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Based on interview and record review, the hospital failed to follow state law regarding medical staff membership when it included clinical laboratory scientists holding a Ph.D. (doctor of philosophy) who were not physicians, dentists, podiatrists, or psychologists in its medical staff. The deficient practice violated state law.

Findings:

Review of Title 22, California Code of Regulations, Section 70703(a) indicated California hospitals are permitted to include physicians, dentists, podiatrists, and psychologists in their medical staff membership.

Review of the hospital's medical staff bylaws dated April, 2018 indicated "Ph.D. degree-holding members of the Pathology service with responsibilities in the clinical laboratory" were eligible for medical staff membership. Review of the hospital's undated medical staff roster indicated Provider E was a member of the medical staff. Review of Provider E's credentials file indicated he was appointed to "Active status" by the governing body "for a two-year period effective 1/20/2017." Provider E's curriculum vitae (CV) indicated he was the associate director of the clinical chemistry and immunology laboratory, and had a state license as a "Clinical Chemist Specialist". Provider E's CV did not indicate he was a physician, dentist, podiatrist, or psychologist.

In an interview on 10/29/19 at 2:17 p.m., the chief quality officer and the vice president of the medical staff both stated Ph.D. laboratorians were on the hospital's medical staff.

Based on observation, interview, and record review, the hospital failed to ensure staff completed assessments of patients with restraints (any manual method, physical or mechanical device, material or equipment that immobilizes or reduces the ability of a patient to move his or her arms, legs, body, or head freely) at a minimum of every two hours per the hospital's policy and procedure for Patients 5 and 6. This failure had the potential to place patients with restraints at risk of injury.

Findings:

During a tour of the Cardiovascular Intensive Care Unit (CVICU) on 10/30/19 at 8:45 a.m. with the critical care services director (CCSD), Patient 5 was observed to be in bilateral soft wrist restraints. Patient 6 was out of restraints (a "no-no pediatric arm immobilizer") with a family member at the bedside at the time of the observation.

A review of Patient 5's clinical record indicated the patient was admitted to the hospital on 8/26/19 with diagnoses including acute respiratory failure. Patient 5 was placed on bilateral soft wrist restraints to prevent her from pulling at her lines and tubes.

During a clinical record review and concurrent interview with the director of practice (DP) on 10/30/19 at 9:07 a.m., Patient 5's restraint documentation record indicated an order was obtained on 10/28/19 at 7:49 p.m. for patient restraint. Further review indicated five of 18 occurrences in which restraint assessments were not completed per hospital policy. No evidence was found in the clinical record supporting a timely assessment.

Documented assessments include:

1) 10/28/19 8:00 p.m. assessment was documented on 10/29/19 at 2:05 a.m.
2) 10/28/19 10:00 p.m. assessment was documented on 10/29/19 at 2:06 a.m.
3) 10/29/19 12:00 a.m. assessment was documented at 2:07 a.m.
4) 10/29/19 6:00 a.m. assessment was documented at 10:01 p.m.
5) 10/29/19 2:00 p.m. assessment was documented at 4:21 p.m.

The DP confirmed the findings.

A review of Patient 6's clinical record indicated the patient was admitted to the hospital on 10/26/19 with diagnoses including respiratory distress. Patient 6 was placed on no-no pediatric arm immobilizer restraints to prevent her from pulling at her lines and tubes.

During a clinical record review and concurrent interview with the DP on 10/30/19 at 9:57 a.m., Patient 6's restraint documentation indicated an order was obtained on 10/29/19 at 12:36 p.m. for patient restraint. Further review indicated eight of 21 occurrences in which restraint assessments were not completed per hospital policy. No evidence was found in the clinical record supporting a timely assessment.

Documented assessments include:

1) 10/28/19 8:00 p.m. assessment was documented on 10/29/19 at 1:00 a.m.
2) 10/28/19 10:00 p.m. assessment was documented on 10/29/19 at 1:00 a.m.
3) 10/29/19 8:00 a.m. assessment was documented at 12:13 p.m.
4) 10/29/19 10:00 a.m. assessment was documented at 12:13 p.m.
5) 10/29/19 8:00 p.m. assessment was documented on 10/30/19 at 1:52 a.m.
6) 10/29/19 10:00 p.m. assessment was documented on 10/30/19 at 1:55 a.m.
7) 10/30/19 2:00 a.m. assessment was documented at 6:11 a.m.
8) 10/30/19 4:00 a.m. assessment was documented at 6:14 a.m.

The DP confirmed the findings.

A review of the hospital's policy, "Restraint Procedure", dated January 2019, indicated "Application and Monitoring: 2. Every 2 hours, the RN will complete and document an assessment. Documentation includes: Vital signs; Circulation; Skin integrity; Patient behavior/mood cognitive functioning."

A review of the hospital's policy, "Documentation-Nursing", dated October 2016, indicated "Additional Documentation Guidelines: d. Document the patient's physical assessment, vital signs, treatments and intake and output in the EHR. Entries should be made as soon as possible after care/event has occurred or at least within 2 hours."

Based on interview and record review, for 1 of 2 sampled adverse events (Patient 1), the hospital failed to monitor the effectiveness of 2 of 5 corrective actions and failed to implement its policy regarding reporting of medical device-related injuries to the manufacturer. Refer to A-286 Part 1. The cumulative effect of these systemic problems resulted in the hospital's inability to ensure the provision of quality health care in a safe environment.

Based on interview and record review, the hospital failed to: 1) obtain governing body approval of its FY (fiscal year) 2020 performance indicators, 2) include methods of data collection in the specifications of 2 of 3 sampled performance indicators, and 3) break down 1 of 3 sampled performance indicators (serious safety events) by patient care unit. The deficient practices diminished leadership involvement in defining the metrics used to monitor the hospital's performance, and eliminated analytic steps demanded by federal regulations in order to scrutinize and act upon those metrics. The deficient practices therefore had the potential to allow problems to go unidentified and unchanged for future patients.

Findings:

1. Review of two versions of the hospital's "QUALITY IMPROVEMENT AND PATIENT SAFETY ANNUAL PLAN", indicated each document contained the hospital's "Quality, Safety & Service Key Performance Indicators". The version with an adhesive note attached marked "FY19" had been "Reviewed & Approved by QSS [quality, service and safety] Committee of the Board: February 2019". The version with an adhesive note attached marked "FY20" indicated, "Reviewed & Approved by QSS Committee of the Board: To be Approved November 2019".

In an interview on 10/31/19 at 1:58 p.m., the director of business operations stated the hospital's fiscal year ended on August 31, and the current fiscal year was FY20. In an interview on 11/1/19 at 12:36 p.m., the chief quality officer (CQO) stated the FY20 quality plan was going to the board for approval on 11/4/19.

2. Review of the hospital's "Quality, Safety & Service Key Performance Indicators Analytics & Clinical Effectiveness", dated 10/19, indicated the "Metric Definitions" for "CLABSI [central line associated bloodstream infection] Rate" and "HAPI [hospital acquired pressure injury] Rate (All Stages)" did not indicate by what method the data would be obtained. Review of the hospital's "QUALITY IMPROVEMENT AND PATIENT SAFETY ANNUAL PLAN" (QIPS plan, approved 2/19), indicated "Data are collected from an appropriate source. These sources may include the electronic or paper medical record, existing databases, observation or survey. Data collection may be ongoing or time limited." The QIPS plan did not further specify the source of data regarding CLABSI or HAPI rates.

In an interview on 11/1/19 at 12:36 p.m., the surveyor asked the CQO, the Wound Care Manager (WCM), and the Executive Director of Quality and Clinical Effectiveness (EDQCE) for the hospital's written specification regarding the methods for generating the HAPI and CLABSI data. None of the three staff directly answered the surveyor's question. The CQO stated the hospital followed methods delineated by consortium of children's hospitals and CMS (Centers for Medicare and Medicaid Services) regarding HAPI. The EDQCE stated the hospital had changed its definition of the HAPI metric for FY 20. The WCM stated the HAPI data came from incident reports which were generated when a wound was identified. The EDQCE stated the hospital identified CLABSI cases by two nurses following up on positive blood cultures and applying NHSN (National Healthcare Safety Network) criteria.

3. Review of the hospital's "Quality, Safety & Service Key Performance Indicators Analytics & Clinical Effectiveness", dated 10/19, indicated SSE's were tracked by month and by severity from April 2018 through September 2019. There was no breakdown of SSE's by patient care unit. In an interview on 11/1/19 at 1:21 p.m., the CQO stated the SSE's were discussed with the units involved, but there was nothing to show as far as a breakdown of SSE's by patient care unit.

Based on interview and record review, for 1 of 2 sampled adverse events (Patient 1), the hospital failed to monitor the effectiveness of 2 of 5 corrective actions and failed to implement its policy regarding reporting of medical device-related injuries to the manufacturer. The hospital also failed to separately track medication errors, adverse drug reactions, and drug incompatibility incidents. The deficient practices had the potential to cause an adverse event similar to Patient 1's to recur, and eliminated required data regarding medication safety.

Findings:

1. Review of intake CA00522120 indicated on 2/10/17, the hospital reported Patient 1 "experienced air emergency on 2/8/17. It is believed that air drew into the ECMO [extracorporeal membrane oxygenation, a machine that supports the heart and lungs] circuit through a vented cap on the stopcock. The cap had not been replaced by with [sic] occlusive cap. The patient experienced cardiac arrest, was resuscitated... Clinical assessments have noted decreased movement in left upper and lower extremity." Patient 1's "CARDIOLOGY DISCHARGE SUMMARY", dated 2/20/17, indicated "On 02/08, his course was complicated by a right frontal infarct [no blood flow to a part of the brain] secondary to air emboli [air in the blood] when air was discovered in his ECMO circuit. This resulted in left sided hemiparesis [weakness on one side of the body] which has shown some mild improvement over the course of the last week..."

Review of the hospital's policy, "Reviewable Event Management and Regulatory Event Reporting", (revised 2/16), indicated "Reportable Event Procedures... Convening Interdisciplinary Team for Root Cause Analysis: For events which meet the Joint Commission [an accrediting organization] and California Department of Public Health's definition of "sentinel event" and other critical events or near misses, review of the event will be coordinated by the Center for Quality and Clinical Effectiveness... The Center... will convene an interdisciplinary team to conduct a structured root cause analysis identifying the causal and contributory factors. The product of the comprehensive analysis is an action plan. The action plan identified [sic] the strategies that the hospital intends to implement in order to reduce the risk of similar events occurring in the future. The plan must address the following... Strategies for evaluating the effectiveness of the actions... Strategies for sustaining the change..." Appendix A of the policy indicated, "Suspected Medical Device-Related Deaths, Illnesses of Injuries: The 'Safe Medical Devices Act' requires hospitals to report suspected medical device-related deaths to both Federal Food and Drug Administration (FDA) and the manufacturer (if known) and serious injuries to the manufacturer of to FDA (if the manufacturer is unknown)."

Review of an undated "RCA [root cause analysis] Action Plan: Massive air ECMO", regarding Patient 1 indicated the hospital's planned "Operational Actions" included "EPIC [a brand of electronic medical record] ECMO Safety Checks to include 'Redcaps [occlusive caps] on all pigtails and stopcocks' [different types of access points to tubing]", "Change the circuit set up to decrease the number of access points on the negative [pressure] side of the circuit", "Change the standard of practice to decrease the frequency RNs [registered nurses] access the negative side of the circuit". The column labeled "Sustainability Plan" was left blank. The action plan indicated the change to the checklist was made in EPIC on 3/9/17, and e-mails were sent to staff regarding desired changes in the setup of and access to the negative pressure side of the ECMO circuit on 2/28/17, but there was no mention of monitoring whether the new checklist was being used or whether staff had changed their practices. Review of documents provided by the hospital regarding its follow-up to Patient 1's RCA indicated they included e-mails (dated 2/8/17 and 3/9/17), an "ECMO TEAM MEETING" slide set (dated 4/5/17), and "ECMO DRILLS JUL-DEC 2017", all communicating desired changes; undated documentation of changes to the EPIC checklist; and revised specifications for ECMO circuits (last revision 9/19/19). None of the documents indicated that the hospital was monitoring whether staff were checking for red caps as demanded by the new checklist or had changed the frequency with which they were accessing the negative side of the circuit. Neither the RCA nor the additional documents provided by the hospital indicated Patient 1's air embolus due to a vented cap had been reported to any device manufacturer or the FDA.

In an interview on 10/28/19 at 11:15 a.m., the director of patient safety and professional practice evaluation (DPSPPE) stated Patient 1's event had not been reported to the FDA through its MedSun system, and that was how the hospital reported device-related events. The DPSPPE stated the event was felt to be attributable to user error rather than a defective product.

In an interview on 10/28/19 at 2:41 p.m. regarding the RCA for Patient 1, the critical care services director (CCSD) and the DPSPPE acknowledged the hospital needed monitoring of implementation. The DPSPPE stated she was not aware of additional air emboli since February, 2017.

In an interview on 10/29/19 at approximately 11:15 a.m., the director of accreditation and regulatory compliance (DARC) stated she did not know if Patient 1's incident would have been reported to the FDA or the device manufacturer since the device was meant to be replaced and the user had put the wrong type of cap back on. In an interview on 10/29/19 at 1:51 p.m., the DARC stated Patient 1's situation did not represent improper use or function of a medical device. The DARC did not explain the apparent discrepancy between her comment and her statement earlier in the day that the wrong type of cap had been used.

In an interview on 10/29/19 at 4:05 p.m., the CCSD stated Perfusionist D performed rounds on the ECMO patients, but would not be able to show evidence of formal monitoring of the changes implemented as a result of the RCA for Patient 1. The CCSD stated the hospital and vendor had changed the specifications of the ECMO circuits and the hospital had conveyed new expectations to staff in meetings. The DPSPPE acknowledged the blank sustainability plan on Patient 1's RCA action plan was "a gap." In an interview on 10/30/19 at 10:47 a.m., Perfusionist D stated she attended rounds on ECMO patients and looked over the circuits, but did not document her findings unless she manipulated the circuit.

2. Review of the hospital's "ADVERSE DRUG EVENT REPORT", (dated 9/19/19), indicated the report presented data on all adverse drug events, and did not separately detail medication errors, adverse drug reactions, and drug incompatibility incidents. The report indicated adverse drug reactions were included in medication errors, but did not mention drug incompatibility incidents. Review of the hospital's Pharmacy & Therapeutics Committee Minutes dated 10/18/18, 11/15/18, 1/17/19, 2/21/19, 3/21/19, 5/16/19, 7/18/19, 8/15/19, and 9/19/19 indicated the committee discussed combined adverse drug events, but did not separately track medication errors, adverse drug reactions, and drug incompatibility incidents.

In a concurrent interview and record review on 10/30/19 at 11:10 a.m., the assistant director of pharmacy (ADP) stated the hospital had generated a report during the survey of drug incompatibility incidents for the past year from its "iCare" incident reporting system. The ADP stated all types of incidents go in the iCare system, which is a database of individual incidents. The ADP stated she reviewed medication related incidents every week or two, determined which "need a deeper dive", scored them by severity, looked for trends, and decided which to refer to the Safe Medication Practices Committee. The ADP stated her analysis of the iCare incidents was captured in a monthly "iCare Summary". Review of the "iCare Summary: September 2019" (dated 10/10/19) indicated the summary provided data on adverse drug events, but did not separately detail medication errors, adverse drug reactions, and drug incompatibility incidents. The ADP acknowledged there was no chart over time of drug incompatibility incidents. The ADP stated adverse drug reactions were reported in iCare but were tracked in reports to committees as part of adverse drug events, which had various subtypes "all mixed in."

Based on interview and record review, the hospital failed to monitor the performance of its perfusionist contractor using quantitative data. The deficient practice limited quality oversight of a contracted service, thereby creating the potential for problems to go unidentified and uncorrected.

Findings:

Review of the hospital's "List of Contracted Services", dated 10/10/19, indicated the hospital had a contract for perfusionist services. Review of "Annual Contract Evaluation Results" dated 2017 and 2019, regarding the perfusionist contractor indicated the vendor had met expectations on six different criteria. No quantitative data were present to substantiate the qualitative conclusions that the vendor had met expectations.

In an interview on 10/31/19 at 3:36 p.m., the director of accreditation and regulatory compliance stated data regarding the perfusionist contractor were discussed in committee minutes but were not documented on the contract evaluation, which was for documenting concerns. At the conclusion of the survey on 11/1/19 at 4:30 p.m., the hospital had not provided quantitative data regarding the performance of the perfusionist contractor.

Based on observation, interview, and record review, it was determined the hospital did not meet the Condition of Participation (COP) for Nursing Services as evidenced by:

1. Failure to ensure implementation of safe standards of practice for maintaining ECMO (Extracorporeal Membrane Oxygenation, treatment that uses an exterior man-made heart and lung to support the body when a person's own organs are dysfunctional) circuits to keep air from reaching patients when air entered Patient 1's ECMO circuit through a vented cap (Refer to A395).

2. Failure to develop and maintain a current and individualized nursing care plans for Patients 3 and 4 in the Cardiovascular Intensive Care Unit (CVICU) (Refer to A396).

The cumulative effects of these systemic problems resulted in the hospital's inability to ensure their provision of care was done in a safe manner to meet patients' needs.

Based on interview and record review, the hospital failed to ensure implementation of safe standards of practice for maintaining an ECMO (Extracorporeal Membrane Oxygenation, treatment that uses an exterior man-made heart and lung to support the body when a person's own organs are dysfunctional) circuit to keep air from reaching a patient. This occurred when air entered Patient 1's ECMO circuit through a vented cap, which resulted in Patient 1 sustaining a stroke (blood supply blockage to the brain, often leading to brain cell death) with residual left-sided hemiparesis (weakness or the inability to move on one side of the body).

Findings:

Review of Patient 1's clinical record yielded the following:

A physician's H&P (history and physical) dated 2/3/17, indicated "[Patient 1's name] is a... 14moM (14 month old male)... after arrival... required emergent placement on... ECMO... He has cardiorespiratory (heart and lungs) failure..."

A physician's progress note dated 2/7/17, indicated "... NEUROLOGIC EXAM... MOTOR... seems to move all extremities symmetrically."

A physician's progress note dated 2/8/17, indicated "ECMO circuit emergency this morning: air entrained from stopcock... circuit clamped as quickly as possible... He (Patient 1) did have an acute arrest (abrupt loss of heart and/or lung function) at that point... CPR (emergency life-saving procedure to facilitate oxygenated blood to circulate to vital organs, such as the brain and heart) was begun...."

An Imaging Result, dated 2/8/17 at 10:51 a.m., indicated "CT of the head or brain... Intracranial air in the right frontal lobe and right border zone, likely corresponding with air within the right arterial distribution."

An Imaging Result, dated 2/9/17 at 12:30 p.m., indicated "CT of the head or brain... Subtle loss of gray-white differentiation in the right frontal lobe and punctuate focus of hyperdensity in the right frontal lobe. This may represent a focus of ischemia corresponding with area of prior air emboli."

A physician's note dated 2/17/17, indicated "...ECMO-related air embolus (a blood vessel blockage caused by air bubble(s) in the circulatory system) that has resulted in left hemiparesis greater in the arm than the lower extremity... LLE (left lower extremity) and LUE (left upper extremity) hypotonia (decreased muscle tension and stiffness) with decreased ROM (range of motion, movement around a specific joint or body part)... Neurologic injury secondary to hypoxia (condition in which the body or a region of the body is deprived of adequate oxygen supply at the tissue level) as well as air embolus while on ECMO."

A physician's discharge summary dated 2/20/17, indicated "On 02/08, his (Patient 1) course was complicated by a right frontal (area of brain) infarct (area of dead tissue resulting from blood supply failure) secondary to (resulting from) air emboli when air was discovered in his ECMO circuit. This resulted in left sided hemiparesis..."

A physician's progress note dated 2/28/18, indicated "He (Patient 1) has residual left-sided hemiparesis... His left arm remains weak... Left hand tends to be more fisted (hand closed tightly)... Reaches for items right > (greater than) left... he may always be weak in the left arm..."

During an interview on 10/28/19 at 10:20 a.m. with physician C, he stated he was the Cardiac ICU (intensive care unit focused on heart related issues) Director during the time of Patient 1's air embolism event on 2/8/17. He stated the embolism event was caused from a lot of air that entered through a vented cap on the negative pressure side of Patient 1's ECMO circuit. He stated the hospital was unable to figure out how the wrong cap ended up on the patient's ECMO circuit. He stated they were unable to determine where the vented cap came from, when it was placed, and who placed it.

During an interview on 10/28/19 at 1:41 p..m. with Perfusionist D, she stated on 2/8/17, when she arrived to Patient 1's air emergency, there was a lot of air in Patient 1's ECMO circuit. She stated registered nurse B told her, while she covered for registered nurse A for a break, she turned a stopcock and air entered into Patient 1's ECMO circuit through a vented cap. She stated Patient 1's ECMO circuit had a white cap and red caps attached. She stated all red caps are non-vented.

During an interview on 10/28/19 at 2:15 p.m. with ECMO trained nurse B (EN B), she stated on 2/8/17, Patient 1's ECMO circuit had more than one white cap attached to it and was unaware one was vented. She stated when she turned a stopcock, air entered through a vented white cap into the circuit. She stated the ECMO nurses did not do safety checks on ECMO circuit caps at the time.

During an interview on 10/29/19 at 10:05 a.m. with the critical care services director (CCSD), he stated, at the time of Patient 1's ECMO circuit event on 2/8/17, the ECMO nurses filled out hourly checklists on patients' ECMO circuits for leaks, but not for whether caps were vented, or not.

During an interview on 10/30/19 at 10:10 a.m. with EN A, she stated, on 2/8/19, she checked Patient 1's ECMO circuit and it was without leaks with caps attached, at least two of which were white. She stated she was relieved for a break just prior to Patient 1's air embolism event; thereafter, she heard an alarm bell, returned to Patient 1, and saw staff attending to his ECMO circuit. She stated, according to her experience at the hospital, white caps could be vented or non-vented, whereas all red caps were occluded (non-vented). She stated during that time at the hospital, the circuit set-ups of ECMO patients varied with red and white caps attached. She stated the ECMO circuit should be a system closed to air.

During an interview on 10/30/19 at 10:52 a.m. with the CCSD, he stated, a standard the hospital followed at the time of Patient 1's air embolism event was that vented caps were always replaced with non-vented caps on the ECMO circuits prior to use on patients. He stated a non-vented cap should have been where the vented cap was found on Patient 1's ECMO circuit on 2/8/17. He stated the hospital followed ELSO (Extracorporeal Life Support Organization, organization supporting healthcare professionals involved in ECMO) guidelines for the ECMO management.

Review of the 2013 ELSO "General Guidelines for all ECLS (Extra Corporeal Life Support, another name for ECMO) Cases, Version 1.3" indicated, "The basic circuit includes a blood pump, a membrane lung (artificial lung), and conduit tubing... Pre pump venous drainage (from blood vessels that carry oxygen-poor blood) line pressure... negative suction pressure by the pump... Luer connectors (tapered fitting used for connecting caps) and stopcocks provide access to the blood in the circuit... Blood access sites should be avoided between the patient and the inlet of the pump because of the risk of... aspiration of air into the venous drainage line... through a connector or open stopcock...

Review of the 2017 ELSO website archive (https://www.elso.org/) indicated, "ECMO uses a pump to take over the work of the heart and... lungs... large tubes... in arteries (blood vessels that carry oxygen-rich blood) or veins... are placed... that allow blood to be taken out of the body... pumped through an... artificial "lung"... treated blood is then... returning to the patient's body... The ECMO team takes every possible measure to prevent... air from reaching the patient, which could cause a serious injury in the brain... called an embolism...; The ECMO specialist - A registered nurse (RN)... or perfusionist who has had... training in running the ECMO machine... will... help manage the ECMO circuit and its effect on the patient..."

Review of the hospital's 2004 "ECMO-Perfusionist Checklist-Setup" indicated, "Circuit set-up... RED CAPS on all stopcocks..."

Review of the hospital's 2015 procedure, "ECMO: Pre-Primed ECMO" indicated, "All stopcocks and ports are capped with red lumen caps..."

Review of the hospital's 2015 ECMO Training for Nursing slide presentation indicated, "ECMO: Most Common Circuit Emergencies... Circuit Air... Venous Lines... Operator Error: Open Stopcocks...; Enter the Circuit technique... Put Luer-Lock syringe (a tube with a nozzle and piston for sucking in and ejecting out fluids) on circuit stopcock... Open stopcock... Aspirate just enough to clear air in stopcock... Cap with RED cap...; ECMO: Circuit Blood Sampling CONSIDERATIONS... VENOUS LINE IS UNDER NEGATIVE PRESSURE... IT WILL SUCK IN AIR... It really will !!!!!!!"

Review of the California Nursing Practice Act (Business and Professional Code, Division 2. Healing arts, Chapter 6, Article 2, §2725 (b) indicated, "The practice of nursing within the meaning of this chapter means those functions, including basic health care, that help people cope with difficulties in daily living that are associated with their actual or potential health or illness problems or the treatment thereof, and that require a substantial amount of scientific knowledge or technical skill, including all of the following: (1) Direct and indirect patient care services that ensure the safety, comfort, personal hygiene, and protection of patients; and the performance of disease prevention and restorative measures..."

Based on observation, interview, and record review, the hospital failed to develop and maintain a current and individualized nursing care plan for Patients 3 and 4 in the Cardiovascular Intensive Care Unit (CVICU). This failure had the potential to result in nursing staff delaying or failing to deliver all necessary care and services, resulting in further compromise of medical status.

Findings:

During an initial tour of the CVICU on 10/28/19 at 10:00 a.m. with the critical care services director (CCSD), Patients 3 and 4 were observed to be on extracorporeal membrane oxygenation (ECMO, a treatment that uses a pump to circulate blood through an artificial lung back into the bloodstream of a very ill baby).

A review of Patient 3's clinical record indicated the patient was admitted to the hospital on 10/22/19 with diagnoses including fulminant myocarditis (sudden onset inflammation of the heart muscle) requiring ECMO. Patient 3 was on ECMO at the time of admission to the hospital.

During a clinical record review and concurrent interview with the nurse practitioner (NP) on 10/29/19 at 9:58 a.m., Patient 3's nursing care plans did not include management of the ECMO. The NP confirmed the record observation.

A review of Patient 4's clinical record indicated the patient was admitted to the hospital on 10/9/19 with diagnoses including sepsis (a potentially life-threatening condition caused by the body's response to an infection) and vasodilatory shock (a condition in which the blood vessels are too relaxed and blood pressure drops) requiring ECMO. Patient 4 was placed on ECMO on 10/27/19 after a cardiac arrest.

During a clinical record review and concurrent interview with the NP on 10/29/19 at 10:34 a.m., Patient 4's nursing care plans did not include management of ECMO. The NP confirmed the record observation.

A review of the hospital's policy, "Care Plan", dated December 2018, indicated "The care plan will be individualized and include information and parameters specific to the interdisciplinary goals identified upon admission, and throughout the hospital stay."

Based on observation, interview, and record review, it was determined the hospital did not meet the Condition of Participation (COP) for Surgical Services as evidenced by:

Failure to maintain stored pre-primed ECMO circuits for patient use when one was found erroneously tagged with the same date for circuit preparation, standby circuit completion, and expiration beyond 30 days (Refer to A951).

The cumulative effects of these systemic problems resulted in the hospital's inability to ensure their provision of ECMO treatments was done in a safe manner to meet patients' needs.

Based on observation, interview, and record review, the hospital failed to maintain a stored ECMO (Extracorporeal Membrane Oxygenation, treatment that uses an exterior man-made heart and lung to support the body when a person's own organs are dysfunctional) circuit when a pre-primed ECMO circuit was found erroneously tagged with the same date for circuit preparation, standby circuit completion, and expiration beyond 30 days. This had the potential for the stored ECMO circuit to be used on a patient beyond 30 days, against hospital procedure.

Findings:

During an observation on 10/30/19 at 1:40 p.m. of the Mechanical Circulatory Support (a storage room) with the critical care services director (CCSD) and perfusionist D, a pre-primed ECMO circuit was found tagged with papers.

During a concurrent record review of the pre-primed ECMO circuit's attached papers, one indicated, "3/8 x 3/8" (fractional units of measure in inches for tubing size) ECMO Circuit Expires 12/23/19." Another indicated "ECMO-Perfusionist Checklist-Setup ... CIRCUIT PREP (preparation): Date ... 12/23/19 ... and Standby circuit completed by ... Date 12/23/19 ..." perfusionist D, confirmed the expiration dates.

During a concurrent interview with the CCSD, after he viewed the "ECMO-Perfusionist Checklist-Setup" circuit prep date, he stated the ECMO circuit's setup date(s) must have been documented in error and the actual setup date could not be determined according to the documentation.

During a concurrent interview with perfusionist D, she stated once an ECMO circuit was primed and completed for ready use, it was good for one month per hospital policy. She confirmed the expiration date attached to the ECMO circuit was beyond one month into the future.

During an interview with perfusionist D on 10/31/19 at 1:33 p.m., she stated she found out the pre-primed ECMO circuit was set up on October 23, 2019.

Review of the hospital's procedure "ECMO: Pre-Primed ECMO circuits," dated June 2015, indicated "for patients who require rapid deployment ECMO support as life-saving therapy ... pre-primed ECMO circuits will be stored and maintained at all times for up to one month (30 days) ... It is visually checked every day by the Pediatric ECMO team and the inspection documented in the circuit checks log."

Review of the 2017 ELSO "General Guidelines for all ECLS (Extra Corporeal Life Support, another name for ECMO) Cases, Version 1.4", indicated "the circuit can be primed at the time of use, or days before. It is not recommended to use a primed circuit after 30 days."

Review of the 2017 ELSO "General Guidelines for Neonatal Respiratory Failure, Version 1.4", indicated "Most centers will discard a crystalloid primed circuit after 30 days due to local infection prevention and control policy."