HospitalInspections.org

Based on observation, interview, and record review, the hospital failed to ensure the GB effectively carried out its responsibilities for the conduct of the hospital as evidenced by:

* The hospital failed to ensure their QAPI program's quality processes were designed and implemented to ensure the quality and safety of patient care provided. Cross reference to A0263.

* The hospital failed to ensure a sanitary environment and an active program to prevent the spread of infections in accordance with the hospital's P&Ps and nationally recognized infection control practices and guidelines. Cross reference to A0747.

* The CEO did not maintain oversight over the infection prevention program. Cross reference to A0756.

* The hospital failed to ensure surgical services were well organized and provided in accordance with the hospital's P&Ps and acceptable standards of practice to ensure the health and safety of the patients. Cross reference to A0940

In an interview with the CEO on 12/3/15 at 1400, he stated the GB reviewed the Quality Council reports, the Quality Council came to the Board with issues, and the PI plan was reviewed quarterly. The CEO further stated he was aware of the issues before they got to the GB level.

The cumulative effect of these systemic failures resulted in the hospital's inability to provide quality healthcare to the patients in a safe environment.

Based on observation, interview, and record review, the hospital failed to ensure their QAPI program's quality processes were designed and implemented to ensure the quality and safety of patient care provided as evidenced by:

1. The hospital failed to ensure the data collected in the surgical services department that affected patient safety and the quality of care provided was reported to the patient safety performance improvement committee and formed the basis for improvements. Cross reference to A0273.

2. The hospital failed to ensure the QAPI program set priorities for performance improvement activities in the high risk area of Surgical Services to identify opportunities for improvement and take actions using the data collected that affected health outcomes, patient safety, and quality of care for all surgical patients. Cross reference to A0283.

3. The hospital failed to ensure complete follow up of an outpatient SSI, the system for tracking SSIs by the physician failed to identify an infection for one physician, and three incidents had been incompletely reviewed and addressed. Cross reference to A0286.

The cumulative effect of these systemic failures resulted in the hospital's inability to provide an efficient QAPI program and quality healthcare to the patients in the hospital.

Based on interview and record review, the hospital failed to ensure the data collected in the surgical services department that affected patient safety and the quality of care provided was reported to the patient safety performance improvement committee and formed the basis for improvements as evidenced by:

1. Failure to ensure issues identified by hospital staff regarding rusty equipment in the ORs, issues with disinfectants used in the OR and procedure rooms, failure of staff to monitor and control temperature and humidity levels in the OR and procedure rooms were followed up and corrected.

2. Failure to ensure the surveillance was done for possible SSIs for the outpatient surgery patients.

3. Failure to ensure an investigation was documented regarding SSIs after the colon surgery; no follow-up discussion or investigation documented regarding possible causes of the persistent elevated number of SSIs after the colon surgery; and the colon surgery was not included as a prioritized risk in the infection prevention plan.

4. Failure to ensure the Cardiovascular program goal and data were presented as part of the QI program data.

These failures created the risk of substandard healthcare to the patients receiving services in the hospital.

Findings:

1. During the observation, interview, and record review in the hospital on 11/10, 11/30, and 12/1/15, departures from the expected standard of infection prevention were observed in the peri-operative environment, including rusty equipment in the ORs, poorly sanitized OR and procedure rooms, and failure to monitor and control the temperature and humidity in the OR and procedure rooms. Many of these issues were noted by hospital staff months prior to the survey, but no remedy was obtained. Cross reference to A0749.

In an interview with the Executive Director QI on 11/10/15 at 1130 hours, she stated there was no reporting by Surgical Services or SPD to the Performance Improvement Patient Safety Committee. The Director stated Surgical Services staff reported data annually to the QI committee.

In an interview with the Executive Director Surgical Services on 11/10/15 at 1325 hours, she confirmed only patient safety issues outside the OR were reported to the Performance Improvement Patient Safety Committee, although an incident report should be completed for incidents.

During an interview with the Executive Director QI on 11/10/15 at 1345 hours, she stated she would start including surgical services data to the Performance Improvement Patient Safety Committee in 2016.

2. The CDC Surgical Site Infection (SSI Event procedure-associated module) modified 4/15 showed "Post-discharge and ante-discharge surveillance methods should be used to detect SSIs following inpatient and outpatient operative procedures. These methods include;

* Direct examination of patients' wounds during follow-up visits to either surgery clinics or physicians' offices

* Review of medical records or surgery clinic patient records

* Surgeon surveys by mail or telephone

* Patient surveys by mail or telephone (though patients may have a difficult time assessing their infections).

Any combination of these methods was acceptable for use; however, the CDC criteria for SSI must be used.

Documentation provided by the hospital showed there was an average of 145 outpatient surgeries monthly during August, September, and October, 2015.

During a review of the surgical site infection surveillance data for the hospital, no surveillance data was seen for the outpatient surgeries.

In an interview with the Executive Director PI on 12/1/15 at 0930 hours, she stated the surveillance for outpatient surgery SSIs was not 100%. The Director stated they did send letters to the physicians, but she was not sure if the letters were for the SSI surveillance.

In an interview with the IP Practitioner on 11/30/15 at 1315 hours, she stated there was no surveillance for SSIs for outpatients except for review of cultures if the culture was sent to the hospital.

In interviews with the IP Program Manager on 11/30/15 at 1320 hours and 12/1/15 at 0940 hours, he stated the hospital followed CDC and APIC IC standards. The Manager stated several years prior, the hospital sent the surveillance letters to the surgeons regarding infections and complications; however, the physicians did not respond, so they stopped sending them.

The Manager stated defibrillator and pacemaker implant procedures were the only outpatient procedures followed up for possible infections. The Manager stated he did check readmissions to determine if there were patients readmitted to the hospital with SSIs.

The Manager concurred that numerous surgeries, such as hysterectomy and cholecystectomy were done on outpatients. The Manager concurred he would not know if there was a patient who was treated as an outpatient for a SSI following outpatient surgery. Cross reference to A0749, example #16.

3. In interviews with the Executive Director QI on 12/1/15 at 0930 and 1030 hours, she stated the IP department data was included in the QI department. The Director stated the dashboard was shown to the Quality Council, CEO, and medical staff board members.

A list of SSIs during 2015 was obtained from the hospital on 11/30/15. The list showed four SSIs following the colon surgery and one following bowel surgery occurred during two weeks in January 2015.

The PI Dashboard for the first quarter of 2015 was reviewed; only one colon SSI was listed.

Review of the Surgery Department meeting minutes dated 2/12/15, did not show a report of the January 2015 infections. A comment was made that the infection rates needed improvement, but no detail about the infections was given, and there was no analysis of the problem, or an action plan.

The IP department's semi-annual infection report to the Quality Council was reviewed. Some data was included from the first quarter of 2015; however, the report did not include data regarding the five SSIs that occurred pursuant to colon and bowel surgeries from 1/5 - 1/19/15.

The colon SSI data reported to the National Healthcare Safety Network was reviewed. For the first quarter of 2015, the report showed four infections after 30 surgeries, compared to the two expected.

The January through May 2015 data showed nine infections after 79 surgeries, compared to the four expected.

The January through August 2015 data presented in the October 2015 Quality Council Infection Prevention Semi-Annual Report showed 11 infections after 112 surgeries, compared to the six expected. The colon surgery was persistently associated with a higher infection rate than the other surgical procedures reported, such as knee replacement.

Review of the 2015-2016 Infection Prevention Risk Assessment showed "As part of its commitment to quality care and service, SMMC (hospital name) conducts a periodic assessment of the risk(s) for transmission and acquisition of infectious agents. This risk assessment incorporates an analysis of the following: ...The results of the organization's surveillance, prevention, and control data.... The risk analysis is conducted at least annually and whenever there is a significant change in any of the above factors." The prioritized risks for surgical site infections included total knee arthroplasty, total hip arthroplasty, coronary artery bypass graft, and pacer/ICD procedures, but not colon surgeries.

4. During the review of QI program data with the Executive Director QI on 12/1/15 at 1520 hours, she displayed data for the time required for a STEMI patient to be transferred to the Cardiac Cath Lab for treatment. The data showed over 95% of the patients were treated within that time frame on repeated assessments. The Director was unable to provide further information about updated goals for time to treatment for Cardiac Cath Lab patients.

In an interview with the Executive Director Cardiac Services on 12/1/15 at 1530 hours, she stated the department had actually formulated a new goal of 60 minutes door to treatment in the Cardiac Cath Lab gathered data for that goal for the past six months. The Director stated their median time was now 55-60 minutes.

During the interviews on 12/1/15 at 1520 hours and on 12/4/15 at 0815 hours, the Executive Director QI stated the departments were visited twice a year to see what they were doing to try to improve the departments. However, she was not aware of the Cardiovascular program goal and data, and the data was not being presented as part of the QI program data.

Based on observation, interview, and record review, the hospital failed to ensure the QAPI program set priorities for performance improvement activities in the high risk area of Surgical Services to identify opportunities for improvement and take actions using the data collected that affected health outcomes, patient safety, and quality of care for all surgical patients, creating the risk of substandard healthcare to the patients receiving services in the hospital.

Findings:

1. IUSS was not provided on both campuses of the hospital following nationally recognized standards and the hospital's P&Ps. There was no tracking or trending of the use of IUSS and there were no documented validations of the competencies of the staff. For two patients (Patients 21 and 22), IUSS was used for hardware implanted surgically with no follow up of the patient by the IC Officer. Cross reference to A0951, example #1.

2. The hospital failed to show evidence of comprehensive investigations for reported and identified contaminated surgical instrument to improve and prevent future incidents.

In an interview with the Executive Director QI on 11/10/15 at 1100 hours, she stated there was an electronic system for reporting events. Risk management was to review the events and task investigation and follow up to the Manager or Supervisor. The Director stated the Manager or Supervisor was to document an investigation.

The Director stated the Risk Management department provided closure to the event and determined if further reporting was needed. The Director stated infection prevention related events were reported through the Infection Prevention department. The Director stated the SPD reported quarterly and by exception to the Infection Prevention department. The Director stated previous incidents were not reported because no pattern was identified until July 2015.

In an interview with the Executive Director Surgical Services on 11/10/15 at 1130 hours, she stated infection prevention issues in the OR were handled by the OR. The Director stated if something serious happened it was reported to Infection Prevention. Cross reference to A0951, example #2.

3.a. During the review of the SSI surveillance data for the hospital, no surveillance data was seen for the outpatient surgeries.

In an interview with the IP Practitioner on 11/30/15 at 1315 hours, she stated there was no surveillance for SSIs for outpatients except for review of cultures if the culture was sent to the hospital.

In an interview with the Executive Director PI on 12/1/15 at 0930 hours, she stated surveillance for outpatient surgery SSIs was not 100%. The Director stated they did send the letters to the physicians, but she was not sure if the letters were for SSI surveillance.

In interviews with the IP Program Manager on 11/30/15 at 1320 hours and 12/1/15 at 0940 hours, he stated the hospital followed CDC and APIC IC standards. He further stated several years prior, the hospital sent the surveillance letters to the surgeons regarding the infections and complications; however, the physicians did not respond, so they stopped sending them.

The Manager stated defibrillator and pacemaker implant procedures were the only outpatient procedures followed up for possible infections. The Manager stated he did check readmissions to determine if there were patients readmitted to the hospital with SSIs.

The Manager concurred that numerous surgeries, such as hysterectomy and cholecystectomy were done on outpatients. The Manager concurred he would not know if there was a patient who was treated as an outpatient for a SSI following outpatient surgery. Cross reference to A0749, example #16.

b. A list of SSIs during 2015 was obtained from the hospital on 11/30/15. The list showed four SSIs following the colon surgery and one following bowel surgery were identified during the two weeks from 1/5 to 1/19/15. Review of the medical records of those five patients (Patients 11, 12, 14, 25, and 26) showed four of the patients had post-surgical cultures positive for E.coli and two were positive for pseudomonas in addition to other positive cultures.

In an interview with the IP Program Manager on 12/1/15 at 1000 hours, he displayed a spreadsheet used to compile data on hip infections during a period of increased incidence in 2014. The spreadsheet included review of multiple parameters such as staff involved and instrument processing.

When asked about the series of colon SSIs in January 2015, the Manager stated the infections did not represent an outbreak because an outbreak had a common denominator; however, the Manager was unable to show documentation a common denominator was sought. The Manager stated he did not do a spreadsheet for the colon surgery SSIs. The Manager stated the IP department made a decision if additional investigation was needed, but the decision was made pursuant to informal discussion; there was no documentation.

Review of the Surgery Department meeting minutes dated 2/12/15, did not show a report of the January 2015 infections. There was a comment the infection rates needed improvement, but there was no detail about the infections, analysis of the problem, or an action plan.

The January through August 2015 data presented in the October 2015 Quality Council Infection Prevention Semi-Annual Report showed 11 infections after 112 surgeries, compared to the six expected. The colon surgery was persistently associated with a higher infection rate than the other surgical procedures reported, such as knee replacement.

Review of the 2015-2016 Infection Prevention Risk Assessment showed "As part of its commitment to quality care and service, SMMC (hospital name) conducts a periodic assessment of the risk(s) for transmission and acquisition of infectious agents. This risk assessment incorporates an analysis of the following: ...The results of the organization's surveillance, prevention, and control data.... The risk analysis is conducted at least annually and whenever there is a significant change in any of the above factors." The prioritized risks for surgical site infections included total knee arthroplasty, total hip arthroplasty, coronary artery bypass graft, and pacer/ICD procedures, but not colon surgeries.

4. Documentation of surveillance rounds by the IP Team dated January to October 2015 of the main ORs, Cardiac Cath Lab, and WC ORs on the LH campus was provided for review on 12/1/15.

Documentation of the February through October 2015 Infection Control Rounds was documented on emails sent by the IP Practitioner or the IP Program Manger to department heads, including the Executive Director Surgical Services, Manager Environmental Services, Manager Plant Operations/Maintenance, and Executive Director Quality Improvement; however, there were no emails found for April, September, and November 2015, only photographs. The emails listed items found out of compliance in the Main OR, Cardiac Cath Lab, and WC ORs with photographs of some of the issues identified.

The IP team identified issues of cleaning of the ORs and procedure rooms. Cross reference to A0748, example #3.

During an interview with the IP Program Manager on 12/3/15 at 1505 hours, the cleaning of the ORs was discussed regarding the cleaning solutions used in the main OR was not the same as the WC OR.

The Manager stated, "we need a system to monitor EVS cleaning in the ORs." In the July 2015 Infection Prevention Committee minutes, the different disinfectants used for the two ORs was discussed. The committee could not come to an agreement. The Main ORs were under the supervision of Surgical Services while the WC ORs were under the EVS department. Nobody could agree on the disinfectants to use as the Oxycide was very hard on the flooring. The Manager was aware the floors were not kept wet for the appropriate times.

On 12/1 at 1030 hours, EVS 4 and the Manager of Housekeeping were interviewed regarding the findings of an observation of the cleaning on the LH campus of a WC OR. Cross reference to A0749, example #9.

An interview was conducted at that time with EVS 4 who stated she was the EVS Supervisor. When asked, EVS 4 stated she inspected the OR's after cleaning by staff; however, EVS 4 stated she did not observe the staff during the cleaning of the OR's. EVS 4 stated EVS staff were taught how to clean an OR upon hire but were not observed or checked after that time.

The employee files for EVS 1 and EVS 2 were reviewed on 12/4/15 at 1030 hours, with the Manager of Housekeeping. The files showed both staff received inservice training for the use of Oxycide and the 710 solution on 6/18/15; however, the last time the staff's competency to clean an LDRP room/OR was validated was June 2009.

5. Observation and review of logs and interview with Surgical Services and Engineering staff on both the SC and LH campuses showed the temperature and humidity levels and were not maintained in the surgical areas and SPD as per the AORN's guidelines for peri-operative practice.

Staff failed to consistently monitor the temperature and humidity levels daily in all areas and failed notify Engineering immediately when the temperature and humidity levels were out of range. Cross reference to A0951, example #8.

During an interview and concurrent document review with the Facility staff on 11/30/15 at 1330 hours, the Facility staff confirmed the temperature and humidity were out of range for the SC campus ORs from July to November 2015. The staff stated he checked the AC system when he was notified of out of range temperature and humidity levels; however, he stated he was unable to pinpoint a reason in the HVAC system.

During an interview and concurrent document review with the Executive Director Building Services on 12/1/15 at 1330 hours, the Director stated the temperature and humidity levels would be validated on monthly basis. The Director stated they had a tool to check the temperature and humidity every month and it would be documented.

The Director was asked what actions were taken when the temperature and humidity levels were not within acceptable range for five months (July, August, September, October, and November 2015) at the SC campus. The Director stated the temperature and humidity levels were changed and were not within normal range because the OR staff adjusted the thermostat. The Director stated the problem was from the user. However, when asked, the Director was unable to provide documented evidence to show whether the OR staff was informed or educated regarding the reason why the temperature and humidity levels were out of normal range.

During an interview with the Executive Director of Building Services and the Supervisor of Building Services and Plant Ops on 12/1/15 at 1330 hours, the staff was asked to review the temperatures and humidity logs for the LH campus WC ORs for October 2015 showing out of range humidity in WC OR 1 from 10/22-10/31/15.

The staff were asked if the logs were kept to show the Engineering department was notified of the out range humidity in the WC ORs. The Director stated if they were called the staff documented on the preventative maintenance log. The Supervisor stated there was log or documentation their department was notified of these out of range humidity.

During an interview with Executive Director Surgical Services on 12/2/15 at 1135 hours, the Director was asked who monitored the temperature and humidity logs for the ORs. The Director stated, "it fell through the cracks the past few months, but the OR Manager does it now for the past three weeks."

During an interview with IP Program Manager on 12/3/15 at 1505 hours, the Director was asked who monitored the temperature and humidity logs for the ORs. The Director stated he made it a point in his rounds but sometimes he did not always have access to the logs. When the levels were found out of range, the Director stated he talked to the staff but he did not document any follow-up.

When asked who was responsible for the follow up for the temperature and humidity levels found out of range, the Director stated, "I don't know, but it is something we may have to do in the future, we acknowledge it is Infection Control's responsibility."

6. Documentation of surveillance rounds by the IP Team dated January to October 2015 of the main ORs, Cardiac Cath Lab, and WC ORs on the LH campus was provided for review on 12/1/15.

Documentation of the February through October 2015 Infection Control Rounds was documented on emails sent by the IP Practitioner or the IP Program Manger to department heads, including the Executive Director Surgical Services, Manager Environmental Services, Manager Plant Operations/Maintenance, and Executive Director Quality Improvement; however, there were no emails found for April, September, and November 2015, only photographs. The emails listed items found out of compliance in the Main OR, Cardiac Cath Lab, and the WC ORs with photographs of some of the issues identified.

Documentation showed rusted equipment in the Main OR and WC ORs was identified for the time period of February through August 2015; however, no further observations of "rusty" casters or equipment was documented from August to November 2015. Cross reference to A0748, example #4.

Observations of the ORs on the SC and LH campuses showed multiple pieces of equipment currently in use in the ORs were rusty. Cross references to A0951, examples #9.c, d, and e.

During an interview with the IP Program Manager on 12/3/15 at 1505 hours, the rusty equipment observed by the surveyors in the two WC ORs was discussed.
The IP Manager was asked why the emails and or photographs with the findings of the Infection Control Rounds did not show rusty equipment in the Main OR after August 2015 or in the WC ORs after March 2015. The Manager stated, "maybe I should have been more aggressive with follow-up on the rusty equipment."

During an interview with Executive Director Surgical Services on 12/4/15 at 1110 hours, she was asked if she received the monthly emails with the results of Infection Control Rounds, especially in the WC ORs. The Director stated she did but stated they might sometimes go to her junk mail folder.

The Director stated she was working with Engineering and replaced some equipment this summer; they might have been "hallway" conversations and Engineering might not have documentation.

When asked if she made scheduled rounds in the WC ORs, the Director stated she depended on her OR Manager to do rounds. The Director stated she never received concerns from the LDRP nurses who worked in those ORs regarding rusty equipment.

At 1400 hours on 12/1/15, the Executive Director of Surgical Services was asked to provide any communication or invoices regarding the purchasing of new equipment; however, at the time of exit on 12/4/15, no documentation was provided.

Based on interview and record review, the hospital failed to ensure complete follow up of an outpatient SSI, the system for tracking SSIs by the physician failed to identify an infection for one physician, and three incidents had been incompletely reviewed and addressed, creating the risk of persistent poor practices and substandard healthcare.

Findings:

1. Data presented by the hospital showed an average of 145 outpatient surgeries were performed monthly at the hospital during August, September, and October 2015. During a review of the SSI surveillance data for the hospital, no surveillance data was seen for the outpatient surgeries.

In interviews with the IP Program Manager on 11/30/15 at 1320 hours and 12/1/15 at 0940 hours, he stated the hospital followed CDC and APIC IC standards. The Manager stated several years prior, the hospital sent the surveillance letters to the surgeons regarding infections and complications; however, the physicians did not respond, so they stopped sending them.

The Manager stated defibrillator and pacemaker implant procedures were the only outpatient procedures followed up for possible infections. The Manager stated he did check readmissions to determine if there were patients readmitted to the hospital with SSIs.

A list of patients who had emergency room visits after outpatient surgery was requested from the hospital. Patient 30 was selected from the list for review as the list indicated he came to the emergency room with an infection.

Follow up of Patient 30's infection was reviewed with the IP Program Manager. The Manager reviewed the patient's medical record and concurred the patient had a positive culture on 12/28/14, after the surgeries on 12/4 and 12/10/14. The Manager stated the infection was not reviewed by the IC Officer; it was missed.

2. Review of the medical records of four colon surgeries and one bowel surgery with subsequent SSIs that occurred pursuant to surgeries between 1/5 and 1/19/15, showed two of the infections occurred pursuant to surgery by DR 1.

One of those two surgeries was a laparoscopic-assisted sigmoid colectomy (bowel surgery through a small incision in the abdomen) and biopsy performed on Patient 11 on 1/16/15. The patient was readmitted to the hospital for an infection on 1/26/15, and had purulent (pus) drainage from the surgical wound. A large pelvic abscess (infection) was drained on 2/6/15.

The credential file of DR 1 showed she was reappointed and granted privileges in the Surgery department on 11/24/15.

In an interview with Clinical Applications Staff on 12/1/15, she stated that coded information should be extracted by the provider performance evaluation computer program, including the information about infections after the surgery.

In an interview with Sr Medical Staff Coordinator on 12/1/15 at 1050 hours, she stated she was unable to find documentation of Patient 11's infection in the care event system that was supposed to help track physician-related care events.

The Clinical Applications staff researched the criteria for an event to be attributed to a physician and determined the computer program was not able to identify that DR 1's patient had a SSI related to DR 1's surgery because during the readmission other physicians cared for the patient. The system was set up to attribute the infection to the physician who was listed as an attending, consulting or performing physician during the readmission, and DR 1 did not fill one of those roles.

3. In an interview with the Executive Director QI on 11/10/15 at 1100 hours, she stated there was an electronic system for reporting events. Risk management was to review the events and task investigation and follow up to the Manager or Supervisor. The Director stated the Manager or Supervisor was to document an investigation.

The Director stated the Risk Management department provided closure to the event and determined if further reporting was needed. The Director stated infection prevention related events were reported through the Infection Prevention department. The Director stated the SPD reported quarterly and by exception to the Infection Prevention department. The Director stated previous incidents were not reported because no pattern was identified until July 2015.

In an interview with the Executive Director Surgical Services on 11/10/15 at 1130 hours, she stated infection prevention issues in the OR were handled by the OR. The Director stated if something serious happened it was reported to Infection Prevention.

a. An incident from 5/27/15, was randomly selected for review from the hospital's incident log and was reviewed with the Risk Manager on 12/1/15 at 1330. The incident reflected concerns about the confusion over whether a surgical assistant was to have been present and whether antibiotics were to have been ordered in addition to possible medical staff behavior issues. A list of questions regarding the incident was sent from the Risk Manager to the Surgical Services Department Manager; but no response to the questions was found.

The operative report by the surgeon showed he believed a substitute RNFA had participated in the surgery. However, review of the medical record for the patient showed no assistant was documented as present.

The incident was also sent for peer review. Review of the peer review documents did not show the problem with accuracy of the medical record was discussed.

b. An incident reported 5/12/15, was selected for review from the hospital's incident log as the incident related to sterilization processes and was reviewed with the Risk Manager on 12/1/15 at 1400. The incident report indicated on 5/11/15, IUSS was used to process an implant when the manufacturer's representative did not bring the desired implant prior to surgery; the desired implant was obtained during the surgery.

Review of the medical record for Patient 22 showed the patient had a rod implanted during spinal surgery on 5/11/15.

Documentation of the follow up of the incident showed the report was sent to the Surgery Department Manager. The Manager responded on 5/14/15, that the staff acted appropriately. There was no documentation to show an investigation or remediating actions were taken and there was no documentation to show the problems found on the forms for the sterilization process were identified.

In an interview with the Executive Director Surgical Services on 12/1/15 at 1530 hours, she stated Patient 22 was in the OR and the incision was open; there was a miscommunication regarding the implant required. The Director stated the implant expected by the staff was the one received; however, the surgeon changed his mind about the desired implant and did not notify the staff. The Director stated she discussed the need for improved communication with the surgeon but concurred she might not have documented actions taken in follow up to prevent such an occurrence in the future.

Review of the report from the SPD to the Infection Prevention Committee on 7/29/15, showed there were no incidents to report. Cross reference to A0951, example #1.

c. An incident regarding a scalpel blade still attached to the handle found during a subsequent surgery was reviewed on 11/10/15. No investigation of the circumstances of the incident was found.

In an interview with the Executive Director Surgical Services on 11/10/15 at 1330 hours, she stated the blade and scalpel were felt to have fallen into a crevice in the processing equipment and therefore the blade and scalpel were not detected by the SPD staff who should have seen the instrument. The Director stated the incident was not documented in the OR Committee minutes. The Director stated she realized there was inadequate documentation of an investigation and follow-up of this incident. Cross reference A0951, example #2.

Based on interview and medical record review, the hospital failed to ensure the medical record for three of 30 sampled patients (Patients 20, 27, and 29) accurately reflected the care provided to the patient as evidenced by:

* The anesthesiologist failed to document and file the pre-anesthesia evaluations prior to providing anesthesia for two patients (Patients 27 and 20) received services at SC campus.

* A physician's order was not written and/or obtained for insertion of an indwelling urinary catheter in the OR for Patient 27.

* The nursing staff failed to document accurately the type of anesthesia provided to Patient 29 during the procedure.

These failures created the potential risk for health care providers' lack of knowledge in providing care to the patients.

Findings:

Review of the hospital's General Medical Staff Rules and Regulation updated 3/15 showed the following:

* A complete medical record is initiated and maintained for each individual assessed and treated.

* Pertinent progress notes shall be recorded at the time of observation or reassessment, sufficient to permit continuity of care and transferability. Each of the patient's clinical problems should be clearly identified and prioritized so that treatment decisions can be made and communicated to the health care team.

1. Review of Patient 27's medical record was initiated on 12/3/15. The patient was admitted to the hospital for a surgery on 11/25/15 at 0837 hours, and was discharged on 11/28/15 at 1545 hours.

a. Review of the Informed Consent for Anesthesia showed Patient 27 signed on 11/25/15 at 1125 hours, and the anesthesiologist signed on 11/25/15 at 1125 hours, for the planed general and/or regional anesthesia.

Review of the Anesthesia Record showed the anesthesia started for Patient 27 on 11/25/15 at 1127 hours, and ended at 1515 hours.

However, review of the section of Anesthesia PreOp (Preoperative) Consult of the Anesthesia Evaluation showed the form noted on 11/25/15 at 1217 hours, and filed on 11/25/15 at 1219 hours, after the anesthesia had started.

During an interview and concurrent medical record review with RN K on 12/13/15 at 1000 hours, the RN confirmed the above finding.

b. Review of the Default Flowsheet Data for Lines/Drains/Airways showed an indwelling urinary catheter was inserted for Patient 27 on 11/25/15 at 1200 hours, in the OR and was removed on 11/26/15 at 0900 hours.

However, there was no documented evidence to show a physician's order was obtained or written for the insertion of an indwelling urinary catheter for Patient 27.

An interview and concurrent review of Patient 27's medical record was conducted with RN K on 12/3/15 at 1000 hours. The RN stated a physician's order was needed when an indwelling urinary catheter was inserted. When asked, the RN was unable to find a physician's order was written or obtained when an indwelling urinary catheter was inserted in the OR for Patient 27 on 11/25/15 at 1200 hours.

2. Review of Patient 20's medical record was initiated on 12/1/15. The patient was admitted to the hospital on 9/18/15 at 1348 hours, and was discharged on 9/19/15 at 1120 hours.

Review of the Informed Consent for Anesthesia showed Patient 20 signed on 9/18/15, and the anesthesiologist signed on 9/18/15 at 1420 hours, for the planned general and/or regional anesthesia.

Review of the Anesthesia Record showed the anesthesia started for Patient 20 on 9/18/15 at 1602 hours, and ended at 1757 hours.

However, review of the section of Anesthesia PreOp (Preoperative) Consult of the Anesthesia Evaluation showed the form noted and filed on 9/18/15 at 1800 hours, after the anesthesia had started.

During an interview and concurrent medical record review with RN K on 12/1/15 at 1435 hours, the RN confirmed the pre-anesthesia evaluation was completed and documented on 9/18/15 at 1800 hours, after the anesthesia had started for the Patient 20.

3. Review of Patient 29's medical record was initiated on 12/4/15. The patient was admitted to the hospital on 10/29/15. On 10/30/15, a procedure was performed for the patient.

Review of the Anesthesia Record dated 10/30/15, showed the anesthesia started at 1831 hours and ended at 2017 hours. The patient received general anesthesia during the procedure.

However, review of the section of the Procedure Data of the Flowsheet Data by Day, documented by RN O (a RN from the contracted vendor) on 10/30/15 at 2104 hours, showed MAC (Monitored Anesthesia Care) was type of sedation/anesthesia provided to the patient.

During an interview and concurrent review of Patient 29's medical record with RN L on 12/4/15 at 1335 hours, the RN confirmed the nursing staff documented Patient 29 received MAC and did not reflect what the patient received during the procedure.

Based on observation, interview, and record review, the hospital failed to ensure a sanitary environment and an active program to prevent the spread of infections in accordance with the hospital's P&Ps and nationally recognized infection control practices and guidelines as evidenced by:

1. The hospital failed to ensure the hospital's Infection Prevention Practitioners developed and implemented the IC polices. Cross reference to A0748.

2. The hospital failed to have an effective system in place to develop, implement, and evaluate measures governing the identification, investigation, reporting, prevention and control of infections, and communicable diseases. Cross reference to A0749.

3. The hospital failed to ensure the CEO maintained oversight over the IC program. Cross reference to A0756.

The cumulative effect of these systemic failures resulted in the hospital's inability to provide quality healthcare to the patients in a safe environment.

Based on observation, interview, and record review, the hospital failed to ensure the hospital's Infection Prevention Practitioners developed and implemented the IC polices throughout the hospital as evidenced by:

1. IUSS was not provided on both campuses of the hospital following nationally recognized standards and hospital P&Ps. There was no tracking or trending of the use of IUSS and there were no documented validations of the competencies of the staff. For two patients (Patients 21 and 22), IUSS was used for hardware implanted surgically with no follow up of the patient by the Infection Control Officer. No risk assessments were conducted for the use of IUSS, or proper disinfection/sterilization for the surgical instruments as per the hospital's 2014-2015 Annual Infection Prevention Plan.

2. There was no investigation or an incomplete and delayed investigation was conducted when there were four incidents of foreign bodies found in sterile surgical trays ready for patient use.

3. The IC surveillance rounds of the LH campus ORs were not done monthly and there was inconsistent follow up of identified issues regarding temperature and humidity, rusty equipment, and cleaning of the ORs.

4. The IC surveillance rounds of the SC campus ORs were not done monthly and there was inconsistent follow up of identified issues regarding temperature and humidity, rusty equipment, and the sterilization process.

5. There was no surveillance for SSIs for outpatients by the IP Program.

6. The IP department's semi-annual infection report to the Quality Council did not show a report regarding five SSIs that occurred pursuant to colon and bowel surgery from 1/5 - 1/19/15.

7. The CDC's recommendations for immunization of health-care personnel were not followed when there was no policy on medical staff health screening and the issue was not in the hospital's Infection Control Plan.

Findings:

Review of the hospital's 2014-2015 Annual Infection Prevention Plan showed the following:

- The IP identified HAIs by review of unusual occurrence reports, review of patient record, and infection prevention rounds.

- The IPs attended surgical services rounds in both campuses on a monthly basis.

- The infection prevention would repeat the disinfection risk assessment throughout the organization. The OR and SPD were monitoring items repeatedly subjected to open sterilization with focus to minimize this practice by buying more of these items. Rapid read-out BIs were used one a day and whenever an implant was being subjected to unwrapped sterilization.

- Infection prevention risk assessment for LH campus and SC campus included proper disinfection/sterilization of reusable patient care equipment/instruction. Identified risk also applies to some/all outpatient areas. The goal was to ensure proper disinfection/sterilization of any-reusable patient care equipment or instructions for inpatient and outpatient location.

1.a. An incident related to sterilization processes reported 5/12/15, was selected for review from the hospital's incident log. The report showed IUSS was used on 5/11/15, to process an implant when the manufacturer's representative did not bring the desired implant prior to surgery; the desired implant was obtained during the surgery.

Review of Patient 22's medical record showed the patient had a rod placed during a spinal surgery on 5/11/15 at the LH campus.

Review of the pre-printed sterilization log form, Autoclave Usage Documentation showed implants intended for Patient 22 were sterilized on 5/11/15 at 1148 and 1221 hours; however, there was no indication on the form to show which implant was sterilized at which time. There was a section on the pre-printed form to document whether if the flashed items were not actually used; however, the section was left blank on both documentation sheets. The log showed a "flash" autoclave was used. No drying time was documented for either load.

On the Autoclave Usage Documentation, the section of the log to document if the BI result was positive (indicating the sterilization cycle was inadequate) was not completed for the implant sterilized at 1221 hours. The section on the form to document the control (a second BI, not sterilized and used to ensure the indicators were working) showed there was no control documented for the 1148 load. The control for the load at 1221 hours, was documented as "negative" (indicating the control was not working) rather than "positive."

Documentation of the follow up of the incident showed the report was sent to the Surgery Department Manager. The Manager responded on 5/14/15, that the staff acted appropriately. There was no documentation to show an investigation or remediating actions were taken and there was no documentation to show the problems found on the forms for the sterilization process were identified.

In an interview with the Executive Director Surgical Services on 12/1/15 at 1530 hours, she stated Patient 22 was in the OR and the incision was open; there was a miscommunication regarding the implant required. The Director stated the implant expected by the staff was the one received; however, the surgeon changed his mind about the desired implant and did not notify the staff. The Director stated she discussed the need for improved communication with the surgeon but concurred she might not have documented actions taken in the follow up to prevent such an occurrence in the future.

Review of the report from the SPD to the Infection Prevention Committee on 7/29/15, showed there were no incidents to report.

b. Review of the Autoclave Usage Documentation Form showed one IUSS load was performed for Patient 21 on 9/6/15 at the SC campus OR.

During an interview and concurrent document review with the SC OR Manager on 11/30/15 at 0910 hours, the OR Manager confirmed IUSS of the above implantable was performed for Patient 21; however, there was no documented evidence to show a biological test was performed for the IUSS load containing implantable items as per hospital's P&P.

Review of Patient 21's medical record was initiated on 12/1/15. The patient was admitted to the hospital on 9/6/15 at 1311 hours, and was discharged on 9/8/15 at 1400 hours. Patient 21 had a surgery on 9/6/15. The surgery started at 1835 hours and ended at 2007 hours. A 3.5 mm locking plateau plate was implanted during the procedure.

Review of the Autoclave Usage Documentation Form (a form used when an IUSS load was performed) showed an implantable item was sterilized for Patient 21 on 9/6/16. The form showed the reason for Flash Autoclave was "unsterile."

An interview and concurrent medical record review was conducted with RN K and the Interim Manager SPD on 12/1/15 at 1500 hours. The Interim Manager SPD stated the 3.5 mm tibial plateau plates documented on the Autoclave Usage Documentation Form was implanted in Patient 21 during the surgery.

c. Review of the Autoclave Usage Documentation Form showed one IUSS load of "Synthes distal radius plate" (an implantable item) was performed for Patient 20 on 9/18/15. The reason for reason for flash autoclave was "Dropped/No replacement." The IUSS load was started at 1535 hours. A biological test was placed in incubator at 1800 hours and was out of incubator at 2100 hours. The result of the biological test was negative.

Review of Patient 20's medical record was initiated on 12/1/15. The patient was admitted to the hospital on 9/18/15 at 1348 hours, and was discharged on 9/19/15 at 1120 hours. Patient 20 had a surgery on 9/18/15. The surgery started at 1624 hours and ended at 1740 hours. A Synthes plate or a radial plate was implanted for the patient during the surgery.

The result biological test was out of incubator on 9/18/15 at 2100 hours, after the end Patient 20's surgery at 1740 hours.

During an interview with the Executive Director Quality Improvement on 12/2/15 at 1450 hours, the Director stated no reports were filed to notify her department for Patients 20 and 21.

During an interview with the Executive Director Quality Improvement, the IP Program Manager, and the IP Practitioner on 12/3/15 at 1500 hours, the Manager was asked about review of the use of IUSS during infection control rounds. The Manager stated he did not review the use of IUSS; he looked at environment and the printed documents from the sterilizer.

The IP Program Manager was informed the staff that performed IUSS in the OR did not have a documented competency and there was no tracking and trending of the IUSS logs. The LH campus OR autoclaves had heavy green deposits on the chambers and there was no documented evidence of maintenance according to the manufacturer's guidelines. The IC Manager stated he was not aware of these findings and did not have a risk evaluation of IUSS in the OR LH. Cross reference to A0951, example #1.

2. On 10/29/15 at 1335 hours, the LH campus OR was toured. During a confidential interview, an OR staff stated approximately four incidents of unclean surgical instruments found on the sterile field had occurred in the past several months.

a. On 10/29/15 at 1503 hours, review of hospital documents with the Clinical Risk Manager showed on 4/23/15, a knife handle with a scalpel blade still loaded from a previous procedure was found in a sterile tray.

b. On 11/2/15 at 1620 hours, during an interview, the Executive Director Surgical Services stated the OR staff reported to her an incident that occurred during a surgical case. The scrub tech noted a drill bit remained in the drill from a previous surgery.

c. On 10/29/15 at 1503 hours, during an interview with the Executive Director Surgical Services review of a hospital documents showed on 6/23/15, staff reported a bone fragment was found in an instrument tray already on the sterile field ready for use during a surgery on LH campus OR.

d. On 10/29/15 at 1335 hours, during an interview, the Executive Director Surgical Services stated on 7/22/15, a fourth incident was reported from the LH campus OR. The scrub technician found a bone fragment in a sterile surgical instrument tray, one of 20 instrument trays utilized for a patient's surgery when opening for the case. Cross reference to A0951, example #2.

3. Documentation of surveillance rounds by the IP Team dated January to October 2015 of the main ORs, Cardiac Cath Lab, and WC ORs on the LH campus was provided for review on 12/1/15.

Documentation dated 1/16/15, titled Infection Control Rounds, Operating and Procedure rooms showed of a list of pre-printed items for surveillance with the same form used for each of the three areas. Documentation showed in the notes column the items were looked at and were okay or non-applicable.

There were three questions on the form to monitor if staff was aware of the proper disinfectant for cleaning the ORs or Cardiac Cath Lab, proper dilution, concentration and contact time for disinfectant solutions, and proper discard of the mop used to clean the dirty OR. Notes documented for the three items in each of the three areas showed the team did not interview staff.

Review of the WC OR surveillance showed all equipment in ORs 1 and 2 was clean. There was no notation to show corrosion was found. Documentation showed the humidity levels were out of range for three days in OR 1 and two days in OR 2. Documentation showed the ST was informed if the humidity was out of range and engineering was called to document on the log.

Documentation for the February through October 2015 Infection Control Rounds was not documented on a checklist. The emails sent by the IP Practitioner or IP Program Manger to department heads, including the Executive Director Surgical Services, Manager Environmental Services, Manager Plant Operations/Maintenance, and Executive Director Quality Improvement were provided for review; however, there was no email found for April, September, and November 2015, only photographs. The emails listed items found out of compliance in the Main OR, Cardiac Cath Lab, and the WC ORs with photographs of some of the issues identified.

a. For the issues of temperature and humidity, the following was identified for the time period of February through November 2015:

During an interview with the IP Program Manager on 12/3/15 at 1505 hours, the humidity levels observed by the surveyors ORs were discussed. The Manager was asked if he was checked the logs at any time during rounds. The Manager stated rounds are done early in the morning in the ORs and they don't have access to the logs on a regular basis. The Manager was asked who was responsible for follow up of the monitoring of the temperature and humidity levels in the ORs. The manager stated, "I don't know, it is something we may have to do in our department in the future. We acknowledge it is the infection control department's responsibility."

* Rounds done 2/13/15, in the Main OR showed temperatures were out of range for two days; no action was documented. In the WC ORs, humidity in OR 1 was out of range for five days and in OR 2 for five days with no action documented.

* Rounds done 8/21/15 showed the humidity was out of range for two days in the Main OR and no corrective action was documented to show engineering were notified.

* Rounds done 9/18/15, showed photographs of the humidity gauges taken during the inspection of WC OR 1 and OR 2. Both rooms were out of range at that time. There was no documentation to show any action taken by the IP team.

* Rounds done 10/9/15, showed out of range humidity in WC OR 1.

b. For the issues of rusted equipment, the following was identified for the time period of February through November 2015:

*Rounds done 2/13/15, in the Main OR showed "rusted" casters were found in multiple rooms.

* Rounds done 3/15/15, in the Main OR showed rusty casters in almost every room with a note in bold, "another repeat from past inspections." In the WC ORs rusted casters were seen with a note in bold "a repeat from prior inspections."
* Rounds done 5/19/15, in the Main OR, listed rusty casters were noted as a repeat from prior inspections.

* Rounds done 5/19/15, in the Main OR, showed rusty casters were noted as a repeat from prior inspections.

* Rounds done 7/10/15, in the Main OR, showed rusty casters were noted in OR 1 and 5.

No further observation of "rusty" casters or equipment was documented from August to November 2015.

During an interview with the IP Program Manager on 12/3/15 at 1505 hours, the rusty equipment observed by the surveyors in the two WC ORs was discussed. Cross references to A0951, examples #9.c, d, and e.

The IP Manager was asked why the emails and or photographs with the findings of the Infection Control Rounds did not show rusty equipment in the WC ORs after March 2015. The Manager stated "maybe I should have been more aggressive with follow-up on the rusty equipment."

c. For the issues of cleaning of the ORs and procedure rooms, the following was identified for the time period of February through November 2015:

* Rounds done 3/15/15, in the Main OR showed rags were soaking in disinfectant, The IP team noted the disinfectant should be prepared previous to use.

* Rounds done 5/19/15, in the Main OR showed the IP team documented it was "agreed several months ago to start using Oxycide to disinfect all ORs" as it offered the advantage of killing C diff spores and has a five minute contact time with surfaces and would replace the use a quatt solution, 710 which had no activity against C diff and has a contact time of 10 minutes. Interview with the EVS staff showed no Oxycide was used, the staff was once again using the 710."

* Rounds done 6/12/15, in the Main OR showed inspection of the housekeeping closet showed the 710 disinfectant solution was found in a bucket; however, the only concern documented was not that the solution was still in use but it was made up with rags soaking and the solution was ineffective once rags were soaked and kept.

* Rounds done 7/10/15, in the Main OR showed a large bucket filled with clean cotton rags wet with a quat disinfectant for use in cleaning the ORs. However, the only concern documented was not that the solution was still in use but it was made up with rags soaking and the solution was ineffective once rags were soaked and kept.

No further observation of EVS issues was documented from August to November, 2015.

During an interview with the the IP Program Manager on 12/3/15 at 1505 hours, the cleaning of the ORs was discussed regarding the cleaning solutions used in the main OR was not the same as the WC OR.

The Manager stated we need a system to monitor EVS cleaning in the ORs. In the July 2015 Infection Prevention Committee minutes the different disinfectants used for the two ORs was discussed. The committee could not come to an agreement. The Main ORs were under the supervision of Surgical Services, while the WC ORs were under the EVS department. Nobody could agree on the disinfectants to use as the Oxycide is very hard on the flooring. The Manager was aware the floors were not kept wet for the appropriate times. Cross references to A0951, examples #9.a and b.


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4. Review of the Infection Control Rounds for 2015 done on the SC campus showed rounds for Surgical Services were conducted on 3/4, 4/28, 6/25, 8/18, 11/2, 11/9, and 11/24/15. There was no documented evidence to show the infection control rounds were conducted for the months of May, July, September, and October 2015 as per the hospital's 2014-2015 Annual Infection Prevention Plan.

During an interview and concurrent document review with the on 12/2/15 at 1150 hours, she confirmed IC rounds for surgical area of the SC campus were not conducted for the above months. The IP Practitioner stated the aim was to conduct the rounds monthly, but they had to prioritize the workflow.

a. Review of the forms Infection Control Rounds Operating & Procedure room dated 3/4, 4/28, 6/25, and 8/18/15, showed a pre-printed list of items for surveillance. The section of Notes was to be documented as "OK," "Yes," or "n/a" (not applicable)-did not interview staff." Further review of the forms showed the following:

* Three items listed on the form to show "all horizontal surfaces are clean/free of dust," "table wheels and casters are clean," and "cleaning equipment is disassembled, cleaned, disinfected and dried before reuse & storage" were documented as "OK."

* Three items listed on the form to monitor whether staff was aware of proper use disinfectants, proper dilution/concentration and proper contact time for disinfectants, and proper disposal of suction contents were documented as "n/a -did not interview staff."

However, review of the Infection Control Rounds and the Comment/Action Taken showed the following:

* Rusty casters were identified on 3/4, 6/25, 8/18, 11/2, 11/9, and 11/24/15.

* Dusty environment was identified on 6/25, 8/18, and 11/24/15.

During an observation, interview, and documentation review during the survey from 11/30/15 to 12/4/15, the following were identified regarding Surgical Services on the SC campus:

* Rusty equipment found in ORs at the SC campus. Cross references to A951, examples #9. c and d.

* Environment was not clean in ORs at the SC campus. Cross references to A951, example #9.c and d.

There was no documented evidence to show IC round was conducted on September and October 2015 or how rusty equipment was followed up on September and October 2015.

During an interview with OR Manager on 11/30/15 at 0910 hours at the SC Campus, the OR Manager was asked about rusty equipment. The Manager stated new equipment was ordered.

During an interview and concurrent document review with the IP Program Manager and the IP Practitioner on 12/1/15 at 1130 hours, they were asked about the dusty environment and rusty equipment identified by the surveyor at the SC Campus.

The Manager stated he identified rusty equipment was an issue. The Manager was asked about follow up. The Manager stated he took photographs during tour rounds, highlighted them as repeated findings, and sent the findings by email to the department Director or Manager.

b. Review of the Infection Control Rounds and the Comment/Action Taken showed the following:

* On 6/25/15:

- The temperature in the decontamination room was too warm; the recommended temperature was 60-65 degrees F.

- The SC OR Inspection Photos showed a document: "Log book missing temperature & Humidity recording dates (in June)."

- The Photo of the temperature and humidity gauge showed the humidity was more than 60% for four out of six days in OR 1, for one out of six days in OR 3, and two of six days in the OR hallway. The section for action taken showed engineering was called.

However, there was no documentation to show whether the elevated humidity levels was addressed in the Infection Control Rounds and the the Comment/Action Taken form.

* On 8/18/15, humidity was identified as constantly above 60%.

* On 11/2 and 11/9/15, the temperature and humidity level in the ORs and SPD was identified as out of range.

During the observations, interviews, and concurrent document review during the survey days from 11/30 to 12/4/15, the temperature and humidity levels in the SC campus ORs and OR hallway were found not maintained and monitored as per AORN standard of practice for five months (July, August, September, October, and November 2015). Cross reference to A0951, example #7.

During an interview with the Executive Director Quality Improvement, the IP Program Manager, and the IP Practitioner on 12/3/15 at 1500 hours, the Manager was asked about temperature and humidity levels for the surgical services. The Manager stated he did monthly surveillance, reviewed logs during rounds, but could not access the logs most of the time.

The Manager stated the OR staff was educated when issues of temperature and humidity were identified, but this was not documented. The Manager stated OR Manager was responsible to notify engineering when the temperature and humidity was out of range, and accountable for things not right in the department.

c. Review of the Comment/Action Taken for the Infection Control Rounds showed on 6/25/15, the autoclave was missing the signature of processing person. The Sterilization QC issue showed "OR Sterilizer printout not initialed (several)."

However, there was no documented evidence to show whether a BI test for the OR Sterilizer was reviewed or interviews with staff were done.

5. In an interview with the IP Practitioner on 11/30/15 at 1315 hours, she stated there was no surveillance for SSIs for outpatients except for review of cultures if the culture was sent to the hospital.

In interviews with the IP Program Manager on 11/30/15 at 1320 hours and 12/1/15 at 0940 hours, he stated the hospital followed CDC and APIC IC standards. The Manager stated several years prior, the hospital sent the surveillance letters to the surgeons regarding infections and complications; however, the physicians did not respond, so they stopped sending them.

The Manager stated defibrillator and pacemaker implant procedures were the only outpatient procedures followed up for possible infections. The Manager stated he did check readmissions to determine if there were patients readmitted to the hospital with surgical site infections.

The Manager concurred that numerous surgeries, such as hysterectomy and cholecystectomy were done on outpatients. The Manager concurred he would not know if there was a patient who was treated as an outpatient for a SSI following outpatient surgery. Cross reference to A0749, example #16.

6. A list of SSIs during 2015, was obtained from the hospital on 11/30/15. The list showed four SSIs following colon surgery and one following bowel surgery were identified during the two weeks from 1/5 to 1/19/15. Review of the medical records of those five patients (Patients 11, 12, 14, 25, and 26) showed four of the patients had post-surgical cultures positive for E.coli and two were positive for pseudomonas in addition to other positive cultures.

In an interview with the IP Program Manager on 12/1/15 at 1000 hours, he displayed a spreadsheet used to compile data on hip infections during a period of increased incidence in 2014. The spreadsheet included review of multiple parameters such as staff involved and instrument processing.

When asked about the series of colon SSIs in January 2015, the Manager stated the infections did not represent an outbreak because an outbreak had a common denominator; however, the Manager was unable to show documentation a common denominator was sought. The Manager stated he did not do a spreadsheet for the colon surgery SSIs. The Manager stated the IP department made a decision if additional investigation was needed, but the decision was made pursuant to informal discussion; there was no documentation.

Review of the IP department's semi-annual infection report to the Quality Council did not show a report regarding the five surgical site infections that occurred pursuant to colon and bowel surgery from 1/5-1/19/15 was included.

Review of the Surgery Department meeting minutes dated 2/12/15, did not show a report of the January 2015 infections. There was a comment the infection rates needed improvement, but there was no detail about the infections, analysis of the problem, or an action plan.

7. During interviews with the Sr Medical Staff Coordinator and Medical Staff 1 on 11/30/15 at 1355 hours, they stated that TB (tuberculosis) screening and influenza vaccination or declination was required for physicians, but that measles, mumps and rubella titers were voluntary. The staff stated there was no also hepatitis B screening for the physicians, although it was required for employees. Cross reference to A0749, example #18.

In an interview with the IP Program Manager on 11/30/15 at 1320, he stated he was not sure how medical staff health screening was done; there was no policy on medical staff health screening and it was not in the Infection Control Plan. The Manager stated they encouraged measles, mumps, and rubella vaccination, but he was not sure about the percent of medical staff vaccinated.

Based on observation, interview, and record review, the hospital failed to have an effective system in place to develop, implement, and evaluate measures governing the identification, investigation, reporting, prevention and control of infections, and communicable diseases within the hospital as evidenced by:

1. IUSS was not provided on both campuses of the hospital following nationally recognized standards and hospital P&Ps. There was no tracking or trending of the use of IUSS and there were no documented validations of the competencies of the staff. For two patients (Patients 21 and 22), IUSS was used for hardware implanted surgically with no follow up of the patient by the Infection Control Officer.

2. The hospital failed to show evidence of comprehensive investigations for reported and identified contaminated surgical instrument to improve and prevent future incidents.

3. Failure to ensure reusable items used for anesthesia services were reprocessed followed the manufacturer's directions and staff received training for the process.

4. The cleanliness of the SPD and substerile areas of the LH campus OR where sterilization of instruments was performed was not maintained.

5. Biological tests were not read and documented as per hospital's P&P and manufacturer's instructions for use at SC Campus.

6. Failure to ensure the autoclaves in the LH campus OR and SPD were maintained per the manufacturer's recommendations.

7. Failure to ensure the temperature and humidity levels were maintained in the surgical areas including LH campus ORs, LH campus WC ORS, SC campus OR and OR hallway, Decontamination room, and Clean room as per the AORN's guidelines for peri-operative practice. In addition, the hospital failed to ensure the OR staff notified engineering immediately when the temperature and humidity levels were out of range.

8. Failure to maintain the required number of air exchanges in the LH campus OR substerile areas, LDRP cleanup in the WC ORs and failed to ensure the air exchange rate was monitored for the OR hall where a sterilizer was located at the SC campus as per the AORN's guidelines.

9. The hospital failed to ensure the peri-operative areas on the LH and SC campuses were maintained in a clean, sanitary manner. In addition, multiple pieces of equipment in the SC campus ORs and the LH campus WC ORs showed rust and corrosion.

10. Expired sutures were found in the patient care area at the SC campus.

11. Expired enzymatic cleaner was used to clean surgical instruments at the SC campus.

12. Safe IV injection practices were not implemented in the LH campus OR during a surgical procedure.

13. An US probe was not cleaned in accordance with the disinfectant wipe manufacturer's directions for use.

14. A used endoscope was not precleaned immediately as per the manufacturer's directions for use.

15. The hospital failed to develop the hospital's P&P to address the cleaning, disinfection and/or the sterilization of a vaginal cylinder (a device used in radiation therapy) at Radiation-Oncology Center.

16. SSI surveillance data was not gathered for the outpatient surgeries to detect SSIs. In addition, the hospital failed to further investigate five surgical site infections that occurred pursuant to colon and bowel surgery in a two week period for Patients 11, 12, 14, 25, and 26.

17. A pistol-grip sprayer was used to clean other surfaces, such as the scrub table in the Cardiac Cath Lab contrary to the AORN guidelines.

18. The CDC's recommendations for immunization of health-care personnel were not followed when there was no policy on medical staff health screening and the issue was not in the hospital's Infection Control Plan.

19. There were no red lines delineating the area as requiring surgical attire and no special signage to cue staff the area required special coverings in the Cardiac Cath Lab suite.

20. During an observation in the Cardiac Cath Lab, no clock was visible from the scrub sink outside Cath Labs 2 and 3.

21. Seven of nine nurses interviewed in five nursing units on the LH Campus were unable to state the contact time for glucometer cleaning.

22. Respiratory care staff failed to follow the hospital's P&P and CDC guidelines for Infection Control when ventilator circuits were replaced on a routine basis.

23. A two-shelf open cart containing uncovered infant diapers and wipes was routinely moved from one OR to the other OR and used for multiple infants.

These failures increased the risk of the spread of infections to the patients in the hospital.

Findings:

1. IUSS was not provided on both campuses of the hospital following nationally recognized standards and hospital P&Ps. There was no tracking or trending of the use of IUSS and there were no documented validations of the competencies of the staff. For two patients (Patients 21 and 22), IUSS was used for hardware implanted surgically with no follow up of the patient by the Infection Control Officer. Cross reference to A0951, example #1.

2. The hospital failed to show evidence of comprehensive investigations for reported and identified contaminated surgical instrument to improve and prevent future incidents. Cross reference to A0951, example #2.

3. Failure to ensure reusable items used for anesthesia services were reprocessed followed the manufacturer's directions and staff received training for the process. Cross reference to A0951, example #3.

4. The cleanliness of the SPD and substerile areas of the LH campus OR where sterilization of instruments was performed was not maintained. Cross reference to A0951, example #4.

5. Biological tests were not read and documented as per hospital's P&P and manufacturer's instructions for use at SC Campus. Cross reference to A0951, example #5.

6. Failure to ensure the autoclaves in the LH campus OR and SPD were maintained per the manufacturer's recommendations. Cross reference to A0951, example #6.

7. Failure to ensure the temperature and humidity levels were maintained in the surgical areas including LH campus ORs, LH campus WC ORS, SC campus OR and OR hallway, Decontamination room, and Clean room as per the AORN's guidelines for peri-operative practice. In addition, the hospital failed to ensure the OR staff notified engineering immediately when the temperature and humidity levels were out of range. Cross reference to A0951, example #7.

8. Failure to maintain the required number of air exchanges in the LH campus OR substerile areas, LDRP cleanup in the WC ORs and failed to ensure the air exchange rate was monitored for the OR hall where a sterilizer was located at the SC campus as per the AORN's guidelines. Cross reference to A0951, example #8.

9. The hospital failed to ensure the peri-operative areas on the LH and SC campuses were maintained in a clean, sanitary manner. In addition, multiple pieces of equipment in the SC campus ORs and the LH campus WC ORs showed rust and corrosion. Cross reference to A0951, example #9.

10. Expired sutures were found in the patient care area at the SC campus. Cross reference to A0951, example #10.

11. Expired enzymatic cleaner was used to clean surgical instruments at the SC campus. Cross reference to A0951, example #11.

12. Review of the APIC Position Paper: Safe injection, Infusion, and Medication vial Practices in Health Care, 2010 showed to use aseptic technique in all aspects of parenteral medication administration, medication vial use, injections. Cleanse the access diaphragm of vials using friction and a sterile 70% isopropyl alcohol, ethyl alcohol, iodophor, or other approved antiseptic swab. Allow the diaphragm to dry before inserting any device into the vial. For IV solution, the practice was to disinfect IV ports by wiping and using a sterile 70% isopropyl alcohol, ethyl alcohol, iodophor, or other approved antiseptic swab. Allow the diaphragm to dry before inserting any device into the vial.

On 11/30/15 at 1025 hours, a surgical procedure was observed in the LH Main OR. MD 1 provided anesthesia services for the patient.

MD 1 was observed performed a spinal anesthesia for the patient. MD 1 donned a pair of sterile gloves and removed the gloves after the injection. Without performing hand hygiene after removing the gloves, MD 1 took a medication vial out from the anesthesia cart, aspirated the liquid medication into a syringe and injected the medication into the patient's IV line via a port. No disinfecting of the vial or IV port was observed.


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13. The hospital failed to ensure an US (Ultrasound) probe was cleaned in accordance with the Sani-Cloth HB (a disinfectant) manufacturer's directions for use.

During an observation in the Breast Center on 12/1/15 at 0855 hours, US Tech 1 used a Sani-Cloth HB wipe for an US probe. The US Tech stated she used a Sani-Cloth HB wipe to clean the US probe; the wet or contact time for the Sani-Cloth HB was two minutes.

Review of the manufacturer's directions for use of Sani-Cloth HB showed the Sani-Cloth HB had a 10 minute contact time. The US Tech confirmed the manufacturer's direction for use was not followed.

14. The hospital failed to ensure a used endoscope was precleaned immediately as per the manufacture's directions for use.

Review of the Cleaning, Disinfection and Sterilization Procedure from the manufacturer of a rhino-laryngofiberscope (a scope with mirrors and a lighting system used for examination of the nose and larynx, or the voice box) showed the following:

* Endoscope reprocessing included precleaning; leakage testing; manual cleaning; high-level disinfection or sterilization; and storage.

* Precleaning was to preclean the endoscope at the bedside in the procedure room immediately following the procedure. These steps are to be performed when the light source is turned off and was still connected to the endoscope. Precleaning included wiping down the insertion tube with a clean, lint-free cloth soaked in detergent solution, and disconnecting the endoscope and reusable parts. If the endoscope is not immediately precleaned, residual organic debris will begin to solidify and it may be difficult to effectively reprocess the endoscopes.

During an interview MA 1 on 12/1/15 at 1020 hours in the Radiation-Oncology Center, the MA stated she brought a used endoscope to the SPD for sterilization or disinfection and would pick up a clean endoscope from SPD.

The MA was asked about the process of transferring a used endoscope to the SPD. MA 1 stated she put a used endoscope into a red biohazard container; closed the container with a lid, and brought it to the SPD. When asked when she brought the used endoscope to the SPD MA 1 stated she brought them to the SPD when the morning schedule was completed.

MA 1 was asked how long a used scope would sit in the red biohazard container prior to transfer to the SPD. MA 1 stated it depended, but sometimes it took two hours. When asked whether a used scope would be precleaned prior to transfer to the SPD, MA 1 stated, no.

During an observation on 12/1/15 at 1025 hours, a red biohazard bin was observed at the nurse station. MA 1 stated the biohazard container contained a used endoscope; the endoscope was used at 0900 hours, placed in the container, and waited to be dropped off at the SPD.

During an interview and concurrent review of the manufacturer's Cleaning, Disinfection and Sterilization Procedure for the rhino-laryngofiberscope with the Executive Director Quality Improvement on 12/3/15 at 1345 hours, the Director was informed and acknowledged a used endoscope was not precleaned immediately as per the manufacturer's directions for use.

14. The hospital failed to develop the hospital's P&P to address the cleaning, disinfection and/or the sterilization of a vaginal cylinder (a device used in radiation therapy) at Radiation-Oncology Center.

During an interview with MA 1 on 12/1/15 at 1020 hours, in the Radiation-Oncology Center, the MA was asked about the process of cleaning or disinfecting of a used vaginal cylinder. The MA stated she wiped the used vaginal cylinder with alcohol, put it in a container and brought it to the SPD for cleaning and disinfecting.

During an interview with the Interim Manager SPD on 12/2/15 at 1125 hours, the Interim Manager stated staff from the Radiation-Oncology Center dropped off the vaginal cylinder for sterilization in the SPD.

The Interim Manager was asked to provide the manufacturer's instruction or the hospital's P&P for the use, cleaning, disinfection, and/or sterilization of the vaginal cylinder. The Interim Manager stated the vaginal cylinder was brought to the SPD and was sterilized by the SPD staff; however, he stated there was no manufacturer's information regarding cleaning or sterilization of the vaginal cylinder.

On 12/3/15 at 1345 hours, the manufacturer's instructions for cleaning, disinfection or sterilization of the vaginal cylinder used at Radiation-Oncology Center was requested.

During an interview with the Executive Director Quality Management, the IP Program Manager, and the IP Practitioner on 12/3/15 at 1500 hours, the Director stated the vaginal cylinder used at Radiation-Oncology Center was custom-made; the manufacturer's instructions for cleaning or disinfection were not available. The IP Program Manager stated the vaginal cylinder was sterilized by steam sterilization.

On 12/4/15 at 0815 hours, the hospital's P&P and/or information for the cleaning, the disinfection and/or the sterilization for vaginal cylinder were requested.

On 12/4/15 at 1030 hours, the Executive Director Quality Management stated the vaginal cylinder was bought 10 years ago. There was no specific documentation or a hospital P&P to address how to clean, disinfect or sterilize the vaginal cylinder.


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16. The CDC Surgical Site Infection (SSI Event procedure-associated module) modified 4/15 showed "Post-discharge and ante-discharge surveillance methods should be used to detect SSIs following inpatient and outpatient operative procedures. These methods include;

* Direct examination of patients' wounds during follow-up visits to either surgery clinics or physicians' offices

* Review of medical records or surgery clinic patient records

* Surgeon surveys by mail or telephone

* Patient surveys by mail or telephone (though patients may have a difficult time assessing their infections).

Any combination of these methods was acceptable for use; however, the CDC criteria for SSI must be used.

a. Documentation provided by the hospital showed there was an average of 145 outpatient surgeries monthly during August, September, and October 2015.

During the review of the SSI surveillance data for the hospital, no surveillance data was seen for the outpatient surgeries.

In an interview with the IP Practitioner on 11/30/15 at 1315 hours, she stated there was no surveillance for SSIs for outpatients except for review of cultures if the culture was sent to the hospital.

In an interview with the Executive Director PI on 12/1/15 at 0930 hours, she stated surveillance for outpatient surgery SSIs was not 100%. The Director stated they did send letters to the physicians, but she was not sure if the letters were for surgical site infection surveillance.

In interviews with the IP Program Manager on 11/30/15 at 1320 hours and 12/1/15 at 0940 hours, he stated the hospital followed CDC and APIC IC standards. He further stated several years prior, the hospital sent the surveillance letters to the surgeons regarding infections and complications; however, the physicians did not respond, so they stopped sending them.

The Manager stated defibrillator and pacemaker implant procedures were the only outpatient procedures followed up for possible infections. The Manager stated he did check readmissions to determine if there were patients readmitted to the hospital with surgical site infections.

The Manager concurred that numerous surgeries, such as hysterectomy and cholecystectomy were done on outpatients. The Manager concurred he would not know if there was a patient who was treated as an outpatient for a surgical site infection following outpatient surgery.

A list of patients who had emergency room visits after outpatient surgery was requested from the hospital. Patient 30 was selected from the list for review as the list indicated he came to the emergency room with an infection.

Follow-up of Patient 30's infection was reviewed with the IP Program Manager. The Manager reviewed the patient's medical record and concurred the patient had a positive culture on 12/28/14, after the surgery for an arterio-venous fistula on 12/4 and 12/10/14. The Manager stated the infection was not reviewed by Infection Prevention because it was missed.

b. A list of SSIs during 2015 was obtained from the hospital on 11/30/15. The list showed four surgical site infections following colon surgery and one following bowel surgery were identified during the two weeks from 1/5 to 1/19/15. Review of the medical records of those five patients (Patients 11, 12, 14, 25, and 26) showed four of the patients had post-surgical cultures positive for E. coli and two were positive for pseudomonas in addition to other positive cultures.

In an interview with the IP Program Manager on 12/1/15 at 1000 hours, he displayed a spreadsheet used to compile data on hip infections during a period of increased incidence in 2014. The spreadsheet included review of multiple parameters such as staff involved and instrument processing.

When asked about the series of colon SSIs in January 2015, the Manager stated the infections did not represent an outbreak because an outbreak had a common denominator; however, the Manager was unable to show documentation a common denominator was sought. The Manager stated he did not do a spreadsheet for the colon surgery SSIs. The Manager stated the IP department made a decision if additional investigation was needed, but the decision was made pursuant to informal discussion; there was no documentation.

Review of the IP department's semi-annual infection report to the Quality Council did not show a report regarding the five SSIs that occurred pursuant to colon and bowel surgery from 1/5-1/19/15, was included.

Review of the Surgery Department meeting minutes dated 2/12/15, did not show a report of the January 2015 infections. There was a comment the infection rates needed improvement, but there was no detail about the infections, analysis of the problem or an action plan.
17. Review of the ARON Guidelines for Perioperative Practice, 2015 Edition, Guideline for Environmental Cleaning, Recommendation II.c.6. showed spray and misting methods (e.g., a spray bottle) should not be used to apply cleaning chemicals in the perioperative practice setting.
During a tour of the Cardiac Cath Lab on 11/30/15 at 0955 hours, the Lead RT indicated the disinfectant Oxycide was used to clean other surfaces, such as the scrub table. The RT displayed a pistol-grip sprayer containing the disinfectant.

In an interview with the EVS Manager on 11/30/15 at 1025 hours, the Manager stated the cath lab staff used the pistol grip sprayer for cleaning.

In an interview with RN 11 on 11/30/15 at 1020 hours, the RN stated he used the pistol-grip sprayer with Oxycide when cleaning in the Cath lab.

In a second interview with the Lead RT on 11/30/15 at 1027 hours, she stated the Cardia Cath Lab followed AORN recommendations for cleaning; the RT stated she was not aware AORN recommended against the use of pistol-grip sprayers for the application of disinfectant.
18. Review of the CDC's, Immunization of Health-Care Personnel: Recommendations of the Advisory Committee on Immunization Practices (ACIP) 11/25/11, showed:

HCP are defined as all paid and unpaid persons working in health-care settings who have the potential for exposure to patients and/or to infectious materials, including body substances, contaminated medical supplies and equipment, contaminated environmental surfaces, or contaminated air. HCP might include (but are not limited to) physicians, nurses, nursing assistants, therapists, technicians, emergency medical service personnel, dental personnel, pharmacists, laboratory personnel, autopsy personnel, students and trainees, contractual staff not employed by the health-care facility, and persons (e.g., clerical, dietary, housekeeping, laundry, security, maintenance, administrative, billing, and volunteers) not directly involved in patient care but potentially exposed to infectious agents that can be transmitted to and from HCP and patients (2).

Diseases for Which Vaccination Is Recommended

On the basis of documented nosocomial transmission, HCP are considered to be at substantial risk for acquiring or transmitting hepatitis B, influenza, measles, mumps, rubella, pertussis, and varicella. Current recommendations for vaccination are provided below.

Hepatitis B - Two single-antigen hepatitis B vaccines, Recombivax HB and Engerix-B and one combination hepatitis A and hepatitis B vaccine, are available in the United States. Primary vaccination consists of =3 intramuscular doses of hepatitis B vaccine or of the combined hepatitis A and hepatitis B vaccine. The hepatitis vaccine series does not need to be restarted if the second or third dose is delayed.

Influenza - Annual influenza vaccination is recommended for all persons aged =6 months who have no medical contraindication; therefore, vaccination of all HCP who have no contraindications is recommended. The influenza vaccine is evaluated annually with one or more vaccine strains updated almost every year. In addition, antibody titers decline during the year after vaccination

Measles - All persons who work in health-care facilities should have presumptive evidence of immunity to measles. This information should be documented and readily available at the work location.

Mumps - All persons who work in health-care facilities should have presumptive evidence of immunity to mumps. This information should be documented and readily available at the work location.

Rubella - All persons who work in health-care facilities should have presumptive evidence of immunity to rubella. Adequate rubella vaccination for HCP consists of 1 dose of MMR vaccine. However, because of the 2-dose vaccination requirements for measles and mumps, the use of the combined MMR vaccine will result in the majority of HCP receiving 2 doses of rubella-containing vaccine, which should provide an additional safeguard against primary rubella vaccine failure.

Pertussis - Regardless of age, HCP should receive a single dose of Tdap as soon as feasible if they have not previously received Tdap and regardless of the time since their most recent Td vaccination.

Varicella - Health-care institutions should ensure that all HCP have evidence of immunity to varicella. This information should be documented and readily available at the work location.

During interviews with the Sr Medical Staff Coordinator and Medical Staff 1 on 11/30/15 at 1355 hours, they stated that TB (tuberculosis) screening and influenza vaccination or declination was required for physicians, but that measles, mumps and rubella titers were voluntary. The staff stated there was no also hepatitis B screening for the physicians, although it was required for employees.


In an interview with the IP Program Manager on 11/30/15 at 1320, he stated he was not sure how medical staff health screening was done; there was no policy on medical staff health screening and it was not in the Infection Control Plan. The Manager stated they encouraged measles, mumps, and rubella vaccination, but he was not sure about the percent of medical staff vaccinated.

In an interview with Credentialing Coordinator on 12/1/15 at 1040 hours, he stated there was a check mark for physician influenza vaccine, but no dates for the physician's influenza vaccination was recorded in the electronic system.

The Credentialing Coordinator provided the health clearance information gathered for DR 1, DR 2, DR 3, DR 4 and PA 1.

For DR 1, reappointed on 11/24/15, a TB test dated 4/7/14, and an influenza vaccination from 2015 were found.

For DR 2, reappointed on 9/23/14, TB screening was performed on 2/12/15.

For DR 3, reappointed on 9/23/14, TB screening and influenza vaccination were performed in 2015.

For DR 4, reappointed 5/26/15, a copy of a 9/4/15, influenza vaccine prescription was provided.

For PA 1, reappraised 4/29/14, TB screening and an influenza vaccination in 2015, was documented

There was no information provided on measles, mumps, rubella or hepatitis B for any of the above medical staff members.

19. During a tour of the Cardiac Cath Lab suite on 11/30/15 at 0940 hours, no red lines delineating the area as requiring surgical attire and no special signage to cue staff the area required special coverings were observed.

During an interview with the Lead RT on 11/30/15 at 0945, she stated there should be a sign on the doors indicating that the area required special coverings, but the signs were missing from the doors of Cath Lab 2 and 3. The RT displayed a sign posted on the door to Cardia Cath Lab 1, which included a stop sign and a pictorial of the garb and handscrub required.

20. During the observation in the Cardiac Cath Lab ante-room on 11/30/15 at 0940 hours, no clock was visible from the scrub sink outside Cath Labs 2 and 3.

In an interview ST 1 on 11/30/15 at 0945 hours, he stated they were to scrub their hands for five minutes at the scrub sink prior to surgery. ST 1 concurred there was no clock visible from the scrub sinks. ST 1 stated there used to be a clock present.


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21. Review of the hospital's P&P titled Blood Glucose Monitoring using Nova Stat Strip Glucose Meter dated 3/15, showed the following:

Cleaning and disinfection: The Glucose Meter should be cleaned before and after each use ensuring there is no blood present on the meter. Acceptable cleaning and disinfection agents are hospital approved disinfectant wipes and hospital approved bleach wipes.

During a general tour of the LH Campus on 11/30/15 at beginning at 0920 hours, accompanied by the Director of Professional Development and Infection Control Practitioner, the following observations were made:

a. During a tour of ICU West:

At 0940 hours, RN N stated the Sani-Cloth Bleach wipes were used to clean the glucometers after each patient use. When asked how if there was a length of time the glucometers should stay wet after wiping, RN N stated she was unsure of the exact time.

Review of the canister label for the Sani-Cloth Bleach showed the cleaning procedure included the treated surface must remain visibly wet for a full four minutes.

At 0945 hours, RN E stated the Super Sani Cloth wipes were used to clean the glucometers after each patient use. RN E further stated the glucometers would be dry and placed in the holder approximately 30 seconds after wiping.

At 0955 hours, RN F stated the Super Sani Cloth wipes were used to clean the glucometers. RN F stated she made sure the meter was dry before returning it to the docking station. RN F stated the meter would not be dry in two minutes; however, she did not time it.

Review of the canister label for the Super Sani Cloth showed the cleaning procedure included the treated surface must remain visibly wet for a full two minutes.

b. During a tour of 2 East Med-Surg Telemetry:

At 1045 hours, RN D stated the Super Sani Cloth wipes were used to clean the glucometers; she had to wait two minutes for them to dry. When asked if the meters had to stay wet for two minutes before touching them, she stated no, the meters just had to be dry.

At 1110 hours, RN M stated she was most concerned the glucometers were dry before placing them in the rack; she did not know how long the meters had to be wet from the Super Sani Cloth wipes.

c. During a tour of 3 West Oncology at 1135 hours, RN C stated the Super Sani Cloth wipes were used to clean the glucometers; she left them out for about 2-3 minutes before putting them back.

d. During a tour of 3 East Ortho at 1410 hours, RN H stated the Sani-Cloth Bleach wipes were used to clean the glucometers; she cleaned them for two minutes. When asked how she ensured the timing of two minutes, RN H stated she could not be sure of the actual time the glucometer was wet.

e. During a tour of the Cath Lab 1, on 11/30/15 at 0950 hours, an i-STAT machine (a hand held device for obtaining immediate blood test results) was seen on the counter. At the top of the machine near where the blood samples were inserted was a 2 x 3 mm in size red-brown spot.

During a concurrent interview with RN 11, he stated the nurse should clean the i-STAT. RN 11 demonstrated wiping the machine with the disinfectant wipe and the spot was easily removed.

f. During a tour of the Cardiac Cath Lab on 11/30/15 at 0955 hours, the Lead RT and RN 11 were interviewed about the use of the Super Sani-cloth disinfectant wipes. Neither staff member knew the wet contact time required for the disinfectant wipe. RN 11 stated there was no need to rewet surfaces once they were wiped.

The wipes were observed in individual packages, each printed with instructions which included a required wet contact time of two minutes.

g. During a tour of the Cardiac Cath Lab on 11/30/15 at 0955 hours, the Lead RT indicated that a second chemical disinfectant, Oxycide, was used to clean other surfaces, such as the scrub table. She was not certain of the required wet contact time for the Oxycide, but thought it was around 5 minutes.

In an interview with RN 11 on 11/30/15 at 1020, he stated that he let the disinfectant sit for 5 minutes.

The Oxycide bottle was consulted, but did not contain instructions for use, and instead referred to instructions printed on the bottle of concentrate.

The bottle of concentrate was sought in the EVS closet, but the closet disinfectant supply also did not contain instructions for use. The directions were requested from the Manager EVS.

22. Review of the hospital's P&P titled Infection Control in Respiratory Care Department Cleaning/Decontamination of Respiratory Care Equipment & Traffic Control dated 9/13 showed all disposable adult ventilator heated wire and non-heated wire circuits (including noninvasive ventilators) will be changed as needed when visibly soiled or mechanically malfunctioning.

Review of the hospital's P&P titled Ventilator Interdisciplinary Team dated 9/11 showed change heat/moisture exchange devices every 48 hrs and as needed.

During a general tour of the ICU on 11/30/15 at 1145 hours, RCP 1 stated circuits were changed on ventilators every three days and the closed tracheal suction system was changed every other day.

On 12/1/15 at 0930 hours, RCP 2 was asked when circuits were changed on patients' ventilators. RCP 2 stated the heated circuits were automatically changed every three days on a non-heated circuit for a new ventilator patient.

On 12/1/15 at 1315 hours, an interview was conducted with the Manager of Respiratory Services who stated the standard of practice through the American Association for Respiratory Care and the CDC's recommendation was to change the circuit only when visibly soiled. The Manager further acknowledged the two P&P's did not reflect the current evidenced based practice and needed to be changed.

23. During an observation in the WC OR's on 12/1/15 at 1030 hours, ST 4 moved a two shelf open cart from OR 2 to OR 1. OR 2 was just cleaned by EVS staff after a caesarean section. On the top shelf in the middle of the cart was an infant scale. On one side of the scale was an open box of diapers. On the other side was packages of diaper wipes and stack of dry paper wipes. Additional diapers and wipes were stored on the open bottom shelf.

During the prior cleaning observation of OR 2 the EVS staff did not move or clean under the scale on the top shelf of the cart and did not clean or replace the diaper wipes or infant diapers located on the cart in open containers.

During an interview with ST 4 on 12/1/15 at 1035 hours, ST 4 stated he moved the cart to OR 1 as that OR room was used for most surgeries. When asked, the ST confirmed the supplies on the cart were used for more than one patient and the open storing of the diapers and wipes in an OR was an infection control issue; the items should be rep

Based on observation, interview, and record review, the hospital failed to ensure the CEO maintained oversight over the IC program, creating the risk of the program not addressing infection prevention needs and the increased risk of the spread of infections.

Findings:

During the observations and interviews in the hospital during the survey dates, gaps were seen in the design and implementation of the infection prevention program. Cross reference to A0749.

In an interview with the CEO on 12/3/15 at 1400 hours, he stated the Governing Board reviewed the Quality Council report; the Quality Council came to the Board with issues; and the performance improvement plan was reviewed quarterly.

The CEO stated he was aware of identified issues before they got to the Board level; however, he stated he was not aware of any issues with foreign bodies found in sterile surgical trays available for patient use and IUSS or the rusty equipment found in the OR of the SC and LH campuses. Cross references A0951, examples #1, 2, 9.c, d, and e.

The CEO stated the IP Consultant was responsible for providing oversight of the infection prevention program.

Based on observation, interview, and record review, the hospital failed to ensure surgical services were well organized and provided in accordance with the hospital's P&Ps and acceptable standards of practice to ensure the health and safety of the patients as evidenced by:

1. The hospital failed to provide a safe and effective environment and maintain high standards of care for patients receiving surgical services. Cross reference to A0951.

2. The hospital failed to ensure the H&Ps for two of four sampled patients receiving surgical services at the SC campus were completed per the General Medical Staff Rules and Regulations. Cross reference to A0952.

3. The hospital failed to ensure the hospital's P&P was implemented related to an informed consent not being fully written for one of four sampled patients reviewed receiving surgical services at the SC campus. Cross reference to A0955.

The cumulative effect of these systemic practices resulted in the hospital's inability to provide safe and effective surgical services to the patients.

Based on observation, interview, and record review, the hospital failed to provide a safe and effective environment and maintain high standards of care for patients receiving surgical services as evidenced by:

1. IUSS was not provided on both campuses of the hospital following nationally recognized standards and hospital P&Ps. There was no tracking or trending of the use of IUSS and there were no documented validations of the competencies of the staff. For two patients (Patients 21 and 22), IUSS was used for hardware implanted surgically with no follow up of the patient by the Infection Control Officer.

2. The hospital failed to show evidence of comprehensive investigations for reported and identified contaminated surgical instrument to improve and prevent future incidents.

3. Failure to ensure reusable items used for anesthesia services were reprocessed followed the manufacturer's directions and staff received training for the process.

4. The cleanliness of the SPD and substerile areas of the LH campus OR where sterilization of instruments was performed was not maintained.

5. Biological tests were not read and documented as per hospital's P&P and manufacturer's instructions for use at SC Campus.

6. Failure to ensure the autoclaves in the LH campus OR and SPD were maintained per the manufacturer's recommendations.

7. Failure to ensure the temperature and humidity levels were maintained in the surgical areas including LH campus ORs, LH campus WC ORS, SC campus OR and OR hallway, Decontamination room, and Clean room as per the AORN's guidelines for peri-operative practice. In addition, the hospital failed to ensure the OR staff notified engineering immediately when the temperature and humidity levels were out of range.

8. Failure to maintain the required number of air exchanges in the LH campus OR substerile areas, LDRP cleanup in the WC ORs and failed to ensure the air exchange rate was monitored for the OR hall where a sterilizer was located at the SC campus as per the AORN's guidelines.

9. The hospital failed to ensure the peri-operative areas on the LH and SC campuses were maintained in a clean, sanitary manner. In addition, multiple pieces of equipment in the SC campus ORs and the LH campus WC ORs showed rust and corrosion.

10. Expired sutures were found in the patient care area at the SC campus.

11. Expired enzymatic cleaner was used to clean surgical instruments at the SC campus.

12. Failed to ensure staff at the SC campus were evaluated for competency for the IUSS process; the RN passed or completed the assigned standardized procedures annually and requirement for competency for administering moderate sedation as per the hospital's P&P.

13. Failure to ensure safe IV injection practices were implemented in LH campus OR during a surgical procedure.

These failures created the risk of substandard healthcare outcomes to the patients receiving services in the hospital.

Findings:

1. Review of AORN Guidelines for Perioperative Practice, Guideline for Sterilization, Published online 3/9/12, Recommendation VII:

IUSS should be kept to a minimum and should be used only in selected clinical situations and in a controlled manner.

Immediate use steam sterilization may be associated with increased risk of infection to patients.

Time constraints may result in pressure on personnel to eliminate or modify one or more steps in the cleaning and sterilization process.

VII.a. Immediate use steam sterilization should be used only when there is insufficient time to process by the preferred wrapped or container method intended for terminal sterilization. Immediate use steam sterilization should not be used as a substitute for sufficient instrument inventory.

VII.a.1. Items to be steam sterilized for immediate use should be subjected to the same decontamination processes as described in AORN's Guideline for Cleaning and Care of Surgical Instruments Decontamination should be performed in an area intended, designed, and equipped for decontamination activities. As with terminal sterilization, proper decontamination is essential for removing bioburden and preparing an item for IUSS. Failures in instrument cleaning have resulted in transmission of infectious agents.

VII.a.2. Immediate use steam sterilization should be performed only if all of the following conditions are met:

The device manufacturer s written instructions include instructions for IUSS.
-The device manufacturer's written instructions for cleaning, cycle type, exposure times, temperature settings, and drying times (if recommended) are available and followed.
-Items are placed in a containment device that has been validated for IUSS and cleared by the FDA for this purpose and in a manner that allows steam to contact all instrument surfaces.
-The containment device manufacturer's written instructions for use are followed.
-Measures are taken to prevent contamination during transfer to the sterile field.
-Items subjected to IUSS are used immediately and not stored for later use or held from one procedure to another.

VII.b. Packaging and wrapping (e.g., textiles, paper-plastic pouches, nonwoven wrappers) should not be used in IUSS cycles unless the sterilizer and the packaging are specifically intended and labeled for this use. Cycle parameters vary according to sterilizer design.

VII.b.1. Sterilizer manufacturers' written instructions should be followed and reconciled with packaging and device manufacturers' instructions for sterilization.

VII.c. Each sterilization cycle should be monitored to verify that parameters required for sterilization have been met.

VII.c.1. The sterilizer operator should use physical monitors to verify cycle parameters for each load. Physical monitors (e.g., printouts, digital reading, graphs, gauges) can indicate immediate sterilizer failure. Physical monitors record cycle parameters (e.g., time, temperature) for each cycle.

VII.c.2. Biological and chemical indicators should be used to monitor sterilizer efficacy and to assess whether conditions of sterilization have been achieved. Although products used to monitor sterilizer efficacy and achievement of required parameters vary according to type of cycle or type of sterilizer, monitoring requirements are the same for all types of steam sterilization. (for more detailed recommendations for a quality monitoring program and application of monitors.)

VII.c.3. A class 5 chemical integrating indicator or a class 6 indicator should be used within each sterilization container or tray used for IUSS Class 6 indicators are cycle-specific and should be used only in the specific cycles for which they are labeled.

VII.d. Devices processed using IUSS should be transported to the point of use in a manner that minimizes the risk of contamination of the item and injury to personnel handling the hot, wet, and possibly heavy trays. Immediate use steam sterilized items may be vulnerable to contamination by exposure to the environment and handling by personnel while transporting the sterile device to the point of use. It is important that sterilization processing be carried out in a clean environment and that IUSS devices are transferred to the point of use in a manner that prevents contamination.
Because drying time is not usually part of a preprogrammed IUSS cycle, the items processed are assumed to be wet at the conclusion of the cycle and will be hot when removed from the sterilizer chamber immediately after the cycle.

VII.e. Rigid sterilization containers designed and intended for IUSS cycles should be used. Rigid IUSS containers protect items so as to reduce the risk of contamination during transport of items to the point of use and facilitate ease of presentation to the sterile field

VII.e.1. After each use, IUSS containers should be cleaned, inspected (e.g., for wear of gaskets and other critical components), and maintained according to the manufacturer ' s written instructions.

VII.e.2. Immediate use steam sterilization containers should be opened and the contents used immediately. Instruments processed in IUSS containers should not be stored for later use or held from one procedure to the next.

VII.e.3. Items processed using IUSS should be differentiated from items processed using terminal sterilization.

VII.f. Immediate use steam sterilization should not be used for implantable devices except in cases of defined emergency when no other option is available. Implants are foreign bodies and they increase the risk of SSI.

Careful planning, appropriate packaging, and inventory management in cooperation with suppliers can minimize the need for IUSS of implantable medical devices.

VII.f.1. When IUSS of an implant is unavoidable, cycle selection should be determined by the manufacturer ' s written instructions for use, and a biological indicator and a class 5 chemical integrating indicator should be run with the load. When an implant is used before the biological indicator results are known and the biological indicator is later determined to have a positive result, the surgeon and infection preventionists should be notified as soon as the results are known. If the implant is not used, it should not be saved as sterile for future use. If, after inspection, it is determined that the implant is suitable for future use, resterilization of the implant is required.

VII.f.2. Every implant should be fully traceable to the patient in whom it was implanted

VII.g Documentation of cycle information and monitoring results should be maintained in a log (i.e., electronic or manual). Documentation of cycle information provides a means for tracking items that are processed using IUSS to individual patients and for quality monitoring.

VII.g.1. Immediate use steam sterilization records should include information on each load, including:
* the items processed,
* the patient on whom the items were used,
* the type of cycle (e.g., gravity-displacement, dynamic air-removal),
* the cycle parameters used (e.g., temperature, duration of cycle),
* monitoring results,
* the date and time the cycle was run,
* the operator information (i.e., person who initiated the cycle, person who retrieved the item from the sterilizer), and
* the reason for IUSS

VII.g.2. A record describing what could have been done to prevent IUSS of the implant should be completed and used as part of a quality monitoring system.
A record of IUSS of implants can be helpful in determining problems, trends, or circumstances that can be addressed to prevent IUSS of implants in the future.

Review of the hospital's P&P titled Sterilization revised 10/14 showed the following:

* Implantable and intravascular medical devices should not be immediate-use sterilized except in a documented of the item is not available. Screws, pins, and mails are considered to be implantable devices.

* If it is absolutely necessary to immediate-use sterilize an implantable or intravascular devices, before biological sport test validation is complete, the sterilization event must be reported to infection control with a description of the sterilization cycle parameters used, the reason for the immediate-use sterilization procedure, the type of device, and patient information so that the patient can be monitored.

* The manufacturer's recommendations must be followed.

Review of the hospital's P&P titled Sterilization Sterility Assurance revised 7/13, showed the following:

* Accepted Practice for Frequency of Biological Monitoring includes all sterilizers are tested with live bacterial spores at least weekly or with each load. Monitoring schedules are as follows:

- The SPD personnel monitor steam/ETO sterilizer every load; Sterrad-daily; Steris 1- weekly.

- The OR staff monitors the sterilizers for the day of use and with all implantables.

* Daily Sterility Monitoring Protocols include:

- Test each sterilizer and each cycle to be used (vacuum assisted, gravity, flash steam sterilization).

- Perform steam biological indicator with companion chemical indicator for wrapped loads, for rigid container load, for unwrapped (flash) loads. If a sterilizer is designed and to be used for multiple types of cycles (prevacuum, gravity, flash in steam sterilizer) then each sterilizer mode must be tested.

- Perform biological indicator with companion chemical indicator for each load containing an implantable or intravascular device; whenever possible should be quarantined until the results of the biological are available. If implantable or intravascular devices are removed before the quarantine period, the surgeon must be notified.

- The flash sterilization log must include the patient's information. A report of all flash sterilized devices must be sent to the infection control coordinator on a quarterly basis. If a device is implanted with inadequate or improper sterilization, it must be reported immediately to the infection control coordinator and physician. A notification form must be filled out.

a. An incident related to sterilization processes reported 5/12/15, was selected for review from the hospital's incident log. The report showed IUSS was used on 5/11/15, to process an implant when the manufacturer's representative did not bring the desired implant prior to surgery; the desired implant was obtained during the surgery.

Review of Patient 22's medical record showed the patient had a rod placed during a spinal surgery on 5/11/15, at the LH campus.

Review of the pre-printed sterilization log form, Autoclave Usage Documentation showed implants intended for Patient 22 were sterilized on 5/11/15 at 1148 and 1221 hours; however, there was no indication on the form to show which implant was sterilized at which time. There was a section on the pre-printed form to document whether if the flashed items were not actually used; however, the section was left blank on both documentation sheets. The log showed a "flash" autoclave was used. No drying time was documented for either load.

On the Autoclave Usage Documentation, the section of the log to document if the BI result was positive (indicating the sterilization cycle was inadequate) was not completed for the implant sterilized at 1221 hours. The section on the form to document the control (a second BI, not sterilized and used to ensure the indicators were working) showed there was no control documented for the 1148 load. The control for the load at 1221 hours was documented as "negative" (indicating the control was not working), rather than "positive."

Documentation of the follow up of the incident showed the report was sent to the Surgery Department Manager. The Manager responded on 5/14/15, that the staff acted appropriately. There was no documentation to show an investigation or remediating actions were taken and there was no documentation to show the problems found on the forms for the sterilization process were identified.

In an interview with the Executive Director Surgical Services on 12/1/15 at 1530 hours, she stated Patient 22 was in the OR and the incision was open; there was a miscommunication regarding the implant required. The Director stated the implant expected by the staff was the one received; however, the surgeon changed his mind about the desired implant and did not notify the staff. The Director stated she discussed the need for improved communication with the surgeon, but concurred she may not have documented actions taken in the follow up to prevent such an occurrence in the future.

Review of the report from the SPD to the Infection Prevention Committee on 7/29/15, showed there were no incidents to report.

b. On 12/2/15 at 0935 hours, ST 7 was interviewed regarding the use of IUSS in the LH campus OR Main substerile area. ST 7 stated he was provided IUSS training upon hire.

ST 7 stated there were four programmed autoclaves in LH campus OR for IUSS. ST 7 stated Autoclave #2 was utilized for ORs 1-4. When instruments needed to be processed by IUSS, the dirty or dropped instruments would be cleaned in the OR dirty utility room and were bought back to one of the OR autoclaves.

The ST stated the instruments were placed in a mesh instrument tray. When the IUSS was completed, the ST would walk out the OR, pass through a door going to substerile area, remove the instrument from the autoclave, and return to the sterile field in the OR.

The ST stated IUSS was utilized when there was no other substitute for that instrument, the vendor of the instrument company did not bring the instrument into the hospital on time, or if in the middle of the case the instrument was dropped and surgeon could not wait for another instrument to come as the vender was not close by.

ST 7 stated the staff who initiated the IUSS would sign on the document as the "Reader's" name. If the IUSS load had a biological indicator run with the load, the circulating RN would read the result of the BI and document the result on the log sheet. ST 7 stated sometimes the instrument was used for the patient before the BI result was read and was confirmed OK for use because the time was limited.

ST 7 stated the four autoclaves were programmed for 1-4 cycles. Cycle one and four were the same: prevac for four minutes, no dry time. ST 7 stated he did not change the parameter of the autoclaves. ST 7 stated the maintenance of the autoclaves was done by the SPD staff. The OR STs only used the autoclaves in the OR.

On 12/2/15 at 1135 hours, the SPD Interim Manager stated the SPD staff did not maintain the autoclaves in OR; the OR staff were responsible for the cleaning and maintenance of the four autoclaves.

On 12/2/15 at 1030 hours, the LH campus OR autoclaves #3 and #4 were observed with the Executive Director Surgical Services. Two "Guard" IUSS containers were observed ready for use. According to the Director those containers were used for long distance travel of instruments sterilized using IUSS.

On 12/2/15 at 1135 hours, during an interview with RN P and the Executive Director Surgical Services, a document was provided showing a total of 1208 surgical procedures were performed at the LH campus OR from September to November 2015. The Executive Director stated the RNs and STs performed IUSS in the OR and staff kept all the sterilization records in the OR.

RN P stated in the past the OR had a secretary to collect all the sterilization records for trending & tracking the compliance performance for IUSS. The result was a percentage statistic number. The LH campus OR did not analyze identified non-compliance. RN P stated the secretary went on a medical leave and currently an RN was doing this job; however, they were behind in collecting the information on the IUSS records for about two months. RN P stated if there was an identified issue, that issue would be discussed with the OR staff in staff meetings.

Review of the SPD Notes for 9/16/15, showed one issue identified was the instrument tray wrappers "were getting torn. Still Occurring." The meeting note showed no discussion for solving this issue.

On 12/2/15, review of the Autoclave Usage Documentation forms (a form used when IUSS was performed) for September, October, and November 2015 showed:

- Documentation six instrumentation tray wrappers were not intact and IUSS was required on 9/8, 9/17, 9/17, 9/25, 11/4, and 11/5/15.

- In the area to document if the IUSS was for an implantable item, the area was left blank for 9/01, 9/02, 9/04, 9/08, 9/21, 9/24, 9/25, 10/06, 10/26, 10/23, 11/05/15.

- In the area to document the reason for IUSS, the area was left blank for 10/09 and 10/28/15.

- In the area to document the type of item sterilized, the area was blank for 8/10, 10/06, 10/13, 10/28, 10/9/15.

- In the area to document the patient's information, the area was blank for 9/25, 10/6, 10/12, 11/5 and 11/11/15.

- Round forceps were IUSS on 10/31 and 11/1/15, with no documentation to show the reason this tray was not able to be sterilized in SPD for the full cycle.

- A cysto tray was been sterilized by IUSS on 10/23/15. The printout of the sterilization time was four minutes. However, review of the manufacturer's recommendations showed five minutes were required.

Continued review of the IUSS Autoclave Usage Documentation forms showed documentation dated 11/11/15, a load of Total Knee instruments were sterilized by IUSS and were utilized for a patient's surgery. The specific manufacturer of the instruments was not documented. There was no method for verifying the proper sterilized time and dry time for this load as per the manufacturer.

Review of a printout of information of a "Zimmer" Orthopaedic device showed the sterilization guidelines required a minimum of 30 minutes for dry time and an additional 30 minutes for cool time. Because of the lack of information documented of the manufacturer of the instrument, there was no way to verify the load was sterilized properly by manufacturer's instructions.

Continued review of the IUSS Autoclave Usage Documentation forms showed surgical items were processed by IUSS for four minutes, no dry time, instead of a full cycle sterilization in the SPD. The documented reason for use of IUSS was documented as either "unsterile" and/or "used for the prior surgery." There was no documentation to show other alternative actions were taken prior to using IUSS to sterilize the instruments. There was no documented evidence of an assessment of there was a sufficient quantity of instruments by the Surgical Department to improve patient quality of care. For example:

- A Femoral Impactor instrument was documented sterilized by IUSS on 9/1, 9/15, 9/29, 10/6, 10/28, 11/3, 11/17 ( two times), and 11/18/15. The reason for Flash was documented as "unsterile," instrument used in a prior case. There was no documented evidence to show the hospital was tracking the reasons IUSS was used for determining the sufficient of the surgical instrument for patient needs.

- One physician's individual tray was sterilized on 9/16 and 9/18/15. The documentation was not specific the reason for this tray was no able to be sterile in SPD for the full cycle.

- Documentation showed a hip extra (an instrumentation utilized for knee joint surgery) was IUSS twice on 9/22/15, because of use on a previous patient.

Further review of the IUSS Instrument Tracking form for September 2015, and the Autoclave Usage Documentation Form for September 2015 showed IUSS loads were performed on 9/8 and 9/17/15, for Autoclave 1 and on 9/1, 9/12, and 9/25/15, for Autoclave 2. However, these IUSS loads were not listed on the IUSS Instrument Tracking log for September 2015.

On 12/3/15 at 1500 hours, the Executive Director Quality Improvement was informed the findings.

On 12/2/15, the hospital provided competency documentation for "IUSS" for six LH campus OR staff. All six staff were checked off for: parameters, cycle, indicators, biological, form used, times and proper placement. For one of six staff, the sign-off initials of the evaluator was blank. According to the Executive Director Surgical Services, the form was an evaluation of the competency of staff performing IUSS. However, there was no explanation given for the use or the purpose of the form.

On 12/3/15 at 1510 hours, the IP Program Manager was interviewed regarding IUSS. According to the Manager, the hospital had a P&P IC-224 revised on 10/14. The Manager stated the hospital should implement this P&P for IUSS in the OR at the LH and SC campuses. The Manager stated he was not aware there was another P&P developed and implemented by Surgical Services for IUSS. The IP Manger stated there should be only one P&P from the IC department to oversee the hospital's IUSS process.

b. A tour of the surgical area at the SC campus was conducted on 11/30/15 at 0910 hours, accompanied by the OR Manager and ST 2. Sterilizer 1 was observed located in the OR Hall. A sheet of paper posted on the sterilizer dated 11/18/15, showed the sterilizer was out of service. The OR Manager stated the sterilizer was used for IUSS, or flash sterilization.

ST 2 stated he ran a biological test for an IUSS load performed for an implantable item when Sterilizer 1 was used; however, ST 2 stated he did not run a biological test daily or when IUSS was performed for items that would not be implanted.

Review of the IUSS Statistics for the SC Campus dated from September to November 2015 showed 11 loads of IUSS were performed at the SC campus.

During an interview and concurrent document review with ST 3 on 11/30/15 at 0945 hours, ST 3 stated a biological test was not performed for Sterilizer 1 daily and/or when an IUSS was performed for items that would not be implanted for a patient. A biological test would be performed when an IUSS load was performed on implantable items.

During an interview and documentation review with the OR Manager on 11/30/15 at 1400 hours, the Manager confirmed the hospital's P&P was not implemented when biological tests were not performed for Sterilizer 1 daily and for non-implantable items.

c. Review of the Autoclave Usage Documentation Form showed one IUSS load was performed for Patient 21 on 9/6/15 at the SC campus OR. Further review showed the following:

* The load was started on 9/6/15 at 1835 hours.

* A box was checked "unsterile" to indicate the reason flash autoclave section was used.

* The Instruments/trays/implant section showed the item was "3.5 tibial plateau plates."

* The box for "YES" was checked for chemical indicator.

* The section to indicate sterilization parameters met was left blank.

* A box for "YES" was checked to indicate this was an implantable item.

- The sections for time in and time out of the incubator were left blank.

- The section of "ATTEST" (a biological test) showed the "LOT#" section was 2017-04 AR. However, the section for results was left blank.

- The section for "CONTROL" (a control test) was left blank.

* The section for the reader's name and the date was left blank.

During an interview and concurrent document review with the SC OR Manager on 11/30/15 at 0910 hours, the OR Manager confirmed IUSS of the above implantable was performed for Patient 21; however, there was no documented evidence to show a biological test was performed for the IUSS load containing implantable items as per hospital's P&P.

d. Review of the Autoclave Usage Documentation Form showed an IUSS load of "3.5 tibial plateau plates," an implantable item, was performed for Patient 21 on 9/6/15. The reason for reason for flash autoclave was "unsterile." There was no documented evidence to show a biological test was performed for this IUSS load.

Review of Patient 21's medical record was initiated on 12/1/15. The patient was admitted to the hospital on 9/6/15 at 1311 hours, and was discharged on 9/8/15 at 1400 hours. Patient 21 had a surgery on 9/6/15. The surgery started at 1835 hours and ended at 2007 hours. A 3.5 mm locking plateau plate was implanted during the procedure.

Review of the Autoclave Usage Documentation Form (a form used when an IUSS load was performed) showed an implantable item was sterilized for Patient 21 on 9/6/16. The form showed the reason for Flash Autoclave was "unsterile."

An interview and concurrent medical record review was conducted with RN K and the Interim Manager SPD on 12/1/15 at 1500 hours. The Interim Manager SPD stated the 3.5 mm tibial plateau plates documented on the Autoclave Usage Documentation Form was implanted in Patient 21 during the surgery.

e. Review of the Autoclave Usage Documentation Form showed one IUSS load of "Synthes distal radius plate," an implantable item, was performed for Patient 20 on 9/18/15. The reason for reason for flash autoclave was "Dropped/No replacement." The IUSS load was started at 1535 hours. A biological test was placed in incubator at 1800 hours, and was out of incubator at 2100 hours. The result of the biological test was negative.

Review of Patient 20's medical record was initiated on 12/1/15. The patient was admitted to the hospital on 9/18/15 at 1348 hours, and was discharged on 9/19/15 at 1120 hours. Patient 20 had a surgery on 9/18/15. The surgery started at 1624 hours and ended at 1740 hours. A Synthes plate or a radial plate was implanted for the patient during the surgery.

The result biological test was out of incubator on 9/18/15 at 2100 hours, after the end Patient 20's surgery at 1740 hours.

During an interview with the Executive Director Quality Improvement on 12/2/15 at 1450 hours, the Director stated no reports were filed to notify her department for Patients 20 and 21.

f. Review of the Sterilization Sterility Assurance revised 7/13, showed the following daily sterility monitoring protocols included:

- Test each sterilizer and each cycle to be used (vacuum assisted, gravity, flash steam sterilization).

- Perform steam biological indicator with companion chemical indicator for wrapped loads, for rigid container load, for unwrapped (flash) loads. If a sterilizer is designed and to be used for multiple types of cycles (prevaccuum, gravity, flash in steam sterilizer) then each sterilizer mode must be tested.

A tour of the surgical area at the SC campus was conducted on 11/30/15 at 0910 hours, accompanied by the OR Manager and ST 2. The OR Manager stated Sterilizer 1 was used for IUSS until it was unable to use about two weeks ago. Sterilizer 2 located in the SPD, was reset to run IUSS cycles as needed while Sterilizer 1 was out of service.

The OR Manager and ST 2 were asked about the frequency of biological testing for sterilizers. ST 2 stated biological tests would be performed for every load for Sterilizer 2.

On 11/30/15 at 0945 hours, ST 3 was asked about the frequency of biological tests for Sterilizer 2. The ST stated biological test would be performed for every load.

During an follow-up interview and concurrent document review with the OR Manager and ST 3 on 11/30/15 at 1400 hours, ST 3 stated a biological test would be performed for every load for Sterilizer 2; however, a biological test was not performed on IUSS mode daily and there was no IUSS load run by using Sterilizer 2 as yet. The OR Manager confirmed biological tests were not performed daily for each mode or each cycle for Sterilizer 2 as per hospital's P&P.

On 12/2/15 at 1545 hours, the survey team met with the Executive Director Quality Improvement, Clinical Risk Manager, CNO, Executive Director Surgical Services, and the IP Program Manager to share their concerns IUSS was used frequently in the ORs on the LH and SC campuses without a system in place for monitoring and tracking, staff did not have documented competencies and staff were not following the hospital's P&P and AORN's recommendations.

On 12/4/15 at 1330 hours, the hospital provided documentation to show an Immediate Action Plan- IUSS was developed and implemented to include revision of the hospital's two P&Ps for the use of IUSS to ensure only trained staff would do IUSS; the manufacturer's instructions would be referenced and a process for quality monitoring and tracking of implants would be instituted by IP.

The plan showed the training of staff on the SC and LH campuses was initiated immediately; staff would not perform IUSS until educated and their competencies were validated.

2. On 10/29/15 at 1335 hours, the LH campus OR was toured. During a confidential interview, an OR staff stated approximately four incidents of unclean surgical instruments found on the sterile field had occurred in the past several months.

a. On 10/29/15 at 1503 hours, review of hospital documents with the Clinical Risk Manager showed on 4/23/15, a knife handle with a scalpel blade still loaded from a previous procedure was found in a sterile tray.

On 11/2/15 at 1620 hours, during an interview, the Executive Director Surgical Services was asked how she investigated the incident. The Director stated she did not interview staff, note the OR room number, or review the instrumentation list to identify the SPD staff who assembled the instrument tray.

b. On 11/2/15 at 1620 hours, during an interview, the Executive Director Surgical Services stated the OR staff reported to her an incident that occurred during a surgical case. The scrub tech noted a drill bit remained in the drill from a previous surgery.

The Director stated evidently the scrub tech during the previous surgery did not remove the drill bit from the drill and dispose of it. However, the Director stated she did not document this report from staf

Based on interview and medical record review, the hospital failed to ensure the H&Ps for two of four sampled patients (Patients 27 and 28) receiving surgical services at the SC campus were completed per the General Medical Staff Rules and Regulations. These failures could create the risk of substandard healthcare outcomes to these patients.

Findings:

Review of the hospital's General Medical Staff Rules and Regulations updated 3/15 showed the followings:

* A comprehensive H&P examination shall be completed by a physician within 24 hours of all inpatient admissions. A complete H&P examination shall include the past medical history and surgical history.

* The admitting/attending physician shall perform a comprehensive H&P examination prior to, but not more than 30 days before an admission, with an update performed by a member of the medical staff with H&P privileges, completed on the day of and prior to the surgery. This is required on all inpatient services and surgeries.

* Non inpatient services (which include outpatient operative and invasive procedure as well as observation patients) require a history and physical. A H&P examination performed by a physician who is not a member of the medical staff may be accepted if all required elements of the H&P are addressed and the H&P is dated within 30 days prior to the surgery or procedure and is cosigned/dated by the primary surgeon/practitioner specialist, who becomes the owner of the H&P. The practitioner performing the surgery or procedure must also perform the H&P update prior to the surgery or procedure.

1. Review of Patient 27's medical record was initiated on 12/3/15. The patient was admitted to the hospital for a surgery on 11/25/15 at 0837 hours, and was discharged on 11/28/15 at 1545 hours. The patient had a history of hypertension (high blood pressure), a past MI, CAD, and angina.

a. Review of Patient 27's H&P dictated on 11/24/15 at 1611 hours, and signed by the physician on 11/25/15 at 0711 hours, showed the section for past medical history showed Patient 27 had previous shoulder and wrist surgery; the patient denied any cancers, blood pressure problems, asthma, or diabetes.

The H&P did not address the patient's history of hypertension, past MI, CAD, and angina.

b. Review of the H&P showed an updated H&P was noted and filed on 11/25/15 at 1012 hours. The form showed the H&P was reviewed; the patient was assessed; and no change had occurred in the patient's condition since the H&P was completed.

However, there was no documentation to show the physician listed Patient 27's medical history in the updated H&P.

During an interview and concurrent medical record review with RN K on 12/3/15 at 1000 hours, the RN confirmed the above findings.

2. Review of Patient 28's medical record was initiated on 12/3/15. The patient was admitted to the hospital for a procedure on 11/23/15 at 0607 hours, and was discharged on 11/23/15 at 0915 hours. The patient was in the procedure room at 0750 hours and out of the procedure room at 0818 hours.

Review of the Encounter dated 11/10/15, showed Patient 28 visited the physician on 11/10/15. The plan was "endoscopy risks discussed."

Review of the H&P showed an updated H&P was noted and filed on 11/23/15 at 0825 hours. The form showed the H&P was reviewed; the patient was assessed; and no change had occurred in the patient's condition since the H&P was completed. The risks and benefits of chosen anesthetic/sedation were discussed with the patient.

Review of the H&P dated 11/23/15 at 0825 hours, showed the H&P was updated to show the H&P was reviewed; the patient was assessed; and no change had occurred in the patient's condition since the H&P was completed. The risks and benefits of the chosen anesthetic/sedation were discussed with the patient. However, the above updated H&P was noted by the physician on 11/23/15 at 0825 hours, after the procedure completed for Patient 28 on 11/23/15.

Review of the Intraop (intra-operative) Administered Meds (medications) form showed Patient 28 received 25 mcg of fentanyl (a pain medication) and 1 mg of Versed (a sedative) at 0805, 0807, and 0809 hours.

During an interview and concurrent review of Patient 28's medical record with the Executive Director Quality Improvement on 12/4/15 at 1030 hours, the Director confirmed the physician documented an updated H&P on 11/23/15 at 0825 hours, after the procedure was completed for Patient 28.

Based on interview and medical record review, the hospital failed to ensure the hospital's P&P was implemented related to an informed consent not being fully written for one of four sampled patients reviewed (Patient 28) receiving surgical services at the SC campus. This could result in the patient's lack of knowledge when making decisions about their plan of care.

Findings:

Review of the hospital's P&P titled Consent: Documentation of Informed revised 7/12 showed the following:

* The physician shall place a note on the chart indicating his/her discussion of the procedure and Informed Consent process with the patient or patient's representative as deemed appropriate. This documentation may include in the History and Physical, Progress Notes, or in the Physician Documentation section of the Verification.

* Documentation of the Verification is the responsibility of the hospital's staff member assigned to the patient. Prior to obtaining the signatures on the Verification the following must be completed:

- The name of the patient.

- The first and last name of the physician(s) performing the procedure(s)

- The name of the procedure(s) to be performed written out fully.

- The patient should understand that anesthesia may be involved.

Review of Patient 28's medical record was initiated on 12/3/15. The patient was admitted to the hospital for a procedure on 11/23/15 at 0607 hours, and was discharged on 11/23/15 at 0915 hours. The patient was in the procedure room at 0750 hours and out of the procedure room at 0818 hours.

Review of the physician's order dated 11/17/15 at 0913 hours, signed by the physician on 11/23/15 at 0828 hours, showed to consent for EGD with possible biopsy (sampling of cells or tissues for examination), possible dilation (to dilate or stretch, a narrowed area of the swallowing tube), possible banding (apply pressure and constrict, or tie off, parts of the body), possible control of hemorrhage (bleeding), possible injection therapy, polypectomy (removal of the polyp, or an abnormal growth of tissue projecting the body), foreign body removal and/or treatment of lesion with sedation."

Review of the Verification of Consent and Authorization for Surgery, Obstetrical, Special Diagnostic, or Therapeutic Procedure form showed Patient 28 signed the consent for "Esophagogastroduodenoscopy with possible biopsy and/or dilation, possible banding, possible control of hemorrhage, possible injection therapy, polypectomy, foreign body removal and/or treatment of lesion" on 11/23/14 at 0730 hours. The physician signed the same consent form on 11/23/15 at 0745 hours.

The name of the procedure on the Verification of Consent and Authorization for Surgery, Obstetrical, Special Diagnostic, or Therapeutic Procedure form did not include the use of "sedation" was not written fully as per the physician's order.
During an interview and concurrent review of Patient 28's medical record with the Executive Director Quality Improvement on 12/4/15 at 1030 hours, the Director confirmed the informed consent form signed by Patient 28 was not fully written to reflect the physician's order.