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1001 NORTH TUSTIN AVENUE

SANTA ANA, CA 92705

WRITTEN DESCRIPTION OF SERVICES

Tag No.: A0584

Based on observation, interview, and record review, the hospital failed to ensure the availability of laboratory services to meet the patient's care needs as evidenced by:

1. The lactate level for one of 14 sampled patients (Patient 1) was not available within the sepsis protocol time. The lactate level ordered as STAT was assigned a routine priority level.

2. The audit of 30 STAT orders conducted by the hospital as part of the POC addressing previous deficiencies did not include the send-out STAT orders.

3. There was no P&P developed to address the processing turnaround time for send-out STAT laboratory orders.

4. The facility failed to implement its Contingency Plan for Laboratory Services as required regarding the notification of physicians, CDPH, staff, and patients about the disruption in services.

5. The laboratory failed to follow the P&P for expired quality controls for hematology.

These failures created the risk of delayed treatment for the patients.

Findings:

Review of the hospital's P&P titled Adult Sepsis Screening dated 3/23 showed the primary care nurse assesses the patient for possible sepsis using the sepsis tab under daily assessment. If the patient exhibits SIRS criteria, the nurse will complete the Sepsis RN Checklist Tool. Upon identification of a positive sepsis screening, the nurse will inform the physician and initiate the sepsis order set.

Review of the Sepsis RN Checklist showed the following:
* For Sepsis Bundle 4 Hour Checklist, initial lactate level.
* For Sepsis Bundle 6 hour Check list, check on second lactic acid, if trending up, or still greater than 2, reassess for need of further fluid resuscitation and repeat lactic acid level.

Review of the Contractor Services Agreement dated December 2021, showed in part, "...During the term, Contractor agrees to provide courier Services to Hospital as follows...0600 hours...1500 hours...2130 hours...Any pickups/delivery outside of the routine scheduled pickups, will be charged separately..."

Review of the STAT Specimen Handling, Testing, and Reporting dated 3/2025 showed all STAT test results will be made available to the nurse or physician immediately upon verification of the results. The P&P also showed occasionally, a physician will request a test be performed STAT that is not on the attached list. The CSL should consult with a supervisor or the Medical Director to determine the appropriateness of the request. Review of the attachment titled STAT TEST AVAILABILITY dated 2/2025 showed the test turnaround time goal for BNP was less than 45 minutes. The attachment showed, "These TAT goals are very aggressive goals. Instrument performance, staffing, overall workload, and other external factors can have a significant impact on the ability of the lab to meet these goals. Theses TAT goals are applicable to in house testing only and do not apply to send-out testing." The test menu did not include the lactate level.

Review of the hospital's P&P titled Reagent Extension Procedures dated 3/28/24, showed a "Reagent Extension", may only be allowed under extreme circumstances in which the inability to perform critical testing would cause serious patient harm or delays in critical treatment or surgery under the direction and discretion of the Laboratory Medical Director. If the Laboratory Medical Director deems a reagent extension necessary, then specific conditions must be met to ensure the accuracy and efficacy of the reagent's use.

The procedure is as follows:

- Ensure that a valid requisition exists for the soon to expire reagent.

- Attempt to borrow from the local medical centers. If the reagents are borrowed from any site the respective site's CEO will be informed via email for documentation purposes. In any case, the borrowing of reagents will be documented on the LS Form 018. Document all efforts to borrow.

- Attempt to borrow from any contracted services such as blood bank suppliers if possible. Document all efforts in the LS Form 018.

- If all effort to secure the necessary reagent is unsuccessful, notify the Medical Director, the Regional Director, and Manager of the need to extend a reagent.

- Consult the reagent's manufacturer to check whether expiration dates have been extended for specific lots. Also, notify manufacturers when testing has been interrupted because of expired test kits and supply shortages. When possible, request the manufacturer to provide a letter of expiration extension for the reagent.

- If possible, consult with the medical center's regulatory agency for guidance and advice as to how to handle a need for reagent extension.

1. On 6/27/25 at 0926 hours, the Laboratory Department was toured with the Quality PI/Review RN. During the tour, Laboratory Technical Assistant 1 was interviewed. Laboratory Technical Assistant 1 stated the reagents for lactate level, Salicylate, BUP, and BNP tests were not available and the specimens were sent to another facility for testing. Laboratory Technical Assistant 1 stated the contracted courier service picked up the specimens routinely and upon request for STAT orders.

On 6/27/25, Patient 1's closed medical record was reviewed and showed Patient 1 was admitted to the hospital on 6/19/25, and discharged on 6/24/25.

Review of the ED Provider Aware Note dated 6/19/25 at 2125 hours, showed the patient's ED diagnosis was septic shock.

Review of the Physician's Order dated 6/19/25 at 2120 hours, showed to test lactate level STAT.

Review of the Reference Lab Report dated 6/19/25 at 2155 hours, showed the blood sample for lactate level was collected.

On 6/20/25 at 1213 hours, the lactate level result was 2.4 mmol/L (14 hours and 18 minutes after the blood sample was collected).

Review of the Status History for the reference lab dated 6/19/25 at 2155 hours, showed the lactate level test ordered as STAT was assigned a routine priority level.

Review of the Physician's Order dated 6/20/25 at 0929 hours, showed to test lactate level routine.

Review of the Status History for the reference lab dated 6/20/25 at 1200 hours, showed the lactate level test ordered as routine was assigned a STAT priority level.

Review of the Reference Lab Report dated 6/20/25 at 1200 hours, showed the blood sample for lactate level was collected.

On 6/20/25 at 2011 hours, the lactate level result was released as 1.8 mmol/L.

On 6/27/25 at 1227 hours, the Director of the Laboratory Services was interviewed. The Director of the Laboratory Services stated the priority level of send-out testing would be assigned to the computer as ordered. The Director of the Laboratory Services verified the priority level for the lactate level was not entered correctly.

On 6/28/25 at 1124 hours, an interview and concurrent medical record review was conducted with the Quality PI/Review RN. The Quality PI/Review RN verified the sepsis bundle protocol was not followed because the result of the lactate level was not available within the sepsis bundle timeline.

2. The acceptable POC for the survey completed on 2/25/25, showed once a month, the Director of the Laboratory would audit 30 STAT orders to ensure the results were available timely as per hospital policies. Any issues identified would be corrected and the staff would be educated. Records of the audits and any corrective actions would be kept.

On 6/27/25 at 0926 hours, the Director of Laboratory Services was interviewed. The Director of Laboratory Services stated the auditing of 30 STAT orders was conducted monthly. The Director of Laboratory Services stated the audits were only conducted for in house STAT orders and not for send-out tests. When asked why the send-out tests were not included in the audit, the Director of Laboratory Services stated there was no policy for the TAT of the send-out STAT orders, so the Director of Laboratory Services was not able to audit the send-out tests.

3. On 6/27/25, a record review was conducted for Patients 4, 5, 6, 7, and 8.

a. Patient 4's medical record showed Patient 4 was admitted to the ED on 6/26/25. Review of the Physician's Order dated 6/26/25 at 2240 hours, showed to test BNP STAT. Review of the Status History for Patient 4 dated 6/27/25 at 0350 hours, showed the BNP level was high and released five hours and 10 minutes after the blood sample was collected.

b. Patient 5's medical record showed Patient 5 was admitted to the ED on 6/26/25. Review of the Physician's Order dated 6/26/25 at 1323 hours, showed to test BNP STAT. Review of the Status History for Patient 5 dated 6/26/25 at 2110 hours, showed the BNP level was released seven hours and 47 minutes after the blood sample was collected.

c. Patient 6's medical record showed Patient 6 was admitted to the ED on 6/26/25. Review of the Physician's Order dated 6/26/25 at 2247 hours, showed to test BNP STAT. Review of the Status History for Patient 6 dated 6/27/25 at 0350 hours, showed the BNP level was high and released four hours and 57 minutes after the blood sample was collected.

d. Patient 7's medical record showed Patient 7 was admitted to the ED on 6/26/25. Review of the Physician's Order dated 6/26/25 at 0842 hours, showed to test BNP STAT. Review of the Status History for Patient 7 dated 6/26/25 at 1536 hours, showed the BNP level was high and released six hours and 54 minutes after the blood sample was collected.

e. Patient 8's medical record showed Patient 8 was admitted to the ED on 6/26/25. Review of the Physician's Order dated 6/26/25 at 1523 hours, showed to test BNP STAT. Review of the Status History for Patient 8 dated 6/26/25 at 2112 hours, showed the BNP level was released five hours and 49 minutes after the blood sample was collected.

On 6/30/25 at 1309 hours, ED Physicians 1 and 2, and the ED PA were interviewed. ED Physicians 1 and 2, and the ED PA stated the STAT BNP results should be released less than 60 minutes of the test order. When asked if it was acceptable for the STAT lactate level result to be released eight hours from the test order, ED Physicians 1 and 2, and the ED PA stated no. When asked how about four hours from the test order, they stated no.

In a concurrent interview, the Quality PI/Review RN stated the facility did not have a P&P for TAT for send-out tests.

4. Review of the hospital's Continuity of Operations Plan undated showed in part, "Laboratory Continuity of Operations Procedures...Notify physicians (explore alternative comparable testing), CDPH, staff and patients of the disruption in services..."

On 6/27/25 at 0926 hours, the Director of Laboratory Services stated some of the reagents to perform the laboratory testing were not available. The Director of Laboratory Services stated the Director of Laboratory Services communicated the issue to the Administration team via email. Upon request for evidence of reporting, the Director of Laboratory Services provided the email correspondence.

Review of the Director of Laboratory Services' email showed the following:

* On 6/10/25 at 0828 hours, the Director of Laboratory Services received an email from the vendor. The email showed the list of orders were awaiting payment processing.

* On 6/10/25 at 0852 hours, the email showed the Director of Laboratory Services requested urgent assistance with the invoices and that the Director of Laboratory Services would be initiating a contingency plan for disruption of testing services on that day. The recipients included the CNO and Corporate CFO.

On 6/27/25 at 1437 hours, a follow-up interview was conducted with the Director of Laboratory Services. The Director of Laboratory Services stated the Laboratory Services placed supply order requests on 5/31/25, and the Purchasing Department placed final supply orders to the vendor on 6/19/25. The Director of Laboratory Services stated the Director of Laboratory Services followed up with the vendor regarding the order status.

On 6/27/25 at 1508 hours, the Director of Laboratory services stated there was no notification to the physicians (explore alternative comparable testing), CDPH, staff and patients of the disruption in services.


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5. On 6/27/25 at 0926 hours, the Laboratory Department was toured with the Quality PI/Review RN. An observation revealed the QC for the hematology testing had expired on 6/14/25. Clinical Laboratory Scientist 1 was interviewed. Clinical Laboratory Scientist 1 stated the QC was to be performed every shift and there were three shifts per day.

On 6/27/25 at 1335 hours, an interview and concurrent review of facility documents was conducted with the Director of Laboratory Services.

Review of the LS Form 018 dated 6/8/25, showed the variance was for a "Reagent Extension."

The description of the variance showed, "Hematology CBC Quality Control - Beckman Coulter 6C control Levels 1, 2, 3...Expired 6/7/24." The contributing factors showed, "Materials Management/Accounts Payable "Credit Hold". The immediate corrective action taken showed, "Running 6C control - Still all values within normal range." Further review of the document showed the Director of Laboratory Services and Medical Director were notified. The pending corrective action showed, "No." On 6/13/25, the Medical Director signed the document; however, there was no further recommendations.

The Director of Laboratory Services stated there was no documented evidence of other measures attempted as per the P&P to secure the necessary reagents.

The Director acknowledged the above findings.

OPERATING ROOM POLICIES

Tag No.: A0951

Based on observation, interview, and record review, the hospital failed to provide the safe and effective environment and maintain the acceptable standards of care for the patients receiving surgical services as evidenced by:

1. Patient 9's surgical case was canceled because the instrument requested by the surgeon could not be sterilized.

2. There was no comprehensive written contingency plan for sterilizing the surgical instruments during the weekend.

3. During the SPD tour, a soiled instrument was observed not to be kept moist as per the AORN's Guidelines.

4. Disposable supplies, which were not intended for reprocessing, were observed in sterilized peel packs.

5. Compromised sterile supplies were identified in the sterile storage room.

6. The OR team failed to perform the Fire Risk Assessment in accordance with the hospital's P&P.

7. The medical staff failed to perform proper hand antisepsis prior to surgery.

8. The hospital failed to ensure the temperature and humidity in the OR were maintained within range.

9. One expired auto-suture stapler was found stored in the OR 2 cabinet. In addition, an OR mattress with visible tears was in use for patient care.

These failures created the potential for poor health outcomes for the patients receiving surgical services in the hospital.

Findings:

1. On 7/1/25 at 1142 hours, the Director for Cardiology and Perioperative Services stated the hospital followed the AORN Guidelines for their infection control practices.

On 6/30/25 at 0905 hours, the Director for Cardiology and Perioperative Services and Lead SPD Tech were interviewed. As of 6/30/25, the hospital did not have a functional sterilizer. The Director for Cardiology and Perioperative Services stated the hospital's SPD staff transported the instruments to Hospital A for sterilization, where Hospital A's SPD staff performed the sterilization. The Director for Cardiology and Perioperative Services stated that SPD staff at Hospital A was unavailable on weekends. The Director for Cardiology and Perioperative Services stated they had to come up with a weekend process.

Review of the Interoffice Memo dated 6/25/25, showed the primary autoclave was currently out of service and awaiting replacement parts for repair. As an immediate intervention, the smaller autoclave located in the OR was being serviced and assessed for temporary use to support essential sterilization needs. To maintain the availability of sterile instruments and ensure uninterrupted patient care, the used instruments were being appropriately transported to Hospital A for sterilization and returned in compliance with all infection control and sterilization standards.

On 6/30/25, Patient 9's closed medical record was reviewed and showed Patient 9 was admitted to the hospital on 6/26/25, and transferred to another hospital on 6/29/25.

On 6/30/25 at 1030 hours, SPD Tech 1 was interviewed. SPD Tech 1 stated SPD Tech 1 was informed to sterilize the loaner surgical instrument requested by Surgeon 1. SPD Tech 1 informed the OR that Hospital A's SPD was not open on weekends.

On 6/30/25 at 1456 hours, RN 1 was interviewed. RN 1 stated Patient 9's case was added on 6/28/25 around 1100 hours. However, the surgery was canceled because the instrument requested by the Surgeon could not be sterilized.

Review of the Progress Note Dated 6/27/25 at 1758 hours, showed the plan for Patient 9 was to receive the surgery once medically optimized.

Review of the DC Planner Progress Note dated 6/28/25, showed to transfer Patient 9 to higher level of care for left hip arthroplasty surgery due to no sterilizer.

Review of the DC Planner Progress Note dated 6/29/25 at 1626 hours, showed Surgeon 1 was unaware of the sterilizer issue in the OR. The transfer center would proceed with the patient's transfer for surgery now that the surgeon was informed.

On 7/2/25 at 0925 hours, the Quality PI/Review RN verified the above findings.

2. Review of the CNO's email dated 6/26/25 at 0825 hours, showed the steps for using the van to transport surgical instruments to Hospital A, included the following:

* Wipe down the van surface with antiseptic prior to use to ensure cleanliness.
* Double wrap sterilized instruments and remove the outer plastic wrap before placing them on the shelves
* Check van temperature, record, and attach reading to the sterilization log from Hospital A before loading and unloading to ensure the van temperature is at 72 to 78 degrees F.
* When instruments are used...the patient sticker is attached to load sticker for recording keeping.

On 7/1/25 at 0900 hours, the Director for Cardiology and Perioperative Services was interviewed. The Director for Cardiology and Perioperative Services stated Hospital A's SPD team would train the hospital's SPD staff. The hospital's SPD staff would be signed off by the trainer. The SPD staff would use the sterilizers at Hospital A during the weekend. When asked about loaner instruments, the Director for Cardiology and Perioperative Services stated the OR charge nurse would communicate with the vendor and request to bring double trays in case the instruments were dropped. If the vendor was unable to bring a duplicate set of instruments, the patients would be transferred to another hospital. The Director for Cardiology and Perioperative Services verified the memo did not fully address the contingency plan.

3. Review of the AORN's Guidelines for Perioperative Practice, 2025 edition, Guideline for Perioperative Practice: Instrument Cleaning, Recommendation 6.4. showed to keep instruments moist until they are cleaned by using either saturation with an enzymatic pretreatment or a towel moistened with water placed over the instruments. Do not use saline.

On 7/1/25 at 1114 hours, the Decontamination area was toured with the Lead SPD Tech and Quality PI/Review RN. The contaminated surgical instrument was observed in the enclosed cart. The Lead SPD Tech stated the instrument in the cart was used during the surgery. The Lead SPD Tech stated the dirty instrument was moist in the OR. However, dry blood was observed on the instrument. The Lead SPD Tech and Quality PI/Review RN verified the finding.

4. Review of the hospital's P&P titled Sterilization - Packaging Systems, Selection and Use of dated 5/24 showed all items to be sterilized will be packaged in accordance with the AORN's "Recommended practice for selection and use of packaging systems."

The AORN's Guidelines for Perioperative Practice, 2025 edition, Guideline for Perioperative Practice: Packaging Systems, Recommendation 10.1.2 showed to monitor activities related to selection and use of packaging systems, including the following:

* Using packaging systems according to their IFU
* Verifying the compatibility of packaging systems with sterilization processes
* Storing packaging materials
* Assembling, handling, and packaging wrapped, pouched, and containerized items; labeling packages for sterilization

On 7/1/25 at 1130 hours, a storage room was toured with the Lead SPD Tech and Quality PI/Review RN. The disposable toothbrushes, cotton balls, and measurement tapes were observed in sterilized peel packs. A request for the IFU to confirm the sterilizability of these items was made. On 7/2/25 at 0925 hours, the Quality PI stated the instructions could not be found.

5. Review of the hospital's P&P titled Sterilization - Packaging Systems, Selection and Use of dated 5/24 showed to be appropriate to the item(s) being sterilized. The package system will maintain sterility of package contents until opened.

The AORN's Guidelines for Perioperative Practice, 2025 edition, Guideline for Perioperative Practice: Sterilization, Recommendation 4.2. showed to establish a process for determining the shelf life of sterilized items. The shelf life should be event-relatedness otherwise specified by the packaging system manufacturer's labeled expiration date.

On 7/1/25 at 1130 hours, a storage room was toured with the Lead SPD Tech and Quality PI/Review RN. It was observed that four peel packs containing sterilized lens paper were labeled with a sterilization date of 8/18/2014. The lens paper was observed to have a light yellowish discoloration. The Lead SPD Tech verified the above findings and stated they should have been discarded.


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6. Review of the hospital's P&P titled Universal Protocol - Comprehensive Surgical Checklist dated 3/24 showed the following:

* Fire Risk Assessment is to be completed by the procedure team prior to the time-out and results reported during the time out process.
* Follow the Fire Risk Assessment tool on the back for the UP (Universal Protocol) Form
* Assign a number to each question: Procedure site or incision above the xiphoid or airway procedure; open oxygen source (face mask/ nasal cannula, LMA (Laryngeal Mask Airway) or ET (endotracheal tube) tube; ignition source (uni-polar cautery, laser, and/or fiber-optic light source).
* A score of 1-2 is a low risk and precautions are limited to alcohol drying, removing alcohol from the field, placing the cautery in the holster, and any other actions that may be taken.

On 7/1/25, a review of Patient 14's medical record was conducted and showed the patient was admitted to the hospital for the right thyroid lobectomy surgery.

On 7/1/25 at 1515 hours, Patient 14's intraoperative care in OR 4 was observed.

During an observation of the time-out procedure, RN 6 failed to communicate Patient 14's fire risk assessment to the OR team, which was inconsistent with the hospital's P&P. The finding was verified with the Quality PI/Review RN.

Review of the Intraoperative Record dated 7/1/25 at 1505 hours, showed RN 1 documented the fire risk assessment as 2, signifying a low risk with potential to convert to high risk. An electrosurgical unit was documented in use during the surgery for Patient 14.

On 7/2/25 at 1100 hours, an interview was conducted with the Director for Cardiology and Perioperative Services. The Director for Cardiology and Perioperative Services stated a fire precaution assessment was required for all surgeries, and the nurse confirmed the precautions out loud during the time-out procedure.

7. Review of the hospital' s P&P titled Hand Scrub Procedure, Surgical dated 3/22, showed before donning a sterile gown and gloves for operative or other invasive procedures, perioperative personnel will perform surgical hand antisepsis using a surgical hand antiseptic or an alcohol-based surgical hand rub designed and interned for use as a surgical hand antiseptic and provided by the health care organization.

Procedure for brushless, waterless hand antisepsis:
- Wash hands and forearms with soap and running water immediately before beginning the surgical hand antisepsis procedure.
- Prior to the first case of the day, clean the subungual areas of both hands under running water using a nail cleaner.
- Rinse hands and forearm under running water.
- Dry hands and forearm under running water.
- Dispense one pump (2 ml) of antiseptic hand prep into the palm of one hand.
- Dip fingertips of the opposite hand into the hand prep and work it under the fingernails.
- Spread the remaining hand prep over the hand and up to just above the elbow, covering all surfaces.
- Dispense another pump (2ml) of antiseptic hand prep; repeat above procedure with the other hand.
- Dispense final pump (2 ml) of antiseptic hand prep into either hand and reapply to all aspect of both hands up to the wrist.
- Rub hands and forearms thoroughly until completely dry.
- Allow to dry before donning sterile surgical gown and gloves.

During an observation of Patient 14's intraoperative care in OR 4 on 7/1/25 at 1635 hours, the Surgeon was observed performing surgical hand antisepsis at a sink area outside OR 4 using only waterless hand antiseptic. The surgeon was not observed washing his hands and forearms with soap and running water immediately before beginning the surgical hand antisepsis procedure. Following the observation, the Surgeon entered OR 4 to begin the surgery for Patient 4. The findings were shared with the Quality PI/Review RN.

On 7/1/25 at 1700 hours, an interview was conducted with the Surgery Tech in the presence of the Quality PI/Review RN about performing surgical hand antisepsis. The Surgery Tech stated the OR staff performed a 10 minute scrub using soap, water, and antimicrobial scrub agent in the morning; and they used an alcohol based antiseptic surgical hand rub during the day.

8. Review of the hospital's P&P titled Temperature, Humidity and Ventilation Requirement in Health Care Facility dated 10/24 showed high risk and sensitive areas and room require daily monitoring of temperature and humidity in each department level. When temperature or humidity is out of range, the following steps will be taken: Local department will adjust the thermostat and humidistat. After 30 minutes, if not resolved, a work order will be created through the intranet. Record the work order number in the Temperature and Humidity form. If an immediate resolution is needed, call Facilities and reference the work order number. Record the temperature and humidity one hour after Facilities repair and follow-up as needed.

Review of the form titled Temperature & Humidity showed the following:

* If temperature or humidity is out of range, call engineering
* Normal temperature range for OR will be between 68 and 75 degrees F
* Normal humidity range for OR will be between 20 to 60%

On 7/1/25 at 1300 hours, an observation of ORs 2 and 4 was conducted with the OR Charge Nurse and Quality PI/Review RN. The humidity level in OR 2 was 62.6% and in OR 4, it was 64.7%.

During Patient 14's surgery in OR 4, which began on 7/1/25 at 1611 hours, there was no documented evidence that correction actions were taken when the humidity levels were out of range prior to the surgery.

Further review of the Temperature & Humidity form for June 2025 showed the following:

* The humidity levels of OR 2 from 6/11 to 6/30/25, were out of range varying from 61.4% to 76%. The work order was submitted on 6/5, 6/20, 6/24, and 6/26/25. The resolution of the issues showed, "none."

* The humidity levels of OR 3 from 6/11 to 6/23/25, and 6/25 to 6/30/25, were out of range varying from 64% to 68.8%. The work order was submitted on 6/20, 6/24, and 6/26/25. The resolution of the issues showed, "none."

* The humidity levels of OR 4 on 6/11- 6/16/25, 6/18- 6/23/25, and 6/25 - 6/30/25 were out of range varying from 61% to 72.4%. The work order was submitted on 6/20, 6/24, and 6/26/25. There was no documented evidence the out-of-range humidity issues were followed up. There was no documented evidence of the correction actions taken to correct the humidity levels when they were out of range.

Review of the Surgery Schedule dated 7/1/25, showed two patients were scheduled for surgery in OR 2, and one patient was scheduled for surgery in OR 3.

On 7/2/25 at 1400 hours, an interview was conducted with the OR Charge Nurse. The OR Charge Nurse verified the above findings and stated the OR night shift staff would check the temperature and humidity levels in all the ORs. When the temperature and humidity levels were out of range, the night shift staff would call the Facilities to adjust the temperature and humidity and to put in work order. The OR Charge Nurse stated the night shift staff failed to notify the Facilities when the humidity levels were out of range.

9. According to the AORN's Perioperative Standards and Recommended Practices 2012 Edition, under Recommended Practices for Environmental Cleaning in the Surgical Practice Setting, Recommended Practice 1 showed patients should be provided with a safe, visibly, and clean environment. Health care-associated infections have been linked to external sources, which can include environmental surfaces.

Review of the hospital's P&P titled Storage of Sterile dated 3/24 showed the following:
- All sterilized materials are packaged, labeled, and stored in a manner to ensure sterility.
- All storage items are rotated according to the principle of "first-in, first-out."

On 7/1/25 at 1300 hours, during an observation of OR 2 with the OR Charge Nurse and Quality PI/Review RN , the following was observed:
- The mattress of the OR table was observed with tears.
- In the cabinet, one TA Auto-suture Stapler was observed with an expiration date of 5/31/25, and another TA Auto-suture Stapler had no expiration date.

The findings were verified with the OR Charge Nurse.