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Based on record review and interview, the Hospital failed to ensure actions were aimed at performance improvement to prevent adverse events for 2 Patients (#1 and #2); 1. Patient #1 sustained a spinal epidural hematoma while on anticoagulation medication with an unchecked critical lab result and 2. Patient #2 was able to make a suicide attempt by ingesting a metal hook in his/her bathroom while on 1:1 constant observation out of a total sample of 10 patients.

Refer to A-0283.

Based on record review and interview, the Hospital failed to ensure actions were aimed at performance improvement to prevent adverse events for 2 Patients (#1 and #2); 1. Patient #1 sustained a spinal epidural hematoma while on anticoagulation medication with an unchecked critical lab result and 2. Patient #2 was able to make a suicide attempt by ingesting a metal hook in his/her bathroom while on 1:1 constant observation out of a total sample of 10 patients.

Findings include:

Review of the Hospital Quality and Patient Safety Plan, revised and approved 4/26/21, indicated the following:

-The plan is designed to engage the entire workforce, working together as a team.

-Develop organizational improvement capabilities and provide support to make improvements across the organization.

-Goals are established and reviewed annually to promote continuous improvement and learning, eliminate preventable medical errors and promote effective communication among care providers.

1. The Hospital's Medical Staff Bylaws indicated in Article 4, section 1, item 3 Standards of Practice: if the attending physician is transferring responsibilities to another medical service, a note covering the transfer of responsibility must be entered into the medical chart by the attending physician. The Hospital ' s Medical Staff Bylaws indicated in Article 4, section 1, item 1 responsibilities of the Admitting/Attending physician included: the medical/surgical care and treatment of each patient in the Hospital, making daily rounds, the prompt complete and accurate preparation of the medical record, and necessary special instructions regarding the care of the patient.

The Hospital's Medical Staff Bylaws indicated in Article 4, section 3 item a., Practitioners are expected to respond within 30 minutes to calls from the Hospital ' s patient care staff regarding their patients by telephone, and item b indicated the expectation was to respond within 60 minutes in person for emergent or critical requests.

Review of the Hospital policy titled "Medication Management: Anticoagulation Policy", approved 9/7/2017, indicated the following:

-Recommended monitoring for heparin use: Baseline aPTT test, Heparin assay, Complete blood count (CBC) with platelets.

-Provider Responsibilities: Baseline INR, PTT, CBC with platelets. Additional drug specific labs should be ordered as indicated by the EPIC order set or patient status.

-Monitor baseline and on-going laboratory tests as needed.

Patient #1 was admitted to the Hospital Emergency Department on 8/5/21 with diagnoses including vision loss and Giant Cell Arteritis (inflammation in the lining of the arteries, most common in the temples); the Patient was subsequently admitted to a medical surgical unit under the care of Physician #1

Review of Patient #1 ' s medical record indicated physician ' s orders for patient #1, dated 8/6/2022, including heparin (an anticoagulant medication) injections three times daily, and a lumbar puncture (medical procedure in which a needle is inserted into the spinal canal, most commonly to collect cerebrospinal fluid for diagnostic testing).

The Procedure Note dated 8/6/2021 indicated a Lumbar Puncture was done by a resident physician under MD#2 ' s authorization and signed attestation; the procedure note indicated 4 attempts with a Quincke needle (a "cutting-tip" needle, with a sharp bevel at the tip) were made to insert the needle into patient #1 ' s spinal canal to retrieve cerebrospinal fluid for testing, and when the fluid was obtained, it was blood tinged before clearing in color (blood in a sample may indicate traumatic needle insertion, as only a few individual red blood cells are found in CSF), the note indicated a pressure dressing was applied at the end of the procedure.

Patient #1 ' s nursing note dated 8/12/21 at 7:35 A.M., on regarding the overnight shift (8/11/21) indicated patient #1 had dark red blood in his/her stool and had a positive guaiac test (a bedside test in which fecal matter was placed on the guaiac paper and solution applied to it, if the solution turned blue it indicated the presence of blood in the sample), the nursing note further indicated the physician had been notified of the findings.

Medical record review indicated on 8/11/2021 at 11:58 P.M., Patient #1 had a lab test drawn for an aPTT test (activated partial thromboplastin time; a measure of the time it takes for blood to clot), a blood type and screen test (lab test prior to blood transfusion), a Complete Blood Count (CBC) and an INR (a test for prothrombin, a measure of the time for blood to clot) the results were returned and a High Critical Value of 155 seconds was recorded in the Medical Record and laboratory technician documented at 1:22 A.M. on 8/12/21 the critical value was called to the nurse and read back. Patient #1 ' s nursing documentation indicated a physician had been notified and was aware of the critically high aPTT results.

Patient #1 ' s Physician progress note dated 8/12/2021indicated the Patient had "dark blood in blood [sic]" and a fibrinogen level was drawn and resulted on 8/11/21 and resulted critically low at 52; an order was placed for Patient #1 to receive 10 units of cryoprecipitate (plasma with clotting factors) on 8/11/21 to increase his/her fibrinogen level. The progress note indicated the level was to be redrawn in the morning. The Progress Note dated 8/12/2021 written by Physician #1 had no indication of the aPTT critical value, nor was it addressed in the plan of care.

Patient #1 ' s Physician ' s progress note dated 8/12/2021 at 4:04 P.M., indicated the resident physician had reviewed recent labs, however, failed to indicate the critically high aPTT test results were reviewed. The progress note was attested to at 5:08 P.M. on 8/12/2021 by Physician #1 (attending physician).

In a nursing note from 8/16/2021, at 9:36 P.M., the nurse reported at 7:00 P.M., patient #1 was found hanging off the bed, and complained of the inability to feel the lower extremities, the nurse called the physician (undefined) to the bedside and the physician said there was a normal neurological exam. The Nursing note further documented a later event of a systolic blood pressure of over 200, and so administered hydralazine (a vasodilator used to treat high blood pressure) and noted a good effect (undefined). The Nursing Note then reported patient #1 ' s heartrate was in the thirties, (normal heartrate 60-100 beats per minute), and when the systolic blood pressure was rechecked, it was in the 60 ' s (critically low), and patient #1 appeared pale and lethargic. The Nursing note documented a Rapid Response activation was called and when the team came to the bedside, patient #1 could no longer move the bilateral lower extremities (both legs), so an emergent head Cat Scan was done.

Further review of Patient #1 ' s medical record indicated the Patient had a head CT (computed tomography) scan performed on 8/17/21 which indicated subdural or epidural hematoma of the upper cervical spinal cord. An MRI (magnetic resonance imaging) scan performed on 8/17/21 indicated Patient #1 sustained an injury consistent with epidural hemorrhage ventrally at the 3rd cephalic vertebra.

Review of the Hospital ' s investigation of Patient #1 ' s spinal epidural hematoma on 8/16/21 indicated the critically high PTT test ordered on 8/11/21was not addressed nor checked. The Hospital ' s investigation indicated the RN (Registered Nurse) sent three text message pages to the physician on 8/12/2021 during the overnight shift indicating the critical lab results in each message, with the last message sent at 5:43 A.M. that indicated the heparin medication was not given by the nurse and the reason was patient was currently bleeding.

The Hospital identified seven areas of potential systems failures in the investigation provided to Surveyors, the document titled Organizational Response for Critical Lab Follow Up, dated 11/23/2021, indicated the following opportunities for re-education:

-adverse event re-education with Neurology Residents

-adverse event re-education with Nursing Unit/Safety Huddles

-adverse event re-education Nursing Unit/Healthstreams (online learning modules)

-adverse event re-education Nursing/Hospital Wide and specifies topics: critical laboratory values, escalation of chain of command, documentation, and identification of spinal cord injury

-review of closed loop communication/critical lab results in global nursing newsletter

-review adverse event with contracted service for apheresis (plasma exchange)

The Hospital document titled Organizational Response for Critical Lab Follow up dated 11/23/2021 indicated the following targeted actions regarding documentation:

-build a phrase into Epic (Electronic medical record software) to support documentation of the follow up to critical lab values

-create a report to monitor compliance with the "phrase"

-improve nursing documentation and follow up of critical lab results by leveraging Epic tools and reports

The Hospital document titled Organizational Response for Critical Lab Follow up dated 11/23/2021 indicated the following targeted actions regarding the development of a plasmapheresis guideline:

-plasmapheresis guideline draft created to be reviewed by Laboratory Medicine and Neurology

-review of revised guideline at MPC/MEC post to Massnet (intranet) with appropriate indexing

-consider expansion of the guideline to other areas

Regarding anticoagulation:

-consider changes to heparin concentration in the line, change to citrate or saline only

-consider reflex heparin assay with critical PTT

Regarding Review current state monitoring critical lab values (undefined):

-review current critical lab value monitor/compliance

-develop audit for PTT and Heparin assay on the unit where the event occurred

At the time of Survey, one year and eight weeks following the Hospital reported event, the Hospital has implemented:

-educated nurses on two units to critical values and the chain of command

-distributed critical values flowsheet tip sheets to medical secretaries and ambulatory care staff (undefined)

-created a new flowsheet in Epic and audit the use of the flowsheet from January 2022- August 2022, found to have 82.05 % compliance, no goal stated, and monitored for Heparin and PTT only, no other critical values

-added a critical values policy review to the newly licensed nurse orientation

-in August 2022, one year following the event, provided education to 611 nursing staff (undefined units as this number does not reflect all nurses on staff) regarding Critical Value and Nursing Communication Case Study, audited for 90.95% compliance, no goal stated

Hospital failed to provide to Surveyors upon request any documentation all physicians that could order anticoagulant medication for patients had been re-educated on the Critical Value Policy or Closed-loop communication. Hospital failed to provide evidence Hospital Clinical Staff were re-educated on signs of spinal cord injury.

During an interview with the Director of Risk Management on 10/13/22 at 9:26 A.M., she said all physicians are able to view any lab results in the electronic medical record. She said physicians can review a patient ' s lab results when evaluating a patient.

During an interview with Physician #1 on 10/13/22 at 3:00 P.M., she said Patient #1 was on SC heparin for deep venous thrombosis prophylaxis. She said Patient #1 ' s primary service when admitted to the Hospital was neurology, but on 8/12/21 lab medicine was going to take over the Patient ' s care; though was unable to provide any documentation Patient #1 would be managed by a separate Department in the Hospital while inpatient. She said one of the resident physicians reported the critically high PTT result to the lab medicine service, but there was no documentation of when this was done or what was done about the PTT test ordered on 8/11/21. Physician #1 said she was not sure if Patient #1 had signs or symptoms of bleeding prior to the critical coagulation lab value on 8/11/2021 of PTT greater than 155 (normal 25-38) and thought the 8/11/2021 nursing report of dark bloody stool was the result of Patient #1 consuming cranberry juice the day before.


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2. Review of the Hospital policy titled "Suicidal, Homicidal Patient, Environment of Care", approved 3/5/2020, indicated the following:
-The continuous observer should accompany the patient wherever they go until the patient is removed from the continuous observation status or unless relieved by another continuous observer or a nurse.
-It is the responsibility of all team members to provide a safe environment for the patient.

Review of the Hospital policy titled "Suicide/Self-harm Screening and Precautions-Utilization of the Columbia Suicide Severity Rating Scale and Risk Stratification Inpatient and Emergency Department", approved 3/4/2021, indicated the following:
-Patient assessed at High suicide risk - put patient on continuous observation 1:1.
-Patient assessed at Moderate suicide risk - put patient on continuous observation 1:1

Patient #2 was admitted to the Hospital Emergency Department on 8/6/21 with diagnoses of foreign body ingestion, suicidal ideation, and depression; Patient #2 underwent a surgical upper endoscopy procedure and was subsequently admitted to an inpatient medical surgical unit.

Review of Patient #2's medical record indicated the Patient presented to the Emergency Department on 8/6/21 with suicidal ideations via Emergency Medical Services (EMS). Patient #2 reported ingesting a battery with the intent to harm him/herself. A Physician's order was placed on 8/6/21 for 1:1 continuous patient observation. An X-ray exam was performed, and a battery was observed in the Patient's mid abdomen and 2 screws were also seen in the right lower quadrant of the Patient's abdomen. The Patient underwent an upper endoscopy (a procedure used to look inside the body using a scope device to examine hollow organs or body cavities.) procedure to retrieve the foreign objects and was admitted to an inpatient medical surgical unit. Patient #2 was assessed on 8/7/21 using the Columbia Suicide Severity Rating Scale (C-SSRS) and was assessed to be high risk for suicide/self-harm. On 8/7/21, Registered Nurse (RN) #1 and RN #2 swept Patient #2's room for safety; risks were identified to still be in place - hooks/whiteboard/screws were observed to still be mounted on the walls and hooks on the bathroom door in the Patient's room and these risks were reviewed with Patient #2's 1:1 observer.

Further review of Patient #2's medical record indicated on 8/12/21, Patient #2 removed a metal hook (command hook - mounted on the door by adhesive) from his/her bathroom door and ingested it; the Patient told Hospital staff she was not being observed by his/her 1:1 observer because the observer was a male and Patient #2 did not want a male observing him/her in the bathroom. The Nurse Practitioner assessing Patient #2 removed the remainder of the command hook from the bathroom door. An abdominal x-ray exam was ordered on 8/11/21; the x-ray exam indicated a metallic hook projecting over the distal stomach. Patient #2 underwent an upper endoscopy on 8/11/21, however, the hook was unable to be retrieved as it had likely passed beyond the duodenum (first third of the small intestine.) Patient #2 subsequently underwent a colonoscopy on 8/22/22 to remove the hook from his/her colon.

Review of the Hospital incident report for Patient #2's ingestion of a foreign body on 8/11/22 indicated the 1:1 observer on duty at the time of the incident admitted to allowing the Patient to use the bathroom unattended.

Review of the Hospital Document titled "Unit: Med-Surg Baseline Room Assessment", updated 3/2021, indicated bathroom door hooks put a patient at risk for death with a likely probability to occur and require continuous observation as a control measure to mitigate the overall risk to a patient. The document failed to indicate any control measures for a removable command hook to a patient's bathroom door.

During an interview with RN #1 on 10/13/22 at 10:15 A.M., she said Patient #2 was admitted to the medical-surgical unit after a procedure was performed to remove a foreign object he/she had ingested. She said Patient #2 was ordered to have a 1:1 constant observer secondary to his/her self-harm risk and history of ingestion of foreign objects. She said she swept Patient #2's room with another RN and removed items that were potentially dangerous to the Patient (cords, tubing, medical supplies). She said there were hooks on the wall of Patient #2's room, and a hook on the bathroom door. She said she was not able to remove the hooks from the Patient's room. She said maintenance was not notified regarding the hooks in the Patient's room. She said 1:1 observers are updated each time a new observer switches in for a patient (every 4 hours). She said 1:1 observers should never take eyes off a patient requiring 1:1 observation and should notify the nurse if a patient needs to use the bathroom and is uncomfortable with that 1:1 observer observing him/her in the bathroom.

During an interview with RN #2 on 10/13/22 at 11:13 A.M., she said she had admitted Patient #2 to the medical-surgical unit. She said Patient #2 was ordered to have a 1:1 constant observer secondary to his/her suicide attempt through swallowing a foreign object. She said she had swept the room with RN #1 for items that were potentially dangerous to the Patient. She said 1:1 observers should never take eyes off a patient requiring 1:1 observation and should notify the nurse if a patient needs to use the bathroom and is uncomfortable with that 1:1 observer observing him/her in the bathroom.

During an interview with the Director of Risk Management and Patient Safety on 10/13/22 at 1:45 P.M., she said typically command hooks can be removed and replaced from patient rooms as necessary. She said the nurses caring for Patient #2 may not have known that the command hooks were not permanent fixtures and could be removed. She said any concerns regarding items in a patient's room can be escalated to facilities management (maintenance).

The Hospital document Compliance by Question, dated September 2022, indicated during audits, RN to Nursing Assistant (NA) hand off documented with each change of observer was at 80%. The Hospital failed to provide any updated action regarding the events in August 2021, in which Patient #2 was able to ingest a removable hook while ordered to be on 1:1 constant observation secondary to his/her risk for self-harm with a known history for the ingestion of foreign objects.