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Based on review of hospital documents and interviews with hospital staff, the governing body did not ensure the medical staff was accountable to the governing body. Meeting minutes did not reflect the governing body reviewed the medical staff meeting minutes to ensure quality of care was being provided to patients. Staff D told the surveyors on the afternoon of 07/23/14 that medical staff meeting minutes were not provided to the governing body for review and action.

Based on medical record review and interviews with hospital staff, the hospital did not ensure that a physician provided adequate oversite and medical supervision of the personnel providing patient care. Two (# 4 and 6) of two patient records that required physician supervision and oversite did not have evidence that a physician provided appropriate supervision.

Findings:

Review of the medical records for Patient #4 and #6 documented each patient had a pain management procedure performed by the Certified Registered Nurse Anesthetist (CRNA).

The medical records for both patients contained an electronic dictated Procedure Note that was dated, timed and electronically signed by the CRNA.

The medical records for Patient's # 4 and #6 did not contain documentation the supervising physician provided oversite to the CRNA.

When asked, Staff C told the surveyors that the supervising/ordering physician was usually not present in the hospital during the procedure, but had an office in the building close to the hospital.

The above information was presented to the administrative staff during the exit conference on the evening of July 23, 2014. No additional information was provided.

Based on review of hospital documents, surveyor observations and interviews with hospital staff, the hospital does not ensure:
a. the pharmacist follows the flow of medications from entry into the hospital to disposition;
b. outdated and unusable drugs are not available for patient use; and
c. maintains control over the medications in all the hospital locations.

Findings:

The surveyors conducted a tour of the main hospital site on the morning of 07/21/14.

Staff KK was asked if she compared the Narcotic Administration Record to the patients' medical records to verify the amount of narcotics the patients' received. She stated no.

Four bags of Lactated Ringers Solution 500 milliliters were observed in a procedure room in the surgery department. All four bags of solution expired in March 2013. This was confirmed by Staff D.

In the surgical department intravenous (IV) fluids and irrigation solutions were observed in the warmers. The IV fluids and solutions did not contain the date they were placed in the warmer or the expiration date. This was confirmed by Staff C during the tour of the surgical department.

The hospital has one automated medication dispensing unit for storing and retrieving controlled medications located in the emergency department. The medical-surgical unit use a "lock and key" method to store and retrieve controlled medications.

Review of the Pharmacy and Therapeutics (P and T) committee meeting minutes, documented several medication errors involving Norco and Percocet. The P and T meeting minutes did not document upon review of the analysis that potential corrective actions were identified and implemented, if appropriate. Staff KK and P both stated the medical-surgical unit is where the majority medication errors involving the Norco/Percocet occur.

On the morning of 07/23/14, during a tour of the off-site clinic, outdated medications and medications not routinely used were observed in the medication room. The surveyors also observed two multi-dose vials that did not contain the date they were opened and the initials of the staff that opened the vials. Staff LL was asked if the pharmacist made visits to the clinic. Staff LL said no.

Based on review of hospital documents, policies and procedures and meeting minutes, surveyors' observations and interviews with staff, the hospital failed to:

a. Develop and maintain an active on-going infection control/infection prevention (IC) program for ensuring a sanitary environment, and identifying and preventing infections and communicable diseases among patients and staff to include Surgical Services;

b. Analyze infection preventionist (IP) surveillance data and concerns, develop corrective actions when needed and conduct follow-up to ensure corrective actions are appropriate and sustained to ensure a sanitary environment and avoid sources and transmission of infections for patients and personnel; and

Findings:

Plan/Program:
1. The hospital has not conducted a hospital-wide IC risk assessment to identify the types of patients, risks/concerns, organisms, and diseases prevalent in the community and hospital.

2. The hospital's current infection control plan (Plan) does not contain details of the types and frequency of monitoring for all departments to ensure infection control policies and procedures are followed and a safe and sanitary environment is maintained according to current accepted standards of practice.

3. These findings were reviewed and confirmed with Staff B and D on 07/22 and 23/14.


Policies and Procedures:
1. The IC policy and procedure manual and the Surgical Services manual did not contain specific IC policies and procedures for Surgical Services and Central Sterile Services, including:
a. Policies and procedures on how to process instruments and the requirements for testing the eye instruments/equipment;
b. Policies and procedures with details for cleaning between patient cases and terminal clean at the end of the day, including which hospital approved disinfectant would be use in specific instances - such as endoscopies.

2. Although the IC policy and procedure manual did contain a hand hygiene policy and procedure, the policy did not address that hand sanitizers should not be used when the organism C-difficile (C-diff) was suspected or confirmed.

3. The IC manual policy and procedure did not contain specific policies for respiratory isolation protection of specialized masks, N-95 respirator. The IC policies and procedures did not specify:
a. Detail on how this was to be accomplished and by whom; and
b. Based on the current standards of practice and requirements by OSHA (Occupational Safety and Health Administration), how often fit testing would be performed and how this would be document and where.
c. The brand of N-95 respirator/mask documented in the policy (NIOSHN95) was not the same as the one currently in use (3M 1860 N-95 masks)

4. The IC manual's policy and procedure for reporting State reportable infections and diseases did not contain the most current list of reportable infections and diseases. The policy and procedure did not detail the procedure to follow to submit data to the proper authorities, with delineation of responsibilities.

5. The IC manual did not contain policies on disinfectant approval and list of approved disinfectants with what area used and application requirements, including:
a. mixture;
b. wet time contact with surface to be effective; and
c. what organisms each approved disinfectant kill.

6. The IC manual's policy for Employee Health did not follow current standards as recommended by CDC (Centers for Disease Control) and its Advisory Committee on Immunization Practices (ACIP). Concerning physicians, the policies only documented "employee physicians" would have health files. It did not address allied health staff.

7. The infection control policy found in the dietary policy and procedure manual for bleach use did not contain the specifications that the bleach mixture should be a one to ten ratio and should be made fresh at least daily.


Surveillance:
1. The IC program has not monitored to ensure all departments followed infection control policies and current recognized infection control practices on a regular scheduled basis to ensure compliance. The documentation of environment monitoring, supplied for review, were environmental cultures and rounds which provide only a "snap shot" and do not contain observation of entire tasks to ensure compliance with recognized standards of practice. Staff B confirmed she did not conduct observations of entire tasks.

2. The Centers for Disease Control (CDC) and the Association for Professionals in Infection Control and Epidemiology (APIC) have identified hand hygiene as the first avenue/most important tool in the prevention of spread of organisms and diseases. The hand hygiene tool Staff B was using did not track all the policy identified times hand hygiene should be performed. The hand hygiene tool only tracked hand hygiene when staff entered and exited patient rooms.

3. Documents provided and meeting minutes did not demonstrate that, other than identifying patient nosocomial infections, the IC program monitored and evaluated infections of patients and staff to ensure infections and communicable diseases were not transmitted between staff and between patients and staff.

4. According to documentation provided, Central sterile processing is not monitored, including, but not limited to:
a. Appropriate cleaning and packaging of instruments occurs, including endoscopes;
b. Sterilization practices - correct temperature, correct sterilizing time and correct dry time;
c. Appropriate disinfection occurs - products used according to manufacture's guidelines;
d. Staff B stated on the afternoon of 07/21/14 that she did not go back to surgery and that it was not her responsibility.

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.
c. With the exception of the housekeeper, staff interviewed did not know if the hospital's disinfectants, Lysol IC Quaternary Disinfectant, was not effective against C-difficile and did not know the "wet" contact times in order for the disinfectants to be effective. Surveyors also found Virex TB and "red-top" PDI Sani-cloth wipes (which also are not effective against C-difficile) and Clorox Bleach wipes.

6. Isolation monitoring was not conducted to ensure:
a. Patients are placed in appropriate isolation according to current CDC guidelines;
b. Isolation materials/supplies are readily available (Although staff knew the locations,staff had to go from area to area to show the surveyor where they would obtain the needed supplies, including the isolation signs.);
c. Staff, physicians, volunteers, and visitor follow appropriate isolation requirements; and
d. Appropriate disinfection of the room occurs.


Observations:
Refer to Tag C-320 for detailed information about surgical services observations. Observations including, but not limited to:
1. The surgical suite did not have a decontamination room with all the required spaces and equipment to clean dirty instruments and scopes.

2. Instruments packed and processed in "peel - pack" envelopes were processed in the close and locked position.

3. The surgical services area contained structures, equipment and supplies with surfaces that could not be adequately cleaned and disinfected.

4. The high level disinfectant in the specialty clinic was in a container in a public access area - at the reception desk and the container was dated 06/28/14. According to the manufacture's guidelines, the chemical was past the date of use. This was also observed by Staff B on 07/23/14.

5. High level disinfectant found at the off-site clinic was outdated - the chemicals had expired between 2010 and 2013.

6. The waterproof mattress cover on one of the sleep lab beds was torn. The comforter and pillow shams were left in the rooms between patients and not laundered/cleaned or replaced between each patient.

7. IV fluids in the computerized tomography room was left handing and used for multiple patients - not single use. Staff F stated the fluids were good for 12 hours.

8. Staff MM told the surveyors on the morning of 07/21/14 that she used PDI Sani-cloth wipes to clean the vaginal probe because they did not have Cidex OPA (the appropriate high level disinfectant).


Meeting Minutes:
Staff B and D told the surveyors that the hospital had infection control committee meeting minutes and then the meetings would be taken to Quality Improvement (the hospital's quality assessment and performance improvement - QAPI). Staff B stated the meeting minutes were they forwards for review to the Medical Staff committee and governing body (Board of Trustees).

1. The meeting minutes did not contain review, evaluation and analysis of infections to ensure infections and communicable diseases were not transmitted between staff and between patients and staff. Although nosocomial/HAI (hospital acquired infections) were identified in the attached reports, there was not review and analysis to determine if process should be changed to improve patient care and outcomes.

2. The meeting minutes did not demonstrate central sterile services were monitored, reviewed and analyzed with corrective actions taken and follow-up to ensure compliance with accepted standards of practice.

3. The meeting minutes did not contain documentation and review of surveillance/monitoring to ensure IC policies and procedures and current standards of practice are followed. Staff B confirmed on 07/22/14 that this did not occur.

4. Concerns identified in meeting minutes showed no review and analysis to determine if corrective actions need to be developed or if current policies and procedures were followed.

5. The meeting minutes did not contain evidence disinfectants used in the hospital had been reviewed annually for appropriateness and approved for use. Staff B confirmed disinfectants had not been reviewed as part of IC.

6. The meeting minutes did not reflect staff influenza immunizations were part of the program. Meeting minutes for 08/13/13 documented start of influenza season and the need to meet or exceed the Oklahoma Hospital Association's challenge of at least 92% compliance. Influenza immunizations were not followed/brought up in meeting minutes again. Annual influenza was not documented on all the files. Review of health files for physicians and allied health files did not show complete immunizations as recommended by CDC and its advisory committee (ACIP).

7. Meeting minutes did not show employee illnesses were reviewed and analyzed to ensure transmission between staff and staff and staff and patients did not occur.

8. The meeting minutes did not reflect isolation monitoring was reviewed and analyzed to ensure:
a. Patients are placed in appropriate isolation according to current CDC guidelines;
b. Isolation materials/supplies are readily available;
c. Staff, physicians, volunteers, and visitor follow appropriate isolation requirements; and
d. Appropriate disinfection of the room occurs.

Based on review of the radiology department documents and interviews with hospital staff, the hospital failed to to protect patients and staff from radiation hazards.

Findings:

The surveyors toured the radiology department on the morning of 07/21/14.

During a tour of the radiology department, Staff MM was asked what disinfectant was used to clean the radiology equipment in-between patients. Staff MM stated the red top PDI-Sani Wipes. Staff MM was asked what is the "wet time' for the wipes, she stated "until it dries".

Radiology staff were using the red top PDI-Sani Wipes to disinfect the transvaginal probes.

A spiked 500 milliliter (ml) bag of single use Normal Saline (NS) and a spiked bottle of intravenous contrast solution was observed hanging in the computerized axial tomography (CT) suite. Staff S stated the NS bags remains spiked and hanging in the CT suite for twelve hours used for multiple patients.

Based on review of hospital documents, medical records and interviews with hospital staff, the hospital failed to assure nursing staff are adequately trained, oriented and competent to provide care to meet the needs of the patients.

Findings:

Respiratory services are provided at the hospital. On the morning of 07/21/14, Staff NN told the surveyors that respiratory treatments are administered by the nursing staff.

Medical records were reviewed on the afternoon of 07/23/14. Review of the medical records for Patient's 5, 16, 17, 18, 21 and 22 revealed the patients all received breathing treatment administered by the nursing staff.

On 07/22/14 Staff NN and B both stated the hospital did not have any documentation of respiratory competencies for the nursing staff by the respiratory therapist.

Based on record review and interviews with hospital staff, the hospital does not ensure medical records are maintained for every inpatient and outpatient evaluated or treated in the hospital. The hospital has a specialty clinic located on the main campus. On 7/21/14, Staff D was asked if the hospital maintained medical records for the patients receiving care at the specialty clinic. Staff D stated no. She again confirmed this on the morning of 07/23/14.

Based on observation, staff interviews and review of hospital documents, the hospital failed to ensure that surgical procedures are performed in a safe manner.

Findings:

On 07/21/14, a tour was conducted of the surgery department.

Review of a surgical policy, titled, "Care and Maintenance of Surgical Instrumentation", documented,"...Assure that all instruments are in an open position when stored in tray..."

Observations:
Surveyors observed sterilized surgical instruments in "peel packs" in the closed position. This was confirmed by Staff C.

Supplies in corrugated boxes were stored in the sterile corridor of the surgical department.

A cloth chair was in operating room (OR) #2.

No handwashing sink in the endoscope decontamination room.

A floor fan was in the central sterile cleaning room.

Linens in plastic overlays were stored on carts in the sterile cleaning room.

In the surgical department intravenous (IV) fluids and irrigation solutions were observed in the warmers. The IV fluids and solutions did not contain the date they were placed in the warmer or the expiration date. This was confirmed by Staff C during the tour of the surgical department.

Four bags of Lactated Ringers Solution 500 milliliters were observed in a procedure room in the surgery department. All four bags of solution expired in March 2013. This was confirmed by Staff D.

Endoscopy procedures such as colonoscopy is performed in the procedure rooms. Bleach-free Clorox Disinfecting wipes were observed on the countertop in the procedure room. The disinfectant is not effective against killing Clostridium difficile (C-diff). C-diff is the most prevalent organism with endoscopic procedures.

Review:
Review of the operating room log indicated seventeen eye cases were performed in OR #1 one day in 2014. The times indicated on the operating room log from the end of one case to the anesthesia start time (this would be the time the patient arrive in the OR) of the next case was one to five minutes. Disinfectant cleaners used by the hospital required a three to ten minute kill time for adequate disinfecting of surfaces.

The instruments used for the eye cases were provided by a contract service. The instruments are made by Bausch and Lomb Incorporated. The instruments were sterilized using a table top (Statim) autoclave in the sub-sterile area.

The reprocessing instructions for the Bausch and Lomb instruments was reviewed. The instructions documented, "...Flash sterilization should be reserved for emergency reprocessing only and should not be employed for routine sterilization processing of the instrument...". The manufacture recommended the instruments should be processed through a full cycle with adequate exhaust time to ensure the instruments were dry.

Review of the operator's manual for the Statim recommended packing or wrapping eye instruments and processing them through the wrapped cycle of the sterilizer. The manual also documented the heavy duty unwrapped cycle is six minutes at a temperature of 135 degrees Celsius.

The eye instruments were sterilized in the Statim unwrapped and processed on the heavy duty unwrapped cycle.

Review of the Statim sterilization logs for the month of December 2013, documented the instruments were processed for six minutes at a temperature no greater than 132 degrees Celsius. No dry/exhaust time was recorded.
On the morning of 07/22/14, Staff C was asked for the preventative maintenance on the Phacoemulsification Machine that is provided by the contract instrument services. None was provided.
Medical records were reviewed on the afternoon of 07/23/14.

Surgical patients were treated differently depending on the type of procedure performed. They were not processed as surgical patients and did not receive nursing care consistent with other surgical patients. For example, patients who had pain management surgical procedures did not receive the same documented pre-operative, intraoperative and recovery nursing assessment. This was confirmed by Staff C during medical record review.

Review of the medical records for Patients # 4 and 6, both had eye surgeries. The medical record did not record the name of all personnel present during the procedure.

Based on review of hospital documents and interviews with surgical staff, the hospital failed to ensure a copy of the physicians' current privileges are kept/available in the surgical suite/area.

Findings:

The surgical department was toured on the morning of 07/21/14.

A binder containing the roster of practitioners with surgical privileges was provided to the surveyors by Staff C. The binder was reviewed by the surveyors.

The binder was not current. The binder contained practitioners who no longer performed surgical procedures at the hospital. The binder did not contain current privileges for the practitioners that are currently performing surgical procedures at the hospital. This was confirmed by Staff C during the review.

Based on review of the hospital's Critical Access Program Evaluation (yearly program evaluation), meeting minutes and interviews with hospital staff, the hospital's yearly program evaluation did not contain review of the total program.

Findings:

1. According to the governing body meeting minutes for 04/29/14 and interviews with Staff D, the hospital offers specialty clinic services of: cardiology, surgery, oncology, nephrology, eye, pacemaker, urology, orthopedics, ENT, pain management and sleep studies.

2. With the exception of sleep studies, the above services were not reviewed as part of the hospital program evaluation.

3. These findings were reviewed and confirmed with Staff D on 07/22/14 at 1525.

Based on policy and procedure manual review and interview with the hospital staff, the hospital failed to ensure all patient care policies were reviewed at least annually.

Findings:

The following policies had no documentation of an annual review:

Infection Control 10/2013
Quality Assessment and Performance Improvement 10/2013
Laboratory 06/2013
Physical Therapy/Rehab and Sleep Study- did not have any evidence of any current review
Pharmacy 05/2013
Radiology 08/2012
Ultrasound 08/2012
Mammogram 05/2013
Nuclear Medication 08/2012
Respiratory 08/2013
Dietary 2011
Swing Bed 11/2012
Nursing (Medical-Surgical) 09/2013
Obstetrics 10/2013
Emergency Department 09/2013
Health Information Management (HIM) 04/2013

These findings were presented to the administrating staff during the exit interview on 07/23/14. No additional information was provided.

Based on review of hospital documents, meeting minutes, and interviews with hospital staff, the hospital does not ensure the hospital has an effective quality assessment and performance improvement (QAPI) program that collects relevant data, including all analysis of the data and implements corrective action to ensure the quality and appropriateness of all patient care that was furnished, with follow-up to ensure the corrective actions were effective and maintained. The quality assurance meeting minutes for 2013 and 2014 provided for review did not have relevant indicators to identify potential problems and opportunities to improve quality of care. There was no analysis of any data that was collected and no evidence of the implementation of any corrective action taken.

Findings:

1. The hospital's Quality Improvement Plan (QAPI Plan) documented the QAPI program has active continuous improvement cycles of Plan, Do, Check and Act and would involve all departments/services. Meeting minutes did not reflect this was being done.

2. There were no indicators for the surgery, anesthesia and central sterile departments. Other than numbers and documentation that biological and control tests were performed appropriately, no tracking of surgical cases was documented. No tracking of the environment occurred.

3. The minutes documented nosocomials (hospital acquired infections - HAIs) occurred, but no analysis of the occurrence occurred with determination if any procedures needed to be changed to effect better patient care outcomes or compared to staff illness to determine whether if there was any correlation between staff and patient illnesses/infections.

4. The minutes provided statical information, but no analysis of the information to look at processes for possible corrective action or any changes that needed to occur to improve patient outcome was demonstrated.

5. Department projects and concerns documented in one meeting would not be followed. Examples include, but not limited to:
a. Dietary - 07/09/13 QAPI meeting minutes recorded new posters for teaching had been utilized for correct food handling and storage. No follow-up occurred to review and determine if this was effective.
b. Nursing - 09/12/13 QAPI meeting minutes documented the focus was to work to ensure patient assessments included at least daily assessments by the RN (registered nurse), the last audit showed only 90% compliance. This topic was not reviewed again. No further data was documented or analyzed.

6. These findings were reviewed with administrative staff on 07/23/14.

Based on review of the hospital's death register/computer list, medical records, the referral reports from the OPO (organ procurement organization - LifeShare of Oklahoma) for the time period of August 2013 through June 2014 and interviews with hospital staff, the hospital failed to ensure:

a. All deaths were reported to the OPO.
b. Incorporate organ procurement activities into the quality assessment and performance improvement (QAPI) program.

Findings:

1. The death register provided to the surveyors on 07/22/14 did not contain all the deaths that occurred in the hospital during the above mentioned time period. Two individuals listed on the LifeShare referral forms were not contained on the hospital's death list.

2. Seven patient names (Patient Records #7, 8, 9, 10,11, 12, and 13) contained on the hospital's death list were not listed on the LifeShare referral sheets supplied to the surveyor.

3. The surveyors asked for the documentation in the medical records to show LifeShare had been contacted. Two of the seven (Patient Records #9 and 13) medical records reviewed did not contain documentation that LifeShare had been notified.

4. These findings were reviewed with Staff P on the afternoon of 07/22/14. He stated he thought only one patient (#9) had not been reported. He brought the surveyors different LifeShare referral sheets. These forms contained the names of the patients for Records #7, 8, 10, 11, 12, and 13, but not #9.

5. On 07/22/14 at 1500, when asked Staff P told the surveyors that OPO was not reported to quality improvement and was not part of the QAPI program.

6. These findings were again reviewed during the exit conference on the afternoon of 07/23/14. No additional information was provided.