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Based on review of facility documents and employee interviews (EMP), it was determined that Governing Body failed to involve in its Quality Assessment and Performance Improvement (QAPI) program, ten of ten contractual services or arrangements reviewed (Lab, Cardiology, Gastroenterology, Endocrinology, Nephrology, Neurology, Orthopedics, Pathology, Podiatry and Urology).

Findings include:

On April 30, 2018, at approximately 1:30 PM, a review was conducted of the "Warren State Hospital Plan for Improving Organizational Performance," revised December 2017. Review of the document revealed, "I. Introduction: Warren State Hospital's Plan for improving Organizational Performance helps assure a planned hospital-wide approach to performance improvement (PI) activities. ... The plan not only outlines the performance improvement process; it also explains how the Hospital's leadership insures [sic.] that PI is integrated into all aspects of patient care services. ... II. Goals of the PI Process: ... 4. The PI process is integrated into all aspects of hospital operations including the provision for patient care services, hospital administration, patient safety and strategic planning."

1. On May 1, 2018, at approximately 9:30 AM, a review was conducted of the Warren State Hospital Governing Body Bylaws, adopted April 26, 2018. The review revealed no requirement or reference for the review of contractual agreements, or for the inclusion of such agreements into the QAPI process.

2. Review of the "Warren State Hospital Plan for Improving Organizational Performance," on April 30, 2018, at approximately 1:30 PM, revealed no requirement or reference for the inclusion of contractual agreements in the QAPI (PI) process.

3. On May 1, 2018, at approximately 9:40 AM, a review was conducted of a document titled, "Warren State Contracted Consultants," revised January 2018. The document listed contracts for services; including but not limited to: Lab, Cardiology, Gastroenterology, Endocrinology, Nephrology, Nephrology, Orthopedics, Pathology, Podiatry and Urology services.

4. When asked, on May 1, 2018, at approximately 9:50 AM, how contractual services are incorporated into the facility QAPI Plan, EMP8 stated, "Does it tie into QAPI? It really doesn't. Not unless there would be a problem."

5. On May 1, 2018, at approximately 10:13 AM, a review was conducted of a document titled, "Budget Contracts 2017-2018." The document was presented with information requested from the facility related to QAPI for contractual services. Review of the document revealed a listing of contractual services, as well as related financial budget and expenditure information. When asked, at the time of the review, about the document and how it would relate to QAPI for contractual services, EMP8 stated, "It's definitely more of a procurement process than a quality process."

6. On May 1, 2018, at approximately 12:53 PM, EMP8 confirmed that the Governing Body By-Laws, PI (QAPI) plan and PI (QAPI) minutes did not include or reflect the inclusion of contractual services.

Based on review of facility documentation, facility observation, and employee interviews (EMP), it was determined that Warren State Hospital failed to develop and implement policies, consistent with manufacturer guidelines, for the cleaning and disinfecting of blood glucose meters used for more than one patient.

Findings include:

1. Review, at approximately 1:00 PM on May 1, 2018, of "Blood Glucose Monitoring," revised June 2017, revealed, "... Plan ... I. Night shift licensed personnel assigned to the Medication Room will perform the weekly cleaning and daily check of the blood glucose meter ... and will document every Sunday in the 'Daily Glucometer Control Form' ... Implementation ... B. The licensed personnel will: ... 5. Utilize the blood glucose meter to obtain a blood glucose level while adhering to Standard Precautions. Refer to the blood glucose meter user's manual (specific to the Glucometer used at Warren State Hospital) for detailed directions and information on the use of the device. ... 10. The blood glucose meter will be cleaned weekly as described in the user's manual. ... Documentation of the cleaning and control checks will be recorded on the Daily Glucometer Control Form ... 11. The blood glucose meter in the EMPLOYEE CLINIC and CENTRAL SUPPLY will be cleaned monthly. Documentation of the cleaning and control checks will be recorded on the Daily Glucometer Control Form. ... Evaluation A. An ongoing monitoring and evaluation of the Standards of Nursing Practice and Standards of Patient Care will be conducted by the RNS to assure proper technique and utilization of the blood glucose meter is maintained ..."

2. On May 1, 2018, at approximately 11:30 AM, a review of the manufacturer guidelines for the [Brand Name] Blood Glucose Monitoring System revealed, "Important Safety Information WARNING * All parts of the glucose monitoring system should be considered potentially infectious and are capable of transmitting blood-borne pathogens between patients and healthcare professionals. ... Clean and disinfect the meter after use on each patient. The [Brand Name] system may only be used for testing multiple patients when Standard Precautions and the [Brand Name] meter cleaning and disinfecting procedures are followed. ... Chapter 6: Cleaning and Disinfecting the Meter ... NOTE Meters used with multiple patients require cleaning and disinfecting after use on each patient. Follow recommendations from the FDA, CDC, and CMC and your facility's policies and procedures for infection control. The FDA recommends that Point of Care testing devices, such as blood glucose meters, should be used only on one patient and not shared. If dedicating blood glucose meters to a single patient is not possible, the meters must be properly cleaned and disinfected after every use following the guidelines on the following pages. Cleaning and Disinfecting ... NOTE The meter should be cleaned and disinfected between each patient use."

3. Review, at approximately 12:00 PM on May 1, 2018, of "Daily Glucometer Control Form," no revision date, revealed that in April 2018, there were 16 out of 30 days that had no documentation indicating that the glucose meter had been cleaned. On May 1, 2018, at approximately 12:00 PM, EMP7 confirmed there was no documentation indicating that the glucose meter was cleaned for 16 out of 30 days stating, "I'm sure it was done. It must have just been an oversite"

4. On May 1, 2018, at approximately 1:00 PM, a review was conducted of the "2018 Yearly Glucometer Training." The review revealed, "Quality Control Testing ... *[Brand Name] are used to clean the meters weekly on Sunday for Monday (night shift) and when visibly 'dirty.'"

5. On May 1, 2018, at approximately 11:25 AM, when asked if all patients had their own glucometer, EMP5 stated, "No." When asked how many glucometers there were on the unit, EMP5 stated, "There is one, well two on this unit." When asked if the glucometer was cleaned after each patient use, EMP5 stated, "No. Just at night." EMP5 further stated that the blood glucose meter was used approximately four to five times a day, for more than one patient.

6. On May 1, 2018, at approximately 11:35 AM, when asked the process for cleaning glucometers, EMP6 stated, "[Name Brand] Wipes. Usually it is the third shift that cleans them." When asked approximately how many patients may be tested on a given day, EMP6 stated, "It is hard to say." After reviewing medication administration records, EMP6 stated that on a given day, up to five patients may be tested with the glucometer. When asked to confirm that the glucometer was not cleaned after each patient use, EMP6 stated, "No. Nights do it."

7. On May 1, 2018, at approximately 1:50 PM, when discussing the findings related to cleaning/disinfecting glucometers after patient use as compared to the facility policy and manufacturer guidelines, EMP8 stated, "I asked and was told no matter our policy, if the book [manufacturer guidelines] says to do it another way, then that is what we should be doing it."

8. On May 2, 2018, at approximately 10:00 AM, EMP9 confirmed that glucometers are used multiple times daily for multiple patients and not cleaned until the evening shift. When discussing the manufacturer guidelines requiring cleaning and disinfecting between use on patients, EMP9 stated, "Wow. That is news to me." EMP7, also present, stated, "They follow the policy [Blood Glucose Monitoring]."