HospitalInspections.org

Based on observation, interview and record review, the hospital failed to have an effective governing body (GB) that is legally responsible for the conduct of the hospital when:

1. The hospital did not protect and promote each patient's rights to informed care and medical decision making, physical and psychological safety, privacy, and care in a safe setting. (A 130, A 131, A 144 Finding 1 and 2, A 146, and A 164)

2. The hospital did not have an active and effective quality assurance and performance improvement (QAPI) program that collected and analyzed data and used the data to implement tracking and monitoring for the reduction of risk of injury and infections. (A 286 and A 309)

3. The hospital did not provide Surgical services in a well-organized manner in accordance with hospital policy and professional standards of practice to ensure safe quality of care. (A 951 and A 957)

4. The hospital failed to have an active Infection Prevention and Control program which adhered to nationally recognized infection prevention and control guidelines for the surveillance, prevention, and control of HAIs (hospital acquired infections) and other infectious diseases (A 750 Findings 1-4)

5. The hospital failed to ensure the medical staff were accountable to the governing body. The Medical Executive Committee did not address physician involvement in 2 adverse events. (Refer to A 049)

The cumulative effect of these systemic problems resulted in the hospital's inability to ensure the provision of quality healthcare in a safe and professional manner.

Based on interview and record review, the hospital failed to ensure the medical staff was accountable to the governing body when the Medical Executive Committee (MEC) did not receive and act upon physician involvement in Adverse Events. Physician conduct and quality of care provided by physicians were not addressed in a timely manner by the MEC.

These failures resulted in the potential of negatively affecting the health and safety of all patients when provider conduct, patient safety and medical care concerns were not monitored or acted upon.

Findings:

The hospital self- reported an adverse event (AE- a harmful and negative outcome that happens to a patient provided medical care) that occurred on 5/23/22 to the California Department of Public Health (CDPH- the state department responsible for public health in California) on 1/10/23, eight months after the AE occurred.

The hospital self- reported an AE that occurred on 4/20/22 to CDPH on 4/11/23, 12 months after the AE occurred. According to Health and Safety Code 1279.3 (statutory law), the AE should have been reported to CDPH no later than five (5) calendar days after the AE was detected.

During a record review of a hospital document listing "AEs and near misses (any event that doesn't lead to harm but does have the potential to cause illness or injury)" from April 2022 through April 2023, the document indicated, on 4/20/22, patient sustained a 10 cm (centimeter- unit of measure) laceration (a tear, cut, or gash in the skin) in the Nuclear Medicine Department (specialized area of radiology) due to improper use of equipment and user error. Investigation was initiated on 4/20/22, day of the AE. The document also indicated, on 5/23/22, there was late identification of an unintended retained foreign item- a drill bit (cutting tool used to remove material and create holes) left in a surgical patient. Investigation was initiated on 7/8/22, 55 days after the AE.

During a review of the Surgical Quality Safety (SQS) Committee meeting minutes for the meetings from February 2022 through January 2023, there was no documented evidence the hospital tracked the data, developed, or implemented performance improvement measures for the identified retained foreign object (RFO) that occurred on 5/23/22. The SQS Committee meeting was cancelled in January 2022, April 2022, July 2022, October 2022, & and March 2023.

During a review of the SQS Committee Meeting minutes, dated 6/8/22, indicated " ... Safety Events (RFO, VE, IOL) 0 [zero] ..."

During a review of the SQS Committee Meeting minutes, dated 11/9/22, indicated " ... Safety Events: 0 ... Annual Workplan Mid-Year Evaluation ... Each year we establish goals under quality and patient safety. Those are submitted through the regional process. Three of our goals fall under Surgical Quality and Safety committee... There has been 57 months since last verification event/ RFO ..."

During a review of the SQS Committee Meeting minutes, dated 12/14/22, indicated, " ... there has been 58 months since the last verification event/ RFO ..."

During a review of the SQS Committee Meeting minutes, dated 1/11/23, indicated, " ... there has been 59 months since the last verification event/ RFO ..."

During a review of the SQS Committee Meeting minutes, dated 2/8/23, indicated, " ... ortho [orthopedics] is doing well ..."

During a review of MEC meeting minutes for meetings from February 2022 through February 2023, there was no documented evidence the hospital tracked the data, developed, or implemented performance improvement measures for the identified RFI that occurred on 5/23/22.

During an interview on 4/14/23, at 2:05 p.m., with the Assistant Physician in Chief (APC), Chief Executive Officer (CEO) and Area Leader Coordinator (QL-PSO), CEO stated the overarching body for delivery of care and quality oversight was GB. The CEO stated GB was responsible for every function of the hospital from "Physician Chief to grassroot staff" as outlined and directed by the "Bylaws" (defines how medical staff will ensure that proper standards of medical care and ethical practices are established and maintained). The CEO stated oversight was achieved through "bidirectional" communications between various committees lead by department leaders and staff, each of which had different responsibilities and reporting timeframes. The CEO stated all committees were responsible to report to Medical Executive Committee (MEC) to ensure patient quality and safety items were reviewed and escalated to GB when indicated. The CEO stated the discovery of the two AEs identified systemic issues in multiple areas of the hospital that were not appropriately presented to leadership. Gaps in the leadership team contributed to items not being addressed by MEC and GB. The CEO stated reportability did not go forward thus impacting the integrity of the quality of care and safe environment for patients.

During a review of the hospital's document titled "[name of hospital] 2023 Medical Executive Committee Charter," dated 1/18/23, the document indicated, " ... The Medical Executive Committee is responsible to ensure the proper functioning of all departments, committees and other activities of the Professional Staff... Monitors the effectiveness of professional staff activities... responsible for the organization of the performance improvement, risk management, compliance, and patient safety activities of the professional staff... Evaluates the mechanisms used to conduct, evaluate, and revise activities defined in the Medical Center quality program description... Makes recommendations... based on reviews of quality performance of providers and services... Provides oversight of Facility's quality committee structure... Ensures adherence to professional staff bylaws.. Receives an acts upon reports and recommendations of departments, and committees and other groups performing services under the bylaws of the professional staff... Coordinates the activities and general policies of the various departments..."

Based on observation interview and record review the facility failed to protect and promote each patient's rights for informed care and medical decision making, physical and psychological safety, and privacy when:

1. Least restrictive interventions (alternative measures used to control behaviors of patients that do not require mechanical restraint or involuntary confinement) were not implemented prior to the use of restraints (a device that restricts movement) for two of three sampled patients (Patient 14 and Patient 15). Assessments to evaluate Patient 14 and Patient 15's need for continued restraints, physical, and psychosocial well-being were not conducted in accordance with hospital policy and procedures. (Refer to A 164)

2. One of three sampled patients (Patient 28), who suffered from effects of anoxic brain injury (caused by lack of oxygen to the brain), was discharged home from the hospital by himself via ambulance. Hospital staff failed to notify Patient 28's responsible person. Discharge instructions, which included wound care, was not reviewed with the responsible person and no follow up communication between the hospital and responsible person was done. (Refer to A 130)

3. The surgeon disclosed to Patient 1 that a drill bit (cutting tool used to remove material and create holes) broke during Patient 1's surgical procedure and the tip of the drill bit (RFI- retained foreign item) was unintentionally left lodged in his left hip. Disclosure occurred the day off surgery, on 5/23/22, in the Post- Anesthesia Care Unit (PACU- specialized unit where the patient's vital signs are closely observed, pain management begins, and fluids are given) while Patient 1 was still drowsy from anesthesia (medicine that produces a local or general loss of sensation) (Refer to A 131)

4. Two of three procedure trays (container that holds surgical instruments) stored and ready for use contained unclean and unsafe surgical instruments that had residue of unknown origin, pitting (damage to the protective layer of surgical instruments), and crevice corrosion (destruction of a metal surface caused by corrosive substances and stagnant solutions). (Refer to A 144 Finding 1)

5. One of one single dose (one time use) intramuscular injection (IM- a shot given in muscle) was left unlabeled, unattended, and with a needle (sharp) attached in the emergency department (ED) "Minor Care" area. (Refer to A144 Finding 2)

6. Protected Health Information (PHI- health information in any form, including physical records, electronic records, or spoken information) was left unattended and displayed on a desktop computer in the facility's radiology department. (Refer to A146)

The cumulative effect of these systemic problems resulted in failure to ensure patients were cared for in a safe manner, free from physical and psychological harm, and their rights were protected and promoted at all times.

Based on interview and record review the hospital failed to ensure the facility followed hospital's policy and procedure titled, "Discharge - Multidisciplinary NCAL [Northern California] Regional Policy" for one of three sampled patients (Patient 28) when Patient 28, a 47 year old male with multiple health conditions was discharged home without reviewing discharge instructions with Patient 28's designated responsible party (RP) and the hospital did not confirm that Patient 28's RP was present at home to receive Patient 28 at the time of discharge.

This failure had the potential to place Patient 28 at risk to not receive care as indicated on Patient 28's discharge instructions. Staff did not provide Patient 28's RP the opportunity to address questions regarding the written discharge instructions and did not assess (analyze) Patient 28's RP's understanding of the discharge instructions at the time of discharge.

Findings:

During a review of Patient 28's "History and Physical" (H&P), dated 4/9/23, the H&P indicated, " ...History of Present Illness. [name of Patient 28] 47 year old male morbid obesity((a disorder involving excessive body fat that increases the risk of health problems), who resides (lives) with his mother and has caregivers, nonambulatory (unable to walk)/wheelchair bound confined to wheelchair)/bed bound (confined to bed) at base line (a minimum or starting point used for comparisons), hx (history) of anoxic brain injury (a complete lack of oxygen to the brain, which results in the death of brain cells after approximately four minutes of oxygen deprivation) (choking incident) in 2014 ... hx of sepsis/bacteremia (bacterial infection in the blood causing the body to go into shock), hx of adenocarcinoma (cancer) of the lung with progressive bone metastasesmetastatic [metastasismetastatic] (the spread of cancer cells from the place where they first formed to another part of the body) ... chronic back pressure ulcer (ongoing bedsore) ... He [Patient 28] presents again with left knee pain, pain continues to progress which led him to come to ER (Emergency Room) ... Assessment/Plan: Spoke to vascular [a specialist who diagnosis and treats problems of blood vessels] and ortho [orthopedic- a specialist who specializes in bones, joints, and muscles] to evaluate patient's left lower extremity findings on exam and imaging ..."

During a review of Patient 28's "Long Operative Report" (LOR), dated 4/9/23, the LOR indicated, " ...Procedure Date and Time: 4/9/23 7:23 p.m. Pre-Op Diagnosis: LEFT KNEE JOINT PAIN. LEFT KNEE CUTANEOUS ABCESS (localized collection of pus in the skin). OPEN WOUND OF LEFT KNEE. Post-Op Diagnosis: LEFT KNEE JOINT PAIN. LEFT KNEE CUTANEOUS ABCESS. OPEN WOUND OF LEFT KNEE. Procedures with Laterality [sides of body, away from the middle]: Procedures (LRB): LEG INCISION AND DRAINAGE OF SKIN AND SUBCUTANEOUS TISSUE (Left) ... Findings: Large mass (abnormal growth) at knee to cause pressure on skin with active tissue infection suspected. It appears cancer mass pushed on skin surface and cause the breakdown. Then this resulted in infection that caused patient to become septic (body's extreme response to infection) ..."

During a review of Patient 28's "Multidisciplinary Discharge Instructions" (MDI), dated 4/11/23 at 2:43 p.m., the MDI indicated, " ...Plan/Recommendations: Right Shoulder/Flank Area. 1. Cleanse with normal saline (salt water) or wound cleanser, pat dry, skin prep barrier to periwound (the skin around the wound that has been affected by the wound). 2. Apply [brand name] to wound bed. 3. Cover with Foam Dressing. 4. Change dressing Mon (Monday), Wed (Wednesday), Fri (Friday) & PRN (as needed) soiling/dislodgement. Left Knee - defer to Ortho (Orthopedic: bone specialty) for Wound Care. Skin Folds. 1. Keep Pt. Clean & dry. 2. Apply [brand name] & change Mon (Monday), Wed (Wednesday), Fri (Friday) & PRN (as needed) soiling/dislodgement. Buttocks/Periarea. 1. Keep Pt. Clean & Dry. 2. Offer frequent toileting. (Avoid adult briefs, which trap heat and moisture and progress skin damage). 3. Apply [brand name] to affected areas liberally PRN exposure to moisture, stool/urine. 4. Use care when cleaning patient, no need to removed all [brand name] after exposure to moisture. 5. Use [brand name] to clean & remove..."

During a concurrent interview and record review on 4/12/23 at 1:45 p.m., with Clinical Nurse Director (CND), Patient 28's "Electronic Health Record" (EHR) was reviewed. The EHR indicated, Registered Nurse (RN) 6 did not review Patient 28's discharge instructions with Patient 28's RP. CND stated, the Patient Care Coordinator Case Manager (PCC CM) was required to complete the discharge plan for Patient 28. CND stated, the RN was required to provide Patient 28 or the designated RP with the discharge instructions but did not. CND stated, if the RP was present then the discharge instructions were reviewed with the RP at the time of discharge. CND stated, when the RP was not present at the time of discharge, the discharge instructions were printed and sent home with the patient.

During a concurrent interview and record review on 4/12/23 3:00 p.m., with the Telemetry (unit in the hospital that monitors a patient's cardiac fucntion continuously) Manager (TM), Patient 28's EHR was reviewed. The TM validated, Registered Nurse (RN) 6 did not review Patient 28's discharge instructions with Patient 28's RP. TM stated, RN 6 left a message on Patient 28's RP's phone to review Patient 28's discharge instructions on 4/12/23 at 12:04 p.m. TM stated, Patient 28's RP did not return the phone call. TM stated, RN 6 did not attempt to contact Patient 28's RP again to review the discharge instructions. TM stated, RN 6 printed Patient 28's discharge instructions and gave the discharge instructions to Emergency Medical Service (EMS; an ambulance transportation service) to give to Patient 28's RP. TM stated, EMS transported Patient 28 home on 4/12/23 at 12:07 p.m. TM stated, the PCC CM was a discharge planner who worked with the family to provide communication, durable medical equipment, and plan time for EMS transport. TM stated, the PCC CM did not review Patient 28's discharge instructions with Patient 28's RP .

During an interview on 4/13/23, at 8:50 a.m., with Patient 28's RP, Patient 28's RP stated, she was Patient 28's mother and Patient 28 lived with her and had a care taker every day but not 24 hours a day. Patient 28's RP stated, she provided care for Patient 28 when the care taker was not there. Patient 28's RP stated, Patient 28 was admitted to the hospital on 4/9/23 for possible amputation (removal) of the left leg, but it was decided not to amputate and let the cancer run its course. Patient 28's RP stated, the hospital removed the infection and mass on Patient 28's left leg on 4/9/23. Patient 28's RP stated, Patient 28 had lung and bone cancer and was discharged from the hospital on 4/12/23 with hospice care (a specialty of care providing service for the sick or terminally ill). Patient 28's RP stated, the hospital did not review Patient 28's discharge instructions her. Patient 28's RP stated, she received the written discharge instructions but would have liked to review the discharge instructions with a staff member.

During an interview on 4/13/23, at 9 a.m., with the Coordination of Care Service Director (CCSD), CCSD stated, Patient 28's mother was his designated RP. CCSD stated, there was no documentation confirming that Patient 28's mother was home on the date of discharge. CCSD stated, Patient 28 was transported home on 4/12/23 via (by)[name] EMS service. CCSD stated, RN 6 documented that the ambulance was at the hospital to transfer Patient 28 home and Patient 28 was turned over to EMS on 4/12/23 at 12:04 p.m. CCSD stated, PCC CM were required to make the arrangement for discharge prior to the discharge with the RP. CCSD stated, confirmation that the RP was present at the time of discharge was not required.

During an interview on 4/13/22 1:59 p.m., with RN 6, RN 6 stated, Patient 28 had a history of anoxic brain injury, was not able to care for himself, had a care giver and his mother was his primary RP. RN 6 stated, Patient 28 was alert and oriented to himself and place only. RN 6 stated, Patient 28 was bed ridden, a very obese bariatric (severely overweight) patient approximately 400 pounds, and required to be turned every two hours. RN 6 stated, Patient 28 was a 2:1 assist (two staff to one patient) and required mechanical lift for transport. RN 6 stated, Patient 28 was unable to feed himself and required feeding assistance. RN 6 stated, Patient 28 was unable to use any of his extremities (arms and legs) and his upper extremities (arms) were very swollen. RN 6 stated, Patient 28 was responsive, able to make his needs known but was unable to use the call light (a device at the bedside to call for assistance). RN 6 stated, she tried calling Patient 28's mother on 4/12/23 before Patient 28 was discharged to review the discharge instructions but Patient 28's mother did not answer the phone. RN 6 stated a message was left for Patient 28's mother to return the call to review Patient 28's discharge instructions. RN 6 stated, she did not attempt to call Patient 28's mother again and highlighted all the important information on the Patient 28's discharge instructions. RN 6 stated, she handed Patient 28's written discharge instructions to EMS personnel to give to Patient 28's mother. RN 6 stated, it was not required to confirm with Patient 28's mother to be home to receive Patient 28 on the day Patient 28 was discharged from the hospital. RN 6, stated there was no risk (possible adverse events) to Patient 28 with the discharge process. RN 6 stated, Patient 28 was discharged home with written discharge instructions, had a place to go, and transportation was provided. RN 6 stated, discharge should not be stopped because Patient 28's mother was not contacted on day of discharge.

During an interview on 4/13/23 12:45 p.m., with RN 7, RN 7 stated, patients must meet criteria for discharge. RN 7 stated, during the coronavirus disease (Covid 19, is an infectious disease caused by the SARS-CoV-2 virus) pandemic (a widespread occurrence of an infectious disease over a whole country or the world at a particular time), discharge instructions were given to patient's designated RP by phone. RN stated, post pandemic, RPs were encouraged to come to the patient's bedside to review the discharge instructions. RN 7 stated, it was important to have the RP present to assess the RP's understanding of the discharge instructions. RN 7 stated, if the RP was unable to come to the hospital to review the discharge instructions, RNs were required to call to speak to the RP and review the patient's discharge instructions by phone. RN 7 stated, it was unacceptable to send written instructions home with the patient without verifying that the patient or RP had received an understanding of the discharge instructions. RN 7 stated, confirming that the RP will be at home to receive care of the patient was also required in order to ensure a safe discharge of the patient.

During a review of Patient 28's "Discharge Planning/Admission Assessment Form" (DPAAF), dated 4/9/23, the DPAAF indicated, "Assessment/Comments/Concerns/Teaching ... Per mother [RP of Patient 28] pt (Patient) has hospice assessment on Tuesday 4/11/2023 does not know which hospice agency per chart review hospice referral was sent by PCP (Primary Care Physician) [name of physician] on 4/7/2023. We want to know what your preferences are. Pt's mother wants to know if hospice will be at home or facility? Informed pt the team will follow up with pt to discuss further ... Patient Discharge Contact Information and Follow Up Preference: Please review DC (discharge) instructions with patient and/or Contact Phone Number is: [name of Patient 8's mother] home [phone number] or cell [phone number]."

During a review of Patient 28's "Patient Care Coordinator Case Manager Referral Discussion" (PCC CM), dated 4/11/23 at 11:29, the PCC CM indicated, "Received referral from physician regarding services for Hospice for this patient (Patient 28). Benefits and criteria have been reviewed, and the patient is appropriate for this/these services ... PCC CM spoke with family member [Mother name]. Informed that whenever possible [name of hospital] will respect the preference of the patient/family. The patient/family have expressed a preference for hospice with [agency name]. Benefits for the service(s) have been reviewed and the patient has a N/A (undefined). The parties verbalized understanding and agreed."

During a review of Patient 28's "PCC CM Discharge Planning Note" (PCC CM), dated 4/11/23 at 11:37 a.m., the PCC CM indicated, "Discharge Plan: Home w/(with) mother and [name] Hospice services this afternoon. Transportation needs to be set up after H/H (laboratory blood values) resulted (transfuse [whole blood or parts of blood that is put into a patient's blood stream through a vein] if < [less than] 7.0)."

During a review of Patient 28's "Hospice Services" (HS), dated 4/11/23 at 11:45 a.m., the HS indicated, "Hospice services have been arranged with the following agency: [name of agency and phone]. The hospice will contact you to arrange a visit time."

During a review of Patient 28's "PCC CM Discharge Note" (PCC CM) dated 4/11/23 at 5:19 a.m., the PCC CM indicated, "Discharge Disposition (w/ referral): Home with [name] Hospice. Transportation: ambulance transport [number] ... Follow up appt. (appointment) with PCP/MD (Medical Doctor): Yes. [name of PCP] date and time ... Discussed discharge plan and preferences with: patient/self and Mother [name] ... Patient's primary contact information @ (at) discharge: Primary Emergency Contact: [name of Patient 28's mother) Home Phone: [number]."

During a review of Patient 28's "PCC CM Discharge note" (PCC CM), dated 4/12/23 at 12:28 p.m., the PCC CM indicated, "Confirmed with [name] at [name] Hospice that patients SOC [start of care date] apt is today at 12:30, requested BLS (basic life support) pick up be pushed to 11:30, DME (durable medical equipment) was delivered yesterday."

During an interview on 4/14/23, at 9:24 a.m., with the Chief Nursing Executive (CNE), CNE stated, safe discharge meant that the patient met discharge criteria. CNE stated, safe discharge criteria was to ensure patient is safe, patient was at baseline, after care was provided, resolution that the patient had a safe place to go to, and the next level of care is appropriate. CNE stated, the discharge planner (PCC CM) worked in collaboration with the interdisciplinary team (team members from different disciplines working collaboratively for the patient) by implementing the discharge order by the physician and that teaching, and equipment was provided. CNE stated the RN was expected to provide the Patient and or RP with the discharge instructions. The CNE stated the standard was that the discharge instructions were reviewed with the patient and or RP. This practice would ensure at minimum confirmation with the RP the day of discharge for a safe discharge of the patient.

During a review of the hospital's policy and procedure (P&P) titled, "Discharge - Multidisciplinary NCAL Regional Policy," dated 10/14/21, the P&P indicated, "Policy Statement: 1.1 Patient Care Services nursing staff is responsible for assessing every patient and identifying and addressing routine discharge needs. The registered nurse (RN) is responsible for discharge teaching and preparing the patient for discharge ... The RN is responsible for ensuring the patient discharge is carried out in a safe and timely manner ... Purpose: This policy provides for timely care coordination for patients transitioning from acute care to post-hospital care and defines the responsibilities of the team members involved in the discharge planning process to ensure the patient is prepared for a safe and timely discharge ... Nursing Personnel Accountabilities: 5.6.2.6 Plan and implement patient and family instructions base on the discharge needs. 5.6.2.7 Document the completion of discharge instructions in the medical record ... 5.6.2.10.10 Ensure that patients who requires supervision when traveling in non-medical transport (private vehicles or non-medical taxi) have an adult present at discharge to accompany them home ..."

Based on interview and record review, the hospital failed to ensure and protect the right to make informed medical decisions and request or refuse treatment for one of one Patients (Patient [Pt] 1) when Pt 1 had a "Total Hip Procedure" on 5/23/22; the drill bit (cutting tool used to remove material and create holes) used in the procedure broke and was intentionally left in Pt 1's hip. The Orthopedic Surgeon (MD 1) notified Pt 1 of the retained foreign item (RFI- drill bit) on 5/23/22, while Pt 1 was in the post-anesthesia recovery unit (PACU- specialized unit where the patient's vital signs are closely observed, pain management begins, and fluids are given), still drowsy from anesthesia (medicine that produces a local or general loss of sensation).

This failure resulted in Pt 1 not fully understanding risks and benefits of the RFI and had the potential for Pt 1 to not seek appropriate medical care to prevent injury or infection.

Findings:

During a record review of Pt 1's medical record, on 4/13/23, at 12 p.m., the record indicated, MD 1 performed a "Left Total Hip Replacement" (a surgical procedure in which the diseased parts of the hip joint are replaced with new, artificial parts) for Pt 1 on 5/23/22. A post-operative (after surgery) x-ray (an imaging study that takes pictures of bones and soft tissues) of Pt 1's left hip, performed in PACU on 5/23/22, identified a RFI in the hip's soft tissue (muscle, fat, fibrous tissue, blood vessels, or other supporting tissue of the body). Physician progress notes (part of a medical record where healthcare professionals record details to document a patient's health status) indicated, the surgical team elected to leave the RFI in Pt 1's hip. Pt 1 was discharged home from the hospital on 5/23/22.

During an interview on 4/12/23, at 8:30 a.m., with MD 1, MD 1 validated he performed a "Left Total Hip Procedure" on 5/23/22 for Pt 1. MD 1 stated the drill bit used in the procedure broke and left a one-millimeter (mm- unit of measure) piece of metal in the hip's soft tissue. MD 1 stated the piece of drill bit was not identified until after the Pt 1's surgery was completed, and Pt 1 was recovering in PACU. MD 1 stated he intentionally left the RFI in Pt 1's left hip to prevent another surgery and subjecting Pt 1 to more anesthesia or potential injury and infection. MD 1 stated he disclosed this information to Pt 1 the same day, on 5/23/22, while Pt 1 was recovering in PACU. MD 1 stated Pt 1 was alert enough to understand what was explained. MD 1 validated he did not disclose the RFI to Pt 1's significant other. MD 1 stated there was no indication that Pt 1 did not understand what he explained to Pt 1.

During a record review of MD 1's "Signed Progress Notes", undated, the progress note indicated, "Postop [post operative] Xrays ... Small tip of drill bit visible in the soft tissues just above the hip joint... finding of a broken drill bit explained to the patient, I don't expect any untoward effect for the patient or change in Postoperative plan."

During an interview, on 4/14/23, at 1:10 p.m., with the Chief of Risk Management and Patient Safety (CRPS), the CRPS stated, MD 1 documented in Pt 1's medical record Pt 1 was notified of the RFI. The CRPS stated patients should also be notified the RFI was unintentional, physician recommendations moving forward, when to return to the hospital (i.e., pain), and patients should be allowed an opportunity to ask questions.

During an interview on 4/14/23, at 9:30 a.m., with Pt 1, Pt 1 validated MD 1 performed the "Total Hip Replacement" of his left hip, on 5/23/22. Pt 1 MD 1 told him that "a piece of metal" was left in his hip after the surgery was done on 5/23/22. Pt 1 stated he did not fully understand what MD 1 told him because "I was still pretty out of it right after surgery." Pt 1 stated he was "it was just a small piece of metal, I thought." Pt 1 stated MD 1 did not speak to his wife, nor did MD 1 mention the "metal piece" during follow up appointments. Pt 1 stated he did not know where the "metal piece" was in his hip, nor potential risks the "metal piece" presented. Pt 1 stated he was not provided education of potential complications to report or when to seek medical attention.

During a review of the hospital's policy and procedure (P&P) titled, "Patient's Rights and responsibilities," dated 11/18/20, the P&P indicated, " ... assure the rights of independence of expression, decision and action, and personal dignity for all [name of hospital] patients... patient rights include, but are not limited to, the patients right to ... be informed about patient's rights ... to be involved in the health care decision ... current information regarding proposed treatments ... problems related to and the likelihood of treatment success... The information is communicated in terms of the patient or family can reasonably be expected to understand..."

During a review of the hospital's P&P titled, "Patient Safety Event Management," dated 1/18/23, the P&P indicated, " ... A sentinel event is a patient safety event (not primarily related to the natural course of a patient 's illness or underlying condition) that reaches the patient and results in death, severe harm, or permanent harm... Unintended retention of a foreign object in a patient after an invasive procedure, including surgery... It is the responsibility of the attending provider or his/her designee to inform the patient of any unanticipated negative health outcomes of care due to medical errors and to document that discussion in the medical record... the patient or the representative will be notified... The documentation should include but may not be limited to; the date and time of the meeting; persons in attendance actions to alleviate and injury; the patient's response to treatment; questions that the patient may have asked, and answers provided; follow-up agreements; any consultation with other disciplines such as ethics or psychiatry if used..."

During a review of the professional reference retrieved from the American Medical Association (AMA- organization of American physicians and medical students) https://www.ama-assn.org/system/files/code-of-medical-ethics-chapter-1.pdf titled, "Code of Ethics Opinions on Patient-Physician Relationships," undated, indicated, " ... Patients Rights... Physicians can best contribute to a mutually respectful alliance with patients by serving as their patients' advocates and by respecting patients' rights ... these include the right: (a) To courtesy, respect, dignity, and timely, responsive attention to his or her needs. (b) To receive information from their physicians and to have opportunity to discuss the benefits, risks, and costs of appropriate treatment alternatives, including the risk, benefits, and costs of foregoing treatment. patients should be able to expect that their physicians will provide guidance about what they consider the optimal course of action for the patient based on the physician's objective professional judgment. (c) to ask questions about their health status or recommended treatment when they do not fully understand what has been described and to have their questions answered. (d) To make decisions about the care the physician recommends and to have those decisions respected. A patient who has decision-making capacity may accept or refuse any recommended medical intervention ..."

Based on observation, interview, and record review, the hospital failed to ensure and protect the right of patients to receive care in a safe environment when:

1. Two of three procedure trays (container that holds surgical instruments) contained unclean and unsafe surgical instruments. Two of 80 instruments in the minor tray (set of instruments used for short and less complex surgical procedure) and ready for use in a surgical procedure, had residue of unknown origin and discoloration on the handles. Two of 65 instruments in the orthopedic tray (set of instruments used in surgical cases involving the skeletal system and its interconnecting parts) and ready for use in a surgical procedure, had pitting (damage to the protective layer of surgical instruments) and crevice corrosion (destruction of a metal surface caused by corrosive substances and stagnant solutions).This failure had the potential to result in injury from the use of a corroded instrument and post- surgical infections to patients.

2. One of one single dose (one time use) intramuscular injection (IM- a shot given in muscle) was left unlabeled, unattended, and with a needle (sharp) attached in emergency department (ED) "Minor Care" area. This failure resulted in an unsafe environment for patients, visitors, and staff.

Findings:

1. During concurrent observation and interviews on 4/11/23, at 1:30 p.m., in the sterile processing department (SPD- department in a hospital that performs sterilization and other actions on medical devices and equipment), with Senior Sterile Processing Technician (SPT) 4 and the Sterile Processing Manager (SPDM), the SPDM described the workflow of the sterile storage area (where sterilized items are stored for later use) and packing area (where clean items are sterilized, assembled, and prepared for issue, storage, or further processing) of SPD. SPDM stated surgical instruments were cleaned and inspected in the decontamination room, then assembled into procedure trays according to "recipe cards" (detailed instructions how a tray should be assembled). SPDM stated surgical instruments were inspected a second time as they were assembled into trays, prior to packaging and sterilization. SPT 4 opened a "Minor Tray", that was sterilized and stored in the sterile storage area. The "Minor Tray" contained a total of 80 surgical instruments. Two forceps (a surgical instrument used to handle tissue) had residue and discoloration on the handles. SPT 4 inspected the two forceps under a magnifying glass and validated there was residue left on the instruments that could be "rubbed off." SPT 4 opened an "Ortho Tray" that was sterilized and stored in the sterile storage area. The "Ortho Tray" contained a total of 65 instruments. Two retractors (a surgical instrument used to hold open the edges of a wound) had deep pitting and corrosion on the angled ends. SPT 4 validated the retractors were worn and had potential to retain bacteria, develop rust (red/ brown substance that breaks down metals), or crack. SPT 4 stated he was aware of the condition of the retractors but was told to maintain them in use until new retractors arrived. SPT 4 states the retractors were ordered "several months ago" but were still on backorder. SPDM stated the department decided to use the instruments since the hospital had only 12 in service for all orthopedic cases performed in the hospital. SPT 4 validated the process was to send the instruments to a vendor to have them repaired or sharpened but it was not done.

During a review of the "Minor Tray- 004" insert, indicated, "Date prepared: 3/31/2023 ... Pre Cnt [count] 2 ... SPD Cnt 2 ... Description ... Forceps, [Name], tissue, Serrated, 4 3/4" w/ Teeth ... Prod [product] # ... BD512R ..."

During a review of the "Ortho Tray- 002" insert, indicated, "Date prepared: 4/8/2023 ... Pre Cnt [count] 2 ... SPD Cnt 2 ... Description ... Retractor, [Name], Double Ended, Angled ... Prod [product] # ... 6210 ..."

During a review of the hospital P&P titled, "Reusable Supplies & Equipment- Disinfection-Receiving-Transport and Distribution," dated 7/22/22, the P&P indicated, " ... To establish the various means by which reusable supplies equipment will be assembled and or wrapped for sterilization, storage and distribution... To define the manner in which reusable equipment and supplies which cannot be sterilized or do not require sterilization will be disinfected... Check all instruments before assembly and/or wrapping to be sure they are in good condition and in good working order... Check for spotting, corrosion, pitting, or discoloration of the finish... Remove instruments in need of repair or maintenance and return them to the originating department or send them to the appropriate clinical instrument repair vendor... physical integrity of all items received in Sterile Processing will be verified and documented by sterile processing personnel... "

During a review of the professional reference from the Association for the Advancement of Medical Instrumentation (AAMI- a primary source for the development, management, and use of safe and effective health technologies for the medical device industry, as well as practical information, support, and guidance for healthcare technology and sterilization professionals) titled, "ANSI/ AAMI ST79:2017," indicated, " ... have a process in place to identify instruments in need of repair/maintenance and removal from service ... inspected for cleanliness, flaws, and damage... Surgical instruments and other medical devices and equipment could pose a significant risk of transmitting infection to patients or health care personnel if they are not properly decontaminated and then disinfected ..."

During a review of the professional reference retrieved from the Joint Commission (a professional organization that identifies, measures, and shares best practices in quality and patient safety), https://www.jointcommission.org/resources/news-and-multimedia/blogs/ambulatory-buzz/2022/08/is-that-instrument-safe-to-use-on-a-patient#.ZEFkz3bMLic titled, "Is That Instrument Safe to Use on a Patient?", dated 8/3022, the professional reference indicated, "... If tissue, bone or other soil is left behind on a surgical instrument, this unsterile condition obviously could carry risk of infection to the next patient, and it should not be reused ... Impact of instrument damage on the provision of safe care needs to be assessed and often results in the decision to completely remove an instrument from service until it can be repaired. Instruments with identification tape that is peeling, cracked or has evidence of corrosion could potentially flake particles into an open wound during surgery and result in a foreign body being left in the wound. Such instruments should be taken out of service, and if necessary, replaced ... Key Actions for Instrument Safety ... Correctly dismantle and inspect instruments for soil or damage ... Establish effective maintenance and refurbishment processes to keep instruments in optimal condition ... Create an effective process for identifying instruments that require repair or replacement ... open and inspect instruments in peel pouches and trays to ensure they are appropriate for sterilization and use ..."

2. During concurrent observation and interview on 4/10/11, at 11:45 a.m., in the ED "Minor Care" area, with the EDM, the EDM described the "Minor Care" area as busy, with high patient turnover, that "fast tracked" patients who required minimal care. The EDM stated the "Minor Care" room routinely had multiple patients waiting for services at any given time. The "Minor Care" room had four patients seated in chairs and no staff present. On a medical tray, was one unlabeled injection syringe with a needle attached. The EDM picked up the syringe and stated the syringe was a single dose 0.5 ml (milliliter- unit of volume) IM Tdap vaccine (protects against tetanus, diphtheria, and pertussis [bacterial infections]) injection that was administered to a patient. The EDM stated the syringe was not labeled and would ask staff which patient received the dose. The EDM stated the syringe should have been immediately discarded in a "sharps" container (rigid container designated for the disposal of needles and sharp items) for safety. The EDM verbally validated everyone (patient, visitor, or staff) was placed at risk for injury and/ or exposure to blood borne diseases (illness that can be spread through contamination by blood and other body fluids).

During a concurrent interview and record review of Patient (Pt) 6's medical record on 4/13/23, at 8:25 a.m., with the EDM, the EDM stated Pt 6 was administered the Tdap vaccine in the ED's "Minor Care" room on 4/10/23.

During a record review of the hospital's Medication Administration Report (MAR- legal record of the drugs administered to a patient) for Pt 6, the "MAR" indicated Pt 6 was administered, "[name of vaccine] 0.5 ml ... ONE TIME ... IM ... 4/10/23 1134 [11:34 a.m.] ...," 11 minutes prior to the syringe found unattended in the "Minor Care" area.

During a review of the hospital's P&P titled "Hazardous Materials/ Wastes (Medical, Hazardous, and Radioactive) and Spill Response Policy)," dated 10/19/22, the P&P indicated, "... Sharps waist: A device that has acute rigid corners, edges, or protuberances capable of cutting or piercing, including, but not limited to, needles, needles with syringes... All needles and syringes (intact and unclipped), scalpels [thin bladded knife], broken lab glassware, etc., must be placed into the opening of rigid puncture resistant sharps container appropriately labeled with the biohazard symbol... Sharps found anywhere other than a sharps container should be carefully retrieved and handled using appropriate equipment and discarded into appropriate sharps container... Employees upon discovery of a sharps not disposed of properly are to immediately notify the manager/ supervisor of the department... Employees are not to leave improper sharps unsupervised/ unmonitored... A person must dispose of the sharps correctly..."

During a review of the hospital's policy and procedure (P&P) titled, "Patient Rights & Responsibilities" dated 11/18/20, the P&P indicated, " ... [name of hospital] staff assures that the rights of all patients are preserved during illnesses... Personal safety... the patient has the right to expect reasonable safety insofar as the Medical Center's practices and environment are concerned ..."

During a review of the hospital's document titled "Patient Rights," undated, the document indicated, " ... 13. receive care in a safe setting, free from mental, physical, sexual or verbal abuse and neglect, exploitation or harassment ..."

Based on observation, interview, and record review, the facility failed to protect Protected Health Information (PHI- health information in any form, including physical records, electronic records, or spoken information) for seven of seven patients (Patient 21, Patient 22, Patient 23, Patient 24, Patient 25, Patient 26, and Patient 27) when the name, date of birth, and medical record numbers of Patients 21, 22, 23, 24, 25, 26, and 27 were left unattended and displayed on the desk top computer in the Radiology Department.

This failure had the potential to result in unauthorized access of Patient 21, 22, 23, 24, 25, 26, and 27's PHI.

Findings:

During a concurrent observation and interview on 4/10/23, at 12:10 p.m., in the X-Ray (a medical test that takes pictures of bones and soft tissues) room, with the Assistant Facility Director Imaging (AFDI), the AFDI provided a guided tour of the Radiology/ Imaging Department. Each camera room had desk top computers used by the technicians. The back x-ray room had a computer left unattended with the computer screen on, in clear view of unauthorized persons (patients and staff) who walked by the computer. The computer screen displayed Pt 21, 22, 23, 24, 25, 26, and 27's name, date of birth, medical record number, and scheduled x-ray procedure. The AFDI validated the computer screen contained patient PHI and should not have been left on and unattended, easily accessible to unauthorized persons. The AFDI stated the expectation was that staff maintain patient PHI always protected. The AFDI stated the technician who last used the computer should have left the screen closed and locked before leaving the workstation.

During a review of the hospital's document titled "Patient Rights," undated, the document indicated, " ... 12. Confidential treatment of all communications and records pertaining to your care and stay in the hospital ..."

During a review of the hospital's policy and procedure (P&P) titled, "Patient Rights & Responsibilities" dated 11/18/20, the P&P indicated, " ... [name of hospital]
staff assures that the rights of all patients are preserved during illnesses... Protected Health Information- PHI... Individually identifiable information (oral, written, or electronic) about a member/ patient's physical or mental health, the receipt of health care, or payment for that care ..."

During a review of the hospital's P&P titled, "Electronic Asset Usage" dated 8/30/21, the P&P indicated, " ... the purpose of this policy is to ensure adequate controls for the business use of [name of hospital] electronic assets to ensure compliance with federal and state regulations... this policy applies to all employees who are employed... Confidential and proprietary information includes any information that is not intended to be accessible to the public... information [name of hospital] is required by law to keep confidential, such as social security numbers and medical records..."

During a review of a hospital document titled "PRESERVE THE TRUST OF OUR MEMBER, PATIENTS, AND CUSTOMERS ... PRINCIPLES OF RESPONSIBILITY" undated, the document indicated, " ... much of the information we collect from patients- including medical condition, history, medications, and family illnesses- is very sensitive and protected under privacy and information security laws... Keep electronic devices secure and passwords protected... Use a privacy screen on your computer monitor if the screen is visible and readable by others... log off of a shared computer or lock your computer before walking away..."

Based on interview and record review, the hospital failed to ensure least restrictive interventions (alternative measures used to control behaviors of patients that do not require mechanical restraint or involuntary confinement) were provided for two of three sampled patients (Pt 14 and Pt 15), when restraints (a device that restricts movement) were ordered. The hospital failed to follow hospital policy and procedures (P&P) for assessments and monitoring of restraints for Pt 14.

This failure resulted in Pt 14 and Pt 15 to be restrained unnecessarily, causing potential psychological and physical harm.

This failure had the potential to place Pt 14 at risk for dehydration, loss of strength and mobility, incontinence, and injury to the restraint site.

Findings:

1. During a review of Pt 14's "History and Physical" (H&P), dated 4/9/23, the "H&P" indicated, Pt 14, " ...with history of CKD [chronic kidney disease-a condition in which the kidneys are damaged and cannot filter blood as well as they should], CHF [congestive heart failure-a long-term condition that happens when your heart cannot pump blood well enough to give your body a normal supply], DM [a disease of inadequate control of blood levels of sugar], HTN [high blood pressure-blood pressure that is higher than normal], HL [hyperlipidemia-an excess of lipids or fat in your blood], who was found to be confused by sister ...she was found to be hypoglycemic [low blood sugar levels in bloodstream] on presentation ..."

During a review of Pt 14's "Physician Orders (PO-the patient's medical management during hospitalization)," dated 4/9/23, the "PO" indicated, orders for soft limb restraints (soft, padded material which are applied to a patient's wrists or ankles to prevent the patient from causing harm to themselves or others) to both wrists were ordered and the clinical reason was pulling out lines and dressings.

During a concurrent interview and record review on 4/12/23 at 2:27 p.m., with the Quality Nurse Consultant (QNC), Pt 14's "Physician Progress Note" (PPN), and Pt 14's "Medication Administration Record" (MAR-to assist health care provider track medications administered to a patient)," dated 4/12/23 was reviewed. The PPN indicated, "Restraints have been ordered for patient safety because of the patient's confusion due to underlying medical condition thereby interfering with medical care and causing the patient to pull on lines and/or drains. All alternatives including medication and redirection have been attempted prior to ordering restraints." The QNC stated, the MAR indicated, Pt 14 was not administered medications for behaviors on 4/9/23 prior to the restraint order.

During a concurrent interview and record review on 4/12/23 at 2:35 p.m., with the QNC, Pt 14's "Restraints, Non-Violent/Non-Self Destructive/Non-behavioral" flowsheet (documentation of the evaluation and monitoring of patient with restraints), dated 4/9/23 and 4/10/23 and the hospital's policy and procedure (P&P) titled "Restraints Policy," dated 11/8/20 were reviewed. The QNC stated, the P&P indicated, monitoring of patients with restraints was every two hours. The QNC stated, the flowsheet indicated, on 4/10/23, from 12 p.m. to 3:30 p.m. there was a three-and-a-half-hour period where Pt 14's restraint assessment and monitoring were not documented according to the policy. The QNC stated, the importance of monitoring a patient every two hours was to monitor skin breakdown, circulation or pressure injuries. The QNC stated, if the restraint assessment and monitoring was not done every two hours, the patient could have skin breakdown from the wrist restraints.

During a review of Pt 15's "H&P," dated 4/13/23, the H&P indicated, " ... [Pt 15] ...with history of hypertension, chronic [an illness occurring again and again for a long time] pain ...was brought into emergency room by paramedics due to shortness of breath [the feeling that you cannot get enough air into your lungs]. O2 saturation [measures how much oxygen is circulating with your red blood cells] was 77% upon arrival [normal ranges in adults are 95%- 100%]..."

During a review of Pt 15's "PO," dated 4/6/23, the PO indicated, on 4/6/23 at 10:03 a.m., Pt 15 had orders for soft limb restraints to both wrists for pulling out lines and/or dressings.

During a review of Pt 15's "Neuro (evaluates brain and nerve tissue in the body)/GCS (Glasgow Coma Scale-scoring system to describe the level of consciousness in a person)" flowsheet, dated 4/6/23, the flowsheet indicated, at 11 a.m., the assessment of Pt 15's strength to the right and left upper extremities (the part of the body that includes the arm, wrist, and hand) had "no muscle contraction (flaccid [limp])" and "no response" to movement of both upper extremities. The flowsheet indicated, Pt 15's Neuro/GCS assessments from the time restraints were placed until the time the restraints were removed, had remained the same. The flowsheet indicated, Pt 15's GCS was a 3 (the lowest possible score and is associated with an extremely high mortality rate (when an event or a disease causes more deaths than expected)) from the time Pt 15 was placed on restraints at 10:49 a.m. until the time the restraints were discontinued at 3:35 p.m.

During a review of Pt 15's "Restraints, Non-Violent/Non-Self Destructive/Non-behavioral" flowsheet, dated 4/6/23, the flowsheet indicated, when Pt 15's restraints were started at 10:49 a.m., under the "Restraint Monitoring at Least Every 2 hours" the assessment indicated, "Restraints still required?...No ...", but Pt 15 continued to have restraints until 3:35 p.m.

During a concurrent interview and record review on 4/13/23, at 10:30 a.m., with Registered Nurse Manager (RNM) 3, Pt 15's "PO," dated 4/8/23 was reviewed. The PO indicated, on 4/8/23 at 10:30 a.m., Pt 15 had orders for mittens to both hands for pulling out lines and or dressings.

During a concurrent interview and record review on 4/13/23, at 10:35 a.m., with RNM 3, Pt 15's "Electronic Health Record (EHR-an electronic version of a patient's chart)," dated 4/13/23 was reviewed. RNM 3 stated, the EHR indicated, there were no narrative physician notes or nursing notes indicating Pt 15's behaviors or less restrictive interventions implemented prior to the use of restraints. RNM 3 stated, "Restraints are placed on a patient when they have attempted all other alternatives and could not keep the patient safe". RNM 3 stated the importance of trying alternative interventions prior to placement of restraints was to ensure the patient was comfortable and safe. RNM 3 stated if a patient was placed in restraints without alternative interventions implemented, then the hospital was not following their policy.

During an interview on 4/13/23, at 11:15 a.m., with RNM 2, RNM 2 stated, when a patient was intubated (tube, a process where a healthcare provider inserts a tube through a person's mouth then down into their windpipe [carries air in and out of the lungs]) and sedated (a state of calmness or sleepiness caused by certain drugs), the physician would put in orders for restraints. The process was to restrain the patient, the nurse could implement the order and once restraints were in place, the physician was required to visually assess the patient to make sure the patient required restraints.

During a concurrent interview and record review on 4/14/23, at 10:37 a.m., with Registered Nurse (RN) 5, the hospital P&P titled, "Restraints Policy," dated 11/8/20 was reviewed. RN 5 stated restraints were placed on patients to protect the safety of the patient as well as prevent the patient from pulling lines, airways, and tubes. RN 5 stated, the least restrictive interventions should be implemented such as getting family involved, distraction, or anything to prevent the patient from being placed in restraints. RN 5 stated, the P&P indicated, alternative interventions included: routinely round on patient, maintain a safe environment, turn on wheel locks on the patient's bed, clip fingernails, remove unnecessary tubes, position lines or catheters (flexible tubes connected to collection bag and inserted in the body) away from the patient, and applying binders to prevent the patient from pulling lines.

During a concurrent interview and record review on 4/14/23, at 10:45 a.m., with RN 5, Pt 15's "Restraints, Non-Violent/Non-Self Destructive/Non-behavioral" flowsheet, dated 4/8/23 was reviewed. RN 5 stated he was assigned to care for Pt 15 on 4/8/23. RN 5 stated, Pt 15 was weaned off (gradually stop) sedation (process which allows the patient to take over their own breathing) on 4/8/23 and his assessment of Pt 15 indicated, Pt 15 was able to move both of her arms so for the safety and prevention of pulling lines or drains, Pt 15 was placed in restraints. The flowsheet indicated, Pt 15 was placed in restraints on 4/8/23 at 10:30 a.m. and in the notes RN 5 indicated, the reason was "weaning sedation". RN 5 stated, the importance of implementing least restrictive interventions were for the safety of the patient and if restraints had to be placed, the restraints should not cause unnecessary harm or pain to the patient and could be easily removed in an emergency. RN 5 stated, if restraints were placed without implementing least restrictive interventions, the patient could have physical discomfort, harm and the patient would not be considered safe if the hospital did not provide the least restrictive interventions.

During an interview on 4/14/23, at 11:30 a.m., with RNM 2, RNM 2 stated, her expectations of registered nurses and the use of restraints on patients were to utilize the least restrictive interventions. RNM 2 stated, some examples of least restrictive interventions included calling family to be at the patient's bedside, opening windows and drapes to decrease confusion, assess patient's medications to see if any of the medications could cause confusion, use sitters, distract the patient with activities, and utilize abdominal binders (fitted elastic material that goes around your abdomen) to hide tubes. RNM 2 stated, the risks and benefits should be taken into consideration and the RN should discuss with the physician prior to placing restraints to ensure patient safety.

During a review of the hospital's P&P titled, "Restraints Policy," dated 11/8/20, the P&P indicated, " ...All patients have the right to be free from physical or mental abuse and corporal punishment. Restraint may only be used to ensure the immediate physical safety of the patient ...or others from harm ...The use of restraint must be discontinued as soon as possible based on an individualized patient assessment and re-evaluation. Restraint may only be used when less restrictive interventions have been determined to be ineffective ...the minimum level of restraint needed to accomplish the desired goal will be used ...use of restraint for any other purpose, such as coercion, discipline, convenience, family request, or retaliation by staff is not permitted ...Orders for the use of restraint shall never be written as a standing order [written protocols that authorize designated members of the health care team to complete certain clinical tasks without having to first obtain a physician order] or on an as needed basis (PRN) ...When restraints are initiated for non-violent, non-self-destructive behavioral purposes, a physician ...examines the patient within 24 hours ...Documentation requirements ...alternative interventions attempted or the rationale for not using alternatives ...less restrictive interventions or determined by staff to be ineffective to protect the patient or to pose a greater risk than the risk of using a restraint ...Examples of alternative interventions and less restrictive devices ...Behavior exhibited ...pulling tubes, wounds or dressings ...remove unnecessary tubes as soon as possible ...hide or camouflage tubing ...supervise confused patients carefully ...less restrictive devices ...mittens ...elbow extenders before limb holders ..."

During a review of the hospital's Order Set (OS-a health care provider's instructions to other health care workers regarding the treatment of a patient) titled, "Intubation, Sedation, Ventilation ...", dated 7/17/18, the OS indicated, restraints for nonviolent patient was included in the order set.

During a review of the hospital's P&P titled, "Patient Rights & Responsibilities," dated 11/18/20, the P&P indicated, " ... [the hospital name] staff assures that the rights of all patients are preserved during illness ... The patient has the right to considerate, respectful care at all times and under all circumstances, with preservation of their personal dignity ..."

During a review of a professional reference from the Annals of the American Thoracic Society titled, "Physical Restraints and Post-Traumatic Stress Disorder in Survivors of Critical Illness," dated 10/19/20, the reference indicated, "Although the intention of physical restraint use is patient safety, their application may inadvertently cause harm such as impaired circulation, increased thrombosis [blood clot] risk, skin damage, nerve damage, pressure areas, and deprivation on patient independence ...it is possible to reduce physical restraint use with educational interventions. This is because improved awareness among nursing staff regarding indications for restraint use, and alternative management options, leads to a reduction in inappropriate application of restraints ..."

During a review of a professional reference from the National Institute of Health (NIH) titled, "Correlation Between Restraint Use and Engaging Family Members in the Care of the ICU Patients," dated 11/5/20, the reference indicated, " ...Mechanical restraints use is prevalent among mechanically ventilated [intubated] adults managed with a sedation protocol in the ICU ...frequently intended for patient or clinician safety, mechanical restraints can lead to adverse physical and psychological consequences, including immobility, agitation, and delirium ...absence of family visitation and use of restraints are known to be individual risk factors for delirium ...engagement of families in the bedside care of patients would correlate with reduced restraint exposure ..."

During a review of a professional reference from the Southwest Respiratory and Critical Care Chronicles titled, "Self-extubation in ICU patients," dated 10/2/14, the reference indicated, " ...Self-extubation, defined as a deliberate action taken by the patient to remove the endotracheal tube [a medical procedure in which a tube is placed into the windpipe through the mouth or nose] ...the patient's level of consciousness is a strong predictor for self-extubation, and incidence is higher in patients with a Glasgow Coma scale score of 9-12 points ...patients with a high risk of self-extubation should be allocated more supervision ...physical restraints have been historically used to prevent self-extubation however ...restraint use is actually associated with self-extubation ...self-extubation is higher during the hour before and after nursing shift change ...adopting a practice of increased patient surveillance during shift changes could help significantly decrease the incidence of self-extubation ..."

Based on interview and administrative document review, the hospital failed to maintain an effective, comprehensive, ongoing, hospital-wide, data-driven quality assessment and performance improvement (QAPI) program when:

1. The program did not identify, collect data, track data, or develop, or implement performance improvement measures for two of two adverse events at the time of their occurrences. The hospital self-reported an unintentional retained item (drill bit) on 1/10/23 and the RFI (retained foreign item) occurred on 5/23/22, eight months before the reporting. An unintended laceration event occurred in the Nuclear Medicine department on 4/20/22 and was not reported and listed as an adverse event until 4/11/23, 12 months later. The Committee did not analyze the root causes to ensure the events would not re-occur. (Refer to A 286 and A 309)

The cumulative effect of these systemic problems resulted in failure jeopardized the health and safety of patients who received care in nuclear medicine and surgical services.

Based on interview and administrative document review, the hospital failed to identify and take action on adverse events (AE- a harmful and negative outcome that happens to a patient provided medical care) at the time of the occurrences. The hospital self-reported a drill bit, an unintentional retained foreign item (RFI- item left inside patient's body after surgery that was not intentional) on 1/10/23 and the RFI occurred on 5/23/22, eight months before the reporting. An unintended laceration event occurred in the Nuclear Medicine department on 4/20/22 and was not reported and listed as an adverse event until 4/11/23, 12 months later. The Quality assurance and performance improvement (QAPI) committee did not track and analyze for two of two adverse events the causes of the adverse events which occurred in the hospital's surgical and nuclear medicine departments nor implement preventive actions affecting patient safety and quality of care.

These failures led to a delay in the implementation of necessary corrective measures resulting in continued risk of injury and infections to Patient (Pt) 1, Pt 35, and patients whom received care in the surgical services and nuclear medicine departments.

Findings:

The hospital self- reported the RFI event that occurred on 5/23/22 to the California Department of Public Health (CDPH- the state department responsible for public health in California) on 1/10/23, eight months after the AE occurred.

The hospital self- reported the unintended laceration event in Nuclear Medicine that occurred on 4/20/22 to CDPH on 4/11/23, 12 months after the AE occurred.

During a record review of a hospital document listing "AEs and near misses (any event that does not lead to harm but does have the potential to cause illness or injury)" from April 2022 through April 2023, the document indicated, on 4/20/22, Pt 35 sustained a 10 cm (centimeter- unit of measure) laceration (a tear, cut, or gash in the skin) to the left ankle in the Nuclear Medicine Department (specialized area of radiology) due to improper use of equipment and user error. Investigation was initiated on 4/20/22, day of the AE. The document also indicated, on 5/23/22, there was late identification of an unintended retained foreign item- a drill bit (cutting tool used to remove material and create holes) left in Pt 1's left hip. Investigation was initiated on 7/8/22, 55 days after the AE.

During concurrent interviews, on 4/14/23, at 1:15 p.m., with the Chief Executive Officer (CEO), the Area Quality Leader/ Patient Safety Office (QL-PSO), the Risk Manager (RM), and the Chief of Risk Management and Patient Safety (CRPS), the RM stated the Risk Management Department (RMD-department in the hospital that is comprised of systems and processes to uncover, mitigate, and prevent risks in healthcare) received patient safety events through internal reporting systems and patient grievances (complaints). The RM stated Pt 1 and Pt 35's safety events (AEs) that occurred on 4/20/22 and 5/23/22 were reported to the RMD the day of each occurrence. The RM stated department leaders were made aware of Pt 1 and Pt 35's AEs and immediate measures were implemented in the separate departments (surgical services and nuclear medicine departments). The CEO validated RM, QL-PSO, and she were aware of Pt 1 and Pt 35's AEs however, no comprehensive systemic analysis (CSAs- a root cause analysis that identifies causes of specific problems and undesired outcomes) were performed and reported to quality and medical executive committees. The CEO stated no tracking of outcomes were formally put into place. The CEO stated she was a member of the Quality and Medical Executive Committees, but never thought to question why Pt 1 and Pt 35's AEs were not reported and or tracked during the monthly/ quarterly meetings. The QL-PSO stated the RMD underwent employee changes in 2022, and Pt 1 and Pt 35's AEs "just fell off the grid." The QL-PSO stated Pt 1 and Pt 35's AEs were identified during an internal year end audit performed December 2022.

During a review of the Ancillary Service Line Committee meeting minutes for the meetings from February 2022 through February 2023, the meeting minutes did not have documented evidence to indicate the hospital tracked the data, developed, or implemented performance improvement measures for Pt 35's AE that occurred in nuclear medicine on 4/20/22. The Ancillary Committee meeting was cancelled in December 2022.

During a review of the Surgical Quality Safety (SQS) Committee meeting minutes for the meetings from February 2022 through January 2023, the meeting minutes did not have documented evidence to indicate the hospital tracked the data, developed, or implemented performance improvement measures for Pt 1's AE that occurred on 5/23/22. The SQS Committee meeting was cancelled in January 2022, April 2022, July 2022, October 2022, & and March 2023.

During a review of the SQS Committee Meeting minutes, dated 6/8/22, indicated " ... Safety Events (RFO [retained foreign object or item]... 0 [zero] ..."

During a review of the SQS Committee Meeting minutes, dated 11/9/22, indicated " ... Safety Events: 0 ... Annual Workplan Mid-Year Evaluation ... Each year we establish goals under quality and patient safety. Those are submitted through the regional process. Three of our goals fall under Surgical Quality and Safety committee... There has been 57 months since last verification event/ RFO ..."

During a review of the SQS Committee Meeting minutes, dated 12/14/22, indicated, " ... there has been 58 months since the last verification event/ RFO ..."

During a review of the SQS Committee Meeting minutes, dated 1/11/23, indicated, " ... there has been 59 months since the last verification event/ RFO ..."

During a review of the SQS Committee Meeting minutes, dated 2/8/23, indicated, " ... ortho [orthopedics- procedures pertaining to bone, joints, and muscle] is doing well ..."

During a review of the hospital policy and Procedure (P&P) titled, "Patient Safety Event Management," dated 1/18/23, the P&P indicated, " ... unexpected or adverse events meeting the definition of a patient safety event as defined in the policy will be reported, communicated, investigated, and analyzed following this policy ... an adverse event is a patient safety event that resulted in harm to a patient...A Sentinel event is a patient safety event (not primarily related to the natural course of the patients illness or underlying condition) that reaches a patient and results in death, severe harm (regardless of duration of harm), or permanent harm (regardless of severity of harm)... ... Regulatory reportable events: events that require reporting to a Regulatory agency (i.e., California Department of public health (CDPH) or the medical board of California (MBC)) ... Unintended retention of a foreign object in a patient after an invasive procedure including surgery... Fluoroscopy [continuous imaging on a monitor] resulting in permanent tissue injury when clinical and technical optimization were not implemented and or recognized practice parameters were not followed... ... Sentinel event, CDPHP reportable events, and SREs [serious reportable events] ... in cases in which the health care organization is uncertain an event meets the definition of a Sentinel event, the event will be presumed to be a patient safety event, requiring comprehensive analysis... patient safety events such as no harm events, close calls, and hazardous conditions which are not an ongoing urgent or emergent threat to the welfare health, or safety of patients, personnel, or visitors may not require a CSA, however, should be tracked and used as opportunities to proactively improve systems and prevent harm... the Medical Center will complete the CSA and submit an executive summary within 45 business days of a detection of the patient safety event... A comprehensive systematic analysis for identifying the casual and contributary factors. Root cause analysis, which focuses on systems and processes is the most common form of the comprehensive systematic analysis used for identifying the factors that underlie a Sentinel event... And action plan of a Sentinel event is to be completed within 45 days of the event or of the date that the event was identified. The action plan must include strategies for measuring effectiveness of actions... the committees will evaluate the effectiveness of action plans at appropriate intervals to ensure the CSA meets all elements of a thorough, credible, effective, and acceptable comprehensive systematic analysis and goals and targets have been established and or achieved... Risk management patient safety committee will review events on at least a quarterly basis to identify trends that may require additional action or oversight. Event learnings will be distributed to operational and clinical leaders, as appropriate. A summary of the events, actions taken, and learnings will be forwarded to the quality oversight committee (QOC) quarterly ..."

During a review of the hospital's "Quality and Patient Safety Program Description Annual Work Plan and Evaluation", dated 2/16/22 (time frame of AEs), the "Quality Plan" indicated, " ... The purpose of this plan is to provide the mechanism for improving hospital quality and safety and to ensure that [name of hospital], senior leaders, medical staff, and hospital staff demonstrate a consistent and collaborative approach to deliver safe, effective, efficient, equitable, patient centered, and timely care within the quality assurance and performance improvement (QAPI) framework ... Structure and oversight ensures that consistent and systemic efforts are maintained to continually measure, assess, and improve processes and outcomes related to services provided... The four service lines: medicine, ancillary, perinatal and surgical serves as the committees to implement, monitor and enhance operational systems to ensure quality improvement, performance improvement and patient safety for the hospital... the Patient Safety and Risk Management Committee strive to reduce risk, improve patient safety and quality outcomes in the delivery of health services across all settings of care. These two committees work in tandem to monitor the effectiveness of the corrective actions taken in response to an adverse or sentinel event to ensure that the risk reduction strategies achieve the expected results... The patient safety and risk management committees shall submit reports related to patient safety and risk management priorities to the Medical Executive Committee regularly and as requested..."

Based on interview and record review, the hospital's governing body, medical staff and administrative officials failed to identify and act on one of one unintended retained foreign item (RFI-- item left inside patient's body after surgery that was not intentional) at the time of the occurrence in surgical services, on 5/23/22. The The Quality assurance and performance improvement (QAPI) program did not collect data, track data, or develop or implement performance improvement measures meant to ensure the event would not re-occur until 1/10/23 (eight months after the occurrence).

These failures resulted in the delay in the implementation of necessary corrective measures resulting in continued risk of injury and infections to patients whom received care in the surgical services.

Findings:

During a record review of the Patient (Pt) 1's adverse event (AE- a harmful and negative outcome that happens to a patient provided medical care) that occurred on 5/23/22, the hospital self- reported the AE to the California Department of Public Health (CDPH- the state department responsible for public health in California) on 1/10/23 (eight months after the AE occurred). According to Health and Safety Code 1279.3 (California statutory law), the Pt 1's AE should have been reported to CDPH no later than five (5) calendar days after the AE was detected.

During a record review of a hospital document listing "AEs and near misses (any event that does not lead to harm but does have the potential to cause illness or injury)" from April 2022 through April 2023, the document indicated, on 5/23/22, there was late identification of an unintended RFI; a drill bit (cutting tool used to remove material and create holes) was left in Pt 1's left hip. Investigation was initiated on 7/8/22, 55 days after the AE.

During concurrent interviews, on 4/14/23, at 1:10 p.m., with the Chief Executive Officer (CEO), the Area Quality Leader/ Patient Safety Office (QL-PSO), the Risk Manager (RM), and the Chief of Risk Management and Patient Safety (CRPS), the CRPS stated the RFI (a patient safety event, incident, or condition that could have resulted and did result in harm to a patient), on 5/23/22, was not prioritized by the Risk Management Department (RMD-department in the hospital that is comprised of systems and processes to uncover, mitigate, and prevent risks in healthcare) as an event that rose to a level of sentinel event (a patient safety event [not primarily related to the natural course of the patients illness or underlying condition] that reaches a patient and results in death, severe harm [regardless of duration of harm], or permanent harm [regardless of severity of harm]). The RMD did not appropriately investigate, analyze, and report Pt 1's AE to CDPH and the appropriate committees (Medical Executive and Quality). Pt 1's RFI event was "found" and formally investigated by the RMD at the end of year, December 2022. The RM stated the RM team performed a root cause analysis (identifies causes of specific problems and undesired outcomes) in January 2023 and determined one factor that contributed to the RFI was the surgeon's failure to fully inspect the drill bit after it was used on the patient. The CRPS stated the case was sent to peer review (evaluation of professional work by others working in the same field), seven months after the event was reported to the RMD. The CRPS stated Pt 1's medical record indicated Pt 1 was notified of the RFI. The CRPS stated patients should be notified the RFI was unintentional, of physician recommendations moving forward, and when to return to the hospital (i.e., pain). The CRPS stated patients should be allowed an opportunity to ask questions. The CRPS stated Pt 1 was not interviewed to evaluate the quality of care provided by the orthopedic surgeon ( MD) 1 nor was asked how MD 1 explained the RFI to the patient.The CEO validated RM, QL-PSO, and she were aware of Pt 1's AE however, no comprehensive systemic analysis (CSAs- a root cause analysis that identifies causes of specific problems and undesired outcomes) were performed and reported to quality and medical executive committees. The CEO stated no tracking of outcomes were formally put into place. The CEO stated she was a member of the Quality and Medical Executive Committees, but never thought to question why Pt 1's AE was not reported nor tracked during the monthly/ quarterly meetings. The QL-PSO stated the RMD underwent employee changes in 2022, and Pt 1's AE "just fell off the grid."

During a review of the Surgical Quality Safety (SQS) Committee meeting minutes for the meetings from February 2022 through January 2023, there was no documented evidence the hospital tracked the data, developed, or implemented performance improvement measures for the identified RFI that occurred on 5/23/22. The SQS Committee meeting was cancelled in January 2022, April 2022, July 2022, October 2022, & and March 2023.

During a review of the SQS Committee Meeting minutes, dated 6/8/22, indicated " ... Safety Events (RFO [retained foreign object or item]... 0 [zero] ..."

During a review of the SQS Committee Meeting minutes, dated 11/9/22, indicated " ... Safety Events: 0 ... Annual Workplan Mid-Year Evaluation ... Each year we establish goals under quality and patient safety. Those are submitted through the regional process. Three of our goals fall under Surgical Quality and Safety committee... There has been 57 months since last verification event/ RFO ..."

During a review of the SQS Committee Meeting minutes, dated 12/14/22, indicated, " ... there has been 58 months since the last verification event/ RFO ..."

During a review of the SQS Committee Meeting minutes, dated 1/11/23, indicated, " ... there has been 59 months since the last verification event/ RFO ..."

During a review of the SQS Committee Meeting minutes, dated 2/8/23, indicated, " ... ortho [orthopedics- procedures pertaining to bone, joints, and muscle] is doing well ..."

During a review of MEC meeting minutes for meetings from February 2022 through February 2023, there was no documented evidence the hospital tracked the data, developed, or implemented performance improvement measures for the identified RFI that occurred on 5/23/22.

During a review of the hospital's "Quality and Patient Safety Program Description Annual Work Plan and Evaluation", dated 2/16/22, the "Quality Plan" indicated, " ... The purpose of this plan is to provide the mechanism for improving hospital quality and safety and to ensure that [name of hospital], senior leaders, medical staff, and hospital staff demonstrate a consistent and collaborative approach to deliver safe, effective, efficient, equitable, patient centered, and timely care within the quality assurance and performance improvement (QAPI) framework ... The medical executive committee is responsible to ensure the proper functioning of all departments, committees and other activities of the professional staff and to monitor the effectiveness of professional staff activities. The MEC has oversight of the quality of care and patient safety provided to patients and their families. The MEC is responsible for the organization of the performance improvement and patient safety activities of the professional staff as well as the mechanisms used to conduct, evaluate, and revise such activities..."

During a review of the hospital's document titled " [name of hospital] 2023 Medical Executive Committee Charter," dated 1/18/23, the document indicated, " ... The Medical Executive Committee is responsible to ensure the proper functioning of all departments, committees and other activities of the Professional Staff... Recommends actions based on reviews of quality performance of providers and services... Provides oversight of Facilities quality committee structure... reviews and approves routine Medical Center quality improvement reports... Analyzes various internal and external data and needs assessments, ensures accountable entities within the organization are aware and act on the report, and when needed recommends additional analysis/ work to further develop the issue..."

During a review of the hospital policy and Procedure (P&P) titled, "Patient Safety Event Management," dated 1/18/23, the P&P indicated, " ... unexpected or adverse events meeting the definition of a patient safety event as defined in the policy will be reported, communicated, investigated, and analyzed following this policy ... an adverse event is a patient safety event that resulted in harm to a patient...A Sentinel event is a patient safety event (not primarily related to the natural course of the patients illness or underlying condition) that reaches a patient and results in death, severe harm (regardless of duration of harm), or permanent harm (regardless of severity of harm)... ... Regulatory reportable events: events that require reporting to a Regulatory agency (i.e., California Department of public health (CDPH) or the medical board of California (MBC)) ... Unintended retention of a foreign object in a patient after an invasive procedure including surgery... Sentinel event, CDPHP reportable events, and SREs [serious reportable events] ... in cases in which the health care organization is uncertain an event meets the definition of a Sentinel event, the event will be presumed to be a patient safety event, requiring comprehensive analysis... patient safety events such as no harm events, close calls, and hazardous conditions which are not an ongoing urgent or emergent threat to the welfare health, or safety of patients, personnel, or visitors may not require a CSA, however, should be tracked and used as opportunities to proactively improve systems and prevent harm..."

Based on observation, interview, and record review, the hospital failed to have an active Infection Prevention and Control program which adhered to nationally recognized infection prevention and control guidelines for the surveillance, prevention, and control of HAIs (hospital acquired infections- infection one gets while receiving treatment in a healthcare facility) and other infectious diseases, when:

1. One of two surgical technicians (ST) 2 inappropriately removed his surgical attire (PPE- specialized clothing or equipment worn by an employee for protection against infectious materials) while in the Operating Room (OR) and sorted and cleaned surgical instruments after the surgery and in the process soiled his surgical scrubs. ST 2 then left OR and wore the contaminated scrubs in outside areas of the OR. This practice was not in accordance with hospital policy and standards published by the Association of Peri-Operative Registered Nurses (AORN- is the leader in advocating for excellence in peri-operative practice and healthcare). (Refer A 750 Finding 1)

2. One of three sterile processing technicians (SPT) 3 did not follow infection control procedures and work-flow patterns to prevent cross contamination (the process by which germs are unintentionally transferred from one object or space to another, with harmful effect). SPT 3 walked from the endoscopic processing "decontamination" area (designated area where the manual cleaning and rinsing of endoscopes [a flexible instrument used to view internal parts of the body] is performed) into the designated "clean" area (designated area where endoscopes are sterilized and dried) with contaminated PPE. (Refer to A 750 Finding 2)

3. Two of three procedure trays (container that holds surgical instruments) contained unclean and unsafe surgical instruments. Two of 80 instruments in the minor tray (set of instruments used for short and less complex surgical procedure) and ready for use in a surgical procedure, had residue of unknown origin and discoloration on the handles. Two of 65 instruments in the orthopedic tray (set of instruments used in surgical cases involving the skeletal system and its interconnecting parts) and ready for use in a surgical procedure, had pitting (damage to the protective layer of surgical instruments) and crevice corrosion (destruction of a metal surface caused by corrosive substances and stagnant solutions). This practice was not in accordance with AAMI which stated that surgical instruments should be free of residue and corrosion. (Refer to A 750 Finding 3)

4.One of four environmental service worker (EVS) 1 did not perform hand hygiene (the cleaning of hands to reduce germs) in accordance with hospital policy and the Centers for Disease Control and Prevention (CDC- a national health protection agency) guidelines for infection prevention and control. (Refer to A 750 Finding 4)

The cumulative effect of these systemic problems resulted in the hospital's inability to ensure the provision of quality patient care in a safe and sanitary environment.

Based on observation, interview, and record review, the hospital failed to maintain a clean and sanitary environment for all patients, visitors, and staff when:

1. One of two surgical technicians (ST) 2 inappropriately removed his surgical attire (PPE- specialized clothing or equipment worn by an employee for protection against infectious materials) while in the Operating Room (OR) and sorted and cleaned surgical instruments after the surgery and in the process soiled his surgical scrubs. ST 2 then left the OR and wore the contaminated scrubs outside of the OR. This practice was not in accordance with hospital policy and standards published by the Association of Peri-Operative Registered Nurses (AORN- is the leader in advocating for excellence in peri-operative practice and healthcare). These failures resulted in ST 2 potentially contaminating (introduction of germs or infectious material to a clean or sterile object, space, or surface) the OR environment and placed patients, visitors, and staff at risk for hospital acquired infections and illnesses.

2. One of three sterile processing technicians (SPT) 3 did not follow infection control procedures and work-flow patterns to prevent cross contamination (the process by which germs are unintentionally transferred from one object or space to another, with harmful effect). SPT 3 walked from the endoscopic processing "decontamination" area (designated area where the manual cleaning and rinsing of endoscopes [a flexible instrument used to view internal parts of the body] is performed) into the designated "clean" area (designated area where endoscopes are sterilized and dried) with contaminated PPE. This practice was not in accordance with the standards as published by the American National Standards Institute and the Association for the Advancement of Medical Instrumentation (ANSI/AAMI- an organization for advancing the development, and safe and effective use of medical devices).

3. Two of three procedure trays (container that holds surgical instruments) contained unclean and unsafe surgical instruments. Two of 80 instruments in the minor tray (set of instruments used for short and less complex surgical procedure) and ready for use in a surgical procedure, had residue of unknown origin and discoloration on the handles. Two of 65 instruments in the orthopedic tray (Ortho tray- set of instruments used in surgical cases involving the skeletal system and its interconnecting parts) and ready for use in a surgical procedure, had pitting (damage to the protective layer of surgical instruments) and crevice corrosion (destruction of a metal surface caused by corrosive substances and stagnant solutions). This practice was not in accordance with AAMI which stated that surgical instruments should be free of residue and corrosion. This failure could result in use of surgical instruments that are not completely sterile and possible post- surgical infection to the patient.

4.One of four environmental service worker (EVS) 1 did not perform hand hygiene (the cleaning of hands to reduce germs) in accordance with hospital policy and the Centers for Disease Control and Prevention (CDC- a national health protection agency) guidelines for infection prevention and control.

These failures resulted in an unsafe and unsanitary environment for all patients, visitors, and staff and increased the potential for hospital acquired infections, illnesses, and injury.

Findings:

1. During an observation on 4/11/23, at 10:15 a.m., in operating room (OR) 6, Orthopedic Surgeon (MD) 1 completed the Left Total Hip Procedure (a surgical procedure in which the diseased parts of the hip joint are replaced with new, artificial parts) for Patient (Pt) 2. ST 2 sorted surgical instruments used in the procedure and left the instruments on the back table (holds most of the surgical instruments and other equipment used during surgery). ST 2 removed his gown (PPE worn over operating room clothing) and discarded the gown in the trash. ST 2 returned to the mayo stand (portable instrument stand used to hold surgical instruments and materials during procedures) to collect the remaining surgical equipment and placed them on the back table. ST 2 was observed tossing instruments from one side of the back table to the other. Blood and tissue residue covered the instruments. ST 2's clothing touched the table's surface multiple times during this process. ST 2 then sprayed the instruments with an enzymatic solution (solution used as part of the first step of the cleaning process to remove or prevent organic material [i.e., tissue or blood] from adhering to the instrument). The pressure exerted from the enzymatic spray can splashed solution from the surgical instruments onto the table and OR wall. ST 2 continued spraying until all instruments were saturated. ST 2 placed the instruments into the surgical trays and placed them in a transport bin for transport to the sterile processing department (SPD- performs sterilization [process to make free from germs] and other actions on medical devices and equipment). After completing this task, ST 2 exited OR 6 and moved about the OR suite wearing the same clothing.

During an interview on 4/11/23, at 10:25 a.m., with ST 2, ST 2 validated he removed his gown before handling the surgical instruments used in Pt 2's surgical procedure. ST 2 stated, "I don't why ... I just did." ST 2 stated it was best practice to wear full PPE (face shield, gown, gloves, and shoe covers) when sorting and cleaning instruments to prevent self-contamination (the process by which germs are unintentionally transferred to oneself). ST 2 stated he did not follow his hospital training and best practice when he removed his PPE.

During an interview on 4/14/23, at 10:20 a.m., with the Infection Preventionist (IP), the IP stated the purpose of the use of PPE in the OR was to protect staff from blood borne pathogens (germs found in human blood) and to prevent the spread of germs to other patients and staff. The IP stated ST 2 exposed himself to such pathogens when he handled the used surgical instruments while not wearing a gown over his OR clothing. The IP stated ST 2 did not follow hospital policy and increased the risk for transmission of infection to patients and staff.

During a review of the hospital policy and procedure (P&P) titled "Surgical Attire NCAL Regional Policy," dated 6/19/20, the P&P indicated, "All personnel entering the semi- restricted and restricted areas of the operating room (OR) and procedural suite where surgery and invasive procedures are conducted including sterile processing department (SPD) staff shall be attired according to the following procedures... surgical attire and personal protective equipment (PPE) are worn to provide a high level of cleanliness and hygiene within the perioperative environment and to promote patient and worker safety. Reducing the patient's exposure to microorganisms that are shed from the skin and hair of perioperative personnel may reduce the patients risk for surgical site infection (SSI)... Surgical attire... Be changed when wet or contaminated by blood, body fluids, or other infectious material... Biological exposures body fluids: wear appropriate PPE (gloves, goggles, gowns, masks, shoe covers) ..."

During a review of the professional reference retrieved from https://aornguidelines.org/guidelines/content?sectionid=173736661&view=book#173736661, titled, "AORN (Association of periOperative Registered Nurses) (eGuidelines) Instrument Cleaning", dated October 2020, the professional reference indicated, "... splashes, splatters, and skin contact can be reasonably anticipated by personnel handling contaminated instruments. Fluid-resistant gowns can prevent transfer of microorganisms [germs] from contaminated items to skin ..."

2. During an observation on 4/10/23, at 2:10 p.m., in the endoscope processing room, Sterile Processing Technician (SPT) 3 wore PPE (face shield, mask, gown, gloves, and shoe covers) to manually clean an endoscope in the decontamination (dirty) area. SPT 3 soaked the endoscope in a detergent solution and scrubbed the exterior and interior of the endoscope with a soft brush and lint free cloth. After completing the cleaning process, SPT 3 began the adenosine triphosphate testing (ATP testing- tests for organic matter remaining after cleaning) phase of the cleaning process. SPT 3 walked into the "clean area" (area where clean and sterilized items are stored) wearing the same PPE to retrieve connection tubing (flexible transparent tube). SPT 3 handled supplies under the "clean" table, then returned to the decontamination area to complete the testing process. SPT 3 did not change PPE nor perform hand hygiene between the "decontamination" and "clean" areas of the processing room.

During an interview on 4/10/23, at 2:50 p.m., with SPT 3 and the Interim Sterile Processing Department Manager (SPDM), SPT 3 validated, he "crossed over" to the clean area to retrieve connection tubing not supplied to the decontamination area. SPT 3 stated the room usually staffed two SPTs, one in the decontamination area and the other in the clean, to prevent crossing into the clean area to sterilize endoscopes or retrieve supplies. SPDM stated SPT 3 should have removed the contaminated PPE prior to entering the clean area or called for assistance to retrieve the supplies. SPDM validated SPT 3 did not follow the unidirectional (moving or operating in one direction) workflow to prevent cross contamination in the processing room.

During an interview on 4/14/23, at 10:20 a.m., with the IP, the IP stated SPT 3 contaminated the clean area of the processing room when he wore the PPE used in the decontamination area to retrieve items from the clean area. The IP stated the workflow design of the processing room was created to prevent personnel from walking back and forth between "dirty" and "clean" areas. The IP stated the processing room was designed to have two SPD staff in the room, one in the decontamination area and the other in the clean area to prevent crossover. The IP stated the practice of walking back and forth between the "dirty" and "clean" areas increased the risk for contaminating equipment that was sterilized for patient use and the surrounding environment.

During a review of the professional reference titled, "Association for the Advancement of Medical Instrumentation ANSI/AAMI ST91:" dated 2021, indicated, " ... Workflow should be unidirectional from the decontamination area to the clean area ... strict unidirectional processing procedures should be in place to reduce risks of cross-contamination. After cleaning, PPE should be changed, and hand hygiene performed..."

During a review of the professional reference titled, "ANSI/ AAMI ST79:2017," dated 2017, the reference indicated, " ... Separating "clean" and "dirty" areas limits environmental contamination and, therefore, the amount of bioburden on devices to be sterilized. Adherence to these functional design recommendations helps contain potential contaminants within a particular portion of the decontamination area and thus helps prevent cross-contamination or recontamination. Segregation of contaminated items from items being removed from mechanical processing equipment is necessary to protect the processed items (e.g., flexible endoscopes, respiratory therapy devices) from recontamination ..."

During a review of the hospital P&P titled, "Cleaning and Storage of Reusable Equipment Policy," dated 1/8/21, the P&P indicated, " ... to provide guidance on how to effectively and safely clean and store reusable instruments and equipment to help prevent the transmission of infections... Perform hand hygiene per protocol..."

During a review of the hospital P&P titled, "Hand Hygiene Policy," dated 4/11/23, the P&P indicated, " ... to prevent the transmission of microorganisms from patient to patient and from inanimate surfaces to patients by the hands of all health care providers... Indications for hand hygiene include... after body fluid exposure/risk or after removal of PPE..."

3. During concurrent observation and interviews on 4/11/23, at 1:30 p.m., in SPD, with Senior Sterile Processing Technician (SPT) 4 and the SPDM, the SPDM described the workflow of the sterile storage area (where sterilized items are stored for later use) and packing area (where clean items are sterilized, assembled, and prepared for issue, storage, or further processing) of SPD. SPDM stated surgical instruments were cleaned and inspected in the decontamination room, then assembled into procedure trays according to "recipe cards" (detailed instructions how a tray should be assembled). SPDM stated surgical instruments were inspected a second time as they were assembled into trays, prior to packaging and sterilization. SPT 4 opened a "Minor Tray", that was sterilized and stored in the sterile storage area. The "Minor Tray" contained a total of 80 surgical instruments . Two forceps (a surgical instrument used to handle tissue) had residue and discoloration on the handles. SPT 4 inspected the two forceps under a magnifying glass and validated there was residue left on the instruments that could be "rubbed off." SPT 4 opened an "Ortho Tray" that was sterilized and stored in the sterile storage area. The "Ortho Tray" contained a total of 65 instruments . Two retractors (a surgical instrument used to hold open the edges of a wound) had deep pitting and corrosion on the angled ends. SPT 4 validated the retractors were worn and had potential to retain bacteria, develop rust (red/ brown substance that breaks down metals), or crack. SPT 4 stated he was aware of the condition of the retractors but was told to maintain them in use until new retractors arrived. SPT 4 states the retractors were ordered "several months ago" but were still on backorder. SPDM stated the department decided to use the instruments since the hospital had only 12 in service for all orthopedic cases performed in the hospital. SPT 4 validated the process was to send the instruments to a vendor to have them repaired or sharpened but it was not done.

During a review of the "Minor Tray- 004" insert, indicated, "Date prepared: 3/31/2023 ... Pre Cnt [count] 2 ... SPD Cnt 2 ... Description ... Forceps, [Name], tissue, Serrated [jagged edges], 4 3/4" w/ Teeth ... Prod [product] # ... BD512R ..."

During a review of the "Ortho Tray- 002" insert, indicated, "Date prepared: 4/8/2023 ... Pre Cnt [count] 2 ... SPD Cnt 2 ... Description ... Retractor, [Name], Double Ended, Angled ... Prod [product] # ... 6210 ..."

During a review of the hospital P&P titled, "Reusable Supplies & Equipment- Disinfection-Receiving-Transport and Distribution," dated 7/22/22, the P&P indicated, " ... To establish the various means by which reusable supplies equipment will be assembled and or wrapped for sterilization, storage and distribution... To define the manner in which reusable equipment and supplies which cannot be sterilized or do not require sterilization will be disinfected... Check all instruments before assembly and/or wrapping to be sure they are in good condition and in good working order... Check for spotting, corrosion, pitting, or discoloration of the finish... Remove instruments in need of repair or maintenance and return them to the originating department or send them to the appropriate clinical instrument repair vendor... physical integrity of all items received in Sterile Processing will be verified and documented by sterile processing personnel... "

During a review of the professional reference from the Association for the Advancement of Medical Instrumentation (AAMI- a primary source for the development, management, and use of safe and effective health technologies for the medical device industry, as well as practical information, support, and guidance for healthcare technology and sterilization professionals) titled, "ANSI/ AAMI ST79:2017," indicated, " ... have a process in place to identify instruments in need of repair/maintenance and removal from service ... inspected for cleanliness, flaws, and damage... Surgical instruments and other medical devices and equipment could pose a significant risk of transmitting infection to patients or health care personnel if they are not properly decontaminated and then disinfected ..."

During a review of the professional reference retrieved from the Joint Commission (a professional organization that identifies, measures, and shares best practices in quality and patient safety), https://www.jointcommission.org/resources/news-and-multimedia/blogs/ambulatory-buzz/2022/08/is-that-instrument-safe-to-use-on-a-patient#.ZEFkz3bMLic titled, "Is That Instrument Safe to Use on a Patient?", dated 8/2022, the professional reference indicated, "... If tissue, bone or other soil is left behind on a surgical instrument, this unsterile [unclean] condition obviously could carry risk of infection to the next patient, and it should not be reused ... Impact of instrument damage on the provision of safe care needs to be assessed and often results in the decision to completely remove an instrument from service until it can be repaired. Instruments with identification tape that is peeling, cracked or has evidence of corrosion could potentially flake particles into an open wound during surgery and result in a foreign body being left in the wound. Such instruments should be taken out of service, and if necessary, replaced ... Key Actions for Instrument Safety ... Correctly dismantle and inspect instruments for soil or damage ... Establish effective maintenance and refurbishment processes to keep instruments in optimal condition ... Create an effective process for identifying instruments that require repair or replacement ... open and inspect instruments in peel pouches and trays to ensure they are appropriate for sterilization and use ..."

4. During a concurrent observation and interview on 4/10/23, at 11:40 a.m., in the Emergency Department (ED), with the Environmental Service Worker (EVS) 1, EVS 1 finished cleaning the communal (shared) bathroom in "Hall #1." EVS 1 exited the bathroom wearing gloves and pushed the housekeeping cart (utility cart that hold cleaning supplies and equipment) across the hallway. EVS 1 entered an unoccupied ED room to clean the room for the next patient. EVS 1 did not remove the gloves, nor performed hand hygiene, and wore the same gloves to clean the unoccupied room. EVS 1 reached for microfiber towels (cloths made from a tightly woven combination of polyester and nylon) soaked in disinfectant solution and squeezed the excess solution out of the towels into the bucket with the same pair of gloves. EVS 1 repeated this process three times during the cleaning of the room. EVS 1 validated he did not perform hand hygiene after cleaning the bathroom. EVS 1 stated he was busy and forgot to change gloves and perform hand hygiene between tasks.

During an interview on 4/14/23, at 10:20 a.m., with the IP, the IP stated EVS 1 did not follow hospital policy and infection control procedures. The IP stated the expectation was for EVS 1 to remove his gloves and perform hand hygiene when he exited the bathroom and when he reached in the bucket for the microfiber towels, each time. The IP stated hand hygiene was important to prevent cross contamination and transmission of disease. The IP stated EVS 1 essentially double dipped and contaminated the disinfecting solution each time he returned to the bucket and did not change his gloves. The IP also stated the disinfectant solution was "neutralized" and made less effective when the solution came into contact with the contaminated gloves.

During a review of the professional reference titled, "CDC, Background E. Environmental Services Guidelines for Environmental Infection Control in Health-Care Facilities (2003)," 5/14/19, the reference indicated, " ... The transferal of microorganisms from environmental surfaces to patients is largely via hand contact with the surface.947, 948 Although hand hygiene is important to minimize the impact of this transfer, cleaning and disinfecting environmental surfaces as appropriate is fundamental in reducing their potential contribution to the incidence of healthcare-associated infections ... Part of the cleaning strategy is to minimize contamination of cleaning solutions and cleaning tools. Bucket solutions become contaminated almost immediately during cleaning, and continued use of the solution transfers increasing numbers of microorganisms to each subsequent surface to be cleaned ... Another source of contamination in the cleaning process is the cleaning cloth or mop head, especially if left soaking in dirty cleaning solutions ..."

During a review of the professional reference titled, "Best Practices for Environmental Cleaning and Health Care Facilities: Resource- Limited Settings Version 2" retrieved from https://www.cdc.gov/hai/pdfs/resource-limited/environmental-cleaning-RLS-H.pdf, indicated, " ... Emergency departments are moderate to high-risk areas because of the wide variability in the condition of patients and admissions, which can: increase the probability of contamination of the environment from infectious agents or blood and body fluids ... make them more susceptible to infection (e.g., trauma patients) ... These are the best practices for cleaning staff PPE: Always perform hand hygiene immediately before wearing gloves (donning) and immediately after removal (doffing) ... When use of gloves is indicated always change them (i.e., reprocess) between each cleaning session ... Use fresh cleaning cloths at the start of each cleaning session ... Ensure that there are enough cleaning cloths to complete the required cleaning session ... Never double-dip cleaning cloths into portable containers (e.g., bottles, small buckets) used for storing environmental cleaning products (or solutions) ..."

During a review of a hospital document titled, "How to Use [disinfectant] (MICROFIBER)", undated, the document indicated, " ... DO NOT Wring Out Cloths To Clean ..."

During a review of the hospital P&P titled, "Hand Hygiene Policy," dated 4/11/23, the P&P indicated, " ... to prevent the transmission of microorganisms from patient to patient and from inanimate surfaces to patients by the hands of all health care providers... Indications for hand hygiene include... before or upon entry to patient's room; Before patient contact or donning personal protective equipment (PPE) ... After body fluid exposure/risk or after removal of PPE ... After contact with patient and patient's environment... After or upon exiting the patient's room..."

Based on observation, interview and record review, the hospital failed to provide surgical services in a well-organized manner in accordance with hospital policy and professional standards of practice when:

1. Two of two staff (Operating Room Nurse [ORN] 1 and Surgical Technician [ST] 2) did not count all items opened on the surgical field in accordance with hospital policy and procedure and professional standards prior to the start of surgery. (Refer to A 951 Finding 1)

2. One of two single use (use one time on one patient) Drill Bits (cutting tool used to remove material and create holes) was not discarded in the operating room (OR) and was sent to the sterile processing department (SPD- performs sterilization and other actions on medical devices and equipment) for processing and reuse against the manufacturer's instructions . (Refer to A 951 Finding 2)

3. Post-operative assessments were not conducted for two of two sampled patients (Patient 33 and Patient 34) in the Post Anesthesia Care Unit (PACU) in accordance with hospital policy and procedure. (Refer to A 957)

The cumulative effect of these systemic problems resulted in the failure to assure surgical services achieved high standards of care jeopardizing the health and safety of surgical patients.

Based on observation, interview, and record review, the hospital failed to ensure surgical care provided to patients achieved the highest standards of medical practice and patient care when:

1. Two of two staff (Operating Room Nurse [ORN] 1 and Surgical Technician [ST] 2) did not count all items opened on the surgical field in accordance with hospital policy and procedure and professional standards prior to the start of surgery.

This failure had the potential to result in incorrect surgical counts of surgical instruments and lead to retained foreign objects (RFO- surgical materials or equipment unintentionally left in a patient's body after completing the operation).

2. One of two single use (use one time on one patient) drill bits (cutting tool used to remove material and create holes) used in Patient 2's surgical procedure was not discarded in the operating room (OR) and was sent to the sterile processing department (SPD- performs sterilization and other actions on medical devices and equipment) for processing and reuse against the manufacturer's instructions .

This failure had the potential for the single use item to be reprocessed (cleaned and disinfected for reuse) and placed back in use which can lead to the injury or post-surgical infections.

Findings:

1. During an observation on 4/11/23, at 7:56 a.m., in OR 6, Patient (Pt) 2 was brought into the OR room by gurney (padded stretcher with legs and wheels used to transport patients) for a Left Total Hip Procedure (a surgical procedure in which the diseased parts of the hip joint are replaced with new, artificial parts) procedure. ST 2 set up surgical instruments and equipment needed for the procedure.

During an observation on 4/11/23, at 8:10 a.m., in OR 6, the ORN 1 and ST 2 counted laparotomy sponges (Lap sponges- absorbent pads used during surgical procedures), sutures (a strand or thread used to tie vessels and tissue), blades (sharp used to cut skin and tissue), drill bits, and bovie (electrosurgical device to cut tissue and control bleeding) and placed the counts on a whiteboard (visual communication tool) located on the wall. Surgical instruments on the sterile field (an area where all surgical items were used during a procedure) were not counted.

During an observation on 4/11/23, at 9:48 a.m., in OR 6, ORN 1 and ST 2 inspected drill bit tips and counted lap sponges, blades, sutures, and bovie. Used lap sponges were separated and placed in individual holders in a counting bag hung on a pole. ORN 1 verified surgical counts with counts written on the whiteboard and called out "correct" to the surgical team (i.e., surgeon, anesthesiologist, assistants, technicians involved in the surgical procedure). Surgical instruments sorted on the sterile field were not counted. The Surgeon (MD) 1 began to suture (stich/ close) the surgical wound.

During an observation on 4/11/23, at 10:03 a.m., in OR 6, ORN 1 waved a surgical wand (RF [radio frequency] technology used to detect a retained item in tissue and near metal) over the surgical site and stated no retained items were detected. ORN 1 and ST 2 then completed the final counts (the process of accounting for all surgical instruments and equipment at the end of a surgical procedure). The lap sponges, sutures, blades, bovie, drill bits, and implants used in the procedure were counted. The items were validated with the counts written on the whiteboard, and the surgical team determined surgical counts were correct. Surgical instruments on the sterile field and used during the procedure were not part of the initial count and not counted at final closure.

During an interview on 4/11/23, at 10:25 a.m., outside OR 6, with ST 2, ST 2 stated he prepared an "Ortho Tray" (orthopedic tray- set of instruments used in surgical cases involving the skeletal system and its interconnecting parts) and "Posterior Hip Tray" (set of instruments used to access the hip from behind the hip joint) for Pt 2's "Left Total Hip Procedure." ST 2 stated the process of counting all surgical instruments was not required for "joint procedures." ST 2 stated the hospital's process was to count all surgical instruments for "large" or "open belly procedures." Otherwise, only "soft" items, blades, needles, and/ or instruments that entered the body were counted. ST 2 stated his practice was not to count every instrument, even if the instrument was used during a procedure.

During an observation on 4/11/23, at 10:20 a.m., in the Operating Room 4 (OR), the contents on the sterile field contained one [brand name] Power Small Cordless 8 Tray (a type of surgical tray with a cordless power device) with nine instruments, one [brand name] Small Bone Power (TPS) Set (a type of surgical tray with a power device) with 15 instruments, one Extremity Tray Set (a type of surgical tray for arms and legs) with 80 instruments, one [brand name] Periarticular Reduction Forceps (a type of surgical tray with pointed ball tips to provide a secure hold of the bone), one [brand name] Bone Forcep Tray (a type surgical tray with tools to grasp bones) with 9 instruments, one [brand name] Distractor tray (a type of surgical tray to pull the bone apart after it has been cut) with 5 instruments, and one [brand name] Ankle Fracture kit (a complete set of instruments consisting of wires, drills, drivers, plates, screws, and clamps for ankle surgery). On the OR count board (a board posted in the OR to count items at the beginning and end of each procedure) listed, "LAPS (sponges): 5, RAYTEC (a type of sponge detectable by X-ray): 10, ATROS (a type of suture needle): 4 + 1/5, BLADES (surgical knife): 6, HYPOS (hypodermic needle): 1, BOVIE (an electrosurgery device): 1, K-wires (a stiff straight wire that are used to repair a broken bone): 4, Drill Bits (cutting tools used to create a hole): 2."

During an interview on 4/11/23, at 10:21 a.m., with the OR Manger (ORM), ORM stated, the surgical count only consisted of what items were used during the procedure. ORM stated, not all the items in the sterile field were counted. ORM stated, the surgical count only consisted of items that were used during the procedure as indicated on the count board.

During an interview on 4/12/23, at 8:30 a.m., with the Assistant Chief of Surgical Specialties (ACSS) and Orthopedic Surgeon (MD) 1, the ACSS stated, the nurse and surgical technicians were responsible for surgical counts in the OR. The ACSS stated, although the surgeon had overall responsibility of the patient, surgical counts were not done with the surgeon. The ACSS stated each person in the OR had assigned roles and the "two" persons assigned to the counts were responsible for the counts. The ACSS stated counts were done in various stages throughout a surgical procedure to ensure nothing was left in the patient's surgical wound. The ACSS stated the surgical items counted varied from case to case. The ACSS stated the hospital does not require OR staff to count all surgical instruments unless the procedure was identified as "open case" (the cutting of skin and tissues so that the surgeon has a full view of the structures or organs involved. i.e., in stomach cavity) or had the potential to turn into an "open case." The ACSS stated she did not know if the hospital's policy and procedure described which procedures required all instruments to be counted. The ACSS stated the hospital had other acceptable measures in place to prevent miscounts and RFOs in patients; use of the surgical wand, post operative (done after surgery complete) x-rays (an imaging study that takes pictures of bones and soft tissues), and SPD's inspection of trays and identification of "missing" instruments from OR. The ACSS stated the primary method of validating items were not left in the patient was for the surgeon to visually inspect the wound prior to wound closure. MD 1 stated he "believed" that the surgical technicians counted all instruments in procedure trays (containers that hold surgical instruments). MD 1 stated instruments should be counted in "large cases", but not in smaller cases where the instruments "were not likely" to stay in a surgical wound. MD 1 stated surgical technicians and nurses determined what surgical instruments/ items were counted on based on procedure type. MD 1 stated he was unaware of a hospital document that outlined which procedures required a full instrumentation count. MD 1 stated he depended on the "people" around him to validate counts were correct. MD 1 stated "his" OR team was aware of his preferences and type of instruments used. MD 1 stated the OR team should be able to identify potentially retained instruments if the instruments were "missing," but validated he did not always have the same OR team. MD 1 stated he agreed with the ACSS that the primary way to identify a RFO was to perform a visual inspection and wound exploration prior to wound closure, not instrument counts.

During an interview on 4/12/23, at 9:45 a.m., with Certified Registered Nurse Anesthetist (CRNA) 1, CRNA 1 validated he was the nurse anesthetist (a registered nurse who has specialized training in anesthesia), on 4/11/23, for Pt 2's surgical procedure. CRNA 1 stated the nurse and surgical technician were responsible for surgical counts. CRNA 1 stated he relied on correct surgical counts to determine if patients were "left on" or "taken off" anesthesia (the use of medicine to prevent pain during surgery or other procedures) in surgery. CRNA 1 stated incorrect counts delayed surgery and kept patients under the effects of anesthesia longer, which could have adverse effects on certain patients. CRNA 1 stated he did not participate in counts but depended on the OR team to notify him when counts were incorrect.

During an interview on 4/12/23, at 11:25 a.m., with the ORM and the Chief Nurse Executive (CNE), the ORM stated the hospital followed AORN standards in the OR. The ORM stated best practice did not include the count of each surgical instrument in procedure trays because "there are too many instruments" and/ or multiple trays were used during one procedure. The ORM stated initial counts occurred in SPD when instruments were checked, then packaged according to the procedure tray's "recipe card" (detailed instructions how a tray should be assembled). The ORM stated each procedure tray had the name, item number, and count of each surgical instrument on a list in the tray, therefore all the instruments did not have to be recounted during the initial OR count. The ORM stated their practice was to only count "soft goods," lap sponges, raytecs (x-ray detectable gauze sponge), or items "added [to] or removed" from the trays during the procedures. The ORM and the CNE validated some "complex" (difficult) cases required a full count of each surgical instrument in the tray. The CNE stated the hospital policy and procedure did not indicate which "complex" cases required full surgical instrument counts.

During an interview on 4/13/23, at 1:15 p.m., with ST 2, ST 2 stated he was not aware of a hospital policy and procedure that outlined which "complex" procedures required all surgical instruments to be counted. ST 2 stated the practice of only counting "soft goods," sponges, and instruments existed since 2003, when ST 2 was employed by the hospital. ST 2 stated he used his "judgement" to determine what surgical instruments were counted. ST 2 stated he did not use the list inserted in procedure trays to count surgical instruments.

During an interview on 4/13/23, at 1:45 p.m., with ORN 1, ORN 1 stated she determined what instruments to count based on procedure type. ORN 1 stated she counted instruments when there was a possibility of an instrument or foreign object to remain in the surgical wound or opening. ORN 1 stated the OR did not have a standardized tool, other than the whiteboard, for surgical counts. ORN 1 stated she did not use the insert list in procedure trays to reconcile the surgical instrument counts with the list of surgical instruments in the procedure trays. ORN 1 stated SPD was responsible for ensuring surgical instrument counts were correct in the trays. ORN 1 stated the "surgical wand" detected sponges, towels, and raytecs with radiopaque tags (visible with radiation) but did not detect metal instruments and/or items left in the wound.

During a review of the "Ortho Tray- 002" insert, the insert indicated, the "Ortho Tray" contained 65 surgical instruments.

During a review of the "Total Hip Hemi Posterior Approach Tray" insert, the insert indicated, the "Total Hip Hemi Posterior Approach Tray" contained 26 surgical instruments.

During a record review of Pt 2's medical record titled "Surgery Information" dated 4/12/23, the record indicated, " ...Counts ... Sponge Initial... Correct? [blank] ... MD Notified? [blank] ... Needles/ Sharps [devices with sharp points or edges that puncture skin] Initial ... Correct? [blank] ... MD Notified? [blank] ... Sponge Closing ... Correct? Yes ... MD Notified? Yes ... Needles/ Sharps Closing ... Correct? Yes ... MD Notified? Yes ... Sponge Final ... Correct? Yes ... MD Notified? Yes ... Needles/ Sharps Final ... Correct? Yes ... MD Notified? Yes ..." There was no documented evidence in the record to indicate the initial count was performed nor the total number of surgical items counted.

During a review of the hospital policy and procedure (P&P) titled, "Retention of Retained Foreign Items (Formerly Count Policy) Policy, dated 4/9/21, the P&P indicated, " ... this is a multidisciplinary policy that involves all members of the surgical, procedural, or invasive team including and not limited to; Surgeon, radiologist, proceduralist, anesthesia provider, registered nurse (RN), or technician... surgical counts must be performed in procedures in which an incision is made, or a wound is created, and surgical items are used or inserted, or when items that have the potential to be unintentionally retained are used. The surgical count is performed to identify any packing errors and monitor the number of items used during the operation or procedure... instruments in tray/ sets are counted audibly using a standardized methodology of counting, verifying, and documenting on pre- printed instrument count sheets... The count process shall be performed before incision (initial count); Closure of a cavity within a cavity (uterus), closure of the fascia or layer before subcutaneous (closing count); Permanent relief of the scrub and slash or circulator (permanent relief count); And when skin closure is initiated and before the completion of the final skin closure (final count)... all soft goods, sharps, needles, instruments, and miscellaneous small items are accounted for throughout the procedure and until the final count is reconciled... Count individual instruments in the instrument tray by name and size. Verify and document the count on the pre-printed instrument count sheets from the tray, or standardized count sheets... count all instruments and miscellaneous items/ devices/ pieces (i.e., wing nuts, miscellaneous pieces that can come apart, etc.) contained in an instrument tray and separately wrapped instruments added to the sterile field..."

During a review of the professional reference retrieved from https://aornguidelines.org/guidelines/content?sectionid=173723395&view=book&expand=true, titled, "AORN (Association of periOperative Registered Nurses) (eGuidelines) Retained Surgical Items [RSIs]", dated 12/9/21, the professional reference indicated, " ... Establishing a system that accounts for all surgical items opened and used during a procedure constitutes a primary and proactive strategy to prevent patient harm... Use a consistent accounting methodology for all surgical counts... RN circulator should... record instrument counts on preprinted count sheets... accurately accounting for items used during a surgical procedure is a primary responsibility of the RN circulator... Accurately accounting for items used during a surgical procedure is a primary responsibility of the scrub person... accurately accounting for items used during a surgical procedure is a primary responsibility of the surgeon and surgical first assistant... items to be counted (EG, soft goods, sharps, miscellaneous items, instruments, items in use)..."

During a professional reference review retrieved from https://www.ast.org/uploadedFiles/Main_Site/Content/About_Us/Standard%20Counts.pdf, titled "Recommended Standard of Practice for Counts", dated 10/27/06, indicated, " ...It is recommended that sponge, needle and instrument counts be performed on all procedures that present with the possibility that a foreign object could be retained in order to increase patient safety practices in the perioperative setting ... Instruments should be counted by the CST [certified surgical technician] and circulator [nurse] for all procedures. Facility policy may indicate procedures or types of procedures, when counts are not required. However, the recommendation is that an instrument count should be performed for all procedures, including minimally invasive, due to unanticipated events that can widen the scope of the procedure ... Instrument counts should be performed in the same sequence each time; facility policy should define the sequence ... A standardized method for conducting the instrument counts aids the surgical team members in knowing that the counts will always be performed the same way for every procedure, in order to contribute to accuracy and efficiency ... The CST and circulator should never assume the instrument count performed in the Central Sterile Processing Department (CSPD) is correct. Not performing an instrument count and assuming the count sheet completed by the CSPD is correct should not be an accepted practice ... Sponge, sharp and instrument counts should be documented in the patient's intraoperative record and included in the patient's chart. 1. The documented counts should include the following information: A. Types of counts B. Number of each item counted C. Names and titles of surgical team members who performed the counts D. Results of the counts, e.g., correct or incorrect E. Measures taken to resolve incorrect counts F. Explanation for counts not performed ..."

During a professional reference review retrieved from the Joint Commission (https:www.jointcommission.org/see_issue_51), titled "Preventing Unintended Retained Foreign Objects (URFO)" dated 10/17/13, indicated " ... The Joint Commission recommends that facilities develop effective processes and procedures for preventing unintended retained foreign objects. Their recommendations include a standardized and highly reliable counting system... Verify that counts printed on prepackaged sponges and instrument sets are correct ... Be performed before the procedure begins, in order to establish a baseline count; before the closure of a cavity within a cavity; before wound closure begins; at skin closure or end of procedure; and at the time of permanent relief of either the scrub person or the circulating registered nurse .... Be applicable in all settings where invasive procedures are performed ... Ensure that the surgeon verbally verifies the results of the counting procedure ..."

2. During an observation on 4/11/23, at 10:15 a.m., in operating room (OR) 6, Orthopedic Surgeon (MD) 1 completed the Left Total Hip Procedure (a surgical procedure in which the diseased parts of the hip joint are replaced with new, artificial parts) for Patient (Pt) 2. ST 2 sorted surgical instruments used in the procedure and left the instruments on the back table (holds most of the surgical instruments and other equipment used during surgery). ST 2 sprayed the instruments with an enzymatic solution (solution used as part of the first step of the cleaning process to remove or prevent organic material [i.e., tissue or blood] from adhering to the instrument) until all instruments were saturated. ST 2 placed the instruments into surgical trays and placed them in a transport bin for transport to the sterile processing department (SPD- performs sterilization and other actions on medical devices and equipment). The transport bin was followed into the SPD decontamination room (soiled instruments are inspected, sorted, and cleaned).

During concurrent observation and interview on 4/11/23, at 10:50 a.m., in the SPD decontamination room, with Sterile Processing Technician (SPT) 3 and the Interim Sterile Processing Department Manager (SPDM), SPT 3 placed the soiled instruments from Pt 2's procedure into a sink filled with water and enzymatic detergent. Each instrument was inspected and cleaned. SPT 3 identified a drill bit that was not part of the instrument tray. SPT 3 stated the instrument was a "single use drill bit" that could not be reprocessed. SPT 3 discarded the "drill bit" into a sharps container (rigid puncture-resistant container). SPDM validated the drill bit was a single use sharp instrument that should have been discarded in the OR.

During an interview on 4/11/23, at 1:01 p.m., with the ORM, ORM stated, "Single use drill bits and screws was single use each for each patient." ORM stated, single use items that were not used during the procedure can be reprocessed (re-sterilized for future use).

During an interview on 4/14/23, at 1:10 p.m., with the ORM, the ORM stated the practice for single use drill bits in the OR changed in March 2023. The ORM stated prior to March 2023, the hospital's practice was to reprocess (treatment in preparation for reuse) "unused" single use drill bits until they were used and discarded in SPD or the OR. The ORM stated, in March 2023, staff were trained to discard all "single use drill bits" in the OR as part of preventative measures associated with an OR incident that occurred May 2022. The ORM stated the current practice was to prepare "two" single use drill bits for orthopedic procedures (i.e., Left Total Hip procedure), one to be used in the procedure and the other to validate the "used" drill bit remained intact. The ORM stated ST 2 should have discarded both, the "used" and "unused", single use drill bits in the sharps container located in the OR after Pt 2's procedure.

During a review of the hospital P&P titled, "Cleaning and Storage of Reusable Equipment Policy", dated 11/16/20, the P&P indicated, " ... single use, disposable patient care supply, equipment and instrument must be disposed of after use and not be cleaned or reprocessed ..."

During a review of the hospital P&P titled, "Hazardous Materials/ Wastes (medical, Hazardous, and Radioactive) and Spill Response Policy", dated 10/19/22, the P&P indicated, " ... Recognizing and reducing the risks associated with the storage, handling, use, and disposal of waste and hazardous materials to our staff, members, patience, visitors, environment ... this policy applies to all employees who are employed ... sharps waist: A device that has acute rigid corners, edges, or protuberances capable of cutting or piercing... Employees are not to leave improper sharps unsupervised/ unmonitored... A person must dispose of the sharps correctly..."

During a review of the professional reference retrieved from https://aornguidelines.org/guidelines/content?sectionid=173724314&view=book&expand=true, "AORN (Association of periOperative Registered Nurses) (eGuidelines) Sharps Safety", dated 11/1/19, the professional reference indicated, " ... sharp devices must be contained, transported, and disposed of safely... select a location for the sharps disposal container by using accessibility criteria that include... close proximity to the point of use... contain an isolate sharps on the sterile field (e.g., back table, Mayo stand) with a sharps containment device... confinement and containment of sharps minimize the risk of injury to personnel as well as reduce the risk of retained surgical items... segregation of sharp instruments minimizes the risk of injury to personnel handling the instruments during decontamination..."

During a review of the Manufacturer's instruction's for use (IFU) titled "Instructions For Use: Surgical Drill Bits," dated 6/1/20, the IFU indicated, " ... [ortho Med] instruments are developed, designed and manufactured with the highest care. Only an appropriate use of the instruments allows best results and a long shelf life. Therefore, the following instructions for use and safety must be followed... this is a single-use device... the products are for single use only and may not be reused... The product has not been designed, intended or sold for uses other than indicated..."

Based on interview and record review the hospital failed to follow the policy and procedure titled, "PCS-PACU-003 Care of the PACU and Procedure Room Patient," for two of two sampled patients (Patient 33 and Patient 34) when post anesthesia care unit (PACU) registered nurse (RN) did not assess and document vital signs (heart rate, blood pressure, oxygenation, and temperature) every five minutes for the first fifteen minutes in the electronic health record (EHR).

This failure had the potential to delay critical interventions during the initial recovering period of the hemodynamically unstable (occurs when there's abnormal or unstable blood pressure, which can cause inadequate blood flow) patient during the arrival of the patient to the PACU from the Operating Room (OR) by not recognizing the changes in vital signs.

Findings:

During a review of Patient 33's "PreOperative History and Physical" (PHP), dated 3/24/23, the PHP indicated, Patient 33 was a 57 year old male with a history of Osteoarthritis (OA; degeneration of joint cartilage and the underlying bone) in the right knee.

During a review of Patient 33's "Long Operative Report" (LOR), dated 4/10/23, the LOR indicated, "Pre-Op Diagnosis: OSTEOARTHRITIS OF BILAT (bilateral; both) KNEES. Post-Op Diagnosis: OSTEOARTHRITIS OF BILAT KNEES. Procedure(s) with Laterality: KNEE REPLACEMENT TOTAL (Right) ... Findings: Moderate medial/Patellofemoral (front of the knee, around the kneecap) arthritis R (right) knee."

During a review of Patient 33's "Anesthesia Record" (AR), dated 4/10/23, the AR indicated, Patient 33 received spinal anesthesia (a type of regional block in which local anesthetic is injected into the subarachnoid space (a space containing the cerespinal fluid, major blood vessels, and cisterns; enlarged pockets of cerebral spinal fluid to created due to the separation of the arachnoid mater from the pia mater based on the anatomy of the brain and spinal cord surface) to provide numbness of the lower extremities) for the procedure. Patient 33 was given Midazolam (sedation medication) 2 mg (milligrams; unit of measurement) intravenous (medication injected into the vein) at 12:32 p.m., 2 mg intravenous at 2:23 p.m., and 1 mg intravenous at 2:43 p.m., Fentanyl (pain medication) 25 mcg (microgram; unit of measurement) intravenous at 2:23 p.m., 25 mcg intravenous at 2:35 p.m., and 25 mcg intravenous at 3:28 p.m., Fentanyl 25 mcg intrathecal (medication injected into the spinal space) at 2:28 p.m., Ropivacaine (anesthetic medication) 10 mL (milliliter; unit of measurement) injection [unspecified] at 12:32 p.m., Propofol (anesthetic medication causing sleepiness) infusion (medication injected into the vein at a rate) 50 mcg/kg (kilogram; unit of measurement)/min (minute) - 31.53 mL/hr (hour) at 2:35 p.m., 75 mcg/kg/min - 47.29 mL/hr at 2:43 p.m., 50 mcg/kg/min - 31.53 mL/hr at 2:56 p.m., 25 mcg/kg/min - 15.76 mL/hr at 3:06 p.m., 75 mcg/kg/min - 47.29 mL/hr and was stopped at 3:50 p.m., Ondansetron (nausea medication 4 mg intravenous at 3:21 p.m., Cefazolin (antibiotic) 2 g (gram; unit of measurement) intravenous at 2:32 p.m., Chloroprocaine (anesthetic medication) 2 mL intrathecal at 2:28 p.m., Dexamethasone (anti-inflammatory medication) 4 mg intravenous at 3:05 p.m., and a total of Lactated Ringers (isotonic crystalloid fluid used for hydration) 800 mL intravenous at 4:01 p.m.

During a review of Patient 33's "PACU Flowsheet" (PF), dated 4/10/23, the PF indicated, Patient 33 arrived to the PACU on 4/10/23 at 4:01 p.m. from the OR. Patient 33's vital signs were assessed and documented at 4:01 p.m., 4:15 p.m., 4:30 p.m., 4:45 p.m., 5:00 p.m., 5:15 p.m., and 6:00 p.m.

During a review of Patient 34's PHP, dated 3/19/23, Patient 34 was a 72 year old female with a history of Osteoarthritis in the right knee.

During a review of Patient 34's LOR, dated 3/19/23, the LOR indicated, "Pre-Op Diagnosis: OSTEOARTHRITIS OF RIGHT KNEE. Post-Op Diagnosis: OSTEOARTHRITIS OF RIGHT KNEE. Procedure(s) with Laterality: KNEE REPLACEMENT TOTAL (Right) ... Findings: Advance OA Right knee."

During a review of Patient 34's AR, dated 4/10/23, the AR indicated, Patient 34 received spinal anesthesia for the procedure. Patient 34 was given Fentanyl 25 mcg intravenous at 12:21 p.m., 25 mcg intravenous at 12:25 p.m., 25 mcg intravenous at 12:29 p.m., 25 mcg intravenous at 12:32 p.m., Midazolam 2 mg intravenous at 10:40 a.m., 2 mg intravenous at 12:33 p.m., 1 mg intravenous at 12:47 p.m., 1 mg intravenous at 12:57 p.m., 1 mg intravenous at 1:04 p.m., Ropivicaine 10 mL injection [unspecified] at 10:40 a.m., Propofol infusion 100 mcg/kg/min - 51 mL/hr at 12:28 p.m., 50 mcg/kg/min - 25.5 mL/hr at 12:35 p.m., stopped at 12:28 p.m., 25 mcg/kg/min - 12.75 mL/hr at 12:43 p.m., stopped at 1:37 p.m., Ephedrine (medication used to increase blood pressure) 10 mg intravenous at 1:10 p.m., Dexamethasone 4 mg intravenous at 12:38 p.m., Ondansetron 4 mg intravenous at 12:42 p.m., Chloroprocaine 2 mL intrathecal at 12:16 p.m., Cefazolin 2 g intravenous at 12:13 p.m., and a total of Lactated Ringers 1200 mL intravenous at 1:42 p.m.

During a review of Patient 34's PF, dated 4/10/23, the PF indicated, Patient 34 arrived to the PACU on 4/10/23 at 1:51 p.m. from the OR. Patient 34's vital signs were assessed and documented at 1:51 p.m., 2:00 p.m., 2:15 p.m., 2:26 p.m., 2:30 p.m., 2:45 p.m., 3:00 p.m., 3:09 p.m., 3:15 p.m., and 3:30 p.m.

During an interview on 4/14/23, at 10:47 a.m., with the Preop (area where patients were prepared for surgery)/PACU Manager (PPM), PPM stated, when the patient arrived to the PACU from the OR, vital signs were required to be assessed and documented every five minutes for the first fifteen minutes to ensure the patient was stable (patients who are awake, oriented and able to speak in full sentences). PPM stated, the first fifteen minutes of the patient's recovery was the most critical time for patient.

During an interview on 4/14/23, at 11:47 a.m., with RN 8, RN 8 stated, it was the PACU RN's responsibility to make sure patients were hemodynamically stable (stable blood flow) coming out of anesthesia. RN 8 stated, patient vital signs were assessed every fifteen minutes on arrival to the PACU from the OR. RN 8 stated, RN 8 was instructed to assess and document vital signs every fifteen minutes during on boarding (orientation to the PACU as a new hire employee). RN 8 stated, RN 8 was not aware of the hospital's policy and procedure to monitor and document vital signs every five minutes for the first fifteen minutes. RN 8 stated, the patient waking up from anesthesia was the most unstable the first 15 minutes.

During a review of the hospital's policy and procedure (P&P) titled, "PCS-PACU-003 Care of the PACU and Procedure Room Patient," dated 11/16/22, the P&P indicated, "Purpose: The purpose of this policy is to ensure safe, consistent, and competent care for all patients recovering from anesthesia ... Procedure: The following will be assessed and documented in the electronic medical record on admission and every 5 minutes for 15 minutes then every 15 minutes until patient meets Phase I and Phase II discharge criteria including, but not limited to: PASS score (a method of evaluating the patient coming out of anesthesia), Temperature, Pulse (heart rate), Respirations (breathing rate), Blood Pressure, Oxygenation saturation (oxygen level), Pain Level, EKG (electrocardiogram graft), IV (intravenous) site, and surgical site assessment ..."

During a professional reference retrieved from https://www.asahq.org/standards-and-guidelines/standards-for-postanesthesia-care titled, "Standards for Postanesthesia Care," dated 10/23/19, the professional reference indicated, "ALL PATIENTS WHO HAVE RECEIVED GENERAL ANESTHESIA, REGIONAL ANESTHESIA OR MONITORED ANESTHESIA CARE SHALL RECEIVE APPROPRIATE POSTANESTHESIA MANAGEMENT ....THE PATIENT'S CONDITION SHALL BE EVALUATED CONTINUALLY IN THE PACU: 1. The patient shall be observed and monitored by methods appropriate to the patient's medical condition. Particular attention should be given to monitoring oxygenation, ventilation, circulation, level of consciousness and temperature [vital signs include heart rate, respirations, temperature, oxygen saturation, pain level]. During recovery from all anesthetics, a quantitative method of assessing oxygenation such as pulse oximetry shall be employed in the initial phase of recovery. This is not intended for application during the recovery of the obstetrical patient in whom regional anesthesia was used for labor and vaginal delivery. 2. An accurate written report of the PACU period shall be maintained. Use of an appropriate PACU scoring system is encouraged for each patient on admission, at appropriate intervals prior to discharge and at the time of discharge. 3. General medical supervision and coordination of patient care in the PACU should be the responsibility of an anesthesiologist .... A PHYSICIAN IS RESPONSIBLE FOR THE DISCHARGE OF THE PATIENT FROM THE POSTANESTHESIA CARE UNIT: 1. When discharge criteria are used, they must be approved by the Department of Anesthesiology and the medical staff. They may vary depending upon whether the patient is discharged to a hospital room, to the Intensive Care Unit, to a short stay unit or home. 2. in the absence of the physician responsible for the discharge, the PACU nurse shall determine that the patient meets the discharge criteria. The name of the physician accepting responsibility for discharge shall be noted on the record."

During a professional reference retrieved from https://www.ncbi.nlm.nih.gov/books/NBK537299/, titled "Spinal Anesthesia," dated 2023, the professional reference indicated, " ... spinal anesthesia (also known as regional anesthesia or Neuraxial anesthesia) is a beneficial anesthesia modality that has helped for a wide range of surgical procedures. It does come with risks of which healthcare providers need to be aware of. Patient selection is critical and should be driven by a careful history and physical examination. The indication for neuraxial anesthesia needs to match the surgical needs of the patient. After surgery, the post-op team needs to be aware of the procedure, and the patient needs to monitored by well-trained personnel ... The patient's hemodynamics requires monitoring in the immediate post-op period until the resolution of the anesthetic. Nurses and physicians from other fields managing the patient need to be aware of the nature of anesthesia that patient underwent ... Upon discharge home, the patient should be able to be contacted by personnel who performed the procedure, and the patient should receive a list of possible complications. The patient should be asked about headaches, backache, and checked for any neurological deficits post-procedure and return of bowel and bladder function. The patient should be reassured and evaluated regarding any complications that may have resulted. A visit to the anesthesia clinic and/or appropriate specialist is the recommendation in the event of any complications". Complications include low blood pressure, headache, back pain, bleeding, nerve injury, arachnoiditis [type of spine infection], nausea, vomiting, total spinal and other medical concerns that need attention.