San Ramon Regional Medical Center

“PATIENT RIGHTS: INFORMED CONSENT CFR(s): 482.13(b)(2) The patient or his or her representative (as allowed under State law) has the right to make informed decisions regarding his or her care. The patient’s rights include being informed of his or her health status, being involved in care planning and treatment, and being able to request or refuse treatment. This right must not be construed as a mechanism to demand the provision of treatment or services deemed medically unnecessary or inappropriate. This Standard is not met as evidenced by: 25205 Based on interview and record review the hospital failed to ensure that one of 30 patients, Patient 11, had the surgical procedure that she consented to. This failure denied Patient 11 the right to make an informed decision regarding accepting or refusing treatment and had the potential that Patient 11 would experience complications and an unsuccessful surgical procedure. The following definitions are provided for clarity. Vertebrae or lamina are small bones which stack up to form the backbone which has an opening through which the spinal cord passes. Spinal disc is a capsule of soft, gel-like material between the vertebrae. Herniated disc occurs when the soft, gel-like material pushes through the tough outer capsule membrane against the spine, causing pain, numbness and/or weakness below the injured disc. Spinal stenosis is an abnormal narrowing of the spinal canal (through which the spinal cord passes) due to age-related bone degeneration (wear and tear of bone cartilage) or herniated discs causing pressure on the spinal cord and nerves, usually resulting in pain, numbness or weakness in the back, arms, or legs. Lumbar refers to the lower spine and consists of five vertebrae (L1 - L5) lumbar level 1 to lumbar level 5. L1 is below the waist at hip level and L5 is the lowest part of the spine on top of the sacrum. The lumbar spine is designed to support upper body weight and enable mobility. Laminectomy is a surgical procedure that removes part or all the vertebral bone (lamina) to relieve pressure on the spinal cord or nerves, typically as a result of spinal stenosis or herniated discs. Fusion is a surgical procedure that permanently joins two or more vertebrae, creating a single, solid bone to eliminate pain caused by motion. Transforaminal Lumbar Interbody Fusion (TLIF) is a posterior (through the back) surgical technique used to treat lower back pain and instability by removing a damaged spinal disc and fusing two vertebrae together using a spacer, bone graft, and posterior screws/rods. It is commonly used for degenerative disc disease and spinal stenosis. Performed through an incision in the back, the surgeon removes the diseased disc, widens the nerve opening, and places a spacer in the disc space to provide stability. Claudication is leg pain, numbness or weakness triggered by walking or standing, caused by compressed nerves in the lumbar spine. Lami is short for laminectomy. Coflex is a U-shaped titanium implant used to treat lumbar spinal stenosis. It is a minimally invasive procedure providing stability and keeping the spinal canal open to relieve nerve pressure and to allow for maintained mobility. It is an alternative to spinal fusion. C-arm is a C-shaped medical X-ray device that allows for flexible, 360-degree positioning, [under a surgical table to obtain images] improving procedural accuracy. O-arm is a cylindrically shaped medical X-ray device providing 2D and 3D images for real-time surgical navigation. AP (anteroposterior or front to back) and lateral (side to side) X-rays provide complementary 2D perspectives, that combined create a comprehensive view of the patient’s anatomy and hardware placement during spinal surgery. While the AP view captures a front-to-back perspective to ensure straight alignment and lateral symmetry, the lateral view provides a side perspective essential for assessing depth, spinal curvature (lordosis), and disc height. Surgeons use both views to precisely locate the correct operative space. Findings: During a review of the hospital document titled, “Consent To Surgery/Special Procedures/Anesthesia (With Physician Certification)”, dated on 11/18/25, and signed by Patient 11, included the following: “1. Your physician has recommended the following operation or procedure: Lumbar Level 3 to Lumbar Level 5 Laminectomy, Lumbar Level 4 to Lumbar Level 5 Transforaminal Lumbar Interbody Fusion ...Diagnosis: Lumbar Level 3-5 Stenosis with Claudication prior Lumbar Level 4-5 Lami and Coflex.” Review of the electronic record showed that Surgeon 1 certified, by electronic signature, that he discussed the above procedure with Patient 11 on 11/18/25. During an interview on 3/3/26 at 1:20 p.m., Surgeon 1 stated, “The table [surgical spinal table designed to turn a patient, with the use of an overbody support, from lying on the back to lying on the chest and abdomen] malfunctioned. It wouldn’t raise up for the C-arm [to go under the table]. We tried different things. We changed the wires and plug. We called the company, but the table wouldn’t move. The patient was positioned [prone on her abdomen and chest], had anesthesia, had [placement] needles in her back. I called the radiologist in. We were able to get an A/P [anterior/ posterior] X-ray image but not a lateral [side] image without the C-arm. Three of us [radiologist, surgeon and physician assistant] believed we were at the correct levels. In retrospect, I’m not sure I’d do anything differently. We were pretty sure we were correct and the patient was far along in procedure. I wanted to continue and not have her go through it again. I’ve followed up with her and she is completely better. What I think is, we were to do L4/L5 fusion and did L3/L4. L2 was stenosed above, and fusing L3 and L4 decompressed L2. The patient refused a revision.” Review of the Final Operative Report dated 11/18/25 at 2:58 p.m., showed the following, “ ...The spine was exposed through a vertical midline incision ...it was at that point that we discovered that the table malfunctioned. It was in a low position. We were not able to raise it to a level that would allow for any lateral intraoperative imaging with either the C-arm or the O-arm. The imaging that we had available was then simply limited to AP X-rays ...” Surgeon 1 described the efforts taken to fix the table and the three-person decision made to continue the surgery. Also, towards the end of the surgery a digital X-ray machine was made available, and a lateral X-ray was obtained. Continued review of the Final Operative Report showed the following: “ ...To our great surprise, at that point it turned out we had done the TLIF at the L3-L4 level, which meant the laminectomy at L2-L3 and L3-L4 ...The screws were placed at L3-L4 instead of L4-L5.” During an interview on 3/5/26 at 10:15 a.m., the Director of Quality (DOQ) stated the hospital did an investigation. The spinal table was checked prior to the surgery and was functioning. The reason Surgeon 1 couldn’t change tables was because two other spinal tables were already in use in other surgical cases. DOQ stated now the surgical schedule is arranged so that there is always one spinal table, not in use, and available if the necessity arises to switch tables. During a phone interview on 3/5/26 at 11:25 a.m., Patient 11 stated the surgery in November “went fine.” Patient 11 said she no longer had pain and numbness in her legs, and she was able to walk. During a review of the Medical Staff Rules and Regulations signed by the Medical Executive Committee on 2/12/25, and by the Governing Board on 5/5/25, the following directions were listed under the title of General Requirements: “...In addition to a general consent obtained by the hospital at the time of the patient’s admission, specific consent must be obtained for any diagnostic or therapeutic intervention ...All regulatory requirements relating to disclosure shall be followed. Both the patient and the responsible practitioner shall sign the consent form prior to diagnostic or therapeutic intervention, to indicate that the practitioner has personally provided specific information on which the patient has based his/her consent. In addition, the form shall provide, over the practitioner’s signature that the patient understood and agreed to the proposed intervention.” During a review of the hospital document, “Consent To Surgery/Special Procedures/Anesthesia (With Physician Certification),” signed by Patient 11 on 11/18/25, indicated the following: “ ...You have the right to be informed of: the nature of the operation or procedure ...Except in cases of emergency, operations or procedures are not performed until you have had the opportunity to receive this information and have given your consent. You have the right to give or refuse consent to any proposed operation or procedure at any time prior to its performance ...””

“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: 50120 Based on interview and record review, the facility failed to follow required anesthesia verification and safety procedures per facility protocol resulting in Patient 22 receiving an unnecessary nerve block in the hip. This wrong site block affected 1 of 30 sampled patients (Patient 22).The anesthesiologist administered a femoral nerve block (a numbing injection near the upper thigh to block pain in the leg and hip) instead of the required interscalene block (a numbing injection near the neck to block pain in the shoulder and upper arm) for a scheduled left humerus (the long bone of the upper arm, from the shoulder to the elbow) ORIF - Open Reduction and Internal Fixation (a surgery where the surgeon realigns the broken bone and secures it with plates or screws). This failure resulted in the patient receiving an unnecessary block to the hip causing postoperative complications requiring inpatient admission and physical therapy evaluation. Findings: During a review of the medical record dated 12/16/25, the face sheet indicated Patient 22, was scheduled for an ORIF of the left humerus on 12/11/25. During a review of the intraoperative record (a detailed, real-time document of everything that happens to a patient while they are in the operating room), dated 12/11/25, the record indicated, Patient 22 arrived in the operating room at 6:26 p.m. for the scheduled left humerus (arm) ORIF (surgery). From 6:26 p.m. to 6:35 p.m., the anesthesiologist (MD) 1 administered a femoral (hip) nerve block (a numbing injection near the upper thigh to block pain in the leg and hip), a block typically used for hip procedures. During an interview on 3/4/26 at 2:50 p.m., Operating Room Registered Nurse (ORN) 1 stated they reminded MD 1 that the surgery involved the left humerus. ORN 1 stated MD 1 proceeded with the femoral block. ORN 1 stated the error was identified only after the surgeon entered the OR and questioned why the interscalene block (a numbing injection near the neck to block pain in the shoulder and upper arm) had not been performed. ORN 1 stated the anesthesiologist did not perform a required time out (a mandatory universal protocol that requires the OR team to pause before a procedure to verify the correct patient and confirm the procedure and site location, before administering the block). During an interview on 3/2/26 at 12:30 p.m., MD 1 stated they “Did not perform an adequate timeout” and believed the case was a hip procedure despite having reviewed the consent form. MD 1 confirmed they administered the femoral block before completing the procedure specific time out and before verifying the correct surgical site and block location. During a review of the surgical consent form, dated 12/11/25, signed at 4:25 p.m., the form indicated the planned procedure was a left proximal humerus ORIF (a surgery that realigns and stabilizes the bone using hardware such as plates or screws). During a concurrent interview and record review on 3/5/26 at 9:37 a.m., the Anesthesia Medical Director (AD) stated the anesthesia record dated 12/11/25 indicated the block was administered at the wrong site (hip rather than left arm). The AD stated the anesthesiologist is required to initiate the time out and the nurse must verify it, including patient identification and correct site. The AD stated the anesthesiologist is responsible for marking the correct block site. During a concurrent interview and record review on 3/5/26 at 9:37 a.m., AD stated the consent form, dated 12/11/25, indicated the surgery required an interscalene block. AD stated there was no documentation supporting the use of a femoral (hip) block. During an interview on 3/4/36 at 2:30 p.m., with the Nursing Director of Surgical Service (DOSS), the DOSS stated a time out is required for every surgery and must include two patient identifiers and verification of the correct surgical site and side. DOSS stated that they are aware that Patient 22 “Did not receive the time out process, a universal standard. The time out process should be done 100% of the time.” During a concurrent interview and record review on 3/5/26 at 1:30 p.m., the Director of Pharmacy (DOP) stated the “Post Op Block Procedure Note and Pharmacy Preop Orders” dated 12/11/25, indicated Patient 22 received a total of 100 mg of Bupivacaine (A long-acting injectable anesthetic used to block nerves). DOP also stated that 50 mg (milligrams) was administered to the hip for the femoral block and 50 mg to the shoulder for the interscalene block. During a review of the medical record, dated 12/12/25, at 5:05 p.m., the record titled “progress note” the orthopedic (bone) surgeon documented in Patient 22’s record “Due to the patient’s LLE (left lower leg) block effect, he is not safe to proceed home at this time and this will be reeval tomorrow with PT (physical therapy). If this was not there, his shoulder would be allowing him to go home.” During a review of the physical therapy note dated 12/13/25, the note indicated, the patient was discharged home and required a hemi walker (A lightweight, foldable walking aid, with four non-slip rubber feet) and left knee brace to prevent knee buckling while ambulating (walking). Patient 22 was walking independently prior to surgery. Review of the facility’s policy and procedure (P&P), titled, “Anesthesia, Surgery and Procedural Time Out (Universal Protocol),” dated 5/18/24, the P&P indicated: “The time out definition is the universal protocol of taking time out to perform appropriate checks to prevent wrong site, wrong procedure, and wrong patient errors ...It is the responsibility of the Proceduralist/procedure Team to complete/address these steps and any applicable safety checklist and/or documentation tool.” “An anesthesia time out is completed prior to all block anesthetic techniques. At a minimum, an anesthesia provider and or registered nurse will participate in the time out at the facility.””