HospitalInspections.org

Based on interview, and record review, the facility failed to assure Medical Staff Committees reviewed, approved, and implemented the policy and procedure to prevent Surgical Retained Foreign Object (RFO) during Surgical procedures, and assure Surgical Services have evaluated and approved policy and procedure to prevent an adverse event with Retained Foreign Object (RFO) during surgical procedure.

This deficient practice has the potential for systemic problems in the surgery services to ensure the provision of quality health care in a safe environment.

Findings:

On 9/8/2022 at 2:30 p.m., during an interview with Director of Operating Room (DOR) and Director of Patient Safety (DPS), the DOR stated Patient 1 had Surgery performed by MD 1 at GACH 1 in 8/13/21 and was discharged. A few weeks later, Patient 1 went to GACH 2 and had a surgical procedure completed by MD 1 at GACH 2 to remove an RFO. MD 1 notified GACH 1 of the RFO removal which was a malleable retractor from Patient 1 at GACH 2.

On 9/9/2022 at 11:10 am, during an interview with Director of Patient Safety (DPS) about the RFO Case, the DPS stated on 10/21/22 RFO case was evaluated as a process. The root cause analysis review included: OR Staff and Medical Staff, end surgery Procedure process, communications, final counts and the definition of when surgery is completed.

On 9/9/2022 at 1:45 pm, Director of Medical Staff Performance improvement (DMS) was asked for documentation Medical Staff received Medical education about the RFO case. The DMS stated Medical Staff Education on the RFO had not taken place. The Medical Staff Committee was awaiting for recommendations from the Surgery Department Medical Staff committee and OB/GYN (Obsterics and Gynecology) Department Medical Staff committee and Medical Executive Committee.

On 9/12/2022 at 12:35 pm, during an interview with the Vice President for Quality Improvement (VPQI), the VPQI stated the root cause analysis (RCA) for the RFO would go for discussion next to Surgery Department and OB GYN Department committee, then to the Medical Executive Committee (MEC), then to the Governing Body (GB). As of 9/12/2022 the RCA had not yet been reviewed by the Surgery Department, OB/GYN Department, Medical Executive Committee, and Governing Body (GB), and the Physician Education had not taken place for the RFO.

A review of a document provided by the facility, undated, titled "Summary of GACH1 Actions Related to RFO," indicated the timeline: Patient 1 had surgery on 8/13/2021. On 9/23/2021 GACH1 was notified of Patient 1's removal of the RFO. RCA started on 10/20/2021 and RCA was completed on 11/1/2021. There was no documentation that the Medical Staff Committee of Surgery Department, the Medical Staff Committee of OB/GYN,the Medical Executive Committee(MEC) or the Governing Body (GB) reviewed and approved any Policies and Procedures. There was no Physician education had taken place as of 9/12/2022.

A facility Policy and Procedure titled Patient Safety Plan dated 6/1/2021, documented the Board delegated the implementation and oversight of the patient safety plan to include: "Oversight is also provided by the Medical Staff through the Medical Staff Committee Structure, the Medical Staff PI Committee and the Medical Staff Executive Committee, ..." The Medical Staff and Management Team are responsible for the day -to-day implementation and evaluation of the processes and activities noted in this program."

A facility Policy and Procedure titled, "Serious Clinical Adverse events," dated 6/16/2022 documented ...."Immediate investigation completion of a comprehensive systematic analysis for identifying the casual and contributory factors, corrective actions, timeline for implementation of corrective actions and systemic improvement."

The cumulative effect of this systemic failure of the surgical services resulted in the inability of the Governing Body to maintain appropriate oversight and to assure quality health care in a safe and sanitary environment.

Based on interview and record review, the facility failed to notify family for a patient with restraint for 1 (one) of 2 (two) sampled patients (Patient 2). This deficient practice resulted in patient representatives not informed of Patient 2's health status, and potential delay in involvement in treatment.

Findings:

A review of Patient 2's History and Physical (H&P), dated 9/3/2022, indicated Patient 2 with depression, Alzheimer's (brain disorder that slowly destroys memory and thinking skills, and, eventually, the ability to carry out the simplest tasks), GERD (Gastroesophageal reflux disease, occurs when stomach acid repeatedly flows back into the tube connecting the mouth and stomach), hypertension, presented to Emergency Room with nontraumatic back pain. Patient 2 was confused and combative per nurses. Patient 2 had progressive (symptoms may be relatively mild at first but they get worse with time) dementia (not a specific disease but is rather a general term for the impaired ability to remember, think, or make decisions that interferes with doing everyday activities) and very forgetful.

A review of Patient 2's Orders, dated 9/4/2022, indicated an order for bilateral (both sides) wrist restraints (something that restricts freedom or prevents someone from doing something; when someone is tied up and prevented from moving, this is an example of restraint) at 8:38 p.m. for agitation, combative behavior, and unable to re-orient patient.

During a concurrent interview and review on 9/12/2022, at 9:44 a.m., with Registered Nurse, Clinical Informatics-01 (RNCI-01), Patient 2's Restraint Orders was reviewed. Order indicated, on 9/9/2022 ,at 1:41 p.m., restraint order was suspended (discontinued).

During a concurrent interview and review on 9/12/2022, at 9:48 a.m., with RNCI-01, Patient 2's electronic medical record (EMR) was reviewed in search of family or representative notification of need for restraint for Patient 2. RNCI-01 stated, unable to find documentation of family or representative notification regarding restraint from 9/9/2022 to 9/12/2022. RNCI-01 stated, "what I would do", family would be notified to collaborate care and made aware of patient status and need for restraint.

A review of facility policy and procedure (P&P), titled "Patient Right and Responsibility," effective date 7/2020, indicated the following:
"4. Receive information about your health status, diagnosis, prognosis, course of treatment, prospects for recovery and outcomes of care (including unanticipated outcomes) in terms you can understand. You have the right to effective communication and to participate in the development and implementation of your plan of care."
"5. Make decisions regarding medical care and receive as much information about any proposed treatment or procedure as you may need in order to give informed consent or to refuse a course of treatment."

Based on observation, interview and record review, the facility failed to:


1. Develop a care plan (provides direction on the type of nursing care the patient or family may need, care plans provide communication among nurses, patients, and other healthcare providers to achieve health care outcomes) within 24 hours of admission, in accordance with the facility's policy and procedure, for one of 36 sampled patients (Patient 26). Patient 26 was admitted to the facility with diagnoses that included hypoxia (an absence of enough oxygen in the tissues to sustain bodily functions), the care plan for this condition was initiated two days after admission. This deficient practice had the potential for a delay in respiratory care.
(Refer to A-396)


2a. Follow surgical perioperative (around the time of surgery) count facility policy for 1 (one) of 16 sampled patients (Patient 1). This failure led to a retained malleable (of a metal or other material; able to be hammered or pressed permanently out of shape without breaking or cracking) retractor (one that retracts: such as a: a surgical instrument for holding open the edges of a wound. b: a muscle that draws in an organ or part) in the abdomen from surgery on 8/13/2021, and subsequently requiring surgical removal of the malleable retractor on 9/24/2021 for Patient 1. (Refer to A398)

2b. Ensure all licensed nurses who provide services in the hospital adhered to the policies and procedures (Cervical Collar Application) of the hospital for one of 36 patients (Patient 15). This deficient practice had the potential to result in a decline in Patient 15's health due to the improper fitting of the cervical collar that Patient 15 was wearing. Patient 15 was constantly moving her head and manipulating the cervical collar during an observation and interview.
(Refer to A-398)

The cumulative effect of these failures resulted in the non-compliance on the Condition of participation for Nursing Services.

Based on observation, interview, and record review, the facility failed to develop a care plan (provides direction on the type of nursing care the patient or family may need, care plans provide communication among nurses, patients, and other healthcare providers to achieve health care outcomes) within 24 hours of admission, in accordance with the facility's policy and procedure, for 1 of thirty-six (36) sampled patients (Patient 26).
This deficient practice had the potential for a delay in respiratory care for hypoxia (an absence of enough oxygen in the tissues to sustain bodily functions).

Findings:

On 9/8/2022, at 3:38 p.m., Patient 26 was observed in bed with his eyes closed. Patient 1 had a tracheostomy (a hole in the windpipe to facilitate breathing) and receiving oxygen via a trach collar (a device used to provide oxygen and humidity). The head of the bed was elevated.

During a concurrent interview and record review of Patient 26's nurses notes and care plans, on 9/12/2022, at 9:38 a.m., the Registered Nurse from Clinical Informatics (RNCI-03) stated Patient 26 was admitted to the facility on 9/5/2022 at 1:08 a.m.. RNCI-03 stated that the nursing admission assessment on 9/5/2022 at 5:03 a.m. indicated Patient 26 had hypoxia. RNCI-03 stated that on 9/5/2022 at 4:05 a.m., Patient 26's was receiving oxygen at 8 liters per minute (L/m) with Fio2 (fraction of inspired oxygen is the concentration of gas mixture) at 28 percent (%) via trach collar. RNCI-03 stated the care plan addressing hypoxia titled, "Gas Exchange Impaired," was initiated on 9/7/2022 at 8:37 p.m., two days after admission.

During a concurrent interview and record review of Patient 26's care plans, the Registered Nurse Infomatics Manager (IM) verified that Patient 26 was admitted with hypoxia on 9/5/2022 and the care plan addressing hypoxia was initiated on 9/7/2022. The IM reviewed the facility's policy and procedure titled, "Standard For Patient Plan of Care (Multidisciplinary)," and verified care plans should be initiated within 24 hours of admission.

A review of Patient 26's "Registration Record," indicated Patient 26 was admitted to the facility on 9/5/2022, at 1:08 a.m. Patient 26's diagnoses included hypernatremia (high concentration of sodium in the blood), acute kidney injury (a sudden decrease in kidney function), altered mental status (a change in mental function), and hypoxia.

A review of Patient 26's History and Physical (H&P), dated 9/5/2022, at 2:46 a.m., indicated Patient 26's chief complaint was increasing ALOC (altered level of consciousness) and decreased oxygen saturation (a measure of how much hemoglobin is currently bound to oxygen compared to how much hemoglobin remains unbound, normal levels are usually above 95%).

A review of Patient 26's "Nursing Plans," indicated the care plan addressing hypoxia, titled "Impaired Gas Exchange," was initiated on 9/7/2022 at 8:37 p.m..

A review of the facility's policy and procedure (P&P) titled, "Standard For Patient Plan of Care (Multidisciplinary)," reviewed on 8/2019, indicated to initiate patient care plan within 24 hours of admission. Patients here for less than 48 hours may not have a detailed plan of care. The patient's care plan will identify priority problems and needs to be assessed by the multidisciplinary team. The patient's care plan will be complete, current, and individualized for each patient. There will be ongoing documentation of the nursing process related to patient needs from admission to discharged.

Based on interview and record review, the facility failed to ensure staffs:

1. Followed surgical perioperative (around the time of surgery) count according to facility's policy and procedure for counting instruments after surgery for 1 (one) of 16 sampled patients (Patient 1). Final count was conducted at the beginning when the surgeon started to close the wound skin not at the final stitch of the wound skin.

This failure led to a retained malleable (of a metal or other material; able to be hammered or pressed permanently out of shape without breaking or cracking) retractor (one that retracts: such as a. a surgical instrument for holding open the edges of a wound. b. a muscle that draws in an organ or part) in the abdomen from surgery on 8/13/2021 and subsequently requiring surgical removal of the malleable retractor on 9/24/2021 for Patient 1.

2. Assessed and ensure a patient's cervical collar fits properly according to facility's policy and procedure for Cervical Collar Application for one of 36 patients (Patient 15).

This deficient practice had the potential to result in a decline in Patient 15's health due to the improper fitting of the cervical collar that Patient 15 was wearing. Patient 15 was constantly moving her head and manipulating the cervical collar during an observation and interview.


Findings:

A review of Patient 1's History and Physical (H&P), dated 8/13/2021, indicated Patient 1 was admitted to facility for ovarian cancer. Patient 1 was to undergo ovarian cancer debulking (removal of as much of the tumor as possible), total abdominal hysterectomy (TAH - removal of the uterus and cervix through an opening in the abdomen) with bilateral salpingo-oophorectomy (BSO-removal of both fallopian tubes and ovaries), omentectomy (the surgical removal of all or part of the omentum; the omentum is a fold of fatty tissue inside the abdomen that surrounds the stomach, large intestine and other abdominal organs), possible bowel resection (surgery to remove any part of the bowel, including the small intestine, large intestine, or rectum), possible ostomy (surgically created opening in your abdomen that allows waste or urine to leave your body).

A review of Patient 1's Operating Room (OR) Nursing Record, dated 8/13/2021, indicated the following:
1. The surgery start time was at 3:35 p.m.
2. The initial count was conducted at 3:51 p.m. by Registered Nurse1 (RN 1) and Surgical Technician-01 (ST-01). The instrument count was correct.
3. The second count was conducted at 5:01 p.m. by RN 1 and ST 1. The instrument count was correct.
4. The final count was conducted at 5:17 p.m. by RN 1 and ST 1. The instrument count was not completed.

A review of Patient 1's Operative Report, dated 8/13/2022, indicated Patient 1's procedure included exploratory laparotomy, ovarian cancer debulking, total abdominal hysterectomy, bilateral salpingo-oophorectomy, omentectomy, CUSA (cavitronic ultrasonic surgical aspirator, device used in surgery) destruction of multiple peritoneal (the tissue that lines the abdominal wall and pelvic cavity) lesions (abnormal changes in any area of skin).

A review of Patient 1's Discharge Summary, dated 8/18/2021, indicated Patient 1 was discharged on 8/18/2021.

A review of facility document titled "Summary of [Facility] Actions Related to RFO (Retained Foreign Object," [undated], facility was notified of RFO on 9/23/2021.

During an interview on 9/9/2022, at 9:55 a.m., with Director of Operating Room (DOR), DOR stated a 3 (three) to 4 (four) centimeter (cm) width of medium-size malleable retractor was found by [Facility 2] during surgery of Patient 1.

During an interview on 9/9/2022, at 8:35 a.m., with Surgical Technician-01 (ST-01), ST-01 stated, during Patient 1's surgery on 8/13/2021, final instrument count was started when surgeon started to close the skin. ST-01 stated, no additional instrument count was completed after surgeon closed the skin.

During an interview on 9/12/2022, at 11:42 a.m., with MD-01 (Physician-01), MD-01 stated, malleable was used when closing the belly. MD-01 added, the malleable was placed to protect the bowel from needle, as needle passed through the fascia (thin casing of connective tissue that surrounds and holds every organ, blood vessel, bone, nerve fiber and muscle in place) during closing. MD-01 also stated, counting of surgical items would be completed when surgery is done, before the last staple is placed on the incision (surgical cut made in skin or flesh). MD-01 further stated, the retractor was discovered 6 (six) to 8 (eight) weeks after initial surgery, removed at another facility.

A review of facility policy and procedure (P&P), titled "Counts: Instruments, Sponges, Sharps and Miscellaneous Items" revised effective date 3/1/2016, reviewed date 6/2021, indicated the following:
"1. All perioperative team members will engage in safe practices that support prevention of RSIs (Retained Surgical Items) ... 14. The final count will not be considered complete until all items (e.g. sponges, malleable retractors, needle holder, scissors) used in closing the wound are moved from the wound and returned to the scrub person and accounted for." Policy indicated, for Instruments",
"2. Do not consider the final instrument count complete until all the instruments used in closing the wound (e.g. malleable retractors, needle holders, scissors) are removed from the wound and returned to the scrub person and accounted for." Policy indicated, "End of surgery is defined as placement of final stitch or staple necessary for skin or incision closure".

2. During an observation on 9/8/2022, at 1:48 p.m., in Patient 15's room, Patient 15 was sitting in a chair next to her bed and continuously moving her neck and cervical collar (a neck collar is an instrument used to support the neck and spine and limit head and neck movement after an injury. Its purpose is to prevent the patient from moving the head and neck until the injury is healed) side to side and up and down.

During an interview with Patient 15, on 9/8/2022, at 1:48 p.m., Patient 15 stated, I have been waiting for my MRI (Magnetic Resonance Imaging [A procedure that uses radio waves, a powerful magnet, and a computer to make a series of detailed pictures of aeras inside the body]), but I keep getting pushed back because of higher precedent patients.

During a concurrent interview and record review, on 9/12/22, at 9:15 a.m., with Clinical Quality Registered Nurse (RNCl-02) and Scribe (SCR), Patient 15 Neurovascular Cervical Collar Assessment, dated 9/5/22 was reviewed. The Neurovascular Cervical Collar Assessment for Patient 15 indicated that there was no documentation from 12:00 p.m. until 9:00 p.m. RNCl-02 confirmed that there was no assessment for those 9 hours, but that there should be documentation for that time period.

During a review of the facility's policy and procedure (P&P), titled "STANDARD OF CARE - PROGRESSIVE NURSING CARE - TIMMC," dated July 7, 2022, indicated in the ASSESSMENT section 1. A, "Collect and document in the patient record to include but not limited to the following: Vital signs at approximately 4 hours intervals (not to exceed 6 hours intervals) and prn (as needed). Unit Routines for serial assessments at approximately 4 hours intervals (not to exceed 6 hours intervals)."

During a review of the facility's policy and procedure (P&P), titled Cervical Collar Application, dated February 18, 2022, indicated, "Assess the patient to make sure that the collar fits properly. The collar must fit snugly (in a way that is tight or close-fitting; securely) and be secure to maintain alignment and immobilization. If the patient can slip the chin inside the collar, the collar isn't sufficiently snug. Replace the collar with a better fitting collar if you can't get the existing collar to fit snugly."



45919

Based on interview and record review, the facility failed to follow policy and procedure for surgical services for 1 (one) of 16 sampled patients (Patient 1).The facility failed to follow policy and procedures for:

1. Counts: Instruments. Sponges. Sharps and miscellaneous items. Facility staffs started the count at the beginning (first stitch) of closing the wound instead of at the end for closing the last stitch on the wound for Patient 1's surgery on 8/13/2022.

2. Serious Clinical Adverse events by facility neglecting to inservice medical staffs (Physicians) after Patient 1 had retained a foreign object (RFO) after a surgery.

The failure resulted to Patient 1 retaining a malleable (of a metal or other material; able to be hammered or pressed permanently out of shape without breaking or cracking) retractor (one that retracts: such as. a : a surgical instrument for holding open the edges of a wound. b : a muscle that draws in an organ or part) in the abdomen from surgery on 8/13/2021 and Patient 1 subsequently requiring surgical removal of the malleable retractor on 9/24/2021, and medical staffs (Physicians providing surgeries) were not inserviced regarding the adverse event that occurred to Patient 1. Other surgical patients had the potential for the sam issue be committed by surgical staff and physicians.

Findings:

1. A review of Patient 1's History and Physical (H&P), dated 8/13/2021, indicated Patient 1 was admitted to facility for ovarian cancer. Patient 1 had undergone ovarian cancer debulking (removal of as much of the tumor as possible), total abdominal hysterectomy (TAH - removal of the uterus and cervix through an opening in the abdomen) with bilateral salpingo-oophorectomy (BSO-removal of both fallopian tubes and ovaries), omentectomy (the surgical removal of all or part of the omentum; the omentum is a fold of fatty tissue inside the abdomen that surrounds the stomach, large intestine and other abdominal organs), possible bowel resection (surgery to remove any part of the bowel, including the small intestine, large intestine, or rectum), possible ostomy (surgically created opening in your abdomen that allows waste or urine to leave your body).

A review of Patient 1's Operating Room (OR) Nursing Record, dated 8/13/2021, indicated the following:
1. The surgery start time was at 3:35 p.m.
2. The initial count was conducted at 3:51 p.m. by Registered Nurse 1 (RN 1) and Surgical Technician-01 (ST-01). The instrument count was correct.
3. The second count was conducted at 5:01 p.m. by RN 1 and ST 1. The instrument count was correct.
4. The final count was conducted at 5:17 p.m. by RN 1 and ST 1. The instrument count was not completed.

A review of Patient 1's Operative Report, dated 8/13/2022 indicated Patient 1's procedure included exploratory laparotomy, ovarian cancer debulking, total abdominal hysterectomy, bilateral salpingo-oophorectomy, omentectomy, CUSA (cavitronic ultrasonic surgical aspirator, device used in surgery) destruction of multiple peritoneal (the tissue that lines the abdominal wall and pelvic cavity) lesions (abnormal changes in any area of skin).

A review of Patient 1's Discharge Summary, dated 8/18/2021, indicated Patient 1 was discharged on 8/18/2021.

A review of facility document titled "Summary of [Facility] Actions Related to RFO (Retained Foreign Object", undated, facility was notified of RFO on 9/23/2021.

During an interview on 9/9/2022 at 9:55 am, with DOR, DOR stated a 3 (three) to 4 (four) centimeter (cm) width of medium-size malleable retractor was found by [Facility 2] during surgery of Patient 1.

During an interview on 9/9/2022 at 8:35 am, with Surgical Technician-01 (ST-01), ST-01 stated, during Patient 1's surgery on 8/13/2021, final instrument count was started when surgeon started to close the skin. ST-01 stated, no additional instrument count was completed after surgeon closed the skin.

During an interview on 9/12/2022 at 11:42 a.m., with MD-01 (Physician-01), MD-01 stated, malleable was used when closing the belly. MD-01 stated, malleable was placed to protect the bowel from needle, as needle passed through the fascia (thin casing of connective tissue that surrounds and holds every organ, blood vessel, bone, nerve fiber and muscle in place) during closing. MD-01 stated, counting of surgical items would be completed when surgery is done, before the last staple is placed on the incision (surgical cut made in skin or flesh). MD-01 stated, the retractor was discovered 6 (six) to 8 (eight) weeks after initial surgery, removed at another facility.

A review of facility policy titled "Counts: Instruments, Sponges, Sharps and Miscellaneous Items" revised effective date 3/1/2016, reviewed date 6/2021, indicated the following:
"1. All perioperative team members will engage in safe practices that support prevention of RSIs (Retained Surgical Items) ... 14. The final count will not be considered complete until all items (e.g. sponges, malleable retractors, needle holder, scissors) used in closing the wound are moved from the wound and returned to the scrub person and accounted for." Policy indicated, for Instruments",
"2. Do not consider the final instrument count complete until all the instruments used in closing the wound (e.g. malleable retractors, needle holders, scissors) are removed from the wound and returned to the scrub person and accounted for." Policy indicated, "End of surgery is defined as placement of final stitch or staple necessary for skin or incision closure".

2. A review of Patient1's History and Physical (H&P), dated 8/13/2021, indicated Patient 1 was admitted to facility for ovarian cancer. Patient 1 had undergone ovarian cancer debulking (removal of as much of the tumor as possible), total abdominal hysterectomy (TAH - removal of the uterus and cervix through an opening in the abdomen) with bilateral salpingo-oophorectomy (BSO-removal of both fallopian tubes and ovaries), omentectomy (the surgical removal of all or part of the omentum ;(theomentum is a fold of fatty tissue inside the abdomen that surrounds the stomach, large intestine and other abdominal organs), possible bowel resection (surgery to remove any part of the bowel, including the small intestine, large intestine, or rectum), possible ostomy (surgically created opening in your abdomen that allows waste or urine to leave your body).

On 9/8/2022 at 2:30 pm: during an interview with the Director of Operating Room (DOR) and Director of Patient Safety (DPS) indicated Patient 1 had surgery performed by Medical Doctor 1 (MD 1) at General Acute Care Hospital 1 (GACH 1) on 8/21/2022 and was discharged. A few weeks later Patient 1 went to GACH 2 and had a surgical procedure completed by MD 1 at GACH 2 . MD 1 removed RFO during surgery of Patient 1 at GACH GACH 2 notified GACH 1 of the RFO removal from Patient 1 at GACH 2. The DOR indicated during Patient 1's surgical procedure of Patient 1 at GACH 1 MD 1 was closing using a malleable retractor. Surgical Tech and Circulating Nurse did final count while MD 1 was closing . RFO removed from Patient 1 at GACH 2 was a malleable retractor.

On 9/12/2022 at 11:45 a.m., during an interview, MD 1 stated not to remember all details but recalled Patient 1 had gone to GACH 2 about 6 to 8 weeks after surgery at GACH 1. MD 1 indicated he did surgery at GACH 2 to remove RFO and notified GACH 1 of RFO removal from Patient 1 at GACH 2. MD 1 explained he used malleable retractor to protect the bowls when closing. MD 1 did not recall any count discrepancy.

A review of Patient 1's medical chart of the description of procedure section on Patient 1's operative note, dated 8/13/2022, indicate documented included: "All sponges, lap, needle, instrument counts were correct x2."

A review of facility's policy and procedure, last reviewed 6/2021 titled, "Counts: Instruments. Sponges. Sharps and miscellaneous items," indicated "The final count will not be considered complete until all items (e.g. sponges, malleable retractors, needle holders, scissors) used in closing the wound are removed from the wound and returned to the scrub person and accounted for."

On 9/9/2022 at 11:10 a.m., during an interview with the DPS about the RFO for Patient 1, DPS indicated in 10/21/2022, RFO case was evaluated and the Root Cause analysis (finding the cause of the problem) reviews included operating room (OR) staff and medical staffs (physicians) regarding end surgery procedure processes that included final counts when a surgery was completed.

On 9/9/2022 at 2:45 p.m., during an interview with DOR and Quality Improvement (QI) Director Surgery Operative Procedure (SOP) indicated Nursing and OR Staff (surgical technicians) were in-serviced, and training were completed on 5/2022 as a result of review of Patient1 ' s RFO incident.

On 9/9/2022 at 1:45 p.m., during an interview, the Director of Medical Staff Performance improvement(MSPI) indicated Performance Improvement Committee (PI ) and Medical Staff Committee (MS) review projects and forwards them to the appropriate Medical Staff department for the Clinical departments involved for Medical Staff committee involved reviews the RFO.

On 9/12/2022 at 12:35 p.m. during interview and record review of the facility ' s "Summary of GACH 1 Actions Related to RFO," with the Vice President (VP) QI indicated all departments have representatives attend staff meetings (PI and MS). VP quality provided the facility ' s undated titled document, "Summary of GACH1 Actions Related to RFO" Timeline. The documented including:
1. Patient1 had surgery on 8/13/2021.
2. On 9/23/2021 GACH 1 was notified of the Patient 1 ' s removal of RFO.
3. Root Cause Analysis (RCA) started on 10/20/2021.
4. RCA was completed on 11/1/2021.

On 9/12/2022 at 12:45 p.m. during interview with VP QI indicated Physicians participated in RCA. The RCA was approved and will go next to Surgery Department and Obstetrics (OB) Gynecology (GYN) Department (area of medicine that involves treatment of women ' s diseases) then Medical Executive Committee (MEC) then Governing Body (GB). There was no documentation provided as to why there was no review and approval: Surgery Department; OB GYN Department; MEC Governing Body (GB), and Physician education from 11/1/21 to 9/12/2022 for the RCA of Patient incident.

A facility policy and procedure titled, "Serious Clinical Adverse Events," dated 6/16/2022, indicated, appropriate response included, "Staff involved in the event, notification of hospital leadership, immediate investigation, completion of a comprehensive systematic analysis for identifying the casual and contributary factors, corrective actions, timeline for implementation of corrective actions and systemic improvement."




42379