Copley Hospital

“CONSTRUCTION CFR(s): The CAH is constructed, arranged, and maintained to ensure access to and safety of patients, and provides adequate space for the provision of services. This Standard is not met as evidenced by: 52756 Based on observation and interview, the CAH failed to ensure the Emergency Department’s environment maintained patient safety, as evidenced by failing to secure a soiled utility room containing housekeeping chemicals. Findings include: During a tour of the Emergency Department (ED) on 6/22/26 at 11:47 AM with the Director of Emergency Services, a soiled utility room located in one of the ED hallways was observed to be unsecured with the door propped open and easily accessible to unauthorized individuals. The hallway was a high-traffic area where patients, visitors, and staff moved about in the ED. The room contained a hopper (“Flushing-rim clinical sink with a bedpan-rinsing device used for disposal of liquid clinical waste), cleaning wipes (isopropyl alcohol & ammonium), two bottles of cleaning liquid, cleaning brush, four empty spray bottles for cleaners, toilet bowl cleaner, two instrument pre-cleaning spray bottles along with a rigid container with a lid to store used medical instruments to be reprocessed for use, and a pump bottle of hand sanitizer. In addition to cleaning supplies, the closet contained an open shelf with patient testing supplies for urine and stool (urine specimen cups & bags, stool specimen collection, and hemoccult (stool test to detect hidden blood in stool). No separation was noted between clean supplies and soiled items. Per interview on 6/22/26 at 12:00 PM, the Director confirmed that the unlocked soiled utility room doors are accessible to anyone attempting to gain entry and open, and that the room’s mixed supplies of soiled items are at risk of cross-contamination. Per review of the CAH policy, “Standard Operating Procedure: Environment of Care Rounds” last revised on 7/30/25, it states, “Separation of clean and dirty/soiled items,” and “Cleaning supplies and patient care supplies are not comingled.””

“PROTECTION OF RECORD INFORMATION CFR(s): The CAH maintains the confidentially of record information and provides safeguards against loss, destruction, or unauthorized use. This Standard is not met as evidenced by: 29776 Based on observation and staff Interview the Critical Access Hospital (CAH) failed to store medical records in a manner that safeguarded against loss, destruction, and unauthorized use. Findings include: During a tour of the Medical Records Department on 6/23/26 at 10:12 AM, accompanied by a Medical Records Manager, paper medical records were observed to be housed in a large storage room on open shelves underneath a sprinkler head. These records were uncovered and there was a potential for water damage from the sprinkler system and/or damage from fire. The Medical Records Manager confirmed at the time of observation on 6/23/26 at 10:12 AM the records were not stored in a protected manner to assure they sustained no damage from water or fire.”

“INFECTION PREVENT & CONTROL POLICIES CFR(s): The infection prevention and control program, as documented in its policies and procedures, employs methods for preventing and controlling the transmission of infections within the CAH and between the CAH and other healthcare settings; This Standard is not met as evidenced by: 52756 Based on observation, interview, and record/policy review, the CAH failed to employ methods to prevent and control the transmission of infections in the Emergency Department and the Radiology Suite. Findings include: 1. During a tour of the Emergency Department (ED) on 6/22/26 at 11:47 AM with the Director of Emergency Services, a soiled utility room in one of the ED hallways was observed containing a mix of clean patient supplies stored alongside soiled items. The room contained a hopper (“Flushing-rim clinical sink with a bedpan-rinsing device used for disposal of liquid clinical waste), cleaning wipes (isopropyl alcohol & ammonium), two bottles of cleaning liquid, cleaning brush, four empty spray bottles for cleaners, toilet bowl cleaner, two instrument pre-cleaning spray bottles along with a rigid container with a lid to store used medical instruments to be reprocessed for use, and a pump bottle of hand sanitizer. In addition to cleaning supplies and used instruments, the closet contained two commodes marked with “clean commode” tape located in front of the hopper sink, an open shelf located above the hopper sink with patient testing supplies for urine and stool (urine specimen cups & bags, stool specimen collection, and hemoccult (stool test to detect hidden blood in stool). No separation was noted between clean supplies and soiled items. Per interview on 6/22/26 at 12:00 PM, the Director confirmed that the soiled utility room contained mixed supplies and is at risk of cross-contamination. Per review of the policy, “Standard Operating Procedure: Environment of Care Rounds” last revised on 7/30/25, it states, “Separation of clean and dirty/soiled items,” and “Cleaning supplies and patient care supplies are not comingled.” 2. During a tour of the Radiology Department on 6/22/26 at approximately 2:00 PM with the Director of Radiology Services, observation of a CT (Computed Tomography) scanner (a diagnostic imaging test that combines multiple X-ray measurements taken from different angles to produce detailed, cross-sectional views of bones, blood vessels, and soft tissue inside the body.) revealed the patient examination table had multiple breaches/tears/holes in the upholstered surface, The damaged surface created an uneven, non-intact surface that could not be effectively cleaned and disinfected between patients. Per interview at the time of this observation, the Director of Radiological Services acknowledged the tears/holes in the examination table and confirmed the damaged surface was present and could not be cleaned effectively between patients. She stated that the machine was scheduled for replacement in one year. Per interview on 6/22/26 at approximately 3:15 PM the Director of Quality, Risk & Informatics confirmed patient care equipment surfaces needed to be maintained in an intact, cleanable condition to ensure appropriate cleaning and disinfection between patient use. She was not able to provide a hospital policy and procedure specific to this requirement. Per interview on 6/22/26 at approximately 2:30 PM the Infection Preventionist confirmed patient care equipment needs to be cleaned between patient use and that all surfaces must be intact to ensure adequate cleaning and disinfection between patient use. S/he stated that s/he could not provide a policy and procedure specific to this requirement.”

“Develop EP Plan, Review and Update Annually CFR(s): §403.748(a), §416.54(a), §418.113(a), §441.184(a), §460.84(a), §482.15(a), §483.73(a), §483.475(a), §484.102(a), §485.68(a), §485.542(a), §485.625(a), §485.727(a), §485.920(a), §486.360(a), §491.12(a), §494.62(a). The [facility] must comply with all applicable Federal, State and local emergency preparedness requirements. The [facility] must develop establish and maintain a comprehensive emergency preparedness program that meets the requirements of this section. The emergency preparedness program must include, but not be limited to, the following elements: (a) Emergency Plan. The [facility] must develop and maintain an emergency preparedness plan that must be [reviewed], and updated at least every 2 years. The plan must do all of the following: * [For hospitals at §482.15 and CAHs at §485.625(a):] Emergency Plan. The [hospital or CAH] must comply with all applicable Federal, State, and local emergency preparedness requirements. The [hospital or CAH] must develop and maintain a comprehensive emergency preparedness program that meets the requirements of this section, utilizing an all-hazards approach. * [For LTC Facilities at §483.73(a):] Emergency Plan. The LTC facility must develop and maintain an emergency preparedness plan that must be reviewed, and updated at least annually. * [For ESRD Facilities at §494.62(a):] Emergency Plan. The ESRD facility must develop and maintain an emergency preparedness plan that must be [evaluated], and updated at least every 2 years. . This Standard is not met as evidenced by: 29776 Based on observation and staff Interview the Critical Access Hospital (CAH) failed to assure the comprehensive emergency preparedness program was maintained through review and updates at least every 2 years. Findings include: An interview was conducted with the Emergency Preparedness [EP] Director on 6/24/26 at 11:06 AM. The EP Director confirmed that the last revision date of the facility’s Emergency Operations Plan was March 2022, and a review and revision was initiated in 2025 but never completed. The EP Director confirmed the facility failed to review and update the comprehensive emergency preparedness program as required by regulation at least every 2 years.”