HospitalInspections.org

This Condition is not met as evidenced by:

Based on review of clinical records, review of hospital policies and procedures, hospital documentation and interviews with hospital and vendor personnel, the Governing Body failed to ensure that services offered and provided met the Conditions of Participation for Patient Rights, QAPI (Quality Assessment and Performance Improvement), Nursing Services, and Infection Control as evidenced by the following:


1. The Governing Body failed to ensure that the medical staff was accountable to the governing body for the quality of care provided to patients. Although there were concerns identified between March 2014 and December 2014 regarding the cleaning/reprocessing of duodenoscopes used in the hospital to perform Endoscopic Retrograde Cholangiopancreatography (ERCP) procedures on 389 patients which exposed the patients to Extended Spectrum Beta-Lactamase E-Coli (ESBL) infection, the medical staff failed to document (in meeting notes or other forum) that 389 patients were exposed to ESBL, failed to document (in meeting notes or other forum) that 12 of the 389 patients were diagnosed with ESBL infections, and failed to document (in meeting notes or other forum) that corrective measures were initiated to prevent further patient exposure to ESBL.

Please see A49


2. The Governing Body failed to ensure that patient's rights were protected and that care was provided in a safe environment for patients who had Endoscopic Retrograde Cholangiopancreatography (ERCP) procedures between 10/1/13 and 12/12/14 where duodenoscopes were used. It was identified on 3/19/14 that patients had been exposed to Extended Spectrum Beta-Lactamase E-Coli (ESBL) infection associated with the use of duodenoscopes. Hospital staff failed to properly monitor or observe the cleaning and reprocessing of the duodenoscopes between 10/1/13 and 12/12/14. The hospital determined that a total of 389 patients were exposed to ESBL infection associated with the use of duodenoscopes, with 12 of the 389 patients being diagnosed with an ESBL infection following ERCP procedures.

Through observations and interviews (conducted between 3/11/15 and 4/27/15) with hospital staff and manufacturer representatives it was identified that the duodenoscope reprocessing procedures used by hospital staff did not follow manufacturer guidelines.

Please see A115 and A144, with additional deficiencies at A171, A173, A179 and A205



3. The Governing Body failed to ensure that the hospital QAPI department was actively engaged in the patient exposure to Extended Spectrum Beta-Lactamase E-Coli (ESBL) infections associated with the cleaning/reprocessing of duodenoscopes used for Endoscopic Retrograde Cholangiopancreatography (ERCP) procedures between 10/1/13 and 12/12/14. In addition, QAPI failed to ensure that any QAPI involvement regarding this exposure was documented and reported to the Governing Body.


Please see A263 and A286

4. The Governing Body failed to ensure appropriate nursing supervision and oversight of staff who were reprocessing duodenoscopes to ensure that manufacturer recommendations were followed.


Please see A395


5. The Governing Body failed to ensure that the Infection Control Department was actively engaged in surveillance activities related to duodenoscopes used for Endoscopic Retrograde Cholangiopancreatography (ERCP) procedures. The hospital determined that between 10/1/13 and 12/12/14, a total of 389 patients were exposed to ESBL infection associated with the use of duodenoscopes, and 12 of the 389 patients were diagnosed with an ESBL infection following ERCP procedures.

Through observations and interviews (conducted between 3/11/15 and 4/27/15) with hospital staff and manufacturer representatives it was identified that the duodenoscope reprocessing procedures used by hospital staff did not follow manufacturer guidelines. The hospital identified that the infection control staff reviewed duodenoscope reprocessing (3/19/14), reviewed the disinfectant process (3/21/14), reviewed the ERCP cleaning process (3/25/14), and confirmed that reprocessing occurred timely (4/17/14). However, interviews with infection control staff identified that they had not directly observed the entire reprocessing procedure. Through observations on 3/12/15 and interviews (conducted between 3/11/15 and 4/27/15) with hospital staff and manufacturer representatives it was identified that the current duodenoscope reprocessing procedures used by hospital staff did not follow manufacturer guidelines.


Please see A747, A749 and A756

Based on review of hospital documentation, review of policies and procedures and interviews with hospital personnel, the medical staff failed to ensure accountability to the governing body for the quality of care provided to patients. Although there were identified concerns regarding the cleaning/reprocessing of duodenoscopes used in the hospital which exposed patients to Extended Spectrum Beta-Lactamase E-Coli (ESBL) infection, the medical staff failed to document that the Governing Body was informed of the patient exposures and subsequent measures that were taken. The findings include:

a. Review of the hospital's infection control documentation, including the hospital's timeline of events identified that in late February/early March 2014, Infection Control Nurse #1 noted an increase in ESBL infection rates. The commonality was patients who had Endoscopic Retrograde Cholangiopancreatography (ERCP) procedures using the same 180v duodenoscope (#31) between 10/1/13 and 3/19/14. It was identified on 3/19/14 that 327 patients had been exposed to Extended Spectrum Beta-Lactamase E-Coli (ESBL) associated with the use of duodenoscope #31 and duodenoscope #31 was removed from service. Between 8/15/13 and 12/12/14, a total of 389 patients were exposed to ESBL, with a total of 12 patients diagnosed with an ESBL infection.

On 5/6/14, the duodenoscopes were returned to the manufacturer for repair and gas sterilization, and the hospital was supplied with loaner duodenoscopes from the manufacturer.

Review of the Governing Body minutes dated August 2014-March 2015 failed to identify that concerns related to the duodenoscope ESBL infections were documented until 2/25/15. On 2/25/15, MD #1 reported to the Infection Control Council/Committee the correlation between the use of duodenoscopes and ESBL infections.

b. Interview with the hospital's Infectious Disease physician (MD #1) on 3/17/15 identified that he/she was aware of the ESBL infections and when the gene sequencing results were received (10/20/14) and identified that the ESBL infections were related, MD #1 had verbal conversations with the Vice President of Medical Affairs and the President of the hospital, however there was no documentation in the Medical Executive Committee and/or Governing Body minutes regarding the ESBL infections with relation to the duodenoscopes.

This Condition is not met as evidenced by:


Based on review of clinical records, review of hospital policies and procedures, hospital documentation, observations and interviews with hospital personnel, the hospital failed to ensure that patient's rights were protected and that care was provided in a safe environment for patients who had Endoscopic Retrograde Cholangiopancreatography (ERCP) procedures between 10/1/13 and 12/12/14 in which duodenoscopes were used. It was identified on 3/19/14 that patients had been exposed to Extended Spectrum Beta-Lactamase E-Coli (ESBL) infection associated with the use of duodenoscopes. Hospital staff failed to properly monitor or observe the cleaning and reprocessing of the duodenoscopes between 10/1/13 and 12/12/14. The hospital determined that a total of 389 patients were exposed to ESBL infection associated with the use of duodenoscopes, and 12 patients were diagnosed with an ESBL infection.
Through observations (3/12/15) and interviews with hospital staff and manufacturer representatives it was identified that the duodenoscope reprocessing procedures used by hospital staff did not follow manufacturer guidelines.


Please refer to A144

Based on clinical record reviews, review of hospital policies and procedures and interviews with hospital and manufacturer personnel, the hospital failed to ensure that patient care was provided in a safe environment for 389 patients who had Endoscopic Retrograde Cholangiopancreatography (ERCP) procedures between 10/1/13 and 12/12/14 and were exposed to Extended Spectrum Beta-Lactamase E-Coli (ESBL) infection associated with the use of duodenoscopes, with 12 patients testing positive for ESBL infections following their ERCP procedures.


The findings include:



a. Review of clinical records identified that Patients #1 through #12 underwent one or more ERCP procedures between 12/23/13 and 4/2/14. Patients #1-#12
were subsequently diagnosed with ESBL infections associated with the use of duodenoscopes used during their ERCP procedures.

b. During tour of the GI Suite on 3/12/15 at 11:00 AM, it was observed that multiple duodenoscopes were dried with a washcloth and not dried with a lint-free cloth or pad prior to placing the scope in the AER (automated endoscope reprocessor). When the duodenoscope was removed from the AER, the scope was placed in a clean room to be dried and hung for storage. It was again observed that the scopes were being dried with a washcloth and not a lint-free cloth/pad in accordance with manufacturers instructions. Review of hospital documentation identified that the hospital did not have a policy that directed how staff were to reprocess duodenoscopes to include the precleaning and disinfection of the scopes, drying of the scopes, the AER processing, and drying prior to storage.

c. Review of manufacturers guidelines identified to dry the external surfaces of the endoscope, the channel plug, and the injection tube by wiping with a clean, lint-free cloth. Inspect all items for residual debris. Should any debris remain, repeat the entire cleaning procedure until all debris is removed. Thoroughly dry the forceps elevator recess after cleaning and disinfection by your AER. Insufficient drying may cause the bacterial proliferation and pose an infection control risk. The manufacturers instructions identified that before storage of a high-level disinfected endoscope, thoroughly dry all parts of the endoscope (especially all internal lumens, the distal end, lenses and electrical contacts) and all accessories.

d. Review of the AER manufacturer guidelines identified that because the internal channels of flexible endoscopes retain water that may contain some level of waterborne microorganisms, proper drying and storage of the endoscope is required.

e. Interview with Nursing Director #1 on 3/12/15 identified that staff had been using washcloths instead of lint-free cloths/pads to dry the duodenoscopes and were not aware that they had to use a lint-free cloth/pad.

f. Interview with the Clinical Coordinator (RN #1) on 3/17/15 identified that he/she had reviewed the annual competency check lists with the GI technicians in June 2014 and used the competency checklist to make observations of staff reprocessing the scopes. RN#1 identfied that washcloths had been used to dry scopes prior to storage since 2005 and did not know that a lint-free cloth was required.

g. Interviews with Representatives #1 and #2 from the duodenoscope manufacturer on 3/17/15 identified that the correct drying process of duodenoscopes is to dry the external surface with a lint-free cloth and if any debris is remaining, the cleaning procedure is repeated until all debris is removed. After being removed from the AER, the endoscope would need to be dried with a lint-free cloth prior to storage. In addition, further interview identified that using a washcloth to dry the duodenoscope can cause scratches, clogging and problems with bacteria.

h. Review of Society of Gastroenterology Nurses and Associates (SGNA) guidelines identified that drying the endoscope with a soft, clean, lint-free towel after every reprocessing cycle, both between patient procedures and before storage is a requisite practice crucial to the prevention of bacterial transmission and nosocomial infection. Drying is as important to the prevention of disease transmission and nosocomial infection as cleaning and high level disinfection.

i. On 3/16/15, an immediate action plan regarding the drying process for the duodenoscopes was developed and implemented by the hospital. The plan identified that lint-free cloths were to be used effective 3/16/15, revision of the competency check list /tool, retraining, and daily observational audits would be conducted.

Based on a review of clinical records, staff interviews, and hospital policies and procedures, for one of two patients' reviewed for restraints (Patient #15), the hospital failed to obtain a physician's order for the use of restraints. The findings included:

1. Review of the clinical record identified Patient #15 was admitted to the hospital on 2/20/15 with diagnoses that included a small bowel obstruction and substance abuse withdrawal. Physician's orders dated 3/8/15 at 9:48 PM directed bilateral ankle restraints due to violent, aggressive and delirious behavior. Review of the nursing assessment intervention flow sheet identified on 3/8/15 from 9:55 PM until 11:00 PM, four side rails were utilized in addition to bilateral ankle restraints absent a physician's order or the rational for the use of more than one restraint. Interview with RN #1 on 3/18/15 at 1:00 PM identified an order should have been obtained for the use of the second restraint (side rails) with justification for its use and did not.

2. Further review of the clinical record identified Patient #15 required the use of restraints on 3/9/15 at 3:46 AM. Physician orders directed bilateral wrist restraints and ankle restraints for violent, aggressive and delirious behavior. Review of the nursing assessment intervention flow sheet identified on 3/9/15 from 3:46 AM until 9:45 AM bilateral wrist restraints were utilized in addition to four side rails absent a physician's order or the rational for the use of more than one restraint. Interview with RN #1 on 3/18/15 at 1:05 PM identified an order should have been obtained for the use of the second restraint (side rails) with justification for its use and did not. The hospital restraint policy directed in part when a restraint is necessary, it is clinically justified, used as a last resort and when other interventions have been determined to be ineffective. The physician or licensed practitioner must be notified immediately and an order must be obtained within one hour.

Based on a review of clinical records, staff interviews, and hospital policies and procedures, for one of two patients' reviewed for restraints (Patient #15), the hospital failed to obtain a physician's order for the renewal of the restraint. The finding included:
Review of the clinical record identified Patient #15 was admitted to the hospital on 2/20/15 with diagnoses that included a small bowel obstruction and substance abuse withdrawal. Physician orders dated 3/9/15 at 3:48 AM directed bilateral wrist restraints and ankle restraints for violent, aggressive and delirious behavior. The restraint was discontinued at 9:45 AM. The record failed to reflect that a physician's order was obtained to continue wrist and ankle restraints within the four hour stipulated time frame in accordance with the hospital policy. The hospital restraint policy directed in part when the original order is about to expire, the registered nurse or licensed practitioner re-evaluates the patient, telephones the physician and, if required, requests that the original order be renewed in four hours.

Based on a review of clinical records, staff interviews, and hospital policies and procedures, for one of two patients' reviewed for restraints (Patient #15), the hospital failed to ensure the patient was seen within one hour after the initiation of the intervention. The finding included:
Review of the clinical record identified Patient #15 was admitted to the hospital on 2/20/15 with diagnoses that included small bowel obstruction and substance abuse withdrawal. Physician orders dated 3/9/15 at 3:48 AM directed bilateral wrist restraints and ankle restraints for violent, aggressive and delirious behavior. The restraint was discontinued at 9:45 AM. Interview and review of the physician's progress notes with RN #1 on 3/18/15 at 1:15 PM identified the physician did not conduct a face to face evaluation of Patient #15 until 5:50 AM two hours after the initiation of the restraint. RN #1 indicated a face to face evaluation should have been conducted by the physician within one hour of the initiation of the restraint in accordance with the hospital policy. The hospital restraint policy directed in part that the physician and/or licensed practitioner must see the patient face-to-face within one hour, evaluate, and document the patient's immediate situation, reaction to the intervention, medical and behavioral condition and need to continue or terminate the restraint.

Based on a review of clinical records, staff interviews, and hospital policies and procedures, for one of two patients' reviewed for restraints (Patient #15), the hospital failed to assess and/or monitor the patient in accordance with the hospital's policies and procedures. The finding included:
Review of the clinical record identified Patient #15 was admitted to the hospital on 2/20/15 with diagnoses that included a small bowel obstruction and substance abuse withdrawal. Physician orders dated 3/9/15 at 3:48 AM directed bilateral wrist restraints and ankle restraints for violent, aggressive, and delirious behavior. The restraint was discontinued at 9:45 AM. Interview and review of the nursing assessment intervention flow sheet with RN #1 on 3/18/15 at 1:20 PM identified nursing failed to monitor Patient #15 while in restraints on 3/9/14 at 5:48 AM and 7:48 AM in accordance with the hospital policy. RN #1 indicated nursing assessments should have been conducted every two hours while Patient #15 was in restraints. The hospital restraint policy directed in part that each patient would be assessed every two hours for proper application and release from restraint (one alternating limb), in addition would assess for signs of injury, physical and psychological status, vital signs, hygiene, food and fluid needs, peripheral circulation, adequate movement, skin integrity, mental status, the ability to perceive touch in restrained extremities and the need for less restrictive interactions and/or discontinuation of restraints. The policy further directed the assessment would be documented in the clinical record.

This Condition is not met as evidenced by:

Based on review of hospital documentation, and interviews with hospital personnel, the hospital failed to ensure an effective hospital wide data driven quality assurance and performance improvement program that measured, analyzed, and tracked indicators related to improved health outcomes, when the hospital became aware of problems with the cleaning/reprocessing of medical equipment used on 389 patients that led to 12 patients being infected with Extended Spectrum Beta-Lactamase (ESBL).


Please refer to A286

Based on review of hospital documentation and interviews with hospital personnel, the hospital failed to ensure that their quality assurance and performance improvement (QAPI) program/committee was actively engaged in the exposure and subsequent infections of patients related to the cleaning/reprocessing of medical equipment. The findings include:


a. Review of the hospital infection control data identified that in late February/early March 2014, Infection Control Nurse #1 noted an increase in ESBL infection rates. The commonality was patients who had Endoscopic Retrograde Cholangiopancreatography (ERCP) procedures using the same 180V duodenoscope (#31) between 10/1/13 and 5/6/14. The duodenoscope was removed from service. It was identified on 3/19/14 that 327 patients had been exposed to Extended Spectrum Beta-Lactamase E-Coli (ESBL) associated with the use of duodenoscope #31 with 12 patients being infected with ESBL. Between 5/6/14 and 12/12/14, 66 additional patients had the ERCP with no patients infected with ESBL.

b. Review of QAPI minutes from January 2014 to March 2015 failed to identify and document that that the hospital's QAPI was actively engaged in the identified exposure of the 389 patients to ESBL infections including the 12 patients diagnosed with ESBL

c. Interview with the Director of Quality and Risk Management on 3/16/15 identified that MD#1 had reported the concern regarding patients who contracted ESBL following ERCP procedures in October 2014 when final laboratory reports identified that gene sequencing identified that all 12 patients diagnosed with ESBL had the same ESBL organism.

d. During tour of the GI Suite on 3/12/15 at 11:00 AM, it was observed that multiple duodenoscopes were not dried with a lint-free cloth or pad prior to placing the scope in the AER (automated endoscope reprocessor). When the duodenoscope was removed from the AER, the scope was placed in a clean room to be dried and hung for storage. It was again observed that the scopes were being dried with a washcloth and not a lint-free cloth/pad. Review of hospital documentation identified that the hospital policy did not include the duodenoscope manufacturers directive to dry the scope with a lint-free cloth.

e. Review of documentation and interview with the Manufacturer Representative on 3/24/15 identified that hospital staff were not inserviced by the manufacturer prior to the use of 180v duodenoscopes in August 2013, because staff identified that the process was similar to current reprocessing all ready in place. In addition, on 5/19/14 the manufacturer representative and the Nurse Manager were onsite observing reprocessing of the 180v scopes. According to the manufacturers field service report, during the 5/19/14 visit there was a recommendation to use wall suction as well as a syringe to flush the forceps elevator. Documentation identified that the nurse manager was having the wall suction put back in the clean room. Further review and interview identified the manufacturer representatives returned to the hospital on 5/20/14, 5/22/14 and 5/27/14 re-inserviced and/or had a meeting with staff on the reprocessing procedure.

f. Interview with the Clinical Coordinator (RN #1) on 3/17/15 identified that he/she had reviewed the annual competency check lists with the GI technicians in June 2014 and used the competency checklist to make observations of staff reprocessing the scopes. RN#1 identfied that washcloths had been used to dry scopes prior to storage since 2005 and did not know that a lint-free cloth was required.

g. Interview with Nursing Director #1 on 3/16/15 identified that he/she had verbally reviewed the self assessment regarding the reprocessing of duodenoscopes with staff at their annual performance evaluation in 10/2014, however, no observations of staff conducting the reprocessing of endoscopes was completed.

h. Interview with Nursing Director #1 on 3/16/15 identified that he/she was aware of the 2/23/15 manufacturer analysis which identified that scope #32 had stains inside the biopsy channel walls which was a characteristic of inadequate reprocessing and insufficient pre-cleaning/brushing of the scopes biopsy channel. Nursing Director #1 identified that on 3/2/2015 the manufacturer representative was on-site to perform endoscope/duodenoscope reprocessing training and staff inservice.
A letter from the manufacturer dated 6/27/14 identified that scope #45 was inspected and found to have foreign material inside the air pipe and the endoscope failed leakage testing (which is a critical step in the reprocessing). A second letter was sent to the hospital on 9/23/14 and identified that duodenoscope #31 was inspected and found with dents on the distal end cover which contributed to the device failing an insulation test. In addition, there were deep scratches on the light guide lens which was likely the result of impact against another object. Further interview with Nursing Director #1 identified that he/she was not aware of manufacturer recommendations from the letters dated 6/27/14 and 9/23/14. However, interview with Infection Control Nurse #2 on 3/16/15 identified that he/she had received both letters from the manufacturer and communicated the manufacturer recommendations to Nursing Director #1. The recommendations identified improper reprocessing techniques may be a contributing factor to ESBL infections and to ensure that all individuals engaged in reprocessing follow all instructions in the reprocessing manual.

i. Interview with the Infection Control Nurse on 3/11/15 identified that the 180v duodenoscopes were put into service in August 2013. Further interview identified that education regarding the high level disinfection was provided by staff in 8/2013.

j. Review of the clinical records of twelve patient's (P#1-P#12) identified that each patient had one or more ERCP's between 12/23/13 and 4/2/14 and subsequently, all twelve were diagnosed with ESBL (Extended Spectrum Beta-Lactamase) infections associated with duodenoscopes used during the ERCP procedure.

This Condition is not met as evidenced by:


Based on review of clinical records, review of hospital policies and procedures, hospital documentation, observation, and interviews with staff and manufacturer representatives, the hospital failed to ensure that duodenoscopes/endoscopes were cleaned/reprocessed in accordance with manufacturer recommendations. and failed to ensure that processing staff had training and/or supervision in manufacturer's guidelines related to the drying of reprocessed duodenoscopes. Between 10/1/13 and 12/12/14, 389 patients were identified as having had ERCP procedures using duodenoscopes. Twelve patients (P#1-P#12) were diagnosed with ESBL (Extended Spectrum Beta-Lactamase) infection.

Please refer to A395

Based on review of clinical records, review of hospital policies and procedures, hospital documentation and interviews with hospital and manufacturer personnel, the hospital failed to ensure that the nursing department provided appropriate supervision of staff who were reprocessing duodenoscopes to ensure that manufacturer recommendations were followed. The findings include:

a. During tour of the GI Suite on 3/12/15 at 11:00 AM, it was observed that multiple duodenoscopes were dried with a washcloth and not dried with a lint-free cloth or pad in accordance with manufacturer instructions prior to placing the scope in the AER (automated endoscope reprocessor). When the duodenoscope was removed from the AER, the scope was placed in a clean room to be dried and hung for storage. It was again observed that the scopes were being dried with a washcloth and not a lint-free cloth/pad.

b. Review of documentation and interview with the Manufacturer Representative on 3/24/15 identified that hospital staff were not inserviced by the manufacturer prior to the use of 180v duodenoscopes because hospital staff identified that the process was similar to current reprocessing all ready in place. According to the manufacturers representive report, on 5/19/14 and 3/10/15, the manufacturer representative accompanied by the Nursing Director #1 was onsite observing reprocessing of the 180v scopes when reprocessing discrepancies were noted. According to the manufacturers field service report, during the 5/19/14 visit there was a recommendation to use wall suction as well as a syringe to flush the forceps elevator. Documentation identified that the nurse manager was having the wall suction put back in the clean room. Further review and interview identified the manufacturer representatives returned to the hospital on 5/20/14, 5/22/14 and 5/27/14 and re-inserviced and/or had a meeting with staff on the reprocessing procedure.

c. Interview with the Clinical Coordinator (RN #1) on 3/17/15 identified that he/she had reviewed the annual competency check lists with the GI technicians in June 2014 and used the competency checklist to make observations of staff reprocessing the scopes. RN#1 identified that washcloths had been used to dry scopes prior to storage since 2005 and did not know that a lint-free cloth was required.

d. Interview with Nursing Director #1 on 3/16/15 identified that he/she had verbally reviewed the self assessment regarding the reprocessing of duodenoscopes with staff at their annual performance evaluation in 10/2014, however, no observations of staff conducting the reprocessing of endoscopes was completed.

e. Interview with Nursing Director #1 on 3/16/15 identified that he/she was aware of the 2/23/15 manufacturer analysis which identified that scope #32 had stains inside the biopsy channel walls which was a characteristic of inadequate reprocessing and insufficient pre-cleaning/brushing of the scopes biopsy channel. Nursing Director #1 identified that on 3/2/2015 that the manufacturer representative was on-site to perform endoscope/duodenoscope reprocessing training and staff inservice.
A letter from the manufacturer dated 6/27/14 identified that scope #45 was inspected and found to have foreign material inside the air pipe and the endoscope failed leakage testing (which is a critical step in the reprocessing). A second letter was sent to the hospital on 9/23/14 and identified that duodenoscope #31 was inspected and found with dents on the distal end cover which contributed to the device failing an insulation test. In addition, there were deep scratches on the light guide lens which was likely the result of impact against another object. Further interview with Nursing Director #1 identified that he/she was not aware of manufacturer recommendations from the letters dated 6/27/14 and 9/23/14. However, interview with Infection Control Nurse #2 on 3/16/15 identified that he/she had received both letters from the manufacturer and communicated the manufacturer recommendations to Nursing Director #1. The recommendations identified improper reprocessing techniques may be a contributing factor to ESBL infections and to ensure that all individuals engaged in reprocessing follow all instructions in the reprocessing manual.

f. Interview with the Infection Control Nurse on 3/11/15 identified that the 180v duodenoscopes were put into service on 8/2013. Further interview identified that education regarding the high level disinfection was provided by staff in 8/2013.

g. Review of the clinical records of twelve patient's (P#1-P#12) identified that each patient had one or more ERCP's between 12/23/13 and 4/2/14 and subsequently, all twelve were diagnosed with ESBL (Extended Spectrum Beta-Lactamase) infections associated with duodenoscopes used during the ERCP procedure.

This Condition is not met as evidenced by:

Based on review of clinical records, review of facility policies and procedures, hospital documentation, observations and interviews with facility personnel, the Infection Control Department failed to ensure that the Infection Control Department was actively engaged in surveillance activities related to duodenoscopes used for Endoscopic Retrograde Cholangiopancreatography (ERCP) procedures. The hospital determined that a total of 389 patients were exposed to ESBL infection associated with the use of duodenoscopes, and 12 patients were diagnosed with an ESBL infection.


Please refer to A 749, A756

Based on review of clinical records, review of hospital policies and procedures, hospital documentation and interviews with hospital personnel, infection control staff failed provide surveillance and oversight regarding the reprocessing of duodenoscopes/endoscopes and failed to report to the infection control committee that 389 patients were exposed to Extended Spectrum Beta-Lactamase (ESBL) associated with duodenoscopes used in Endoscopic Retrograde Cholangiopancreatography (ERCP) procedures between 10/1/13 and 12/12/14 with 12 patients (P#1-#12) being diagnosed with ESBL infections. The findings include:



a. Review of hospital documentation dated 8/2013 identified that 180v duodenoscopes/endoscopes were put in service and education was provided at that time regarding high level disinfection by infection control personnel. However, the hospital failed to provide documentation of surveillance activities related to 180v duodenoscopes used for Endoscopic Retrograde Cholangiopancreatography (ERCP) procedures between 8/15/13 and 3/12/15.

b. Hospital Documentation (time line) identified that the infection control staff reviewed duodenoscope reprocessing (3/19/14), reviewed the disinfectant process (3/21/14), reviewed the ERCP cleaning process (3/25/14), and confirmed that reprocessing occurred timely (4/17/14). Through surveyor observations (3/12/15) and interviews with hospital staff and manufacturer representatives (conducted between 3/11/15 and 4/27/15) it was identified that the duodenoscope cleaning/reprocessing procedures used by hospital staff did not follow manufacturer guidelines. Interviews with infection control staff identified that they had not directly observed the entire reprocessing procedure.

c. During tour of the GI Suite on 3/12/15 at 11:00 AM, it was observed that multiple duodenoscopes were not dried with a lint-free cloth or pad prior to placing the scope in the AER (automated endoscope reprocessor). When the duodenoscope was removed from the AER, the scope was placed in a clean room to be dried and hung for storage. It was again observed that the scopes were being dried with a washcloth and not a lint-free cloth/pad. Review of hospital documentation identified that the hospital did not have a policy that directed how staff were to reprocess duodenoscopes to include the precleaning and disinfection of the scopes, drying of the scopes, the AER processing, and drying prior to storage.

d. Review of documentation and interview with the Manufacturer Representative on 3/24/15 identified that hospital staff were not inserviced by the manufacturer prior to the use of 180v duodenoscopes because staff identified that the process was similar to current reprocessing all ready in place. In addition, on 5/19/14, the manufacturer representatives and the Nurse Manager were onsite observing reprocessing of the 180v scopes. According to the manufacturers field service report, during the 5/19/14 visit there was a recommendation to use wall suction as well as a syringe to flush the forceps elevator. Documentation identified that the nurse manager was having the wall suction put back in the clean room. Further review and interview identified the manufacturer representatives returned to the hospital on 5/20/14, 5/22/14 and 5/27/14 and re-inserviced staff and/or had a meeting regarding the suctioning and flushing reprocessing procedures.

e. Interview with the Clinical Coordinator (RN #1) on 3/17/15 identified that he/she had reviewed the annual competency check lists with the GI technicians in June 2014 and used the competency checklist to make observations of staff reprocessing the scopes. RN#1 identfied that washcloths had been used to dry scopes prior to storage since 2005 and did not know that a lint-free cloth was required.

f. Interview with Nursing Director #1 on 3/16/15 identified that he/she had verbally reviewed the self assessment forms regarding the reprocessing of duodenoscopes with staff at their annual performance evaluation in 10/2014, however, no observations of staff conducting the reprocessing of endoscopes was completed.

g. Interview with Nursing Director #1 on 3/16/15 identified that he/she was aware of the 2/23/15 manufacturer analysis which identified that scope #32 had stains inside the biopsy channel walls which was a characteristic of inadequate reprocessing and insufficient pre-cleaning/brushing of the scopes biopsy channel. Nursing Director #1 identified that on 3/2/2015 that the manufacturer representative was on-site to perform endoscope/duodenoscope reprocessing training and staff inservice.
A letter from the manufacturer dated 6/27/14 identified that scope #45 was inspected and found to have foreign material inside the air pipe and the endoscope failed leakage testing (which is a critical step in the reprocessing). A second letter was sent to the hospital on 9/23/14 and identified that duodenoscope #31 was inspected and found with dents on the distal end cover which contributed to the device failing an insulation test. In addition, there were deep scratches on the light guide lens which was likely the result of impact against another object. Further interview with Nursing Director #1 identified that he/she was not aware of manufacturer recommendations from the letters dated 6/27/14 and 9/23/14. However, interview with Infection Control Nurse #2 on 3/16/15 identified that he/she had received both letters from the manufacturer and communicated the manufacturer recommendations to Nursing Director #1. The recommendations identified improper reprocessing techniques may be a contributing factor to ESBL infections and to ensure that all individuals engaged in reprocessing follow all instructions in the reprocessing manual.

h. Review of hospital documentation dated 5/5/14-12/12/14 identified that although the infection control nurse provided oversight to high level disinfection in the endoscopy reprocessing area, the oversight/surveillance of endoscopes was not conducted by the clinical coordinator in collaboration with the infection control department, and was not reported to the Infection Control Committee or the Infection Control Council until 2/25/15.

i. Interview with the hospital's Infectious Disease physician (MD #1) on 3/17/15 identified that he/she was aware of the ESBL infections and when the gene sequencing results were received (10/20/14) and identified that the ESBL infections were related, MD #1 had a verbal conversation with the President and the Vice President of Medical Affairs in the hospital administration, however there was no documentation in the Medical Executive Committee and/or Governing Body minutes regarding the relation of the ESBL infections and the duodenoscopes.

j. Review of the clinical records of twelve patient's (P#1-P#12) identified that each patient had one or more ERCP's between 12/23/13 and 4/2/14 and subsequently, all twelve were diagnosed with ESBL (Extended Spectrum Beta-Lactamase) infections associated with duodenoscopes used during the ERCP procedure.

k. Review of the hospital infection prevention and control plan for 2014 and 2015 identified that when a problem is identified, special studies, focused reviews or multidisciplinary working groups may be formed to investigate important infection control issues.

Based on review of hospital documentation, review of policies and procedures and interviews with hospital personnel, the hospital failed to ensure that the Infection Control Committee and the Infection Control Council were notified of a potential concern with Extended Spectrum Beta-Lactamase E-Coli (ESBL) exposures and identified infection rates associated with duodenoscope procedures in a timely manner.

The findings include:

a. Review of hospital documentation identified that in March 2014, the hospital identified an increase in ESBL rates and identified that the commonality was the use of duodenoscopes used in Endoscopic Retrograde Cholangiopancreatography (ERCP) procedures between 10/1/13 and 12/12/14. Review of the Infection Control Committee and the Infection Control Council minutes dated 8/2014-1/2015 failed to identify the ESBL exposures and the 12 confirmed infections associated with duodenoscopes were reported to the hospital and/or the hospital system-wide infection control council until 2/25/15.

b. Interview with the hospital's Infectious Disease physician (MD #1) on 3/17/15 identified that he/she was aware of the ESBL infections and when the gene sequencing results were received (10/20/14) and identified that the ESBL infections were related, MD #1 had a verbal conversation with the hospital president and the vice president of medical affairs regarding the relation of ESBL infections and the duodenoscopes. However there was no documentation in the Medical Executive Committee and/or Governing Body minutes regarding the infections.

c. Review of hospital policies identified that significant infection control findings would be reported to the Infection Control Committee. Further review of hospital policy indicates that the Infection Control Committee shall report all activities, on a monthly basis, to the Executive Committee of the Medical Staff.