HospitalInspections.org

Based on observation, staff interview, medical record and document review, the hospital failed to effectively govern the activities and conduct of the hospital staff and processes to provide safe and quality care to all patients as evidenced by:

A. The hospital failed to provide Pharmaceutical Services to meet the needs of all patients by preventing and minimizing risks for harm from medication errors. The hospital failed to develop an effective and reliable system to alert providers when high risk blood thinner medications were ordered and processed, in time to prevent unsafe administration of the medications. (Refer to A 0491.)

B. The Medical Staff failed to provide safe quality care for patients who need blood thinner medications, and be accountable to the Governing Body. (Refer to A 0347 A 0395 A 0405 A 0491 .)

C. The hospital failed to ensure that an effective, ongoing, hospital-wide, data-driven quality assessment and performance improvement program that included measurable improvement activities was developed, implemented and maintained for high risk patient care activities throughout the hospital that ensured clear expectations were established for patient safety. (Refer to A 0273 and A 0286).

D. The hospital failed to ensure the Nursing Services were organized to meet the needs of all patients. (Refer to A 0385.)

These failures put patients at risk for adverse events, serious bleeding, and death, and contributed to Patient 1's death.

The cumulative effect of these systemic problems resulted in the inability to comply with the statutorily-mandated Condition of Participation for Governing Body.

Findings:

Review of the 5/8/19 governing body bylaws documented under Section 5-7-A-2 that the governing body's powers and responsibilities included, "To supervise the Corporation's quality improvement activities, including all aspects of patient care evaluation." Section 10-1 noted that the governing body was "responsible for the quality of professional care rendered in the Corporation's medical facilities. It shall discharge that responsibility by assuring that the organized Medical Staff(s) carry out the specific quality related functions delegated to the Medical Staff."

In an interview on 12/6/19 at 10:05 a.m., the Chief of the Medical Staff and the Chief Medical Executive acknowledged that the medical staff was responsible to oversee the quality and safety of patient care and report to the governing body, but that the governing body was ultimately responsible for same quality and safety of hospital patients.

Based on interviews and document reviews the hospital failed to maintain an effective data-driven Quality Assessment and Performance Improvement (QAPI) program as evidenced by:

1. The hospital failed to measure, analyze, and track quality indicators for alert fatigue after an erroneous administration of Apixaban and Heparin to Patient 1 which resulted in massive internal bleeding, hemorrhagic shock and death (See A-0286 and A-0273).

2. The hospital failed to develop the medication alert system in order to improve patient safety when the medication alert system was not improved upon to prevent alert fatigue following a medication error, in which alert fatigue was a contributing factor, that resulted in internal bleeding and death (See A-0297).

3. Hospital leaders failed to develop and implement an effective system to timely investigate and analyze serious adverse events (AEs) and/or medical errors that resulted in patient harm and/or potential for harm, and failed to set clear expectations for safety through its adverse event analysis design and policy design (See A-0286).

The cumulative effects of these systemic problems resulted in the hospital's inability to maintain an effective quality assessment and performance program in accordance with the statutorily-mandated Conditions of Participation for Quality Assessment and Performance Improvement Program.


26917

Based on interview and record review the hospital failed to evaluate, measure, analyze and/or update the safety practices on safe use of the newer anticoagulation (blood thinner) medications known as DOAC (or Direct Oral Anti-Coagulants) per policy and the current standards of practice to prevent adverse outcomes when Patient 1 (Pt-1) was administered three concurrent anticoagulant blood thinners (apixaban, heparin, and aspirin) for a period of 4 days which led to massive internal bleeding and death.

Findings:

A 12/5/19 review of Patient 1s (Pt-1) medical records, accompanied by Medication Safety Pharmacist (RPH-MS) and Pharmacy Supervisor 1 (RX-Sup-1), indicated Pt-1 was admitted through the Emergency Department for weakness and cough on 3/21/19. Pt-1s home medications included a blood thinner called apixaban which was re-ordered to be continued in the hospital upon admission on 3/22/19 at 3:45 p.m. Furthermore, another blood thinner medication called heparin was ordered on the same day on 3/22/19. Additionally, Pt-1 was prescribed aspirin (a blood thinner and pain reliever) for daily use on 3/23/19.

A 12/5/19 record review, indicated that Pt-1s hospital orders were verified and reviewed by pharmacists without addressing the potential risks of concurrent use of blood thinners.

A 12/5/19 record review, indicated Pt-1 experienced a drop in blood pressure and blood counts on 3/25/19 and was transferred to the Intensive Care Unit (ICU-a higher level of medical care in a hospital) and later surgery for further care. Duplicate anticoagulation use was recognized when medication orders adjusted and a delayed lab work showed a dramatic drop in the patient's hemoglobin blood counts (a blood marker that shows anemia or blood loss.) Pt-1 expired two days later on 3/27/19, as a result of what was described as hemorrhagic shock or excessive internal bleeding.

A review of the American Society of Health-System Pharmacy (ASHP) Guidelines, a nationally recognized professional standard of practice, accessed on 12/6/19, the document titled, "ASHP Guidelines: Minimum Standard for Pharmacies in Hospitals", indicated the following:
*"There shall be an ongoing program for monitoring drug utilization...to ensure that medications are used appropriately, safely, and effectively, and to increase the probability of desired patient outcomes..."
*"Drugs used by hospital must be reviewed by the hospital's Pharmacy and Therapeutic Committee (a hospital committee responsible for all matters related to the safe use of medications) [and] the risk assessment should address the likelihood of an error occurring and the risk of injury should that error occur."

On 12/5/19, a review of hospital's policy #6506015 titled, "Anticoagulation Management Plan Policy (SHVA)", accompanied by Medication Safety Pharmacist (RPH-MS), indicated that "The management of the therapeutic anticoagulation...includes patients on therapeutic anticoagulation therapy (e.g. warfarin, low molecular weight heparins, heparin, argatroban, rivaroxaban, etc...) and "excluded patients, include those receiving...subcutaneous prophylaxis for VTE (venous thromboembolism; blood clot in a vein)." The policy further included a statement that "Evidence suggests that an anticoagulation management approach that encourages...proactive provider monitoring and intervention ... Oral anticoagulation can cause significant morbidity and mortality when the patient is inadequately monitored." Further review of the same policy, on section D, titled "Other Anticoagulants (e.g. Argatroban, rivaroxaban, bivalridin, apixaban, dabigatran) indicated, "Use facility drug specific approved order sets or panels to address initial dosing and dose adjustments as required if present." The performance improvement (a process of setting goals, implementing systematic changes, measuring results, and making subsequent appropriate improvements) section of the same policy further included:
*"Evaluation and update of anticoagulation plan, processes and safety practices to assure appropriate goals or improvement are achieved within and between facilities (e.g. Medication Use Evaluation);"
*"Evaluation of new anticoagulation medication and emerging treatments [and];"
*"Prescriber and staff education is performed as indicated."

During a concurrent interview and record review on 12/5/19 at 10 a.m., the RPH-MS could not provide any medication use data or report, prior to Pt-1's incident, to support an ongoing or retrospective (or look back) audit plan to assess the risks associated with the use of a newer generation of blood thinners, known as DOACs as was noted in their policy.

In an interview with RPH-MS on 12/6/19 at 1:09 p.m., she acknowledged the current hospital policy did not address monitoring and proactive management of the newer generation of oral anticoagulants or blood thinners known as DOAC (Direct Oral Anti Coagulation) that could pose a significant bleeding risk if inadequately monitored.

In an interview with the RX-Sup-2 and RPH-MS on 12/6/19 at 11:06 a.m. and 1:03 p.m., respectively, they both acknowledged that they were not aware of any Medication Use Evaluation (MUE-a quality review of high risk medications use within the hospital) of the newer anticoagulant medications as noted in their policy. They also acknowledged there had not been a formal review to address how the newer anticoagulants could be included in the hospital's performance improvement as indicated in the policy. RX-Sup-2 added, currently the two main DOACs in use, namely apixban and rivaroxiban (blood thinners medications), were approved by regional and local Pharmacy and Therapeutic Committee (a hospital committee responsible for all matters related to the safe use of medications). She noted these drugs were much safer than warfarin (a blood thinner) and did not required drug level monitoring. Rx-Sup-2 and RPH-MS could not explain what safeguards in terms of proactive risks and monitoring assessment were recommended when DOAC drugs were approved for use in the hospital.

On 12/5/19, a review of hospital's policy #6861274 titled "High Alert Medication, Management of", indicated, "high alert medications are drugs that bear a heightened risk of causing significant patient harm when they are used in error...the consequences of an error are clearly more devastating to patients." The policy further included two appendices with separate medication lists for both nursing and pharmacy staff. The pharmacy's list included warfarin, an oral anticoagulant, with dosing and monitoring per a hospital approved protocol. The list did not include the newer anticoagulants medications that had the same level of risk a noted in their policy.

Further concurrent interview and policy review with RPH-MS on 12/6/19 at 1:03 p.m., indicated that she performed a gap analysis (a comparison of actual performance with potential or desired performance) last year and noticed that the newer oral agents were not part of the pharmacy's high alert medication system. RPH-MS's request to include them and address the safety issues was referred to a system wide fix by the organization.

A 12/6/19 review of the Pharmacy and Therapeutic Committee (P&T, a hospital committee responsible for all matters related to the safe use of medications) minutes, dated 1/11/19, indicated an external safety report by the Institute for Safe Medication Practices (ISMP, an organization devoted entirely to preventing medication errors) titled "ISMP Action Agenda" for 3rd quarter of 2018 (July-September.) The ISMP report stated that "almost all inpatient settings... maintain a facility-specific list but only two-thirds have special precaution in place to prevent errors ... the medications that caused the most concern with regard to medications errors include anticoagulants ..." ISMP further recommended that the organization "employ effective risk-reduction strategies, especially for anticoagulants ...". ISMP's action agenda tool which helped organizations assess their safeguards on reported external safety alerts, was presented to the hospital's P&T committee on Jan 11, 2019, indicated no "action required" to address safe use and monitoring of the newer anticoagulant blood thinner medications.

On 12/6/19 at 1:37 p.m., RPH-MS stated that ISMP risk assessment tool was prepared by the previous medication safety personnel and acknowledged the lack of follow up on addressing safety practices related to the newer blood thinner anticoagulants. RPH-MS later stated that they have decided to add the DOAC drugs to the high alert medication list and it did not require a committee approval.

Based on staff interviews, medical record and document reviews, hospital leaders failed to develop and implement an effective system to timely investigate and analyze serious adverse events (AEs) and/or medical errors that resulted in patient harm and/or potential for harm, and failed to set clear expectations for safety through its adverse event analysis design and policy design when:

1. There was no singular experienced professional ("coordinator") with a healthcare background who took ownership over the entire quality assessment and performance improvement (QAPI) process for analysis of Patient 1's AE. Patient 1 died from massive internal bleeding after multiple blood thinner medications were administered for 4 days in error.

2. The principals most closely involved ("responsible for"), and thus most knowledgeable about Patient 1's adverse event (AE), were not deeply involved in the analysis of its cause and development of an action plan for resolution.

3. Analysis and resolution planning did not include the initial AE driver, the ordering physician (MD 1) for Patient 1's AE, and there was a lack of medical provider engagement from the beginning of the AE analysis process for Patient 1's event as well as for other medication error events, thereby delaying effective improvement actions.

4. Measurable hospital-wide improvement action plan targets with timely deadlines were not set, which resulted in continued lack of staff awareness and education about direct oral anticoagulation (DOAC, type of medication to prevent blood clots from forming, a blood thinner) medication safety, bleeding risks, drug interactions, and rescue options for anticoagulation toxicity.

5. Effective communication was not evident in Pharmacy and Nursing leadership resolution activities.

6. The hospital relied on quality improvement (QI) processes which weren't sufficiently nimble or quick for effective resolution, failing to use existing hospital systems which could have worked or to develop other systems for success.

7. The hospital failed to measure, analyze, and track quality indicators for alert fatigue after an erroneous administration of Apixaban and Heparin to Patient 1 which resulted in massive internal bleeding, hemorrhagic shock and death.

These failures contributed to a second medication error with potential for serious harm to Patient 2 on 4/6/19, and put all patients prescribed blood thinners at risk for serious bleeding or death.

Findings:

In a document titled "R3 Report: Requirement, Rationale, Reference," published 12/7/18, The Joint Commission (TJC, a national accrediting agency which certified the hospital eligible to receive state and federal funds) stated, "National Patient Safety Goal for anticoagulant therapy: Effective July 1, 2019, eight new elements of performance will be applicable to all Joint-Commission-accredited hospitals...These eight new requirements are at NPSG 03.05.01...For years, this NPSG has played an important role in improving the safety of patients receiving anticoagulation therapy (treatments with medications to prevent blood from clotting, blood thinners). However, there has been a rise in adverse drug events associated with direct oral anticoagulants (DOACs)...relevant updates to this NPSG to address DOACs may help reverse that trend...."

On its website at https://www.jointcommission.org/sentinel_event_policy_and_procedures/, TJC described information about patient safety under the heading "Sentinel Event Policy and Procedures," "The Joint Commission adopted a formal Sentinel Event Policy in 1996...Careful investigation and analysis of Patient Safety Events (events not primarily related to the natural course of the patient's illness or underlying condition), as well as evaluation of corrective actions, is essential to reduce risk and prevent patient harm...A sentinel event is a Patient Safety Event that reaches a patient and results in any of the following: Death, Permanent harm, Severe temporary harm and intervention required to sustain life...Such events are called "sentinel" because they signal the need for immediate investigation and response...."

Hospital Policies

Review of administrative policy #5991781 titled, "Performance Improvement (PI) and Patient Safety (PS) Program 2019," approved 3/8/19, documented the policy's purpose, "the PI Plan reflects the complexity of the hospital's organization and services, involves all hospital departments and services...and focuses on indicators related to improved health outcomes and the prevention and reduction of medical errors to ensure that patient care, processes and outcomes are measured, analyzed, and improved." Objective #8-b read, "A proactive approach to the identification and mitigation of patient safety risks." Objective #8-e read, "Timely, appropriate and effective response when an error does occur."

Review of the hospital's 6/20/19 "Anticoagulation Management Plan Policy" reflected, "The Joint Commission National Patient Safety Goal (NPSG) 03.05.01 focuses on anticoagulation therapy. The rationale for this requirement is that anticoagulation is a high-risk treatment which commonly leads to adverse drug events due to the complexity of dosing these medications, monitoring their effects...Oral anticoagulation can cause significant morbidity and mortality when the patient is inadequately monitored. The cost...of hemorrhagic [bleeding] complications with over-anticoagulation...can be substantial ...."

On 12/3/19 at 2:30 p.m. and 12/4/19 at 9:30 a.m., reviews of two current hospital patient safety policies, "Patient Safety Reporting Policy" (PSRP, approved 5/29/19) and "Patient Safety Event Analysis and Reporting" (PSEAR, approved 10/28/19), were conducted with the Health Risk Officer (HCR), Quality Operations Director (QOD) and the Assistant Administrator for Quality and Patient Safety (AAQPS). The three quality and risk leaders stated the two policies were considered comparable to policies in place in March, 2019 when Patient 1's medication error occurred. They confirmed the hospital expectations noted in these two policies:

PSEAR Purpose-To outline the method(s) of review and analysis of Sentinel Events and Patient Safety Events, including but not limited to Root Cause Analysis (RCA) and Intensive Analysis (IA, review of less significant events with no patient harm resulting, "near misses" which are safety events prevented from reaching patients and precursor events which are undesirable incidents that can lead to subsequent adverse events).

PSEAR Section C-2-The purpose of an RCA is to identify and understand the underlying causes and variations that contributed to the event and to develop, implement and evaluate the effectiveness of a corrective action plan.

PSEAR Section C-3-The RCA process includes these key functions to perform that a thorough and credible review is performed [sic]: item (c) Review of the relevant literature, and (d) An action plan that includes (ii) person/role accountable for completing each corrective action, (iii) timeline/deadline for completion, (iv) quantifiable measures for whether an action is effective and sustained.

PSEAR Section C-4-The RCA will be facilitated and managed by the HCR staff.

PSEAR Section C-5-HCR is responsible to monitor implementation and follow-up of the RCA action plan and report to the CEO (Chief Executive Officer) or designee.

PSEAR Section C-6-The CEO (or designee) is accountable for the overall RCA outcome, including implementation and evaluation of the effectiveness of the corrective action plan.

PSEAR Section D listed requirements for IA level events that were similar to Section C, but with responsibility for conducting and "owning" the IA by "Operational Leaders" (department managers or service directors for the area in which the event occurred) instead of Risk leaders. However, Operational Leaders were expected to "outline immediate and remedial actions," and to ensure "IA completion and documentation, including implementation and evaluation of the effectiveness of a corrective action."

PSRP Purpose-Define how PSRs are reviewed and assessed to determine safety event classification. "Patient Safety Events are reported, reviewed, and assessed."

PSRP Section B-Timely Review, Assessment and Follow-up.

PSRP Section B-1-Operational Leaders are accountable for reviewing events and completing documentation of PSRs in a timely manner. Guidance for "timely" in Attachment A expected IA review within 3-5 business days, and PSR documentation completed and submitted within 14 business days. Serious events with patient harm expected the Operational Leader to refer to Healthcare Risk for RCA.

PSRP Section B-2-Operational Leaders were also expected to refer to other department managers as identified.

PSRP Attachment B titled ,Safety Event Classification (SEC), provided guidance to Operational Leaders who perform event review and assessment. Item 1 explained how to determine if the information gathered by the Operational Leader deviated from "generally accepted performance standards (GAPS)." If so, subsequent items explained the significance of deviations and how to classify the level of patient harm. A heading below that read, "Best Practice Tips in Safety Event Classification." Five best practices were listed. The first one noted, "Identify a consistent group of people to serve as a 'Safety Event Review Panel' to provide expertise, consistency, and integrity in event classification. The group should be a mix of clinicians and methodology experts."

Errors for Patient 1

During collaborative reviews of Patient 1's medical record on 11/5/19 with a Health Informatics Nurse (HI) at 9 a.m., 11 a.m., and 3 p.m., with Medical Doctor (MD 1) on 11/7/19 at 9 a.m., with Registered Nurses (RNs) 1 and 2 on 11/7/19 at 10:15 a.m., with RN 3 on 11/7/19 at 10:50 a.m., with the Director of Pharmacy (DOP) on 11/5/19 at 3:10 p.m., with MD 5 on 12/4/19 at 12:04 p.m., with the Chief Medical Executive (CME) and the Administrative Director for Hospital Supervision and Medical Surgical Units (ADHS) on 12/5/19 at 11:30 a.m., and with CME and ADHS on 12/6/19 at 1 p.m., the following was confirmed:

Patient 1 was weak and tired with a cough for 1-2 days per Emergency Department records dated 3/21/19. Patient 1 was then admitted to the hospital on 3/22/19 for acute, unexplained liver dysfunction and influenza infection without pneumonia. Patient 1 had the following risk factors for bleeding:

-Kidney failure and dependent on dialysis (life-sustaining process in which a machine filters waste products and excessive fluid from the blood when the kidneys are not working) for at least 20 years
-Liver failure
-Already anticoagulated (blood was thin from a home medication-apixaban)
-Concurrent home medication (amiodarone) that can interfere with liver metabolism of blood thinner medications (such as apixaban and heparin)
-Chronic but stable heart disease
-History of upper intestinal bleeding in 2010
-Age 70
-Weight at or below 60 kilograms (kg - unit of weight measurement)

Admission History and Physical Examination (H&P) Assessments written by MD 1 and separately by a Nurse Practitioner student (NP 2), both described intent (1) to continue giving the home blood thinner medication (apixaban, a DOAC) daily for a pre-existing intermittent heart rhythm problem (atrial fibrillation, A Fib- irregular heartbeat) that was already under control, (2) to give daily aspirin (also a blood thinner) for concern that Patient 1 was at risk for acute heart attack (though examination findings and heart function tests did not support a heart attack and the Medication Administration Record, or MAR, did not list the indication for the aspirin drug order), and (3) to start a third blood thinner medication (subcutaneous, or SQ, heparin, injected into the skin 3 times/day) to prevent blood clots forming in the legs and chest while being less active in the hospital (known as venous thromboembolism, or VTE, prophylaxis). MD 1 explained that MD 1 was interrupted during Patient 1's assessment which was conducted in a busy emergency room, and forgot that Patient 1 was already anticoagulated and did not need the SQ heparin. MD 1 did not re-review the home medication list or notice that Patient 1 was already on apixaban when orders were signed. When MD 1 co-signed NP 2's note as the supervising physician, MD 1 did not notice in NP 2's note that Patient 1 was already anticoagulated with apixaban as a home medication and heparin was unnecessary for VTE prophylaxis.

When apixaban and SQ heparin orders were processed by pharmacy staff on 3/22/19, two pharmacy computer software alerts were generated for duplicative anticoagulants and potential drug-drug interactions (changes in a medication's effect on the body when that drug is taken together with a second drug) between apixaban and heparin. The alerts were reviewed by Pharmacist 1 (RPH 1) who was supposed to notify MD 1 to clarify intent or alternatives. RPH 1 did not contact MD 1, over-rode the alert, and the orders were processed for nurses to administer the drugs. No alerts for duplicate anticoagulation or drug-drug interactions were generated by the computer software for the combination of SQ heparin with aspirin, and no clarifications were documented.

In addition, a home medication to control heart rhythm (amiodarone, which can affect the liver and result in accumulation of apixaban and heparin in the blood) was also ordered at admission without triggering any computer software alerts. In a review of pharmacy records on 12/5/19, the medication safety pharmacist (RPH-MS) confirmed that MD 1 issued an electronic communication request on 3/23/19 at noon for a pharmacist to review all of Patient 1's current medications to determine which drugs could be toxic to the liver. In response to MD 1's request, RPH 4 documented on 3/23/19 at 12:55 p.m., "Spoke to [MD 1] most likely cause of sudden hepatotoxicity (liver dysfunction) is amiodarone and levofloxacin (an antibiotic)." RPH 4 further described all the mediations that potentially could have contributed to liver damage and included aspirin and apixaban among those. However, from that review of all medications, RPH 4 failed to note (and warn the physician of) the presence of duplicate therapy with apixaban and heparin, or added bleeding risk from aspirin.

Patient 1's MAR showed that amiodarone was given to Patient 1 on 3/22/19 at 10:51 p.m., and again on 3/23/19 at 9:51 a.m., after which it was discontinued. Patient 1's elevated liver tests peaked on 3/23/19 and showed improved trends after the amiodarone was stopped.

On 3/24/19, a cardiologist (MD 5) wrote a consultation assessment to help guide management of A Fib (atrial fibrillation or irregular heart rhythm). MD 5 listed all 3 blood thinner medications in the consultation note without commenting on their necessity or their raising the risk for bleeding. MD 5 determined that Patient 1 had not had a heart attack, was not in heart failure, and Patient 1's heart rhythm condition was stable. MD 5 indicated that the amiodarone likely caused the liver problems, which were improving.

Between 3/22/19 and 3/25/19, RNs administered blood thinner medications to Patient 1 on 19 occasions without clarifying the medication orders for 3 different ones, or documenting discussions of bleeding risks with the treating physicians.

Review of laboratory (lab) orders and results indicated no baseline tests to measure Patient 1's blood clotting status (coagulation studies, coag labs), and no periodic coag labs ordered between 3/22/19 and the evening of 3/25/19. Complete blood count (CBC) tests to measure hemoglobin (a molecule inside each red blood cell that carries oxygen to organs and tissues) and platelet count (blood particles that form blood clots) were performed on 3/22/19, 3/23/19, and 3/24/19, but not ordered for 3/25/19 until early evening, after Patient 1 experienced a series of 5 episodes of significant low blood pressure (BP) throughout the day without recovery to previous hospital baseline. These episodes required administration of 5 fluid boluses (volumes of salt water injected into the bloodstream ranging from 8 to 16 ounces at a time) to stabilize Patient 1's BP. On 3/25/19 while this was occurring, two physicians (MD 2 and MD 6) assessed Patient 1 without documenting concern for bleeding as a cause of the unstable BP, or ordering tests to further assess. Following the first episode of low BP that resulted in administration of the first fluid bolus at 10:38 a.m., RN 3 proceeded to administer the 3 blood thinners at their scheduled time (at 10:40 a.m.), without clarifying intent or risk.

On 3/25/19 at 11:29 a.m., MD 2 documented an assessment that noted, "Medications Reviewed." On 3/25/19 at 11:35 a.m., MD 2 wrote an order for SQ heparin with a longer frequency interval from the previous order. This order triggered an alert to the pharmacy staff, who contacted MD 2, after which all SQ heparin was stopped entirely. However, MD 2 issued no orders at that time for a CBC or coag labs to determine the current coagulation profile, or to better understand why low BP was occurring. MD issued no orders for medications to reverse the effects of the duplicative anticoagulants that had been given for 4 days, which may be producing internal (non-visible) bleeding and causing low BP. MD 2 did not document consultation with specialists in blood disorders or liver diseases to assist in the analysis of potential anticoagulation toxicity and significant increased bleeding risk.

Previous CBCs drawn between 3/22/19 and 3/24/19 showed a gradual decline in hemoglobin measurement from 11.5 to 10.4 (normal value is 11.7-15.5 grams/deciliter), and a platelet count from 210,000 to 163,000 (platelets can be diminished by heparin and fail to function effectively, normal value is 175,000-450,000 per microliter but may be elevated as a result of chronic kidney disease). 8-9 hours after the low blood pressure episodes began on 3/25/19, when a CBC was eventually obtained, the hemoglobin result was much lower, 7.3, and platelet count was 143,000. CME and ADHS agreed that the degree of hemoglobin drop was consistent with shock from bleeding.

Further review of Patient 1's medical record indicated that during Patient 1's 4th episode of low blood pressure at 2:26 p.m., a Rapid Response Team Nurse (RRT 1, member of a clinical team which brings critical care expertise to the bedside when requested) was summoned to assess and treat low BP through an RRT's authority to implement physician approved protocols. RRT 1 documented at 3 p.m. that MD 2 ordered a fluid bolus and a medication to raise BP. RRT 1 did not document why she did not implement the RRT protocol for low BP, which directed the RRT to order a CBC and administer a fluid bolus. RRT 1 did not document a physical assessment (also required by the protocol), but noted, "Stabilized and remained on the unit (not transferred to a critical care unit)." In addition, the medication ordered by MD 2 to raise the BP was never administered.

Patient 1 had a 5th episode of low BP at 4:27 p.m., for which RRT 1 was again involved. RRT 1 documented on 3/25/19 at 4:40 p.m. (at the second RRT encounter for that afternoon) that Patient 1's abdomen was firm, distended, and painful to touch (physical signs of possible internal bleeding).

ADHS indicated that at both encounters, RRT 1 had authority (through protocols) to order laboratory tests such as a CBC when assessing low BP in a patient at high risk for bleeding, but did not pursue such orders or document discussing lab test orders with a physician. After the 5th low blood pressure episode, MD 2 ordered a CBC and abdominal x-ray, but coag labs were not ordered and treatments were not given to reverse the effects of the blood thinner medications.

A review of nursing assessment documentation on 3/24/19 and 3/25/19 revealed incomplete documentation. Early morning nursing notes on 3/24/19 documented skin bruising at the blood vessel site in Patient 1's arm where needles could be inserted to cleanse the blood of toxins (dialysis arteriovenous fistula) and bruises on the abdomen where SQ heparin injections were given (bruising can be a sign of thin blood and minor bleeding from medications or disease). 3/24/19 evening nurse assessments for skin and abdomen were not documented. Similarly, on the morning of 3/25/19, a head-to-toe nursing assessment which should have included skin and abdomen, were not documented. RRT 1 failed to document a physical assessment of organ systems relevant to low BP at a first RRT encounter on 3/25/19 at 3 p.m., and mentioned only the abdominal findings at the second RRT encounter on 3/25/19 at 4:40 p.m. Specifically, RRT 1 did not specify the presence or absence of bleeding at skin sites or elsewhere on the body.

On 3/25/19 at 4:40 p.m., RRT 1 documented that MD 3 was at the bedside to assess Patient 1. MD 3 documented at 5:17 p.m. a comprehensive H&P-like assessment with a plan to move Patient 1 to the Intensive Care Unit (ICU) to stabilize the blood pressure. MD 3's note did not capture significant aspects of Patient 1's condition leading up to the events of 3/25/19. For example, there was no mention of liver dysfunction caused by amiodarone, and that once amiodarone was stopped on 3/23/19, the severity of liver dysfunction was improving (awareness of amiodarone's previous potential to cause accumulation of apixaban and heparin, in the clinical context of low BP and abdominal pain that was sudden and new, could strongly point to internal bleeding, even if liver tests were improving on 3/24/19). Patient 1's low BP was sudden and abrupt on the morning of 3/25/19. Just the day prior on 3/24/19, MD 5 had found Patient 1 not to be in heart failure and not to have had a heart attack. Yet, MD 3 determined the cause of Patient 1's unstable BP and need for ICU care to be from heart failure, or possibly a blood infection (abdominal pain, distention, and tenderness with unstable BP are not typical features of heart failure or blood infection, but more likely suggest sluggish blood circulation from blood loss). Lastly, if MD 3 believed Patient 1's shock was caused by blood infection, MD 3 never ordered blood culture tests to confirm. In addition, MD 3 documented intent to resume amiodarone if Patient 1's intermittent heart rhythm problem surfaced, a drug which had just been shown to damage Patient 1's liver. MD 3 documented intent to administer apixaban "if necessary," which would only increase the risk for further bleeding.

According to the ICU physician coverage schedule for 3/25/19, as explained by the ICU's Clinical Manager (CM) on 11/5/19 at 12:05 p.m., MD 3's assigned work shift ended at 5 p.m. However, MD 3 issued medication orders for Patient 1 on 3/25/19 at 5:32 p.m. and 6:35 p.m. A nursing note entered at 7:55 p.m. documented that MD 5 was "assessing patient," after an episode at 7:30 p.m. when Patient 1's blood pressure was 75/49 (significantly low, normal BP=120/80 millimeters of mercury).

Nursing flowsheet pain assessments on the night of 3/25/19 in the ICU documented:
-7:34 p.m. abdomen pain on palpation and with movement, pain at rest 4/10 [numerical pain scale where 0 represents no pain, and 10 represents severe pain], pain with activity 10/10.
-8 p.m. no change in pain, per patient "as long as I don't move a lot. It would not hurt." Pain at rest 4/10, pain with activity 10/10.
-10 p.m. no change in pain, pain at rest 4/10, pain with activity 10/10.
-Midnight no change in pain, pain at rest 4/10, pain with activity 10/10.
-2 a.m. (on 3/26/19) no change in pain, pain at rest 4/10, pain with activity 10/10.

Nursing flowsheet gastrointestinal system entries on the evening of 3/25/19 noted:
-6:38 p.m. and 7:34 p.m. dark brown stools (these were not sent to test for intestinal bleeding).
-8 p.m. abdomen firm, tender, taut all quadrants, dry-heaving, intermittent nausea, bruise(s) at the left upper arm [dialysis fistula] site (when Patient 1 had had no dialysis treatment since 3/22/19), bruising around skin puncture site (the last skin injection was at 10:40 a.m.).

Per the nursing entries and order times, MD 3 remained on site and was involved in Patient 1's care for several hours after Patient 1 arrived to the ICU at 6:49 p.m. The CBC lab result with low hemoglobin of 7.3 was known (reported at 6:29 p.m.) while MD 3 was present. MD 3 was at the bedside "assessing" at 7:55 p.m. MD 3 issued an order for coag tests at 8:22 p.m. The RN was documenting significant pain "as long as I don't move a lot," firm tender abdomen, bruises at the dialysis fistula site, and continued unstable BP. Throughout this period, MD 3 did not document any further progress notes or assessments of Patient 1's shock. MD 3 did not document serial abdominal examinations for a potential surgical abdomen emergency, and did not document assessments to reflect consideration of (a) abdominal bleeding as a cause of Patient 1's shock, (b) a need to urgently reverse any of the blood thinner medications, or (c) an urgent need for surgical consultation.

A nursing note entered at 10:11 p.m. on 3/25/19 documented, "msg [message] sent to night rounding [MD] regarding lab result, abd gen [abdomen general] appearance and pt c/o [patient complaining of] pain. [MD 4], seen the patient and with orders."

On 3/25/19 at 9:46 p.m., MD 4 issued an order for routine abdominal CT exam (computerized tomography, type of imaging test) for "weakness and cough, abdominal pain," but no mention of unstable low blood pressure, drop in hemoglobin, distended firm abdomen, or increased bleeding risks (liver and kidney conditions). MD 4 also did not document any physical assessments of Patient 1, or progress notes to reflect the purpose of the imaging test and update the status of Patient 1's condition (stable or deteriorated) after "seeing the patient" around 10 p.m. The CT exam was performed at 10:20 p.m. but it was not promptly interpreted by a radiologist because it had not been ordered "STAT" (immediate).

According to the ICU physician coverage schedule for 3/25/19, MD 4 was assigned to take over care for MD 3's patients between 5 p.m. and 11 p.m. From 10 p.m. to 8 a.m., the responsibility for as many as 48 ICU patients was then assigned to NP 1, with one hour of overlap with MD 4 between 10 p.m. and 11 p.m.

No physical assessments of Patient 1 were documented by NP 1 from the time NP 1 started his shift at 10 p.m., 3/25/19 until after Patient 1 suffered a cardiac arrest (heart not pumping effectively and blood not circulating to vital organs) at 3:09 a.m. 3/26/19. There was therefore no documentation to indicate that NP 1 periodically assessed Patient 1 and evaluated Patient 1's abdominal condition, unstable blood pressure, and coag labs during the 10 p.m., 3/25/19-3:09 a.m., 3/26/19 interval. Coag labs were elevated consistent with increased risk for bleeding (International Normalized Ratio [INR) was 1.6 [normal is less than 1.2], prothrombin time [PT] was 19.4 seconds, [normal is less than 15.1] and partial thromboplastin time [PTT] was 62.6 seconds (normal is less than 36)]. A nursing entry at 33 minutes after midnight documented, "MD were [sic] made aware of coags studies result." The record was unclear who was "made aware" and when, as the elevated coag level results had been ready at 9:07 p.m.

A nursing note entered at 1:18 a.m., 3/26/19 documented, "Called film room (imaging department) regarding CT ABD result. [MD 4] earlier informed me that he had ordered stat CT abd, but the order entered was for routine. Staff at film room will change the routine order to stat and will have result in approx. [approximately] 1 hour or so."

Not until the bedside RN called the imaging department well after midnight for the abdominal CT exam result did anyone realize that the CT was not ordered STAT. The CT exam result was then called to the bedside nurse at 1:47 a.m. on 3/26/19. The CT exam showed a large fluid collection (likely blood) in the lower abdomen that posed a threat to the bowel's blood supply, and a more definitive type of CT (with contrast dye) was recommended. It is possible that had the initial physician order included more detail about the patient's serious condition, the Imaging Department may have used the information to expedite the resulting of the scan.

A nursing note entered at 1:55 a.m. documented, "Received call from CT film room of the CT abd result. And message sent to [NP 1] ...Awaiting callback/orders from [NP 1]."

NP 1 ordered a STAT abdominal CT with contrast at 2:03 a.m., 3/26/19, which was performed at 2:53 a.m. [To perform an abdominal CT exam, a patient must lie flat on the back. For patients with shock from bleeding into the abdomen, such a position can compromise blood pressure and circulation to vital organs.] The CT exam started at 2:54 a.m. in the imaging department. By 3:09 a.m., the CT exam had been completed and Patient 1 had returned to the ICU. At 3:09 a.m., Patient 1 suffered a cardiac arrest. NP 1 and ICU nurses successfully provided aggressive rescue interventions. At 3:10 a.m., the CT exam with contrast results was called to NP 1 who was busy with Patient 1's rescue. The results were definitively communicated to NP 1 by 3:37 a.m. The CT showed a very large blood collection in the muscle of the abdominal wall, and the blood supply to the bowel was cut off with gas leaking to surrounding tissues, posing a surgical emergency.

At 5:12 a.m., an offsite "eICU" (electronic ICU, a program in which critically-ill patients are remotely monitored using live interactive video and other specialized diagnostic tools and technologies) physician (MD 9) ordered a blood product "to reverse coagulopathy [condition where blood won't form clots sufficiently, bleeding will result] caused by [apixaban]." Emergency surgery was performed at 6:08 a.m., 3/26/19.

The medical record indicated MD 9 was the only provider to recognize the possible accumulation and toxicity of multiple blood thinner medications, or at least for apixaban. Unfortunately, the attempt to reverse the effects of Patient 1's blood thinners did not come until 20 hours after the first signs of low blood pressure began; low BP was the first sign of blood thinner toxicity. During encounters with 5 physician level providers and 3 or more RN providers throughout that period, none of those providers documented recognition of bleeding related to the blood thinner medications, which can be reversed if recognized timely.

In total, from Patient 1's admission on 3/22/19 when multiple blood thinner medications were ordered and continued to be administered, Patient 1 passed through the hands of 9 physician level providers, most of whom documented assessments where medication reviews (had they been conducted correctly) showed treatment with 3 blood thinners in a patient already at risk for bleeding. Patient 1 passed through multiple RNs who administered those medications on 19 occasions. Once the first pharmacy over-ride alert for apixaban and SQ heparin occurred, the pharmacists never correctly re-reviewed Patient 1's anticoagulation drug safety profile, until MD 2 attempted to revise but not stop a SQ heparin order on 3/25/19. No other effective safeguards were in place to prevent repeated errors, after the first and only pharmacy safeguard failed.

During surgery on 3/26/19, Patient 1's large bowel was found to be severely damaged with leakage into surrounding tissues that can be deadly. It was repaired, but after surgery, Patient 1 experienced organ failures and treatment was then directed to "comfort care." Patient 1 died on 3/27/19 at 11:27 a.m. Patient 1's death certificate listed the immediate cause of death to be "hemorrhagic (bleeding) shock," with a major underlying cause, "massive internal bleeding."

Errors for Patient 2

During review of Patient 2's medical record on 12/5/19 at 9 a.m., Clinical Effectiveness Consultant (CEC, a registered nurse who assisted the Healthcare Risk Officer) confirmed that Patient 2 was admitted to the hospital's ICU on 4/6/19, ten days after Patient 1's death. Patient 2 appeared on a log of medication errors generated from patient safety reports and produced by the Pharmacy department. Patient 2, age 77, had chronic conditions that included diabetes and high blood pressure. Patient 2 had developed pneumonia and breathing difficulty with chest pain and was admitted to treat a heart attack and stabilize the lung function. Heart function was also significantly reduced.

At the time of admission on 4/6/19 at 9 a.m., a blood thinner medication (enoxapar

Based on interview and document review, the hospital failed to develop and implement a medication alert system to ensure patient safety when the medication alert system was not improved upon to prevent alert fatigue following a medication error.

This failure was a contributing factor to a medication error that resulted in internal bleeding and death.

Findings:

During an interview on 12/03/19 at 12:31 p.m., the Director of Pharmacy (DOP) stated that Staff Pharmacist 1 (RPH 1) verified an order to administer Apixaban and Heparin (medications that prevent the blood from clotting that when used together could cause excessive bleeding and death). DOP also stated that the orders were administered for several days, and should not have been verified for administration. DOP explained the pharmacy computer system did warn (via an alert) RPH 1 of the risk of administering Apixaban and Heparin together. However, RPH 1 ignored the medication alert and verified the orders to be administered. DOP stated RPH 1 had contributed the medication error to alert fatigue.

The term alert fatigue describes how clinicians become desensitized to safety alerts, and as a result ignore or fail to respond. A review of the Institute of Safe Medication Practice (ISMP), a nationally recognized medication safety resource, document dated 02/28/19 and titled, "Your Attention Please"...Designing effective warnings indicated, "false alarms [false alerts], clinically insignificant alerts, and overwarning will lead to alert fatigue and cause rational practitioners to overlook them or habitually bypass them, even if that is not the intended action. When a warning is disregarded before it can be read, it becomes completely useless. The most effective way to reach the target audience and promote understanding and compliance is to make sure the warning is clinically important."

During an interview on 12/05/19 at 9:58 a.m., the Pharmacy Supervisor 2 (RxSup 2) stated that she had interviewed RPH 1 about her decision to override the pharmacy alerts for the anticoagulants, contributing to the medication error. RxSup 2 said that during the interview, RPH 1 was visibly distraught and wanted everyone to know about the error so others could learn from her mistake. RPH 1 had told RxSup 2 the alerts were not helpful or wrong causing alert fatigue. RxSup 2 revealed RPH 1 had sent her, via email, multiple examples of non-clinically important alerts. RxSup 2 stated these emails were deleted.

During an interview on 12/04/19 at 12:30 p.m., the Medication Safety Pharmacist (RPH-MS)stated that the medication alerts were categorized based on severity or risk of patient harm if the medication was administered: "low, moderate and major." "Low" indicated a low risk of patient harm and "major" signified a high risk of harm.

Evidence of the medication alert that occurred for RPH 1 on 3/22/19, regarding the apixaban and heparin drug interaction/duplication, was reviewed. RPH 1 reviewed Patient 1's medications, but ignored the alert before verifying the orders. The alert for the apixaban and heparin drug interaction/duplication specified two risks for harm, "low/major risk".

During a concurrent interview on 12/04/19 at 12:35 p.m., RPH-MS stated the medication alert for the duplicate anticoagulant therapy should have been listed as "major". RPH-MS voiced she did not know why the drug-drug interaction was categorized as both "major and low." RPH-MS acknowledged the alert was confusing.

A review of the Institute of Safe Medication Practice (ISMP), a nationally recognized medication safety resource, document dated 2/28/19 and titled, "Your Attention Please"...Designing effective warnings indicated "Medication-related warning systems are...used to inform...practitioners...about risks, or remind them about known risks associated with the use of medications....To be effective, warnings must: 1) reach their target audience; 2) capture the attention of recipients at the right time; 3) cause recipients to understand the risk, believe that the warning relates to them, and understand the actions they need to take; and 4) lead the recipients to respond appropriately..."

A review of a list of all hospital drug interaction/duplicate therapy alerts for anticoagulants (Heparin, Warfarin, Apixaban, and Enoxaparin) from 11/1/19 thru 12/14/19, indicated that 17 out of 194 alerts (91%) were real (true and meaningful) alerts and the remaining were false. There was a total of 177 false alerts. The false alerts did not include drug interactions or duplications, but would alert as such (e.g. heparin was identified as a duplicate drug but no other anticoagulants were prescribed). More specifically, the 177 false alerts did not signify any anticoagulant drug to drug interactions or duplicate therapies

During an interview on 12/05/19 at 10:26 a.m., RPH 2 stated he relied on the medication alert system. RPH 2 stated the alerts were important to inform the pharmacists of any drug interactions or duplications. False alerts were very common RPH 2 explained, and the medication alert system had a lot of room for improvement.

During an interview on 12/05/19 at 10:15 a.m., RPH 3 stated she relied on the accuracy of the medication alerts. RPH 3 stated that she experienced alert fatigue due to the large amount of false alerts.

During an interview on 12/05/19 at 9:56 a.m., RxSup 2 stated the medication alerts were not helpful and many were false. RxSup 2 also stated it would be beneficial for the pharmacist to have less and clinically relevant alerts.

During an interview on 12/04/19 at 3:45 p.m., DOP stated the pharmacy medication alert system needed improvement. DOP also stated the medications alerts were not appropriately prioritized in regards to severity or risk. DOP said that he was aware of the ISMP guidelines for appropriate medication alerts and acknowledged the hospital medication alerts did not meet the ISMP guidelines.

During an interview on 12/05/19 at 10:52 a.m., the Clinical Applications Analyst (CAA) stated there were ways to change the medication alert system. CAA stated a request to the developers of the medication alert system could be made to make changes to the alerts. CAA explained that if they could not make the requested changes, a request could be made through Electronic Health Record Pharmacy Operations Committee (EPOC) and, with their approval, the Medication Management Team could make the changes. CAA said, that within the last year, only a few requests for medication alert changes came from the hospital. No requests to address alert fatigue were made.

An observation of the combined Apixiban and Heparin medication alert on 12/04/19 at 10:47 a.m., showed a "low" risk alert. During an interview on 12/04/19 at 4:02 p.m., DOP stated he did not know why the alert was showing "low" risk. He also stated the Apixiban and Heparin drug to drug medication alert should specify "major" risk. This demonstrated that since the medication error on 3/22/19, in which Pharmacist 1 verified orders for Apixiban and Heparin (which were then administered concurrently to Patient 1), the hospital erroneously changed the Apixiban and Heparin medication alert to "low" risk.

During an interview on 12/05/19 at 12:45 p.m., DOP stated that historically the hospital had not improved the medication alert system to address alert fatigue. In addition, no improvements to address alert fatigue were made since the medication error effecting Patient 1.

Based on observation, staff interview, medical record and document review, the Medical Staff failed to provide quality care and ensure the safety of all patients when:

A. The Medical Staff failed to be accountable to the governing body for patient quality and safety by ensuring safe systems of medication administration. (Refer to A 0347, A 0405, and A 0491.)

B. The Medical Staff failed to ensure an effective Quality Assessment and Performance Improvement system to identify and correct serious system problems. (Refer to A 0273 A 0286 A 0297.)

These failures put patients at risk for adverse events, serious bleeding, and death, and contributed to Patient 1's death from massive internal bleeding and shock.

The cumulative effect of these systemic problems resulted in the inability of the hospital to comply with the statutorily-mandated Condition of Participation for Medical Staff.

Based on staff interviews, medical record and document reviews, the medical staff failed to ensure accountability to the governing body for safe and high quality medical care in accordance with professional standards of practice, medical staff bylaws and rules, governing body bylaws, and hospital policies when:

1. The medical staff failed to minimize bleeding risks for patients prescribed blood thinner medications as evidenced by:

a. The medical staff failed to identify and correct significant system problems with medical staff performance as well as nursing and pharmacy systems in response to a medication error for Patient 1, and recognize potential adverse effects on all patients who were prescribed blood thinner medications, in order to prevent subsequent errors for other similar patients;

b. The medical staff failed to conduct timely and effective peer review to provide feedback and identify learning opportunities for 7 of 7 medical staff members (Medical Doctors-MDs 1, 2, 3, 4, 5, 6, and NP 1) involved in the care of a patient who received excessive blood thinner medications, developed bleeding, and died (Patient 1); and

c. The medical staff failed to provide education/guidance to all medical staff members who prescribe complex blood thinner medications as one of Patient 1's safety event improvement actions.

These failures put all patients prescribed blood thinner medications at risk for medication accumulation and toxicity and life-threatening bleeding or death.

Findings:

1.a. The medical staff failed to take effective actions to identify potential delays in care, correct systems that could improve care, and educate providers.

In a 12/6/19 at 10:05 a.m. interview, the Chief of Staff (COS, highest medical staff leader) reported that COS presided over the Medical Executive Committee (MEC), which reviews the activities and patient care related results from each medical staff committee, including the Quality Council (Quality and Patient Safety Council, QPSC), and evaluations of medication errors and patient harm adverse events. The COS provided information about such activities to the Board of Directors (BOD, the hospital's governing body) either by attending monthly meetings of the BOD's Medical Affairs Committee or by submitting minutes from the MEC and Quality Council committees.

The COS further indicated that each medical staff department reviewed the performance of its members by assigning the department chief or another "peer" with comparable education/training and skills to review the patient records for various situations, e.g., unexpected deaths, complications, referrals from other departments or hospital committees, and for sentinel events (errors associated with serious patient harm). The COS expected the reviewers of the records to evaluate and clearly document whether the provider involved performed in accordance with the standard of practice, or if feedback or opportunities to improve were identified for that provider. If the reviewer identified other providers who may have made errors or not provided standard care, the reviewer was expected to "cross refer" to the department that was responsible for oversight of that provider's care.

Errors for Patient 1

During collaborative reviews of Patient 1's medical record on 11/5/19 with a Health Informatics nurse (HI) at 9 a.m., 11 a.m., and 3 p.m., with Medical Doctor-MD 1 on 11/7/19 at 9 a.m., with Registered Nurses (RNs) 1 and 2 on 11/7/19 at 10:15 a.m., with RN 3 on 11/7/19 at 10:50 a.m., with the Director of Pharmacy (DOP) on 11/5/19 at 3:10 p.m., with MD 5 on 12/4/19 at 12:04 p.m., with the Chief Medical Executive (CME) and the Administrative Director for Hospital Supervision and Medical Surgical Units (ADHS) on 12/5/19 at 11:30 a.m., and with CME and ADHS on 12/6/19 at 1 p.m., the following was confirmed.

Patient 1 was weak and tired with cough for 1-2 days per Emergency Department records dated 3/21/19. Patient 1 was then admitted to the hospital on 3/22/19 for acute unexplained liver dysfunction and influenza infection without pneumonia. Patient 1 had the following risk factors for bleeding:

-Kidney failure and dependent on dialysis (life-sustaining process in which a machine filters waste products and excessive fluid from the blood when the kidneys are not working) for at least 20 years
-Liver failure
-Already anticoagulated (blood was thin from a home medication-apixaban)
-Concurrent home medication (amiodarone) that can interfere with liver metabolism of blood thinner medications (such as apixaban and heparin)
-Chronic but stable heart disease
-History of upper intestinal bleeding in 2010
-Age 70
-Weight at or below 60 kilograms (kg)

Admission History and Physical Examination (H&P) Assessments written by MD 1 and separately by a Nurse Practitioner student (NP 2) both described intent (1) to continue giving the home blood thinner medication (apixaban, a DOAC) daily for a pre-existing intermittent heart rhythm problem (atrial fibrillation, A Fib) that was already under control, (2) to give daily aspirin (also a blood thinner) for concern that Patient 1 was at risk for acute heart attack (though examination findings and heart function tests did not support a heart attack and the Medication Administration Record, or MAR, did not list the indication for the aspirin drug order), and (3) to start a third blood thinner medication (subcutaneous, or SQ, heparin, injected into the skin 3 times/day) to prevent blood clots forming in the legs and chest while being less active in the hospital (known as venous thromboembolism, or VTE, prophylaxis). MD 1 explained that MD 1 was interrupted during Patient 1's assessment which was conducted in a busy emergency room, and forgot that Patient 1 was already anticoagulated and did not need the SQ heparin. MD 1 did not re-review the home medication list or notice that Patient 1 was already on apixaban when orders were signed. When MD 1 co-signed NP 2's note as the supervising physician, MD 1 did not notice in NP 2's note that Patient 1 was already anticoagulated with apixaban as a home medication and heparin was unnecessary for VTE prophylaxis.

When apixaban and SQ heparin orders were processed by pharmacy staff on 3/22/19, two pharmacy computer software alerts were generated for duplicative anticoagulants and potential drug-drug interactions (changes in a medication's effect on the body when that drug is taken together with a second drug) between apixaban and heparin. The alerts were reviewed by Staff Pharmacist 1 (RPH 1) who was supposed to notify MD 1 to clarify intent or alternatives. RPH 1 did not contact MD 1, over-rode the alert, and the orders were processed for nurses to administer the drugs. No alerts for duplicate anticoagulation or drug-drug interactions were generated by the computer software for the combination of SQ heparin with aspirin, and no clarifications were documented.

In addition, a home medication to control heart rhythm (amiodarone, which can affect the liver and result in accumulation of apixaban and heparin in the blood) was also ordered at admission without triggering any computer software alerts. In a review of pharmacy records on 12/5/19, the medication safety pharmacist (RPH-MS) confirmed that MD 1 issued an electronic communication request on 3/23/19 at noon for a pharmacist to review all of Patient 1's current medications to determine which drugs could be toxic to the liver. In response to MD 1's request, RPH 4 documented on 3/23/19 at 12:55 p.m., "Spoke to [MD 1] most likely cause of sudden hepatotoxicity (liver dysfunction) is amiodarone and levofloxacin (an antibiotic)." RPH 4 further described all the mediations that potentially could have contributed to liver damage and included aspirin and apixaban among those. However, from that review of all medications, RPH 4 failed to note (and warn the physician of) the presence of duplicate therapy with apixaban and heparin, or added bleeding risk from aspirin.

Patient 1's MAR showed that amiodarone was given to Patient 1 on 3/22/19 at 10:51 p.m., and again on 3/23/19 at 9:51 a.m., after which it was discontinued. Patient 1's elevated liver tests peaked on 3/23/19 and showed improved trends after the amiodarone was stopped.

On 3/24/19 a cardiologist (MD 5) wrote a consultation assessment to help guide management of A Fib. MD 5 listed all 3 blood thinner medications in the consultation note without commenting on their necessity or their raising the risk for bleeding. MD 5 determined that Patient 1 had not had a heart attack, was not in heart failure, and Patient 1's heart rhythm condition was stable. MD 5 indicated that the amiodarone likely caused the liver problems, which were improving.

Between 3/22/19 and 3/25/19, RNs administered blood thinner medications to Patient 1 on 19 occasions without clarifying the medication orders for 3 different ones, or documenting discussions of bleeding risks with the treating physicians.

Review of laboratory (lab) orders and results indicated no baseline tests to measure Patient 1's blood clotting status (coagulation studies, coag labs), and no periodic coag labs ordered between 3/22/19 and the evening of 3/25/19. Complete blood count (CBC) tests to measure hemoglobin (a molecule inside each red blood cell that carries oxygen to organs and tissues) and platelet count (blood particles that form blood clots) were performed on 3/22/19, 3/23/19, and 3/24/19, but not ordered for 3/25/19 until early evening, after Patient 1 experienced a series of 5 episodes of significant low blood pressure (BP) throughout the day without recovery to previous hospital baseline. These episodes required administration of 5 fluid boluses (volumes of salt water injected into the bloodstream ranging from 8 to 16 ounces at a time) to stabilize Patient 1's BP. On 3/25/19 while this was occurring, two physicians (MD 2 and MD 6) assessed Patient 1 without documenting concern for bleeding as a cause of the unstable BP, or ordering tests to further assess. Following the first episode of low BP that resulted in administration of the first fluid bolus at 10:38 a.m., RN 3 proceeded to administer the 3 blood thinners at their scheduled time (at 10:40 a.m.), without clarifying intent or risk.

On 3/25/19 at 11:29 a.m., MD 2 documented an assessment that noted, "Medications Reviewed." On 3/25/19 at 11:35 a.m. MD 2 wrote an order for SQ heparin with a longer frequency interval from the previous order. This order triggered an alert to the pharmacy staff, who contacted MD 2, after which all SQ heparin was stopped entirely. However, MD 2 issued no orders at that time for a CBC or coag labs to determine the current coagulation profile, or to better understand why low BP was occurring. MD issued no orders for medications to reverse the effects of the duplicative anticoagulants that had been given for 4 days, which may be producing internal (non-visible) bleeding and causing low BP. MD 2 did not document consultation with specialists in blood disorders or liver diseases to assist in the analysis of potential anticoagulation toxicity and significant increased bleeding risk.

Previous CBCs drawn between 3/22/19 and 3/24/19 showed a gradual decline in hemoglobin measurement from 11.5 to 10.4 (normal value is 11.7-15.5 grams/deciliter), and in platelet count from 210,000 to 163,000 (platelets can be diminished by heparin and fail to function effectively, normal value is 175,000 - 450,000 per microliter but may be elevated as a result of chronic kidney disease). 8-9 hours after the low blood pressure episodes began on 3/25/19, when a CBC was eventually obtained, the hemoglobin result was much lower, 7.3, and platelet count was 143,000. CME and ADHS agreed that the degree of hemoglobin drop was consistent with shock from bleeding.

Further review of Patient 1's medical record indicated that during Patient 1's 4th episode of low blood pressure at 2:26 p.m. on 3/25/19, a Rapid Response Team nurse (RRT 1, member of a clinical team which brings critical care expertise to the bedside when requested) was summoned to assess and treat low BP through an RRT's authority to implement physician approved protocols. RRT 1 documented at 3 p.m. that MD 2 ordered a fluid bolus and a medication to raise BP. RRT 1 did not document why she did not implement the RRT protocol for low BP, which directed the RRT to order a CBC and administer a fluid bolus. RRT 1 did not document a physical assessment (also required by the protocol), but noted, "Stabilized and remained on the unit (not transferred to a critical care unit)." The medication ordered by MD 2 to raise BP was never administered.

Patient 1 had a 5th episode of low BP at 4:27 p.m. on 3/25/19, for which RRT 1 was again involved. RRT 1 documented on 3/25/19 at 4:40 p.m. (at the second RRT encounter for that afternoon) that Patient 1's abdomen was firm, distended, and painful to touch. (Physical signs of possible internal bleeding)

ADHS indicated that at both encounters RRT 1 had authority (through protocols) to order laboratory tests such as CBC when assessing low BP in a patient at high risk for bleeding, but did not pursue such orders or document discussing lab test orders with a physician. After the 5th low blood pressure episode, MD 2 ordered a CBC and abdominal x-ray, but coag labs were not ordered and treatments were not given to reverse the effects of the blood thinner medications.

Review of nursing assessment documentation on 3/24/19 and 3/25/19 was incomplete. Early morning nursing notes on 3/24/19 documented skin bruising at the blood vessel site in Patient 1's arm where needles could be inserted to cleanse the blood of toxins (dialysis arteriovenous fistula) and bruises on the abdomen where SQ heparin injections were given. (Bruising can be a sign of thin blood and minor bleeding from medications or disease.) 3/24/19 evening nurse assessments for skin and abdomen were not documented. Similarly, on the morning of 3/25/19, a head-to-toe nursing assessment which should have included skin and abdomen, were not documented. RRT 1 failed to document physical assessment of organ systems relevant to low BP at a first RRT encounter on 3/25/19 at 3 p.m., and mentioned only the abdominal findings at the second RRT encounter on 3/25/19 at 4:40 p.m. Specifically, RRT 1 did not specify the presence or absence of bleeding at skin sites or elsewhere on the body.

On 3/25/19 at 4:40 p.m., RRT 1 documented that MD 3 was at the bedside to assess Patient 1. MD 3 documented at 5:17 p.m. a comprehensive H&P-like assessment with a plan to move Patient 1 to the Intensive Care Unit (ICU) to stabilize the blood pressure. MD 3's note did not capture significant aspects of Patient 1's condition leading up to the events of 3/25/19. For example, there was no mention of liver dysfunction caused by amiodarone, and that once amiodarone was stopped on 3/23/19, the severity of liver dysfunction was improving. (Awareness of amiodarone's previous potential to cause accumulation of apixaban and heparin, in the clinical context of low BP and abdominal pain that was sudden and new, could strongly point to internal bleeding, even if liver tests were improving on 3/24/19.) Patient 1's low BP was sudden and abrupt on the morning of 3/25/19. Just the day prior on 3/24/19, MD 5 had found Patient 1 not to be in heart failure and not to have had a heart attack. Yet, MD 3 determined the cause of Patient 1's unstable BP and need for ICU care to be from heart failure, or possibly a blood infection. (Abdominal pain, distention, and tenderness with unstable BP are not typical features of heart failure or blood infection, but more likely suggest sluggish blood circulation from blood loss.) Lastly, if MD 3 believed Patient 1's shock was caused by blood infection, MD 3 never ordered blood culture tests to confirm. In addition, MD 3 documented intent to resume amiodarone if Patient 1's intermittent heart rhythm problem surfaced, a drug which had just been shown to damage Patient 1's liver. MD 3 documented intent to administer apixaban "if necessary," which would only increase the risk for further bleeding.

According to the ICU physician coverage schedule for 3/25/19, as explained by the ICU's Clinical Manager (CM) on 11/5/19 at 12:05 p.m., MD 3's assigned work shift ended at 5 p.m. However, MD 3 issued medication orders for Patient 1 on 3/25/19 at 5:32 p.m. and 6:35 p.m. A nursing note entered at 7:55 p.m. documented that MD 5 was "assessing patient," after an episode at 7:30 p.m. when Patient 1's blood pressure was 75/49 (significantly low, normal BP=120/80 millimeters of mercury).

Nursing flowsheet pain assessments on the night of 3/25/19 in the ICU documented:
-7:34 p.m. abdomen pain on palpation and with movement, pain at rest 4/10, pain with activity 10/10
-8 p.m. no change in pain, per patient "as long as I don't move a lot. It would not hurt." Pain at rest 4/10, pain with activity 10/10
-10 p.m. no change in pain, pain at rest 4/10, pain with activity 10/10
-Midnight no change in pain, pain at rest 4/10, pain with activity 10/10
-2 a.m. (on 3/26/19) no change in pain, pain at rest 4/10, pain with activity 10/10

Nursing flowsheet gastrointestinal system entries on the evening of 3/25/19 noted:
-6:38 p.m. and 7:34 p.m. dark brown stools (these were not sent to test for intestinal bleeding)
-8 p.m. abdomen firm, tender, taut all quadrants, dry-heaving, intermittent nausea, bruise(s) at the left upper arm [dialysis fistula] site (when Patient 1 had had no dialysis treatment since 3/22/19), bruising around skin puncture site (the last skin injection was at 10:40 a.m.)

Per the nursing entries and order times, MD 3 remained on site and involved in Patient 1's care for several hours after Patient 1 arrived to the ICU at 6:49 p.m. The CBC lab result with low hemoglobin of 7.3 was known (reported at 6:29 p.m.) while MD 3 was present. MD 3 was at the bedside "assessing" at 7:55 p.m. MD 3 issued an order for coag tests at 8:22 p.m. The RN was documenting significant pain "as long as I don't move a lot," firm tender abdomen, bruises at the dialysis fistula site, and continued unstable BP. Throughout this period, MD 3 did not document any further progress notes or assessments of Patient 1's shock. MD 3 did not document serial abdominal examinations for a potential surgical abdomen emergency, and did not document assessments to reflect consideration of (a) abdominal bleeding as a cause of Patient 1's shock, (b) a need to urgently reverse any of the blood thinner medications, or (c) an urgent need for surgical consultation.

Nursing note entered at 10:11 p.m. on 3/25/19 documented, "msg [message] sent to night rounding [MD] regarding Lab result, abd gen [abdomen general] appearance and pt c/o [patient complaining of] pain. [MD 4], seen the patient and with orders."

At 9:46 p.m. MD 4 issued an order for routine abdominal CT exam (computerized tomogram, type of imaging test) for "weakness and cough, abdominal pain," but no mention of unstable low blood pressure, drop in hemoglobin, distended firm abdomen, or increased bleeding risks (liver and kidney conditions). MD 4 also did not document any physical assessments of Patient 1, or progress notes to reflect the purpose of the imaging test and update the status of Patient 1's condition (stable or deteriorated) after "seeing the patient" around 10 p.m. The CT exam was performed at 10:20 p.m. but it was not promptly interpreted by a radiologist because it had not been ordered "STAT" (immediate).

According to the ICU physician coverage schedule for 3/25/19, MD 4 was assigned to take over care for MD 3's patients between 5 p.m. and 11 p.m. From 10 p.m. to 8 a.m., the responsibility for as many as 48 ICU patients was then assigned to NP 1, with one hour of overlap with MD 4 between 10 p.m. and 11 p.m.

No physical assessments of Patient 1 were documented by NP 1 from the time NP 1 started his shift at 10 p.m., 3/25/19 until after Patient 1 suffered a cardiac arrest (heart not pumping effectively and blood not circulating to vital organs) at 3:09 a.m. 3/26/19. There was therefore no documentation to indicate that NP 1 periodically assessed Patient 1 and evaluated Patient 1's abdominal condition, unstable blood pressure, and coag labs during the 10 p.m., 3/25/19 - 3:09 a.m., 3/26/19 interval. Coag labs were elevated consistent with increased risk for bleeding (International Normalized Ratio [INR) was 1.6 [normal is 1.2], prothrombin time [PT] was 19.4 seconds, [normal is less than 13] and partial thromboplastin time [PTT] was 62.6 seconds (normal is less than 30)]. A nursing entry at 33 minutes after midnight documented, "MD were [sic] made aware of coags studies result." The record was unclear who was "made aware" and when, as the elevated coag level results had been ready at 9:07 p.m.

A nursing note entered at 1:18 a.m., 3/26/19 documented, "Called film room (imaging department) regarding CT ABD result. [MD 4] earlier informed me that he had ordered stat CT abd, but the order entered was for routine. Staff at film room will change the routine order to stat and will have result in approx. [approximately] 1 hour or so."

Not until the bedside RN called the imaging department well after midnight for the abdominal CT exam result did anyone realize that the CT was not ordered STAT. The CT exam result was then called to the bedside nurse at 1:47 a.m. on 3/26/19. The CT exam showed a large fluid collection (likely blood) in the lower abdomen that posed a threat to the bowel's blood supply, and a more definitive type of CT (with contrast dye) was recommended. It is possible that had the initial physician order included more detail about the patient's serious condition, the Imaging Department may have used the information to expedite the resulting of the scan.

A nursing note entered at 1:55 a.m. documented, "Received call from CT film room of the CT abd result. And message sent to [NP 1] ... Awaiting callback/orders from [NP 1]."

NP 1 ordered a STAT abdominal CT with contrast at 2:03 a.m., 3/26/19, which was performed at 2:53 a.m. [To perform an abdominal CT exam, a patient must lie flat on the back. For patients with shock from bleeding into the abdomen, such a position can compromise blood pressure and circulation to vital organs.] The CT exam started at 2:54 a.m. in the imaging department. By 3:09 a.m., the CT exam had been completed and Patient 1 had returned to the ICU. At 3:09 a.m., Patient 1 suffered a cardiac arrest. NP 1 and ICU nurses successfully provided aggressive rescue interventions. At 3:10 a.m. the CT exam with contrast results were called to NP 1 who was busy with Patient 1's rescue. The results were definitively communicated to NP 1 by 3:37 a.m. The CT showed a very large blood collection in the muscle of the abdominal wall, and the blood supply to the bowel was cut off with gas leaking to surrounding tissues, posing a surgical emergency.

At 5:12 a.m., an offsite "eICU" (electronic ICU, a program in which critically-ill patients are remotely monitored using live interactive video and other specialized diagnostic tools and technologies) physician (MD 9) ordered a blood product "to reverse coagulopathy [condition where blood won't form clots sufficiently, bleeding will result] caused by [apixaban]." Emergency surgery was performed at 6:08 a.m., 3/26/19.

The medical record indicated MD 9 as the only provider to recognize the possible accumulation and toxicity of multiple blood thinner medications, or at least for apixaban. Unfortunately, the attempt to reverse the effects of Patient 1's blood thinners did not come until 20 hours after the first signs of low blood pressure began; low BP was the first sign of blood thinner toxicity. During encounters with 5 physician level providers and 3 or more RN providers throughout that period, none of those providers documented recognition of bleeding related to the blood thinner medications, which can be reversed if recognized timely.

In total, from Patient 1's admission on 3/22/19 when multiple blood thinner medications were ordered and continued to be administered, Patient 1 passed through the hands of 9 physician level providers, most of whom documented assessments where medication reviews (had they been conducted correctly) showed treatment with 3 blood thinners in a patient already at risk for bleeding. Patient 1 passed through multiple RN's who administered those medications on 19 occasions. Once the first pharmacy over-ride alert for apixaban and SQ heparin occurred, the pharmacists never correctly re-reviewed Patient 1's anticoagulation drug safety profile, until MD 2 attempted to revise but not stop a SQ heparin order on 3/25/19. No other effective safeguards were in place to prevent repeated errors, after the first and only pharmacy safeguard failed.

During surgery on 3/26/19, Patient 1's large bowel was found to be severely damaged with leakage into surrounding tissues that can be deadly. It was repaired, but after surgery, Patient 1 experienced organ failures and treatment was then directed to "comfort care." Patient 1 died on 3/27/19 at 11:27 a.m. Patient 1's death certificate listed the immediate cause of death to be "hemorrhagic (bleeding) shock," with a major underlying cause, "massive internal bleeding."

In an interview and review of Patient 1's medical record on 12/6/19 at 1 p.m., the Chief Medical Executive (CME) acknowledged that Patient 1's clinical picture of sudden, unexplained low blood pressure which progressed to abdominal pain and distention over 5- 6 hours on 3/25/19 (when just the previous day Patient 1 had no abdominal pain, no heart failure, no blood infection) was consistent with acute bleeding into abdominal wall muscle, and bleeding to compromise circulation to the bowel from which Patient 1 never recovered (died). CME agreed there was no other likely explanation for the significant bleeding episode besides the multiple blood thinner medications administered to Patient 1 over 4 days.

1.a. and b. Standards of Practice

In 11/5/19 at 1:30 p.m. and 11/5/19 at 2:40 p.m. interviews, the Clinical Manager for ICU (CM) and the Director of Pharmacy (DOP) stated that hospital policies and practices for medication safety, including blood thinner medications, relied on guidance from an Online Medication Information Resource (OMIR). In fact, electronic orders provided links for nurses to access the OMIR directly when withdrawing medications from a storage container prior to administering a drug to a patient.

Review of guidance published by the OMIR for heparin noted the following:

-Warnings/Precautions
Concerns related to adverse effects:
o Bleeding: May occur, including fatal events. Use with caution in patients with an increased risk of bleeding, including ... concomitant treatment with platelet inhibitors; ... severe liver disease; ... renal failure; ... or in patients (especially women) >60 years of age. Monitor patient closely for signs or symptoms of bleeding. Discontinue if bleeding occurs; severe hemorrhage or overdosage may require protamine (a medication used to reverse the effects of heparin- consult Protamine monograph for dosing recommendations).

-Drug Interactions
Apixaban: May enhance the anticoagulant effect of Anticoagulants. Refer to separate drug interaction content and to full drug monograph content regarding use of apixaban with vitamin K antagonists (VKA- a medication that acts against and blocks an action) (eg, warfarin, acenocoumarol) during anticoagulant transition and bridging periods. Risk X: Avoid combination
Aspirin: May enhance the anticoagulant effect of Heparin. Risk C: Monitor therapy

-Pharmacodynamics/Kinetics (effects of drugs and the mechanism of their action and movement throught the body): Additional Considerations
Renal (kidney) function impairment: The half-life may be increased.
Hepatic (liver) function impairment: The half-life may be increased or decreased.
Geriatric (elderly, over age 60-65): Plasma levels may be higher.

-Advanced Practitioners Physical Assessment/Monitoring
Obtain CBC including platelets and if there is any concern for bleeding stool occult (not visibly apparent or hidden) blood tests. Obtain aPTT (activated partial thromboplastin time- measures blood clotting time) prior to heparin therapy, 6 hours (pediatric: 4 hours) after initiation, and 6 hours (pediatric: 4 hours) after any dosage change; ... Blood coagulation (clotting) studies (anti-Xa, ACT (activated clotting time), or aPTT-tests to measure blood clotting time or levels) should guide therapy for full dose heparin. ... Screen for known or suspected history of heparin-induced thrombocytopenia (HIT-low platelet count). Monitor patient's weight prior to treatment and periodically throughout. Use caution in elderly patients; they have been shown to be sensitive to heparin, requiring lower doses ... Assess for signs and symptoms of bleeding, neurological impairment, and heparin-induced thrombocytopenia with/without thrombosis (blood clots). Consider protamine administration in patients that experience serious bleeding. Evaluate risk vs benefit of continuing/discontinuing.

Review of guidance published by the OMIR for apixaban noted the following:

-Monitoring Parameters
CBC, aPTT, PT, serum creatinine (measures the level of a waste product in the blood), and liver function tests prior to initiation, when clinically indicated, and at least annually (AHA/ACC/HRS [January 2014]; Leung 2019) ... In clinical situations when assessment of the anticoagulant effect is useful (eg, acute care, periprocedural settings, absorption), evaluating a recent creatinine clearance (CrCl, kidney test) and time since the last dose was ingested is usually sufficient for guiding clinical decisions. No commonly used coagulation tests can definitively exclude the presence of clinically relevant serum concentrations. A prolonged PT suggests clinically relevant serum concentrations are present, but normal PT and aPTT values cannot rule out the presence of apixaban. If available, the preferred test to rule out clinically significant serum concentrations and quantify anticoagulant effect is antifactor Xa activity calibrated specifically for apixaban (undetectable anti-Xa activity likely excludes clinically relevant drug concentrations). An antifactor Xa assay (a test to measure the presence or amount) calibrated for low molecular weight heparin can rule out clinically relevant drug concentrations, but is not useful for quantification (ACC [Tomaselli 2017]; AHA [Raval 2017]; Leung 2019).

-Advanced Practitioners Physical Assessment/Monitoring
Obtain renal function tests, CBC, and liver function tests as clinically indicated and at least annually. Consider patients age and weight as dose reduction or alternative therapy may be needed. Consider using an antifactor Xa assay or mass spectrometry (a test to analyze the molecular composition) to help guide treatment. Assess other medicines patient may be taking, alternate therapy or dosage adjustments may be needed. Assess for signs and symptoms of bleeding and neurological impairment ... Andexanet alfa (a DOAC reversal) is available as a reversal agent.

-Nursing Physical Assessment/Monitoring
Check ordered labs and report any abnormalities. Monitor for signs and symptoms of bleeding (bruising or bleeding that is not normal, changes in menstrual periods like lots of bleeding, spotting, or bleeding between cycles, nosebleeds that won't stop, bowel movements that are red or black like tar, throwing up blood or liquid that looks like coffee grounds).

-Metabolism: Hepatic predominantly via CYP3A4/5 (enzyme pathways) and to a lesser extent via CYP1A2, 2C8, 2C9, 2C19, and 2J2 to inactive metabolites

-Hepatic impairment: Use with caution in moderate impairment (Child-Pugh class B) as there is limited clinical experience in these patients; dosing recommendations cannot be provided. Use in severe hepatic impairment (Child-Pugh class C) is not recommended

-Renal impairment: Systemic exposure increases with worsening renal function. Bleeding risk may be increased in severe renal impairment (CrCl <15 to 29 mL/minute); use with caution. Patients with significant renal impairment (eg, CrCl <30 mL/minute) were excluded from clinical trials. Dosage reduction is recommended for patients with nonvalvular atrial fibrillation (an abnormal heart rhythm not associated with heart valve problems) and 2 of the 3 following risk factors: Serum creatinine [less than or equal to]1.5 mg/dL, age [less than or equal to] 80 years, or weight [less than or equal to] 60 kg. Compared to warfarin, apixaban has been shown to be

Based on staff interview, medical record and document review, the hospital failed to safely provide nursing services when:

A. Registered Nurses (RNs) failed to document physical assessments according to policy, policies lacked guidance for nurses related to anticoagulant medication (blood thinners) and, educational opportunities were missed to ensure RNs were competent to care for patients on anticoagulant medications. (Refer to A395) and;

B. Registered Nurses (RNs) administered medications to Patient 1 including three anticoagulant (blood thinner) medications concurrently and Patient 2 received two anticoagulant medications concurrently. These medication errors contributed to Patient 1's death on 3/27/19 and to a second medication error with Patient 2 on 4/6/19 (refer to A405).

These failures placed patients at risk for inconsistent and substandard care, injury and harm, including death.

The cumulative effect of these systemic failures resulted in the inability of the hospital to comply with the Condition of Participation: Nursing Services.

Based on interview and record review, the hospital failed to ensure Registered Nurses (RNs) delivered patient care in accordance with accepted standards of practice and hospital policy and procedures when:
a. There was a lack of documented physical assessments of Patient 1's deteriorating condition;
b. Policies lacked guidance for nurses related to anticoagulant medication (blood thinners) and;
c. Critical education was not provided to RNs to ensure they were competent to care for patients on anticoagulant medications.

These failures contributed to (a.) the healthcare team not having access to critical information needed to guide clinical decision making for Patient 1 and (b. and c.) put all patients prescribed blood thinners at risk for serious bleeding or death.

Findings:

a. During collaborative reviews of Patient 1's medical record on 11/5/19 with Health Informatics (HI) at 9 a.m., 11 a.m., and 3 p.m., with Medical Doctor-MD 1 on 11/7/19 at 9 a.m., with RNs 1 and 2 on 11/7/19 at 10:15 a.m., with RN 3 on 11/7/19 at 10:50 a.m., with MD 5 on 12/4/19 at 12:04 p.m., with the Chief Medical Executive (CME) and Administrative Director of Hospital Supervision and Medical Surgical Units (ADHS) on 12/5/19 at 11:30 a.m., with CME and ADHS on 12/6/19 at 1 p.m., all of the following documentation in the clinical record of Patient 1 and/or missing documentation was confirmed.

A review of Patient 1's Admission History and Physical Examination (H&P) Note written by MD 1 indicated Patient 1 was admitted to the hospital on 3/22/19 for acute unexplained liver dysfunction and influenza infection. Patient 1's risk factors for bleeding included chronic kidney failure on hemodialysis (a procedure to filter the blood and remove extra fluids), liver failure, chronic heart disease, age 70, and a weight below 60 kilograms (kg - a measurement of weight). Patient 1 was anticoagulated (blood clotting time was prolonged or inhibited) on admission from a home medication she was previously taking, apixaban (a blood thinner).

A review of the medication orders according the Medications and Administration (MAR) at the time of admission included the following blood thinners or anticoagulant drugs:
-apixaban 2.5 mg (milligrams) to be given 2 times daily, no indication was included in the order;
-heparin 5,000 units to be injected into the subcutaneous tissue (under the skin) every 8 hours, indication was for "moderate risk" of blood clots forming in the legs or chest; and
-aspirin 81 mg to be given once daily, no indication was included in the order.

Between 3/22/19 and 3/25/19, RNs administered the 3 different blood thinner medications on 19 occasions. There was no documented evidence any RN clarified the orders or discussed bleeding risks with the treating physicians.

Review of nursing assessment documentation on 3/24/19 and 3/25/19 was incomplete:
3/24/19, 7:40 a.m. flowsheet entry included an assessment of "bruises" to Patient 1's fistula (a blood vessel site in the arm where needles could be inserted to perform dialysis) on the left arm and bruising to the abdomen, however, the night shift nurse on 3/24/19 did not document assessments for skin and/or abdomen.

In an interview and medical record review with RN 3 on 11/7/19 at 10:50 a.m., RN 3 stated she was the primary nurse for Patient 1 on 3/25/19. She described Patient 1 as having an episode of low blood pressure that resulted in administration of a fluid bolus (a treatment to increase blood volume) at 10:38 a.m. RN 3 verified she administered the 3 blood thinners at 10:40 and 10:41 a.m. RN 3 stated Patient 1 continued to have significant drops in blood pressure (documented as low as 70/36; normal BP=120/80 mmHg millimeters of mercury) while receiving repeated boluses throughout the day. RN 3 acknowledged a head-to-toe nursing assessment which should have included skin and abdomen, were not documented.

In a 12/6/19, 11:20 a.m. interview with the Nurse Manager (NM) for the medical surgical unit where Patient 1 was admitted to, the NM verified it was the expectation that RNs document a full head- to -toe assessment of their patient's at least one time per shift and again as needed for a change of condition.

During Patient 1's 4th episode of low blood pressure on 3/25/2019 at 2:26 p.m., a Rapid Response Team nurse (RRT 1, member of a clinical team which brings critical care expertise to the bedside when requested) was summoned to assess and treat low BP through an RRT's authority to implement physician approved protocols. RRT 1 documented at 3 p.m. that MD 2 ordered a fluid bolus and a medication to raise BP. RRT 1 did not document why she did not implement the RRT protocol for low BP, which directed the RRT to order a CBC (Complete Blood Count- tests to measure hemoglobin- blood cell molecule that carries oxygen to organs and tissues) and administer a fluid bolus. RRT 1 did not document a physical assessment (also required by the protocol), but noted, "Stabilized and remained on the unit (not transferred to a critical care unit)." The medication ordered by MD 2 was never administered. RRT 1 failed to document physical assessments of organ systems relevant to low BP at a first RRT encounter on 3/25/19 at 3 p.m., and mentioned only the abdominal findings at the second RRT encounter on 3/25/19 at 4:40 p.m. Specifically, RRT 1 did not specify the presence or absence of bleeding at skin sites or elsewhere on the body.

Patient 1 had a 5th episode of low BP (70/36 mmHg) on 3/25/2019 at 4:27 p.m., for which RRT 1 was again involved. RRT 1 documented on 3/25/19 at 4:40 p.m. (at the second RRT encounter for that afternoon) that Patient 1's abdomen was firm, distended, and painful to touch (physical signs of possible internal bleeding).

In an 8:35 a.m., 12/4/19 interview, RRT 1 concurred that if using an RRT protocol, all interventions within that protocol were to be done and stated there would "always be documentation" of an RRT call in the medical record. The nurse (RRT 1) added that the documentation would "always" include patient assessment results.

The ADHS indicated that at both encounters RRT 1 had authority (through protocols) to order laboratory tests such as CBC when assessing low BP in a patient at high risk for bleeding, but did not pursue such orders or document discussing lab test orders with a physician.

Due to Patient 1's signs and symptoms of a deteriorating clinical condition she was transferred to the Intensive Care Unit (ICU) on the evening on 3/25/19.

A review of laboratory orders indicated no baseline tests to measure Patient 1's coagulation function were completed on admission or done until the early evening of 3/25/19. CBC and platelet count (blood particles that form blood clots) were performed on 3/22/19, 3/23/19, and 3/24/19, but not ordered for 3/25/19 until early evening.

According to an Operative Note dated 3/26/19 at 7:07 a.m., Patient 1 underwent emergency surgery.

During surgery, Patient 1's large bowel was found to be severely damaged. It was repaired but after surgery Patient 1 experienced significant organ failures. Patient 1 died on 3/27/19 at 11:27 a.m.

Patient 1's Certificate of Death listed the immediate cause of death as, "Hemorrhagic (bleeding) Shock" and the underlying cause as "Massive Internal Bleed".

Review of the hospital policy for "Routine Vital Sign, I&O, Assessments, Unit Protocols", last revised 10/4/19 directed, "Nursing Staff are responsible for completing and documenting ... assessments ..." The Policy stipulated Medical Surgical Units and Oncology/ BMT (Bone Marrow Transplant) Units assessments are to be done as follows, "Head to toe assessment Q (every) shift and focused reassessment as condition warrants". The Policy cites the evidence as, "Taking vital signs [blood pressure, heart rate, etc.] is an important part of the role of a nurse. It is a mechanism, for monitoring patient progress and detecting potential complications. Some researchers have concluded, however, that complications are most often found by generalized observation by the nurse, not vital signs ..."

Review of the Policy Standardized Procedure for Rapid Response Team (RRT) interventions, effective 8/2/18, stipulated, "The RRT RN will perform the following steps in practice: Obtain and document an initial assessment in the medical record ... RRT RN will notify physician with outcomes of treatment and/or abnormal data..." Also, "Record all assessments in the medical record. Document interventions and/or treatment follow-up in the medical record."

The policy titled, "Chain of Command for Management of Patient Care Concerns", revised 8/9/2019, described, "If a healthcare professional has reason to doubt or question the care provided to any patient, or believes that the best interests of the hospital or its patients have been, or may be jeopardized by the behavior of any hospital employee or Medical Staff member, intervention is required ... Every healthcare provider holds a duty of care... requires that questions regarding the medical treatment plan for the patient are resolved in a timely manner and in the patient's best interests ... In all such cases, the quality review process will be employed retrospectively to identify opportunities for learning and practice enhancement." The directive included, "When an RN has a specific concern ... it is that RN's responsibility to communicate those concerns to the treating physician to seek resolution." The policy describes the process of elevating concerns to or from the primary RN and treating physician, and if unresolved it is to be elevated to the Nurse Director/ Supervisor. If still unresolved the concern is elevated to the Chief of Service or designee and so on. The documentation requirement included, "The medical record needs to show that the chain of command was used to provide the best possible treatment for the patient."

According to the hospital's Job Description for the Chief Nurse Executive (CNE), last revised 12/16/19, the responsibilities of the CNE are as follows:
"...serves as the primary resource in assuring the delivery of high quality ... nursing care ..."
" ...This position has overall accountability for providing leadership, direction, and administration of day-to-day operations associated with direct patient care activities and clinical education and development including continuous improvement of nursing services ..."
" ...Ensures timely implementation to support achievement of system-wide goals and targets ..."
" ...Responsible for the development and implementation of policies, standards and programs that support clinical practice and provide nursing care ..."

b. Review of the hospital policy for "Adult and Pediatric Anticoagulation Therapy", effective 3/19/18, listed the following anticoagulants: warfarin, [enoxaparin], heparin, and "Other agents used for anticoagulation include: ... apixaban [a Direct Oral Anticoagulant- DOAC] ..." The policy included a table which included the "drug, labs to evaluate, reversal, adverse events, and nursing implications". This table did not include DOACs. The policy directed, "Initial Assessment: 1. Review and verify physician order for anticoagulation administration and parameters for monitoring/ reporting lab results. 2. Check appropriate baseline labs as ordered by physician. Report if abnormal ..." and "Ongoing Care: 1. Every shift, assess patient for evidence of active bleeding: evaluate mucous membrane, bruising/ petechiae (very small bruise-like spots due to bleeding under the skin), blood in urine, stool, emesis, excessive menstrual bleeding ..." The policy stipulated notifying the physicians with evidence of active bleeding and critical lab values. The "Procedure" section of the policy did not include DOACs.

The hospital policy titled, "Management of High Alert Medications", revised 8/27/19, defined high alerts medications as, "drugs that bear a heightening risk of causing significant patient harm when they are used in error ... consequences of an error are clearly more devastating to patients". Appendices to the policy included lists of high alert medications and "comments" or "Safety Strategies" which included monitoring, administration instructions, and dosing adjustments. The appendix A was "a nursing- specific reference outlining interventions required for administration of certain high alert medications". Review of Appendix A revealed it did not include the blood thinners warfarin, DOACs, subcutaneous heparin, or enoxaparin. However, Appendix B "a pharmacy- specific reference outlining some of the strategies the pharmacy uses" included enoxaparin and warfarin. Appendix B did not include DOACs or subcutaneous heparin.

Review of the hospital's 6/20/19 "Anticoagulation Management Plan Policy" reflected, "The TJC [The Joint Commission, the organization which accredits the hospital, thus allowing it to receive federal and State reimbursement for medical expenses] National Patient Safety Goal (NPSG) 03.05.01 focuses on anticoagulation therapy. The rationale for this requirement is that anticoagulation is a high-risk treatment which commonly leads to adverse drug events due to the complexity of dosing these medications, monitoring their effects ...Oral anticoagulation can cause significant morbidity (disease or sickness) and mortality (death) when the patient is inadequately monitored. The cost... of hemorrhagic [bleeding] complications with over-anticoagulation ...can be substantial... Nurses: 1. Assure awareness of patient safety issues of anticoagulation and NPSG 03.05.01. 2. Assure competency on anticoagulation therapy and patient safety ...Performance Improvement... Staff education is performed as indicated ...."

During an 11:46 a.m. interview on 12/3/19, Registered Nurse 12 (RN 12) stated that if she encountered orders for more than one anticoagulant medication, she would review the reasons each drug was ordered, including a pharmacist in the review as needed. RN 12 indicated she would contact the patient's physician, ask if both medications should be given, and document the answer in the medical record. In addition, RN 12 stated she would assure that coagulation-related laboratory tests were done before giving the first dose of an anticoagulant medication and she would monitor test results and bleeding risks. RN 12 indicated she would assess for bleeding if a patient developed low blood pressure and ensure it was documented accordingly.

According to the hospital's Job Description for the Chief Nurse Executive (CNE), last revised 12/16/19, the responsibilities of the CNE are as follows:
"...serves as the primary resource in assuring the delivery of high quality... nursing care..."
"...This position has overall accountability for providing leadership, direction, and administration of day-to-day operations associated with direct patient care activities and clinical education and development including continuous improvement of nursing services ..."
"...Ensures timely implementation to support achievement of system-wide goals and targets..."
"...Responsible for the development and implementation of policies, standards and programs that support clinical practice and provide nursing care..."

c. In an interview on 11/7/19 at 2:15 p.m., the Director of Pharmacy (DOP) stated that in December 2018 TJC announced its plan to adopt a new NPSG for DOACs by July 2019. "We knew this was coming."

In an interview on 12/6/19 at 1:03 p.m., the Medication Safety Pharmacist (RPH-MS) indicated that she knew about the TJC requirement last December.

During an 8:25 a.m. interview on 12/5/19, the Administrative Director of Clinical Resources (ADCR) stated that the hospital had received a TJC "Sentinel Event Alert" which indicated the accrediting organization "was starting to see issues nationwide" with direct oral anticoagulants.

The 7/30/19 "Sentinel Event Alert 61" and its accompanying "10 ways to be prepared to treat patients on direct oral anticoagulants (DOACs)" document reflected, "Anticoagulants are the No. [Number] 2 top medications involved in error incidents causing death or serious harm ...Avoid therapeutic duplication. Because not all providers are familiar with all DOACs, they may accidentally prescribe a second anticoagulant ...The Joint Commission revised its National Patient Safety Goal ...on anticoagulation, effective July 1, 2019 ...Take actions to improve safety practices..."

In interviews on 12/3/19, 12/4/19 and 12/5/19, nurses on the adult medical and surgical units and intensive care units reported no awareness about Patient 1's event, any formal education, training, or guidance offered from hospital leaders to expand knowledge about newer anticoagulant medication use and risks, and/or how to assess and minimize the risks for bleeding in patients prescribed concurrent blood thinner medications, as follows:

During an 11:46 a.m. interview on 12/3/19, Registered Nurse 12 (RN 12) stated she was unable to recall receiving any inservice regarding anticoagulant administration in either the online education system or during in-unit huddles (team meetings at the start of shift).

In a 1:54 p.m., interview on 12/3/19, RN 13 stated she could not recall receiving any education this year regarding anticoagulant use.

During an 8:55 a.m.interview on 12/4/19, RN 15 stated she was unable to recall specific education offered related to anticoagulation therapy.

During an interview on 12/3/19 at 3:05 p.m., RN 7 stated she was not aware of any anticoagulant or DOAC problems within the hospital and confirmed there had been no shared learning or inservices regarding the use of DOACs. RN 7 stated she did not recall any online education system lessons regarding DOACs or anticoagulants.

In a 12/3/19, 3:15 p.m. interview RN 8 stated she was not aware of any online education system lessons for DOACs or anticoagulants and has had no inservices.

In an interview on 12/3/19 at 3:20 p.m., RN 9 confirmed she had not had any online education system lessons for DOACs or other anticoagulants, nor did she remember any inservices or shared learning.

Review of educational files of seven intensive care unit RNs 10 - 16 reflected no specific training related to anticoagulant or antiplatelet drugs (medications used to prevent or reduce the risk of blood clot formation) since 1/1/19.

In an e-mail with the Asst. Administrator for Quality and Risk (AAQPS) on 12/19/19, the AAQPS confirmed the Job Description for the Chief Nurse Executive (CNE), last revised 12/16/19, was substantively the same since March of 2019. The Job Description included the responsibilities of the CNE as follows:
"...serves as the primary resource in assuring the delivery of high quality ... nursing care ..."
" ...This position has overall accountability for providing leadership, direction, and administration of day-to-day operations associated with direct patient care activities and clinical education and development including continuous improvement of nursing services ..."
" ...Ensures timely implementation to support achievement of system-wide goals and targets ..."
" ...Responsible for the development and implementation of policies, standards and programs that support clinical practice and provide nursing care ..."

Based on interview and record review, the hospital failed to ensure Registered Nurses (RNs) administered medications in accordance with accepted standards of practice and hospital policy and procedures when:
a. Patient 1 received three anticoagulant (blood thinner) medications concurrently and;
b. Patient 2 received two anticoagulant medications concurrently.

These medication errors contributed to Patient 1's death on 3/27/19 and to a second medication error with Patient 2 on 4/6/19.

Findings:

a. Patient 1
During collaborative reviews of Patient 1's medical record on 11/5/19 with Health Informatics (HI) at 9 a.m., 11 a.m., and 3 p.m., with Medical Doctor-MD 1 on 11/7/19 at 9 a.m., with RNs 1 and 2 on 11/7/19 at 10:15 a.m., with RN 3 on 11/7/19 at 10:50 a.m., with MD 5 on 12/4/19 at 12:04 p.m., with the Chief Medical Executive (CME) and Administrative Director of Hospital Supervision and Medical Surgical Units (ADHS) on 12/5/19 at 11:30 a.m., with CME and ADHS on 12/6/19 at 1 p.m., all of the following documentation in the clinical record of Patient 1 and/or missing documentation was confirmed.

A review of Patient 1's Admission History and Physical Examination (H&P) Note written by MD 1 on 3/22/2019 indicated Patient 1 was admitted to the hospital on 3/22/19 for acute unexplained liver dysfunction and influenza infection. Patient 1's risk factors for bleeding included chronic kidney failure on hemodialysis (a procedure to filter the blood and remove extra fluids), liver failure, chronic heart disease, age 70, and a weight below 60 kilograms (kg - a measurement of weight). Patient 1 was anticoagulated (blood clotting time was prolonged or inhibited) on admission from a home medication she was previously taking, apixaban (Direct Oral Anticoagulant [DOAC]- a blood thinner).

A review of the medication orders according the Medications and Administration (MAR) at the time of admission included the following blood thinners or anticoagulant drugs:
-apixaban 2.5 mg (milligrams) to be given 2 times daily, no indication was included in the order;
-heparin 5,000 units to be injected into the subcutaneous tissue (under the skin) every 8 hours, indication was for "moderate risk" of blood clots forming in the legs or chest; and
-aspirin 81 mg to be given once daily, no indication was included in the order.

The H&P Note written by MD 1 and separately by a Nurse Practitioner (NP 2) student both described intent to continue giving the home medication (apixaban) for an episodic heart rhythm problem, to start a heparin in the hospital to prevent blood clots from forming, and to give aspirin for concern that Patient 1 was at risk for acute heart attack.

In an interview with the Director of Pharmacy (DOP) on 11/5/19 at 3:10 p.m., the DOP explained when the apixaban and heparin orders were processed by pharmacy staff on 3/22/19, two alerts were generated for duplicative anticoagulants and drug-drug interactions. The alerts were reviewed by Pharmacist 1 who over-rode the alert, and the orders were processed for nurses to administer the drugs.

According to Patient 1's, "Medications and Administration" (MAR), the following anticoagulant medications were given by multiple RNs as follows-
-Apixaban 2.5 mg:
3/22/19 at 10:52 p.m.
3/23/19 at 2:05 a.m. and 9:51 a.m.
3/24/19 at 8:33 a.m. and 8:44 p.m.
3/25/19 at 10:40 a.m.

-Aspirin 162 mg: was given in the Emergency Department on 3/22/19 at 9:03 a.m.
81 mg: were administered on 3/23/19 at 9:19 p.m.
3/24/19 at 8:35 a.m.
3/25/19 at 10:41 a.m.

-Heparin 5,000 units:
3/22/19 at 4:00 p.m. and 11:04 p.m.
3/23/19 at 9:51 a.m. and 4:56 p.m.
3/24/19 at 1:03 a.m., 8:33 a.m., 5:18 p.m., and 11:14 p.m.
3/25/19 at 10:41 a.m.

Between 3/22/19 and 3/25/19, RNs administered the 3 different blood thinner medications on 19 occasions. There was no documented evidence any RN clarified the orders or discussed bleeding risks with the treating physicians.

During a concurrent interview and medical record review on 11/7/19 at 10:15 a.m. with RN 1 and RN 2, both stated they cared for Patient 1 on 3/24/19. The RNs acknowledged they gave apixaban, aspirin, and heparin concurrently to Patient 1 as evidenced by the MAR. RN 1 and RN 2 could not recall seeking clarification from the physician or pharmacist. When asked if they should have administered the medications as ordered, RN 2 stated "probably not".

In an interview and medical record review with RN 3 on 11/7/19 at 10:50 a.m., RN 3 stated she was the primary nurse for Patient 1 on 3/25/19. She described Patient 1 as having an episode of low blood pressure that resulted in administration of a fluid bolus (a treatment to increase blood volume) at 10:38 a.m. RN 3 verified she administered the 3 blood thinners at 10:40 and 10:41 a.m. RN 3 stated Patient 1 continued to have significant drops in blood pressure with repeated boluses throughout the day. Patient 1 had with signs and symptoms of a deteriorating clinical condition and therefore was transferred to the Intensive Care Unit (ICU) in the evening on 3/25/19. RN 3 stated if she had lab results from coagulation tests (examples were prothrombin time or activated partial thromboplastin time- to assess blood clotting function in patients) that were elevated (prolonged clotting time), RN 3 stated she, "definitely would not have given the heparin". RN 3 also stated, "I should have asked the doctor" regarding the orders for apixaban and aspirin.

A review of all laboratory orders indicated no baseline tests to measure Patient 1's coagulation function were completed on admission or done until the early evening of 3/25/19. Complete blood count (CBC) tests to measure hemoglobin (blood cell molecule that carries oxygen to organs and tissues) and platelet count (blood particles that form blood clots) were performed on 3/22/19, 3/23/19, and 3/24/19, but not ordered for 3/25/19 until early evening.

A review of the Radiology Orders and Results for Patient 1 verified a CT (computed tomography scan- diagnostic imaging) was completed on 3/25/19 and 3/26/19 that showed a large blood collection in the abdomen and pelvis and the blood supply to the bowel was cut off, posing a surgical emergency.

A physician note written by an offsite "eICU" physician (MD 9) dated 3/26/19 at 5:23 a.m., indicated MD 9 ordered a blood product "to reverse coagulopathy (excessive bleeding) caused by [apixaban]." MD 9 was the only provider to document the accumulation and toxicity of multiple blood thinner medications. The note was documented 20 hours after the first signs of low blood pressure on 3/25/2019 despite encounters with 5 physician level providers and 3 or more RN providers throughout that period.

According to an Operative Note, dated 3/26/19 at 7:07 a.m., Patient 1 underwent emergency surgery.

During surgery, Patient 1's large bowel was found to be severely damaged. It was repaired but after surgery Patient 1 experienced significant organ failures. Patient 1 died on 3/27/19 at 11:27 a.m.

Patient 1's Certificate of Death listed the immediate cause of death as "Hemorrhagic (bleeding) Shock" and the underlying cause as "Massive Internal Bleed".

b. Patient 2
During a concurrent interview and review of Patient 2's medical record on 12/5/19 at 9:00 a.m., with the Clinical Effectiveness Consultant (CEC) the following was confirmed:

According to a Critical Care Progress note written by MD 3, dated 4/7/19 at 11:58 a.m., Patient 2 was admitted to the hospital's ICU on 4/6/19 [ten days after Patient 1's death]. The note indicated Patient 2 had chronic conditions that included diabetes (high blood sugar levels) and high blood pressure. Patient 2 had developed pneumonia and breathing difficulty with chest pain and was admitted to treat a heart attack and stabilize the lung function. Patient 2's heart function was also significantly reduced.

MD 3 documented that treatment for the heart attack included a heparin drip (a blood thinner to be continuously delivered intravenously, through a tube placed into a vein) and aspirin (a blood thinner) to be given daily. For VTE prophylaxis (Venous thromboembolism- to prevent blood clots from forming), MD 3 noted the same intravenous heparin drip was also intended for that. In the medication review portion of the note, MD 3 listed enoxaparin 40 mg (a blood thinner injected under the skin) to be given every 24 hours without indication of its purpose.

A review of "All Administrations of enoxaparin" and "All Administrations of Heparin...Drip", indicated the enoxaparin was administered on 4/6/19 at 10:53 a.m. Later on 4/6/19 at 5:09 p.m., the heparin drip was started. Enoxaparin was administered again on 4/7/19 at 8:59 a.m. On 4/7/19 at 12:05 p.m. enoxaparin was "discontinued." The heparin drip continued until 4/9/19.

There was no documented evidence of nursing notes or physician entries addressing the concern for Patient 2 receiving two medications for VTE prophylaxis, or being at increased risk for bleeding while receiving 2 blood thinner medications concurrently. A plan to monitor Patient 2 specifically for these unintended risks was not documented. No actual bleeding or need to reverse the blood thinners was identified in the record.

Standards and Policy-
In an interview with the DOP on 11/5/19 at 2:40 p.m., the DOP stated an [Online Medication Information Resource (OMIR)] was used as reference for nursing staff utilization.

Review of guidance published by the OMIR for heparin noted the following:
Concerns related to adverse effects: Bleeding: May occur, including fatal events. Use with caution in patients with an increased risk of bleeding, including... concomitant treatment with platelet inhibitors;... severe liver disease;... renal failure;... or in patients (especially women) >60 years of age. Monitor patient closely for signs or symptoms of bleeding.
-Drug Interactions
Apixaban: May enhance the anticoagulant effect of Anticoagulants... Risk X: Avoid combination
Aspirin: May enhance the anticoagulant effect of Heparin. Risk C: Monitor therapy

Review of guidance published by the OMIR indicated adverse effect warnings on concurrent use of two similar blood thinners such as heparin and enoxaparin plus aspirin as described below:
"Bleeding: May occur, including fatal events. Use with caution in patients with an increased risk of bleeding, including... concomitant treatment with platelet inhibitors (prevent clot formation); recent GI (gastrointestinal) bleeding; impaired hemostasis (inability to stop bleeding)..."
"Aspirin: May enhance the anticoagulant effect of Heparin."
"Agents with Antiplatelet (prevention clot formation) Properties... May enhance the anticoagulant effect of Enoxaparin."

Review of guidance published by the OMIR for apixaban noted the following:
The guidance indicated adverse effect warnings on concurrent use of apixaban with other anticoagulants and aspirin as noted below:
"As with all anticoagulants, bleeding is the major adverse effect of apixaban. Hemorrhage (bleeding) may occur at virtually any site...", "May increase the risk of bleeding, including severe and potentially fatal bleeding. Concomitant use of drugs that affect hemostasis increases the risk of bleeding...",
"Apixaban may enhance the anticoagulant effect of (other) Anticoagulants...", "Aspirin: May enhance the adverse/toxic effect of Apixaban. Specifically, the risk for bleeding may be increased."
-Nursing Physical Assessment/Monitoring: Check ordered labs and report any abnormalities. Monitor for signs and symptoms of bleeding (bruising or bleeding that is not normal...
-Hepatic (liver) impairment: Use with caution in moderate impairment... as there is limited clinical experience in these patients; dosing recommendations cannot be provided. Use in severe hepatic impairment...is not recommended.
-Renal (kidney) impairment: Systemic exposure increases with worsening renal function. Bleeding risk may be increased in severe renal impairment; use with caution. Use with caution in patients on hemodialysis; limited information is available.

During an 11:46 a.m. interview on 12/3/19, Registered Nurse 12 (RN 12) stated, "There is a hyperlink to [an online medication information resource]" for each ordered drug in the electronic medical record. In a concurrent demonstration, RN 12 accessed information regarding the anticoagulant enoxaparin and aspirin. The online medication information resource reflected possible adverse drug interactions between enoxaparin and other anticoagulants including heparin and DOACs, and medications classified as "antiplatelets."

In an interview with Health Informatics (HI) on 11/5/19 at 12:30 p.m., HI stated nurses do not receive "pop ups" or "best practice advisories"(electronic warning screens or alerts) in the electronic health record related to duplicate anticoagulation orders when administering medications.

During an 11:46 a.m. interview on 12/3/19, Registered Nurse 12 (RN 12) stated she had never received a warning "about two like medications."

During an 11:46 a.m. interview on 12/3/19, Registered Nurse 12 (RN 12) stated that if she encountered orders for more than one anticoagulant medication, she would review the reasons each drug was ordered, including a pharmacist in the review as needed. RN 12 indicated she would contact the patient's physician, ask if both medications should be given, and document the answer in the medical record. In addition, RN 12 stated she would assure that coagulation-related laboratory tests were done before giving the first dose of an anticoagulant medication and she would monitor test results and bleeding risks. RN 12 indicated she would assess for bleeding if a patient developed low blood pressure.

In an 8:35 a.m. interview on 12/4/19, RN 15 stated she "would question in the beginning if a patient was on two anticoagulants." RN 15 indicated she would clarify the medication orders with the physician and document the conversation in the medical record. In addition, she would assure that pertinent laboratory tests were ordered and would perform ongoing patient assessments.

Review of eight patient records reflected all medications in each electronic medication administration record were listed alphabetically. Medications were not listed by medication classification, which could help healthcare staff to identify like medications.

According to the hospital policy titled, Medication Administration (Adult and Pediatric), effective 6/25/18, " ...A well-planned and implemented medication management system supports patient safety and improves the quality of care, treatment and services..." Furthermore, the policy directed, "Consider concomitant and previously administered medications for drug interactions or additive adverse effects when administering medications". The policy reflected a medication's indication was only required for PRN (as needed) medications. The policy directed, "Questioning orders: See Administrative Policy for Chain of Command".

The policy titled, "Chain of Command for Management of Patient Care Concerns", revised 8/9/19, described, "If a healthcare professional has reason to doubt or question the care provided to any patient, or believes that the best interests of the hospital or its patients have been, or may be jeopardized by the behavior of any hospital employee or Medical Staff member, intervention is required ... Every healthcare provider holds a duty of care... requires that questions regarding the medical treatment plan for the patient are resolved in a timely manner and in the patient's best interests ... In all such cases, the quality review process will be employed retrospectively to identify opportunities for learning and practice enhancement." The directive included, "When an RN has a specific concern ... it is that RN's responsibility to communicate those concerns to the treating physician to seek resolution." The policy describes the process of elevating concerns to or from the primary RN and treating physician, if unresolved it is to be elevated to the Nurse Director/ Supervisor. If still unresolved the concern is elevated to the Chief of Service or designee and so on. The documentation requirement included, "The medical record needs to show that the chain of command was used to provide the best possible treatment for the patient."

The hospital policy titled, "Management of High Alert Medications", revised 8/27/19, defined high alerts medications as, "drugs that bear a heightening risk of causing significant patient harm when they are used in error ... consequences of an error are clearly more devastating to patients". Appendices to the policy included lists of high alert medications and "comments" or "Safety Strategies" which included monitoring, administration instructions, and dosing adjustments. The appendix A was "a nursing- specific reference outlining interventions required for administration of certain high alert medications". Review of Appendix A revealed it did not include the blood thinners warfarin, DOACs, subcutaneous heparin, or enoxaparin. However, Appendix B "a pharmacy- specific reference outlining some of the strategies the pharmacy uses" included enoxaparin and warfarin. Appendix B did not include DOACs or subcutaneous heparin.

Review of the hospital's 6/20/19 "Anticoagulation Management Plan Policy" reflected, "The TJC [The Joint Commission, the organization which accredits the hospital, thus allowing it to receive federal and State reimbursement for medical expenses] National Patient Safety Goal (NPSG) 03.05.01 focuses on anticoagulation therapy. The rationale for this requirement is that anticoagulation is a high-risk treatment which commonly leads to adverse drug events due to the complexity of dosing these medications, monitoring their effects ...Oral anticoagulation can cause significant morbidity and mortality when the patient is inadequately monitored. The cost ...of hemorrhagic [bleeding] complications with over-anticoagulation ...can be substantial ...Nurses: 1. Assure awareness of patient safety issues of anticoagulation and NPSG 03.05.01. 2. Assure competency on anticoagulation therapy and patient safety ...Performance Improvement ...Staff education is performed as indicated ..."

Review of the hospital policy for "Adult and Pediatric Anticoagulation Therapy", effective 3/19/18, listed
the following anticoagulants: warfarin, [enoxaparin], heparin, and "Other agents used for anticoagulation include: ... apixaban [a DOAC] ..." The policy included a table which included the "drug, labs to evaluate, reversal, adverse events, and nursing implications". This table did not include DOACs. The policy directed, "Initial Assessment: 1. Review and verify physician order for anticoagulation administration and parameters for monitoring/ reporting lab results. 2. Check appropriate baseline labs as ordered by physician. Report if abnormal ..." and "Ongoing Care: 1. Every shift, assess patient for evidence of active bleeding: evaluate mucous membrane, bruising/ petechiae (very small bruise-like spots due to bleeding under the skin), blood in urine, stool, emesis, excessive menstrual bleeding ..." The policy stipulated notifying the physicians with evidence of active bleeding and critical lab values. The "Procedure" section of the policy did not include DOACs.

Based on observations, interviews and document review, the hospital failed to provide Pharmaceutical Services that meet the needs of the patients as evidenced by:

1. The hospital failed to prevent, identify and minimize patient harm as it related to the use and monitoring of high risk anticoagulants (medications that thin the blood) in accordance to professional standards of practice for 2 out of 8 sampled patients (Pts 1 and 2) when Patient 1 (Pt-1) was administered three concurrent anticoagulants (apixaban, heparin, and aspirin) for a period of 3 days which resulted in massive internal bleeding, hemorrhagic shock and death; and Patient 2 (Pt-2) was administered three concurrent anticoagulants (enoxaparin, heparin, and aspirin), after Patient 1's medication error, which could have resulted in excessive bleeding and harm (See A-0491).

2. The medication alert system did not alert medication interactions/duplications in accordance with professional standards of practice when Staff Pharmacist 1 (RPH 1), with alert fatigue, verified a significant medication interaction/duplication (Heparin/Apixaban) which was then administered, resulting in massive internal bleeding, hemorrhagic shock and death (See A-0491).

3. The hospital medical staff failed to establish policies and procedures for the safe administration of anticoagulants (blood thinner medication) consistent with professional standards of practice (See A-0273, A-0286, A-0297, A-0347).

4. The hospital failed to ensure that registered nurses administered anticoagulant medications within acceptable standards of practice (See A-0405).

An Immediate Jeopardy (IJ) situation was identified on 12/5/2019 at 4:40 p.m. related to Pharmaceutical Services tag A-491 [42 CFR 482.25], in the presence of the hospital's leadership.

The hospital developed and submitted an acceptable action plan that addressed the IJ situation, and the immediacy was removed on 12/05/19 at 10:05 p.m. The hospital implemented immediate corrective actions to address the issues, which included:

1. Two pharmacists validating appropriateness of all new oral anticoagulation orders known as DOAC or Direct Oral Anti-Coagulant.
2. Daily monitoring to review all patients on oral anticoagulants for duplication of therapy, dose adjustment, appropriate indication, drug interaction and laboratory review.
3. All ICU (Intensive Care Unit) and non-ICU patients on concurrent blood thinner medications will be reviewed for signs of bleeding including changes to blood laboratory work by both medical providers and Rapid Response Team (RRT) every 12 hours.

*More specific monitoring included any hemoglobin (a blood component vital to body function) decrease by 10 percent or more.
*Prompt notification of medical providers if any adult patient showed signs of bleeding or required fluid for resuscitation.
*RRT staff education on blood thinner medications and the new reporting procedure to medical providers.

4. Medical staff education regarding concurrent use of newer generation blood thinners including its use, risks and monitoring.
5. Medical Staff will document a bleeding risk assessment on a daily basis if a patient was on concurrent blood thinners.
6. Nursing staff education on monitoring and bleeding risk assessment.

The survey team conducted observations, interviews, and record reviews to ensure the changes took place before the IJ was removed on 12/06/19 at 5:30 p.m.

The cumulative effects of these systemic problems resulted in the hospital's inability to safely provide pharmaceutical services that meet the needs of the patients in accordance to the statutorily-mandated Conditions of Participation for Pharmaceutical Services.

40903

Based on interview, observation and record review the hospital, through its medical staff and pharmaceutical services, failed to prevent, identify and minimize patient harm as it related to the use and monitoring of high risk anticoagulants (medications that thin the blood) in accordance to professional standards of practice for 2 out of 8 sampled patients (Patient 1 and Patient 2) when:

1. Patient 1 (Pt-1) was administered three concurrent anticoagulant blood thinners (apixaban, heparin, and aspirin) for a period of 4 days which led to massive internal bleeding and death, and
2. Patient 2 (Pt-2) was administered three concurrent anticoagulation blood thinners (enoxaparin, heparin, and aspirin), after Patient 1's medication error, which could have resulted in excessive bleeding and harm, and
3. The medication alert system did not alert medication interactions/duplications in accordance with professional standards of practice when a pharmacist, with alert fatigue, verified a significant medication interaction/duplication (Heparin/Apixaban).

An Immediate Jeopardy (IJ-a situation in which the entity noncompliance has placed the health and safety of recipients in its care at risk for serious injury, serious harm, serious impairment, or death) situation was identified on 12/5/19 at 4:40 p.m. related to Pharmaceutical Services tag A-491 [42 CFR 482.25], in the presence of the hospital's leadership, including Chief Executive Officer (CEO), Chief Medical Executive (CME), Chief Nurse Executive (CNE), and Assistant Administrator for Quality and Risk (AAQPS).

The hospital developed and submitted an acceptable action plan that addressed the IJ situation, and the immediacy was removed on 12/05/19 at 10:05 p.m. The hospital implemented immediate corrective actions to address the issues, which included:

1. Two pharmacists validating appropriateness of all new oral anticoagulation orders known as DOAC or Direct Oral Anti-Coagulant.
2. Daily monitoring to review all patients on oral anticoagulants for duplication of therapy, dose adjustment, appropriate indication, drug interaction and laboratory review.
3. All ICU (Intensive Care Unit) and non-ICU patients on concurrent blood thinner medications will be reviewed for signs of bleeding including changes to blood laboratory work by both medical providers and Rapid Response Team (RRT) every 12 hours.

*More specific monitoring included any hemoglobin (a blood component vital to body function) decrease by 10 percent or more.
*Prompt notification of medical providers if any adult patient showed signs of bleeding or required fluid for resuscitation.
*RRT staff education on blood thinner medications and the new reporting procedure to medical providers.

4. Medical staff education regarding concurrent use of newer generation blood thinners including its use, risks and monitoring.
5. Medical Staff will document a bleeding risk assessment on daily basis if a patient was on concurrent blood thinners.
6. Nursing staff education on monitoring and bleeding risk assessment.

The survey team conducted observations, interviews, and record reviews to ensure the changes took place before the IJ was removed on 12/06/19 at 5:30 p.m.

Findings:

1. A review of Lexicomp online, a nationally recognized medication information resource, last accessed on 12/5/2019, indicated adverse effect warnings on concurrent use of apixaban with other anticoagulants and aspirin as noted below:

*Apixaban: "As with all anticoagulants, bleeding is the major adverse effect of apixaban. Hemorrhage (uncontrolled bleeding) may occur at virtually any site."
*Apixaban: "May increase the risk of bleeding, including severe and potentially fatal bleeding. Concomitant use of drugs that affect hemostasis (means flow of blood) increases the risk of bleeding."
*"Apixaban may enhance the anticoagulant effect of (other) Anticoagulants."
*"Aspirin: May enhance the adverse/toxic effect of Apixaban. Specifically, the risk for bleeding may be increased."

A 12/5/2019 review of Patient 1s (Pt-1) medical records, accompanied by Medication Safety Pharmacist (RPH-MS) and Pharmacy Supervisor 1 (Rx-Sup-1), indicated Pt-1 was admitted through the Emergency Department for weakness and cough on 3/21/2019. Pt-1s home medications were reordered to be continued in the hospital upon admission on 3/22/2019 at 15:45 p.m. Home medications included a blood thinner called apixaban that was used to treat his heart rhythm problems. Furthermore, Medical Doctor 1 (MD-1) ordered another blood thinner medication called heparin on the same day on 3/22/2019.

Further review of Pt-1s medical records on 12/5/2019, Pharmacist 1 (RPH-1) verified medications orders and reviewed them on 3/22/2019 without addressing the potential risk of duplicate blood thinner use as outlined below:

*On 3/22/2019 at 4:10 p.m., hospital's Electronic Health Record (or EHR, a computerized version of a patient's chart that made information available instantly and securely) alerted RPH-1 of duplicate medication therapy as a high level or "major" warning when apixaban and heparin were used together. RPH-1 overrode this "major" alert with no follow up or documentation of any intervention.

Review of Patient 1s Medication Administration Record (or MAR where medication administrations were recorded) indicated the following medications orders that were administered by various nursing staff:

Apixaban 2.5 mg orally twice daily; was administered on
3/22/19 at 10:52 p.m.,
3/23/19 at 2:05 a.m., and 9:51 a.m.,
3/24/19 at 8:33 a.m., and 8:44 p.m.,
3/25/19 at 10:40 a.m.

Aspirin 162 mg: was given as a one-time dose in the Emergency Department on 3/22/19 at 9:03 a.m.
Aspirin 81 mg orally once daily; was administered on
3/23/19 at 9:19 p.m.,
3/24/19 at 8:35 a.m.,
3/25/19 at 10:41 a.m.

Heparin 5,000 units inject subcutaneously (or SQ, injected under the skin) every 8 hours; was administered on
3/22/19 at 4:00 p.m., and 11:04 p.m.,
3/23/19 at 9:51 a.m., and 4:56 p.m.,
3/24/19 at 1:03 a.m., 8:33 a.m., 5:18 p.m., and 11:14 p.m.,
3/25/19 at 10:41 a.m.

Further review of Pt-1s medical records on 12/5/2019, accompanied by RPH-MS, indicated two opportunities for the pharmacists to address or intervene the duplicate orders and the drug interactions on 03/23/2019 as described below:

A. On 3/23/2019 at 12:00 p.m., concerns over Pt-1's elevated liver enzymes (elevated liver enzymes may indicate damage to liver) laboratory markers, prompted the MD-1 to ask Pharmacist 4 (RPH-4) to review the drug profile for any medication that may have contributed to the liver issue. RPH-4's medication list review, as described below, failed to detect the duplicate use of the blood thinners:

I. The order was written as "Rx-communication- General Pharmacy Communication" and noted "Please review current medication list to determine what is hepatotoxic (means toxic to the liver)."

II. In response to MD-1's request, RPH-4 documented an intervention dated 3/23/2019 at 12:55 p.m., as written in the records: "Spoke to MD-1- most likely cause of sudden hepatotoxicity is amiodarone (drug for heart rhythm) and levofloxacin (an antibiotic)." RPH-4, furthermore, described in detail all the medications that potentially could have contributed to the liver damage and included aspirin and apixaban in his review. RPh-4, however, failed to detect duplicate therapy with apixaban and heparin when he reviewed Pt-1s medication list. RPH-4 was not available for an interview per Medication Safety Pharmacist (RPH-MS) as he was off work for the whole week.

B. On 3/23/2019 at 8:34 p.m., MD-1 ordered aspirin to be given on a daily basis. Pharmacist 5 (RPH-5) reviewed and verified this order on 3/23/2019 at 8:42 p.m., when a "major" duplicate alert was overridden. There was no documentation of any note or intervention indicating justification for addition of aspirin to two other blood thinners already on the medication list.

In an interview with RPH-5 on 12/5/2019 at 10:45 a.m., he could not recall why he bypassed aspirin alert on 3/23/2019. He stated, Pt-1s medication list would have shown up on the right hand corner of his computer screen during order verification process and he may have missed noticing the duplicate orders. Furthermore, RPH-5 could not recall if he reviewed the blood lab work related to drop in hemoglobin (blood count) and platelet (platelet is a blood cell that forms clots - these labs could be markers of thinned blood or bleeding) or if he questioned the use of aspirin for an indication in the setting of triple blood thinner use.

A 12/5/2019 medical record review, indicated Pt-1 experienced a drop in blood pressure and blood counts on 3/25/2019, and was transferred to the Intensive Care Unit (ICU- a higher level of medical care in a hospital) and later surgery for further care. Duplicate anticoagulation was recognized when medication orders adjusted and a delayed lab work showed a dramatic drop in the patients' hemoglobin blood counts (a blood marker that shows anemia or blood loss). Pt-1 expired 2 days later on 3/27/2019, as a result of what was described as hemorrhagic shock (an acute medical condition associated with a fall in blood pressure) or excessive internal bleeding.

In an interview on 12/4/19 at 12:08 p.m., MD 5 (a heart doctor who documented a consultation for Patient 1 on 3/24/19) agreed that the concurrent administration of apixaban, heparin, and aspirin in a patient with kidney failure and liver failure significantly increased Patient 1s risk for bleeding. MD 5 agreed that with Patient 1's risk factors, the blood levels of heparin and apixaban could accumulate and produce unpredictable toxicity and bleeding. MD 5 stated, "The doses need to be reduced," and the heparin was unnecessary since Patient 1 was already anticoagulated with apixaban.

In an interview and review of Patient 1s medical record on 12/6/19 at 1 p.m., the Chief Medical Executive (CME) acknowledged that Patient 1s clinical picture of sudden, unexplained low blood pressure which progressed to abdominal pain and distention over 5- 6 hours on 3/25/19 (when just the previous day Patient 1 had no abdominal pain, no heart failure, no blood infection) was consistent with acute bleeding into the abdominal wall muscle, and bleeding to compromise circulation (blood flow) to the bowel from which Patient 1 never recovered (died). CME agreed there was no other likely explanation for the significant bleeding episode besides the multiple blood thinner medications administered to Patient 1 over 4 days.

A 12/5/2019 review of Sacramento County Certification of Death, issued on 10/30/2019, indicated "immediate cause of death was "hemorrhagic shock" and subsequent conditions leading to death was noted as "massive internal bleed", "ischemic colitis [an inflammatory condition of the large intestine, or colon that develops when there is not enough blood flow to the colon] with septic [blood stream infection] shock" ...


2. A review of Lexicomp online, a nationally recognized medication information resource, last accessed on 12/5/2019, indicated adverse effect warnings on concurrent use of two similar blood thinners such as heparin and enoxaparin plus aspirin as described below:
*"Bleeding: May occur, including fatal events. Use with caution in patients with an increased risk of bleeding, including ...concomitant treatment with platelet inhibitors; recent GI bleeding; impaired hemostasis..."
*"Aspirin: May enhance the anticoagulant effect of Heparin."
*"Agents with Antiplatelet Properties ...: May enhance the anticoagulant effect of Enoxaparin."

In a concurrent interview and review of Patient 2s (Pt-2) medical records on 12/6/2019 at 11:06 a.m., accompanied by RPH-MS and Pharmacy Supervisor-2 (Rx-Sup-2), indicated Pt-2 was admitted on 4/5/2019 and while in the Emergency Department, she was prescribed a preventive dose of enoxaparin, an anticoagulant or blood thinner. The first dose of enoxaparin was administered on 4/6/2019 at 10:53 a.m. On the same day on 4/6/2019 at 5:09 p.m., the physician ordered another anticoagulant called heparin to be given through IV (into the vein) infusion. Additionally, Pt-2 was placed on daily aspirin on 4/5/2019. Further review of the medical records indicated the following:
*The hospital's electronic health record did not produce a duplication alert for the pharmacist to see a concurrent use of pre-mixed IV heparin (drug mixed in a fluid for administration) and the enoxaparin.
*The hospital's electronic health system did not produce an alert for aspirin use which was ordered on 4/5/2019, and continued through 4/10/2019.
Patient 2 received IV heparin continuously in addition to another dose of blood thinner enoxaparin on 4/7/2019 at 08:59 a.m. This error was discovered on 4/7/2019 at 12:07 p.m., during Intensive Care Unit (ICU) rounds (means a care team of health care professionals including doctors and pharmacists) as documented in the medical record.

Interviews on 12/5/2019 at 09:30 a.m. and 12/6/2019 at 11:06 a.m., both RPH-MS and RX-Sup-2 acknowledged this error had a similar potential for harm and it happened about 2 weeks after the Pt-1s medication error event. This error was discovered when the RPH-MS was auditing the pharmacist's interventions. Both RPH-MS and RX-Sup-2, acknowledged the duplicate alert issue for pre-mixed heparin product had yet to be resolved and required a human factor to be vigilant in preventing similar errors. RPH-MS, additionally, stated that IV heparin infusion and other blood thinners were often used in the hospital's non- ICU units where no interdisciplinary (a team of health care professionals including doctors and pharmacists review patient status) rounding with a pharmacist was in place to monitor and intercept similar errors.

A review of the American Society of Health-System Pharmacy (ASHP) Guidelines, a nationally recognized professional standard of practice, accessed on 12/6/2019, in the document, entitled ASHP Guidelines: Minimum Standard for Pharmacies in Hospitals, indicated the following: "Medication therapy monitoring shall be conducted by pharmacists. Medication therapy monitoring includes a proactive assessment of patient problems and an assessment of the therapeutic appropriateness of the patient's medication regimen; Therapeutic duplication or omissions in the patient's medication regimen; and Medication-medication, medication-laboratory test ... and medication-disease interactions."

In an interview with Director of Pharmacy (DOP) on 12/3/2019 at 12:13 p.m., and 12/5/2019 at 12:55 p.m., he stated the heparin alert was a very common alert and there had been inconsistent flagging by their Electronic Health Record (EHR- a computerize system that tracks and facilitates shared medical information) system. DOP, described on a typical work day, a pharmacist would cover about 30-60 patients for order verifications and drug monitoring. The daily monitoring of anticoagulant medication was mostly focused on warfarin (a blood thinner) and the review of other medications that could show up in the renal report (a report that showed medication cleared through kidney). The DOP acknowledged, the computer generated renal (kidney) report was not designed to catch the duplication errors or replace the full anticoagulation monitoring. DOP's action plan to prevent further errors, was to educate the pharmacists on how to use anticoagulant tab in the EHR system and how to screen for duplication at the point of order verification. He agreed that this was not a full proof fix since the alert system had not been fully addressed by information technology team yet. Additionally, the renal report in its existing format was not able to detect the duplication of therapy for both Pt-1 and Pt- 2 cases.

In another interview with RPH-MS on 12/4/2019 at 3:21 p.m., she stated that the proposed duplication check at the point of order verification was not a forced function and it could not be tracked if a pharmacist missed it. Additionally, checking for presence of aspirin would add additional steps to order verification process since it could not be located in the same tab as anticoagulants within the EHR system. RPH-MS acknowledged, the ongoing monitoring of the newer blood thinner anticoagulants so far was not in the pharmacist's daily workflow and the hospital's corporate central office was working on a policy to address the routine monitoring of the new blood thinners.

In an interview with staff Pharmacist 7 (RPH-7) on 12/3/2019 at 2:46 p.m., she stated during her shift she reviewed and verified medication orders from her assigned units in addition to pharmacy managed protocols. She stated new anticoagulant orders were reviewed during order verification or if it showed up in the renal protocol (a protocol is a hospital approved procedure or system to review or monitor drugs) report for dosage adjustments.

In an observation and interview with staff Pharmacist 8 (RPH-8) in the Pharmacy on 12/3/2019 at 3:20 p.m., he stated they were told via email to look for duplicate anticoagulants by using the therapeutic class screening in the Electronic Health Record (EHR) system. He added, the only pharmacy managed anticoagulation protocol and monitoring in use, was warfarin (a blood thinner) dosing, education and laboratory review. RPH-8 stated that, in general, every order verification was an opportunity to do medication profile review if time permitted. He was able to run a real time report on all anticoagulants currently in use. This type of report, however, was not part of workflow, not operational and they were not required to routinely monitor and review the newer oral anticoagulant medications use in the hospital.

In an observation and interview with Pharmacist 6 (RPh-6) in the Pharmacy on 12/4/2019 at 11:50 a.m., he stated that they were required to document all medications discrepancy in the EHR interventions system. RPH 6 was observed verifying multiple duplicate pain medication orders and for each duplicate medication he had to put the order on hold and document an open intervention for follow up. RPH-6 stated the oral anticoagulant duplication with other similar agents should be reviewed the same way if intercepted during order verification phase. RPH-6 was able to run a real time report in the computer for a list of the newer anticoagulants in use. He, however, acknowledged that he was not aware of any workflow or report on how to review or monitor these newer anticoagulants on a routine basis.

In an interview with the pharmacy's operation manager (ADOP) on 12/4/2019 at 11:50 a.m., she confirmed the anticoagulation report was not part of the staff pharmacist's workflow yet. She cited that the medication safety pharmacist and regional information technology were working to make it operationalized. The ADOP added, the front line pharmacists were instructed to be vigilant and assess duplication and appropriateness upon order verification. However, she stated daily follow up and systemic focused monitoring of the newer anticoagulants was not part of workflow as of yet.

On 12/5/2019, a review of the undated hospital pharmacy's action plan titled, "Case Review + New process for High Risk Medications: Anticoagulation", indicated factors which contributed to Patient 1s (Pt-1) harm due to duplicate use of oral and injectable anticoagulant. The analysis mostly focused on missed duplicate alert, drug-drug interaction warning and asked pharmacist to review all medications in a different section of the EHR system. However, it did not have an ongoing or mandatory daily systemic monitoring of DOAC drugs.

On 12/5/2019 at 09:00 and 10:09 a.m., in an interview with Medication Safety Pharmacist (RPH-MS), she stated since the incident harming Patient-1, she had performed daily audits of oral anticoagulants for 3 months (May through July 2019), and then was changed to spot-check afterward. She added, so far her audits did not show any duplicate orders that a pharmacist may have missed during order verification. RPH-MS, however, acknowledged intercepting a duplicate anticoagulant use for Patient-2 on April 2019 which was reported to the hospital's medication error system. She was not aware of how the risk department had addressed this error and was not authorized to provide any further information. The RPH-MS also acknowledged the safety alerts and therapeutic duplications continue to pose a risk if missed by front line pharmacists when a forced function or a systemic workflow with emphasis on drug monitoring were not in place. The Medication Safety Pharmacist (RPH-MS), additionally, stated her efforts to help pharmacists proactively prevent harm had been limited to education of pharmacists in person or via email, on how to check for duplication of drugs in EHR system. The availability of an effective report to help operationalized routine monitoring of high risk blood thinners and its documentation were being considered by the hospital and its corporate organization.

A review of the American Society of Health-System Pharmacy (ASHP) Guidelines, a nationally recognized professional standard of practice, in the document, copyright 2013, entitled ASHP Guidelines: Minimum Standard for Pharmacies in Hospitals, indicated the following,"There shall be an ongoing program for monitoring drug utilization ... to ensure that medications are used appropriately, safely, and effectively, and to increase the probability of desired patient outcomes."

On 12/5/2019, a review of hospital's policy # 6506015 titled, "Anticoagulation Management Plan Policy (SHVA)" dated 6/20/19 indicated that, "The management of the therapeutic anticoagulation ... includes patients on therapeutic anticoagulation therapy (e.g. warfarin, low molecular weight heparins, heparin, argatroban, rivaroxaban, etc...) and "Excluded patients, include those receiving ... subcutaneous prophylaxis for VTE [prevention of blood clots]." The policy further included a statement that "Evidence suggests that an anticoagulation management approach that encourages ... proactive provider monitoring and intervention ... Oral anticoagulation can cause significant morbidity and mortality when the patient is inadequately monitored." The same policy in section D, titled "Other Anticoagulants (e.g. Argatroban, rivaroxaban, bivalridin, apixaban, dabigatran) further indicated, "Use facility drug specific approved order sets or panels to address initial dosing and dose adjustments as required if present." The performance improvement section of the same policy further included:
"Evaluation and update of anticoagulation plan, processes and safety practices to assure appropriate goals or improvement are achieved within and between facilities (e.g. Medication Use Evaluation)"
"Evaluation of new anticoagulation medication and emerging treatments"
"Prescriber and staff education is performed as indicated."

In an interview with RPH-MS on 12/6/2019 at 1:09 p.m., she acknowledged the current hospital policy did not address monitoring and proactive management of the newer generation of oral anticoagulants or blood thinners known as DOAC (Direct Oral Anti Coagulation) that could pose a significant bleeding risk if inadequately monitored.

In an interview with the RX-Sup-2 and RPH-MS on 12/6/2019 at 11:06 and 1:03 p.m., respectively, RX-Sup-2 stated that she were not aware of any Medication Use Evaluation (MUE- is a type of quality review of high risk medications use within the hospital) of the newer anticoagulant blood thinner medications as noted in their policy. RX-Sup-2 She also acknowledged there had not been a formal review to address the newer and emerging anticoagulants to be included in the hospital's performance improvement as indicated in the policy. Rx-Sup-2 added the two main DOAC currently in use, namely apixiban and rivaroxiban (blood thinners medications), were approved by regional and local Pharmacy and Therapeutic committee. She noted these drugs were much safer than warfarin (a blood thinner) and did not require drug level monitoring. RX-Sup-2 and RPH-MS could not explain what safe guards in terms of proactive risks and monitoring assessment were recommended when these drugs were approved for use in the hospital. RX-Sup-2 added, if a patient came to the hospital with a non-formulary (non-formulary drugs means the drugs that are not included in the list of preferred medications that a committee of pharmacists and doctors deem to be the safest and most effective) DOAC blood thinner, they will make all the efforts to have it available or use patient's own medication. However, no guidelines were in place for frontline staff on how to monitor them as of yet.

A 12/6/2019 review of the Pharmacy and Therapeutic Committee (P&T, an interdisciplinary hospital committee including medical staff responsible for all matters related to the safe use of medications) minutes from 1/11/2019, indicated an external safety report by the Institute for Safe Medication Practices (ISMP, an organization devoted entirely to preventing medication errors) titled "ISMP Action Agenda" for 3rd quarter of 2018 (July-September.) The ISMP report stated that "almost all inpatient settings... maintain a facility-specific list but only two-thirds have special precaution in place to prevent errors ... the medications that caused the most concern with regard to medications errors include anticoagulants ..." ISMP further recommended that the organization "employ effective risk-reduction strategies, especially for anticoagulants ...". ISMP's action agenda tool which helped organizations assess their safeguards on reported external safety alerts, was presented to the hospital's P&T committee on Jan 11, 2019, indicated no "action required" to address safe use and monitoring of the newer anticoagulant blood thinner medications.

Review of the facility policy titled, "Anticoagualtion Therapy, Adult and Pediatric" last revised on 10/1/2015 and approved on 3/19/2018 included the following, "Policy Statement ...Other agents used for anticoagulation include: Argatraban, Bivalirudin, Dabigatran, Apixaban, Fondaparanox, and Rivaroxaban." The section of the policy titled Drug which listed labs to evaluate, reversal, adverse events, and nursing implications listed only the following medications; heparin, lovenox, and warfarin.

Under section 11.15-2-a of the Medical Staff Rules, the Pharmacy and Therapeutics team was directed to "develop and implement professional policies regarding evaluation, selection, procurement, distribution, administration, safety, and other matters pertinent to drug use ... develop and implement related educational activities to meet the needs of physicians, pharmacists, and nurses." Critical elements of the facility policy titled, "Anticoagulation Management Plan Policy" approved 6/20/2019 were either not included in the policy or were not implemented as described within the policy. Review of the Medical Executive Committee (MEC) meeting minutes from January 2019 to October 2019 did not reflect approval of any other anticoagulation safety policies.

3. During an interview on 12/03/19 at 12:31 p.m., the Director of Pharmacy (DOP) stated that Staff Pharmacist 1 (RPH 1) verified an order to administer apixaban and heparin (medications that prevent the blood from clotting when used together could cause death due to excessive bleeding), resulting in the medications being administered for several days. DOP said the two drugs apixaban and heparin have not been verified for concurrent administration. DOP explained the pharmacy computer system did warn (with an alert) RPH 1 of the risk of concurrent administration of apixaban and heparin, however, RPH 1 ignored the medication alert, overrode the warning and verified the orders. The DOP stated that during the interview with RPH 1, RPH 1 had attributed the error to alert fatigue (clinician desensitization to safety alerts and as a result ignored or failed to respond to them.)

A review on 12/4/19 of the Institute of Safe Medication Practice (ISMP), a nationally recognized medication safety resource, document dated 2/28/19 and titled, "Your Attention Please"...Designing effective warnings indicated, "false alarms [false alerts], clinically insignificant alerts, and overwarning will lead to alert fatigue and cause rational practitioners to overlook them or habitually bypass them, even if that is not the intended action. When a warning is disregarded before it can be read, it becomes completely useless. The most effective way to reach the target audience and promote understanding and compliance is to make sure the warning is clinically important."

During an interview on 12/05/19 on 9:56 a.m., the Pharmacy Supervisor 2 (RxSup 2) stated she had directly interviewed RPH 1 regarding over-riding the medication alert, contributing to the medication error. RxSup 2 revealed that during her interview with RPH 1, RPH 1 was visibly distraught about her part in the medication error. RPH 1 had wanted everyone to know about the over-ride error, so others could learn from her mistake. RxSup 2 said RPH 1 had told her the medication alerts were not helpful and were often wrong, contributing factor to the alert fatigue and error. RxSup 2 said that RPH 1 had sent her multiple examples of non-clinically important and false alerts via email. RxSup 2 stated that these emails were deleted.

During an interview on 12/04/19 at 12:30 p.m., the Medication Safety Pharmacist (RPH-MS) stated that the medication alerts were categorized based on severity or risk of patient harm if the medication was administered: "low, moderate and major." "Low" indicated a low risk of patient harm and "major" signified a high risk of harm.

Documentation of the medication alerts that occurred for RPH 1 on 3/22/19, regarding the apixaban and heparin drug interaction/duplication, were reviewed. The DOP stated that RPH 1 had reviewed Patient 1's medications, but ignored the alert before verifying the orders. The alert for the apixaban and heparin drug interaction/duplication specified two risks for harm, "low/major risk".

During a concurrent interview on 12/04/19 at 12:35 p.m., RPH-MS stated the medication alert for the duplicate anticoagulant therapy should have been listed as "major". RPH-MS voiced she did not know why the drug-drug interaction was categorized as both "major and low." RPH-MS acknowledged the alert was confusing.

A review of the Institute of Safe Medication Practice (ISMP), a nationally recognized medication safety resource, document dated 02/28/19 and titled, "Your attention please...Designing effective warnings" indicated, "Medication-related warning systems are...used to inform...practitioners...about risks, or remind them about known risks associated with the use of medications....To be effective, warnings must: 1) reach their target audience; 2) capture the attention of recipients at the right time; 3) cause recipients to understand the risk, believe that the warning relates to them, and understand the actions they need to take; and 4) lead the recipients to respond appropriately..." The medication alerts for Apixaban and Heparin generated by the hospitals computer system did not effectively warn RPH 1 and prompt actions to prevent the duplication that led to massive internal bleeding for Patient 1.

A review of a list of all hospital drug interaction/duplicate therapy alerts for anticoagulants (Heparin, Warfarin, Apixaban, and Enoxaparin) from 11/1/19 thru 12/14/19 indicated that 17 out of 194 alerts (91%) were real (true and meaningful) alerts and the remaining were false alerts. There was a total of 177 false alerts. Medications triggering false alerts without drug interactions/duplications would alert as such (e.g. heparin would show as a drug interaction/duplication but no other anticoagulants were prescribed). More specifically, the 177 false alerts did not signify anticoagulant drug to drug interactions or duplicate therapies .

During an interview on 12/5/19 at 10:26 a.m., Staff Pharmacist 2 (RPH 2) stated he relied on the medication alert system. RPH 2 stated that the alerts were important to inform the pharmacists of drug interactions and duplicate medications. RPH 2 said false alerts were very common and the pharmacy medication alert system had a lot of room for improvement.

During an interview on 12/5/19 at 10:15 a.m. RPH 3 stated that she relied on the accuracy of the medication alerts. RPH 3 stated that she experienced alert fatigue due to the large amount of false alerts.

During an interview on 12/5/19 at 9:56 a.m. RxSup 2 stated the medication alerts