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 REGIONAL MEDICAL CTR 300 E CROCKETT CLEVELAND, TX Aug. 29, 2014
VIOLATION: LICENSURE OF HOSPITAL Tag No: A0022
Based on record review and interview, the facility failed to comply with the licensure requirements set forth by the state.

On tour of the facility on 8/15/2014 at 9:00 AM with staff #5, it was observed the facility's Surgery Department and Obstetrical Department were closed.

A review of the record titled, "Texas Administrative Code, Chapter 133, Hospital Licensing Rules" revealed the following:

(18)General hospital--An establishment that:
(A) offers services, facilities, and beds for use for more than 24 hours for two or more unrelated individuals requiring diagnosis, treatment, or care for illness, injury, deformity, abnormality, or pregnancy; and
(B) regularly maintains, at a minimum, clinical laboratory services, diagnostic X ray services, treatment facilities including surgery or obstetrical care or both, and other definitive medical or surgical treatment of similar extent.
(19) Governing body--The governing authority of a hospital which is responsible for a hospital's organization, management, control, and operation, including appointment of the medical staff; includes the owner or partners for hospitals owned or operated by an individual or partners.
(20) Governmental unit--A political subdivision of the state, including a hospital district, county, or municipality, and any department, division, board, or other agency of a political subdivision.
(21) Hospital--A general hospital or a special hospital.
(22) Hospital administration--Administrative body of a hospital headed by an individual who has the authority to represent the hospital and who is responsible for the operation of the hospital according to the policies and procedures of the hospital's governing body."

An interview with the Chief Nursing officer on 8/15/2014 at approximately 10:30 AM confirmed the last day of surgery was April 29, 2014 and the Obstetrical Department closed March 2, 2013.
VIOLATION: GOVERNING BODY Tag No: A0043
Based on record review and interview the Governing Body failed to:

A. failed to ensure the appointment of the Chief of Staff to the medical staff.
Refer to Tag A045

B. provide a safe environment for patients seeking medical treatment.
Refer to Tag A0701, A0726

C. appoint a licensed Medical Doctor as the Medical Director and Medical Supervisor of Emergency Services.
Refer to Tag A1102, A1111
VIOLATION: MEDICAL STAFF Tag No: A0045
Based on document review and interview, the Governing Body removed the Chief of Staff Elect #15 and appointed Medical Staff #13 to the position of Chief of Staff on May 9, 2014. Not until August 8, 2014 was Medical Staff #13 notified of his appointment to Chief of Staff.
A review of the document titled, "Governing Board Meeting Agenda" for May 9, 2014 revealed in 2.16 Approval of CRMC Medical Executive Committee Discussion: The Board Chairman, staff #1 informed the voting members that the current Medical Executive Committees and Medical Staff Officers will be abolished ....The new MEC presented to the voting members for approval will consist of staff #2(CEO); staff #1(MD), as chief Medical Officer; and staff #13(MD), will continue as Chief of Staff ...... 2.17 Approval of CRMC Medical Directors; Discussion: The Board Chairman reported to the voting members for approval the existing Medical Director ... The newly appointed Medical Directors include ..... staff #19(MD) as the ER Medical Director ...
A review of the document titled, "Medical Staff Bylaws and Medical Staff Rules and Regulations" revealed 10.1(h)(1) Chief of Staff: The Chief of Staff shall serve as Chief Medical Officer and principal official of the staff. As such he/she will: (iii) Be responsible to the Board, in conjunction with the MEC, for the quality and efficiency of clinical services and professional performance with the hospital and for the effectiveness of patient care evaluations and maintenance functions delegated to the staff; work with the Board in implementation of the Board's quality, performance, efficiency and other standards.
An interview with staff #13 (MD) on 8/14/2014 at approximately 4:00pm in his office revealed staff #13 (MD) received a phone call from staff #4 on 8/8/2014 informing him that he was the Chief of Staff. It was not until then was he aware he was the Chief of Staff. Staff #13 was asked if he had been made aware of hospital occurrence regarding staff #19, Medical Director of Emergency Services, not reporting for his scheduled shift on 7/15/2014 in the emergency room . As a result, an internal disaster was declared. Staff #13 stated, "No." Staff #13 was asked if he had been made aware as a result of the internal disaster the emergency room was placed on divert. The hospitalized patients were discharged and an emergency room patient was transferred. Staff #13 stated, "No." Staff #13 was asked if he had been made aware on August 8, 2014 the facility lost electricity from the main service provider. As a result of this loss of power the emergency service was not able to provide lab services or x-ray services to the patients seeking emergency treatment. Staff #13 stated, "No."
VIOLATION: EMERGENCY SERVICES Tag No: A0092
Based on document review and interview the Governing Body failed to provide an organized Emergency Services Department.
On July 15, 2014 a scheduled emergency room Physician staff #19 (the Director of Emergency Services) did not report for his scheduled shift.
August 8, 2014 the facility lost electricity from the main service provider. As a result of this loss of power the emergency services was not able to provide lab services or x-ray services to the patients seeking emergency treatment.
An interview with staff #13 (MD) on 8/14/2014 at approximately 4:00 pm in his office revealed staff #13(MD) received a phone call from staff #4 on 8/8/2014 informing him that he was the Chief of Staff. It was not until then was he aware he was the Chief of Staff. Staff #13 was asked if he had been made aware of a hospital occurrence regarding staff #19, Medical Director of Emergency Services, not reportong for his scheduled shift on 7/15/2014 in the emergency room . As a result, an internal disaster was declared. Staff #13 stated, "No". Staff #13 was asked if he had been made aware as a result of the internal disaster the emergency room was placed on divert. The hospitalized patients were discharged and an emergency room patient was transferred. Staff #13 stated, "No." Staff #13 was asked if he had been made aware on August 8, 2014, the facility lost electricity from the main service provider. As a result of this loss of power the emergency service was not able to provide lab services or x-ray services to the patients seeking emergency treatment. Staff #13 stated, "No."
VIOLATION: PATIENT RIGHTS Tag No: A0115
Based on observation, document review and interview the facility failed to:

A. provide an organized Emergency Services Department.
Refer to tag A0092

B. provide a safe environment for patients to receive their health care.
Refer to tag A144

C. Sanitary and temperature controlled environment for the storage of medications.
Refer to tag A491, A500

D. provide lab services and x-ray services to patients seeking emergency treatment.
Refer to tag A0726

E. provide a Medical Director of Emergency Services
Refer to tag A

F. ensure Emergency Services supervised by a member of the medical staff..
Refer to tag A1111
VIOLATION: PATIENT RIGHTS: CARE IN SAFE SETTING Tag No: A0144
Based on observation, record review, and interview, the facility failed to ensure the surgical patients at facility "A" were receiving the same level of care at facility "B" on 6 ( #5,#6, #7, #8, #9, and #10) of 10 surgical patients.
A record review of the surgical patients' files revealed all the procedures were performed at the facility "A". A review of the surgical log revealed only patients #5, #6, #7, #8, #9, and #10 had procedures performed at facility "A". Staffs #4, #7, and #8 were asked where did patients #1, #2, #3, and #4 have their surgical procedure. Staff #4, #7, and #8 stated, "All these patients' files were from facility "B" and that was where the procedure was performed." Staffs #4, #7, and #8 were asked how you know the patients are from facility "B". Staff #4, #7, and #8 stated, "The patients' files in these 13 boxes stacked on the floor are from other facilities. The surgical files are from facility "B" because the facility "A" sticker has been placed over facility "B" name and if you look in facility "A" computer system, these patients will not be listed in the computer system." Staff #4 and #8 stated," All patients' files are brought from the other facilities to be scanned into facility "A" computer system for billing purposes.
A review of the surgical log revealed the last surgery was done on April 29, 2014 at facility "A".
A review of patients' records #1, #2, #3, and #4 revealed physicians #1 and #10 had performed the surgical procedure at facility "B".
An interview with the Staff #1 (owner) on 8/15/2014 at approximately 5:00PM revealed the following:
The owner was asked why surgical procedures were performed at another facility. The owner stated, "I am not comfortable doing surgical procedures on my patients at facility "A". There is no anesthesia provided at this facility." Owner was asked why you allow other patients having the same procedure to be performed at facility "A". The owner stated, "It is physician choice." The surveyor stated, "It may be physician choice, but you stated you are not comfortable with your patients having surgery at facility "A" but you are the owner and you are allowing different standards of care for the patients in this community." Owner stated, "I am uncomfortable with patients having surgery in facility "A" and not having anesthesia being provided. I have allowed physicians to do surgical procedures at facility "A".
VIOLATION: MEDICAL STAFF BYLAWS Tag No: A0353
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**

Based on observation, record review, and interview, the facility medical staff failed to ensure the bylaws were carried out with the physician's credentialing files containing the basic qualifications for membership to the medical staff on 7 (#13, 16, 17, 18, 20, 21, and #22) of 7 files reviewed. The facility also failed to follow the Medical Staff Bylaws and Medical Staff Rules and Regulations.
A review of physician #13's file revealed the certification of liability insurance had expired on July 5, 2014.
A review of physician #16's file revealed no proof of certification of liability insurance and no DEA/DPS controlled substances license. The Texas Medical Board order requested 100% review of all physician #16's medical records. A review of records found no documentation that the review had taken place. The medical executive committee had recommended the physician withdraw from membership and apply as a physician assistant under the supervision of physician #23. A review of record revealed no documentation that the physician #16 had been supervised as a physician assistant.
A review of physician #17's file revealed the certification of liability insurance had expired on [DATE].
A review of physician #18's file revealed the certification of liability insurance had expired on July 1, 2014.
A review of physician #20's file revealed in the Texas Standardized Credentialing Application no date of when the application was completed. It was also written in the application that the physician was not allowed to care for Medicaid patients. The physician was approved to medical staff to work as a hospitalist. The facility admits Medicaid patients for care to be provided. A review of the record revealed no proof of certification of liability insurance.
A review of physician #21's file revealed the certification of liability insurance had expired on [DATE].
A review of the contract emergency room physician #22's file revealed the certification of liability insurance had expired on [DATE].
A review of the record titled, "Medical Staff Bylaws and Medical Staff Rules and Regulations, Article III, NATURE OF MEDICAL STAFF MEMBERSHIP" revealed the following:
"Medical Staff membership is a privilege extended by the Hospital, and is not a right of any person. Membership on the Medical Staff shall be extended only to professionally competent Practitioners who continuously meet the qualifications, standards and requirements set forth in these Bylaws. Membership on the Medical Staff shall confer on the practitioner only such clinical privileges and prerogatives as have been granted by the Board in accordance with these Bylaws. No person shall admit patients to, or provide services to patients in the Hospital, unless he/she is a member of the Medical Staff with appropriate privileges as provided herein.

BASIC QUALIFICATIONS FOR MEMBERSHIP
(a) Basic Qualifications
The only people who shall qualify for membership on the Medical Staff are those practitioners legally licensed in Texas, who:
(1) Document their professional experience, background, education, training, demonstrated ability, current competence, and physical and mental health status with sufficient adequacy to demonstrate to the Medical Staff and the Board that any patient treated by them will receive quality care and that they are qualified to provide needed services within the Hospital;
(2) Are determined, on the basis of documented references, to adhere strictly to the ethics of their respective professions, to work cooperatively with others and to be willing to participate in the discharge of staff responsibilities;
(3) Comply and have complied with federal, state and local requirements, if any, for their medical practice, are not and have not been subject to any challenges to licensure, or loss of Medical Staff membership or privileges which will adversely affect their services to the Hospital;
(4) Have professional liability insurance that meets the requirements of
Section 14.1;
(5) Are graduates of an approved college holding appropriate osteopathic, allopathic, dental, or podiatric degrees;
(6) Have successfully completed an approved internship program or the equivalent where applicable;
(7) Maintain a good reputation in his/her professional community and have the ability to work successfully with other professionals and have the physical and mental health to adequately practice his/her profession;"

An interview with staff #7 on 8/15/2014 at approximately 6:00 PM confirmed the above findings.
VIOLATION: FORM AND RETENTION OF RECORDS Tag No: A0438
Based on observation, record review, and interview, the facility failed to secure patient records.

During a tour of the facility on 8/28/2014 at approximately 11:00 AM it was observed patients' medical records were in a closet without a door knob. The closet was open and accessible to anyone passing through the hallway. The medical records were in a cardboard box without any label. The lid was off so the patients' information was visible to anyone walking down the hallway. Across the hallway was an empty patient room filled with boxes of patients' information that was labeled complaints and grievances. The room was not secure.

An interview with Staff #3 on 8/28/2014 at 11:00 AM confirmed the above findings.
VIOLATION: PHARMACEUTICAL SERVICES Tag No: A0490
Based on documentation review and interview the facility failed to:
A. provide a sanitary and temperature controlled environment for the storage and administration of medications.
Refer to tag A491
B. maintain a temperature controlled environment for the safe storage of medications.
Refer to tag A500
VIOLATION: PHARMACY ADMINISTRATION Tag No: A0491
Based on observation, document review and interview the facility failed to provide a sanitary and temperature controlled environment for the storage and administration of medications.
A tour of the pharmacy was conducted on 8/28/2014 at approximately 1:00 PM. Upon entering the Pharmacy the temperature was elevated. The recorded temperature was 84 degrees. The staff reported the air conditioner had not been working correctly for about a month. An observation of the temperature log confirmed the report. Immediately above the entry door was an air vent. The air vent was stained with a black fuzzy substance. The tour continued to an adjoining room. A shelving unit was observed filled with medications. Directly above the shelving unit was an air vent that was covered with a black, fuzzy substance. The substance appeared to have drained down the wall, extending down the wall about eighteen inches. The tour continued across the hallway to the mixing/ compounding room. Upon entering the room a thermometer was visible and recorded ninety degrees. To the right of the door was a hand sink. The staff member reported the sink did not work. The staff member reported having to go down the hallway to wash hands.
A review of the "U.S. Pharmacopeia" revealed:

10.30.60. Controlled Room Temperature
" Controlled room temperature " indicates a temperature maintained thermostatically that encompasses the usual and customary working environment of 20? to 25? (68? to 77?F); that results in a mean kinetic temperature calculated to be not more than 25?; and that allows for excursions 15? and 30? (59? and 86?F) that are experienced in pharmacies, hospitals, and warehouses. Provided the kinetic temperature remains in the allowed range, transient spikes up to 40? are permitted as long as they do not exceed 24 hours.

Ideally, the controlled compounding rooms should be 66?F +/- 2? F to ensure employee comfort when fully garbed. Relative humidity (RH) recommendations should be between 30 and 65% RH. "
The staff #30 was present during the Pharmacy tour and confirmed the findings. Staff 30 reported that the director of environmental services had been notified numerous times about the elevated temperatures and "mold" on the walls and air vents. Staff #30 revealed the director of environmental services had been notified of the broken sink in the mixing/compounding room. Staff #30 revealed the fore mentioned items had been reported to the Pharmacy Director.
An interview with staff #29 confirmed the facility's Administration had been made aware of the broken air conditioner. Staff #29 confirmed because of the unstable and continued elevated temperatures in the Pharmacy, the efficacy of the medications could not be guaranteed.
An interview with staff #24 confirmed that Administration was aware of the broken air conditioner. Staff #24 confirmed knowledge of the "mold" on the walls and vents in the Pharmacy area. Staff #24 revealed the fan's housings on top of the roof were rusted and had penetrations that allowed rain water to enter the air ductwork and the water would flow out of the air vents into the Pharmacy.
VIOLATION: DELIVERY OF DRUGS Tag No: A0500
Based on record review and interview, the facility failed to maintain the "U.S. Pharmacopeia" recommended "controlled room temperature" of 68? to 77? Fahrenheit.
A review of the "U.S. Pharmacopeia" revealed:
10.30.60. Controlled Room Temperature
"Controlled room temperature" indicates a temperature maintained thermostatically that encompasses the usual and customary working environment of 20? to 25? (68? to 77?F); that results in a mean kinetic temperature calculated to be not more than 25?; and that allows for excursions 15? and 30? (59? and 86?F) that are experienced in pharmacies, hospitals, and warehouses. Provided the kinetic temperature remains in the allowed range, transient spikes up to 40? are permitted as long as they do not exceed 24 hours.

Ideally, the controlled compounding rooms should be 66F +/-2 F to ensure employee comfort when fully garbed. Relative humidity (RH) recommendations should be between 30 and 65 % RH. "
A review of the Pharmacy temperature log revealed the daily room temperatures for the month of August:
August 1, AM 80, PM 80
August 4, AM 80, PM 82
August 5, AM 82, PM 82
August 6, AM 80, PM 82
August 7, AM 82, PM 84
August 8, AM 82, PM 86
August 11, AM 88, PM 85
August 12, AM 82, PM 82
August 13, AM 80, PM 84
August 14, AM 80, PM 82
August 15, AM 80, PM 82
August 18, AM 82, PM 86
August 19, AM 82, PM 80
August 20, AM 82, PM 82
August 21, AM 80, PM 84
August 22, AM 84
August 25, AM 82, PM 86
August 26, AM 82, PM 82
August 27, AM 82, PM 86
August 28, AM 84

A review of the Compounding Room temperature log revealed the daily room for the month of August:
August 1, AM 76, PM 78
August 4, AM 78, PM 78
August 5, AM 80, PM 80
August 6, AM 80, PM 80
August 7, AM 80, PM 80
August 8, AM 80, PM 80
August 11, AM 90, PM 90
August 12, AM 86, PM 84
August 13, AM 84, PM 86
August 14, AM 78, PM 82
August 15, AM 80, PM 84
August 16, AM 82, PM 82
August 18, AM 82, PM 82
August 19, AM 82, PM 82
August 20, AM 80, PM 82
August 21, AM 84, PM 84
August 22, AM 80, PM 84
August 25, AM 84, PM 84
August 26, AM 80, PM 84
August 27, AM 82, PM 82
August 28, AM 84

An interview with staff #30 confirmed the accuracy of the temperature logs.

An interview with staff #29 confirmed the accuracy of the temperature logs. Staff #29 confirmed because of the unstable and continued elevated temperatures in the Pharmacy, the efficacy of the medications could not be guaranteed.
An interview with staff #24 and staff #25 confirmed the air conditioning was not working correctly.
VIOLATION: PHYSICAL ENVIRONMENT Tag No: A0700
Based on record review, observation, and interview, the facility failed to:
A. provide a safe environment for patients admitted to the hospital and to the patients seeking emergency care. The emergency exit doors were locked, preventing patients admitted to second floor from using exits in the case of an emergency. Fire doors were blocked open preventing them to close in the case of a fire.
Refer to tag A701
B. maintain the appropriate temperature to the facility's lab department and the facility's Radiology Department while on emergency generator power.
Refer to tag A726
C. maintain the temperature and storage of sterile and non-sterile patient supplies.
The facility also failed to maintain a clean and infectious free environment.

Refer to tag A726
VIOLATION: MAINTENANCE OF PHYSICAL PLANT Tag No: A0701
Based on observation and interview the facility failed to provide a safe environment for patients admitted to the hospital and to the patients seeking emergency care.
A. During a tour of the second floor patient care area on 8/15/2014 an attempt was made by the surveyor to use the stairs to exit the second floor. The doors leading to the stairs were observed to be locked. The nurse at the nurse's station was asked to unlock the door. The nurse's reply was she didn't have the code to unlock the door. The nurse stated all the exit doors were locked.

During a tour of the facility on 8/15/2014 at 12:40 PM the following was observed:
A doorway to the laboratory break room was propped open with a trash can in the main hospital hallway.
The double door to one of the patient care areas was half open and half closed. The magnetic fire alarm system that releases the doors when there is a fire in the building was not working properly.
The surgical doors to the operating rooms x 4 were propped open using surgical equipment.
On the main surgical hallway to the recovery room, the double doors were half open and half closed. The magnetic fire alarm system that releases the doors when there is a fire in the building was not working properly.
On the cabinet in the surgical area were 33 expired Foley catheters dated 5/2014 available to staff members.
The surgical area was not locked or secured. Access to the surgical area equipment and supplies were available to staff members and visitors.
The doorway from the surgical pre-op area had a computer sitting on the floor propping the door open. In the same doorway, was an extension cord connected to a fan sitting on the floor blowing cool air from the surgical area down the main hallway. The extension cord was lying completely across the doorway approximately 6 feet. Down the main hallway where the fan was blowing, there were also double doors that were propped open with fire extinguishers. At the end of the hallway was another fan sitting on the floor blowing air down another hallway.
An interview with staff member #5 on 8/15/2014 at 1:00 PM confirmed that doors were being propped open and fans on the floor in the hallway due to the air conditioner was not working in certain areas of the hospital.
An interview with staff #24 and staff #25 confirmed the doors were being propped open and fans on the floor in the hallway due to the air conditioner was not working in certain areas of the hospital.
A review of the NFPA (National Fire Protection Association), "Means of Egress" revealed:
"NFPA 101 defines "means of egress" as; any door or doors that serves as an exit from a room, area or building.

NFPA 101 further defines the characteristics for the doors, corridors and other exiting elements.

Access Control
Access control systems, designed to restrict access of people(coming into the area from the outside) through 'means of egress' doors, are permitted (in many code defined building occupancies) if the system is installed so that occupants are always able to exit the building in an emergency.

NFPA codes specifically require that electric locks "open" (unlock) upon;

Detection of approaching occupant by a request-to-exit (REX) motion detector
Activation of a manual release device (push button) located beside the door......

.....These NFPA code requirements typically apply to Electromagnetic Locks. Electric Strikes "avoid" the NFPA code requirements because an occupant can exit a door at any time by simply turning or pushing the latch/lever set. Electric strikes are most often used in a system that control entry through a door but do not control exit (egress) in the other direction."

An interview with staff #5 revealed the the second floor was once a pediatric patient unit and required egress to be controlled. When the facility converted the second floor to a Medical Surgical Unit the locks were not removed. Staff #5 confirmed the doors were locked.

B. An interview was held on 8/15/2014 at approximately 12:30 PM in the hallway of the facility with staff #26 confirming the facility's lab equipment was shut down on 8/8/2014 as a result of temperatures rising to an unsafe level in which the equipment would not operate correctly.
An interview was held on 8/15/2014 at approximately 11:30 AM in the hallway of the facility with staff #27 confirming the facility's Radiology equipment was shut down on 8/8/2014 as a result of temperatures rising to an unsafe level in which the equipment would not operate correctly.
An interview was held on 8/14/2014 at approximately 11:30 AM in the hallway of the facility with staff #25 confirming the facility's Radiology equipment and lab equipment was shut down on 8/8/2014 as a result of temperatures rising to an unsafe level in which the equipment would not operate correctly. Staff #25 confirmed the problem still exists if the facility needed to be placed on emergency power supplied by the generator.
An interview was held on 8/15/2014 at approximately 11:30 AM in the hallway of the facility with staff #24 confirming the facility's Radiology equipment and lab equipment was shut down on 8/8/2014 as a result of temperatures rising to an unsafe level in which the equipment would not operate correctly. Staff #24 confirmed the problem still exists if the facility needed to be placed on emergency power supplied by the generator.

It was determined this deficient practice created an Immediate Jeopardy situation and placed patients at risk and the likelihood of harm, serious injury, and subsequent death. These failed practices had the likelihood to affect all patients admitted to the facility.
VIOLATION: FIRE CONTROL PLANS Tag No: A0714
Based on observation, document review and interview the facility failed to implement the established Fire Response Plan.
The following was observed during a fire drill at the facility on 08/28/2014 at approximately 09:30AM. The fire alarm was pulled in the area of Administration.
In the area of Administration, office personnel gathered in the hallway holding their hands over their ears. Approximately 10 staff members were in the hallway. There was not an overhead call by the operator, announcing a fire drill. One staff member responded to the fire drill.
Fire drill rounds were made with the CEO staff #2 and plant operation staff #25. Immediately upon entering the obstetrical unit that was described by the CEO and the plant ops. personnel as being closed, the biohazard room door was observed open. The room contained approximately four large red container filled with biohazard material. All of the patient care room doors were open. Near the nurses' station a door was propped open with a blue tackle box. The blue tackle box contained needles and syringes. The room with the door propped open contained needles and syringes. A set of doors at the end of the hallway was open. The doors did not have fire alarm releases that would allow the doors to close during a fire or drill.
Just outside of the obstetrical unit an extension cord was observed lying in the floor of the hallway. The extension cord traveled between to two doors, exiting one and entering another. The extension cord was found to be supplying electricity to a computer tower. The metal door of the computer tower had been removed and was propped against the wall. Next to the metal door a plug receptacle had been removed from the wall and was dangling with exposed wires with in 0ne inch of the metal computer tower door.
The rounds continued to the front entry area of the hospital. The double doors that separated the emergency room from the lobby area did not operate correctly and close during the fire drill.
The rounds continued to the outside of the building where an employee's car was observed parked on the public sidewalk. The sidewalk was obstructed by the car. An employee's car was observed in a fire zone obstructing the fire valves. The fire valves were where the fire trucks would park to connect to the building and pump water to the selected area of the hospital in case of a fire.
On the second floor, patient care unit, the operator's announcement of a fire drill was not heard. The nursing staff on the second floor was observed closing patient doors at the beginning of the fire drill alarm. After staff closed some selected doors on the patient care unit, the staff retreated to the nurses' station leaving other doors open.
Staff was observed using the elevator during the fire drill. The double doors located near the elevator did not function correctly and close during the fire alarm.
The double doors entering Central supply was observed being propped open with a box during the fire drill.
A review of the document titled "Fire Drill Policy" revealed
"Procedure:
2. Fire Drills are conducted as realistically as possible ......
4. Employees who work in buildings where patients are housed or treated participate in drill according to Cleveland Regional Hospital Fire Response Plan ...."
A review of the document titled "Fire Response Plan" revealed
"IV. Procedures:
The Fire Plan should be implemented:
During a Fire Drill.

Staff response at the Area of the Fire: 1. R- Remove people from the fire Room or area. A- Sound the Alarm .... The verbal alarm, "Code Red" is announced overhead by the Switchboard Operator .....They will also announce on the overhead paging system, "Code Red" three times followed by the location as additional direction to responding staff. C- Contain the fire by closing the doors. This is a critical step to minimize the spread of smoke going into patient rooms. Closing all doors is a critical step to prevent additional deaths or illnesses. All room doors to corridors should be closed as quickly as practical, even if no smoke is evident ... ... 3. Elevators should not be used in the building where the fire is located unless directed to do so by the fire Department ..... 4. Staff location: Remain where you are during a fire or fire drill. To protect patients and staff, the fire doors will close automatically ..... Only a limited number of staff are designated to respond to the scene of the fire.

Staff Response Away From the Fire Zone: Staff in other areas of the hospital should take action upon announcement or activation of the fire alarm and should: 1. Close doors: This is a critical step in all areas because it will minimize the spread of smoke. Even if there is no smoke visible or no smoke odor, doors should be closed until the drill or activation is over. This includes all room doors, smoke and fire doors, doors to hazardous areas and doors to stairwells. 2. Check Equipment: Check fire extinguishers. pull stations and other fire response equipment ....

Fire Drills in the Hospital (Main Building)
In order to assure the safety of staff and patients all know their roles, fire drills are performed as required throughout the hospital. In each fire drill, staff is expected to react the same as they would in an actual fire situation.

Special Staff Roles during Fire Emergencies: The security officer will be detailed at the time of the alarm to report to the scene."

Staff #2 and staff #25 confirmed the fire drill findings at the time of the rounds.
VIOLATION: VENTILATION, LIGHT, TEMPERATURE CONTROLS Tag No: A0726
Based on record review, observation, and interview, the facility failed to:
A. maintain the appropriate temperature to the facility's lab department and the facility's Radiology Department while on emergency generator power. The lab temperature could not be maintained while on emergency generator power, causing the lab equipment to overheat and be shut down. The Radiology Department temperature could not be maintained while on emergency generator power, causing the radiology equipment to overheat and be shut down. The facility's CT (X-ray computed tomography) was not connected to the facility's emergency generator power. The facility could not provide lab services or radiology services to patients seeking medical care.
An interview was held on 8/15/2014 at approximately 12:30 PM in the hallway of the facility with staff #26 confirming the facility's lab equipment was shut down on 8/8/2014 as a result of temperatures rising to an unsafe level in which the equipment would not operate correctly.
An interview was held on 8/15/2014 at approximately 11:30 AM in the hallway of the facility with staff #27 confirming the facility's Radiology equipment was shut down on 8/8/2014 as a result of temperatures rising to an unsafe level in which the equipment would not operate correctly.
An interview was held on 8/14/2014 at approximately 11:30 AM in the hallway of the facility with staff #25 confirming the facility's Radiology equipment and lab equipment was shut down on 8/8/2014 as a result of temperatures rising to an unsafe level in which the equipment would not operate correctly. Staff #25 confirmed the problem still exists if the facility needed to be placed on emergency power supplied by the generator.
An interview was held on 8/15/2014 at approximately 11:30 AM in the hallway of the facility with staff #24 confirming the facility's Radiology equipment and lab equipment was shut down on 8/8/2014 as a result of temperatures rising to an unsafe level in which the equipment would not operate correctly. Staff #24 confirmed the problem still exists if the facility needed to be placed on emergency power supplied by the generator.
Based on a follow up visit made on 8/28/2014 the facility failed to maintain temperature in the Pharmacy.
A review of the "U.S. Pharmacopeia" revealed:
10.30.60. "Controlled Room Temperature" revealed the following:
"Controlled room temperature indicates a temperature maintained thermostatically that encompasses the usual and customary working environment of 20? to 25? (68? to 77?F); that results in a mean kinetic temperature calculated to be not more than 25?; and that allows for excursions 15? and 30? (59? and 86?F) that are experienced in pharmacies, hospitals, and warehouses. Provided the kinetic temperature remains in the allowed range, transient spikes up to 40? are permitted as long as they do not exceed 24 hours.
Ideally, the controlled compounding rooms should be 66?F +/- 2?F to ensure employee comfort when fully garbed. Relative humidity (RH) recommendations should be between 30 and 65 % RH."
A review of the Pharmacy temperature log revealed the daily room temperature for the month of August was as followed:

August 1, AM 80, PM 80
August 4, AM 80, PM 82
August 5, AM 82, PM 82
August 6, AM 80, PM 82
August 7, AM 82, PM 84
August 8, AM 82, PM 86
August 11, AM 88, PM 85
August 12, AM 82, PM 82
August 13, AM 80, PM 84
August 14, AM 80, PM 82
August 15, AM 80, PM 82
August 18, AM 82, PM 86
August 19, AM 82, PM 80
August 20, AM 82, PM 82
August 21, AM 80, PM 84
August 22, AM 84
August 25, AM 82, PM 86
August 26, AM 82, PM 82
August 27, AM 82, PM 86
August 28, AM 84

A review of the Compounding Room temperature log revealed the daily room temperature for the month of August was as followed:
August 1, AM 76, PM 78
August 4, AM 78, PM 78
August 5, AM 80, PM 80
August 6, AM 80, PM 80
August 7, AM 80, PM 80
August 8, AM 80, PM 80
August 11, AM 90, PM 90
August 12, AM 86, PM 84
August 13, AM 84, PM 86
August 14, AM 78, PM 82
August 15, AM 80, PM 84
August 16, AM 82, PM 82
August 18, AM 82, PM 82
August 19, AM 82, PM 82
August 20, AM 80, PM 82
August 21, AM 84, PM 84
August 22, AM 80, PM 84
August 25, AM 84, PM 84
August 26, AM 80, PM 84
August 27, AM 82, PM 82
August 28, AM 84

An interview with staff #30 confirmed the accuracy of the temperature logs.

An interview with staff #29 confirmed the accuracy of the temperature logs.

An interview with staff #24 and staff #25 confirmed the air conditioning was not working correctly.





B. During the follow-up survey from 8/27/2014 through 8/28/2014, the Immediate Jeopardy cited on the Conditions of Participation for Physical Environment was found to remain at the Immediate Jeopardy level.
Based on record review, observation, and interview, the facility failed to maintain the appropriate temperature and storage of sterile and non-sterile patient supplies.The facility also failed to maintain a clean and infectious free environment.

During a tour of the facility on 8/27/2014 at approximately 10:30 AM the following was observed:
Sterile and Non-sterile Supply Storage

During the tour of the patient supply area (which was a closed nursing unit), it was observed that there were numerous ceiling tiles stained with brown circles. The stains appeared to be water stains from leakage. Some of the ceiling tiles were missing and wires and plumbing were exposed with the likelihood to allow rodents to enter the building. The floors were unclean and dirty in appearance. Dead roaches were observed among the supplies that were lying on the floor.

The temperature was not being controlled. The air conditioning was not working where the patient's sterile and non-sterile supplies were being stored.
Observed in the hallway were 26 cardboard boxes stacked against the wall. Review of records found no evidence of temperature and humidity being monitored in this area where sterile supplies were being stored.
Numerous sterile and non-sterile supplies were being stored in the hallway of a nursing unit that was closed and also stored in 4 patient's rooms off this same hallway. The fire door to this hallway was propped open with a box of patient supplies. Among the supplies stored in the hallway were also stacks of empty opened cardboard boxes.
One of the rooms was so full of supplies the door would not fully open.
Numerous boxes of sterile supplies were being stored on the floor of the hallway. Laparotomy sponges (18 packages) used for abdominal surgery were out of the box lying on the floor.
There were 4 patient rooms filled with supplies. The supplies were found stored on wire racks without barriers on the bottom shelf. The supplies were covered in dust. There were numerous supplies on the floor with some of the supplies in boxes and some supplies were just lying on the floor. There were numerous (too many to count) external cardboard shipping boxes on the shelving stored above open patient supplies available for use. Expired supplies were mixed with current supplies. Also observed was a half empty box of sterile 4x4's on the floor. (It appeared the staff had been obtaining supplies from this box for patient use.)
In one of the supply storage room areas were two rusted drains in the ceiling which were dripping water into a rusted sink. Patient supplies were being stored on the shelf beside the sink. The wall in this same area had plaster peeling off 6x6 inch in size. In this same storage area was a commode full of feces. A wall in the storage area was missing a panel. The plumbing was completely exposed allowing rodents to enter this area. The floor was full of insulation, trash, and dust particles.
In one of the storage rooms an air conditioner filter that was dirty in color and covered in dust particles was observed.
In the area where the supply clerk checked and issued patient supplies, it was observed to be cluttered with open patient supplies, food, soda, and papers in disarray. On the back counter an open package of a partially eaten cookie was sitting beside patient supplies. On the same counter top a used copy toner was sitting beside patient supplies. On another back counter was an open bio-hazard container filled with needles and intravenous tubing with no lid. On the same counter were more patient supplies.
A review of the record titled, "OSHA Food and Beverage in Clinical Areas" revealed the following:"OSHA 1910.1030 and 1910.141, is aware that hospital staff work in an environment which when in clinical areas, have the potential for exposure to contaminated surfaces where infectious pathogens are present. These contaminants pose infection risk if an employee ingests food or drink which has been in contact with these surfaces."
A review of the record titled, "Association of Advanced Medical Instruments" revealed the following:

"External shipping containers have been exposed to unknown and potentially high microbial contamination. Also, shipping cartons, especially those made of corrugated material; serve as generators of and reservoirs for dust." (AAM1 ST46-Section 5.2 Receiving items).

An interview with the Chief Nursing Officer on 8/28/2014 at 10:30 AM confirmed the above findings.

Nursing Unit

During a tour of the nursing unit, it was observed that a light fixture in the ceiling did not have a cover. The fixture was covered with rust spots and had a burnt appearance. Also the temperature at the nursing station was noted to be warm and a rusted fan with no electric safety sticker was observed.

In a patient's room a fan with no electric safety sticker was observed. Patient was asked why there was a fan in the room. Patient stated, "Sometimes the air conditioner does not cool very well."

In an empty patient room it was observed the air conditioner was disassembled and the room temperature was warm.

In an empty patient room, an infusion pump with rust spots was observed and in need of preventive maintenance. The patient's bathroom floor appeared to be dirty and stained. Staff #31 was asked if this room was ready for a patient. Staff #31 stated, "Yes."

In the utility room an ice scoop in a cardboard bucket was observed. Beside the ice scoop bucket on an unclean cart was a cooler of ice. Staff # 31 was asked is this how patients get ice water. Staff #31 stated, "Yes." A review of policies revealed no policy or procedure for cleaning the ice scoop or the cooler.

An interview with Staff #31 on 8/28/2014 at 11:00 AM confirmed the above findings.

Clean Utility Room

During the tour of the clean utility room (on the nursing unit), the computer system for the telemetry unit was sitting in the middle of the room. The computer system was not encased and exposed wires were on the floor and protruding out the sides of the system. The system was in front of the door which made it hazardous to staff hitting the wires as they entered or exited the room. Also observed was a flexible duct blowing air directly onto the system. The ceiling tile was missing where the flexible duct was hanging from the ceiling. The floor was covered with trash, ceiling particles and dust particles. There was also an extension cord running to the plug. Sitting on top of the computer system was a spray can of electronic dust remover. The entrance to the clean utility room had a dislodged ceiling tile.

An interview with Staff #25 on 8/28/2014 at 11:23 AM confirmed the above findings.

Bio-Hazard Room

During the tour of the bio-hazard room (on the nursing unit), 8 packages of 100cc Normal saline on top of the bio-hazard container was observed. Beside the bio-hazard container was a stack of six cardboard boxes sitting on the floor. Staff #30 was asked why intravenous solutions were in the bio-hazard room. Staff #30 stated, "The fluids are expired and I haven't had time to dispose of them." The intravenous fluids were available to staff and employees for usage.

An interview with Staff #30 on 8/28/2014 at 3:00 PM confirmed the above findings.


Pharmacy Mixing Room

During a tour of the pharmacy, it was observed that the sink for washing hands prior to mixing medications was not working. Staff #30 was asked how you wash your hands prior to mixing medications. Staff #30 stated, "I have to go down the hall and then come back to the mixing room." The staff member had to open three doors before entering "the hood" room. The sink had not been fixed as of August 28, 2014.

A review of a record revealed Staff #30 had reported on March 19, 2014 the IV room (Intravenous Mixing room for medication) of the pharmacy had found "the hood" pushed to the middle of the room and the door behind the hood was propped open. Again on March 24, 2014 Staff #30 reported "the hood" was pushed to the middle of the room; but the door behind "the hood" was closed.

A review of the record titled, "Compliant Compounding Meeting USP 797 Pharmacy Regulations" revealed the following:
Maintaining the sterility of an environment where pharmaceuticals are prepared protects both patients and pharmacy staff. That is why the Food and Drug Administration (FDA), state boards of pharmacy and accrediting agencies such as the Joint Commission and the Pharmacy Compounding Accreditation Board enforce the standards of the United States Pharmacopeia's (USP's) General Chapter 797 Pharmaceutical Compounding-Sterile Preparations, which is commonly known as "USP 797".
A compliance action plan should include written procedures to standardize such tasks as gowning, gloving and hand washing. Also, compliance action plans should include a formalized cleaning plan. The main goal of the cleaning plan is to minimize air particulate contaminations introduced into the clean room environment by pharmacy staff and the products staff use. The plan should include scheduled cleanings of the anteroom and compounding area based on the classification of the room and surface area, as designated by the USP 797 guidelines."
An interview with staff #30 on 8/28/2014 at 3:00 PM stated, "I reported the occurrences to the pharmacist and environmental services."
An interview with the infection control nurse on 8/29/2014 at 10:00 AM confirmed she had not been informed that the pharmacy mixing room had been entered twice. She confirmed no infection control report had been written.
An interview with the CEO and Quality /Risk management staff on 8/28/2014 at 5:00 PM confirmed they were not notified of the occurrences.
It was determined this deficient practice created an Immediate Jeopardy situation and placed patients at risk and the likelihood of harm, serious injury, and subsequent death. These failed practices had the likelihood to affect all patients admitted to the facility
VIOLATION: INFECTION CONTROL Tag No: A0747
Based on observation, record review, and interview, the facility failed to provide a sanitary and infectious free environment. The facility failed to keep the pharmacy temperature regulated per the U.S. Pharmacopoeia's recommended "controlled room temperature" of 68 to 77 digress Fahrenheit. The facility also failed to maintain the appropriate temperature to the facility's lab department and the facility's Radiology Department while on emergency generator power.
Refer to TAG A0726
VIOLATION: EMERGENCY SERVICES Tag No: A1100
Based on interview the facility failed to:
A. provide an organized Emergency Services Department.
Refer to tag A0092
B. provide lab services and x-ray services to patients seeking emergency treatment.
Refer to tag A0726
C. provide a Medical Director of Emergency Services
Refer to tag A
D. ensure Emergency Services supervised by a member of the medical staff..
Refer to tag A1111
VIOLATION: ORGANIZATION OF EMERGENCY SERVICES Tag No: A1102
Based on interview the facility failed to provide a Medical Director of Emergency Services.
An interview on 8/14/2014 at approximately 09:55 AM with staff #2 in the Marketing Conference Room revealed staff #14 was the Medical Director of Emergency Services. Staff #2 was asked if staff #14 was a member of the Medical Staff, staff #2 replied "no." The regulatory requirement that the Emergency Service be under the directions of a qualified member of the medical staff was reviewed with staff #2. Staff #2 changed his response by saying staff #1 was the medical director of emergency services. Staff #2 was asked to provide documentation from the medical staff meetings of the governing body meetings assigning staff #1 as director of emergency services. No documentation was provided. Staff #2 revealed staff #14 did not have a valid medical license to practice medicine in the state of Texas.
An interview on 8/14/2014 at approximately 09:40 AM with staff #4 in the Marketing Conference Room revealed staff #14 was the Medical Director of Emergency Services.
An interview on 8/14/2014 at approximately 09:40 AM with staff #28 in the Marketing Conference Room revealed staff #14 was the Medical Director of Emergency Services.
An interview on 8/15/2014 at approximately 05:40 PM with staff #3 in the Marketing Conference Room revealed staff #14 was the Medical Director of Emergency Services.
An interview with staff #13(MD) on 8/14/2014 at approximately 4:00pm in his office revealed he did not know who the Medical Director of Emergency Services.
VIOLATION: SUPERVISION OF EMERGENCY SERVICES Tag No: A1111
Based on interview the facility failed to have Emergency Services supervised by a member of the medical staff..
An interview on 8/14/2014 at approximately 09:55 AM with staff #2 in the Marketing Conference Room revealed staff #14 was the Medical Director of Emergency Services. Staff #2 was asked if staff #14 was a member of the Medical Staff, staff #2 replied "No." The regulatory requirement the Emergency Service be under the directions of a qualified member of the medical staff was reviewed with staff #2. Staff #2 changed his response by saying staff #1 was the medical director of emergency services. Staff #2 was asked to provide documentation from the medical staff meetings of the governing body meetings assigning staff #1 as director of emergency services. No documentation was provided. Staff #2 revealed staff #14 did not have a valid medical license to practice medicine in the state of Texas.
An interview with staff #4 on 8/14/2014 at approximately 09:40 AM in the Marketing Conference Room revealed staff #14 was the Medical Director of Emergency Services.
An interview with staff #28 on 8/14/2014 at approximately 09:40 AM in the Marketing Conference Room revealed staff #14 was the Medical Director of Emergency Services.
An interview with staff #13(MD) on 8/14/2014 at approximately 4:00pm in his office revealed he did not know who the Medical Director of Emergency Services.
An interview with staff #3 on 8/15/2014 at approximately 05:40 PM in the Marketing Conference Room revealed staff #14 was the Medical Director of Emergency Services.