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Based on observations, record reviews, and interviews, the hospital failed to meet the requirement for the Condition of Participation for QAPI as evidenced by failing to ensure adverse patient events/potential events related to surgical services/SPD were measured, the causes were analyzed, preventive actions were implemented, and feedback was provided to allow for learning amongst the OR and SPD staff.


There were five observations made during the survey of failure to implement the procedure for preparing and packaging items for sterilization, and there were 105 incident reports documented from 03/01/18 through 09/10/18 related to surgical services/SPD due to delay in patient care, surgery delays/cancel, issues with instrument sterilization, contaminated/damaged equipment, equipment failure while in use, equipment not available, contaminated instruments, and equipment issue (see findings in tag A0286).

Based on observations, record reviews, and interviews, the hospital failed to ensure adverse patient events/potential events related to surgical services/SPD were measured, the causes were analyzed, preventive actions were implemented, and feedback was provided to allow for learning amongst the OR and SPD staff.


1) Five observations were made of failure to implement the procedure for preparing and packaging items for sterilization on 09/10/18 at 11:09 a.m. (Patient #1), 09/10/18 at 12:15 p.m. (Patient #3), 09/11/18 at 10:20 a.m. (Patient R17), and 09/11/18 from 10:35 a.m. to 11:00 a.m. (Patient R16), and opening of a major vascular tray in the SPD for inspection on 09/10/18 at 3:50 p.m.


2) There were 105 incident reports documented from 03/01/18 through 09/10/18 related to surgical services/SPD due to delay in patient care, surgery delays/cancel, issues with instrument sterilization, contaminated/damaged equipment, equipment failure while in use, equipment not available, contaminated instruments, and equipment issue. Two incident reports were reviewed for missing items for procedures performed on 05/21/18 for Patients #4 and #5 and had no documented evidence that an investigation was conducted to determine which staff member had assembled the tray to determine if additional education and competency evaluation was needed.


Findings:


1) Five observations were made of failure to implement the procedure for preparing and packaging items for sterilization:


Patient #1
Observation on 09/10/18 at 11:09 a.m. in OR 15 revealed S8CST was setting up the sterile table for a Left Femoral Tibial Bypass for Patient #1. Continuous observation revealed a label on the outside of the small vascular set indicated the applicator/bull dog applying forceps was missing. During the set-up of the sterile field, S8CST noted the applicator/bull dog applying forceps was not missing and was present in the tray.


Patient #3
Observation on 09/10/18 at 12:15 p.m. in OR 11 revealed S15ST was setting up the sterile table for an Open Reduction Internal Fixation of the right ankle for Patient #3. Continuous observation revealed S15ST had not lifted a box of screws that was in the vendor tray. After the surveyor asked S15ST (who indicated she didn't usually remove the box of screws until the procedure had started) to lift the box of screws so the liner could be seen under the box of screws, a white thin strip approximately 0.5 centimeters wide by 3 centimeters long that looked like plastic was in the bottom of the vendor tray under the box of screws.


Patient R17
Observation on 09/11/18 at 10:20 a.m. in OR 1 revealed S18ST was setting up the sterile table for an Open Reduction Internal Fixation of the Mandible for Patient R17. She opened the vendor tray and indicated she didn't see an indicator in the tray. After removing her gown and checking the tray, S18ST indicated the indicator was inside one of the sets and should have been on top where it would be visible.

Observation on 09/11/18 at 10:54 a.m. in OR 1 after the vendor tray was replaced, a brownish-yellow stain was noted on the tray liner in the mandible tray (brought to attention of S18ST by the surveyor).


Patient R16
An observation on 09/11/18 at 11:00 a.m. in OR 15 revealed a sterile tray containing a cord and a light source for a bronchoscope, when opened in preparation for a surgical procedure, had a moderate to large amount of bright blue discoloration on the white paper liner in the bottom of the tray. The tray and its contents were examined by S41STS and S40ST. S40ST reported there was a Sterrad indicator in the tray, in addition to the chemical indicators for steam sterilization, and the blue discoloration was from the Sterrad indicator. S16SPM was called to the OR and examined the tray and the shrunken and deformed Sterrad indicator. S16SPM reported the indicator was not made for steam sterilization (the sterilization process through which this surgical equipment tray had undergone), and the Sterrad indicator did not affect the sterility of the tray, but should not have been placed into this surgical tray for sterilization. S40ST instructed the surgical tech student to break down the surgical table and begin again, because she could not ensure the sterility was not affected by the Sterrad indicator when it underwent the steam sterilization cycle.


Observation in the SPD on 09/10/18 at 3:50 p.m. revealed a Major Vascular Tray was opened by S16SPM to be observed by the surveyors. Observation revealed a light brownish-yellow residue on the bottom of the cloth (identified by surveyors and not by S16SPM). Observation revealed 6 to 7 areas of the liner were noted with the residue.



Patient #4
Review of Patient #4's electronic medical record revealed she had a Coronary Artery Bypass Graft Mammary on 05/21/18. Review of a BSafe report (the hospital's incident reporting system) dated 05/21/18 revealed a second microheart tray was missing 2 pickups, and there were no peel packs to be found. Review of the action taken revealed the instruments needed to be replaced in trays that the hospital needed to re-order. Switching companies temporarily slowed the ordering process. There was no documented evidence that an investigation was conducted to determine which staff member had assembled the tray to determine if additional education and competency evaluation was needed.


Patient #5
Review of Patient #5's electronic medical record revealed he had a Coronary Bypass Graft times 2 and an endoharvest of the vein left leg on 05/21/18. Review of the BSafe report dated 05/21/18 revealed two trays were missing items. The heart tray had a sternum retractor missing, and the case can't be done without it. There was not another one found that peel-packed or wrapped. The second heart tray was incomplete. The temp tube holder was missing, and it had the wrong sternal retractor. There were no peel packs, and no one in SPD could locate one. Review of the action taken revealed the instruments needed to be replaced in trays that the hospital needed to re-order. Switching companies temporarily slowed the ordering process. There was no documented evidence that an investigation was conducted to determine which staff member had assembled the tray to determine if additional education and competency evaluation was needed.


In an interview on 09/12/18 at 11:45 a.m., S16SPM indicated "problems happen everywhere." He further indicated he doesn't think they have a process problem, but there can be an execution problem, meaning the indicator not present is an execution problem, because the process is there. He indicated the problem is they have a lot of new staff and a lot of travel staff. He further indicated there will be training errors with increased growth. He said his personal opinion is that they have a lot of new people and there's a problem with them executing the process. S16SPM indicated "the law of probability is an error will happen." When the surveyor asked what they've done to minimize this, S16SPM indicated they got more staff, brought in travel staff, and experienced contracted staff with Company B. He confirmed competency evaluations are self-assessments and not conducted by qualified hospital staff. S16SPM indicated almost everyone he's hired does not have prior experience in SPD. When asked by the surveyor about what was found in the bottom of the pan during the observation on 09/10/18, he indicated the set was still considered sterile, and that was a clinical call in the room. He indicated he probably would have switched the pan. He said if it was contaminated, he would have made the call, but it was not scientifically contaminated. When asked if it was appropriate to use as determined by his position, he said "I would not have used it." S16SPM indicated the water has been tested for hardness but hasn't been tested to know if there minerals present that could be causing residue.


In an interview on 09/12/18 at 1:40 p.m., S4SPOD indicated the observations made during the survey was the first time she saw the stained liners. Regarding the stain and the vendor tray with the plastic piece, she indicated they are now opening all vendor trays and checking them. She indicated she wasn't so alarmed with the stain, because she knows the sterilization process. She indicated you wouldn't stop the case, but if you saw a trend, she would want to remove the disintegration. She indicated the stained liners wouldn't have affected the case, because the temperature and time was reached. S4SPOD indicated she should have seen the problem with the stained liners on a BSafe report. She indicated they will continue using the instruments with stained liners while waiting for the test report that she has arranged to be done.



2) There were 105 incident reports documented from 03/01/18 through 09/10/18 related to surgical services/SPD:


Patient #4
Review of Patient #4's electronic medical record revealed she had a Coronary Artery Bypass Graft Mammary on 05/21/18. Review of a BSafe report (the hospital's incident reporting system) dated 05/21/18 revealed a second microheart tray was missing 2 pickups, and there were no peel packs to be found. Review of the action taken revealed the instruments needed to be replaced in trays that the hospital needed to re-order. Switching companies temporarily slowed the ordering process. There was no documented evidence that an investigation was conducted to determine which staff member had assembled the tray to determine if additional education and competency evaluation was needed.


Patient #5
Review of Patient #5's electronic medical record revealed he had a Coronary Bypass Graft times 2 and an endoharvest of the vein left leg on 05/21/18. Review of the BSafe report dated 05/21/18 revealed two trays were missing items. The heart tray had a sternum retractor missing, and the case can't be done without it. There was not another one found that peel-packed or wrapped. The second heart tray was incomplete. The temp tube holder was missing, and it had the wrong sternal retractor. There were no peel packs, and no one in SPD could locate one. Review of the action taken revealed the instruments needed to be replaced in trays that the hospital needed to re-order. Switching companies temporarily slowed the ordering process. There was no documented evidence that an investigation was conducted to determine which staff member had assembled the tray to determine if additional education and competency evaluation was needed.


Review of the "Detail Listing Of Incidents" from 03/01/18 through 09/10/18, presented by S5DQ, revealed a total of 105 incident reports had been documented related to OR/SPD. There were 21 for delay in patient care (specific cause not documented), 4 for surgery delays/cancel, 2 for issues with instrument sterilization, 5 for contaminated/damaged equipment, 4 for equipment failure while in use, 39 for equipment not available (not broken down by cause), 23 for contaminated instruments, and 7 for equipment issues.


Review of the hospital's Performance Improvement and Patient Safety Plan revealed, in part, "...Department Heads are responsible for monitoring, evaluating, and improving the services provided on behalf of the organization. This is accomplished through participation on hospital committees, improvement teams, and monitoring of departmental indicators. Indicators may include:...and trends in safety reports generated by their department. Department Heads are responsible for developing action plans to address identified deficiencies. Department Heads ensure that performance improvement and patient safety initiatives are in place for any regulatory required measures related to their department." Further review revealed, "Patient Safety: The Patient Safety Program is an integral part of the UMCNO Quality Program. Patient Safety initiatives provide an integrated and coordinated approach to error reduction throughout the organization. Patient Safety initiatives include all events of concern, actual or potential regarding patient safety... Safety Reports- The primary source for recording the facts contributing to health care errors or patient safety occurrences. The risk database reporting system provides a mechanism for prompt reporting, intervention, investigation, and resolution of errors in order to prevent avoidable recurrence. B SAFE Internal Phone Line-A Quality and Risk Department Phone line can be used to report errors, concerns, or safety issues. This provides an alternate method of communicating when time or technical system failures may not allow data entry into the database system. The phone messaging system enables anonymous reporting if the person does not want to be identified." The internal phone number and email address were provided and noted that it could be accessed from any email account.


In an interview on 09/13/18 at 2:45 p.m. with S2CNO and S5DQ present, S5DQ indicated the incident reports go to the department for full investigation and review. She further indicated they have noticed they have some communication opportunities, such as the data base isn't what it should be. S2CNO indicated she asked the risk manager to send her a weekly summary of incident reports related to SPD. S5DQ indicated the department trends and tracks the issues. She indicated incident reports are "just that; until the investigation is done, it may not become part of quality assurance." She indicated the department has been asked to report only confirmed events. She indicated they don't know if it's an increase of events or rather an increase in reporting of events. She further indicated she doesn't know if anyone has reviewed the incidents to see if they were actual events or not. When informed that the review of the two incident reports for Patients #4 and #5 revealed S16SPM's action didn't get down to what caused the problem, neither S2CNO nor S5DQ offered a comment. S2CNO indicated she wasn't saying that what S16SPM did was optimal. Both S2CNO and S5DQ indicated they knew there was a problem with S16SPM's investigation and had spoken with him about it. The surveyor asked if they had documentation of their discussions. S5DQ answered "no", and S2CNO indicated she wasn't sure. No documentation of any action/discussion was presented as of the end of the survey. S5DQ indicated the reporting system is "not optimal."


30420

30420



Based on observations, record reviews, and interviews, the infection control officer failed to develop and/or implement a system for identifying, reporting, investigating, and controlling infections and communicable diseases of patients and personnel. The Infection Control Officer failed to implement surgery-related risk mitigation measures contributing to healthcare-associated infections as evidenced by:


1) Failure to ensure safe injection practices were implemented as evidenced by observations of staff not cleaning the rubber septum of injectable medications prior to withdrawing the medication with a syringe on 09/11/18 at 10:30 a.m. and 11:36 a.m.;


2) Failure to ensure hand hygiene practices were implemented in accordance with hospital policy or AORN guidelines as evidenced by an observation of a breach in hand hygiene on 09/11/18 at 11:10 a.m.; and


3) Failure to ensure SPD data related to occurrences of instruments or equipment not adequately decontaminated/disinfected was reported in Infection Control.


Findings:

1)Failure to ensure safe injection practices were implemented:


An observation was made in OR #15 09/11/18 at 10:30 a.m. of S37CRNA drawing medications from individual vials into labeled syringes in preparation for administration to the surgical patient. Further observation revealed S37CRNA withdrew medications from 5 vials into syringes without first cleaning the rubber septum with alcohol after removing the plastic tops.


Observation on 09/11/18 at 11:36 a.m. in OR 1 during the surgery on Patient R17 revealed S21MD drew up anesthesia drugs without swabbing the hub of the vial with an alcohol wipe.


Review of the 2018 edition of Guidelines for Perioperative Practice revealed, in part, under Recommendation V.k., with respect to Medication Safety, the rubber septum on all vials should be "disinfected with alcohol and allowed to dry before each entry ...to remove any contaminant present on the stopper."


Review of the Hospital Infection Control policy # 9.04, titled "Reuse of Multiple and Single Use Containers, provided by S45ICO as current, revealed in part that, "Rubber stoppers and rubber injection ports must first be cleaned with alcohol before entry. This must be done even on new containers. The protective covering on new containers does not prevent contamination of the rubber stopper; it only prevents damage to the rubber stopper."


In an interview on 09/11/18 at 10:30 a.m., S37CRNA verified that he did not clean the rubber septum on the vials before inserting the needle and withdrawing the medication. The CRNA reported it was not his usual practice to do so. He asked if he was supposed to and when that had gone into effect.


In an interview on 09/11/18 at 11:43 a.m. with S20MD and S21MD present, S21MD confirmed she did not wipe the hub of the vial before withdrawing medication into the syringe.


In an interview 09/12/18 at 9:57 a.m., S3RN reported , "We watch anesthesia (personnel) for accessing (IV) lines, like wiping, but don't believe they (anesthesia personnel) have to wipe the top of vials, if it's a one-time dose." She reported she was not aware that the vial's rubber septum had to be wiped with alcohol prior to puncture with the needle on a newly opened medication vial. S3RN verified that the hospital's surgical department followed AORN guidelines.



2) Failure to ensure hand hygiene practices were implemented in accordance with hospital policy or AORN guidelines:


Observation on 09/11/18 at 11:10 a.m. revealed S20MD removed his gloves after assisting S21MD to intubate Patient R17 in OR 1. After removing his gloves and not performing hand hygiene, S20MD documented on the computer in the room and removed eye drops from the Omnicell (medication dispensing system).


Review of hospital policy and procedure #2.00 titled "Standard Precautions", provided by S45ICO as current, revealed in part, "It is the policy of the University Medical Center New Orleans to require all health care workers to follow Standard Precautions. Standard precautions are a group of infection prevention practices that are designed to reduce the transmission of microorganisms form both recognized and unrecognized sources of infection and shall be applied to all patients receiving care, regardless of their diagnosis or presumed infection status. Standard Precautions include, but are not limited to the use of proper hand hygiene practices... Procedures: 1) Hand hygiene: Immediately following contact with blood or other potential infectious materials, Heath Care Workers must wash hands (even after glove removal)...Waterless hand sanitizers may be used if there is no soiling or contamination to hands..."


In an interview on 09/11/18 at 11:43 a.m. with S20MD and S21MD present, S20MD confirmed he did not perform hand hygiene after removing his gloves prior to documenting on the computer and obtaining medication from the Omnicell.


3) Failure to ensure SPD data related to occurrences of instruments or equipment not adequately decontaminated/disinfected was reported in Infection Control.:


Review of 2018 quality metrics provided to Infection Control, provided by S5DQ, revealed the following::

SPD Department Specific Metrics:
Metric: Jan Feb March April May June
Dirty Instruments 1 2 2 1 4
Improper Assembly 5 9 4 4 1 1
Mislabeled Tray 3 1
Wrapper Holes 4 1 1
IUSS Events
Container Moisture 1
Missing Instruments 1 1 1


Review of the "Detail Listing Of Incidents" from 03/01/18 through 09/10/18 related to surgical services, presented by S5DQ, revealed 4 reports were documented for contaminated equipment and 23 reports were documented for contaminated instruments.


In an interview 09/13/18 at 2:00 p.m. with S45ICO, S38MD, and S39MD present, all 3 members of the Infection Control Committee reported they were not aware of the discrepancies between the reported number of instances of dirty instruments in the monthly reports to Infection Control and the instances reported in the list of incidents (incident reporting system).

Based on observations, record reviews, and interviews, the hospital failed to meet the requirements for the Condition of Participation of Surgical Services as evidenced by:


1) Failing to ensure the organization of surgical services was appropriate to the scope of services offered as evidenced by failure to have documentation of the competency of the staff performing SPD services. There was no documented evidence of orientation and evaluation of competency for 12 (S24CSPDT, S25CRCST, S26CRCST, S27CRCST, S28CSPDT, S29CRCST, S30CRCST, S31CRCST, S32CRCST, S33CSPDT, S34SPT, S35SPTC) of 12 personnel files reviewed of contracted travel staff from Company A. There was no documented evidence of a competency evaluation for skills being performed by 3 (S17IET, S36IT, S43SPT) of 6 (S14SPT, S16SPM, S17IET, S36IT, S43SPT, S44SPIC) SPD staff's personnel files reviewed for SPD competency from a sample of 12 personnel files reviewed (see findings in tag A0941).


2) Failing to ensure policies governing surgical care were designed and implemented to assure the achievement and maintenance of high standards of medical practice and patient care. The hospital failed to ensure the procedure for preparing and packaging items for sterilization was implemented for 4 observations made on 09/10/18 at 11:09 a.m. (Patient #1), 09/10/18 at 12:15 p.m. (Patient #3), 09/11/18 at 10:20 a.m. (Patient R17), and 09/11/18 from 10:35 a.m. to 11:00 a.m. (Patient R16), for an observation of 1 major vascular tray opened in the SPD on 09/10/18 at 3:50 p.m., and for 2 incident reports reviewed for missing items for procedures performed on 05/21/18 (Patients #4 and #5) (see findings in tag A0951).

Based on observation, record reviews, and interviews, the hospital failed to ensure the organization of surgical services was appropriate to the scope of services offered as evidenced by failure to have documentation of the competency of the staff performing SPD services. There was no documented evidence of orientation and evaluation of competency for 12 (S24CSPDT, S25CRCST, S26CRCST, S27CRCST, S28CSPDT, S29CRCST, S30CRCST, S31CRCST, S32CRCST, S33CSPDT, S34SPT, S35SPTC) of 12 personnel files reviewed of contracted travel staff from Company A. There was no documented evidence of a competency evaluation for skills being performed by 3 (S17IET, S36IT, S43SPT) of 6 (S14SPT, S16SPM, S17IET, S36IT, S43SPT, S44SPIC) SPD staff's personnel files reviewed for SPD competency from a sample of 12 personnel files reviewed.


Findings:


Observation on 09/10/18 at 2:52 p.m. in the SPD revealed S17IET was assembling a mandible set tray. Continuous observation revealed S17IET checked the Frazier suction by instilling sterile water from a syringe through the cannula into the container of sterile water from which she had aspirated the water. Continuous observation revealed she placed each instrument on the stringer (an instrument on which each forceps and scissor is strung onto before being placed in the tray) without examining each instrument for cleanliness and damage. Observation revealed she didn't open each forceps to inspect for cleanliness and damage, and she didn't check the scissors for sharpness by cutting a strip on a paper pad available for this process.


Observation on 09/11/18 at 10:20 a.m. in OR 1 revealed S18ST was setting up the sterile table for an Open Reduction Internal Fixation of the Mandible for Patient R17. She opened the vendor tray and indicated she didn't see an indicator in the tray. After removing her gown and checking the tray, S18ST indicated the indicator was inside one of the sets and should have been on top where it would be visible.


An observation 09/11/18 at 1:35 p.m. in the decontamination room of SPD revealed S14SPT was cleaning and decontaminating surgical instrument sets. S14SPT was observed to load hinged instruments onto an instrument stringer (with instrument hinged jaws open), rinse them, move them to a sink of enzymatic detergent where they were soaked, and then moved them to the third sink where they were rinsed with water. At no time during this process was S14SPT observed to visually examine the instruments for any debris or bioburden in the teeth or hinges of the instruments. S14SPT verified that she did not examine the instruments closely in the hinged areas or areas of those instruments with teeth. S14SPT verified examination was part of the process, and she should have examined the instruments for any debris or tissue remaining or trapped in those areas.


Review of the 2018 AORN guidelines revealed items to be sterilized should be inspected for cleanliness and proper function. Debris remaining on a device may compromise the subsequent sterilization process. Further review revealed personnel should receive initial and ongoing education and competency validation for sterilization practices. Competency assessment verifies that the perioperative personnel have an understanding of sterilization and sterilization practices.


Review of the "Workforce Optimization South Central Region" electronic facility binder presented by S2CNO revealed central sterile technicians (CSPDT, CRCST) had to have the knowledge of sterile techniques, instrument identification, and surgical procedures or equipment, had to have mandatory CRCST or equivalent certification, and preferred 2 to 3 years' experience.


Review of the job description for an Instrument Equipment Technician in the Sterile Processing Department revealed the Position Summary included "Ensures the decontamination, preparation and sterilization of surgical instrumentation and operating room equipment and accurately selects surgical case supplies." Further review revealed skills included the following: identify surgical instrumentation, equipment, and supplies; decontaminates instrumentation and prepares for sterilization process; operate sterilization equipment and understand principles of sterilization; use computer to access information.


Review of the personnel files of S24CSPDT, S25CRCST, S26CRCST, S27CRCST, S28CSPDT, S29CRCST, S30CRCST, S31CRCST, S32CRCST, S33CSPDT, S34SPT, and S35SPTC revealed they were contracted through Company A. Further review revealed no documented evidence each had received orientation to the hospital's SPD and had documentation of demonstrated competency in performing their assigned skills/duties. The skills checklists contained in each file was a self-assessment of their skills. Review of the files of S26CRCST, S29CRCST, and S30CRCST revealed their certifications had expired and were no longer valid.


Review of the personnel file of S17IET revealed a date of hire as 06/25/18. Further review revealed her competency checklists, dated 07/15/18 and 07/18/18, for decontamination: environment, assembly module. environment, assembly module: prep and pack, sterilization module: low temperature sterilization, and sterilization module: steam sterilization had the action plan to support progression of skills documented as in-service and training in areas lacking experience, training in all areas, or "Needs more training and education. Will revisit in 2 weeks." There was no documented evidence further training had been provided and a subsequent competency evaluation. S17IET was observed on 09/10/18 at 2:52 p.m. assembling a tray for sterilization with observed breaches in the assembly process.


Review of the personnel file of S36IT revealed competency evaluations for flexible and rigid scope transport and sterile processing for a sterile tray management that included demonstrating how to store objects, demonstrating how to send objects, demonstrating how to search for trays, trouble shooting, and verbalizing what to do for a power outage. There was no documented evidence that S36IT had received training on assembling trays for sterilization and had documentation of competency in doing so. S36IT had assembled the tray that was brought to OR on 09/12/18 that did not have a chemical indicator in it for Patient R18.


Review of the competency file provided for S43SPT revealed skill competency verification for Hand Hygiene, PPE use, Flexible and Rigid Scope Transport and Sterile Tray Management. Further review revealed Sterile Tray Management skills competency was a validation of scanning trays, scanning the location the tray is to be stored, scanning the location to which a tray is being sent, and the search for trays in the electronic program. Further review revealed no documentation of any competencies of cleaning/decontaminating , assembling , or packaging of instruments for sterilization, operation of sterilization equipment, and use of or interpretation of indicators, inspection, handling, storage, or any other steps in the sterilization process.


A review of the SPD competency reports for S14SPT revealed she was evaluated as competent to perform decontamination/cleaning of surgical instruments, and she was checked off by the educator with Company B who signed and dated the form on 07/18/18.


In an interview on 09/10/18 at 2:52 p.m., S17IET confirmed she doesn't squirt the water through the cannula of the suction onto a white cloth to be able to see if debris is released from the suction cannula. She indicated she worked 2 years as a chef at the hospital and had been in the SPD for 3 months. When asked how she learned the instruments, she indicated she was first in decontamination and then on this side (sterilization) for a little over a month. She indicated she had training on the instruments with someone who was certified. She further indicated if she's not sure what a particular instrument looked like, she could go Google it by typing the name of the instrument, and a picture of the instrument would appear. When asked by the surveyor what "check integrity" meant when it came upon the computer screen during the assembly, S17IET indicated it meant the needle holders and Adisons had to be checked to see if the instrument worked properly. When asked if she checked them, S17IET said she had not. She further indicated she was supposed to check if scissors were sharp. She indicated she looked, but she didn't cut the paper from the book that was provided for this purpose. She indicated she visually inspected the instruments by opening and visually looking for debris. When told by the surveyor that continuous observation revealed S17IET was not observed to visually inspect each instrument for debris, she offered no comment.


In an interview on 09/10/18 at 3:34 p.m., S16SPM indicated that S17IET's tray would be assessed for quality by an experienced staff member. When asked if the quality assessment would reveal that S17IET had not inspected each instrument and tested scissors for sharpness, he answered, "no." He confirmed the above observations of S17IET assembling the tray were breaches in the process.


In an interview 09/11/18 at 1:55 p.m., S46LSPDT reported the decontamination and cleaning process is to visually inspect each instrument, looking at any hinged areas, or depressed areas such as those with "teeth" . S46LSPDT verified S14SPT should have performed this step during the cleaning and decontamination process. S46LSPDT reported that S14SPT was still in training, but had been evaluated as competent in the decontamination area of SPD, so she was working independently without supervision.


In an interview on 09/11/18 at 3:15 p.m., S16SPM indicated the tray for Patient R17 was sterilized on 09/10/18 at 9:53 a.m. and was assembled by S25CRCST, a traveler with Company A.


In an interview on 09/12/18 at 11:45 a.m., S16SPM indicated the travel staff attend the hospital's orientation, but they don't go through the hospital's SPD-specific training. He further indicated they are precepted in each area by another experienced SPD staff member. S16SPM indicated the competency evaluation is done by the travel company and not by hospital staff. He further indicated almost everyone he's hired for SPD has not had prior experience in SPD. He indicated New Orleans "does not have a plethora of experience." S16SPM indicated training includes the following: they start 4 weeks straight in decontamination; 4 weeks in instrumentation; they go back to decontamination 2 weeks and 2 weeks back in instrumentation; 2 weeks of sterilization. He indicated they're physically doing it with a qualified staff with them, "as side-by-side as possible." S16SPM indicated staff will assemble sets to be assessed for quality to make sure they're clean and such. He confirmed there should have been someone seated with S17IET when she was observed on 09/10/18.


In an interview on 09/12/18 at 1:40 p.m., S4SPOD indicated S17IET was checked off by the educator with Company B as a trainee. She further indicated the educator wrote a note that S17IET had problems and needed to be reassessed in 2 weeks on 07/19/18. S4SPOD indicated there was no follow-up of training and a competency evaluation. She indicated S17IET should not have been working unsupervised when she was observed on 09/10/18. She confirmed the SPD traveler from Company A does a self-assessment, and there's no competency evaluation by a qualified hospital staff member.


In an interview on 09/13/18 at 10:55 a.m., S16SPM confirmed S36IT was the person who assembled the tray for Patient R18 that did not have a chemical indicator in it on 09/12/18.


In an interview on 09/13/18 at 2:35 p.m., S1CEO indicated he was not aware that the travel SPD staff contracted through Company A had not received orientation to the hospital's SPD and had not been evaluated for competency by a qualified hospital staff member.


30420

Based on observations, record reviews, and interviews, the hospital failed to ensure policies governing surgical care were designed and implemented to assure the achievement and maintenance of high standards of medical practice and patient care as evidenced by:


1) Failing to ensure the procedure for preparing and packaging items for sterilization was implemented for 4 observations made on 09/10/18 at 11:09 a.m. (Patient #1), 09/10/18 at 12:15 p.m. (Patient #3), 09/11/18 at 10:20 a.m. (Patient R17), and 09/11/18 from 10:35 a.m. to 11:00 a.m. (Patient R16), observation of 1 major vascular tray opened in the SPD on 09/10/18 at 3:50 p.m., and for 2 incident reports reviewed for missing items for procedures performed on 05/21/18 (Patients #4 and #5).


2) Failing to ensure the surgical attire policy was implemented as evidenced by multiple observations of hair and facial hair not contained within the bouffant hat, mask, and/or beard cover on 09/10/18 and 09/11/18.


Findings:


1) Failing to ensure the procedure for preparing and packaging items for sterilization was implemented:


Patient #1
Observation on 09/10/18 at 11:09 a.m. in OR 15 revealed S8CST was setting up the sterile table for a Left Femoral Tibial Bypass for Patient #1. Continuous observation revealed a label on the outside of the small vascular set indicated the applicator/bull dog applying forceps was missing. During the set-up of the sterile field, S8CST noted the applicator/bull dog applying forceps was not missing and was present in the tray.


Patient #3
Observation on 09/10/18 at 12:15 p.m. in OR 11 revealed S15ST was setting up the sterile table for an Open Reduction Internal Fixation of the right ankle for Patient #3. Continuous observation revealed S15ST had not lifted a box of screws that was in the vendor tray. After the surveyor asked S15ST (who indicated she didn't usually remove the box of screws until the procedure had started) to lift the box of screws so the liner could be seen under the box of screws, a white thin strip approximately 0.5 centimeters wide by 3 centimeters long that looked like plastic was in the bottom of the vendor tray under the box of screws.


Patient R17
Observation on 09/11/18 at 10:20 a.m. in OR 1 revealed S18ST was setting up the sterile table for an Open Reduction Internal Fixation of the Mandible for Patient R17. She opened the vendor tray and indicated she didn't see an indicator in the tray. After removing her gown and checking the tray, S18ST indicated the indicator was inside one of the sets and should have been on top where it would be visible.


Observation on 09/11/18 at 10:54 a.m. in OR 1 after the vendor tray was replaced, a brownish-yellow stain was noted on the tray liner in the mandible tray (brought to attention of S18ST by the surveyor).


Patient R16
An observation on 09/11/18 at 11:00 a.m. in OR 15 revealed a sterile tray containing a cord and a light source for a bronchoscope, when opened in preparation for a surgical procedure, had a moderate to large amount of bright blue discoloration on the white paper liner in the bottom of the tray. The tray and its contents were examined by S41STS and S40ST. S40ST reported there was a Sterrad indicator in the tray, in addition to the chemical indicators for steam sterilization, and the blue discoloration was from the Sterrad indicator. S16SPM was called to the OR and examined the tray and the shrunken and deformed Sterrad indicator. S16SPM reported the indicator was not made for steam sterilization (the sterilization process through which this surgical equipment tray had undergone), and the Sterrad indicator did not affect the sterility of the tray, but should not have been placed into this surgical tray for sterilization. S40ST instructed the surgical tech student to break down the surgical table and begin again, because she could not ensure the sterility was not affected by the Sterrad indicator when it underwent the steam sterilization cycle.


Observation in the SPD on 09/10/18 at 3:50 p.m. revealed a Major Vascular Tray was opened by S16SPM to be observed by the surveyors. Observation revealed a light brownish-yellow residue on the bottom of the cloth (identified by surveyors and not by S16SPM). Observation revealed 6 to 7 areas of the liner were noted with the residue.


Patient #4
Review of Patient #4's electronic medical record revealed she had a Coronary Artery Bypass Graft Mammary on 05/21/18. Review of a BSafe report (the hospital's incident reporting system) dated 05/21/18 revealed a second microheart tray was missing 2 pickups, and there were no peel packs to be found. Review of the action taken revealed the instruments needed to be replaced in trays that the hospital needed to re-order. Switching companies temporarily slowed the ordering process. There was no documented evidence that an investigation was conducted to determine which staff member had assembled the tray to determine if additional education and competency evaluation was needed.


Patient #5
Review of Patient #5's electronic medical record revealed he had a Coronary Bypass Graft times 2 and an endoharvest of the vein left leg on 05/21/18. Review of the BSafe report dated 05/21/18 revealed two trays were missing items. The heart tray had a sternum retractor missing, and the case can't be done without it. There was not another one found that peel-packed or wrapped. The second heart tray was incomplete. The temp tube holder was missing, and it had the wrong sternal retractor. There were no peel packs, and no one in SPD could locate one. Review of the action taken revealed the instruments needed to be replaced in trays that the hospital needed to re-order. Switching companies temporarily slowed the ordering process. There was no documented evidence that an investigation was conducted to determine which staff member had assembled the tray to determine if additional education and competency evaluation was needed.


Review of the policy titled "Preparing and Packaging Items for Sterilization", presented as a current policy by S5DQ, revealed all items are thoroughly inspected, assembled, and prepared using the correct materials and methods of packaging to ensure optimal sterilization and sterility maintenance. Trays and containers must go through a mechanical or manual cleaning process prior to entering the clean preparation and packaging area. Remove instruments from the tray to prepare for inspection. Verify each instrument is clean, complete, in working condition, and no damage is present. Ensure delicate items have appropriate tip protectors and/or sleeves. Hinged items must be held opened during sterilization using instrument stringers or other validated items. Place instruments in tray according to count sheet order and instructions and follow tray set-up requirements. If an instrument is missing, exhaust all efforts to locate the missing item; if the item is still unable to be located, follow up with leadership to verify that the tray can or cannot be processed without the missing item. If the tray can proceed with processing, modify the count sheet with the missing item and print missing item label to be placed on the tray after packaged. Place appropriate Steam or Low-Temp Gas Plasma chemical indicators in opposing corners of the tray. For multi-level trays, place indicators in opposing corners on each level.


Review of the documentation of the preference card for the small vascular set that was opened in OR 15 on 09/10/18 at 11:09 a.m. for Patient #1 revealed "0/1" (meaning none were present) for bulldog applying forceps.


In an interview on 09/10/18 at 12:15 p.m., S3RN indicated the white thin strip in the tray for Patient #3 looked like paint had chipped off the tray. She further indicated it should not be coming off, but it's "not a reason to break down the instruments and reset the table."


In an interview on 09/10/18 at 12:15 p.m. during the observation in OR 11, S15ST indicated she had not seen it (a white thin strip of unidentified material) when she lifted the box of screws for the surveyors to look under the box (of surgical screws located in the sterile tray)..


In an interview on 09/10/18 at 12:20 p.m. when S16SPM was called to OR 11, S16SPM indicated it (the white thin strip of unidentified material) was a piece that chipped off from the tray. He further indicated they should look at replacing the pan that it was contained in. He indicated it was the vendor's tray. S16SPM further indicated it was alright to use the instruments from the tray. He further indicated he "wasn't saying it wouldn't be smart to replace it." The tray was not replaced.


In an interview on 09/10/18 at 12:30 p.m., S15ST indicated she looks for blood and bone or something with a "smudge on it." She further indicated she's looking for "crust." She indicated most of the vendor trays are probably 15 years old.


In an interview on 09/10/18 at 3:50 p.m., S16SPM indicated, regarding the Major Vascular Tray opened for the surveyors review in the SPD, if a tray goes to the OR and there's doubt to its cleanliness or sterility, it would be replaced. S2CNO indicated the hospital doesn't have a water softener, so it may be due to hard water. S16SPM indicated they had gotten trays back from OR before with the residue stain, but it wasn't a trend. He rubbed against the white liner, and nothing came off. He indicated he didn't think it was bioburden, because with as many areas with it, there should be an odor if it was bioburden. He further indicated he didn't think it was rust either. S16SPM indicated the tray was processed on 08/31/18. He further indicated his "guess" would be that it was a "mineral deposit from the water."


In an interview on 09/11/18 at 10:54 a.m. during the observation of the mandible tray with the stain on the liner, S18ST indicated she was alright with the tray being used. She indicated there were some stains, but it was probably from the indicator. She confirmed she sees similar stains sometimes. She confirmed she hasn't asked about the stains or brought it to anyone's attention. She indicated when she sees something questionable on an instrument, she wipes the instrument to see if bioburden comes off.


In an interview on 09/11/18 at 11:01 a.m., S18ST indicated she wanted to correct what she said earlier at 10:54 a.m. She indicated sometimes the instruments are older which can be the cause of the stain rather than the stain being from the indicator. She confirmed the intraoral set had a small brownish-yellow stain on the intraoral tray.


In an interview on 09/11/18 at 11:50 a.m., S4SPOD indicated the hospital checked with the company who said they thought the stains were from the water, but the hospital would have to get it checked.


In an interview on 09/12/18 at 9:38 a.m., S12MD indicated there was a problem on 09/10/18 and over the previous weekend with his partner whereby there was a problem with a vendor set that caused the surgery to be delayed. The problem both times was there was a hole in the set.


In an interview on 09/12/19 at 10:19 a.m., S22ST indicated when it comes to instrumentation, they're still having problems, and nothing's being done. She further indicated they call downstairs from the OR to SPD, and they can't help because they're busy or someone hangs up on her. She indicated they have problems with missing surgical instruments in sets or instruments that don't need to be there. S22ST indicated she thinks the techs are so aggravated that they see it, they just don't report it. She further indicated seeing yellowish-tan residue on a tray liner is not alright to use. She indicated regarding the finding of what looked like plastic, the tray should have been removed and a new set used.


In an interview on 09/12/18 at 11:45 a.m., S16SPM indicated "problems happen everywhere." He further indicated he doesn't think they have a process problem, but there can be an execution problem, meaning the indicator not present is an execution problem, because the process is there. He indicated the problem is they have a lot of new staff and a lot of travel staff. He further indicated there will be training errors with increased growth. He said his personal opinion is that they have a lot of new people and there's a problem with them executing the process. S16SPM indicated "the law of probability is an error will happen." When the surveyor asked what they've done to minimize this, S16SPM indicated they got more staff, brought in travel staff, and experienced contracted staff with Company B. He confirmed competency evaluations are self-assessments and not conducted by qualified hospital staff. S16SPM indicated almost everyone he's hired does not have prior experience in SPD. When asked by the surveyor about what was found in the bottom of the pan during the observation on 09/10/18, he indicated the set was still considered sterile, and that was a clinical call in the room. He indicated he probably would have switched the pan. He said if it was contaminated, he would have made the call, but it was not scientifically contaminated. When asked if it was appropriate to use as determined by his position, he said "I would not have used it." S16SPM indicated the water has been tested for hardness but hasn't been tested to know if there minerals present that could be causing residue.


In an interview on 09/12/18 at 1:40 p.m., S4SPOD indicated the observations made during the survey was the first time she saw the stained liners. Regarding the stain and the vendor tray with the plastic piece, she indicated they are now opening all vendor trays and checking them. She indicated she wasn't so alarmed with the stain, because she knows the sterilization process. She indicated you wouldn't stop the case, but if you saw a trend, she would want to remove the disintegration. She indicated the stained liners wouldn't have affected the case, because the temperature and time was reached. S4SPOD indicated she should have seen the problem with the stained liners on a BSafe report. She indicated they will continue using the instruments with stained liners while waiting for the test report that she has arranged to be done.


In an interview on 09/12/18 at 3:10 p.m., S23RN indicated they have a consistent problem with instruments. She indicated the sets aren't complete, they're being strung backwards, and chest retractors are being put together backwards which renders them useless (have to be taken apart and put back together). S23RN indicated this morning (day of interview) she had a set with a used suture in an instrument set. They were delayed 31 minutes because they had to break down and reset the room. It was found when the back table was set up, and the surgical tech lifted the string of instruments onto the table. They saw the suture with no needle under the string of instruments. She further indicated she also had a set this day that didn't have an indicator in it. S23RN indicated their instrument sets are rarely complete (have red tags on them) or have the correct instruments in them.


2) Failing to ensure the surgical attire policy was implemented:


Observation on 09/10/18 at 11:09 a.m. in OR 15 revealed S6RN had hair protruding from the bouffant cap at the sideburns and nape of the neck. Further observation revealed her personally laundered cloth cap was protruding from the bouffant cap at the forehead. Further observation revealed S7RN had hair protruding at the nape of the neck and sideburns. S2CNO's hair was protruding from the nape of her neck. These observations were confirmed by S2CNO and S9AORD.


Observation on 09/10/18 at 11:35 a.m. in OR 9 revealed S10RN had hair protruding from the surgical hat at the sideburns and nape of the neck. This was confirmed by S9AORD. Further observation revealed at 11:54 a.m. S47MS had his beard exposed at the left side of his mask. This was confirmed by S11CST.


Observation on 09/10/18 at 3:27 p.m. in the SPD revealed S24CSPDT with his beard exposed from the beard cover. This was confirmed by S2CNO.


Observation on 09/11/18 at 10:40 a.m. in OR 1 revealed S18ST had hair exposed from her bouffant cap at the nape of her neck.


Observation on 09/11/18 at 11:10 a.m. in OR 1 revealed S21MD adjusted her goggles which caused her hair to protrude from the surgical hat at her sideburns.


An observation made 09/11/18 at 10:25 a.m. revealed S42RT wheeling a portable x-ray machine out of OR 13 where a patient and the surgical team remained. Further observation revealed S42RT exited the currently occupied room wearing a surgical hat, with approximately 2 inches of her hair exposed in the lower back of her head. S2CNO, present for the observation, verified the observation. S7RN, part of the OR staff in OR 13 also verified the findings and indicated all of S42RT's hair should have been covered.


An observation 09/11/18 at 11:15 in OR 15 revealed S13MD was supervising S37CRNA while the patient was placed under anesthesia. S13MD was observed to wear a face mask that left facial hair exposed on the sides of his face and head. S13MD left the room for a minute, then returned with his facial hair still exposed. S2CNO, present for the observation, verified the observation and that no one on the surgical team acknowledged the breech in surgical attire, or made an effort to notify the physician that he had exposed facial hair with the surgical table set and open.


Review of the policy titled "Surgical Attire". Presented as a current policy by S5DQ, revealed it is the hospital's policy that clean surgical attire be worn in semi-restricted and restricted areas. Surgical attire must be laundered in a hospital-approved laundry facility after each use and when contaminated. Reusable head coverings will be completely covered by a disposable bouffant hat. A clean surgical hair cover or hood that confines all hair and completely covers the ears, scalp, skin, sideburns, and nape of the neck must be worn. There was no documented evidence the policy addressed facial hair, such as beards.


Review of the 2018 edition of Guidelines for Perioperative Practice revealed, in part, Recommendation III under Surgical Attire read, "Personnel entering the semi-restricted and restricted areas should cover the head, hair, ears, and facial hair ...The benefit of covering the head, ears, and hair is the reduction of the patient's exposure to potentially pathogenic microorganisms from the perioperative team member's head, hair, ears, and facial hair."


In an interview on 09/10/18 at 11:00 a.m., S4SPOD and S2CNO confirmed the hospital's surgical department followed and based their policies on AORN recommendations.


In an interview on 09/12/18 at 1:40 p.m., S4SPOD indicated there was a full campaign to address surgical attire. She indicated exposed hair and beards had improved since the last survey (which resulted in a citation related to surgical attire in the restricted areas). She further indicated the audits related to surgical attire were not as thorough regarding exposed hair and beards. S4SPOD indicated they needed to get to the environment where staff are comfortable to call out someone else who wasn't meeting the standard for surgical hats.


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