HospitalInspections.org

Based on observation, interview and document review, the Governing Body failed to ensure systems were effectively established and implemented to ensure care was provided in a safe manner by staff and contracted services. This failure had the potential to affect all current patients in the hospital and any future patients that would be admitted to the hospital.

Findings include:

The hospital was found not to be in compliance with the Condition of Governing Body 42 CFR 482.12. The hospital failed to ensure the water room of the acute end stage renal disease (ESRD) unit had safety equipment necessary for deionization water processing in accordance with professional standards. These findings led to an immediate jeopardy (IJ) situation for 4 of 4 ESRD patients who were currently receiving hemodialysis while hospitalized. See additional documentation at A0084.

The hospital was found not to be in compliance with the Condition of Patient Rights at 42 CFR 482.13 related to the failure to ensure appropriate water monitoring for dialysis care, and safe surgery practices including surgical instrument counts. These deficient practices had the potential to effect all patients receiving dialysis and/or surgical services in the hospital. See additional documentation at A-0144.

The hospital was found not to be in compliance with the Condition of Quality Assessment and Performance Improvement 42 CFR 482.21 due to the hospital's failure to ensure quality assurance processes were in place to minimize and/or prevent medical errors: 1) Related to review of audits in the ESRD water room and review of adverse events reports. This had the potential to affect the current four ESRD patients and any future ESRD patient(s) who received dialysis. 2) Related to the lack of safe surgical practices including instrument counts for surgical patients who underwent a surgical procedure when the possibility existed that an instrument could be unintentionally retained. These findings had the potential to affect any future patient who had a surgical procedure when the possibility existed that an instrument could be unintentionally retained. 3) Related to adequate safeguards for electronic physician orders/protocols where the hospital failed to ensure the approved order set language was maintained when the hospital transitioned to a new electronic medical record (EHR) for patients who had orders for the hospital's Clinical Institute for Withdrawal Assessment (CIWA) protocol utilized for 1 of 2 patients whose death records were reviewed (P23), and for 1 of 2 currently admitted patients who had current orders for the CIWA protocol (P16). These issues had the potential to affect future patients who had orders for implementation of these. In addition, the hospital was aware nursing staff had not always followed the CIWA protocol and had not yet implemented appropriate actions. See additional documentation at A0273.

The hospital was found not to be in compliance with the Condition of Nursing 42 CFR 482.23 where an Immediate Jeopardy was issued on 1/16/15, at 5:30 p.m. because nursing staff failed to provide ongoing assessment and physician notification for the use of the CIWA protocol for 1 of 2 deceased patients, (P23) and 1 of 2 current hospital inpatients (P16), reviewed who had the CIWA protocol prescribed. See additional documentation at A0385, A0396 and A0405.

The hospital was found not to be in compliance with the Condition of Surgical Services 42 CFR 482.51 where an Immediate Jeopardy was issued on 1/15/15, at 2:00 p.m. as the hospital failed to ensure safe surgical practices were followed in accordance with acceptable standards of practice related to instrument counts for 3 of 3 surgical patients (P32, P33 and P36) in the sample who underwent surgical procedures where the possibility existed that an instrument could be unintentionally retained. See additional documentation at A0940, A0951 and A0959.

Based on observation, interview, and document review, the hospital failed to ensure the water room located near the acute end stage renal disease (ESRD) unit was equipped with the appropriate safety equipment as a component of the deionization (DI) of water processing in accordance with the Advancement of Medical Instrumentation (AAMI) standards to ensure the safety of the water used during dialysis. These findings led to an immediate jeopardy (IJ) situation for 4 of 4 ESRD patients (P1, P2, P3, P4) who currently received hemodialysis while hospitalized. In addition, the hospital failed to ensure there was adequate space in the unit to provide safe care to patients in the event of an emergency. This had the potential to affect each of the 4 current ESRD patients and any future ESRD patients.

Findings include:

Water quality safety:

The IJ began on 1/14/15, at 5:00 p.m. when it was determined the hospital lacked an automatic divert to drain system in the ESRD unit and lacked audio and visual alarms to alert staff of inadequate water quality on the ESRD treatment floor. At that time, the chief nursing officer was notified the lack of standard safety systems put the four ESRD patients at serious risk for health and safety and that an IJ was being called. The immediate jeopardy was removed and the deficient practice was corrected on 1/15/15.

On 1/14/15, at 10:30 a.m. the water room of the acute inpatient ESRD unit was observed with registered nurse (RN)-Z. RN-Z stated the ESRD water purification system utilized in the dialysis unit was deionization (DI). RN-Z further stated she was a contracted employee and floats to many inpatient hospital ESRD units in the metro area. RN-Z stated she had been trained on the deionization water purification system but could not remember when. RN-Z confirmed the water room did not have a current schematic showing where all of the different parts of the water purification system were and how they could be identified. When RN-Z was asked whether there was an automatic divert to drain mechanism plumbed into the water room, she stated she was unfamiliar with that reference. When RN-Z was asked about the facility's alarm monitor used to sound in the event of poor water quality, RN-Z pointed to an alarm that was unplugged and not functioning. RN-Z then offered for the biomedical engineer to come to the unit and walk through the water room with the surveyor so that all of the components could be verified. RN-Z verified an audible and visual alarm was not being appropriately implemented on the ESRD treatment unit. RN-Z stated an alarm would sound in the water room which was approximately 40 feet from the ESRD treatment room. She stated the door to the water room was closed and locked. RN-Z also stated she would rely on intensive care unit staff to notify her if the alarm was sounding because the water room was located in a closer proximity to that unit.

The hospital's biomedical engineer was interviewed on 1/14/15, at 12:00 p.m. The biomedical engineer stated he had been responsible for the maintenance of the water room at the hospital since 2008. He confirmed there was currently no functioning automatic divert to drain system plumbed into the water room to automatically divert water from reaching the dialysis machines if the water quality reached below 1 megohm ( a unit of measure). The biomedical engineer stated he had started to plumb the automatic divert to drain in the water room approximately six months prior but had not completed the installation because he did not have the right booster pump available to hook it up. The biomedical engineer confirmed that having the automatic divert to drain plumbing was a necessary industry safety standard established by the association for the AAMI RD52 standards (in absence of these safety standards dialysis patients would be at risk for negative health outcomes). He also acknowledged the importance of having audible and visual alarms in place on the treatment room unit when using deionization for water purification in accordance with AAMI RD52 standards for safety. The Biomedical engineer confirmed the audible alarm that monitored the water quality (resistivity) could not be heard if sounding on the treatment room floor and confirm staff had not been monitoring the resistivity of the water according to facility policy. The biomedical engineer also stated that the facility did not have a policy related to using and testing the auto divert to drain equipment in the water room.

Review of the hospital services agreement between St. John's Health East and the contracted service Davita Healthcare Partners Inc. (DaVita) (unsigned and undated) identified the following: "[DaVita] shall provide, maintain in good operating condition, and repair all dialysis and related equipment necessary for the provision of the Treatment Services. All equipment provided by [DaVita] will be maintained by [DaVita] to meet requirements of applicable codes."

Review of the Acute Services Policy & Procedure Manual, #1 DaVita Inc. dated as last updated on March 2013 titled WATER QUALITY MONITORING FOR MULTI-STATION (NON-PORTABLE) WATER TREATMENT SYSTEMS revealed the following: "...8. In the event the RO [reverse osmosis] is inoperable or a deionization (DI) system is used as a polish: the DI monitoring log will be implemented ...The resistivity monitor readings should be record on the DI monitoring log every four (4) hours of each treatment day. This should be concurrent with documenting Total Chlorine checks."

Review of the Acute Services Policy & Procedure Manual, #1 DaVita Inc. dated as last updated on March 2013 titled MINIMUM COMPONENTS FOR MULTI-STATION (NON-PORTABLE) WATER TREATMENT SYSTEMS revealed the following: "4. All water systems will include a posted schematic diagram which identifies components, valves, sample ports, and flow directions. Additionally, piping will be labeled to indicate the contents in the pipe and direction of flow."

The immediate jeopardy that began on 1/14/15, was removed on 1/15/15, when the hospital had implemented corrective action including: installation of an automatic divert to drain system, had developed and initiated a monitoring system to monitor the resistivity of the water, had provided training for the ESRD staff in relation to the systems, and had instituted appropriate water monitoring devices including audio and visual alarms on the ESRD treatment room floor.

Safe space for emergency treatment for dialysis:

P1 was admitted to the hospital on 1/9/15, with diagnoses that included ESRD. P1 required hemodialysis per the History and Physical (H&P).
P2 was admitted to the hospital on 1/7/15, with diagnoses that included ESRD. P2 required hemodialysis per the H&P.
P3 was admitted to the hospital on 1/5/15, with diagnoses that included ESRD. P3 required hemodialysis per the H&P.
P4 was admitted to the hospital on 1/9/15, with diagnoses that included ESRD. P4 required hemodialysis per the H&P.

On 1/14/15, at 10:00 a.m. P1 was observed on the acute inpatient ESRD unit while receiving dialysis through a right internal jugular vein catheter. The ESRD unit was observed to be a standard double bed room that had been converted into a dialysis unit. It was noted the dialysis unit had two patients (P1 and P2) receiving treatment while lying in standard size hospital beds. Both patients were dialyzing on dialysis machines and both patients were observed to have cardiac monitors in place. During the observation it was noted there was no more than 3 feet between the beds P1 and P2 occupied as they dialyzed. Additionally, On 1/14/15, at 10:30 a.m. RN-Y was observed to have trouble maneuvering around equipment to provide care for P1. RN-Y was observed to trip over a cardiac monitor while trying to respond to a dialysis machine alarm. At that time, RN-Y was interviewed and stated the dialysis unit was not large enough to run two patients at one time because it was hard to maneuver around the patients. RN-Y stated that on the ESRD unit if the patient in bed 2 of the unit (closest to the inside wall) required emergency assistance they would have to disconnect the patient in the first bed and remove the patient from the room before life-saving equipment from the crash cart could be moved into the room for emergency response. RN-Y also stated the patient beds were so close to each other they were in each other's "splash zone" (an industry standard described as a four foot area around a patient where blood splash or spray would be likely to occur during the dialysis procedure). RN-Y confirmed she had never experienced cross transfer of patient blood splash or spray while providing dialysis at St. Johns Health East. RN-Y stated they routinely provide hemodialysis to two patients at a time in the ESRD unit. RN-Y stated she had reported her concern to the dialysis facility administrator on more than one occasion however; nothing had been done to change the space situation.

On 1/14/15, at 12:00 p.m. P4 was observed in Bed 2 (side closest to the wall) while P3 occupied the first bed. Both P3 and P4 were observed to occupy standard hospital beds while they received hemodialysis. During this observation, it was again noted there was no more than 3 feet between the beds as P3 and P4 were dialyzing, thus creating a safety hazard in case of an emergency.

The facility administrator (FA) was interviewed on 1/14/15, at 11:40 a.m. during which she confirmed that the RN staff had reported concerns regarding lack of adequate space and safety concerns while providing dialysis for two patients at a time in the small ESRD unit. The FA stated that there was no other room in the hospital allotted for the ESRD patients so they would have to make do with what they had.

Incident reports were requested to ensure there had not been a cross transfer of blood spray from one patient to another. The FA was interviewed on 1/15/14, at 10:30 a.m. during which she stated that she had not had any incident reports of any kind in over a year.

Review of the hospital services agreement between St. John's Healtheast and the contracted service DaVita Healthcare Partners Inc. (DaVita) (unsigned and undated) identified the following: "Hospital shall provide the following adequate space, consistent with all applicable guidelines and regulations, to store sufficient equipment, water systems and medical supplies required, at Company's sole discretion, by patient volume, complexity of Treatment Services, and consistent with response time and scheduling requirements set forth in this Agreement.

Based on observation, interview and documentation review, the hospital failed to ensure care was provided in a safe setting related to lack of safe and appropriate water mechanisms for dialysis which could affect 4 of 4 current inpatient dialysis patients; and failure to count surgical instruments when the potential for surgical instrument retention existed for 3 of 3 surgical patients. The deficient practice had the potential to affect any dialysis or surgical patients who received care from the hospital.

The findings include:

The failure to ensure appropriate water monitoring for dialysis and surgical instrument counts resulted in the hospital's inability to ensure patient safety.

Therefore the hospital was unable to meet the Condition of Participation of Patient Rights at 42 CFR 482.13. These deficient practices had the potential to effect all patients receiving services in the hospital.

See A-0144.

Based on observation, interview and document review, the hospital failed to provide care to patients in a safe environment for 4 of 4 end stage renal disease (ESRD) inpatients (P1, P2, P3, P4) who required dialysis, and failed to ensure surgical services were provided in accordance with safe practices for 3 of 3 surgical patients (P32, P33, P36) who underwent surgical procedures with the potential for retention of surgical instruments.

Findings include:

Water quality safety:

During observation on 1/14/15, it was determined the hospital lacked an automatic divert to drain system in the ESRD unit and lacked audio and visual alarms to alert staff of inadequate water quality for dialysis.

On 1/14/15, at 10:30 a.m. the water room of the acute inpatient ESRD unit was observed with registered nurse (RN)-Z. RN-Z stated the ESRD water purification system utilized in the dialysis unit was deionization (DI). RN-Z further stated she was a contracted employee and floats to many inpatient hospital ESRD units in the metro area. RN-Z stated she had been trained on the deionization water purification system but could not remember when. RN-Z confirmed the water room did not have a current schematic showing where all of the different parts of the water purification system were and how they could be identified. When RN-Z was asked whether there was an automatic divert to drain mechanism plumbed into the water room, she stated she was unfamiliar with that reference. When RN-Z was asked about the facility's alarm monitor used to sound in the event of poor water quality, RN-Z pointed to an alarm that was unplugged and not functioning. RN-Z then offered for the biomedical engineer to come to the unit and walk through the water room with the surveyor so that all of the components could be verified. RN-Z verified an audible and visual alarm was not being appropriately implemented on the ESRD treatment unit. RN-Z stated an alarm would sound in the water room which was approximately 40 feet from the ESRD treatment room. She stated the door to the water room was closed and locked. RN-Z also stated she would rely on intensive care unit staff to notify her if the alarm was sounding because the water room was located in a closer proximity to that unit.

The hospital's biomedical engineer was interviewed on 1/14/15, at 12:00 p.m. The biomedical engineer stated he had been responsible for the maintenance of the water room at the hospital since 2008. He confirmed there was currently no functioning automatic divert to drain system plumbed into the water room to automatically divert water from reaching the dialysis machines if the water quality reached below 1 megohm (a unit of measurement). The biomedical engineer stated he had started to install the automatic divert to drain in the water room approximately six months prior but had not completed the installation because he did not have the right booster pump available to hook it up. The biomedical engineer confirmed that having the automatic divert to drain plumbing was a necessary industry safety standard established by the association for the AAMI RD52 standards (in absence of these safety standards dialysis patients would be at risk for negative health outcomes). He also acknowledged the importance of having audible and visual alarms in place on the treatment room unit when using deionization for water purification in accordance with AAMI RD52 standards for safety. The Biomedical engineer confirmed the audible alarm that monitored the water quality (resistivity) could not be heard if sounding on the treatment room floor and confirmed staff had not been monitoring the resistivity of the water according to facility policy. The biomedical engineer also stated that the facility did not have a policy related to using and testing the auto divert to drain equipment in the water room.

Review of the hospital services agreement between St. John's Healtheast and the contracted service Davita Healthcare Partners Inc. (DaVita) (unsigned and undated) identified the following: "[DaVita] shall provide, maintain in good operating condition, and repair all dialysis and related equipment necessary for the provision of the Treatment Services. All equipment provided by [DaVita] will be maintained by [DaVita] to meet requirements of applicable codes."

Review of the Acute Services Policy & Procedure Manual, #1 DaVita Inc. dated as last updated on March 2013 titled WATER QUALITY MONITORING FOR MULTI-STATION (NON-PORTABLE) WATER TREATMENT SYSTEMS revealed the following: "...8. In the event the RO [reverse osmosis] is inoperable or a deionization (DI) system is used as a polish: the DI monitoring log will be implemented ...The resistivity monitor readings should be record on the DI monitoring log every four (4) hours of each treatment day. This should be concurrent with documenting Total Chlorine checks."

Review of the Acute Services Policy & Procedure Manual, #1 DaVita Inc. dated as last updated on March 2013 titled MINIMUM COMPONENTS FOR MULTI-STATION (NON-PORTABLE) WATER TREATMENT SYSTEMS revealed the following: "4. All water systems will include a posted schematic diagram which identifies components, valves, sample ports, and flow directions. Additionally, piping will be labeled to indicate the contents in the pipe and direction of flow."


Safe space for emergency treatment in dialysis:

On 1/14/15, at 10:00 a.m. P1 was observed on the acute inpatient ESRD unit while receiving dialysis through a right internal jugular vein catheter. The ESRD unit was observed to be a standard double bed room that had been converted into a dialysis unit. It was noted the dialysis unit had two patients (P1 and P2) receiving treatment while lying in standard size hospital beds. Both patients were dialyzing on dialysis machines and both patients were observed to have cardiac monitors in place. During the observation it was noted there was no more than three feet between the beds P1 and P2 occupied as they dialyzed. Additionally, On 1/14/15, at 10:30 a.m. RN-Y was observed to have trouble maneuvering around equipment to provide care for P1. RN-Y was observed to trip over a cardiac monitor while trying to respond to a dialysis machine alarm. At that time, RN-Y was interviewed and stated the dialysis unit was not large enough to run two patients at one time because it was hard to maneuver around the patients. RN-Y stated that on the ESRD unit if the patient in bed 2 of the unit (closest to the inside wall) required emergency assistance they would have to disconnect the patient in the first bed and remove the patient from the room before life-saving equipment from the crash cart could be moved into the room for emergency response. RN-Y also stated the patient beds were so close to each other they were in each other's "splash zone" (an industry standard described as a four foot area around a patient where blood splash or spray would be likely to occur during the dialysis procedure). RN-Y confirmed she had never experienced cross transfer of patient blood splash or spray while providing dialysis at St. Johns Healtheast. RN-Y stated they routinely provide hemodialysis to two patients at a time in the ESRD unit. RN-Y stated she had reported her concern to the dialysis facility administrator on more than one occasion however; nothing had been done to change the space situation.

On 1/14/15, at 12:00 p.m. P4 was observed in Bed 2 (side closest to the wall) while P3 occupied the first bed. Both P3 and P4 were observed to occupy standard hospital beds while they received hemodialysis. During the observation, it was again noted there was no more than three feet between the beds as P3 and P4 were dialyzing, thus creating a safety hazard in case of an emergency.

P1 was admitted to the hospital on 1/9/15, with diagnoses that included ESRD. P1 required hemodialysis per the History and Physical (H&P).
P2 was admitted to the hospital on 1/7/15, with diagnoses that included ESRD. P2 required hemodialysis per the H&P.
P3 was admitted to the hospital on 1/5/15, with diagnoses that included ESRD. P3 required hemodialysis per the H&P.
P4 was admitted to the hospital on 1/9/15, with diagnoses that included ESRD. P4 required hemodialysis per the H&P.

The facility administrator (FA) was interviewed on 1/14/15, at 11:40 a.m. during which she confirmed the RN staff had reported concerns regarding lack of adequate space and safety concerns while providing dialysis for two patients at a time in the small ESRD unit. The FA stated there was no other room in the hospital allotted for the ESRD patients so they would have to make do with what they had.

Review of the hospital services agreement between St. John's Healtheast and the contracted service DaVita Healthcare Partners Inc. (DaVita) (unsigned and undated) identified the following: "Hospital shall provide the following adequate space, consistent with all applicable guidelines and regulations, to store sufficient equipment, water systems and medical supplies required, at Company's sole discretion, by patient volume, complexity of Treatment Services, and consistent with response time and scheduling requirements set forth in this Agreement.

Surgical instrument safety:

During observations on 1/13/15, it was determined the surgical services staff did not count surgical instruments during surgical procedures.

P32 was observed in the surgical suite at the hospital on 1/13/15, at 1:06 p.m. undergoing a endoscopy retrograde chloangiopancreagraphy and laproscopy cholecystectomy. With that case there was a possibility the surgeon may need to do a open cholecystectomy. A whiteboard was observed on the wall which included surgical count information. The circulating nurse and the certified surgical technician counted the sponges, needles, blades and cautery tips and entered that count on the whiteboard. A large number of surgical instruments were observed on sterile fields on the back table and on a Mayo stand (type of medical table used in surgery), however none of the instruments were observed to be counted prior to starting the surgical procedure.

During an interview on 1/13/15, at 1:06 p.m. clinical manager of surgical services (CMSS)-K stated the facility does not count instruments. He said they count only sharps, needles, bulldogs and aneurysm clamps. "We don't count instruments."

P36 was observed in the surgical suite at the hospital on 1/13/15, at 1:30 p.m. undergoing a laparoscopic subtotal colectomy which had the potential of becoming a laparotomy. A whiteboard was on the wall which included surgical count information. The circulating nurse and the certified surgical technician counted the sponges, needles, blades and cautery tips and entered that count on the whiteboard. A large number of surgical instruments were on sterile fields on the back table and on a Mayo stand, however none of the instruments had been counted prior to starting the surgical procedure. A review of the electronic health record (EHR) indicated the initial sponge, needle, blade and cautery tip count had been documented in the EHR. There was no indication an instrument count had been documented in the EHR.

The director of acute care operating rooms was interviewed on 1/13/15, at 2:10 p.m. and stated instrument counts were not done for any surgical procedures performed at the hospital. She stated the hospital followed Association of Operating Room Nursing (AORN) standards in the surgical suite but did not count instruments for any surgical cases, even if there was the potential an instrument could be unintentionally retained. She verified there was no policy related to counting surgical instruments for any surgical procedure which had the potential an instrument could be unintentionally retained.

The medical director of surgery was interviewed on 1/13/15, at 3:30 p.m. and stated surgical instruments counts had not been done at the hospital for years.

The group director, acute care surgical services was interviewed on 1/13/15, at 3:40 p.m. She stated instrument counts were not completed for any surgical procedure performed in the surgical suite, Maternity Care and the Midway Surgical Center. She stated surgical policies were identical in all three surgical areas. She state the hospital did not have a policy which addressed a count of surgical instruments. She stated the AORN (association of operating room nurses) perioperative standards and recommendations titled Recommended Practices for Prevention of Retained Surgical Items, dated 2014, were recommendations and not AORN standards. She stated it was the hospital's decision not to count instruments for any surgical procedures, even if there was the potential an instrument could be unintentionally retained.

P33 was observed in the surgical suite at the hospital obstetrical unit on 1/14/15, at 1:15 p.m. undergoing a cesarean section. A whiteboard was observed on the wall which included surgical count information. The circulating nurse and the certified surgical technician counted the sponges, needles, blades and cautery tips and entered that count on the whiteboard. A large number of surgical instruments were observed on sterile fields on the back table and on a Mayo stand, however none of the instruments were counted prior to starting the surgical procedure.

An interview on 1/14/15, at 12:44 p.m. with surgical tech (ST)-Q we count cautery tips, sharps, blades, needles, injection needles. ST-Q said, "we do not count instruments."

A review of the hospital policy Counts: Sponges, Sharps and Others, last reviewed/approved 12/19/14, indicated needles, blades, sponges, packing intended to be removed, cautery tips and cleaners, suture boots, vessel loops, umbilical tape, bulldog clamps, corneal shields and Penrose drains used for retraction were to be counted. The policy did not indicate any other surgical instruments were to be counted.

Based on observation, interview and document review, the hospital failed to ensure the hospital had quality assurance processes in place to minimize and/or prevent medical errors, ensure patient safety, and ensure contracted services were conducted in compliance with industry standards. This had the potential to affect all current patients and any future patients that would be admitted to the hospital for end stage renal dialysis (ESRD), surgery, or who had physician prescribed order sets.

Findings include:

The hospital failed to ensure quality assurance processes were in place to minimize and/or prevent medical errors including:
1) The hospital failed to audit the ESRD water room and review of adverse events reports. The hospital was found not to be in compliance with the Condition of Governing Body 42 CFR 482.12 and an immediate jeopardy (IJ) was issued on 1/14/15. See additional documentation at A0084.
2) Safe surgical practices were not followed in accordance with acceptable standards of practice related to instrument counts for surgical patients. The hospital was found not to be in compliance with the Condition of Surgical Services 42 CFR 482.51 and an Immediate Jeopardy was issued on 1/15/15. See additional documentation at A0951, and A0406.
3) Electronic physician orders/protocols related to the Clinical Institute for Withdrawal Assessment (CIWA) were not accurately implemented or transitioned to the new electronic medical record (EHR). This affected 1 of 2 deceased patients (P23), and 1 of 2 current patients (P16) who received medications outside the protocol parameters. In addition, the hospital was aware nursing staff had not always followed the CIWA protocol and had not yet implemented appropriate actions. The hospital was found not to be in compliance with the Condition of Nursing 42 CFR 482.23 and an Immediate Jeopardy was issued on 1/16/15. See additional documentation at A0406.

The severity and cumulative effect of these system failures resulted in the hospital's inability to ensure patient safety and consistency of care based on individual patient needs, physician orders, and nursing assessments to provide quality care.

Based on observation, interview and document review, the hospital failed to incorporate patient care data into their quality assurance processes (QAPI) in order to minimize and/or prevent medical errors and to promote safe patient care for 4 of 4 current end stage renal dialysis (ESRD) patients (P1, P2, P3, P4), and for 3 of 3 surgical patients (P32, P33, P36) and for 2 of 4 patients (P23, P16) who had physician prescribed order sets for alcohol withdrawal treatment. This deficient practice had the potential to affect any dialysis patients, surgical patients with risk for retained surgical instruments, and patients who had physician prescribed order sets for alcohol withdrawal treatment who received care at the hospital.

The findings include:

Although the hospital was aware of the importance of appropriate equipment to ensure water quality in the dialysis unit, the hospital had not conducted any quality review of the current processes with risk to patients.

Water quality safety for dialysis:

On 1/14/15, at 10:30 a.m. the water room of the acute inpatient ESRD was observed with registered nurse (RN)-Z during which she established that the system used for water purification was deionization (DI). RN-Z further established that she was a contracted employee of St. John's Healtheast and floats to many inpatient hospital ESRD units in the metro area including St. John's Healtheast. RN-Z confirmed she had been trained related to the DI system and confirmed that a current schematic diagram which identified the various operating components of the system was not available in the location of the water room. When questioned whether there was an automatic divert to drain mechanism plumbed in the water room in the event of unsafe/poor water quality, RN-Z stated that she lacked any knowledge. When further questioned about the location of the alarm monitor which alerted staff in the event of poor water quality, RN-Z pointed to an alarm which was unplugged and non-functioning. The biomedical engineer was then summoned to identify the various components of the DI water system. RN-Z further verified that an audible and visual alarm was not evident on the dialysis (ESRD) treatment room floor to alert staff of poor water quality. RN-Z further stated that should the alarm be activated in the water room, she would rely on the intensive care unit (ICU) staff to notify the dialysis nurse (in dialysis treatment room) when the alarm sounded because the water room was approximately 40 feet from the ESRD treatment room and the door to the water room was closed and locked.

The biomedical engineer was interviewed on 1/14/15, at 12:00 noon and established that he had been responsible for the maintenance of the water room at St. John's Healtheast since 2008. The biomedical engineer confirmed there was not a functioning automatic divert to drain plumbed in the water room that would automatically divert water from reaching the
dialysis machines in the event the water quality reached below 1 ego (a unit of electrical resistance equal to the resistance between two points on a conductor when a potential difference of one volt between them produces a current of one ampere). The biomedical engineer stated he had started to plumb the automatic divert to drain in the water room approximately six months prior but had not yet completed the installation because he did not have the right booster pump to hook it up. The biomedical engineer confirmed the automatic divert to drain plumbing was a necessary industry safety standard established by the association for the advancement of medical instrumentation (AM) RD52 standards. The biomedical engineer further established that having audible and visual alarms on the treatment room floor when using deionization for water purification were also AAMI RD52 standards for safety that had not been implemented for St. Johns Healtheast acute ESRD unit. The biomedical engineer confirmed the audible alarm that monitored the water quality (resistivity) could not be heard if sounding on the treatment room floor and staff had not been monitoring the resistivity of the water according to facility policy. The biomedical engineer stated that the facility did not have a policy related to using and testing the auto divert to drain equipment in the water room of St. John's Healtheast.

The hospital quality assessment and performance improvement committee was interviewed on 1/15/15, at 9:30 a.m. during which they confirmed that they had not incorporated into their quality assurance activities any audits of the water room of the acute inpatient ESRD dialysis unit and review of adverse event reports. The acute inpatient ESRD facility administrator (FA) was asked to provide the adverse event reports for the past year on 1/15/15, at 10:15 a.m. during which she stated that there had not been any documented events. When asked whether there had been any adverse event reports reviewed in the past three years the FA responded no. The FA stated that she had not provided the hospital quality assessment and performance improvement committee with any quality monitoring audits or adverse event reports, and further stated she was not part of the hospital quality assessment and performance improvement committee.

Although the hospital had instituted protocols for counting surgical supplies, they had not established or implemented protocols for counting surgical instruments.

Surgical Services Safety:

The Director of Acute Care Operating Rooms was interviewed on 1/13/15, at 2:10 p.m. and stated surgical instrument counts were not done for any surgical procedures performed at the hospital. She stated the hospital followed Association of Operating Room Nursing (AORN) standards in the surgical suite but did not count instruments for any surgical cases, even if there was the potential an instrument could be unintentionally retained. She also verified there was no hospital policy related to counting surgical instruments when there was a potential for a surgical instrument to be unintentionally retained during surgery.

During interview on 1/13/15, at 3:30 p.m. the Medical Director of Surgery stated surgical instruments counts had not been done at the hospital for years. On 1/13/15, at 3:40 p.m. the Group Director, Acute Care Surgical Services was interviewed and confirmed instrument counts were not completed for any surgical procedure performed in the surgical suite, Maternity Care and the Midway Surgical Center. She stated surgical policies were identical in all three surgical areas. She stated the hospital did not have a policy which addressed a count of surgical instruments. She also stated the AORN perioperative standards and recommendations titled Recommended Practices for Prevention of Retained Surgical Items, dated 2014, were recommendations and not AORN standards. She stated it was the hospital's decision not to count instruments for any surgical procedures, even if there was the potential an instrument could be unintentionally retained.

A review of the hospital policy Counts: Sponges, Sharps and Others, last reviewed/approved 12/19/14, indicated needles, blades, sponges, packing intended to be removed, cautery tips and cleaners, suture boots, vessel loops, umbilical tape, bulldog clamps, corneal shields and penrose drains used for retraction were to be counted. The policy did not indicate any other surgical instruments were to be counted.

The hospital had not developed or implemented any quality measures to ensure patient safety during surgery in order to prevent and/or minimize the risk of unintentional retention of surgical instruments.

Prescription Order Sets:

During a review of medical records for P23 and P16 who had been prescribed order sets for the Clinical Institute Withdrawal Assessment (CIWA) protocols, it was determined that on 11/27/14 the hospital had determined the CIWA protocol had not been followed for P23. The CIWA protocol was intended to be an assessment tool used to obtain objective data of symptoms of withdrawal from drugs and alcohol, and provided medication order guidance for patients whose symptom assessment revealed scores higher than 10. According to the protocol, the CIWA protocol was to be assessed hourly, and as needed for increased symptoms.

Review of P23's Medication Administration Record (MAR) revealed P23 had received Valium (an anti-anxiety medication) which was identified on the CIWA protocol order set to be administered if the patient's CIWA score was 10 or above. Review of the patient's MAR indicated the protocol had not been followed as written:

11/25/14, at 4:11 p.m. 10 mg Valium was administered intravenously (IV). There was no corresponding CIWA assessment score.
On 11/26/14, at 12:23 a.m. 10 mg Valium was administered orally, however the CIWA assessment score was identified as 10 at 12:25 a.m. (Two minutes following the Valium administration).
-At 8:44 a.m. 10 mg Valium was administered orally. However, the CIWA assessment score had only been identified as four at 8:24 a.m., with no additional CIWA assessment score identified prior to the Valium administration.
- At 11:51 a.m. 10 mg Valium was administered orally. However, the last CIWA assessment score documented was a six, which had been assessed at 11:00 a.m.
- At 4:20 p.m. 10 mg Valium was administered orally. However a CIWA assessment score was identified as a seven at 4:29 p.m. after P23 had received 10 mg of Valium.
- At 6:34 p.m. 10 mg Valium was administered orally even though the CIWA assessment score was only a seven when assessed at 6:23 p.m.
- At 10:22 p.m. 10 mg of Valium was administered orally. However a CIWA score assessment was not conducted prior, and was identified as a six at 10:39 p.m.

P23 died on 11/27/14, and a subsequent root cause analysis had identified staff failure to implement the CIWA protocol as prescribed.

Review of P16's record revealed the following entries related to the use of the CIWA protocol on 1/7/15:

1:54 p.m. CIWA score was 13. (Per CIWA protocol, a score of 10 or greater indicated the patient was to receive Valium 10 mg however, nursing had administered the Valium 10 mg at 1:50 p.m. prior to the CIWA assessment.

2:00 p.m. CIWA score was 13. (This assessment was conducted within six minutes of the assessment done at 1:54 p.m.). Although no further CIWA assessment was documented prior, P16 was administered Valium 10 mg again at 2:51 p.m.

3:22 p.m. CIWA score was 10. No Valium administered

5:09 p.m. Valium 10 mg. was administered, even though there was not a corresponding CIWA score to determine whether the administration of Valium was appropriate.

During interview on 1/15/15, at 10:00 a.m. group director of nursing (DON)-D stated the facility had reviewed P23's MAR in December 2014 and had identified the patient had received Valium, which was not administered according to the physician orders off the CIWA order set. DON-D stated P23 should have only received the Valium if the CIWA assessment total score was 10 or over. DON-D verified P23's CIWA had only reached 10 once out of the seven times the Valium had been administered during P23's hospital stay. DON-D stated the hospital had identified the nurses required re-education on the CIWA protocol and administering medication according to the physician orders, however, no education had been implemented yet, no additional monitoring had been instituted, and the goal was to begin education with nurses on 1/31/15.

On 1/16/15, at 10:20 a.m. RN-E was interviewed and stated when a patient has a CIWA order set; the nurses would complete assessments on the patient to determine whether they are having any signs or symptoms of alcohol withdrawal. RN-E stated the CIWA order set gave instructions to administer medication (Valium or Ativan, depending on the physician orders) if a patient's total CIWA score was 10 or above. However, RN-E also stated the nurse was able to use, "critical thinking skills" and administer the medications even if the patient did not score 10 or above if the nurse felt the patient was experiencing symptoms of withdrawal. RN-E stated nurses did not need to call the physician because the medications were already prescribed by the CIWA protocol order set.

On 1/16/15, At 10:30 a.m. RN-D was interviewed and stated the CIWA protocol was a baseline for nurses to go by as a guide, and nurses were able to use their judgment on administering medication if the patients CIWA score did not meet a total score of 10 or above. RN-D stated she did not need to call the physician to obtain an order for administering the medication not according to the order set, however, she would notify the physician to let them know the patient was having symptoms of withdrawal which required medication to be administered. When interviewed nursing staff stated they were allowed to use their clinical judgment and could medicate the patient per protocol even if the score were 6, 7, 8, or 9.

On 1/16/15, at 1:50 p.m. physician (P)-R the medical director responsible for psychiatric care was interviewed. P-R stated the CIWA protocol was designed to be driven by objective assessment data, and medications were not to be given unless the patient scored ten or greater on the CIWA scale, P-R stated the nursing staff should not have medicated a patient with a CIWA score less than ten.

On 1/16/15 at approximately 3:00 p.m. clinical nurse specialist (CNS)-D explained that once the physician made choices (selected medications) on the order set/protocol, the order dispersed to its component pieces such as medication orders and CIWA assessments, and was no longer able to be viewed as an order set/protocol. CNS-D further explained the order set was not reproducible in the closed medical record either.

On 1/16/15 at 5:00 p.m. the hospital administrative staff shared email correspondence with the survey team and explained the CIWA protocol order set as approved by the pharmacy and therapeutics committee (PNT) in June 2013, had been unintentionally changed when it had been built into the new EHR in June of 2014. The subjective word "anxiety" had been inadvertently added to the protocol order for Valium, and appeared to have allowed the nursing staff to give Valium for a CIWA score of less than ten. The paper order set (downtime backup orders), directed staff to medicate only if a patient's CIWA score was greater than 10. Amongst the emails reviewed, were correspondence with P-R which revealed he had suspected a change had somehow been made to the order set, had checked online to determine if that had happened, and had subsequently communicated his concerns to the hospital. At that time P-R verified the order set as written and approved by the PNT committee did not allow Valium to be given for anxiety for a CIWA score less than 10 and an error occurred in the EHR order set.

During the interview on 1/16/15 at 5:00 p.m., the director of nursing (DON)-D stated she had spoken with P-R a few hours prior, and discovered the CIWA order set in the hospital computer system (which had been being utilized since 6/14), had some errors and was not exactly what had been approved when the hospital implemented their new patient electronic medical record system. The word "anxiety" had somehow gotten into the protocol for assessing the CIWA score under the instructions indicating, "Valium 10 mg orally (by mouth), every one hour PRN, anxiety, for signs and symptoms of alcohol withdrawal as per the CIWA guidelines for withdrawal." DON-D stated the word anxiety could have been misleading to the nurses who may have interpreted it to mean that they could administer the medication just for anxiety. DON-D further identified that the instructions for nurses to check patient vital signs with every CIWA score assessment that was completed, was missing from the protocol.

Although it had been determined following P23's death that nursing staff lacked knowledge about how to implement the protocol, neither additional education, nor monitoring had been implemented to prevent continued noncompliance with protocol implementation.

On 1/20/15, at 3:00 p.m. the chief information officer (CIO) stated the process for building order sets in the new EHR did include a set of content experts, nursing and pharmacy staff to review the orders, to ensure no errors occurred. CIO could not explain how the CIWA order set error had occurred and verified it had not been noticed, in the order set in the new EHR, even though it had been reviewed by content experts, nursing and pharmacy staff.

The policy undated and untitled partial policy numbered 4823-8520-1697v.1 provided by the hospital directed...1.3.1 a. The attending member of the Healtheast Staff shall be responsible for the preparation of a complete and legible medical record for each patient. Its contents shall be pertinent and current...diagnostic and therapeutic orders ...
The hospital had not developed nor implemented any QAPI processes to ensure order sets were accurate for patient medication safety when the hospital had transitioned from a paper record based system to an electronic record based system in June of 2014, nor had they implemented monitoring to ensure corrective action when they had identified a problem with staff knowledge and use of the CIWA order sets.

Based on interview and document review, the hospital failed to provide patient care based on ongoing assessment of individual patient needs, for 1 of 2 deceased patients (P23), and 1 of 2 current patients (P16) who received medications outside the Clinical Institute Withdrawl Assessment (CIWA) physician order set protocols prescribed. This resulted in an immediate jeopardy (IJ) situation for P16 and any future patients who might have CIWA protocols ordered.

Findings include:

The hospital did not meet the Condition of Participation of Nursing Services at 42 CFR 482.23. These deficient practices had the potential to impact all patients, especially those with symptoms of alcohol withdrawal requiring medication intervention based off the CIWA protocol according to nursing assessments.

The IJ began on 12/11/14, when the facility failed to initiate proper assessment to implement physician prescribed order sets to care for patients with alcohol withdrawl symptoms. The hospital's administrative staff were informed of the IJ on 1/16/15, at 5:30 p.m. The IJ was removed on 1/20/15.

The facility's established protocols to treat patients' alcohol withdrawal symptoms had not been implemented as prescribed for P23 prior to his death, nor for P16 a current patient. Instead, nursing staff independently determined when to implement medications identified on the established protocol, did not complete comprehensive assessments, and failed to communicate with the patients' physicians to ensure patients received care in a safe manner.

The severity and cumulative effect of these system failures resulted in the hospital's inability to ensure patient care was implemented based on individual patient needs, physician orders, and nursing assessments.

The IJ that began on 12/11/14 was removed on 1/20/15, when it was verified by interview and document review that the hospital's nursing leadership had educated staff to policies and procedures related to patient assessment, protocol orders and physician notification; Nurses providing care to patients who required CIWA were provided just in time training and assigned completion of electronic education modules to ensure care was provided in accordance with protocols to ensure safe and appropriate patient care would be provided; And monitoring to ensure continued compliance was established and implemented. Refer to A0396.

The hospital failed to ensure nursing staff administered medications according to the physician electronic signed order sets for 2 of 4 patients (P23, P16) reviewed who received medications according to the Clinical Institute Withdrawal Assessment (CIWA) protocol. Refer to A0406.

Based on interview and document review, the hospital failed to develop, implement, and revise nursing care plans based on ongoing assessments of patient needs, and failed to provide care and medications in accordance with the Clinical Institute Withdrawal Assessment (CIWA) protocol. In addition, the nursing staff failed to provide ongoing assessment and physician notification for the use of the protocol for 1 of 2 deceased patients, (P23) and 1 of 2 current hospital inpatients (P16), reviewed who had the CIWA protocol prescribed resulting in an immediate jeopardy (IJ) situation.
Findings include:
The IJ began on 12/11/14, when the facility failed to initiate proper assessment to implement physician prescribed order sets to care for patients with alcohol withdrawl symptoms. The hospital's administrative staff were informed of the IJ on 1/16/15, at 5:30 p.m. The IJ was removed on 1/20/15.

Record review and interview verified the facility's established protocols to treat patients' alcohol withdrawal symptoms were not implemented as prescribed for P16 and P23. Instead, nursing staff independently determined when to implement medications identified on the established protocol, did not complete comprehensive assessments, and failed to communicate with the patient's physician to ensure the patient was cared for in a safe manner.

P23 was admitted to the facility on 11/25/14, with a diagnosis of Pancreatitis, and was placed on the CIWA protocol for potential alcohol withdrawal.
According to the CIWA protocol order set from the electronic medical record, the physician was directed to order medications to be given to a patient for signs and symptoms of alcohol withdrawal based off the nursing assessment. The CIWA protocol indicated the following:
· Valium 10 milligrams (mg) orally (by mouth), every one hour PRN (as needed) anxiety, for signs and symptoms of alcohol withdrawal as per the CIWA guidelines for withdrawal.
· CIWA score less than 10; no treatment and reassess every two-four hours or sooner if clinically indicated.
· CIWA score equal to or greater then 10; administer dose and reassess every one hour or sooner if clinically indicated.
· CIWA score equal to and greater than 10 every one hour OR patient unable to take medications by mouth; call house officer or attending physician AND consider transfer to higher acuity clinical unit. Attending physician to provide ongoing orders.
Additionally, per the protocol, the physician could chose to order Ativan 1 mg instead of the Valium which was suggested for patients with hepatic failure, who were elderly, or who were taking other medications that could cause CNS (central nervous sytem) depression due to the high risk for respiratory depression or delirium.
The protocol indicated the CIWA score was supposed to be based off a nursing assessment which involved assessing a patient's current condition and assigning each individual area a score of zero-two. A score of zero would indicate no signs or symptoms and a score of two would indicate significant signs and symptoms in each of the following areas:
- Nausea and vomiting, tactile disturbances, tremor, auditory disturbances, paroxysmal sweats, visual disturbances, anxiety, headache, agitation, and orientation.
In addition, according to the CIWA protocol, if the patient's total score was 10 or above in the areas assessed, the nurse was to administer the chosen medication ordered by the physician from the protocol, either Valium or Ativan.
Review of P23's Medication Administration Record (MAR) revealed P23 had received Valium, which was ordered by the physician off the CIWA protocol to be administered if the CIWA score was 10 or above. The MAR contained the following entries:
11/25/14, at 4:11 p.m. 10 mg Valium was administered intravenously (IV). There was no corresponding CIWA assessment score.
On 11/26/14, at 12:23 a.m. 10 mg Valium was administered orally, however the CIWA assessment score was identified as 10 at 12:25 a.m. (Two minutes following the Valium administration).
-At 8:44 a.m. 10 mg Valium was administered orally. However, the CIWA assessment score had only been identified as four at 8:24 a.m. with no additional CIWA assessment score identified prior to the Valium administration.
- At 11:51 a.m. 10 mg Valium was administered orally. However, the last CIWA assessment score documented was a six, which had been assessed at 11:00 a.m.
- At 4:20 p.m. 10 mg Valium was administered orally. However a CIWA assessment score was identified as a seven at 4:29 p.m. after P23 had received 10 mg of Valium.
- At 6:34 p.m. 10 mg Valium was administered orally even though the CIWA assessment score was only a seven when assessed at 6:23 p.m.
- At 10:22 p.m. 10 mg of Valium was administered orally. However a CIWA score assessment was not conducted prior, and was identified as a six at 10:39 p.m.

P23's MAR also indicated P23 was experiencing severe pain and received Dilaudid IV. On 1/16/15, the hospital pharmacy provided the black box warnings for Dilaudid which indicated, "Risk for producing respiratory depression." Dilaudid was administered the following dates/ times to P23.
11/25/14- 1 mg at 5:27 p.m., 1 mg at 5:56 p.m., 2 mg at 7:31 p.m., and 2 mg at 9:54 p.m.
11/26/14- 1 mg at 12:22 a.m., 1 mg at 5:21 a.m., 2 mg at 6:39 a.m., 2 mg at 8:37 a.m., 1 mg at 11:51 a.m., 1 mg at 2:19 p.m., 1 mg at 3:50 p.m., 2 mg at 6:34 p.m., 2 mg at 8:39 p.m., and 2 mg at 10:35 p.m.
11/27/14- 2 mg at 12:28 a.m. That was the last dose of Dilaudid P23 received before his death on 11/27/14, at 3:13 a.m.
Review of P23's electronic medical record indicated the patient had a GI (gastrointestinal) consult on 11/26/14. The note indicated, "Patients pain has been difficult to control despite IV Dilaudid...Patient complains of sleepiness, hallucinations and 'talking to myself' since starting the narcotic pain medications. Complains of faintness..."
P23's physician discharge note dated 11/27/14 indicated, "Significant pain throughout admission, requiring large quantities of IV narcotics. Patient was also placed on CIWA alcohol withdrawal protocol with multiple assessments revealing auditory and visual hallucinations, restlessness, and tremor. His alcohol withdrawal was treated with PO (oral) diazepam (Valium)... per [CIWA] protocol. Difficulties obtaining any reliable lab results as blood draw samples were continually lipemic and hemolized... In the early morning of 11/27/14, code blue was called to the patients room where he was found to be unresponsive, cool to touch, and pulseless at 2:40 a.m. [P23] was last seen alert at 2:00 a.m. CPR was performed for over 20 minutes... remained pulseless throughout resuscitation attempts. Patient declared deceased at 3:13 a.m. and resuscitation efforts ceased at this time."
Review of multiple vital signs in P23's medical record throughout the hospital stay indicated the following on 11/26/14:
- At 3:51 p.m.- BP (blood pressure) was 137/63, R (respirations) were 20.
- At 4:12 a.m. BP was 157/68, no R were documented at this time.
- At 6:55 p.m.- BP was 140/80, no R were documented at this time.
- At 8:39 p.m.- BP was 152/65, R were 20.
P23's vital signs on 11/27/14, at 12:06 a.m. were documented by a nursing assistant (NA) as BP of 98/50, and R of 32. Under the documented high respirations of 32, there was a comment written by the NA, "Let RN know."
According to P23's assessment flowsheet, a registered nurse (RN) assessed P23 at 12:15 a.m. on 11/27/14. The assessment indicated the patient was having moments of clear comprehensible speech, and then incomprehensible. Although several minutes prior the NA had documented abnormal vital signs for P23 and indicated the RN was notified, there were no vital signs rechecked at this time.
On 11/27/14, at 1:56 a.m. the RN documented on the flowsheet P23's respiratory and cardiac status were WDL (within defined limits), however, P23's vital signs were not rechecked at this time.
P23 had a CIWA protocol assessment score on 11/27/14, documented on the flowsheet with a total score of four. The documentation indicated the time of the CIWA assessment was at 2:00 a.m., however, the electronic medical record indicated the entry was not entered in the medical record until 3:32 a.m., and edited at 4:05 a.m., both of which were made after P23 had died. The CIWA assessment score indicated P23 received a score of one for tremors, one for auditory disturbances, one for visual disturbances, and one for anxiety. There was no nursing progress notes regarding any of the identified symptoms the nurse had assessed as part of the CIWA protocol, nor did the nurse do any further assessment of vital signs or monitoring of P23.
During interview on 1/15/15, at 10:00 a.m. group director of nursing (DON)-D stated the facility had reviewed P23's MAR 12/11/14 and had identified the patient had received Valium, which was not administered according to the physician orders off the CIWA order set. DON-D stated P23 should have only received the Valium if the CIWA assessment total score was 10 or over. DON-D verified P23's CIWA had only reached 10 once out of the seven times the Valium had been administered during P23's hospital stay. DON-D stated the hospital had identified the nurses required re-education on the CIWA protocol and administering medication according to the physician orders, however, no education had been implemented yet, no additional monitoring had been instituted, and the goal was to begin education with nurses on 1/31/15.



15508

P16 was admitted 1/5/15, with a diagnoses gastrointestinal bleeding, end stage liver disease and alcoholism. The physician's orders of 1/5/15, stipulated the CIWA protocol was to be implemented for the P16.

Review of P16's alcohol withdrawal record, on 1/7/15, reflected the implementation of the CIWA protocol as follows:

1:54 p.m. CIWA score was 13. (Per CIWA protocol, a score of 10 or greater indicated the patient was to receive Valium 10 mg however, nursing had administered the Valium 10 mg at 1:50 p.m. prior to the CIWA assessment.

2:00 p.m. CIWA score was 13. (This assessment was conducted within six minutes of the assessment done at 1:54 p.m.). Although no further CIWA assessment was documented prior, P16 was administered Valium 10 mg again at 2:51 p.m.

3:22 p.m. CIWA score was 10. No Valium administered

5:09 p.m. Valium 10 mg. was administered, even though there was not a corresponding CIWA score to determine whether the administration of Valium was appropriate.

During interview on 1/16/15, at 10:20 a.m., registered nurse (RN)-E stated when a patient has a CIWA order set, the nurses would complete assessments on the patient to determine if they are having any signs or symptoms of alcohol withdrawal. RN-E stated the CIWA order set gave instructions to administer medication (Valium or Ativan, depending on the physician orders) if a patients total CIWA score was 10 or above. However, the nurse was able to use, "Critical thinking skills," and administer the medication even if the patient does not score 10 or above, but if they felt the patient was experiencing symptoms of withdrawal. RN-E stated nurses did not need to call the physician because the order set and medication were already ordered.
During interview on 1/16/15, at 10:30 a.m. RN-D stated the CIWA protocol was a baseline for nurses to go by as a guide, and nurses were able to use their judgement on administering medication if the patients CIWA score did not meet a total score of 10 or above. RN-D stated she did not need to call the physician to obtain an order for administering the medication not according to the order set, however, she would notify the physician to let them know the patient was having symptoms of withdrawal which required medication to be administered.
On 1/16/15, at 1:50 p.m. physician (P)-R the medical director responsible for psychiatric care was interviewed. P-R stated the CIWA protocol was designed to be driven by objective assessment data, and medications were not to be given unless the patient scored ten or greater on the CIWA scale. P-R stated the CIWA protocol was very specific and was not meant to be used as a baseline, but was a specific physician order. P-R stated if a nurse assessed a patient and the CIWA score was only eight or nine, the expectation would be for the nurse to go back and reassess the patient in five to ten minutes to see if the CIWA score was now 10 or above, or to call the physician if they had concerns. P-R stated the CIWA order set/ protocol was available so all staff would be consistent on administering medications to patients with alcohol withdrawal, and if a nurse administered medications outside of the specific protocol, the nurse would be giving medications without a physician order. P-R stated hospital staff had called and spoke to him the previous day on 1/15/15, regarding P23. P-R stated he had concerns regarding the patient receiving Valium which was given outside of the specific CIWA protocol orders, as well as the patient receiving Valium vs Ativan related to the significant amount of CNS depressants (Dilauded) the patient was receiving. P-R stated he would expect, based on the CIWA protocol, the physician should have ordered Ativan instead of Valium, and P23 should have had close, constant, monitoring of vital signs. P-R further stated the nurses should be completing a full set of vital signs each time they assessed a patients CIWA score which was part of the protocol. P-R stated the Valium and Ativan were meant to be used for withdrawal symptoms, not for anxiety.
During the interview on 1/16/15 at 5:00 p.m., the director of nursing (DON)-D stated she had spoken with P-R a few hours prior, and discovered the CIWA order set in the hospital computer system (which had been being utilized since 6/14), had some errors and was not exactly what had been approved when the hospital implemented their new patient electronic medical record system. The word "anxiety" had somehow gotten into the protocol for assessing the CIWA score under the instructions indicating, "Valium 10 mg orally (by mouth), every one hour PRN, anxiety, for signs and symptoms of alcohol withdrawal as per the CIWA guidelines for withdrawal." DON-D stated the word anxiety could have been misleading to the nurses who may have interpreted it to mean that they could administer the medication just for anxiety. DON-D further identified that the instructions for nurses to check patient vital signs with every CIWA score assessment that was completed, was missing from the protocol.

The facility provided the approved paper copy of the CIWA protocol dated 6/13, which was identified as the protocol the facility had been following since 2013, and should have been the same protocol which was transferred over to the electronic system. The paper protocol included, "Perform full set of vital signs each time that CIWA is performed... Valium 10 mg PO/IM [intramuscular]/IV [intravenous] for signs and symptoms of alcohol withdrawal as per the CIWA table below..." The approved protocol did not include the indication of anxiety for the use of Valium.

The facility policy titled, Notification of Physicians/ LIP (Licensed Independent Practitioner) Regarding Significant Change in a Patients Condition and Critical Test Results dated 12/10 instructed staff, "The RN will notify the LIP in a timely manner of... significant change in a patients condition... Significant changes in a patients condition may include but are not limited to the following: Changes in clinical status and/ or assessment with regards to significant alterations in physiologic parameters (BP, heart rate, respiratory rate), physical changes (neurological, circulatory, respiratory, etc.), and/ or behavioral changes..." The policy further instructed the nurse to, "Document the following in the electronic health record: Name of physician/ provider and time called and time responded. Number of attempts over a specific time period to reach physician/ LIP, as appropriate. Objective information regarding patients condition reported to the physician/ LIP. Physician/ LIP response, including any new orders."

The facility policy titled, Nursing Assessment/ Reassessment of the Patient dated 1/15, instructed staff, "When ALL criteria for a category are met for a patient, the option of WDL [within defined limits] can be documented within most classes of assessments/ interventions..."
The facility policy titled, Protocol Initiated Orders dated 7/14, indicated, "Under no circumstances are protocols used in a manner that requires any staff not authorized to write patient orders to make clinical decisions outside of their scope of practice to initiate such protocols..."

The IJ that began on 12/11/14, was removed on 1/20/15, at 10:00 a.m. when it was verified by interview and document review that the hospital's nursing leadership had educated staff to policies and procedures related to patient assessment, protocol orders and physician notification; Nurses providing care to patients who required CIWA were provided just in time training and assigned completion of electronic education modules to ensure care was provided in accordance with protocols to ensure safe and appropriate patient care would be provided; And monitoring to ensure continued compliance was established and implemented.

Based on interview and document review, the facility failed to ensure medications were administered according to the physician electronic signed order set for 2 of 4 patients (P23, P16) reviewed who had physician's orders for the facility's order set referred to as the Clinical Institute Withdrawal Assessment (CIWA) protocol.

Findings include:

P23 was admitted to the facility on 11/25/14, with a diagnosis of pancreatitis and was placed on the CIWA protocol for potential alcohol withdrawal. According to the CIWA protocol order set for P23, the nurse was instructed to assess the patient for symptoms of alcohol withdrawal, assign a corresponding number to each assessment piece, and if the patient scored a total of 10 or above according to the withdrawal assessment, the nurse was to administer Valium (an antianxiety medication) 10 milligrams (mg).

P23's Medication Administration Record (MAR) indicated the patient was to receive Valium, per the CIWA protocol if the CIWA score was 10 or above:

On 11/25/14, at 4:11 p.m. 10 mg Valium was administered intravenously (IV), however there was no corresponding CIWA assessment score.

On 11/26/14, at 12:23 a.m. 10 mg Valium was administered orally, however the CIWA assessment score was identified as 10 at 12:25 a.m.
-At 8:44 a.m. 10 mg Valium was administered orally. However, the CIWA assessment score had only been identified as a 4 at the time of an 8:24 a.m., with no additional CIWA assessment score identified prior to the Valium administration.
- At 11:51 a.m. 10 mg Valium was administered orally. However, the last CIWA assessment score documented was a six, which had been assessed at 11:00 a.m.
- At 4:20 p.m. 10 mg Valium was administered orally. However a CIWA assessment score was identified as a seven at 4:29 p.m., after P23 had received 10 mg of Valium.
- At 6:34 p.m. 10 mg Valium was administered orally even though the CIWA assessment score was only a seven when assessed at 6:23 p.m.
- At 10:22 p.m. 10 mg of Valium was administered orally. However a CIWA score assessment was not conducted prior, and was identified as a six at 10:39 p.m.

During interview on 1/15/15, at 10:00 a.m. group director of nursing (DON)-D stated the facility had reviewed P23's MAR and verified the patient had received Valium outside the parameters of the physician prescribed CIWA order set. DON-D stated P23 should only have received the Valium if the CIWA assessment total score was 10 or over, which had only happened once during the hospital stay- on 11/26/14, at 12:25 a.m.

P16 was admitted 1/5/15, with a diagnoses of gastrointestinal bleeding, end stage liver disease, and alcoholism. The Physician's Orders dated 1/5/15, directed staff to implement the CIWA protocol order set, which included administering Valium 10 mg, up to once per hour, based on a CIWA assessment score of 10 or above.

Review of P16's alcohol withdrawal record and MAR for 1/7/15, indicated P16 received Valium as follows:
- At 1:54 p.m. P16's CIWA score was identified as 13, however P16 received the Valium 10 mg at 1:50 p.m. (prior to the CIWA score).
- At 2:00 p.m. the CIWA score was also identified as 13, six minutes after the last CIWA assessment, and 10 minutes after the last administration of Valium.
- At 2:51 p.m. P16 received Valium 10 mg. There was no other CIWA assessment score completed since the prior assessment at 2:00 p.m., 51 minutes prior to administration of the Valium.
- At 3:22 p.m. the CIWA score was 10. According to the CIWA protocol, P16 should have received Valium at that time however, no Valium was administered.
- At 5:09 p.m. P16 received 10 mg of Valium, however, there was no corresponding CIWA assessment score to determine if the resident required the medication.

During interview on 1/16/15, at 10:20 a.m. RN-E stated when a patient had a CIWA order set; the nurses performed assessments on the patient to determine if they were having any signs or symptoms of alcohol withdrawal. RN-E stated the CIWA order set instructed if a patients CIWA score was 10 or above, the nurse was suppose to administer either Valium or Ativan (an antianxiety medication), depending on what the physician ordered. However, RN-E also stated the nurse was able to use, "Critical thinking skills," and administer the medication even if the patient did not score 10 or above, if the nurse felt the patient was experiencing symptoms of withdrawal. RN-E also stated nurses did not need to call the physician because the order set and medication were already ordered in the CIWA protocol.

During interview on 1/16/15, at 10:30 a.m. RN-D stated the CIWA protocol was a baseline for nurses to go by as a guide, and nurses were able to use their judgment on administering medication if the patient's CIWA score did not meet 10 or above. RN-D stated the nurses did not need to call the physician to obtain an order to administer medications outside the parameters of the order set. However, RN-D said she would notify the physician to let them know the patient was having symptoms of withdrawal.

During interview on 1/16/15, at 1:50 p.m. physician (P)-R stated the CIWA protocol was very specific and was not meant to be used as a baseline. P-R stated if a nurse assessed a patient and the CIWA score was only eight or nine, the expectation would be for the nurse to go back and reassess the patient in five to 10 minutes to see if the CIWA score had increased to 10 or above, or to call the physician if they had concerns. P-R stated the CIWA order set/protocol had been developed to ensure staff was consistent with administering medications to patients with alcohol withdrawal, and if a nurse administered medications outside of the specific protocol, the nurses would be giving medications without a physician order.

The facility policy titled Protocol Initiated Orders dated 7/2014, indicated, "Under no circumstances are protocols used in a manner that requires any staff not authorized to write patient orders to make clinical decisions outside of their scope of practice to initiate such protocols..."

Based on interview and document review, the facility failed to ensure electronic physician orders/protocols were appropriately implemented for 1 of 2 deceased patients (P23), and for 1 of 2 current patients (P16) who had prescriptions medication administered based off the Clinical Institute Withdrawal Assessment (CIWA) protocol. This had the potential to affect all future patients who could be prescribed the CIWA protocol.

Findings include:

During a review of medical records for P23 the CIWA protocol was instituted on 11/25/14. The CIWA protocol was an assessment tool to be used to obtain objective data of symptoms of withdrawal from drugs and alcohol, and to provide medication if the symptom assessment scored higher than 10. The CIWA protocol was to be assessed hourly, and as needed for increased symptoms.

Review of P23's Medication Administration Record (MAR) indicated P23 received Valium (an anti-anxiety medication) which was ordered by the physician off the CIWA protocol to be administered if the CIWA score was 10 or above. The MAR indicated P23 received Valium six separate times from 11/25/14 to 11/26/14, although P23's CIWA score assessment was only scored a 10, one of six times Valium was administered.

P16 was admitted 1/5/15, with a diagnoses gastrointestinal bleeding, end stage liver disease, and alcoholism. The physician's orders dated 1/5/15, stipulated the CIWA protocol was to be implemented for P16.

Review of P16's alcohol withdrawal record on 1/7/15, reflected the implementation of the CIWA protocol as follows:

1:54 p.m. CIWA score was 13. (Per CIWA protocol, a score of 10 or greater the patient was to receive Valium 10 milligrams (mg) nursing administered Valium 10 mg at 1:50 p.m.

2:00 p.m. CIWA score was 13. (The assessment was conducted within six minutes of the assessment done at 1:54 p.m.).Valium 10 mg. administered at 2:51 p.m.

3:22 p.m. CIWA score was 10. No Valium administered

5:09 p.m. Valium 10 mg. was administered, even though there was not a corresponding CIWA score to determine if that was an appropriate administration of Valium.

On 1/16/15, at 10:20 a.m. registered nurse (RN)-E was interviewed and stated when a patient has a CIWA order set; the nurses would complete assessments on the patient to determine if they are having any signs or symptoms of alcohol withdrawal. RN-E stated the CIWA order set gave instructions to administer medication (Valium or Ativan-antianxiety medication, depending on the physician orders) if a patients total CIWA score was 10 or above. However, RN-E also stated the nurse was able to use "Critical thinking skills" to administer the medication even if the patient did not score 10 or above if they felt the patient was experiencing symptoms of withdrawal. RN-E stated nurses did not need to call the physician because the order set and medication were already ordered.

During interview on 1/16/15, at 10:30 a.m. RN-D stated the CIWA protocol was a baseline for nurses to go by as a guide, and nurses were able to use their judgment on administering medication if the patients CIWA score did not meet a total score of 10 or above. RN-D stated she did not need to call the physician to obtain an order for administering the medication not according to the order set, however, she would notify the physician to let them know the patient was having symptoms of withdrawal which required medication to be administered. When interviewed nursing staff stated they were allowed to use their clinical judgment and could medicate the patient per protocol even if the score were 6, 7, 8, or 9.

During interview on 1/16/15, at 1:50 p.m. physician (P)-R stated the CIWA protocol was driven by objective assessment data, and medication should not be given unless the score was ten or greater on the CIWA scale, and confirmed the nursing staff should not have medicated a patient with a CIWA score less than ten.

During interview on 1/16/15, at approximately 3:00 p.m. clinical nurse specialist (CNS)-D stated once the physician made choices (selected medications) on the CIWA order set/protocol, the order dispersed to its component pieces such as medication orders and CIWA assessments, and was no longer able to be viewed as an order set/protocol. CNS-D further explained the order set was not reproducible in the closed medical record of what was originally checked and ordered by the physician.

During interview on 1/16/15 at 5:00 p.m. director of nursing (DON)-D stated she had spoken with physician (P)-R a few hours prior, and had discovered the CIWA order set in the hospital's computer system (which had been being utilized since 6/14), had some errors and was not exactly what had been approved when the hospital had implemented their new patient electronic medical record system. DON-D stated the word "anxiety" had somehow gotten into the protocol for assessing the CIWA score under the instructions indicating, "Valium 10 mg orally (by mouth), every one hour PRN [as needed], anxiety, for signs and symptoms of alcohol withdrawal as per the CIWA guidelines for withdrawal." DON-D stated the word anxiety could have been misleading to the nurses who may have interpreted it to mean that they could administer the medication just for anxiety. DON-D further identified instructions for nurses to check patient vital signs with every CIWA score assessment was missing from the protocol.

The facility provided the approved paper copy of the CIWA protocol dated 6/13, which was identified as the protocol the facility had been following since 2013, and should have been the same protocol which was transferred over to the electronic system. The paper protocol included, "Perform full set of vital signs each time that CIWA is performed... Valium 10 mg PO/IM [intramuscular]/IV [intravenous] for signs and symptoms of alcohol withdrawal as per the CIWA table below..." The approved protocol did not include the indication of anxiety for the use of Valium.

During interview on 1/16/15, at 5:00 p.m. the hospital administrative staff provided emails and explained the CIWA protocol order set which was currently being used, had been approved by the pharmacy, nutrition, and pharmacy and therapeutics committee (PNT) in June 2013. However, there had been an unintentional change to the CIWA protocol order set when it had been built into the new electronic health record (EHR) in June of 2014. The subjective word "anxiety" had been added to the protocol order for Valium, which could have been interpreted by staff that Valium could be given for anxiety, which was not the intention of the CIWA protocol. The paper order set (downtime backup orders), which were the original approved orders, did not contain the wording of "anxiety" and directed staff to medicate only if the CIWA score was greater than 10. P-R's emails revealed he suspected an unintentional change had been made to the order set regarding indicating anxiety, and had checked if that had happened, then communicated that concern to the hospital. At that time P-R verified the order set as written and approved by the PNT committee did not allow Valium to be given for anxiety for a CIWA score less than 10, and an error occurred in the EHR order set which had been being utilized for patients since June 2014.

During interview on 1/20/15, at 3:00 p.m. the chief information officer (CIO) stated the process for building order sets in the new EHR did include a set of content experts, nursing, and pharmacy staff to review the orders, to ensure no errors occurred. CIO could not explain how the indication of "anxiety" had been added and not noticed in the order set in the new EHR, when it had been reviewed by content experts, nursing, and pharmacy staff.

The undated and untitled partial policy numbered 4823-8520-1697v.1 provided by the hospital directed..."1.3.1 a. The attending member of the Healtheast medical Staff shall be responsible for the preparation of a complete and legible medical record for each patient. Its contents shall be pertinent and current...diagnostic and therapeutic orders ..."

Based on observation, interview and document review, the hospital did not ensure intravenous solutions (IVs) were stored according to manufacturer's recommendations in 2 of 2 blanket warmers located in the surgical suite. This had the potential to affect any IV and solutions placed in the blanket warmers.

Findings include:

The hospital did not ensure IV solutions were stored in the blanket warmers in the surgical suite according to manufacturer's recommendations.

During a tour of the surgical suite on 1/14/15, at 10:50 a.m. an Amsco blanket warmer was observed in the ante room between operating rooms five and six. The blanket warmer contained Baxter solutions in their overpouches which included two 1000 ml (milliliter) plastic bags which contained 0.9% sodium chloride IV solution. Neither of these IV solutions included a date on the bag which indicated when they had been placed in the blanket warmer. The temperature of the blanket warmer was observed to measure 92.1 degrees Fahrenheit (F).

Another blanket warmer was located in the ante room between operating rooms one and two. The warmer contained one plastic bag of 1000 ml. 0.9% Normal Saline IV solution. The IV bag had a note on it which indicated it was for a specific surgeon's case on Wednesday July 2nd at 12:30 p.m. The temperature of the blanket warmer was observed to measure 98.1 degrees F.

The clinical manager of the operating room was interviewed on 1/14/15, at 11:05 a.m. He verified the solutions had not been dated and should have been dated when the solutions were put in the warmer. He stated he thought IV solutions could remain in the warmer for two weeks. He was unable to identify when these solutions had been put into the warmer.

The hospital provided a letter dated 1/15/15, from Baxter, the manufacturer of the IV solutions which were observed in the warmer. The manufacturer's recommendations for large volume intravenous solutions (IV solutions greater than 150 cc.) could be placed in the warmer in their overpouches at temperatures no higher than 104 degrees for a period no longer than 14 days.

The pharmacist in charge was interviewed on 1/15/15, at 1:15 p.m. The pharmacist stated he was aware of the manufacturer's recommendations and stated the IV fluids should not be in the blanket warmer for longer than fourteen days. The pharmacist was unable to identify when these IV solutions had been placed in the warmer.

The pharmacist who was the director of operations was interviewed on 1/15/15, at 1:15 p.m. He stated there was not a current policy related to the length of time IV fluid solutions could remain in the warmer. He stated pharmacy staff were currently writing a policy and the policy would be shared with the surgical services staff.

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

Findings include:

Please refer to Life Safety Code inspection tags: K-0029, K-0033, K-0050, K-0056, K-0062, and K-0078.

Based on interview and document review, the facility failed to ensure the organ procurement organization (Life Source) was contacted in a timely manner for 1 of 6 patients (P23) whose death record was reviewed.

Findings include:

Review of P23's Electronic Medical Record Post Mortem Flow sheet indicated the patient died on 11/27/14, at 3:13 a.m. The flow sheet indicated the Life Source donation coordinator was not notified because, "This is a medical examiner's case."

During interview on 1/14/14, at 2:10 p.m. clinical nurse specialist (CNS)-U, who was identified as the person in charge of the hospital organ donation program, stated Life Source was required to be notified of all deaths, regardless if the patient was a medical examiner's case. CNS-U stated Life Source should have been contacted regarding P23's death, and the nurses needed more education regarding contact of Life Source for all deaths.

The facility's policy Donation of Organ, Tissue, and Eye dated 7/2013, directed staff, "...It is the policy of [facility] to refer all deaths, regardless of age or medical history, to the regional procurement agencies ... "

Based on observation, interview, and document review, the hospital was found not to be in compliance with the Condition of Participation for Surgical Services (CFR 482.51) due to failure to follow acceptable standards of practice related to surgical instrument counts for 3 of 3 surgical patients observed (P32, P33, P36). In addition, the hospital failed to ensure post operative reports were completed in a timely manner for 1 of 6 patients (P9).

Findings include:

The hospital failed to ensure safe surgical practices were followed in accordance with acceptable standards of practice related to instrument counts for 3 of 3 surgical patients (P36, P32, P33) in the sample who underwent surgical procedures when the possibility existed that an instrument could be unintentionally retained. Therefore an immediate jeopardy was identified on 1/15/15, at 2:00 p.m. These findings had the potential to affect any patient who had a surgical procedure when the possibility existed that an instrument could be unintentionally retained. Refer to findings at A-0951.

The facility failed to ensure 1 of 6 patient's (P9) surgical records reviewed had completed written or dictated documentation related to a surgical procedure immediately post-operatively. Refer to A-0959.

Based on observation, interview and document review, the hospital failed to ensure safe surgical practices were followed in accordance with acceptable standards of practice related to instrument counts for 3 of 3 surgical patients (P36, P32, P33) in the sample who underwent a surgical procedure where the possibility existed that an instrument could be unintentionally retained. The failure to count surgical instruments resulted in an immediate jeopardy (IJ) which had the potential to affect any patient who had a surgical procedure when the possibility existed that an instrument could be unintentionally retained.

Findings include:

The IJ began on 1/13/15, at 1:30 p.m. when it was determined the facility failed to ensure systems were implemented to ensure surgical instrument counts were conducted when the possibility existed that an instrument could be unintentionally retained. The hospital administrative staff were notified of the IJ on 1/15/15, at 2:00 p.m. The IJ was removed on 1/20/15, at 3:05 p.m.

P36 was observed in the surgical suite at the hospital on 1/13/15, at 1:30 p.m. undergoing a laparoscopic subtotal colectomy which had the potential of becoming a laparotomy. A whiteboard was on the wall which included surgical count information. The circulating nurse and the certified surgical technician counted the sponges, needles, blades and cautery tips and entered that count on the whiteboard. A large number of surgical instruments were on sterile fields on the back table and on a Mayo stand, however none of the instruments had been counted prior to starting the surgical procedure. A review of the electronic health record (EHR) indicated the initial sponge, needle, blade and cautery tip count had been documented in the EHR. There was no indication an instrument count had been documented in the EHR.

The director of acute care operating rooms was interviewed on 1/13/15, at 2:10 p.m. and stated instrument counts were not done for any surgical procedures performed at the hospital. She stated the hospital followed Association of Operating Room Nursing (AORN) standards in the surgical suite but did not count instruments for any surgical cases, even if there was the potential an instrument could be unintentionally retained. She verified there was no policy related to counting surgical instruments for any surgical procedure which had the potential an instrument could be unintentionally retained.

The medical director of surgery was interviewed on 1/13/15, at 3:30 p.m. and stated surgical instruments counts had not been done at the hospital for years.

The group director, acute care surgical services was interviewed on 1/13/15, at 3:40 p.m. She stated instrument counts were not completed for any surgical procedure performed in the surgical suite, Maternity Care and the Midway Surgical Center. She stated surgical policies were identical in all three surgical areas. She state the hospital did not have a policy which addressed a count of surgical instruments. She stated the AORN perioperative standards and recommendations titled Recommended Practices for Prevention of Retained Surgical Items, dated 2014, were recommendations and not AORN standards. She stated it was the hospital's decision not to count instruments for any surgical procedures, even if there was the potential an instrument could be unintentionally retained.





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P32 was observed in the surgical suite at the hospital on 1/13/15, at 1:06 p.m. undergoing a endoscopy retrograde chloangiopancreagraphy and laproscopy cholecystectomy. With that case there was a possibility the surgeon may need to do a open cholecystectomy. A whiteboard was on the wall which included surgical count information. The circulating nurse and the certified surgical technician counted the sponges, needles, blades and cautery tips and entered that count on the whiteboard. A large number of surgical instruments were observed on sterile fields on the back table and on a Mayo stand (type of medical table used in surgery), however none of the instruments were observed to be counted prior to starting the surgical procedure.

During an interview on 1/13/15, at 1:06 p.m. clinical manager of surgical services (CMSS)-K stated the facility does not count instruments. He said they count only sharps, needles, bulldogs and aneurysm clamps. "We don't count instruments."

P33 was observed in the surgical suite at the hospital obstetrical unit on 1/14/15, at 1:15 p.m. undergoing a cesarean section. A whiteboard was on the wall which included surgical count information. The circulating nurse and the certified surgical technician counted the sponges, needles, blades and cautery tips and entered that count on the whiteboard. A large number of surgical instruments were observed on sterile fields on the back table and on a Mayo stand, however none of the instruments were counted prior to starting the surgical procedure.

An interview on 1/14/15, at 12:44 p.m. with surgical tech (ST)-Q we count cautery tips, sharps, blades, needles, injection needles. ST-Q said, "we do not count instruments."


29249

During interview on 1/14/15, at 8:20 a.m. clinical manager outpatient surgery center (CM)-Y stated the outpatient surgery center follows the hospital policy on counting instruments. CM-Y stated they are instructed they are not required to count basically any surgical instruments, "That are metal."

A review of the hospital policy, Counts: Sponges, Sharps and Others, last reviewed/approved 12/19/14, indicated needles, blades, sponges, packing intended to be removed, cautery tips and cleaners, suture boots, vessel loops, umbilical tape, bulldog clamps, corneal shields and Penrose drains used for retraction were to be counted. The policy did not indicate any other surgical instruments were to be counted.

The IJ was removed at 3:05 p.m. on 1/20/15, when it was verfied by interview, document review and observation, that the hospital had established and implemented systems for ensuring accurate surgical instrument counts; hospital leadership had developed and implemented systems for ensuring surgical staff had been educated to policies and procedures related to unintentional retention of surgical instruments; surgery staff verified through interview these procedures, and surgical observations verified the implementation of such systems. In addition, the hospital had developed systems for ongoing monitoring for continued compliance.

Based on interview and document review, the facility failed to ensure an operative report was completed immediately following surgery for 1 of 6 patients (P9) whose surgical records were reviewed.

Findings include:

P9's medical record was reviewed on 1/15/15. Documentation of an immediate post operative report was lacking for a back related surgical procedure P9 had undergone on 1/12/15. The medical record lacked the time of the surgery, the names of practitioners assisting with surgical tasks, the pre-operative and post-operative diagnoses, the type of anesthesia administered, indication of whether or not P9 had experienced any complications, or if tissue or blood loss had occurred during the surgery. In addition, there was no postoperative note from the spine surgeon regarding P9's surgical procedure on 1/12/15.

During interview with the Group Director of Acute Care Surgical Services (GDASS) at 11:45 a.m. on 1/15/15, GDASS verified there was no surgical note from the spine surgeon and stated the spine surgeon should have dictated a note in P9's chart.

The medical staff bylaws provided by the hospital on 1/16/15, undated indicated "1.3.11 ... Operative reports should be dictated or written in the medical record immediately after surgery..."

Based on observation, interview, and document review, the hospital failed to ensure the water room located near the acute end stage renal disease (ESRD) unit was equipped with the appropriate safety equipment as a component of the deionization (DI) of water processing in accordance with the Advancement of Medical Instrumentation (AAMI) standards to ensure the safety of the water used during dialysis. These findings led to an immediate jeopardy (IJ) situation for 4 of 4 ESRD patients (P1, P2, P3, P4) who currently received hemodialysis while hospitalized. In addition, the hospital failed to ensure there was adequate space in the unit to provide safe care to patients in the event of an emergency. This had the potential to affect each of the 4 current ESRD patients and any future ESRD patients.

Findings include:

Water quality safety:

The IJ began on 1/14/15, at 5:00 p.m. when it was determined the hospital lacked an automatic divert to drain system in the ESRD unit and lacked audio and visual alarms to alert staff of inadequate water quality on the ESRD treatment floor. At that time, the chief nursing officer was notified the lack of standard safety systems put the four ESRD patients at serious risk for health and safety and that an IJ was being called. The immediate jeopardy was removed and the deficient practice was corrected on 1/15/15.

On 1/14/15, at 10:30 a.m. the water room of the acute inpatient ESRD unit was observed with registered nurse (RN)-Z. RN-Z stated the ESRD water purification system utilized in the dialysis unit was deionization (DI). RN-Z further stated she was a contracted employee and floats to many inpatient hospital ESRD units in the metro area. RN-Z stated she had been trained on the deionization water purification system but could not remember when. RN-Z confirmed the water room did not have a current schematic showing where all of the different parts of the water purification system were and how they could be identified. When RN-Z was asked whether there was an automatic divert to drain mechanism plumbed into the water room, she stated she was unfamiliar with that reference. When RN-Z was asked about the facility's alarm monitor used to sound in the event of poor water quality, RN-Z pointed to an alarm that was unplugged and not functioning. RN-Z then offered for the biomedical engineer to come to the unit and walk through the water room with the surveyor so that all of the components could be verified. RN-Z verified an audible and visual alarm was not being appropriately implemented on the ESRD treatment unit. RN-Z stated an alarm would sound in the water room which was approximately 40 feet from the ESRD treatment room. She stated the door to the water room was closed and locked. RN-Z also stated she would rely on intensive care unit staff to notify her if the alarm was sounding because the water room was located in a closer proximity to that unit.

The hospital's biomedical engineer was interviewed on 1/14/15, at 12:00 p.m. The biomedical engineer stated he had been responsible for the maintenance of the water room at the hospital since 2008. He confirmed there was currently no functioning automatic divert to drain system plumbed into the water room to automatically divert water from reaching the dialysis machines if the water quality reached below 1 megohm ( a unit of measure). The biomedical engineer stated he had started to plumb the automatic divert to drain in the water room approximately six months prior but had not completed the installation because he did not have the right booster pump available to hook it up. The biomedical engineer confirmed that having the automatic divert to drain plumbing was a necessary industry safety standard established by the association for the AAMI RD52 standards (in absence of these safety standards dialysis patients would be at risk for negative health outcomes). He also acknowledged the importance of having audible and visual alarms in place on the treatment room unit when using deionization for water purification in accordance with AAMI RD52 standards for safety. The Biomedical engineer confirmed the audible alarm that monitored the water quality (resistivity) could not be heard if sounding on the treatment room floor and confirm staff had not been monitoring the resistivity of the water according to facility policy. The biomedical engineer also stated that the facility did not have a policy related to using and testing the auto divert to drain equipment in the water room.

Review of the hospital services agreement between St. John's Health East and the contracted service Davita Healthcare Partners Inc. (DaVita) (unsigned and undated) identified the following: "[DaVita] shall provide, maintain in good operating condition, and repair all dialysis and related equipment necessary for the provision of the Treatment Services. All equipment provided by [DaVita] will be maintained by [DaVita] to meet requirements of applicable codes."

Review of the Acute Services Policy & Procedure Manual, #1 DaVita Inc. dated as last updated on March 2013 titled WATER QUALITY MONITORING FOR MULTI-STATION (NON-PORTABLE) WATER TREATMENT SYSTEMS revealed the following: "...8. In the event the RO [reverse osmosis] is inoperable or a deionization (DI) system is used as a polish: the DI monitoring log will be implemented ...The resistivity monitor readings should be record on the DI monitoring log every four (4) hours of each treatment day. This should be concurrent with documenting Total Chlorine checks."

Review of the Acute Services Policy & Procedure Manual, #1 DaVita Inc. dated as last updated on March 2013 titled MINIMUM COMPONENTS FOR MULTI-STATION (NON-PORTABLE) WATER TREATMENT SYSTEMS revealed the following: "4. All water systems will include a posted schematic diagram which identifies components, valves, sample ports, and flow directions. Additionally, piping will be labeled to indicate the contents in the pipe and direction of flow."

The immediate jeopardy that began on 1/14/15, was removed on 1/15/15, when the hospital had implemented corrective action including: installation of an automatic divert to drain system, had developed and initiated a monitoring system to monitor the resistivity of the water, had provided training for the ESRD staff in relation to the systems, and had instituted appropriate water monitoring devices including audio and visual alarms on the ESRD treatment room floor.

Safe space for emergency treatment for dialysis:

P1 was admitted to the hospital on 1/9/15, with diagnoses that included ESRD. P1 required hemodialysis per the History and Physical (H&P).
P2 was admitted to the hospital on 1/7/15, with diagnoses that included ESRD. P2 required hemodialysis per the H&P.
P3 was admitted to the hospital on 1/5/15, with diagnoses that included ESRD. P3 required hemodialysis per the H&P.
P4 was admitted to the hospital on 1/9/15, with diagnoses that included ESRD. P4 required hemodialysis per the H&P.

On 1/14/15, at 10:00 a.m. P1 was observed on the acute inpatient ESRD unit while receiving dialysis through a right internal jugular vein catheter. The ESRD unit was observed to be a standard double bed room that had been converted into a dialysis unit. It was noted the dialysis unit had two patients (P1 and P2) receiving treatment while lying in standard size hospital beds. Both patients were dialyzing on dialysis machines and both patients were observed to have cardiac monitors in place. During the observation it was noted there was no more than 3 feet between the beds P1 and P2 occupied as they dialyzed. Additionally, On 1/14/15, at 10:30 a.m. RN-Y was observed to have trouble maneuvering around equipment to provide care for P1. RN-Y was observed to trip over a cardiac monitor while trying to respond to a dialysis machine alarm. At that time, RN-Y was interviewed and stated the dialysis unit was not large enough to run two patients at one time because it was hard to maneuver around the patients. RN-Y stated that on the ESRD unit if the patient in bed 2 of the unit (closest to the inside wall) required emergency assistance they would have to disconnect the pati

Based on observation, interview and document review, the hospital failed to provide care to patients in a safe environment for 4 of 4 end stage renal disease (ESRD) inpatients (P1, P2, P3, P4) who required dialysis, and failed to ensure surgical services were provided in accordance with safe practices for 3 of 3 surgical patients (P32, P33, P36) who underwent surgical procedures with the potential for retention of surgical instruments.

Findings include:

Water quality safety:

During observation on 1/14/15, it was determined the hospital lacked an automatic divert to drain system in the ESRD unit and lacked audio and visual alarms to alert staff of inadequate water quality for dialysis.

On 1/14/15, at 10:30 a.m. the water room of the acute inpatient ESRD unit was observed with registered nurse (RN)-Z. RN-Z stated the ESRD water purification system utilized in the dialysis unit was deionization (DI). RN-Z further stated she was a contracted employee and floats to many inpatient hospital ESRD units in the metro area. RN-Z stated she had been trained on the deionization water purification system but could not remember when. RN-Z confirmed the water room did not have a current schematic showing where all of the different parts of the water purification system were and how they could be identified. When RN-Z was asked whether there was an automatic divert to drain mechanism plumbed into the water room, she stated she was unfamiliar with that reference. When RN-Z was asked about the facility's alarm monitor used to sound in the event of poor water quality, RN-Z pointed to an alarm that was unplugged and not functioning. RN-Z then offered for the biomedical engineer to come to the unit and walk through the water room with the surveyor so that all of the components could be verified. RN-Z verified an audible and visual alarm was not being appropriately implemented on the ESRD treatment unit. RN-Z stated an alarm would sound in the water room which was approximately 40 feet from the ESRD treatment room. She stated the door to the water room was closed and locked. RN-Z also stated she would rely on intensive care unit staff to notify her if the alarm was sounding because the water room was located in a closer proximity to that unit.

The hospital's biomedical engineer was interviewed on 1/14/15, at 12:00 p.m. The biomedical engineer stated he had been responsible for the maintenance of the water room at the hospital since 2008. He confirmed there was currently no functioning automatic divert to drain system plumbed into the water room to automatically divert water from reaching the dialysis machines if the water quality reached below 1 megohm (a unit of measurement). The biomedical engineer stated he had started to install the automatic divert to drain in the water room approximately six months prior but had not completed the installation because he did not have the right booster pump available to hook it up. The biomedical engineer confirmed that having the automatic divert to drain plumbing was a necessary industry safety standard established by the association for the AAMI RD52 standards (in absence of these safety standards dialysis patients would be at risk for negative health outcomes). He also acknowledged the importance of having audible and visual alarms in place on the treatment room unit when using deionization for water purification in accordance with AAMI RD52 standards for safety. The Biomedical engineer confirmed the audible alarm that monitored the water quality (resistivity) could not be heard if sounding on the treatment room floor and confirmed staff had not been monitoring the resistivity of the water according to facility policy. The biomedical engineer also stated that the facility did not have a policy related to using and testing the auto divert to drain equipment in the water room.

Review of the hospital services agreement between St. John's Healtheast and the contracted service Davita Healthcare Partners Inc. (DaVita) (unsigned and undated) identified the following: "[DaVita] shall provide, maintain in good operating condition, and repair all dialysis and related equipment necessary for the provision of the Treatment Services. All equipment provided by [DaVita] will be maintained by [DaVita] to meet requirements of applicable codes."

Review of the Acute Services Policy & Procedure Manual, #1 DaVita Inc. dated as last updated on March 2013 titled WATER QUALITY MONITORING FOR MULTI-STATION (NON-PORTABLE) WATER TREATMENT SYSTEMS revealed the following: "...8. In the event the RO [reverse osmosis] is inoperable or a deionization (DI) system is used as a polish: the DI monitoring log will be implemented ...The resistivity monitor readings should be record on the DI monitoring log every four (4) hours of each treatment day. This should be concurrent with documenting Total Chlorine checks."

Review of the Acute Services Policy & Procedure Manual, #1 DaVita Inc. dated as last updated on March 2013 titled MINIMUM COMPONENTS FOR MULTI-STATION (NON-PORTABLE) WATER TREATMENT SYSTEMS revealed the following: "4. All water systems will include a posted schematic diagram which identifies components, valves, sample ports, and flow directions. Additionally, piping will be labeled to indicate the contents in the pipe and direction of flow."


Safe space for emergency treatment in dialysis:

On 1/14/15, at 10:00 a.m. P1 was observed on the acute inpatient ESRD unit while receiving dialysis through a right internal jugular vein catheter. The ESRD unit was observed to be a standard double bed room that had been converted into a dialysis unit. It was noted the dialysis unit had two patients (P1 and P2) receiving treatment while lying in standard size hospital beds. Both patients were dialyzing on dialysis machines and both patients were observed to have cardiac monitors in place. During the observation it was noted there was no more than three feet between the beds P1 and P2 occupied as they dialyzed. Additionally, On 1/14/15, at 10:30 a.m. RN-Y was observed to have trouble maneuvering around equipment to provide care for P1. RN-Y was observed to trip over a cardiac monitor while trying to respond to a dialysis machine alarm. At that time, RN-Y was interviewed and stated the dialysis unit was not large enough to run two patients at one time because it was hard to maneuver around the patients. RN-Y stated that on the ESRD unit if the patient in bed 2 of the unit (closest to the inside wall) required emergency assistance they would have to disconnect the patient in the first bed and remove the patient from the room before life-saving equipment from the crash cart could be moved into the room for emergency response. RN-Y also stated the patient beds were so close to each other they were in each other's "splash zone" (an industry standard described as a four foot area around a patient where blood splash or spray would be likely to occur during the dialysis procedure). RN-Y confirmed she had never experienced cross transfer of patient blood splash or spray while providing dialysis at St. Johns Healtheast. RN-Y stated they routinely provide hemodialysis to two patients at a time in the ESRD unit. RN-Y stated she had reported her concern to the dialysis facility administrator on more than one occasion however; nothing had been done to change the space situation.

On 1/14/15, at 12:00 p.m. P4 was observed in Bed 2 (side closest to the wall) while P3 occupied the first bed. Both P3 and P4 were observed to occupy standard hospital beds while they received hemodialysis. During the observation, it was again noted there was no more than three feet between the beds as P3 and P4 were dialyzing, thus creating a safety hazard in case of an emergency.

P1 was admitted to the hospital on 1/9/15, with diagnoses that included ESRD. P1 required hemodialysis per the History and Physical (H&P).
P2 was admitted to the hospital on 1/7/15, with diagnoses that included ESRD. P2 required hemodialysis per the H&P.
P3 was admitted to the hospital on 1/5/15, with diagnoses that included ESRD. P3 required hemodialysis per the H&P.
P4 was admitted to the hospital on 1/9

Based on observation, interview and document review, the hospital failed to incorporate patient care data into their quality assurance processes (QAPI) in order to minimize and/or prevent medical errors and to promote safe patient care for 4 of 4 current end stage renal dialysis (ESRD) patients (P1, P2, P3, P4), and for 3 of 3 surgical patients (P32, P33, P36) and for 2 of 4 patients (P23, P16) who had physician prescribed order sets for alcohol withdrawal treatment. This deficient practice had the potential to affect any dialysis patients, surgical patients with risk for retained surgical instruments, and patients who had physician prescribed order sets for alcohol withdrawal treatment who received care at the hospital.

The findings include:

Although the hospital was aware of the importance of appropriate equipment to ensure water quality in the dialysis unit, the hospital had not conducted any quality review of the current processes with risk to patients.

Water quality safety for dialysis:

On 1/14/15, at 10:30 a.m. the water room of the acute inpatient ESRD was observed with registered nurse (RN)-Z during which she established that the system used for water purification was deionization (DI). RN-Z further established that she was a contracted employee of St. John's Healtheast and floats to many inpatient hospital ESRD units in the metro area including St. John's Healtheast. RN-Z confirmed she had been trained related to the DI system and confirmed that a current schematic diagram which identified the various operating components of the system was not available in the location of the water room. When questioned whether there was an automatic divert to drain mechanism plumbed in the water room in the event of unsafe/poor water quality, RN-Z stated that she lacked any knowledge. When further questioned about the location of the alarm monitor which alerted staff in the event of poor water quality, RN-Z pointed to an alarm which was unplugged and non-functioning. The biomedical engineer was then summoned to identify the various components of the DI water system. RN-Z further verified that an audible and visual alarm was not evident on the dialysis (ESRD) treatment room floor to alert staff of poor water quality. RN-Z further stated that should the alarm be activated in the water room, she would rely on the intensive care unit (ICU) staff to notify the dialysis nurse (in dialysis treatment room) when the alarm sounded because the water room was approximately 40 feet from the ESRD treatment room and the door to the water room was closed and locked.

The biomedical engineer was interviewed on 1/14/15, at 12:00 noon and established that he had been responsible for the maintenance of the water room at St. John's Healtheast since 2008. The biomedical engineer confirmed there was not a functioning automatic divert to drain plumbed in the water room that would automatically divert water from reaching the
dialysis machines in the event the water quality reached below 1 ego (a unit of electrical resistance equal to the resistance between two points on a conductor when a potential difference of one volt between them produces a current of one ampere). The biomedical engineer stated he had started to plumb the automatic divert to drain in the water room approximately six months prior but had not yet completed the installation because he did not have the right booster pump to hook it up. The biomedical engineer confirmed the automatic divert to drain plumbing was a necessary industry safety standard established by the association for the advancement of medical instrumentation (AM) RD52 standards. The biomedical engineer further established that having audible and visual alarms on the treatment room floor when using deionization for water purification were also AAMI RD52 standards for safety that had not been implemented for St. Johns Healtheast acute ESRD unit. The biomedical engineer confirmed the audible alarm that monitored the water quality (resistivity) could not be heard if sounding on the treatment room floor and staff had not been monitoring the resistivity of the water according to facility policy. The biomedical engineer stated that the facility did not have a policy related to using and testing the auto divert to drain equipment in the water room of St. John's Healtheast.

The hospital quality assessment and performance improvement committee was interviewed on 1/15/15, at 9:30 a.m. during which they confirmed that they had not incorporated into their quality assurance activities any audits of the water room of the acute inpatient ESRD dialysis unit and review of adverse event reports. The acute inpatient ESRD facility administrator (FA) was asked to provide the adverse event reports for the past year on 1/15/15, at 10:15 a.m. during which she stated that there had not been any documented events. When asked whether there had been any adverse event reports reviewed in the past three years the FA responded no. The FA stated that she had not provided the hospital quality assessment and performance improvement committee with any quality monitoring audits or adverse event reports, and further stated she was not part of the hospital quality assessment and performance improvement committee.

Although the hospital had instituted protocols for counting surgical supplies, they had not established or implemented protocols for counting surgical instruments.

Surgical Services Safety:

The Director of Acute Care Operating Rooms was interviewed on 1/13/15, at 2:10 p.m. and stated surgical instrument counts were not done for any surgical procedures performed at the hospital. She stated the hospital followed Association of Operating Room Nursing (AORN) standards in the surgical suite but did not count instruments for any surgical cases, even if there was the potential an instrument could be unintentionally retained. She also verified there was no hospital policy related to counting surgical instruments when there was a potential for a surgical instrument to be unintentionally retained during surgery.

During interview on 1/13/15, at 3:30 p.m. the Medical Director of Surgery stated surgical instruments counts had not been done at the hospital for years. On 1/13/15, at 3:40 p.m. the Group Director, Acute Care Surgical Services was interviewed and confirmed instrument counts were not completed for any surgical procedure performed in the surgical suite, Maternity Care and the Midway Surgical Center. She stated surgical policies were identical in all three surgical areas. She stated the hospital did not have a policy which addressed a count of surgical instruments. She also stated the AORN perioperative standards and recommendations titled Recommended Practices for Prevention of Retained Surgical Items, dated 2014, were recommendations and not AORN standards. She stated it was the hospital's decision not to count instruments for any surgical procedures, even if there was the potential an instrument could be unintentionally retained.

A review of the hospital policy Counts: Sponges, Sharps and Others, last reviewed/approved 12/19/14, indicated needles, blades, sponges, packing intended to be removed, cautery tips and cleaners, suture boots, vessel loops, umbilical tape, bulldog clamps, corneal shields and penrose drains used for retraction were to be counted. The policy did not indicate any other surgical instruments were to be counted.

The hospital had not developed or implemented any quality measures to ensure patient safety during surgery in order to prevent and/or minimize the risk of unintentional retention of surgical instruments.

Prescription Order Sets:

During a review of medical records for P23 and P16 who had been prescribed order sets for the Clinical Institute Withdrawal Assessment (CIWA) protocols, it was determined that on 11/27/14 the hospital had determined the CIWA protocol had not been followed for P23. The CIWA protocol was intended to be an assessment tool used to obtain objective data of symptoms of withdrawal from drugs and alcohol, and provided medication order guidance for patients whose symptom assessment revealed scores

Based on interview and document review, the hospital failed to develop, implement, and revise nursing care plans based on ongoing assessments of patient needs, and failed to provide care and medications in accordance with the Clinical Institute Withdrawal Assessment (CIWA) protocol. In addition, the nursing staff failed to provide ongoing assessment and physician notification for the use of the protocol for 1 of 2 deceased patients, (P23) and 1 of 2 current hospital inpatients (P16), reviewed who had the CIWA protocol prescribed resulting in an immediate jeopardy (IJ) situation.
Findings include:
The IJ began on 12/11/14, when the facility failed to initiate proper assessment to implement physician prescribed order sets to care for patients with alcohol withdrawl symptoms. The hospital's administrative staff were informed of the IJ on 1/16/15, at 5:30 p.m. The IJ was removed on 1/20/15.

Record review and interview verified the facility's established protocols to treat patients' alcohol withdrawal symptoms were not implemented as prescribed for P16 and P23. Instead, nursing staff independently determined when to implement medications identified on the established protocol, did not complete comprehensive assessments, and failed to communicate with the patient's physician to ensure the patient was cared for in a safe manner.

P23 was admitted to the facility on 11/25/14, with a diagnosis of Pancreatitis, and was placed on the CIWA protocol for potential alcohol withdrawal.
According to the CIWA protocol order set from the electronic medical record, the physician was directed to order medications to be given to a patient for signs and symptoms of alcohol withdrawal based off the nursing assessment. The CIWA protocol indicated the following:
· Valium 10 milligrams (mg) orally (by mouth), every one hour PRN (as needed) anxiety, for signs and symptoms of alcohol withdrawal as per the CIWA guidelines for withdrawal.
· CIWA score less than 10; no treatment and reassess every two-four hours or sooner if clinically indicated.
· CIWA score equal to or greater then 10; administer dose and reassess every one hour or sooner if clinically indicated.
· CIWA score equal to and greater than 10 every one hour OR patient unable to take medications by mouth; call house officer or attending physician AND consider transfer to higher acuity clinical unit. Attending physician to provide ongoing orders.
Additionally, per the protocol, the physician could chose to order Ativan 1 mg instead of the Valium which was suggested for patients with hepatic failure, who were elderly, or who were taking other medications that could cause CNS (central nervous sytem) depression due to the high risk for respiratory depression or delirium.
The protocol indicated the CIWA score was supposed to be based off a nursing assessment which involved assessing a patient's current condition and assigning each individual area a score of zero-two. A score of zero would indicate no signs or symptoms and a score of two would indicate significant signs and symptoms in each of the following areas:
- Nausea and vomiting, tactile disturbances, tremor, auditory disturbances, paroxysmal sweats, visual disturbances, anxiety, headache, agitation, and orientation.
In addition, according to the CIWA protocol, if the patient's total score was 10 or above in the areas assessed, the nurse was to administer the chosen medication ordered by the physician from the protocol, either Valium or Ativan.
Review of P23's Medication Administration Record (MAR) revealed P23 had received Valium, which was ordered by the physician off the CIWA protocol to be administered if the CIWA score was 10 or above. The MAR contained the following entries:
11/25/14, at 4:11 p.m. 10 mg Valium was administered intravenously (IV). There was no corresponding CIWA assessment score.
On 11/26/14, at 12:23 a.m. 10 mg Valium was administered orally, however the CIWA assessment score was identified as 10 at 12:25 a.m. (Two minutes following the Valium administration).
-At 8:44 a.m. 10 mg Valium was administered orally. However, the CIWA assessment score had only been identified as four at 8:24 a.m. with no additional CIWA assessment score identified prior to the Valium administration.
- At 11:51 a.m. 10 mg Valium was administered orally. However, the last CIWA assessment score documented was a six, which had been assessed at 11:00 a.m.
- At 4:20 p.m. 10 mg Valium was administered orally. However a CIWA assessment score was identified as a seven at 4:29 p.m. after P23 had received 10 mg of Valium.
- At 6:34 p.m. 10 mg Valium was administered orally even though the CIWA assessment score was only a seven when assessed at 6:23 p.m.
- At 10:22 p.m. 10 mg of Valium was administered orally. However a CIWA score assessment was not conducted prior, and was identified as a six at 10:39 p.m.

P23's MAR also indicated P23 was experiencing severe pain and received Dilaudid IV. On 1/16/15, the hospital pharmacy provided the black box warnings for Dilaudid which indicated, "Risk for producing respiratory depression." Dilaudid was administered the following dates/ times to P23.
11/25/14- 1 mg at 5:27 p.m., 1 mg at 5:56 p.m., 2 mg at 7:31 p.m., and 2 mg at 9:54 p.m.
11/26/14- 1 mg at 12:22 a.m., 1 mg at 5:21 a.m., 2 mg at 6:39 a.m., 2 mg at 8:37 a.m., 1 mg at 11:51 a.m., 1 mg at 2:19 p.m., 1 mg at 3:50 p.m., 2 mg at 6:34 p.m., 2 mg at 8:39 p.m., and 2 mg at 10:35 p.m.
11/27/14- 2 mg at 12:28 a.m. That was the last dose of Dilaudid P23 received before his death on 11/27/14, at 3:13 a.m.
Review of P23's electronic medical record indicated the patient had a GI (gastrointestinal) consult on 11/26/14. The note indicated, "Patients pain has been difficult to control despite IV Dilaudid...Patient complains of sleepiness, hallucinations and 'talking to myself' since starting the narcotic pain medications. Complains of faintness..."
P23's physician discharge note dated 11/27/14 indicated, "Significant pain throughout admission, requiring large quantities of IV narcotics. Patient was also placed on CIWA alcohol withdrawal protocol with multiple assessments revealing auditory and visual hallucinations, restlessness, and tremor. His alcohol withdrawal was treated with PO (oral) diazepam (Valium)... per [CIWA] protocol. Difficulties obtaining any reliable lab results as blood draw samples were continually lipemic and hemolized... In the early morning of 11/27/14, code blue was called to the patients room where he was found to be unresponsive, cool to touch, and pulseless at 2:40 a.m. [P23] was last seen alert at 2:00 a.m. CPR was performed for over 20 minutes... remained pulseless throughout resuscitation attempts. Patient declared deceased at 3:13 a.m. and resuscitation efforts ceased at this time."
Review of multiple vital signs in P23's medical record throughout the hospital stay indicated the following on 11/26/14:
- At 3:51 p.m.- BP (blood pressure) was 137/63, R (respirations) were 20.
- At 4:12 a.m. BP was 157/68, no R were documented at this time.
- At 6:55 p.m.- BP was 140/80, no R were documented at this time.
- At 8:39 p.m.- BP was 152/65, R were 20.
P23's vital signs on 11/27/14, at 12:06 a.m. were documented by a nursing assistant (NA) as BP of 98/50, and R of 32. Under the documented high respirations of 32, there was a comment written by the NA, "Let RN know."
According to P23's assessment flowsheet, a registered nurse (RN) assessed P23 at 12:15 a.m. on 11/27/14. The assessment indicated the patient was having moments of clear comprehensible speech, and then incomprehensible. Although several minutes prior the NA had documented abnormal vital signs for P23 and indicated the RN was notified, there were no vital signs rechecked at this time.
On 11/27/14, at 1:56 a.m. the RN documented on the flowsheet P23's respiratory and cardiac status were WDL (within defined limits), however, P23's vital signs were not rechecked at this time.
P23 had a CIWA protocol assessment score on 11/27/14, documented on the flowsheet with a total score of four. The documentation indicated the time of the CIWA assessment

Based on observation, interview and document review, the hospital failed to ensure safe surgical practices were followed in accordance with acceptable standards of practice related to instrument counts for 3 of 3 surgical patients (P36, P32, P33) in the sample who underwent a surgical procedure where the possibility existed that an instrument could be unintentionally retained. The failure to count surgical instruments resulted in an immediate jeopardy (IJ) which had the potential to affect any patient who had a surgical procedure when the possibility existed that an instrument could be unintentionally retained.

Findings include:

The IJ began on 1/13/15, at 1:30 p.m. when it was determined the facility failed to ensure systems were implemented to ensure surgical instrument counts were conducted when the possibility existed that an instrument could be unintentionally retained. The hospital administrative staff were notified of the IJ on 1/15/15, at 2:00 p.m. The IJ was removed on 1/20/15, at 3:05 p.m.

P36 was observed in the surgical suite at the hospital on 1/13/15, at 1:30 p.m. undergoing a laparoscopic subtotal colectomy which had the potential of becoming a laparotomy. A whiteboard was on the wall which included surgical count information. The circulating nurse and the certified surgical technician counted the sponges, needles, blades and cautery tips and entered that count on the whiteboard. A large number of surgical instruments were on sterile fields on the back table and on a Mayo stand, however none of the instruments had been counted prior to starting the surgical procedure. A review of the electronic health record (EHR) indicated the initial sponge, needle, blade and cautery tip count had been documented in the EHR. There was no indication an instrument count had been documented in the EHR.

The director of acute care operating rooms was interviewed on 1/13/15, at 2:10 p.m. and stated instrument counts were not done for any surgical procedures performed at the hospital. She stated the hospital followed Association of Operating Room Nursing (AORN) standards in the surgical suite but did not count instruments for any surgical cases, even if there was the potential an instrument could be unintentionally retained. She verified there was no policy related to counting surgical instruments for any surgical procedure which had the potential an instrument could be unintentionally retained.

The medical director of surgery was interviewed on 1/13/15, at 3:30 p.m. and stated surgical instruments counts had not been done at the hospital for years.

The group director, acute care surgical services was interviewed on 1/13/15, at 3:40 p.m. She stated instrument counts were not completed for any surgical procedure performed in the surgical suite, Maternity Care and the Midway Surgical Center. She stated surgical policies were identical in all three surgical areas. She state the hospital did not have a policy which addressed a count of surgical instruments. She stated the AORN perioperative standards and recommendations titled Recommended Practices for Prevention of Retained Surgical Items, dated 2014, were recommendations and not AORN standards. She stated it was the hospital's decision not to count instruments for any surgical procedures, even if there was the potential an instrument could be unintentionally retained.





33560

P32 was observed in the surgical suite at the hospital on 1/13/15, at 1:06 p.m. undergoing a endoscopy retrograde chloangiopancreagraphy and laproscopy cholecystectomy. With that case there was a possibility the surgeon may need to do a open cholecystectomy. A whiteboard was on the wall which included surgical count information. The circulating nurse and the certified surgical technician counted the sponges, needles, blades and cautery tips and entered that count on the whiteboard. A large number of surgical instruments were observed on sterile fields on the back table and on a Mayo stand (type of medical table used in surgery), however none of the instruments were observed to be counted prior to starting the surgical procedure.

During an interview on 1/13/15, at 1:06 p.m. clinical manager of surgical services (CMSS)-K stated the facility does not count instruments. He said they count only sharps, needles, bulldogs and aneurysm clamps. "We don't count instruments."

P33 was observed in the surgical suite at the hospital obstetrical unit on 1/14/15, at 1:15 p.m. undergoing a cesarean section. A whiteboard was on the wall which included surgical count information. The circulating nurse and the certified surgical technician counted the sponges, needles, blades and cautery tips and entered that count on the whiteboard. A large number of surgical instruments were observed on sterile fields on the back table and on a Mayo stand, however none of the instruments were counted prior to starting the surgical procedure.

An interview on 1/14/15, at 12:44 p.m. with surgical tech (ST)-Q we count cautery tips, sharps, blades, needles, injection needles. ST-Q said, "we do not count instruments."


29249

During interview on 1/14/15, at 8:20 a.m. clinical manager outpatient surgery center (CM)-Y stated the outpatient surgery center follows the hospital policy on counting instruments. CM-Y stated they are instructed they are not required to count basically any surgical instruments, "That are metal."

A review of the hospital policy, Counts: Sponges, Sharps and Others, last reviewed/approved 12/19/14, indicated needles, blades, sponges, packing intended to be removed, cautery tips and cleaners, suture boots, vessel loops, umbilical tape, bulldog clamps, corneal shields and Penrose drains used for retraction were to be counted. The policy did not indicate any other surgical instruments were to be counted.

The IJ was removed at 3:05 p.m. on 1/20/15, when it was verfied by interview, document review and observation, that the hospital had established and implemented systems for ensuring accurate surgical instrument counts; hospital leadership had developed and implemented systems for ensuring surgical staff had been educated to policies and procedures related to unintentional retention of surgical instruments; surgery staff verified through interview these procedures, and surgical observations verified the implementation of such systems. In addition, the hospital had developed systems for ongoing monitoring for continued compliance.