Lexington Medical Center

“QAPI CFR(s): 482.21 The hospital must develop, implement and maintain an effective, ongoing, hospital-wide, data-driven quality assessment and performance improvement program. The hospital’s governing body must ensure that the program reflects the complexity of the hospital’s organization and services; involves all hospital departments and services (including those services furnished under contract or arrangement); and focuses on indicators related to improved health outcomes and the prevention and reduction of medical errors. The hospital must maintain and demonstrate evidence of its QAPI program for review by CMS. This Condition is not met as evidenced by: 52713 Based on a review of the hospital’s Quality Assessment Performance Improvement (QAPI) Program, record review and interviews, the facility failed to implement auditing measures to prevent recurrence for an adverse event in which a fragment of a Nintinol (thin, flexible medical wire used to guide other medical instruments) guidewire was retained after a surgical procedure for one of 10 surgical patients, Patient 1 (P1) reviewed for surgical procedures. The findings include: Cross Reference to A-286 Patient Safety”

“ANESTHESIA SERVICES CFR(s): 482.52 If the hospital furnishes anesthesia services, they must be provided in a well-organized manner under the direction of a qualified doctor of medicine or osteopathy. The service is responsible for all anesthesia administered in the hospital. This Condition is not met as evidenced by: 52713 Based on record review, a review of the hospital’s policies and interviews, Anesthesiologist (A)#1 failed to ensure the correct site before the initiation of an block (type of regional anesthesia that numbs a specific area of the body) for one of four patients, Patient 2 (P2) reviewed for receiving a block. The findings included: Cross reference A-1002 Delivery of Anesthesia Services”

“PATIENT SAFETY CFR(s): 482.21(a), (c)(2), (e)(3) (a) Standard: Program Scope (1) The program must include, but not be limited to, an ongoing program that shows measurable improvement in indicators for which there is evidence that it will ... identify and reduce medical errors. (2) The hospital must measure, analyze, and track ...adverse patient events ... (c) Program Activities ..... (2) Performance improvement activities must track medical errors and adverse patient events, analyze their causes, and implement preventive actions and mechanisms that include feedback and learning throughout the hospital. (e) Executive Responsibilities, The hospital’s governing body (or organized group or individual who assumes full legal authority and responsibility for operations of the hospital), medical staff, and administrative officials are responsible and accountable for ensuring the following: ... (3) That clear expectations for safety are established. This Standard is not met as evidenced by: 52713 Based on record review, a review of the hospital’s Quality Assessment Performance Improvement (QAPI) Program, and interviews, the hospital failed to timely implement interventions to prevent recurrence for an adverse event in which a retained fragment of a Nitinol (thin, flexible medical wire used to guide other medical instruments) guidewire was retained after a surgical procedure for one of 10 patients, Patient 1 (P1) reviewed for surgical procedures. The findings include: Review of P1’s record on 06/02/25 at 3:26 PM revealed P1 was admitted on 03/17/2025 for a right knee arthroscopy (a thin tube with a camera at the end inserted into a small incision), anterior cruciate ligament reconstruction with allograft, partial medial meniscectomy, and loose body removal. P1’s history and physical assessment dated 3/28/25, revealed OS#1 documented, “ ....unfortunately on [P1’s] x-ray we can see that there is a fragment of the tibial nitinol guidewire that is retained. It likely broke as or placing [sic] the cannulated screw in the tibia. I suspect that it is embedded in the bone and not mobile ...I have already posted [Patient #1] for Monday for a right knee arthroscopy and foreign body removal in case we need to proceed with surgery... I have verified with the vendor that the material is nickel and titanium, about a 60/40 ratio. These materials are commonly seen in permanent orthopedic implants and tolerated well...” During an interview on 06/03/2025 at 10:24AM, the Interim Director of Anesthesia and Perioperative Services (IDAP) was asked what measures were put in place to prevent another reoccurrence of the retained guidewire. He/she stated that the guidewire is to be measured on the sterile back table before incision and at the conclusion of the surgical procedure. The IDAP was subsequently asked how is this data being tracked and audited. The IDAP stated he/she “goes into the rooms to see if it is being done” The IDAP was asked about multiple orthopedic surgical procedures happening simultaneously and how feasible it was for one person to monitor all procedures at once, the IDAP stated, “I have charge nurses, assistant nurse managers, and a nurse manager.” During an interview on 06/03/2025 at 2:31PM, registered nurse (RN)2 stated that he/she was the operating room circulator for the surgical procedure on 03/17/2025. During P1’s second surgery on 03/31/25, RN2 stated that he/was the circulator as well. When asked if he/she was aware of any new changes regarding the use of guidewires during surgical procedures, he/she stated that the guidewires will be measured by the surgeon and surgical technologist before the start of surgery and after it’s completion. During an interview on 06/03/2025 at 4:11PM with orthopedic surgeon OS#1, he/she stated that review of the post-operative x-ray revealed P1 had a retained piece of the guidewire. OS#1 stated the facility will be implementing a new process of measuring the nitinol guidewire on the sterile back table where all of the other instruments are kept. The surgical technologist and the surgeon will both verify the measurements at the start and end of each procedure. During an interview on 06/04/2025 at 12:07PM with the IDAP, he/she was asked if there have been any implemented interventions such as trainings, or a tracking system to show that internal audits have been initiated since the incident on 03/17/2025. He/she responded, “not at this time”.”

“SUPERVISION OF CONTRACT STAFF CFR(s): 482.23(b)(6) All licensed nurses who provide services in the hospital must adhere to the policies and procedures of the hospital. The director of nursing service must provide for the adequate supervision and evaluation of all nursing personnel which occur within the responsibility of the nursing service, regardless of the mechanism through which those personnel are providing services (that is, hospital employee, contract, lease, other agreement, or volunteer). This Standard is not met as evidenced by: 52713 Based on record review, interview, and policy review, registered nurse (RN) #1 failed to verify the correct surgical site during time out and before the initiation of the block for one of four patients, Patient 2 (P2) reviewed who received a block. The findings included: Medical record review on 06/02/2025 at 3:26PM revealed P2 was admitted to the facility on 05/06/2025 for a left knee arthroplasty surgical procedure. RN#1 documented that the correct site was verified during the time out. A review of the hospital’s incident report revealed that Anesthesiologist (A) #1 performed the block on the right leg, when it should have been done on the left leg. During an interview on 06/03/2025 at 2:15PM, RN#1 explained his/her duties in the preoperative area as verifying the patient’s information and getting consent forms ready for the physicians. RN#1 stated that the case was originally scheduled as one of the first procedures in the operating room. P2 was marked by orthopedic surgeon (OS) #2. RN#1 then notified A#1 to come and initiate the block. RN#1 stated that he/she does not remember A#1 asking or stating the correct leg during the timeout. RN#1 stated that he/she was made aware of the block being done on the wrong leg after P2 was already in the operating room. A#1 notified him/her that the block was done on the right leg instead of the left leg. Review of the hospital policy, “Surgical and Procedural Site Marking and Time Out Policy and Procedure”, revised on September 2024, revealed the correct procedure, correct site and correct side will be identified on all patients undergoing a surgical, interventional, invasive or diagnostic treatment or procedure. All members of the healthcare team are responsible for the verification process. 1. Verification Process. Verification of the correct person, correct site/side and correct procedure, occurs at the following times: 1. At the time the procedure is scheduled. 2. At the time of preadmission testing and assessment. 3. At the time of entry or admission into the facility for a procedure, whether elective or emergent. 4. Before the patient leaves the pre-procedure area or enters the procedure room. 5. Any time the responsibility for care of the patient is transferred to another member of the procedural team at the time of, and during the procedure. 6. With the patient involved, awake and aware, if possible. If the patient is sleeping ...Preoperative/Preprocedural Phase: The following needs to be completed in the pre-procedural area: 1. Correct patient identification (using full name and date of birth), procedure, site marking, position, and side. 2. Relevant documentation (ex. Nursing assessment and pre-anesthesia assessment as required)....”

“DELIVERY OF ANESTHESIA SERVICES CFR(s): 482.52(b) Anesthesia services must be consistent with needs and resources. Policies on anesthesia procedures must include the delineation of pre-anesthesia and post-anesthesia responsibilities. The policies must ensure that the following are provided for each patient: This Standard is not met as evidenced by: 52713 Based on record review, interviews and review of the hospital’s policies, Anesthesiologist (A)#1 failed to ensure that the correct body part was accurately identified before the initiation of the block; thus, doing the block on the wrong surgical site for one of four patients, Patient 2 (P2) reviewed who received a block. The findings included: Medical record review on 06/02/2025 at 3:26PM revealed P1 was admitted to the facility on 05/06/2025 for a left knee arthroplasty (a thin tube with a camera at the end inserted into a small incision) surgical procedure. Orthopedic Surgeon (OS) #2 signed the consent on 05/06/2025 at 7:02AM. A review of the hospital’s incident report revealed that A#1 performed the block on the right leg, when it should have been done on the left leg. During an interview on 06/03/2025 at 2:48PM with the Chief of Anesthesia (COA), he/she stated that the procedural steps for nerve block administration includes seeing the patient, assessing the patient, getting anesthesia consent from them, and performing a timeout would be done before the start of the block. The COA stated that the timeout will be done after the surgeon does the marking of the correct surgical site. During an interview on 06/04/2025 at 10:05AM with OS#2, he/she identified that the block was done on the wrong leg when the surgical team started to prepare and drape the correct site. OS#2 stated that he saw and marked the P2 before the block was performed. During a telephone interview on 06/09/2025 at 2:47PM, A1 acknowledged P2 was scheduled for a left knee arthroscopy. A#1 stated when doing the timeout, P2 lifted his/her right leg instead of the left leg. When asked if he/she observed and verified the surgical marking on the patient, a response was given as, “I cannot recall if there was a surgical marking present on the patient at the time of the block”. A1 was asked if the consent was looked at visually while doing the timeout. A1 responded by saying, “I cannot recall if I did so or not”. Review of the hospital policy, “Surgical and Procedural Site Marking and Time Out Policy and Procedure”, revised September 2024 revealed that the correct procedure, correct site and correct side will be identified on all patients undergoing a surgical, interventional, invasive or diagnostic treatment or procedure. All members of the healthcare team are responsible for the verification process. 1. Verification Process. Verification of the correct person, correct site/side and correct procedure, occurs at the following times: 1. At the time the procedure is scheduled. 2. At the time of preadmission testing and assessment. 3. At the time of entry or admission into the facility for a procedure, whether elective or emergent. 4. Before the patient leaves the pre-procedure area or enters the procedure room. 5. Any time the responsibility for care of the patient is transferred to another member of the procedural team at the time of, and during the procedure. 6. With the patient involved, awake and aware, if possible. If the patient is sleeping ...Preoperative/Preprocedural Phase: The following needs to be completed in the pre-procedural area: 1. Correct patient identification (using full name and date of birth), procedure, site marking, position, and side. 2. Relevant documentation (ex. Nursing assessment and pre-anesthesia assessment as required).... Review of the hospital policy, “Anesthesia Assessment Care of the Patient”, approved March 2025, revealed that practices employed in the delivery of anesthesia care shall meet the intent of the Medical Staff policies and the Anesthesia Standards of Care as noted from ASA (American Society of Anesthesiologists) and AANA (American Association of Nurse Anesthesiology), Standards and Ethics of Anesthesia Practice. Under Procedure/Protocol, Quality of Anesthesia Care revealed that the anesthesia provider will be responsible for the pre-anesthesia evaluation of the patient....For non-emergent cases the pre-op assessment will include at a minimum: patient ID, consent, surgical site; allergies, surgical anesthetic history, medical history, airway evaluation, current medication, ASA type, and anesthetic plan. The policy included information that the electronic Pre-op checklist with associated icons will be used as a communication tool only. A completed pre-op checklist does not relieve the individual of their pre-anesthetic duties.”