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Based on record review and interviews with staff, the hospital failed to have an agreement with an outside source for credentialing and quality assurance as required. This was reviewed and confirmed with Staff E on 08/05/14.

Based on record review and interviews with hospital staff, the governing body does not ensure that all practitioners providing patient care are qualified and have current privileges granted and health histories. Two (# L and M) of two contract ophthalmology personnel credential files reviewed were incomplete and did not have evidence of current privileges granted and complete health histories. This was confirmed by Staff E on the morning of 08/05/14.

Based on review of hospital documents and meeting minutes, surveyors' observations, and interviews with hospital staff, the hospital failed to develop and provide infection control services according to standards and written policies, as evidenced by failure to:

a. Process instruments according to manufacture guidelines and recognized standards of practice. This same deficient practice was cited in the last survey in 2010.

b. Ensure a safe and sanitary environment.

c. Monitor all areas/departments of the hospital to ensure infection control standards and policies and procedures were followed.

Refer to Tag C-278 for details.

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; and

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.

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 has not conducted a tuberculosis risk assessment.

3. The hospital does not have a current infection control plan (Plan) that details 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 on the afternoon or 08/06/14. They were also reviewed during the exit conference on 08/07/2014. No additional information was provided.

4. The program does not have a physician appointed/assigned to be a member and attend meeting where infection control data is reviewed, analyzed and corrective actions taken. This requirement was also documented as a requirement in the "Organization" portion of the Infection Control policy and procedure manual.


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 respiratory isolation policy that identified N-95 masks would be required for anyone who entered the respiratory isolation patient's room, the policy did not specify, nor did any other policy exist in the IC manual, that it would be 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.

3. 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.

4. The hospital does launder surgery and emergency department scrubs. The hospital did not have specific policies and procedures for the cleaning of the clothing. This finding was confirmed with Staff N on 08/04/14 at 1430.


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 supplied for review, were patient infection reports. There were no observations 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. On 08/05/14 at 1615, Staff B stated she had just started observing hand hygiene compliance, but had only completed a few and had not brought the findings to the infection control portion of the quality assessment and performance improvement meetings for review and analysis.

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 08/05/14 that she had not gone back to surgery.

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. On the morning of 08/04/14, Staff N and Staff B told the surveyors that Super HDQL-10 was the hospital's recognized disinfectant. This disinfectant was not effective against Clostridium-difficile (C-diff). Surveyors also found HdqC-2, Peroxy, HDQ Neutral. and "purple-top" and "green-top" PDI Sani-cloth wipes (which also are not effective against C-diff).
d. Only three staff ( Staff N, R and LL) knew that bleach products were effective against C-diff and only Staff N, the hospital's certified dietary manager, knew the dilution/concentration and that it needed to be made daily.
e. Staff F and W could not tell the surveyors the appropriate times for the disinfectants' applications.

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:
1. Refer to Tag C-320 for detailed information about surgical services observations. Observations including, but not limited to:
a. Instruments are not sterilized according to the hospital's autoclave instructions.
b. Although the hospital has a decontamination room and a clean processing room, staff are not utilizing these areas. Processing of eye instruments are routinely performed in the sub-sterile room.
c. Staff could not provide the manufacturer's guideline for processing the eye instruments, but according to the American Society of Cataract and Refractive Surgery (article published 2007), surgical eye instruments should be thoroughly cleaned and inspected before sterilizing and "flash"/immediate use sterilization "...should not be used to save time or as a substitute for sufficient instrument inventor...Flash sterilization is designed to manage unanticipated, urgent needs for instruments..."
d. The surveyors did not observe an endoscope processing log to trace which endoscope was used on each patient. On 08/05/14, Staff D confirmed this did not occur.

2. Although the hospital told the surveyors that it contracted for laundry service, on 08/04/14, Staff N stated the hospital staff laundered emergency and surgery departments scrub uniforms in-house. The hospital's washer and dryer was not commercial grade and did not reach the temperatures recommended. Staff N stated no bleach was added so that lower temperatures would ensure the clothing was disinfected.

3. The clean supplies in storage room where covered in dust. This was also the room where the hospital's washer and dryer were located.

4. Respiratory staff were cleaning dirty instruments/equipment in the clean storage room.

5. On the hospital observation tour on the morning of 08/04/14, one surveyor observed an open container in the clean storage room. Staff KK told the surveyor that the basin contained Cidex disinfectant. The manufactures of Cidex recommends this product be used with special ventilation. None was provided. Radiology staff also stated they cleaned ultrasound probe in Cidex. (The surveyors confirmed that staff did not mean Cidex OPA, which does not require a ventilation

Meeting Minutes:
Staff B and E told the surveyors that the hospital's infection control committee was part of the hospital's quality assessment and performance improvement (QAPI) meeting minutes. Staff E stated the meeting minutes were then forwarded for review to the governing body (Board of Trustees). Staff E stated on 08/06/14 at 0900 that QAPI meeting minutes were not forwarded to the Medical Staff unless there was a specific issue or unresolved problem.

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. There were no infection control data submitted for the 2014 meetings. The 2013 meeting minutes reviewed only contained information about patient infections and did not contain any information about staff infections or illnesses. Although nosocomial/HAI (hospital acquired infections) were identified in the attached reports, there was no 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 08/05/14 that this did not occur.

4. 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.

5. Staff told the surveyors that the hospital had exceeded the Oklahoma Hospital Association's challenge of at least 92% compliance. The meeting minutes did not reflect staff influenza immunizations were part of the program. Annual influenza was not documented in the personnel's health files, but the hospital was able to provide documentation kept elsewhere. Review of health files for contract staff, physicians and allied health files did not show complete immunizations as recommended by CDC and its advisory committee (ACIP).

6. 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.

7. 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 Medical Staff meeting minutes, the hospital current diet manual and dietary policies and procedures, and an interview with hospital staff, the hospital failed to ensure the current diet manual and the dietary policies and procedures are approved by the dietitian and the medical staff. This findings was reviewed and confirmed with Staff D and E on the morning of 08/04/14.

Based on review of medical records and hospital meeting minutes and interviews with staff, the hospital failed to provide complete policies and procedures for the electronic medical records.


Findings:

1. The hospital converted to an Electronic Medical Record (EMR) system in 2003. This was confirmed by Staff E and N.

2. The hospital did not have specific policies and procedures for EMR.

3. During record review on 08/05/2014 Staff B, the staff assigned by the hospital as being able to locate all information in the EMR needed for review, was unable to locate patient information in the EMR requested by surveyors.

Review of policies and procedures with the administrator confirmed the EMR was established in 2003. The administrator also explained that not all records were being entered into the EMR.

Based on review of medical records and interviews with hospital staff, the hospital failed to ensure medical records contain pertinent orders and information. Documentation pertinent to the continued care of the patient was missing or not completed. This occurred in eight (Patients #2 through 9) of eight surgery medical records reviewed.

Findings:

The hospital use a hybrid system for medical records (written, computerized and dictated).

Patients # 2 through 9 all had surgical procedures performed at the hospital.

Records # 2, 3, 4 and 5- The pre-printed Pre-Operative Orders did not contain the amount of intravenous (IV) fluids to be administered to the patients.

Record #3 did not contain Intra-Operative nursing notes.
Record #5 did not contain an initial nursing assessment.

Records # 2, 3 and 4- did not contain the total amount of IV fluids that was administered to the patients.

Records # 6, 7, 8 and 9- did not contain the date and time the Aldrete Score was performed and the amount of IV fluids administered.

The above information was confirmed by Staff A on the afternoon of 08/05/14.

Based on review of medical records and interviews with hospital staff, the hospital failed to ensure all entries in the medical record were signed and contained the date and time of the signatures/authentication. This occurred in eight of eight (#2 through 9) surgery medical records reviewed for completed entries.

Findings:

The hospital use a hybrid system for medical records (written, computerized and dictated).

Record #2, 3, 4 and 5-the History and Physical did not contain the time the physician signed/authenticated the dictated document.

Records #2, 3, 4, 5, 6, 7, 8 and 9 - the Operative Report did not contain the date and time the physician signed/authenticated on the dictated document.

Records #2, 3, 4 and 5- the pre-printed Pre-Operative Orders did not contain the time the physician signed/authenticated the dictated document.

The above findings were confirmed with Staff MM on the afternoon of 08/05/14.

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 08/04/14, a tour was conducted of the surgery department with Staff A and D.

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

No handwashing sink in the decontamination room.

Review of a hospital policy, with the subject, Personnel Attire-Dress Code, documented, "...Artificial nails should not be worn by scrub personnel..."

Staff D had artificial nails, wrist watch on the left arm, rings on the left and right ring fingers, ring on the right thumb, and a bracelet on the right wrist.

Multi-dose vial of Lidocaine 1% found in the sub-sterile area with an expiration date of September 2013.

The scopes used for endoscopic procedures did not have identifiers. This was confirmed by Staff D.

Review:

The surveyors requested the endoscope log. None was provided. This was confirmed by Staff D on 08/05/14.

The ophthalmology operating room log was reviewed for 2014 for the following months, February, March, May and June. The times indicated on the operating room (OR) 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 averaged eleven minutes. Disinfectant cleaners used by the hospital required a ten minute kill time for adequate disinfecting of surfaces.

Ophthalmology surgery,including staff (L, M, Y and Z), surgical instruments and the phacoemulsification (Phaco) machine were provided by a contract service.

The hospital was asked for the manufacturers instruction for use for the surgical instruments and the preventative maintenance for the Phaco machine. None was provided.

The hospital was asked for the credential files for Staff L and M. None were provided. Refer to Tag C-241 for further details.

The surgical instruments were sterilized using a table top (M7 Speedclave) autoclave in the sub-sterile area.

Review of the operator's manual for the M7 documented the minimum temperature to sterilize surgical instruments is 270 degrees Fahrenheit.

Review of the sterilization logs for the eye instruments from February 2014 to June 2014, documented the instruments were processed for fifteen minutes at a temperature of 250 degrees Fahrenheit. No dry/exhaust time was recorded. This was confirmed by Staff D.

Surveyors requested the temperature and humidification logs for the operating room. None was provided. On the afternoon of 08/04/14, Staff E stated the hospital did not track the temperature and humidity in the OR.

The policies and procedures for the operating room were last reviewed December 2006.

The policies and procedures for endoscopy were last reviewed August 2006.

The OR log did not designate which staff functioned as the circulating and scrub nurse.

Medical records were reviewed on the afternoon of 08/05/14. Refer to Tag C-306 for further details.

Based on observations and interviews with hospital staff, the hospital failed to ensure a copy of the physicians' current privileges are kept/available in the surgical suite/area (OR). During the tour of the surgical unit on the morning of 08/04/14, Staff A told the surveyor that a list of surgical privileges for the physicians were not maintained in the OR area.

Based on review of the hospital's annual periodic evaluation and policy and procedure manual and interviews with the hospital staff, the hospital failed to ensure all patient care policies were reviewed at least annually.

Findings:

The policy manuals for pharmacy, surgery and anesthesia did not show they have been reviewed within the last year.

The hospital's annual periodic evaluation did not stipulate the above manual had bee reviewed.

These findings were reviewed and confirmed with Staff E on 08/05/14.

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 Assurance Plan (QAPI Plan) documented the QAPI program was:(the following was paraphrased) to:
a. Establish an ongoing monitor for problem identification;
b. Objectively assess the cause and scope of identified problems;
c. Establish priorities for the resolution of identified problems and implement appropriate mechanisms for problem solving;
d. Assure that corrective action is appropriate and sustained through ongoing follow-up of problem solving activities.

Meeting minutes did not reflect this was being done.

2. There were no indicators for the surgery, anesthesia and central sterile departments. No tracking of surgical cases was documented, including processing of surgical instruments and endoscopes. No tracking of the environment occurred.

3. The 2013 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 or the documented plan of action was just to "continue to monitor". Examples include, but not limited to:
a. Housekeeping - reported in QAPI 11/05/13 was cleaning compliance of 70-75% (The plan or action was to continue monitoring). The 01/30/14 minutes reported cleaning compliance was 50-75% compliance (The plan of action was to continue to monitor).
b. Dietary - The QAPI minutes for 01/30/14 reported 50-65% compliance with documentation. Other that continue to monitor, no plan of action was shown.
c. Human resources reported in the 04/24/14 meeting that 23 of 163 employees had not completed the Safety Fair, that this was down from the previous year and only 2 had completed make-up. No plan of action for the rest of the employees was documented.

6. QAPI meeting minutes did not reflect any physician attended the meetings and the minutes were not forwarded to Medical Staff for review, analysis or action. Infection control policies and procedures stipulate a physician will be on the infection control committee.

7. Organ procurement/Life Share is not followed through the QAPI program.

8. These findings were reviewed with hospital administrative staff during the exit conference on 08/06/14. No additional information was provided.


These findings were reviewed with administrative staff on 08/06/14.

Based on record review and interviews with staff, the hospital failed to have an agreement with an outside source as part of the quality assessment and performance improvement (QAPI) program to assure the quality and medical necessity of medical care at the hospital.

Findings:

The hospital has two credentialed physicians that provide surgical services. One physician performs eye cataract surgeries. The physician does endoscopies. The rest of the credentialed physician's do not provide surgical services.

Currently, medical record review for appropriate diagnosis and treatment of the surgical cases (peer review) is not being performed by other physicians with similar privileges.

Staff E confirmed on 08/05/14 that the hospital did not have an outside source to review medical records and perform peer review functions to determine if appropriate diagnosis and treatment occurred.