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Based on document review, policy and procedure review and staff interview, it was determined the hospital failed to:

a. inform patients and/or their representatives of all patient rights. See Tag A-0117;

b. provide an established and approved process for the management of patient complaints and grievances. See Tag A-0118;

c. ensure the Governing Body approved the complaint and grievance process. See Tag A-0119;

d. develop a process to notify patients/patients' representatives of the right for referral to the Quality Improvement Organization (QIO), the Oklahoma Foundation for Medical Quality, for concerns regarding care or early hospital discharge. See Tag A-0120;

e. ensure the process for submitting a complaint or grievance was clearly defined for the patient. See Tag A-0121;

f. ensure the written notice given in response to a grievance included the steps taken to investigate the issue and the results of the process. See Tag A-0123;

g. maintain surgical patients' privacy and dignity during the post operative period. See Tag A-0143;

h. ensure care was provided in a safe environment. See Tag A-0144; and

i. the hospital failed to develop and implement an effective policy to protect and prevent patient abuse by staff. See Tag A-0145.

Based on hospital documents and records reviewed, surveyors' observations and staff interviews, the hospital failed to ensure nursing service provides a safe delivery of patient care.

Findings:

1. The hospital failed to ensure the Chief Nursing Officer staffed all nursing areas when patients were present. Refer to Tag A-0386.

2. The hospital failed to ensure trained registered nurses were available for immediate bedside care and supervision of patients on all specialty units. Refer to Tag A-0392.

3. The hospital failed to ensure nursing staff were adequately trained, oriented and have demonstrated skills competencies for their assigned patient care areas. See Tag A 0397;

Based on observation, record review and staff interview, it was determined the hospital failed to:

a. ensure the condition of the hospital was maintained for the safety and well-being of patients. See Tag A-0701;

b. develop, approve and implement emergency preparedness plans. See Tag A-0701;

c. provide routine and preventive maintenance and testing for all medical equipment and for all mechanical systems of the physical plant. See Life Safety Code Survey Tag K-0130;

d. comply with the applicable provisions of the Life Safety Code for emergency lighting and power. See Tag A-0702;

e. ensure proper storage and disposal of biohazardous waste. See Tag A-0713;

f. ensure therapeutic facilities were provided in areas specifically designed for those purposes. See Tag A 0723;

g. identify equipment in need of repair and ensure it was tagged and taken out of service. See Tag A-0724;

h. maintain supplies and equipment to ensure safety and quality. See Tag A-0724; and

i. failed to monitor and maintain temperature, humidity and airflow in the operating rooms. See Life Safety Code Survey Tag K-0067.

Based on observation, interviews with staff and review of hospital documentation, the hospital failed to maintain an active ongoing program to prevent, control, and investigate infections and communicable diseases to minimize infections and communicable diseases in patients and staff.

Findings:

1. The staff identified as the infection control preventionist, Staff T, has not had training in establishing and maintaining an effective ongoing infection control program. Staff D, the person identified as helping educate Staff T did not have has not had ongoing training in establishing and maintaining an effective ongoing infection control program. (Refer to Tag A - 748)

2. The infection control practitioner has not ensured that infection control policies and procedures have been developed for each unit/area of the hospital and reflect current standards of practice. (Refer to Tag A-748)

3. The disinfectants used throughout the hospital have not been reviewed and approved by the hospital's Infection Control committee through the quality program. (Refer to Tag A-749)

4. The hospital does not have an ongoing infection control program that reviews hospital practices and infections/communicable diseases, analyzes data on these practices and infections, develops qualitative plans of actions to and provides follow-up to ensure corrective actions are appropriate, working and sustained. (Refer to Tag A-749).

5. Leadership does not ensure infection control concerns and issues are identified, reviewed, analyzed and corrective actions are taken through the quality assessment and performance improvement process. (Refer to Tag A-756).

6. The operating room was not cleaned and disinfected between every surgery patient. On 09/18/13, a surgery patient was brought into the operating room when contaminated instruments, supplies and trash used on the previous patient were still set up in the room. Eventually those items were removed from the room, however, the room was not cleaned and no surfaces were disinfected for the new patient already in the room.

7. Sterile instruments and supplies for the next surgery case were brought into the operating room while surgery was being performed.

8. When the OR staff did use the disinfectant agent TB Cide, it was not properly applied. It required a five minute contact time. The staff did not thoroughly wet the surface and did not allow it to remain for more than a few seconds.

9. Alcohol-based hand sanitizer was not available to staff inside the individual operating rooms. Operating room staff did not sanitize their hands as required after removing contaminated gloves or after touching potentially contaminated surfaces. If staff chose to use hand sanitizer, they had to leave the OR to obtain it.

10. Handwashing sinks were not provided in the surgical instrument decontamination room, the endoscope decontamination room and in the sterile processing room. The handwashing sink in the endoscopy procedure room was not designed to be used "hands-free" as required.

11. Surgical instruments processed for sterilization by the hospital did not conform to national standards. Surgical instruments were double-packaged incorrectly for sterilization. The inner packages were too large and were folded to fit.

12. Internal chemical indicators of adequate sterilization were not used in peel packs. External chemical indicators were not used so that sterile versus non-sterile items could be easily identified by staff.

13. Sterile items were stored incorrectly and were at risk for contamination. For example, multiple peel packs were stuffed into large plastic bags. The sterile peel packs were crushed, bent and compressed. The staff said these plastic bags were set up "for emergency cases."

14. Wrapped instrument sets were stored on solid metal shelves inside closed cabinets. The shelves were dirty and showed evidence of rust and other dried contaminants. Heavy instrument sets were stacked on top of each other.

15. Outside shipping containers and corrugated cartons were used to store items in the sterile supply room and in the operating rooms.

16. Sterile and non-sterile items were stored together.

17. Sterile surgical supplies in the surgery department were not stored where temperature and humidity was monitored and controlled. The surgery sterile supply room did not have adequate air exchanges.

18. Surgery sterile and clean items were stored close to the floor, on the floor, touching outside walls, and less than two inches from the ceiling. Items stored on bottom shelves were not protected from housekeeping activities.

19. The hospital had inadequate records of sterilization. The hospital did not label each sterile product with a lot control identifier. Immediate use steam sterilization loads were not documented appropriately. Each sterilization cycle did not have adequate information documented, such as:

lot number
specific contents of the load: quantity, department, and description
exposure time/temperature
the name of the operator
biological or Bowie-Dick testing and results, if applicable

20. Non-hospital staff were allowed to process surgical instruments without authorization from the medical staff and without verification of competency to perform those tasks. The hospital had no policies for the special care, cleaning and sterilization of eye instruments.

21. The room used for sterile instrument processing was dirty, cluttered and in disrepair. Staff food and drink items were observed in this area. There was evidence of insect infestation. The sterile processing room was open and shared air exchanges with the decontamination room.

22. Surgical endoscopes were processed in an area too small and inadequately designed for the task. This allowed for cross-contamination when high level disinfection was performed. The endoscope decontamination room was open and shared air exchanges with the clean endoscopy procedure room.

23. The endoscope decontamination room was not terminally cleaned. Feces-contaminated irrigation/flushing water was observed in a wall-mounted suction container after endoscopes had been processed for the day. The contaminated water remained there during two days of the survey.

24. The cabinet used to store clean endoscopes was dirty. The floor of the cabinet was lined with white towels that had evidence of brown drips on them. Cardboard containers were stored in the bottom of the cabinet had evidence of the same brown, liquid stains on them.

25. The hospital did not keep adequate records of endoscope disinfection.

26. Clean and contaminated equipment and supplies were stored together in various areas throughout the hospital.

27. Medical equipment was not adequately disinfected between patients. Observations were made of multiple staff failures to clean/disinfect equipment between patients. A bolster, wrapped in a pillowcase, was used to support patients' knees during surgery. The pillowcase was not removed, the bolster cleaned, and a clean pillowcase put on, between patients.

28. Single patient use items were reused on multiple patients. For example, disposable pillows and disposable foam head positioners for surgery were reused between patients. Neither of these items could be disinfected between patients.

29. The operating room set up to perform cesarean sections was not adequately cleaned. A blood pressure cuff attached to the anesthesia machine was hanging on the floor. The infant warmer in the OR was not cleaned. Unnecessary supplies and equipment were in the room and did not have evidence they were terminally cleaned between surgical cases.

30. None of the surgical department areas had evidence of deep cleaning and floor maintenance.

31. Labor and delivery rooms designated as ready for use were not adequately cleaned.

32. The hospital did not have a process for receiving and storing surgical supplies and equipment that conformed to infection control standards. Surgery supplies shipped to the hospital were received directly into the surgical department without unpacking. Corrugated shipping boxes were found in all areas of the surgery department, including the operating rooms.

33. A large contaminated needle collection box was open, sitting on the floor and accessible to patients and visitors in the labor and delivery area. The labor and delivery area had no identified biohazardous waste room. There was no area identified to handle contaminated linens and regular trash.

34. Full needle collection containers were observed in patient rooms on the medical-surgical unit.

35. Operating room table padding was cracked and torn, exposing the inner foam that could not be adequately disinfected between patients.

36. There were mimimal policies to guide staff on the special infection control requirements for the surgery department. The few policies available were outdated and did not reflect current standards and guidelines from professional infection control organizations.

Based on observation, record review and staff interview, it was determined the hospital failed to provide surgical services according to acceptable standards of practice as evidenced by:

a. The hospital did not consider endoscopy procedures to be surgery. The endoscopy procedure room and it's associated services were not organized as a part of the hospital's surgery department and were not supervised by an experienced registered nurse. See Tags A-0941 and A-0942.

b. Surgical services policies and procedures were not based on Federal and State regulations and guidelines, nor based on nationally recognized professional organization standards and recommendations. They were not approved by the chief of surgery, the medical staff and the governing body. See Tag A-0951.

c. A circulating nurse was not assigned to all surgical procedures. The hospital did not ensure that non-hospital technicians assisting the circulating nurses were qualified to do so. See Tag A-0944.

d. The surgical services department did not maintain a roster of practitioners with surgical privileges or those with suspended or restricted privileges. See Tag A-0945.

e. The surgery department did not provide and maintain emergency equipment as required. See Tag A-0956.

f. The hospital failed to provide post-operative care in accordance with acceptable standards of practice. See Tag A-0957.

g. The hospital failed to provide an operating room register with all the required elements. See Tag A-0958.

h. Inpatient and outpatient surgical services were not included in the hospital's QAPI program.

i. Observations were made of breaks in aseptic and sterile technique during surgical procedures.

j. Observations were made when there was no cleaning between surgical cases. When there was cleaning performed, it was not carried out appropriately. The staff did not perform terminal cleaning adequately.

k. Equipment was available for sterilization, but it was not monitored, inspected, tested and maintained by the hospital's biomedical program. There was no evidence the surgery staff followed the manufacturer's recommendations for the use of the equipment.

l. Sterilized materials were not packaged, handled, labeled and stored in a manner to maintain sterility. Sterilized materials were subjected to moisture and dust.

m. Temperature, air exchanges and humidity in the surgery department was not maintained within acceptable parameters.

Based on observation, document review and staff interview, it was determined the hospital failed to provide anesthesia services in a well organized manner. Findings:

On 09/17/13 and 09/18/13 observations were made of the areas where anesthesia/analgesia care was provided and where patients received pre and post anesthesia care.

The surgery staff were asked about the supplies and medications to manage malignant hyperthermia. They stated they used to surgery department crash cart. It was observed the cart contained only six vials of dantrolene. (Up to 36 vials may be needed.) There were insufficient types and amounts of supplies and equipment necessary for the management of this emergency. The OR did not stock cold IV solutions and sterile irrigation fluids for the treatment of malignant hyperthermia crisis.

The staff in the emergency department stated that anesthesia/analgesia care was provided by the staff in surgery and in the emergency department. The staff stated conscious sedation was provided in the endoscopy room that was also within the emergency department.

The staff stated the emergency department staff were responsible for the endoscopy room. It was observed that the room did not have an emergency cart. Staff stated they relied on the emergency department's cart for cardiac and respiratory emergencies in the endoscopy room.

The patient care coordinator was asked if the hospital had policies and procedures for rescue of patients who inadvertently became sedated at a deeper level than intended, such as moderate sedation patients who became deeply sedated. She stated she did not know about that and the surgery staff would have to answer that question.

Nurses who provided conscious sedation were asked about rescue capabilities. They stated they did not know the specifics on that. They stated they were unsure if a policy or protocol existed for that. They stated they did obtain some emergency medications to have on stand-by when they gave conscious sedation to patients.

No rescue policy was provided.

None of the files reviewed for the registered nurses who provided conscious sedation had documentation of annual training and skills competency evaluation to perform this function.

The staff stated CRNAs provided anesthesia and there was no anesthesiologist on staff. They stated some of the CRNAs were employed by the hospital and some others came from an out of town group to provide anesthesia services when one physician came to perform endoscopy procedures.

The staff was asked who coordinated anesthesia services. They stated they did not know. No anesthesia department organizational chart was available. The staff did not know who was identified as the chairman of anesthesia services. There was no document provided that reflected the responsibilities of the department chairman.

The surgery manager was asked who was responsible for oversight of the nursing care provided pre and post anesthesia. She stated, "I guess I am."

She was asked where patients recovered from procedures. She stated some patients were recovered in the area within the emergency department identified as the "recovery room." This room was also used for emergency department patient "overflow" beds.

The manager responsible for endoscopy procedures stated endoscopy patients recovered in outpatient clinic examination rooms.

The hospital did not have current policies and procedures that reflected the anesthesia services provided by the hospital. There were no current policies and procedures for the provision of pre and post anesthesia care.

There was no documentation anesthesia services policies and procedures were based on nation standards and guidelines.

Anesthesia services were not included in the hospital's QAPI program.

Based on hospital document review, record review and staff interview, the hospital's governing body failed to ensure medical staff requirements were met. This occurred in one (HH) of two records reviewed.

Findings:

1. The Governing Body failed to ensure all medical staff had evidence of current licensure. There was no documentation of a current license in Staff HH's personnel file.

2. The Governing Body failed to ensure the medical staff had evidence of current training such as advance cardiac life support (ACLS), pediatric advance life support (PALS), and basic life support (BLS). There was no documentation of ACLS, PALS, and BLS in Staff
HH's personnel file.

a. On the morning of 09/18/13, the chief nursing officer (CNO) provided surveyors with a hospital policy and procedure titled, "Procedural Sedation and Analgesia" that documented, "...all physicians intending to perform procedural sedation in the ED will show competence by education, training or both..."

b. Staff HH told surveyors, "I perform colonoscopies and endoscopic procedures Monday through Thursday, from 0630 to about 0900 in the emergency department procedure room. On Tuesdays and Fridays I perform general surgery procedures."

3. On the afternoon of 09/18/13, the Chief Nursing Officer (CNO) verified that the medical staff personnel files were complete.

Based on review of personnel and credential files and hospital staff interview, the hospital does not ensure that personnel providing patient care services under contract have competencies, orientation to the hospital, immunization history, current licensure and background checks as required for hospital employees.

Findings:
Dietitian, rehabilitation and radiology services are provided by contracted staff, these employees did not have evidence of orientation, competencies, an immunization history, or current licensure.

Staff F was the consultant pharmacist there was no evidence of orientation, competency and current licensure.

On the morning of 9/17/13, Staff D stated the hospital did not maintain personnel, educational and health files on contracted staff.

Based on document review, observation, and staff interview, it was determined the hospital failed to inform patients and or their representatives of all patient rights.

Findings:

1. On 09/17/13, the hospital administrative staff were asked to provide all patient rights information given to patients at the time of registration.

2. Staff provided an inpatient and an observation patient folder that did not include information about the complaint/grievance process.

3. Staff (X, LL through OO) stated outpatients did not receive the patient bill of rights information for emergency department (ED) services.

4. Two (#5 and #6) of two medical records reviewed had no documentation the patients received patient's rights information.

Based on policy and procedure review, document review, and staff interview, the hospital failed to provide an established and approved process for the management of patient complaints and grievances.

Findings:

1. On 09/17/13, the hospital's grievance policy was reviewed. The policy had no documentation it had been approved.

2. The policy did not distinguish between a complaint and a grievance.

3. The policy did not provide the patient or patient ' s representative with a phone number, address, and website for filing a complaint or grievance with the State agency.

4. The hospital's policy did not document patients could contact the QIO or State Agency directly to file a grievance.

5. The policy did not include information that informed the complainant of the right to seek review by the Quality Improvement Organization (QIO).

6. A document provided by the hospital's administrative staff titled, " An Important Message from Medicare About your Rights " documented incorrect contact information for the QIO.

7. On the afternoon of 09/17/13, surveyors observed a posted document titled, "Patient Rights and Responsibilities" in the emergency department / outpatient lobby. The notice contained incorrect contact information for the State Agency for filing complaints and grievances.

8. A review of patient rights handouts and admission packets had no documentation patients were given State Agency contact information (including the OSDH website, for lodging complaints and grievances).

9. There was no documentation the hospital reviewed grievances through the Quality Improvement Committee.

10. The surveyors verified these findings with the Director of Patient Care and the Chief Nursing Officer (CNO) at the time of review.

Based on policy and procedure review, document review and staff interview, it was determined the hospital failed to ensure the Governing Body approved the complaint and grievance process.

Findings:

1. On 09/17/13, the chief nursing officer (CNO) was asked to provide governing body meeting minutes for the past year. Over the course of the survey, the governing body meeting minutes were reviewed.

2. There was no documentation in the meeting minutes that indicated the governing body reviewed and approved the hospital's grievance process.

3. The hospital's grievance policy was not signed as approved by any entity.

4. There was no documentation the governing body reviewed grievance, complaints, and incidents.

5. There was no documentation of a grievance committee.

6. The Chief Nursing Officer (CNO) told surveyors she handled complaints and grievances.

7. There was no documentation the grievance and complaint information was reviewed and analyzed to improve care.

8. There was no documentation staff members were trained on the complaint and grievance process.

Based on review of patient information handouts, patient rights documents, review of policies and procedures and interviews with hospital staff, it was determined the hospital failed to develop a process to notify patients/patients' representatives of the right for referral to the Quality Improvement Organization (QIO), the Oklahoma Foundation for Medical Quality, for concerns regarding care or early hospital discharge.

Findings:

1. On the afternoon of 09/18/13, patient information handouts, forms, and posted signage in the emergency department (ED) / outpatient waiting area did not provide notification to the patient or patient's representative that they could ask for a QIO review if they had concerns regarding quality of care provided or premature discharge. The CNO and Director of Patient Care verified this at the time of the hospital facility tour.

2. A hospital document, titled, "An Important Message from Medicare About your Rights" documented incorrect contact information for the QIO.

3. Hospital policies did not include documentation that patients/patients' representatives were provided information regarding complaints to the QIO.

4. The CNO and Director of Patient Care verified this at the time of document review.

Based on a review of policies and procedures and staff interviews, it was determined the hospital failed to ensure the process for submitting a complaint or grievance was clearly defined for the patient.

Findings:

1. The hospital policy does not correctly define a grievance with all the required elements.

2. A policy titled, "Patient Grievance/Complaint Process" documented, "...A significant grievance/complaint is defined as one that involves patient concerns regarding quality of care or premature discharge. Written or verbal grievances/complaints by patients, family members or representatives of the patient will be received, reviewed, and resolved if at all possible..."

3. The hospital policy did not clearly explain how the grievance process worked.

4. The hospital inpatient admission packet and the observation admission packet had different sets of patient rights information.

5. The Director of Patient Care and the Chief Nursing Officer (CNO) verified that this was the patient rights information given to patients.

Based on document review, policy and procedure review and staff interview, it was determined the hospital failed to ensure the written notice given in response to a grievance included the steps taken to investigate the issue and the results of the process.

Findings:

Complaints and grievances were reviewed for 2012 and 2013. The written responses given did not include the investigative steps and the outcome of the investigation.

Some grievances had no documentation of a written response to the complainant.

The CNO, who was responsible for this process, confirmed this finding.

Based on observation and staff interview, it was determined the hospital failed to maintain surgical patients' privacy and dignity during the post operative period.

Findings:

On 09/17/13, observations were made of the hospital's recovery room. This room was located within the emergency department and was not located in a separate area of the hospital. The recovery room was a considerable distance from the operating room.

The staff explained that when surgery patients left the operating room, they were transported through hospital public hallways, past public waiting areas and into the emergency department. Sedated and unconscious patients were exposed to observation by patients and visitors.

Once in the emergency department, surgery patients were placed in the recovery room. The recovery room was open and could be visualized from the emergency department nurses' station and was visible to other patients and visitors in the emergency department.

Recovering patients, including endoscopy patients who frequently need to use the restroom, were required to use the emergency department restroom shared by emergency patients and families.

Based on review of hospital documents, surveyors' observations, and staff interviews, the hospital failed to ensure care was provided in a safe environment. This was found throughout the hospital environment.

Findings:

1. On the afternoon of 09/18/13 and the morning of 09/19/13, a first-time mother, Patient #4, and newborn were on an enclosed, locked unit without a nurse assigned to the unit for immediate bedside care. The patient had delivered at 1300 on 09/18/13.

2. On 09/18/13 at 1700, Staff EE told the surveyors that once obstetric patients had delivered and recovered from anesthesia, they were routinely left on the unit with no nursing staff assigned to the unit.

3. On the afternoon of 09/18/13, the surveyors observed a open sharps container over half-filled with used needles and syringes in the nursing area between the two labor and delivery patient rooms. With no nursing staff present on the unit, visitors have access to this area.

4. Sterile and clean equipment and supplies are stored in the same area/room as dirty. (Refer to Tag A-749 for details).

5. Staff O, W, X, Y, Z, LL, MM, and OO did not know the manufacturer's recommended time the disinfectant must remain wet on the surface to be effective.

6. The disinfectant used in the endoscope room (this room was also used an an ER when endoscopy procedures were not being performed), is not effective against Clostridium difficile, the most prevalent organism for colonoscopies.

7. The hospital failed to ensure correct ventilation is maintain in the surgical and endoscopy work areas.

8. Surveyors were told that post endoscopy patients were taken from the procedure room and recovered on an examination table in a clinic room or in a wheelchair. Staff stated only occasionally were patients recovered on a carrier. The examination tables did not have side rails for safety.

Based on document review, policy and procedure review and staff interview, it was determined the hospital failed to develop and implement an effective policy to protect and prevent patient abuse by staff.

Findings:

A hospital policy, titled, "Patient Abuse or Neglect By Employee," did not document a pre-employment screening process that checked for a record of abuse or neglect.

Another policy, titled, "Criminal Background Record," documented, "... all persons who have accepted a conditional job will undergo a criminal background check which will include: criminal history, licensure/certification verification, OIG (Office of Inspector General) Medicare/Medicaid sanction report and a check of the nurse aide registry..."

Sixteen of sixteen employee files reviewed for background investigation had no evidence this had been done. There was no documentation of a criminal background check or a check of the state's nurse aide registry.

Staff were asked if the employee files were complete. They stated they were.

On 09/17/13, the hospital administrative staff was asked to provide the hospital's abuse policy. The policy did not properly specify what training employees received to prevent, identify, and report abuse.

Review of thirteen of thirteen employee training files did not contain evidence of abuse training.

Based on document review, surveyors' observations and staff interviews, the director of the nursing service (Chief Nursing Officer/CNO) did not ensure all nursing areas of the hospital were:

a. Staffed with trained nurses, and
b. Staffed to ensure the the immediate availability of a registered nurse for bedside care on each unit.

Findings:

1. On the afternoon of 09/18/13 and the morning of 09/19/13, a first-time mother, Patient #4, and her newborn were on an enclosed, locked unit without a nurse assigned to the unit for immediate bedside care. The patient had had delivered at 1300 on 09/18/13.

2. On 09/18/13 at 1700, Staff EE told the surveyors that once obstetric patients had delivered and recovered from anesthesia, they were routinely left on the unit with no nursing staff assigned to the unit.

3. On the morning of 09/19/13, the CNO was aware of the lack of assigned staff to the locked obstetric unit. At the time the surveyors left on 09/19/13 after 1100, patient census and staffing on the obstetric's unit remained the same.

4. Nurses assigned to pharmacy, discharge planning, surgery, endoscopy, and emergency room did not have demonstrated competency to perform those assigned positions. Refer to Tag A-397.

Based on surveyors' observations and staff interviews, the hospital failed to ensure a registered nurse was immediately available for bedside care on the locked obstetric unit.

Findings:

1. On the afternoon of 09/18/13 and the morning of 09/19/13, a first-time mother, Patient #4, and her newborn were on an enclosed, locked unit without a nurse assigned to the unit for immediate bedside care. The patient had had delivered at 1300 on 09/18/13.

2. On 09/18/13 at 1700, Staff EE told the surveyors that once obstetric patients had delivered and recovered from anesthesia, they were routinely left on the unit with no nursing staff assigned to the unit.

3. After the observation on 09/18/13, the surveyors relayed to the administrator that having patients on a locked unit without nursing staff on the unit and immediately available was not a safe situation. At the time the surveyors left on 09/19/13 after 1100, patient census and staffing on the obstetric's unit remained the same.

Based on hospital document review, record review, and staff interview, it was determined the hospital failed to ensure nursing personnel had valid and current licensure. This occurred in six (Staff X, BB, LL through Staff OO) of six personnel files reviewed. On the afternoon of 09/18/13, the chief nursing officer (CNO) verified that hospital personnel files were complete.

Based on review of hospital documents personnel files, and medical records and staff interviews, the hospital failed to ensure nursing staff are licensed, adequately trained, oriented and have demonstrated competencies for their assigned care areas and are competent to provide care to meet the needs of the patients. This occurred in of ten (Staff Q, R, T, X, BB, GG, LL, MM, NN, and OO) of twelve nursing personnel files reviewed.

Findings:

1. Six (Staff X, BB, LL through Staff OO) personnel records reviewed did not have a current license.

2. Staff S was designated as the Drug Room Supervisor/Pharmacy department manager, Staff Q and R was designated as Drug Room/Pharmacy Tech. Review of their personnel files did not contain evidence competency evaluations and orientation by the Consultant Pharmacist, specific for the duties they performed in the drug room.

3. On 09/17/13, Staff D stated to the surveyors that Staff T was the discharge planner. Review of Staff T ' s personnel file had no evidence of prior job experience, specialized training or continuing education as a discharge planner.

4. Staff T was also designated as the infection control practitioner. Review of Staff T's personnel file did not show training in establishing and maintaining an effective ongoing infection control program. This findings was confirmed with Staff D.

5. Craig General Hospital's website documented, concerning the emergency room, "...Our nurses maintain advanced cardiac life support training..."

Six (Staff X, BB, LL through Staff OO) personnel records reviewed for this, did not have cardiopulmonary resuscitation (CPR) and did not have advanced cardiac life support (ACLS).

6. On the morning of 09/18/13, the chief nursing officer (CNO) provided surveyors with a hospital policy and procedure titled, "Procedural Sedation and Analgesia" that documented, "...Nursing staff should be required to show competence to perform appropriate monitoring and should undergo annual evaluation of the same..."
a. Nursing files reviewed for this did not contain this competency.
b. On the afternoon of 09/18/13, the chief nursing officer (CNO) verified that hospital personnel files were complete.

7. The registered nurse identified as the nurse in charge of endoscopy, Staff X, had no documentation of prior experience and training in endoscopy or surgery. She stated she had been trained by a product representative on endoscope cleaning.

8. The surgery department manager, Staff GG, stated she had several years experience in surgery. The personnel file did not contain a resume and did not have any documentation of prior experience in surgery and/or management.

Based on review of medical records, hospital documents, and staff interview, the facility failed to ensure medical orders were timed by a practitioner authorized to write orders for care. This occurred in two (#5, #6) of two emergency department (ED) medical records reviewed.

Findings:

1. Two ED medical records reviewed were not timed by a practitioner authorized to write orders for care.

2. On the afternoon of 09/18/13, the ED Director told surveyors, "I do not have to write a time when I write the order; the time is authenticated when the clerk or nurse puts the order in the computer."

3. On the afternoon of 09/18/13, the chief nursing officer (CNO) and ED nurse manager verified that there was no documented time by the ordering practitioner.

Based on observation and staff interview, it was determined the hospital failed to ensure medications were stored in a manner to maintain safety and to prevent contamination.

Findings:

1. Medications were not stored correctly in the operating room. On 09/18/13, observations were made of the following:

~Multiple open vials of medications were found inside one operating room. None of the medications had been labeled with the date they were first opened.
~Internal medications were stored with external medications. Eye medications were stored with ear medications.
~Containers of formalin were stored with medications.
~A large bottle of phenol was stored with injectable medications.
~Lugol's solution, ferric sulfate and rubbing alcohol were stored with medications.
~Expired hydrogen peroxide was found with internal medications.
~Marcaine was found inside a box labeled lidocaine.
~Medications were stored in an unlocked supply cabinet in the OR hallway
~IV fluids were stored in the original shipping boxes on the bottom shelf of a supply cabinet. The IV fluids were found stored with SCD machines and other equipment.

The surgery manager was asked if the drug room supervisor checked medications in the operating room. She stated, "Sometimes."

It was observed that the anesthesia carts where medications were stored was locked. The surgery manager was asked if the drug room supervisor checked medications in those carts. She stated, "The pharmacy asked for keys to these carts so they could check them, but they were not given keys." She further stated only the CRNAs had keys to the anesthesia carts.

2. Medications were not stored correctly in the emergency department. On the afternoon of 09/17/13, the following observations were made:

~A box of normal saline one liter bags was stored in an unsecured dirty utility room in the emergency department, directly next to the hopper (a receptacle to flush feces, vomit, and urine).

~Open topical lubricant was left on top of a sharps container unsecured and not monitored in the pre-operative/post-operative area.

~Open injectable xylocaine, lidocaine with epinephrine, and normal saline was left on top of the anesthesia regional block cart unsecured and not monitored in the pre-operative/post-operative area.

~Open injectable Sodium Bicarbonate and sterile sodium chloride was left on top of the paper shred box unsecured and not monitored.

Based on record review and staff interview, the hospital does not ensure the consultant pharmacist coordinates all the activities, supervises and evaluates the performance and competency of pharmacy personnel who provide pharmacy services when the Consultant Pharmacist is not on the premises. Three (Q, R and S) of three pharmacy/drug room personnel files reviewed did not have evidence of competency evaluations and orientation specifically for the pharmacy/drug room by the Consultant Pharmacist/Pharmacist in Charge.

Findings:

Staff S was designated as the Drug Room Supervisor/Pharmacy department manager, Staff Q and R was designated as Drug Room/Pharmacy Tech. Review of their personnel files did not contain evidence competency evaluations and orientation by the Consultant Pharmacist, specific for the duties they performed in the drug room.

The " Controlled Drug Administration Record " for the Operating Room (OR), was requested and provided. Staff S stated the narcotics for the OR are kept in the OR area until patient use. Medications are removed by the OR staff for individual patient use and documented on the " Controlled Drug Administration Record " , once the record is complete it is returned to the pharmacy department. Staff S was asked if the pharmacist reconciled the surgery narcotic records to determine that all scheduled drugs are in order. Staff S stated no.

Based on observation and staff interview, the hospital failed to ensure all compounding, packaging and dispensing of drugs was performed under the supervision of a licensed pharmacist.

Findings:

1. On 09/17/13, it was determined the hospital utilized a part-time consultant pharmacist. The hospital maintained a drug room staffed with a registered nurse and two LPNs. The pharmacist was not present at the time of the survey.

2. Staff S, who was not a pharmacist, informed surveyors that he mixed intravenous (IV) antibiotics and various medications for patients in the hospital. There was no pharmacist available on site for the supervision of these tasks.

3. Drug room staff said they routinely mixed drugs and dispensed medications to hospital staff without pharmacist supervision. According to staff, the consultant pharmacist was present at the hospital one day a week.

Based on observation, staff interview, and hospital document review, the hospital failed to ensure all drugs and biologicals were kept in a secure and locked area.

Findings:

1. On the morning of 09/17/13, surveyors requested pharmacy policies and procedures for the hospital. None of the policies and procedures had documentation they were reviewed and approved by the medical staff.

2. There were no policies that addressed the security of locked and unlocked medication carts containing drugs and biologicals.

3. On the afternoon of 09/17/13, the surveyors observed medications stored in multiple unsecure areas of the facility, including:

~A box of normal saline one liter bags was stored in an unsecured dirty utility room in the emergency department.

~A file cabinet, near the emergency department patient restroom, contained multiple of medication samples. The file cabinet was unsecured, unlocked, and was accessible to patients or visitors.

~Rapid sequence intubation medications and normal saline vials were unsecured and not monitored in the emergency department crash cart.

~A bag of sequential numbered breakable locks used to secure medications and supplies in the crash cart was sitting on top of the crash cart unsecured and not monitored.

~Open topical lubricant was left on top of a sharps container unsecured and not monitored in the pre-operative/post-operative area.

~Open injectable xylocaine, lidocaine with epinephrine, and normal saline was left on top of the anesthesia regional block cart unsecured and not monitored in the pre-operative/post-operative area.

~Open injectable Sodium Bicarbonate and sterile sodium chloride was left on top of the paper shred box unsecured and not monitored.

4. The Chief Nursing Officer (CNO) accompanied surveyors into the dirty utility room and asked the surveyors, "Are we not supposed to store sterile supplies and medications in here?"

5. The CNO and emergency department (ED) manager informed surveyors that medications are stored in various places throughout the hospital.

Based on observation and staff interview, it was determined the hospital failed to ensure outdated and unusable drugs were not available for patient use.

Findings:

1. On 09/17/13, drugs were observed in the hospital's pre and post-operative room that were out of date and available for patient use. One vial of xylocaine 1% with an expiration date of August 2013 was observed on top of the unlocked anesthesia regional block cart.

2. Staff OO verified that the xylocaine 1% had an expiration date of August 2013.

3. On 09/18/13, expired medications were found in an anesthesia cart and in a storage cabinet in the operating room. Open and undated medications were also found.

Based on record review and staff interview, it was determined the hospital failed to develop and implement a system to take appropriate action when notified that blood or blood components it received may be at increased risk of transmitting HIV (human immunodeficiency virus) or HCV (hepatitis C virus).

Findings:

On 09/17/13, the lab policies and procedures were requested and reviewed via computer. There was no policy that addressed the actions needed if the hospital was notified of HIV or HCV contaminated blood or blood products.

On 09/18/13, Staff D was asked if the hospital had a system in place to address the situation of a potentially infectious blood or blood component and the notification of patients. She left to ask the lab manager; returned to the surveyors; and stated the hospital did not have currently have a policy.

Based on policy and procedure review and hospital meeting minutes review, the hospital failed to ensure the dietary manual was approved by the dietician and the medical staff.

Findings:
On 9/17/13, the hospital's diet manual was provided to the surveyors. The manual contained a cover sheet without any signatures.

Review of medical staff meeting minutes did not reflect the medical staff had approved the Therapeutic Diet Manual.

Based on observation, record review and staff interview, it was determined the hospital failed to ensure:

a. the condition of the hospital was maintained for the safety and well-being of patients;

b. routine and preventive maintenance and testing was performed for all medical equipment and for all mechanical systems of the physical plant;

c. equipment identified in need of repair was tagged and taken out of service; and

d. failed to ensure emergency preparedness plans were developed, approved and implemented.

Findings:

On 09/17/13 and 09/18/13 tours were conducted of the hospital. The following observations were made:

1. The surgery department was not maintained and repaired as needed. There were defects in ceilings, walls, and floors that would not allow for proper disinfection. There were gaps and holes in ceiling tiles. Overhead florescent lights did not have covers. Floors were unfinished in the janitor's closet. The surgery HVAC system was not completely operational. The vacuum pump for the OR had a leak that was not fixed. Smoke evacuation for the OR was not tested.

The endoscopy decontamination room had exposed plumbing and an unfinished floor.

2. The medical gas liquid reserve was not installed by a licensed professional and had not been certified as safe for patient use.

3. There were malfunctions in the nurse call system in the labor and delivery area. Ceiling tiles in the labor and delivery area had evidence of water leaks. The labor and delivery area had no secure biohazardous waste storage room. The labor and delivery area nurse's workstation area, where medications and sterile supplies were stored, was accessible to patients and to visitors. Patients and visitors had access to an open used needle container.

4. The hospital maintenance staff stated the hospital had no biomedical routine or preventive maintenance program. There was no documentation of routine testing of all mechanical systems within the physical plant.

5. Broken equipment was found in various places in the hospital. It was not tagged as in need of repair and was stored with working equipment. Staff stated they did not know the proper procedure for dealing with broken equipment.

6. The hospital's emergency operations plan was not signed, dated and was not approved. The plan was not complete and did not address the specific hazards identified for the area. There was no documentation the plan was developed in conjunction with local authorities. Other than fire, there was no documentation the plan addressed other types of emergencies.

There was no documentation staff had been trained and drilled on emergency preparedness.

Based on observation and staff interview, it was determined the hospital failed to comply with the applicable provisions of the Life Safety Code for emergency lighting and power.

See Life Safety Code Survey Report Form CMS 2786.

Based on observation and staff interview, it was determined the hospital failed to ensure the proper storage and disposal of biohazardous waste. Findings:

On 09/18/13, observations were made of the operating rooms, the labor and delivery rooms, the emergency department, the endoscopy suite and the patient rooms.

The operating rooms, the emergency department, the endoscopy departments did not have dedicated rooms for the collection of biohazardous waste. Some areas that were identified as soiled utility rooms were used to store general trash, biohazardous waste and were also used as general storage for clean items.

The labor and delivery department stored biohazardous waste in a "dressing room" that was contained by a curtain. A large plastic used needle collection device was stored in this area. The device did not have an effective lid and used needles, syringes and medication vials were accessible to staff, patients and visitors.

Many patient rooms on the medical-surgical unit had used needle collection devices on the walls that were full and should have been replaced.

When staff were interviewed, they did not understand that biohazardous waste must be contained in a properly labeled room, secured to prevent access by unauthorized persons, and dedicated solely to containment of biohazardous waste.

Based on observation and staff interview, it was determined the hospital failed to ensure therapeutic facilities were provided in areas specifically designed for those purposes. Findings:

On 09/17/13, and again on 09/18/13, the hospital leadership staff was asked to provide original floor plans for the hospital. None were provided. The staff was asked to provide current floor plans that identified rooms within the hospital. None were provided.

1. The endoscopy procedure room did not have a free-standing handwashing fixture with a hands-free sink as required by State regulations. It could not be determined that the procedure room provided the necessary air exchanges.

2. The endoscope decontamination room did not contain two remote sinks and did not allow for the appropriate workflow from the contaminated area to the clean area to storage without the likelihood of cross contamination. The room was not large enough to perform scope decontamination and to hold the necessary supplies and equipment (such as PPE) needed for this area. The room had no free-standing handwashing fixture as required by State regulation. The room did not maintain negative airflow pressure.

3. The staff stated the current surgery sterile supply area was previously the labor and delivery room with a patient bathroom and shower. Sterile supplies could not be appropriately stored in this area as it was not designed and built for surgical sterile supply storage. Doors were blocked by supply cabinets and supply racks. The main door to the sterile supply room was propped open at all times.

4. The surgery department janitor's closet that contained a sink and a hopper, was used for clean and dirty storage and was open to the surgery suite. This room also contained biohazardous waste.

5. The post-anesthesia care unit (PACU) was not located near the surgery department, but was located within the emergency department (ED). Recovering surgical patients were brought on stretchers from the operating room, through a public outpatient corridor, then through the emergency department, and were transported past ED staff and patients. The PACU was not a separate area of the hospital and did not have the design standards as required in State and Federal regulations.

6. Outpatient clinic examination rooms were used to recover endoscopy patients. These rooms did not meet the requirements of a recovery room.

7. The labor and delivery area was located on a remote locked hallway, separate from other patient care areas, and not easily accessible to the nursing staff. Nursing staff assigned to care for these patients were located on another wing of the hospital. The area was not supplied with emergency equipment necessary for post-partum patients and newborn infants.

8. In the labor and delivery area, staff/visitor dressing rooms with curtains, not doors, were used for biohazardous waste storage and for sterile supply and linen storage.

Based on observation and interview, it was determined the hospital failed to maintain supplies and equipment to ensure safety and quality. Findings:

On 09/17/13 and 09/18/13, observations were made of the following:

1. In the operating room, emergency department, and the labor and delivery area, sterile supplies were stored with non-sterile supplies. Medical supplies were stored with office supplies, holiday decorations and linens. Sterile supplies were stored in a manner that compromised the integrity of the packaging.

2. Supplies and equipment were stored too close to the ceiling, stored blocking doors and stored on the floor in multiple areas. Equipment was stored in hallways that limited movement of patients and staff.

3. Clean medical items and equipment, such as suction cannisters, wheelchairs and IV pumps were stored in soiled utility rooms.

4. Broken medical equipment was stored with functioning equipment. Staff did not ensure broken equipment was tagged to alert staff not to use it.

5. Medications and intravenous fluids were stored with caustics, such as phenol, and other non-medicinal items. External medications were stored with internal medications.

6. Used needles, syringes and medication vials were found accessible to patients and visitors in the labor and delivery area.

7. Medications, intravenous fluids, sterile supplies, infant formula and food items were stored unsecured and without staff monitoring in the labor and delivery area. These items were freely accessible to patients and visitors and the safety and the integrity of the items could not be assured. Staff were asked if these items were vulnerable to tampering. No reply was made.

8. Staff verified the hospital did not have a preventive maintenance program for medical equipment. There was no documentation medical equipment was serviced and repaired as needed.

Based on observation, record review and staff interview, it was determined the hospital failed to monitor and maintain temperature, humidity and airflow in the operating rooms. See Life Safety Code Survey Tag K-0067.

Based on review of personnel files and meeting minutes, and interviews with hospital staff, the hospital failed to ensure:

a. The staff identified as the infection control preventionist (ICP) has training in establishing and maintaining an effective ongoing infection control program based on current principals and methods of infection control;

b. The ICP has developed infection control policies and procedures for each department/area of the hospital according to current standards of practice.

Findings:

1. On 09/17/13, administrative staff identified Staff T as the person responsible for infection control. Medical staff meeting minutes for September 2013 documented appointment of Staff T as the ICP; however, the June 26, 2013 Infection Control Committee meeting minutes documented Staff T was introduced "...as taking over Infection Control/Employee Health...." after the past ICP retired in August.

2. Review of Staff T's personnel file did not demonstrate Staff T had any training or experience in establishing and maintaining an effective and ongoing infection control program. This was confirmed with Staff D on 09/19/13

3. On 09/17/13, Staff D stated she used to be the hospital's ICP and was helping and teaching Staff T. Review of Staff D's personnel file did not demonstrate Staff D had any ongoing training in establishing and maintaining an effective and ongoing infection control program since her State sponsored classes in 2011.

4. The infection control policy and procedure manuals provided to the surveyors during the survey were reviewed.
a. With the exception of the two policies provided by Staff D that she said she had developed, the most current review date of the policies reviewed was 2006, but most of the policies had not been reviewed since 2002.

b. The policy and procedure manual did not contain department specific infection control procedures to be followed for each department/area or refer to the individual departments for the specific infection control policies.

c. The policy entitled "Body Substance Isolation", with a last review date of 03/01, documents precautions and procedures for what is currently know as Standard Precautions.

d. Although the manuals contained a policy and procedure for "Occupational Exposure Control Plan", it was last reviewed in 2003 and did not reflect current standards - Occupational Safety and Health Administration requirements.

e. The infection control policies for surgery services was developed in 1979 and documented the last review date as May 2002. The policies have not been updated to reflect current standards of practice and resources. While the policy referenced an accepted standards of practice source, the AORN (Association of periOperative Registered Nurses), the reference is the 1988 publication. The current publication for this resource is 2013.

One of the policies for surgical services referenced surgical "shave" as part of the surgical prep. Shaving patients as part of the surgical prep is no longer considered a standard of practice.

Based on observation, review of infection control data, surveillance activities, personal files, meeting minutes, and hospital documents, and interviews with hospital staff, the hospital failed to ensure the infection control practitioner (ICP) developed and maintained an ongoing comprehensive system for reporting, analyzing and controlling infections and communicable diseases among patients and staff and ensuring a sanitary environment.

The hospital does not have an ongoing infection control/prevention (IC) program that reviews hospital practices and infections/communicable diseases, analyzes data on these practices and infections, develops qualitative plans of actions to and provides follow-up to ensure corrective actions are appropriate, working and sustained.

Findings:

Program:
1. The hospital IC program had not performed a hospital risk assessment to determine what organisms are most likely to occur in the hospital and what organisms are most likely to be present in the community.

2. The hospital IC program had not performed an annual tuberculosis (TB) risk assessment.

3. The hospital IC program had not developed a system to ensure appropriate infection control procedures were developed and followed in each department of the hospital.

4. The hospital IC program had not reviewed the disinfectants used in the hospital, HDQL 10, Dispatch, and TB-cide, to ensure they are appropriate and used effectively.

5. The hospital IC program had not developed a protocol to ensure respiratory isolation mask fit testing was performed yearly and included the medical questionnaire. Staff D stated the respiratory therapist had just started doing the fit test.

6. These findings were reviewed and verified with Staff D on 07/18/13.


Observations:
1. Surgery:
a. The operating room was not cleaned and disinfected between every surgery patient. On 09/18/13, a surgery patient was brought into the operating room when contaminated instruments, supplies and trash used on the previous patient were still set up in the room. Eventually those items were removed from the room, however, the room was not cleaned and no surfaces were disinfected for the new patient already in the room.

b. Sterile instruments and supplies for the next surgery case were brought into the operating room while surgery was being performed.

c. When the OR staff did use the disinfectant agent TB Cide, it was not properly applied. It required a five minute contact time. The staff did not thoroughly wet the surface and did not allow it to remain for more than a few seconds.

d. Alcohol-based hand sanitizer was not available to staff inside the individual operating rooms. Operating room staff did not sanitize their hands as required after removing contaminated gloves or after touching potentially contaminated surfaces. If staff chose to use hand sanitizer, they had to leave the OR to obtain it.

e. Handwashing sinks were not provided in the surgical instrument decontamination room, the endoscope decontamination room and in the sterile processing room. The handwashing sink in the endoscopy procedure room was not designed to be used "hands-free" as required.

f. Surgical instruments processed for sterilization by the hospital did not conform to national standards. Surgical instruments were double-packaged incorrectly for sterilization. The inner packages were too large and were folded to fit.

g. Internal chemical indicators of adequate sterilization were not used in peel packs. External chemical indicators were not used so that sterile versus non-sterile items could be easily identified by staff.

h. Sterile items were stored incorrectly and were at risk for contamination. For example, multiple peel packs were stuffed into large plastic bags. The sterile peel packs were crushed, bent and compressed. The staff said these plastic bags were set up "for emergency cases."

i. Wrapped instrument sets were stored on solid metal shelves inside closed cabinets. The shelves were dirty and showed evidence of rust and other dried contaminants. Heavy instrument sets were stacked on top of each other.

j. Outside shipping containers and corrugated cartons were used to store items in the sterile supply room and in the operating rooms.

k. Sterile and non-sterile items were stored together.

l. Sterile surgical supplies in the surgery department were not stored where temperature and humidity was monitored and controlled. The surgery sterile supply room did not have adequate air exchanges.

m. Surgery sterile and clean items were stored close to the floor, on the floor, touching outside walls, and less than two inches from the ceiling. Items stored on bottom shelves were not protected from housekeeping activities.

n. The hospital had inadequate records of sterilization. The hospital did not label each sterile product with a lot control identifier. Immediate use steam sterilization loads were not documented appropriately. Each sterilization cycle did not have adequate information documented, such as:
i. lot number
ii. specific contents of the load: quantity, department, and description
exposure time/temperature
iii. the name of the operator
iv. biological or Bowie-Dick testing and results, if applicable

o. Non-hospital staff were allowed to process surgical instruments without authorization from the medical staff and without verification of competency to perform those tasks.

p. The room used for sterile instrument processing was dirty, cluttered and in disrepair. Staff food and drink items were observed in this area. There was evidence of insect infestation. The sterile processing room was open and shared air exchanges with the decontamination room.

q. Surgical endoscopes were processed in an area too small and inadequately designed for the task. This allowed for cross-contamination when high level disinfection was performed. The endoscope decontamination room was open and shared air exchanges with the clean endoscopy procedure room.

r. The endoscope decontamination room was not terminally cleaned. Feces-contaminated irrigation/flushing water was observed in a wall-mounted suction container after endoscopes had been processed for the day. The contaminated water remained there during two days of the survey.

s. The cabinet used to store clean endoscopes was dirty. The floor of the cabinet was lined with white towels that had evidence of brown drips on them. Cardboard containers were stored in the bottom of the cabinet had evidence of the same brown, liquid stains on them.

t. The hospital did not keep adequate records of endoscope disinfection.

u. Clean and contaminated equipment and supplies were stored together in various areas throughout the hospital.

v. Medical equipment was not adequately disinfected between patients. Observations were made of multiple staff failures to clean/disinfect equipment between patients. A bolster, wrapped in a pillowcase, was used to support patients' knees during surgery. The pillowcase was not removed, the bolster cleaned, and a clean pillowcase put on, between patients.

w. Single patient use items were reused on multiple patients. For example, disposable pillows and disposable foam head positioners for surgery were reused between patients. Neither of these items could be disinfected between patients.

x. The operating room set up to perform cesarean sections was not adequately cleaned. A blood pressure cuff attached to the anesthesia machine was hanging on the floor. The infant warmer in the OR was not cleaned. Unnecessary supplies and equipment were in the room and did not have evidence they were terminally cleaned between surgical cases.

y. None of the surgical department areas had evidence of deep cleaning and floor maintenance.

z. The hospital did not have a process for receiving and storing surgical supplies and equipment that conformed to infection control standards. Surgery supplies shipped to the hospital were received directly into the surgical department without unpacking. Corrugated shipping boxes were found in all areas of the surgery department, including the operating rooms.

aa. Operating room table padding was cracked and torn, exposing the inner foam that could not be adequately disinfected between patients.


2. Emergency Department (ER):
a. The ER room, designated as both the Pre-operative and Post-operative room during surgery time, was observed on the morning of 07/18/13 contained both types of patients. During the observation period, between 0830 and 1100, the following occurred:
i. Staff Y and Z did not clean/disinfect patient used chairs between patients and before returning them to other ER rooms.
ii. Staff Y did not perform hand hygiene between patient care activities and before donning and after removing gloves for two patients (Patients #1 and #3) or between those patients. She washed her hands between Patient #3 and #2, but did not perform hand hygiene after patient care or before donning and after removing gloves.
iii. Staff Y and Z did not disinfect all surfaces of the three patient carriers. Two of the carriers had breaks in the waterproof covering and cannot be adequately disinfected. Staff Y and Z did not know the manufacturer's recommended time the disinfectant must remain wet on the surface to be effective.
iv. On 07/18/13 at 1530, this room contained an ER patient.
v. The wheelchair used to transport patients was not disinfected before returning it to the area containing other wheelchairs in the ER.

b. The ER room, designated as the endoscope procedure room during endoscopic procedure days, was also used for ER patients. For deficient practices observed for this room see above Surgery observations #1. e, q, r, s, and t.

c. Other ER observations:
i. Staff O, W and X did not know the know the manufacturers recommended "wet time" for the disinfectants used in the ER.
ii. ER Staff O and W did not clean all patient touch surfaces between patients.
iii. On the morning of 07/18/13, ER Staff W did not perform hand hygiene after patient care. Radiology tech, Staff V did not perform hand hygiene between patient care activities and touching other surfaces.
iv. Clean and dirty equipment and supplies were stored in the same room.


3. Obstetrics:
a. A large contaminated needle collection box was open, sitting on the floor and accessible to patients and visitors in the labor and delivery area.

b. The labor and delivery area had no identified biohazardous waste room. There was no area identified to handle contaminated linens and regular trash.

c. Dirty and clean and sterile supplies were located in the same area/room, identified by Staff EE as the staff changing room/area.

d. Labor and delivery rooms designated as ready for use were not adequately cleaned.


4. Medical/Surgical unit:
Full needle collection containers were observed in patient rooms on the medical-surgical unit.

Based on review of personnel files, hospital policy and procedures, and staff interview, the hospital failed to ensure an appropriately qualified person developed, implemented and evaluated the discharge planning for patients.

Findings:

On 09/19/13, the hospital discharge planning policies were reviewed. The policy provided to the surveyors contained two different typed policies stapled together with handwritten text throughout the documents. The documents provided were not current and had not been approved by the hospital. Staff A stated that the hospital was in the process of re-writing the discharge planning policy.

On 09/17/13, Staff D stated to the surveyors that Staff T was the discharge planner.

The personnel file for Staff T was reviewed. The file had no documentation of prior job experience, specialized training or continuing education as a discharge planner.

There was no job description, orientation, competencies or evaluation for discharge planning found in Staff T ' s personnel file.

Based on record review and staff interview, it was determined the hospital failed to define the scope of surgical services in writing, failed to approve the scope of surgical services by the medical staff and failed to provide an organizational chart that indicated lines of authority and delegation of responsibility.

Findings:

The hospital's policies and procedures for surgical services had no documentation to define the scope of surgical services. There was no documentation the medical staff approved the scope of surgical services.

The operating room staff stated they did not have a current surgery department organizational chart.

The CNO stated the endoscopy suite was not considered a part of the surgery department. She stated the emergency room staff were in charge of the endoscopy suite.

Based on record review and staff interview, it was determined the hospital failed to ensure all surgical services, including endoscopy, were supervised by an experienced registered nurse.

Findings:

The surgery department manager stated she had several years experience in surgery. The personnel file did not contain a resume and did not have any documentation of prior experience in surgery and/or management. The personnel file contained a job description that had not been signed by the surgery manager.

The personnel file had no documentation of membership in AORN, although she stated she was a member. She stated she had not attended any professional continuing education conferences due to "budget cuts."

The registered nurse identified as the nurse in charge of endoscopy had no documentation of prior experience and training in endoscopy or surgery. She stated she had been trained by a product representative on endoscope cleaning.

The surgery policies and procedures had no documentation of the qualifications of the surgery department manager and did not document the duties and responsibilities of the position.

Based on observation, staff interview and clinical record review, it was determined the hospital failed to ensure a registered nurse was assigned as the circulating nurse for all surgery patients and failed to ensure non-hospital technicians who assisted with circulating duties were qualified to do so.

Findings:

On 09/17/13 and 09/18/13, registered nurses who worked in the endoscopy procedure room indicated at times, they were assigned to provide moderate sedation and simultaneously assigned as the circulating nurse.

One nurse stated some endoscopy procedures were performed with the moderate sedation nurse and the physician alone, without an additional RN circulator and without a surgical technologist.

Clinical records for EGD patients documented only one registered nurse was present. The nurse was identified as the moderate sedation nurse and also identified as the circulator.

On 09/18/13, observations were made of two non-hospital staff working as assistants to the circulating nurse during surgical procedures. Staff stated they were "scrub techs who came with the physician."

The surgery manager stated she "assumed" the hospital had checked out their credentials and qualifications to be present and assist in the OR.

The CNO was asked if the hospital had files for the non-hospital staff that came with the physician. She stated there were no files. The hospital had no documentation of qualifications, training and skills competency of the non-hospital staff who assisted with circulating duties.

Based on record review and staff interview, it was determined the hospital failed to maintain a roster of practitioners with current surgical privileges or those with suspended or restricted privileges.

Findings:

On 09/17/13, operating room staff were asked to provide the above documentation. None was provided.

On 09/18/13, the surgery manager stated she did not have this documentation in the department and that maybe administration had it.

The hospital had no documentation of surgical privileges for unlicensed staff (techs) who accompanied physicians and assisted in the operating room.

Based on policy and procedure review, observation and staff interview, it was determined the hospital failed to develop, implement and enforce surgical policies and procedures based on current nationally recognized standards.

Findings:

1. On 09/17/13 and 09/18/13, surgery policies and procedures were reviewed. None of the policies had evidence they had been approved by the chief of surgery, the medical staff and the governing body.

2. None of the policies referenced State or Federal regulations. There was no documentation the policies were based on professional organization standards and recommendations.

3. Some policies contained significantly outdated information or were based on old sources. For example, the conscious sedation policy was dated February 2001 and was based on a CRNA publication dated 1994. The policy did not reference the Oklahoma Board of Nursing guidance on this subject. Interviews with nursing staff indicated the hospital did not enforce appropriate practices by registered nurses who performed conscious sedation.

4. A malignant hyperthermia "policy" was actually an article written in 2003. The hospital had no comprehensive malignant hyperthermia policy and procedure. There was no documentation that described the required supplies and equipment necessary to manage a malignant hyperthermia crisis. There was no documented protocol for this event.

The staff stated the surgery department did not have adequate supplies and equipment to respond to a malignant hyperthermia crisis.

5. The hospital did not have all the policies as required including:

current sterilization and disinfection procedures, including special processes for eye instruments
housekeeping requirements and procedures
pre-operative work-up
patient consents
clinical procedures and protocols
safety practices unique to the OR
patient identification
staff duties and responsibilities, lines of authority
surgical counts
case scheduling and staff scheduling
personnel policies unique to the OR, including attire, restriction from duty, etc.
emergency procedures unique to the OR
DNR status
handling and processing of surgical specimens
handling infectious waste

Staff who were responsible for endoscopy procedures did not have surgery policies and procedures. There were no policies that guided staff on how this area should function.

6. The OR staff stated they did not use alcohol-based skin preparations; however, there was no policy that documented this. If alcohol preps were used, there was no policy to guide staff on the safety requirements for it's use.

7. The surgery department did not have a "time out" procedure. During observations of surgical procedures on 09/18/13, no time out step was performed by staff.

8. The surgery manager stated she was working on policy revisions but they were not complete.

Based on observation and staff interview, it was determined the hospital failed to ensure:

a. a tracheotomy set was provided as a part of the operating room's emergency equipment;

b. surgery emergency equipment was inspected, tested and maintained through the biomedical program; and

c. failed to ensure emergency equipment and medications were stored in a safe and secure manner.

Findings:

On 09/17/13, the surgery department crash cart was observed. It was locked with a numbered break-away plastic tag. The staff did not document the tag number when it was replaced on the cart. The staff did not document when and why the cart was opened.

The cart was unorganized and cluttered. The cart did not contain a tracheotomy set. When staff were asked if a tracheotomy set was available, they stated "maybe anesthesia has one in their cart."

The defibrillator was not checked and maintained through a biomedical program.

The OR stated medication for a malignant hyperthermia crisis was stored inside the crash cart. Six vials of dantrolene were observed. Up to 36 vials may be needed. There was no other supplies and equipment for the treatment of malignant hyperthermia found in the cart. The OR did not stock cold IV solutions and sterile irrigation fluids for the treatment of malignant hyperthermia crisis.

The outside and inside of the cart showed evidence of rust, dirt, dust and grime. The cart was stored directly outside an opened janitor's closet that contained a hopper and a dismantled sink that allowed sewer gas to escape into the operating room corridor.

Based on observation, policy and procedure review and staff interview, it was determined the hospital failed to provide post-operative care in accordance with acceptable standards of practice.

Findings:

1. Observations were made of the recovery room. It was not a separate area of the hospital. The recovery area was located within the emergency department and was not located in close proximity to the operating rooms. The recovery room did not meet the state requirements for the design of a post-operative care area. Recovery patients shared a restroom with emergency room patients.

2. Post-anesthesia surgery patients were taken on stretchers through public hallways and then into the emergency department. The patients were pushed past emergency department staff and patients.

3. Staff stated that endoscopy patients recovered in outpatient clinic examination rooms on exam tables and not in the recovery room.

4. Staff stated the recovery room beds were also used for overflow emergency department patients.

5. The hospital was asked to provide policies and procedures for post-operative care. No current, approved policies were provided.

6. There was no policy that addressed transfer requirements to and from the recovery room. There was no policy that addressed what types of surgical patients did not require transfer to the recovery room.

7. There was no documentation of an organizational structure that documented who was assigned to supervise the recovery area.

8. None of the registered nurse files reviewed had documentation of training and skills competencies for post-anesthesia care.

Based on document review and staff interview, it was determined the hospital failed to provide an operating room register with all the required elements.

Findings:

On 09/17/13, the hospital leadership staff were asked to provide the operating room register. The staff stated endoscopy procedures were performed at the hospital but none were documented in the register.

The CNO stated since endoscopy procedures were not considered "surgery", they were listed on an outpatient log. The surveyors reviewed this documentation.

The documentation for endoscopy procedures was missing:

patient age
full name and title of physician
full name and title of RNs and surgical technicians
name and title of person giving conscious sedation
pre and post operative diagnosis
total time of operation
full name of procedure to include biopsies, etc
any observers, assistants, vendor names and affiliation

Based on document review and staff interview, it was determined the hospital failed to develop, approve and implement adequate policies and procedures related to anesthesia services.

Findings:

On 09/17/13, hospital leadership staff were asked to provide policies and procedures related to anesthesia services. Two separate manuals were provided.

The majority of the policies were not dated and were not documented as reviewed and approved by the medical staff.

A conscious sedation policy was dated as last reviewed in 2001. The policy referenced a CRNA article published in 1994. Another policy titled "IV Conscious Sedation" was dated as reviewed in 1998. The policy was not current and did not reflect accepted standards of practice.

A malignant hyperthermia policy was not a written policy. The item labeled as a "policy" was an article discussing malignant hyperthermia that was published in 2003.

There was no documentation the anesthesia policies were based on nationally recognized standards of practice. There was no evidence the policies were developed with the collaboration of the CRNAs who worked in the hospital.

There were no policies that addressed:

~informed consent for anesthesia
~infection control requirements related to the provision of anesthesia
~safety practices and requirements in the anesthetizing areas
~protocols for cardiac and respiratory emergencies
~reporting requirements
~documentation requirements
~equipment requirements
~pre and post anesthesia staff responsibilities

The surgery manager stated there were no other policies and procedures available.

Based on document and staff interview, it was determined the hospital failed to ensure emergency department policies and procedures were approved by the medical staff.

Findings:

1. On the morning of 09/17/13, surveyors requested policies and procedures for the hospital's emergency services.

On the afternoon of 09/18/13, the chief nursing officer (CNO) brought emergency department (ED) policies and procedures to the surveyors. She stated that the facility was using the policies and procedures currently which could be found either the hospital intranet or in the nursing manual and was approved by hospital administrative and medical staff.

2. The ED policies did not contain evidence of review, revision and or approval by appropriate staff.

3. On the morning of 09/19/13, surveyors observed multiple hospital policies on the hospital's intranet with modified dates (09/18/13 and 09/19/13) signed by the CNO.

4. The CNO verified to surveyors that she changed the policies and procedures.

Based on hospital document review, record review, and staff interview, it was determined the hospital failed to ensure physicians and nursing staff working in the emergency department (ED) had specialized training and had demonstrated skills competencies for seven of eight staff records reviewed.

Findings:

1. Staff training and education files were reviewed for evidence of specialized training and demonstrated skills competencies for tasks performed in the emergency department.

2. On the afternoon of 09/17/13, Staff NN was asked to demonstrate how to test defibrillator. Staff NN told surveyors he was unsure because day shift nurses don't check the defibrillators; night shift staff checks the defibrillators. Staff NN was unable to articulate and demonstrate how to use defibrillator in the ED.

3. On the morning of 09/19/13, Staff X told surveyors, "The hospital provides online skills training but does not perform hands on competency training for nursing staff."

4. On the morning of 09/19/13, Staff OO stated the hospital had not provided skills competency training and had not performed competency testing for nursing staff that worked in the ED.

5. The chief nursing officer (CNO) was asked if the hospital required ED skills competency training. She stated the hospital requires competency training.

6. On the afternoon of 09/18/13, the CNO verified that hospital personnel files were complete. Seven (Staff X, BB, HH, and LL through Staff OO) of eight personnel records did not have: a current license; CPR; ACLS; and PALS certification.

7. On the afternoon of 09/18/13, hospital administrative staff brought surveyors a hospital policy titled, "Procedural Sedation and Analgesia" which documented,
"... Nursing staff...required to show competence to perform appropriate monitoring...annual evaluation of the same..." Six (Staff X, BB, LL through Staff OO) of eight ED personnel files reviewed, six personnel records did not have evidence of procedural sedation and analgesia competencies.

8. A hospital policy titled, "NCCLS Guidelines for Specimen Tube Collection (Order or Draw)" documented, "... It is recommended that the following order of collection be followed when obtaining blood samples...to insure proper testing results..." Five (Staff X, LL through Staff OO) of five staff were unable to articulate what the recommended order of specimen tube collection for blood draws in the ED as stated in the facility's policy.

Based on review of hospital documents, personnel files and staff interview, the hospital failed to develop and organize the scope of rehabilitative services to be provided to the hospital's patients.

Findings:

Rehabilitation (rehab) services (physical therapy, speech therapy and occupation therapy) are provided by contracted staff. There was no evidence of hospital orientation, competency, evaluation and current licensure for these employees. There was no policies and procedures for rehab services.

On 9/18/13 Staff A stated the hospital did not have personnel, educational and health files for contracted staff.

The surveyors requested the hospital's policy and procedures for rehab. No policies and procedures were provided. The hospital's computerized policies and procedures did not contain rehab policies and procedures.

On 9/19/13 at 0835, Staff A stated the hospital did not have any policies and procedures for rehab, because they are a contracted service.

Based on review of hospital documents and interviews with staff the hospital failed to ensure rehabilitation services are provided by qualified staff to meet the needs of the patients. Rehabilitation services (physical, speech and occupational) are provided through a contracted provider. There is no documentation of hospital orientation, competency, evaluation and current licensure for these employees. On 9/18/13 Staff A stated the hospital did not have personnel, educational and health files for contracted staff.

Based on policy and procedure review, staff interview, and review of personnel files the facility does not ensure personnel providing radiology services are appropriately trained and competent to provide services to patients.

Findings:

In an interview with Staff G on 9/17/13, Staff G indicated some radiology procedures were performed by contract staff. There was no personnel files stipulating contract staff are licensed and/or registered, competent, oriented and trained to the hospital.

Both Staff A and D both stated that the hospital did not maintain personnel, educational and health files on contracted staff.

A hospital policy, titled, " Staff Qualifications and Competency " , for the radiology department, documented, " ...It is the policy of this organization to demonstrate, assess, maintain and improve staff competence on an ongoing basis ... "

Five (G, H, I, J and K) of five radiology educational files reviewed did not contain documentation of competencies that had been reviewed and approved by the Radiologist and department director.

Five (G, H, I, J and K) of five radiology personnel files reviewed did not contain current licensure.

Based on review of hospital documents and meeting minutes concerning infection control, and infection control policies and procedures, and interviews with hospital staff, the hospital's leadership failed to ensure infection control activities, issues, and problems, were processed through quality assessment and performance improvement (QAPI) committee and:

1. Were monitored throughout the hospital, reviewed and analyzed;

2. Corrective actions were taken to prevent, identify and manage infections and communicable diseases with measures that resulted in improvement on an ongoing basis; and

3. Corrective actions were followed to ensure improvement resulted and alternative solutions/actions were not needed.

Findings:

1. Meeting minutes reviewed for infection control, quality assessment and performance improvement and medical staff executive committees did not demonstrate deficient infection control practices identified by the surveyor had been identified or reviewed by the hospital's leadership with corrective actions implemented.

2. Meeting minutes did not contain evidence the hospital leadership ensured policies and procedure were developed and implemented for all areas of the hospital according to current accepted standards of practice for infection control.

3. Meeting minute documentation did not show evidence the hospital leadership provided oversight of the total infection control program to ensure a safe patient/staff environment.