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10502 NORTH 110TH EAST AVENUE

OWASSO, OK 74055

CONTRACTED SERVICES

Tag No.: A0085

Based on record review and interviews with hospital staff, the hospital does not ensure a list of all contracted and shared services is maintained with the scope and nature of the services provided. The list provided to the surveyor for review did not have the shared services provided by Hillcrest Health Center which provides some services for the hospital. The list also did not have a complete list of patient care services provided by contract and their scope.

Findings:

1. Physical therapy and speech pathology services provided by contract were not on the list provided for review.

2. The list did not have contract services on the list of Life Share, the organ procurement organization, the dietitian, and Cardinal Health, pharmacy services.

3. Staff C stated that some contracts are corporate. These were not on the list provided for review.

PATIENT RIGHTS: PERSONAL PRIVACY

Tag No.: A0143

Based on observation and staff interview, it was determined the hospital failed to maintain the confidentiality of patient information. Findings:

On 08/26/13, a tour was conducted of the surgical department. A large dry erase marker board was observed hanging on a wall outside the surgery suite.

The board was placed in a semi-restricted hallway. However, various ancillary and support staff (who may have had no reason to know this patient information) had access to the hallway. In addition, patients and family members had access to the hallway.

The dry erase board contained the following information about surgery patients:

Date and time of surgery
Patient's name, sex, age
Diagnosis
Surgical procedure
Surgeon's name
Anesthesia type
Anesthesiologist's name
Staff assignment

In addition, the board contained patient information related to allergies and other special needs.

The staff were asked why the surgery schedule board was placed in a semi-restricted area outside the surgery suite. The staff stated it was for staff convenience.

QAPI PERFORMANCE IMPROVEMENT PROJECTS

Tag No.: A0297

Based on record review and interviews with hospital staff, the hospital failed to include as part of their quality assessment and performance improvement program (QAPI) indicators that reflect the scope and complexity of the hospital's services and operations. Indicators for surgical services and infection control did not reflect the scope and complexity of the services provided.

Findings:

1. The hospital provides surgical services that include orthopedic surgery, bariatric surgery, general surgery, endoscopy procedures and caesarian sections. Review of QAPI minutes did not have evidence of indicators to identify and monitor processes in surgery to identify potential patient safety problems.

2. The infection control portion of the QAPI minutes did not demonstrate surgical services were monitored by infection control. The minutes did not demonstrate the leadership of the hospital ensured surgical services were provided in a safe and sanitary environment according to current standards of practice (Refer to Tag A 749 for details).

3. The QAPI program has not provided oversite of the infection control program to ensure a safe environment. With the exception of hand hygiene, the meeting minutes did not reflect the hospital's leadership ensured surveillance/monitoring of all areas was performed to ensure current standards of practice in infection control were followed. This included, but not limited to:
a. Fit testing;
b. Isolation practices;
c. Disinfectant practices;
d. Instrument and equipment cleaning practices;
e. Sterilization practices;
f. Environmental services.

4. The surgery department was supervised by an inexperienced registered nurse who had no evidence of previous training or experience as a surgery department manager, special certifications or job specific training outside of the usual hospital specific requirements.

5. Performance improvement projects documented for surgical services in the QAPI meeting minutes for 2012 and 2013 were as follows: Unwrapped Sterilized Sets. There were four columns labeled prevac, flash, total, documented. There was no reason stated why they were looking at this or if this was important to the quality and safety of patient services.

QAPI GOVERNING BODY, STANDARD TAG

Tag No.: A0308

Based on record review and interviews with hospital staff, the governing body does not ensure the QAPI program reflects the complexity of the hospital's organization and services and involves all hospital departments including contracted or shared services. Indicators for high risk and complex services such as surgical services and infection prevention did not reflect the important aspects and risks of these services. There was no evidence that all contract or shared services were evaluated by the QAPI program.

Findings:

1. The hospital failed to maintain an active ongoing infection control program to prevent, control, and investigate infections and communicable diseases to minimize infections and communicable diseases in patients and staff and is part of the hospital's QAPI program.

2. QAPI indicators for surgical services and infection control did not reflect the scope and complexity of the services provided.

3. Review of governing body meeting minutes and QAPI meeting minutes for 2012 and 2013 did not have evidence of review of services provided by Hillcrest Health System or Hillcrest Medical Center.

4. Staff C stated that some contracts are reviewed at the corporate level, but no evidence was provided for review.

STAFFING AND DELIVERY OF CARE

Tag No.: A0392

Based on clinical record review and staff interview, it was determined the hospital failed to ensure nursing care was provided as ordered. Findings:

On 08/27/13, surgical patient records were reviewed.

1. The record for patient #19 included a pre-printed physician's order form that documented a set of orders for the admission, intra-procedure and post procedure areas. All three sets of orders were signed by one RN, the pre-op nurse, although different nurses cared for the patient in all three areas.

The record had no admission orders documented. The patient received an IV, signed informed consent for an EGD and had other pre-operative care provided, as determined by the nurse, as there was no physician order for these things.

The pre-printed orders for admission did not instruct the nurse on the amount of IV fluid to be started.

2. The record for patient #20 had no documentation a nurse signed off on the post-procedure orders.

The pre-printed physician's order form had all three sets of orders signed off by one nurse, although different nurses cared for the patient in all three areas. An intra-procedure order for benadryl did not include the route it was to be administered.

3. The preoperative orders for patient #23 documented the following:

"IV LR 1000 mL or NS 500 mL to be started on admission." The physician did not indicate which one should be started.

The orders also documented,

"Versed 2 mg IVP
Decadron 4 mg IV
Zofran 4 mg IV
Robinul 0.2 mg IV"

There was no documentation of the order and timing of these medications.

The medication administration record documented the patient received lidocaine for the IV insertion and a pre-op antibiotic. There was no documentation the Versed, Decadron, Zofran and Robinul was administered, although it was included on the nursing medication administration record.

RN SUPERVISION OF NURSING CARE

Tag No.: A0395

Based on clinical record review and staff interview, it was determined the hospital failed to ensure a registered nurse adequately evaluated the care for each patient. Findings:

1. The clinical record for patient #20 included a set of physician's orders for the GI lab. There was documentation of physicians orders for medication administration. The order form included a space to record patient allergies. However, nothing was documented. There was no documentation the nurse confirmed the patient's NPO status.

There was also no documentation of allergies on the GI Lab Flow Sheet. A nurse administered moderate sedation medications.

There was no documentation the nurse evaluated the patient's lung sounds and bowel sounds prior to the procedure.

There was no documentation the patient's vital signs were monitored during the procedure. The nurse documented one sedation level during the procedure. It was recorded as "alert."

The record documented the patient had a pre-procedure baseline blood pressure of 131/77. The patient's blood pressure was recorded after the procedure as follows:

11:20 88/50
11:25 100/57
11:30 101/57
11:35 94/58
11:40 no blood pressure recorded

The patient was discharged at 11:56. No vital signs were recorded at the time of discharge. There was no documentation the patient's blood pressure returned to baseline before he was discharged.

2. The clinical record for patient #19 included a patient preoperative health assessment/questionnaire. When the patient answered "yes" to sleep apnea/CPAP machine/BiPAP machine, there was no comment documented by the nurse. The patient also indicated she had "back trouble." There was no documentation of evaluation of this by the nurse.

There was no documentation of allergies on the physician's order form. There was no documentation of admission orders, although the patient signed a consent and had an IV inserted. There was no documentation the nurse confirmed the patient's NPO status.

There was no documentation the patient's vital signs were monitored during the procedure. The nurse documented one sedation level during the procedure. It was recorded as "alert." There was no documentation of the patients post procedure and discharge Aldrete score.

The patient's blood pressure was recorded at the time of admission to the post-procedure area. No other blood pressure was recorded prior to discharge.

3. Patient #22 had general anesthesia for one hour and 45 minutes. The patient was discharged 45 minutes after arrival to the post anesthesia recovery room.

CONTENT OF RECORD: ORDERS DATED & SIGNED

Tag No.: A0454

Based on review of medical records, document review, and interviews with hospital staff, the hospital failed to ensure all verbal orders were signed by the physician with the date and time of signature. This occurred in two (#7 through #10) of four closed emergency department (ED) medical records reviewed for order completeness and in two (#20 and #23) of five surgery records with verbal orders.

Findings:
1. The hospital form titled, "Physical Restraint Physician's Orders, requires the physician's signature, date, and time.

2. Clinical records #8 and #10 did not contain a physician signature, date, and time for physical restraint orders.

3. On 08/27/13 at 1500, surveyors interviewed the Director of Medical Records who verified that electronic health record (EHR) did not have a physician signature, date and time on the hospital form, "Physical Restraint Physician's Orders". This was verified at the time of record review by the director of medical records and the director of the ED.

4. The clinical record for patient #20 documented verbal orders for admission, intra-procedure and post-procedure areas were obtained on 06/19/13. On 08/27/13, the verbal orders had not been authenticated by the physician.

5. The clinical record for patient #23 documented verbal orders for preoperative anitbiotic prophylaxis were obtained on 07/11/13. On 08/27/13, the verbal orders had not been authenticated by the physician.

6. Findings of the closed medical record review were discussed during the exit conference on the afternoon of 08/27/13.

COMPLEXITY OF FACILITIES

Tag No.: A0725

Based on observation and staff interview, it was determined the hospital failed to ensure areas within the surgical department were maintained and used according to the original design. Findings:

According to NFPA 101 2000 Edition chapter 5.1.7., the hospital is required to "... maintain design features constructed for the building. To continue to meet the performance goals and objectives of the Code, the Building shall be maintained in accordance with performance goals and objectives that include, complying with all documented assumptions and design specifications. Any variations shall require the approval of the authority having jurisdiction prior to the actual change..."

During tours of the surgical areas on 08/26/13 and 08/27/13, the following observations were made:

A review of the original hospital plans indicated the surgery suite design and room usage had changed without the approval from the Plan Review Section for Medical Facilities at the Oklahoma State Department of Health.

A sub-sterile room between two operating rooms was used to flash sterilize instruments but was also used as a store room for casting supplies, OR table parts and patient positioning devices. Housekeeping and biohazard containment equipment was also stored in this area.

The functionality of the sterile processing department had been modified and had the appearance of a mixture of "clean", "semi-clean" and "dirty" areas all occupying the same space. The area used to repair and maintain surgical instruments was located adjacent to the sterile packaging area. The room had the appearance of a workshop rather than an impeccably clean sterile processing area. The floor in this area was dirtier than the loading dock service hallway. The area was not restricted and the OR staff entered and exited the area frequently and unnecessarily.

According to staff, a clean utility room had been converted into the anesthesia work room. The room was being used as an office and also used as storage for clean and sterile anesthesia supplies. In addition, the room was being used clean anesthesia equipment.

The room designed as the surgical suite's janitors closet was no longer used for that purpose. The surgery staff did not have a space to store housekeeping and janitorial supplies. Dirty mop buckets, mops and dusters were stored in the hallways outside the operating rooms. When staff needed to fill or empty mop buckets, they had to leave the surgery suite and access an area in the endoscopy suite.

The soiled utility room's roll-up pass through window (allowing dirty instruments to be passed through to the decontamination area) was not operable. This required the staff to leave the surgical suite, enter the service hallway near the loading dock and carry contaminated instruments outside the suite and into the decontamination area. Staff then came out of the decontamination room and traveled back through the service hallway and back into the surgery suite. According to regulations, movement from a back entrance "in and out" violates the department's one way traffic requirement.

A soiled utility room between two endoscopy procedure rooms has been modified. Initial gross decontamination of endoscopes is done on both sides of the room where sinks are located. The final cleaning of the scopes is also on one side of the room, requiring cross contamination between the "clean" and "dirty" processes.

The final cleaning of scopes (made ready for use) should be done in an area completely segregated from the gross decontamination areas. In addition, a soiled utility area is required to have negative airflow pressure and the final cleaning area should have positive airflow. Therefore, these processes have to be done in to separate areas.

The double door entrance to the surgery suite had been modified with a motion sensor. The doors opened automatically when someone crossed within the sensor field. During the tour, the doors opened and closed needlessly numerous times, just because someone walked close to the area.

The staff were asked why the sensor was placed on the doors to the restricted surgery suite. They stated it was because the hand operated control had been blocked by a large supply cart, making it inoperable.

It was also noted the surgery suite had no control station that was manned while the department was open as a safe-guard to control access to the surgery area. There was no monitoring of the entrance to the surgery suite by any staff person. None of the other nurses' stations in the other areas (pre-op, post-op, endoscopy) had visual contact with the operating room doors.

The CEO stated he did not know why the OR was designed in that manner.

Staff was asked who approved the changes to the functionality of the areas within the surgical suite. No answer was given.

INFECTION PREVENTION CONTROL ABX STEWARDSHIP

Tag No.: A0747

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 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. (Refer to Tag A-748)

The disinfectants used throughout the hospital have not been reviewed and approved by the hospital's Infection Control committee through the quality program and the products observed and identified by staff as the one they would use is not effective against Clostridium difficile (C-diff). (Refer to Tag A-749)

3. 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).

4. The hospital does not ensure the infections control program has a current tracking mechanism for patients and staff to track infections and possible transmissions of infections and communicable diseases.

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

INFECTION CONTROL PROFESSIONAL

Tag No.: A0748

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 ongoing 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.

Findings:

1. On 08/26 and 27/13, administrative staff identified Staff D as the person responsible for infection control.

2. Review of Staff D's personnel file did not demonstrate, with the exception of training in loading data to the NHSN (National Healthcare Safety Network), Staff D had any ongoing training in establishing and maintaining an effective and ongoing infection control program since her State sponsored classes in 2011.

3. On 08/27/13 at 1600, Staff D told surveyor that she had taken "webinars", but could not produce evidence this had been accomplished or what the courses detailed.

4. The infection control policy and procedure manual provided to the surveyors during the survey was reviewed.

a. Eleven out of twenty-two policies reviewed had a last review/revision date of 2006, the remaining eleven had a last review/revision date of 2010.

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 manual did not contain a policy and procedure/protocol to coordinate with federal, state and local emergency preparedness and health authorities to address communicable disease threats, bioterrorism and outbreaks.

d. Although the manual contain a policy about reporting communicable diseases, it did not give clear directions to staff about how to report or contain an attachment of the most current state reportable diseases and infections.

e. With the exception of tuberculin skin testing requirements, the policy manual did not contain a policy or policies that designated the immunizations required based on current standards of practice recommendations.

INFECTION CONTROL PROGRAM

Tag No.: A0749

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 IC program did not contain a review of staff immunization history.

5. The IC program did not develop measures to evaluate staff and volunteers exposed to patients with infections and communicable diseases.

Disinfectant:
1. On 08/27/13 at 1615, the ICP could not identify the names of the products/disinfectants used in the hospital, but stated the hospital had three products: a purple top wipes, a spray, and a bleach/gold top wipes. Only the PDI Sani-Cloth Bleach (gold top wipes) is effective against Clostridium difficile (C-diff of C-difficile).

2. The hospital's surgical services included endoscopy procedures. The most prevalent organism for colonoscopies is Clostridium difficile (C-diff). The hospital had PDI Sani-Cloth Plus Wipes (red top container) throughout the surgery area. This produce is not effective against C-diff.

Surveillance/Monitoring:

At the time of entrance to the hospital, the surveyors requested infection control documentation, including "all surveillance/monitoring activities" for the past 12 months. This request was repeated twice on 08/27/13. The surveyor reviewed all data presented.

Review of infection control surveillance/monitoring data did not show the infection control monitored all departments and units to ensure compliance with established hospital policies and procedure and standards of practice to maintain a safe and sanitary environment, including, but not limited to:

1. Surgical Services:
a. There was no oversight and monitoring of flash sterilization practices. The surveyor reviewed the autoclave envelopes. According to the review, the hospital not only "flashed"/used shortened cycles for single instruments, entire sets were flash sterilized. Flash sterilization loads did not document a patient name associated with the flashed item and there was no documentation of the reason for flashing. There was no documentation if the flashed items were processed wrapped or unwrapped. Reports from the sterile processing supervisor indicated there was no flash sterilization occurring in the surgery department.

b. Routine sterilization was not reviewed or monitored for adequate cycles.

c. Routine endoscope processing was not reviewed for adequate cycles.

d. There was no system in place to monitor and identify when a scope had been stored for five or more days without reprocessing. The staff stated they did not know this was a requirement.

e. There were no records that documented the endoscope number used on each patient so that if a post operative infection was identified, a review could be done of the disinfection cycle.

f. Although the ICP gave the surveyor a piece of paper that recorded the hospital had not surgical site infections. Staff D stated she monitored for infections by contacting the surgeons. When asked for monitoring activities, Staff D stated she had none.

2. Environmental Services:
Only one environmental round was provided. This was a review of only one room and one employee, not a hospital wide review. The review did not indicate the observer monitored the application of disinfectant to ensure the employee followed manufacture guidelines for effectiveness. The observer documented identified problems.

3. Obstetrics and Gynecology:
In addition to vaginal births, this area performs Caesarean sections. No surveillance material was provided to show infection control monitored this area.

4. Isolation is not monitored to ensure:
a. Patient are placed in appropriate isolation according to current CDC guidelines,
b. Isolation carts are stocked appropriately,
c. Staff, physicians, volunteers, and visitor follow appropriate isolation requirements,
d. Appropriate disinfection of the room occurs.

5. No monitoring of disinfectant applications throughout the hospital departments and locations to ensure:
a. Appropriate disinfectants are selected and used; and
b. The disinfectants are applied and remain "wet" contact time according to the manufacturers guidelines.

6. The ICP did not monitor and track staff illness to ensure infections and communicable diseases were not transmitted between staff and between patients and staff.

7. The ICP did not monitor staff immunizations to ensure the personnel files were up to date and staff immunizations reflected those required by Oklahoma State Hospital Licensure Standards and recommended by Centers for Disease Control (CDC) and its Advisory Committee on Immunization Practices (ACIP).

8. The ICP does not monitor to ensure all staff that have patient contact are fit tested yearly and as needed to ensure all appropriate staff have N-95 respirator masks available and they are the correct fit. Five of thirteen staff, whose personnel files were reviewed and would have patient contact did not have evidence of current respiratory mask fit testing. This included one housekeeper staff. Staff D told the surveyor on the afternoon of 08/27/13 that he had not performed fit testing on housekeeping staff, but did agree those individuals would need proper equipment/masks.

Observations:

1. On 08/26/13, a tour was conducted of the surgical areas. The following observations were made:

The OR Suite
~OR equipment dedicated to the surgery suite was stored outside the surgical suite in a semi-restricted alcove

~dirty mop buckets with cleaning solution, wet mops and floor dusters were stored in the hallways outside the operating rooms

~housekeeping supplies (trash bags, etc.) were stored with clean and sterile supplies in various areas within the surgery department

~the OR hallways were cluttered with numerous pieces of equipment, carts and supplies

~supply carts and other pieces of equipment in the hallways had not been cleaned and evidence of dirt and dust

~patient beds were parked outside the operating rooms and in front of scrub sinks in the splash zone

~all floors in every area of the surgery department were extremely dirty with scuff marks, dirt, dust, grime and debris

~all department ancillary rooms were crowded, cluttered, dusty and dirty

~the disinfectant agent in the surgery suite was not effective against C-difficile

~the double doors into the restricted surgery area where modified with a sensor. The doors opened automatically whenever someone or an object came within the sensor zone. The doors opened and closed numerous times unnecessarily because someone or something had accidentally triggered the sensor.

Sub-Sterile Area
The sub-sterile room between two operating rooms was dirty. The walls and floor showed evidence or dirt, dust, grime and splashes. The steam sterilizer in this room was dirty inside and outside. There were mineral deposits and evidence of old adhesive tape on it. The sink in the room was dirty and had mineral deposits. The room was also used inappropriately as a general store room for a non-sterile cast cart and numerous pieces to operating room tables, as well as patient positioning devices. One padded OR table piece was ripped and the inside foam was exposed. The item could not be disinfected between patients. The room also held biohazard containment boxes and housekeeping supplies for other areas. The staff stated they cleaned the sub-sterile area themselves and there was no process for routine deep cleaning.

Sterile Processing
The sterile processing area was disorganized, cluttered, dusty and dirty. Surfaces and equipment had not been disinfected. There was no process or schedule for terminal cleaning and routine deep cleaning. Stainless steel work surfaces used to wrap and package surgical materials for sterilization were covered with wrapping material that could not be cleaned. Masking tape was placed in areas where instruments would rest while being processed. Numerous personal items were present in the sterile processing area. The functionality of the area had been modified and there was the appearance of a mixture of "clean", "semi-clean" and "dirty" areas occupying the same space. Cleaning and housekeeping supplies were interspersed with sterile processing supplies. The area used to repair and maintain surgical instruments was located adjacent to the sterile packaging area. The room had the appearance of a workshop rather than an impeccably clean sterile processing area. The floor in this area was dirtier than the loading dock service hallway. The area was not restricted and the OR staff entered and exited the area frequently and unnecessarily.

Sterile Supply Room
The sterile supply room was cluttered and overcrowded. Sterile materials were stored with non-sterile materials. Liquids were stored above sterile packaged supplies. Housekeeping supplies were stored with sterile surgical supplies. Instrument sets were stored on shelves that did not allow air circulation to all sides. The floor was dirty.

Instrument Decontamination Room
The instrument decontamination room floor, walls and sinks were dirty. There was no process for terminal cleaning and regular deep cleaning. The room had no enclosed storage to keep supplies and equipment (including personal protective equipment) protected from contamination.

Endoscopic Procedure Rooms
The disinfectant agent used in these rooms was not effective against C-difficile.

Endoscope Decontamination Room
The endoscope decontamination room had no clear designation or segregation between "clean" and "dirty" processing. The room had no enclosed storage to protect supplies and equipment (including personal protective equipment) from contamination. Pass through windows from the procedure rooms to the decontamination room were left open at the end of the work day and allowed air to circulate between the "clean" and "dirty" areas. The room had not been terminal cleaned at the end of the day. Both sinks were dirty. One sink held sleep study masks and air tubing for reprocessing. Towels used during the day were still on the counter tops. An open cylinder of rubbing alcohol was left on the counter top. Endoscopes and other items that had been processed in the automated washer were left in the machine wet. The staff had left for the day. The endoscope storage cabinets were observed open on both days of the survey. The disinfectant agent used in this area was not effective against C-difficile.

Sleep Study Mask and Air Tubing Reprocessing
The hospital staff stated sleep study masks and air tubing for c-pap and bi-pap machine were reprocessed. The staff stated they did not have a written policy and procedure for this and did not have the manufacturer's instructions. The staff were asked to explain how they did the reprocessing. The sterile supply supervisor stated the sleep study staff brought the masks and tubing to the endoscopy decontamination area and they were placed in the scope decontamination sink. He stated the masks and tubing were washed with detergent and rinsed. He said the masks and tubing were disinfected with an alcohol rinse. He was asked how the cloth and Velcro pieces were cleaned. He stated they were discarded. He was asked how many times the masks and tubing could be reprocessed. He stated he did not know.

The staff had no documentation of reprocessing cycles.

The manufacturer's instruction manual for the masks documented the masks should be disinfected using high level thermal disinfection (water temperature of 158 degrees F to 194 degrees F with varying exposure time requirements) or high level chemical disinfection (Cidex OPA or Cidex Plus) or sterilized in the Sterrad machine. The instructions indicated some parts had to be removed and replaced between patients. The instructions also documented there were limits on the number of times the masks could be safely reprocessed (15-20 times depending on the type of mask).

The manufacturer's instructions for the air tubing documented the tubing could be processed with high level thermal disinfection (167 degrees F for 30 minutes) or high level chemical disinfection (Cidex OPA or others) and rinsing with drinking quality water and immersion for one minute and repeating the rinsing process two additional times with fresh water.

2. On 08/27/13 at 1430, one surveyor toured the emergency department, observed the environment and interviewed staff. The following occurred:
The only disinfect available for staff use was the PDI Super Sani-Cloth (purple top) wipes.

The surveyor interviewed Staff FF about disinfectant products used for diarrhea and Clostridium difficile. Staff FF stated, "I would use the purple top Sani Wipes at the bed side, then let it dry for 5 minutes."

The Center for Disease Control and Prevention guidelines, regarding possible C-diff encounter, documented patient care areas need to be cleaned thoroughly with an EPA registered sporicidal agent. The EPA registered purple top Sani Wipes do not kill the Clostridium difficile spores indicated directly on the manufacture's label.

3. A surveyor toured the second floor medical/surgical unit. The only disinfectant observed available for use was the PDI Super Sani-Cloth (purple top) wipes.

4. A surveyor toured the obstetric/gynecology unit. The only disinfectant observed available for use was the PDI Super Sani-Cloth (purple top) wipes.

Meeting Minutes:

1. On 08/27/13 at 1615, the ICP told the surveyors that the disinfectants had been reviewed and approved in the infection control/PIC meeting minutes. Review of the PIC meeting minutes from November 2012 to present did not demonstrate this had occurred.

2. PIC meeting minutes for infection control did not demonstrate review and analysis of patient and staff illnesses to ensure infections and communicable diseases were not transmitted between staff and between patients and staff. Safety committee meeting minutes documented the ICP, who is also the employee health nurse, reported she was not being provided all employee illnesses. No actions were taken in the safety committee. This concern/problem was not addressed in the infection control section of the PIC meeting minutes.

3. PIC meeting minutes did not demonstrate immunization histories were reviewed and discussed. Review of seven of twenty-eight staff files and nine of nine credentialed physician and allied health files did not contain complete immunization histories as required by Oklahoma State Hospital Licensure Standards and recommended by Centers for Disease Control (CDC) and its Advisory Committee on Immunization Practices (ACIP).

4. PIC meeting minutes did not demonstrate review and analysis of staff exposures with review to ensure OSHA (Occupational Safety and Health Administration) guidelines were followed. The staff exposures were contained in the regular health files and not maintained as a separate confidential file as required.

5. PIC meeting minutes did not demonstrate that any of the observations or problems identified by the surveyors had been identified or reviewed for compliance.

No Description Available

Tag No.: A0756

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 Performance Improvement Committee (PIC) and:

1. Were monitored, 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. On the morning of 08/27/13, hospital staff, including the person designated as the infection control officer, told the surveyor that all infection control activities were handled in the hospital's PIC on a quarterly basis.

2. Hospital meeting minutes, PIC, medical staff and governing body, containing infection control data did not contain evidence/demonstrate the hospital leadership:
a. Reviewed and analyzed infection control data or lack thereof;
b. Ensured that all departments/units of the hospital were included and monitored through the infection control/prevention program.
c. Ensured infection control/prevention policies and procedures were developed, implemented and followed.
d. Developed corrective plans of action to reduce and/or prevent transmission of organisms and improve patient care, ensure a safe and sanitary environment, and decrease or prevent infections and communicable diseases; and
e. Provide follow-up/monitoring to ensure corrective actions taken were effective and sustainable.

2. The same hospital minutes did not contain review and analysis of employee immunizations, illness and infections to ensure infections and diseases were not transmitted between patients and staff. The hospital's leadership failed to ensure employee exposures were processed according to standards of practice. Meeting minutes did not demonstrate the incidents were analyzed or provision of corrective actions to reduce exposures were considered.

3. Meeting minutes did not contain evidence the hospital's leadership has ensured policies and procedure were developed for all areas of the hospital concerning current accepted standards of practice in infection control.

4. The hospital offers surgical services, including endoscopy procedures. The infection control portion of the PIC minutes did not demonstrate surgical services was monitored by infection control. The minutes did not demonstrate the leadership of the hospital ensured surgical services were provided in a safe and sanitary environment according to current standards of practice (Refer to Tags A 749 for details).

5. The PIC program has not provided oversite of the infection control program to ensure a safe environment. With the exception of hand hygiene, the meeting minutes did not reflect the hospital's leadership ensured surveillance/monitoring of all areas was performed to ensure current standards of practice in infection control were followed. This included, but not limited to:
a. Fit testing;
b. Isolation practices;
c. Disinfectant practices;
d. Instrument and equipment cleaning practices;
e. Sterilization practices;
f. Environmental process inspections.

SURGICAL SERVICES

Tag No.: A0940

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

a. define the scope of surgical services in writing and provide an organizational chart with lines of authority. See Tag A 0941;

b. ensure the surgical department was supervised by an experienced registered nurse. See Tag A 0942;

c. provide a registered nurse circulator for each surgical case. See Tag A 0944;

d. fully develop and implement policies and procedures for the surgical department to ensure services were provided in accordance with nationally recognized standards. See Tag A 0951; and

e. the hospital failed to integrate surgical services into the QAPI program. See Tag A 0264.

ORGANIZATION OF SURGICAL SERVICES

Tag No.: A0941

Based on document review and staff interview, it was determined the hospital failed to define the scope of surgical services in writing and failed to provide a surgical department organizational chart with delineated lines of authority.

On 08/26/13, the interim surgery department manager confirmed these findings.

OPERATING ROOM SUPERVISION

Tag No.: A0942

Based on document review and staff interview, it was determined that the hospital failed to ensure the surgery department was supervised by an experienced registered nurse. Findings:

On 08/26/13, the CEO stated an interim surgery department manager had been appointed approximately six weeks prior to the survey.

The interim manager was asked about her education and experience. She stated she began working at the hospital in 2009, shortly after she received her registered nursing license. She stated she had been a scrub tech before she finished her nursing degree.

The manager's human resources file was reviewed. No job application or resume could be found. There was no documentation of education level, special certifications or job specific training outside the usual hospital specific requirements. The file documented the manager's advanced cardiac life support certification and pediatric advanced life support certification were to expire in August 2013.

The file had no documentation of conscious sedation training and competency. There was no documentation of orientation to the manager role.

The human resources file for the previous OR manager was reviewed. There was no documentation of specialized training or certification in peri-operative nursing. Although the CEO stated the previous manager had membership in AORN, there was no documentation in the file. There was no documentation of attendance at professional meetings or seminars.

Upon review of both files for specific hospital based training, the documentation did not detail what course content was actually presented. Certificates labeled as annual training did not describe in sufficient detail was subject matter was reviewed.

Neither of the files had documentation of department specific annual training, inservices or attendance at special surgery related seminars.

OPERATING ROOM CIRCULATING NURSES

Tag No.: A0944

Based on record review and staff interview, it was determined the hospital failed to ensure a registered nurse performed circulating duties for every surgical case. Findings:

On 08/26/13, the OR manager was asked if registered nurses provided conscious sedation during endoscopy or other procedures in the surgical area. She stated they did.

She was asked if another RN circulator was assigned to the room. She stated, "Not always." She stated a circulator was assigned to the room when a CRNA provided conscious sedation.

She further stated when an RN provided conscious sedation, he/she also performed circulating nurse duties, including all the documentation related to conscious sedation and intraoperative care.

OPERATING ROOM POLICIES

Tag No.: A0951

Based on observation, document review, policy and procedure review and staff interview, it was determined that the hospital failed to fully develop and implement policies and procedures for the surgical department to ensure services were provided in accordance with nationally recognized standards. Findings:

On 08/26/13 and 08/27/13, the surgical department policies and procedures were reviewed. None of the policies had documentation they were developed based on nationally recognized standards.

The most recent update for some of the policies was documented in 2010. The majority of polices and procedures had not been updated or reviewed since 2006. Some of the policies addressed important departmental issues, but were incomplete or lacking current information.

There were no policies that addressed infection control surveillance and prevention activities in the surgery department. There were no policies to guide staff on transmissible diseases, environmental cleaning requirements, contaminated sharps and biohazardous material, traffic control and flow in the OR, surgical hand scrub requirements, routine hand hygiene, the use of alcohol hand sanitizer, and special employee health requirements.

There was no surgical attire policy. During the survey, surgery staff were observed in surgical scrubs without a lab coat cover in other areas of the hospital, including the public cafeteria.

Safety policies and procedures were missing to include, the use of alcohol preps and surgical fires, electrical safety, radiation safety, departmental alarms, blanket and warming solution cabinet use, medical gas cylinders, chemicals such as bone cement, formaldehyde, glutaraldehyde among others. There were no policies on the management of hazardous waste.

There were no policies and procedures related to medication safety, storage and reporting of errors that were specific to the surgical areas. There were no specimen handling policies.

Surgery specific patient care policies were missing to include deep vein thrombosis prevention, perioperative hypothermia, local anesthesia, patient positioning, patient safety procedures.

Individual job descriptions and lines of authority were not found in the department manual.

During a tour of the surgical department, the staff were asked to provide policies for various specific activities in their work areas. None were provided. For example, the sterile processing supervisor was asked to provide the policy and procedure for reprocessing sleep lab masks and tubing. He stated he did not have a policy. He further stated he did not have the manufacturer's guidelines for reprocessing.

Observations of the surgical areas (OR, endoscopy, decontamination, sterile processing) showed evidence policies and procedures were not followed. Many of the routine practices observed in these areas did not indicate personnel adhered to nationally recognized standards. When staff were interviewed, they stated they relied on other staff for training on processes, but they did not have policies and procedures or resource material for reference.

DELIVERY OF ANESTHESIA SERVICES

Tag No.: A1002

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

a. a qualified physician evaluated every surgical patient for the appropriateness of registered nurse-administered sedation/analgesia based on criteria defined by the hospital;

b. moderate/conscious sedation was performed by registered nurses who were trained and deemed competent to do so; and

c. failed to ensure registered nurses who provided moderate/conscious sedation to patients were not also assigned to perform circulating nurse duties. Findings:

On 08/26/13, anesthesia policies and procedures were reviewed. One policy documented the hospital selected the American Society of Anesthesiologists (ASA) Physical Status Classification system as a means to evaluate patients before the administration of anesthesia.

The policy did not require a physician to evaluate patients using the ASA score to determine the appropriateness of registered nurse-administered sedation/analgesia.

On 08/27/13, clinical records were reviewed for patients who received moderate/conscious sedation provided by a registered nurse. None of the records documented a physician evaluated the patient using the ASA score prior to the administration of sedation by a nurse. This found in the surgery/endoscopy department and in the emergency department.

Employee training and competency files were reviewed. None of the nurses who provided conscious sedation (in the records reviewed) had evidence of annual training and competency evaluation to provide conscious sedation.

The Chief Nursing Officer stated those records should be in the files.

The clinical records also documented registered nurses provided sedation while assigned other responsibilities such as circulating nurse duties and direct assistance to the physician during a procedure.