Sharon Regional Medical Center

“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: 49830 Based on review of facility documentation, medical record review (MR), and employee interview (EMP), it was determined the facility failed to follow the facility policy to ensure patients received care in a safe setting when the facility did not ensure that patients were appropriately screened for increased elopement risk and by failing to secure valuable property allowing for patient elopements. Findings include: A review on June 5, 2026, at 12:30 pm, of Patient Elopement and Leaving Against Medical Advice, Chapter: Rights and Responsibilities, Policy Number: RI 40, Origination Date: 4/25/25, revealed, “... Definitions ... Likelihood of Serious Harm: means (i) substantial risk of physical harm to the person himself/herself as manifested by evidence of threats of, or attempts at suicide or seriously bodily harm; and /or, (ii) substantial risk of physical harm to other persons as manifested by evidence of homicidal or other violent behavior or evidence that others are placed in reasonable fear of violent behavior and serious physical harm them; and (iii) a very substantial risk of physical impairment or judgement is so affected that he/she is unable to protect himself/herself in the community and the reasonable provision of his/her protection is not available in the community ... 2. Patient Elopement Outside the Emergency Department ... c. The Nurse Manager/Charge Nurse shall notify the patient’s physician and the following Hospital employees of the elopement: i. Risk Manager ii. Administrator on Call (who will contact Media Relations if necessary) ... e. The patient’s family/representative(s) will immediately be contacted to determine if the patient was removed from the Hospital by these individuals ... For a patient who lacks Medical Decision - Making Capacity, a healthcare proxy, power of attorney (medical), guardian and/or next of kin must be contacted. If it is determined that a true elopement has occurred, and the patient is found outside the Hospital, the patient’s physician must determine whether the patient had Medical Decision-Making Capacity ... g. If an eloped patient lacks Medical Decision-Making Capacity, the legal representative (guardian, health care proxy, power of attorney (medical) and/or next of kin (if no legal representative) shall be contacted immediately and informed of the elopement and will be encouraged to return the patient to the Hospital for the continuing care if/when the patient return/is located, as appropriate h. Documentation in the medical record should include: i. condition of patient at time of elopement, including patient’s mental status; ii. Date and time patient reported missing/eloped; iii. Notification of the physician; and iv. Notification of the family ... j. An incident report documenting the facts of the elopement and subsequent staff actions shall be completed by Nursing and Security staff for all patient’s elopement cases ... 3. Patient Elopement from the Emergency Department ... e. In the event the ED attending physician or QMP has a reason to believe that failure to hospitalize an eloped patient would create a likelihood of serious harm by reason of mental illness, a Hospital specific procedure in accord with the state regulations describing Emergency Restraint and Hospitalization of Persons Posing Risk of Serious Harm by Reason of Mental Illness will be followed. Initiation of the process will be completed by the ED attending physician to involuntarily return an eloped patient to the Hospital’s ED. See Hospital Policy specific to Emergency Restraint and Hospitalization of Persons Posing Risk of Serious Harm by Reason of Mental Illness. The ED attending physician may also, as appropriate, provide the completed document (when applicable) to local law enforcement to ensure that the patient is returned to the ED for appropriate assessment, care and treatment ...” 1. Review, at approximately 12:38 PM on June 5, 2026, of internal facility documentation revealed that the patient from MR11 had eloped from the facility on May 15, 2026. Further review revealed that the patient was found outside, under the canopy, outside the Emergency Room entrance. Further review revealed, “... Patient with dementia made her way down to the ED entrance thinking she was discharged. Security staff found her talking with another patient who had been discharged and was waiting for a ride. Staff from 4W came down and she was escorted back to her room. No injury ...” Further review revealed that the patient’s bed alarm had been silenced or not turned on at the time the patient eloped. 2. Review, from approximately 4:00 PM-5:30 PM on June 6, 2026, of MR11, revealed no documentation of an elopement risk assessment. Review of documentation from the patient’s History and Physical, on May 14, 2026, revealed, “... HPI [History of Present Illness] ... Alzheimer dementia ... resides with a companion who administers medication due to confusion secondary to dementia General Appearance: disoriented, confused ...” Review of a General Medicine Progress Note from 6:47 AM on May 15, 2026, revealed, “... General Appearance: alert, disoriented, confused, mild distress ...” Additional review of MR11 revealed that during a Fall Risk Assessment on May 14, 2026, at 2:45 PM, the patient was determined to be a High Fall Risk, and bed alarms were implemented. 3. At approximately 10:50 AM on June 15, 2026, EMP1 confirmed that at the time the patient eloped, his/her bed alarm was either turned off or silenced. 4. At approximately 1:00 PM on June 15, 2026, EMP1 confirmed that the facility does not have a policy to regarding Elopement Risk Assessments for medical inpatients. EMP1 added, “... We have precautions, but there’s nothing that would trigger an assessment.” Review on June 15, 2026, at 12:41 PM of Essential Patient Property and Valuable, Chapter: Rights and Responsibilities, Policy Number: RI 46, Origination Date: 4/24/25, revealed, “... Definitions ... Valuables: Money, wallets/purses, credit/debit cards, checkbooks, jewelry to include earrings, necklaces, bracelets, rings, watches, etc., cell phone, keys, ipods, laptops, any items of significant personal value personal papers and effects, and medications as defined blew ... Procedure ... B. Handling of Patient Property: Emergency Department...4. Emergency Department staff will secure personal belongings of behavioral health patients in a designated secure location(s) within the Emergency Department. Behavioral Health patient valuables will be secured in a Patient Valuables Envelope and sent to a Hospital safe/secure location ...” 1. An interview on June 5, 2026, with EMP2, at approximately 11:51 AM, confirmed that, “... if the patient triggers moderate to high on the suicide scale, it automatically triggers for an observation order. [this patient (MR1) did not] ... so even though the patient was on a 302, [he/she] would not have been automatically ordered observation ...” 2. At approximately 12:30 PM, on June 8, 2026, EMP3 confirmed that a Behavioral Health patient (MR1) in the Emergency Department under an involuntary Behavioral Health (302) admission was not screened for elopement risk and was permitted to keep [his/her] cell phone. The patient subsequently eloped from Emergency Department.”

“FORM AND RETENTION OF RECORDS CFR(s): 482.24(b) The hospital must maintain a medical record for each inpatient and outpatient. Medical records must be accurately written, promptly completed, properly filed and retained, and accessible. The hospital must use a system of author identification and record maintenance that ensures the integrity of the authentication and protects the security of all record entries. This Standard is not met as evidenced by: 27359 Based on review of medical records (MR) and employee interview (EMP), it was determined that the facility failed to ensure that the hospital maintained medical records that were accurately written for one of two medical records reviewed for unusual incidents (MR11). Findings include: Review of Policy RI30, “Incident Reports: General Overview,” dated April 17, 2025, revealed, “... Procedure ... IV. Reporting within the hospital/Sharon ... Documentation in the Medical Record 1. The medical record should contain a complete, accurate record of clinical information pertaining to the event. When applicable, the documentation should include: a. Objective detail of the event written in non-judgmental language - facts only b. The patient’s condition immediately before the event c. Intervention and patient response d. Notification of the physician e. Notification/discussion with the family ...” 1. Review, at approximately 12:38 PM on June 5, 2026, of internal facility documentation revealed that the patient from MR11 had eloped from the facility on May 15, 2026. Further review revealed that the patient was found outside, under the canopy, outside the Emergency Room entrance. Further review revealed, “... Patient with dementia made her way down to the ED entrance thinking she was discharged. Security staff found her talking with another patient who had been discharged and was waiting for a ride. Staff from 4W came down and she was escorted back to her room. No injury ...” Further review revealed that the patient’s bed alarm had been silenced or not turned on at the time the patient eloped. 2. Review, between 4:00 and 5:30 PM on June 6, 2026, of MR11 revealed no documentation of the patient’s elopement from the facility. 3. When asked to view documentation regarding the patient’s elopement, at approximately 11:37 AM on June 8, 2026, EMP1 confirmed there was no documentation, internal or in the medical record (MR11) regarding the elopement.”

“DISPOSAL OF TRASH CFR(s): 482.41(b)(6) (4) The hospital must have procedures for the proper routine storage and prompt disposal of trash. This Standard is not met as evidenced by: 27359 Based on review of facility documentation, facility tour, and employee interviews, it was determined the facility failed to ensure prompt and or routine disposal of waste and trash. Findings include: Review, on April 29, 2026, of “Sharon Regional Health System Hazardous Materials and Waste Management Plan 2026,” revealed, “... Regulated Medical Waste Risk Management ... Regulated medical waste is picked up on a regular scheduled as determined by the hospital or licensed off-site and transported appropriately to an off-site disposal location. ... Municipal Solid Waste Municipal solid waste is commonly known as trash or garbage. The hospital has procedures for the proper routine storage and prompt disposal of trash. ...” 1. At approximately 11:30 AM on April 29, 2026, a First Floor storage closet, between an electrical room and Elevator 3, with no signage on the door, was found to have nine 55-gallon trash receptacles with lids, preventing the door from being opened completely. Inspection of these receptacles revealed the receptacles contained used kitchen grease. When asked why these receptacles were in this closet and not disposed of, EMP4 stated, “I’m still working on that contract.” The estimated amount of grease was approximately 270 gallons of grease. EMP4 could not provide an approximate amount of time the kitchen grease had been stored in the closet; however, one of the receptacles of grease had a substance accumulating on top of the grease. 2. At approximately 11:51 AM on April 29, 2026, in the Second Floor Morgue, three blue barrels were found. One was labeled as Regulated Material. One was labeled as Hazardous Waste and Corrosive. One was labeled as Hazardous Waste and Flammable. All three barrels were labeled with a date of December 11, 2025. EMP4 and EMP5 confirmed the findings at the time of observation. EMP5 confirmed that the barrels were ready for pick-up in December [2025]; however, it was not confirmed why the barrels had not been picked up.”

“INFECTION CONTROL SURVEILLANCE, PREVENTION CFR(s): The infection prevention and control program includes surveillance, prevention, and control of HAIs, including maintaining a clean and sanitary environment to avoid sources and transmission of infection, and addresses any infection control issues identified by public health authorities; and This Standard is not met as evidenced by: 27359 Based on review of facility documentation, facility tour, and employee interviews, it was determined the facility failed to maintain a clean and sanitary environment. Findings include: Review of Policy “NUTR 52 Prevention and Infection Control,” dated April 16, 2025, revealed, “... Procedure: ... IV. Equipment Sanitation ... b. ... Non-food contact surfaces of equipment shall be cleaned as often as is necessary to keep them free of dust, dirt, food particles and other debris. ...” 1. A tour of the facility was conducted on April 29, 2026. At approximately 10:46 AM on April 29, 2026, tour of the Dietary Department revealed that the kitchen vent hoods and piping above the grill and fry cooking area had a visible layer of dust. Visualization of the inspection sticker of the vent hoods revealed that the last cleaning had been August 5, 2025. EMP4 confirmed the date and stated that vent hoods are “supposed to be done twice a year.” Further tour of the Dietary Department revealed a trash receptacle in the food preparation area had layered food substances dried on it around the top, bottom and down the sides of the trash receptacle. EMP4 confirmed the findings at the time of observation. EMP4 confirmed that it did not appear as though the trash receptacle had not been cleaned. When asked for a policy on cleaning, EMP4 confirmed that the facility did not have a policy.”

“TRANSFER PROTOCOLS CFR(s): Effective July 1, 2025, the hospital must have written policies and procedures for transferring patients under its care (inclusive of inpatient services) to the appropriate level of care (including to another hospital) as needed to meet the needs of the patient. The hospital must also provide annual training to relevant staff regarding the hospital policies and procedures for transferring patients under its care. This Standard is not met as evidenced by: 27359 Based on review of facility documents and transfer medical records (MR), as well as employee interview (EMP), it was determined that the facility failed to document pertinent patient information sent and/or informed consent per policy for the transfer of 13 Emergency Department (ED) patients (MR2, MR3, MR4, MR6, MR10, MR11, MR13, MR14, MR18, MR19, MR20, MR23, and MR24) and three inpatient transfers (MR1, MR8 and MR9). Findings include: Review, on April 22, 2026, of POC 55, “Hospital to Hospital Transfer of Inpatients for Medical Care,” dated January 23, 2025, revealed, “... Scope This policy covers only inpatient transfers to another hospital, and is not applicable to Emergency Department transfers. See Steward Policy RI 23 Emergency Medical Treatment and Active Labor Act (EMTALA) for hospital policy regarding transfers from the Emergency Department. ... Procedure I. Process ... B. Consent/Refusal to Transfer: 1. If, after offer of transfer and an explanation of the risks and benefits associated with such transfer, a. the patient/agent consents to the transfer, the attending physician or his/her designee (who may be a nurse, Hospitalist or social worker) shall document the consent and arrange the transfer ... E. Appropriate Transfer. ... 1. A transfer pursuant to this policy is considered to be appropriate when: ... c. The hospital sends with the patient at least the following information: a completed Discharge Summary, when available; relevant information (e.g., admission history and physical, progress notes, pertinent laboratory values, radiology reports, etc.); an inventory of patient’s personal effects and valuables which are being transported with the patient; and any other medical information that the transferring physician in collaboration with the receiving hospital deems necessary to the care of the patient. ... F. Coordination of Transfer: 1. A member of the nursing staff caring for the patient, in consultation with he attending physician and Discharge Planning Coordinator, coordinates all aspects of the transfer, ... preparing records to accompany the patient ...” Review, on April 22, 2026, of RI 23, “Emergency Medical Treatment and Active Labor Act (EMTALA),” dated April 17, 2025, revealed, “... Procedure ... III. Treatment of Patients with EMCs ... 2. A Transfer is appropriate under EMTALA when all the following conditions are met: ... c. The Hospital sends to the receiving facility copies of all pertinent medical records available at the time of Transfer, including (i) available history; (ii) records related to the patient’s EMC; (iii) observations of signs or symptoms; (iv) preliminary diagnoses; (v) results of diagnostic studies or telephone reports of the studies; (vi) treatment provided; (vii) results of any tests; and (viii) a copy of the Hospital’s Transfer form, including, as applicable, the certification of risks and benefits by a physician or QMP or the signed patient request ... 3. Documentation Relating to Transfer a. Documentation of Transfer must be completed for each patient being transferred to a higher level of care. All applicable fields on the “Authorization for Transfer Form” (3 part form) are to be completed. ... b. Documentation of a patient’s request/consent/refusal to Transfer must be completed for each patient being transferred. All applicable fields on “Signature Page for Patient’s Request/Refusal/Consent to Transfer” should be completed. ...” Review, on April 22, 2026, of “Sharon Regional Health System Rights and Responsibilities,” last revised February 3, 2023, revealed, “... Patient Rights: You have the right to: ... When medically permissible, a patient may be transferred to another facility only after he or his next of kin or other legally responsible representative has received complete information and an explanation concerning the needs for and alternatives to such a transfer. ...” 1. Review, between April 21 and April 22, 2026, of ED transfer MR, revealed 13 of 20 MR without accompanying documentation of medical record information being sent with the transfer patient (MR2, MR3, MR4, MR6, MR10, MR11, MR13, MR14, MR18, MR19, MR20, MR23, and MR24). EMP4 confirmed the findings at the time of review. 2. Review, between April 21 and April 22, 2026, of inpatient transfer MR, revealed three of four MR without accompanying documentation of medical record information being sent with the transfer patient (MR1, MR8, and MR9). EMP4 confirmed the findings at the time of review. 3. Review, between April 21 and April 22, 2026, of inpatient transfer MR, revealed three of four MR without documentation of informed consent of the transfer (MR1, MR8, and MR9). EMP4 confirmed the findings at the time of review.”

“GOVERNING BODY CFR(s): 482.12 There must be an effective governing body that is legally responsible for the conduct of the hospital. If a hospital does not have an organized governing body, the persons legally responsible for the conduct of the hospital must carry out the functions specified in this part that pertain to the governing body ... This Condition is not met as evidenced by: 39272 Based on review of facility documentation, facility tour, and employee interviews (EMP), it was determined that the Governing Body failed to ensure corrective actions were taken related to resources needed to correct heating issues affecting patient care areas (A-726) between December 6, 2025, and December 17, 2025. Cross reference: 482.41(d)(4) Ventilation, Light, Temperature Controls”

“PHYSICAL ENVIRONMENT CFR(s): 482.41 The hospital must be constructed, arranged, and maintained to ensure the safety of the patient, and to provide facilities for diagnosis and treatment and for special hospital services appropriate to the needs of the community. This Condition is not met as evidenced by: 49830 Based on review of facility documentation, facility tour, and employee interviews (EMP), it was determined that the facility failed to ensure a safe environment for patient care by not maintaining proper temperature control in appropriate areas (A-726), including inpatient rooms, surgical area, cardiac catheterization lab, special procedure rooms, a sterile storage and the Behavioral Health Unit between December 6, 2025, and December 17, 2025. Additionally, the facility failed to maintain a safe environment by maintaining compliance with the 2012 Edition of the National Edition of the National Fire Protection Association (NFPA) 101, Life Safety Code (LSC). Please refer to the FORM CMS-2567 Life Safety Report FFS421, completed on December 18, 2025. Cross reference: 482.41(d)(4) Ventilation, Light, Temperature Controls”

“REGULAR FIRE AND SAFETY INSPECTIONS CFR(s): 482.41(b)(8) (6) The hospital must maintain written evidence of regular inspection and approval by State or local fire control agencies. This Standard is not met as evidenced by: 27359 Based on employee interview (EMP), it was determined that the facility failed to maintain written evidence of regular inspection by the local fire control agencies. Findings include: At approximately 09:15 on December 16, 2025, a request was made for documentation of inspection by the local fire agency. At approximately 5:30 PM on December 16, 2025, a second request was made for documentation of inspection by the local fire agency. At approximately 09:30 AM on December 17, 2025, a third request was made for documentation of inspection by the local fire agency. At the time of the survey team’s exit from the facility on December 18, 2025, documentation of inspection by the local fire agency had not be provided by the facility. Cross reference: 482.41 Physical Environment”

“VENTILATION, LIGHT, TEMPERATURE CONTROLS CFR(s): 482.41(c)(4) There must be proper ventilation, light, and temperature controls in pharmaceutical, food preparation, and other appropriate areas. This Standard is not met as evidenced by: 27359 Based on review of facility documentation, facility tour, and employee interviews (EMP), it was determined that the facility did not maintain proper temperature control in all appropriate areas, including inpatient rooms, surgical area, cardiac catheterization lab, special procedure rooms, sterile storage and the Behavioral Health Unit between December 6, 2025, and December 17, 2025. Findings include: Review of Policy UT02, “Air Handling, Ventilation and Indoor Air Quality, “ dated April 4, 2025, revealed, “... Policy ... In critical care areas designed to control airborne contaminants ... the ventilation system provides ... temperature ... The hospital maintains ... temperature ... levels suitable for the care, treatment, and services provided. ... Procedure A. General ... 6. ... Temperature ... requirements can change for products used or stored in identified rooms and risk assessments are conducted for those areas. In addition to Sharon policy, various States have adopted different versions of the FGI guidelines. A link to the current adoption of edition guidelines by state can be found at the following website: ... 7. Operating rooms, Catheterization Labs, Special Procedure rooms, Central Sterile Processing areas, Endoscopy Procedure rooms, ... and Sterile Storage areas are maintained at temperature ... per the guidelines or risk assessment. ...” Review of an excerpt from the December 11, 2025, Board of Managers Meeting Minutes, revealed, “... (EMP7) reported that last week we had a heating issue and surgery was out for several days. (EMP2) was advised to contact a contractor to resolve this issue. ...” Review of a statement (no date) provided by the facility on December 18, 2025, revealed, “(EMP7), as a member of the Board of Directors, has recommended to the Director of Facilities and Maintenance to contract a mechanical contractor and as a second recommendation, work on ancillary heating while simultaneously working on a permanent redundancy for the current heating issue. Respectfully, (EMP2) ...” Review of work orders submitted by facility staff revealed the following: “12/05/2025 07:37 AM ... Customer description: it’s too cold in OPSU waiting room on the 3rd floor ... 12/08/2025 02:19 PM ... Customer description: It’s too cold in patient rooms on 4PA ... 12/09/2025 10:50 AM ... Customer description: It’s too cold in ER Waiting Room. Patients have started to complaint about the cold, it has gotten worse since yesterday. Is there a space heater or other solution to help? There is not a thermometer, so I am unable to know the exact temperature. ... 12/11/2025 12:05 PM ... Customer description: Heat is not working ... 12/12/2025 04:32 AM ... Customer description: It’s too cold in 411 No heat from heating/cooling unit ... 12/14/2025 06:28 PM ... Customer description: Unit rooms are cold- patients are complaining “too cold” ... 12/15/2025 02:56 PM ... Customer description: It’s too cold in PACU/Recovery room. Temperature states 63 degrees. Dr ... states that it is too cold. “Something is wrong”. Maintenance called and stated that they are aware and to put in a maintenance request. ...” Review of a temperature log for Cardiac Cath Lab 2 revealed, “... Notify Engineering immediately for inappropriate ... temperature ... out of the following ranges: Temperature 68-73 [degrees] ...” Review of the log revealed temperatures between 60-66 degrees, below 68 degrees, from December 6-17, 2025. Review of temperature logs for the OR area revealed that the facility identified 68-73 as acceptable temperature ranges for the areas identified, which included: OR’s, Clean Storage, hallways within the OR, Sterile Supply Rooms, Cystoscopy Room, Instrument Room, Dirty Workroom, Clean Workroom, Implant Room, and Rep Room. It was noted that temperatures were not documented on days that the Surgical Department was not utilized [weekends]. Review of the log for OR2 revealed temperatures ranging from 65.1-67.8 on December 1-5, 2025; December 9-10, 2025; and December 15-16, 2025. Review of the log for OR3 revealed temperatures ranging from 67.3-67.6 on December 3-4, 2025. Review of the log for OR5 revealed temperatures ranging from 64.4-67.9 on December 9-12, 2025; and December 15-16, 2025. Review of the log for OR6 revealed temperatures ranging from 63.1-67.5 on December 9, 2025; December 11-12, 2025; and December 15-17, 2025. Review of the log for OR7 revealed temperatures ranging from 63.0-67.8 on December 9-12, 2025; and December 15-18, 2025. Review of the log for OR8 revealed temperatures ranging from 63.1-67.6 on December 1-5, 2025; December 9-12, 2025; and December 15-17, 2025. Review of the log for OR9 revealed temperatures ranging from 64.2-67.8 on December 3-5, 2025; December 9-12, 2025; and December 15-17, 2025. Review of the log for Clean Storage revealed temperatures ranging from 52.9-64.0 on December 1-5, 2025; December 8-12, 2025; and December 15-18, 2025. Review of the log for the hallway outside OR9 revealed temperatures of 65.8 and 65.7 on December 15 and 16, 2025, respectively. Review of the log for Sterile Supply Room revealed temperatures ranging from 62.2-67.6 on December 1-5, 2025; December 8-12, 2025; and December 15-18, 2025. Review of the log for Cyto [sic] revealed temperatures of 65.8 and 67.6 on December 15 and 16, 2025, respectively. Review of the log for the Instrument Room revealed temperatures of 60.3-66.7 on December 1-5, 2025; December 10-12, 2025; and December 15-16, 2025. Review of the log for the area across from OR2 revealed temperatures ranging from 65.1-67.3 on December 2-5, 2025; and December 15-16, 2025. Review of the log for the Dirty Workroom revealed temperatures of 67.8 and 63.9 on December 5 and 15, 2025, respectively. Review of the log for the Clean Workroom revealed temperatures ranging from 62.2-67.6 on December 1-5, 2025; December 9, 2025; and December 12-16, 2025. Review of the log for the hallway between OR6 and OR7 revealed temperatures of 66.6 and 67.8 on December 15 and 16, 2025, respectively. Review of the log for the hallway across from the storage room revealed a temperature of 67.8 on December 15, 2025. Review of the log for the Implant Room revealed temperatures of 66.0-66.7 on December 1-5, 2025 and December 10, 2025. Review of the log for the Rep Room revealed a temperature of 67.3 on December 15, 2025. Review of the Temperature log for the PACU revealed, “Notify Engineering immediately for inappropriate ... temperature ... out of the following ranges: Temperature: 70 - 75 [degrees] ...” Review of the log revealed temperatures between 66-68, below 70 degrees on the following dates: December 5, 2025; December 10-12, 2025; and December 16-16, 2025. During an interview on December 15, 2025, with EMP2, it was stated that the part to resolve the heating problem had been ordered. Later review of documentation, on December 17, 2025, revealed that the part had not been ordered until December 17, 2025. The heating issue was identified on December 6, 2025. Review of documentation from an outside contractor to EMP2, dated December 17, 2025, revealed that the steam trap and heat exchanger failed and required investigation on December 6, 2025. Further review revealed, “... c) Received intention to proceed w/ procurement ... and installation of new tube for Heat Exchanger ... on Friday, 12/12. - Terms of proposal state that order will not be processed until 50% deposit is issued/received. d) Received 50% deposit to procure and install new tube for heat exchanger ... on Wednesday 12/17. ...” On December 16, 2025, a tour of inpatient units, 4 West and Cardiovascular Unit (CVU), was completed with EMP2 and EMP3. It was determined that space heaters were being used to supply heat to occupied patient rooms. Interview with EMP3 revealed that the space heaters had been put into place after being tagged by an electrician. On December 17, 2025, at 11:57 am, an interview with EMP8, confirmed that facility-wide temperature monitoring had begun on December 16, 2025, at 7:00 pm and the temperatures obtained at that time were while using facility provided space heaters. Review of room temperature logs, provided by the facility, for the date range of December 17, 2025, into the morning of December 18, 2025, revealed that the facility was utilizing a temperature range of 68-72 degrees as a reference range. Review of the log revealed that within the CVU, Room 207 was documented as 63.5 at 6:00 PM. Review revealed that Rooms 202, 203, 204, 205, and 207 ranged between 60.3-64.8 at 10:00 PM. Review revealed that Room 205 was 62.1 and Room 207 was 63.1 at 2:00 AM. Review revealed that Rooms 201, 202, 203, 204, 205, and 207 ranged between 61.2-67.0 at 6:00 AM. Review revealed that Rooms 201, 202, 203, 204, 205 and 207 ranged between 60.6-62.8 at 10:00 AM. On December 22, 2025, a tour of inpatient unit 4 West, Cardiovascular Unit (CVU), and Adult Behavioral Health Unit was completed. It was determined in the tour of 4 West that 10 of 12 rooms were not within the standard range of 70 to 75 degrees Fahrenheit. A tour conducted in Adult Behavioral Health revealed that 11 of 11 rooms were not within the standard range of 70 to 75 degrees Fahrenheit. A tour conducted in CVU revealed 6 of 6 rooms were not within the standard range of 70 to 75 degrees Fahrenheit. An interview with EMP6 confirmed that temperatures in the Adult Behavioral Health Unit were not routinely monitored due to the acuity level of patients on the unit. Cross reference: 482.41 Physical Environment”

“INFECTION CONTROL SURVEILLANCE, PREVENTION CFR(s): The infection prevention and control program includes surveillance, prevention, and control of HAIs, including maintaining a clean and sanitary environment to avoid sources and transmission of infection, and addresses any infection control issues identified by public health authorities; and This Standard is not met as evidenced by: 39272 Based on review of facility documentation, medical record review (MR), and employee interview (EMP), it was determined that the facility failed to complete catheter care as ordered for two of two applicable medical records reviewed. (MR4 and MR10). Findings include: On December 18, 2025, review of Policy IC 07, Prevention of Catheter-Associated Urinary Tract Infections (CAUTI), origination date January 23, 2025, revealed, “... Procedure ... G. Catheter-Associated Urinary Tract Infection (CAUTI) Prevention Program The following elements in the CAUTI prevention program are coordinated by Infection Control Enterprise Committee: 1. Education and Training a. Healthcare personnel involved in the insertion, care, and maintenance of urinary catheters will be educated about CAUTI prevention, including alternatives to indwelling catheters, and procedures for catheter insertion, management, and removal during the orientation and updated annually thereafter. ... Methodologies to prevent infection ...” 1. On December 18, 2025, review of MR4 revealed that a Foley catheter was ordered on December 9, 2025. EMP8 confirmed that the order for the Foley catheter included catheter care to be completed twice per day. EMP1 confirmed catheter care was not documented as being completed twice per day as required. 2. On December 18, 2025, review of MR10 revealed that a Foley catheter was ordered on December 15, 2025. EMP8 confirmed that the order for the Foley catheter included catheter care to be completed twice per day. EMP1 confirmed catheter care was not documented as being completed twice per day as required. ********************************************************************** Based on facility documentation, a facility tour, and employee interview (EMP), it was determined that the facility failed to maintain a sanitary environment within the Surgical Services Department between December 9, 2025, and December 16, 2025, as evidenced by a confirmed active leak from the ceiling in a restricted corridor between OR8 and OR9, across from the Sterile Processing Department. Findings include: 1. On December 16, 2025, during a tour of the Surgical Services Department, an active leak from the ceiling of a restricted corridor between OR8 and OR9, across from the Sterile Processing Department was observed. Further observation revealed a standard waste receptacle containing gloves, sitting on top of towels with rust-colored stains, to be collecting the actively dripping rust-colored substance from the ceiling. EMP2, EMP3, and EMP4 confirmed the finding at the time of the observation. Further confirmed that OR8 was actively being utilized between December 9, 2025, and December 16, 2025. 2. On December 16, 2025, review of facility documentation revealed that a work order was submitted on December 9, 2025, for a “stained ceiling tile in hallway between OR 8 and OR 9 ...” EMP9 confirmed that the work order submitted on December 9, 2025, was associated with the identified leak within Surgical Services. Resolution was not completed until December 16, 2025, at which point, a diverter system was put in place to contain the active leak.”

“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: 39272 Based on review of facility documents and policies, as well as employee interviews (EMP), it was determined that the facility failed to ensure that its performance improvement activities focused on problem-prone areas that affected patient safety and quality of care, including periodic inspections of radiology equipment and infection control for surgical services. An Immediate Jeopardy (IJ) was called on October 9, 2025, at 2:20 PM, for the CoP Quality Assessment and Performance Improvement Program. The IJ was removed on October 9, 2025, at approximately 5:22 PM, after the State Survey Agency verified the hospital implemented sufficient immediate corrective actions to address the IJ. Cross referenced: §482.21(b)(2)(ii),(c)(1), (c)(3) Quality Improvement Activities”

“RADIOLOGIC SERVICES CFR(s): 482.26 The hospital must maintain, or have available, diagnostic radiological services. If therapeutic services are also provided, they, as well as the diagnostic services, must meet professionally approved standards for safety and personnel qualifications. This Condition is not met as evidenced by: 39272 Based on review of facility documentation and policies, as well as employee interviews (EMP), it was determined that the facility failed to follow facility policy to ensure periodic inspections were conducted of the computed tomography scanner (CT) and magnetic resonance imaging (MRI). An Immediate Jeopardy (IJ) was called on October 9, 2025, at 2:20 PM, for the CoP Radiologic Services. The IJ was removed on October 9, 2025, at approximately 5:22 PM, after the State Survey Agency verified the hospital implemented sufficient immediate corrective actions to address the IJ. Cross referenced: §482.26(b)(2) Periodic Equipment Maintenance”

“INFECTION PREVENTION CONTROL ABX STEWARDSHIP CFR(s): 482.42 The hospital must have active hospital-wide programs for the surveillance, prevention, and control of HAIs and other infectious diseases, and for the optimization of antibiotic use through stewardship. The programs must demonstrate adherence to nationally recognized infection prevention and control guidelines, as well as to best practices for improving antibiotic use where applicable, and for reducing the development and transmission of HAIs and antibiotic resistant organisms. Infection prevention and control problems and antibiotic use issues identified in the programs must be addressed in collaboration with the hospital-wide quality assessment and performance improvement (QAPI) program. This Condition is not met as evidenced by: 39272 Based on review of facility documentation, a facility tour, and employee interview (EMP), it was determined that the facility failed to maintain equipment for the cleaning and sterilization of surgical equipment. These failures resulted in an Immediate Jeopardy (IJ), posing a serious risk of harm to patients. An Immediate Jeopardy (IJ) was called on October 9, 2025, at 2:20 PM. The IJ was removed on October 9, 2025, at approximately 5:22 PM, after the State Survey Agency verified the hospital implemented sufficient immediate corrective actions to address the IJ. Cross referenced: §482.42(a)(3) Infection Control Surveillance, Prevention”

“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: 41958 Based on review of facility documentation and medical record review (MR), and employee interview (EMP), it was determined the facility failed to follow the facility policy to ensure patients received care in a safe setting when the facility did not ensure time-outs were completed prior to invasive procedures as required per facility policy for six of eight medical records reviewed (MR2-MR6; MR8). Findings include: Review, on October 8, 2025, of facility policy, Universal Protocol for Correct Person, Correct Procedure, Correct Site Verification, POC23, dated January 23, 2025, revealed “... Policy An identification and verification process for patient undergoing invasive procedures will be performed: ... Immediately before the procedure is started. The process includes verification of correct patient, correct procedure and correct site (level and laterality). ... Definitions ... Universal Protocol: A pre-procedure verification process established ... to ensure that the correct patient receives the correct procedure at the correct site. The process also includes a time-out conducted immediately before starting the procedure to address any missing information, equipment or any discrepancies. ... Time out: The active communication process among all team members of the invasive/surgical team in the location where the procedure will be done, just before starting the procedure. Invasive Procedures: ... defines invasive procedures as involves ’ the puncture or incision of the skin, insertion of an instrument, or insertion of foreign material into the body for diagnostic or treatment related purposes. ’ ... However, examples of procedures such as PICC line and all central line insertions chest tube insertion and other similar types of common procedures are included. J. ‘TIME OUT’ IMMEDIATELY BEFORE STARTING THE PROCEDURE ... 2. ‘Time out’ must be conducted in the location where the procedure will be done, immediately before starting the procedure and restarted from the beginning anytime there is an interruption prior to the start of the procedure. ... 4. The physician responsible for the surgery/procedure is responsible for the ‘time-out’. 5. The circulating nurse/lead staff member will initiate and prompt all team members during the ‘Timeout’. ... 12. The time out will be documented in the procedure note, or the electronic medical record. ...” 1. On October 8, 2025, review of MR2 did not reveal documentation of a completed time-out prior to the start of the procedure. 2. On October 8, 2025, review of MR3 did not reveal documentation of a completed time-out prior to the start of the procedure. 3. On October 8, 2025, review of MR4 did not reveal documentation of a completed time-out prior to the start of the procedure. 4. On October 8, 2025, review of MR5 did not reveal documentation of a completed time-out prior to the start of the procedure. 5. On October 8, 2025, review of MR6 did not reveal documentation of a completed time-out prior to the start of the procedure. 6. On October 8, 2025, review of MR8 did not reveal documentation of a completed time-out prior to the start of the procedure. On October 9, 2025, EMP3 confirmed the above findings.”

“DATA COLLECTION & ANALYSIS CFR(s): 482.21(a), (b)(1),(b)(2)(i), (b)(3) (a) 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 improve health outcomes ... (2) The hospital must measure, analyze, and track quality indicators ... and other aspects of performance that assess processes of care, hospital service and operations. (b)Program Data (1) The program must incorporate quality indicator data including patient care data, and other relevant data such as data submitted to or received from Medicare quality reporting and quality performance programs, including but not limited to data related to hospital readmissions and hospital-acquired conditions. (2) The hospital must use the data collected to-- (i) Monitor the effectiveness and safety of services and quality of care; and .... (3) The frequency and detail of data collection must be specified by the hospital’s governing body. This Standard is not met as evidenced by: 27359 Based on review of facility documents and policies, as well as employee interviews (EMP), it was determined that the facility failed to use data to monitor the safety of services and quality of care, including periodic inspections of radiology equipment and infection control for surgical services. Findings include: Review, at approximately 12:30 PM on October 10, 2025, of “Sharon Regional Health System Tenor Health Foundation, LLC Quality and Patient Safety Plan Effective for Calendar Year 2024-2025,” updated December 2024, revealed, “... I. Introduction Sharon Regional Medical Center embraces a culture of excellence, safety and continuous improvement. The Board, senior management and the organized medical staff work together in pursuit of excellence. ... The Sharon Regional plan consists of two major components: ... The following provisions will be defined within the program plan: Hospital ... Hospital/Medical Staff Policy/Procedures to insure compliance with expectations specific to all relevant regulating agencies Policy and Responsibilities of the Quality Committee of the Board of Directors as well as other committees who oversee elements of the Plan. ... I. Guiding Principles of Quality and Patient Safety Sharon Regional Medical Center has adopted principles for quality and patient safety to guide its efforts to improve organizational performance that in turn will provide the safest possible care and optimize the patient care experience for all our patients and families. ... C. Quality and Safety Committee of the Board of Directors (QCBD) ... The QCBD has responsibility delegated from the Board for the following: ... 2. Regulatory Activities: The QCBD ensures the Hospital is compliant with all expectations of state and federal regulating agencies including but not limited to ... Medicare Conditions of Participation for Hospitals, State Department of Health, ... Functions include appropriate policy development and distribution, auditing of hospital activities and reporting through appropriate committees to ensure ongoing compliance with all established rules and regulations. ...” 1. Review of the Quality and Safety Committee Meeting Minutes for January through August 2025, at approximately 2:00 PM on October 3, 2025, revealed no documentation of monitoring for physicist or preventive maintenance checks for radiology equipment. 2. At approximately 12:00 PM on October 9, 2025, an interview was conducted with members of the administrative team. When asked if the out-of-date inspections for the CT scanner and MRI had been added to the Quality Plan, as these have been identified concerns in the past, EMP3 stated, “It’s not. ...” EMP4 added, “There’s not a performance improvement plan for PM’s [preventative maintenance].” 3. When asked, at approximately 12:25 PM on October 9, 2025, if instruments are being tracked as part of the quality program, EMP3 confirmed that they are not. 4. Review of documentation revealed that the facility became aware of concerns with radiation safety inspections in February 2025. 5. Review of documentation revealed that the facility became aware of concerns with failing to maintain equipment for the cleaning and sterilization of surgical and procedural materials in accordance with accepted standards, manufacturer’s recommendations, and maintaining a sanitary environment in March 2024.”

“CONTENT OF RECORD: INFORMED CONSENT CFR(s): 482.24(c)(4)(v) [All records must document the following, as appropriate:] Properly executed informed consent forms for procedures and treatments specified by the medical staff, or by Federal or State law if applicable, to require written patient consent. This Standard is not met as evidenced by: 41958 Based on review of facility documentation, medical record review (MR), and employee interview (EMP), it was determined that the facility failed to follow facility policy to ensure a properly executed informed consent was completed for four of eight procedural medical records reviewed (MR4, MR6, MR7, MR9). Findings include: On October 8, 2025, review of policy number RI 33, “Rights and Responsibilities,” origination date April 25, 2025, revealed “... Procedure I. Informed Consent for Procedures ... C. the process of informed consent is ultimately the sole responsibility of the primary practitioner completing the procedure. D. Documentation of the informed consent process may be completed by the physician or his/her designee and should include discussion and understanding with the patient of the risks, benefits and alternative procedures or course of treatment. ... E. Specific clinical procedures requiring informed consent are approved by the Medical Staff and may include the following general categories: 1. Major/minor surgical or invasive procedures. Any procedure involving general anesthesia, moderate or deep sedation, or regional blocks; ...” 1. On October 8, 2025, review of MR4 contained a signed informed consent dated July 18, 2025, for an US [ultrasound guided] thoracentesis. Upon review, the “PATIENT” and “Dr.” section of the form were not completed. Additionally, it did not contain a witness signature. 2. On October 8, 2025, review of MR6 contained a signed informed consent dated September 18, 2025, for a CT guided lung biopsy. The “Dr.” section of the informed consent had not been completed. 3. On October 8, 2025, review of MR7 contained a signed informed consent dated September 2, 2025, with the sections patient name, physician name, name of proceduralist and credentials sections, not completed. 4. On October 8, 2025, review of MR9 contained a signed informed consent dated September 8, 2025, for a PICC line placement. The name of the proceduralist and credentials section were not completed. On October 8, 2025, EMP3 confirmed the above findings at the time of review.”

“PERIODIC EQUIPMENT MAINTENANCE CFR(s): 482.26(b)(2) Periodic inspection of equipment must be made and hazards identified must be promptly corrected. This Standard is not met as evidenced by: 27359 Based on review of facility documentation and policies, as well as employee interviews (EMP), it was determined that the facility failed to follow facility policy to ensure that periodic inspections were conducted of the computed tomography scanner (CT) and magnetic resonance imaging (MRI). Findings include: Review, at approximately 1:11 PM on October 7, 2025, of Policy 33, “Equipment,” revised September 3, 2025, revealed, “... Policy I. Acceptance testing may be performed by the following: A. Radiologist B. Manufacturer C. Physicist (as required or needed) ... III. Equipment Records A. Downtime, Repairs, and Preventative Maintenance Records Records are maintained in the Bio Med Department or respective departments. B. Physicist Quality Control Records are maintained in the Medical Imaging Manager’s Office ...” Review, at approximately 1:50 PM on October 9, 2025, of Policy 9, “Quality Control of Equipment,” revised September 4, 2025, revealed, “... I. Performance Testing A. Radiographic and fluoroscopic equipment test performed by the Radiation Physicist 1. Scheduled basis a. radiographic - annually b. fluoroscopic - annually ... B. Radiographic and fluoroscopic equipment safety checks performed by the Radiation Physicist. 1. Scheduled basis - annually ...” Review, at approximately 1:53 PM on October 9, 2025, of “Sharon Regional Medical Center Plan for the Provision of Care - Medical Imaging 2025,” revised June 13, 2023, revealed, “... Standards and Guidelines The Medical Imaging Department follows the Regulations, Standards and Guidelines and Best Practices of multiple organizations including but not limited to: PA Department of Environmental Protection (DEP) PA Department of Health (DOH) ... American College of Radiology (ACR) ... Quality Improvement Members of the Imaging department will continually work to improve processes, and outcomes for our patients. We will regularly and systematically conduct quality improvement initiatives to benefit our patients. ...” Review, at approximately 1:26 PM on October 7, 2025, of the Philips Ingenuity Family Manufacturer’s Instructions for Use, printed June 2016, revealed, “... 3. Safety ... Warning The X-ray unit may be dangerous to patient and operator unless safe exposure factors, operating instructions, and maintenance schedules are observed. ... Warning Do not use the CT system for any application until you are sure that the Image Performance Quality Assurance has been satisfactorily completed, and that the Preventative Maintenance Program is up to date. ... 5 Quality Assurance Read this section carefully and follow all instructions regarding scheduling and performance of Quality Assurance (QA) checks. These instructions represent the manufacturer’s required QA and constancy performance checks. If additional testing is required by your national or local authorities, please contact your Philips Service Engineer. ...” 1. Review, at approximately 1:08 PM on October 6, 2025, of the Annual Audit License and QM program reports from OTH1, revealed that the CT-Main [Scanner] had not been inspected by a physicist since July 9, 2024. When asked, at approximately 1:45 PM on October 6, 2025, for the annual physicist report, EMP6 was unable to provide the document. As of the survey team’s departure on October 10, 2025, an up-to-date annual physicist report had not be provided to the survey team. At approximately 12:00 PM on October 9, 2025, an interview was conducted with EMP6. EMP6 clarified that the CT Scanner is currently still in use and the inspection is out-of-date. 2. Review, at approximately 1:29 PM on October 6, 2025, of Annual Audit License and QM program report from OTH1, revealed that the MRI had not been inspected by a physicist since February 15, 2024. When asked, at approximately 1:50 PM, on October 6, 2025, for up-to-date annual inspection documentation, EMP6 stated, “Yeah, [physicist] should’ve done it this year. We were closed when [he/she] should’ve done it. ...” At approximately 12:00 PM on October 9, 2025, an interview was conducted with EMP6. When asked if the MRI physicist inspection was out-of-date, EMP6 stated, “It is.” When asked if the MRI was currently still in use, EMP6 stated, “As of right now, the machine is still being used.” At approximately 12:31 PM on October 6, 2025, an interview was conducted with EMP7. When asked to confirm if preventative maintenance had been performed on the MRI equipment. EMP7, stated “No they are not done”.”

“INFECTION CONTROL SURVEILLANCE, PREVENTION CFR(s): The infection prevention and control program includes surveillance, prevention, and control of HAIs, including maintaining a clean and sanitary environment to avoid sources and transmission of infection, and addresses any infection control issues identified by public health authorities; and This Standard is not met as evidenced by: 39272 Based on review of facility documentation, a facility tour, and employee interviews (EMP), it was determined that the facility failed to maintain a sanitary environment for the cleaning and sterilization of surgical supplies. Findings include: On October 9, 2025, review of “2025 Infection Prevention and Control Annual Assessment and Plan,” approved July 1, 2025, revealed, “... Infection Preventionist ... The IP [Infection Preventionist] develops, implements, monitors and enforces the IPC [Infection Prevention and Control] program. They also develop and update the IC [Infection Control] plan and policies with ongoing facility-wide surveillance and reporting of HAI’s [Hospital Acquired Infections], outbreaks, Pennsylvania reportable diseases, and breaches in IC practices. ... Sterile Processing. Sterile processing of surgical instruments and devices is carried out onsite by facility HCP [Health Care Provider]. HCP have access to surgical instrument/devices and sterile reprocessing equipment manufacturer IFU [Instructions For Use] documents located in a binder in Sterile Processing. ... Surgical instruments/devices are cleaned and disinfected by facility HCP according to the manufacturer IFUs and in accordance with the AAMI ST79:2017 Amendment 4:2020 and AORN guidelines. Sterile storage of instrument trays and devices are stored in a restricted and environmentally controlled sterile storage room. An event-related shelf-life practice is used for sterile storage which means that the sterilized product (e.g., wrapped surgical instrument tray, sterile peel pouch, etc.) should remain sterile until an event (e.g., tear in packaging, broken seal, etc.) causes the item to become contaminated in accordance with Policy IC 18 Storage and Handling of Medical and Surgical Supplies. Sterilize report fall-outs or issues are submitted to the Infection Prevention and Control Committee by the Director of Surgery. Accurate logs are completed and reviewed by Infection Prevention and Control. If the facility is reprocessing single use items for a selected vendor - the items will be reprocessed in accordance with FDA guideline via the vendor. ... see Policy IC 50 Sterilization Processes including Immediate-Use Steam Sterilization (IUSS). ... EDUCATION. Infection prevention education is provided to employees at hire and annually as required based on job description. ... Mandatory education for HCP Mandatory IC education is completed by all HCP upon hire (i.e., prior to providing patient care), annually, and as needed if changes occur ... Competency-based training is completed by all HCP upon hire (i.e., prior to performing task independently), annually, and as needed if changes occur, when responsible for cleaning/disinfection and/or sterilization of equipment, surgical instruments/devices or environmental surfaces, and when responsible for invasive device insertion or maintenance. See Policy IC 24 Infection Control Education for more information. ... Compliance Monitoring. The facility IP and/or trained designee performs at least weekly environmental rounding and monthly compliance monitoring of IC practices ... and routine monitoring of appropriate use of PPE [Personal Protective Equipment], use of Standard Precautions and TBPs [Transmission Based Precautions], proper cleaning, disinfection and sterilization practices used for equipment, surgical instruments/devices and environmental surfaces. Immediate feedback/real-time correction is provided when non-compliance is observed. Environmental rounding and compliance monitoring data are reported to the ICC [Infection Control Committee] and disseminated to HCP as needed. ...” On October 14, 2025, review of Policy Number IC: 18, “Storage and Handling of Medical and Surgical Supplies,” origination date January 23, 2025, revealed, “Policy Medical and surgical supplies will be handled, transported, and stored in a manner that protects product integrity, prevents contamination, and provided protection against conditions that might compromise sterility and/or packaging. Adequate manufacturer and lot number information will be available for all items in the event of a product recall ... Definitions ... Large Sterile Storage Areas: Areas where large volumes of sterile supplies are kept. ... 7. Small sterile storage areas will be managed through staff surveillance. ...” On October 14, 2025, review of Policy IC 50, “Sterilization Processes,” origination date January 23, 2025, “... Scope this policy provides guidance for sterilization processes of reusable instruments and medical devices used in perioperative and procedural settings throughout [OTH2] and licensed off-site facilities ... Definitions ... Chemical Indicator: A sterilization-monitoring device used to monitor the attainment of one or more critical parameters required for sterilization. A characteristic color or other visual change indicates a defined level of exposure based on the classification of the chemical indicator used. ... One Tray System: FDA-cleared, sealed container system, intended to be used to hold temperature tolerant medical devices, surgical supplies, and instruments and/or instrument sets for immediate use steam sterilization and provide for the safe transport and assured delivery for immediate use of the enclosed devices in a sealed, secured container. ...” 1. A tour of the Surgical Services Department was conducted on October 7, 2025. On October 7, 2025, EMP1 confirmed there was not a current process in place within the Surgical Services Department to track surgical inventory or supplies, as recommended by AORN Guidelines. On October 7, 2025, EMP3 further confirmed this finding when he/she was unable to provide requested documentation of inventory tracking for surgical supplies. Observation of the Sterile Storage Area revealed two peel packaged scissors to have a rust-like appearance on them. EMP1 confirmed supplies within the area were ready for patient use. EMP1 further confirmed the identified scissors should be removed from the Sterile Storage Area. 2. A tour of the Surgical Services Department was completed on October 8, 2025. During a tour of the Sterile Processing Department, interview with EMP2 revealed that single use supplies were being reprocessed. EMP1 confirmed that Lister Bandage Scissors were single use items. EMP1 further confirmed that Lister Bandage Scissors were reprocessed. On October 8, 2025, EMP3 confirmed that the single use items were not permitted to be used within the Surgical Services Department. Observation of the Sterile Processing Room revealed 13 sterilized tray systems, seven sterilized pieces of equipment, and 11 peel-packaged scissors identified on a cart documented as clean. EMP2 confirmed that contents of the cart were previously removed for use due concerns with integrity after staff had become aware that the survey team would be conducting an additional tour of the Surgical Services. Observation of the Sterile Storage Area did not reveal the chemical indicator strip to be colored as required for one bone mill, and one bone vice. EMP1 confirmed that the colored indicator strip should have black markings if sterilized. EMP1 confirmed supplies within the area were required to be sterilized prior to use. EMP1 further confirmed that identified sterilized instruments should be removed from the Sterile Storage Area due to indicator tape not being colored as required. EMP1 was unaware of facility protocol and/or policy, when asked, what the process was for monitoring the integrity of the supplies within the Sterile Storage Area. During a tour of the Sterile Storage Area, EMP1 confirmed single use bandage scissors were being reprocessed. Observation of the area did not reveal surgical scissors to be within the associated labeled bin. EMP1 confirmed sterilized scissors were removed from the bin upon discovery of scissors being single use items, during the survey. EMP2 further confirmed that the removal of the sterilized scissors occurred after staff had become aware that the survey team would be conducting an additional tour of the Surgical Services. On October 8, 2025, EMP3 confirmed that the single use items were not permitted to be used within the Surgical Services Department. 3. During a tour of the Sterile Storage Area, a sample of sterilized tray sets were selected for observation. A surgical instrument tray was identified to have an accumulation of adhesive-like residue, unknown foreign matter, and rust-like substance on the sterilized equipment. EMP1 was present for observations. The tray was documented to have been sterilized on June 19, 2025. EMP1 confirmed supplies within the area were required to be sterilized prior to use. EMP1 further confirmed the tray set should be removed from the Sterile Storage Area. When asked, EMP1 was unaware of the facility protocol/policy related monitoring the integrity of sterile supplies. A Major Tray was identified to have an accumulation of adhesive-like residue, unknown foreign matter, and rust-like substance on the sterilized equipment. EMP1 was present for observations. The tray was documented to have been sterilized on August 11, 2025. EMP1 confirmed supplies within the area were required to be sterilized prior to use. EMP1 further confirmed the tray set should be removed from the Sterile Storage Area. When asked, EMP1 was unaware of the facility protocol/policy related monitoring the integrity of sterile supplies. An Ortho Tray was identified to have an accumulation of adhesive-like residue, unknown foreign matter, and rust-like substance on the sterilized equipment. The tray was documented to have been sterilized on September 24, 2025. EMP1 was present for observations. EMP1 confirmed supplies within the area were required to be sterilized prior to use. EMP1 further confirmed the tray set should be removed from the Sterile Storage Area. When asked, EMP1 was unaware of the facility protocol/policy related monitoring the integrity of sterile supplies.”

“EMERGENCY SERVICES POLICIES CFR(s): 482.55(a)(3) [If emergency services are provided at the hospital --] (3) The policies and procedures governing medical care provided in the emergency service or department are established by and are a continuing responsibility of the medical staff. This Standard is not met as evidenced by: 41958 Based on review of facility documents, observation, and staff interview (EMP), it was determined the medical staff failed to ensure agreements/contracts were established according to facility policy, and that facility policy reflects current scope of services for the Emergency Department (ED) and care of obstetrical patients. Findings include: Review, on August 18, 2025, of facility documentation, Amended and Restated Medical Staff Bylaws, revealed “... 6.2 Duties & Responsibilities The purposes and responsibilities of the organized Medical Staff are described below. 6.2.1 Administration and Enforcement of Bylaws and Policies The organized Medical staff develops, adopts, reviews, amends, complies with, monitors and enforces compliance with these Bylaws and Medical Staff Policies necessary for the proper functioning of the Medical Staff and the integration and coordination of Staff Members with the functions of the Hospital. Review on August 18, 2025, of facility policy, Emergency Medical Treatment and Active Labor Act (EMTALA), RI 23, revealed “... Procedure V. On Call/Physicians/Transfer Agreements ... E. As necessary, the Hospital shall also maintain appropriate transfer agreements with other area facilities for patients who may need specialty services not otherwise provided by the Hospital. ...” Review, on August 18, 2025, of facility policy, Care of the Antepartum, Intrapartum, or Postpartum Patient with Hypertensive Emergency, Preeclampsia or Eclampsia, MCH 35, revealed “... Procedure In order to decrease maternal morbidity and mortality, standardization of care is required. This will improve patient outcomes. Optimal response requires the coordination of effort of team members from multiple disciplines and departments. ... Obstetrical unit ... Obstetrical LPs, Obstetrical RNs ...” 1. Review on August 18, 2025, of facility ED call list while on tour, did not reveal an obstetrician on-call. 2. Interview with EMP2 revealed calling OTH1 directly when asked the process for transferring OB patients. When asked if there was a written policy for arranging an obstetrical transfer EMP2 indicated “it’s a verbal agreement ... from years ago ...” 3. Interview with EMP1 confirmed the facility does not provide obstetrical services and revealed there is no contract in place for obstetrical consults or transfer agreement with OTH1, an area facility that provides obstetrical services. EMP1 further confirmed current, MCH 35 policy references obstetrical unit, obstetrical LPs, and Obstetrical RNs, though the hospital does not provide obstetrical services.”

“QUALIFIED EMERGENCY SERVICES PERSONNEL CFR(s): 482.55(b)(2) There must be adequate medical and nursing personnel qualified in emergency care to meet the written emergency procedures and needs anticipated by the facility. This Standard is not met as evidenced by: 27359 Based on review of facility documentation, a facility tour, medical record review (MR) and employee interview (EMP), it was determined that the facility failed to ensure that the staff were trained to maintain and treat Obstetrical emergency patients for 16 of 23 medical records reviewed (MR1, MR3, MR5, MR8, MR9, MR11-MR18, and MR20-MR22). Findings include: Review, on August 12, 2025, of facility, OB Triage Policy, Care of Pregnant Patients presenting to the Hospital, RI 68, origination date: 4/7/25, revealed, “... Medical Screening Examination (MSE): Means the screening process required to determine with reasonable clinical confidence whether an Emergency Medical Condition does or does not exist. Depending on the patient’s presenting symptoms, the MSE represents a spectrum ranging from a simple process involving only a brief history and physical examination to a complex process that also involves performing ancillary studies and procedures within the capability of the Hospital. Triage does not constitute a MSE. Triage involves clinical assessment of the patient’s presenting signs and symptoms at the time of arrival at the Hospital in order to prioritize when the patient will be seen by a physician of QMP. Qualified Medical Personnel (QMP): Means those individuals, in addition to physicians, who are authorized by the Hospital in accordance with its medical staff bylaws and/or governing body-approved Hospital policies to a MSE within their scope of practice and/or certify false labor. ...” 1. On August 12, 2025, during a tour of the Emergency Department, fetal monitoring equipment was identified within the equipment storage room. At that time, EMP2 confirmed that the facility staff was unable to interpret fetal monitoring. 2. On August 12, 2025, review of MR1, MR3, MR5, MR8, MR9, MR11-MR18, and MR20-MR22 were identified to be patients who presented for obstetrical purposes. Further review of medical records did not reveal documentation of fetal monitoring being performed. 3. On August 13, 2025, EMP3 confirmed that the facility had fetal monitoring capabilities. 4. On August 15, 2025, EMP1 confirmed that the facility had fetal monitoring capabilities. Further confirmed that facility staff are not educated on fetal interpretation to fetal monitoring. 5. On August 15, 2025, during an employee interview, EMP5 was unaware that the facility had fetal monitoring capabilities. Further confirmed that the facility does not have anyone that is qualified to interpret fetal monitoring. 6. Review of PF1-PF10 did not reveal education specific to fetal monitoring training.”

“GOVERNING BODY CFR(s): 482.12 There must be an effective governing body that is legally responsible for the conduct of the hospital. If a hospital does not have an organized governing body, the persons legally responsible for the conduct of the hospital must carry out the functions specified in this part that pertain to the governing body ... This Condition is not met as evidenced by: 41958 Based on review of facility documentation, medical records (MR) and employee interview (EMP), it was determined the Governing Body failed to maintain adequate supplies to provide surgical services for 29 of 29 surgical cases reviewed (MR20-MR48). Review of facility documentation revealed vendor holds resulted in the inability to obtain necessary supplies for 29 surgical cases (MR20-MR48). Cardiac cases for MR49 and MR50 were attempted but unable to be completed due to the lack of necessary supplies. Despite being aware of the lack of necessary surgical supplies, the hospital failed to implement actions to address the non-payment issues. An Immediate Jeopardy was called at 3:53 PM on March 28, 2024, when it was identified the facility did not have a process in place to ensure supplies were available for routine and emergent procedures. Immediate Jeopardy (IJ) was identified for the CoP Governing Body. The facility failed to provide an acceptable removal plan and implement immediate corrective action prior to exit on March 29, 2024. Cross Reference: 482.12(d) Institutional Plan and Budget 482.12(e)(1) Contracted Services 482.21(e)(4) Providing Adequate Resources”

“PHYSICAL ENVIRONMENT CFR(s): 482.41 The hospital must be constructed, arranged, and maintained to ensure the safety of the patient, and to provide facilities for diagnosis and treatment and for special hospital services appropriate to the needs of the community. This Condition is not met as evidenced by: 41958 Based on review of facility documentation, facility tours, and employee interview (EMP), the facility failed to ensure the physical environment of the hospital was safe for patient care. This failure resulted in an Immediate Jeopardy (IJ), posing a serious risk of harm to patients. An Immediate Jeopardy was called at 2:16 PM on March 6, 2024, when it was identified the facility was utilizing rooms with non-functioning nurse call bells within rooms 6, 7, and 15 of the Emergency Department. The Immediate Jeopardy was removed at 6:02 PM on March 6, 2024, after the facility submitted and acceptable Immediate Jeopardy removal plan. State Survey Agency verified implementation of an acceptable removal plan when confirmed the facility did a hospital-wide internal audit of all nurse call bell systems. Areas internally identified included the Emergency Department, the Behavioral Health Unit, and 5 West (Med-Surg). Further review of the plan revealed the facility had placed the identified rooms without functioning call bell systems on the Med-Surg and Behavioral Health Unit out of service until the call bells could be fixed. Emergency Department rooms that were identified to have non-functioning call bells were to have staff immediately outside of the rooms for visualization when in use. A tour of the facility revealed the affected Emergency Department rooms utilized at the time of the tour to have staff outside of the room, and rooms on the Med-Surg and the Behavioral Health Unit to be out of service. Confirmation of payment to vendor to obtain necessary supplies was received March 7, 2024. Further ED call bells were functioning effective March 7, 2024. Additionally, the facility failed to maintain a safe environment by maintaining compliance with the 2012 Edition of the National Edition of the National Fire Protection Association (NFPA) 101, Life Safety Code (LSC). Please refer to the FORM CMS-1567 Life Safety Report ZL0421, completed on March 14, 2024. Cross Reference: 482.41(d)(2) Facilities, Supplies, Equipment, Maintenance”

“INFECTION PREVENTION CONTROL ABX STEWARDSHIP CFR(s): 482.42 The hospital must have active hospital-wide programs for the surveillance, prevention, and control of HAIs and other infectious diseases, and for the optimization of antibiotic use through stewardship. The programs must demonstrate adherence to nationally recognized infection prevention and control guidelines, as well as to best practices for improving antibiotic use where applicable, and for reducing the development and transmission of HAIs and antibiotic resistant organisms. Infection prevention and control problems and antibiotic use issues identified in the programs must be addressed in collaboration with the hospital-wide quality assessment and performance improvement (QAPI) program. This Condition is not met as evidenced by: 41958 Based on review of facility documentation, a facility tour, and employee interview (EMP), it was determined that the facility failed to maintain equipment for the cleaning and sterilization of surgical and procedural materials in accordance with accepted standards with manufacturer’s recommendations and failed to maintain a sanitary environment. These failures resulted in an Immediate Jeopardy (IJ), posing a serious risk of harm to patients. An Immediate Jeopardy was called on March 7, 2024, at approximately 3:50 PM, an Immediate Jeopardy (IJ) was identified for the CoP for Infection Control. On March 12, 2024, at approximately 4:39 PM, the facility was unable to maintain surgical equipment when they were unable to provide documentation that washer # 1 washer # 2 were cleaned according to Manufacturer Guidelines. On March 13, 2024, at approximately 11:15 AM, the facility was unable to provide documentation of cleaning of the Sterilizer as required per Manufacturer Guidelines. On March 14, 2024, at approximately 2:15 PM, the facility was unable to provide documentation of required maintenance for two of two endoscopy reprocessors. On March 15, 2024, at approximately 5:24 PM Immediate Jeopardy was removed after the facility provided an acceptable IJ Removal Plan. SA verified implementation of acceptable removal plan when a tour of the Surgical Services Department revealed that the facility took action to enforce a sanitary environment within the Department. Additional actions included the immediate delegation of responsible party to ensure cleaning and maintenance of washer # 1, washer # 2, and the sterilizer. Applicable staff attested to re-education of sterilization processes and maintenance for sanitary environment. The facility temporary ceased Endoscopy Services until maintenance of endoscopy reprocessors was able to be completed, which was completed for one of two endoscopy reprocessors on March 18, 2024. Cross Reference: 482(a)(3) Infection Control Surveillance, Prevention (A 750)”

“INSTITUTIONAL PLAN AND BUDGET CFR(s): 482.12(d) The institution must have an overall institutional plan that meets the following conditions: (1) The plan must include an annual operating budget that is prepared according to generally accepted accounting principles. (2) The budget must include all anticipated income and expenses. This provision does not require that the budget identify item by item the components of each anticipated income or expense. (3) The plan must provide for capital expenditures for at least a 3-year period, including the year in which the operating budget specified in paragraph (d)(2) of this section is applicable. (4) The plan must include and identify in detail the objective of, and the anticipated sources of financing for, each anticipated capital expenditure in excess of $600,000 (or a lesser amount that is established, in accordance with section 1122(g)(1) of the Act, by the State in which the hospital is located) that relates to any of the following: (i) Acquisition of land; (ii) Improvement of land, buildings, and equipment; or (iii) The replacement, modernization, and expansion of buildings and equipment. This Standard is not met as evidenced by: 41958 Based on review of facility documentation and employee interview (EMP) it was determined the facility failed to have an operating budget to maintain an adequate stock of supplies and equipment and failed to take action to address the non-payment issues. Findings include: On March 22, 2024, at approximately 2:39 PM, review of Chief Financial Officer (CFO) job description, revealed “... Job Summary: Under the direction of the President, the CFO is responsible for the Hospital’s accounting practices, the maintenance of its fiscal records, and the preparation and interpretation of the financial reports for senior management. The CFO plans, organizes, directs, controls and supports the Financial Planning process. Serves as a key member of the Sharon Regional Medical Center (SRMC) Senior Leadership team that sets the hospital’s strategic direction as well as financial and organization goals. ... Key Competencies: Annual Budgeting ... develops and oversees the budgeting and financial process. ... Project hospital-wide departmental volume for budget year for review and update with senior leadership. Develop and instruct department heads concerning budget polices, procedures, forms and timetable. Coordinate and run annual budget meetings with department managers. Prepare annual budget report including comprehensive pro forma financial statements. ... Cost Accounting Provides financial analysis to evaluate special projects, capital expenditures and product costing when necessary. ... “ Review on March 22, 2024, of the facility organization chart revealed the CEO/President is the top position at the organization. 1. On March 22, 2024, at approximately 9:30 AM, the facility was requested to provide the annual operating budget. The facility was unable to provide an annual operating budget that included all anticipated income expense, capital expenditures, anticipated sources of financing for each anticipated capital expenditure in excess of $600,000. 2. On March 22, 2024, at approximately 11:18 AM, EMP1 and EMP2 confirmed the facility did not have a Chief Financial Officer at the hospital since November 2023. EMP2 confirmed the governing body at the hospital is non-fiduciary and has no financial authority. The CEO sends requests for funding to the Corporate level and is dependent on Corporate to release funds for the facility”

“CONTRACTED SERVICES CFR(s): 482.12(e)(1) The governing body must ensure that the services performed under a contract are provided in a safe and effective manner. This Standard is not met as evidenced by: 41958 Based on review of facility documentation and employee interview (EMP), it was determined the facility failed to ensure contracted services were provided in an effective manner (OTH11). Findings include: On March 22, 2024, at approximately 2:26 PM, review of the facility contracts provided revealed that OTH11 provided Environmental Services for the hospital. A request was made on March 2, 2024, for proof of payment to the Environmental Services contractor. This information was not provided. On March 22, 2024, at approximately 2:27 PM, review of Quality Improvement data of contract services revealed OTH11 met only 73% of facility cleanliness standards for the first, second, and third quarters for the 2023 calendar. No data was provided for the fourth quarter of 2023. EMP2 confirmed the above findings at the time of review.”

“QUALITY IMPROVEMENT ACTIVITIES CFR(s): 482.21(b)(2)(ii), (c)(1), (c)(3) (b) Program Data (2) [The hospital must use the data collected to - .....] (ii) Identify opportunities for improvement and changes that will lead to improvement. (c) Program Activities (1) The hospital must set priorities for its performance improvement activities that-- (i) Focus on high-risk, high-volume, or problem-prone areas; (ii) Consider the incidence, prevalence, and severity of problems in those areas; and (iii) Affect health outcomes, patient safety, and quality of care. (3) The hospital must take actions aimed at performance improvement and, after implementing those actions, the hospital must measure its success, and track performance to ensure that improvements are sustained. This Standard is not met as evidenced by: 39272 Based on review of facility documentation and employee interview (EMP), it was determined the facility failed to monitor identified cancelled surgical cases due to vendor holds that resulted in the inability to have necessary supplies within the Quality Improvement Plan. Findings Include: On March 11, 2024, review of facility policy, LD 07, last revised January 13, 2023, revealed “... Quality and Patient Safety Plan ... 2023-2024 updated December 2022 ... II. [OTH12] ... Accountability: ... Accepting responsibility for continuous performance improvement, embracing change and seeking new opportunities to serve. ... Stewardship: ... Managing our financial and human resources responsibly in caring for those entrusted to us while holding firm our mission and values we seek to create a community-based healthcare system that provided the highest quality care in a financially sound manner ... A. Senior managers and leaders of the organized medical staff work with the Board to define their unique and share responsibilities. The board remains responsible for setting clear expectations for safety; advocating for adequate resources for measuring, assessing, improving, and sustaining the hospital’s performance and reducing risk to patients; and enhancing the efficacy and quality of care through an appropriate number of performance improvement initiatives ... B. ... The roles of the MEC [Medical Executive Committee] include (but are not limited to): ... Receiving and acting upon departmental and committee reports concerning patient care issues and other quality management activities; ...” Review on March 21, 2024, of a surgical cancellation list from September 2023 through March 2024 (a period of six months) related to insufficient supplies revealed 29 of 29 cancelled cases reviewed (MR20-MR48) were identified to be cancelled due to inadequate supplies. Additionally, there were two of two cancelled cardiac cases one for a heart catheterization on September 28, 2023, (MR49) and one for a Percutaneous Coronary Intervention on November 24, 2023, (MR50). The cardiac cases were attempted but unable to be completed due to inadequate supplies. On March 22, 2024, EMP2 confirmed the facility had not completed any quality/monitoring of identified cancelled cases due to vendor holds that resulted in the inability to obtain supplies.”

“PROVIDING ADEQUATE RESOURCES CFR(s): 482.21(e)(4) [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:] (4) That adequate resources are allocated for measuring, assessing, improving, and sustaining the hospital’s performance and reducing risk to patients. This Standard is not met as evidenced by: 41958 Based on review of facility documents, medical records (MR) and interview of staff (EMP) it was determined the facility’s Governing Body failed to ensure the facility had adequate supplies for surgical procedures for MR20-MR48 to be completed. Findings Include: Review on March 22, 2024, of the Governing Body Bylaws, revealed “... Section 2. Duties. Except as otherwise provided in these Bylaws, the Board of Directors shall be responsible for the following: ... (d) Overseeing quality of care at the Corporation, including providing appropriate physical resources and personnel required to meet the needs of the patients and participate in planning to meet the health needs of the patients and health needs of the community ...” Review on March 21, 2024, of a surgical cancellation list for the previous six months (September 2023 through March 2024) related to insufficient supplies revealed 29 cancelled cases reviewed (MR20-MR48) were identified to be cancelled due to inadequate supplies. Interview with EMP2, on March 22, 2024, confirmed 29 surgical cases were cancelled due to the inability to obtain necessary supplies. Cross Reference: 482.12(d) Institutional Budget 482.12(e)(1) Contracted Services”

“FACILITIES, SUPPLIES, EQUIPMENT MAINTENANCE CFR(s): 482.41(c)(2) Facilities, supplies, and equipment must be maintained to ensure an acceptable level of safety and quality. This Standard is not met as evidenced by: 39272 Based on review of facility documentation, facility tours, and employee interview (EMP), the facility failed to ensure nurse call bells were functional in all Emergency Department rooms. An Immediate Jeopardy was called at 2:16 PM on March 6, 2024, when it was identified the facility was utilizing rooms with non-functioning nurse call bell systems within rooms 6, 7, and 15 of the Emergency Department. The Immediate Jeopardy was removed at 6:02 PM on March 6, 2024, after the facility submitted and implemented an acceptable Immediate Jeopardy removal plan. State Survey Agency verified implementation of an acceptable removal plan when confirmed the facility did a hospital-wide internal audit of all nurse call bell systems. On March 7, 2024, review of facility policy, Environment of Care, EOC 09, dated August 9, 2023 revealed “... Procedure A. The Facilities/Plant Operations Department provides a system in which an emergency or urgent situation, can be addressed in a prompt and efficient manner. The goal is to maintain a safe environment for patients, visitor, and employees. ... B. Utilities equipment is categorized into groups of high-risk utility components that supports: (1) Life Support, (2) Infection Control, (3) Non-Life Support but essential for patient care and (4) All other utilities equipment. 1. Any work order received that affects Life Support or Infection Control will take priority over all other work. This work must be undertaken and corrected at a planned completion rate of 100% with no exceptions. This work will be overseen by the Facilities/Plant Operations Director/designee, who will determine when the work is accomplished to the customers’ needs. 2. Work that is Non-Life Support but essential for patient care will take the next priority. 3. All other work will be prioritized based on first in first out, staff availability, part availability, or cost. ...” On March 6, 2024, review of open work order log revealed call bell systems within the Emergency Department was on the log for maintenance, effective February 4, 2024. On March 6, 2024, tour of the ED confirmed Exam Rooms 6, 7, and 15 did not have functioning nurse call bells. On March 6, 2024, review of a facility audit identified non-functioning nurse call bells in the Behavioral Health Unit and on the 5 West Medical Surgical Unit. On March 6, 2024, employee interview with EMP8 revealed that parts for call bells within the Emergency Department were on order for approximately three months. Further confirmed that the rooms within the Emergency Department had non-functioning call bells. On March 6, 2024, employee interviews with EMP9 and EMP10 confirmed call bells within Exam Rooms 6 and 7 of the Emergency Department were not consistently functioning. Cross reference: 482.41 Condition of Participation: Physical Environment 41958”

“INFECTION CONTROL SURVEILLANCE, PREVENTION CFR(s): The infection prevention and control program includes surveillance, prevention, and control of HAIs, including maintaining a clean and sanitary environment to avoid sources and transmission of infection, and addresses any infection control issues identified by public health authorities; and This Standard is not met as evidenced by: 39272 Based on review of facility documentation, a facility tour, and employee interview (EMP), it was determined that the facility failed to maintain equipment for the cleaning and sterilization of surgical and procedural materials in accordance with accepted standards of practice and manufacturer’s recommendations and failed to maintain a sanitary environment. Findings include: On March 25, 2024, review of the facility’s “2023 Infection Prevention and Control Annual Assessment and Plan,” revised 1/13/2023, revealed “ ... Strategies Environmental: Rounds ... Description The Infection Preventionist participates in environmental rounds with facility team members to assess patient safety and environmental safety, and quality. Plan ... Participate in environmental rounds with facility team members. Provide education on a case-by-case basis to staff, patients and visitors as identified. ... Sterilizer testing is done in accordance with AORN, AAMI and CDC recommendations. ... Sterilizer report fall-outs or issues will be submitted to the Infection Prevention Control Committee by the Director of Surgery. ... Accurate logs will be completed and reviewed by the Infection Prevention and Control. ...” On March 8, 2024, review of the Operator Manual for Washer # 2, dated 3/31/2008, revealed “ ...Alteration of equipment which could adversely affect its operation ... Routine Maintenance ... Daily Cleaning ... After last cycle of day, allow unit to cool. Then, remove and clean debris screens in bottom of wash chamber and suction filter at the bottom sump. Always clean screens while they are still wet, before foreign matters dries ... 2. Remove rise valve and inspect for debris. Brush and rinse under tap water if necessary. Monthly Cleaning ... On a weekly basis, perform the following routine procedures; 1. Clean washer exterior as follows: ... a. Using a damp cloth or sponge, apply cleaner in a back-and forth motion, rubbing in same direction as surface grain b. Thoroughly wipe off cleaner. C. Polish surface with a clean, dry, lint-free cloth. 2. Wash chamber interior with a moderately alkaline detergent solution. Rinse with tap water and dry with a lint-free cloth ... Monthly Cleaning ... Remove hard water deposits from chamber and loading accessories as follows, using DESCALER cycle especially designed for this purpose. ... “ On March 11, 2024, review of the facility policy IC 50, “ Sterilization Processes, “ last reviewed June 23, 2022, revealed, “ ... 6. All sterilizers are used according to manufacturer’s written instructions. ... 12. Responsibilities with regards to sterilization processes: a. SPD manager is responsible for direct oversight of sterilization processes throughout the hospital. ... b. Infection Control has the overall responsibility to ensure that there is an effective program for cleaning, disinfection, and sterilization of reusable medical and surgical supplies. ... “ On March 11, 2024, review of the Operators Manual for the Sterilizer, dated 4/6/2016, revealed “ ... In addition to the weekly flushing ...steam generator requires quarterly cleaning and yearly descaling (minimum recommended frequency). Have a qualified service person perform these procedures. ... “ On March 14, 2024, review of the Operators Manual for Washer #1, dated 3/31/2008, revealed “ ... Routine Maintenance 6.2 Daily Cleaning ... Weekly Cleaning ... “ On March 14, 2024, review of Operators Manual for the endoscope reprocessor, dated 1/11/2012, revealed “ ... After use, reprocess and store this equipment referring to the instructions ...End-of-day-checks in this manual. Inappropriate care and storage could present an infection control risk and/or cause equipment damage and malfunction. ... If any irregularity is observed, do not use the equipment ... If the lamp of the PERIODICAL MAINTENANCE indicator described in Section 2.5, Control Panels on page 24 blinks, contact [Manufacturer]. ... “ A policy for maintaining a clean and sanitary environment was requested on March 6, 2024. This policy was not provided prior to exit of survey. 1. On March 7, 2024, a tour of the sterile processing clean room revealed a visible accumulation of green and brown debris on the inside of window of washer # 2, an accumulation of matter on the outside of washer # 2, visible accumulation of thick dust above washer # 2. EMP3 confirmed the above finding at the time of the tour. On March 13, 2024, the facility was unable to provide documentation that daily maintenance and cleaning had been performed on washer # 1. EMP2 further confirmed documentation was not available on March 13, 2024. On March 13, 2024, surgical staff at the facility were unable to identify the processes for daily cleaning and maintenance for washer # 1, and washer # 2, according to manufacturer’s guidelines. 2. On March 14, 2024, a tour of the endoscopy suite revealed the lamp of the periodical maintenance indicators had been blinking on two of two endoscopic reprocessors. Further observation revealed the endoscopic reprocessors were in use at the time of tour. Staff were unable to provide documentation of manufacturer service as required per manufacturer guidelines. EMP7 confirmed finding occurred due to vendor holds. 3. On March 6, 2024, Intensive Care Unit (ICU) tour revealed room 450 to be observed to have an overflowing waste receptacle and a cracked outlet cover near the head of the bed. EMP3 confirmed the room was cleaned prior to the observation. Additional observations of the ICU revealed chipped paint throughout the walls and door frames throughout the unit and discoloration of ceiling tiles. EMP3 confirmed findings at the time of the tour. EMP3 further confirmed that discoloration of ceiling times was from prior ceiling leak. Timeframe of leak was unable to be identified. Above findings in the ICU were not included on the open work order list provided prior to tour of the ICU. 4. On March 6, 2024, a tour of the Medical Imaging Department revealed the following findings: Ultrasound room 2 observed to have chipped paint on the walls, countertops, and cabinetry, exposing surface integrity. Attached room was observed to have a cracked pipe under the sink. MRI hallway observed to have substantial discoloration of ceiling tiles. Ceiling tile discoloration in the Medical Imaging Department was identified to be included on the open work list provided, effective December 20, 2023. Remaining findings above were not included on the list provided prior to tour of the Department. Dressing rooms observed to have visible accumulated debris on walls. X-Ray Room 2 and 4 observed to have chipped cabinetry, exposing the surface integrity. CT Room observed to have chipped paint, exposing surface integrity, and discoloration of wall. EMP11 confirmed wall discoloration was from prior leak from the Maintenance Department that was located directly above the area. Unable to identify timeframe. Changing area restroom observed to have discolored ceiling tiles and holes within the tiles. EMP3 confirmed above findings at the time of the tour. On March 13, 2024, EMP12 confirmed the facility had difficulties obtaining necessary cleaning supplies for the Medical Imaging Department due to vendor holds. Above findings in the Medical Imaging Department were not included on the open work order list provided prior to tour of the Department. 5. On March 6, 2024, a tour of the Emergency Department revealed the following findings: Decontamination area attached to Emergency Department room 1 revealed chipped shower tiles, and cracked ceiling tiles. Emergency Department room 6 revealed multiple chipped areas exposing wood on the surface of the overbed wall-unit, dark grey speckling of a mold-like substance on the ceiling tile above the wall mounted cabinetry, and a food-substance on the window of the sliding door. EMP3 confirmed room 6 was cleaned prior to observation. Emergency Department rooms 7, 16, and 18, revealed scuffed paint, and chipped areas on the surface of the head wall unit. Above findings in the ED were not included on the open work order list provided prior to tour of the Department. 6. On March 6, 2024, a tour of the Dietary Department revealed multiple areas non-intact flooring. There was exposed and burrowing cement. The floor surfaces were uneven with large areas of indentations, exposing the cement beneath. Additionally, an accumulation of debris was observed behind the ice machine, and an air handler unit pipe was duct taped together. EMP13 confirmed duct taped pipe was due to prior leak. Unable to identify timeframe of the leak. EMP3 confirmed above findings at the time of the tour. Above findings in Dietary were not included on the open work order list provided prior to tour of the Dietary. 7. On March 7, 2024, a tour of the Surgical Services Department revealed the following: The sterile processing dirty room revealed the surface of the sink and surrounding cabinetry to contain a large amount of rust. A sub-sterile area located at the end of the hallway had an actively leaking sink, with a green film inside the bowl of that sink that extended up the faucet. Visible water damage and mold-like substance identified under the sink cabinetry. Main operating room corridor was identified to have discoloration of approximately twelve ceiling tiles. EMP3 confirmed discoloration was due to prior roof leak that occurred approximately one week prior to the observation. Further confirmed that the roof leaks when it rains. Operating Rooms 5 and 6 were identified as being cleaned. Both rooms were observed to have debris and a build-up of unknown substance on the floor. EMP3 confirmed above findings at time of the tour. Above findings in the Surgical Services Department were not included on the open work order list provided prior to tour of the Department. 8. On March 7, 2024, tour of the Physical Therapy Department revealed approximately six overhead lights to be non-functional. Further observation revealed discolored ceiling tiles above the linen carts and active medical gas outlet, a cut ceiling tile surrounding a sprinkler, observation of a tube to be protruding from the ceiling tiles leading into a waste receptacle. The surrounding approximate three feet of ceiling tiles and floor space was discolored. Ceiling discoloration extended into the adjacent storage room, which contained an electrical panel. EMP3 confirmed above findings at time of the tour. Above findings were not included on the open work order list provided prior to tour of the Department. 9. On March 7, 2024, tour of the Laboratory revealed the following findings. Observation of exposed wiring in the ceiling, discolored ceiling tiles, and approximately nine missing light bulbs. EMP14 confirmed light bulbs were removed from the light fixtures approximately one year ago. Observation of the central processing room of the lab revealed two over head lights to be nonfunctioning and approximately three discolored ceiling tiles, counter tops to be cracked, exposing surface integrity, a cracked receptacle outlet, an approximate three-foot high shelf that was previously dislodged from the wall exposing a hole in the wall. The identified shelf was propped up with use of a biohazard waste receptacle. Observation of the chemistry area and microbiology area revealed approximately sixteen non-functioning lights, an uncapped exposed pipe on the lab wall, a non-functioning pneumatic tube system, and various cracked and peeling floor tiles. EMP14 confirmed the pneumatic tube system had not been working for approximately one week prior. Further confirmed delay in fixing was related to vendor holds. Observation of the specimen collection area revealed a ceiling tile with a hose protruding into a waste receptacle adjacent to an electrical panel box, and specimen collection refrigerator. Bottom shelf of the specimen refrigerator was observed to contain debris and a build-up of brown matter. 10. On March 7, 2024, a tour of Cath Lab 2 revealed approximately four batteries sitting on top an electrical box, exposed wiring from a missing wall mounted digital clock, a thermostat loosely secured to the wall, and an accumulation dust within the recessed lighting. Additional observation revealed uneven floor surfaces directly outside the room. 11. On March 7, 2024, a tour of 4 West and 6 West (Med-Surg) revealed observation of wide-spread nonfunctioning overhead lighting throughout. 12. On March 11, 2024, review of an internal environment checklist, completed by EMP6 on January 23, 2024, revealed identified concerns within the Emergency Department. No actions taken upon internally identifying concerns. Further confirmed no actions were taken as a result of internally identified concerns during employee interview with EMP6 on March 22, 2024. 13. On March 11, 2024, review of internal environment checklists, completed by EMP6 on February 27, 2024, revealed infection control concerns identified within the Surgical Services Department. No actions taken upon internally identifying concerns. Further confirmed no actions were taken because of internally identified concerns during employee interview with EMP6 on March 22, 2024. On March 22, 2024, EMP6 confirmed all elements of the facility’s Infection Control Plan were not enforced.”