HospitalInspections.org

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Based on interview and document review, the facility failed to incorporate quality indicator data including patient care data, and other relevant data.

Failure to document and report instances of "near miss" incidents may hinder the facility's ability to put processes and protections in place to prevent negative patient health outcomes, illness, or death.

Findings included:

1. Review of the hospital policy titled, "Organization Coordinated Quality Improvement Plan, 815," #11818317 effective date 05/22, showed that the philosophy of the Kadlec Community Mission Board, Executive Leadership Team, Medical Staff, professional and support service staff of Kadlec strives to ensure that the mission to provide safe compassionate care is fulfilled resulting in improved health outcomes and prevention of medical errors. The pursuit of quality and improved care is the responsibility of all caregivers, including employees, practitioners, departments, services and others across the system.

2. Review of the hospital policy titled, "Datix Event Reporting, 1906," #11106222 effective date 01/22, showed that the Datix Event Reporting process is a non-punitive process designed to identify unanticipated outcomes and events involving patient care, visitors, students, lost or damaged personal property, or facility property. Events are reported as they occur or are identified, Kadlec Regional Medical Center (KRMC) relies upon its staff and its culture of patient safety to report events that occur during the course of patient care and services. Any event that poses a threat to the organization including any risk, event, error, hazardous condition or set of circumstances that has harmed or could lead to harm to a patient or their representative or loss to the organization should be reported.

3. On 05/31/22 at 11:58 AM, during an interview with the investigator, a pharmacy technician (Staff #7) stated that they had noticed dark colored material under the laminar flow hood worktop seen through the grate of hood #4. They stated they had reported the dark material to the lead and supervisor verbally prior to 03/27/22. On 03/27/22, when Staff #7 was cleaning the back of the hood, orange streaks were noted on the sterile gown they were wearing. The material transferred to the gown was reported to the pharmacist on duty who recommended that an SBAR (situation, background, assessment and recommendation) notice be emailed to the pharmacy manager. Staff #7 stated that the SBAR was sent.

4. On 05/31/22 between 11:00 AM and 3:30 PM, 7 pharmacy employees were interviewed and stated that they were aware of the spill and cleanup but did not file a Datix Event Report, notify infection control or risk management (Staff #5, Staff #6, Staff #7, Staff #8, Staff #9, Staff #10, Staff #11).

5. Review of hospital event report log for 03/01/22 through 04/30/22 showed that there were no reports related to spills in the pharmacy.

6. On 06/01/22 at 10:49 AM, during an interview with the investigator, the manager for risk and patient safety (Staff #14) stated that they were unaware of a sill event or cleanup on 03/29/22. No Datix Event reports were received and no telephone or email messages were recieved related to the spill and clean up.

7. On 06/01/22 at 12:30 PM, during an interview with the investigator, the manager of infection control (Staff #12) stated that they were not aware of a spill in the laminar flow hood in the pharmacy. They stated there had been no clusters of infections that may have been related to a spill in the pharmacy.
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Based on observation, interview and document review, the facility failed to discard medication left over from a single-dose/single-use vial when the 6-hour time limit allowed by USP 797 had expired.

Failure to adhere to principles of medication compounding risks administering medications that could carry infectious agents, causing poor health outcomes, including death.

Reference: Centers for Disease Control One and Only Campaign Injection Safety Guidelines showed "Do not use medications packaged as single-dose or single-use for more than one patient."

Findings included:

1. On 06/01/22 at 3:30 PM, Investigator #25 observed daptomycin in the clean room refrigerator labeled as reconstituted date 05/31 and 06/07 Beyond Use Date (BUD).

2. Review of the hospital policy titled, "Preventing Infections from Misuse of Vials, 600.03.03, #11159078, effective date 03/22, showed that contents of single-dose/single-use vials are not to be combined or pooled, and are not to be stored for later use, no matter what the size of the vial.

3. Review of the email and information from Cubist Pharmaceuticals dated 07/30/10 showed that although daptomycin is supplied as a sterile lyophilized cake, sterility of the reconstituted solution over time has not been tested. Daptomycin contains no preservatives, fungistatic agents, or bacteriostatic agents.

4. USP 797 showed that single dose vials may not be used beyond 6 hours if punctured under ISO 5 conditions and that to extend the beyond use dating of any final solution, both stability and sterility must be tested.

5. Review of the hospital's By Use Date list, no number, no date, showed that daptomycin discard date is 7 days refrigerated.

6. On 05/31/22 at 11:24 AM, during an interview with investigators #13 and #25, a pharmacy technician (Staff #8) stated that when daptomycin is reconstituted, they clean the top with alcohol and put a blue seal on top with date. It is good for 7 days in the refrigerator. The bottle is labeled with a yellow sticker with the date the medication was reconstituted and use by date 7 days from the day of reconstitution. The label is initialed by the tech and the pharmacist.

7. On 06/01/22 at 1:30 PM, during an interview with investigators #13 and #25, the Senior Pharmacy Manager (Staff #4) stated that the Cubist report showed that the medication is stable for 10 days, but the hospital used 7 days. Reconstitution if done in the hood in the single dose vial. If the vial isn't completely used, it is kept in the refrigerator with use by date 7 days after reconstitution. Staff #4 was shown the Cubist report section immediately below the paragraph highlighted by the hospital staff. The following paragraph showed that sterility of the reconstituted solution over time has not been tested and that daptomycin contains no preservatives, fungistatic agents or bacteriostatic agents.

8. On 06/03/22 at 11:30 AM, during a telephone interview with Investigator #13, the Director of Pharmacy (Staff #3) stated that a change in process regarding antibiotics [such as extending the beyond use date for daptomycin] would not be presented to medical staff committees for approval because it is just what we use to do our work.

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Based on interview and document review, the hospital failed to ensure a clean and sanitary environment in the pharmacy to avoid sources and transmission of infection.

Failure to ensure a clean and sanitary environment, puts patients at risk of poor health outcomes, illness, and death.

Findings included:

1. On 06/01/22 at 1:30 PM, during an interview with Investigators #13 and #25, the senior pharmacy manager (Staff #4) stated they became aware of the dark substance under the laminar flow hood work surface when a pharmacy technician (Staff #7) sent an email on 03/27/22 that outlined the observation of a dark substance under the grate of laminar flow hood #4, and stains on their sterile gown from leaning over the hood surface to clean the back area.

2. On 05/31/22 at 11:58 AM, during an interview with the investigators, a pharmacy technician (Staff #7) stated that on 03/29/22 three pharmacy technicians (Staff #7, Staff #9, Staff #10), the senior pharmacy manager (Staff #4)and the pharmacy director(Staff #3) took hood #4 out of service and began to clean it. The automated compounding device was moved to hood #3, and hood #4 was moved to the anteroom for cleaning. The spill was reported to be large, partially wet, partially congealed and partially dried. It was reported to be orange/brown/black in color and strong smelling.

3. On 05/31/22 at 11:58 AM, during an interview with the investigators, a pharmacy technician (Staff #7) stated that no one was sure how to open the hood to clean under the work surface where the spill had collected and that the senior pharmacy manager (Staff #4) looked up the procedure on You Tube. The top of the hood had to be pried open due to the dried spill. Cleaning of the spill was attempted with alcohol, 409, comet, and sterile water. A butter knife and a paint scraper were tried. Sterile water was most effective at cleaning the spill.

4. On 05/31/22 at 11:24 AM, during an interview with investigators # 13 and #25, the Pyxis Training Specialist (Staff #8) stated that the laminar flow hoods were new last year during a remodel. There were no equipment manuals available for staff and there was no training provided on how to clean the interior where the spill tray was located. Staff were unaware that there was a spill tray under the working surface. Laminar flow hood #4 was used to prepare total parenteral nutrition (TPN) for the Neonatal Intensive Care Unit (NICU).

5. Review of notes from a required IV Room Huddle, dated 04/21/22 at 4:30 PM, showed that large spills in the hoods can enter the grates to the spill tray, and possible scenarios where that could happen. New cleaning procedures to visually inspect the grates and to notify management of any concerns and any spills were included in the meeting.

6. On 06/01/22 at 1:30 PM, during an interview with Investigator #13 and Investigator #25, the senior pharmacy manager (Staff #4) stated that following the cleaning of the hood, it was left open overnight to dry. The following day, the hood was closed, and a triple clean process was completed, as required by hospital policy.

7. Review of the hospital policy titled, "Quality Assurance for Sterile Compounding, 44.15.00," #11206742, effective date 02/22, showed that all cleaning activities are to be documented on designated logs.

8. Review of the March and April 2022 cleaning logs showed that the extensive cleaning of the spill, and the triple clean the following day were not documented on the cleaning log.

9. On 05/31/22 between 11:00 AM and 2:50 PM and on 06/01/22 between 1:30 PM and 3:30 PM, during interviews with Investigators #13 and #25, 9 staff members each stated they were aware of the spill and subsequent cleaning of the laminar flow hood #4. No one filled out a Datix Event Report or notified infection control or risk management (Staff #3, Staff #4, Staff #5, Staff #6, Staff #7, Staff #8, Staff #9, Staff #10, Staff #11).

10. Review of the Datix Event Reporting log for March and April 2022 showed that there were no reports filed related to the pharmacy spill and subsequent cleanup.

11. On 06/01/22 at 11:00 AM, during an interview with Investigator #13, the risk manager (Staff #14), stated that they were unaware of any spill or cleanup activity in the pharmacy department.

12. On 06/01/22 at 12:30 PM, during an interview with Investigator #13, the infection prevention manager (Staff #12), stated that they were unaware of any spill or cleanup in the pharmacy department. Staff #12 stated that they would not expect to be notified of a spill in the pharmacy unless there was concern for growth.

13. Review of the Sampling Action Report, dated 03/31/22, 04/01/22, and 04/02/22, showed that sampling was done on the left side, the right side and the bottom of the hood for laminar flow hood #4.

14. On 06/01/22 at 1:30 PM, during an interview with the investigators, the senior pharmacy manager (Staff #4) stated that the spill was not tested. They didn't see any mold or indication of contamination.

15. On 06/01/22 at 2:17 PM, during an interview with the investigators, the director of pharmacy (Staff #3) stated that they were a microbiologist by training and they saw no obvious colonies but the spill smelled like sugar or burned teriyaki.

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