HospitalInspections.org

Based on interview and record review the facility failed to have a periodic evaluation of contracted services. The facility census was one Acute Care patient, one Swing Bed (Swing Bed - a Medicare program in which a patient can receive acute care services, then if needed Skilled Nursing Home Care) patient and three Observation (Observation - outpatient services provided to a patient while the patient's physician decides whether to admit the patient to Acute Care services or to discharge the patient) patients for a total census of five.

1. During an interview on 11/05/23 at 3:45 PM, Staff H, Chief Executive Officer, stated there was no current review of contracted services and the most recent one had been done in 2021.

2. Review of a facility document dated 12/05/23, showed a list of four contracted services utilized by the facility for anesthesia, teleradiology, emergency room physicians, and housekeeping.

Based on interview, the facility failed to ensure staff was provided education and training in measures to take when staff either observed or received a report of abuse towards patients admitted to the facility. This failure increased the risk of all patients' safety admitted to the facility seeking care, treatment and services. The facility census was one Acute Care patient, one Swing Bed (Swing Bed - a Medicare program in which a patient can receive acute care services, then if needed Skilled Nursing Home Care) patient and three Observation (Observation - outpatient services provided to a patient while the patient's physician decides whether to admit the patient to Acute Care services or to discharge the patient) patients for a total census of five.

Findings included:

1. Even though requested, the facility failed to provide a policy related to staffs' responsibility for reporting either observed or reported patient abuse and neglect.

2. During an interview on 12/04/23 at 2:00 PM, Staff A, Clerk, stated if they witnessed abuse or a patient reported abuse to them, they would call the house supervisor. Staff A stated they would "get someone else to handle it."

During an interview on 12/04/23 at 2:05 PM, Staff B, Admissions Clerk, stated if they witnessed abuse or a patient reported abuse to them, they would call the house supervisor. Staff B stated it was "not within their authority to intervene."

During an interview on 12/04/23 at 2:20 PM, Staff C, Occupational Therapy (OT, focuses on the use of fine motor and cognitive skills to perform tasks required in daily life) Assistant, stated:
- If they witnessed abuse, they would call the house supervisor, and depending on the situation, they might get involved.
- They only recalled receiving training on abuse and neglect during their orientation.
- They have worked at the hospital for over four years.

During an interview on 12/05/23 at 9:21 AM, Staff P, Registered Nurse (RN), stated:
- The facility did not provide any education or training on patient abuse or what staffs' responsibility was if staff witnessed abuse towards a patient.
- If staff witnessed abuse of a patient, staff was expected to report the observed abuse to the nursing supervisor.
- The nursing supervisor was responsible for removing the abuser from the patient and not Staff P's responsibility.

During an interview on 12/05/23 at 1:30 PM Staff F, Director of Rehabilitation, stated if they witnessed abuse or a patient reported abuse to them, they would go and find administration first, then go to the supervisor of the clinical area. They received training for abuse and neglect upon hire and yearly.


46856

Based on policy review, record review, and interview, the hospital failed to ensure staff were trained on a periodic basis in first aid related to restraints for five staff (F, J, Q, W, and CC) of five staff, whose personnel files were reviewed. This failure had the potential to result in serious injury or death to patients who required restraints in the hospital. The facility census was one Acute Care patient, one Swing Bed (Swing Bed - a Medicare program in which a patient can receive acute care services, then if needed Skilled Nursing Home Care) patient and three Observation (Observation - outpatient services provided to a patient while the patient's physician decides whether to admit the patient to Acute Care services or to discharge the patient) patients for a total census of five.

Findings included:

1. Review of the hospital's policy titled, "Restraints for Acute Medical-Surgical," dated 09/2023, showed all direct care staff involved in the use of restraints or seclusion shall demonstrate knowledge of the following:
- Underlying causes of threatening behavior;
- Aggressive behavior related to medical conditions;
- Effect of staff behavior;
- De-escalation and other self-protection techniques; and
- Recognizing the signs of physical distress.
Staff who perform 30-minute checks must demonstrate competency in the following:
- Taking and interpreting vital signs;
- Recognizing nutritional and hydration needs;
- Checking circulation and range of motion (ROM);
- Addressing physical and psychological status and comfort;
- Helping patients meet behavioral criteria for discontinuing restraints and seclusion;
- Recognizing signs of incorrect application of restraints; and
- Recognizing when to contact the physician.
Staff will be educated during orientation and annually. The policy did not include information specific to restraint first aid training.

2. Review of the hospital's restraint log showed restraints had been used on one patient in the past six months.

3. The hospital failed to provide additional restraint education other than their restraint policy. They were unable to provide documentation regarding restraint first aid education.

4. Review of five personnel files showed no periodic restraint first aid training for the following staff:
- Staff F, Director of Rehabilitation Services;
- Staff J, Registered Nurse, Interim Chief Nursing Officer;
- Staff Q, Emergency Department Nurse Manager;
- Staff W, Director of Respiratory Services; and
- Staff CC, Certified Registered Nurse Anesthetists (CRNA, registered nurses who have obtained graduate-level education and board certification in anesthesia).

5. During an interview on 12/06/23 at 11:20 AM, Staff H, CEO, stated "we don't have restraint first aid training. I have not heard of that before."

Based on policy review, record review, and interview, the facility failed to:
- Complete a comprehensive quality of life activities assessment, which identified specific individualized, activity interest for one of one current Swing Bed (Swing Bed - a Medicare program in which a patient can receive acute care services, then if needed Skilled Nursing Home Care) patient (#3) and for four of four discharged Swing Bed patients (#17, #18, #19 and #20) reviewed for a complete comprehensive quality of life activities assessment.
- Provide specific, individualized activity interests that stimulated the patient's physical and mental well-being for one of one current Swing Bed patient (#3) and for four of four discharged Swing Bed patients (#17, #18, #19 and #20) reviewed for specific, individualized activity interests.
- Develop a comprehensive activity care plan, which included activity interests and interventions for one of one current Swing Bed patient (#3) and for four of four discharged Swing Bed (#17, #18, #19 and #20) patients reviewed for a comprehensive activity care plan.
These failed practices had the potential to affect all Swing Bed patients by failing to stimulate their minds, body and social interests. The facility census was one Acute Care patient, one Swing Bed patient and three Observation (Observation - outpatient services provided to a patient while the patient's physician decides whether to admit the patient to Acute Care services or to discharge the patient) patients for a total census of five.

Findings included:

1. Review of the facility's policy titled, "Activities for Swing Bed Residents," dated 05/21/14, in part showed staff directives: The facility must provide for an on-going program of activities designed to meet, in accordance with the comprehensive assessment, the interest and the physical, mental, and psychosocial well-being of the resident. The resident will be asked during the psychosocial assessment what their activities of interest are.

Review of the facility's policy titled, "Patient Plan of Care," dated 12/2013, in part showed staff directives:
- The planning and provision of care will be based on individual patient assessment and focuses on the patient's response to actual or potential to health.
- Integration of the plan will be accomplished through collaboration with various disciplines/departments, and is communicated through assessments, physician's orders, consults, progress notes, discharge plans and interdisciplinary meetings.
- Goals for the patient are based on assessment, needs and diagnosis and are evident in the planning and provision of care as defined by the various disciplines involved in the care.

2. Review of Patients' Electronic Medical Health Records (EMHR) showed:
- Patient #3 was admitted to the facility's Swing Bed program on 11/28/23, with complaints of transient ischemic attack (TIA - a stroke like attack that resolves within minutes or hours), dizziness and generalized weakness;
- Patient #17 was admitted to the facility's Swing Bed program on 03/10/22, with complaints of pneumonia and generalized weakness;
- Patient #18 was admitted to the facility's Swing Bed program on 10/13/22, with complaints of hypertension (high blood pressure), stroke and type 2 diabetes;
- Patient #19 was admitted to the facility's Swing Bed program on 12/30/21 with complaints of cellulitis (skin infection) of the scrotum; and
- Patient #20 was admitted to the facility's Swing Bed program on 10/05/21 for complaints of shortness of breath.

The EMHR for patients #3, #17, #18, #19, and #20 showed staff failed to conduct a comprehensive quality of live activity assessment of the patients to assist in identifying the patients' activity interests and staff failed to develop a comprehensive activity care plan for the patients during their admission in the facility's Swing Bed program.

3. During an interview on 12/06/23 at 4:31 PM, Staff U, Licensed Practical Nurse, Electronic Health Record Quality Coordinator, stated Patients #3, #17, #18, #19 and #20 EMHR did not include either an activity assessment or an activity care plan for the patients while admitted to the facility's Swing Bed program.

During an interview on 12/07/23 at 9:12 AM, Staff J, Interim Chief Nursing Officer, acknowledged patients admitted to the facility's Swing Bed program needed an activity assessment and activity care plan.

Based on observation, interview and policy review, the facility failed to ensure medications were prepared and administered in a timely manner per facility policy, for five pre-drawn medications, drawn three days prior to administration in operating room (OR) suite #2's crash cart. These practices failed to provide a safe and effective medication administration that potentially damaged the medication integrity and/or quality for all patients that presented to the facility for surgical procedures. The facility census was one Acute Care patient, one Swing Bed (Swing Bed - a Medicare program in which a patient can receive acute care services, then if needed Skilled Nursing Home Care) patient and three Observation (Observation - outpatient services provided to a patient while the patient's physician decides whether to admit the patient to Acute Care services or to discharge the patient) patients for a total census of five.

Findings included:

1. Review of the facility's policy titled, "Medication Administration," last revised on 11/2013, showed single dose vials, syringes should never be held over or reused.

Interview upon observation on 12/05/23 at 10:15 AM in OR suite #2 crash cart, showed five pre-drawn Lidocaine (medication used as anesthetic blockade for local and regional anesthesia) syringes laying in drawer five and Staff X, OR Director, stated anesthesia left those in the crash cart and the next procedures were not until Thursday (approximately three days after the last procedures on Monday).

During an interview on 12/06/23 at 8:20 AM, Staff I, Director of Pharmacy, stated the anesthetists should have never pre-drawn Lidocaine and left in the crash cart drawers.

Based on policy review, observation, record review and interview, the facility failed to ensure outdated medications, intravenous (IV - in the vein) solutions, flushes and heparin (a medication used as a blood thinner or to prevent blood clots from forming) were removed from the Medical-Surgical Unit and Outpatient Services Unit crash carts so the expired items were not available for staff use during an emergency.
This failed practice had the potential to affect all patients that received care, treatments, and services at the facility. The facility census was one Acute Care patient, one Swing Bed (Swing Bed - a Medicare program in which a patient can receive acute care services, then if needed Skilled Nursing Home Care) patient and three Observation (Observation - outpatient services provided to a patient while the patient's physician decides whether to admit the patient to Acute Care services or to discharge the patient) patients for a total census of five.

Findings included:

1. Review of the facility's policy titled, "Crash Cart Management," dated 05/2022, in part showed staff directive: On the first of the month, the crash cart will be opened to check inventory and expiration dates of medications and supplies.

Review of the facility's policy titled, "Unit Inspection," undated, in part showed staff directives: Drugs shall not be kept in stock after the expiration date on the label and no contaminated or deteriorated drugs shall be available for use. Emergency (crash cart) drugs are available, complete and within the expiration period.

2. Observation, review of facility document, and concurrent interview on 12/05/23 at 10:33 AM, on the Medical-Surgical Unit showed:
- Four expired bottles of Naloxone (medication used to rapidly reverse opioid overdose) 0.4 milligrams (mg - measurement of dosage strength) per milliliter (ml - measurement of liquid) with lot #101106 and expiration date 10/2023 located inside the Adult Crash Cart.
- One 500 ml bag of IV Lactated Ringers (fluid used to replace water and electrolyte loss in patients with low blood volume or low blood pressure) solution with lot #Y398923 and expiration date 10/2023 located inside the Adult crash cart.
- Review of the facility document titled, "Adult Crash Cart Med Tray," located inside the crash cart's medication tray showed Naloxone 0.4mg/ml expires on 10/2023.
Staff O, Director of Quality/Hospital Educator, acknowledged the four bottles of Naloxone medication and one 500 ml bag of Lactated Ringers solution located inside the Adult Crash Cart on the Medical-Surgical Unit was expired.

Observation on 12/05/23 at 2:45 PM, on the Outpatient Services Unit, showed the crash cart had medications that were expired. The expired items included:
- One normal saline (NS, solution made of salt and water) prepackaged syringe flushes expired in 11/2022;
- Five NS prepackaged syringe flushes expired in 12/2022;
- Three NS prepackaged syringe flushes expired in 01/2023; and
- Five heparin lock flushes, expired on 05/31/23.

3. During an interview on 12/06/23 at 8:09 AM and 8:30 AM, Staff I, Director of Pharmacy, stated every month IV fluids and medications are to be checked by pharmacy staff for outdates/expiration. Staff I stated heparin flushes and normal saline flushes were considered supplies and were stocked from Central Supply and not through the Pharmacy.




46856

Based on policy review, record/document review, and interview, the facility's Utilization Review (UR) department failed to ensure:
- The facility's UR plan was current and approved by the Governing Body.
- The facility's Quality Control Quality Improvement Organization (QIO) agreement was current, signed and dated by the facility's administrator.
- The required number of current active members of the medical staff served on the UR committee.
- The Governing Body has delegated to the UR committee the authority and responsibility to conduct the UR functions.
- The UR department maintained on-going reviews of patients' medical records to ensure appropriateness and medical necessary admission, duration of stay, and professional services provided to patients seeking care, treatment, and services at the facility.

The severity and cumulative effects of these deficient practices resulted in the facility's overall non-compliance with 42 CFR §482.30 Condition of Participation: Utilization Review.

Refer to A-0653, A-0654 and A-0655 for examples.

Based on document review, and interview, the facility failed to ensure the facility's Utilization Review (UR) department's UR plan was current and approved by the Governing Body and the facility's Quality Control Quality Improvement Organization (QIO) agreement was current, signed and dated by the facility's administrator. These failed practices had the potential to affect all patients admitted to the facility seeking care, treatment, and services. The facility census was one Acute Care patient, one Swing Bed (Swing Bed - a Medicare program in which a patient can receive acute care services, then if needed Skilled Nursing Home Care) patient and three Observation (Observation - outpatient services provided to a patient while the patient's physician decides whether to admit the patient to Acute Care services or to discharge the patient) patients for a total census of five.

Findings included:

1. Review of the facility's document titled, "Utilization Review Plan," dated 04/2022, showed the facility did not have a current UR Plan in place approved by the facility's governing body for staff to utilize to ensure:
- Appropriate allocation of the facility's resources, including over-utilization, and inefficient scheduling of resources.
- High quality patient care was provided in the most effective manner through the analysis, review, and evaluation of charts.
- Effective discharge planning.
- Identification of utilization-related problems, including appropriateness and medical necessity of admissions, continued stays and supportive services.
- All patients' medical records meet optimal standards and reflect appropriate documentation of medical events.

2. During an interview on 12/07/23 at 4:34 PM, Staff T, UR Director, stated they became the UR director on 11/13/23 and to date staff was unable to locate a current updated UR Plan approved by the facility's governing body.

3. Review of the QIO document titled, "Memorandum of Agreement (MOA) Instructions," dated 06/06/19, showed on page #8, I agree to conduct the signing of this MOA electronically and the box next to no was checked. The area for the facility's administrator to sign and date the MOA was left blank.

4. During a telephone interview on 12/18/23 at 11:07 AM, Staff T, UR Director, stated staff has not been able to locate a signed and dated QIO agreement dated 06/06/19 with the facility administrator's signature and date. Staff T stated without the facility administrator's signature and date on the QIO agreement, the agreement was not valid.

The agreement between the QIO and the facility did not contain neither an electronic signature and date by the facility's administrator nor a handwritten signature and date. Without a proper signature and date by the facility's administrator, the QIO agreement was not a valid contract between the facility and QIO.

Based on policy review, document review, and interview, the facility failed to ensure the required number of current active members of the medical staff served on the Utilization Review (UR) committee and failed to ensure the Governing Body delegated to the UR committee the authority and responsibility to conduct the UR department functions. These failed practices had the potential to affect the appropriateness of cares, treatments and services provided to patients admitted to the facility. The facility census was one Acute Care patient, one Swing Bed (Swing Bed - a Medicare program in which a patient can receive acute care services, then if needed Skilled Nursing Home Care) patient and three Observation (Observation - outpatient services provided to a patient while the patient's physician decides whether to admit the patient to Acute Care services or to discharge the patient) patients for a total census of five.

Findings included:

1. Review of the facility's policy titled, "Utilization Review Committee," dated 05/12/22, showed in part staff directive: The UR committee shall be comprised of three members of the active medical staff.

2. Review of the facility's document titled, "Utilization Review Committee Membership Roster," updated 12/05/23, showed under Physician Members: Staff GG, Medical Director, was the only physician listed as an active member from the medical staff serving on the UR committee.

3. During an interview on 12/07/23 at 6:34 PM, Staff T, UR Director, stated Staff GG, Medical Director, was currently the only active member from the medical staff serving on the facility's UR committee and Staff GG was responsible for performing peer reviews for the facility. Staff T acknowledged the facility did not have the minimum required number of at least two active members of the facility's medical staff serving on the UR committee to fulfill and conduct the functions of the UR department.

4. Even though requested, the facility failed to provide evidence that the facility's Governing Body has delegated the UR committee the authority and responsibility to perform the duties of the UR plan.

5. During an interview on 12/07/23 at 6:34 PM, Staff T, UR Director, stated staff was unable to locate current and updated evidence the facility's Governing Body has delegated to the UR committee authority and responsibility to conduct and perform the duties of the facility's UR plan.

These failures increased the risk of the facility to fail in maintaining the highest quality of patient care/safety and in monitoring the efficiency of hospital cares, treatments, and services provided to patients admitted to the facility.

Based on document review, and interview, the facility failed to ensure the facility's Utilization Review (UR) department maintained on-going review of patients' medical records to ensure appropriateness and medical necessity of admissions, duration of stays, and professional services provided to patients seeking care, treatment, and services at the facility. The failed practice to review patients' medical records for appropriateness of medical necessity for admissions, duration of stays, cares, treatments, and services decreased the potential for optimal care provided to patients admitted to the facility. The facility census was one Acute Care patient, one Swing Bed (Swing Bed - a Medicare program in which a patient can receive acute care services, then if needed Skilled Nursing Home Care) patient and three Observation (Observation - outpatient services provided to a patient while the patient's physician decides whether to admit the patient to Acute Care services or to discharge the patient) patients for a total census of five.

Findings included:

1. Review of the facility's document titled, "Utilization Review Plan," reviewed and updated 04/2022, showed in part staff directives:
- The UR function is preformed by the Quality Council as a combined committee of the Medical Staff. Along with UR Function, this committee is responsible for the Medical Record review function.
COMMITTEE FUNCTIONS
- Establishment and maintenance of a program admission certification and continued stay review of patients admitted to the hospital, regardless of payer source.
- Review and recommendation of criteria for admission and continued stay review, as well as retrospective review utilizing Milliman Care Guidelines (MCG - criteria used by providers that supports clinical decisions that help patients get the right level of care and the appropriate care activities for the right amount of time needed to provide care, services, and treatments for patients admitted to a facility).
- Identification of utilization-related problems, including appropriateness and medical necessity of admissions, continued stays and supportive services.
- Submission of recommendations through on-going medical care evaluation studies to the medical staff as a result of review findings, with specific attention to over-utilization patterns, under-utilization patterns, and inefficient scheduling of resources.
- Performance of the medical record function through the use of established criteria, with recommendations and follow-up as needed.
- Review of Medicare, Medicaid, and all other payer type admissions.

2. Review of the facility document titled, "Letter of Off-Site Peer Review," dated 03/05/21 and concurrent interview on 12/06/23 at 10:40 AM, showed the last peer review conducted on the appropriateness of patients care, services, and treatments provided by Staff EE, Medical Director of Surgical Services, was dated 03/05/21. Staff H, Chief Executive Officer, stated this letter to Staff EE was the most recent peer review completed.

The facility's last peer review of services provided by the facility's medical staff to patients was conducted two years and nine months ago. The failure to perform on-going peer review of services provided by the facility's medical staff increased the risk of services provided to patients' not meeting the MCG criteria and requirements for appropriateness of admissions, duration of stays, cares, treatments, and services provided, which could impact the denial of payment of the patient's admission stay at the facility.

3. During an interview on 12/07/23 at 6:34 PM, Staff T, UR Director, stated:
- On 11/13/23, Staff T became the UR Director.
- Staff GG, Medical Director, was currently the only active member on the facility's UR committee.
- Staff GG was responsible for performing the peer reviews for the facility.
- The facility did not have the minimum required number of at least two active members of the facility's medical staff serving on the UR committee to fulfill and conduct the functions of the UR department.
- Before 11/13/23, Staff T has not been able to locate medical reviews of patients' admissions, duration of stays and appropriateness of cares, treatments, and services provided that included the required MCG elements and/or criteria to perform the reviews.
- The UR department has not had any Quality Assurance Performance Improvement indicators or projects conducted for the appropriateness of the functions conducted by the department since 2020 to staff's knowledge.

Based on policy review, observation, interview, and document review, the facility failed to ensure:
- The Medical-Surgical Unit Pediatric Crash Cart's (mobile cart that contains emergency medical supplies, equipment, and medications) drawers where emergency medications were stored was easily accessible by staff during an emergency.
- Outdated equipment and supplies were not available for staff use in the Respiratory Boxes (secured boxes with emergency airway supplies/equipment) placed on top of crash carts located on various patient care units.
- Outdated equipment and supplies were not available for staff use in the crash carts for patient use during an emergency located on various patient care units.
These failed practices by the facility had the potential to negatively affect the health and safety of all patients admitted to various patient care units throughout the facility.
The facility census was one Acute Care patient, one Swing Bed (Swing Bed - a Medicare program in which a patient can receive acute care services, then if needed Skilled Nursing Home Care) patient and three Observation (Observation - outpatient services provided to a patient while the patient's physician decides whether to admit the patient to Acute Care services or to discharge the patient) patients for a total census of five.

Findings included:

1. Review of the facility's policy titled, "Crash Cart Management," dated 05/2022 in part showed staff directives: On the first of every month, the crash cart will be opened to check inventory and expiration dates of medications and supplies.

Review of the facility's titled, "Crash Cart," revised 08/2021, showed the direction for staff to check the crash carts for expired drugs and supplies.

ACCESSIBILITY OF MEDICAL-SURGICAL UNIT PEDIATRIC CRASH CART DRAWERS
2. Observation on 12/05/23 at 10:07, showed Staff O, Director of Quality/Hospital Educator, removed the red plastic locking key on the Medical-Surgical Unit's Pediatric Crash Cart. Staff O attempted to open the drawers that stored emergency medications and supplies; however; when Staff O tried to open the drawers, they would not open. Staff O pushed the bottom cover in to release the drawers; however; the drawers did not release and would not open. After approximately 10 minutes, Staff O was able to place the bottom cover completely in and the mechanism released the drawers and Staff O was able to open the drawers.

During an interview on 12/05/23 at 10:17 AM, Staff O, Director of Quality/Hospital Educator, acknowledged the pediatric crash cart drawers were not easily accessible. Staff O stated approximately 10 minutes to access the drawers that contained emergency medications and supplies was too long for staff to access the contents inside the drawers in an emergency.

RESPIRATORY BOXES
3. Observation on 12/05/23 at 10:20 AM, on the Medical-Surgical Unit showed expired equipment/supplies in the Pediatric/Infant Airway Respiratory Box:
- One BD 10-millimeter syringe luer-loc tip (BD syringe - used to provide a leak-free connection between needles and syringes used during medication administration) with lot #: 813868418 and expiration date 04/30/23.
- Two packages of Covidien Nellcor Pediatric Colorimetric c02 (carbon dioxide) Detector (used to verify endotracheal tube placement) with lot #203000407 and expiration date 10/20/22.
- Review of the paper document that listed the contents inside the box and the last date inspected for expired equipments/supplies taped on top of the Pediatric/Infant Airway Respiratory Box showed the last documented date the respiratory box was checked by staff was on 01/25/23.

During an interview on 12/05/23 at 10:20 AM, Staff O, Director of Quality/Hospital Educator stated the respiratory department staff was responsible for the Respiratory Boxes on top of crash carts located on various patient care units.

During an interview on 12/05/23 at 10:25 AM, Staff DD, Certified Respiratory Therapist (CRT), stated the Respiratory Boxes are checked by respiratory department staff every six months for outdates/expirations of equipment and supplies.

CRASH CARTS
4. Observation on 12/05/23 at 9:30 AM, in Operating Room (OR) #1's crash cart, showed four laboratory tubes with an expiration date of 05/2022.

Observation on 12/05/23 at 09:40 AM, in OR #2's crash cart, showed one Shiley 8.0 (tracheostomy tube, to maintain airway), with an expiration date of 08/28/23 and three laboratory tubes with expiration dates of 04/08/23.

Observation and concurrent interview on 12/05/23 at 10:33 AM, on the Medical-Surgical Unit showed expired equipment/supplies in the Adult Crash Cart:
- One Yankauer (oral suctioning tool used in medical procedures) suction tip with lot #1806484164 and expiration date 03/11/23.
- One Tegaderm film dressing with lot #334483 and expiration date 02/23/22.
- One Non-conductive suction tubing with lot #J18011038S and expiration date 01/01/23.
- One box that contained 4 X 4 gauze sponges with lot #18D019362 and expiration date 04/2023.
Staff O, Director of Quality/Hospital Educator, acknowledged the Medical-Surgical Unit's Adult Crash Cart contained expired equipment and supplies available to staff for use in an emergency.

Observation on 12/05/23 at 2:45 PM, on the Outpatient Services Unit, showed the crash cart had multiple supplies that were expired. The expired items included the following:
- Six out of six intravenous (IV, in the vein) start kits, expired on 10/30/22;
- One out of one central venous catheter (long, thin, flexible tube placed in a large vein and the end of the tube sits in a large blood vessel near to or in part of their heart, allowing multiple fluids to be given and blood to be drawn) kit, expired in 03/2022;
- One of one minor laceration (a deep cut or tear in skin) repair tray, expired on 02/16/22;
- 11 out of 11 intravenous catheters (IVC, small flexible tube inserted into a vein through the skin to deliver medications or fluids into the bloodstream), size 20 gauge, expired on 07/30/23;
- Six out of six IVCs, size 22 gauge, expired on 08/31/22; and
- Six out of six IVCs, size 24 gauge, expired on 12/31/22.




36473




46856

Based on observation, interview, nationally-recognized standards review and policy review, the hospital failed to have systemic practices in place to ensure:
- The containment and separation of the Sterile Processing clean room (room used to sterilize surgical instruments) from the exposure of contaminants.
- A sanitary environment was preserved through maintenance and cleaning that would not harbor bacteria and transmit infections in the Sterile Processing clean room, Sterile Processing decontamination room, two Operating Rooms (OR)s, Post-Anesthesia Care Unit (PACU), "dirty room," [used to clean intravenous (IV) pumps, poles and sequential compression devices (SCDs) located next to materials management) and the kitchen.
- Housekeeping staff terminally cleaned the two surgical ORs, Sterile Processing decontamination room and the Sterile Processing clean room each day the areas were used.
- Staff performed hand hygiene (washing hands with soap and water or use of appropriate hand sanitizer) when indicated when staff prepared medications, provided care and treatments to patients.
- Staff wore gloves when indicated and performed hand hygiene before gloving and after glove removal.
- Staff kept 24 out of 24 pediatric laryngoscope blades (a scope used for visualization of the vocal cords to place a tube in the windpipe to assist patient with breathing), and 14 out of 14 adult laryngoscope blades sealed in individual packaging available on and or inside the crash carts located in various patient care units throughout the facility.
- Staff maintained clean surfaces inside the Medical-Surgical Unit's Pediatric Crash Cart where emergency medical supplies, medications and equipment are stored.

The severity and cumulative effects of these systemic practices resulted in the hospital's non-compliance with 42 CFR 482.42 Condition of Participation: Infection Prevention and Control and Antibiotic Stewardship Programs and resulted in the hospital's failure to ensure quality health care and safety.

Please refer to A-0749 and A750 for details.

Based on policy review, nationally-recognized standards review, observation, and interview, the facility failed to ensure staff:
- Performed hand hygiene (washing hands with soap and water or use of appropriate hand sanitizer) when indicated when staff prepared medications, provided care and treatments to patients.
- Wore gloves when indicated and performed hand hygiene before gloving and after glove removal.
- Kept 24 out of 24 pediatric laryngoscope blades (a scope used for visualization of the vocal cords to place a tube in the windpipe to assist patient with breathing), and 14 out of 14 adult laryngoscope blades sealed in individual packaging available either on top or inside the crash carts located in various patient care units throughout the facility.
- Maintained clean surfaces inside the Medical-Surgical Unit's Pediatric Crash Cart where emergency medical supplies, medications and equipment are stored.
These failed practices had the potential to expose all patients, visitors, and staff to cross-contamination and increased the potential to spread infection. The facility census was one Acute Care patient, one Swing Bed (Swing Bed - a Medicare program in which a patient can receive acute care services, then if needed Skilled Nursing Home Care) patient and three Observation (Observation - outpatient services provided to a patient while the patient's physician decides whether to admit the patient to Acute Care services or to discharge the patient) patients for a total census of five.

Findings included:

HAND HYGIENE - GLOVE USE
1. Review of the facility's policy titled, "Hand Hygiene," dated 05/2022, in part showed staff directives:
- Hand hygiene is done to protect personnel, patients, residents, families, and visitors from the spread of infections.
- Personnel should always wash their hands or use hand sanitizer:
- Before and after having direct contact with patients (passing medications, taking a pulse, blood pressure, or lifting), even if gloves were used.
- Before and after the use of all gloves, sterile and non-sterile, and protective equipment.
- After contact with inanimate objects, including medical equipment, in the immediate vicinity of the patient.
- Gloves are not a substitute for hand hygiene. If the task requires gloves, perform hand hygiene:
- Prior to donning gloves, before touching the patient or the patient environment.
- Immediately after removing gloves.
- In between a glove change.

Observation on 12/05/23 at 9:00 AM, on the Medical-Surgical Unit showed Staff P, Registered Nurse (RN), prepared medications for Patient #27. Staff P failed to:
- Perform hand hygiene upon entry into the medication room, after typing on the automated medication dispensing system's (AMDS) keyboard, after retrieving the medications from the AMDS and before opening/removing each medication from the packaging.
- Perform hand hygiene before staff handled each pill and placed them into a medication cup.
- Perform hand hygiene after staff touched the patient's identification (ID) band to verify the patient was the correct patient and before gloving to administer the medications to the patient.

During an interview on 12/05/23 at 9:21 AM, Staff P, RN, stated staff was provided education/training on infection control prevention from the facility and the facility provided staff with a booklet that contained information of expectations of staff related to hand hygiene and glove use.

Observation on 12/05/23 at 2:20 PM, on the Medical-Surgical Unit, showed Staff G, RN, did not perform hand hygiene nor don gloves prior to administering an oral medication to Patient #3.

Observation on 12/06/23 at 8:52 AM, on the Medical-Surgical Unit showed Staff R, RN, prepared medications for Patient #27. Staff R failed to:
- Perform hand hygiene upon entry into the medication room, after typing on the AMDS's keyboard, after retrieving medication from the AMDS and before reconstituting an intravenous (IV- n the vein) antibiotic medication.
- Remove gloves and perform hand hygiene after staff touched the patient's ID band to verify the patient was the correct patient, before staff removed each pill from the package and handled each pill to place into a medication cup.
- Remove gloves, perform hand hygiene and re-glove to administer the medications to the patient.

Observation on 12/06/23 at 9:26 AM, on the Medical-Surgical Unit showed Staff R, RN, prepared and administered an IV medication for Patient #21. Staff R performed hand hygiene upon entry into the patient's room. Staff R gloved and touched the patient's ID band to verify the correct patient; however; after Staff R touched the patient's ID band, staff failed to remove gloves, perform hand hygiene and re-glove to administer the IV medication to the patient.

Observation on 12/05/23 at 9:00 AM, on the Outpatient Services Unit, showed Staff D, RN, did not perform hand hygiene prior to touching Patient #1 to obtain her vital signs (body temperature, blood pressure, heart rate, and breathing rate). Staff D did not perform hand hygiene before or after removing her gloves after cleaning the vital sign machine.

Observation on 12/05/23 at 10:05 AM, in the Rehabilitation Department, showed Staff F, Director of Rehabilitation, failed to perform hand hygiene before or after touching Patient #2 during his therapy session.

Observation on 12/05/23 at 1:20 PM, on the Medical-Surgical Unit, showed Staff F, Director of Rehabilitation, failed to perform hand hygiene after taking off her gloves after assisting Patient #3 to the bedside commode (portable toilet that does not use running water).

During an interview on 12/06/23 at 9:20 AM, Staff J, Interim Chief Nursing Officer and Infection Preventionist, stated she expected staff to perform hand hygiene upon entry/exit of patients' rooms, and wash their hands before touching a patient or anything in the patient's room.

Observation on 12/06/23 at 9:45 AM, on the Medical-Surgical Unit showed Staff R, RN, performed foley catheter (a small flexible tube inserted into the opening of the urinary tract to drain urine) care (process of cleaning around the insertion site of the catheter and the catheter tubing) for Patient #21. After Staff R cleansed the foley catheter site and tubing with soap, Staff R removed gloves; however; Staff R failed to perform hand hygiene after glove removal and before re-gloving to wash off the soap. At the completion of providing foley catheter care for the patient, Staff R removed gloves but failed to perform hand hygiene after glove removal.

During an interview on 12/06/23 at 9:58 AM, Staff R, RN, stated staff received infection control education and training from the facility. Staff R stated staff was expected to perform hand hygiene before and after gloves, upon entry/exit of patients' rooms, and after contact with patients.

LARYNGOSCOPE BLADES
2. Review of the Association of PeriOperative Registered Nurses (AORN), "Guideline for Cleaning and Care of Surgical Equipment and Materials," dated 2023, showed directives:
- After each use, clean reusable laryngoscope blades and high-level disinfect or sterilize them according to manufacturer's instruction for use (IFU).
- Clean and low-level disinfect reusable laryngoscope handles after each use. Reusable laryngoscope handles may be high-level disinfected or sterilized if specified in the manufacturer's IFU.
- Package and store reusable laryngoscope blades and handles that have been high-level disinfected or sterilized in a manner that prevents contamination and identifies them as ready for use.
Laryngoscope blades are semi-critical items according to the Spaulding Classification system and at a minimum should be high-level disinfected or sterilized if possible. The handle is considered non-critical and should be low-level disinfected according to the Spaulding Classification.

Observation on 12/05/23 at 9:30 AM, in Operating Room (OR) #1's crash cart, showed one unpackaged laryngoscope in the fifth drawer exposed to unclean items.

Observation on 12/05/23 at 10:00 AM, in OR #2's crash cart, showed one unpackaged laryngoscope in the fifth drawer exposed to unclean items.

Observation on 12/05/23 at 10:20 AM, on the Medical-Surgical Unit showed the Pediatric/Infant Airway Respiratory Box (secured boxes with emergency airway supplies/equipment) on top of the Pediatric Crash Cart contained four Curved laryngoscope blades sized #00, #1, #2 and #3 and four Straight blade laryngoscope blades sized #0, #1, #2, and #3 for a total of eight laryngoscope blades. The laryngoscope blades were located in a green cloth rescue laryngoscope blade carrying case; however; all eight blades were not sealed in individual packaging to keep the blades free from contamination.

During an interview on 12/05/23 at 10:30 AM, Staff O, Director of Quality/Hospital Educator stated the Respiratory Boxes located on top of crash carts throughout the facility was the responsibility of the respiratory department staff.

Observation on 12/05/23 at 10:33 AM, on the Medical-Surgical Unit showed the Adult Airway Respiratory Box located on top of the Adult Crash Cart contained two Miller Laryngoscope blades sized #3 and #4 and two Macintosh laryngoscope blades sized #3 and #4 for a total of four laryngoscope blades. The laryngoscope blades were located in a green cloth rescue laryngoscope blade carrying case; however; the four blades were not sealed in individual packaging to keep the blades free from contamination.

Observation on 12/05/23 at 3:00 PM, on the Outpatient Services Unit showed the Pediatric/Infant Airway Respiratory Box contained four Curved laryngoscope blades sized #00, #1, #2 and #3 and four Straight blade laryngoscope blades sized #0, #1, #2, and #3 for a total of eight laryngoscope blades. The laryngoscope blades were located in a green cloth rescue laryngoscope blade carrying case; however; all eight blades were not sealed in individual packaging to keep the blades free from contamination.

Observation on 12/05/23 at 3:10 PM, on the Outpatient Services Unit, the Adult Airway Respiratory Box located on top of the Adult Crash Cart contained two Miller Laryngoscope blades sized #3 and #4 and two Macintosh laryngoscope blades sized #3 and #4 for a total of four laryngoscope blades. The laryngoscope blades were located in a orange cloth rescue laryngoscope blade carrying case; however; the four blades were not sealed in individual packaging to keep the blades free from contamination.

During an interview on 12/07/23 at 3:14 PM, Staff W, Director of Respiratory Therapy Services, stated:
- The Respiratory Boxes located on top of crash carts was the responsibility of the respiratory department staff.
- The Respiratory Boxes are checked at least every six months and on an as needed basis.
- The facility maintained three Pediatric/Infant Airway and three Adult Airway Respiratory Boxes for a total of six Respiratory Boxes.
- Laryngoscope blade(s) will be autoclaved after the blade has been used for a patient; however; the laryngoscope blades are not routinely autoclaved.
- The 24 pediatric laryngoscope blades and 12 adult laryngoscope blades inside the cloth rescue carrying cases located inside the Respiratory Boxes were not individually sealed.
- The two laryngoscope blades located inside the OR's crash carts were not individually sealed.

Crash Cart Cleaning
Review of the facility's policy titled, "Crash Cart Management," dated 05/2022, showed staff directives:
- To provide guidelines for nursing personnel on managing the crash cart on each nursing unit.
- It is the responsibility of all nursing personnel to abide by these guidelines.
- The sharps containers, supplies, and all equipment located on the crash cart will be checked at the beginning of every shift. The crash cart will also be cleaned and restocked as necessary.
- The equipment and medical supplies on the crash cart will be checked at the beginning of each shift. The cart shall be cleaned and restocked after each use.

Observation on 12/05/23 at 10:07 AM, on the Medical-Surgical Unit showed the bottom shelf on the Pediatric Crash Cart contained a moderate amount of dust and dirt build-up on the surface.

During an interview on 12/05/23 at 10:15 AM, Staff O, Director of Quality/Hospital Educator, acknowledged the dust and dirt build-up located on the bottom shelf of the Pediatric Crash Cart located on the Medical-Surgical Unit.


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46856

Based on observation, interview, nationally-recognized standards, and policy review, the hospital failed to ensure:
- The containment and separation of the Sterile Processing clean room (room used to sterilize surgical instruments) from the exposure of contaminants.
- A sanitary environment was preserved through maintenance and cleaning that would not harbor bacteria and transmit infections in the Sterile Processing clean room, Sterile Process decontamination room, two Operating Rooms (OR)s, Post-Anesthesia Care Unit (PACU), "dirty room," [used to clean intravenous (IV) pumps, poles and sequential compression devices (SCDs) located next to materials management) and the kitchen.
- Housekeeping staff terminally cleaned the two surgical ORs, Sterile Processing decontamination room and the sterile processing clean room each day the areas were used.
These failures had the potential to expose patients, visitors and staff to cross-contamination and increased the potential to spread infection. The facility census was one Acute Care patient, one Swing Bed (Swing Bed - a Medicare program in which a patient can receive acute care services, then if needed Skilled Nursing Home Care) patient and three Observation (Observation - outpatient services provided to a patient while the patient's physician decides whether to admit the patient to Acute Care services or to discharge the patient) patients for a total census of five.

Findings included:

Containment and Separation
1. Review of the American National Standards Institute (ANSI) and Association for the Advancement of Medical Instrumentation (AAMI) document titled, "ANSI/AAMI ST79:2017, Comprehensive Guide to Steam Sterilization and Sterility Assurance in Health Care Facilities," dated 2017, showed the Sterilization area should be:
- A designated area located within the clean work room;
- Be designed so that material flows from the preparation and packaging area to the sterilization area and then on to sterile storage or distribution;
- Allow space for all methods of sterilization; the staging and loading of sterilizer carts; the storage of long, heat-resistant gloves, sterilizer cleaning supplies, and record-keeping supplies; and handwashing stations;
- Provide a holding area for load cooling on sterilizer carts;
- In a restricted-access area and not in high-traffic areas or near any potential sources of contamination
Segregation of clean/sterile items during transport, clean/sterile items should be contained and segregated from contaminated items.

Observation on 12/05/23 at 10:00 AM, in the Sterile Processing clean room, showed no designated area separating the clean room from contaminated areas (materials management, a high traffic department that processed the planning and control of material flow of hospital supplies, inventory and material distribution).

During a telephone interview on 12/13/23 at 4:00 PM, Staff X, Director of the OR, stated staff was unaware the Sterile Processing clean room lay out was wrong.

During a telephone interview on 12/13/23 at 9:00 AM, Staff J, Interim Chief Nursing Officer/previous Infection Preventionist, stated they followed AORN, CMS and CDC and thought the layout of the Sterile Processing clean room was ok since it was on the opposite side of the room.

During a telephone interview on 12/13/23 at 4:30 PM, Staff EE, Medical Director of the OR, stated staff was not aware the Sterile Processing clean room was not contained and open to Materials Management.

Sanitary Environment
2.Review of the Association for Professionals in Infection Control and Prevention (APIC), "Infection Preventionists Guide to the Operating Room," dated 2018, showed the operating room environment required surfaces that were smooth, cleanable, non-absorptive, and capable of withstanding cleaners and disinfectant solutions with no cracks and crevices where dirt can become trapped. Other materials (e.g., vinyl) can rip or wear in ways that create environmental reservoirs for microorganisms.

Review of the facility's policy titled, "Maintenance," revised on 09/2022, showed the direction for the maintenance department to maintain all walls, ceilings and peeling wall surfaces to provide a sanitary environment.

Review of the facility's policy titled, "Dietary," revised 09/2022, showed the direction for staff to:
- Clean floors after each meal or as needed;
- Clean ceilings and walls on a routine basis;
- Clean refrigerators daily;
- Clean Freezers weekly and monthly.

Observation on 12/05/23 at 10:05 AM, in the Sterile Process clean room, approximated five feet from the sterilizer (machine that uses steam under pressure to kill harmful bacteria, viruses, fungi and spores), showed:
- A bucket on a countertop catching water drainage from the ceiling;
- A large stained ceiling tile above the bucket; and
- Mold (a fungus with the potential to cause respiratory conditions) spots in the middle of the ceiling tile.

Observation on 12/05/23 at 9:15 AM, in OR #1, showed:
- Three carts with 12 rusted (reddish-brown oxidation of metal that can harbor bacteria) wheels;
- Old tape marks (sticky substance that can harbor bacteria) on the arm of the procedure bed;
- Rust spots on one stainless steel ceiling tile;
- Two surgical light arms with the covering off on corners with exposed wires; and
- Unclean floors.

Observation on 12/05/23 at 9:30 AM, in the Sterile Processing decontamination room, showed two rusted tape dispensers and one cart with four rusted wheels.

Observation on 12/05/23 at 9:40 AM, in OR #2, showed one cart with four rusted wheels, wall damage on full length of left wall and unclean floors.

Observation on 12/05/23 at 10:30 AM, in PACU, showed ceiling damage and one door damaged.

Observation on 12/05/23 at 10:10 AM, in the Materials Management "dirty room," showed wall damage around two soap dispensers and two rusted and molded vents.

Observation on 12/04/23 at 2:00 PM, in the kitchen, showed:
- Two carts with eight rusted wheels;
- Wall damage (pulled away with particle shedding);
- Ceiling stainage;
- Unclean floors with rust in the cracks;
- Rust inside convection oven;
- Ceiling above hood had large crack and soilage;
- Unclean with oil residue to the right of the deep fryer;
- Rust spots on ceiling;
- Clean dish cart with four rusted wheels;
- Large soiled rusted area in the ceiling in the serving area;
- Sprinklers rusted;
- Broken dishwasher;
- Rust and mold in one cooler;
- Rust in one cooler and two freezers;
- One wall in one cooler covered with ice.

During an interview on 12/07/23 at 1:08 PM, Staff K, Dietary Manager, stated the dietary staff made environmental rounds and provided results to the administrative staff and felt they were short staffed.

During an interview on 12/13/23 at 9:00 AM, Staff J, Interim Chief Nursing Officer/previous Infection Preventionist, stated they had made observations in the kitchen approximately six months ago and saw no mold or rust. Staff J stated they never went into the walk-in coolers and freezers.

Terminal Cleaning
3. Review of the Association of PeriOperative Registered Nurses (AORN) "Guideline for Environmental Cleaning," dated 2023, showed the direction to terminally clean operating rooms and sterile processing areas each day the areas were used.

Review of the facility's policy titled, "Housekeeping Services," revised on 08/2021, showed cleaning schedules and project cleaning schedules should be maintained by the Housekeeping Department and the OR Supervisor was responsible for seeing the needs were met.

Although requested, the facility failed to provide cleaning logs for the two ORs and Sterile Processing clean rooms.

During an interview on 12/13/23 at 4:00 PM, Staff X, Director of the OR, stated staff was unaware there was no housekeeping cleaning log.

During an interview on 12/06/23 at 3:00 PM, Staff FF, Director of Housekeeping, stated housekeepers failed to log their terminal cleans and in the past had addressed with leadership about the Sterile Processing clean room being open to Materials Management, making it unable to terminally clean.

During an interview on 12/13/23 at 9:00 AM, Staff J, Interim Chief Nursing Officer/previous Infection Preventionist, stated they were unaware there were no terminal cleaning logs and previously observed surgical procedures and did not observe the Sterile Processing rooms.

Based on interviews, the facility failed to ensure the tracking and surveillance of hospital-wide infections. These failures to identify systemic patterns of patient infections, had the potential to have continued exposure for all patients, visitors and staff to cross-contamination and increased the spread of infection. The facility census was one Acute Care patient, one Swing Bed (Swing Bed - a Medicare program in which a patient can receive acute care services, then if needed Skilled Nursing Home Care) patient and three Observation (Observation - outpatient services provided to a patient while the patient's physician decides whether to admit the patient to Acute Care services or to discharge the patient) patients for a total census of five.

Findings included:

Although requested, the facility failed to provide a log of surgical-site infections for the past year.

Observation between 12/04/23 through 12/07/23, showed staff failures to provide:
- The containment and separation of the Central Sterile clean room (room used to sterilize surgical instruments) from the exposure of contaminants.
- A sanitary environment was preserved through maintenance and cleaning that would not harbor bacteria and transmit infections in the Central Sterile clean room, Central Sterile decontamination room, two Operating Rooms (OR)s and the Post-Anesthesia Care Unit (PACU).
- Terminal cleaning of the two surgical ORs, Central Sterile decontamination room and the central sterile clean room each day the areas were used.
These failures increased the potential of surgical-site infections and an increased need to log surgical-site infections.

During an interview on 12/13/23 at 4:00 PM, Staff X, Director of the OR, stated they were unaware the Infection Preventionist was not tracking surgical-site infections.

During an interview on 12/06/23 at 4:00 PM, Staff K, Interim Chief Nursing Officer/previous Infection Preventionist, stated they did not track surgical-site infections

EGBased on policy review and record review, the hospital failed to specify the required time frame in their policy for organ donation to notify the Organ Procurement Organization (OPO) of the death of a patient and failed to notify the OPO within the time frame specified in the contract for two patients (#13 and #14) out of five discharged death records reviewed. This could adversely affect the suitability of organ donors. The facility census was one Acute Care patient, one Swing Bed (Swing Bed - a Medicare program in which a patient can receive acute care services, then if needed Skilled Nursing Home Care) patient and three Observation (Observation - outpatient services provided to a patient while the patient's physician decides whether to admit the patient to Acute Care services or to discharge the patient) patients for a total census of five.

Findings included:

1. Review of the hospital's policy titled, "Vital Organ and Tissue Donation," dated 06/2022, showed that in the event of a hospital death, the opportunity to donate organs and/or tissue will be offered to the next-of-kin for suitable candidates for organ/tissue donation. The request for donation will be made by representative of Mid-America Transplant. The nurse assigned to the deceased will call Mid-America Transplant and report the death. There was no designated time frame within the policy to guide staff on when to call Mid-America Transplant.

2. Review of the hospital's document titled, "Statement of Agreement Between Pemiscot Memorial Health Systems and Mid-America Transplant," dated 08/28/23, showed that referrals are made in a timely manner so that an on-site evaluation can be conducted by a Mid-America Transplant representative to determine the medical and behavioral suitability of the referral prior to consultations. Timely manner is defined as within 90 minutes of death.

3. Review of Patient #13's medical record showed the following:
- Patient #13 was a three-month-old male who presented to the ED via ambulance on 10/13/23 at 12:47 AM. The patient was in cardiac arrest (when the heart suddenly and unexpectedly stops pumping) and Cardiopulmonary Resuscitation (CPR, emergency life-saving procedure performed when a person's breathing or heartbeat has stopped) was in progress.
- At 1:16 AM, the patient was pronounced dead by the physician.
- At 4:30 AM, Mid-America Transplant was contacted.
- The total time between time of death and contacting Mid-America Transplant was three hours and 14 minutes.

4. Review of Patient #14's medical record showed the following:
- Patient #14 was a 42-year-old male who presented to the Emergency Department (ED) via ambulance on 11/28/23 at 9:30 AM. The patient was alert and oriented times three (to be aware of who you are, where you are, and the approximate time). The patient stated "I can't breathe." Upon pulse check, no pulse was found. CPR was initiated.
- At 10:14 AM, the patient was pronounced dead by the physician.
- At 12:15 AM, Mid-America Transplant was contacted.
- The total time between time of death and contacting Mid-America Transplant was two hours and one minute.

Based on observation, interview, record review and nationally-recognized standards review, the facility failed to provide policies and staff education to ensure staff followed guidelines for the Sterile Processing Department (SPD, where contaminated surgical equipment and instruments are cleaned), packaging of sterile instruments, fire risk assessments prior to surgical procedures and terminal cleaning requirements. This had the potential to lead to high levels of bioburden (the number of bacteria living on a surface that has not been sterilized) remaining on the surgical instruments which could lead to contamination, surgical patient infections or surface breakdown of the instruments and placed surgical patients and staff at an elevated fire risk.

These failed practices had the potential to compromise the safety and health of all patients undergoing procedures at the facility. The facility performed approximately 60 procedures per month.

The cumulative effect of these failures resulted in non-compliance with 42 CFR 482.51 CoP Surgical Services.

Please refer to A-0951 for further details.

Based on observation, interview, record review and nationally-recognized standards review, the facility failed to provide policies and staff education to ensure staff followed guidelines for the Sterile Processing Department (SPD, where contaminated surgical equipment and instruments are cleaned), packaging of sterile instruments, fire risk assessments prior to surgical procedures and terminal cleaning requirements. This had the potential to lead to high levels of bioburden (the number of bacteria living on a surface that has not been sterilized) remaining on the surgical instruments which could lead to contamination, surgical patient infections or surface breakdown of the instruments and placed surgical patients and staff at an elevated fire risk. The facility census was one Acute Care patient, one Swing Bed (Swing Bed - a Medicare program in which a patient can receive acute care services, then if needed Skilled Nursing Home Care) patient and three Observation (Observation - outpatient services provided to a patient while the patient's physician decides whether to admit the patient to Acute Care services or to discharge the patient) patients for a total census of five.
.
Findings included:

Policies and Staff Education
1. Review of the American National Standards Institute (ANSI) and Association for the Advancement of Medical Instrumentation (AAMI) document titled, "ANSI/AAMI ST79:2017, Comprehensive Guide to Steam Sterilization and Sterility Assurance in Health Care Facilities," dated 2017, showed the sterile processing staff responsibility for sterile processing should be assigned to qualified individuals who have demonstrated competence in all aspects of sterile processing, including biohazard transportation, decontamination, preparation, packaging, sterilization, sterile storage, and distribution of sterile medical devices. Qualifications include demonstrated knowledge of and documented competence in:
- All aspects of decontamination, including sorting, disassembly/reassembly, manual and mechanical cleaning methods, microbicidal processes, equipment operation, standard and transmission-based precautions, and engineering and work-practice controls;
- The principles of sterilization and infectious disease transmission; infection prevention and control; and all aspects of steam sterilization (including decontamination, inspection, and packaging of items to be sterilized, sterilizing procedures, equipment operation, and safety precautions);
- Worker safety as it relates to medical device processing and sterilization;
- All personnel performing sterile processing activities should be certified within two years of employment and should maintain that certification throughout their employment.

Although requested, the facility failed to provide sterile processing policies for staff guidance and failed to provide any documented education for the sterile processing staff.

During an interview on 12/13/23 at 9:00 AM, Staff J, Interim Chief Nursing Officer and previous Infection Preventionist, stated that they followed AORN, CMS and CDC.

Observation on 12/05/23 at 10:00 AM, in the Sterile Processing clean room, showed the materials management staff performed sterile processing duties without personal protection equipment (PPE) and Staff Z, Director of Materials Management, stated the materials management staff were in charge of the sterile processing clean room.

During an interview on 12/06/23 at 2:00 PM, Staff H, Chief Executive Officer (CEO), stated they were unaware that the Sterile Processing staff had pulled staff from materials management to perform Sterile Processing and the materials management staff had no required education or required certification.

Sterile Packaging
2. Review of the Association of PeriOperative Registered Nurses (AORN) "Guideline for Sterilization Packaging Systems," dated 2023, showed unless otherwise specified in the manufacturer's IFU, when double pouching, place the sealed inner pouch within the outer pouch without folding it and facing the same direction as the outer pouch (i.e., plastic or polyester film faces plastic or polyester film, and paper or polyethylene material faces paper or polyethylene material). Folding the sealed inner pouch may entrap air and inhibit sterilant contact and can lead to polyethylene material seal failure at the fold.

Observation on 12/05/23 at 9:30 AM, in OR #1, showed five long hemostatic forceps (used to clamp blood vessels to stop blood flow) double packaged, with the inner pouch folded over.

Although requested, the facility failed to provide a sterile packaging policy for staff guidance.

During an interview on 12/13/23 at 4:00 PM, Staff X, Director of the Operating Room (OR), stated they were unaware of not being able to fold double pouches.

Fire-Risk Assessment
3. Review of the Association of PeriOperative Registered Nurses (AORN) "Guideline for Fire Prevention Practices," dated 2023, showed the direction for staff to:
- Perform a fire-risk assessment as part of the preprocedural briefing process, to include ignition, fuel, and oxidizer sources present in the OR.
- Include cognitive aids (eg, algorithms, checklists).
- Collaborate on and implement interventions based on the fire-risk assessment.
- Document the fire-risk and the actions taken to address them.
- Prevent contact between fuel sources (eg, drapes, skin antisepsis agents) and ignition sources (eg, electrosurgical devices).
- Prevent pooling of flammable skin antiseptic agents under, on, or near the patient.
- Prevent the pooling of flammable antiseptic agents by:
o placing sterile or clean towels near the surgical preparation site to absorb excess solution from pooling;
o using sterile towels to absorb excess solution from the prepped site;
o removing materials (eg, sterile or clean towels) that become wet with the skin preparation solution before draping; and
o moving flammable antiseptic soaked materials away from ignition sources and outside of the patient care vicinity (ie, at least 6 ft away).
- Allow the skin antiseptic agent to dry before applying surgical drapes. Follow the manufacturer's IFU for dry time.
- Use a water-soluble gel for the patient's head and hair when performing procedures that involve the head of neck.
- Use moistened radiopaque sponges near oxidizer and ignition sources during airway procedures.
The operating room contains several elements of the fire triangle, including oxygen (oxidizer), lasers and electrosurgical devices (ignition sources), and alcohol-based skin antiseptics and surgical drapes (fuel). The perioperative team can help reduce the risk of fire by performing a fire risk assessment and implementing interventions (eg, preventing contact between fuel sources and ignition sources) based on that assessment.

Observation on 12/07/23 at 8:13 AM, for Patient #45, in OR #1, showed prior to a skin removal with biopsy surgical procedure, staff failed to perform a fire-risk assessment.

Review of discharged surgical Patients #39, #40, #41, #42, #43 and #44 medical records, showed no fire-risk assessments performed prior to their surgeries.

Although requested, the facility failed to provide a policy with fire risk assessment guidance for staff.

During an interview on 12/13/23 at 4:00 PM, Staff X, Director of the OR, stated she was unaware they needed to document fire-risk assessments.

During an interview on 12/13/23 at 4:30 PM, Staff EE, Medical Director of the OR, stated the staff was performing the fire-risk assessments and not documenting them.

Terminal Cleaning
4. Review of the Association of PeriOperative Registered Nurses (AORN), "Guidelines for Terminal Cleaning," dated 2023, showed the direction for staff to:
- Terminally clean operating and procedure rooms each day the rooms are used.
- Clean and disinfect the exposed surfaces, including wheels and casters, of all items:
o anesthesia carts, including the top and drawer handles
o anesthesia equipment
o anesthesia machines, including dials, knobs, and valves
o patient monitors, including cables
o OR beds
o reusable table straps
o OR bed attachments
o positioning devices
o patient transfer devices
o overhead procedure lights
o tables and Mayo stands
o mobile and fixed equipment
o storage cabinets, supply carts, and furniture
o light switches
o door handles and push plates
o telephones and mobile communication devices
o computer accessories (eg, keyboards, mouse, touch screen)
o chairs, stools, and step stools
o trash and linen receptacles
- Clean and disinfect the entire floor, including areas under the OR bed and mobile equipment, using either a wet vacuum or mop.
Terminal cleaning is thorough environmental cleaning performed at the end of each day the room or area is used. It is not necessary to perform terminal cleaning or close the OR after a contaminated or dirty/infected procedure (ie, Class III, Class IV). Enhanced environmental cleaning should be performed If the patient is infected with a multidrug-resistant organism (MDRO).

Although requested, the facility failed to provide a terminal cleaning log for the two operating rooms (ORs) and the sterile processing rooms.

Although requested, the facility failed to provide a terminal cleaning policy.

During an interview on 12/06/23 at 3:00 PM, Staff FF, Director of Housekeeping, stated housekeepers failed to log their terminal cleans.

During an interview on 12/13/23 at 4:00 PM, Staff X, Director of the OR, stated they were unaware there were no terminal cleaning logs for the ORs and Sterile Processing rooms.