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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

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

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.

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.

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

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

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







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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)

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.