The information below comes from the statement of deficiencies compiled by health inspectors and provided to AHCJ by the Centers for Medicare and Medicaid Services. It does not include the steps the hospital plans to take to fix the problem, known as a plan of correction. For that information, you should contact the hospital, your state health department or CMS. Accessing the document may require you to file a Freedom of Information Request. Information on doing so is available here.

MEMORIAL MISSION HOSPITAL AND ASHEVILLE SURGERY CE 509 BILTMORE AVE ASHEVILLE, NC 28801 May 28, 2021
VIOLATION: GOVERNING BODY Tag No: A0043
Based on review of hospital policies and procedures, medical record reviews, observations and staff and physician interviews, the hospital's governing body failed to provide oversight and have systems in place to ensure the protection and promotion of patient's rights to receive care in a safe setting and to ensure an effective nursing service to provide supervision and evaluation of patient care.

Findings include:

1. The hospital failed to provide care in a safe setting by failing to secure the patient environment to prevent patient access to unattended saline flushes, failing to follow a physician order for liquid pain medicine, and failing to escalate observations and assessments to the physician.

~cross refer to 482.13 Patient Rights: Tag 0144

2. Hospital nursing staff failed to prevent access to unattended saline flushes, to provide a timely admission assessment to communicate the change in a patient's mood, and to escalate observations and assessments for 1 of 1 medical/surgical patients with a substance abuse history for 1 of 1 medical/surgical patients with a substance abuse history sampled. (Patient #6).

~cross refer to 482.23 Nursing Services: Tag 0395

3. The hospital failed to have an effective quality assessment and performance improvement program to analyze, track, and make improvement for patient safety by failing to monitor pharmacy modifications to physician orders to determine if they met approved parameters, and failing to evaluate actions and to implement a facility-wide response plan after a patient safety event.

~cross refer to 482.21 Quality Assessment and Performance Improvement: Tag 0286
VIOLATION: PATIENT RIGHTS Tag No: A0115
Based on policy and procedure review, observations, medical record review, and staff and physician interviews, the hospital failed to promote and protect a patient's rights by failing to provide a safe environment for a medical/ surgical patient with a known history of substance abuse.

Findings include:

The facilty failed to provide care in a safe setting by failing to prevent unattended access to saline flushes, failing to follow a physician order for liquid pain medicine, and failing to escalate observations and assessments for 1 of 1 medical/surgical patients with a substance abuse history (Patient #6)

~cross refer to 482.13 Patient Rights' Standard: Tag 0144
VIOLATION: PATIENT RIGHTS: CARE IN SAFE SETTING Tag No: A0144
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**

Based on policy review, medical record review, and staff interview, the facility staff failed to provide care in a safe setting by failing to prevent patient access to unattended saline flushes, failing to follow a physician order for liquid pain medicine, and failing to escalate observations and assessments for 1 of 1 medical/surgical patients with a substance abuse history sampled (Patient #6).

The findings included:

Review of facility policy, "Safety Precautions for the Patient with Behavioral Health Needs - All facilities" revised 02/26/2018, revealed, "...B. All inpatients will receive routine assessments of mental status including assessment of safety. Patients should also be screened for safety issues after a potentially distressing event occurs such as, but not limited to ...bad news form a healthcare provider ... C. When a patient is identified as having serious safety concerns, immediate action must be taken to ensure the safety of that patient ... D. A high level of safety will be maintained in the patient's environment ... staff must be aware of hazard potential associated with such items and the patient will be monitored closely for unsafe behaviors. To make the care environment as safe as possible, the following precautions will be initiated: ... 2. To enhance safety of the environment, the patient room/environment should be checked at least once per shift and after the patient has had visitors: .... e. ... IV supplies must be removed from room ...."

Review of facility policy, "Pharmacist Clinical Expectations and Guidelines" revised 04/01/2013, "...I. Clinical Expectations A. Pharmacist Daily Clinical Responsibilities. 1. Verify medication orders i. During verification, pharmacist reviews medications and monitoring and intervenes as needed... III...A. Mechanism: 1. When a clinical intervention is identified, the Pharmacist may use three methods of intervention according to their clinical judgement: a. Direct contact with prescriber (preferred)..."

Review of facility policy, "Facility Event and Close Call Reporting" revised 08/2019, revealed, "...These should be completed as soon as possible after the event, but no later than the end of the shift ... PROCEDURE: ... 1. Patient notifications include events or close calls that involve, impact, or in any way may be connected to a patient under the care of the facility at the time of the event or close call .... DEFINITIONS: Event: A discrete, auditable and clearly defined occurrence ... Close Call: Events or situations that could have resulted in an adverse event (Accident, injury, or illness), but did not, whether by change or through timely intervention..."

Closed medical record review of Patient #6 revealed the patient was admitted to a medical/surgical floor at the facility on 01/26/2021 at 1302 with chief complaints of intractable nausea and vomiting and abdominal pain. Review of the History and Physical revealed Patient #6 was "alert and oriented x4" and had a history of illicit (illegal) drug use - Suboxone (buprenorphine and naloxone - used to treat opioid addiction), and remote history of IVDA (intravenous drug abuse). Review of toxicology report collected 01/26/2021 at 1310 revealed the Urine Drug Screen (UDS) for Patient #6 was positive for buprenorphine (compound found in Suboxone-medication used for opiate addiction) and cannabinoid (compound found in cannabis/marijuana). Review revealed Patient #6 was subsequently diagnosed with [DIAGNOSES REDACTED]"). Medical record review revealed Addiction Medicine consulted on 02/11/2021 at 0829 for Suboxone and pain management recommendations prior to the "Whipple procedure" (pancreaticoduodenectomy - operation to remove the head of the pancreas, the first part of the small intestine, gallbladder, and bile duct) for Patient #6. Review of Addition Medicine Note dated 02/11/2021 at revealed, "Psychiatric History: reports one psychiatric hospitalization but numerous diagnoses including bipolar, DID (Dissociative Identity Disorder), PTSD (Post Traumatic Stress Disorder), depression and anxiety. She does not accept the dx (diagnosis) of biolar (sic) stating that prior manic behavior was due to stimulant abuse. Does report ongoing PTSD symptoms including nightmares, flashbacks and hypervigilance. She does report OD (overdose) attempts in the past during which "I kind of hoped I wouldn't make it" but denies SI (suicidal ideation) for many years ... Family History: her sister also has opiate use disorder, her maternal grandmother reportedly did as well ..." Review of Admission assessment dated [DATE] 0515 revealed, "Mental Health History: Anxiety, Depression, Other: hx(history) of opiate abuse". Review revealed Patient #6 was moved to a general surgery unit on 02/18/2021 at 2150. Review of Addiction Medicine Progress Note dated 02/18/2021 at 0958 revealed, "Interval History. Now increasingly concerned about the gravity of planned procedure, worried about pain control. Would prefer to taper off buprenorphine now ... Impression and Plan ...Opiate use disorder - severe Stimulant use disorder - moderate - on low dose suboxone, now preferring to taper off prior to surgery 2/24 - plan decrease by 2mg/day(milligrams per day) with prn (as needed) Oxycodone (medication for moderate to severe pain) for pain or withdrawal symptoms ..." Review of Addiction Medicine Progress Note dated 02/22/2021 at 1022 revealed, "tapered down to 2mg buprenorphine with minimal withdrawal sx(symptoms) except some worsening of her chronic back pain and other aches and pains. Has been using oxycodone with good relief ... will sign off for now, however please call if new issues should arise..." Review of Surgical Oncology Progress Note dated 02/22/2021 at 1208 revealed, "Overnight she had a bad episode of anxiety ... This morning although she feels well, she reports severe anxiety ..." Review of Surgical Oncology Progress Note Addendum dated 02/23/2021 at 1927 revealed, "Addendum ... New onset tachycardia w/fevers today .... Suspect PICC (peripherally inserted central catheter) line infection, blood cultures drawn and d/c'ing (discontinuing) PICC ..." Review revealed the surgical procedure for Patient #6 was rescheduled from 02/24/2021 to 03/03/2021. Review of Nursing Assessment for Mental Status dated 02/24/2021 at 2100 revealed, "depressed." Review of Nursing Annotations dated 02/25/2021 at 0152 revealed, "patient found down in bathroom sitting up. IV (intravenous) flushes found near patient on the floor. Patient states she was flushing her ear out. IV tubing was found disconnected from patient. MD paged." Record review revealed on 02/25/2021 at 0219 the provider was notified and ordered a UDS. Review revealed an order restricting personal belonging access was ordered 02/25/2021 at 0754. Review of Safety Monitoring Flowsheet revealed a patient safety attendant (sitter) was initiated on 02/25/2021 at 0845. Review of Surgical Oncology Progress Note Addendum dated 02/25/2021 at 0958 revealed, "Patient clinically looks normal and no further fevers overnight. Tachycardia persists and had some soft pressures which have normalized this morning ...This is probably because she apparently either fell or passed out in her bathroom with several saline flushes. It is unclear how she got these but there is obvious concern for IV drug abuse given her history. This would further explain the PICC line infection that she clearly had preoperatively. I spoke with Dr. (named Addiction Medicine physician) who will see her and ordered a sitter this morning ...." Review of Addition Medicine Progress Note dated 02/25/2021 at 0945 revealed, "Impression and Plan ... Gastric outlet obstruction, possible pancreatic CA (cancer) - Whipple planned 2/24, postponed due to tachycardia and fevers, tentatively rescheduled for 3/3. Opiate use disorder - severe. Stimulant use disorder - moderate - did well on low dose suboxone, tapered off prior to surgery per her request and started on moderate dose opiate agonists - suspicious incident with saline flushes yesterday - pt (patient) claims cleaning out her ears. Denies cravings or illicit behavior. While this is plausible, patients with IVDU (intravenous drug use) have been known to use saline flushes to recreate process/feeling of illicit IV use. - very upset about having a sitter again. Readily agrees to liquid oxycodone for decreased diversion risk and to have belongings searched if sitter can be dc'ed (discontinued). Patients with intent to divert meds are often reluctant to agree to these measures. - repeat UDS pending, while this obviously would not reveal any diversion of oxycodone it would allow us to rule out use of illicit substance brought from outside ..." Review of the Medication Administration Record revealed the Addiction Medicine physician ordered Oxycodone in liquid form on 02/25/2021 at 0933. Review of the Medication Administration Record - Order History revealed the Pharmacist modified the Oxycodone order to pill form at 0937. Review of the toxicology report collected 02/25/2021 at 1530 revealed the UDS for Patient #6 was positive for methamphetamine, benzodiazepine, buprenorphine, cannabinoid, opiates, and oxycodone. Review of Surgical Oncology Progress Note dated 02/26/2021 at 0827 revealed, "Impression and Plan ... Urine drug screen positive for methamphetamines; addiction medicine following and will have social work search patient's belongings, restrict visitors, may no longer need sitter after these 2 interventions ..." Review of Surgical Oncology Progress Note Addendum dated 02/26/2021 at 0939 revealed, "blood growing out oral flora, U tox (urine toxicology) demonstrating amphetamines, cannabinoids among other things. Working with addiction medicine for plan. Currently continue sitter ..." Review of CM-Inpatient SBIRT (Substance Brief Intervention and Referral to Treatment - team for early intervention and treatment approach for substance use disorders) Note dated 02/26/2021 at 1215 revealed, " ...LCSW (Licensed Clinical Social Worker) met with patient for HRSU(High Risk Substance Use) rounding and to discuss events of the last 48 hours which resulted in the patient's UDS being tested ...and came back positive .... PRESENTATION: Patient was seen awake, alert, oriented x4 and presents with angry mood and congruent affect often yelling, cursing and raising her voice throughout this meeting ....She adamantly denies any substance use and reports she finds it insulting and offensive that she is accused of this. She insists the UDS is wrong and that the "tester" is wrong and demands a new UDS ... INTERVENTION: ...communicated multiple times with Dr. (named Addiction Medicine physician) .... VISITATION STATUS: No visitors as per Dr. (named Addiction Medicine physician) Patient may have access to her personal belongings once they have been searched by security. PLAN: Patient's belongings/room to be searched by security. Sitter can be discontinued after the search has been performed. Patient is to have no visitors. A confirmatory test has been ordered for the UDS sent yesterday to determine it the methamphetamine was a false positive ..." Record review revealed a personal search order entered at 1242 and signed by Addiction Medicine physician. Review of Safety Monitoring Flowsheet revealed the sitter was removed at 02/26/2021 at 1315. Review of Surgical Oncology Progress Note dated 02/27/2021 at 1220 revealed, "Drug screen positive for methamphetamine. Report drinking a lot of fluids..." Review of Surgical Oncology Progress Note Addendum dated 02/27/2021 at 1422 revealed, "In light of multiple substances found on tox screens, could potentially be substance-withdrawal related as well." Review of GMED Progress Note dated 02/27/2021 at 1519 revealed ... Impression and Plan ... Fever: ...The patient may have been using her IV access for injection .... History of IV drug abuse: Suspicious activity in the hospital concerning for further drug abuse. I agree with high risk substance abuse protocol in the presence of a sitter ..." Review of GMED Progress Note dated 02/28/2021 at 1904 revealed ... Impression and Plan ... History of IV drug abuse: ... I agree with high risk substance abuse protocol in the presence of a sitter ..." Review of annotations dated 03/01/2021 at 0750 revealed, "patient found unresponsive. No pulse agonal breathing. CPR started." Review revealed Patient #6 died on [DATE] at 0835. Review of Surgical Oncology Brief Progress Note dated 03/01/2021 at 0838 revealed, "Patient was seen this morning and was doing overall well however a little tearful about the delays with surgery ... Patient was talking to us, coherent and was doing overall okay ...the patient did have some suspicious activity around Wednesday/Thursday last week where her IV was disconnected anther were flushes on the floor and she lost consciousness in the bathroom for which the patient had a sitter for several days. She did have positive UDS for methamphetamine which was negative on admission. Addiction medicine was involved and recommended that the patient's room be searched, to restrict visitors, and that the sitter could be discontinued. Patient did not have a sitter this morning. There is concern that etiology may be related to further in-hospital drug abuse." Review of Death Summary dated 03/01/2021 at 1339 revealed, "Cause of Death - Preliminary - Cardiac Arrest Due to suspicion for in hospital IV drug use overdose although etiology is not known at this time .... CODE BLUE was called over intercom at 8 AM on this patient. Nurse reported that patient's IV was beeping and that she went in to fix it and noticed that the patient was breathing agonally, IV disconnected, with a flush nearby the bed ..." Medical record review failed to reveal notification of a provider and implementation of mental health interventions after mental status changes, failed to reveal notification to the ordering provider regarding changing the medication from liquid to pill form and failed to reveal an order for the High Risk Substance Use (HRSU/IVDA) plan even though there was provider documentation of supporting the plan.

Review of (named hospital) Security Department Search Authorization Form dated 02/26/2021 at 1305 revealed a search was completed of Patient #6's room, "Subject: room search for illegal substances ... Reason for Search: suspected illegal substances ...Physician notified: yes (named) ... Subject Response: cooperative ... List of items removed. Where are they stored? Who secured them? Knives locked up with security ..."

Request for incident reports related to events on 02/25/2021 at 0152 where Patient #6 was found on the floor or 02/25/2021 at 1900 to 02/26/2021 at 0030 when an unknown white substance was found in the room of Patient #6 revealed there were no incidents reported.

Observation on 05/25/2021 at 1200, during tour of Unit A in room 457, revealed a supply cart in the patient room with two (2), 10 milliliter (ml) pre-filled, 0.9% Sodium Chloride (normal saline) flushes (flush #1 and #2) lying, unsecured, on top of the supply cart. Observation revealed flush #1 was unopened and labeled "0.9% Sodium Chloride." Flush #2 was open and labeled "0.9% Sodium Chloride" and contained 7 mls of solution. Observation revealed both flushes were disposed of in the sharps container by the Nurse Manager (NM) upon discovery.

Observation on 05/28/2021 at 0934, during tour of Unit B in room 402, revealed an unopened 10 ml pre-filled, 0.9% Sodium Chloride (normal saline) flush lying, unsecured on the counter beside the sink in the patient ' s room. Observation revealed the flush was disposed of in the sharps container by the (Carrie) prior to leaving the patient ' s room.

Interview on 05/25/2021 at 1200, with Nurse Manager #2, during tour of Unit A, revealed "Extra supplies should not be left in the patient ' s rooms."

Interview on 05/26/2021 at 0920 with RN #1 revealed she provided nursing care for Patient #6 on the night shift (1900 - 0700) of 02/25/2021. Interview revealed Patient #6 was assessed as depressed and no additional interventions were started because a sitter was in place. Interview revealed Patient #6 was focused on sitter removal and asked, "when she could get rid of her sitter." Interview revealed "white powder" was found on the back of the pants of a sitter and a chair in the room of Patient #6 on night shift of 02/25/2021. Interview revealed the charge nurse was notified of the unknown substance and RN #1 received instructions from the Charge Nurse to clean the area up and wash her hands. Interview revealed no incident report was completed. Interview revealed RN #1 kept the door to Patient #6 opened and checked in frequently due to concerns for the safety of the sitter. Interview revealed RN #1 did not recall leaving saline flushes in the patient's room. Interview revealed the High Risk Substance Use (IVDA) plan was not implemented during night shift of 02/25/2021.

Interview on 05/26/2021 at 0935 with Nurse Manager #1 revealed the admission assessment identified suicide risk at the time of admission. Interview revealed if a staff member had concerns about changes in the mental status of a patient at any point during the hospitalization , then the physician should be notified.

Interview on 05/26/2021 at 0945 with Pharmacist #1 revealed the pharmacist changed the physician order for Oxycodone from liquid to pill form. Interview revealed the ordering provider was not contacted prior to the modification of the Oxycodone order. Interview revealed an error was made when the pharmacist manually selected pills instead of liquid.

Interview on 05/26/2021 at 1005 with the Pharmacy Manager #1 revealed a pharmacist should not modify a physician order unless it met specific criteria outlined in the clinical guidelines. Interview revealed the medication for Patient #6 did not meet the specific criteria. Interview acknowledged an error was made and a "systems problem." Interview revealed the "systems problem" related to the way the physician order displayed for pharmacist verification. Interview revealed the pharmacist should have called the provider.

Interview on 05/26/2021 at 1035 with RN #2 revealed she provided nursing care for Patient #6 on the day shifts (0700 - 1900) of 02/25/2021 and 02/26/2021. Interview revealed Patient #6 had "two different moods based on sitter situation." Interview revealed on 02/25/2021, Patient #6 was observed as depressed, "didn't say much," "didn't get out of bed". Interview revealed the changes in mood and mental status of Patient #6 were not shared with the medical team. Interview revealed Patient #6 refused to urinate for the UDS for majority of the shift. Interview revealed "could have gotten them (saline flushes) from the room or out in the hallway." Interview revealed Patient #6 "liked to stroll the halls." Interview revealed RN #2 was present during the "Code Blue" response on 03/01/2021 for Patient #6. Interview revealed the IV tubing was disconnected and flushes were found in the bed of Patient #6. Interview revealed a more thorough room search should have been conducted on Patient #6.

Interview on 05/26/2021 at 1125 with LCSW #1 revealed she provided support through the SBIRT(Substance Brief Intervention and Referral to Treatment - team for early intervention and treatment approach for substance use disorders) team. Interview revealed Patient #6 was anxious about the upcoming procedure. Interview revealed the High Risk Substance use plan was never fully implemented. Interview revealed LCSW#1 had "red flags" related to Patient #6 defensiveness about positive UDS and PICC line infection. Interview revealed LCSW #1 discussed the 2/25/2021 event and Patient #6 was "upset because her sister was on the way to visit her." Interview revealed the full High Risk Substance Use (IVDA) plan (no visitors, no access to cell phone/tablet, landline only phone calls, etc.) should have been implemented for Patient #6. Interview revealed Patient #6 had been on the IVDA plan/SBIRT rounding list on a previous admission 01/04/2021 - 01/21/2021. Interview revealed the previous visit should have triggered awareness of Patient #6 substance use and proper safety measures implemented.

Interview on 05/26/2021 at 1225 with CNA #1 revealed she assisted Patient #6 after the 02/25/2021 bathroom incident and was a sitter on 02/26/2021. Interview revealed Patient #6 was on the bathroom floor with a saline flush and puddle of fluid from the disconnected IV tubing. Interview revealed after the incident, Patient#6 was "weird," her talking was "not at baseline," and she appeared "confused." Interview revealed Patient #6 was able to walk after the bathroom incident and was guided back to bed by staff. Interview revealed staff continued routine care and more frequent checks were not implemented. Interview revealed Patient #6 was very irritated with having sitters.

Interview on 05/26/2021 at 1620 with Security Officer #1 revealed he performed the room search for Patient #6. Interview revealed no illicit substances were found in the room search. Interview revealed the room search did not include a search of the patient. Interview revealed security found and confiscated knives from Patient #6.

Interview on 05/26/2021 at 1635 with Security Officer #2 revealed he performed the room search for Patient #6. Interview revealed Patient #6 had several stuffed animals with unstitched seams and security searched the items as well as possible. Interview revealed no illicit substances or flushes were found in the room search. Interview revealed the security confiscated knives from Patient #6 after the room search.

Interview on 05/27/2021 at 1133 with MD #1, revealed she consulted on Suboxone and pain management for Patient #6. Interview revealed Addiction Medicine does not implement the High Risk Substance Use plan and deferred to the attending physician to order the plan. Interview revealed on the 02/25/2021 visit after the incident, Patient #6 appeared "anxious" and "destabilized." Interview revealed Patient #6 felt worse due to the presence of sitters and Patient #6 "didn't like being watched". Interview revealed the safety contract (liquid Oxycodone, room search) with Patient #6 was created to preserve the therapeutic relationship and minimize patient-staff conflict. Interview revealed Pharmacy did not contact MD #1 to discuss medication form changes. Interview revealed MD #1 was unaware that the order was changed from liquid to pill form until the root cause analysis. Interview revealed MD #1 felt Pharmacy should have called about the medication order. Interview revealed more frequent visits, targeted questions about Patient #6 suicidal ideation and mental health history, thorough room search, and restricting patient access to flushes should have been implemented.

Follow up Interview on 05/27/2021 at 1315 with the Nurse Manager #1 revealed saline flushes should not be left in patient rooms or accessible to patients. Interview revealed Nurse Manager #1 expected staff to keep saline flushes in the medication rooms or "in their(staff) pockets". Interview revealed the expectation of staff to report patient observations and concerns to the provider team. Interview revealed the events from finding Patient #6 on the floor and the unknown substance found in the room of Patient #6 should have been reported as incidents.

Interview on 05/27/2021 at 1402 with the House Supervisor #1 revealed she responded to the Code Blue on 03/01/2021. Interview revealed the House Supervisor was informed that a syringe was in the bed with Patient #6 and her IV was disconnected. Interview revealed the medical examiner and police were notified due to the unexpected nature of Patient #6's death. Interview revealed the items found (syringe/flush) were not isolated and tested .

Interview on 05/27/2021 at 1515 with MD #2, who assumed care for Patient #6 on 02/15/2021, revealed he assumed medical care for Patient #6 and transferred her to the general surgery floor. Interview revealed "Addition Medicine was involved from the beginning." Interview revealed Patient #6 was "emotional" and "distraught" about the procedure being rescheduled. Interview revealed providers suspected that Patient #6 had used substances in-hospital. Interview revealed MD #2 felt Patient #6 had been tampering with her line after the culture results returned positive for oral flora. Interview revealed Patient #6 did not have visitor restrictions for the majority of her stay and items could have been brought by visitors. Interview revealed the sitter for Patient #6 should have remained in place and the full implementation of the High Risk Substance Use (IVDA) plan.

Interview on 05/27/2021 at 1624 with RN #3 revealed she provided care for Patient #6 on the night shift (1900 - 0700) of 02/28/2021. Interview revealed Patient #6 was "laughing and cutting up" with staff the morning of 03/01/2021. Interview revealed bedside shift report was performed at approximately 0715 and Patient #6 requested pain medication. Interview revealed RN #3 returned to administer the Oxycodone at approximately 0730. Interview revealed RN #3 was leaving the unit when the Code Blue was called overhead. Interview revealed she responded and "was shell shocked" at the scene in Patient #6 room. Interview revealed Patient #6 "seemed fine" the last time she saw her. Interview revealed staff could have been more observant and consistent in the care of patients with history of substance abuse.

Interview on 05/27/2021 at 1658 with RN #4 revealed he performed the Admission Assessment on Patient #6. Interview revealed the Admission Assessment was performed late. Interview revealed RN#4 worked on a different unit than the unit where Patient #6 expired. Interview revealed RN #4 had not received any education on patients with a history of substance abuse.

Interview on 05/28/2021 at 0910 with RN #5 revealed she provided nursing care for Patient #6 on the day shift (0700 - 1900) of 03/01/2021. Interview revealed Patient #6 was awake and talking during bedside shift report. Interview revealed RN #5 and another staff RN heard beeping coming from the room of Patient #6. Interview revealed after entering the room, Patient #6 had agonal breathing and did not respond to a sternal rub. Interview revealed the Code Blue was initiated and RN #5 went to retrieve the code cart. Interview revealed RN #5 recalled conversations about the IV being disconnected, flushes in the bed, and a vape pen being discussed. Interview revealed Patient #6 did not have a sitter at the time and the High Risk Substance Use plan was not implemented. Interview revealed staff could have been tighter with the saline flushes being left unattended.

Interview on 05/28/2021 at 0934, with Quality Leader #1, during tour of Unit B, revealed "That should not be left in the patient ' s room."

Interview on 05/28/2021 at 0950 with Accreditation Leader #1 revealed incidents should have been reported related to finding powder on the pants of a sitter and a chair in Patient #6's room and also when Patient #6 was found on the floor. Interview revealed education was not disseminated to other units that provide care for patients with a history of substance use.

Interview on 05/28/2021 at 1520 with RN #6 revealed she functioned as a sitter the night of 02/25/2021. Interview revealed she found a "weird, white powder" on her pants and a chair in the room of Patient #6. Interview revealed the Charge RN was notified of the findings. Interview revealed no testing of the substance was performed.

Interview on 05/28/2021 at 1640 with Charge RN #1 revealed she was informed of the "white powder" found in the room of Patient #6 on the night shift (1900-0700) of 02/25/2021.Interview revealed the substance was reported at the "beginning half of the shift." Interview revealed the substance was not collected nor tested . Interview revealed no incident report was created. Interview revealed the information was not communicated to the rest of the multidisciplinary team.

In summary, Patient #6 was admitted to a medical/surgery unit with a history of substance abuse on 01/26/2021. Patient #6 was assessed as depressed on 02/24/2021 at 2100 and no communication or escalation of change in mental status was relayed to the physician. On 02/25/2021 at 0152 (approximately 5 hours later) Patient#6 was found on the bathroom floor with saline flushes and a disconnected IV. On 02/25/2021, an unknown powder substance was found in her room and no communication or further escalation to a physician was noted. The two events were not reported via the incident reporting system. On 02/25/2021, a pharmacist modified the physician order for liquid Oxycodone (component of a safety plan) to pill form without communication. The sitter was removed on 02/26/2021 at 1310 and the High Risk Substance Use (IVDA) plan was never fully implemented. Patient #6 expired on [DATE] at 0835 with her IV disconnected and flushes found in her bed. The culmination of the above created a setting that was not safe for Patient #6, or any patient with a history of substance use. Observations on unit tours revealed 2 of 9 units with unattended saline flushes and interview revealed the action plan items were not implemented facility-wide.
VIOLATION: QAPI Tag No: A0263
Based on policy review, medical record review, incident report review and staff interviews the hospital failed to provide an effective data-driven quality assessment and performance improvement (QAPI) program.

Findings include:

The hospital staff failed to ensure an effective QAPI program to analyze, track and make improvements for patient safety by failing to monitor pharmacy modifications to physician orders to determine if the modifications met approved parameters and to evaluate if education provided was effective, and by failing to implement a facility-wide response plan to an adverse outcome and root cause analysis.

~cross refer to 482.21 QAPI Patient Safety Standard: Tag 0286
VIOLATION: PATIENT SAFETY Tag No: A0286
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**

The hospital failed to ensure an effective QAPI program to analyze, track, and make improvements for patient safety by failing to monitor if pharmacy modifications met approved physician parameters, failing to ensure reporting of events and close calls (an event that could have caused an adverse outcome but did not), and by failing to implement a facility-wide response plan to an adverse event.

The findings included:

Review of facility policy, "Facility Event and Close Call Reporting" revised 08/2019, revealed, " ...These should be completed as soon as possible after the event, but no later than the end of the shift ... PROCEDURE: ... 1. Patient notifications include events or close calls that involve, impact, or in any way may be connected to a patient under the care of the facility at the time of the event or close call ... IV. Process for Investigation and Analysis of Incident Trends... B. These reports are utilized for risk identification, performance improvement, and committee reporting as appropriate. C. Data should be utilized to assist with the development of facility educational and improvement initiatives ... DEFINITIONS: Event: A discrete, auditable and clearly defined occurrence ... Close Call: Events or situations that could have resulted in an adverse event (Accident, injury, or illness), but did not, whether by chance or through timely intervention ..."

Closed medical record review of Patient #6 revealed the patient was admitted to a medical/surgical floor at the facility on 01/26/2021 at 1302 with chief complaints of intractable nausea and vomiting and abdominal pain. Review of the History and Physical revealed Patient #6 was "alert and oriented x4" and had a history of illicit (illegal) drug use - Suboxone (Buprenorphine and naloxone - used to treat opioid addiction), and remote history of IVDA (intravenous drug abuse). Review of Nursing Annotations dated 02/25/2021 at 0152 revealed, "patient found down in bathroom sitting up. IV (intravenous) flushes found near patient on the floor. Patient states she was flushing her ear out. IV tubing was found disconnected from patient. MD paged." Review of annotations dated 03/01/2021 at 0750 revealed, "patient found unresponsive. No pulse agonal breathing. CPR started." Review revealed Patient #6 expired on [DATE] at 0835.

Review of Incident Reports related to Patient #6 on 05/26/2021 revealed no events on 02/25/2021 at 0152 where Patient #6 was found on the floor or 02/26/2021 from 1900 to 0000 when an unknown white substance was found in the room. Incident Reports did reveal reports related to the Code Blue of Patient #6.

Review of Follow Up Facility Actions from a Serious Event Analysis on 05/27/2021, revealed a "Serious Event Analysis" meeting was performed on 03/04/2021 at 0730. Review of "Immediate Abatement" on the "Affected Unit (name of Patient #6's unit)" with a 03/02/2021 implementation due date revealed, "Immediate debrief with the team, established that no flushes in patient rooms", "Shared path of escalation. Any concerns initiate chain of command", and "immediate notification to provider of positive UDS (urine drug screen) during admission without cause. IVDA (High Risk Substance Use/IVDA plan) protocol to be implemented." Review of "Action Items" revealed, Root Cause - Pharmacist changed form of medication without consulting provider, Mitigation Strategy - Audit of 30 charts per month to ensure medication dosage forms are appropriate for high risk patients, Implementation Due Date - (no date). Review of Follow Up Facility Actions failed to reveal Action Items that analyzed other units need for education related to unattended saline flushes, chain of command, and High Risk Substance Use (IVDA) plan. Review failed to reveal Action Items were implemented on other units that provide care for patients with a history of substance abuse. Review failed to reveal monitoring of pharmacy audits related to dosage form changes. Review failed to reveal a facility-wide approach to the findings of the Root Cause Analysis.

Interview on 05/26/2021 at 0920 with RN #1 revealed she provided nursing care for Patient #6 on the night shift (1900 - 0700) of 02/25/2021. Interview revealed "white powder" was found on the back of the pants of a sitter and a chair in the room of Patient #6 on night shift of 02/25/2021. Interview revealed the charge nurse was notified of the substance and RN #1 received instructions to clean the area up and wash her hands. Interview revealed no incident report was completed.

Interview on 05/26/2021 at 1005 with the Pharmacy Manager acknowledged an error was made with Patient #6 medication form selection and the error identified a "systems problem."

Follow-up Interview on 05/26/2021 at 1545 with the Pharmacy Manager revealed no reports or metrics were reviewed related to the selection of Pharmacy product selections or form changes. Interview revealed the inability to determine how many medication form changes were performed by Pharmacy. Interview revealed monitoring and audits had not been initiated as of 05/26/2021.

Interview on 05/27/2021 at 1315 with the Nurse Manager #1 revealed the expectation is for staff to report patient observations and concerns to the provider team. Interview revealed the events from finding Patient #6 on the floor and the unknown substance found in the room of Patient #6 should have been reported as incidents.

Interview on 05/27/2021 at 1427 with Quality Leader #1 revealed Action Items from the Root Cause Analysis impacted multiple disciplines. Interview revealed inconsistent practices on saline flushes throughout the facility. Interview revealed Patient #6 was cared for on three different nursing units (one of three units is currently closed). Interview revealed only one unit received targeted education identified through the root cause analysis.

Interview on 05/28/2021 at 0950 with Accreditation Leader #1 revealed units that commonly care for patients with substance abuse history were not assessed for deficits related to action items identified in the Root Cause Analysis. Interview revealed an incident should have been reported related to the finding of powder in the room of Patient #6. Interview revealed facility-wide implementation of the education was not included in the action plan. Interview revealed education was not disseminated to other units that provide care for patients with a history of substance use.

Interview on 05/28/2021 at 1640 with Charge RN #1 revealed she was informed of the "white powder" found in the room of Patient #6 on the night shift (1900-0700) of 02/25/2021. Interview revealed the substance was reported at the "beginning half of the shift." Interview revealed the substance was not collected nor tested . Interview revealed no incident report was created.
VIOLATION: NURSING SERVICES Tag No: A0385
Based on policy and procedure review, observations, medical record review and staff and physician interviews the hospital's nursing staff failed to have an effective nursing service to ensure oversight of day to day operations by failing to secure a patient's environment and to assess, notify and escalate observations and care concerns.

Findings include:

Hospital nursing staff failed to prevent patient access to unattended saline flushes, to provide a timely admission assessment, and to communicate and escalate observations and change in assessments for 1 of 1 medical/surgical patients with a substance abuse history sampled (Patient #6).

~cross refer to 482.23 Nursing Services Standard Tag 0395
VIOLATION: RN SUPERVISION OF NURSING CARE Tag No: A0395
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**

Based on policy review, medical record review, and staff and physician interview hospital nursing staff failed to prevent patient access to unattended saline flushes, to provide a timely admission assessment, and to communicate and escalate observations and change in assessments for 1 of 1 medical/surgical patients with a substance abuse history sampled (Patient #6).

Findings include:

Review of facility policy, "Assessment and Reassessment" revised 09/21/2018, revealed, " ...Section I: Inpatient Scope of Assessment/Reassessment. Admission History - within 24 hours ... Focused Assessment - every 12 hours or more frequently based on nursing judgement ... D. Focused Assessments will be performed by the RN ... A focused assessment is based upon, but not limited to the following: status related to diagnosis, patient care needs or nursing diagnosis/problems identified in the Individualized Plan of Care (IPOC), response to treatment, or change in condition .... C. The RN assesses, observes, interprets the information to determine abnormalities, conducts further observations to clarify information and then identifies the patient problems to address in the individualized plan of care plan ..."

Review of facility policy, "Safety Precautions for the Patient with Behavioral Health Needs - All facilities" revised 02/26/2018, revealed, " ...B. All inpatients will receive routine assessments of mental status including assessment of safety. Patients should also be screened for safety issues after a potentially distressing event occurs such as, but not limited to ...bad news form a healthcare provider ... C. When a patient is identified as having serious safety concerns, immediate action must be taken to ensure the safety of that patient ... D. A high level of safety will be maintained in the patient's environment ... staff must be aware of hazard potential associated with such items and the patient will be monitored closely for unsafe behaviors. To make the care environment as safe as possible, the following precautions will be initiated: ... 2. To enhance safety of the environment, the patient room/environment should be checked at least once per shift and after the patient has had visitors: .... e. ... IV supplies must be removed from room ...."

Review of facility policy, "Facility Event and Close Call Reporting" revised 08/2019, revealed, " ...These should be completed as soon as possible after the event, but no later than the end of the shift ... PROCEDURE: ... 1. Patient notifications include events or close calls that involve, impact, or in any way may be connected to a patient under the care of the facility at the time of the event or close call .... DEFINITIONS: Event: A discrete, auditable and clearly defined occurrence ... Close Call: Events or situations that could have resulted in an adverse event (Accident, injury, or illness), but did not, whether by change or through timely intervention ..."

Closed medical record review of Patient #6 revealed the patient was admitted to a medical/surgical floor at the facility on 01/26/2021 at 1302 with chief complaints of intractable nausea and vomiting and abdominal pain. Review of the History and Physical revealed Patient #6 was "alert and oriented x4" and had a history of illicit (illegal) drug use - Suboxone (buprenorphine and naloxone - used to treat opioid addiction), and remote history of IVDA (intravenous drug abuse). Review of toxicology report collected 01/26/2021 at 1310 revealed the Urine Drug Screen (UDS) for Patient #6 was positive for buprenorphine (compound found in Suboxone-medication used for opiate addiction) and cannabinoid (compound found in cannabis/marijuana). Review revealed Patient #6 was subsequently diagnosed with [DIAGNOSES REDACTED]"). Medical record review revealed Addiction Medicine consulted on 02/11/2021 at 0829 for Suboxone and pain management recommendations prior to the "Whipple procedure" (pancreaticoduodenectomy - operation to remove the head of the pancreas, the first part of the small intestine, gallbladder, and bile duct) for Patient #6. Review of Addition Medicine Note dated 02/11/2021 at revealed, "Psychiatric History: reports one psychiatric hospitalization but numerous diagnoses including bipolar, DID (Dissociative Identity Disorder), PTSD (Post Traumatic Stress Disorder), depression and anxiety. She does not accept the dx (diagnosis) of biolar (sic) stating that prior manic behavior was due to stimulant abuse. Does report ongoing PTSD symptoms including nightmares, flashbacks and hypervigilance. She does report OD (overdose) attempts in the past during which "I kind of hoped I wouldn't make it" but denies SI (suicidal ideation) for many years ... Family History: her sister also has opiate use disorder, her maternal grandmother reportedly did as well ..." Review of Admission assessment dated [DATE] 0515 revealed, "Mental Health History: Anxiety, Depression, Other: hx(history) of opiate abuse" (19 days after admission). Review revealed Patient #6 was moved to a general surgery unit on 02/18/2021 at 2150. Review of Addiction Medicine Progress Note dated 02/18/2021 at 0958 revealed, "Interval History. Now increasingly concerned about the gravity of planned procedure, worried about pain control. Would prefer to taper off buprenorphine now ... Impression and Plan ...Opiate use disorder - severe Stimulant use disorder - moderate - on low dose suboxone, now preferring to taper off prior to surgery 2/24 - plan decrease by 2mg/day(milligrams per day) with prn (as needed) Oxycodone (medication for moderate to severe pain) for pain or withdrawal symptoms ..." Review of Addiction Medicine Progress Note dated 02/22/2021 at 1022 revealed, "tapered down to 2mg buprenorphine with minimal withdrawal sx(symptoms) except some worsening of her chronic back pain and other aches and pains. Has been using oxycodone with good relief ... will sign off for now, however please call if new issues should arise..." Review of Surgical Oncology Progress Note dated 02/22/2021 at 1208 revealed, "Overnight she had a bad episode of anxiety ... This morning although she feels well, she reports severe anxiety ..." Review of Surgical Oncology Progress Note Addendum dated 02/23/2021 at 1927 revealed, "Addendum ... New onset tachycardia w/fevers today .... Suspect PICC (peripherally inserted central catheter) line infection, blood cultures drawn and d/c'ing (discontinuing) PICC ..." Review revealed the surgical procedure for Patient #6 was rescheduled from 02/24/2021 to 03/03/2021. Review of Nursing Assessment for Mental Status dated 02/24/2021 at 2100 revealed, "depressed." Review of Nursing Annotations dated 02/25/2021 at 0152 revealed, "patient found down in bathroom sitting up. IV (intravenous) flushes found near patient on the floor. Patient states she was flushing her ear out. IV tubing was found disconnected from patient. MD paged." Record review revealed on 02/25/2021 at 0219 the provider was notified and ordered a UDS. Review revealed an order restricting personal belonging access was ordered 02/25/2021 at 0754. Review of Safety Monitoring Flowsheet revealed a patient safety attendant (sitter) was initiated on 02/25/2021 at 0845. Review of Surgical Oncology Progress Note Addendum dated 02/25/2021 at 0958 revealed, "Patient clinically looks normal and no further fevers overnight. Tachycardia persists and had some soft pressures which have normalized this morning ...This is probably because she apparently either fell or passed out in her bathroom with several saline flushes. It is unclear how she got these but there is obvious concern for IV drug abuse given her history. This would further explain the PICC line infection that she clearly had preoperatively. I spoke with Dr. (named Addiction Medicine physician) who will see her and ordered a sitter this morning ...." Review of Addition Medicine Progress Note dated 02/25/2021 at 0945 revealed, "Impression and Plan ... Gastric outlet obstruction, possible pancreatic CA (cancer) - Whipple planned 2/24, postponed due to tachycardia and fevers, tentatively rescheduled for 3/3. Opiate use disorder - severe. Stimulant use disorder - moderate - did well on low dose suboxone, tapered off prior to surgery per her request and started on moderate dose opiate agonists - suspicious incident with saline flushes yesterday - pt (patient) claims cleaning out her ears. Denies cravings or illicit behavior. While this is plausible, patients with IVDU (intravenous drug use) have been known to use saline flushes to recreate process/feeling of illicit IV use. - very upset about having a sitter again. Readily agrees to liquid oxycodone for decreased diversion risk and to have belongings searched if sitter can be dc'ed (discontinued). Patients with intent to divert meds are often reluctant to agree to these measures. - repeat UDS pending, while this obviously would not reveal any diversion of oxycodone it would allow us to rule out use of illicit substance brought from outside ..." Review of the toxicology report collected 02/25/2021 at 1530 revealed the UDS for Patient #6 was positive for methamphetamine, benzodiazepine, buprenorphine, cannabinoid, opiates, and oxycodone. Review of Surgical Oncology Progress Note dated 02/26/2021 at 0827 revealed, "Impression and Plan ... Urine drug screen positive for methamphetamines; addiction medicine following and will have social work search patient's belongings, restrict visitors, may no longer need sitter after these 2 interventions ..." Review of Surgical Oncology Progress Note Addendum dated 02/26/2021 at 0939 revealed, "blood growing out oral flora, U tox (urine toxicology) demonstrating amphetamines, cannabinoids among other things. Working with addiction medicine for plan. Currently continue sitter ..." Review of CM-Inpatient SBIRT (Substance Brief Intervention and Referral to Treatment - team for early intervention and treatment approach for substance use disorders) Note dated 02/26/2021 at 1215 revealed, " ...LCSW (Licensed Clinical Social Worker) met with patient for HRSU(High Risk Substance Use) rounding and to discuss events of the last 48 hours which resulted in the patient's UDS being tested ...and came back positive .... PRESENTATION: Patient was seen awake, alert, oriented x4 and presents with angry mood and congruent affect often yelling, cursing and raising her voice throughout this meeting ....She adamantly denies any substance use and reports she finds it insulting and offensive that she is accused of this. She insists the UDS is wrong and that the "tester" is wrong and demands a new UDS ... INTERVENTION: ...communicated multiple times with Dr. (named Addiction Medicine physician) .... VISITATION STATUS: No visitors as per Dr. (named Addiction Medicine physician) Patient may have access to her personal belongings once they have been searched by security. PLAN: Patient's belongings/room to be searched by security. Sitter can be discontinued after the search has been performed. Patient is to have no visitors. A confirmatory test has been ordered for the UDS sent yesterday to determine it the methamphetamine was a false positive ..." Record review revealed a personal search order entered at 1242 and signed by Addiction Medicine physician. Review of Safety Monitoring Flowsheet revealed the sitter was removed at 02/26/2021 at 1315. Review of Surgical Oncology Progress Note dated 02/27/2021 at 1220 revealed, "Drug screen positive for methamphetamine. Report drinking a lot of fluids..." Review of Surgical Oncology Progress Note Addendum dated 02/27/2021 at 1422 revealed, "In light of multiple substances found on tox screens, could potentially be substance-withdrawal related as well." Review of GMED Progress Note dated 02/27/2021 at 1519 revealed ... Impression and Plan ... Fever: ...The patient may have been using her IV access for injection .... History of IV drug abuse: Suspicious activity in the hospital concerning for further drug abuse. I agree with high risk substance abuse protocol in the presence of a sitter ..." Review of GMED Progress Note dated 02/28/2021 at 1904 revealed ... Impression and Plan ... History of IV drug abuse: ... I agree with high risk substance abuse protocol in the presence of a sitter ..." Review of annotations dated 03/01/2021 at 0750 revealed, "patient found unresponsive. No pulse agonal breathing. CPR started." Review revealed Patient #6 died on [DATE] at 0835. Review of Surgical Oncology Brief Progress Note dated 03/01/2021 at 0838 revealed, "Patient was seen this morning and was doing overall well however a little tearful about the delays with surgery ... Patient was talking to us, coherent and was doing overall okay ...the patient did have some suspicious activity around Wednesday/Thursday last week where her IV was disconnected anther were flushes on the floor and she lost consciousness in the bathroom for which the patient had a sitter for several days. She did have positive UDS for methamphetamine which was negative on admission. Addiction medicine was involved and recommended that the patient's room be searched, to restrict visitors, and that the sitter could be discontinued. Patient did not have a sitter this morning. There is concern that etiology may be related to further in-hospital drug abuse." Review of Death Summary dated 03/01/2021 at 1339 revealed, "Cause of Death - Preliminary - Cardiac Arrest Due to suspicion for in hospital IV drug use overdose although etiology is not known at this time .... CODE BLUE was called over intercom at 8 AM on this patient. Nurse reported that patient's IV was beeping and that she went in to fix it and noticed that the patient was breathing agonally, IV disconnected, with a flush nearby the bed ..." Medical record review failed to reveal notification of provider and implementation of mental health interventions after mental status changes, failed to complete a timely Admission Assessment, and failed to reveal documentation related to an unknown powder substance in the room of Patient #6.

Request for incident reports related to events on 02/25/2021 at 0152 where Patient #6 was found on the floor or 02/25/2021 at 1900 to 02/26/2021 at 0030 when an unknown white substance was found in the room of Patient #6 revealed there were no incidents reported.

Observation on 05/25/2021 at 1200, during tour of Unit A in room 457, revealed a supply cart in the patient room with two (2), 10 milliliter (ml) pre-filled, 0.9% Sodium Chloride (normal saline) flushes (flush #1 and #2) lying, unsecured, on top of the supply cart. Observation revealed flush #1 was unopened and labeled "0.9% Sodium Chloride." Flush #2 was open and labeled "0.9% Sodium Chloride" and contained 7 mls of solution. Observation revealed both flushes were disposed of in the sharps container by the Nurse Manager (NM) upon discovery.

Observation on 05/28/2021 at 0934, during tour of Unit B in room 402, revealed an unopened 10 ml pre-filled, 0.9% Sodium Chloride (normal saline) flush lying, unsecured on the counter beside the sink in the patient ' s room. Observation revealed the flush was disposed of in the sharps container by the (Carrie) prior to leaving the patient ' s room.

Interview on 05/25/2021 at 1200, with Nurse Manager #2, during tour of Unit A, revealed "Extra supplies should not be left in the patient ' s rooms."

Interview on 05/26/2021 at 0920 with RN #1 revealed she provided nursing care for Patient #6 on the night shift (1900 - 0700) of 02/25/2021. Interview revealed Patient #6 was assessed as depressed and no additional interventions were started because a sitter was in place. Interview revealed Patient #6 was focused on sitter removal and asked, "when she could get rid of her sitter." Interview revealed "white powder" was found on the back of the pants of a sitter and a chair in the room of Patient #6 on night shift of 02/25/2021. Interview revealed the charge nurse was notified of the substance and RN #1 received instructions to clean the area up and wash her hands. Interview revealed no incident report was completed. Interview revealed RN #1 was unsure if observations were reported to the the provider team. Interview revealed she did not recall leaving flushes in the patient's room.

Interview on 05/26/2021 at 0935 with Nurse Manager #1 revealed the admission assessment identified suicide risk at the time of admission. Interview revealed if a staff member had concerns about changes in the mental status of a patient at any point during the hospitalization , then the physician should be notified.

Interview on 05/26/2021 at 1035 with RN #2 revealed she provided nursing care for Patient #6 on the day shifts (0700 - 1900) of 02/25/2021 and 02/26/2021. Interview revealed Patient #6 had "two different moods based on sitter situation." Interview revealed on 02/25/2021, Patient #6 was observed as depressed, "didn't say much," "didn't get out of bed". Interview revealed the changes in mood and mental status of Patient #6 were not shared with the medical team. Interview revealed Patient #6 refused to urinate for the UDS for majority of the shift. Interview revealed "could have gotten them (saline flushes) from the room or out in the hallway." Interview revealed Patient #6 "liked to stroll the halls." Interview revealed RN #2 was present during the "Code Blue" response on 03/01/2021 for Patient #6. Interview revealed the IV tubing was disconnected and flushes were found in the bed of Patient #6. Interview revealed a more thorough room search should have been conducted on Patient #6.

Interview on 05/26/2021 at 1225 with CNA #1 revealed she assisted Patient #6 after the 02/25/2021 bathroom incident and was a sitter on 02/26/2021. Interview revealed Patient #6 was on the bathroom floor with a saline flush and puddle from the disconnected IV tubing. Interview revealed after the incident, Patient#6 was "weird," her talking was "not at baseline," and she appeared "confused." Interview revealed Patient #6 was able to walk after the bathroom incident and was guided back to bed by staff. Interview revealed staff continued routine care and more frequent checks were not implemented. Interview revealed Patient #6 was very irritated with having sitters.

Interview on 05/27/2021 at 1133 with MD #1 revealed she consulted on Patient #6 Suboxone and pain management. Interview revealed Addiction Medicine does not implement the High Risk Substance Use plan and deferred to the attending physician for ordering the plan. Interview revealed on the 02/25/2021 visit after the incident, Patient #6 appeared "anxious" and "destabilized." Interview revealed Patient #6 felt worse due to the presence of sitters and Patient #6 "didn't like being watched". Interview revealed the safety contract (liquid Oxycodone, room search) with Patient #6 was created to preserve the therapeutic relationship and minimize patient-staff conflict. Interview revealed more frequent visits, targeted questions about Patient #6 suicidal ideation and mental health history, thorough room search, and restricting patient access to flushes should have been implemented.

Follow up Interview on 05/27/2021 at 1315 with the Nurse Manager #1 revealed saline flushes should not be left in patient rooms or accessible to patients. Interview revealed Nurse Manager #1 expected staff to keep saline flushes in the medication rooms or "in their(staff) pockets". Interview revealed the expectation of staff to report patient observations and concerns to the provider team. Interview revealed the events from finding Patient #6 on the floor and the unknown substance found in the room of Patient #6 should have been reported as incidents.

Interview on 05/27/2021 at 1402 with the House Supervisor #1 revealed she responded to the Code Blue on 03/01/2021. Interview revealed the House Supervisor was informed that a syringe was in the bed with Patient #6 and her IV was disconnected. Interview revealed the medical examiner and police were notified due to the unexpected nature of Patient #6's death. Interview revealed the items found (syringe/flush) were not isolated and tested .

Interview on 05/27/2021 at 1624 with RN #3 revealed she provided care for Patient #6 on the night shifts (1900 - 0700) of 02/28/2021. Interview revealed Patient #6 was "laughing and cutting up" with staff the morning of 03/01/2021. Interview revealed bedside shift report was performed at approximately 0715 and Patient #6 requested pain medication. Interview revealed RN #3 returned to administer the Oxycodone at approximately 0730. Interview revealed RN#3 was leaving the unit when the Code Blue was called overhead. Interview revealed she responded and "was shell shocked" at the scene in Patient #6 room. Interview revealed Patient #6 "seemed fine" the last time she saw her. Interview revealed staff could have been more observant and consistent in the care of patients with history of substance abuse.

Interview on 05/27/2021 at 1658 with RN #4 revealed he performed the Admission Assessment on Patient #6. Interview revealed the Admission Assessment was performed late. Interview revealed RN#4 worked on a different unit than the unit where Patient #6 expired. Interview revealed he had not received any education on patients with a history of substance abuse.

Interview on 05/28/2021 at 0910 with RN #5 revealed she provided nursing care for Patient #6 on the day shift (0700 - 1900) of 03/01/2021. Interview revealed Patient #6 was awake and talking during bedside shift report. Interview revealed RN #5 and another staff RN heard beeping coming from the room of Patient #6. Interview revealed after entering the room, Patient #6 had agonal breathing and did not respond to a sternal rub. Interview revealed the Code Blue was initiated and RN #5 went to retrieve the code cart. Interview revealed RN #5 recalled conversations about the IV being disconnected, flushes in the bed, and a vape pen being discussed. Interview revealed Patient #6 did not have a sitter and the High Risk Substance Use plan was not implemented. Interview revealed staff could have been tighter with the saline flushes being left unattended.

Interview on 05/28/2021 at 0934, with Quality Leader #1, during tour of Unit B, revealed "That should not be left in the patient ' s room."

Interview on 05/28/2021 at 0950 with Accreditation Leader #1 revealed incidents should have been reported related to the finding of powder in the room of Patient #6 and Patient #6 on the floor. Interview revealed education was not disseminated to other units that provide care for patients with a history of substance use.

Interview on 05/28/2021 at 1520 with RN #6 revealed she worked as a sitter the night of 02/25/2021. Interview revealed she found a "weird, white powder" on her pants and a chair in the room of Patient #6. Interview revealed the Charge RN was notified of the findings. Interview revealed no testing of the substance was performed.

Interview on 05/28/2021 at 1640 with Charge RN #1 revealed she was informed of the "white powder" found in the room of Patient #6 on the night shift (1900-0700) of 02/25/2021. Interview revealed the substance was not collected nor tested . Interview revealed no incident report was created. Interview revealed the information was not communicated to the rest of the multidisciplinary team.

In summary, Patient #6 was admitted to a medical/surgery unit with a history of substance abuse on 01/26/2021. The Admission Assessment was completed on 02/14/2021; 19 days after admission to the facility. Patient #6 was assessed as depressed on 02/24/2021 at 2100 and no communication or escalation of change in mental status was relayed to the physician. On 02/25/2021 at 0152 (approximately 5 hours later) Patient#6 was found on the bathroom floor with saline flushes and a disconnected IV. On 02/26/2021, an unknown powder substance was found in her room and no communication or further escalation to a physician was noted. The two events were not reported via the incident reporting system. Patient #6 expired on [DATE] at 0835 with her IV disconnected and flushes found in her bed. Observations on unit tours revealed 2 of 9 units with unattended saline flushes and interview revealed the action plan items were not implemented facility-wide. The culmination of the above displayed a failure of nursing staff to supervise and evaluate nursing care to patients with a history of substance abuse.
VIOLATION: HOSPITAL PROCEDURES Tag No: A0410
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**

Based on hospital policy review, medical record review and staff interview, the hospital nursing staff failed to obtain vital signs for 2 of 2 patients who received a blood transfusion per hospital policy (Patient #8 and #9).

Findings include:

Review on 05/25/2021 of the hospital's "Blood and Blood Component Administration (Blood Transfusion) ..." policy, last revised 05/19/2020, revealed, " ... 5. Obtain baseline vital signs (temperature, pulse, respiration, and blood pressure). ... Febrile patients may receive blood, but fever documented before transfusion should not be considered as a transfusion reaction unless a temperature rise of > 1.8 [degrees] F and of at least 100.4 [degrees] F is noted. ... c. Check complete set of vital signs 15 minutes into the transfusion. ... f. Check complete set of vital signs every hour during infusion and at completion and document ... 3. Febrile Non[DIAGNOSES REDACTED] Reactions: Febrile non[DIAGNOSES REDACTED] reactions are indicated by the presence of at least one of the below criteria: a. A fever > 38 [degrees] or 100.4 [degrees] F orally and a change of at least a temperature rise > 1.8 [degree] F or 1 [degree] C occurring in association with transfusion and without other explanation. ... 5. Implementation: If a [DIAGNOSES REDACTED] or febrile non[DIAGNOSES REDACTED] transfusion reaction....is suspected: a. STOP the transfusion immediately. ..."

1. Medical record review on 05/26/2021, revealed Patient #8 was admitted [DATE] at 1323 anemia, hemoglobin of 6.3, hyponatremia, and sepsis due to a urinary tract infection. Record review revealed an order to transfuse 2 units of blood on 05/11/2021 at 1101. Review of the blood transfusion and vital signs nursing documentation revealed the second unit of blood was started at 2304. Vital signs at 2304 were recorded as T 99.4, P 114, R 17 and BP 133/60. Vital signs at 2324 (20 minutes later) were recorded as T 101.8, P 115, T 17 and BP 127/60. Review of a nursing progress note by the RN administering the blood at 2347 revealed , "MD notified, continue transfusion." Vital signs at 0000 (13 minutes after MD notification) were P 109 (no T, R or BP were recorded). Vital signs at 0207 (2 hours, 43 minutes after last full set of recorded vital signs) were recorded as T 102.1, P 114, R 18 and BP 124/69. The transfusion was noted to end at 0210. Review failed to reveal the nurse stopped the blood transfusion prior to calling the MD and vital signs per policy.

Request for interview revealed the registered nurse (RN #12) who administered the blood was not available for interview.

Interview with a Nurse Supervisor (NS) #2 on 05/27/2021 at 1403 revealed a complete set of vital signs, including temperature, pulse, respirations and blood pressure, should be taken "every hour during the blood transfusion and when the transfusion is completed."

2. Medical record review on 05/26/2021, revealed Patient #9 was admitted [DATE] at 1915 for electrolyte abnormalities, anemia and failure to thrive secondary to endometrial cancer. Review of the History and Physical, dated 05/13/2020 at 1654, revealed that on arrival to the hospital, the patient had an episode of bloody diarrhea with "frank, bright red bleeding." Record review revealed an order to transfuse 2 units of blood on 05/14/2021 at 1212. Review of the blood transfusion and vital signs nursing documentation revealed the second unit of blood was started at 1751. Vital signs were recorded at 1856 and not recorded again until 2042 (1 hour, 46 minutes later). Vital signs were recorded as T 98.5, P 110, no respirations recorded and BP 133/64. Review failed to reveal vital signs per policy.

Telephone interview with the RN #11 (Registered Nurse) who administered the blood, on 05/27/2021 at 1003, revealed vital signs should be done 15 minutes after a blood transfusion is started and should include temperature, pulse, respirations and blood pressure, "to assess how the patient is tolerating it [transfusion], hourly during the transfusion and obtain another set of vital signs after the blood is complete." Interview revealed the second unit of blood was transfusing at shift change, "which a rough time for us. It's not an excuse, but it's the only thing I can think of that may have caused the oversight."

Interview with a Nurse Supervisor (NS) #2 on 05/27/2021 at 1403 revealed a complete set of vital signs, including temperature, pulse, respirations and blood pressure, should be taken "every hour during the blood transfusion and when the transfusion is completed."

NC 543, NC 297, NC 369, NC 693, NC 548