Manchester Memorial Hospital

“SURGICAL SERVICES CFR(s): 482.51 If the hospital provides surgical services, the services must be well organized and provided in accordance with acceptable standards of practice. If outpatient surgical services are offered the services must be consistent in quality with inpatient care in accordance with the complexity of services offered. This Condition is not met as evidenced by: 48364 The Conditions of Participation for Surgical services was not met. Based on tour of the hospital, observations, review of hospital documentation, and interviews, the hospital failed to ensure hinged/ratcheted instruments were in an open position during sterilization and reprocessing according to policy and the Association for the Advancement of Medical Instrumentation (AAMI) guidelines and failed to ensure the correct implant component was placed during a surgical procedure resulting in a second surgery for component removal (A0951). Please cross reference 482.51(b) Operating Room Policies (A0951)”

“OPERATING ROOM POLICIES CFR(s): 482.51(b) Surgical services must be consistent with needs and resources. Policies governing surgical care must be designed to assure the achievement and maintenance of high standards of medical practice and patient care. This Standard is not met as evidenced by: 48364 Based on a review of clinical records, observations, review of hospital documentation, and interviews, the hospital failed to ensure hinged/ratcheted instruments were in an open position during sterilization and reprocessing according to policy and the Association for the Advancement of Medical Instrumentation (AAMI) guidelines resulting in a finding of Immediate Jeopardy. In addition, for one (1) of ten (10) patients reviewed for surgical services (Patient #1), the hospital failed to ensure the correct implant component was placed during a surgical procedure resulting in a second surgery to remove the component. In addition, for two (2) of ten (10) patients reviewed for surgical services, (Patient #3 and Patient #8) the facility failed to ensure accurate and complete documentation of patient records in accordance with facility policy. The findings include: 1a. Observations made during a tour of the central core of the operating rooms with the Operating Room Registered Nurse Manager on 3/28/25 at 11:20 AM identified ten (10) self-seal sterilization packages that contained hinged instruments (scissors and clamps) in a closed position with the tips of the instrument touching. Interview with Surgical Technician #1 on 3/28/2025 at 11:30 AM indicated she would place a hinged/ratcheted instrument on the operating room sterile field as long as the ratchet was unlocked but would not be concerned if the tips were touching. Interview with the Sterile Processing Department Manager on 3/28/2025 at 1:24 PM indicated that hinged/ratcheted instruments should be processed in an open position with the tips of the instruments not touching. She further indicated that she had cardboard separators (keep the instruments in an open position during processing) available in her department for approximately 2-3 years and should be utilized. 1b. During a tour of the Central Sterile Department with the Sterile Processing Manager on 3/28/25 at 1:24 PM, Sterile Processing Technician #1 was observed processing a hinged/ratcheted Kelly clamp in a self-sealing package but did not use the cardboard separator to keep the instrument in an open position. Interview with Tech #1 indicated he considered a hinged/ratcheted instrument in an open position when the tips of the instrument are not touching, and the ratchet was not locked. He further identified that when he processed hinged/ratcheted instruments, he did not use the cardboard separator that was available to him because “it was not his preference”. Interview with the Sterile Processing Department Manager on 3/28/2025 at 1:24 PM identified that hinged/ ratcheted instruments should be processed in an open position with the tips of the instruments not touching. She further indicated that she had cardboard separators available in her department for approximately 2-3 years but that her staff may not be trained in using the separators. She further indicated the facility follows Association for the Advancement of Medical Instrumentation (AAMI) guidelines. Review of facility policy on packaging techniques for instrumentation (not included in trays) identified that box locks/hinges will be kept in an open position. The Association for the Advancement of Medical Instrumentation (AAMI) guidelines directed instruments should be positioned to allow the sterilant to come into contact with all surfaces and all jointed instruments should be in the open or unlocked position with ratchets not engaged. Racks, pins, stringers, and other specifically designed devices can be used to hold the instrument in the open position. The guidelines further indicate that individual instruments may be packaged in an acceptable packaging material, with the instrument held open, unlocked, or disassembled, and sterilized in a position that ensures adequate steam contact with all surfaces. 2. Patient #1 was admitted to the hospital on 1/16/2025 for a right sided total knee arthroplasty with Mako robot (a robotic arm to guide the placement of the implant) assist. A review of the universal protocol/safety checklist dated 1/1/2025 indicated that the correct patient, correct procedure, correct site, correct procedure, and correct implant options were available was verified by the surgical team. A review of MD #1’s operative report dated 1/16/2025 indicated, in part, “the patella was then sized, and prepped for cementless patella fixation”. A review of Hospital documentation and interview with the Chief of Quality on 3/31/2025 at 11:20 AM identified it was determined MD #1 had requested implant components to be cementless, however, the implant components used during the operative procedure required cement, The Chief of Quality stated the surgical team (physician, scrub technician, and Operating Room (OR) Registered Nurse (RN)) failed to follow implant process verification according to facility policy, resulting in a wrong implant component being inserted and Patient #1 required a second surgery to correct the implant error. Patient #1 was made aware of the wrong implantation of components in the right knee arthroplasty at a post operative outpatient follow up appointment with Physician (MD) #1. On 3/28/25 at 11:30 AM, the boxes that contained the components for a total knee arthroplasty were observed to be clearly labeled as cemented and non-cemented. Interview with MD #1 (surgeon) on 3/28/2025 at 12:34 PM identified he had a verbal discussion, out loud, with the implant component vendor representative, prior to the start of the surgical procedure and his surgical team (OR RN #1 and Surgical Tech (ST) #2) and requested cementless implant components for patient #1’s right total knee arthroplasty. MD #1 further indicated it is the vendor representative’s job to acquire the correct implant components and bring the implants into the operating room. MD #1 recalls the boxes of the implant components were shown to him prior to being placed on the surgical field for validation and verification but he does not recall if the boxes stated “cementless” or “cemented” on them. Interview with RN #1 (circulating RN) on 3/31/2025 at 12:00 PM indicated prior to the start of the surgical procedure MD #1 would have a discussion with the RN, ST, and implant vendor representative to discuss the implant components to be used and whether the procedure will include cement or no cement with the implants. RN #1 stated once the surgical procedure was ready for the implant components, the ST, MD #1, the vendor, and himself would look at the surgical component boxes to verify size, laterality, expiration dates, and cemented verses cementless components. Then once everyone has agreed on the correct implant components RN #1 would remove the components from the box and present the components to the sterile surgical field. RN #1 stated that according to his documentation and as “far as I can tell we followed those steps and procedures”. Interview with ST #2 on 3/31/2025 at 12:31 PM identified that prior to this surgical procedure, the implant vendor representative confirmed the implant component boxes with MD #1 and RN #1, removed the components from inside the box, handed RN #1 the components from inside the box, RN #1 showed the inside component container to herself to verify size, laterality, and expiration date and then presented the components to her to place on the sterile operating field. ST #2 did not recall looking at the box and further reported the inside component container did not specify whether the component was cemented or cementless. A review of the Guideline for Reviewing and Passing Implants to the Sterile Field policy indicated the surgeon will be responsible for: clear communication of verbal orders of sizes, styles, and combination of implants requested. For final visual verification of packages to ensure that correct implants have been chosen as the ones to be open to the field and verbalizing agreement with the circulator. For final review of actual implants prior to implantation. The circulator will be responsible for: identifying correct implants based on the verbal orders of the surgeon. For visual identification and verbal agreement with surgeon prior to opening implant to sterile field. For passing implant packages to ensure that only correctly chosen implants in the verified packages are open to the field. The scrub person will be responsible for: knowing which type, laterality, and sizes of implants have been verbally ordered by the surgeon. Will use technique of repeating the surgeons’ requests out loud in order to clarify verbal orders of surgeon. For showing the surgeon the size indicators on the implants prior to the assembly or implantation. 3a. Patient #3 was admitted to the hospital on 1/1/2025 for diagnostic laparoscopy and laparoscopic appendectomy. A review of Patient #3’s intraoperative universal protocol/safety checklist with a date of 1/1/2025, under the time out section of the chart failed to indicate if the correct procedure and correct site were identified, allergies were reviewed, preop medications were reviewed, operative site markings were visualized, blood bank status was addressed, correct implant options were available, difficult airway/ aspiration risk was addressed, anesthesia check list was completed, pulse oximeter was on the patient and functioning, and radiographic images were properly labeled and displayed. A review of Patient #3’s anesthesia record with a date of 1/1/2025 failed to identify a postoperative anesthesia note was completed by the attending practitioner indicating the patients condition prior to the transfer of care. b. Patient #8 was admitted to the hospital on 2/14/2025 for a laparoscopic right salpingo-oophorectomy and left salpingectomy. A review of Patient #8’s intraoperative anesthesia record with a date of 2/14/2025 failed to identify the attending anesthesia provider: re-evaluated patient immediately prior to induction, was present at induction, was present at emergence, was immediately available throughout the case, monitored the case at frequent intervals as was medically necessary, ensured all procedures were performed by qualified anesthesia personnel, or broken medical direction- unable to meet the requirements listed above. Further review of the anesthesia record failed to identify a postoperative anesthesia note that was completed indicating the patient’s condition prior to the transfer of care. An interview with Manager #2 on 3/31/2025 at 2:00 PM indicated that all fields in the universal protocol/ safety checklist should be filled out completely. She further indicated that she would not consider this document accurate or complete. An interview with MD #3, the chief of anesthesiology, on 4/1/2025 at 12:57 PM indicated the attending anesthesia attestation area should always be filled out when an anesthesiologist is supervising a Certified Registered Nurse Anesthetist. He further indicated the post operative anesthesia note should always be filled out by the provider who delivered care during anesthesia prior to discharging patients to the next level of care (i.e. back to the floor or to the post anesthesia care area) to indicate the patient’s condition. MD #3 further indicated he would not consider these anesthesia records to be complete and accurate. A review of the facility policy universal protocol indicates the universal protocol is a verification process that requires a standard procedure, with multiple checkpoints, to minimize the risk of performing an incorrect invasive procedure and/or performing an invasive procedure on an incorrect patient or at an incorrect site. The universal protocol safety checklist form is to be used as a checklist during the time out process. A review of the facility policy Intra-anesthesia care/standards of care indicates if the physician is not personally administering the anesthetic but assisting in the care and management of the patient, his/her availability for supervision and direction will be clear. The policy further indicates the events of the procedure will be accurately recorded. Documentation will include any other pertinent information relevant to the management of the anesthetized patient.”

“PATIENT RIGHTS CFR(s): 482.13 A hospital must protect and promote each patient’s rights. This Condition is not met as evidenced by: 14216 This CONDITION was not met as evidenced by: Based on a review of clinical records, review of hospital documentation, policies, and staff interviews for 1 of 3 sampled patients reviewed for allegation of abuse (patient #9), the hospital failed to ensure the patient was free from abuse and failed to ensure the staff was removed from patient care areas according to hospital policy. Cross Reference: 482.13(c)(2) Patient Rights: Care in Safe Setting (A0144) 482.13(c)(3) Patient Rights: Free from Abuse/harassment (A0145)”

“PATIENT RIGHTS: CARE IN SAFE SETTING CFR(s): 482.13(c)(2) The patient has the right to receive care in a safe setting. This Standard is not met as evidenced by: 14216 Based on a review of clinical records, hospital documentation, policies, and staff interview for 1 of 3 sampled patients reviewed for injury, the hospital failed to administer safe care when a Certified Nurses’ Aide (CNA) applied a hot pack to the patient resulting in a third degree burn. The finding includes: Patient #68 was admitted to the hospital on 11/25/23 for back pain and lower extremity edema. Review of hospital documentation dated 11/26/23 noted the patient was found with a left upper flank wound, the dermis pulled off, reddened and a small upper area noted with 3rd degree burns. The documentation identified 2 cold wet washcloths were found rolled up in a towel. The documentation further identified the patient reported asking for a hot pack earlier in the day and CNA #1 placed the hot washcloths on the patients back. The nurse’s notes dated 11/26/23 at 9:30 PM noted upper center of wound with greater loss of epidermis measurement 4cm by 7 centimeter (cm) with a depth of 0.15cm, binder on to keep dressing in place. Review of the wound care notes dated 11/30/24 at 10:08 AM identified a 3rd degree wound to the patient’s left upper back, measuring 16.5cm by 19cm by 0.1cm, the wound bed is 60% granulation tissue, 10% adherent yellow slough and 20% of the wound is a deep maroon eschar measuring 6.5cm by 7.5cm. The wound was treated and covered with a dressing. Interview with the Quality Improvement Manager on 9/24/24 at 1:45 PM stated that the patient complained of back pain to the CNA, the aide then went to the RN to report it, but the RN was in the middle of a code with another patient. It was later identified that the CNA applied hot wash cloths to the patient’s back. The Quality Improvement Manager indicated that the CNA should have gone to another nurse about the back pain before applying the wet washcloths. The Quality Improvement Manager indicated that if a patient requests or requires a hot pack, the RN would get a physician’s order, apply the hot pack and then monitor the patient’s skin during the application. The Manager further indicated that after the incident staff were educated on the hospital policy on the use of hot packs/Aquamat and were provided a demonstration of how to use it. Review of the hospital Aquamat policy identified that Aquamat can only be used with practitioner/AHP order. Licensed nursing staff is responsible for the correct set up of the equipment. Area covered by aquamat is checked in 30 minutes after application for heat tolerance and every (2) hours thereafter. RN #20 and CNA #1 were unavailable for interview.”

“PATIENT RIGHTS: FREE FROM ABUSE/HARASSMENT CFR(s): 482.13(c)(3) The patient has the right to be free from all forms of abuse or harassment. This Standard is not met as evidenced by: 14216 Based on a review of clinical records, review of hospital documentation, policies, and staff interviews for 1 of 3 sampled patients reviewed for allegation of abuse (patient #9), the hospital failed to ensure the patient was free from abuse and failed to ensure the staff was removed from patient care areas according to hospital policy. The finding includes: Patient #9 was admitted to the hospital on 8/13/24 for alcohol abuse and withdrawal. Nurse’s notes dated 8/17/24 at 6:11 AM identified that at approximately 4:45 AM patient #9 pulled off the tele leads and his/her central line. The note identified the patient was agitated, yelling, kicking at staff and equipment. The note identified security was called to assist with manual hold position while the patient was medicated. The patient was observed thrashing, kicking and attempting to spit at staff. The Advanced Practice Registered Nurse (APRN) was called to the bedside and the patient was again medicated. The note further identified the patient continued to kick and punch at staff and 4-point restraints were applied. Review of the hospital documentation dated 8/17/24 noted the patient became agitated, pulling out lines, and security was called to hold the patient down for medication administration. The documentation noted that security guard #1 was observed to take the seizure pad off the bed and place it horizontally across the patient’s face, holding pressure on top of the pad, pushing the patient’s face down into the mattress and was yelling “shut up, if you don’t shut up I’m going to punch you in the face”. The security guard was swearing at the patient. The documentation further identified the patient was placed in 4-point restraints and the seizure pad was removed from his/her face. Review of security guard #1’s time sheet identified the security guard punched out from their shift at 8:00 AM (approximately 2 hours and 15 minutes after the security guard was observed yelling at patient #9 and holding the patient’s head down with a seizure pad). Review of security guard #1’s badge swipe log dated 8/17/24 identified after the allegation of abuse was reported, security guard #1 swiped his badge numerous times between 5:27 AM and 7:44 AM going in and out of the ambulance bay in the emergency department (ED) and the main entrance in the ED into patient care areas. Review of the administrative leave checklist dated 8/17/24 identified security guard #1 was placed on leave on 8/17/24. Interview with security guard #2 on 9/19/24 at 1:55 PM indicated that she and security guard #1 were called to the unit to assist with a patient. Security guard #2 stated that security guard #1 pushed the patient’s head into the mattress and placed a seizure pad on the patient’s face, while the patient was saying “let me go” and security guard #1 was yelling and swearing at the patient. Security guard #2 stated that after the patient was restrained, she and security guard #1 left the unit and went back to the security office. Security guard #2 stated that because she was so flustered with what happened it did not occur to her to report what she observed. Interview with RN #9 on 9/26/24 at 9:25 AM stated that she called security to assist with patient #9 because the patient was combative, threatening and pulling out lines. RN #9 stated that the patient attempted to spit at the security guard and security guard #1 became very agitated/yelling to the patient “I’m going to punch you in the face.” RN #9 stated that security guard #1 took the seizure pad off the bed and began to smash it into the patients face. RN #9 stated that she told the security guard to remove the pad, the security guard said, “I’m not letting go, if he/she spits, I’m going to punch him/her in the face.” RN #9 stated that after they got the patient restrained security left the floor and she reported the incident to the charge nurse. RN #9 further stated that she observed the charge nurse talking with the RN Supervisor but did not hear what was said and the RN Supervisor did not ask her anything about the incident. Interview with RN #10 on 9/26/24 at 9:50 AM stated that she was in patient #9’s room while the patient was being restrained and she observed security guard #1 holding a seizure pad on the patients face and yelling/swearing at the patient. RN #10 stated that RN #9 reported the incident to the charge nurse, and she was present when the charge nurse told the RN Supervisor that the security guard was rough and swearing at the patient. RN #10 stated that the supervisor reiterated the patient’s behaviors and being in restraints but appeared focused on making sure there was staff available to do the one-to-one observation while the patient was in restraints. RN #10 stated that she and the charge nurse told the supervisor a second time what happened with patient #9 and security guard #1 but all the supervisor said was okay and left the area. Interview with RN #11 (charge) on 9/24/24 at 7:40 AM identified that RN #9 and RN #10 reported that security #1 was rough, held the patient’s head/face down with a seizure pad and was yelling and swearing at patient #9. RN #11 stated she reported to the RN Supervisor what had happened, and the supervisor said “okay”. RN #11 stated RN #10 was present and reported the rough handling by the security guard to the supervisor. RN #11 stated that she completed the hospital documentation of the event but did not see the supervisor assess the patient and she did not know what was done. Interview with RN #12 (RN Supervisor) on 9/24/24 at 9:30 AM identified that she was not told of the incident. RN #12 stated that if she was told of rough inappropriate handling, she would have followed the hospitals abuse policy. Interview with the Director of Security on 9/19/24 at 2:15 PM stated that when it was reported to him that security guard #1 yelled at patient #9 and held the patient down using a seizure pad, he contacted the security guard and placed him on administrative leave. Interview with the Director of Quality on 9/20/24 at 11:30 AM stated that she was reviewing hospital incident reports when she noted the report related to patient #9. The director stated that she reviewed the report and contacted the Director of Security, and security guard #1 was placed on administrative leave at that time. Interview with the Chief Nursing Officer (CNO) on 9/20/24 at 12:10 PM stated that when she spoke with the RN Supervisor, the RN supervisor reported that she did not hear the word “inappropriate” during conversation with the charge nurse. The CNO stated that staff are aware of the hospital’s abuse policy, and she felt there was a communication issue related to this incident. The CNO stated that the supervisors and charge nurses were educated at that time regarding communication and ensuring that they hear what was being said. The CNO further identified that security guard #1 remained on administrative leave. Multiple attempts to interview security guard #1 were unsuccessful. Review of the hospital abuse policy identified any form of suspected abuse or harassment allegations regarding a patient will be immediately reported to the manager, supervisor or director. The policy identified as soon as the allegation is known, in order to ensure the safety and well-being of those involved, the employee will be removed from patient care and patient care areas until the investigation is completed.”