HospitalInspections.org

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

1. Follow its policy and procedure on Basic Aseptic Technique (a procedure that healthcare providers use to prevent the spread of germs that cause infection) when a contaminated intravenous (IV-within the vein) spike (pointed end of the IV set that is inserted into the IV fluid bag or bottle to allow the fluid to flow from the bag into the tubing) was used during a surgical procedure for one of one sampled patient (Patient 18).

2. Ensure eight of eight sampled hinged instruments were sterilized in an open position.

3. Provide a weighing scale to ensure six of six sampled surgical instrument trays did not exceed the maximum weight of 25 pounds.

These failures had the potential to result in post-operative surgical site infections due to the contaminated IV spike and surgical instruments not properly sterilized.

Findings:

1. During a review of Patient 18's "History & Physical (H&P)," dated 3/9/25, the H&P indicated, Patient 18 developed sciatica (nerve pain from an injury or irritation to the sciatic nerve caused by a herniated disc [the cushion-like cartilage between the bones of the spine] or an overgrowth of bone that puts pressure on the lower back nerve roots) in his right lower extremity with associated pain, numbness, tingling, and weakness. The recommended treatment was laminectomy (a surgical procedure to relieve pressure on one's nerves by removing the arched back piece of the spinal bone), decompression (removal of pressure), and diskectomy (surgical removal of the damaged part of a disc [spongy cushions that separate the bones of the spine] of the L4-L5 (fourth and fifth vertebrae in the lumbar [L] spine) level.

During an observation on 3/10/25 at 3:04 p.m. in Operating Room (OR) 1, Patient 18's microdiscectomy (minimally invasive surgical procedure performed on patients with a herniated lumbar disc) was started with Surgeon 1 as the primary surgeon and Registered Nurse First Assist (RNFA) 1 as the surgeon's assistant. At 3:07 p.m. the Circulating Registered Nurse (CRN) opened an IV spike set. The IV spike fell on the floor. CRN picked up the IV spike from the floor, wiped the IV spike with alcohol wipes, and inserted the IV spike into the 0.9% Normal Saline solution bag, and connected it to the aquamantys (medical device used by the surgeon to seal and control blood of an exposed tissue or bony surface) during the surgical procedure. It was noted CRN did not notify Surgeon 1 of the incident. Surgeon 1 continued to use the contaminated IV solution during Patient 18's surgery.

During an interview on 3/10/25 at 4:08 p.m. with CRN in the presence of the OR Nurse Manager (ORNM), CRN stated, "I made a mistake. I should have discarded and replaced the IV spike."

During an interview on 3/11/25 at 1:59 p.m. with Surgeon 1, Surgeon 1 stated he was not made aware CRN dropped the tip (referring to the IV spike) on the floor. Surgeon 1 stated CRN should have replaced it. Surgeon 1 stated he had not notified the patient nor the family.

During an interview on 3/11/25 at 2:16 p.m. with Infection Prevention and Control Manager (IPCM), IPCM stated he was not informed CRN used a contaminated IV spike during the surgical procedure. IPCM stated there's a potential risk for infection. IPCM stated anything that falls on the floor should not be used for the patient, and should be discarded.

During a review of the hospital's policy and procedure (P&P) titled, "Basic Aseptic Technique," the P&P indicated, "Purpose: To ensure maximum protection from a postoperative wound infection through the practice of aseptic technique throughout the perioperative experience."


44134


2. During a concurrent observation and interview on 3/11/25 at 10:37 a.m. with Sterile Processing Technician (SPT) 1 in the sterilization (process that eliminates all forms of germs through the use of high heat and pressure) supply room, staff packaged and sterilized one Ryder (brand name) needle holder (hinged surgical instrument) without ensuring the needle holder was in an open position. SPT 1 stated, "That individual did not follow the rules." SPT 1 stated staff should ensure the instrument was in the open position prior to sterilization.

During a concurrent observation and interview on 3/11/25 at 10:40 a.m. with ORNM in the sterilization supply room, staff had packaged and sterilized eight hinged instruments without ensuring the instruments were in an open position. The following hinged instruments were not sterilized in open position:

one needle holder French eye
two (Ryder) needle holders
two Metzenbaum scissors
one straight Kelly (type of forcep)
one Demartel scissors
one bulldog clip (type of forcep)

ORMN stated the staff should have ensured the instruments were in an opened position during sterilization.

During a review of the AORN Guidelines for periOperative Practice, dated 2019, the Guidelines indicated, "Items to be sterilized should be positioned within the packages to allow sterilant contact within all surfaces. . .Sterilant contact is necessary for sterilization to be achieved. . .Items to be sterilized should be placed in the package or tray in an open or unlocked position. . .The open or unlocked position facilitates sterilant contact of all surfaces of the item."

3. During a concurrent observation and interview on 3/11/25 at 9:56 a.m. with Certified Lead Sterile Processing Technician (CLSPT) in the sterilization supply room, an open cart contained six open metal containers. Each container was filled with multiple surgical instruments. CLSPT stated the instruments were trauma "loaner boxes" that had been cleaned and the department was was waiting for the vendor to re-assess and restock, so staff can sterilize them.

During an interview on 3/11/25 at 10:44 a.m. with CLSPT, CLSPT stated the Sterile Processing Department only had one scale and it broke last week. CLSPT stated the staff had not replaced the scale. CLSPT stated there were no records of surgical instrument tray weights being measured prior to the sterilization process.

During an interview on 3/11/25 at 10:45 a.m. with Sterile Processing Manager (SPM), SPM stated the Sterile Processing Department should have a scale to weigh surgical instruments prior to the sterilization process.

During a review of the facility's P&P titled, "Loaner Trays," dated 11/27/18, the P&P indicated, "All loaner instrument trays will be checked by the Sterile Processing technician or supervisor upon arrival in the department. The trays will be decontaminated, cleaned, sterilized, and documented properly. . .Procedure. . D. SPD [Sterile Processing Department] will weigh loaner trays to ensure they do not exceed the maximum weight of 25 pounds. E. If the loaner tray is over 25 pounds, the vendor must adjust or separate the tray to meet the 25 pound maximum requirement. F. Trays over 25 pounds will not be reprocessed."

Based on interview and record review, the hospital failed to ensure one of one sampled Registered Nurse First Assist ([RNFA 1], an advanced practice registered nurse that actively assists the surgeon during surgery) had an annual competency (knowledge and skills necessary to perform a job) completed. This failure had the potential to result in the facility not knowing if RNFA 1 was knowledgeable and had the skills to perform the role of a Registered Nurse First Assist.

Findings:

During a concurrent interview and record review on 3/12/25 at 2:52 p.m. with Director of Talent Acquisition (DOTA), RNFA 1's employee file (EF) was reviewed. The EF indicated, RNFA 1 had a "RNFA Checklist-Initial Credentialing" completed on 10/3/19. DOTA stated this was RNFA 1's competency completed upon hire. DOTA stated this document showed that four surgeons had signed off RNFA 1 on her skills. DOTA stated she was unable to find a current annual RNFA competency in RNFA 1's EF.

During an interview on 3/12/25 at 4:12 p.m. with Operating Room Nurse Manager (ORNM), ORNM stated a surgeon has not signed off a current annual competency for RNFA 1 to indicate that RNFA's skills/competency had been reviewed.

During a review of the facility's policy and procedure (P&P) titled, "Performance Management and Competency Assessment Program," dated 8/23/23, the P&P indicated, "It is the policy of [Facility Name] to assess, maintain, develop and improve employee performance and competence on an ongoing basis. Performance is formally evaluated on an annual basis. . .Competency is the demonstrated ability to integrate the knowledge, skills, and attitudes required in a designated role or setting. Competency is verified through utilization of techniques such as demonstration, review of policy/procedure, verbalization, and/or written testing. The performance evaluation and competency assessment process ensures that the requirements of the position are met."

Based on interview and record review, the hospital failed to ensure a post-anesthesia evaluation (assessment conducted by the anesthesiologist[doctor who gives medication to put patients to sleep for surgery so the patient does not feel pain] to evaluate a patient's condition after receiving anesthesia [temporary loss of sensation or awareness caused by medications]) was completed after surgery for two of 30 sampled patients (Patient 12, Patient 14). This failure had the potential for anesthesia complications to negatively impact Patient 12 and Patient 14.

Findings:

1. During a concurrent interview and record review on 3/11/25 at 3:50 p.m. with Clinical Informaticist (CI) and Assistant Nurse Manager (ANM), Patient 12's Electronic Medical Record (EMR) was reviewed. The EMR indicated Patient 12 had an anterior cervical discectomy (removal of a damaged disc to relieve spinal cord or nerve pressure to alleviate pain) on 2/24/25. Surgeon 1 was the surgeon and Certified Registered Nurse Anesthetist (CRNA) administered the anesthesia. Patient 12's EMR indicated Patient 12 was discharged on 2/25/25. CI and ANM were unable to find CRNA completed a post-anesthesia evaluation for Patient 12 and they both stated the evaluation should have been documented in the EMR.

During a concurrent interview and record review on 3/12/25 at 1:35 p.m. with CRNA, Patient 12's EMR was reviewed. CRNA stated he administered the anesthesia during Patient 12's surgery on 2/24/25. CRNA stated he did not complete a post-anesthesia evaluation for Patient 12. CRNA stated it was an error on his side and stated he should have completed the post-anesthesia evaluation. CRNA stated the post-anesthesia evaluation should have been completed within 48 hours from the surgery.

2. During a concurrent interview and record review on 3/11/25 at 4:20 p.m. with CI and ANM, Patient 14's EMR was reviewed. The EMR indicated Patient 14 had a left total knee replacement (a surgical procedure to replace the surface of the knee joint to relieve pain) on 2/24/25. Patient 14's EMR indicated Surgeon 2 performed the surgery and MD 1 was the Anesthesiologist. Patient 14's EMR indicated Patient 14 was discharged home on the same day of the surgery. CI and ANM were unable to find documentation MD 1 completed a post-anesthesia evaluation on Patient 14 and they both stated it should have been documented in the EMR.

During a concurrent interview and record review on 3/12/25 at 9:30 a.m. with MD 1, Patient 14's EMR was reviewed. MD 1 stated Anesthesia Resident Physician (ARP- physician in training in Anesthesia) provided anesthesia for Patient 14 under my supervision. MD 1 stated ARP should have completed the post-anesthesia evaluation for Patient 14. MD 1 stated there was no post-anesthesia evaluation in Patient 14's EMR, and stated there should have been. MD 1 stated she normally completes the post-anesthesia evaluation two to three hours after surgery.

During a review of the hospital's "Medical Staff Bylaws (MSB)," dated 2020, the MSB indicated, "A post-anesthesia evaluation will be completed and documented by an individual qualified and credentialed to administer anesthesia no later than 48 hours after surgery or a procedure requiring anesthesia services."