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Based on observation, interview, and record review, the facility failed to ensure the hospital's infection control program was maintained, methods to prevent the transmission of infections were employed within the hospital, sanitary environmental conditions were maintained, necessary training was provided to staff, and infection control and prevention practices were implemented in accordance with the facility's policy and procedure and the standards of practice when:

1. Contract personnel (Vendors) entered the Neonatal Intensive Care Unit (NICU, unit for critically ill newborn patients) and did not perform hand hygiene (any action of hand cleansing to physically or mechanically remove dirt, organic material, or microorganisms [bacteria that is microscopic]) (A 0749);

2. The manufacturer's guidelines were not implemented for sanitizing and disinfecting food contact surfaces prior to preparing infant formula (A 0749);

3. The manufacturer's guidelines were not implemented for disinfecting an isolation room (A 0749);

4. The environmental service (EVS) staff did not follow the manufacturer's instructions for use (IFU) on cleaning the NICU (A 0749);

5. An opened single use bottle of water was stored on Patient 6's bedside table (A 0749);

6. There was grey fuzzy matter and black matter throughout the floors; grey fuzzy matter on the wall vents; orange-brown spots surrounding the examination tables; two suction cannisters contained a red and blackish substance; one suction tube was on the floor; several pieces of tape attached to the floor that contained grey and black fuzzy matter; and orange-brown matter on the intravenous (IV, into the vein) pole's casters for two of two sampled obstetrics operating rooms (OBOR 1 and OBOR 2, ORs used for labor and delivery). OBOR 1 and OBOR 2 had been cleaned and were designated as ready for patient use (A 0750);

7. There was brown and black spots scattered throughout the floor; black stains on the wall's baseboard; brownish matter was on the IV pole's caster and hamper casters; debris on the floors; thick grey fuzzy matter behind the anesthesia carts; tape with greyish, black matter attached to IV poles and medication carts; thick grey fuzzy matter on the wall vents; used cover gowns and three expired opened packages of sterile gloves stored on a shelf; one missing baseboard that created a hole in the wall; one torn arm board and one ripped mattress for two of four sampled operating rooms (OR 4 and OR 6). OR 4 and OR 6 had been cleaned and were designated as ready for patient use (A 0750);

8. The anesthesia (medications used to prevent patients from feeling pain during surgical procedures) cart contained an opened single-use packet of electrocardiogram leads (EKG, electrode pads used to connect a patient to a heart monitor/recorder); one opened Yankauer suction tip (an oral suctioning tool used in medical procedures); brown tape and several pieces of clear tape with grey fuzzy matter; several pieces of clear tape with greyish, black matter attached to the IV pole; two gas tops stored on top of the anesthesia cart with grey fuzzy matter; and debris observed under and behind the anesthesia cart for one of four sampled anesthesia work areas (AOR 6). AOR 6 had been cleaned and was designated as ready for patient use (A 0750);

9. Two corrugated cardboard boxes were stored in the clean utility room (A 0750);

10. 49 of 49 sampled emergency eye-wash stations and showers were not inspected or flushed weekly (A 0750);

11. Two biohazard sharp containers (a regulated waste container used to store needles, glass, and sharp objects contaminated with blood and/ or body fluid) were not in use and were not closed for two of four sampled operating rooms (OR 3 and OR 5) (A 0750);

12. The sterile processing department (SPD, an area within a health care facility that processes and controls medical supplies, devices, and equipment, sterile and not sterile, for some or all patient care areas of the facility) clean work area's carts had torn wheels and the cart's casters were covered with thick brown-orange matter. The carts had been cleaned and designated as ready for patient use; two of three sampled autoclaves (a machine that uses steam under pressure to kill harmful germs) contained orange-brown matter on the base of the chamber; four of four sampled ceiling air vents had brown stains and were covered with grey fuzzy matter; the floor contained grey fuzzy matter, black and brown stains, and debris throughout the SPD's clean work area with an increase amount of staining and debris near the washers (A 0750);

13. The SPD's decontamination work area water drain was filled with debris, stains, and contained black fuzzy matter; two of two sampled washers had brown and orange matter on the base of the chambers; the decontamination work area floor had a large amount of scattered grey fuzzy matter, debris, and black/brown stains. The decontamination work area had been terminally cleaned (a thorough environmental cleaning procedure that is performed at the end of each day when the area is being used) (A 0750);

14. The hospital did not follow the nationally recognized infection prevention and control regulatory requirement for a hand washing sink in the decontamination work area (A 0750);

15. The hospital did not follow the hospital's protocol or the nationally recognized infection prevention and control guidelines for unidirectional functional workflow (operating or moving in one direction only: not changing directions (A 0750);

16. The hospital did not follow the hospital procedure or the nationally recognized infection prevention and control guidelines on cleaning surgical instruments (A 0750);

17. The manufacturer's instructions for use (IFU) were not followed for cleaning the endoscope (a medical device used to view the inside of organs) (A 0750);

18. EOC rounds were not implemented, for two of five sampled departments (the surgical service department including the operating rooms [OR] and the sterile processing department [SPD]).

19. 19 vials of outdated medications were observed stored in the cardiovascular perfusion specialty cart (CPSC, a cart used to store CP supplies) available for patient use (A 0775);

20. Five corrugated cardboard boxes were stored in the CPSC and the CPSC and supplies were ready for patient use (A 0775);

21. CP equipment was not disinfected between patient cases and the equipment was designated as "clean" and ready for patient use (A 0775);

22. The hospital did not implement the contract service agreement for staff orientation (A 0775);

23. Infection control and prevention practices were not monitored and performance improvement measures and indicators were not placed to track incidents of breaches on infection control and prevention practices (A 0263 and A 0283);

24. The hospital did not evaluate SpecialtyCare Cardiovascular Resources, LLC, services at least annually (A 0084);

25. There was no signed Service Agreement between "SpecialtyCare Cardiovascular (having to do with the heart or blood vessels) Resources, LLC, and the hospital, since February 28, 2023 (A 0084); and

26. The Governing Body (GB) failed to maintain a complete list of contract services when the hospital did not have a written contract agreement for cardiovascular perfusion (a process for the passage of blood through the circulatory system to an organ or tissue) services (A 0085).

The cumulative effect of these systemic problems resulted in the facility failure to ensure the governing body was effective in carrying out its responsibilities for the conduct of the facility which resulted in substandard infection prevention services and had the potential for further injury and prolonged hospitalization for patients.

Based on interview and record review, the hospital failed to ensure contracted services were evaluated annually, for one of two sampled contracted services (SpecialtyCare Cardiovascular [related to the heart and blood vessels] Resources), when,

1. The hospital did not evaluate SpecialtyCare Cardiovascular Resources, LLC, services at least annually; and

2. There was no signed Service Agreement between "SpecialtyCare Cardiovascular Resources, LLC, and the hospital, since February 28, 2023.

These failures resulted in substandard infection prevention services and safety services for all patients requiring cardiovascular perfusion within the hospital and had the potential for further injury and prolonged hospitalization for the patients.

Findings:

A review of the hospital's "Bylaws Governing: The Board of Trustees," dated July 25, 2018, included the following:

"...Article VII. Section 7.4. Management of the Environment of Care: 7.4.1. The Board shall oversee the planning and implementation of methods for providing for the safety, protection, and care of hospital patients and others, and ensure allocation of appropriate resources to maintain a safe secure environment...

...Article VII. Section 7.6 Contracted Services:

7.6.1: The Board shall provide mechanisms to ensure that services provided under contract are in compliance with all applicable HIPAA [Health Insurance Portability and Accountability Act, privacy regulation] requirement, HHS/CMS [Department of Health and Human Services/ Centers for Medicare & Medicaid Services, United States Government Agencies] Conditions of Participation, regulations...and any pertinent laws, regulations, or standards for the contracted service.

7.6.2: The Board shall ensure that contracted services are performed safely and effectively through implementation and participation of contracted services in the performance improvement program, and through mechanisms used to ensure that contracted service staff members are qualified and competent..."

During an interview with the Infection Control Director (ICD), on June 6, 2023, at 9:20 a.m., in the conference room (CR), the ICD stated the hospital followed the following nationally recognized guidelines:

A. Centers for Disease Control and Prevention (CDC, the national public health agency of the United States);

B. Association of periOperative (around the time of surgery) Registered Nurses (AORN, a nationally recognized infection control guidelines for perioperative areas);

C. Occupational Safety and Health Administration (OSHA, a large regulatory agency of the United States Department of Labor);

D. ANSI/AAMI ST79 (2017) (American National Standards/Association for the Advancement of Medical Instrument, standards development organizations) Comprehensive Guide to Steam Sterilization and Sterility Assurance in Healthcare Facilities; and

E. Association for Professionals in Infection Control and Epidemiology (APIC, professional association for infection prevention).

1. A review of the Contractor's document titled, "SpecialtycareClinical Competency-Perfusion (the process of the passage of blood through the circulatory system to an organ or tissue)," dated January 26, 2023, indicated the Contractor evaluated Cardiovascular Perfusionist (CP) 1 received the following score "3-Exceeds Performance Standard," under the following topics:

- "13. Termination/Post Procedure: Environmental Care: Cleans all equipment according to the facility and manufacturer's guidelines."

- "6. Demonstrates awareness of patient safety procedures and standards: Follow performance standards: Safety; Medical equipment."

- "8. Administers Medications per Protocol."

An observation was conducted of the termination/post procedure cleaning practices for the cardiovascular perfusion (CP) equipment (equipment used for the perfusion of the heart and lungs) and the CP work area on June 8, 2023, at 1:05 p.m., in OR (operating room) 5. CP 1 was observed wiping the equipment and the CP work area with Pre-Klenz (a pre-treatment solution).

During an interview conducted with CP 1 on June 8, 2023, at 1:05 p.m., in OR 5, CP 1 stated he had disinfected the CP equipment and the CP work area with Pre-Klenz. CP 1 was observed to read the manufacturer's instructions for use (IFU) on the Pre-Klenz bottle's label and stated the IFU did not indicate Pre-Klenz was a disinfectant. CP 1 stated he was certain that Pre-Klenz was the hospital's approved disinfectant, and he did not know how long the Pre-Klenz solution took to kill microorganisms (an organism that is microscopic such as bacteria). CP 1 confirmed that he did not receive education and training on the hospital's approved disinfectants and stated, "If the disinfectant is in the hospital, it must be an approved hospital disinfectant."

An observation of the cardiovascular perfusion specialty cart (CPSC) was conducted with ICP (Infection Control Preventionist) 1, the SSD (Surgical Services Director), and the Assistant Vice President of Infection Control (AVPIC), on June 7, 2023, at 11:30 a.m., in OR 5. The following medications were observed in the CPSC:

A tour of Operating Room (OR) 5 was conducted with Infection Control Preventionist (ICP) 1, ICP 2, the Surgical Services Director (SSD), and the Assistant Vice President of Infection Control (AVPIC), on June 7, 2023, at 11:30 a.m.. The following medications were observed in the CPSC:

a. Seven out eight sampled vials containing Spyagent Green (an imaging agent used to visualize blood flow and tissue perfusion) labels indicated an expiration date of April 2023. The outdated medications were available for patient use; and

b. 12 out of 13 sampled vials containing Amiodaron Hydrochloride (medicine used to treat abnormal heart rhythms) labels indicated an expiration date of March 2023.

During an interview conducted with CP 1, on June 8, 2023, at 1:20 p.m., CP 1 stated he was aware the medications in the CPSC. CP1 stated the medications "May have expired." CP 1 stated he kept all unused medications, and he only checked for expired medication on a quarterly basis. CP 1 stated he routinely checked medications quarterly for expiration dates and if a medication expired before the designated quarterly check date, he stated, "I just keep it." CP 1 stated again, "I only remove expired medications from my cart quarterly." CP 1 stated if medications in the CPSC expired, "It would just be unfortunate." CP 1 clarified his statement and stated, "It would be unfortunate for the patient." CP 1 stated he did not know the hospital's policy for returning unused medications to the pharmacy because he did not follow the hospital's policy, he followed his company's (SpecialtyCare Cardiovascular Resources, LLC, limited liability company) protocols for medication storage.

During an interview conducted with the ICD and the Accreditation Director (AD), on June 8, 2023, at 2:30 p.m., in the conference room, the ICD nor the AD could not explain who was responsible for ensuring CPs received hospital specific competency-based training, education, and/or orientation on providing safe patient care services within the hospital.

There was no documented evidence that showed the hospital evaluated CP 1 annually on the following hospital's contract services criteria:

- The hospital's infection control plan which included disinfecting equipment between patients and/or cleaning and maintaining the CP's work area space for patient safety and patient rights.

- The hospital's policies, procedures, and/or rules, to ensure CP 1 was providing safe patient care.

- The same requirements for annual education and competency validation as employees within the hospital.


2. A review of the hospital's contract service agreement titled, "SpecialtyCare Cardiovascular Resources, LLC," dated March 1, 2020, showed the contract expired on February 28, 2023, and there was no documented evidence that showed the hospital and the Contractor had signed an agreement for services after the expiration date of the contract.

During an interview with the Chief Executive Officer (CEO) on June 8, 2023, at 3:10 p.m., in the conference room, the CEO stated, after February 28, 2023, there was no signed service agreement between the hospital and the contractor.

A review of the hospital's policy and procedure (P&P) titled, "Pyxis (automated medication dispensing system) Procedures-Medication Removal, Returning, Wasting and Discrepancy Resolution," revised November 2020, indicated the following, "...B. Returning a Medication to the Pyxis Return Bin 1. Intact, unopened, and untampered medications removed from the Pyxis and not administered to the patient may be returned to the Pyxis return bin promptly..."

A review of the AORN's guidelines for Perioperative Practice (2023), Guideline for Medication Safety indicated the following, "...Recommendation 15.3 Collaborate with pharmacy personnel to determine methods for returning unused and unopened medications in medication storage areas to the pharmacy...

Rationale: Returning medications to the pharmacy increases the accuracy for accounting for unused medications and may improve the chances for exchanging the medications to avoid outdates and consequent waste..."

A review of the OSHA's requirements for bloodborne pathogens (microorganisms that cause disease and transmitted via blood), dated August 9, 2007, indicated the following, "...29 CFR 1910.1030(d)(4)(i)...requires that...General. Employers shall ensure that the worksite is maintained in a clean and sanitary condition. The employer shall determine and implement an appropriate written schedule for cleaning and method of decontamination (procedure to remove dangerous substances or germs) based upon the location within the hospital, type of surface to be cleaned, type of soil present, and tasks or procedures being performed in the area...

29 CFR 1910.1030(d)(4)(ii)...All equipment and environmental and working surfaces shall be cleaned and decontaminated after contact with blood or other potentially infectious materials...

29 CFR 1910.1030(d)(4)(ii)(A)...Contaminated work surfaces shall be decontaminated with an appropriate disinfectant after completion of procedures; immediately or as soon as feasible when surfaces are overtly contaminated or after any spill of blood or other potentially infectious materials; and at the end of the work shift if the surface may have become contaminated since the last cleaning..."

A review of the hospital's P&P titled, "Environmental Sanitation - OR," reviewed December 2022, indicated the following, "... Policy: The surgical patient will be provided a clean, safe environment. Environmental cleaning is a team effort involving surgical personnel and environmental services. Items that come in contact with the patient and/or the sterile field shall be considered contaminated and will be either sterilized, disinfected, or contained for disposal..."

A review of the hospital's P&P titled, "Contract Services-Evaluation of," revised August 2019, indicated the following, "...Policy: All clinical contract services will be included in the hospital's performance improvement program. Clinical contract services will be evaluated at least annually. II. Procedure ...

3. Clinical contract services will be evaluated at least annually by the hospital and medical staff based on the following criteria:

a. the vendor has current policies and procedures that are approved by [Name of the Hospital] and the vendor staff adheres to those policies and procedures...

c. the vendor provides safe and compassionate care and provides care/services in a safe manner...

d. the vendor maintains their equipment according to the hospital policy...

5. Contract personnel should meet the same requirements for orientation, annual education, and competency validation as employees within the facility ...

6. Contract services will be reviewed on an annual basis by the Medical Executive Committee and Board of Trustees..."

Based on interview and record review, the Governing Body (GB) failed to maintain a complete list of contract services when the hospital did not have a written contract agreement for cardiovascular perfusion services.

This failure resulted in substandard services and had the potential for further injury and prolonged hospitalization.

Findings:

A review of the hospital's "Bylaws Governing: The Board of Trustees," dated July 25, 2018, indicated the following,

"...Article VII. Section 7.4. Management of the Environment of Care: 7.4.1. The Board shall oversee the planning and implementation of methods for providing for the safety, protection, and care of hospital patients and others, and ensure allocation of appropriate resources to maintain a safe secure environment..."

"...Article VII. Section 7.6 Contracted Services:

7.6.1: The Board shall provide mechanisms to ensure that services provided under contract are in compliance with all applicable HIPAA [Health Insurance Portability and Accountability Act, privacy regulations] requirement, HHS/CMS [Department of Health and Human Services/ Centers for Medicare & Medicaid Services, United States Government Agencies] Conditions of Participation, regulations...and any pertinent laws, regulations, or standards for the contracted service.

7.6.2: The Board shall ensure that contracted services are performed safely and effectively through implementation and participation of contracted services in the performance improvement program, and through mechanisms used to ensure that contracted service staff members are qualified and competent...

7.6.3: The Board shall require that the Hospital maintain a list of all contracted services and written agreement with contracted services that shall include the nature, scope, of service, and delineation of the contractor responsibilities..."

A review of the hospital's contract service written agreement titled, "SpecialtyCare Cardiovascular Resources, LLC," dated March 1, 2020, indicated the contract expired on February 28, 2023. There was no documented evidence the hospital and the Contractor had a written signed agreement for services after the expiration date of the contract.

During an interview conducted with the Accreditation Director (AD) on June 8, 2023, at 12 p.m., in the conference room, the AD stated the hospital did not have a signed contract for the Cardiovascular Perfusion Team to provide care within the hospital.

During an interview with the Chief Executive Officer (CEO) on June 8, 2023, at 3:10 p.m., in the conference room, the CEO stated, after February 28, 2023, there was no signed/written service agreement between the hospital and the contractor.

A review of the hospital's policy and procedure titled, "Contract Services-Evaluation of," revised August 2019, indicated the following, "...Policy...Contract services will be reviewed on an annual basis by the Medical Executive Committee and Board of Trustees..."

Based on interview and record review, the facility failed to ensure quality assurance and performance improvement activities included indicators to track infection control and prevention practices in the facility when infection control and prevention practices were not monitored and performance improvement measures and indicators (measures of performance to evaluate progress towards the intended results) were not implemented to track incidents of breaches on infection control and prevention practices (A 0263 and A 0283).

The cumulative effect of these failures resulted in the facility's failure to not identify areas of needed improvement in infection control and prevention practices which may have contributed to the development of Methicillin Resistant Staphylococcus Infection (infection with Staphylococcus Aureus bacteria which does not respond to some antibiotics) in the Neonatal Intensive Care Unit (unit for critically ill infants), and increased the risk of spreading infections to the patients receiving care in the hospital. These failures had the potential to result in cross-contamination (spread of infection to other patients), other outbreaks, and prolonged hospitalization and possible death of the patients.

Based on interview and record review, the facility failed to ensure quality assurance and performance improvement activities included indicators to track infection control and prevention practices in the facility when infection control and prevention practices were not monitored and performance improvement measures and indicators (measures of performance to evaluate the progress towards the intended results) were not implemented to track incidents of breaches on infection control and prevention practices.

This failure resulted in a lack of infection prevention program oversight and had the potential for increased risk of avoidable disease transmission for patients and staff within the departments.

Findings:

A tour was conducted of the obstetric operating rooms (OBOR) on June 6, 2023, at 2:10 p.m., with the Obstetric Manager (OBM), the Assistant Chief Nurse Officer (ACNO), and Infection Control Preventionist (ICP) 1.

During an interview conducted with the OBM, on June 6, 2023, at 2:45 p.m., in OBOR 1, the OBM stated she had not performed environment of care (EOC, regular inspections conducted by a healthcare facility to ensure that EOC standards are being met) rounds with the Infection Prevention Program, and she did not have written documentation that showed EOC rounds had been performed.

During an interview conducted with the Environmental Service Manager (EVSM) on June 6, 2023, at 3:15 p.m., in OBOR 1, the EVSM stated he did not perform active EOC rounds with the Infection Prevention Program. The EVSM stated the infection prevention department emails him if there were EVS concerns.

A tour was conducted of the surgical service department (OR) on June 6, 2023, at 3:45 pm, with the Director of Surgical Services (SSD) and Charge Nurse (CN) 2.

During an interview conducted with the SSD and CN 2, on June 6, 2023, at 4:15 p.m., in OR 6, the SSD stated she did not know if EOC rounds were conducted in the ORs or the SPD. CN 2 stated she had not witnessed EOC rounds for the operating rooms.

A tour of the Sterile Processing Department (SPD) was conducted on June 7, 2023, at 8:30 a.m., with the Manager of the SPD (SPDM), the Assistant Vice President of Infection Control (AVPIC) and ICP 1, to investigate infection prevention activities.

During an interview conducted with the SPDM, on June 7, 2023, at 9:05 a.,m. in the SPD, the SPDM stated she could not recall EOC rounds being conducted in SPD, and she did not have documentation that showed EOC rounds had been performed in SPD.

During an interview conducted with ICP 1 on June 7, 2023, at 9:20 a.m., in the SPD, ICP 1 stated the infection control department had performed individual EOC rounds in the SPD and the ORs and if there were infection control concerns, she would notify the EVS department through email.

A request was made to review the EOC findings and outcomes related to the OR and the SPD rounding activities. No documentation was provided.

There was no documented evidence the Infection Preventionists were rounding in the SPD and ORs.

During a concurrent interview and record review on June 8, 2023, at 2:10 p.m., conducted with the Quality Assurance and Performance Improvement (QAPI) committee members during the QAPI meeting, the facility document titled, "Quality Assurance & Performance Improvement (QAPI) Report," dated June 8, 2023, was reviewed. The report indicated infection control areas the facility was tracking which included Central Line-associated Bloodstream Infection (CLABSI, a serious infection that occurs when germs enter the bloodstream through a catheter or tube), catheter-associated urinary tract infections (CAUTI, infection of the urinary tract caused by a tube inserted to drain urine), Clostridium difficile (C. Diff, highly contagious bacterial infection that can spread person to person), and Methicillin-resistant Staphylococcus aureus (MRSA, a type of bacteria that causes an infection that does not respond to common antibiotics).

The Chief Medical Officer (CMO) stated the infection control related projects the QAPI committee was working on were to reduce hospital-acquired infections and patient length of stay. The CMO stated he meets with the Chief Nursing Officer (CNO) and infection prevention every Wednesday to analyze weekly data. The QAPI report also indicated, "...Increased IP Rounding and Education..." When the CMO was informed IP rounding was not being done in the SPD and ORs, he had no comment.

There was no documented evidence the Infection Prevention Program communicated and rounded with department managers/directors to monitor the effectiveness of infection control practices on an ongoing basis.

During an interview conducted with the Infection Control Director (ICD), on June 8, 2023, at 2:55 p.m., in the conference room, the ICD stated the infection control department did not have documentation that showed EOC rounds were implemented in the ORs and the SPD. The ICD stated active EOC rounds for infection control were not performed in the SPD and the OR's. The ICD stated the infection control plan was to round in the ORs and the SPD, but the Infection Prevention Program did not include the ORs and the SPD due to short staffing and other infection prevention activities performed on the other units. The ICD stated the Infection Prevention Program should have performed EOC rounds for the ORs and SPD.

A review of the hospital's policy and procedure, titled "Infection Control Plan," effective March 22, 2023, indicated the following, "...Mission: The Infection Prevention Program supports [Name of Hospital] that above all else, we are committed to the care and improvement of human life...Infection Prevention Program Description: The infection Prevention (IP) Program utilizes a multidisciplinary, systematic approach to quality patient care that emphasizes disease transmission risk reduction in the healthcare environment by using sound epidemiological principles and evidence-based practices. Effectiveness is achieved by integrating principles of infection prevention with each department's standards. Activities of the IP program are appropriate to the number of employees as assessed during the yearly risk assessment..."

A review of the hospital's policy and procedure (P&P) titled, "Quality Improvement Plan," revised March 2023, indicated, "...Goals and Objectives...The goal of the organization and the performance improvement plan is to create an environment where departments and services work collaboratively to identify opportunities for improvement in a coordinated, systematic approach to improve patient care, processes, and prevention of medical errors...Quality & Safety Committee...assures the integration and coordination of leadership, department directors, medical staff, nursing, and support service performance improvement activities...Coordination and evaluation of quality improvement and patient safety related activities hospital wide...Ensuring data is systematically aggregated and analyzed on an ongoing basis for levels of performance, trends, patterns, and benchmarking..."

Based on observation, interview, and record review, the facility failed to ensure the hospital's infection control program were maintained, methods to prevent the transmission of infections were employed within the hospital, sanitary environmental conditions were maintained, necessary training were provided to staff, and infection control and prevention practices were implemented in accordance with the facility's policy and procedure and the standards of practice, for five of five sampled patients (Patients 1,2,3,4,and 5) when,

1. Contract personnel (Vendors) did not perform hand hygiene (any action of hand cleansing to physically or mechanically remove dirt, organic material, or microorganisms) before entering the Neonatal Intensive Care Unit (NICU, unit for critically ill newborn patients) (A 0749);

2. The manufacturer's guidelines for Multi-Surface Wipes were not implemented for sanitizing and disinfecting food contact surfaces prior to preparing infant formula (A 0749);

3. The manufacturer's guidelines for Sani-Cloth: Germicidal Disposable Wipe were not implemented for disinfecting an isolation room (special hospital room which keep patients with certain medical conditions separate from other people while they receive medical care) (A 0749);

4. The environmental service (EVS) staff did not follow the manufacturer's instructions for use (IFU) of Oxivir Disinfectant Cleaner on cleaning the NICU (A 0749);

5. An opened single use bottle of water for suctioning of secretions was stored on Patient 6's bedside table (A 0749);

6. There was grey fuzzy matter and black matter throughout the floors; grey fuzzy matter on the wall vents; orange-brown spots surrounding the examination tables (used to assist patients during a medical examination or treatment); two suction cannisters (temporary storage container that's used to collect this infectious medical waste until it is disposed of properly) contained a red and blackish substance; one suction tube (a flexible tube used to draw out fluids, secretions, and other substances) was on the floor; several pieces of tape attached to the floor that contained grey and black fuzzy matter; and orange-brown matter on the intravenous (IV, into the vein) pole's casters (wheels) for two of two sampled obstetrics operating rooms (OBOR 1 and OBOR 2, ORs used for labor and delivery). OBOR 1 and OBOR 2 had been cleaned and were designated as ready for patient use (A 0750);

7. There was brown and black spots scattered throughout the floor; black stains on the wall's baseboard; brownish matter was on the IV pole's caster and hamper casters (wheels); debris on the floors; thick grey fuzzy matter behind the anesthesia carts (carts used for storage of medication and equipment used to induce insensitivity to pain during a surgical procedure); tape with greyish, black matter attached to IV poles and medication carts; thick grey fuzzy matter on the wall vents; used cover gowns and three expired opened packages of sterile gloves stored on a shelf; one missing baseboard that created a hole in the wall; one torn arm board and one ripped mattress for two of four sampled operating rooms (OR 4 and OR 6). OR 4 and OR 6 had been cleaned and were designated as ready for patient use (A 0750);

8. The anesthesia cart contained an opened single-use packet of electrocardiogram leads (EKG, electrode pads used to connect a patient to a heart monitor/recorder); one opened Yankauer suction tip (an oral suctioning tool used in medical procedures); brown tape and several pieces of clear tape with grey fuzzy matter; several pieces of clear tape with greyish, black matter attached to the IV pole; two gas tops (used to deliver medical gas to patients) stored on top of the anesthesia cart with grey fuzzy matter; and debris observed under and behind the anesthesia cart for one of four sampled anesthesia work areas (AOR 6). AOR 6 had been cleaned and was designated as ready for patient use (A 0750);

9. There were two corrugated cardboard boxes stored in the clean utility room (A 0750);

10. 49 of 49 sampled emergency eye-wash stations and showers (plumbed equipment used to wash the eyes for decontamination [the process of removing contaminants on an object or area, including chemicals, micro-organisms or radioactive substances]) were not inspected or flushed weekly (A 0750);

11. Two biohazard sharp containers (a regulated waste container used to store needles, glass, and sharp objects contaminated with blood and/ or body fluid) were not in use and were not closed for two of four sampled operating rooms (OR 3 and OR 5) (A 0750);

12. The sterile processing department (SPD, an area within a health care facility that processes and controls medical supplies, devices, and equipment, sterile and not sterile, for some or all patient care areas of the facility) clean work area's carts had torn wheels and the cart's casters were covered with thick brown-orange matter. The carts had been cleaned and designated as ready for patient use; two of three sampled autoclaves (a machine that uses steam under pressure to kill harmful germs) contained orange-brown matter on the base of the chamber; four of four sampled ceiling air vents had brown stains and were covered with grey fuzzy matter; the floor contained grey fuzzy matter, black and brown stains, and debris throughout the SPD's clean work area with an increase amount of staining and debris near the washers (A 0750);

13. The SPD's decontamination work area water drain was filled with debris, stains, and contained black fuzzy matter; two of two sampled washers had brown and orange matter on the base of the chambers (used to hold liquid chemical/s); the decontamination work area floor had a large amount of scattered grey fuzzy matter, debris, and black/brown stains. The decontamination work area had been terminally cleaned (a thorough environmental cleaning procedure that is performed at the end of each day when the area is being used) (A 0750);

14. The hospital did not follow the nationally recognized infection prevention and control regulatory requirement for a dedicated hand washing sink in the decontamination work area (A 0750);

15. The hospital did not follow the hospital's protocol or the nationally recognized infection prevention and control guidelines for unidirectional functional workflow (operating or moving in one direction only: not changing directions) in the SPD area (A 0750);

16. The hospital did not follow the hospital procedure or the nationally recognized infection prevention and control guidelines of brushing equipment under water when cleaning surgical instruments (A 0750);

17. The manufacturer's instructions for use (IFU) were not followed for cleaning the endoscope (a medical device used to view the inside of organs) while immersed in detergent (A 0750);

18. EOC rounds were not implemented, for two of five sampled departments (the surgical service department including the operating rooms [OR] and the sterile processing department [SPD]);

19. 19 vials of outdated medications were observed stored in the cardiovascular perfusion specialty cart (CPSC, a cart used to store CP supplies) and were available for patient use (A 0775);

20. Five corrugated cardboard boxes were stored in the CPSC and the CPSC and supplies were ready for patient use (A 0775);

21. CP equipment was not disinfected between patient cases and the equipment was designated as "clean" and ready for patient use (A 0775); and

22. The hospital did not implement the contract service agreement for staff orientation in the provision of education and complete competency verification activities related to the principles and processes of environmental cleaning to a Cardiovascular Perfusionists (CPs, healthcare professionals who operate the bypass machine during open heart surgery) (A 0775).

The cumulative effect of these failures resulted in ineffective infection control practices in the facility and unsafe healthcare practices which may have contributed to the development of Methicillin Resistant Staphylococcus Infection (infection caused by a type of bacteria which could not be treated with many antibiotics) in the NICU, and increased the risk of spreading infections to the patients receiving care in the hospital. These failures had the potential to result in cross-contamination, other outbreaks, and prolonged hospitalization and possible death of patients.

Based on observation, interview, and record review, the hospital failed to ensure the hospital's infection control program was maintained or methods to prevent the transmission of infections were employed within the hospital when:

1. Contract personnel (Vendors) did not perform hand hygiene (any action of hand cleansing to physically or mechanically remove dirt, organic material, or microorganisms) before entering the Neonatal Intensive Care Unit (NICU, unit for critically ill newborn patients);

2. The manufacturer's guidelines for Multi-Surface Wipes were not implemented for sanitizing and disinfecting food contact surfaces prior to preparing infant formula;

3. The manufacturer's guidelines for Sani-Cloth: Germicidal Disposable Wipe were not implemented for disinfecting an isolation room (special hospital room which keep patients with certain medical conditions separate from other people while they receive medical care);

4. The environmental service (EVS) staff did not follow the manufacturer's instructions for use (IFU) of Oxivir Disinfectant Cleaner on cleaning the NICU; and

5. An opened single use bottle of water for suctioning of secretions was stored on Patient 6's bedside table.

These failures created an increased risk of spreading infections to the patients receiving care in the hospital.

Findings:

During an interview with the Infection Control Director (ICD), on June 6, 2023, at 9:20 a.m., in the conference room (CR), the ICD stated the hospital followed the following nationally recognized guidelines:

A. Centers for Disease Control and Prevention (CDC, the national public health agency of the United States);

B. Association of periOperative Registered Nurses (AORN, a nationally recognized infection control guidelines for perioperative areas);

C. Occupational Safety and Health Administration (OSHA, a large regulatory agency of the United States Department of Labor);

D. ANSI/AAMI ST79 (2017) (American National Standards/Association for the Advancement of Medical Instrument, standards development organizations) Comprehensive Guide to Steam Sterilization and Sterility Assurance in Healthcare Facilities; and

E. Association for Professionals in Infection Control and Epidemiology (APIC, professional association for infection prevention).

The ICD stated five NICU patients were diagnosed with methicillin-resistant staphylococcus aureus (MRSA, a type of bacteria that is resistant to several antibiotics) from May 17, 2023, to May 25, 2023, and the hospital defines a disease outbreak as two or more identified cases within a 30-day period. The ICD stated the NICU cases met the hospital's criteria for a MRSA outbreak.

A record review was conducted of MRSA infections that occurred from May 17, 2023, to June 7, 2023, for five of six sampled NICU patients (Patients 1, 2, 3, 4, and 5). The findings were as follows:

- For Patient 1, a review of Patient 1's "History and Physical" (H & P) showed Patient 1 was admitted to the NICU on May 17, 2023, with diagnoses of respiratory distress syndrome (RDS, a condition which occurs in babies born early [premature] whose lungs are not fully developed) to rule out (r/o, to eliminate or exclude something from consideration) sepsis (infection).

A review of Patient 1's "Laboratory Report," dated May 24, 2023, indicated the following: "Positive. Growth for MRSA present;"

- For Patient 2, a review of Patient 2's H & P indicated Patient 2 was admitted to the NICU on May 2, 2023, with diagnoses of RDS and prematurity (infants born alive before 37 weeks of pregnancy are completed).

A review of Patient 2's "Laboratory Report," dated May 19, 2023, indicated the following: "Positive. Growth for MRSA present;"

- For Patient 3, a review of Patient 3's H & P indicated Patient 3 was admitted to the NICU on April 18, 2023, with diagnoses of RDS and prematurity.

A review of Patient 3's "Laboratory Report," dated May 25, 2023, indicated the following: "Positive. Growth for MRSA present;"

- For Patient 4, a review of Patient 4's H & P indicated Patient 4 was admitted to the NICU on April 10, 2023, with diagnoses of RDS and prematurity.

A review of Patient 4's "Laboratory Report," dated May 22, 2023, indicated the following: "Positive. Growth for MRSA present;" and

- For Patient 5, a review of Patient 5's H & P indicated Patient 5 was admitted to the NICU on May 6, 2023, with diagnosis of prematurity.

A review of Patient 5's "Laboratory Report," dated May 25, 2023, indicated the following: "Positive. Growth for MRSA present."

1. A tour of the NICU was conducted with the ICD, Infection Control Preventionist (ICP) 1, and the NICU Director (NICUD), on June 6, 2023, at 9:45 a.m.. Vendors 1 and 2 were observed entering the NICU with biohazard containers. Neither Vendor 1 nor Vendor 2 were observed to have not performed an initial hand hygiene scrub (scrubbing from fingernails to the elbows with prescribed handwashing solutions) prior to entering the NICU area.

During an interview conducted with Vendor 1, Vendor 2, the Assistant Chief Nursing Officer (ACNO), and ICP 1, on June 6, 2023, at 10:03 a.m., in the NICU, Vendor 1 stated, "I did not know I needed to scrub before entering the NICU." Vendor 2 stated, "We routinely enter the NICU to change out the biohazard waste containers and the hospital has never asked us to scrub in." Vendor 1 stated, "We follow precaution signs for PPE's (personal protective equipment, equipment worn to minimize exposure to a variety of hazards including infectious agents) before we enter patient rooms, but the hospital has never provided education on hand scrubs for entering the NICU." Vendor 2 stated, "Is this new?" ICP 1 stated the environmental service director (EVSD) should have educated Vendor 1 and Vendor 2 on the protocol for entry into the NICU area.

During an interview conducted with the EVSD, on June 6, 2023, at 10:20 a.m., in the NICU, the EVSD confirmed he was responsible for ensuring Vendors 1 and 2 followed the hospital's policies and procedures. The EVSD stated the NICU department had recently updated their protocol for entering the NICU area and Vendors 1 and 2 had not been educated to the new procedure. The EVSD stated he should have ensured all EVS vendors were educated on the new procedure prior to entering the NICU area.

Multiple requests were made for the hospital's policy and procedure titled, "Hand Hygiene in NICU." On June 6, 2023, at 4:30 p.m., ICP 1 stated the NICU department did not have a new hand hygiene policy. The NICU had a hand hygiene education packet titled, "Hand Hygiene in NICU."

A review of the CDC's guidelines for Recommendations for Prevention and Control of Infections in NICU Patients (2020): a. Interventions to prevent transmission of S aureas [Staphylococcus Areus, a type of bacteria] (MRSA) in NICUs: a.1. Multi-intervention Strategies, indicated, "...Hand hygiene, cleaning and disinfection, contact precautions (preventative steps needed to be taken by healthcare team members and staff at healthcare facilities to prevent the spread of infections), education and training..."

2. A review of the manufacturer's label, titled "Multi-Surface Wipes," dated 2022, indicated the following IFU, "Directions for use to sanitize and disinfect food contact surfaces: 1. Use a wipe to clean the surface to be treated 2. Use another wipe to treat the cleaned surface. Wipe enough for treated surface area to remain wet for one (1) minute. 3. Let dry. No rinsing required."

During an observation conducted with ICP 1, on June 6, 2023, at 10:40 a.m., in the formula preparation room, Registered Nurse (RN) 2 was observed to don (put-on) the PPEs and wiped the counter's surface with a multi-surface wipe. RN 2 was observed to drop three single-use, ready-to-feed bottles onto the floor, picked the bottles up from the floor, and placed the bottles back into the patient care supplies. RN 2 was observed to place one bottle, one nipple, and other supplies onto the counter, then proceeded to wipe the counter. RN 2 did not ensure the counter was visibly wet for one minute after using the multi-surface wipe.

During an interview conducted with RN 2 and ICP 1, on June 6, 2023, at 10:55 a.m., in the formula preparation room, RN 2 confirmed she picked the bottles up from the floor and placed the bottles into the patient care supply. ICP 1 stated the disposable bottles were considered contaminated after the bottles were on the floor. RN 2 was observed to read the manufacturer's IFU on the multi-surface wipes bottle's label and stated the IFU indicated the counter needed to remain visibly wet for one minute. RN 2 stated she did not allow the counter to remain visibly wet for one minute. ICP 1 stated RN 2 did not follow the manufacturer's direction for sanitizing and disinfecting the counter.

A review of the hospital's P&P titled, "Clean Patient Equipment," revised June 2022, indicated the following, "...Policy Statement...Cleaning will be done with hospital approved germicide according to manufacturer's guideline..."

3. A review of the manufacturer's label, titled "Sani-Cloth: Germicidal Disposable Wipe," dated 2019, indicated the following IFU, "...Allow treated area to remain wet for one (1) minute. Let air dry."

During an observation with ICP 1, on June 6, 2023, at 11:10 a.m., in the isolation room, RN 3 was observed cleaning the high touch surface areas (surfaces that are frequently touched by healthcare workers and patients) with the hospital's approved germicidal disposable wipes. RN 3 was observed to wipe the nurses' surface area, telephone, the surfaces in the ante room (area before entrance to a room), then entered the patient area and wiped the surface areas surrounding Patient 1. The computer was located in Patient 1's room and RN 3 was not observed to wipe the computer area or the computer keyboard.

During a concurrent observation and interview conducted with RN 3 and ICP 1, on June 6, 2023, at 11:20 a.m., in the ante room, RN 3 stated Patient 1 was diagnosed with MRSA and Patient 1 was on contact isolation. RN 3 stated she cleaned the high touch areas in Patient 1's room daily to prevent cross-contamination (transfer of harmful bacteria from one person, object or place to another). RN 3 confirmed the computer area and computer keyboard keys were high touch areas and she did not clean the computer keyboard. RN 3 was observed to read the manufacturer's IFU from the germicidal disposable wipe label and stated the label indicated the surfaces should remain wet for one minute. RN 3 stated the surfaces she wiped did not remain wet for one minute. ICP 1 stated the surfaces should have remained wet for one minute to ensure the germicidal was effective. ICP 1 stated the computer's keyboard was difficult to clean and/or disinfect because the keyboard may be damaged if the keys remained wet for one minute several times in a day. ICP 1 stated more education was needed on disinfecting the keyboards and contact/wet time (the appropriate amount of time that a disinfectant has to remain visibly moist on the surface being cleaned to effectively kill the germs, viruses, or bacteria).

A review of the CDC's guidelines for Prevention of Transmission of Multidrug Resistant Organisms: Cleaning and Disinfection (edited February 2017), indicated the following, "...MRSA is usually spread by direct contact with an infected wound or from contaminated hands, usually those of healthcare providers...Cleaning and Disinfection: Methicillin-resistant Staphylococcus aureus (MRSA) can survive on some surfaces, like towels, razors, furniture, and athletic equipment for hours, days, or even weeks. It can spread to people who touch a contaminated surface, and MRSA can cause infections if it gets into a cut, scrape, or open wound..."

4. During an observation conducted with the EVSD and ICP 1, on June 6, 2023, at 11:59 a.m., in the NICU sitting area, EVS 1 was observed cleaning a table and four chairs. EVS 1 was observed to wipe the table and proceeded to wipe the cushion of the chairs and arm rests with the hospital germicidal solution.

During an interview conducted with the EVDS and EVS 1, on June 6, 2023, at 12:05 p.m., near the EVS closet, EVS 1 stated she cleaned the NICU sitting area daily and after use. EVS 1 stated she did not know the "contact time" for the germicidal solution. EVS 1 read the manufacturer's IFU on the germicidal solution's label and stated the IFU indicated the table and chairs needed to remain wet for one minute. The EVDS confirmed the table did not remain wet for one minute and stated a refresher course was needed on the use of hospital approved disinfectants.

A review of the manufacturer's label,titled, "Oxivir Disinfectant Cleaner (brand of a germicidal solution)," dated 2020, indicated the following instructions for use (IFU), "...Allow treated area to remain wet for one (1) minute. Let air dry."

5. A review of Patient 6's "Clinical Note," dated June 6, 2023, indicated Patient 6 was admitted to the hospital on April 29, 2023, with diagnosis of prematurity. On June 2, 2023, Patient 6 was diagnosed with bronchopulmonary dysplasia (BPD, a form of chronic lung disease that affects newborns).

During an observation of the NICU's patient care area, on June 6, 2023, at 11:35 a.m., conducted with the NICUD, Patient 6 was observed to be intubated (placement of a flexible plastic tube into the airway for the delivery of oxygen into the lungs) and was lying in an isolette. There was an opened, uncapped bottle of sterile water observed stored at Patient 6's bedside.

During an interview conducted with RN 1, on June 6, 2023, at 11:40 a.m., in the NICU, RN 1 stated Patient 6 required frequent suctioning(mechanical removal of secretions) and the bottle of sterile water was used for suctioning Patient 6's secretions. RN 1 was observed to read the manufacturer's IFU from the bottle's label and stated the bottle's label indicated the sterile water was for a single use. RN 1 stated the bottle should have been discarded after the suctioning of Patient 6's secretions.

On June 6, 2023, at 11:45 a.m., in the nurse's station, the P&P on suctioning procedures in the NICU was requested. The NICUD did not provide a policy and procedure on suctioning procedures in the NICU.

Based on observation, interview, and record review, the hospital failed to provide and maintain a hospital wide safe and sanitary environment to avoid the potential of transmission of infections and communicable diseases when:

1. There was grey fuzzy matter and black matter throughout the floors; grey fuzzy matter on the wall vents; orange-brown spots surrounding the examination tables (used to assist patients during a medical examination or treatment); two suction cannisters (temporary storage container that's used to collect this infectious medical waste until it is disposed of properly) contained a red and blackish substance; one suction tube (a flexible tube used to draw out fluids, secretions, and other substances) was on the floor; several pieces of tape attached to the floor that contained grey and black fuzzy matter; and orange-brown matter on the intravenous (IV, into the vein) pole's casters (wheels) for two of two sampled obstetrics operating rooms (OBOR 1 and OBOR 2, ORs used for labor and delivery). OBOR 1 and OBOR 2 had been cleaned and were designated as ready for patient use;

2. There was brown and black spots scattered throughout the floor; black stains on the wall's baseboard; brownish matter was on the IV pole's caster and hamper casters (wheels); debris on the floors; thick grey fuzzy matter behind the anesthesia carts (carts used for storage of medication and equipment used to induce insensitivity to pain during a surgical procedure); tape with greyish, black matter attached to IV poles and medication carts; thick grey fuzzy matter on the wall vents; used cover gowns and three expired opened packages of sterile gloves stored on a shelf; one missing baseboard that created a hole in the wall; one torn arm board and one ripped mattress for two of four sampled operating rooms (OR 4 and OR 6). OR 4 and OR 6 had been cleaned and were designated as ready for patient use;

3. The anesthesia cart contained an opened single-use packet of electrocardiogram leads (EKG, electrode pads used to connect a patient to a heart monitor/recorder); one opened Yankauer suction tip (an oral suctioning tool used in medical procedures); brown tape and several pieces of clear tape with grey fuzzy matter; several pieces of clear tape with greyish, black matter attached to the IV pole; two gas tops (used to deliver medical gas to patients) stored on top of the anesthesia cart with grey fuzzy matter; and debris observed under and behind the anesthesia cart for one of four sampled anesthesia work areas (AOR 6). AOR 6 had been cleaned and was designated as ready for patient use;

4. Two corrugated cardboard boxes were stored in the clean utility room (A 0750);

5. 49 of 49 sampled emergency eye-wash stations and showers (plumbed equipment used to wash the eyes for decontamination [the process of removing contaminants on an object or area, including chemicals, micro-organisms or radioactive substances]) were not inspected or flushed weekly;

6. Two biohazard sharp containers (a regulated waste container used to store needles, glass, and sharp objects contaminated with blood and/ or body fluid) were not in use and were not closed for two of four sampled operating rooms (OR 3 and OR 5));

7a. The sterile processing department (SPD, an area within a health care facility that processes and controls medical supplies, devices, and equipment, sterile and not sterile, for some or all patient care areas of the facility) clean work area's carts had torn wheels and the cart's casters were covered with thick brown-orange matter. The carts had been cleaned and designated as ready for patient use; two of three sampled autoclaves (a machine that uses steam under pressure to kill harmful germs) contained orange-brown matter on the base of the chamber; four of four sampled ceiling air vents had brown stains and were covered with grey fuzzy matter; the floor contained grey fuzzy matter, black and brown stains, and debris throughout the SPD's clean work area with an increase amount of staining and debris near the washers;

7b. The SPD's decontamination work area water drain was filled with debris, stains, and contained black fuzzy matter; two of two sampled washers had brown and orange matter on the base of the chambers (used to hold liquid chemical/s); the decontamination work area floor had a large amount of scattered grey fuzzy matter, debris, and black/brown stains. The decontamination work area had been terminally cleaned (a thorough environmental cleaning procedure that is performed at the end of each day when the area is being used);

8. The hospital did not follow the nationally recognized infection prevention and control regulatory requirement for a dedicated hand washing sink in the decontamination work area (A 0750);

9. The hospital did not follow the hospital's protocol or the nationally recognized infection prevention and control guidelines for unidirectional functional workflow (operating or moving in one direction only: not changing directions) in the SPD area;

10. The hospital did not follow the hospital procedure or the nationally recognized infection prevention and control guidelines of brushing equipment under water when cleaning surgical instruments; and

11. The manufacturer's instructions for use (IFU) were not followed for cleaning the endoscope (a medical device used to view the inside of organs) while immersed in detergent.

These failures resulted in unsafe healthcare practices and had the potential to cause further harm and prolonged hospitalization to patients being cared for in the facility.

Findings:

During an interview with the Infection Control Director (ICD), on June 6, 2023, at 9:20 am, in the conference room (CR), the ICD stated the hospital followed the following nationally recognized guidelines:

A. Centers for Disease Control and Prevention (CDC, the national public health agency of the United States);

B. Association of periOperative (around the time of surgery) Registered Nurses (AORN, a nationally recognized infection control guidelines for perioperative areas);

C. Occupational Safety and Health Administration (OSHA, a large regulatory agency of the United States Department of Labor);

D. ANSI/AAMI ST79 (2017) (American National Standards/Association for the Advancement of Medical Instrument, standards development organizations) Comprehensive Guide to Steam Sterilization and Sterility Assurance in Healthcare Facilities; and

E. Association for Professionals in Infection Control and Epidemiology (APIC, professional association for infection prevention).

1. A tour of the obstetric department was conducted on June 6, 2023, at 2:00 p.m., with the Director of Obstetric (OBD), the Obstetric Manager (OBM), Charge Nurse 1 (CN 1), the Assistant Chief Nursing Officer (ACNO), and Infection Control Preventionist (ICP) 1. The following findings were observed as follows:

a. For OBOR 2, at 2:05 p.m., there was grey fuzzy matter and black stains behind the medication cart and in the corners of the room; there was grey fuzzy matter on the wall vents; a Salem sump (size 18-suction tube) tube was observed on the floor; there were several pieces of tape attached to the floor that contained grey and black fuzzy matter; there was orange-brown matter on the IV pole's casters; and clean supplies were stored on top of the anesthesia cart.

During a concurrent interview, on June 6, 2023, at 2:10 p.m., the OBM confirmed OBOR 2 had been cleaned and the OBM stated OBOR 2 was scheduled for a 2:30 p.m. (June 6, 2023) procedure. The OBM picked the Salem sump tube up from the floor and placed it on top of the anesthesia cart among the clean supplies. During a concurrent interview, ICP 1 stated items found on the floor were considered contaminated; and

b. For OBOR 1, at 2:55 p.m., there was grey fuzzy matter and black matter throughout the floor; there were orange-brown spots surrounding the examination table; and there were two suction cannisters on the wall near the infant warmers (a key piece of equipment in neonatal intensive care units, aimed at providing the newborn with a comfortable thermal area that maintains its body temperature between 36 and 37 degrees) and both canisters contained a red and blackish substance.

During an interview conducted with the OBM on June 6, 2023, at 3 p.m., in OBOR 1, the OBM stated she did not know if the procedure rooms were terminally cleaned (a thorough environmental cleaning procedure that is performed at the end of each day when the area is being used) on June 5, 2023.

During an interview conducted with Respiratory Care Practitioner (RCP) 1 and the ACNO, on June 6, 2023, at 3:15 p.m., in OBOR 1, RCP 1 stated the canisters were used as suction overflows and the content in the canisters was "bloody secretions." The ACNO stated the canisters were not clean and the canisters should not be in OBOR 1.

During a concurrent observation and interview conducted with the Environmental Service Manager (EVSM), on June 6, 2023, at 3:29 p.m., in OBOR 1, the EVSM stated all procedures rooms had been terminal cleaned on June 5, 2023. The EVSM was observed to dampen a cloth with water and easily removed black matter and orangish-brown spots from the floor. The EVSM stated the grey fuzzy matter on the floor was dust and the black matter was dirt. The EVSM stated the EVS staff needed additional coaching on terminal cleaning and cleaning between cases to ensure the ORs were properly cleaned.

A review of the hospital's policy and procedure (P&P) titled, "Environmental Sanitation-OR," revised December 2022, indicated the following, "...Room Preparation Between Cases...All horizontal surfaces, equipment & room furniture, including the overhead surgical lights, will be cleaned with a hospital approved germicidal disinfectant. Cleaning will progress from the cleanest areas to the most soiled..."

2. A tour of the surgical service department was conducted on June 6, 2023, at 3:45 p.m., with the ACNO, ICP 1, the Surgical Service Director (SSD), and Charge Nurse (CN) 2. The following findings were observed:

a. For OR 4, at 3:55 p.m., there were brown and black spots scattered throughout the floor; black stains were on the wall's baseboard; brownish matter was on the IV pole's caster and hamper casters; debris was observed on the floor; thick grey fuzzy matter was behind the anesthesia cart; tape with greyish, black matter was attached to IV poles and medication cart; and the wall vent contained thick grey fuzzy matter; and

b. For OR 6, at 4:18 p.m., there was a used cover gown and three opened packages of sterile gloves stored on a shelf. The gloves had an expiration date of August 24, 2022; there was a missing baseboard that created a hole in the wall; there was one torn arm board and one ripped mattress; and there was thick grey fuzzy matter behind the anesthesia cart.

During a concurrent observation and interview conducted with the SSD, CN 2, and the EVSM, on June 6, 2023, at 4:30 pm, in OR 6, the SSD stated the room should have been terminally cleaned on June 5, 2023, and OR 6 had not been used on June 6, 2023.The SSD stated the cover gown had been left by a staff member and she did not know why the gown or the gloves were stored on the shelf. The EVSM stated the bed was not cleaned as indicated in the cleaning policy and the EVS staff should have ensured the mattress and armrest were replaced prior to designating OR 6 as cleaned and ready for patient use. The EVSM stated he could not confirm that the walls were disinfected properly due to the missing baseboard. The EVSM and the DSS confirmed the brown-orange matter on the IV pole caster was rust and should have been removed. The EVSM stated, "Additional training and coaching is needed on terminal cleaning."

A review of the hospital's P&P titled, "Environmental Sanitation-OR," revised December 2022, indicated the following, "...Terminal Cleaning: 1. Surgical and invasive procedures rooms should be terminally cleaned daily to decrease number of pathogens, dust, and debris created during the day. 2. Terminal cleaning should be done when scheduled procedures are completed for the day or each 24-hour period during regular work week. 3. Unused rooms should be cleaned once each 24-hour during regular work week..."

3. An observation of the anesthesia work area was conducted with the SSD, CN 2, and EVSM, on June 6, 2023, at 4:25 p.m., in OR 6. The findings were as follows:

One single-use packet of electrocardiogram leads was stored on top of the anesthesia cart and two electrode pads were missing from the packet. The EKG pads were available for patient use; one Yankauer suction tip was stored on top of the anesthesia cart. The Yankauer packet was opened and available for patient use; brown tape and several pieces of clear tape with grey fuzzy matter was observed attached to both sides of the cart and on the surface of the cart; several pieces of clear tape with greyish, black matter were observed attached to the IV pole; and two gas tops were stored on top of the cart with grey fuzzy matter.

During a concurrent observation and interview with the SSD, CN 2, and the EVSM, conducted on June 6, 2023, at 4:35 p.m., in OR 6, the SSD stated OR 6 should have been terminally cleaned on June 5, 2023, and OR 6 had not been used on June 6, 2023. CN 2 was observed to roll the anesthesia cart away from the wall and CN 2 stated there was thick dust and debris under and behind the anesthesia cart. The EVSM stated he did not know who maintained the floor behind the anesthesia cart because the EVS staff were not allowed to move the cart.

During an interview conducted with Anesthesiologist 1 and the Chief Medical Officer (CMO), on June 7, 2023, at 1:20 p.m., in the conference room, Anesthesiologist 1 stated the anesthesia department was responsible for cleaning and maintaining the anesthesia cart. Anesthesiologist 1 stated the patient care items observed on the cart, on June 6, 2023, should not have been opened. Anesthesiologist 1 stated EKG pads were single use pads and if pads were missing from the packet, the unused pads should have been discarded. Anesthesiologist 1 stated she could not explain why tape was attached to the cart because after each case, the anesthesiologist or the anesthesia technician should have removed any tape that was attached to the cart and disinfected the cart with the hospital's approved disinfectant. Anesthesiologist 1 stated the anesthesia department was not responsible for cleaning under or behind the cart and she did not know which department was responsible for disinfecting the floor. The CMO confirmed the anesthesia department did not maintain the hospital's floors and stated, "That will be fixed."

A review of the AORN's guidelines for Perioperative Practice (2020), Guideline for Environmental Cleaning indicated the following, "...Regulatory Requirement 4.2 Operating and procedure rooms must be cleaned and disinfected after each patient procedure...Recommendation...4.2.3 Clean and disinfect all items used during patient care, including anesthesia carts, including the top and drawer handles...anesthesia equipment (e.g., IV poles, IV pumps)...anesthesia machines, including dials, knobs, and valves...

Rationale...The anesthesia work area, consisting of the anesthesia machine, anesthesia cart, IV poles, IV pumps, and monitoring equipment, contains irregular, complex surfaces that encounter frequent hand contact. Failing to clean these surfaces properly can lead to cross transmission of potential pathogens. Moderate-quality evidence supports cleaning of the anesthesia machine and cart after patient care..."

A review of the hospital's P&P titled, "Environmental Sanitation-OR," revised December 2022, indicated the following, "...Policy: The surgical patient will be provided a clean, safe environment. Environmental cleaning is a team effort involving surgical personnel and environmental services. Items that come in contact with the patient and/or the sterile field shall be considered contaminated and will be either sterilized, disinfected, or contained for disposal..."

The P&P did not indicate which department was responsible for cleaning and disinfecting the anesthesia work area between patients.

4. A tour of the OR's sterile storage room and clean utility room was conducted with the ACNO, ICP, and the SSD, on June 6, 2023, at 4:45 p.m. There were two corrugated cardboard boxes observed stored in the clean utility room. The cardboard boxes were observed on a shelf, behind the clean supplies and the boxes were observed to be covered with thick grey fuzzy matter.

During a concurrent observation and interview conducted with the SSD, on June 6, 2023, at 4:50 p.m., in the OR's clean utility room, the SSD was observed to pick up one of the boxes and stated the grey fuzzy matter was "dust." The SSD was observed to remove some of the dust and opened the box. The SSD stated she was not familiar with the "specialized batteries" enclosed in the boxes and the corrugated cardboard boxes should not have been stored with the clean equipment and patient care supplies.

A review of the AORN's guidelines for Perioperative Practice (2018), Guideline for Sterilization, Storage of Sterile Items indicated the following, "...Recommendation: 4.4: Remove supplies and equipment from external shipping containers and open-edged corrugated cardboard boxes before transfer to the sterile storage area or point of use. External shipping containers and open-edged cardboard boxes may collect dust, debris, and insects during shipment and may carry contaminants into the surgical suite..."

A review of the hospital's P&P titled, "Guidelines for the Storage of Patients Care Supplies," reviewed January 2021, indicated the following, "...Procedure...Cardboard corrugated material delivered to healthcare areas should be broken down and the cardboard removed in a timely manner. Internal shipping boxes (not corrugated boxes) may be used to dispense sterile and clean supplies but should be discarded when the box has been emptied..."

5. A review of the hospital's "Weekly Eye Wash Station and Shower Inspection Logs," dated January 6, 2023, to June 3, 2023, was conducted. There was no documented evidence 49 of 49 sampled eyewash stations and three of three sampled showers were inspected from February 10, 2023, to February 25, 2023 (15 days).

During an interview with the Director of Engineering (ENGD), on June 8, 2023, at 11:55 a.m., in the conference room, the ENGD stated the eye wash stations were plumbed eyewash stations and the engineering department was responsible for inspecting and flushing the emergency showers and eye wash station for proper functioning at weekly intervals. The ENGD stated the hospital's policy was not followed for inspecting and flushing the equipment weekly. The ENGD stated more education was needed on the importance of inspecting and flushing the emergency equipment weekly.

A review of the AORN's guidelines for Perioperative Practice (2018), Guideline for Environment of Care indicated the following, "...Recommendation: 10. Chemicals...10.10.2. Plumbed eyewash stations should be flushed weekly...

Rationale: "Weekly flushing removes stagnant water, which may contain microbial contamination, from the system..."

A review of the hospital's P&P titled, "Showers and Eyewash Stations," revised March 2019, indicated the following, "...Intended Use: The emergency showers and eyewash stations in the laboratory and pathology departments will be checked for proper functioning at weekly intervals by the engineering department...Procedure...The showers and eye-wash stations are to be checked for good working condition at least once a week..."

6. A tour of the surgical service department was conducted on June 7, 2023, at 11:50 a.m., with the Vice President for Infection Prevention (AVPIC) and ICP 1. Two biohazard sharp containers on medical trolley carts were observed stored in OR 3 and OR 5. The containers were observed to be filled with sharp objects, needles, and broken glass. The containers were not closed and were not in use. The containers were clearly labeled, "Biohazard."

During an interview conducted with the AVPIC and ICP 1, on June 7, 2023, at 12:00 pm, in OR 5, the AVPIC confirmed biohazard waste was regulated waste and the hospital followed Occupational Safety and Health Administration requirements for bloodborne pathogens (infectious microorganisms in human blood that can cause disease in humans). The AVPIC stated she was not aware biohazard waste containers required lid covers in the perioperative areas (areas used immediately before, during, and immediately after a surgery) .

A review of OSHA's regulatory requirement indicated the following, "...29 CFR 1910.1030(d)(4)(iii)(B)(1)(i), dated 08/09/2007 (August 9, 2007), requires that '...Regulated waste shall be placed in containers which are: ...Closable..."

A review of the hospital's P&P titled, "Medical Waste Management," effective March 1, 2021, indicated the following, "...Policy: To provide for safe and efficient handling of regular waste, biohazardous waste, sharps waste, pharmaceutical waste, and hazardous wastes..."

The facility's policy did not address regulated waste being stored in closable containers nor did the policy address regulated waste container should be closed when the container was not in use.

7. A tour of the SPD was conducted, on June 7, 2023, at 8:30 a.m., with the AVPIC, ICP 1, and the SPD Manager (SPDM). SPD's clean work area for case cart storage was observed and two of six sampled cart's wheels were torn, and four of six sampled cart's casters were covered with thick orange-brown matter. Two of three sampled autoclaves contained orange-brown matter on the base of the chamber; four of four sampled ceiling air vents had brown stains and were covered with grey fuzzy matter; the floor contained grey fuzzy matter, black and brown stains, and debris throughout the SPD's clean work area with staining and debris near the washers.

During a concurrent observation and interview conducted with the SPDM on June 7, 2023, at 9:30 a.m., in the SPD, the SPDM stated the hospital followed the manufacturer's instruction for use (IFU) for maintenance and care of the SPD equipment. The SPDM stated she did not know when EVS performed terminal cleaning in the SPD. The SPDM was observed to dampen a cloth with water and easily removed several black stains from the floor. The SPDM stated the black and brown stains was "dirt" and the grey fuzzy matter was "dust." The SPDM was observed to dampen another cloth with water and scrubbed excessively to remove some of the brown staining from the cart's casters. The SPDM stated the brown staining on the cart's casters was "rust."

A tour of the SPD's decontamination work area was conducted, on June 7, 2023, at 10 a.m., with the AVPIC, ICP 1, and the SPDM. One water drain in the decontamination work area was observed filled with debris and contained black fuzzy matter. The surface of the drain was observed to be stained with orange-brown matter; two of two sampled washers were observed to have brown and orange matter on the base of the chambers; the decontamination work area floor was observed to have a large amount of scattered grey fuzzy matter, debris, and black/brown stains.

During a concurrent interview and record review conducted with the EVSM, on June 7, 2023, at 10:25 am, in the SPD's work area, the terminal cleaning logs were reviewed from May 8, 2023, to June 6, 2023. The terminal cleaning logs indicated the EVS staff performed terminal cleaning daily for the SPD from May 8, 2023, to June 6, 2023. The EVSM viewed the SPD floors, air vents, walls, and water drain and stated he could not explain the lack of cleanliness that he observed in the SPD, on June 7, 2023.

A review of the hospital's P&P titled, "Terminal Cleaning for Sterile Procedural Areas," effective January 26, 2022, indicated the following, "...Procedure: When to Perform Terminal Cleans...Surgical spaces for daily terminal clean are OR suites, sub-sterile (areas placed between two operating rooms to provide emergent sterilization of unwrapped items to be used during surgery), decontamination, sterile storage..."

8. A tour of the SPD's decontamination work area was conducted, on June 7, 2023, at 10:00 am, with the AVPIC, ICP 1, and the SPDM. There was no hand washing sink observed in the decontamination area.

During an interview conducted with the SPDM, on June 7, 2023, at 10:15 a.m., the SPDM stated the hospital followed AORN guidelines for the decontamination work area and she was aware the decontamination area did not have a handwashing sink. The SPDM did not explain which sink the employees used to perform handwashing. The SPDM stated the decontamination area should have a hand washing sink for employees.

A review of the AORN's guidelines for Perioperative Practice (2020), Guideline for Instrument Cleaning indicated the following, "...Regulatory Requirement: 2. Sterile Processing Area...The decontamination area must contain an eyewash station and a dedicated hand hygiene sink...

Rationale: "The Occupational Safety and Health Administration...requires that an eyewash station be provided where chemicals that are hazardous to the eyes are located. Hand hygiene facilities are required by OSHA for use after removal of PPE (personal protective equipment, protective clothing, helmets, goggles, or other garments or equipment designed to protect the wearer's body from injury or infection)..."

9. During an observation conducted with the SPDM on June 7, 2023, at 10:15 a.m., in the SPD's decontamination work area, SPDT 1 was observed to exit the SPD's clean work area and to enter the SPD's decontamination work area through the side door and then retrieved a cart. SPDT 1 was then observed to reenter the SPD's clean work area through the same door.

During an interview conducted with the SPDM on June 7, 2023, at 10:20 a.m., the SPDM stated SPDT 1 should not have used the side door to enter the SPD's clean work area.

During an interview with SPDT 1 on June 7, 2023, at 10:40 am, SPDT 1 stated, "I have no excuse. I should not have used the side door."

During a follow-up interview conducted with SPDT 1 on June 8, 2023, at 12:25 p.m., a request was made for the P&P related to the SPD's workflow. The SPDM stated the hospital followed AORN guidelines for the SPD workflow and stated, "One way in and one way out." The SPDM stated the hospital did not have a specific policy. The SPDM stated, "The workflow is unidirectional" (operating or moving in one direction only; not changing direction: a unidirectional flow).

A review of the AORN's guidelines for Perioperative Practice (2020), Guideline for Instrument Cleaning indicated the following, "...Recommendation: 2. Sterile Processing Area...The sterile processing area should be designed for unidirectional functional workflow patterns as described in the AORN Guideline for Design and Maintenance of the Surgical Suite..."

10. A review of the hospital's poster, titled "Decontamination," undated, indicated the following instructions:

"Decontamination

Step 1: Rinse

Step 2: Wash Under Enzymatic Water (water with chemicals)

Step 3: Rinse

Step 4. Sonic

Step 5: Mechanic Washer"

During an observation of the SPD's routine cleaning process conducted on June 7, 2023, at 10:45 a.m., in the SPD's decontamination area, SPDT 2 was observed to place the soiled surgical instruments near the decontamination sink. SPDT 2 was then observed to turn on the tap water and to place one instrument under the running tap water. SPDT 2 was observed to pick up a cleaning brush from the sink and began brushing the instrument under the running water. The AVPIC stated to ICP 1, "Back away from the sink before you get splashed." After SPDT 2 had brushed the instrument, he was observed to place the instrument into the enzymatic presoak and cleaner water and repeated the process again until all the instruments were in the enzymatic presoak and cleaner water. The instructions for the decontamination process were observed to be posted on the wall above the decontamination sink and indicated to wash the instruments under enzymatic water).

During an interview conducted with SPDT 2 on June 7, 2023, at 10:53 a.m., in the SPD's decontamination area, SPDT 2 stated he routinely placed the instruments under running water to brush off the excessive blood before placing the instruments into the enzymatic presoak and cleaner water (water with chemicals used to submerge instruments in). SPDT 2 stated he did not receive education related to brushing instruments immersed under water to prevent splashing the contaminated water and/or splashing potentially infectious material. SPDT 2 stated, "I understand, I can brush off the excess blood before putting the instruments in the [enzymatic presoak and cleaner] water."

During an interview conducted with the SPDM on June 8, 2023, at 12:20 p.m., in the conference room, the SPDM stated the hospital follows the AORN guidelines for brushing instruments and SPDT 2 should have brushed the instruments immersed under water. The SPDM stated additional coaching was needed on the importance of brushing soiled instruments immersed under water.

There was no documented evidence SPDT 2 had a current unit specific competencies.

A review of the AORN's guidelines for Perioperative Practice (2020), Guidelines for Instrument Cleaning indicated the following, "...Recommendation: 9. Cleaning and Decontamination...Perform brushing under the surface of the water during manual cleaning...

Rationale: "Brushing under water reduces the risk of aerosolization (turning into a fine mist or spray containing minute [very small] particles) of chemicals and contaminants during manual cleaning..."

A review of the hospital's P&P titled, "Decontamination," reviewed March 2022, indicated the following, "...All items should be pretreated with an initial cold-water rinse with running tap water or an initial soak in water and/or a clinical-soil-dissolving pretreatment product (e.g., an enzymatic cleaner or pH (measure of acidity and basicity) neutral detergent..."

The hospital's P&P on "Decontamination" did not address procedures on brushing instruments immersed under water to prevent splashing.

11. A tour of the gastrointestinal (GI) department was conducted on June 7, 2023, at 2:20 p.m., with the AVPIC, ICP 1, GI Manager (GIM), and GI Technician (GIT) 1. GIT 1 was observed cleaning an endoscope in the endoscopy processing room. The endoscope was observed immersed in detergent solution water and GIT 1 was observed to raise the endoscope above the surface of the water line and began to brush the endoscope.

During an interview conducted with GIT 1 on June 7, 2023, at 2:35 p.m., in the endoscopy processing room, GIT 1 stated when he started brushing the endoscope, the endoscope was not immersed in the detergent solution water. GIT 1 stated the endoscope should have remained immersed in the detergent solution water while he brushed the endoscope.

During an interview conducted with the GIM on June 7, 2023, at 2:50 p.m., outside of the endoscopy processing room, the GIM stated GIT did not need to "submerge" his hand under water to brush the endoscope.

A review of the AORN's guidelines for Perioperative Practice (2020), Guidelines for Instrument Cleaning indicated the following, "...Recommendation: 9. Cleaning and Decontamination...Clean and decontaminate surgical instruments and equipment according to the manufacturer's validated, written IFU..."

A review of the undated manufacturer's guidelines, titled "Reprocessing Manual," indicated the following, "...Warning: Be sure to thoroughly brush the inside of the instrument channel, the instrument channel port, the suction channel, and the suction cylinder of the endoscope (parts of an endoscope, an instrument with a camera used to visualize internal organs). Insufficient brushing may pose an infection control risk...

To avoid splashing the detergent solution when the brush is pulled out from the endoscope, keep the endoscope immersed in the detergent while brushing..."

Based on observation, interview, and record review, the Infection Prevention Program failed to implement hospital-wide environment of care rounds (EOC, regular inspections conducted by a healthcare facility to ensure that EOC standards are being met) when EOC rounds were not implemented, for two of five sampled departments (the surgical service department including the operating rooms [OR] and the sterile processing department [SPD]).

This failure resulted in inadequate infection prevention program oversight of the ORs or the SPD and had the potential for the increased risk of avoidable disease transmission for patients and staff within the departments.

Findings:

A tour was conducted of the obstetric operating rooms (OBOR) on June 6, 2023, at 2:10 p.m., with the Obstetric Manager (OBM), the Assistant Chief Nurse Officer (ACNO), and Infection Control Preventionist (ICP) 1.

During an interview conducted with the OBM, on June 6, 2023, at 2:45 p.m., in OBOR 1, the OBM stated she had not performed environment of care (EOC, regular inspections conducted by a healthcare facility to ensure that EOC standards are being met) rounds with the Infection Prevention Program, and she did not have written documentation that showed EOC rounds had been performed.

During an interview conducted with the Environmental Service Manager (EVSM) on June 6, 2023, at 3:15 p.m., in OBOR 1, the EVSM stated he did not perform active EOC rounds with the Infection Prevention Program. The EVSM stated the infection prevention department emails him if there were EVS concerns.

A tour was conducted of the surgical service department (OR) on June 6, 2023, at 3:45 p.m., with the Director of Surgical Services (SSD) and Charge Nurse (CN) 2.

During an interview conducted with the SSD and CN 2, on June 6, 2023, at 4:15 p.m., in OR 6, the SSD stated she did not know if EOC rounds were conducted in the ORs or the SPD. CN 2 stated she had not witnessed EOC rounds for the operating rooms.

A tour of the Sterile Processing Department (SPD) was conducted on June 7, 2023, at 8:30 a.m., with the Manager of the SPD (SPDM), the Assistant Vice President of Infection Control (AVPIC) and ICP 1, to investigate infection prevention activities.

During an interview conducted with the SPDM, on June 7, 2023, at 9:05 a.,m. in the SPD, the SPDM stated she could not recall EOC rounds being conducted in SPD, and she did not have documentation that showed EOC rounds had been performed in SPD.

During an interview conducted with ICP 1 on June 7, 2023, at 9:20 a.m., in the SPD, ICP 1 stated the infection control department had performed individual EOC rounds in the SPD and the ORs and if there were infection control concerns, she would notify the EVS department through email.

A request was made to review the EOC findings and outcomes related to the OR and the SPD rounding activities. No documentation was provided.

During an interview conducted with SPD Technician (SPDT) 2 on June 7, 2023, at 10:53 a.m., in the SPD, SPDT 2 stated, "There is no infection prevention team."

There was no documented evidence the IPs were rounding in the SPD and ORs.

During an interview conducted with the Infection Control Director (ICD), on June 8, 2023, at 2:55 p.m., in the conference room, the ICD stated the infection control department did not have documentation that showed EOC rounds were implemented in the ORs and the SPD. The ICD stated active EOC rounds for infection control were not performed in the SPD and the OR's. The ICD stated the infection control plan was to round in the ORs and the SPD, but the Infection Prevention Program did not include the ORs and the SPD due to short staffing and other infection prevention activities performed on the other units. The ICD stated the Infection Prevention Program should have performed EOC rounds for the ORs and SPD.

A review of the hospital's policy and procedure, titled "Infection Control Plan," effective March 22, 2023, indicated the following, "...Mission: The Infection Prevention Program supports [Name of Hospital] that above all else, we are committed to the care and improvement of human life...Infection Prevention Program Description: The infection Prevention (IP) Program utilizes a multidisciplinary, systematic approach to quality patient care that emphasizes disease transmission risk reduction in the healthcare environment by using sound epidemiological principles and evidence-based practices. Effectiveness is achieved by integrating principles of infection prevention with each department's standards. Activities of the IP program are appropriate to the number of employees as assessed during the yearly risk assessment..."

Based on observation, interview, and record review, the Infection Control Director (ICD) failed to ensure Cardiovascular Perfusionists (CPs, healthcare professionals who operate the bypass (surgical procedure to treat heart diseases) machine during open heart surgery) had competency-based training and education on the hospital's infection control plan for preventing and controlling the transmissions of infections within the hospital when:

1. 19 vials of outdated medications were observed stored in the cardiovascular perfusion specialty cart (CPSC, a cart used to store CP supplies) and were available for patient use;

2. Five corrugated cardboard boxes were stored in the CPSC and the CPSC and supplies were ready for patient use;

3. CP equipment was not disinfected between patient cases and the equipment was designated as "clean" and ready for patient use; and

4. The hospital did not implement the contract service agreement for staff orientation in the provision of education and complete competency verification activities related to the principles and processes of environmental cleaning to a CPs.

These failures had the potential for cross-contamination (transfer of harmful bacteria from one person, object or place to another) and may result in an avoidable hospital acquired injury to patients being cared for in the facility.

Findings:

During an interview conducted with the ICD, on June 6, 2023, at 9:20 am, in the conference room (CR), the ICD stated the hospital followed the following nationally recognized guidelines:

A. Centers for Disease Control and Prevention (CDC, the national public health agency of the United States);

B. Association of PeriOperative (around a surgery) Registered Nurses (AORN, a nationally recognized infection control guidelines for perioperative areas);

C. Occupational Safety and Health Administration (OSHA, a large regulatory agency of the United States Department of Labor);

D. ANSI/AAMI ST79 (2017) Comprehensive Guide to Steam Sterilization (procedure of exposing instruments to moist heat in the form of saturated steam under pressure for sterilization) and Sterility Assurance in Healthcare Facilities.

E. Association for Professionals in Infection Control and Epidemiology (APIC- Professional association for infection prevention).

1. A tour of Operating Room (OR) 5 was conducted with Infection Control Preventionist (ICP) 1, ICP 2, the Surgical Services Director (SSD), and the Assistant Vice President of Infection Control (AVPIC), on June 7, 2023, at 11:30 a.m.. The following medications were observed in the CPSC:

a. Seven out eight sampled vials containing Spyagent Green (an imaging agent used to visualize blood flow and tissue perfusion) labels indicated an expiration date of April 2023. The outdated medications were available for patient use; and

1b. 12 out of 13 sampled vials containing Amiodaron Hydrochloride (medicine used to treat abnormal heart rhythms) labels indicated an expiration date of March 2023.

During an interview conducted with Registered Nurse (RN) 4, on June 7, 2023, at 11:40 a.m., RN 4 confirmed the seven vials of Spyagent and the 12 vials of Amiodaron Hydrochloride medications were expired and stated she did not know why expired medication were stored in the CPSC. RN 4 stated the CPs were responsible for maintaining the CPSC.

During an interview conducted with CP 1, on June 8, 2023, at 1:20 p.m., CP 1 stated he was aware the medications in the CPSC. CP1 stated the medications "May have expired." CP 1 stated he kept all unused medications, and he only checked for expired medication on a quarterly basis. CP 1 stated he routinely checked medications quarterly for expiration dates and if a medication expired before the designated quarterly check date, he stated, "I just keep it." CP 1 stated again, "I only remove expired medications from my cart quarterly." CP 1 stated if medications in the CPSC expired, "It would just be unfortunate." CP 1 clarified his statement and stated, "It would be unfortunate for the patient." CP 1 stated he did not know the hospital's policy for returning unused medications to the pharmacy because he did not follow the hospital's policy, he followed his company's (SpecialtyCare Cardiovascular Resources, LLC, limited liability company) protocols for medication storage.

During an interview conducted with the SSD, on June 8, 2023, at 1:40 p.m., the SSD stated all unused medications should have been returned promptly to the pharmacy and expired medication had the potential to be less effective and/or lead to other complications in the body.

There was no documented evidence the facility provided CP 1 with competency-based training related to medication storage or outdated medication.

A review of the AORN's guidelines for Perioperative Practice, (2023), Guideline for Medication Safety, indicated the following, "...Recommendation 15.3 Collaborate with pharmacy personnel to determine methods for returning unused and unopened medications in medication storage areas to the pharmacy...

Rationale: Returning medications to the pharmacy increases the accuracy for accounting for unused medications and may improve the chances for exchanging the medications to avoid outdates and consequent waste..."

A review of the hospital's policy and procedure (P&P) titled, "Pyxis Procedures-Medication Removal, Returning, Wasting and Discrepancy Resolution," revised November 2020, indicated the following, "...B. Returning a Medication to the Pyxis Return Bin 1. Intact, unopened, and untampered medications removed from the Pyxis and not administered to the patient may be returned to the Pyxis return bin promptly..."

2. During an observation of the CPSC supplies on June 7, 2023, at 11:45 am, in OR 5, the CPSC was observed to have been cleaned. The CPSC was observed to be designated as ready for patient use and the following items were observed stored in the CPSC:

a. Two cardboard boxes filled with nine "Heparin (a blood thinner medication) Assay Cartridges" (supplies used for CP equipment to test blood samples), nine needles, and nine syringes;

b. One cardboard box filled with 18 "High Range Activated Clotting Time Cartridges," nine syringes, and nine needles;

c. Two cardboard boxes filled with nine "Heparin Dose Response Cartridges," nine needles, and nine syringes.

RN 4 removed two of the cardboard boxes from the drawer and grey fuzzy matter was observed on the surface of the drawer. The CP supplies were observed to be available for patient use.

During an interview conducted with the SSD on June 7, 2023, at 11:50 a.m., the SSD confirmed the supplies were stored in cardboard boxes and she was not aware cardboard boxes were stored in the OR. The SSD confirmed the hospital followed AORN guidelines and stated she was aware cardboard boxes should not be stored in the OR.

During an interview conducted with CP 1 on June 8, 2023, at 1:25 p.m., in OR 5, CP 1 stated the supplies stored in the cardboard boxes were used for every cardiovascular procedure. CP 1 stated he did not know if cardboard boxes could be potentially contaminated or cause cross-contamination for surgical patients. CP 1 stated the boxes in the CPSC were clean and he did not explain how he disinfected the boxes between patients. CP 1 stated the facilityl, nor his company had not provided education on cardboard boxes in the OR.

A review of the AORN's guidelines for Perioperative Practice (2018), Guideline for Sterilization, Storage of Sterile Items indicated the following, "...Recommendation...Remove supplies and equipment from external shipping containers and open-edged corrugated cardboard boxes before transfer to the sterile storage area or point of use. External shipping containers and open-edged cardboard boxes may collect dust, debris, and insects during shipment and may carry contaminants into the surgical suite..."

A review of the hospital's P&P titled, "Guidelines for the Storage of Patients Care Supplies," reviewed January 2021, indicated the following, "...Procedure...Cardboard corrugated material delivered to healthcare areas should be broken own and the cardboard removed in a timely manner. Internal shipping boxes (not corrugated boxes) may be used to dispense sterile and clean supplies but should be discarded when the box has been emptied..."

3. A review of the manufacturer's label titled, "Pre- Klenz: A Point of Use Processing Gel," dated 2016, indicated the following instructions for use (IFU), "...Pre-Klenz point of use processing gel is a ready-to-use, neutral pH (neither acidic nor basic) gel designed to keep soils moist and initiate the cleaning process on reusable surgical instruments at the point of use..."

An observation of the cleaning practices for the cardiovascular perfusion machine (CPM) 1 (heart and lung machine, machines used for open heart surgery) was conducted with the SSD, ICP 1, and the AVPIC, on June 8, 2023, at 1:05 p.m., in OR 5. Upon entering OR 5, the patient was observed to be not conscious and was lying on the procedure table. CP 1 was observed sitting on a stool with his back to the patient. CP 1 was observed to pick up a cloth from a nearby table and began to wipe the CPM 1.

During a concurrent observation and interview conducted with CP 1, on June 8, 2023, at 1:10 p.m., CP 1 stated that he could not answer any questions at that time because he needed to monitor the patient until the patient left the room. After the patient was placed on a gurney and transported out of OR 5, CP 1 stated he had "already sprayed" the cloth with Pre-Klenz, cleaned most of the nearby surfaces, and cleaned most of the CP equipment with the hospital approved disinfectant. CP 1 stated CPM 1 was an artificial blood pump and during the treatment process, CPM 1 came in direct contact with a patient's blood supply. CP 1 stated CPM 1 was used for testing blood samples, and it was not unusual for a small amount of residual blood to spill around CMP 1's salvage reservoir (a disposable device designed to catch the remaining blood from the needle). CP 1 stated he cleaned the dirtiest (blood spill) portion of CPM 1 first and then proceeded (using the same cloth) to clean the outer portion of the machine. CP 1 read the manufacturer's IFU on the Pre-Klenz bottle's label and stated the IFU did not indicate Pre-Klenz was a disinfectant. CP 1 stated he was certain that Pre-Klenz was the hospital's approved disinfectant, and he did not know how long the Pre-Klenz solution took to kill microorganism. CP 1 confirmed that he did not receive education and training on the hospital's approved disinfectants and stated, "If the disinfectant is in the hospital, it must be an approved hospital disinfectant."

During an interview conducted with the ICD, on June 8, 2023, at 2:45 p.m., in the CR, the ICD stated Pre-Klenz was a hospital approved product used to pre-treat surgical instruments and she did not know why CP 1 used Pre-Klenz to disinfect equipment between patients. The ICD could not explain who was responsible for ensuring CPs received appropriate training on preventing and controlling the transmissions of infections within the hospital. The ICD stated she could not confirm if CP 1 had received education on the hospital's approved disinfectants and there was no documented evidence that showed CP 1 had received education on the hospital's approved disinfectants.

A review of the AORN's guidelines for Perioperative Practice (2018), Guideline for Environmental Cleaning OR and Procedure Rooms," indicated the following, "...Recommendation 4.2.1: Do not begin environmental cleaning, including trash and contaminated laundry removal, until the patient has left the OR or procedure room..."

A review of the AORN's guidelines for Perioperative Practice (2018), Guideline for Environmental Cleaning "1. Selection and Use," indicated the following, "...Recommendation 1.6: Do not use a spray bottle to apply disinfectants to environmental surfaces in the perioperative practice setting..."

A review of the CDC's guidelines for "Best Practices for Environmental Cleaning in Healthcare Facilities" (2019), indicated the following, "...3.3 Supplies and equipment for environmental cleaning: Surface cleaning supplies- Squeeze bottles are preferred over spray bottles for applying cleaning or disinfectant solutions directly to cleaning cloths before application to a surface..."

A review of the OSHA's requirements for bloodborne pathogens (August 9, 2007), indicated the following, "...29 CFR 1910.1030(d)(4)(i), requires that...General. Employers shall ensure that the worksite is maintained in a clean and sanitary condition. The employer shall determine and implement an appropriate written schedule for cleaning and method of decontamination based upon the location within the hospital, type of surface to be cleaned, type of soil present, and tasks or procedures being performed in the area...

29 CFR 1910.1030(d)(4)(ii): All equipment and environmental and working surfaces shall be cleaned and decontaminated after contact with blood or other potentially infectious materials...

29 CFR 1910.1030(d)(4)(ii)(A): Contaminated work surfaces shall be decontaminated with an appropriate disinfectant after completion of procedures; immediately or as soon as feasible when surfaces are overtly contaminated or after any spill of blood or other potentially infectious materials; and at the end of the work shift if the surface may have become contaminated since the last cleaning..."

A review of the CDC's guidelines for "Best Practices for Environmental Cleaning in Healthcare Facilities" (2019), indicated the following, "...4.1 General environmental cleaning techniques: Proceed From Cleaner To Dirtier-Proceed from cleaner to dirtier areas to avoid spreading dirt and microorganisms..."

A review of the hospital's P&P titled, "Environmental Sanitation - OR," reviewed December 2022, indicated the following, "... Policy: The surgical patient will be provided a clean, safe environment. Environmental cleaning is a team effort involving surgical personnel and environmental services. Items that come in contact with the patient and/or the sterile field shall be considered contaminated and will be either sterilized, disinfected, or contained for disposal..."

4. A review of the hospital's contract service agreement titled, "SpecialtyCare Cardiovascular Resources, LLC," dated March 1, 2020, indicated the following, "...6. Facility Responsibilities. Facility shall...e. Provide the following to the staff (at facility's expense, unless noted otherwise below): (i) Orientation to facility's policies, procedures, rules, and guidelines applicable to Services..."

During an interview conducted with CP 1, on June 8, 2023, at 1:20 p.m., in OR 5, CP 1 stated the hospital did not provide an orientation related to hospital's policies, procedures, and/or rules. CP 1 stated his company provided protocols that he followed for all hospitals. CP 1 stated, "I don't follow hospital policies. I follow my company's protocols."

During an interview conducted with the Infection Control Director (ICD) and the Accreditation Director (AD), on June 8, 2023, at 2:30 p.m., in the CR, the ICD nor the AD could explain who was responsible for ensuring CPs received competency-based training, education, and/or orientation on providing safe patient care services within the hospital. There was no evidence of a documented orientation packet that showed CP 1 received training or education on hospital policies, procedures, and/or rules, prior to providing patient care. The ICD stated the service agreement was not followed for the orientation process.

A review of the AORN's guidelines for Perioperative Practice (2018), Guideline for Environmental Cleaning: "11. Education," indicated the following, "...Recommendation 11.1: Provide education and complete competency verification activities related to the principles and processes of environmental cleaning...

Regulatory Requirement 11.2: Personnel at risk for occupational exposure to blood, body fluids, or other potentially infectious materials must receive training before assignment to tasks where occupational exposure may occur, at least annually, and when changes to procedures or tasks effect occupational exposure risk..."

A review of the hospital's P&P titled, "Contract Services-Evaluation of," revised August 2019, indicated the following, "...Procedure... 5. Contract personnel should meet the same requirements for orientation, annual education, and competency validation as employees within the facility..."