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Based on observation, document review and interview, it was determined that for 2 Medical Surgical Unit, and the Emergency Department (ED), the hospital failed to ensure that patients health information was not accessible to unauthorized staff and visitors. This had the potential to affect the privacy of 70 patients on census as of 8/8/2023.

Findings include:

1. On 08/08/2023 between 9:30 AM -11:40 AM, an observational tour of the 2C-medical-surgical unit was conducted. During the tour the following was observed:

- At the entrance of the unit in front of the nurses station by the visitors hallway, there was a 65 inches monitor/television on the wall, called the nurse responder, that displayed, room number, patient first name and last initial, name of the attending physician, name of registered nurse, name of patient care technician and contact telephone number.

2. On 08/08/2023 between 1:00 PM - 2:30 PM, an observational tour of the 1C -Medical-Surgical unit was conducted. During the tour the following was observed:

-At the entrance of the unit in front of the nurses station by the visitors hallway, there was a 60 inches monitor/television on the wall, called the nurse responder, that displayed all the information as seen on the 2C-medical-surgical unit.

3. On 8/08/2023, between approximately 1:00 PM and 2:20 PM, an observational tour was conducted of the hospital's ED. During the tour, two (2) patient tracker boards by the nurses' station contained patient information including last name with first initial, age, ESI (Emergency Severity Index), length of stay, icons of services ordered (blood, imaging), disposition (Facility name with discharge time) and additional information in the comment section such as one to one monitoring and SANE [Sexual Abuse Nurse Examiner]). These tracker boards were available for any staff or visitor in the ED to review.

4. On 08/08/2023, the hospital's policy titled, "HIPAA [Health Insurance Portability and Accountability Act] Program Structure" dated 08/04/2022, was reviewed and required, "...the establishment and maintenance of system-wide structure for all ...entities in accordance with the Health Insurance Portability and Accountability Act (HIPAA) ...their implementing regulations, state specific privacy laws, and any amendments there to protect the privacy and security of Protected Health Information (PHI) ...practices, the manner in which PHI is kept confidential and secure, and specific requirements for obtaining satisfactory assurances ...keeping PHI confidential ..."

5. On 08/08/2023, the hospital's policy titled, "Patient Rights and Responsibilities" dated 11/24/2020, was reviewed and required, "...A patient has privacy rights established under the Health Insurance Portability and Accountability Act (HIPAA)..."

6. On 08/08/2023 at approximately 9:40 AM, the registered nurse (E #8) was interviewed. E #8 stated that the nurse responder board had the patient information, so when a doctor walks into the unit they can identify who is the nurse taking care of which patient and the telephone number to contact the nurse on the unit for any particular patient.

7. On 08/09/2023 at approximately 1:40 PM, the Regional Director of Accreditation and Compliance (E #11) was interviewed. E #11 stated that she had questioned and validated with the hospital's regional compliance officer (E #24) regarding the same information when she (E #11) had walked into the medical-surgical unit one day.

8. On 08/09/2023 at 2:00 PM, a telephone interview was conducted with E #24. E #24 stated, "We limited the patient identifiable to first name, and last initial, to facilitate for the physicians and nurses." E #24 stated that privacy violation was minimal and was okayed by the corporate office from Florida. E #24 stated that he plan on moving the nurse responder board/television on both the medical-surgical units to a location where no visitors can see the board.

Based on observation, document review, and interview, it was determined that for 1 of 1 patient (Pt. #4) observed in the intensive care unit (ICU) wearing mittens for prevention of pulling out his breathing tube, the hospital failed to ensure procedures for the application of restraint were followed.

Findings include:

1. On 8/8/2023 between approximately 9:30 AM and 11:15 AM, an observational tour of the ICU was conducted. At approximately 10:30 AM, Pt. #4 was observed wearing right and left hand mittens. Pt. #4's was with eyes closed and not agitated or moving upper extremities and could not intentionally remove the mittens.

2. On 8/8/2023, the hospital's policy titled, "Restraint Management" (12/2021) was reviewed and required, "... IV. Each episode of the restraint or seclusion must be ordered by a physician... A... The restrained patient's plan of care will be modified to address the intervention... B. Documentation in the patient medical record shall reflect that the patient and/or family are educated regarding the hospital policy of using restraints. C... The patient shall be monitored at regular intervals... IV. Definitions. A. Manual Restraint. Any... mechanical device, material or equipment that immobilizes or reduces the ability of a patient to move his or her arms... and cannot be removed by the patient. 1. Hand Mitts would be considered a restraint if... d. The mitts cannot be easily removed intentionally by the patient in the same manner it was applied by staff considering the patient's physical condition..."

3. On 8/8/2023, the clinical record for Pt. #4 was reviewed. Pt. #4 was admitted to the ICU due to cardiac arrest. Pt. #4's clinical record lacked documentation of the following: physician's order, modification of plan of care, family education, as well as periodic monitoring while restraints were in use.

4. On 8/8/2023 at approximately 11:00 AM, an interview was conducted with E #48 (ICU registered nurse). E #48 stated that the mittens were used to prevent Pt. #4 from pulling out his breathing tube. E # 48 stated that Pt. #4 has been wearing bilateral mittens since Pt. #4 was taken off of from intravenous sedative infusion.

Based on observation, document review, and interview, it was determined that for 2 of 2 patients' (Pt. #11 and Pt. #15) reviewed for intravenous therapy, the hospital failed to ensure that IV (intravenous) site assessments were conducted and that IV administration set was changed every 96 hours, as required.

Findings include:

1. On 08/08/2023 between 9:30 AM - 11:40 AM, an observational tour of the 2C-Medical Surgical Unit was conducted. During the tour following was observed:

-At 10:10 AM, Pt. #11 in Room #6233-A was seen with intravenous normal saline 1000 ml (milliters) bag infusing via the IV site located in her right anti-cubital area (inner part of the elbow) with no date and time at the IV dressing site and no date and time label on the IV tubing.

- At 10:15 AM, Pt. #15 in Room #6210-A was seen with intravenous normal saline 1000 ml bag infusing via the IV site located in her right wrist area, with no date and time at the IV dressing site and no date and time label on the IV tubing.

2. On 08/08/2023, Pt. #11's clinical record was reviewed. Pt. #11 was admitted to the hospital on 08/07/2023 at 5:40 PM, with the diagnosis of sepsis. Pt. #11's clinical record included a physician's order dated 08/07/2023, sodium chloride 0.9 percent normal saline at 75 ml/hr (milliliters per hour). Pt. #11's clinical record lacked IV site shift assessments from 08/07/2023 through 08/08/2023.

3. On 08/08/2023, Pt. #15's clinical record was reviewed. Pt. #15 was admitted to the Hospital on 08/06/2023 at 8:09 AM, with a diagnosis of urinary tract infection. Pt. #15's clinical record included a physician order dated 08/06/2023, 0.9 percent normal saline at 100 ml/hr. Pt. #15's clinical record lacked IV site shift assessments from 08/06/2023 through 08/08/2023.

4. On 08/08/2023, the hospital's policy titled, "IV Management" dated 04/01/2022, was reviewed and required, "...Replace administration sets that are continuously used...no more than 96-hours...all catheter insertion sites will have a dressing ...is changed every 96 hours ...the nurse will continue to document assessment of the site every shift..."

5. On 08/08/2023 at approximately 10:30 AM, the registered nurse (E #8) was interviewed. E #8 stated that E #8 was not sure why the IV tubing was not labeled and the IV site sticker date and time of dressing change at the IV site was missing.

6. On 08/08/2023 at approximately 10:40 AM, the Nursing Director (E #10) was interviewed. E #10 stated that the IV tubing and the IV site must be dated and labeled to avoid any types of infection. E #10 stated that IV site shift assessments should be documented in the nursing flowsheet.

Based on observation, document review and interview, it was determined that for 1 of 2 (Pt. #11) patients observed in mittens, the hospital failed to ensure that the nursing care plan reflects the nursing care to be provided to meet the patient's needs.

Findings include:

1. On 08/08/2023, between 9:30 AM - 11:45 AM, an observational tour of the 2C - Medical-Surgical Unit was conducted. During the tour following was observed:

-At approximately 10:30 AM, while in room #6233-A, Pt. #11 was seen lying on her back in bed, with white colored cloth mittens to both hands fastened around the wrist.

2. On 08/08/2023 at 10:45 AM, Pt. #11's clinical record was reviewed. Pt. #11 was admitted to the hospital on 08/07/2023, with a diagnosis of sepsis. Pt. #11's clinical record lacked a physician's order to place the patient on mittens. Pt. #11's nursing plan of care lacked the documentation of patient being placed on mittens, goals, and nursing care to be provided to meet patient needs.

3. On 08/08/2023, the hospital's policy titled, "Interdisciplinary Plan of Care (IPOC)" dated 11/01/2017, was reviewed and required, "...A plan of care will be initiated within 4 hours of admission...The plan of care will include: a. problems b. goals with appropriate target dates c. indicators and d. interventions...should be added, modified or discontinued based on the continued assessment and/or reassessment..."

4. On 08/08/2023 at approximately 10:50 AM, the registered nurse (E #8) was interviewed. E #8 stated that mittens are not considered as restraints. E #8 acknowledged that the nursing plan of care was not updated indicating the mittens being used for the patient's (Pt. #11's) safety avoiding from pulling the tubings. E #8 stated she was unable to identify on what date and time, patient (Pt. #11) was placed on mittens.

5. On 08/08/2023 at approximately 10:55 AM, the Director of Nursing (E #10) was interviewed. E #10 stated that there should have been nursing documentation to indicate the reason for the use of mittens for the patient.

Based on document review and interview, it was determined that the hospital failed to ensure the completion of medical record after 30 days of patient discharge.

Findings include:

1. On 08/11/2023, the hospital's Rules and Regulations of the Medical Staff of (name of organization) was reviewed and included, "Medical Record (amended 3/27/08) a. Delinquent-the medical record is considered delinquent if specific sections are not completed within the required statutory time frame and in accordance with these bylaws. The entire medical record must be completed within 30 days of the patient's discharge. Delinquency begins on day 31."

2. On 08/11/2023 at approximately 1:15 PM, the Director of Quality and Accreditation (E #11) presented an attestation letter signed by the Health Information Manager (E#47) dated August 11, 2023, and included, "Delinquent Medical Records... has a total of 13 delinquent medical records."

3. On 08/11/2023 at approximately 1:50 PM, an interview with the Health Informative Manager (E#47) was conducted. E#47 stated that there were thirteen delinquent records.

Based on document review, observation, and interview, it was determined that for 1 of 1 MRI (Magnetic Resonance Imaging) machine, the hospital failed to ensure that weekly quality control measurements were documented as required.

Findings include:

1. During a tour of the MRI trailer on 8/9/2023, at approximately 11:20 AM, the "Weekly MRI Equipment Quality Control For Large Phantom" log from 5/5/2023 to 8/9/2023 (present) was reviewed and lacked any documentation that quality control measurements were completed weekly after 6/21/2023. The MRI Technologist (E#21) present stated that E#21 performed the quality controls in July. E#17 presented a sticky note that contained numbers representing log values for "Center Frequency" and "TX [transmitter] Gain of Attenuation"; however, no dates were associated with these values, and there were no additional measurements recorded as required by the log such as the "Setup & Table Position Accuracy", "Geometric Accuracy", "High-Contrast Spatial Resolution", "Low-Contrast Detectability", and "Artifact Evaluation." A copy of the log sheet was requested on 8/9/2023, at approximately 11:30 AM. A copy was provided by the Regional Direction of Accreditation and Regulatory (E#11), on 8/9/2023, at approximately 3:50 PM, and the log sheet now contained added documentation of weekly measurements from 6/28/2023 to 8/4/2023.

2. During the tour, E#21 demonstrated how to take measurements for quality control from the scanned images on the computer. E#21 displayed scans of the tools used to take measurements between 6/21/2023-8/4/2023; however, the weekly scans from 7/7/2023 and 7/28/2023 were missing (E#21 was unable to find records of scanned images from these dates). It was noted that the scans do not record the actual measurements as the operator must actively measure the images on the computer.

3. On 8/9/2023 at approximately 11:30 AM an interview was conducted with E #21. E#21 stated that they were busy in July so some tests were missed. E#21 stated that the scanned images for quality control are saved on the computer, and the operator needs to take the measurements of each one and document them on the log sheet. E#21 stated that E#21 did not document the measurements for July on the log nor in E#21's notes and stated, "I could do them now."

4. An interview was conducted with the Director of Radiology (E#36) on 8/10/2023, at approximately 1:00 PM. E 36 stated that there is no policy or manufacturer's guidelines for the weekly quality controls; however, stated that it is a standard practice.

Based on document review, observation, and interview, it was determined that for 3 of 3 staff (E#17-E#19) observed during an interventional radiology (imaging guided) procedure in the Cath Lab (Catheterization Laboratory), the hospital failed to ensure that staff wore their assigned dosimeter badges as required when radiology equipment was in use.

Findings include:

1. The hospital's policy titled, "Safe Operating Procedures for Radiographic Imaging Sources" (dated 07/14/2022), was reviewed and required, "...Regulatory Compliance for Use of Radiographic Equipment... Whole body film badges will be worn at chest or waist level. When a protective garment is worn, the badges will be positioned outside of the protective garment, at collar level..."

2. During a tour of the Cath Lab on 8/9/2023, at approximately 10:25 AM, a patient was in Cath Lab Room #1, receiving an interventional radiology procedure to replace a G-tube (feeding tube). Three staff (1 Radiology Technician / E#17 and 2 Nurses / E#18 and E#19) were observed in the room with the patient during the procedure. At the end of the procedure, the Radiology Technician (E#17) removed E#17's lead shielding and no dosimeter badge was observed on E#17. The badges of all three staff (E#17-#18) were observed hanging on the wall in the control room.

3. An interview was conducted with E#17 on 8/9/2023, at approximately 10:32 AM. E#17 stated that E#17 forgot to wear the dosimeter badge, but stated that it should be worn on the body under the lead apron shielding (contrary to the hospital's policy requiring badges to be positioned outside protective garment at collar level).

4. An interview was conducted with the registered nurse (E#25) monitoring the procedure from the control room. E#25 stated that each staff have their own assigned dosimetry badge (only one). E#25 stated that all staff in the Cath Lab should wear their own badge during a procedure. E#25 confirmed that E#17-E#19 did not wear their badges during the procedure, as the badges were hanging on the wall.

Based on observation, document review and interview, it was determined that for dry and cold food items that were stored in the kitchen, were readily available for patient use, the hospital failed ensure that food items were labeled with a use-by-date and that outdated items were discarded. This had the potential to affect 68 patients receiving meal service as of 08/09/2023.

Findings include:

1. On 08/09/2023 between 9:30 AM - 11:45 AM, an observational tour of Food and Dietary Services was conducted and the following were observed:

- Twelve (12) hamburger buns in a plastic bag dated use by 08/04/2023.
- Eight (8) Bagels in a plastic bag kept by the cooking area with no use-by or expiration date.
-Two (2) boxes with a dozen blueberry muffins in each box opened with no use-by or expiration date, an orange label indicated received on 08/01/2023.

-Dry storage area: One (1) five (5) pounds box of opened corn muffin mix with no use-by or expiration date, fresh fruits stored in the dry storage area in a tray.

-Walk-In Freezer: Two (2) bags of five (5) pounds meatballs with no use-by or expiration date, two (2) trays of cooked coconut crumble cookies wrapped in plastic paper with no use-by or expiration date, and two (2) pounds of garlic bread wrapped in plastic paper with no use-by or expiration date.

-Walk-In Food Cooler #1: Three (3) pounds of Jalapeños (hot peppers) opened on 08/04/2023 and expired on 08/07/2023, three (3) large trays of cooked chicken with no use-by or expiration date and one (1) can of 2 pounds apple sauce, with date of preparation labeled 07/29/2023 and use by label dated 08/01/2023.

-Walk-In Produce Cooler #2: Four (4) half pound bag of green beans in food storage bags with no use-by or expiration date, ten (10) bags of flour tortillas with manufacturer expiration date 07/26/2023, and one (1) bag of open corn tortillas with no use-by or date-of-open.

-Patient Food Tray Table: Two (2) peanut butter jelly sandwich wrapped in plastic paper with no use-by or expiration date and one (1) turkey sandwich wrapped in plastic paper with no use-by or expiration date.

2. On 08/09/2023, the hospital's contracted dietary service policy titled "Food and supply storage" dated 01/2022 was reviewed and required "...Discard food past the use-by or expiration date ...observe safety practices ..."

3. On 08/09/2023 at approximately 11:30 AM, the Food Services Director (E #13) was interviewed. E #13 stated that expired food could be contaminated and cannot be used. E #13 stated that it is not acceptable to have any food item without a use-by label if the food item had been opened from the box.

Based on observation during the survey walk-through, staff interview, and document review during the Life Safety Code portion of a Full Survey Due to a Complaint conducted on 8/8/2023 through 8/9/2023, the facility failed to provide and maintain a safe environment for patients, staff and visitors.

This is evidenced by the number, severity, and variety of Life Safety Code deficiencies that were found. Also see A710.

Based on observation during the survey walk-through, staff interview, and document review during the Life Safety Code portion of a Full Survey Due to a Complaint conducted on 8/8/2023 through 8/9/2023, the facility does not comply with the applicable provisions of the 2012 Edition of the NFPA 101 Life Safety Code.

See the Life Safety Code deficiencies identified with K-Tags.

Based on observation, document review interview, it was determined that the hospital failed to comply with the Condition of Participation 42 CFR 482.42 Infection Prevention Control Antibiotic Stewardship.

Findings include:

1. The hospital failed to ensure that the results of biological and chemical indicators were documented to determine whether sterilization parameters were met. See deficiency A-750 A.

2. The hospital failed to ensure that quality control tests were performed according to manufacturer's instructions as required. See deficiency A-750 B.

3. The hospital failed to ensure that immediate-use steam sterilization (IUSS) was used appropriately in emergency cases and not for insufficient inventory of instruments and that the exact contents of the loads were documented. See deficiency A-750 C.

4. The hospital failed to ensure that expired supplies were not available for use and that opened items were dated according to the manufacturer's shelf-life requirements. See deficiency A-750 D.

5. The hospital failed to ensure that equipment and surfaces were disinfected to prevent potential cross contamination. See deficiency A-750 E.

6. The hospital failed to ensure that hand hygiene was performed as required to prevent the transmission of infection. See deficiency A-750 F.

7. The hospital failed to ensure the staff adherence to infection control practices to prevent the risk of cross-contamination. See deficiency A-776.

A. Based on observation, document review, and interview, it was determined that for 3 of 5 staff (E #31/Registered Nurse, E #32/Surgical Scrub Technician, and MD #3/Orthopedic Surgeon) observed in the operating room (OR), the hospital failed to ensure that staff adhered to the surgical attire requirement.

Findings include:

1. On 8/10/2023, the hospital's policy titled, "Surgical Attire" (10/2021) was reviewed and included, "...III... I. All personnel will cover head and facial hair... when in the semi-restricted or restricted areas..."

2. On 8/10/2023, an observational tour was conducted in OR #4, where a sterile field was open. Between 9:45 AM through 11:00 AM, approximately 3-5 inches of E #31, E #32, and MD #3's hair on the back of their heads were uncovered.

3. On 8/10/2023 at approximately 11:45 AM, findings were discussed with E #26 (Director of Surgical Services) and E #43 (Regional Director of Infection Control). E #26 and E #43 stated that hair should be covered when inside the OR room where a sterile field is open.

B. Based on observation, document review and interview, it was determined that for 1 of 1 anesthesiologist (MD #2) observed in the OR, the hospital failed to ensure MD #2's adherence to aseptic technique in medication prepararation and administration.

Findings include:

1. On 8/10/2023, the hospital's policy titled, "Multiple Dose Injectable Products - Medications" (1/2022) was reviewed and included, "... IV. A... Multiple dose injectable products should be dedicated to a single patient - OR (operating room)... D. When preparing doses using multiple dose injectable product... 3. Aseptic technique will be used during preparation of dose..."

2. On 8/10/2023, an observational tour of the operating room was conducted. At approximately 10:45 AM, in OR #4, MD #2 was observed drawing intravenous medications from a vial and administering the medications to Pt. #30's intravenous port. Prior to drawing the medications, MD #2 did not wipe the tip of the medication vials and prior to administering the medications through Pt. #30's intravenous port with antiseptic wipe.

3. On 8/10/2023, the clinical record for Pt. #30 was reviewed. On 8/10/2023, Pt. #30 was admitted in the OR for right total hip arthroplasty (joint hip surgery). Pt. #30's clinical record indicated that MD #2 administered intravenous fentanyl and midazolam (anesthesthetics) to Pt. #30 at 10:47 AM and 10:49 AM.

4. On 8/10/2023 at approximately 11:45 AM, findings were discussed with E #26 (Director of Surgical Services) and E #43 (Regional Director of Compliance/Infection Control). E #26 and E #43 stated that MD #2 should have wiped the medication vial prior to drawing the medication, including the intravenous port before administering the medication.

C. Based on observation, document review, and interview, it was determined that for 3 of 3 (E #22/Inpatient Pharmacy Manager, and 2 registered nurses E #48 and E #49) hospital staff observed in the intensive care unit (ICU), the hospital failed to ensure staff's compliance with skin and nail care requirements.

Findings include:

1. On 8/8/2023 between approximately 9:30 AM through 11:15 AM, an observational tour of the ICU was conducted. During the tour, E #22, E #48, and E #49, were observed with long finger nails (longer than 1/4 inch). E #22 was accessing and handling medications for ICU patients. E # 48 and E #49 provide direct contact with patients.

2. On 8/10/2023, the hospital's policy titled, "Hand Hygiene" (6/2023) was reviewed and required, "... II. This policy is to educate providers, associates... on the proper methods of hand hygiene to prevent the spread of microorganism and reduce incidence of healthcare associated infections... IV... Skin and Nail Care... 2. Nails. i. For associates that have direct contact with patients: 1. Artificial nails are not to be used. ii. Natural nails are to be kept no longer than 1/4 inch in length and well maintained. iii. Nail polish, if worn, may not be chipped or separating from the nail..."

3. On 8/10/2023 at approximately 3:45 PM, an interview was conducted with E #43 (Regional Director of Compliance/Infection Control). E #43 stated that staff providing direct patient care should not have long nails. E #43 stated that all staff are expected to follow the hospital policy.

A. Based on document review and interview, it was determined that for 4 of 4 steam sterilizer (#1, #2, #1A, and #2B) logs reviewed, the hospital failed to ensure that the results of biological and chemical indicators were documented to determine whether sterilization parameters were met. This had the potential to affect any patients receiving surgical services.

Findings include:

1. The hospital's policy titled, "Process Monitoring" (dated 07/21/2022), was reviewed and required, "...Internal chemical integrators (CI) are included in every tray, package and container system. In addition, the process challenge device (PCD) placed in every steam sterilization load in SPD contains both a chemical integrator and a BI [biological indicator]... Results for every biological indicator contained within a sterilization load and incubated are recorded in a log with a pass or fail determination. Results of the chemical indicator/integrator included in the cycle are maintained with load information..."

2. The "Steam Sterilization Logs" from 6/1/2023-8/10/2023 for all four steam sterilizers (#1 and #2 in Sterile Processing Department/SPD and #1A and #2B in the Surgical Operating Room (OR) area) were reviewed on 8/10/2023 and lacked the following:
- Logs for Sterilizer #1 lacked chemical indicator results on 7/3/2023 for Load #3, 7/13/2023 for Load #3, and 8/3/2023 for Load #5; and lacked BI results on 8/8/2023 for Load #2.
- Logs for Sterilizer #2 lacked both BI and chemical indicator results on 7/20/2023 for Load #3.
- Logs for Sterilizer #1A lacked BI results on 7/17/2023 Load #2 and chemical indicator results on 7/31/2023 Load #2.
- Logs for Sterilizer #2B lacked chemical indicator results on 7/31/2023 Load #2.

3. An interview was conducted with Sterile Processing Technician (E#39) and the Covering SPD Manager (E#40) on 8/10/2023, at approximately 9:00 AM. E#39 stated that in SPD, a chemical indicator and biological indicator is run with each load of instruments. E#39 stated that SPD staff will mark the results of the indicators on the envelope for that day/load. E#40 stated that there should be some record of the results whether it's documentation and/or retaining the indicator strips. E#40 confirmed there was no other location where the results would be documented or stored.

B. Based on document review and interview, it was determined that for 4 of 4 steam sterilizers (#1, #2, #1A, and #2B) observed, the hospital failed to ensure that quality control tests were performed according to manufacturer's instructions as required. This had the potential to affect any patient receiving surgical services.

Findings include:

1. The Steam Sterilizers Manufacturer's Operating Instructions (dated 4/6/2016), was reviewed and required, "...Dart (Bowie-Dick) Test: Conduct a residual air test (e.g., Bowie-Dick test) at the beginning of each day... Run the Vacuum Leak test cycle daily or weekly. This test measures the integrity of the sealed pressure vessel and associated piping to assure air is not being admitted to the sterilizer during the vacuum draw downs... A leak rate of greater than 1.0 mmHg (millimeters of mercury) per minute indicates a problem with the sterilizer that must be addressed..."

2. Sterilizer Logs from 6/1/2023-8/10/2023 for all four steam sterilizers (#1 and #2 in Sterile Processing Department/SPD and #1A and #2B in the Surgical Operating Room (OR) area) were reviewed on 8/10/2023 and lacked any records of leak tests being performed weekly as required.

3. An interview was conducted with Sterile Processing Technician (E#41) and the Covering SPD Manager (E#40) on 8/10/2023, at approximately 9:30 AM. E#41 stated that they were instructed recently to start performing leak tests on the sterilizers; however, E#41 admitted that they have not started yet. E#41 stated that E#41 has not received training yet on how to do the leak test and what the results/value indicate. E#40 stated that the leak test should be done weekly and that if the leak rate is greater than 1 [mmHg per minute], the machine needs to be taken out of use and serviced.

C. Based on document review and interview, it was determined that for 2 of 2 steam sterilizers (#1A and #2B) in the Surgical Area (OR), the hospital failed to ensure that immediate-use steam sterilization (IUSS) was used appropriately in emergency cases and not for insufficient inventory of instruments and that the exact contents of the loads were documented. This had the potential to affect any patients receiving surgical services.

Findings include:

1. The hospital's policy titled, "Immediate Use Sterilization" (dated 7/21/2022), was reviewed and required, "Immediate Use Sterilization (previously referred to as Flash Sterilization) will be used ONLY with Surgical Services Director/Manager approval when: 1. There is an immediate need for an individual item (i.e. critical instrument is missing or contaminated and needs to be replaced)... The following information will be recorded on the Documentation Log for Immediate Use Sterilization for tracking of the sterilized items: ...Load Contents..." The policy did not include insufficient instrument inventory as a reason to use IUSS immediate use steam sterilization).

2. IUSS Logs from 6/22/2023-8/3/2023 were reviewed and included the following:

- 6/22/2023: Load Contents: "Ortho Instruments"; Reason: "Insufficient Inventory"
- 7/6/202023: Load Contents: "Hip Instruments"; Reason: "Insufficient Inventory"
- 7/27/2023 Load #3: Load Contents: "Reason: "Inadequate SPD Turnover Time"
- 7/27/2023 Load #4: Load Contents: "Ortho Instruments (Knee)"; Reason: "Insufficient Inventory"
- 7/27/2023 Load #6 and #7: Load Contents: Reason: "Inadequate SPD Turnover Time"
- 8/3/2023: Load Contents: "Ortho Instrument"; Reason: "Insufficient Inventory"
- The records did not specify exactly which ortho or hip instruments were sterilized.

3. An interview was conducted with the Director of Surgical Services (E#26) on 8/10/2023, at approximately 4:00 PM. E#26 stated that staff should document the exact instrument that is being flashed so that E#26 can monitor exactly which instruments are being flashed repeatedly to see if they need to order more of that instrument. E#26 stated that flash/IUSS should only be used in emergencies for example if an item is dropped or an emergent case came up. E#26 stated that they will remove the reason of insufficient inventory from the log so that staff are not using that as a reason to flash instruments.


D. Based on observation and interview, it was determined that for 2 of 3 bleach containers and 2 of 2 opened bottles of barium suspensions observed in the Radiology Department, the hospital failed to ensure that expired supplies were not available for use and that opened items were dated according to the manufacturer's shelf-life requirements. This had the potential to affect any patients receiving radiology imaging procedures.

Findings include:

1. A tour of the Radiology Department on 8/9/2023, at approximately 10:00 AM, in the X-Ray area on the second floor, there were 2 of 3 tubs of bleach that were expired (12/2022 and 7/2023). In the storage cabinet, there were two opened bottles of barium suspension (used for swallow studies) that were not labeled with the date opened (or the date to discard). The instructions on the bottles label included, "Once opened, may be used for up to 21 days..."

2. An interview was conducted with the Ultrasound Lead Technician (E#42) on 8/9/2023, at approximately 10:00 AM. E#42 stated that the expired bleach wipes should have been discarded and replaced. E#42 stated that speech therapists usually manage the barium suspensions used for swallow studies. E#42 stated that if the manufacturer states that it can only be used for a certain period after opening, then it should be labeled with the date it was opened or the date to discard it.

3. On 8/10/2023 at approximately 1:00 PM, the Regional Director of Accreditation and Regulatory (E #11) was interviewed. E #11 stated the hospital does not have a policy for expired items. E #21 stated "Expired is expired and should be discarded."

E. Based on document review, observation, and interview, it was determined that for 2 of 2 staff (E#42 and E#20) interviewed in the Radiology Department for cleaning practices, the hospital failed to ensure that equipment and surfaces were disinfected to prevent potential cross contamination. This had the potential to affect any patient receiving ultrasounds or CT (computerized tomography) scans.

Findings include:

1. The hospital's policy titled, "Cleaning and Disinfection of Non-Critical, Reusable Patient Care Equipment and Workstations on Wheels" (dated 8/3/2023), was reviewed and required, "All reusable equipment must be cleaned and disinfected immediately if visibly soiled, and immediately after use on patients..."

2. The Vaginal Ultrasound Probe manufacturer's instructions for use were reviewed on 8/10/2023 and included a list of approved agents to clean the probe. The instructions did not include hand soap and water.

3. During a tour of the Ultrasound Area, there was a sink observed in the room where the ultrasound probe disinfection equipment was located. The sink in the room was not labeled as clean or dirty and had a hand soap dispenser mounted nearby.

4. An interview was conducted with the Lead Ultrasound Technician (E#42) on 8/9/2023, at approximately 10:20 AM. E#42 stated that after an transvaginal probe is used on patient, the protective "condom" is removed and the probe is washed with hand soap and water in the sink before it is wiped and then placed in the disinfection machine. E#42 stated that the sink may be used for hand washing as well.

5. An interview was conducted with the Lead CT Technician (E#20) on 8/9/2023, at approximately 11:00 AM. E#20 stated that after a CT procedure, E#45 stated that the linens are changed. E#20 stated that the table is only wiped if the patient has COVID-19 (a respiratory infection) or was on contact precautions (for an infectious organism).

6. An interview was conducted with the Director of Radiology (E#36) on 8/10/2023, at approximately 1:00 PM. E#36 stated that the transvaginal ultrasound should not be submerged in water.

7. An interview was conducted with the Infection Control Preventionist (E#44) on 8/10/2023, at approximately 3:45 PM. E#44 stated that the same sink to wash hands should not be used to wash contaminated ultrasound probes.








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F. Based on observation, document review and interview, it was determined that for 3 of 3 staff (MD #3 Orthopedic Surgeon, E #33/Environmental Service Staff/EVS and MD #1/Gastroenterologist), the hospital failed to ensure that hand hygiene was performed as required to prevent the transmission of infection.

Findings include:

1. On 08/09/2023, the hospital's policy titled "Hand Hygiene" dated 06/07/2023 was reviewed and required, "...Gloves do not provide complete protection against hand contamination and hand hygiene should be performed before donning and after doffing gloves ..."

2. On 8/10/2023 from 8:30 AM through 12:15 PM, an observational tour of the operating room was conducted:

- At approximately 10:20 AM, E #33 (Environmental Service Staff/EVS) cleaned the OR bed in OR #3. After cleaning the bed, E #33 removed his gloves, wore another pair of gloves, then mopped the floor. Without changing his gloves and performing hand hygiene, E #33 pushed the cleaned bed into OR #4, where a sterile field was open.

- At approximately 11:05 AM, MD #3 (Orthopedic Surgeon) was observed scrubbing his hands with the preoperative surgical scrub brush. Once finished cleaning MD #3's hands, MD #3 picked up the packet that contained the scrub brush from the sink and discarded packet to the garbage.

3. On 08/10/2023 between 9:00 AM - 10:30 AM, an observational tour of the GI lab was conducted along with the ED/ICU (emergency department/intensive care) nurse educator (E #28). During the tour following was observed:

- At 10:53 AM, Pt. #28 was brought into GI lab (Gastrointestinal Laboratory) via stretcher for a colonoscopy (exam to detect abnormalities or changes in the large intestine and rectum).
- At 10:58 AM, the GI Physician (MD #1) walked into the GI lab, greeted the staff, continued with donning the sterile gown and gloves, and got ready for the timeout. MD #1 did not perform hand washing prior to donning the sterile gown and gloves.

3. On 08/10/2023 at 11:15 AM, the ED/ICU nurse educator (E #28) was interviewed. E #28 stated he acknowledged the physician (MD #1) not washing his hands prior to performing the colonoscopy procedure.

4. On 08/10/2023 at 11:30 AM, the finding was discussed with the Director of Surgical Services (E #26). E #26 stated that it is absolutely not acceptable, the physician should have washed his hands to avoid the risk of cross contamination. E #26 stated that he might have used the hand sanitizer outside the room during the entrance.

5. On 8/10/2023, between approximately 11:45 AM and 3:45 PM findings were discussed with E #26 (Director of Surgical Services) and E #43 (Regional Director of Compliance and Infection Control). E #26 and E #43 stated that E# 33 should have performed hand washing after cleaning the bed and prior to entering a sterile area. E #43 also stated that MD #3 should have not picked up the packet with cleaned/scrubbed hands.

Based on observation, document review and interview, it was determined that for 1 of 1 (Pt. #14) patient observed for blood glucose monitoring, the hospital failed to ensure the staff adherence to infection control practices to prevent the risk of cross-contamination.

Findings include:

1. On 08/08/2023 between 9:30 AM to 11:40 AM, an observational tour of the 2C- Medical-Surgical Unit was conducted along with the Director of Nursing (E #10) and the following was observed:

- At 11:15 AM, the Patient Care Technician (PCT) (E #9) was seen donning gloves after using the hand sanitizer, went by Pt. #14's bedside, placed the glucometer (portable blood glucose testing machine) on the bed, with the same gloved hand reached into her left hand side scrub pockets and removed the alcohol swab and reached into her right hand side scrub pockets and removed the lancet and glucose test strips container to be used for blood glucose testing. E #9 then checked the patient identification band and completed the blood glucose testing. After blood glucose testing, E #9 removed the used test strip from the glucometer and discarded lancets along with the used test strips into the sharp container, and placed the glucometer on the patient bed. E #9 with contaminated gloves then proceeded to place the glucometer in her left hand side scrub pocket and blood test strip container into her right hand side scrub pocket without cleaning the glucometer. E #9 removed contaminated gloves and use the hand sanitizer. Upon asking, regarding the cleaning of the glucometer, E #9 walked towards the nurses station, after donning gloves, removed the used glucometer from her pocket and wiped the glucometer once using Sani-wipes (disinfecting wipes)and placed it in the docking station. The blood glucose test strips container remained in E #9's pocket.

2. On 08/08/2023, Pt. #14's clinical record was reviewed. Pt. #14 was admitted to the hospital on 08/02/2023 with a diagnosis of congestive heart failure (CHF). Pt. #14's physician order dated 09/21/2022, included, "...blood glucose testing four times daily before meals and at HS [night time] ..."

3. On 08/08/2023, the hospital's policy titled, "Glucose, Whole Blood Monitoring - Nova Statsstrip system - POC [point of care]" dated 12/24/2022, was reviewed and required, "...Cleaning and Disinfecting the Meter: ...meter must be disinfected after each patient use ...a. Clean the meter: ...wipe the external surface of the meter thoroughly ...Disinfect the meter: 1. Using a second new, fresh germicidal wipe, wipe the surface of the meter top, bottom, left, and right sides a minimum of 3 times horizontally followed by 3 times vertically ...c. Observe surface contact time: ...ensure meter surface stays wet for 2 minutes and is allowed to air dry for an additional 1 minute ..."

4. On 08/08/2023, at approximately 11:25 AM, the PCT (E #9) was interviewed. E #9 stated that the glucometer is cleaned only once with one sani-wipe and placed into the docking station. E #9 stated that she forgot to remove her dirty gloves. E #9 stated that she was not thinking while placing the dirty glucometer into her scrub pockets.

5. On 08/08/2023 at 11:30 AM, the Director of Nursing (E #10) was interviewed. E #10 stated that she (E #9) should not have placed the used glucometer in her scrub pockets.