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Based on the review of the hospital's bylaws, hospital governing body documentation, hospital organization charts, and hospital operating budgets, the facility failed to organize the hospital's institutional structure as one distinct entity under the Medicare provider number 362029 as evidenced by the Governing Body's failure to appoint a Chief Executive Officer who is responsible for managing the hospital (A057) and the facility failed to have one overall operating budget (A073). The cumulative effect of these systemic practices resulted in the facility's inability to demonstrate that one distinct hospital was in operation under the Medicare Provider Number. This has the potential to affect all patients receiving services at the facility. The total census at the time of survey was 47.

Based on review of the facility's quality assurance and performance improvement (QAPI) documentation, organizational charts and staff interview the facility failed to develop, implement and maintain an effective, on-going, hospital-wide, data-driven quality assessment and performance improvement plan (A-0263) and failed to ensure the governing body developed a single hospital wide comprehensive QAPI program that reflected the complexity of the hospital organization and services including all hospital departments and services (including those services furnished under contract or arrangement. (A-0308) The cumulative effect of this systemic practice resulted in the facility's inability to demonstrate that one distinct Quality Assurance and Performance Improvement Program was developed and contained the cumulative data from all hospital locations. This finding had the potential to affect all 47 patients at the facility.

Based on policy and manufacturer documentation review, observations and staff interviews, the facility failed to ensure staff changed gloves after contamination during terminal cleaning of a patient room, failed to maintain a sanitary environment in the dietary department and failed to sanitize food surfaces with effective sanitizing solution, failed to ensure proper gloving and hygiene was performed while providing care for patients, failed to follow proper care of supplies and failed to follow proper care of a patient's indwelling catheter.(A749) The cumulative effect of these systemic practices resulted in the facility's inability to provide infection control measures. This had the potential to affect all 47 patients at the facility.

Based on review of hospital organizational charts, staff interview, hospital Bylaws, and hospital governing body documentation the hospital failed to have only one chief executive officer (CEO). This finding has the potential to affect the entire census of 47.

Findings include:

Review of the Bylaws for Regency Hospital of North Central Ohio, LLC Governing Board Bylaws, revised, mended and approved on 03/02/16 directed under the Definitions that:

"Hospital means Regency Hospital of North Central Ohio, LLC, with a primary location at 4200 Interchange Corporate Center, Warrensville Heights, Ohio, and a satellite location at 6990 Engle Road, Middleburg Heights, Cuyahoga County, Ohio."

"Chief Executive Officer, means an individual appointed by the Board of Directors and confirmed by the Governing Body of the Hospital to act on behalf of the Governing Body in the overall management of the Hospital and its satellite location (s). Whenever CEO is used in these Bylaws, it shall mean the Chief Executive Officer of the Hospital."

Upon entrance to the hospital on 01/23/17 located at 4200 Interchange Center Rd in Warrensville Heights, Ohio a request was made to identify the hospital CEO as well as all locations under the one assigned (CMS) Provider Number, 362029, along with the hospital's organizational chart.

Interview with Staff Z on 01/23/17 at 9:03 AM revealed Staff Z identified self as the CEO of the hospital. Staff Z confirmed the hospital had two locations under the one provider number, the location at Interchange Center Drive in Warrensville Heights, Ohio as well as one offsite location on 6990 Engle Road in Middleburg Heights, Ohio.

Review of the organizational chart presented on 01/23/17 was labeled as Regency Hospital Cleveland East, LLC. This organizational chart identified Staff Z as the CEO and directly responsible to the president of Division V (Hospital S). The organizational chart failed to include any staff member departmental listings from the hospital's offsite location in Middleburg Heights, Ohio.

A request was made to Staff Z to ensure information from both locations was included on any documentation provided. Staff Z provided a second organizational chart that read Hospital W and identified Staff Y as the CEO and only listed the departments located at the Middleburg Heights, Ohio location and that the CEO was directly responsible to the president of Division V (Hospital S). A request was made for any other organizational charts at which time it was stated there were no other organizational charts except these two which revealed the hospital had two CEO's.

A request was made to Staff Z for documentation that the hospital's governing body had appointed Staff Z as the CEO.

On 01/25/17 Staff Z presented a copy of the hospital's governing body documentation titled Hospital N "Action of the Sole Director by Consent in Writing that read effective October 1, 2016 the hospital's governing body had appointed Staff Z as a member of the hospital's governing body."

A second request was made for documentation that the governing body had appointed Staff Z as the hospital's CEO. Staff Z presented a second document on 01/27/17 that revealed the governing body had appointed Staff Z as the hospital CEO that was dated as effective October 1, 2016. The document was signed on 01/24/17 after the request for documentation by the governing body of appointment as hospital CEO.

A visit was made to the hospital off site location in Middleburg Heights, Ohio the morning of 01/24/17.

Interview on 01/24/17 at 7:45 AM with Staff W revealed the CEO of the hospital was Staff Y. Staff W identified herself as the Chief Nursing Officer (CNO). Staff W described the relationship between the hospital in Warrensville Heights, Ohio and this location as two different hospitals. Staff W stated she was the CNO at Hospital W and answered only to the CEO, Staff Y.

Interview with Staff Y on 01/24/17 at 9:20 AM confirmed he was the CEO of Hospital W and staff at the 6990 Engle Road, Middleburg Heights, Ohio location answered only to him.

Based on review of hospital Bylaws, staff interview and review of the hospital operating budgets the hospital failed to have one overall operating budget. This finding has the potential to affect the entire census of 47.

Findings include:

Review of the hospital's Bylaws stated under the heading of Responsibilities of the Governing Body "shall establish an annual operating budget that is prepared according to generally accepted accounting principles to include all anticipated income and expenses and to provide for a three (3) year plan for capital expenditures with appropriate input from and consideration by the hospital's medical staff and administration."

On 01/24/17 a request was made to Staff Z, the chief executive officer (CEO) at the hospital's main location at 4200 Interchange Center Rd in Warrensville Heights, Ohio for the facility's three year overall budget.

On 01/25/17 Staff Z presented two separate operating budgets, a comprehensive overall budget for the location at Warrensville Heights and a second comprehensive overall budget for the offsite location in Middleburg Heights, Ohio.

Interview with Staff Z on 01/25/17 at 9:41 AM confirmed the locations at Warrensville Heights and Middleburg Heights were under the same (CMS) Provider Number.

Staff Z confirmed the hospital failed to have one overall operating budget.

Based on medical record review, policy review and interview, the facility failed to renew the physician's orders for use of a restraint. This affected two (Patient #2 and #25) of three restraint medical records reviewed of a total of 30 records reviewed. This has the potential to affect all 47 patients receiving services at the facility.

Findings include:

Review of the facility's policy on Restraints and Seclusion (Number R02-N), revised on 06/12, revealed a comprehensive assessment must be performed by a physician, licensed independent practitioner or registered nurse (RN). Step 1 of the procedure also revealed a written order is entered in the patient's record on a daily basis.

1. Review of the medical record for Patient #2 revealed the patient was admitted on 12/27/16 with the diagnoses of respiratory failure and pneumonitis. Review of Patient #2's medical record revealed a Restraint Order/Assessment Sheet, dated 01/18/17 at 5:00 PM. This order was signed by the physician but had no assessment by the RN, no less restrictive measures attempted and no type of restraint identified. Review of the Nurse Progress and Narrative Notes for Patient #2 revealed on 01/18/17 at 10:30 AM the patient remained in a right wrist restraint. Review of the restraint orders for Patient #2 revealed there was an order on 01/19/17 at 7:00 AM for a wrist restraint for the right upper extremity, due to the patient trying to remove his/her tracheostomy tube. Review of the Nurse Progress and Narrative Notes for Patient #2 revealed circulation checks (for the use of restraints) were done on 01/20/17, however, there were no physician's orders or nurses notes for the use of restraints.

2. Review of the medical record for Patient #25 revealed the patient was admitted on 12/23/16 with diagnoses of heart failure, shock and kidney disease and discharged on 12/31/16. Review of Patient #25's medical record revealed a Restraint Order/Assessment Sheet, dated 12/28/16 at 6:00 AM, for left and right upper extremity wrist restraints, due to patient attempting to remove oxygen tubing and corpak (feeding tube). Review of the Restraint Order/Assessment Sheet on 12/29/16 revealed the order was signed by the physician on 12/29/16 at 11:00 AM, but there was no type of restraint identified. The Restraint Order/Assessment Sheet for 12/30/16 and 12/31/16 was signed by the physician but lacked the date and time of signature.

On 01/26/17 at 3:00 PM, Staff B confirmed the above findings.

Based on medical record review, policy review and interview, the facility failed to monitor patients restrained according to the facility's policy. This affected two (Patient #2 and #25) of three patients with restraints.This has the potential to affect all 47 patients receiving services at the facility.


Findings include:

Review of the facility's policy on Restraints and Seclusion (Number R02-N), revised on 06/12, revealed the patient was to be observed every two hours for interventions including safety, comfort, toileting and skin integrity.

1. Review of the medical record for Patient #2 revealed observation and interventions of Patient #2 for use of a wrist restraint was not done every two hours. Review of the Nurse Narrative and Progress Notes revealed the restraint observations and interventions were not done on 01/18/17 between 5:00 PM and 10:00 PM; on 01/19/17 between 5:54 AM and 10:00 PM on 01/20/17 from 12:00 AM to 6:00 AM and between 6:00 PM and 10:00 PM; on 01/21/17 from 12:00 AM to 10:00 PM and on 01/22/17 from 12:00 AM to 6:00 AM and at 4:00 PM.


2. Review of the medical record for Patient #25 revealed observation and interventions of Patient #25 for use of left and right wrist restraints revealed every two hour observations and interventions were not done between 12/27/16 at 6:00 PM and 12/28/16 at 4:03 AM; every two hour observations and interventions were not done between 12/28/16 at 4:03 AM and 12/28/16 at 8:40 PM; every two hour observations and interventions were not done between 12/28/16 at 10:00 PM and 12/29/16 at 2:00 AM; and every two hour observations and interventions were not done between 12/29/16 at 6:30 AM and 12/29/16 at 12:00 PM.

On 01/26/17 at 3:00 PM, Staff B confirmed the above findings.

Based on review of the hospital's governing body bylaws, hospital organizational improvement (OIC) committee reports and staff interview the governing body failed to ensure the development of a single hospital wide comprehensive QAPI program. This finding had the potential to affect the entire census of 47 patients.


Findings include:


Review of the hospital bylaws directed under the section titled governing body responsibilities, "to ensure that there was an effective, hospital wide quality assurance and performance improvement program to evaluate the provision of care and making decisions regarding quality of service to be made available at the hospital, which included establishing a mechanism for review of the quality of services provided by individuals who were not subject to the medical staff delineation process."

Review of the hospital's Organizational Improvement Committee (OIC) meeting minutes and QAPI program data revealed each of the hospital locations had a set of binders, one for Regency Hospital Cleveland East location and a set of binders of the Hospital W location. The QAPI documentation was distinct to each individual location and rates and percentages of the collected quality data was calculated separately for each of the hospital's two locations. There were no combined calculations or combined data for a comprehensive evaluation of the entire hospital's quality assurance and performance improvement data.

Interview with Quality Staff A, on 01/30/17 at 1:53 PM revealed each hospital had different quality indicators and quality project and calculations. There was no combining of collected data which represented the hospital in its entirety. Staff A further explained that each location presented their individual QAPI data to the hospital's governing body as a stand alone report during a conference call to the governing body. Regency Hospital of Cleveland East presented their sole QAPI data and calculations and then Hospital W presented their sole data. There was no hospital wide (encompassing both locations) QAPI data. Staff A verbalized that there were two separate quality managers that were equal, one for the east location and one for the west off-site location.

Interview with Quality Staff T on 01/30/17 at 2:34 PM revealed the same process of the off site location to collect QAPI data separately. Staff T further verbalized there was no combined data for the hospital as a collective whole, "that is the way Hospital S wants it, all locations wide collect only their locations' data.

This finding was confirmed with Staff T on 01/30/17 at 2:34 PM.

Based on review of organizational chart and contracts and staff interviews, the facility failed to appoint a radiologist to supervise ionizing radiology services. This had the potential to effect all 47 patients in the facility.


Findings include:


Interview with radiology technician, Staff D, at Regency Hospital East location on 1/27/17 at 8:30 AM revealed the x-rays and computed tomography (CT) images were sent to a contracted teleradiology company for interpretation. Staff D revealed this company was located in Minnesota. Staff D revealed, Staff J was the Radiologist he/she would contact regarding any questions about radiology interpretation.

Interview on 01/27/17 at 2:24 PM with Staff I, credentialing manager, confirmed there was nothing in privileging documentation that revealed Staff J was the medical director for Radiology. The reappointment for Staff J was for teleradiologist to have Consulting privileges for Diagnostic Radiology from 08/12/15 through 08/11/17.

Review of the contract on 01/27/17 for the Radiology services revealed the contracted radiology company was to perform teleradiology services for interpretation. There was nothing in the contract that Staff J was to perform services of the medical director of Radiology.

Review of the facility's organizational chart on 01/23/17 revealed the radiology technician was to report to the interim chief nursing officer. There was no Radiology Director on the organizational chart. Review of the facility's Clinical Directors revealed a Radiologist was not listed as a Physician Director.

Interview with Staff D on 01/30/17 at 9:30 AM revealed Staff J had not been on site for oversight of the Radiology department and Staff D had no communication with Staff J about safety and infection control in the Radiology department.

Based on review of facility policies, observations, review of patient tray temperature logs and staff interviews the facility failed to ensure the dietary food manager followed facility policies and procedures for safety practices for food handling. This had the potential to affect all 47 patients at the facility.


Findings included:


Review of the facility policy titled Food Safety FNFP04 was completed on 01/27/17. The policy stated "the Food Service Director/ Manager is responsible for the frequent observation of food handling techniques that are compliance to standards."

Review of the facility policy titled Patient Tray Service- Assembly/ Delivery/ Retrieval FN-FD03 was completed on 01/27/17. The policy stated "cold food should be the last items placed on the meal tray".

1. On 01/23/17 at 11:45 AM , upon entering the kitchen area it was observed a rack of patient lunch trays containing cold items already on them.

Staff L, the cook, was observed performing temperature checks on the hot food items. At 12:05 PM, Staff L began testing items pulled from the refrigerator and not the cold items already on the patient trays. Staff F, the food service manager, was made aware the cold items had been on the patients' trays for at least 20 minutes prior to the dishing of the hot foods.

2. Review of Patient Tray Temperature Logs was completed. The Tray Logs contain space for documentation of hot and cold items for breakfast, lunch and dinner. The logs revealed temperatures were not documented on 01/23/17 Lunch (cold), 01/26/17 dinner, 01/27/17 breakfast & lunch, and from 05/01/16 through 05/30/16 each day had several or all temperatures missing.

On 01/26/17 2:00 PM these findings were confirmed by Staff F.

Based on policy and manufacturer documentation review, observations and staff interviews, the facility failed to change gloves after contamination during terminal cleaning of a patient room, failed to maintain a sanitary environment in the dietary department by dietary staff not wearing proper attire and by failing to sanitize food surfaces with effective sanitizing solution, failed to ensure proper gloving and hygiene was performed while providing care for two patients(Patient #20 and #13), failed to follow proper care of supplies (Patient #1) and failed to follow proper care of indwelling catheter. (Patient #2) A total of 14 patients were observed for infection control. This finding had the potential to affect all 47 patients.

Findings included:

Review of the Facility Policy titled Cleaning Patient Rooms after Discharge, IC VIII-2 was completed on 01/27/17. The policy stated " Proceed with bathroom cleaning: 1. Pour a small amount of disinfectant restroom cleaner onto the toilet bowl swab. Scrub inside of the toilet bowl and let stand while you clean rest of the bathroom using the disinfectant restroom cleaner " .

1. On 01/23/2017 at 3:00 PM Housekeeping staff was observed terminally cleaning patient room #123 in the South Corridor. While cleaning the bathroom, staff hand cleaned the inside and outside of the commode without the use of a toilet bowl swab. Staff discarded the cloth afterwards, however, without changing gloves, proceeded to clean the sink and rest of the bathroom while wearing the contaminated gloves. At this time Staff A, Director of Quality Management, confirmed these findings.

Review of the Facility Policy titled Personal Hygiene- Food Service Personnel, FN-S07 was completed on 01/27/17. The policy stated "wear and maintain clean outer clothing to prevent contamination of food, equipment, utensils, linens and single service and single use articles. Remove apron prior to entering the restroom and going on break. Change apron when moving from dirty to clean duties. Wear hair restraints such as hats, hair coverings or nets, beard restraints, and clothing that cover all hair, including body hair."

2. On 01/23/2017 at 11:00 AM Staff F, the food service manager, and staff preparing peach pies failed to completely cover their hair with nets. Staff F had hair hanging below his/her net. Staff F confirmed these findings at this time.

3. On 01/25/2017 at 11:20 AM Staff F was observed to not have his/her hair completely covered. Two staff in the food preparation area were not wearing aprons or chef coats. Per interview with Staff F at this time, dietary staff wear scrubs in from home and the use of aprons is optional.

Review of the Policy titled Cleaning & Sanitizing Food Surface Equipment/ WorkAreas , FN-S02 was completed on 01/27/17. The policy stated " cleaning products are to be stable, non-corrosive and approved for food service operation. Follow manufacturer's instructions carefully .....Follow general cleaning steps or manufacturer's cleaning and sanitizing instructions" .

Review of the manufacturer documentation titled Ecolab Broad Range Sanitizer Frequently Asked Questions (FAQ), provided by Staff F was completed. The FAQ stated "to ensure you have enough active ingredients in the sanitizer to meet Food Code, you should use test strips to measure the parts per million (ppm) of the sanitizer in the buckets. You should change the solution in your buckets when the ppm of the active sanitizer fall to 150 ppm or below ".
On 01/23/17 at 11:00 AM Staff F was observed checking the sanitation buckets at two different prep stations with the sanitation concentration indicator strips. The strips registered zero both times. There was no evidence the solution was changed as required per policy. Staff F confirmed these findings at this time.



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Review of the Facility Policy titled Hand Hygiene IC III-2 was completed on 01/27/17. The policy stated when to perform hand hygiene "before donning either sterile or non-sterile gloves, between glove changes and after removing gloves. "

On 01/25/17 at 2:45 PM Staff E was observed performing tracheostomy care on Patient #20. Staff E donned PPE, washed hands, donned non-sterile gloves, explained procedures to Patient #20 and set up supplies. Staff F then removed the tracheostomy speaking valve, removed the inner cannula and then put the cannula to soak in 1/2 strength Hydrogen Peroxide. Staff E then removed dressing around the trach stoma and discarded. Staff E then applied a sterile glove over the already soiled glove on her right hand and suctioned the patient's trachea. Staff E contained the soiled suction catheter in her gloved right hand, removed both gloves from the right hand and discarded. Staff E then reapplied a glove to right hand without hand hygiene, cleansed the inner cannula and with the same gloved hands opened the bottle of sterile water, rinsed the cannula by pouring water over it. Staff E changed gloves without hand hygiene, reinserted the inner cannula, applied the speaking valve and applied a new dressing around the stoma. Staff E discarded the used supplies and changed gloves without hand hygiene.

Observation of tracheostomy suctioning process on 01/26/17 at 7:17 AM revealed Staff U performed hand hygiene prior to entering Patient #13's room. Staff U gathered non-sterile gloves, donned the gloves and removed a stethoscope from the front pocket of his/her scrub top uniform and listened to the patient's lung sounds. Staff U placed the stethoscope back into his/her uniform pocket. No disinfection of the stethoscope was performed. Staff U proceeded to gather a suction kit, open the kit on the bedside table and remove the sterile suction catheter. Staff U attached the suction catheter to the suction hose. Staff U then picked up the sterile gloves from the suction kit and donned the sterile gloves on top of the used gloves and continued to use the suction catheter to suction Patient #13's trach. After completion of the suctioning, Staff U placed the suction catheter back into the paper wrapper it came from and set it on the suction canister. Staff U proceeded to remove his gloves, drop them onto the container prepared at the start of the process filled with sterile solutions. Staff U returned to the suction canister, removed the suction catheter and tubing from the canister, picked up the soiled glove from the solution containers and proceeded to rinse the suction catheter in the prepared solution. Staff U discarded the used suction catheter and with still soiled gloved hands reached into his uniform pocket, gathered the stethoscope and again listened to Patient #13's lungs, replaced the stethoscope without disinfection of the equipment back into his/her uniform pocket, remove his/her gloves, performed hand gel sanitizer and exited the room. This observation was confirmed with Staff U.


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During an observation on 01/23/17 at 10:25 AM, Staff H brought three intravenous (IV) catheters in Patient #1's room to restart the peripheral IV catheter and placed them on the patient's bed. Staff B was also present and restarted the peripheral IV on Patient #1 using one of the three catheters. Staff H discarded the supplies used, except for the IV catheter that was not opened and not used. Staff H put this catheter that was contaminated after touching the patient's bed back into the supply medication drawer for any patient on the unit to use.

On 01/23/17 at 10:30 AM, Staff H confirmed the above findings with Staff B present.

Patient #2 was observed in his/her bed on 01/23/17 at 11:35 AM. Patient #2's indwelling catheter bag was observed hooked on the bottom side rail and the bottom of the bag was on the floor. Staff B confirmed the catheter bag was touching the floor at the time of the observation.

On 01/24/17 at 8:15 AM, an observation was made of Patient #2 in his/her bed. Patient #2's indwelling catheter bag was observed attached to the frame of the bed. The bottom of the indwelling catheter bag was touching the floor. Staff A confirmed this finding at the time of the observation. Staff A stated Patient #2 was in a low bed and also stated a bag to cover the catheter bag could be used.