The information below comes from the statement of deficiencies compiled by health inspectors and provided to AHCJ by the Centers for Medicare and Medicaid Services. It does not include the steps the hospital plans to take to fix the problem, known as a plan of correction. For that information, you should contact the hospital, your state health department or CMS. Accessing the document may require you to file a Freedom of Information Request. Information on doing so is available here.

CLEVELAND EMERGENCY HOSPITAL 1017 S TRAVIS AVE CLEVELAND, TX 77327 Jan. 18, 2019
VIOLATION: REQUIRED OPERATING ROOM EQUIPMENT Tag No: A0956
Based on observation and interview, the facility failed to ensure that a tracheotomy set was available to 3 (Operating Room #1, Operating Room #2, and Procedure Room #1) of 3 operating room suites.

This deficient practice had the likelihood to cause harm to all surgical patients.


Findings:

During an observation tour of the facility on 1/15/2019, no tracheotomy set was found in the Surgical Department.

During an interview with Staff #11 on 1/15/2019 after 11:00 AM the following was revealed:

Staff #11 was asked where the emergency tracheotomy set was located. Staff #11 stated that there is no tracheotomy set in the Surgical Department.

Review of the facility policies and procedures did not reveal any policy or procedure that listed guidelines for required emergency equipment.
VIOLATION: NURSING SERVICES Tag No: A0385
Based on record review and interview, the facility failed to:


A. ensure that there was a Chief Nursing Officer (CNO) with a signed job description that encompassed the responsibilities of the CNO and supervision required.

Refer to Tag A0386



B. 1. provide a Director for the Operating Room (OR) for supervision of nursing staff administering drugs and biological's.

2. have a policy and procedures in place that addressed the required components of the conscious sedation training, ongoing in-services, continuing education (to demonstrate competence in conscious sedation), or any conscious sedation administration oversight for the Operating Room.

3. ensure nursing staff had satisfactorily completed the moderate sedation medication education program in 3 (#7, #22, and #27) of 3 employee files reviewed.

4. follow its own policy and procedures to monitor patients after conscious sedation for one hour before discharge in 1 (#1) of 3 charts reviewed.

5. ensure nursing documented what nurse or provider administered conscious sedation to a patient in 1 (#7) of 3 charts reviewed.

Refer to Tag A0405
VIOLATION: ORGANIZATION OF NURSING SERVICES Tag No: A0386
Based on record review and interview, the facility failed to have a Chief Nursing Officer (CNO) with a signed job description that encompassed the responsibilities of the CNO and supervision required.


An interview was conducted with staff #2 on 1/16/19. Staff #2 stated that she was the Chief Nursing Officer (CNO) for the hospital system, the Operating Room (OR) Director, and an Advanced Practice Registered Nurse (APN) with regular office hours. Staff #2 was also the supervisor and has oversight responsibilities for the surgery department on 1017 South Travis Avenue hospital location.


Review of Staff #2's employee file revealed no job description for the CNO position or for the OR Director. Staff #2 stated, she was not aware that there were no signed job descriptions and could not attest to it. Staff #2 reported that she had been in the position for the last year but did not give an exact date of hire nor was there written evidence when she became the CNO and OR Director.


Staff #10 was the new incoming DON and did have a job description in her chart. Staff #10 stated that she had just started this week and was still on orientation. Staff #10 and #2 confirmed that Staff #10 was training and had not assumed the duties of CNO.
VIOLATION: ADMINISTRATION OF DRUGS Tag No: A0405
Based on review and interview, the facility failed to:

1.) provide a Director for the Operating Room (OP) for supervision of nursing staff administering all drugs and biologicals.

2.) have a policy and procedures in place that addressed the required components of the conscious sedation training, ongoing in-services, continuing education (to demonstrate competence in conscious sedation), or any conscious sedation administration oversight for the Operating Room.

3.) ensure nursing staff had satisfactorily completed the moderate sedation medication education program in 3 (#7, #22, and #27) of 3 employee files.

4.) follow its own policy and procedures to monitor patients, after conscious sedation, for one hour before discharge in 1 (#1) of 3 charts reviewed.

5.) ensure nursing documented what nurse or provider administered conscious sedation to a patient in 1(#7) of 3 charts reviewed.


Review of Patient #7's chart revealed, she had a surgical procedure on 9/28/18. Patient #7 was having hardware removed from her great toe from a surgery performed on 7/16/18.

Review of the Patient #7's chart revealed a verbal physician order dated 9/28/18 at 0915 (9:15AM). The order read, "Administer Versed 2 mg IVP and Fentanyl 50 mcg IVP." The order was taken by staff #13 RN.

Review of the "Procedures Intraoperative Record" dated 9/28/18 revealed, there was only two Registered Nurses (RN) Staff #22 and #26 listed in the Operating Room (OR). Staff #22 was the circulator and Staff # 26 was the observer.

Review of the operative report dated 9/28/18 revealed the physician documented, "The patient was brought into the operating room in a mildly sedated state and transferred to the operating table in the supine position with safety belt secured to the midsection and light conscious sedation was initiated."

Review of the "Procedures Intraoperative Record" dated 9/28/18 revealed, Patient #7 came in the OR at 0904 (9:04AM). There was no time listed under "anes start:" (anesthesia start). On the second page of the Intraoperative Record revealed there was five sections.

1.) Nursing Care Plan
2.) ALDRETE SCORE
3.) Procedure Vital Signs
4.) Medications
5.) Nursing Notes/ line for Nurse signature, date and time.


The care plan and ALDRETE SCORE was filled out with no initials. The vital signs were taken every 5 minutes from 0904 (9:04AM) - 0945(9:45AM) and initialed by staff #13.

The medication Versed 2 mg IVP and Fentanyl 50 mcg IVP was documented as given at 0915 (9:15AM). There was no initials or signature to determine who administered the medication. There was no found conscious sedation log or form. The bottom of the page was signed by staff #13. Staff #13 was not documented as part of the surgical team or in the OR room to administer the medication.

Review of the operative "Recovery Record" dated 9/28/18 revealed, the patient came into recovery at 0946 (9:46AM) Staff #13 signed the record. The record stated that Staff #13 received report from Staff #22. Staff #13 documented that Patient #7 was discharged to home at 10:10AM, less than 1 hour from start of surgery and 24 minutes after patient arrived to recovery.


Review of the policy and procedure titled "Sedation" revealed:

"Patients requiring moderate sedation and who meet the criteria for patient selection will be monitored by an RN trained in basic EKG/arrhythmia, current BCLS certification, and has satisfactorily completed the moderate sedation medication education program, in addition to a technician or nurse assisting the LIP.

Monitoring will include:

Physical assessment
Blood pressure
Heart rate
Respirations (frequency and volume)
Oxygen saturation
Cardiac monitoring
Level of consciousness (sedation scale)
Skin color

The patient will be continuously monitored and reassessment will be documented every five (5) minutes until the procedure is completed. Emergency resuscitation equipment will be readily available. All outpatients who receive sedation for any procedure must be observed and monitored for a minimum of one (1) hour prior to being discharged home."


Review of employees files revealed there was no training for conscious sedation for Staff #13 and Staff #22. The Policy and procedures did not address the required components of the conscious sedation training for a Registered Nurse to administer the biologicals.

Staff #2 had stated in an interview conducted on 1/16/18 that she was the Chief Nursing Officer (CNO) for the hospital system and OR Director, as well as an Advanced Practice Registered Nurse (APN) with regular office hours. Staff #2 was also the supervisor and have oversight for the surgery department on 1017 South Travis Avenue.

Review of Staff #2's employee file revealed there was no job description for the CNO position or the OR Director. Staff #2 stated, she was not aware that there were no signed job descriptions and could not attest to it. Staff #2 reported that she had been in the position for the last year but did not give an exact date of hire nor was there written evidence when she became the CNO and OR Director.

An interview was conducted on 1/17/18 in the afternoon with staff #2. Staff #2 was asked by the surveyor what training was given for conscious sedation to the nurses. Staff #2 stated, "I'm not aware of any training. The nurses don't do any conscious sedation here." Staff #2 was shown surgical charts of conscious sedation performed by the nurses in surgery. Staff #2 stated, "Well, that's a surprise to me." Staff #2 reported that she is back in the surgery area a few times a week.
VIOLATION: ORGANIZATION OF SURGICAL SERVICES Tag No: A0941
Based on observation, record review, and interview, the facility failed to have appropriate equipment available during surgical procedures at 1 (300 East Crockett Street location) of 2 surgery locations.

This deficient practice had the likelihood to cause harm to all patients in the Cardiac Cath Lab area.

Findings:

An observation tour of the 300 East Crockett Street location was conducted on 1/17/2019 with Staff #17 and Staff #25. No storage of sterile instruments or surgical instrument trays were observed in the Cardiac Cath Lab area. No central sterilization services or equipment were available at the 300 East Crockett Street location.

An interview was conducted with Staff #17 and Staff #25. During the interview Staff #17 and Staff #25 were asked about the lack of sterile instruments and tray storage along with the availability of sterile instruments and trays during surgical procedures. Staff #25 confirmed that there were no sterile instruments or trays kept in the Cardiac Cath Lab. Staff #25 said, they "borrow" instrument trays from another facility and pick them up from the facility and transport them to 300 East Crockett Street location, Cardiac Cath Lab for use when a surgical procedure has been scheduled. Staff #25 confirmed that there were no backup instrument trays during procedures. Staff #25 confirmed that there was no availability for immediate use sterilization in the event an instrument becomes contaminated during a procedure.


Review of the nationally accepted standards set by the "Association of periOperative Registered Nurses (AORN), Perioperative Standards and Recommended Practices", was as follows:

"Care of Instruments, Recommendation III
Borrowed or consigned (ie, loaner) instruments should be examined, cleaned, and sterilized by the receiving health care organization before use, according to the manufactures' written instructions."


Review of "Surgical Services Plan of Care Policy, Reference #8034, revised 08/23/2015" was as follows:

"PROCEDURE:
Nursing actions in the intraoperative setting include the following:
...
Assurance of appropriate and properly functioning equipment and supplies
...
VIOLATION: OPERATING ROOM SUPERVISION Tag No: A0942
Based on observation, record review, and interview, the facility failed to appoint a qualified Operating Room Director that provided oversight of all Surgical Services at 2 of 2 locations (1017 South Travis Avenue and 300 East Crocket Street).

This deficient practice had the likelihood to cause harm to all surgical patients.

Findings:

During an observation tour on 1/15/2019 after 11:00 AM, the following was noted:

Staff #11 was observed wearing an ID Badge that identified her as Surgical Director. A surgical department office was identified by Staff #11 as her office. The sign read, "Director of Surgical Services."

During an interview with Staff #11 on 1/15/2019, the following was revealed:

Staff #11 was asked what her job duties included in the Surgery Department. Staff #11 said, she was over the day to day operations of the department and acted as a liaison between the nurses and Staff #2. Staff #11 said, she was functioning as the Operating Room Director; however, she was officially the OR Administrator that functioned similar to a Clinical Coordinator.


An interview was conducted with Staff #2 on 1/16/2019. Staff #2 said, she was the Chief Nursing Officer for the hospital system, OR Director, and was an Advanced Practice Registered Nurse with regular office hours.


On 1/16/2019 a review of personnel files revealed the following:

Review of the Staff #11's personnel file showed, the record did not contain any signed job description for Operating Room Director. Staff #11 was not a Registered Nurse. Staff #11 was a Surgical Technologist and OR Administrator. Staff #11's personnel folder had signed job descriptions for Surgical Technologist and OR Administrator.


Review of facility document titled, "OR Administrator Job Description" revealed the following:

" ...Qualifications
High school diploma or equivalent
Bachelor's Degree/Certification preferred
3 years experience in the area of specialty
Must have an understanding of basic medical terminology ..."


Review of Staff #2's personnel records showed that she had a credentialing file and personnel file. The personnel file did not contain a signed job description for OR Director.


Staff #11 confirmed her job description was OR Administrator; however, she was functioning as the OR Director.
VIOLATION: PATIENT RIGHTS: PERSONAL PRIVACY Tag No: A0143
Based on observation and interview, the facility failed to ensure records with patients' protected health information on them were destroyed or stored in a manner that prevented unauthorized personnel from accessing them.

Findings:

On the afternoon of 1-15-2018, a tour of the facility was conducted. Storage room 153, next to the laboratory was observed to have cardboard boxes stacked on the floor. Two boxes contained patient records for labs for 2017. Two boxes contained patient records for labs for 2018. Records included patient names, date of birth, admitted s, diagnosis, attending physician, account numbers, and other protected health information.

Interview was conducted with Staff #1. Staff #1 confirmed that multiple departments that had no need to have access to the patient records had access to the room and records, including security, maintenance, and nursing.
VIOLATION: QAPI Tag No: A0263
Based on record review and interview, the facility failed to have an ongoing, effective, and hospitalwide Quality Assurance Performance Improvement (QAPI)program. The facility does not have a QAPI plan in place and approved by the Governing Body. There was no quality indicators, data collection and analysis, no QAPI Committee designated members, no QAPI avtivity since February 2018.

Refer to Tag A0273
VIOLATION: Basis and Scope Tag No: A0008
Based on record reviews and interviews, the hospital failed to meet the requirements of 42 CFR 482.1 as evidenced by failing to be primarily engaged in providing inpatient services.

The regulation at 42 CFR 482.1 implements the statutory requirement at Section 1861(e) of the Social Security Act (Act). The regulation requires that: (i) Hospitals participating in Medicare must meet certain specified requirements and (ii) The Secretary may impose additional requirements if they are found necessary in the interest of the health and safety of the individuals who are furnished services in hospitals.

The Act defines hospital as: an institution that ". . . is primarily engaged in providing, by or under the supervision of physicians, to inpatients (A) diagnostic services and therapeutic services for medical diagnosis, treatment, and care of injured, disabled, or sick persons, or (B) rehabilitation services for the rehabilitation of injured, disabled, or sick persons..."

Findings:

Upon entrance to the hospital on 1-15-2019, the survey team was told that the hospital had two patients admitted as inpatient. The survey was initiated. Later that day, after review of the printed census provided, it was determined the hospital did not have any inpatients. The patients in the hospital had been placed in outpatient observation status. The team returned on 1-16-2019 to continue to investigate the complaint and determine if the hospital meets the statutory definition of a hospital. At that time, it was determined that the hospital had two inpatients so that care of the patients could be observed. The survey was continued at that time.

On 1-16-2019, a database worksheet was completed with Staff #15, Chief Operating Officer (COO). The hospital was found to have multiple campuses. The services for the following locations were determined to be:

Cleveland Emergency Hospital (CEH)
4 inpatient beds
2 operating room
1 endoscopy room
Emergency Department Services
Outpatient Radiology
Outpatient Laboratory

Texas Emergency Hospital (TEH) located in Cleveland, Texas
12 inpatient beds
1 cardiac catheterization room (opened 11-30-2018)
Emergency Department Services
Outpatient Radiology
Outpatient Laboratory

There were 3 Hospital Outpatient Departments (HOPD) that provided emergency department services, outpatient laboratory services, and outpatient radiology services. These were located in the cities of Springs, Porter, and Humble, Texas.

The hospital provided a report titled "Admit List from 01/01/2018 to 12/31/2018"; one report for each of the two inpatient hospital locations. Based off the information provided, it was determined there were a combined total of 102 patients admitted during that period. Further review revealed the following:

Month and Year Inpatient Admission
January 2018 5
February 2018 12
March 2018 12
April 2018 11
May 2018 11
June 2018 2
July 2018 9
August 2018 7
September 2018 7
October 2018 7
November 2018 6
December 2018 13



Month and Year Average Length of Stay (days)
January 2018 2.6
February 2018 2.8
March 2018 3.8
April 2018 3.6
May 2018 2.1
June 2018 2.3
July 2018 3.3
August 2018 2.7
September 2018 2.8
October 2018 2.9
November 2018 1.7
December 2018 2.9



Month and Year Average Daily Census
January 2018 0.42
February 2018 1.18
March 2018 1.45
April 2018 1.43
May 2018 0.81
June 2018 0.23
July 2018 0.97
August 2018 0.61
September 2018 0.73
October 2018 0.74
November 2018 0.33
December 2018 1.23


Review of the admission and discharge patterns by day of the week from January 2018 through December 2018 (12 months) revealed the following:
Sunday: 11 admissions and 14 discharges
Monday: 19 admissions and 14 discharges
Tuesday: 22 admissions and 13 discharges
Wednesday: 10 admissions and 13 discharges
Thursday: 14 admissions and 24 discharges
Friday: 14 admissions and 13 discharges
Saturday: 12 admissions and 11 discharges

One patient was admitted on Christmas Eve. No admissions were made on New Years Day, Memorial Day, Thanksgiving, Christmas Day, or New Year Eve during 2018.


On 1-18-2019, Staff #16, the Medical Records Director, assisted in determining the number of inpatient surgeries and outpatient encounters at the two hospital locations and 3 HOPD locations from January 2018 through December 2018. The following was determined:


Inpatient Surgeries
CEH - 20
TEH - 0
Total - 20

Outpatient Observation Surgeries
CEH - 121
TEH - 4
Total - 125

Outpatient Day Surgeries
CEH - 92
TEH - 0
Total - 92


Outpatient encounters through the Emergency Departments, Laboratory, and Radiology.
CEH - 5,349
TEH - 4,689
HOPDs - 7,746
Total - 17,784

Patients from outpatient departments amitted for observation:
CEH - 348
TEH - 258
Total - 606


For the year of 2018 the totals represent:
Inpatients - 102
Outpatient encounters - 18,482


Staffing Patterns

Inpatient Locations:
Hospital floors with certified inpatient beds were found to be staffed with sufficient nursing staff to provide care on all shifts and over the weekends and holidays.

Surgery:
Interview was conducted on 1-15-2019 with Staff #11 and Staff #13 during a tour of the surgical area. Both confirmed that surgeries were performed Monday through Friday. Both denied that there was an on-call schedule for nursing, anesthesia, or surgeons.

Interview was conducted with Staff #17 on 1-17-2019 during a tour of the Cardiac Catheterization Lab. Staff #17 confirmed that Cardiac Catheterizations were performed Monday through Friday. Staff #17 confirmed there was no on-call schedule for nursing, anesthesia, or surgeons.


Utilization Review

On the morning of 1-17-2019, an interview was conducted with Staff #18 concerning the Utilization Review program. Through the interview, it was determined that the hospital did not have an effective Utilization Review program. Staff #18 stated that the hospital had a physician reviewer who looked at charts for medical necessity. Staff #18 stated that 99% of the charts reviewed were from the emergency department and not inpatient encounters. When questioned about the physician reviewer and the physician reviewer's credential file, Staff #18 stated that the reviewer had been through medical school, but did not have a physician's license and was not credentialed as part of the medical staff.

Staff #18 provided a copy of a Utilization Review Plan that was effective 07/03/17. Upon review of the plan, it was determined the plan did not provide for a Utilization Review Committee. Review of the Medical Staff Bylaws, Rules, and Regulations did not include provisions for a Utilization Review Committee to oversee the Utilization Review Function. Staff #18 confirmed that there was not a Utilization Review Committee, therefore there were no Utilization Review meetings to discuss or take action on Utilization Review matters.

Refer to Tag A0652


Discharge Planning

Through interviews and document review, it was determined that an effective Discharge Planning program was not in place. An interview was conducted with Staff #19 and Staff #20 on the afternoon of 1-17-2019 in regards to discharge planning for Patient #1 and Patient #2. After review of Patient #1 and Patient #2's charts, no evidence of discharge planning was found. Staff #20 was an agency nurse. Staff #20 stated, she did not know who was responsible for the discharge planning in the hospital. Staff #19 was the Charge Nurse. Staff #19 stated that the physician was responsible for discharge planning. Staff #19 stated that when the physician writes orders for discharge, the financial manager for the hospital will assist in setting up those services ordered, such as Home Health or Outpatient Services.

Review of the Cleveland Emergency Hospital Discharge Planning policy showed that it was last revised 08-23-2015. It was confirmed with Staff #10 that this policy was in effect for the patient location being surveyed. The provisions for discharge planning contained within the policy were not being followed.

Refer to Tag A0799
VIOLATION: GOVERNING BODY Tag No: A0043
Based on observation, review of records, and interview, the facility failed to:

A. ensure that the Governing Board Bylaws were reviewed and approved every two years as required by its bylaws. The current bylaws were last approved on 8/23/15.

Findings:

Review of the Governing Board (GB) Bylaws, provided by staff # 1, revealed the last time the bylaws were approved was on 8/23/15.

Review of the GB Bylaws written exactly as follows, stated, "ARTICLEXI REVIEW AMENDMENT &REPLACEMENT
Thesebylawsshallbe reviewedbytheBoardandCorporationasneeded,butatleasteverytwo (2) years,andshallbedatedtoindicatethetimeofthelastreview.
These bylaws may be amended by affirmative vote of two-thirds majority of the members oftheBoard, providing a full presentation of such proposed amendment shall have been published in thenoticeof meeting, and provided the amendments are approved in writing by Corporation. Corporationreservesthe right to amend or replace these bylaws as necessary for the operation of the Hospital in the event ofachange in circumstances or emergency so dictating. Corporation thereafter promptly will consult withtheBoardonpermanentamendmentstothesebylaws(ifany)necessarytomeetthechangeofconditi ons,policy, or continuingemergency." (SIC)


An interview with staff #1 and #15 on 1/17/19 confirmed the GB bylaws dated 8/23/2015 were the current bylaws.






B. ensure that there was an ongoing, hospitalwide Quality Assurance Performance Improvement (QAPI)program.
Refer to Tag A0273


C. ensure that there was a Chief Nursing Officer (CNO) with a signed job description that encompassed the responsibilities of the CNO and supervision required.
Refer to Tag A0386


D. 1. provide a Director for the Operating Room (OR) for supervision of nursing staff that administer drugs and biological's.

2. have a policy and procedures in place that addressed the required components of the conscious sedation training, ongoing in-services, continuing education (to demonstrate competence in conscious sedation), or any conscious sedation administration oversight for the Operating Room.

3. ensure that nursing staff had satisfactorily completed the moderate sedation medication education program in 3 (#7, #22, and #27) of 3 employees reviewed.

4. follow its own policy and procedures to monitor patients, after conscious sedation, for one hour before discharge in 1 (#1) of 3 charts reviewed.

5. ensure nursing documented what nurse or provider administered conscious sedation to a patient in 1 (#7) of 3 charts reviewed.
Refer to Tag A0405



E. ensure that all drugs and biological's were stored in a secure area in 1 (Medical Surgical -Texas Rural Campus) out of 4 (ER, Medical Surgical - Cleveland Campus, Medical Surgical- Texas Rural Campus, Surgery) medication rooms.
Refer to Tag A0502


F. ensure that outdated narcotics were not available for patient use in 1 (Surgical Unit) out of 4 (ER, Medical Surgical - Cleveland Campus, Medical Surgical- Texas Rural Campus, Surgery) medication rooms.
Refer to Tag A0505


G. establish a Utilization Review Committee to carry out the Utilization Review functions of the hospital.
Refer to Tag A0654



H. develop and implement a Utilization Review plan that identified the frequency that cases would be reviewed or monitored by a Utilization Review Committee or the method used to identify those cases that may be outliers based on high cost or duration of stay.
Refer to Tag A0655


I. establish and implement a process for a Utilization Review Committee to review professional services provided to patients.
Refer to Tag A0658


J. maintain a sanitary environment in 8 (Surgery, Patient Isolation Room 175, Soiled Room, Patient Supply Room, Storage Room, Inpatient Nursing Station, emergency room , Radiology) out of 9 (Surgery, Patient Isolation Room 175, Soiled Room, Patient Supply Room, Storage Room, Inpatient Nursing Station, emergency room , Radiology, Dietary) area's observed.
Refer to Tag A0747


K. follow its own policy for initiating referrals to a Discharge Planner for focused discharge planning in 2 patients (Patient #1 and Patient #2) of two inpatient admissions reviewed.
Refer to Tag A0800


L. establish a discharge planning needs assessment for all patients identified as needing discharge planning.
Refer to Tag A0806


M. define the qualifications for personnel other than nurses or social workers who are performing discharge planning evaluations.
Refer to Tag A0807


N. ensure discharge planning evaluations were completed, documented, and placed in the patient charts for 2 (Patient #1 and Patient #2) out 2 patients reviewed.
Refer to Tag A0812


The following deficient practices listed under O. through BB. posed an Immediate Jeopardy to patient health and safety and placed all patients at risk for the likelihood of harm, serious injury, and/or subsequent death.


O. ensure that all flexible endoscopes were cleaned and high-level disinfected prior to patient use. A review of the Endoscopy Logs dated February 2018 through January 2019 failed to document that flexible endoscopes were cleaned and disinfected in 55 of 55 patients.
Refer to Tag A0940


P. ensure that the facility documented Rapicide OPA/28 chemical indicator strips (chemical indicator strips to determine the proper concentration of the Rapicide OPA/28) were used to test the Rapicide OPA/28 prior to cleaning endoscopes for 55 of 55 patients when manual processing of flexible endoscopes was done.
Refer to Tag A0940


Q. ensure that the Endoscope Processing Room was ventilated.
Refer to Tag A0940


R. ensure that the length of time in between processing flexible endoscopes did not exceed the "hang time" (the length of time a flexible endoscope can be stored before the next patients use) according to the recommended guidelines in 30 of 55 patients. Six Flexible Endoscopes were observed hanging in a drying cabinet with no identification of the date they were processed.
Refer to Tag A0940


S. ensure that surgical instruments were sterilized, stored, and transported in accordance with nationally accepted standards set forth by the AORN and ANSI/AAMI. Sterile instruments stored on a wire rack in the Sterile Room that were ready for patient use, did not complete the sterilization process in 7 of 7 instrument sets observed. Also, 60 of 60 sterile instruments used in Cardiac Catheterization at the 300 East Crockett Street location were transported to the 1017 South Travis Ave for disinfection and returned to the sending facility by private car. There was no way to ensure the instrument sterility and temperature/humidity levels were maintained during transport.
Refer to Tag A0940


T. ensure that the infection control officer developed a system that maintained a clean and sanitary environment for the provision of surgical services in 5 (OR #1, OR #2, Pre-Operative, Post-Operative, and Medication Room) of 10 areas.
Refer to Tag A0940


U. ensure that the temperature in the Operating room (OR) was within acceptable standards to inhibit microbial growth, reduce the risk of infection, promote patient comfort, and assure the physical safety of all patient's in 7 (OR #1, OR #2, Sterile Room, Autoclave Room, Clean Supply, Decontamination, and Procedure Room Decontamination) of 7 areas. The temperature was out of range for 134 of 245 days reviewed. There was no documentation on the log to indicate corrective action taken and the temperature on follow up after corrective action was done.
Refer to Tag A0940


V. ensure that the facility appropriately stored equipment available during surgical procedures at 1 (300 East Crockett Street location) of 2 surgery locations. The facility was performing cardiac catheterization procedures and did not have any way to sterilize instruments that were contaminated during the procedure. Also, the facility did not store any instruments to replace an instrument if one was contaminated or broken during a procedure.
Refer to Tag A941


W. ensure that a qualified Operating Room Director was appointed to provide oversight of all Surgical Services at 2 locations (1017 South Travis Avenue and 300 East Crocket Street) of 2 locations.
Refer to Tag A0942


X. ensure that facility policies were approved by the Medical Staff and Governing Body, up-to-date, and referenced current standards of practice in 2 (1017 South Travis Ave and 300 Crockett Street) of 2 locations.
Refer to Tag A951


Y. ensure that the physician documented a complete History and Physical and/or update that included changes in the patient's condition prior to the surgical procedure in 5 (Patient #'s 5, 6, 7, 8, and 9) of 7 Patient charts reviewed.
Refer to Tag A952


Z. ensure that a tracheotomy set was available to 3 (Operating Room #1, Operating Room #2, and Procedure Room #1) of 3 Operating room suites.
Refer to Tag A956


AA. ensure that the Operating Room Log register was complete, accurate, and up-to-date in 91 of 91 Patients.
Refer to Tag A958


BB. ensure that Post-Operative Notes were complete and documented (Complications, Estimated Blood Loss, Assistants) in 3 (Patient #5, Patient #9, and Patient #10) of 3 Post-Operative Notes.
Refer to Tag A959
VIOLATION: PROGRAM SCOPE, PROGRAM DATA Tag No: A0273
Based on review and interview, the facility failed to have an ongoing, effective, and hospitalwide Quality Assurance Performance Improvement (QAPI)program.


The QAPI minutes, relevant data, Perfomance Improvement (PI), tracking for quality indicators , and plan was requested form Staff #1 on 1/15/19 through the 1/17/19. The materials were requested multiple times on these days. On the afternoon of 1/17/19, the surveyor discussed with Staff #1, #15, and #18 concerning the delay of QAPI materials requested. On the last day of the survey (1/18/19), Staff #1 brought in meeting minutes from 2/18, 5/18, and 10/18. There was no QAPI plan included. Staff #1 confirmed that the materials supplied to the survey team was all that was available.


Review of the QAPI minutes and data provided by Staff #1 revealed that there was no QAPI plan approved by Governing Board (GB). Staff #1 provided the surveyor with an "Integrity Quality Compliance Committee Charter" (IQC). The IQC was responsible to "review the effectiveness of Cleveland Emergency Hospital's Quality Management Plan, Standard of Conduct, Integrity, & Compliance program and other compliance programs and policies on a quarterly basis and shall recommend proposed changes for approval." There was no documentation of who was on this committee or when they met.


Review of Governing Body bylaws revealed there was no detailed plan for QAPI and did not include the frequency and detail of data collection.


Review of the minutes from 2/2018, 5/2018, and 10/2018, revealed that there was no data, tracking, analysis of data, or performance improvement (PI).


An interview was conducted with Staff # 2 on 1/17/18 concerning the nursing involvement in QAPI. Staff # 2 reported she had attended some meetings but was not monitoring anything and had no PI projects for the year of 2018/2019.
VIOLATION: Condition of Participation: Pharmaceutical Se Tag No: A0489
Based on review, observation, and interviews the facility failed to:

A. ensure that all drugs and biological's were stored in a secured area in 1 (Medical Surgical -Texas Rural Campus) out of 4 (ER, Medical Surgical - Cleveland Campus, Medical Surgical - Texas Rural Campus, Surgery) medication rooms.

Refer to Tag A0502


B. ensure that outdated narcotics were not available for patient use in 1 (Surgical Unit) out of 4 (ER, Medical Surgical -Cleveland Campus, Medical Surgical - Texas Rural Campus, Surgery) medication rooms.

Refer to Tag A0505
VIOLATION: SECURE STORAGE Tag No: A0502
Based on observation, record review, and interviews, the facility failed to ensure that all drugs and biological's were stored in a secure area in 1 (Medical Surgical -Texas Rural Campus) out of 4 (ER, Medical Surgical - Cleveland Campus, Medical Surgical - Texas Rural Campus, Surgery) medication rooms.

A tour was taken in the afternoon of 1/17/19 of the Texas Rural Hospital campus. During the tour, on the medical surgical floor, a nurse was found pulling keys out of drawer in the nurses station. The keys were to the medication room and locked narcotic boxes. The keys were in a drawer that was unlocked. The nurse was asked if that is where they normally keep the keys to the medication room. The nurse stated, "yes. We put it in the back of the drawer. We all share the keys."

An interview was conducted with staff # 10 and #15 on the afternoon of 1/17/19. Staff #10 and #15 confirmed that they saw the nurse pull the medication room keys out of a unsecured drawer in the nurses station. Staff # 10 reported that she had talked with the nurse and informed her to keep the keys in her possession until shift change.

Review of the policy and procedure "Security: Receiving, Storage, Access, Dispensing & Returning" stated, "Locked/Coded Cabinets/Doors. The Pharmacy, and each department contains doors and cabinets where medication is located with limited individual access. There are locked cabinets for controlled substances, and Pharmacy keeps a log as to who is allowed access, and logs as to what medications are being removed on the Narcotic Administration Record (NAR).

Limited Individuals - Access to Medications. The keys to the locked/coded cabinets are kept in a locked/coded key box, and one set is kept in the Pharmacy. Approved individuals have codes to the doors/cabinets."
VIOLATION: UNUSABLE DRUGS NOT USED Tag No: A0505
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**



Based on record review, observation, and interviews, the facility failed to ensure that outdated narcotics were not available for patient use in 1 (Surgical Unit) out of 4 (ER, Medical Surgical - Cleveland Campus, Medical Surgical - Texas Rural Campus, Surgery) medication rooms.


During a tour on the morning of 1/15/19 revealed, there was expired narcotics in the surgical medication room available for patient use. The following medications were found expired as follows:

1 vial of Hydromorphone (Dilaudid) 2 mg per 2 ml. expired on ,d+[DATE]

2 vials of Meperidine (Demerol) 25mg-1ml. expired on ,d+[DATE]

7 vials of Midazolam (Versed) 2 mg-2ml. Expired 10/18

4 syringes of Morphine 2mg -1ml. Expired 11/18


Review of the policy and procedure "Security: Receiving, Storage, Access, Dispensing & Returning" stated, "7. The Hospital Pharmacy diligently removes all expired, damaged, and/or contaminated medications and stores them separately from medications to document and have the approved Company pickup for safe disposal. 8. Medications are removed prior to expiration dates and documented, removed from the active medications from the appropriate department Inventory Spreadsheets or Pharmacy Inventory Spreadsheet. The expired medications are placed in "Expired Medication" bins and stored in a secure closed cabinets until retrieved from the Hospital selected Medication Company for removal from the Hospital."


An interview with staff #11, #21, and #22 was conducted in the morning of 1/15/19. Staff #21 and #22 confirmed the above mentioned narcotics had expired for at least 6 months and the nurses had not noticed the medications were expired. Staff # 21 confirmed that the medications were counted each shift and had the count sheets present. Staff #21 and #22 stated that the pharmacy technician comes into the medication room and looks for expired medications.

An interview was conducted with pharmacist on 1/16/19. Staff # 23 stated that the medications are to be checked monthly for expiration dates. Staff #23 stated that staff #24 was responsible for checking the medications but had apparently missed the expired drugs.
VIOLATION: UTILIZATION REVIEW Tag No: A0652
Based on review of records and interview, the facility failed to develop and implement an effective Utilization Review Plan. The facility failed to:

A. establish a Utilization Review Committee to carry out the Utilization Review functions of the hospital.

Refer to Tag A0654



B. develop and implement a Utilization Review plan that identified the frequency that cases would be reviewed or monitored by a Utilization Review Committee or the method used to identify those cases that may be outliers based on high cost or duration of stay.

Refer to Tag A0655


C. establish and implement a process for a Utilization Review Committee to review professional services provided to patients.

Refer to Tag A0658
VIOLATION: UTILIZATION REVIEW COMMITTEE Tag No: A0654
Based on review of records and interview, the facility failed to establish a Utilization Review Committee to carry out the Utilization Review functions of the hospital.

Findings:

A request was made on 1-17-2019 for the Utilization Review Plan and the meeting minutes of the Utilization Review Committee. Staff #18 was unable to provide minutes. Staff #18 confirmed that there was no Utilization Review Committee.

The Utilization Review Plan, Reference #7014, was provided and reviewed. The effective date was 07/03/17. The plan did not designate a Utilization Review Committee. Review of plan was as follows:

"PURPOSE:

The Cleveland Emergency Hospital Utilization Review Plan provides a structure for the systematic review and evaluation of patient care to improve the utilization of its facility and resources. This review process examines aspects of care including the medical necessity for admission, the appropriateness of the setting in which services are provided, and the medical necessity of hospital stays and professional services. As a result, opportunities to improve outcomes and implement process changes to enhance quality of care are identified.

ORGANIZATION AND SCOPE:

The Utilization Management program is intended to enhance the appropriate utilization of health care resources. This is accomplished through monitoring and evaluation process on a semi-annual basis. Utilization Review includes physician reviewers who will be responsible for reporting findings to the Quality Council and Medical Executive Committee. Recommendations will be made to the Governing Board when indicated. No review shall be conducted by a physician who has professional involvement in the care of the patient under review."

Review of the Medical Staff Bylaws, Rules and Regulations, Approval Date: October 17, 2018, was made as follows:

"13.4 MEDICAL STAFF FUNCTIONS

a. Composition of Committees and Appointment

i. The MEC shall designate appropriate Medical Staff committees to perform the functions of the Medical Staff.

ii. Medical staff committees performing medical staff functions required by these Bylaws or Hospital policy may include representative of any appropriate hospital department.

iii. Unless otherwise specifically provided, the Chief of Staff appoints medical staff committee members. Each committee selects its chair unless the committee chair is provided for in these Bylaws.

iv. The Chief of Staff and the Hospital Administrator, or the representative designee, serves as a non-voting, ex-officio committee member unless the voting privilege is expressly given.

b. Functions - The functions of the Medical Staff are to:

iii. Conduct or coordinate utilization review / management activities;

14.6.2 MINUTES

Minutes of all meetings shall be prepared by the secretary of the meeting and shall include a record of attendance and the vote taken on each matter. Copies of such minutes shall be signed by the presiding officer, approved by the attendees, forwarded to the Medical Executive Committee, and made available to the staff. A department file of the minutes of each meeting shall be maintained."
VIOLATION: SCOPE AND FREQUENCY OF REVIEW Tag No: A0655
Based on review of records and interview, the facility failed to develop and implement a Utilization Review plan that identified the frequency that cases would be reviewed or monitored by a Utilization Review Committee or the method used to identify those cases that may be outliers based on high cost or duration of stay.

Findings:

An interview was conducted with Staff #18 on 1-17-2019. During the interview, Staff #18 stated that an individual who was not a licensed physician was reviewing Emergency Department cases for services provided. The findings of the review were presented to the physician over the Emergency Departments. When asked if the reviewer looked at Emergency Department cases only, Staff #18 replied, "99% of them are".

No record was provided of inpatient admission cases reviewed by a physician for duration of stay or professional services rendered.

Review of the Utilization Review plan did not include provisions for the frequency that cases would be reviewed or monitored by a Utilization Review Committee or the method to identify those cases "reasonably assumed to be outlier cases" that would require a review by a committee. The Utilization Review Plan, Reference #7014, Effective: 07/03/17 was as follows:

"STRATEGIES:

1. Analyze results of review data generated through claims and finance and, where appropriate, make recommendations for changes in policies, procedures, or practices.

2. Monitor utilization patterns to identify inefficiencies and improvement opportunities. Monitoring will include:

a. Patient days or stays which do not meet medical necessity screening criteria

b. Payer initiated denials of payment for clinical reasons

c. Delay or possibly avoidable days related to deliver of service or discharge

d. Length of stay data

e. Readmissions

f. Professional services, including drugs and diagnostics

g. Extended observation stays (>48 hrs)

3. Evaluate data for trends or patterns to identify opportunities to improve the efficiency of services, scheduling and discharge planning.

4. Identify the need for corrective actions when problems or opportunities are identified and forward to the appropriate clinical department.

5. Conduct follow up assessments to determine performance improvement.

6. Provide utilization management education for hospital administration and medical staff as needed.

7. Route identified issues to the appropriate place of resolution and monitor for corrective action.


PHYSICIAN REVIEWERS:

Physician Reviewers will serve as consultants to the program by making determinations regarding medical necessity of admission or continued stay for cases that do not meet approved screening criteria.

UTILIZATION MANAGEMENT PROCESS:

The UR process includes a review of medical necessity, extended length of stay, payer initiated denials due to clinical reasons and appropriateness of level of care on a sample basis. In addition, other topics include:

1. Unscheduled re-admission for the same diagnosis within 48 hours following discharge

2. Patient allegations or complaint about pre-mature discharge

3. Unscheduled transfers for higher level of care within 24 hours of admission

4. Cases reasonably assumed to be outlier cases on extended length of stay

5. Cases reasonably assumed to be outlier cases based on extraordinarily high costs

PROGRAM EVALUATION:

The effectiveness of the UR process, is evaluated and approved on an annual basis."

The plan stated that physicians would review cases that did not meet the approved screening criteria for medical necessity for admission or continued stay. No provision was found for what the "approved screening criteria" to be used was. No provision was found for who would screen with the approved screening criteria or when/how often the cases would be screened. The plan stated it would be done on "sample basis". The plan did not identify how the sample would be selected and how often the samples would be reviewed. The plan provided for the effectiveness of the process to be evaluation and approved on an annual basis. However, the plan had not been reviewed and approved since 07/03/2017.
VIOLATION: REVIEW OF PROFESSIONAL SERVICES Tag No: A0658
Based on interview, the facility failed to establish and implement a process for a Utilization Review Committee to review professional services provided to patients.

Findings:

An interview was conducted with Staff #18 on 1-17-2019. During the interview, Staff #18 confirmed that there was no Utilization Review Committee established to carry out the utilization review function for the review of professional services.
VIOLATION: FACILITIES, SUPPLIES, EQUIPMENT MAINTENANCE Tag No: A0724
Based on observation, the following items were found expired and ready for patient use in 1( Surgery) of 3 (emergency room , Radiology, Medical Surgical) areas.



Surgery:

13 Blue top blood vials were found in the pre-op/post- op area expired. The tubes were ready for patient use and had expired in May of 2018.

27 Tiger top blood vials were found in the pre-op/post- op area expired. The tubes were ready for patient use and had expired in June of 2018.







During an observation tour on 1/15/2019 after 11:00 AM the following was observed:



MEDICATION ROOM

There was an emergency airway box stored in the medication room that contained 2 adult Co2 detectors that were expired. The CO2 detectors expired 1-8-2019, seven days prior.

During an observation tour on 1/16/2019 after 11:00 AM the following was observed:


OR #1:

In the anesthesia cart one Adult Co2 detector was found expired. The expiration date was 1/08/2015, 4 years ago.

Staff #11 confirmed the above findings.
VIOLATION: INFECTION CONTROL Tag No: A0747
Based on observation and interview, the facility failed to maintain a sanitary environment in 8 (Surgery, Patient Isolation Room 175, Soiled Room, Patient Supply Room, Storage Room, Inpatient Nursing Station, emergency room , Radiology) out of 9 (Surgery, Patient Isolation Room 175, Soiled Room, Patient Supply Room, Storage Room, Inpatient Nursing Station, emergency room , Radiology, Dietary) areas observed.


1.) Surgery

The Nurses desk in the preoperative area was found to have broken Formica on the desk and pulling apart from the frame leaving exposed particle board. This would result in the inability to clean properly and harbor infection. The handle was broken on one of the drawers.

The rolling vital sign machines (used to take the patients vital signs) was found to be soiled with dust and hair.

The pre-operative area had no patients and was considered clean and ready for new patients. Three biohazard trash cans were found to have trash in them.

One of the three post-operative bays was found to be used as a storage area. The bed had soiled shipping boxes on them and was not a clean area. There was only a curtain around the bed and was not sealed off from the other patient beds.

Observation of the six beds used in the pre/post-operative areas were found to be soiled with dust, hair, and rust. Staff # 11 confirmed the same soiled stretchers was taken from pre/op, to surgery, and back out to post op. The dirty beds were taken into the surgery suite exposing the patient to potential hazardous infections.

13 Blue top blood vials were found in the pre-op/post- op area expired. The tubes were ready for patient use and had expired in May of 2018.

27 Tiger top blood vials were found in the pre-op/post- op area expired. The tubes were ready for patient use and had expired in June of 2018.

Room "C" in the pre-op/post-op area had clean surgical uniforms hanging on a rack. The uniforms were used for staff to put on for surgery. The uniforms were not covered. The uniforms were in a room with soiled equipment. The floor of the room was soiled with dust and hair. The bed in the room had a soiled mattress and dirty blanket wadded up on the mattress. Three wheel chairs were found in the room uncovered and soiled with dust and hair.

In the medication room, medical supplies and office supplies were co-mingled. Paper forms were stacked in a particle board divider next to patient supplies. The particle board divider was dusty and soiled. The cabinet space used to count and prepare medications was soiled.

In the medication room, a metal sink was found to be heavily soiled and rusted. A black plastic box was found sitting next to the sink. The box was heavily soiled with dust and a white residue. The top of the box said "bait box".

In the medication room a sharps container (holds dirty used needles) was found to be hanging on the wall. The top of the box was covered with white residue.


2.) Patient Isolation Room 175

The room was used for patients that require isolation from other patients, to prevent the spread of contagious disease, or to protect the patient from an infectious disease. The room was considered clean and waiting to be used by a new patient. The door was found propped open with a piece of cardboard from a box.

A wooden chair was found in the room with multiple scratch marks exposing the porous wood underneath. This could be a source of possible infection.

The bed linen was found to have holes.

The bedside table had nicks in the table exposing particle board. The bedside table was rusted on the legs and soiled with dust and hair.

The patient monitor was dusty and the time on the monitor was not correct. The monitor was 13 minutes fast. There was no up to date preventative (PM) sicker on the monitor. The time was 2:59PM and the monitor said 15:12 (3:12PM).

Behind the head of the bed, the floor was found to be soiled with dust and trash.

The wall behind the bed was found to be missing paint and sheetrock was exposed.

The IV pole was found to be rusted and missing paint. The top of the pole had a plastic hanger on it where a medication bag had been hanging.

Inside a closet in the patient room, a large fan on a stand was pulled out of the closet. The fan was visibly soiled with dust, hair, and dirt. The last time the fan had been inspected was 7/9/16, 2 years later ago. Staff #2 reported that the she was unaware the fan was kept in the room.

Inside the closet next to the fan, was a bedside commode found with plastic under the commode lid. The plastic was removed and the commode was full of old urine. Mold was growing inside the commode. The commode chair was soiled and had rusted. Staff #2 confirmed the urine was in the commode and was unsure why this was in a cleaned room. Staff #1 called in the house keeper and showed her the commode and instructed her to clean it.

The room contained a pull out couch that can be converted into a bed. The cushion was removed from the couch and dirt, dust, and food particles were found.

In the bathroom, a plastic shower chair was found. The chair was found to be soiled and covered in a white dried residue.

The shower curtain rod was rusted.

The shower head and hardware was rusted and covered in a heavy hard water stains.


3.) Soiled Room

In the patient care area, the soiled room, had trash cans with trash in them. Next to the trash cans was the house cleaning cart that was taken into patient rooms to clean. The room also held clean supplies to clean the facility, soap, trash can liners, gloves, tissues and paper products. Staff #1 and housekeeping staff confirmed there was no room in the clean closet to place the housekeeping cart and clean supplies were stored with trash in a soiled room.


4.) Patient Supply Room

In the patient supply room patient, supplies were found sitting less than six inches from the floor. The floor was soiled with dust and hair.


5.) Storage Room

In a storage room there were multiple walkers, a bedside commode chair, monitors, isolation carts, 6 open vinyl glove boxes, and miscellaneous equipment found. The equipment was uncovered and unable to determine if the equipment was clean and ready for use or soiled. In a corner of the room was 4 large boxes of lab reports and 6 large binders. The reports had patient names and identifiers of past patients. It was determined that multiple people had access to this room including, maintenance, security, and housekeeping.


6.) Inpatient Nursing Station

The floors around the inpatient nursing station were heavily soiled with dirt and hair.


7.) emergency room

In emergency room #2, an IV pole was found missing paint and rusted. The stretcher fitted sheet had holes in it. The frame and railing of the stretcher was missing paint and rusted.

A wheelchair, available for patient use, was found with torn and worn arms exposing the foam underneath.


8.) Radiology

In the CAT scan room, the head rest had a pillow on it. The pillow was wrapped in plastic and tape. The tape was discolored and the plastic was ripped. The head rest was soiled and unable to clean from all the old tape and residue.

The floor in the CAT scan room was soiled with dust and dirt. There was 4 deep holes in the concrete. The holes were filled with dirt and debris. Tiles were broken and missing.

In the GI room, the scope closet was found to be holding four scopes. Scope parts were found sitting in a basket on the bottom of the closet. There was no system or documented proof when the scopes had last been used or cleaned.

The GI mobile workstation was found to be soiled with dust and rust.
VIOLATION: DISCHARGE PLANNING Tag No: A0799
Based on review of records and interview, the facility failed to ensure an effective discharge planning process was developed and implemented. The facility failed to:


A. follow its own policy for initiating referrals to a Discharge Planner for focused discharge planning in 2 patients (Patient #1 and Patient #2) of two inpatient admissions reviewed.

Refer to Tag A0800


B. establish a discharge planning needs assessment for all patients identified as needing discharge planning.

Refer to Tag A0806


C. define the qualifications for personnel other than nurses or social workers who are performing discharge planning evaluations.

Refer to Tag A0807


D. ensure discharge planning evaluations were completed, documented, and placed in the patient charts for 2 (Patient #1 and Patient #2) of 2 patients reviewed.

Refer to Tag A0812
VIOLATION: CRITERIA FOR DISCHARGE EVALUATIONS Tag No: A0800
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**




Based on review of records and interview, the facility failed to follow its own policy for initiating referrals to a Discharge Planner for focused discharge planning in 2 (Patient #1 and Patient #2) of 2 inpatient admissions reviewed.

Findings:

Patient #1 was an [AGE]-year-old male, admitted through the emergency department with pneumonia.

Patient #2 was an [AGE]-year-old male, admitted through the emergency department with pleural effusions and pneumonia.

No evidence of discharge planning or referral to a Discharge Planner for focused discharge planning was found in the chart.


Interview was conducted with Staff #19 and Staff #20. Staff #20 was an agency nurse. Staff #20 stated, she did not know who was responsible for the discharge planning in the hospital. Staff #19 was the Charge Nurse. Staff #19 stated that the physician was responsible for discharge planning. Staff #19 stated, the hospital didn't have a Discharge Planner. Staff #19 stated that when the physician writes orders for discharge, the financial manager for the hospital will assist in setting up those services ordered, such as Home Health or Outpatient Services. Neither Staff #19 or Staff #20 knew where a formal discharge planning needs assessment would be documented.


Review of "Cleveland Emergency Hospital Discharge Planning, Reference #1076, Effective and Revised: 08-23-15" was made. Staff #10 confirmed that this policy was in effect at the patient location being surveyed. Review was as follows:

Page 5 of 7
"Additionally, an automatic referral to the Discharge Planner for focused discharge planning shall be made for all "high-risk" patients:
Adult high-risk patients include:
Those admitted through the Emergency Department"
VIOLATION: DISCHARGE PLANNING NEEDS ASSESSMENT Tag No: A0806
Based on review of records and interview, the facility failed to establish a discharge planning needs assessment for all patients identified as needing discharge planning.

Findings:

Review of Patient #1 and Patient #2's charts revealed no evidence of discharge planning or a discharge planning needs assessment in either of the charts. Staff #19 was asked where the discharge planning would be documented. Staff #19 stated, the physician was responsible for discharge planning and it would be documented in the physician progress notes. No discharge planning assessment or needs were found in the physician progress notes for either patient.

Review of "Cleveland Emergency Hospital Discharge Planning, Reference #1076, Effective and Revised: 08-23-15" was done. Staff #10 confirmed that this policy was in effect at the patient location being surveyed. Review was as follows:

Page 5 of 7
"Discharge planning needs shall be based on the patient's plan of care."


No provision for a discharge planning needs assessment that evaluated the patient's ability for self-care or to be cared for in the setting they entered the hospital from was found in the policy.
VIOLATION: DISCHARGE PLANNING Tag No: A0812
Based on review of records and interview, the facility failed to ensure discharge planning evaluations were completed, documented, and placed in the patient charts for 2 (Patient #1 and Patient #2) of 2 patients reviewed.

Findings:

Review of Patient #1 and Patient #2's charts revealed no evidence of discharge planning or a discharge planning evaluation found in either of the charts.

An interview was conducted with Staff #19 and Staff #20 on the afternoon of 1-17-2019 in regards to discharge planning for Patient #1 and Patient #2. Staff #20 was an agency nurse. Staff #20 stated, she did not know who was responsible for the discharge planning in the hospital.

Staff #19 was the Charge Nurse. Staff #19 stated that the physician was responsible for discharge planning. Staff #19 stated that when the physician writes orders for discharge, the financial manager for the hospital will assist in setting up those services ordered, such as Home Health or Outpatient Services.


Review of "Cleveland Emergency Hospital Discharge Planning, Reference #1076, Effective and Revised: 08-23-15" was done. Staff #10 confirmed that this policy was in effect at the patient location being surveyed. No provision was found for the documentation of a discharge planning evaluation to be made and the results to be placed in the chart.
VIOLATION: SURGICAL SERVICES Tag No: A0940
Based on observation, record review, and interview, the facility failed to:


A. ensure that all flexible endoscopes were cleaned and high-level disinfected prior to patient use. A review of the Endoscopy Logs dated February 2018 through January 2019 did not document that flexible endoscopes were cleaned and disinfected in 55 of 55 patients.


During a tour of the Surgical Services Department on 1/16/2019 after 10:00 AM, revealed the following:

In the Endoscopy decontamination/processing room, (a small room located in between Procedure Room #1 and Operating Room #2), there was an automatic washer (automatic flexible endoscope washer) that was out of service and not being used. Staff #11 stated that the washer had been out of service since February 2018 and they were processing the endoscopes manually.

Observed beside the washer was a sink that was being used to clean the flexible endoscopes. Next to the sink, on the countertop, was a 1gallon bottle of Medline Dual Enzymatic Detergent and Presoak (a detergent used to presoak and wash flexible endoscopes). Staff #11 was asked what the detergent was used for. Staff #11 said, it was used for washing the flexible endoscopes. Staff #11 was then asked about the dilution rate of the detergent to water ratio and how the facility verified the water/detergent ratio in the sink was correct. Staff #11 said that 1/2 to 1 ounce of detergent to 1 gallon of water is the correct ratio. Staff #11 said, we measure the detergent with the cup and put it in the sink with water. Staff #11 was asked how they measured the amount of water. Staff #11 stated there was no way to determine the exact amount of water in the sink because the line is no longer there.


Across from the sink, there was a large white plastic basin with a closed lid labeled, "Rapicide OPA Expires 2-13-19". The expiration dates were listed on a piece of paper taped to the lid on the plastic bin. There were previous expiration dates that had been marked through with a black marker and were unreadable. Beside the basin was a 1-gallon bottle of Rapicide OPA/28 that was opened with no open or expiration date. Staff #11 confirmed that the basin had been filled with Rapicide OPA/28.


During an interview with Staff #11 on 1/16/2019 after 10:00 AM the following was revealed:

Staff #11 was asked how the facility processed flexible endoscopes. Staff #11 said, they were washed in the sink next to the washer and then soaked in the Rapicide. Staff #11 was asked if the facility followed manufacture guidelines on manual cleaning/high level disinfecting of flexible endoscopes. Staff #11 confirmed the facility had no manufacture guidelines.


Review of the Rapicide OPA/28 manufactures guidelines revealed the following:

" ...Rapicide OPA/28

HIGH-LEVEL DISINFECTANT
REF ML02-0127

Storage Conditions and Expiration Date:

1. Store Rapicide OPA/28 in its original sealed container at controlled room temperature of 15C - 25C (59F -77F) in a well ventilated area.

2. Once opened, the unused portion of the solution may be stored in its original container for up to 75 days until used.

3. The expiration date of Rapicide OPA/28 may be found on the bottle label of the immediate container. DO NOT use product from an unopened or
opened bottle after the labeled expiration date.

4. The reuse period of Rapicide OPA/28 should never exceed 28 days ..."


Review of the facility policy titled, "Guidelines For The Use of Rapicide OPA/28, Reference #6.102, Effective 8/22/2015 was as follows:


" ...GUIDELINES FOR THE USE OF RAPICIDE 0PA/28
Rapicide 0PA/28 Disposal:

Discard Rapicide 0PA/28 solution after 28 days, even if the test strips indicate an adequate concentration ..."





B. ensure that the facility documented Rapicide OPA/28 chemical indicator strips (chemical indicator strips to determine the proper concentration of the Rapicide OPA/28) were used to test the Rapicide OPA/28 prior to cleaning endoscopes for 55 of 55 patients when manual processing of flexible endoscopes was done.


During an interview on 1/16/2019 after 11:00 AM, Staff #11 said that the facility was using Rapicide OPA Test Strips prior to disinfecting endoscopes. Staff #11 said, the test strips were being used every time a scope was washed.

Review of facility document titled, "Endoscope Patient Log" revealed test results were not monitored with a pass or fail according to the facility policy. On the endoscope patient log there was a column pass/fail. There were check marks documented in the column when an endoscope was processed. There was no key on the log to indicate if a check mark meant pass or fail.


Review of facility policy titled, "GUIDELINES FOR THE USE OF RAPICIDE 0PA/28 TEST STRIPS", Reference #6.103, Effective: 08/22/2015, was as follows:

" ...Test Procedure:

Initiate timer and immerse entire indicator pad of test strip into the Rapicide 0PA/28 solution for a full 3 seconds. Hold motionless, do not wave back and forth.

Remove strip and touch the long edge on a paper towel to remove excess solution.

Lay strip, pad side up, on paper towel.

Compare indicator pad to the color blocks on the bottle at exactly 90 seconds and interpret the result.

Record the results in Rapicide 0PA/28 log ..."



C. ensure the Endoscope Processing Room was ventilated.

During an observation tour on 1/16/2019, there was no vent in the endoscope processing room.

In an interview on 1/16/2019 after 11:00 AM, Staff #11 was asked how the endoscope processing room was ventilated. Staff #11 confirmed that there was no ventilation in the room.


Review of the policy titled, "GUIDELINES FOR THE USE OF RAPICIDE 0PA/28, Reference #6.102, Effective 08/22/2015, was as follows:


" ... E. Safety guidelines
Always use Rapicide 0PA/28 in a well-ventilated area to avoid irritation to eyes, mucous membranes etc ..."



D. ensure that the length of time in between processing flexible endoscopes did not exceed the "hang time" (the length of time a flexible endoscope can be stored before the next patients use) according to the recommended guidelines in 30 of 55 patients. Six Flexible Endoscopes were observed hanging in a drying cabinet with no identification of the date they were processed.

During an interview on 1/16/2019 after 11:00 AM, Staff #11 was asked what the facility process was for monitoring the length of time endoscopes hung in the cabinet between processing. Staff #11 said, they refer to the Endoscope Patient Log to determine last processed date.

Review of the Endoscope Patient Log for 1/15/2019 showed endoscope labeled as C 4068 was processed. The last processed date for endoscope C 4068 noted on the Endoscope Patient Log was 11/12/2018. Staff #11 confirmed that the last date that Scope C 4068 had been processed according to the Endoscope Patient Log was 11/12/2018. According to the log, the endoscope hung in the cabinet for almost two months and was used on a Patient prior to being processed.


Review of the AORN (Association of periOperative Registered Nurses) Perioperative Standards and Recommended Practices revealed the following:


"Recommendation IX

Flexible endoscopes should be stored in a manner that protects the device from damage and minimizes microbial contamination ....

IX.b. Flexible endoscopes should be reprocessed before use if unused for more than five days. In research studies, flexible endoscopes cleaned and processed as recommended and stored by hanging in closed cabinets have been shown to grow organisms after five days of no use ..."



E. ensure that surgical instruments were sterilized, stored, and transported according to nationally accepted standards or practice such as the AORN and ANSI/AAMI standards. Sterile instruments stored on a wire rack in the Sterile Room that were ready for patient use did not complete the sterilization process in 7 of 7 instrument sets observed. Also, 60 of 60 sterile instruments used in Cardiac Catheterization at the 300 East Crockett Street location, off campus location, were transported to the 1017 South Travis Ave, main campus, for disinfection and returned to the sending facility by private car. There was no way to ensure the instrument sterility and temperature/humidity levels were maintained during transport.


During an observation tour on 1/16/2019 after 11:00 AM, 7 instruments sets stored in the Sterile Room for patient use had an outside chemical indicator tape that indicated sterilization had not been completed. Staff #11 was asked why the unsterile instrument sets were stored with the sterile instrument sets. Staff #11 said, she did not know.

During an interview on 1/6/2019 after 10:00 AM, Staff #11 stated, "Someone brings them over in their personal car in a plastic bin with disinfecting chemicals and we sterilize them and send them back to the hospital with a dust cover over them."


Review of the "Steam Sterilization Log #1" revealed 28 of 68 instruments were sterilized at the CEH facility between June 2018 and November 2018.

Review of the "Steam Sterilization Log #2" revealed 32 of 44 instruments were sterilized at the CEH facility between June 2018 and December 2018.
Staff #11 confirmed the findings.


The facility failed to provide a policy on transportation of contaminated and sterile instruments.

Staff #11 confirmed that the 300 East Crockett Street location transports all contaminated instruments to the 1017 South Travis Street for disinfection and sterilization. After sterilization the instruments are returned to 300 East Crockett Street location for use in cardiac catheterizations. (An invasive procedure that is performed to look at the vessels that supply blood to the heart).





Review of the nationallt accepted standards set by the "Association of periOperative Registered Nurses (AORN), periOperative Standards and Recommend Practices for Inpatient and Ambulatory Settings", was as follows:

"Recommendation XV
Sterilized materials should be labeled and stored in a manner to ensure sterility, and each item should be marked with the sterilization date."


Review of the nationallt accepted standards set by the 2017 "Association for the Advancement of Medical Instrumentation" ANSI/AAMI ST79:2017, the guidelines were as follows:

"ANSI/AAMI ST79:2017 -- Comprehensive guide to steam sterilization and sterility assurance in health care facilities.

13 Process monitoring, testing, and quality control

13.3 Product identification and traceability

13.3.1 General considerations

Each item or package intended for use as a sterile product should be labeled with a lot control identifier to allow full traceability of that item to the patient; alternately, an instrument tracking system may be used. Each load should have a load control record that includes a detailed content list, including specific identification of sets and the contents of sealable pouches.

13.3.2 Package labeling and expiration dating, if applicable
Each item or package intended for use as a sterile product should be labeled with a lot control Identifier prior to sterilization. The lot control identifier should identify:

a) the sterilizer identification number or code;

b) a detailed list of the contents (e.g., identification of multiple sets and the contents of paper-plastic pouches);

c) the person who assembled the package;

d) the date of sterilization;

e) the cycle number (cycle run of the sterilizer); and

f) the patient, if applicable, Items processed for immediate use should include a patient identifier."



Review of the facility policy titled, "EVENT-RELATED SHELF LIFE-STERILE STORAGE", Reference #4018, Effective 3/04/2015 was as follows:

" ...Load identification labels shall be applied to all items sterilized for recall purposes only.

Each item shall have the following documentation:
Department name
Item description
Date of sterilization
Sterilizer number
Sterilizer load number
Assembler initials

No expiration date shall routinely be assigned. Expiration dates may be used if medication or materials that deteriorate with time are contained in the package. Package shall be dated, per manufacturer's recommendation when this occurs ..."


It was determined that these deficient practices posed an Immediate Jeopardy to patient health and safety and placed all patients at risk for the likelihood of harm, serious injury, and/or subsequent death.


F. ensure the infection control officer developed a system that maintained a clean and sanitary environment for the provision of surgical services in 5 (OR #1, OR #2, Pre-Operative, Post-Operative, and Medication Room) of 10 areas.


During an observation tour on 1/15/2019 after 11:00 AM the following was observed:



MEDICATION ROOM

There was an emergency airway box stored in the medication room that contained 2 adult Co2 detectors that were expired. The CO2 detectors expired 1-8-2019, seven days prior.

There was a bottle of Iodoform packing strips used to pack open wounds that was stored in the room. The bottle was opened. The label on the bottle did not indicate the supply bottle was multiuse.


PRE-OP BAY#1
In Pre-Op bay #1 observed suction tubing opened and connected to suction canister. The suction tubing was out of the manufacturers package and left open to contaminants. Staff #11 was asked if the suction tubing was clean or dirty. Staff #11 said she did not know and there was no indication on the tubing.


POST OP BAY B
Observed in Post-Operative Bay B there was a stretcher that had rust colored stains on the frame of the entire stretcher. There was a patient monitor noted to have an expired Preventative Maintenance sticker that was out of date. The sticker listed the last date of inspection as 11/2017. The sticker did not indicate when the next inspection was due.


POST-OP BAY #3
A defibrillator (a device used on patients during a cardiac emergency) stored on the crash cart had a sticker that listed the last day of inspection as 11/2017. The sticker did not indicate when the next inspection was due.


Review of the facility document titled, "Cleveland Emergency Hospital, Preventative Maintenance Log" revealed the following:

" ...All equipment is due for annual preventative maintenance in January of each year."

The log did not indicate a date of last inspection for the hospital equipment, nor did it indicate the date when the next inspection was due.



PRE-OP AREA
Observed in a patient restroom was baseboard that were pulled away from the walls. This created missing paint and exposed sheetrock in the restroom. There was a toilet tissue holder under the side rail. The holder was soiled with tan colored debris. The floor in the restroom around the toilet was heavily stained with a buildup of dust, debris, and rust colored stains.


During an observation tour on 1/16/2019 after 11:00 AM the following was observed:

OR #1:
On the frame and base of the operating bed, rust colored stains were observed.

The patient moving device (a roller), an approximately 5-inch tear in the seam was noted.

On the floor next to the operating bed, a hole in the linoleum was observed with a yellow/orange color. This tear had not been sealed and was approximately 3x3 inches.

In the anesthesia cart one Adult Co2 detector was found expired. The expiration date was 1/08/2015, 4 years ago.


Staff #11 confirmed the above findings.



G. ensure the temperature in the Operating room (OR) was within acceptable standards to inhibit microbial growth, reduce the risk of infection, promote patient comfort and assure the physical safety of all patient's in 7 (OR #1, OR #2, Sterile Room, Autoclave Room, Clean Supply, Decontamination, and Procedure Room Decontamination) of 7 areas. The temperature was out of range for 134 of 245 days reviewed. There was no documentation on the log to indicate corrective action taken and the temperature on follow up after corrective action was done.


Review of the Surgical Services Temperature Log for the months of June 2018 through January 2019 was as follows:

Review of the Temperature Logs for June 2018 revealed the following:

OR1 - The temperature was documented out of range 5 of 30 days.

OR2 - The temperature was documented out of range 4 of 30 days.

Sterile Room - The temperature was documented out of range 3 of 30 days.

Autoclave Room - The temperature was documented out of range 2 of 30 days.

Clean Supply - The temperature was documented out of range 2 of 30 days.

Decontamination Room - The temperature was documented out of range 2 of 30 days.

Procedure Rm Decontam. - The temperature was documented out of range 5 of 30 days.


Review of the Temperature Logs for July 2018 revealed the following:

OR2 - The temperature was documented out of range 1 of 31 days

Autoclave Room - The temperature was documented out of range1of 31 days.

Decontamination Room - The temperature was documented out of range 1 of 31 days.


Review of the Temperature Logs for August 2018 revealed the following:

OR1 - The temperature was documented out of range 1 of 31 days.

OR2 - The temperature was documented out of range 2 of 31 days.

Sterile Room - The temperature was documented out of range 4 of 31 days.

Autoclave Room - The temperature was documented out of range 5 of 31 days.

Clean Supply - The temperature was documented out of range 6 of 31 days.

Decontamination Room - The temperature was documented out of range 5 of 31 days.

Procedure Room Decontamination - The temperature was documented out of range 5 of 31 days.


Review of the Temperature Logs for September 2018 revealed the following:

OR1 - The temperature was documented out of range 1 of 30 days.

OR2 - The temperature was documented out of range 5 of 30 days.

Sterile Room - The temperature was documented out of range 4 of 30 days.

Autoclave Room - The temperature was documented out of range 2 of 30 days.

Clean Supply - The temperature was documented out of range 1 of 30 days.

Decontamination Room - The temperature was documented out of range 2 of 30 days.

Procedure Room Decontamination - The temperature was documented out of range 1 of 30 days.


Review of the Temperature Logs for October 2018 revealed the following:

OR1 - The temperature was documented out of range 3 of 31 days.

OR2 - The temperature was documented out of range 3 of 31 days.

Sterile Room - The temperature was documented out of range 3 of 31 days.

Autoclave Room - The temperature was documented out of range 3 of 31 days.

Clean Supply - The temperature was documented out of range 5 of 31 days.

Decontamination Room - The temperature was documented out of range 2 of 31 days.

Procedure Room Decontamination - The temperature was documented out of range 1 of 31 days


Review of the Temperature Logs for November 2018 revealed the following:

OR1 - The temperature was documented out of range 2 of 30 days.

OR2 - The temperature was documented out of range 1 of 30 days.

Sterile Room - The temperature was documented out of range 3 of 30 days.

Autoclave Room - The temperature was documented out of range 4 of 30 days.

Clean Supply - The temperature was documented out of range 2 of 30 days.

Decontamination Room - The temperature was documented out of range 4 of 30 days.

Procedure Room Decontamination - The temperature was documented out of range 3 of 30 days.


Review of the Temperature Logs for December 2018 revealed the following:

OR1 - The temperature was documented out of range 1 of 31 days.

OR2 - The temperature was documented out of range 1 of 31 days.

Sterile Room - The temperature was documented out of range 1 of 31 days.

Autoclave Room - The temperature was documented out of range 6 of 31 days.

Clean Supply - The temperature was documented out of range 1 of 31 days.

Decontamination Room - The temperature was documented out of range 3 of 31 days.

Procedure Room Decontamination - The temperature was documented out of range 2 of 31 days.


Review of the Temperature Logs for January 2019 revealed the following:

OR1 - The temperature was documented out of range 1 of 15 days

OR2 - The temperature was documented out of range 1 of 15 days

Autoclave Room - The temperature was documented out of range 2 of 15 days.

Clean Supply - The temperature was documented out of range 1 of 15 days.

Decontamination Room - The temperature was documented out of range 1 of 15 days.

Procedure Room Decontamination - The temperature was documented out of range 3 of 15 days.



Review of the nationallt accepted standards of practice set by the "Association of periOperative Registered Nurses, Perioperative Standards and Recommended Practices" revealed the following:

" ...Temperature should be maintained between 68 degrees F to 73 degrees F (20 degrees to 23 C) within the operating room suite and general work areas in sterile processing.

Relative humidity should be maintained between 30% and 60% within the perioperative suite, including operating rooms, recovery area, cardiac catheterization rooms, endoscopy rooms, instrument processing areas, and sterilizing areas and should be maintained below 70% in sterile storage areas.

Low humidity increases the risk of electro static charges, which pose a fire hazard in an oxygen-enriched environment or when flammable agents are in use and increases the potential for dust. High humidity increases the risk of microbial growth in areas where sterile supplies are stored or procedures are performed.

Humidity should be monitored and recorded daily using a log format or documentation provided by the HVAC (heating, ventilation, and air conditioning) system.

Temperature should be monitored and recorded daily using a log format or documentation provided by the HVAC (heating, ventilation, and air conditioning) system."



Review of the facility Policy titled, "Infection Prevention and Control Measures", Reference #4005, Effective 8/23/2015 was as follows:

" ...Temperature of the operating rooms will be maintained at 68 to 73 degrees F (American Institute of Architects, 1996, 2001) ..."



During a phone interview on 1/21/2019 after 8:00 AM Staff #11 confirmed the findings.


H. ensure that the facility stored appropriate equipment available during surgical procedures at 1 (300 East Crockett Street location) of 2 surgery locations. The facility was performing cardiac catheterization procedures and did not have any way to sterilize instruments that were contaminated during the procedure. Also, the facility did not store any instruments to replace an instrument if one was contaminated or broken during a procedure.

Refer to Tag A941



I. ensure a qualified Operating Room Director was appointed to provide oversight of all Surgical Services at 2 locations (1017 South Travis Avenue and 300 East Crocket Street) of 2 locations.

Refer to Tag A0942



J. ensure facility policies were approved by the Medical Staff and Governing Body, up-to-date, and referenced current standards of practice in 2 (1017 South Travis Ave and 300 Crockett Street) of 2 locations.

Refer to Tag A951



K. ensure the physician documented a complete History and Physical and/or update that included changes in the patient's condition prior to the surgical procedure in 5 (Patient #'s 5,6,7,8, and 9) of 7 patient charts reviewed.

Refer to Tag A952



L. ensure that a tracheotomy set was available to 3 (Operating Room #1, Operating Room #2, and Procedure Room #1) of 3 Operating room suites.

Refer to Tag A956



M. ensure the Operating Room Log register was complete, accurate, and up-to-date in 91 of 91 patient entries.

Refer to Tag A958


N. ensure Post-Operative Notes were complete and documented ... ... .... Complications, Estimated Blood Loss, Assistants in 3 (Patient #5, Patient #9, and Patient #10) of 3 Post-Operative Notes.

Refer to Tag A959
VIOLATION: OPERATING ROOM POLICIES Tag No: A0951
Based on document review and interview, the facility failed to ensure that Surgical Services Policies in 2 (1017 South Travis Ave and 300 Crockett Street) of 2 locations were approved by the Medical Staff and Governing Body, up-to-date, and referenced current standards of practice.

This deficient practices had the likelihood to cause harm to all patients.

Findings:

Review of a sample of Surgical Service Policies and Procedures was as follows:

"Surgical Site Identification, Reference #8024, Effective: 08/23/2015".

"Cleaning the Surgery Department, Reference #4031, Effective: 08/23/2015",
Standard referenced, "Association of periOperative Registered Nurses (AORN), Perioperative Standards and Recommended Practices for Inpatient and Ambulatory Settings, 2011 Edition".

"Accountability for Sponges, Sharps, and Instruments, Reference #8040, Effective: 08/23/2015", Standard referenced, "Association of perioperative Registered Nurses (AORN), Perioperative Standards and Recommended Practices for Inpatient and Ambulatory Settings, 2011 Edition" and "Association of perioperative Registered Nurses (AORN) Journal: June 2000, Clinical Issues".

"Infection Prevention and Control Measures, Reference #4005, Effective 08/23/2015", Standards referenced, "Centers for Disease Control and Prevention (CDC), Guidelines for Prevention of Surgical Site Infection, 1999, Alicia J. Mangram, MD; Teresa C. Horan, MPH, CIC; Michele L. Pearson, MD; Leah Christine Silver, BS; William R. Jarvis, MD; The Hospital Infection Control Practices Advisory Committee" and "Association of perioperative Registered Nurses (AORN), Management Connections, New Rules for Humidity in the OR, May 2010".


A review of Cleveland Emergency Hospital Corporate Compliance policy, Reference #1010, Effective: 12/08/2016, page 2 of 6 was as follows:

" ...III. Policy/Procedure Review.
At least every three years, all department leaders will review and, as necessary, update the current policies/procedures applicable to their area of responsibility to maintain compliance with current laws and regulations. Each department leader is responsible for ensuring that policies and procedures are appropriately maintained and utilized in their area of responsibility ..."

These policies were found to be out of date using outdated references. AORN standards have been updated annually with the most recent standard published in 2019.

An interview was conducted with Staff #17 on 1/17/2019 at the 300 East Crockett Street location. Staff #17 was asked about policies used at that location. Staff #17 provided a manual of policies that she stated were currently in use.


Review of the Governing Body meeting minutes for 2018 showed that those policies in use had not been approved by the Governing Body.

Staff #15 confirmed the above findings.




Review of the Governing Board (GB) meeting minutes and Medical Executive Committee (MEC) meeting minutes for 2018 revealed there was no policy and procedures approved for the Cardiac Catheterization Department. There were no meetings for January 2019 at this time.

An interview with staff #15 was conducted on the afternoon of 1/17/19. Staff #15 confirmed that there were no policy and procedures brought before the MEC or GB at this time. Staff #15 stated, "I just missed it. I plan on bringing them to the MEC and Governing Body this month when we have our meetings."
VIOLATION: HISTORY AND PHYSICAL Tag No: A0952
Based on record review, the facility failed to ensure that the physician documented a complete History and Physical (H&P) and/or update to include changes in the patient's condition prior to the surgical procedure, in 5 (#5, #6, #7, #8, #9) of 7 patient charts reviewed.

This deficient practice had the likelihood to cause harm to all surgical patients.


Findings include:

A review of Patient #5 's record revealed no history and physical update documented by Personnel #29 in the record that indicated any changes in the patients' condition prior to surgery on 11/16/2018. A review of the history and physical did not indicate Patient #5 had a medical emergency prior to surgery.

A review of Patient #6 's record revealed no history and physical update documented by Personnel #28 in the record that indicated any changes in the patients' condition prior to surgery on 10/02/2018. A review of the history and physical did not indicate Patient #6 had a medical emergency prior to surgery.

A review of Patient #7 's record revealed no history and physical update documented by Personnel #28 in the record that indicated any changes in the patients' condition prior to surgery on 7/20/2018 and 9/28/2018. A review of the history and physical did not indicate Patient #7 had a medical emergency prior to surgery.

A review of Patient #8 's record revealed no history and physical update documented by Personnel #28 in the record that indicated any changes in the patients' condition prior to surgery on 8/10/2018. A review of the history and physical did not indicate Patient #8 had a medical emergency prior to surgery.


A review of Patient #9 's record revealed no history and physical update documented by Personnel #28 in the record that indicated any changes in the patients' condition prior to surgery on 9/21/2018 and 10/12/2018. A review of the history and physical did not indicate Patient #9 had a medical emergency prior to surgery.


Review of the Medical Staff Bylaws, Rules and Regulations approved 10/17/2018 revealed the following:

"16.7 HISTORY AND PHYSICALS

a. General

...ii. A patient history and physical assessment is required on all inpatients and medical and psychiatric observation patients. The elements to be included in the history are present complaint, past pertinent medical and surgical history, current medications, allergies, and social history. The physical assessment should be extensive enough to support the care provided.

ii. Outpatients requiring H&P as required by the medical staff

1) H&Ps may be completed up to 30 calendar days prior to outpatient procedure provided an update documenting any changes in the patient's condition is completed prior to surgery or procedure requiring anesthesia, deep or moderate sedation, whichever occurs first; and

2) The update occurs at the time of (day of) and prior to the outpatient procedure.

3) H&Ps performed greater than 30 calendar days prior to procedure as described above ARE NOT ACCEPTABLE...


d. Update Requirements

ii. The update must document the examination by an appropriate privileged practitioner of any changes in the patient's condition since the patient's H&P was performed that might be significant for the planned course of treatment.

iii. The update must be documented even if no changes have occurred with the patient's status. In this case the update should reflect the patient's H&P was reviewed, the patient was examined and no changes have occurred in the patient's conditions since the H&P was completed.

iv. The update must be on or attached to the H &P.

v. Additionally, if the practitioner finds that the H&P that he/she is updating is incomplete, inaccurate, or otherwise unacceptable, the practitioner reviewing the H&P, examining the patient, and completing the update may disregard the existing H&P, and conduct and document in the medical record a new H&P within timeframes described in above Timeframe for Completing and Updating H&Ps ...."


Review of "History and Physical Policy, Reference #8003, Effective 08/23/2015" was as follows:

"HISTORY AND PHYSICAL:

A comprehensive medical history and physical (H&P) examination shall be completed within 24 hours of admission to inpatient services, or prior to surgery or any procedure requiring anesthesia.

A comprehensive H&P shall be completed prior to surgery and prior to procedures requiring anesthesia services, regardless of whether care is being provided on an inpatient or outpatient basis.

H&P examinations may be completed ahead of time, though no more than 30 days prior to admission or readmission, and only by the appropriate practitioner privileged to perform H&Ps.

When an H&P is performed prior to admission, an updated H&P, including any changes in the patient's condition, must be completed and documented by a licensed practitioner who is credentialed and privileged by the hospital's medical staff to perform an H&P, within 24 hours after admission or registration, but prior to surgery or a procedure requiring anesthesia services, when the medical history and physical examination are completed within 30 days before admission or registration ..."
VIOLATION: OPERATING ROOM REGISTER Tag No: A0958
Based on review of record and interview, the facility failed to maintain a complete, accurate, and up-to-date operating room log/register in 91 of 91 patients.

This deficient practiced had the likelihood to cause every harm to all surgical patients.


Findings:

During an observation tour on 1/15/2019 after 11:00 AM, the Operating Room Log was requested. Staff provided a log titled, "CEH OR Procedure Report". During an interview on 1/15/2019, Staff #11 said, she developed the "CEH OR Procedure Report" and used the information from the "Surgery/PACU Log Book" to complete the procedure report. Staff #11 then provided copies of the "Surgery/PACU Log Book". The log book contained entries for the months of January 2018 through October 2018. No records after October 2018 were provided.


Review of the document titled, "Surgery/PACU Log Book" for the months of January 2018 through October 2018 revealed the operating room register was missing the following information:

1 of 91 patients did not have a hospital ID number documented.

8 of 91 patients did not have a date of operation documented.

4 of 91 patients did not list the operation performed.

28 of 91 patients did not identify the operating surgeon and assistant.

5 of 91 patients did not have the type of anesthesia used and the name of the person administering it documented.

9 of 91 patients did not have the time the operation began and ended documented (inclusive or total time of the operation).

91 of 91 patients did not list the names of scrub and circulating personnel.

91 of 91 patients did not include pre and post-op diagnosis.

1 of 91 patients did not list the age of the patient.


Staff #11 confirmed the above findings.
VIOLATION: OPERATIVE REPORT Tag No: A0959
Based on record review, the facility failed to ensure post-operative notes contained all the required information in 3 (Patient #5, Patient #9, and Patient #10) of 3 post-operative surgical notes.

This deficient practice had the likelihood to cause harm in all surgical patients.


Findings:

A review of Patient #5 's surgical record dated 11/16/2018 revealed that the post-operative note was missing the following elements:

The Post-operative note did not identify the assistant.


Review of Patient #9 's surgical record dated 11/05/2018 revealed the post-operative note was missing the following elements:

The post-operative note was timed before the start of the procedure by Personnel #28.


A review of Patient #10 's record revealed the post-operative note did not contain a description of techniques and listed none under complications. Review of "Cleveland Emergency Hospital Incident Report" revealed on 1/14/2019 a Hydrocelectomy was performed on the right testicle. However, the initial incision was made on the left side. No record of the additional incision and how the wound was closed was documented on the post-operative note.


Review of the Medical Staff Bylaws, Rules, and Regulations with an approval date of October 17, 2018 revealed the following:

"16.7 HISTORY AND PHYSICALS
a. General

...iv. All operative procedures performed shall be fully written or dictated in the patient's record within 24 hours following the procedure. Patient records without a written or dictated operative report within 24 hours following the procedure shall be considered delinquent. A brief operative note is required to be on the patient's chart immediately following the procedure.
The report includes the following information:

The name(s) of the licensed independent practitioner(s) who performed the procedure and his or her assistant(s);
The name of the procedure performed;
A description of the procedure;
Findings of the procedure;
Estimated blood loss;
Any specimens removed;
The postoperative diagnosis ..."