Gifford Medical Center

“SURGICAL SERVICES CFR(s): If a CAH provides surgical services, surgical procedures must be performed in a safe manner by qualified practitioners who have been granted clinical privileges by the governing body, or responsible individual, of the CAH in accordance with the designation requirements under paragraph (a) of this section. This Condition is not met as evidenced by: 35636 Based on observation, interview, and policy review the Condition of Surgical services was not met as evidenced by the Critical Access Hospital’s (CAH’s) failure to assess how prolonged low humidity levels affect the safety of the perioperative suite’s operation, supplies, instruments, and equipment; and the failure to ensure the methods for preventing and controlling the transmission of infections were followed as evidenced by blood observed on an Operating Room (OR) table in an OR that was cleaned, an opened package of intubation (putting a tube down one’s throat to breathe) instruments left on an anesthesia cart in an OR that was cleaned, opened patient care supplies in the OR’s and Endoscopy Suite (area in which instruments are introduced into the body to give a view of its internal parts) for undetermined times and dates, and inconsistencies with staff performing hand hygiene while cleaning an operating room after a surgical case. The cumulative effect of these systemic problems resulted in the CAH’s inability to ensure the quality of health care in a safe environment. Findings include: 1.) During a tour of the perioperative suite on 12/12/23 at 1:00 PM the humidity level in the sterile instrument storage area read 15% and the temperature read 69 degrees. The humidity level in the sink area between OR #1 and OR #2 was 15% and the temperature read 68 degrees. The humidity level in the endoscopy suite read 19% and temperature read 69.7 degrees. When asked what the acceptable humidity level was, the Nurse Manager stated that it should be above 20% and confirmed that the facility has had some “humidity issues” lately; and further stated that the CAH was aware of the problem and was working with a contractor. S/He stated that the staff in the perioperative suite monitor the temperature and humidity daily; and that S/He had noticed a trend of low levels starting in November 2023. On 12/13/23 at 11:00 AM, a second tour of the perioperative area was made. The humidity of the sterile instrument storage area read 15% and temperature read 68 degrees. In OR #1, The humidity level read 15% and the temperature read 68.2. In OR #2, the humidity level read 10% and the temperature read 68 degrees. Per interview with the Nurse Manager at that time, S/He was not aware of any policy/procedure that the facility had to monitor the supplies, instruments, equipment, and/or plans to cease operation. S/He stated that there was a fire mitigation protocol that was followed if the humidity and temperature levels went above 60% and/or 75 degrees. Per review of the perioperative suite humidity log, the humidity range given was 20-60%. The following values represent the number of times the humidity was checked, the area checked, and how many times the humidity was in/out of range. These checks were done once a shift, randomly between the hours of 7:00 AM to 3:30 PM by the perioperative staff: October 2023: OR 1 checked 15 times, 1/15 out of range (<20% humidity) OR 2 checked 15 times, all in range. OR 3 checked 15 times, all in range. November 2023: OR 1 checked 12 times, 12/12 out of range (<20% humidity) OR 2 checked 13 times, 11/13 out of range (<20% humidity) OR 3 checked 13 times, 7/13 out of range (<20% humidity) Endoscopy checked 10 times, 9/10 times out of range (<20% humidity) December 2023: OR 1 checked 6 times, 6/6 out of range (<20% humidity) OR 2 checked 6 times, 6/6 out of range (<20% humidity) OR 3 checked 6 times, 5/6 out of range (<20% humidity) Endoscopy checked 6 times, 1/6 out of range (<20% humidity) There is no notation in these logs regarding the action that was taken when the values were out of range. Per interview on 12/12/23 at 4:26 PM with the Director of facilities, S/He stated that S/He was aware of the low humidity levels in the perioperative and endoscopy areas. S/He stated that low humidity was not ideal because of the potential for fires. S/He stated that the hospital had fire policies in place; and that S/He was working with a group of contractors to fix the system. S/He further stated that the humidity was checked daily between 8:00 and 9:00 AM by a staff member from maintenance and that “a lot of times when it’s low” we “cannot do anything about it”. S/He also stated that S/He was not aware of any recommendations from the manufacturers related to supplies, instruments, and equipment when there are consistently low levels of humidity in the perioperative and endoscopy suites. Per interview on 12/12/23 at 4:43 PM with the Vice President of Nursing, S/He stated that humidity in the perioperative and endoscopy suites was monitored daily by facilities. The CAH’s policy refers to the upper limits of humidity, not low limits. The reference used for clinical practice and policy development is Association of periOperative Registered Nurses (AORN). S/He stated that with low humidity the worry is fire and that there is a procedure that is followed for fire mitigation. On 12/13/23 at approximately 9:00 AM, S/He confirmed that there was no policy to monitor supplies, instruments, and equipment when the humidity is low and out of range. “Prolonged variations in temperature and humidity in perioperative areas can have serious effects on surgical services (eg, increased infection risk, decreased patient safety, disruptions in business continuity, significant fiscal loss). Rapid identification of temperature or humidity variations can prevent adverse consequences by promoting timely restoration of environmental controls and proactive relocation of at-risk supplies and other items. In the case of prolonged disruption to temperature and humidity, exiting guidelines advise performing a risk assessment to guide mitigation. Perioperative personnel should make patient safety the top consideration when assessing and responding to these events.” Reference: Curless, M., Bow, L., Lentz, T, Trexler, P, Maragakis, L. (2021) “Management and Mitigation Temperature and Humidity Events in the Perioperative Setting” AORN Vol 114, (6), 563-571. 2.) On 12/12/23 at approximately 1:15 PM, a tour of OR #1 was made, a blood stain approximately the size of the bottom of a coffee cup was noted on the base of the operating table, an opened package containing a laryngoscope blade and a stylet (tools used to put a tube down one’s throat to breathe) were noted on the anesthesia cart; clear tubing was attached to the suction canister located on the anesthesia cart; and a package containing a Yank-our (type) suction tip (removes secretions from one’s mouth) was opened and located on top of the suction canister. There was no indication when the clear tubing and Yank-our were opened and/or how long they had been in the room. Per interview with the Nurse Manager at that time, S/He confirmed that this OR had been cleaned and that there should be no opened packages containing instruments and no visible blood in the operating room after cleaning. S/He stated that anesthesia oversaw the suction set up and supplies and it was his/her understanding that the suction tubing was changed once it was used. S/He did not know how long it had been there and/or how long the opened package containing the Yank-our had been there. At approximately 2:15 PM, a tour of the endoscopy suite was made, a breathing mask was noted to be attached to tubing on an anesthesia cart, clear tubing was opened and attached to the suction canister, and a package containing a Yank-our suction tip was opened and located approximately one foot from the floor. All these patient care supplies had no date and/or time noted when opened. Per interview with the Nurse Manager at that time S/He confirmed that the mask was most likely used and should not have been left attached and that S/He did not know how long the suction tubing and/or Yank-our had been there. Per interview on 12/13/23 at 12:03 PM with an Anesthesia Provider, S/He stated that S/He checked his/her suction and supplies prior to every surgery and needed the suction supplies “at the ready” in case of an emergency. S/He confirmed that S/He did not know when the supplies were opened and/or how long they were usable when open in the OR and Endoscopy suites. S/He stated that best practice was not to have anything opened; however, every provider had their own practice. Per interview on 12/13/23 at 3:23 PM with the Infection Preventionist and Vice President of Quality and Compliance, they confirmed that the above observations were not acceptable infection control practices. On 12/14/23, during an interview at approximately 12:30 PM with the Vice President of Quality and Compliance, S/He revealed that the CAH had no policy related to suction tubing and supplies being left open in the OR’s and/or Endoscopy Suite. Per review of the policy, “Infection Preventions in Surgical Services”-last reviewed 8/23/22, it states “Infection preventions involves the use of specific actions and activities to prevent contamination and maintain sterility of individual areas during operative and other invasive procedures. All individuals who are involved in operative or other invasive procedures have a responsibility to provide a safe environment for patients ....1. Healthcare workers should use standard precautions when caring for all patients in the perioperative setting (AORN) ...a. All personnel should follow established hand hygiene practices ...b. perioperative personnel should wear PPE whenever the possibility exists for exposure to blood or other potentially infectious materials.” Per review of the policy, “Cleaning of Surgical Suite”-last reviewed 5/27/22, it states, “Effective cleaning of the OR suite insures a diminished risk of infection ...I. Cleaning and removal of soil should be done on a regular scheduled basis ...B. After each surgical procedure, the surgical staff will clean and disinfect the OR suite as outlined in AORN’s Guidelines for Perioperative Practice.” 3.) On 12/13/23 at 11:30 AM, during observation of the cleaning of OR #1 after a surgical case, Staff Member #2 entered OR #1 without gloves, used the computer that was in the room, without sanitizing his/her hands, proceeded to don gloves, and started to clean one of the anesthesia carts and then moved to the next cart. Once Staff Member #2 was finished with the carts, S/He removed his/her gloves and without sanitizing his/her hands donned new gloves and proceeded to clean other areas of OR #1. Per interview at 11:42 AM with Staff Member #2, S/He stated that after removing gloves you were supposed to use “Purell (brand of hand sanitizer)” prior to donning clean gloves. Per review of the policy, “Hand Hygiene”-last reviewed 8/30/22, it states, “Hand Hygiene, a term that applies to hand washing, antiseptic hand wash, antiseptic hand rub or surgical antisepsis, is a core element of patient safety for the prevention of healthcare-associated infections and the spread of antimicrobial resistance. To prevent person to person transmission of infections decontaminate hands with either a hygienic alcohol based hand rub for 20-30 seconds or by washing hands with antimicrobial soap and water for at least 40-60 seconds ...1. Hand Hygiene should be performed ...A. Before patient contact/care ...B. Before putting on gloves ...G. After removing gloves ...””

“ANESTHETIC RISK AND EVALUATION CFR(s): (1) A qualified practitioner, as specified in paragraph (a) of this section, must examine the patient immediately before surgery to evaluate the risk of the procedure to be performed. (2) A qualified practitioner, as specified in paragraph (c) of this section, must examine each patient before surgery to evaluate the risk of anesthesia. (3) Before discharge from the CAH, each patient must be evaluated for proper anesthesia recovery by a qualified practitioner, as specified in paragraph (c) of this section. This Standard is not met as evidenced by: 35636 Based on interview and record review the CAH failed to ensure that surgical patients prior to discharge were evaluated for proper anesthesia recovery regarding cardiopulmonary status, level of consciousness, follow-up care/observations, and complications for two of three records reviewed (Patient #4 and Patient #19). Findings include: 1.) Per record review Patient #4 has a history of right upper quadrant pain with nausea and biliary hyperkinesia (rapid contractions and emptying of the gallbladder). On 11/8/23, a laparoscopic cholecystectomy (gallbladder removal) was performed. Per review of the “Anesthesia Record” from 11/8/23, it states, “Recovery ...Location: ACC, Arrival Time: 1229, Vitals at 1231 ...Fully Awake ...Active Airways: None ...Supplemental Oxygen: Room Air.” There is no evidence of follow up care/observations and complications noted in this evaluation. 2.) Per record review Patient #19 has a history of a fall with a left-sided distal fibular fracture (broken bone in ankle). On 11/21/23, Patient #19 underwent surgical repair of this fracture. Per review of the “Anesthesia Record”, it states, “Recovery ...Location: PACU, Arrival Time: 1005 ...Vitals ... Responsiveness: [Left blank] ...Active Airways: None ...Supplemental Oxygen: Simple Mask”. There is no evidence that the patient’s level of consciousness, follow up care/observations, and complications were noted in this evaluation. Per interview on 12/13/23 at 12:03 with an Anesthesia Provider, S/He stated that S/He does not write a post anesthesia evaluation unless the patient is admitted. Per review of the policy, “Documentation of Anesthesia Patient Care”-last reviewed 5/2022, it states, “Documentation is a factor in the provision of quality anesthesia care, and it is the responsibility of the Anesthesiologist/Anesthetist to accurately document the care provided ...III. Post-anesthesia ...A. Patient evaluation on admission and discharge from the post-anesthesia care unit. B. A time-based record of vital signs and level of consciousness. C. All drugs administered and their dosages. D. Type and amounts of intravenous fluids administered including blood and blood products. E. Any unusual events including post-anesthesia or post-procedural complications. F. Post-anesthesia visits.””