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Based on observation, interview and document review the facility failed to ensure that the physician order for the restriction of a patients freedom of movement for non-violent/non-self-destructive patient was renewed in writing at least every twenty four (24) hours, for three of four (patient #1,2, &3) patients in restraint/restriction of freedom records reviewed, resulting in the potential for unauthorized use of restraint/seclusion/restriction of rights for all patients treated at this facility. Findings include:

On 10/16/2018 at 1010 during the tour of the Surgical Intensive Care (SICU) unit the patient #1 was observed to be in 2 soft wrist restraints.
On 10/16/2018 at 1025 during review of the electronic medical record for patient #1 the Initial order for soft wrist restraint for a non-violent/non-self-destructive patient was dated 10/15/2018 at 0816, the renewal order had not yet been written.

On 10/16/2018 at 1040 during the tour of the Neurological Intensive Care (NICU) unit the patients #2 and #3 were both observed to be in 2 soft wrist restraints.

On 10/16/2018 at 1045 during review of the electronic medical record for patient #2 the Initial order for soft wrist restraint for a non-violent/non-self-destructive patient was dated 10/15/2018 at 0700, the renewal order had not yet been written.

On 10/16/2018 at 1055 during review of the electronic medical record for patient #3 the order for soft wrist restraint for a non-violent/non-self-destructive patient was dated 10/15/2018 at 0015 the renewal order had not yet been written.

On 10/16/2018 at 1100 staff #1 was asked when is the renewal to be written. Staff #1 stated "every 24 hours, we try to have then all renewed at midnight so that the order is not missed."

On 10/17/2018 at 1600 the policy titled "Restraint in the Non-Psychiatric Healthcare Setting" #1 CLN 008 dated effective 04/30/2018 was reviewed. On page 7 of 19 under W. Non-Violent/Medical Support Restraint... 6. it states "Continued use of restraint beyond the first day requires an order by the physician/Midlevel provider designee no less than once every calendar day based on his/her face-to-face assessment of the patient."

The facility failed to maintain an ongoing infection control program designed to prevent, control and investigate infections and communicable diseases for 12 of 12 months reviewed, resulting in the potential for transmission of infectious agents for all patients served by the facility. See specific tags:

-- A 0749 - 1. The facility failed to follow infection control policy and procedure for donning and removal of gloves and hand hygiene. 2. The facility failed to ensure that the Infection Control Plan and surveillance policies followed nationally recognized guidelines and their 2018 Infection Control Program Plan.

-A 0756 -1. The facility failed to ensure that the hospital -wide Quality Assessment and Performance Improvement program addressed problems identified by the Infection Control Department for six (#19, #21,#22 #25, #26, and #27) of seven patients with surgical site infections reviewed, out of a total of 15 reported on 2018 surveillance logs, resulting in the potential for missed opportunities for corrective action and quality improvement. 2. failed to ensure that breaches in sterile processing of surgical instruments were documented, investigated and corrective measures implemented in coordination with the Infection Control Department for two (#35 and one unidentified) of five patients reviewed for problems with sterile instrument processing out of a total of six contaminated instrument events documented by the facility for 9/15/18 through 10/5/18, resulting in the potential for Surgical Site Infections.

This citation has two Deficient Practice Statements.

Deficient Practice Statement #1

The facility failed to ensure that the Infection Control Plan and surveillance policies followed nationally recognized guidelines and their 2018 Infection Control Program Plan resulting in failure to report, investigate and implement corrective measures for those surgical site infections not under mandatory government reporting requirements for 12 of 12 months reviewed, resulting in missed opportunities to prevent post operative infections and improve quality of care with the potential to effect all patients receiving surgeries at the facility. Findings include:

On 10/17/18 at 1000 the Infection Control Program was reviewed with the Infection Control Lead, Staff QQ. Review of the 2018 IC Program Risk Analysis revealed that neurological (neuro) surgeries were assessed as high risk for surgical site infections (SSI) with a score of 30 (Score of 12-23 requires surveillance for trends, scores > 24 requires intervention). There was no risk analysis done for any other type of surgery that didn't require mandatory reporting to the Center for Disease control (CDC)'s National Healthcare Safety Network (NHSN). There was no surveillance documented for any other SSI except Neuro-Surgery and Open Reduction of Fractures (ORIF) without mandatory NHSN reporting requirements. There was no SSI surveillance documented for surgeries where contaminated instruments were entered on Adverse Event Reports.

Review of facility Infection Control (IC) Reports from 08/2017 through 09/2018 at this time revealed no infection rates were calculated for Neuro-Surgeries since 01/10/18.

On 10/17/18 at approximately 1100 Staff QQ was asked about this and stated that administration made structural changes in the hospital network resulting in staff lay offs, so administration instructed the Infection Control (IC) Department to only do surveillance for the healthcare acquired infections (HAI) that the hospital was required to report to NHSN (mandatory reporting requirement).

On 10/17/18 at approximately 1115, the Infection Control (IC) Program Committee meeting minutes and agendas from 01/17 through 10/18 were reviewed with Staff QQ and revealed hospital acquired infection (HAI) rates were only discussed and noted for HAI that the hospital was required to report to NHSN. No rates of Neuro Surgery Surgical Site Infections (SSI) were reported to the Infection Control Committee during 2018.

Review of the "Adult Central Campus HAI Reports" from January 2018 through August 2018 at this time with Staff QQ revealed months where the SSI rate was reported as "none" when SSI surveillance logs reviewed at this time noted SSI occurred. The February report given to the Central IC Program Committee meeting on 3/14/18 noted only discussion of one Hysterectomy SSI (mandated reporting to NHSN). Review of IC logs at this time revealed two patients with lumbar-spinal surgeries had developed SSI during February 2018. Review of the March IC report presented to the Central Campus IC meeting on 4/25/18 revealed the notation, "SSI: None to report". Review of IC surveillance logs at this time revealed documentation that one patient who had Neuro-surgery and three patients who had ORIF had developed SSI.

On 10/18/18 at approximately 1330, the Director of Quality, Staff GGG was interviewed regarding the IC Program and stated that administration informed her when she was hired that they did surveillance for HAI infections with NHSN mandatory reporting requirements. Staff GGG stated that Administration was currently working on the 2019 Infection Control Plan and that the decision was already made that surveillance would be limited to those HAI's with mandatory reporting requirements. Staff GGG expressed surprise when told that their 2018 risk analysis had identified neurological surgeries as high risk for SSI and the 2018 IC Plan required tracking, trending (surveillance and reporting of rates) and interventions for Neuro-Surgery SSI. Staff GGG stated that she did not realize that it was a national standard for Infection Control programs to identify high risk/high volume surgeries and do tracking and trending of SSI for these surgeries. Staff GGG was unable to explain why SSI surveillance was not periodically audited for surgeries with the types of instrument sets most frequently identified as having sterile processing problems.



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Deficient Practice Statement #2
Based on observation, interview and policy review the facility failed to follow infection control policy and procedure for donning and removal of gloves and hand hygiene following removal of gloves, during three of five observations of staff (TT, VV, and WW) in the operating room (OR), and for one of one observations of staff (Y) in the surgical soiled utility room, resulting in the potential for transmission of infectious agents for all patients undergoing surgery by the facility. Findings include.

On 10/16/18 at 1035 in OR #4, two medical staff (VV and WW) were observed assisting with patient placement on the OR table. Medical staff VV and WW were observed to don and remove non-sterile gloves 2 times with no hand hygiene between and following glove removal. Medical staff WW was observed to remove non-sterile gloves and open a supply cabinet and remove packages of sterile gloves and place them on a side table in the OR. Both medical staff VV and WW were observed to exit the OR without performing hand hygiene prior to exit. At 1045 Circulating Registered Nurse (RN) staff N was informed of the above noted observation and shook her head side to side and stated the two staff were a medical resident and a medical student.

On 10/17/18 at 1142 in OR #3, physician (TT) was observed to enter the OR following the surgical procedure he had performed. Physician TT observed the closure of the incision by a medical Resident and the removal of the patient drapes. The Resident cleaned the incision area and placed a dressing over the surgical incision. Physician TT was observed to remove a roll of surgical tape from a common supply bin which contained multiple rolls of tape under a metal stand. Physician TT did not perform hand hygiene or don gloves and was observed to lay the roll of tape on the dressing and pull a strip off while pressing it onto the patient's incision dressing and skin. Physician TT repeated the application of the surgical tape to the dressing three times and then returned the roll of tape to the common bin under the metal stand. Physician TT was observed a few minutes later to again remove a roll of tape from the common bin and apply another strip of tape to the dressing in the same manner noted above and return the tape to the common bin. At 1155 the RN OR manager (staff Q) was informed of the above observation and made no comment, just shook her head side to side.

On 10/18/18 at 0930 the facility policy 2 IC 000 titled Hand Hygiene Policy, dated 1/2017 documented the following: "Objective/purpose: To prevent the transmission of microorganisms from person to person in all health care settings. . .Policy: Hand hygiene is the single most effective method to reduce the transmission of infection. . .All DMC department managers are responsible for enforcing hand hygiene. . .Procedure and.\provisions: . .B. Indications for hand hygiene are: 1. Upon patient room entry and exit. 2. Before having direct contact with patients. 3. Before donning sterile and exam gloves. 4. Prior to the insertion of invasive devices. . . 5. Before and after dressing changes. 6. Between clean and contaminated tasks on the same patient. 7. After care of the patient including contact with the patient's intact skin. 8. After contact with a source of microorganisms. . .9. After contact with equipment or surfaces likely to be contaminated. . .13. After removal of gloves. . .I. Other aspects of hand care and protection: 1. Glove use: a) Gloves are never a substitute for hand hygiene. b) Gloves are worn for anticipated contact with blood and body fluids. . .c) Gloves are worn when handling items or surfaces soiled with blood or body fluids. d) Hand hygiene must be performed every time gloves are removed. . ."


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Additionally, on 10/16/18 at approximately 1400, Tech Staff Y was observed in the Surgical Area Soiled Utility Room spraying Pre-Klenz cleaner on instrument sets while ungloving and regloving without performing hand hygiene. Interview with the Surgical Manager Q, on 10/16/18 at approximately 1405, verified that Staff Y did not perform hand hygiene per policy/procedure, she stated, "She should have washed her hands after ungloving."

This citation has two Deficient Practice Statements.

Deficient Practice Statement #1:

Based on interview and record review, the Chief Executive Officer, Medical Staff and Director of Nursing Services failed to ensure that the hospital -wide Quality Assessment and Performance Improvement program addressed problems identified by the Infection Control Department for six (#19, #21,#22 #25, #26, and #27) of seven patients with surgical site infections reviewed, out of a total of 15 reported on 2018 surveillance logs, resulting in the potential for missed opportunities for corrective action and quality improvement. Findings include:

On 10/17/18 from approximately 1000 through 1300, the 2018 Infection Control (IC) Program, 2018 surveillance logs and Infection control reports were reviewed with the Infection Control Lead, Staff QQ. The following five surgical site infections (SSI) from the IC 2018 surveillance logs were reviewed and noted to have no documentation of review, problem identification or corrective measures done by the Nursing Department, Medical Staff, or facility Administration:

Four Surgical Site Infections (SSI) (Patients #19,#25, #26, #27) in surgeries with mandatory reporting requirements (to the Center of Disease Control's (CDC) National Healthcare Safety Network [NHSN]) were reviewed with Staff QQ. There was no documentation that investigation, root cause analysis or corrective measures were discussed by or with the respective Surgeons, the Department of Surgery Nursing Staff, Nursing Administration, the hospital Quality Improvement (QAPI) department or the Chief Executive Officer (CEO). The facility RCA forms used for documentation of follow up and communication between the IC and Surgery Departments were blank on the parts which were supposed to be completed by surgery with surgeon input and feedback. Staff QQ stated that she sent reports of SSI to the Surgery (OR) Department per protocol and never heard anything back.

Review of the undated facility RCA Protocol entitled, "DMC Surgical Site Infection (SSI) Review Process - Colon surgery, Hysterectomy, Hip and Knee (surgeries with mandatory NHSN reporting requirements)" revealed the following instructions, " for infections identified by the IC department will send the SSI review form (RCA), and the Administrative Director of Peri-operative Services (Staff UU) will be responsible for conducting the RCA. The respective surgeon, Surgery Department leadership, the Quality Director, the Patient Safety Officer, and the IC department will be involved in the RCA process."

Two SSI for Lumbar/Spinal surgeries (Neuro-Surgeries) were reviewed with Staff QQ (Patients #21 and #22). There was no documentation of feedback from the OR department or the respective surgeons, and no documentation to indicate the cases were investigated per the 2018 IC plan. Staff Q stated that she had sent Infection Documentation request forms to the OR department for feedback, investigation and surgeon input/notification but had received nothing back. Review of Patient #20's clinical record with Staff QQ revealed multiple unanswered questions. Patient #22# had a laminectomy (neurological/spine surgery) on 7/2/18 and went back to surgery on 7/4/18 for a laminectomy on the same vertebrae. There was no explanation in the clinical record for the second surgery.

On 10/17/18 at approximately 1310 the Director of Surgery Staff UU, and the Director of Perioperative Support Staff II were asked about cooperation with the Infection control Department in investigating SSI and determining corrective measures. Staff UU stated that they completed the RCA forms on Patient #19, #25, #26, and #27 and reviewed the cases with the respective surgeons and then sent the results back to the Infection Control Department. Staff UU and Staff II were asked to provide documentation of this for these four patients but failed to do so during survey. Staff UU and Staff II stated that they did not believe that the facility required them to investigate or follow up on Patients #21 and #22 because they were not surgeries that the hospital was required to report to NHSN.

On 10/17/18 at approximately 1330 the chief Nursing Officer (CNO) was asked about Nursing, Medical Staff (Surgeons) and QAPI follow up and review of these five SSI documented by the IC department on their Infection logs, and stated that Patients #19, #25, #26, and #27's SSI cases were all discussed with the surgeons, the Surgical Department and Nursing Administration and reported to the CEO via the Leadership Performance Improvement Coordinating Committee (LPIC) (the facility's QAPI committee) and the Medical Staff Operations Committee (MSOC). Documentation of this was requested but not provided by exit.

Review of LPIC (QAPI) monthly meeting minutes from 3/1/18 through 8/22/18 at this time (provided per request of all LPIC meetings held in 2018) revealed no documentation of review of SSI rates or of individual cases (RCA review). The only notation of discussion of Infection Control Rates or concerns in LPIC meeting agendas was on 5/23/18, noted that they were considering alterations in surveillance methodology to reduce the facility's high rates of Catheter Associated Bloodstream Infections (CLABSI) and Catheter Associated Urinary Tract Infections (CAUTI), both of which were types of infections the facility was required to report to NHSN. The 5/23/18 LPIC minutes noted, "CAUTI/CLABSI continue to occur at high levels (rates not specified), Looking at central surveillance definitions to make sure we are reporting appropriately." The CNO was not able to provide documentation or evidence that the Infection Control Department or Professionals with training or experience in Infection Prevention and NHSN requirements were consulted in this "look at surveillance definitions (definitions of Health Care Acquired [HAI]."

Review of MSOC meeting minutes for 2018 revealed no documentation of SSI review or of any SSI RCA review or results. Two sentences documented on 4/11/18 , "SSI are high due to low denominator data. there is a new SSI process plan pending approval." The CNO was asked to provide any documentation of RCA process review for any SSI for 2018, and was unable to do so by survey exit. The CNO did not elaborate on the new SSI process plan but denied that Administration was attempting to revise the definition of HAI in an attempt to lower infection rates. There was no documentation of the actual SSI rates, and no explanation why the MSOC committee believed they were inaccurate due to math errors (low denominator data).

On 10/18/18 at approximately 1000 the facility Medical Director of the Infection Control Department Staff EEE was interviewed and stated, "We are not doing RCA deeper dives (thorough investigation) of SSI due to lack of cooperation from the Surgeons and the Surgery Department leadership. Leadership doesn't follow up. Part B of the RCA forms is for the Surgery Department to fill out and return to me within seven days. We used the nationally recognized SSI "bundles" (evidenced based protocols) to develop these RCA forms. The surgery department never reports back. The loop doesn't close. We have a major unmet need and a gap with SSI and RCAs." Staff EEE reported that she had been instructed by the CNO Staff J and the CEO Staff FFF to only report infection rates for those Healthcare acquired infections (HAI) that were NHSN mandated. Staff EEE reported that she was not a member of the LPIC or MSOC committees. Staff EEE stated that she had not been invited to the QAPI Committee (LPIC) meetings since January 2018. Staff EEE stated that she was "occasionally" invited to the Medical Executive Committee meetings (MSOC) and was invited to attend one time in 2018.

On 10/18/18 at approximately 1145 the facility CEO was interviewed and reported that he "never had any feedback from the IC department regarding the RCA process." The CEO reported that he never heard anything about any NeuroSurgery SSIs in the facility. The CEO stated that he never told the IC department that they shouldn't report all SSI. The CEO stated that he "was never asked to relax the definitions of infections."Additional documentation of CEO and Quality Management collaboration with the Infection Control Program, and/or reporting of SSI infection rates and concerns to the Quality Improvement Department was requested but not provided at this time.

On 10/18/18 at approximately 1330, the Director of Quality, Staff GGG was interviewed regarding the IC Program and stated that administration informed her when she was hired that they only did surveillance on HAI with NHSN mandatory reporting requirements. The Director of Quality Staff GGG reported that she was unable to find documentation that the facility RCA process was implemented per protocol. Staff GGG reported that LPIC was the facility Quality Assessment and Performance Improvement (QAPI) body for the facility. Review of LPIC agendas and minutes from 3/18 through 8/18 (9/18 not provided) revealed there was no report from either the Infection Control Department or the Central Processing and Supply Department since March of 2018. "It's a gap", stated Staff GGG.

Deficient Practice #2:

Based on interview and record review, the Chief Executive Officer, Medical Staff and the Director of Nursing Services failed to ensure that breaches in sterile processing of surgical instruments were documented, investigated and corrective measures implemented in coordination with the Infection Control Department for two (#35 and one unidentified) of five patients reviewed for problems with sterile instrument processing out of a total of six contaminated instrument events documented by the facility for 9/15/18 through 10/5/18, resulting in the potential for Surgical Site Infections. Findings include:

On 10/16/18 at approximately 1000, the Manager of the Central Sterile Processing Department (CSPD) Staff AA was interviewed regarding an incident reported in the press. The allegation was that Orthopedic Surgeon Staff KKK received a dirty (used) casket (case) of surgical instruments for a surgery. Staff AA reported that the incident had occurred, but not as it was reported in the press. Staff AA stated that the dirty casket of instruments was not brought into the operating room because the Scrub Technician (scrub tech) had noticed that the indicator locks on the casket were missing, indicating that the casket was opened and therefor not sterile. Staff AA stated that the Scrub Tech didn't bring the dirty case into the operating room, but reported it to CSPD. The adverse event report and investigation (Midas report) for the incident were requested on multiple occasions but not provided. Staff AA stated that there was no way a dirty set of instruments could be sent out from CSPD as the clean instrument and dirty instrument areas were physically separated. Staff AA stated that she believed that someone from the surgical department must have placed the dirty casket of instruments back into the clean instrument storage area in the surgical department without realizing that it was used. No proof of this investigation was provided by survey exit.

On 10/16/18 at approximately 1100, Staff HHH was observed loading cart with sterile instrument sets to take to the Surgical Department. A bar coded form taped to the top of the cart was filled out with the number and type of sets inside. Individual instrument sets and caskets inside the cart were not scanned. Staff HHH scanned the form on top of the cart with a bar code scanner and CSPD Aide Staff CC took the scanned cart full of sterilized instrument sets and left CSPD.

On 10/17/18 at approximately 1100, the Infection Control Department (IC) lead Staff QQ was interviewed regarding the allegation that a set of dirty instruments was provided to Staff KKK for an Orthopedic surgery. Staff QQ reported that she was not involved in, or consulted on the adverse event investigation or corrective measures, but had heard about it during "morning huddle" (daily management staff briefing) the day after it occurred. Staff QQ stated that it was reported to the morning huddle group as a "surgical tech error". Staff QQ stated that they were told that someone in the sister hospital (the facility CSPD processes their sterile instruments) "did not handle the tray appropriately. It got put back in clean after it was used." Staff QQ was unable to provide the name of the patient involved or any additional information. Staff QQ stated that she had not seen an Adverse Event Report (Midas Report) for the incident.

On 10/18/18 at approximately 1045, the CNO was requested to provide documentation of the alleged dirty instrument incident involving Staff KKK and reported in the press. The CNO reported that the results of the investigation were inconclusive as they could not prove that the instruments were returned to CSPD for reprocessing after use before they were put back into the sterile supply in the Surgery Department.The adverse event report and investigation were requested multiple times but not received by survey exit. Documentation that the incident was discussed in QAPI was requested but not provided. The name of the affected patient, the date the event occurred, and the names of the Surgery Department Staff who witnessed the event were requested but not provided.

On 10/18/18 at approximtely 1444, the Director of CSPD Staff SS was interviewed and reported that the facility was unable to perform a complete investigation of the event for Staff KKK's dirty surgical instruments as there was no way to track whether an instrument set sent to the Surgery Department was returned to CSPD after use. Staff SS reported that they scanned the carts full of multiple instruments when they left CSPD, but did not track when the individual instruments inside the cart returned, as only the carts, not the individual sets inside were scanned into the electronic tracking system. The Surgery Department QA form (form filled out by Surgery staff and sent to CSPD management for problems with surgical instruments) for the event was requested but not provided. The Adverse Event (MIDAS) report for the incident was requested but not provided. The facility investigation of the incident was requested but not provided. The date of the alleged event and names of staff witnesses were requested but not provided.

On 10/16/18 at approximately 1030 Surgical Patient Care Aide Staff CC and CSPD Aide Staff DD were interviewed regarding the contaminated instrument set mentioned in the press and both denied knowledge of it. Staff CC reported that she had seen a surgical instrument set opened in the Operating Room two weeks ago which had an ink pen inside the instrument tray. Staff DD confirmed knowledge of the event.

On 10/16/18 at approximately 1035 the CSPD Director Staff SS was asked about the incident involving a pen found inside a tray of surgical instruments in the operating room and stated that she had not heard of this incident. The adverse event report for this incident was requested but not provided until 1400 PM on the third (last) day of survey.

On 10/17/18 at approximately 1300 review of the facility log of adverse events related to OR and CSP revealed no documentation of a pen found in a tray of surgical instruments during surgery. Documentation of an incident involving a dirty tray of surgical instruments provided to Surgeon Staff KKK for surgery was not located on the log.

On 10/17/18 at approximately 1300, the Safety Manager Staff B was interviewed and reported that no adverse event report was completed for this incident.

On 10/17/18 at approximately 1330 the Surgery Director Staff UU and the Surgery Manager Staff Q were interviewed and reported that no adverse event (MIDAS report) or facility investigation was completed yet for the pen found in the surgical instrument set. Staff UU and Staff UU stated that the operating room Circulating Nurse had filled out a QA (Quality Assessment) form for the event during surgery and had turned it in to her manager (Staff Q) after the surgery, and Staff Q had "batch filed it" (pooled it with other similar forms to be completed together later at a more convenient time).

On 10/18/18 at approximately 1400 the Chief Nursing Officer Staff J, the Patient Safety Officer B, and the CSPD Director Staff SS were interviewed regarding this incident and the QA form (dated 9/27/18) and the Midas report (dated 10/17/18) were provided and reviewed. The following information was revealed:

Patient #35 was a 50 year old male who had surgery on 9/27/18. The QA form (CSP set assembly QA form - used for OR staff to notify CSPD of errors and problems related to instrument sets) noted Patient #35's name, the date and time the set was assembled, method of sterilization, set number, and the build number. The comments noted, "ink pen in tray. Set taken to (Staff Q) new set brought to room." The surgery was not one with mandatory NHSN reporting requirements so no surveillance for SSI from this event would be done.

On 10/18/18 at approximately 1430 The Alex Gold system (CSPD electronic instrument tracking system) tracking to identify the CSP Technician (tech) responsible for assembling and processing the set with the pen inside was reviewed with Staff SS. Staff SS stated that they had a culture of safety in the facility and that she would discuss the incident with CSP staff on all three shifts and reeducate all staff without singling out the staff member involved, but that the error would be noted on the staff member's personnel record so that trends could be tracked.

On 10/18/18 at approximately 1500 the CSPD Director Staff SS and the Quality Director Staff GGG were interviewed and reported that they expected a serious error in sterilized processing like an ink pen found inside a suppposedly sterile instrument tray to be reported via the MIDAS System within 24 hours, and noted this was not done, and the incident was only brought to their attention by the surveyor. There was no documentation to indicate that the Infection Control Department was consulted regarding the investigation and corrective measures for this event.

A facility policy on Adverse Event Reporting and investigation was requested but not provided by exit. The names of the six contracted sterile processing technicians who performed the daily audits (spot checks) of instrument processing in CSPD and proof of their training, certifications and competency were requested but not provided by exit.