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.

COMMUNITY HOSPITAL OF SAN BERNARDINO 1805 MEDICAL CENTER DRIVE SAN BERNARDINO, CA 92411 Jan. 10, 2020
VIOLATION: PATIENT RIGHTS: RESTRAINT OR SECLUSION Tag No: A0175
Based on interview and record review, the hospital failed to follow their policy and procedure for elopement (when a patient makes an intentional, unauthorized departure from a 24-hour medical facility, putting the patient at risk for serious injury or death) prevention when the emergency exit door was unlocked and staff did not check the door hourly for one of 30 sampled patients (Patient 16).

These failures resulted in Patient 16 eloping from the hospital, and had the potential to cause harm to self and others.

Finding:

During a review of Patient 16's "Behavioral Health Consultation" (Consult note), dated March 20, 2018, the Consult note indicated, Patient 16 was placed on a 5150 hold (involuntary hold when a person is a danger to self and others) for "throwing rocks at people and wanting to kill himself." Patient 16 was admitted to the hospital "to be treated per psychiatry."

During a record review of Patient 16's "Progress Notes-Nursing (Progress Note)," dated March 20, 2018, the Progress Note indicated, " ...Pt (Patient) was reported to have kicked open the back door on the unit and AWOL (absent without leave). Security was alerted and code green (hospital emergency alert system) was activated, all responding staff attempted to locate pt in parking lot but unsuccessful ..."

During an interview, on January 7, 2020, at 2:54 PM, with the Security Officer (SEC), the SEC stated, security staff are required to check all emergency doors hourly, document the findings and sign the log. The SEC stated the security supervisor is responsible for verifying the emergency doors are checked and secured on each shift.

During a follow-up concurrent interview and record review, on January 7, 2020, at 2:56 PM, with the SEC, the "Behavioral Health Locked West-Required Security Checks" (Security Log), dated March 21, 2018 and March 22, 2018 were reviewed. The Security Log indicated, "Doors should be locked and secured. Checks must be done every hour." The SEC stated security staff did not check the exit doors on the following shifts:

March 21, 2018, for 8:30 PM

March 22, 2018, from 1:30 AM to 4:30 AM

March 22, 2018, from 7:30 AM to 12:30 PM

The SEC stated, the logs should have signatures to demonstrate the doors were checked, locked and secured.

During an interview, on January 8, 2020, at 1:15 PM, with the Director of Risk Management (DOR), the DOR stated, the surveillance camera was reviewed during the time period Patient 16 eloped. The emergency exit door was left "cracked open" when staff had exited the unit. The DOR further stated, there was no alarm on the door before Patient 16 had eloped. The DOR stated, there should have been an alarm on the emergency exit door.

During a review of the facility's policy and procedure (P&P) titled, "Security Department Post Orders," undated, the P&P indicated, " ...2.A. ALL SHIFTS. SECURITY OFFICER (S) 1. Hourly patrol of Behavioral Health Units and complete sign off sheet in unit. Officers are expected to check doors, and check in with nurses or charge nurse to make see if there are any patient valuables or contraband to be locked up or taken away. Also, Patrol officer should check in with charge nurse to make sure the behavior on the unit is stable before exiting the unit ..."

During a review of the facility's policy and procedure (P&P) titled, "Code Green (Patient Elopement)," effective date March 2012, the P&P indicated, " ...Policy: It is the policy of [Hospital Name] to provide a reasonable level of search, pursuit, communication and documentation in the event a patient has eloped from the facility. Patients who are involuntarily detained through the Lanterman Petris Short (LPS) Act, those patients identified as danger to self or others, and those patients who lack the capacity to make reasonable medical decisions will not be allowed to depart [Hospital Name]. Any of these patients that attempt to depart will be considered an elopement ..."
VIOLATION: PRE-ANESTHESIA EVALUATION Tag No: A1002
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**

Based on observation, interview, and record review, the facility failed to implement safe practices for anesthesia service procedures for two of 30 sampled patients (Patient 9 and Patient 14) when:

1. For Patient 9, the facility did not ensure a spinal needle (a surgical item that was not intended to remain in a patient's body after an operation or procedure) was accounted for, and was not left behind in Patient 9's lower back.

This failure resulted in a spinal needle retained in Patient 9's back for 30 hours after the conclusion of the procedure causing lower back pain.

2. For Patient 14, the Anesthesiologist did not maintain aseptic technique (steps to prevent and minimize infections) during intravenous (IV-into the vein) medication administration.

This failure had the potential to result in cross-contamination (the transfer of harmful bacteria) causing a preventable bloodstream infection and prolonged hospitalization .

Findings:

1. During a review of Patient 9's "History and Physical" (H&P), dated September 19, 2017, the H&P indicated, Patient 9 was admitted to the facility with diagnoses of [DIAGNOSES REDACTED]

During a review of the Patient 9's "Nursing Notes" dated September 20, 2017, the Nursing Notes indicated, "Events: pt (patient) up to shower, called me to room, feels something in her back, needle protruding from back [name of nurse manager] notified, [Name of Anesthesiologist] to room, removed needle, bandages placed over site. No complaints from patient, no headaches, moves all extremities."

During a concurrent interview and review of Patient 9's "Anesthesia Progress Notes," dated September 20, 2017, with the Director of Risk Management (DOR), on January 8, 2020, at 4:10 PM, the DOR stated Anesthesiologist 2's progress notes indicated he had removed one needle that was less than one centimeter (unit of measurement) from Patient 9's lower back.

During an interview with Anesthesiologist 1, on January 9, 2020, at 12:50 PM, in the conference room, Anesthesiologist 1 stated two needles were inserted into Patient 9's lower back for a spinal anesthesia (medicine delivered through a needle into the lower back for pain relief) procedure and one needle was removed at the conclusion of the procedure. Anesthesiologist 1 stated the retained needle was discovered after Patient 9 complained of lower back pain. Anesthesiologist 1 stated after the retained needle was discovered, the facility did not provide him coaching or implement a policy and procedure to ensure spinal needles were accounted for or tracked at the conclusion of spinal anesthesia procedures. Anesthesiologist 1 stated spinal needles should be double-checked by another staff member/anesthesia personnel to ensure all needles used in the procedure are intact, on the procedure field, and are accounted for. Anesthesiologist 1 stated he had missed counted and one needle was unintentionally retained in Patient 9's lower back after the procedure.

During a concurrent interview with the Director of Labor and Delivery (ND 3), the Senior Director of Nursing (DON), and Registered Nurse 11 (RN 11), on January 9, 2020, at 2:05 PM, in the conference room, RN 11 stated she did not account for or track spinal needles in collaboration with the anesthesia department after a procedure. RN 11 stated spinal needles should be double-checked with the anesthesiologist to ensure needles are accounted for and are not retained in a patient's back. ND 3 stated assisting anesthesiologist with needle counts are not common practice and it is not nursing's responsibility to verify that spinal needles were not retained in a patient's back. The DON stated it was the responsibility of the anesthesiologist to ensure all items used during anesthesia procedures are accounted for by the anesthesia department.

During a follow-up interview with the DOR, on January 9, 2020, at 2:35 PM, in the conference room, the DOR stated, "It is the role of the anesthesiologist and nursing to ensure patient safety."

During a review of the facility's policy and procedure (P&P) titled, "Prevention of Retained Surgical Items (RSI)," dated January 24, 2018, the P&P indicated, "Policy: 4. To provide guidelines for anesthesiologist and anesthesia personnel to prevent retention of surgical items .... C. Sharps and Needles: 1. Sharps must be handled according to OSHA (Occupational Safety and Health Administration- a government agency responsible for maintaining standards for health and safety in work places) guidelines. 2. Disposable punctured-resistant plastic container boxes should be available for containment of used needles and blades. 3. Sharps must be counted on all procedures ...Anesthesia Responsibilities: ...5. At the conclusion of all procedures performed by anesthesia personnel inspect the anesthesia area and site to ascertain that all items used during the procedure are intact and on the field (e.g. guide wire is present [for example-a medical wire used as a guide for placement of a larger device]) ..."




2. During a review of Patient 14's "Operative Report" (Op Note), dated January 8, 2020, the Op Note indicated, Patient 14 had a laparoscopic cholecystectomy (a surgery procedure to remove gallbladder) for chronic [DIAGNOSES REDACTED] (swelling of gallbladder) with cholelithiasis (gallstones) surgery.

During an observation of Patient 14's laparoscopic cholecystectomy procedure, on January 8, 2020, at 9:13 AM, in Operating Room (OR) 2, Patient 14 was lying on the procedure room's table receiving IV therapy. Anesthesiologist 1, removed (twisted off) one green cap from the needleless connector (closed system access port of the catheter for administer medication, fluids, or blood) port and placed the green cap on top of the anesthesia cart. Anesthesiologist 1 administered medication to Patient 14 through the uncapped IV port. Anesthesiologist 1 did not perform hand hygiene (cleaning hand). After the medication had been delivered, Anesthesiologist 1 did not apply a new green cap to the port. Anesthesiologist 1 put on gloves, and picked up a laryngoscope (rigid tube to help look into throat and vocal cord) and endotracheal (ET) tube (catheter inserted into the throat to help with breathing) to perform an intubation procedure (process of inserting ET tube through mouth to throat to assist with breathing). After the completion of the intubation procedure, Anesthesiologist 1 removed his gloves and did not perform hand hygiene. Anesthesiologist 1 administered another dose of IV medication and he did not disinfect (kill germ) the port prior to administering the medication. After Anesthesiologist 1 administered the IV medication, he dropped the used syringe on the floor, picked it up, and discarded the contaminated (dirty) syringe into the trash can. Anesthesiologist 1 did not perform hand hygiene. Anesthesiologist 1 picked up a new syringe, he did not disinfect the port and administered IV medication.

During a concurrent observation and interview, on January 8, 2020, at 9:35 AM, with the Director of Perioperative Service (DPS), the DPS stated, Anesthesiologist 1 gave IV medication before and after the intubation procedure, and he did not perform hand hygiene. She further stated Anesthesiologist 1 did not perform hand hygiene after he removed the gloves, or picked up the contaminated syringe from the floor. The DPS stated, Anesthesiologist 1 should have maintained aseptic technique throughout the IV medication administration to prevent cross-contamination.

During an interview, on January 8, 2020, at 11:04 AM, with Anesthesiologist 1, Anesthesiologist 1 confirmed he did not perform hand hygiene during the IV medication administration, intubation procedure, or when he picked up the contaminated syringe from the floor. Anesthesiologist 1 stated, "I wore gloves for intubation. I didn't know I have to hand gel after removed gloves. I'm sorry. I missed that." Anesthesiologist 1 further stated that hand washing should be done before and after surgery, "I did wash in and wash out." Anesthesiologist 1 confirmed the needleless connector port was not disinfected after each used and he did not apply a new disinfection cap onto the port. Anesthesiologist 1 stated, "I thought with using the Curos (disinfected cap), I don't ever have to clean the port."

During an interview, on January 10, 2020, at 10:28 AM, with the Medical Staff President (Physician 1), the Physician 1 stated, hand hygiene must be implemented as "gel in and gel out" or prior to entering the OR and before leaving the OR. Physician 1 stated anesthesiology services should implement aseptic technique when handling items. Physician 1 stated, hand hygiene should have been performed after gloves were removed and after touching potentially contaminated items.

During a review of the facility's policy and procedure (P&P) titled, "Hand Hygiene," effective date February 8, 2017, the P&P indicated, "A. Indications for Hand Hygiene ...3. Health care workers shall decontaminate (clean) hands using alcohol-based hand rub or washing with soap (plain or antimicrobial [kill germ]) and water under the following circumstances: a. Before and after patient contact. b. Before donning (wear) sterile gloves. c. Before inserting an invasive device. d. Before handling an invasive device, including before accessing intravenous devices for medication administration. e. Before moving from a contaminated (unclean) body site to a clean body site on the same patient. f. Before preparing or handling medication in anticipation of patient care (e.g. in medication room or at medication cart before patient encounter). g. After contact with patient's intact or non-intact skin, mucous membranes (layers of tissues that cover organs body), wound dressings or other objects likely to be contaminated. h. After contact with inanimate (no life) objects that are used for direct patient care in the immediate vicinity of the patient. i. After removing gloves ..."

During a review of the facility's P&P titled, "Peripheral Intravenous Catheter Insertion and Maintenance (Adult)," effective date October 24, 2018, the P&P indicated, " ...E. Disinfection Caps: 1. Peripheral IV catheters must have a new disinfection cap placed on all needleless connectors at the following times: a. Upon completion of IV device insertion. b. After each use of a needleless connector ...4. Any time the needleless connector becomes or has potentially become contaminated during use, the access valve (IV port) must be disinfected with 70% isopropyl alcohol (alcohol based cleaning) by scrubbing for a minimum of 15 seconds and allowed to air dry prior to use ..."
VIOLATION: GOVERNING BODY Tag No: A0043
Based on interview and record review, the hospital failed to ensure the Condition of Participation Governing Body was met by:

1. Failing to ensure the facility's policy and procedure was implemented for the "procedure verification process" (Procedural Time-Out-verification of an accurate and signed procedure consent, verification of the patient, verification of the procedure, and verification of the procedure site) before performing an invasive procedure. This failure resulted in a chest tube inserted into the wrong side of the chest causing an unnecessary invasive procedure and hospitalization . (Refer to A-0339)

2. Failing to ensure the facility's policy and procedure was implemented for procedure site marking (the physician verifies the correct site and mark the site with their initials) before inserting a chest tube. This failure resulted in a chest tube inserted into the wrong side of the chest causing an unnecessary invasive procedure and hospitalization . (Refer to A-0339)

3. Failing to ensure spinal needles (a surgical item that was not intended to remain in a patient's body after an operation or procedure) were accounted for, and was not left behind in Patient 9's lower back. This failure resulted in a spinal needle retained in Patient 9's back for 30 hours after the conclusion of the procedure causing lower back pain. (Refer to A-1002)

4. Failing to ensure anesthesiologists maintained aseptic technique (steps to prevent and minimize infections) during intravenous (IV-into the vein) medication administration. This failure had the potential to result in cross-contamination (the transfer of harmful bacteria) causing a preventable bloodstream infection and prolonged hospitalization . (Refer to A-1002)

5. Failing to ensure the behavioral health unit emergency exit door was locked and monitored hourly for one of 30 sampled patients (Patient 16). These failures resulted in Patient 16 eloping from the hospital, and had the potential to cause harm to self and others. (Refer to A-0175)

6. Failing to ensure Patient 11 and Patient 12 were monitored and supervised in the emergency department behavioral health area. This failure resulted in Patient 11 and Patient 12 not being monitored or supervised and Registered Nurse 7 (RN 7) did not intervene or stop Patient 12 from repeatedly touching Patient 11 on or near the genitalia. (Refer to A-0144)

7. Failing to ensure computer screens were not left unattended displaying patient information. This failure had the potential for unauthorized individuals to have access to protected health and sensitive information. (Refer to A-0146)

8. Failing to ensure a fall risk assessment was completed and fall interventions were implemented. This failure resulted in Patient 15 falling to the floor sustaining a head injury causing a cardiac arrest (a condition where the heart suddenly stops beating), cerebral edema (brain swelling), herniation (pressure in the brain), and brain death. (Refer to A-0392)

The cumulative effects of these systemic problems resulted in the inability of the facility to ensure the provision of care in a safe and effective manner.
VIOLATION: PATIENT RIGHTS Tag No: A0115
Based on interview and record review, the facility failed to ensure the Condition of Participation Patient's Rights was met when:

1. Registered Nurse 7 (RN 7) was observed on the facility's surveillance camera at the nursing station, with her head on the counter, eyes closed, and did not monitor, intervene, supervise, or perform safety checks (a visual assessment to make sure patients are free of harm) for two of two sampled patients (Patient 11 and Patient 12). This failure resulted in Patient 11 and Patient 12 not being monitored or supervised and RN 7 did not intervene or stop Patient 12 from repeatedly touching Patient 11 on or near the genitalia. (Refer to A-0144)

2. The computer screen displayed patient information and was in view of unauthorized individuals. This failure had the potential for unauthorized individuals to have access to protected health and sensitive information. (Refer to A-0146)

3. The emergency exit door was unlocked and staff did not check the door hourly for one of 30 sampled patients (Patient 16). These failures resulted in Patient 16 eloping from the hospital, and had the potential to cause harm to self and others. (Refer to A-0175)

The cumulative effect of these deficient practices resulted in the facility failing to meet the Condition of Participation Patient's Rights.
VIOLATION: PATIENT RIGHTS: CARE IN SAFE SETTING Tag No: A0144
Based on Observation, Interviews and Record Review, the facility failed to follow their policy and procedure for safe and effective care for the Behavioral Health holding area (a waiting area in the emergency department used for patients suspected to have a mental disorder which makes them an imminent danger to themselves or to others) when Registered Nurse 7 (RN 7) was observed on the facility's surveillance camera at the nursing station, with her head on the counter, eyes closed, and did not monitor, intervene, supervise, or perform safety checks ( a visual assessment to make sure patients are free of harm) for two of two sampled patients (Patient 11 and Patient 12).

This failure resulted in Patient 11 and Patient 12 not being monitored or supervised and RN 7 did not intervene or stop Patient 12 from repeatedly touching Patient 11 on or near the genitalia.

Findings:

During a review of Patient 11's "History and Physical" (H&P), dated November 1, 2018, the H&P indicated, Patient 11 was admitted to the emergency department behavioral health holding area, on November 1, 2018, with diagnosis of anxiety.

During a review of Patient 12's "History and Physical" (H&P), dated November 1, 2018, the H&P indicated, Patient 12 was admitted to the emergency department behavioral health holding area, on November 1, 2018, with diagnosis of anxiety.

During an observation, on January 7, 2020, at 9:20 AM, in the emergency department behavioral health (BH) holding area, one patient was observed sitting in a chair watching television and a sitter was visually monitoring the patient.

During an Interview, on January 7, 2020 at 9:25 AM, with Certified Nurse's Aide 1 (CNA 1), in the BH holding area, CNA 1 stated patients in the BH holding area are observed, monitored, and supervised at all times to prevent them from harming themselves and others. CNA 1 stated her duties included safety checks which are documented every 15 minutes, vital signs are taken every four hours, constant observation, ensuring nutritional/hydration needs are met, and ensuring bathroom needs are met. CNA 1 stated Registered Nurses (RN) or Emergency Medical Technicians (EMT) relive for lunch and breaks. CNA 1 stated patients in the holding area are never left unsupervised.

During an interview, on January 7, 2020, at 3:50 PM, with the Director of Risk Management (DOR), in the conference room, the DOR stated Patient 12 repeatedly touched Patient 11 on or near her genitalia. The DOR stated RN 7 was asleep at the desk with her back to the BH holding area while the Behavioral Health Worker 1 (BHW 1-assigned sitter) was on break. The DOR stated after Patient 11 reported the incident to BHW 1, the Security Department reviewed the surveillance camera video for the BH holding area and immediately called the local police department and Patient 12 was arrested. The DOR stated RN 7 was asleep during the incident and did not supervise or intervene during the time period that Patient 12 was observed on surveillance camera repeatedly touching Patient 11 on or near the genitalia. The DOR stated RN 7 should have visually monitored the patients and environment for safety and provided appropriate interventions as needed.

During a concurrent interview and review of the "BH Holding Area Surveillance Video," dated November 2, 2018, with the Director of Security (DOS), on January 7, 2020, at 4:00 PM, in the conference room, the surveillance video for Patient 11 and Patient 12 was reviewed. The DOS stated the surveillance video indicated Patient 12 was awake in a recliner chair (Chair 1) and Patient 11 appeared to be asleep in a reclining chair (Chair 3) and was covered with a blanket. An unoccupied chair (Chair 2) was located between Patient 11 and Patient 12. The DOS stated the surveillance video indicated after BHW 1 left the BH holding area, RN 7 was seated at the nurse's station with her back to the BH holding area, with her head down, eyes closed, and wrapped in a blanket. The DOS stated, the video showed Patient 12 getting up from Chair 1 and pacing the room for a while then sitting down in Chair 2 next to Patient 11. The DOS stated RN 7 did not turn toward the BH holding area to assess why Patient 12 was pacing the floor. The DOS stated the video showed Patient 12 getting up from Chair 2, fondled his genitals and returned to Chair 2 next to Patient 11, who appeared to be asleep. The DOS stated RN 7 did not intervene. The DOS stated Patient 12 placed his hand on top of Patient 11's blanket near her genitalia and RN 7 did not intervene. The DOS stated the video showed Patient 12 placing his hand under Patient 11's blanket on or near the genitalia repeatedly and RN 7 never moved from her seat or intervened. The DOS stated, "It appeared [Patient 12] was startled and quickly moved back to Chair 1 when [Patient 11] began to wake up." The DOS stated RN 7 did not perform visual checks nor supervised Patient 11 and Patient 12. The DOS stated RN 7 should have been facing the BH holding area to monitor patient activities and to ensure patient safety.

During a review of the facility's policy and procedure (P&P) titled "Care of the Behavioral Health Patient in the Emergency Department" dated January 2019, the P&P indicated, "Purpose: To ensure a safe and effective continuum of care for behavioral health patients during their stay in the Emergency Department through to discharge or admission into a Behavioral facility. 1.0 [Name of Facility] will ensure all behavioral health patients who present in our Emergency Department receive appropriate medical and behavioral health care ... 3.0 Those patients who have been identified as potential danger to self and or danger to others will be considered "hold able" until evaluated by the ED Physician and or the Psychiatrist on call (which may include Tele psych), and have behavioral observer assigned to perform 15 minute safety checks ... 7.0 The Emergency Department Charge Nurse will be made aware of the patient via a handoff from the triage nurse. Any patient who is doomed to be an imminent danger to self or to others will be immediately laced on behavioral observation and 15-minute safety checks by the behavioral observer will be documented. 8.0 Those patients, if at all possible will be placed in the behavioral health treatment room, as it has been specially modified for the safety of patients with behavioral health needs. 9.0 The Behavioral Health Unit (BHU) holding area will be staffed by (1) one Registered Nurse and (1) Mental Health Worker/CNA or other crossed-trained emergency department personnel.

During a review of the facility's policy and procedure (P&P) titled "Abuse Allegations: Internal Occurrence Reporting and Investigation" dated July, 2012, (P&P) indicated, ... "Policy: [Name of Facility] creates and maintains a proactive approach to identify events and occurrences that may constitute or contributes to abuse and neglect" ...
VIOLATION: PATIENT RIGHTS: CONFIDENTIALITY OF RECORDS Tag No: A0146
Based on observation, interview, and record review, the facility failed to follow their policy and procedure for safeguarding protected health information when the computer screen displayed patient information and was in view of unauthorized individuals.

This failure had the potential for unauthorized individuals to have access to protected health and sensitive information.

Findings:

During an observation with the Emergency Department Manager (EDM), on January 6, 2020, at 2:30 PM, in the emergency department, there were three beds located in the fast track area. Bed 11 and Bed 12 were occupied. Bed 13 had a computer on wheels located at the bedside and the electronic screen displayed patient information which included name, diagnosis, age, present problems, and laboratory results.

During a concurrent interview with Registered Nurse 2 (RN 2) and the EDM, on January 6, 2020, at 2:36 PM, RN 2 stated he had something to do and left the screen open displaying patient information. The EDM stated patient information should never be displayed in a manner that unauthorized individuals may view sensitive patient information. The EDM stated RN 2 should have safeguarded the computer screen prior to leaving the area.

During a review of the facility's policy and procedure (P&P) titled, "Safeguarding Protected Health Information (PHI) and Sensitive Information," dated January 22, 2019, the P&P indicated, " ...B. In non-Restricted areas where sensitive information is maintained and access is not controlled, or otherwise restricted, business units or department managers shall implement the following safeguards. 1. Keep information that is electronically displayed from view of unauthorized individuals. For example, this may require the use of privacy screens, physical reorientation of the monitor, password protected screen savers, or other appropriate methods ..."
VIOLATION: QAPI Tag No: A0263
Based on interview and record review, the hospital failed to ensure the Condition of Participation Quality Assessment and Performance Improvement Program was met by:

1. Failing to ensure the facility's policy and procedure was implemented for the "procedure verification process" (Procedural Time-Out-verification of an accurate and signed procedure consent, verification of the patient, verification of the procedure, and verification of the procedure site) before performing an invasive procedure. This failure resulted in a chest tube inserted into the wrong side of the chest causing an unnecessary invasive procedure and hospitalization . (Refer to A-0339)

2. Failing to ensure the facility's policy and procedure was implemented for procedure site marking (the physician verifies the correct site and mark the site with their initials) before inserting a chest tube. This failure resulted in a chest tube inserted into the wrong side of the chest causing an unnecessary invasive procedure and hospitalization . (Refer to A-0339)

3. Failing to ensure spinal needles (a surgical item that was not intended to remain in a patient's body after an operation or procedure) were accounted for, and was not left behind in Patient 9's lower back. This failure resulted in a spinal needle retained in Patient 9's back for 30 hours after the conclusion of the procedure causing lower back pain. (Refer to A-1002)

4. Failing to ensure anesthesiologists maintained aseptic technique (steps to prevent and minimize infections) during intravenous (IV-into the vein) medication administration. This failure had the potential to result in cross-contamination (the transfer of harmful bacteria) causing a preventable bloodstream infection and prolonged hospitalization . (Refer to A-1002)

5. Failing to ensure the behavioral health unit emergency exit door was locked and monitored hourly for one of 30 sampled patients (Patient 16). These failures resulted in Patient 16 eloping from the hospital, and had the potential to cause harm to self and others. (Refer to A-0175)

6. Failing to ensure Patient 11 and Patient 12 were monitored and supervised in the emergency department behavioral health area. This failure resulted in Patient 11 and Patient 12 not being monitored or supervised and Registered Nurse 7 (RN 7) did not intervene or stop Patient 12 from repeatedly touching Patient 11 on or near the genitalia. (Refer to A-0144)

7. Failing to ensure computer screens were not left unattended displaying patient information. This failure had the potential for unauthorized individuals to have access to protected health and sensitive information. (Refer to A-0146)

8. Failing to ensure a fall risk assessment was completed and fall interventions were implemented. This failure resulted in Patient 15 falling to the floor sustaining a head injury causing a cardiac arrest (a condition where the heart suddenly stops beating), cerebral edema (brain swelling), herniation (pressure in the brain), and brain death. (Refer to A-0392)

9. Failing to identify inconsistent operating room terminal cleaning. These failures had the potential for cross-contamination (the process by which bacteria or other microorganisms are unintentionally transferred from one substance or object to another, with harmful effect), which could impact the patient's health and safety, and cause prolonged hospitalization . (Refer to A-0750)

10. Failing to ensure care plans were developed to provide individualized plans for two of 30 sampled patients (Patient 19, and 20). This failure had the potential to cause Patient 19, and 20s' inability to follow and participate in the treatment plan. (Refer to A-0396)

11. Failing to ensure central vascular catheter (CVC-a catheter placed into a large vein) dressing was labeled, the peripheral intravenous (PIV- a plastic tube inserted into a vein in the forearm) dressings were labeled, and the PIV insertion site were assessed each shift. These failures had the potential for delay in detecting an IV infiltration (IV needle or catheter came out of the vein and fluid was going under the skin) and/or blood stream infections causing prolonged hospitalization . (Refer to A-0395)

12. Failing to ensure arterial lines (A-line-a catheter placed into the artery to measure blood pressure) were assessed in the intensive care unit (ICU). This failure resulted in the A-line not being assessed, and had the potential for an inaccurate blood pressure measurement, causing an error for treatment modality. (Refer to A-0395)

13. Failing to ensure staff follow physician orders for Vasopressin (medication given to help increasing blood pressure) medication administration. This failure had the potential to place Patient 17 at a greater risk for low blood pressure that could cause multiple organ failure (a condition where the systems in the body cannot perform function to keep people alive without help) and lead to death. (Refer to A-0405)

14. Failing to ensure medication (Lidocaine- medicine used for temporary numbness/loss of feelings) was not stored in wound carts. This failure had the potential for unauthorized individuals to have access to medications. (Refer to A-0405)

15. Failing to ensure multi-dose (medication intended for injection or infusion that contains more than one dose of medication) vials of insulin (medicine used to keep the blood sugar level from getting too high or too low) and the expiration dates were verified prior to insulin administration. This failure had the potential for increased risk of infection from microbial (germs) growth if the insulin vial was opened longer than instructed by the drug manufacturer. (Refer to A-0405)

16. Failing to ensure physician's orders were followed for Propofol (a short acting medication used to decrease the level of response) administration for one of 30 sampled patients (Patient 13). This failure placed Patient 13 at greater risk for over-sedation and/or medication errors causing cardiorespiratory depression (a condition that the heart and lung do not work properly which can lead to death) and prolonged hospitalization . (Refer to A-0410)

17. Failing to ensure nursing verified a chest tube placement consent was completed and placed in Patient 10's medical record prior to inserting a chest tube into the wrong side of the chest. These failures resulted in Patient 10 not being assessed and a chest tube inserted into the wrong side of the chest causing an unnecessary invasive procedure and hospitalization . (Refer to A-0392)

18. Failing to ensure nursing performed physical assessments (heart rate, breathing rate, oxygen saturation [oxygen in the blood], blood pressure, and pain) during or after a chest tube placement. These failures resulted in Patient 10 not being assessed and a chest tube inserted into the wrong side of the chest causing an unnecessary invasive procedure and hospitalization . (Refer to A-0392)

19. Failing to ensure nursing confirm and document the "Procedure Verification Process" (Procedural Time-Out-verification of an accurate and signed procedure consent, verification of the patient, verification of the procedure, and verification of the procedure site) on the procedural record. These failures resulted in Patient 10 not being assessed and a chest tube inserted into the wrong side of the chest causing an unnecessary invasive procedure and hospitalization . (Refer to A-0392)

The cumulative effects of these systemic failures resulted in the hospital failing to meet the Condition of Participation Quality Assurance and Performance Improvement Program.
VIOLATION: PATIENT SAFETY Tag No: A0286
Based on interview and record review, the facility failed to ensure their quality committee implemented preventive measures for the following:

The facility did not ensure spinal needles (a surgical item that was not intended to remain in a patient's body after an operation or procedure) were accounted for, and was not left behind in the lower back for one of 30 sampled patients (Patient 9).

This failure resulted in a spinal needle retained in Patient 9's back for 30 hours causing lower back pain.

Findings:

During a review of Patient 9's "History and Physical" (H&P), dated September 19, 2017, the H&P indicated, Patient 9 was admitted to the facility with diagnoses of a cesarean section (C-Section-use of surgery to deliver babies) and bilateral tubal ligation (a surgical procedure that prevent pregnancy).

During a review of the Patient 9's "Nursing Notes" dated September 20, 2017, the Nursing Notes indicated, "Events: pt (patient) up to shower, called me to room, feels something in her back, needle protruding from back [name of nurse manager] notified, [Name of Anesthesiologist] to room, removed needle, bandages placed over site. No complaints from patient, no headaches, moves all extremities."

During a concurrent interview and review of Patient 9's "Anesthesia Progress Notes," dated September 20, 2017, with the Director of Risk Management (DOR), on January 8, 2020, at 4:10 PM, the DOR stated Anesthesiologist 2's progress notes indicated he had removed one needle that was less than one centimeter (unit of measurement) from Patient 9's lower back.

During an interview with Anesthesiologist 1, on January 9, 2020, at 12:50 PM, in the conference room, Anesthesiologist 1 stated two needles were inserted into Patient 9's lower back for a spinal anesthesia (medicine delivered through a needle into the lower back for pain relief) procedure and one needle was removed at the conclusion of the procedure. Anesthesiologist 1 stated the other spinal needle was retained in Patient 9's lower back for 30 hours after the conclusion of the procedure and the retained needle was discovered after Patient 9 complained of lower back pain. Anesthesiologist 1 stated after the retained needle was discovered, the facility did not provide him coaching or implement a policy and procedure to ensure spinal needles were accounted for, or tracked, at the conclusion of spinal anesthesia procedures. Anesthesiologist 1 stated spinal needles should be double-checked by another staff member/anesthesia personnel to ensure all needles used in the procedure are intact, on the procedure field, and are accounted for. Anesthesiologist 1 stated he had missed counted and one needle was unintentionally retained in Patient 9's lower back after the procedure.

During a concurrent interview with the Director of Labor and Delivery (ND 3), the Senior Director of Nursing (DON), and Registered Nurse 11 (RN 11), on January 9, 2020, at 2:05 PM, in the conference room, RN 11 stated she did not account for, or track spinal needles in collaboration with the anesthesia department after a procedure. RN 11 stated spinal needles should be double-checked with the anesthesiologist to ensure needles are accounted for, and are not retained in a patient's back. ND 3 stated assisting anesthesiologist with needle counts are not common practice and it is not nursing's responsibility to verify that spinal needles were not retained in a patient's back. The DON stated it was the responsibility of the anesthesiologist to ensure all items used during anesthesia procedures are accounted for, by the anesthesia department.

During a follow-up interview with the DOR, on January 9, 2020, at 2:35 PM, in the conference room, the DOR stated, "It is the role of the anesthesiologist and nursing to ensure patient safety."

During a review of the facility's policy and procedure (P&P) titled, "Prevention of Retained Surgical Items (RSI)," dated January 24, 2018, the P&P indicated, "Policy: 4. To provide guidelines for anesthesiologist and anesthesia personnel to prevent retention of surgical items .... C. Sharps and Needles: 1. Sharps must be handled according to OSHA (Occupational Safety and Health Administration- a government agency responsible for maintaining standards for health and safety in work places) guidelines. 2. Disposable punctured-resistant plastic container boxes should be available for containment of used needles and blades. 3. Sharps must be counted on all procedures ...Anesthesia Responsibilities: ...5. At the conclusion of all procedures performed by anesthesia personnel inspect the anesthesia area and site to ascertain that all items used during the procedure are intact and on the field (e.g. guide wire is present [for example-a medical wire used as a guide for placement of a larger device]) ..."

During a review of the facility's spinal anesthesia education titled, "Neuraxial Anesthesia Safety: Nursing Considerations for Patients with Epidural and Spinal Anesthesia" (medication given into the lower back for pain control) undated, with the DOR, on January 9, 2020, at 3:30 PM, the DOR stated safety education was developed for the operating room staff, post-anesthesia care unit (PACU) staff, and anesthesia services, following the discovery of the retained needle. The DOR stated the safety measures included in the education packets for preventing retained spinal needles were never implemented.

During an interview with members of the quality committee, on January 10, 2020, at 10:10 AM, the DOR stated the quality committee focused on nursing assessments for procedure puncture sites after the patient was transferred from the operating room to the PACU. The DOR stated the committee did not implement preventive actions or mechanisms that included feedback and learning to ensure spinal needles were accounted for, or tracked at the conclusion of spinal anesthesia procedures.

They did not have clear expectations for safety established for accounting for spinal needles to ensure spinal needles were not retained in patients.
VIOLATION: MEDICAL STAFF Tag No: A0338
Based on interview and record review, the facility failed to ensure the Condition of Participation Medical Staff was met by:

1. Failing to ensure the facility's policy and procedure was implemented for the "procedure verification process" (Procedural Time-Out-verification of an accurate and signed procedure consent, verification of the patient, verification of the procedure, and verification of the procedure site) before performing an invasive procedure. This failure resulted in a chest tube inserted into the wrong side of the chest causing an unnecessary invasive procedure and hospitalization . (Refer to A-0339)

2. Failing to ensure the facility's policy and procedure was implemented for procedure site marking (the physician verifies the correct site and mark the site with their initials) before inserting a chest tube. This failure resulted in a chest tube inserted into the wrong side of the chest causing an unnecessary invasive procedure and hospitalization . (Refer to A-0339)

3. Failing to ensure spinal needles (a surgical item that was not intended to remain in a patient's body after an operation or procedure) were accounted for, and was not left behind in Patient 9's lower back. This failure resulted in a spinal needle retained in Patient 9's back for 30 hours after the conclusion of the procedure causing lower back pain. (Refer to A-1002)

4. Failing to ensure anesthesiologists maintained aseptic technique (steps to prevent and minimize infections) during intravenous (IV-into the vein) medication administration. This failure had the potential to result in cross-contamination (the transfer of harmful bacteria) causing a preventable bloodstream infection and prolonged hospitalization . (Refer to A-1002)

The cumulative effect of these deficient practices resulted in the facility failing to meet the Condition of Participation Medical Staff.
VIOLATION: COMPOSITION OF THE MEDICAL STAFF Tag No: A0339
Based on interview and record review, the facility failed to ensure safe practices were implemented for invasive procedures (any procedure performed which involves a puncture or incision of the skin, or insertion of an instrument) for one of 30 sampled patients (Patient 10) when:

1. The facility did not perform the "procedure verification process" (Procedural Time-Out-verification of an accurate and signed procedure consent, verification of the patient, verification of the procedure, and verification of the procedure site) before performing an invasive procedure.

2. Physician 2 did not mark the procedure site (the physician verifies the correct site and mark the site with their initials) before inserting a chest tube.

These failures resulted in a chest tube inserted into the wrong side of the chest causing an unnecessary invasive procedure and hospitalization .

Findings:

During a review of Patient 10's "History and Physical" (H&P), dated October 31, 2018, the H&P indicated, Patient 10 was admitted to the emergency department on October 31, 2018, with diagnosis of chest pain with pressure.

During a review of Patient 10's "General Radiology Report" (Radiologist note), dated October 31, 2018, and "Procedure: Chest Tube Insertion" (Physician note), dated October 31, 2018, with the Director of Risk Management (DOR), on January 8, 2020, at 9:15 AM, in the conference room, the DOR stated the Radiologist report indicated, Patient 10 had "10-15% (percent-unit of measurement) left-sided pneumothorax (left-sided collapsed lung)" and the physician's note indicated Physician 2 inserted the chest tube into the right-side of the chest. The DOR stated the chest tube should have been inserted into the left-side of the chest.

During a telephone interview with Physician 2, on January 8, 2020, at 10:00 AM, Physician 2 stated the procedure verification process (time-out) and the procedure marking were not done prior to the insertion of the chest tube into the wrong site. Physician 2 stated the procedure verification process and the procedure site marking should have been done prior to the chest tube insertion. Physician 2 stated he inserted the chest tube into the wrong side of the chest and Patient 10 had an unnecessary invasive procedure on October 31, 2018, causing hospitalization the following day (November 1, 2018).

During a concurrent interview and review of Patient 10's "Procedural Nursing Record" (nursing notes), dated October 31, 2018, with RN 12, on January 9, 2020, at 9:30 AM, in the conference room, RN 12 stated she was the procedure nurse assigned to Patient 10, on October 31, 2018. RN 12 stated a signed consent was not obtained prior to the procedure. RN 12 stated verification of the patient, verification of the procedure, or verification of the procedure site, were not confirmed prior to inserting the chest tube into the wrong side. RN 12 stated the verification process should have been performed prior to the start of the procedure.

During a follow-up interview with the DOR, on January 9, 2020, at 9:48 AM, the DOR stated the procedure and procedure site were not confirmed with the patient using a signed procedure consent and confirmation of the procedure and site must be confirmed with the patient prior to the procedure.

During a review of the facility's "Medical Staff Bylaws," dated December 21, 2018, the Medical Staff Bylaws indicated, " ...H. Responsibilities of Membership: Each medical staff member and each practitioner exercising temporary privileges shall continuously meet all the following responsibilities: ...4. Conform to the Medical Staff Bylaws; Rules and Regulations and policies; and conform to hospital rules, regulations, policies and procedures, relating to patient care or professional practice must be approved by the Medical Executive Committee ...6. Provide patients with quality of care meeting the professional standards of the medical staff of the hospital ..."

During a review of the facility's "Medical Staff Rules and Regulations," dated November 28, 2017, the Medical Staff Rules and Regulations indicated, " ...7. It shall be the responsibility of the attending physician to obtain appropriate consents from every patient admitted to the hospital. Appropriate informed consents, signed by or on behalf of every patient admitted to the Hospital, must be obtained prior to treatment of procedures (except in emergency cases). When consent is not obtainable, the reason is entered in the record ..."

During a review of the facility's policy and procedure (P&P) titled, "Universal Protocol" reviewed September 2016, the P&P indicated, "Purpose: all patients undergoing a surgical or invasive procedure are to be considered at risk for a wrong patient, procedure, or wrong site. Certain patients are considered at a higher risk including those patients undergoing multiple procedures with one or more physicians or those patients that have unusual characteristics such as a physical deformity or massive obesity. The purpose of this policy is to provide guidelines for preoperative verification of the correct patient, procedure, and site (as appropriate) for all surgical or invasive procedures insuring all necessary documentation, diagnostic/radiology results, blood, implants, devices, and special equipment for the procedure are present and/or completed. Policy: 1.0 For the purpose of this policy and associated procedures, the term "Procedure Verification" includes verification of patient, procedure, and site, as applicable, and any implants, diagnostic/radiology results, blood, devices, and special equipment. This policy is applicable to all departments or units performing surgical or invasive procedures. 2.0 all staff and physicians participating in a surgical or invasive procedure are required to actively participate in the Procedure Verification process as described in this policy to ensure the correct patient, procedure, and site (as applicable) is assessed prior to the star of the procedure. Staff will document the verification steps on the preoperative or pre-procedure checklist. 3.0 The process to prevent wrong patient, wrong procedure, and wrong site surgery or invasive procedure at [Name of Facility] is reflective, and includes all required elements of the Universal Protocol. Responsibility: This policy applies to all staff and physicians participating in a surgical or invasive procedure in all locations approved to perform surgical or invasive procedures. 1. 0 Patients undergoing a surgical or invasive procedure will have a procedure verification process that includes the following:

1.1 Completion of an intervention/pre-surgical checklist
1.2 Identification of the patient using two patient identifiers, being name and medical record number.
1.3 Identification of the scheduled procedure as stated in the physician's documentation.
1.4 Marking of the procedure site by the physician performing the procedure, using his/her initials with an indelible marking pen prior to moving the patient to the location where the procedure will be performed.
1.5 Verification of the correct patient position by the physician performing the procedure.
1.6 Verification that the surgical skin prep (preparation) is dry and not pooled prior to incision.
1.7 Availability of correct implants, diagnostic/radiology results, blood, devices, and special equipment.
1.8 Surgical or procedural time out conducted immediately prior to the start of the procedure utilizing active communication with all team members present in the room or at the bedside. Note: Whenever there is more than one procedure performed by separate procedure teams, there will be a time out completed and documented by each procedure team. The time out will take place immediately prior to the start of each individual procedure ...
6.0. Site Marking: Site marking is conducted for all procedures involving incision or percutaneous puncture of insertion. The marking takes into consideration laterality, the surface (flexor, extensor [bend, straight]), the level (spine) or specific digit or lesion to be treated.
6.1 Prior to marking the site (s), the physician performing the procedure/surgery verifies the patient's identity using two patient identifiers, name and medical record number and active identification by the patient/family, consent (s), medical record data including history and physical and radiographs.
6.2 the physician performing the procedure/surgery asks the patient (or legal representative) to state the procedure(s) and site(s)/side(s) of surgery.
6.3 In collaboration with the patient or patient's family member, the physician shall mark the correct site with an indelible marker prior to the patient being transferred to the procedure/operating room unless the anatomical site is exempted per policy guidelines ..."
VIOLATION: NURSING SERVICES Tag No: A0385
Based on interview and record review, the facility failed to ensure the Condition of Participation Nursing Services was met when:

1. Care plans were not developed to provide individualized plans for two of 30 sampled patients (Patient 19, and 20). This failure had the potential to cause Patient 19, and 20s' inability to follow and participate in the treatment plan. (refer to A-0396)

2. For Patient 17, the central vascular catheter (CVC-a catheter placed into a large vein) dressing was not labeled, the peripheral intravenous (PIV- a plastic tube inserted into a vein in the forearm) dressing was not labeled, and the PIV insertion site was not assessed each shift. These failures had the potential for delay in detecting an IV infiltration (IV needle or catheter came out of the vein and fluid was going under the skin) and/or blood stream infections causing prolonged hospitalization for Patient 17. (Refer to A-0395)

3. For Patient 18, the PIV dressing was not labeled, and the IV site was not assessed each shift. These failures had the potential for delay in detecting an IV infiltration (IV needle or catheter came out of the vein and fluid was going under the skin) and/or blood stream infections causing prolonged hospitalization for Patient 18. (Refer to A-0395)

4. For Patient 17, the arterial line (A-line-a catheter placed into the artery to measure blood pressure) was not assessed after arrival to the Intensive Care Unit (ICU). This failure resulted in the A-line not being assessed, and had the potential for an inaccurate blood pressure measurement, causing an error for treatment modality. (Refer to A-0395)

5. For Patient 17, the nursing staff did not follow the physician order and administered Vasopressin (medication given to help increasing blood pressure) outside of the standardized time schedule policy. This failure had the potential to place Patient 17 at a greater risk for low blood pressure that could cause multiple organ failure (a condition where the systems in the body cannot perform function to keep people alive without help) and lead to death. (Refer to A-0405)

6. One vial of Lidocaine (medicine used for temporary numbness/loss of feelings) was stored in the emergency department wound cart. This failure had the potential for unauthorized individuals to have access to medications. (Refer to A-0405)

7. For Patient 2, one open multi-dose (medication intended for injection or infusion that contains more than one dose of medication) vial of insulin (medicine used to keep the blood sugar level from getting too high or too low) and the expiration date was not verified prior to insulin administration. This failure had the potential for increased risk of infection from microbial (germs) growth if the insulin vial was opened longer than instructed by the drug manufacturer. (Refer to A-0405)

8. Nursing staff did not follow the physician's order for administering Propofol (a short acting medication used to decrease the level of response) for one of 30 sampled patients (Patient 13). This failure placed Patient 13 at greater risk for oversedation and/or medication errors causing cardiorespiratory depression (a condition that the heart and lung do not work properly which can lead to death) and prolonged hospitalization . (Refer to A-0410)

9. For Patient 15, a fall risk assessment was not completed and fall interventions were not implemented. This failure resulted in Patient 15 falling to the floor sustaining a head injury causing a cardiac arrest (a condition where the heart suddenly stops beating), cerebral edema (brain swelling), herniation (pressure in the brain), and brain death. (Refer to A-0392)

10. For Patient 10, nursing did not verify a chest tube placement consent was completed and placed in Patient 10's medical record prior to inserting a chest tube into the wrong side of the chest. These failures resulted in Patient 10 not being assessed and a chest tube inserted into the wrong side of the chest causing an unnecessary invasive procedure and hospitalization . (Refer to A-0392)

11. For Patient 10, nursing did not perform physical assessments (heart rate, breathing rate, oxygen saturation [oxygen in the blood], blood pressure, and pain) during or after a chest tube placement. These failures resulted in Patient 10 not being assessed and a chest tube inserted into the wrong side of the chest causing an unnecessary invasive procedure and hospitalization . (Refer to A-0392)

12. For Patient 10, nursing did not confirm or document the "Procedure Verification Process" (Procedural Time-Out-verification of an accurate and signed procedure consent, verification of the patient, verification of the procedure, and verification of the procedure site) on the procedural record. These failures resulted in Patient 10 not being assessed and a chest tube inserted into the wrong side of the chest causing an unnecessary invasive procedure and hospitalization . (Refer to A-0392)

The cumulative effect of these deficient practices resulted in the facility failing to meet the Condition of Participation Nursing Services.
VIOLATION: STAFFING AND DELIVERY OF CARE Tag No: A0392
Based on interview and record review, the facility failed follow their policy and procedure for patient assessment for two of 30 patients (Patient 10 and Patient 15) when:

1. For Patient 15, a fall risk assessment was not completed and fall interventions were not implemented.

This failure resulted in Patient 15 falling to the floor sustaining a head injury causing a cardiac arrest (a condition where the heart suddenly stops beating), cerebral edema (brain swelling), herniation (pressure in the brain), and brain death.

2a. For Patient 10, nursing did not verify a chest tube placement consent was completed and placed in Patient 10's medical record prior to inserting a chest tube into the wrong side of the chest.

2b. For Patient 10, nursing did not perform physical assessments (heart rate, breathing rate, oxygen saturation [oxygen in the blood], blood pressure, and pain) during or after a chest tube placement.

2c. For Patient 10, nursing did not confirm or document the "Procedure Verification Process" (Procedural Time-Out-verification of an accurate and signed procedure consent, verification of the patient, verification of the procedure, and verification of the procedure site) on the procedural record.

These failures resulted in Patient 10 not being assessed and a chest tube inserted into the wrong side of the chest causing an unnecessary invasive procedure and hospitalization .

Findings:

1. During a review of Patient 15's "History and Physical" (H&P), dated December 15, 2018, the H&P indicated, Patient 15 was admitted to the intensive care unit (ICU), on December 15, 2018, with diagnoses of pneumonia (lung disease), possible sepsis (infection), and was placed on a breathing machine to help with his breathing.

During a review of Patient 15's "Computerized Tomography (CT- X-ray) Scan Report" dated December 18, 2018, the CT scan report indicated Patient 15 had a CT scan of the head. The report further showed cerebral edema, patterns of herniation, and brain death.

During an interview, on January 6, 2020, at 3:50 PM, with Registered Nurse (RN) 8, in ICU, RN 8 stated upon admission to the ICU, each patient receives an initial physical assessment which includes a fall risk assessment (a standardized scale to predict a patient risk for falls). If the patient is at risk for falls, fall interventions are implemented which includes a yellow wrist band, side rails are up, yellow non-slip slippers, a fall mat placed at the bedside, fall signs are placed outside of the door, and a yellow dot is placed next to the patient's name on the white board at the nurse's station to identify the patient as a fall risk. RN 8 stated fall risk precautions were not implemented for Patient 15.

During a concurrent interview and record review, on January 7, 2020, at 3:20 PM, with the Director of Risk Management (DOR), Patient 15's "Emergency Department (ED) Initial Screening (initial screening)" dated December 15, 2018 and "Emergency Department Physician Notes" dated December 15, 2018, were reviewed. The DOR stated the initial screening indicated Patient 15 had been placed on fall precautions with interventions in the emergency department which included the application of a yellow wrist band, yellow booties, fall indicator, and side rails up. The DOR stated the physician note indicated Patient 15's inpatient orders included a fall risk alert. The DOR stated fall precautions should have been implemented.

During a concurrent interview and record review, on January 10, 2020, at 8:20 AM, with RN 5, in the conference room, Patient 15's "Intensive Care Shift Screening Documentation (shift screening)," dated December 16, 2018, was reviewed. RN 5 stated there was no documentation for fall precautions implemented and there was no fall assessment documented for Patient 15 after he had arrived to ICU. RN 5 stated, he did not understand how he missed completing the fall risk assessment. RN 5 stated he did not complete a fall risk assessment or implement fall risk precautions. RN 5 stated he was providing care for another patient when Patient 15 had fell . RN 5 stated when he arrived into Patient 15's room, Patient 15 was on the floor, connected to the cardiac (heart) monitor, the breathing machine was disconnected, and the intravenous (IV-into the vein) line was disconnected. RN 5 stated Patient 15 was in cardiac arrest and a code blue was activated (hospital emergency response system). RN 5 stated a fall risk assessment should have been completed and fall precautions should have been implemented for Patient 15.

During a review of the facility's policy and procedure (P&P) titled, "Fall Prevention and Management Policy" dated December 13, 2017, indicated, "Policy: The organization will provide a safe environment and minimize the risk of falls to patients by using standardized fall risk and injury risk assessments and implementation of appropriate evidence based fall precaution interventions." ... "Procedure: A Assessment/Reassessment/Interventions 1. The RN will assess each patient's fall risk at the time of initial physical assessment, at the time of admission, every shift, upon transfer to another level of care, and after a patient fall or change in patient condition." ...






2. During a review of Patient 10's "History and Physical" (H&P), dated October 31, 2018, the H&P indicated, Patient 10 was admitted to the emergency department on October 31, 2018, with diagnosis of chest pain with pressure.

During a review of Patient 10's "General Radiology Report" (Radiologist note), dated October 31, 2018, and "Procedure: Chest Tube Insertion" (Physician note), dated October 31, 2018, with the Director of Risk Management (DOR), on January 8, 2020, at 9:15 AM, in the conference room, the DOR stated the Radiologist report indicated, Patient 10 had "10-15% (percent-unit of measurement) left-sided pneumothorax (left-sided collapsed lung)" and the physician's note indicated Physician 2 inserted the chest tube into the right-side of the chest. The DOR stated the chest tube should have been inserted into the left-side of the chest.

During a telephone interview with Physician 2, on January 8, 2020, at 10:00 AM, Physician 2 stated a consent for a chest tube insertion was not obtained and placed in Patient 10's medical record prior to the procedure. Physician 2 stated a procedure consent should have been obtained prior to inserting the chest tube. Physician 2 stated he inserted the chest tube into the wrong side of the chest and Patient 10 had an unnecessary invasive procedure on October 31, 2018, causing hospitalization the following day (November 1, 2018).

During a concurrent interview and review of Patient 10's "Procedural Nursing Record" (nursing notes), dated October 31, 2018, with RN 12, on January 9, 2020, at 9:30 AM, in the conference room, RN 12 stated she was the procedure nurse assigned to Patient 10, on October 31, 2018. RN 12 stated a signed consent was not obtained prior to the procedure. RN 12 stated she did not perform assessments during the procedure or at the end of the procedure and nursing assessments should have been done throughout the procedure and after the procedure. RN 12 stated she did not have an explanation for not ensuring a consent was in the medical record, or not performing assessments during and after the procedure, or documenting the procedure verification process.

During a follow-up interview with the DOR, on January 9, 2020, at 9:48 AM, the DOR stated the procedure and procedure site were not confirmed with the patient using a signed procedure consent and confirmation of the procedure and site must be confirmed with the patient prior to the procedure.

During a concurrent interview and review of Patient 10's "Procedural Nursing Record" (nursing notes), dated October 31, 2018, with the Emergency Department Manager (EDM), on January 9, 2020, at 10:19 AM, in the conference room, the EDM stated the policy and procedure was not followed for invasive procedures or obtaining a consent for treatment/procedure. The EDM stated nursing should have verified the signed consent, confirm and document the procedure verification process, and performed assessments during and after the procedure.

During a review of the facility's policy and procedure (P&P) titled, "Universal Protocol" reviewed September 2016, the P&P indicated, "Purpose: all patients undergoing a surgical or invasive procedure are to be considered at risk for a wrong patient, procedure, or wrong site. Certain patients are considered at a higher risk including those patients undergoing multiple procedures with one or more physicians or those patients that have unusual characteristics such as a physical deformity or massive obesity. The purpose of this policy is to provide guidelines for preoperative verification of the correct patient, procedure, and site (as appropriate) for all surgical or invasive procedures insuring all necessary documentation, diagnostic/radiology results, blood, implants, devices, and special equipment for the procedure are present and/or completed. Policy: 1.0 For the purpose of this policy and associated procedures, the term "Procedure Verification" includes verification of patient, procedure, and site, as applicable, and any implants, diagnostic/radiology results, blood, devices, and special equipment. This policy is applicable to all departments or units performing surgical or invasive procedures. 2.0 all staff and physicians participating in a surgical or invasive procedure are required to actively participate in the Procedure Verification process as described in this policy to ensure the correct patient, procedure, and site (as applicable) is assessed prior to the star of the procedure. Staff will document the verification steps on the preoperative or pre-procedure checklist. 3.0 The process to prevent wrong patient, wrong procedure, and wrong site surgery or invasive procedure at [Name of Facility] is reflective, and includes all required elements of the Universal Protocol. Responsibility: This policy applies to all staff and physicians participating in a surgical or invasive procedure in all locations approved to perform surgical or invasive procedures. 1. 0 Patients undergoing a surgical or invasive procedure will have a procedure verification process that includes the following: 1.1 Completion of an intervention/pre-surgical checklist 1.2 Identification of the patient using two patient identifiers, being name and medical record number. 1.3 Identification of the scheduled procedure as stated in the physician's documentation. 1.4 Marking of the procedure site by the physician performing the procedure, using his/her initials with an indelible marking pen prior to moving the patient to the location where the procedure will be performed. 1.5 Verification of the correct patient position by the physician performing the procedure. 1.6 Verification that the surgical skin prep (preparation) is dry and not pooled prior to incision. 1.7 Availability of correct implants, diagnostic/radiology results, blood, devices, and special equipment. 1.8 Surgical or procedural time Out conducted immediately prior to the start of the procedure utilizing active communication with all team members present in the room or at the bedside. Note: Whenever there is more than one procedure performed by separate procedure teams, there will be a time out completed and documented by each procedure team. The time out will take place immediately prior to the start of each individual procedure ..."

During a review of the facility's policy and procedure (P&P) titled, "Consent/Informed Consent" reviewed July 2017, the P&P indicated, " ...22.3 Nursing: 22.3.1 Nursing verifies that the physician obtained informed consent and that the physician has documented in the patient's medical record he or she provided the information needed for an inform consent. 22.3.2 Nursing verifies that an executed "Consent to Surgery or Special Procedure" form is in the record or completes the form using information provided by the doctor in his or her orders and has the patient or a surrogate decision-maker sign the form ..."
During a review of the facility's policy and procedure (P&P) titled, "Assessment and Reassessment of Patients" Revised march 2018, the P&P indicated " ... Additional Assessments: 1.0 Additional assessments/reassessments are made throughout the patient's treatment to meet the patient's needs, as appropriate. These additional assessments/reassessments include, but are limited to: 1.1 Pre/post-surgical 1.2 Pre/post anesthesia ..."
VIOLATION: RN SUPERVISION OF NURSING CARE Tag No: A0395
Based on observation, interview, and record review, the hospital failed to follow their policy and procedure for intravenous (into the vein) site care and maintenance for two of 30 sampled patients (Patient 17, and 18) when:

1) For Patient 17, the central vascular catheter (CVC-a catheter placed into a large vein) dressing was not labeled, the peripheral intravenous (PIV- a plastic tube inserted into a vein in the forearm) dressing was not labeled, and the PIV insertion site was not assessed each shift.

2) For Patient 18, the PIV dressing was not labeled, and the IV site was not assessed each shift.

These failures had the potential for delay in detecting an IV infiltration (IV needle or catheter came out of the vein and fluid was going under the skin) and/or blood stream infections causing prolonged hospitalization for Patient 17 and 18.

3) For Patient 17, the arterial line (A-line-a catheter placed into the artery to measure blood pressure) was not assessed after arrival to the Intensive Care Unit (ICU).

This failure resulted in the A-line not being assessed, and had the potential for an inaccurate blood pressure measurement, causing an error for treatment modality.

Finding:

1. During a review of Patient 17's "History and Physical" (H&P), dated January 6, 2020, the H&P indicated, Patient 17 was admitted with diagnoses which included cardiac arrest (sudden loss of heart function), and acute respiratory failure (a condition when the lungs cannot release oxygen into the blood) with hypoxia (low oxygen level in the body).

During a concurrent observation and interview, on January 7, 2020, at 11:18 AM, with Registered Nurse (RN) 10, in Patient 17's room, Patient 17 was observed in bed with a CVC in the left internal jugular (IJ-a large vein in the neck) and a PIV in the right antecubital (AC-the shallow area of the forearm). RN 10 stated, Patient 17's CVC and PIV dressings were not labeled to indicate when the CVC and PIV dressings should be changed. RN 10 stated, the nurse should have labeled the dressings with time, date, and staff initials to prevent infection.

During a concurrent observation and interview, on January 7, 2020, at 11:21 AM, with the Manager of Intensive Care Unit (MICU), the MICU stated, the dressings should have been labeled with the time, date, and staff initials, to identify when the dressings were placed. The MICU stated, IV assessments should have been completed when Patient 17 arrived to the unit and on each shift to ensure dressings were changed within 7 days.

During a concurrent interview and record review, on January 7, 2020, at 11:35 AM, with the MICU, Patient 17's "Flow Sheet IV Assessment," dated January 6, 2020, was reviewed. The MICU stated, there were no documentation for a peripheral IV assessment upon arrival to the unit on January 7, 2020, at 00:30 AM. The MICU stated, the PIV assessment should have been completed with the initial admission assessment.

During a review of the facility's policy and procedure (P&P) title, "Peripheral Intravenous Catheter Insertion and Maintenance (Adult)," effective date October 24, 2018, the P&P indicated, " ...C. Assessment: 1. Peripheral IV catheter sites will be assessed every shift, with each use, and PRN (as needed) for signs and symptoms of phlebitis (damaged of vein), infection, or infiltration. Assessment includes verification of line patency ...D. Dressing: ...3. Dressings will be labeled with time, date, and clinical staff's initials to identify when the dressing was placed ..."

2. During a review of Patient 18's "History and Physical" (H&P), dated January 6, 2020, the H&P indicated, Patient 18 was admitted for induction of labor (the use of medication to bring on contraction for giving birth).

During a concurrent observation and interview, on January 7, 2020, at 9:28 AM, in Patient 18's room, Patient 18 was observed in bed receiving IV therapy to the left hand. The PIV dressing was not labeled to identify when the dressing was placed. Patient 8 stated, she did not remember when the IV was inserted.

During a concurrent observation and interview, on January 7, 2020, at 9:54 AM, with RN 13, RN 13 stated, Patient 18's PIV dressing was not labeled to indicate the date, time, or staff's initials. RN 13 stated, "It must have fallen off." RN 13 further stated, the assessment should have been completed every shift and documented in Patient 18's medical record.

During a concurrent interview and record review, on January 7, 2020, at 10:00 AM, with RN 9, Patient 18's "Flow Sheet IV Assessment," dated January 6, 2020, was reviewed. RN 9 stated, there was no documentation for an IV Assessment on AM shift of January 6, 2020.

During a concurrent interview and record review, on January 9, 2020, at 9:40 AM, with RN 14, Patient 18's "Flow Sheet IV Assessment," dated January 6, 2020, and January 7, 2020, were reviewed. RN 14 stated, there was no documentation for an IV Assessment on the following shifts: AM shift of January 6, 2020, and night shift of January 7, 2020. RN 14 further stated, the assessment should be documented every shift.

During a review of the facility's policy and procedure (P&P) title, "Peripheral Intravenous Catheter Insertion and Maintenance (Adult)," effective date October 24, 2018, the P&P indicated, " ...C. Assessment: 1. Peripheral IV catheter sites will be assessed every shift, with each use, and PRN (as needed) for signs and symptoms of phlebitis (damaged of vein), infection, or infiltration. Assessment includes verification of line patency ...D. Dressing: ...3. Dressings will be labeled with time, date, and clinical staff's initials to identify when the dressing was placed ..."

3. During a review of Patient 17's "History and Physical" (H&P), dated January 6, 2020, the H&P indicated, Patient 17 was admitted with diagnoses which included cardiac arrest (sudden loss of heart function), and acute respiratory failure (a condition when the lungs cannot release oxygen into the blood) with hypoxia (low oxygen level in the body).

During a concurrent interview and record review, on January 8, 2020, at 3:45 PM, with RN 14, Patient 17's "Flow Sheet Arterial Line Assessment," dated January 6, 2020 through January 8, 2020 were reviewed. RN 14 stated, there was no documentation for the A-line assessment since Patient 17 arrived to the ICU. RN 14 stated, the admission assessment was started on January 7, 2020, at 2:34 AM, and the A-line assessment should have been completed during the admission process.

During a concurrent interview and record review, on January 10, 2020, at 1:27 PM, with the MICU, Patient 17's "Flow Sheet Arterial Line Assessment," dated January 6, 2020 through January 8, 2020 were reviewed. The MICU confirmed the A-line was not assessed when Patient 17 was transferred to ICU. The MICU stated, Patient 17's A-line should have been assessed and documented on the admission and once a shift thereafter to ensure an accurate treatment modality.

During a review of the facility's policy and procedure (P&P) title, "Assessment and Reassessment of Patients Interdisciplinary," effective date August 1997, the P&P indicated, " ...Initial Admission Assessment 1.0 The Registered Nurse (RN) will complete the admission assessment that includes consideration of the biophysical (all body systems), psychosocial (social factors including thought and behavior), spiritual (religion), nutritional (food), presence of pain, and discharge planning needs ...2.0 Complete the initial assessment within 4 hours of admission. 2.1 Special care (ICCU-Intensive Coronary Care Unit, CCU-Coronary Care Unit, NICU-Neonatal Intensive Care Unit, Labor & Delivery, Emergency Department, and Pediatrics) initial assessments must be completed within 1 hour of admission and documented within 4 hours of admission ..."
VIOLATION: NURSING CARE PLAN Tag No: A0396
Based on interview, and record review, the facility failed to follow their policy and procedure when care plans were not developed to provide individualized plans for two of 30 sampled patients (Patient 19, and 20).

This failure had the potential to cause Patient 19, and 20s' inability to follow and participate in the treatment plan.

Finding:

1. During a review of Patient 19's "History and Physical" (H&P), dated January 7, 2020, the H&P indicated, Patient 19 "was transferred from psych (psychiatry) service, BHU (Behavioral Health Unit), to the MedSurg (Medical Surgical) unit when it was discovered that the abscess (pus) that she had on the distal (outside) left lower extremity (leg) was growing MRSA (Methicillin Resistant Staphylococcus Aureus-bacterial infection)."

During a concurrent interview and record review, on January 9, 2020, at 10:55 AM, with Registered Nurse (RN) 14, the plan of care (POC) was reviewed. RN 14 stated, "The care plan was not individualized to the patient." RN 14 further stated, the POC did not reflect Patient 19's MRSA infection and the POC should have included the primary reason why the patient was admitted to the hospital such as "wound, skin, and infection."

During a review of the facility's policy and procedure (P&P) titled, "Interdisciplinary plan of care," effective date August, 2000, the P&P indicated, " ...Policy: An individualized interdisciplinary plan of care will be completed for all patients presenting to [Hospital Name]. Procedure: 1.0 Patient's needs will be identified and prioritized and an interdisciplinary plan of care will be initiated ..."

2. During a review of Patient 20's H&P, dated January 6, 2020, the H&P indicated, Patient 20 "reports of having nausea, but significant abdominal pain, vomiting, fever, chills ...Pt appears to be going through an alcohol withdrawal (changes to body when suddenly stops drinking alcohol)."

During a concurrent interview and record review, on January 9, 2020, at 11:50 AM, with RN 14, the POC was reviewed. RN 14 stated, "The care plan was not individualized to the patient. RN 14 further stated the POC did not include care for alcohol withdrawal and the POC should have included electrolyte replacement and maintenance, and alcohol withdrawal treatment.

During a review of the facility's policy and procedure (P&P) titled, "Interdisciplinary plan of care," effective date August, 2000, the P&P indicated, " ...Policy: An individualized interdisciplinary plan of care will be completed for all patients presenting to [Hospital Name]. Procedure: 1.0 Patient's needs will be identified and prioritized and an interdisciplinary plan of care will be initiated ..."
VIOLATION: ADMINISTRATION OF DRUGS Tag No: A0405
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**

Based on observation, interview, and record review, the facility failed to follow their policy and procedure for safe medication storage, preparation, and administration when:

1. For Patient 17, the nursing staff did not follow the physician order and administered Vasopressin (medication given to help increasing blood pressure) outside of the standardized time schedule policy.

This failure had the potential to place Patient 17 at a greater risk for low blood pressure that could cause multiple organ failure (a condition where the systems in the body cannot perform function to keep people alive without help) and lead to death.

2. One vial of Lidocaine (medicine used for temporary numbness/loss of feelings) was stored in the emergency department wound cart.

This failure had the potential for unauthorized individuals to have access to medications.

3. For Patient 2, one open multi-dose (medication intended for injection or infusion that contains more than one dose of medication) vial of insulin (medicine used to keep the blood sugar level from getting too high or too low) and the expiration date was not verified prior to insulin administration.

This failure had the potential for increase risk of infection from microbial (germs) growth if the insulin vial was opened longer than instructed by the drug manufacturer.

Finding:

1. During a review of Patient 17's "History and Physical" (H&P), dated January 6, 2020, the H&P indicated, Patient 17 was admitted with diagnoses which included cardiac arrest (sudden loss of heart function), and acute respiratory failure (a condition when the lungs cannot release oxygen into the blood) with hypoxia (low oxygen level in the body).

During a review of Patient 17's "Order Sheet," undated, the "Order Sheet" indicated, Vasopressin was ordered to start at 0.04 units/minute (unit of measurement) on January 7, 2020, at 4:37 PM.

During a concurrent interview and record review, on January 8, 2020, at 3:50 PM, with Registered Nurse (RN) 14, Patient 17's "Medication Administration Record (MAR)," dated January 7, 2020, was reviewed. The MAR indicated, Vasopressin was started on January 7, 2020, at 11:19 PM. RN 14 stated, she could not explain the reason for the medication being delayed for six hours, and she could not find documentation indicating nursing staff communicate to a physician to verify the mediation administration.

During a concurrent interview and record review, on January 8, 2020, at 5:05 PM, with the Manager of Pharmacy (Pharm), the order tracking of Vasopressin was reviewed. The Pharm stated, Vasopressin was ordered on January 7, 2020, at 4:37 PM, Vasopressin was verified by pharmacy on January 7, 2020, at 4:55 PM, and prepared on January 7, 2020, at 5:12 PM. The Pharm further stated, the ICU should have received the medication by "5:15 PM."

During a concurrent interview and record review, on January 10, 2020, at 1:27 PM, with the Manager of Intensive Care Unit (MICU), Patient 17's "MAR," dated January 7, 2020, was reviewed. The MICU stated, she called a physician to request an order for Vasopressin in anticipation should Patient 17 needed an additional medication to support blood pressure. The MICU reviewed the MAR which indicated, Vasopressin was ordered to start on January 7, 2020, at 4:37 PM. The MICU further stated, she should have requested Vasopressin with an instruction to start as needed. The MICU stated the order was not written with a specific instruction to explain the delay of Vasopressin administration. The MICU confirmed Vasopressin was started on January 7, 2020, at 11:19 PM, and there was no clinical evidences to explain the reason why Vasopressin was not administered at the order time.

During a review of the facility's policy and procedure (P&P) titled, "Medications-Standardized Time Schedule," effective date March 1991, the P&P indicated, " ...Definitions: ...2.0 Time-critical scheduled medications are those where early or delayed administration of maintenance doses of greater than 30 minutes before or after the scheduled dose may cause harm or result in substantial sub-optimal therapy or pharmacologic effect. Time-critical medications include: 2.1 Intravenous (IV-into the vein) antibiotics (medication for bacterial infection) given more frequently than every 8 hours. 2.2 IV anticonvulsants (medication for seizure). 2.3 Medications prescribed more frequently than every 4 hours. 2.3 Medications ordered with specific time parameter ...Policy: ...4.0 The dose of medication will be administered as a "now" dose unless otherwise ordered by the prescriber. Subsequent doses will be scheduled or adjusted for the time designated by the frequency ..."





2. During an observation with the Emergency Department Manager (EDM), on January 6, 2020, at 2:20 PM, in the emergency department, one vial of Lidocaine was stored in the wound cart.

During an interview with the EDM, on January 6, 2020, at 2:25 PM, the EDM viewed the medication label and stated medications should not be stored in the wound cart.

During an interview with the Pharmacist, on January 7, 2020, at 9:58 AM, in the telemetry unit (unit with monitored beds) medication room, the Pharmacist stated, areas designated for medication storage are approved by the Director of Pharmacy and wound carts are not approved medication storage areas. The Pharmacist stated medications should not be stored in areas not approved for medication storage.

During a review of the facility's policy and procedure (P&P) titled, "Safe Storage of Medications," revised December 2017, the P&P indicated, "Policy: Medications will be stored under appropriate conditions to maintain medication integrity, promote the availability of medications when needed, minimized the risk of medications diversion, and reduce potential dispensing errors. All medication will be stored in accordance with all applicable laws and regulations and manufacturer's guidelines. Responsibility: The Director of Pharmacy is responsible for safe storage of medications throughout the hospital. All pharmacy staff, nursing staff, and respiratory care practitioners are responsible for compliance with all medication storage procedures. Procedures: 1.0 Areas designated for medication storage will be approved by the Director of Pharmacy. All medication not designated from the pharmacy and not immediately administered to the patient must be secured in an approved medication storage area, including locked medication carts, medication rooms, medications refrigerators, or automated dispensing machines (ADMs). 2.0 Medication storage areas must be secured at all times so that unauthorized persons cannot obtain access to them ...6.0 A pharmacist will inspect all medication storage areas at least monthly to ensure that medication areas stored properly."

3. During a review of Patient 2's "History and Physical" (H&P), dated January 5, 2020, the H&P indicated, Patient 2 was admitted to the facility on on [DATE], with diagnosis of COPD exacerbation (chronic obstructive pulmonary disease-lung damage causing more coughing and difficulty in breathing than usual).

During an observation, on January 7, 2020, at 9:50 AM, with the Telemetry Unit (unit with monitored beds) Director (ND 1), in the medication room, an open multi-dose vial of insulin was observed in Patient 2's medicine drawer. The label was smeared and not legible.

During a concurrent interview with ND 1 and the Pharmacist, on January 7, 2020, at 9:55 AM, the Pharmacist stated the label had been wet and the information on the label was not legible. ND 1 stated she could not read the expiration date on the insulin vial.

During an interview with Registered Nurse 1 (RN 1), on January 7, 2020, at 10:05 AM, in the nurse station, RN 1 stated on January 7, 2020, at 8:00 AM, she had administered insulin to Patient 2 and the insulin label was smeared. RN 1 stated she could not verify the expiration date, "So, I just gave it."

During a follow-up interview with the Pharmacist, on January 7, 2020, at 10:09 AM, in the nurse station, the Pharmacist stated multi-dose vials should be discarded within 28 days after opening. The Pharmacist stated the expiration date must be clearly labeled and the nurse must verify the date prior to drug administration.

During a review of the facility's policy and procedure (P&P) titled, "Multiple Dose Vials" (MDVs) revised January 2017, the P&P indicated, "Purpose: to provide guidelines for the safe use of multiple dose (multi-dose) vials for injectable medication ...7.0 MVDs should be discarded within 28 days after opening unless otherwise labeled by the pharmacy or specified by the manufacturer. 8.0 All vials will be discarded whenever sterility is compromised or questionable, including those placed on a used procedure tray or used during an emergency procedure, even if the vial is unopened/unused."

During a review of the facility's policy and procedure (P&P) titled, "Barcode Medication Administration (BCMA) and Electronic Medication Administration Record (EMAR)," revised March 2019, the P&P indicated, " ... 2.0 Prior to Administration: The licensed person should begin administration procedures in adequate time before the dose is scheduled and proceed as follows: 2.1 Verify the patient has the correct identification wrist band in place with no defects. 2.2 Ensure that the correct medication had been selected based on the medication order. 2.3 Check the medication expiration date ..."
VIOLATION: HOSPITAL PROCEDURES Tag No: A0410
Based on interview, and record review, the facility failed to follow their policy and procedure for intravenous (into the vein) medication administration when nursing staff did not follow the physician's order for administering Propofol (a short acting medication used to decrease the level of response) for one of 30 sampled patients (Patient 13).

This failure placed Patient 13 at greater risk for oversedation and/or medication errors causing cardiorespiratory depression (a condition that the heart and lung do not work properly which can lead to death) and prolonged hospitalization .

Finding:

During a review of Patient 13's "History and Physical" (H&P), dated January 6, 2020, the H&P indicated, Patient 13 was admitted with diagnoses which included respiratory acidosis (a condition with increased level of carbon dioxide in blood), influenza (flu) positive, and acute exacerbation of chronic obstructive pulmonary disease (COPD-is a sudden worsening respiratory symptoms including shortness of breath).

During a review of Patient 13's "Order Sheet," undated, the "Order Sheet" indicated, Propofol was ordered to start at 10 microgram (mcg)/kilogram (kg)/ minute (min) (unit of measurement), "adjust by 5 mcg/kg/min as often as every 5 minutes based on vital signs and RASS (Richmond Agitation Sedation Scale-a medical score used to measure the sedation (response) level of a patient) assessment until target RASS is achieved. (-4) Deep Sedation-No response to voice, Maximum recommended dose = 65 mcg/kg/min., start: 1/6/20 3:37 AM."

During a concurrent interview and record review, on January 9, 2020, at 10:47 AM, with Registered Nurse (RN) 14, Patient 13's "Medication Administration Record (MAR)," dated January 6, 2020 and January 7, 2020, were reviewed. The MAR indicated, Propofol was started on January 6, 2020, at 3:42 AM, at the rate of 10 mcg/kg/min. The rate was increased on January 6, 2020, at 3:45 AM to 15 mcg/kg/min. RN 14 stated, Propofol was increased within 3 minutes of administration, and should have been increased at five minutes as ordered by a physician. RN 14 further stated, there was no documentation to indicate why the medication was titrated in three minutes.

During a follow-up concurrent interview and record review, on January 9, 2020, at 10:49 AM, with RN 14, Patient 13's "MAR," dated January 7, 2020, and "Flow Sheet RASS Assessment," dated January 7, 2020 were reviewed. The MAR and RASS assessment indicated as follows:
1/7/20 at 8:00 AM Propofol was given at 60 mcg/kg/min, RASS score of -5 (unarousable).
1/7/20 at 9:00 AM Propofol was given at 60 mcg/kg/min, no RASS score documented
1/7/20 at 10:35 AM Propofol was titrated to 55 mcg/kg/min, RASS score of -4
RN 14 stated, there was no documentation to indicate why the medication was not decreased as ordered by a physician based on RASS assessment at 8:00 AM. RN 14 further stated, Propofol should have been decreased when patient became unarousable to make sure patient was not received too much sedation. RN 14 confirmed, there was no documentation of RASS assessment at 9:00 AM, and the RASS assessment should have been completed hourly.

During a review of the facility's policy and procedure (P&P) titled, "Propofol Use in the ICCU (Intensive Coronary Care Unit)/ED (Emergency Department)," dated June 2008, the P&P indicated, " ...Procedure 1.0 Patient will have continuous/frequent cardiac (heart), blood pressure and oxygen saturation (oxygen level in blood) monitoring. 1.1 Cardiac rate, blood pressure, and Richmond Agitation Sedation (RASS) score will be monitored and documented every 5 minutes upon initiation and with each rate increase until desired sedation level is achieved and is subsequently monitored and documented every hour ...7.0 Infusion of Propofol will begin at 5 mcg/kg/min and may be increased per physician order every 5 minutes based on patient response measured by RASS score to achieve the ordered level of sedation ..."
VIOLATION: INFECTION CONTROL Tag No: A0747
Based on observation, interview, and record review, the facility failed to ensure the Condition of Participation Infection Control was met when:

1. For Patient 18, Aseptic technique (a method used to prevent contamination with microorganisms) was not maintained during a central venous catheter (CVC- a tube placed into a large vein that extends close to the heart to give medications and blood) site dressing change.

This failure had the potential for cross-contamination (the process by which bacteria or other microorganisms are unintentionally transferred from one substance or object to another, with harmful effect) causing a preventable central line associated blood stream infection (CLASBI- bloodstream infection in a patient with a central line) and prolonged hospitalization . (Refer to A-0750)

2. For Patient 3, indwelling urinary catheter assessments were not done. This failure had the potential for a catheter-associated urinary tract infection (CAUTI- a urinary tract infection), and result in prolonged hospitalization . (Refer to A-750)

3a. One carton of expired milk was observed inside the patient's refrigerator on the Behavioral Health West Unit.

3b One used pulse oximetry (pulse ox) probe (an adhesive tape attached to finger to measure oxygen in the body) was observed inside a clean room on the Labor and Delivery Unit.

3c. Daily terminal cleaning (a cleaning method used in healthcare environments to control the spread of infections) was not completed from October 2019 through December 2019, for six of 12 procedure areas (Sterile Process Department, GI Room, GI Broncoscope, GI Decontamination, OB OR 1, and OB OR 2).

These failures had the potential for cross-contamination (the process by which bacteria or other microorganisms are unintentionally transferred from one substance or object to another, with harmful effect), which could impact the patient's health and safety, and cause prolonged hospitalization . (Refer to A-750)

4. For Patient 14, the Anesthesiologist did not maintain aseptic technique (steps to prevent and minimize infections) during intravenous (IV-into the vein) medication administration. This failure had the potential to result in cross-contamination (the transfer of harmful bacteria) causing a preventable bloodstream infection and prolonged hospitalization . (Refer to A-1002)

The cumulative effect of these deficient practices resulted in the facility failing to meet the Condition of Participation for Infection Control.
VIOLATION: INFECTION CONTROL LOG Tag No: A0750
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**

Based on observation, interview, and record review, the facility failed to ensure safe practices were implemented for infection control when:

1. Aseptic technique (a method used to prevent contamination with microorganisms) was not maintained during a central venous catheter (CVC- a tube placed into a large vein that extends close to the heart to give medications and blood) site dressing change for one of 30 sampled patients (Patient 18).

This failure had the potential for cross-contamination (the process by which bacteria or other microorganisms are unintentionally transferred from one substance or object to another, with harmful effect) causing a preventable central line associated blood stream infection (CLASBI- bloodstream infection in a patient with a central line) and prolonged hospitalization .

2. The indwelling urinary catheter assessments were not done for one of 30 sampled patients (Patient 3).

This failure had the potential for a catheter-associated urinary tract infection (CAUTI- a urinary tract infection), and result in prolonged hospitalization .

3a. One carton of expired milk was observed inside the patient's refrigerator on the Behavioral Health West Unit.

3b One used pulse oximetry (pulse ox) probe (an adhesive tape attached to finger to measure oxygen in the body) was observed inside a clean room on the Labor and Delivery Unit.

3c. Daily terminal cleaning (a cleaning method used in healthcare environments to control the spread of infections) was not completed from October 2019 through December 2019, for six of 12 procedure areas (Sterile Process Department, GI Room, GI Broncoscope, GI Decontamination, OB OR 1, and OB OR 2).

These failures had the potential for cross-contamination (the process by which bacteria or other microorganisms are unintentionally transferred from one substance or object to another, with harmful effect), which could impact the patient's health and safety, and cause prolonged hospitalization .

Findings:

1. During a review of Patient 8's "History and Physical" (H&P), dated January 2, 2020, the H&P indicated, Patient 8 was admitted to the facility on on [DATE], with diagnoses which included hypertension and left AV fistula (arteriovenous fistula -surgical connection between an artery and a vein for hemodialysis treatment [a machine used to clean the blood]) bleeding.

During an interview with Registered Nurse 4 (RN 4), on January 7, 2020, at 10:59 AM, in the nurse station, RN 4 stated Patient 8 had undergone physical therapy (January 7, 2020, at 10:30 AM) and his CVC exit site started to bleed.

During an observation, on January 7, 2020, at 11:05 AM, in Patient 8's room, Patient 8 was watching television. Patient 8 had a CVC in his left femoral vein (large vein located in the upper thigh and pelvic region) and blood was observed at the CVC exit site. RN 4 performed hand hygiene (a term used that applies to handwashing or antiseptic [a substance used on the hands to stop or slow down the growth of germs] hand cleaning) and removed two juice cups, one comb, and one cup of water from Patient 8's bedside table and placed the sterile CVC dressing supply kit (contain germ free supplies needed to change a CVC dressing) on the bedside table. RN 4 did not disinfect the table prior to placing the sterile CVC supply kit on the table or perform hand hygiene after removing the items from the table. RN 4 put on a pair of non-sterile gloves (used to help prevent germ transmission) and covered her mouth and nose with the mask. RN 4 removed the soiled (contaminated) dressing, biopatch (a small patch filled with medicine to help kill germs or stop germ growth), and blood, from the CVC exit site. RN 4 removed her contaminated non-sterile gloves and put on sterile gloves (germ free) from the sterile CVC supply kit. RN 4 removed the Chlorhexidine applicator (a skin cleaner to help prevent infections) and prepared it for use. RN 4 cleaned the CVC exit site with the applicator and placed a new biopatch onto the CVC exit site and covered the site with a transparent dressing. RN 1 did not perform hand hygiene after she had removed the soiled dressing or before she put on the sterile gloves.

During a concurrent interview with RN 4 and Nursing Director 1 (ND 1), on January 7, 2020, at 11:20 AM, outside of Patient 8's room, ND 1 stated RN 4 should have disinfected the table before starting the procedure. RN 4 stated she should have performed hand hygiene after removing her gloves and before putting on sterile gloves.

During an interview with the Infection Control Preventionist (ICP), on January 9, 2020, at 11:45 AM, the ICP stated hand hygiene is important to prevent transmission (cross-contamination) of germs between staff and patients and gloves were not a substitute for hand hygiene. The ICP stated hand hygiene should be performed after gloves are removed and before putting on sterile gloves.

During a review of the facility's policy and procedure (P&P) titled, "Hand Hygiene" dated February 8, 2017, the P&P indicated, "Purpose: Hand hygiene is performed to remove dirt, organic material and transient microorganisms (germs) from the hands of health care workers. Appropriate hand hygiene is a critical component in preventing the transmission of microorganisms between personnel and patients in the healthcare settings. The Center of Disease Control (CDC- a national health institute to protect public health and safety through the control and prevention of disease) states that hand hygiene is the single most important procedure for preventing health care acquired infections. Procedure: A. Indications for hand Hygiene: 1. The choice pf plain soap, soap with antiseptic agents, alcohol-based hand rub, or surgical antisepsis should be based on the degree of hand contamination. 2. At minimum, healthcare workers shall wash hands with soap (plain or antimicrobial) and water under the following circumstances: ...d. After contact with blood and bloody fluids. 3. Health care workers shall decontaminate hands using alcohol-based hand rub or washing with soap (plain or antimicrobial) and water under the following circumstances: a. before and after patient contact b. Before donning (putting on) sterile gloves d. Before handling an invasive device, including before accessing intravenous devices for medication administration e. Before moving from a contaminated body site to a clean body site on the same patient ...g. After contact with inanimate objects that are used for direct patient care in the immediate vicinity of the patient i. After removing gloves ... C. Other Aspects of Hand Hygiene: ...3. Gloves: a. Use of gloves is not a substitute for hand hygiene ..."

2. During a review of Patient 3's "History and Physical" (H&P), dated January 4, 2020, the H&P indicated, Patient 3 was admitted to the facility on on [DATE], with diagnosis of infected ulcer (wound) to the right buttock.

During a concurrent interview and record review of Patient 3's "Urinary Catheter Flowsheet (nursing notes)" from January 6, 2020 through January 8, 2020, with the Medical-Surgical Manager (MSM), on January 9, 2020, at 10:40 AM, in the nurse station, the MSM stated indwelling urinary catheter assessments were not done on the following nursing shifts:

January 6, 2020: 7 PM through 7 AM (PM shift).

January 7, 2020: 7 AM through 7 PM and 7 PM through 7 AM (AM shift and PM shift).

January 8, 2020: 7 AM through 7 PM and 7 PM through 7 AM (AM shift and PM shift).

The MSM stated staff should have assessed Patient 3's indwelling urinary catheter each shift.

During an interview with the Infection Control Preventionist (ICP), on January 9, 2020, at 11:45 AM, in the conference room, the ICP stated staff should have assessed Patient 3's urinary catheter every shift for, "Catheter continued justification, device securement, drainage bag location, and site condition, to prevent a hospital acquired infection."

During a review of the facility's policy and procedure (P&P) titled, "Urinary Catheter and Bladder Management," dated March 20, 2019, the P&P indicated, "Policy: It is the policy of [Facility Name] to ensure the health and safety of patients through the use of evidence based practice and national guidelines to manage indwelling urinary catheters (ICU) and reduce unnecessary urinary catheterization. Indwelling urinary catheters shall be inserted only when indicated and removed as soon as possible to prevent catheter associated urinary tract infections (CAUTIs) ...Procedure: ...3. Nursing Assessment and Interventions: a. RN shall assess the patient every shift and upon transfer to a lower acuity unit (e.g., ICU to Telemetry [for example intensive care unit to a monitored unit]) to determine if the patient continues to meet criteria for urinary catheter ..."





3a. During an observation, on January 6, 2020, at 2:22 PM, in the day room of the Behavioral Health West Unit, one expired unopened carton of milk was in the refrigerator with an expiration date of January 5, 2020.

During a concurrent observation and interview, on January 6, 2020, at 2:23 PM, with the Senior Director of Nursing, the expired unopened carton of milk was observed in the refrigerator. The DON stated, the expiration date on the carton was January 5, 2020, and the expired carton of milk should have been discarded on or before the expiration date.

During a review of the facility's policy and procedure (P&P) titled, "Food and Nutritional Services (FNS): Floor and Pantry Inventory Management," effective date September 19, 2018, the P&P indicated, " ...Policy: 1. Food and Nutrition Services (FNS) highest ranked leader: a. Collaborates with clinical areas to develop par (Periodic Automatic Replenishment-minimum level of necessary stock on hand) levels for stocking pantries and schedule for restocking pantries. Par levels will be based on patient census within the respective units. b. Creates pantry inventory requisition based on par levels. c. Assigns stocking pantries to job assignments, and based on First in First out (FIFO-newer items are placed behind existing items such that the older items will be used first) method. d. Monitors that pantries are filled to meet par levels, and documents it ...4. Outdated pantry stock is removed and discarded. If expired items arrive from the vendor, they are returned ..."

3b. During a concurrent observation and interview, on January 7, 2020, at 9:21 AM, with the Interim Director of Maternal Child Health (DMCH), in Room 7 of the Labor and Delivery Unit, one used pulse ox probe was attached to the pulse oximeter machine (a device attached to probe to measure oxygen). The adhesive tape on a pulse ox probe was unattached from a plastic cover with a single strain of hair attached to the tape. The DMCH stated, nursing staff should have discarded the used supplies after the patient was discharged .

During a review of the facility's P&P titled, "Cleaning and Disinfection [kill germ] of Patient Care Items and Equipment," effective date May 1997, the P&P indicated, " ...Procedure. 1.0 General Guidelines ...1.13 After patient discharge, healthcare provider personnel will remove equipment and supplies that are not native to the patient room so that the room can be quickly and efficiently cleaned by Housekeeping staff. a. Remove all unused linen stored in closets, cupboards, bedside stands or in the bathroom. b. Discard used, or partially used, ointments, lotions, soaps, shampoos, etc. c. Discard any open supplies ..."

3c. During a concurrent interview and record review, on January 9, 2020, at 3:34 PM, with the Director of Environmental Services (DES), the logs from October 2019 to December 2019 were reviewed. DES stated, each area in the logs needed to have staff initials or signatures on each day of the week to show daily terminal cleaning was completed. DES confirmed there were missing staff's initials and signatures on the logs for the following dates: October 13, 2019, October 21, 2019, October 24, 2019, October 31, 2019, November 3, 2019, November 11, 2019, November 20, 2019, and December 22, 2019. The DES further stated he needed to review with the night shift supervisor to get an explanation.

During an interview, on January 10, 2019, at 10:53 AM, with the Chief Operating Officer (COO), the COO stated, the logs were discussed with staff yesterday (January 9, 2020), and the logs were incomplete with no appropriate management oversight of the logs. The COO stated, daily terminal cleaning was not done from October 2019 to December 2019.

During a follow-up concurrent interview and record review, on January 10, 2019, at 1:06 PM, with the DES and COO, the logs with missing staff initials or signatures from October 2019 to December 2019 were reviewed. The DES stated, the logs indicated daily terminal cleaning was not done on the following dates for the following areas:

October 3, 2019 for Sterile Processing Department.

November 3, 2019 for GI Room, GI Broncoscope Room, and GI Decontamination Room.

November 11, 2019 for Sterile Processing Department.

December 22, 2019 for OB Operating Room 1 and OB Operating Room 2.

During a review of the facility's P&P titled, "Terminal Cleaning of Procedural Areas," effective date February 25, 2016, the P&P indicated, " ...Purpose. To ensure an aseptically clean environment for patients and staff through strict adherence to daily and weekly terminal cleaning schedules. Policy Statement: Procedural areas will terminally cleaned in accordance with AORN (Association of perioperative Registered Nurses) standards ..."