Behavioral Health Environment of Care/Ligature Risk Tour check off indicated awareness of the presence of the cords, protruding handles, shower rod and curtain, external hinges along with other identified ligature risks in the unit.

Review of the hospital's Behavioral Health Ligature Risk Assessment-Mitigation dated 1/9/18, indicated consideration of the 3C unit and intent to implement the Columbia Risk Tool and educate staff on awareness of the environment and patient population. There was no evidence in the mitigation plan of any intention to implement environmental mitigation for the 3C unit, even though it was an inpatient psychiatric unit.

Based on interview and document review, the hospital failed to ensure a process for Quality Assessment and Performance Improvement (QAPI) activities that reflected the need for patient safety and enhanced health outcomes to ensure immediate preventive actions and timely reviews were completed and implemented after sustained adverse events occurred placing patients at high risk for serious harm and/or injury or death from similar situations when 2 of 5 patient (P3, P80) adverse events sustained harm/death as a result of the event. In addition, the hospital had not completed 11 adverse event investigations within 45 days according to their policies and procedures.

The failure to ensure the Quality Assessment and Performance Improvement committee had a process to identify quantitative and qualitative measures in accordance with the hospital's complexity to provide a safe environment. Therefore, the hospital was unable to meet the Condition of Participation: Quality Assessment and Performance Improvement Program at 42 CFR 482.21. The cumulative effect of this system failure resulted in the hospital's inability to ensure an effective QAPI program. The deficient practice had the potential to impact all patients receiving services at the hospital.

The findings include:

See A-268: Based on interview and document review, the hospital failed to ensure immediate preventive actions and timely reviews were completed and implemented after sustained adverse events placing patients at high risk for serious harm and/or injury or death from similar situations. The lack of taking immediate action, and completing timely reviews based on root cause analysis, for sentinel or adverse events constituted an immediate jeopardy (IJ) situation to the health and safety of patients for 2 of 5 (P3, P80) adverse events where patients sustained harm/death as a result of the event. In addition, the hospital had not completed 11 adverse event investigations within 45 days according to their policies and procedures, ranging from 4 days to 31 days late.

See A-309: Based on interview and document review, the hospital failed to implement an effective process for Quality Assessment and Performance program (QAPI) that reflected the need for patient safety when the hospital leadership failed to monitor the adverse/sentential events process at their facility and implement actions to ensure timely stop gap measures were implemented if needed, and a root cause analysis with correction plans was implemented on a timely basis. This has the potential to affect all patients in the hospital.


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Based on interview and document review, the hospital failed to ensure immediate preventive actions and timely reviews were completed and implemented after sustained adverse events placing patients at high risk for serious harm and/or injury or death from similar situations. The lack of taking immediate action, and completing timely reviews based on root cause analysis, for sentinel or adverse events constituted an immediate jeopardy (IJ) situation to the health and safety of patients for 2 of 5 (P3, P80) adverse events where patients sustained harm/death as a result of the event. In addition, the hospital had not completed 11 adverse event investigations within 45 days according to their policies and procedures, ranging from 4 days to 31 days late.

The IJ began on 7/5/18, when a capnography machine's (monitoring device that measures the concentration of carbon dioxide in exhaled air) audible alarm and alert system malfunctioned and P3 was found to be in respiratory arrest. The facility had not removed the capnography machine from patient service but allowed the machine to return to service for other patients' use. The event was reported but the facility had not implemented any stop gap preventive measures as part of their sentinel/adverse event process to prevent this from reoccurring to other patients who used capnography equipment. P80 had an adverse event occurred on 6/2/18, when he was found unresponsive and not breathing. His tracheostomy tube was out of his stoma, and did not have continuous oxygen saturation monitoring as directed by the physician. Cardio-pulmonary resuscitation (CPR) was performed, but P80 later died. The event was reported but the facility had not implemented any stop gap preventive measures as part of their sentinel/adverse event process to prevent this from reoccurring to other patients who had tracheostomies . The facility was not consistently implementing their system to ensure timely interventions were implemented, to avoid similar events from reoccurring.

On 7/12/18, at 4:02 p.m. the hospital president, chief nursing executive, and director of regulatory compliance were notified of the IJ to patient health and safety. The IJ was removed on 7/17/18, when the hospital successfully implemented a removal plan. However, condition-level non-compliance remained having potential to affect all patients receiving care in the hospital continued.

Findings include:

P3's PACU (Post Anesthesia Care Unit) to Inpatient Nursing Handoff report dated 7/5/18, at 5:42 p.m. identified P3 had a Lumbar 3 - Pelvis TILF (transforaminal lumbar interbody fusion; a procedure to fuse sections of the spine) and had past medical history which included difficulty with intubation and interstitial lung disease. P3 was recorded as having received general anesthesia, and was transferred to the inpatient unit on Dilaudid (a narcotic medication) via patient controlled analgesia (PCA) machine. P3 had no inpatient telemetry monitoring ordered, and a separate section labeled as, "Capnography," was left blank with no recorded orders or recent readings. P3's vital signs were listed as follows:

- 137/89 (blood pressure),
- 98.4 F (degrees Fahrenheit),
- 105 (pulse) and,
- 12 respirations per minute.

Further, P3 was on 2 LPM (liters per minute) of oxygen through a nasal cannula, and had a recorded SpO2 (oxygen saturation in the blood) of 99% (recorded 0-100%; the higher the number the more oxygen in the blood).

When interviewed on 7/9/18, at 2:20 p.m. P3 stated she admitted to the hospital on 7/5/18, for back surgery and came to the inpatient unit afterwards. P3 expressed she "had a scare" the night of her surgery, as the nurse caring for her had come to check on her after a "span of time" and found her unresponsive and "blue." P3 explained she was not sure what happened to cause this, adding she had been hooked up to equipment to monitor her and "nothing was going off." P3 explained this episode resulted in her being coded (code blue; arrest) and transferred to the intensive care unit (ICU) on the opposite campus.

P3's medical record was reviewed. P3's Progress Notes dated 7/5/18, at 10:20 p.m. identified the following event(s):

"[6:45 p.m.] - Pt [patient] admitted to unit from PACU. A&O [alert and orientated], VSS [vital signs stable], Tele - NSR [telemetry; normal sinus rhythm]. 2L NC [2 liters of oxygen via nasal cannula. Capno [capnography] patent. IPI 8-9 [integrated pulmonary index; normal value 8-10], EtCO2 41 [mmHg (partial pressure or maximal concentration of carbon dioxide; normal values are 35-45 mmHg)], O2 96%.

[8:00 p.m.] - Charge RN left room after administering medication [with] Pt A&O, VSS, Pt's husband in room at bedside.

[8:52 p.m.] - Assigned RN (writer) decided to stop in room to check on Pt prior to RN taking a break. Notice PT unresponsive, snoring labored respirations + cynaotic [blueish coloration to skin]. Sternum chest rub, Charge RN notified. Capno EtCO 115 [mmHg], IPI 1, O2 96% on 2L NC. Pt maintained pulse at all times.

[8:53 p.m.] - Code blue called.

[9:02 p.m.] - Disconnected from ketamine/PCA.

Pt was intubated with by [sic] code team suctioning intermittently, transfers to 4A [intensive care unit] by EMS [emergency medical service]. Ortho team notified. Husband notified. Report given to staff on 4A. Pt belongings sent via courier service."

P3's Surgical ICU H&P (history and physical) assessment dated 7/6/18, identified P3 had an uncomplicated surgery and immediate postoperative course, however, "...was found down on the floor after starting PCA and ketamine [drip], requiring reintubation. Unknown down time; narcan was not administered. Transferred to SICU [surgical intensive care unit] ..." A subsequent Orthopaedic Daily Progress Note dated 7/6/18, at 7:25 a.m. identified P3 had been found to be unresponsive and intubated [on 7/5/18]. "Thought at this time for etiology is overmedication. Patient awake."

When interviewed on 7/9/18, at approximately 2:50 p.m. registered nurse unit manager (RN)-I stated P3 had admitted to the unit on 7/5/18, after back surgery and had required reintubation as she had a respiratory arrest. RN-I explained the capnography machine attached to P3 was flashing when the nurse entered P3's room, however, it should have been audibly alarming, too. RN-I explained the documentation in P3's medical record did not describe what the capnography machine was or was not doing, however, she interviewed the nurse working the night P3 arrested and the machine was only flashing in the room. RN-I could not recall further details without consulting her notes and investigation of the adverse event.

On 7/10/18, at 8:16 a.m. a subsequent interview was held with RN-I, and the chief nursing executive was in attendance. RN-I explained her investigation of the capnography machine included speaking with the nurse working on the night of 7/5/18. The capnography machine had not alerted aloud in the room, nor on the nurses' telephone system, however, was flashing that identified an elevated CO2 reading and P3 having "odd breathing." The capnography machine was removed after P3 was transferred to the ICU and placed in the soiled utility room to be collected, however, it was picked up by someone and the staff were unable to locate the machine since it was removed from P3's room. RN-I stated the hospital staff were going to have a meeting later this week to discuss P3's event and the machine being unable to be located, and expressed she would have liked to seen the capnography machine before it was picked up by someone to determine if repairs were needed. Further, RN-I stated she placed a note in her weekly newsletter to the staff to make sure potentially malfunctioning equipment was sequestered and BioMed (the bio-medical engineering department) was notified so it could be inspected.

A provided Fairview Claims & Employee Incidents event detail report dated 7/11/18, identified an ongoing report of events surrounding P3's adverse event sustained on 7/5/18. An original narrative was listed which described P3 as a post-operative patient on capnography monitoring and plugged in correctly; however, the alarm did not audibly alarm as intended, nor alert the RN via their Ascom telephone system when the patient exceeded the parameters. The narrative listed the occurrence as being equipment related and causing temporary harm with intervention being required. A series of subsequent note(s) were entered into the report which identified the unit manager followed up and determined the potentially malfunctioning machine was picked up by SPD instead of BioMed, and the Ascom phone system was working as intended at the time of the incident. Further, BioMed had determined the device was not able to be located and/or sequestered as no asset number was identified. The report lacked any further information on what step(s) were taken to locate the device, if any testing had been completed on the device, nor if any testing had been done on other capnography machines to locate and/or determine they were safe, and functioning correctly.

When interviewed on 7/10/18, at 1:51 p.m. the clinical engineering manager (CEM) stated he was aware of the incident pertaining to P3 which occurred on 7/5/18, and explained how the capnography machines were tracked in the hospital. There were two ways the machines could be delivered to a patient, including from the receiving unit or a central supply. CEM stated the BioMed department still was unaware which specific machine had malfunctioned; however, if a piece of equipment is suspected to have malfunctioned, it should be sequestered until BioMed can pick it up, update the hospital's risk management department, and then have it tested and verified before being reinstated for use on other patients.

CEM stated P3's malfunctioning capnography machine was picked up the night of 7/5/18; however, went to SPD instead of going to BioMed to be serviced and tested which was "not our process." CEM again restated BioMed was unaware which machine P3 had been using, adding they were not sure if it was still being used on other patients as there were "too many of them" in use to know. Further, CEM stated it was important to ensure malfunctioning equipment was sequestered and tested before being used as it was "best for patient care," however, added he was not concerned with not being able to locate the malfunctioning capnography machine as it would have been flagged again "by now," if it was indeed malfunctioning.

During subsequent interview on 7/11/18, at 8:00 a.m. CEM stated they still were unable to locate the capnography machine, and a root cause analysis (RCA) meeting was set-up to review P3's incident from 7/5/18. The machines should have an audible alarm and signal the nurses' phone system (Ascom) if parameters are breached; however, CEM was not sure if these alarms worked or not for P3's event. When questioned about actions or steps to address all capnography machines, since one is potentially malfunctioning and does not alarm, the hospital was unsure of its whereabouts. CEM stated the staff were not going to pull or test any of the other capnography machines in the hospital as doing so would be a "way bigger risk" than just seeing if the one in question potentially malfunctioned again.

During interview on 7/11/18, at 8:15 a.m. the chief nursing executive (CNE) stated she was initially notified of the events surrounding P3 by the daily safety call and an email which had been sent out to her. From there, a serious safety event notification was sent out on Friday afternoon (7/6/18) and a "fact finding meeting" was going to be conducted to review the circumstances around the event. From there, the team comes back and does action planning on a weekly basis.

CNE explained P3's capnography machine was hooked up "as expected" when her change in status occurred, and to CNE's knowledge the machine was working correctly. After P3's event, the machine was removed and placed in the soiled utility room to be sequestered; however, "someone picked it up" and the machine went back to central supply instead of BioMed for testing. The staff searched for the machine again on Friday (7/6/18) morning; however, were not able to locate the device.

CNE explained that anytime a code or serious event happens, the leadership and management staff are notified and the unit managers are instructed to do immediate stop gaps to help prevent additional occurrences. A RCA was conducted through the "fact finding" and determination meetings held every Thursday. CNE clarified leadership was "not aware" if the capnography machine had audibly sounded; however, verified it should be audibly alarming in the patient's room at a minimum. Further, CNE stated there had been no house-wide notification to staff, nor testing of the capnography machines to ensure they were all functioning correctly to her knowledge.

On 7/11/18, at 1:18 p.m. RN-J was interviewed. RN-J explained the capnography machines had several alarms in place to alert staff to changing patient vital signs, including activating the phone system, turning the call light on above the patient door, flashing on the display and having an audible alarm in the room.

A provided Fact Finding Meeting report dated 7/11/18, identified P3 was transferred to the inpatient unit in stable condition after spinal fusion surgery. P3 was found to be in respiratory distress with the capnography machine flashing due to high CO2 levels and a code blue was called. The report described the capnography machine did not function as intended as there was no audible alarm or alert to the nurse via their Ascom phone. Further, the machine had been removed from service, however, still had not been found.

A discussion amongst the safety team identified the unit manager was notified of the machine and unable to locate it after P3's event. The machine was still unable to be located, and staff were unaware if the device was being used or not. A total of 138 capnography machines were used campus-wide; and SPD was unable to identify the machine, either, as the number on the machine was not tracked for the patient. The team identified if the battery charge is low, the devices will only flash and not audibly alarm and the settings programmed into the machine revert and do not communicate or alarm to the Ascom system. In addition, the default settings for the alarms are unable to be adjusted and RNs were not expected to go into the settings on the devices. Further, it was determined there was no process in place to routinely checking the settings to see if it went into default settings, so machines could potentially be sent back into service with the machine in the default setting and not alarming as intended. There was no recorded response or dictation to determine if all capnography machines could be tested or inspected to ensure appropriate and safe functioning. Further, an updated entry recorded on 7/12/18, identified the team had consulted with Medtronic (maker of the machines) who verified the Ascom system alert will be disabled if the internal battery is depleted, and the settings needs to be manually reset by BioMed technician(s). Further, the updated entry identified the capnography machines are used on post-operative patients and nurses have other patients to check on adding a similar event like P3 sustained could happen again, and at any time.

On 7/12/18, at approximately 2:00 p.m. the CNE and lead BioMed technician (BIO)-A were interviewed. CNE explained the "fact finding meeting" was held yesterday and the situation was reviewed. As a result of the meeting, an email was sent out to make sure staff were aware of the incident and machines possibly reverting to default settings. The staff were informed using a "verbal cascading" method in their verbal handoff and reports. BIO-A stated the capnography machines were configured with Fairview settings, and "behind the scenes," staff discovered they revert to default settings when the battery dies as part of their investigation. BIO-A explained he had worked with SPD to try to locate the potentially malfunctioning machine; however, staff still were not able to locate it. A remedy was implemented "yesterday [7/11/18]" which SPD went to each of the capnography machines and checked their settings to make sure they were correct; however, neither SPD nor BioMed completed any testing of the devices for function or alarms to ensure they worked as intended. BIO-A explained testing a capnography machine for function would take "maybe five minutes" for each machine; however, again stated staff had not been directed to do so. Further, CNE stated the machines "possibly could" be used on either campus (West or East Bank).


P80 was admitted to the hospital on 5/16/18, with diagnoses which included hypotension, episodes of loss of consciousness with concern for syncope versus seizure, status post ependymomo of the brain (brain tumor) with removal (4/9/18), and status post tracheostomy placement (4/13/18). P80 had an order for continuous pulse oximetry (to monitor oxygen levels in the blood).

On 6/1/18, respiratory therapy (RT) downsized P80's tracheostomy. On that same day at 7:30 p.m., P80 was transferred to a different unit, with plans to discharge to an acute rehab unit the following day. P80's orders for pulse oximetry were not followed through when he was transferred. At approximately 2:00 a.m. on 6/2/18, P80 was found unresponsive in his room, cardio-pulmonary resuscitation (CPR) was performed, and P80's tracheostomy tube was found out of his stoma. P80 later died.

A Determination Meeting was held on 6/7/18, to aid in developing a root cause analysis and corrective action plan for the event. At that time, there were concerns P80 did not have continuous pulse oximetry (oxygen monitoring) following transfer to another unit, and concerns P80's tracheostomy had come out prior to performing CPR. The Determination Meeting also indicated P80's death may have been preventable, but details of the event were still being investigated.

During interview on 7/12/18 at 3:07 p.m. the patient safety director (PSD) and PSC stated the facility patient safety/adverse events start with an I-Care report which staff complete when an event occurs. The I-Care system gives the event a specific letter A-I, identifying the severity of the event. These I-Care reports are reviewed within 24 to 72 hours by the nurse manger, and patient safety consultant to determines if the letter was accurate. Once this is completed an initial fact finding meeting is conducted with various staff, and then a root cause analysis (RCA) is completed with a committee and physician expert if needed. A corrective action plan is determined and implemented after the RCA occurs.

The PSD stated they had no plans or schedule of when P80's RCA would occur even though it had been 40 days since the occurrence of the event. She stated the event was in the "que," but had no schedule or process developed to determine when the RCA would occur and they were still gathering information about the event. She was uncertain of the hospital policy was regarding time frames, and thought they had 60 days to complete these events.

During interview on 7/12/18, at 2:30 p.m. PDS, and PSCs both stated they reviewed the policy and a root cause analysis for events should be completed 45 days following the event, according to hospital policy. The PSD stated they were aware they were behind on completing RCAs of these events but was unsure exactly how many they were behind. The safety care committee provided an adverse event tracking report, undated, which identified 15 adverse events occurred between 4/5/18 and 6/26/18. Out of these events there were 11 events where a root cause analysis had not occurred within the 45 day time frame as identified by the facility policy. The PSD stated they were aware they were behind but was unsure how far behind they were until the data was collected.

Review of the undated, hospital events report identified the following:

Event 1279, notified on 4/5/18, RCA due date 5/20/18, RCA date 5/31/18, 11 days late.
Event 1280, notified on 4/6/18, RCA due date 5/30/18, RCA date 6/5/18, 6 days late.
Event 1281, notified on 4/9/18, RCA due date 5/24//18, RCA date 6/13/18, 20 days late.
Event 1285, notified on 4/13/18, RCA due date 5/28/18, RCA date 6/27/18, 31 days late.
Event 1292, notified on 4/17/18, RCA due date, 6/1/18, RCA date 6/29/18, 28 days late.
Event 1289, notified on 4/19/18, RCA due date 6/18/18, RCA date 6/25/18, 7 days late.
Event 1290, notified on 4/19/18, RCA due date 6/18/18, RCA date 7/2/18, 14 days late.
Event 1293, notified on 4/25/18, RCA due date 6/9/18, RCA date 6/13/18, 4 days late.
Event 1297, notified on 4/30/18, RCA due date 6/14/18, RCA date 6/20/18, 6 days late.
Event 1303, notified on 5/17/18, RCA due date 7/1/18, RCA date 7/18/18, 17 days late.
Event 1312, notified on 5/30/18, RCA due date 7/14/2018, RCA date undetermined.

During interview on 7/17/18, at 9:58 a.m. the PSD stated she reports the I-CARE events that are overdue in a monthly report to the lead of quality. They were unsure how overdue the event processes were until they completed the time tracking log at the surveyor's request. They thought the 45 days time frame was a goal, but they were using 60 days instead. The team was not clear of the expectations, and not aware of the extent and number of days they were back logged for these events.

The hospital Adverse Health Care Event Report policy printed on May 22, 2018, identified under reporting process that each Fairview entity designated the department responsible for facilitating a root cause analysis (RCA) of the reportable adverse heath event and development of a corrective action plan (CAP), which must be completed within 45 calendar days of the occurrence of the event.

The facility Sentinel Event/Patient Safety Event policy printed July 11, 2018, identified the goal of learning from sentinel events and patient safety events was to improve processes and systems to eliminate or minimize likelihood of events reoccurrence. Adverse Event were defined as a patient safety event that resulted in harm to a patient, and a sentinel event was a subcategory of an Adverse Event. A comprehensive systematic analysis and corrective actions plan development is completed. Immediate stopgap processes are put in place as indicated for patient or caregiver safety if they are not already occurred. Actions are recommended and implemented as appropriate leaders identify them.

The IJ was removed on 7/17/18, at 12:00 noon when the hospital successfully implemented a removal plan which included screening and testing of all capnography machines, educating staff on policies and procedures to ensure potentially malfunctioning equipment were sequestered and tested appropriately. The patient safety team as part of QAPI reviewed all the adverse patient events for the past six months, and initiated a plan to ensure RCA were completed within the 45 day time frame. The facility changed their process, and staff education was provided to ensure the administrator in charge was notified of any event with rating of E or higher within 24 hours, to ensure stop gaps were implemented if needed. The hospital policies and procedures were updated and staff were educated about the process so stop gaps, analysis, and corrective action plans were implemented timely for adverse/sentinel events.


29433




10562

Based on interview and document review, the hospital failed to implement an effective process for Quality Assessment and Performance Improvement program (QAPI) that reflected the need for patient safety when the hospital leadership, including governing body failed to monitor the adverse/sentential events process at their facility and implement actions to ensure timely stop gap measures were implemented if needed, and a root cause analysis with correction plans was implemented on a timely basis. This has the potential to affect all patients in the hospital.

Findings include:

The hospital's failure to incorporate surveillance activities to identify patient adverse/sentential events were monitored, in order for the hospital to take immediate preventive actions as needed, and to ensure timely reviews were completed, did not occur. Therefore, corrective actions were not implemented in a timely manner to prevent other patients from being at risk for serious harm, injury or death from similar situations.

During interview on 7/17/18, at 9:58 a.m. the Patient Safety Director (PSD) verified she reported verbally to the hospital's lead quality director, regarding how many adverse/sentential events are overdue on a monthly basis. The PSD stated the lead quality director reports the information forward to the governing body. The PSD also clarified she was using a 60 day time frame to complete root cause analysis, and to implement interventions versus the 45 days identified in hospital policy.

Refer to A- 286 for further information. The failure to take immediate action, and complete timely reviews based on root cause analysis, for sentinel or adverse events constituted an immediate jeopardy (IJ) situation to the health and safety of for 2 of 5 patients (P3, P80) when adverse events caused the patients to sustain harm/death as a result of the event. In addition, the hospital had not completed adverse event investigations in accordance with hospital policies and procedures.

Based on interview and document review, the hospital failed to ensure patient vital signs were monitored and recorded in accordance with established orders, polices, and procedures for 1 of 5 patients (P3) reviewed for adverse events.

Findings include:

A hospital provided, blank SUR Spine Inpatient Post Op order set dated 7/19/17, identified the standing orders to be completed for inpatient patients. A section labeled, "Vital Signs" directed vital signs were to be completed after transfer to an inpatient unit as follows: Every 30 minutes X (times) 2, then every 1 hour X 2, then every 4 hours X 2, then every shift.

P3's PACU (Post Anesthesia Care Unit) to Inpatient Nursing Handoff report dated 7/5/18, at 5:42 p.m. identified P3 had a Lumbar 3 - Pelvis TILF (transforaminal lumbar interbody fusion; a procedure to fuse sections of the spine). P3 was recorded as having received general anesthesia, and a section of vital signs were listed, and P3 was recorded as follows:

- 137/89 (blood pressure),
- 98.4 F (degrees Fahrenheit),
- 105 (pulse) and,
- 12 respirations per minute.

When interviewed on 7/9/18, at 2:20 p.m. P3 stated she admitted to the hospital on 7/5/18, for back surgery and came to the inpatient unit afterwards. P3 expressed she, "Had a scare" the night of her surgery, as the nurse caring for her had come to check on her after a, "Span of time" and found her unresponsive and, "Blue." P3 explained she was not sure what happened to cause this, however, this episode resulted in her being coded (code blue; cardiac arrest) and transferred to the intensive care unit (ICU) on the opposite campus.

Following P3's interview, P3's medical record was reviewed with registered nurse unit manager (RN)-I. P3 admitted to the inpatient unit on 7/5/18, at 6:45 p.m. P3's vital signs flowsheet dated 7/5/18, from 3:15 p.m. to 10:15 p.m. identified vital signs were recorded upon admission to the inpatient unit at 6:50 p.m., however, no further vital signs were recorded until 10:00 p.m. RN-I verified there were no recorded values in the flowsheet to demonstrate P3's vital signs had been assessed as directed by the hospital's standing orders.

When interviewed on 7/10/18, at 8:16 a.m. RN-I stated P3 had been hooked up to a monitor which should have recorded the vital signs into the medical record automatically if directed to by the staff. RN-I explained the nurse and the nursing assistant caring for P3 were responsible to ensure the vital signs were recorded; however, it had been, "Hectic" and the vital signs did not get recorded.

During interview on 7/11/18, at 8:15 a.m. the chief nursing executive (CNE) explained the standing order set provided was the policy for when vital signs should be recorded. P3's vital sign machine would have automatically recorded the vital signs if input was given by the nurse adding, "That's a bit of the question" as to if the lack of vital sign monitoring was human error or machine related. CNE stated it was important to ensure vital signs were completed and recorded to demonstrate the patient is recovering and stable.

Based on observation, interview and document review, the hospital was found to be out of compliance with the Condition of Participation (COP) 482.41 Physical Environment due failure to appropriately sequester potentially malfunctioning equipment to prevent further patient use when a patient sustained a respiratory arrest due to failure of audible alarms, and failed to ensure medical equipment that is place on an alternate equipment maintenance program was appropriate to minimize potential safety risks to patients.

The cumulative effect of these systemic issues resulted in the hospital's inability to ensure safety for patients and therefore did not meet the COP.

Findings include:

Refer to A724. The hospital failed to take immediate action to ensure capnography machines (medical device used to monitor respiratory gas [carbon dioxide] and function) were in safe and functional order after a machine was not appropriately sequestered from service when it was identified to be potentially malfunctioning and not alarming as designed when attached to 1 of 5 patients (P3) reviewed who sustained an adverse event. In addition, the hospital failed to monitor its alternative equipment maintenance program to ensure medical equipment received preventative maintenance.

Based on observation, interview, and documentation review, the hospital was found to be out of compliance with Life Safety Code (LSC) requirements. These findings have the potential to affect all patients in the hospital.

Findings include:

Please refer to LSC deficiencies cited at K-351 and K-353 for additional information.

Based on observation, interview and document review, the hospital failed to take immediate action to ensure capnography machines (medical device used to monitor respiratory gas [carbon dioxide] and function) were in safe and functional order after a machine was not appropriately sequestered from service when it was identified to be potentially malfunctioning and not alarming as designed when attached to 1 of 5 patients (P3) reviewed who sustained an adverse event. In addition, the hospital failed to monitor its alternative equipment maintenance (AEM) program to ensure medical equipment received preventative maintenance.

Findings include:

CAPNOGRAPHY MACHINE:

P3's Op Note (operative note) dated 7/5/18, identified P3 had several surgical procedures completed on her back including a Osteotomy (surgical cutting of bone) and TILF (transforaminal lumbar interbody fusion; a procedure to fuse sections of the spine). P3 was recorded as being, "...taken to recovery after extubation in stable condition."

P3's PACU (Post Anesthesia Care Unit) to Inpatient Nursing Handoff report dated 7/5/18, at 5:42 p.m. identified P3 had a Lumbar 3 - Pelvis TILF and had past medical history which included difficulty with intubation and interstitial lung disease. P3 was recorded as having received general anesthesia; however, had no inpatient telemetry monitoring ordered, and a separate section labeled as, "Capnography," was left blank with no recorded orders or recent readings.

A section of vital signs were listed, and P3 was recorded as follows:

- 137/89 (blood pressure),
- 98.4 F (degrees Fahrenheit),
- 105 (pulse) and,
- 12 respirations per minute.

Further, P3 was on oxygen at 2 liters per minute (LPM) through a nasal cannula, and had a recorded SpO2 (oxygen saturation in the blood) of 99% (recorded 0-100%; higher the number the more oxygen in the blood).

When interviewed on 7/9/18, at 2:20 p.m. P3 stated she admitted to the hospital on 7/5/18, for back surgery and came to the inpatient unit afterwards. P3 expressed she, "Had a scare" the night of her surgery, as the nurse caring for her had come to check on her after a, "Span of time" and found her unresponsive and "Blue." P3 explained she was not sure what happened to cause this, however, added she had been hooked up to equipment to monitor her, however, "Nothing was going off." P3 explained this episode resulted in her being coded (code blue; cardiac arrest) and transferred to the intensive care unit (ICU) on the opposite campus.

P3's medical record was reviewed. P3's Progress Notes dated 7/5/18, at 10:20 p.m. identified the following event(s):

"[6:45 p.m.] - Pt [patient] admitted to unit from PACU. A&O [alert and orientated], VSS [vital signs stable], Tele - NSR [telemetry; normal sinus rhythm]. 2L NC [2 liters of oxygen via nasal cannula. Capno [capnography] patent. IPI 8-9 [integrated pulmonary index; normal value 8-10], EtCO2 41 [the partial pressure or maximal concentration of carbon dioxide; normal values are 35-45 mmHg], O2 96%.

[8:00 p.m.] - Charge RN left room after administering medication [with] Pt A&O, VSS, Pt's husband in room at bedside.

[8:52 p.m.] - Assigned RN (writer) decided to stop in room to check on Pt prior to RN taking a break. Notice PT unresponsive, snoring labored respirations + cyanotic [bluish coloration to skin]. Sternum chest rub, Charge RN notified. Capno EtCO 115 [mmHg], IPI 1, O2 96% on 2L NC. Pt maintained pulse at all times.

[8:53 p.m.] - Code blue called.

[9:02 p.m.] - Disconnected from ketamine/PCA.

Pt was intubated with by [sic] code team suctioning intermittently, transfers to 4A [intensive care unit] by EMS [emergency medical service]. Ortho team notified. Husband notified. Report given to staff on 4A. Pt belongings sent via courier service."

When interviewed on 7/9/18, at approximately 2:50 p.m. registered nurse unit manager (RN)-I stated P3 had admitted to the unit on 7/5/18, after back surgery and had required reintubation as she had a respiratory arrest event. RN-I explained the capnography machine attached to P3 was flashing when the nurse went into the room, however, it was not audibly alarming which it should have been. RN-I explained the documentation in P3's medical record did not describe what the capnography machine was or was not doing, however, she had interviewed the nurse working the night P3 arrested and understood it to only be flashing. RN-I could not recall further details without consulting her notes and investigation of the adverse event.

On 7/10/18, at 8:16 a.m. a subsequent interview was held with RN-I, and the chief nursing executive (CNE) was in attendance. RN-I explained P3's capnography machine had not alerted aloud in the room, nor on the nurses' telephone system, however, was just flashing with an elevated CO2 reading and P3 having, "Odd breathing." The capnography machine was removed after P3 was transferred to the ICU and placed in the soiled utility room to be collected, however, it was picked up by someone and the staff were unable to locate the machine since it was removed from P3's room. RN-I stated the hospital staff were going to have a meeting later this week to discuss P3's event and the machine being unable to be located, and expressed she would have liked to have seen the capnography machine before it was picked up by someone so she could determine if it needed repair. Further, RN-I stated she placed a note in her weekly newsletter to the staff to make sure potentially malfunctioning equipment was sequestered and BioMed (the bio-medical engineering department) was notified so it could be inspected.

When interviewed on 7/10/18, at 1:51 p.m. the clinical engineering manager (CEM) stated he was aware of the incident pertaining to P3 which happened on 7/5/18, and explained how capnography machines were tracked in the hospital. There were two ways the machines could be delivered to a patient, including from the receiving unit or a central supply. CEM stated the BioMed department still was unaware which specific machine had malfunctioned; however, if a piece of equipment is suspected to have malfunctioned, it should be sequestered until BioMed can pick it up, update the hospital's risk management department, and then have it tested and verified before being reinstated for use on other patients.

CEM stated P3's malfunctioning capnography machine was picked up the night of 7/5/18; however, went to SPD instead of going to BioMed to be serviced and tested which was "not our process." CEM again restated BioMed was unaware which machine P3 had been using, adding they were not sure if it was still being used on other patients as there were, "Too many of them" in use to know. Further, CEM stated it was important to ensure malfunctioning equipment was sequestered and tested before being used as it was, "Best for patient care," however, added he was not concerned with not being able to locate the malfunctioning capnography machine as it would have been flagged again, "By now," if it was indeed malfunctioning.

During subsequent interview on 7/11/18, at 8:00 a.m. CEM stated they still were unable to locate the capnography machine, and a root cause analysis (RCA) meeting was set-up to review P3's incident from 7/5/18. CEM stated the machines should have an audible alarm and signal the nurses' phone system (Ascom) if parameters were breached; however, CEM was not sure if these alarms worked or not for P3's event. When questioned about actions or steps to address all capnography machines, since one is potentially malfunctioning and not alarming, and the hospital is unsure of it's whereabouts, CEM stated the staff were not going to pull or test any of the other capnography machines as doing so would be a, "Way bigger risk" than just seeing if the one in question potentially malfunctioned again.

During interview on 7/11/18, at 8:15 a.m. the chief nursing executive (CNE) stated she was initially notified of the events surrounding P3 by the daily safety call and an email which had been sent out to her. From there, a serious safety event notification was sent out on Friday afternoon (7/6/18) and a, "Fact finding meeting" was going to be used to review the circumstances around the event. From there, the CNE stated, the team comes back and does action planning on a weekly basis.

CNE explained P3's capnography machine was hooked up, "As expected" when her change in status occurred, and to CNE's knowledge the machine was working correctly. After P3's event, the machine was removed and placed in the soiled utility room to be sequestered; however, "Someone picked it up" and the machine went back to central supply instead of BioMed for testing. The staff searched for the machine again on Friday (7/6/18) morning; however, were not able to locate the device.

CNE explained that anytime a code or serious event happens, the leadership and management staff are notified and the unit managers are instructed to do immediate stop gaps to help prevent additional occurrences. A RCA was conducted through the, "Fact finding" meeting and determination meetings held every Thursday. CNE clarified leadership was, "Not aware" if the capnography machine had audibly sounded or not yet; however, verified it should be audibly alarming in the patients room at a minimum. Further, CNE stated there had been no house-wide notification to staff, nor testing of the capnography machines to ensure they were functioning correctly to her knowledge.

On 7/11/18, at 1:18 p.m. RN-J was interviewed. RN-J explained the capnography machines had several alarms in place to alert staff to changing patient vital signs, including activating the phone system, turning the call light on above the patient door, flashing on the display, and having an audible alarm in the room.

A provided Fact Finding Meeting report dated 7/11/18, identified P3 was transferred to the inpatient unit in stable condition after spinal fusion surgery. P3 was found to be in respiratory distress with the capnography machine flashing due to high CO2 levels and a code blue was called. The report described the capnography machine did not function as intended as there was no audible alarm or alert to the nurse via their Ascom phone. Further, the machine had been removed from service, however, still had not been found.

The safety team identified a total of 138 capnography machines were used campus-wide; and SPD was unable to identify the machine, either, as the number on the machine was not tracked for the patient. The team identified if the battery charge was low, the devices will only flash and not audibly alarm and the settings programmed into the machine revert and do not communicate or alarm to the Ascom system. In addition, the default settings for the alarms are unable to be adjusted, and RN's were not expected to go into the settings on the devices. Further, it was determined there was no process in place to routinely checking the settings to see if it went into default settings, so machines could potentially be sent back into service with the machine in the default setting and not alarming as intended. There was no recorded response or dictation to determine if all capnography machines could be tested or inspected to ensure appropriate and safe functioning. Further, an updated entry recorded on 7/12/18, identified the team had consulted with Medtronic (maker of the machines) who verified the Ascom system alert will be disabled if the internal battery is depleted, and the settings needs to be manually reset by BioMed technicians. Further, the updated entry identified the capnography machines are used on post-operative patients and nurses have other patients to check on adding a similar event like P3 sustained could happen again, and at any time.

On 7/12/18, at approximately 2:00 p.m. the CNE and lead BioMed technician (BIO)-A were interviewed. CNE explained the, "Fact finding meeting" was held yesterday, and the situation was reviewed. As a result of the meeting, an email was sent out to make sure staff were aware of the incident and machines possibly reverting to default settings. The staff were informed using a, "Verbal cascading" method in their verbal handoff and reports. BIO-A stated the capnography machines were configured with Fairview settings, and "Behind the scenes," staff discovered they revert to default settings when the battery dies as part of their investigation. BIO-A explained he had worked with SPD to try to locate the potentially malfunctioning machine; however, staff still were not able to locate it. A remedy was implemented, "Yesterday [7/11/18]" which SPD went to each of the capnography machines and checked their settings to make sure they were correct; however, neither SPD nor BioMed completed any testing of the devices for function or alarms to ensure they worked as intended. BIO-A explained testing a capnography machine for function would take, "Maybe five minutes" for each machine; however, again stated staff had not been directed to do so. Further, CNE stated the machines, "Possibly could" be used on either campus (West or East Bank).

A hospital Repairs and Maintenance of Medical Equipment policy dated 08/2016, identified a purpose of ensuring all medical devices are maintained and managed to provide safe and functional equipments for patients and staff. The policy directed the Clinical Engineering Department was responsible for maintenance of the equipment along with ensuring it was, "...not presenting any potential for harm to the user or the patient." The owner department manager was designated as responsible to ensure equipment was processed through clinical engineering before being used again or at any point it required service and/or maintenance.

In addition, a hospital Medical Device: Occurrence Known or Possibly Associated with policy dated 02/2017, identified a purpose of assuring "...prompt and appropriate actions are taken when an occurrence is, or may be, associated with a medical device failure." This was done to protect patient safety, comply with regulatory requirements, and prevent or minimize similar occurrences. All staff were responsible to identify occurrences with medical equipment and remove it from service immediately; and these devices would be retained and inspected via Risk Management if the may have been, or was harmed as a result of the device. A procedure directed staff in a patient care area to, "Remove the medical device/equipment/product from patient care setting to assure it does not get used again," and then (if patient harm was sustained, or may have been) the clinical engineering would retrieve the device and complete the required documentation, notify the risk management division, and facilitate the evaluation process.


30951

AEM PROGRAM:

During observations of medical equipment it was noted that a variety of equipment had stickers that indicated, "No preventative maintenance required," or the wording of, "Exempt" including oxygen analyzers.

On 7/9/18, a tour of the Neonatal Intensive Care Units on 4th floor and 11th floor were conducted. On the 11th floor a blanket warmer was noted to have no preventative maintenance equipment tag, however, it did have a temperature tracker attached to the machine, and the display was reading 128 degrees Fahrenheit.

On 7/10/18, an airflow/oxygen mixer Fairview (F) equipment tag F0027855 was labeled, "Exempt." This piece of equipment had a gauge on top that was labeled 0-20-40-60-80-100, indicating how much oxygen would be mixed with air, then delivered by oxygen mask to a patient. When asked why an oxygen delivery system was exempt from preventative maintenance, director of respiratory stated she did not know, that decision was made by Biomed (Clinical Engineering). If equipment was damaged or broken it was given to Biomed with a work order. The respiratory tech support person managed everything on inventory list for ventilators and nebulizer machines, and maintained an inventory list of all equipment. A request was made to receive a list of all equipment on the AEM list for the hospitals.


On 7/12/18, at 1:30 p.m. the AEM list was reviewed and included oxygen mixers, oxygen analyzers, suction regulators, nurse call devices, telemetry transmitters, vital signs monitors, endoscopes, colonoscopes, gastroscopes, variable voltage transformer, warming units, laboratory analyzers and a additional direct and indirect hospital patient equipment. Biomed-A stated equipment was added to the AEM list by a technician putting a piece of equipment on a list, and submitting it to a manager. The manager would then bring the recommendations to the quarterly meeting to discuss it and give it a rating, and then decided to whether to put it on the AEM list or not. Biomed-A did not know if there was a process to remove a piece of equipment from the list.

Biomed-A was unable to say why some of the equipment such as oxygen analyzers were included on the list, or why one telemetry monitor was included on the list, but not all of them. Biomed-A was also unable to say why one pulse oximeter was on the list, but not all of them, was unable to say why endoscopic, and colonscopic equipment was on the list. Biomed-A was unable to say why the laboratory equipment was on the list, since preventative maintenance and repair of laboratory analyzers was a contracted service by the vendor. Biomed-A was not aware that new equipment, and life support equipment could not be put into a AEM program. Items from the AEM list were identified on the East Bank and West Bank, and Biomed reports were requested for that equipment.

The AEM report for the West Bank had 2/9 items listed as, "Unable to locate." 1/9 had, "No history" as the equipment inventory and repair system. 1/9 were listed as, "Incoming", even though new equipment should not be added to an AEM program. From the AEM report from the East Bank, 3/10 were incoming equipment including a compressed gas proportioner/oxygen equipment, even though new equipment does not quality for AEM. 1/10 was listed as, "Retired, broken beyond repair" but remained on the list. 1/10 was listed as, "Does not exist in TMS (equipment tracking and repair log)," 5/10 were listed as in TMS, but no history. The West Bank report did not include dates of when the equipment was placed in the system for those with no history.

The facility Alternative Maintenance Schedule Worksheet (undated), lacked information on equipment that can not be included on the AEM schedule/program.

The facility policy titled Repairs and Maintenance of Medical Equipment dated December 1999, reviewed May 2011, and August 2016, directed: inspection, testing, and maintenance of all equipment in the medical equipment inventory are performed and documented. Clinical Engineering will complete repairs in accordance with manufacturers' guidelines and will document all activities. All work orders and supporting documentation will be kept in a data base and will [sic] readily accessible for review and audit.

On 7/14/18, at 11:00 a.m. the director of clinical engineering stated they should standardize the language used in the work orders and reports between the East and West Bank.

Based on observation, interview, and document review, the hospital failed to ensure staff properly cleaned and disinfected blood glucose monitoring equipment to prevent the spread of blood-borne pathogens following patient use for 1 of 2 patients (P7) observed to receive blood glucose testing with a multi-patient use glucometer.

Findings include:

P7 was observed on 7/10/18, at 11:23 a.m. to have glucose monitoring conducted with the use of a glucometer by nursing station technician (NST)-A. NST-A donned gloves and obtained the glucometer device from the docking station on the wall of P7's room. NST-A scanned a test strip, then used NST-A badge to be scanned, and then P7's wrist band was scanned. NST-A cleansed P7's finger, poked P7's finger with a lancet for a blood sample, and applied the blood sample to the test strip in the glucose monitoring device. NST-A removed the soiled gloves, and placed the lancet in the sharps container. NST-A placed the glucometer in the docking station on the wall in P7's room. NST-A did not disinfect the glucometer after use.

During an interview on 7/11/18, at 4:46 p.m. NST-A stated after NST-A was done using the glucometer, it was put back into the docking station on the wall of the patient's room. NST-A stated at the end of the shift, the glucometers were brought out to the desk and cleaned/disinfected, then returned to the patient's rooms and put in the docking stations. NST-A stated when a patient is in a private room, they did not clean/disinfect the glucometer in-between uses. NST-A stated when the glucometer is disinfected, it is wiped down for 90 seconds with the purple top super Sani cloth.

During an interview on 7/11/18, at 2:40 p.m. registered nurse (RN)-F stated staff are to disinfect the glucometer in between patient use, even if the glucometer is in a single patient room.

During an interview on 7/12/18, at 9:44 a.m. NST-B stated each room on the unit have their own glucometer. NST-B stated if the glucometer was not working in one patient room, then staff would go to another patient room and get a different glucometer to use. NST-B stated the glucometer needs to be disinfected and wiped down for 30 seconds after use, then returned to the docking station.

During an interview on 7/12/18, at 9:49 a.m. RN-E stated staff are able to go to one patient room to get a glucometer for use in another patient room. RN-E stated the glucometer should be kept wet for a time of two minutes when disinfecting.

During an interview on 7/12/18, at 9:30 a.m. RN-F stated staff are to use the purple top Sani wipes to disinfect the glucometer after use. RN-F stated staff are able to use any glucometer from any patient room, and the expectation was that staff disinfect the glucometer after every use.

The hospital policy, Glucose by Meter Nova Statstrip dated 7/16, directed to ensure the meter surface stays wet for two minutes (purple top wipe) or four minutes (orange top wipe), and then allow to air dry.

Based on observation, interview, and document review, the hospital failed to ensure the safe use of an electrocautery device, resulting in a risk for fire in the operating room and/or risk for patient burns for 1 of 5 patients (P15) observed during a surgical procedure where the surgeon and/or surgical staff failed to operate the electrocautery device as directed by hospital policy and manufacturer recommendations.

Findings include:

P15 was observed on 7/10/18, at 2:42 p.m. during a tonsillectomy/adenoidectomy surgical procedure (removal of the tonsils and adenoids). P15 was observed to utilize oxygen during the surgical procedure. During the procedure, it was noted the use of a Force FX Electrosurgical Generator (a cautery pencil device) was utilized by medical doctor (MD)-I and was placed on top of P15's surgical drape. MD-I and surgical technician (ST)-J failed to place the electrocautery device into the holster during the procedure as follows:

At 2:45 p.m. MD-I was observed to utilize the cautery pencil and place it on top of the drape next to P15's head (the cautery holster was not utilized). After 30 seconds, MD-I picked up the cautery and handed it to ST-J.

At 2:46 p.m. ST-J was observed to place the cautery pencil device on top of P15's draped chest instead of the holster provided. The cautery laid on the patient's drape for 20 seconds before picking it up and placing it in the holster.

Interview with ST-J on 7/10/18, at 3:00 p.m. confirmed the cautery pencil was placed on the drape near P15's head, as well as on his draped chest. ST-J indicated she had been trained on the safe use of the cautery pencil, and should have placed it in the holster instead of on the drape.

Interview on 7/10/18, at 3:15 p.m. MD-I confirmed the cautery pencil had been placed on the drape next to P15's head after use during the surgical procedure. MD-I indicated the cautery should have been placed in the holster, but further included she has always relied on the STs to place the cautery in the holster for her.

A review of the hospital's incident/accident reports for the past year revealed no incidents of fire/injury had occurred related to the use of electrocautery devices.

Review of the hospital's policy, Fire Safety in the Operating Room dated 1/2017, included standard precautions for surgical cases with fire risk. The policy directed any heat generating device (electrocautery) not in the hand of the provider during a procedure is either in a holster, or appropriately managed by an intra-operative team member.

Review of the undated manufacturer's guidance for use of the Force FX Electrosurgical Generator (cautery pencil), with the subject title, "Warning" directed staff: "Fire Hazard: do not place active cautery equipment near or in contact with flammable materials (such as gauze or surgical drapes) flammable gases, or high levels of oxygen. Electrosurgical accessories that are activated or hot from use can cause fire. When not using active accessories, place them in a holster or in a clean dry, nonconductive, and highly visible area not in contact with the patient. Inadvertent contact with the patient may result in burns."