The information below comes from the statement of deficiencies compiled by health inspectors and provided to AHCJ by the Centers for Medicare and Medicaid Services. It does not include the steps the hospital plans to take to fix the problem, known as a plan of correction. For that information, you should contact the hospital, your state health department or CMS. Accessing the document may require you to file a Freedom of Information Request. Information on doing so is available here.

ADVOCATE LUTHERAN GENERAL HOSPITAL 1775 DEMPSTER ST PARK RIDGE, IL 60068 Jan. 16, 2014
VIOLATION: INFECTION CONTROL OFFICER RESPONSIBILITIES Tag No: A0749
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**


Based on interview, record review, and observation, it was determined for 9 of 113 patients (Pts. #2, 3, 5 - 8, 10, 29, & 38) who had "signs and symptoms" from CRE (carbapenem-resistant Enterobacteriacease) NDM-l (New Delhi Metallo beta lactamase) after ERCP (Endoscopic Retrograde Cholangiopancreatography) procedures, the hospital failed to reprocess ERCP endoscopes as recommended by the endoscope manufacturer

Findings include:

1. On 1/15/14 from 9:20 AM until 9:35 AM, an interview was conducted with the Vice President of Medical Management (MD #3). MD #3 stated in the spring of 2013, patients were found to have the CRE NDM, known but rare bacteria. "There was one, then another, then another." Infection control began asking why they were seeing these rare bacteria. About 7 or 8 patients had the infection and all had had ERCPs.

2. MD #3 stated Scope A was removed and sent to CDC where cultures were positive for CRE NDM. It was unknown how the scope became infected.

3. MD #3 stated, other cases arose with 2 other scopes (B & C). A "cohort of patients" had been scoped using 3 scopes (A, B, & C). These ERCP patients were asked to come in for screening. There were 243 patients between January 2013 and September 2013 who underwent ERCP procedures. They were all sent certified letters and some phone calls. One hundred fourteen came for screening. Thirty eight were positive, but only 10 had signs and symptoms. The 10 [Pts. #1 - 3, 5 - 8, 10, 29, & 38] were treated and released. In the fall the hospital added gas sterilization (a 12 hour process) to the ERCP scope cleaning and disinfection process, beyond the manufacturer ' s recommendations. "There have been no signs of the organism since."

4. On 1/14/13 at 2:30 PM, the clinical record of Pt. #2 was reviewed. Pt. #2 was an [AGE] year old female, admitted on [DATE], with diagnoses of gallstone pancreatitis, choledocholithiasis, Alzheimer disease, and failure to thrive. Pt. #2's endoscopy report (scope A) dated 1/28/13 included, "Procedure: ERCP with balloon dilation, ERCP with sphincterotomy, ERCP with removal of stones, ERCP with stent placement..." Pt. #2's discharge summary report, included, "The patient was transferred to a skilled care nursing facility for rehabilitation" and Pt. #2 was discharged on [DATE].

5. Pt. #2 was readmitted on [DATE] with a urinary tract infection (UTI). Pt. #2's urine culture dated 3/26/13, included, "greater than 100,000 CFU/ml Escherichia Coli ... New Delhi Metallo Beta Lactamase (NDM)... Culture confirmed by [CDC]..." Pt. #2 was treated for UTI and discharged to a nursing home on 3/30/13.

6. On 1/14/13 at 3:00 PM, the clinical record of Pt. #3 was reviewed. Pt. #3 was a [AGE] year old male, admitted on [DATE], with diagnoses of subdural and subarachnoid bleed, atrial fibrillation, and ETOH (alcohol) intoxication. Pt. #3's endoscopy report (scope A) dated 1/30/13, included, "Procedure: ERCP with removal of stones, ERCP with sphinctertomy..." Pt. #3's discharge summary report, included, "The patient was transferred to... Medical Center for further treatment and rehab" and Pt. #3 was discharged on [DATE].

7. Pt. #3 was readmitted on [DATE] for septic shock. Pt. #3's urine culture dated 3/28/13, included, " Many Escherichia Coli... New Delhi Metallo Beta Lactamase (NDM)... Culture confirmed by [CDC]..." Pt. #3 expired in the hospital on [DATE] at 11:59 PM.

8. On 1/15/13 at 9:00 AM, the clinical record of Pt. #5 was reviewed. Pt. #5 was a [AGE] year old female, admitted on [DATE], with a diagnosis of obstructive jaundice due to cholangiocarcinoma. Pt. #5's endoscopy report (scope A) dated 4/4/13, included, "Procedure: ERCP with sphinctertomy." Pt. #5's discharge summary report, dated 4/6/13, included, " Patient discharged in improved condition... " and was discharged home on 4/6/13.

9. Pt. #5 was readmitted on [DATE] with cholangiocarcinoma of hepatic hylum. She underwent a robotic-assisted resection of the common bile duct and cholecystectomy on 4/18/13. An abdominal wound culture dated 4/21/13, included, " Many Escherichia Coli... New Delhi Metallo Beta Lactamase (NDM)... Culture confirmed by [CDC]... "

10. During an interview with the Manager of Hospital Epidemiology and Infection Control (E #5) on 1/14/14 at 1:15 PM, E #5 stated Pt. #5's abdominal wound infection was treated with antibiotics. Pt. #5 was admitted to another hospital with sepsis, as reported by the Cook County Department of Public Health (CCDPH), and later discharged home, date unknown.

11. On 1/15/13 at 9:30 AM, the clinical record of Pt. #6 was reviewed. Pt. #6 was a [AGE] year old female, admitted on [DATE], with diagnoses of acute cholecystitis, biliary dilatation, cholelithiasis and dyslipidemia. Pt. #6's endoscopy report (scope A) dated 5/17/13, included, "Procedure: ERCP with sphinctertomy, balloon sweeps." Pt. #6's discharge summary report, included, "discharged home in improved stable condition " and was discharged on [DATE]

12. E #5 discussed Pt. #6 during an interview on 1/16/14 at 9:40 AM. Pt. #6 returned to the hospital on [DATE] for cholecystomy tube placement via ERCP, with scope B. An abdominal abscess culture dated 6/26/13, included, " Few Escherichia Coli... New Delhi Metallo Beta Lactamase (NDM)... Confirmation performed at the [CDC]..." Pt. #6 had erythemia, purulent drainage and was discharged home, where a wound vacuum was applied and she has not returned to the hospital.

13. On 1/15/13 at 12:00 PM, the clinical record of Pt. #7 was reviewed. Pt. #7 was a [AGE] year old female, admitted on [DATE], with diagnoses of "acute pancreatitis status post ERCP 6/25/13 complicated by retroperitoneal duodenal perforation, 2) Acute respiratory failures..." Pt. #6's endoscopy report (scope B) dated 6/25/13, included, "Procedure: ERCP with sphinctertomy, multiple balloon sweeps." A sputum culture dated 6/30/13, included, "Rare Escherichia Coli... New Delhi Metallo Beta Lactamase (NDM)... Confirmation performed at the [CDC] ... " Pt. #7 ' s discharge summary report, included, "Patient was discharged home with home help and help from children" and was discharged on [DATE].

14. E #5 stated Pt. #7's retroperitoneal duodenal perforation did not happen during surgery but several days later. Pt. #7 returned to the hospital on [DATE] with pleural effusion and was discharged home. Pt. #7 visited E #5 at the hospital this week, and "is alive and well."

15. On 1/14/13 at 12:10 PM, the clinical record of Pt. #8 was reviewed. Pt. #8 was a [AGE] year old female, admitted on [DATE], with a diagnosis of pancreatic cancer. Pt. #8's endoscopy report (scope A) dated 2/23/13, included, "Procedure: ERCP with sphinctertomy, ERCP with stent placement." Pt. #7's discharge summary report, included, " Patient was discharged home... " and was discharged on [DATE].

16. E #5 stated Pt. #8 was readmitted to the hospital for E. Choli sepsis and had a " possible wound infection" on 7/14/13. A blood culture dated 7/14/13, included, "Escherichia Coli... New Delhi Metallo Beta Lactamase (NDM)... Confirmation performed at the [CDC]..." Pt. #8 was discharged home on 7/23/13 on antibiotics.

17. On 1/14/13 at 12:30 PM, the clinical record of Pt. #10 was reviewed. Pt. #10 was an [AGE] year old female, admitted on [DATE], with fever, UTI, and anemia. Pt. #10's history and physical dated 9/24/13 (from second admission), included, "Patient traveled to India form May 2013 to September 2013, where she was hospitalized for about a month, initially due to diarrhea. She then developed sepsis secondary to UTI with Klebsiella... Patient returned to the US on 9/3/13 with a foley catheter still in place, and was admitted to another hospital on [DATE] due to weakness and diarrhea... Patient was discharged in stable condition to a nursing home on 9/13/13.

19. Pt. #10 was readmitted on [DATE], with a complaint of intermittent fevers and chills for 8 days. A urine culture dated 9/22/13, included, "greater than 100,000 CFU/ml Klebsiella Pneumoniae... New Delhi Metallo Beta Lactamase (NDM)... Confirmation performed at the [CDC]..." Pt. #10's discharge summary report, dated 10/12/13 included, " Hospital course... ERCP on 10/1/13 with sphincterotomy showed cholilithiasis with shadowing stones and sludge in gallbladder... On morning of 10/5/13, patient experienced bradycardia with HR in 30s... Family decided at that time for comfort care measures only. Heart rate continued to decrease; patient declared dead at 3:05 AM on 10/5/13." The death certificate dated 10/5/13 included, cause of death was: sepsis with multi organ failure, enterococcal urinary tract infection, and cholysystitis.

20. On 1/15/13 at 3:30 PM, the clinical record of Pt. #35 was reviewed. Pt. #35 was an [AGE] year old male, who underwent ESRD procedures on 6/5/13 (with scope A) on and 8/22/13 (with scope C). A rectal swab culture dated 10/14/13, included, "Escherichia Coli... New Delhi Metallo Beta Lactamase (NDM)... Confirmation performed at the [CDC]..." Pt. #35 was discharge to a nursing home, date unknown.

21. Pt. #38 clinical record was reviewed on 1/16/14 at 3:10 PM. Pt. #38 was a [AGE] year old male, who under-went an ERCP on 8/24/13. The ERCP procedure report (scope C) dated 8/24/13, included, "ERCP with removal of calculus/calculi, ERCP with sphincterotomy/ papiliotomy, and ERCP with stent placement."

22. During an interview on 1/16/14 at 2:40 PM, with E #4, the Director of Clinical Excellence and Safety, E #4 stated, Pt. #38 was not a hospital in-patient, but did have an ERDC procedure as an outpatient on 8/24/13 and was "genetically linked" by the CCDPH. Pt. #38 was admitted to another hospital and was treated for E. Coli MBL sepsis. As of 12/31/13, Pt. #38 was alive, per CCDPH. Pt. #38 was the last patient who contracted NMD at the hospital.

23. The Pentax Video GI Scopes 90I & 90K Series Instructions were reviewed on 1/21/14 at 5:00 PM. The hospital only used Pentax ERCP Video GI ED-3490TK scopes, included in these instructions. The instructions included a caution on page 19, "It is highly recommended that only Pentax cleaning brushes specified in our instructions for use should be used to clean Pentax endoscopes. Pentax cleaning brushes have been specially designed to clean various Pentax internal channel systems and valves/ports/ cylinders. Validation studies have been performed supporting the use of Pentax supplied brushes and cleaning adapters for cleaning Pentax endoscopes following Pentax manual reprocessing instructions."

24. The Pentax Compatible Reprocessing Systems/ Agents Instructions were reviewed on 1/21/14 at 5:10 PM. Eight enzymatic detergent solutions were included, but not Surg-Enz (used by the hospital). The instructions included, "Tests have shown these solutions to be compatible with materials used in the construction of Pentax endoscopes..."

25. On 1/14/14 at 9:35 AM, an interview was conducted with E #6, a GI Technician who reprocessed endoscopes. E #6 stated Pentax is the manufacturer of all the approximately 50 endoscopes in the hospital. The ERCP scopes have elevators that required additional processing than other scopes. E #6 explained the endoscope cleaning process. The scopes are washed with an enzyme [Surg-Enz CST 303C Advanced Multi-Enzymatic Detergent] and 3 disposable brushed are used to clean the scope.

26. On 1/16/14 at 2:45 PM, a memo from E #5, dated 9/26/13, regarding " CRE Cluster Update" was reviewed. The memo included, "Spoke with Pentax 9/25/13. 1. They completed FDA response and sent 9/20 - Non Pentax cleaning brushes (Off label use). - Surg-Enz enzymatic is not on Pentax approved list of enzymatic (off label use)..."

27. On 1/21/14 at 1:47 PM, a memo was sent from E #5, in response to a surveyor question, has the hospital made a decision to change the ERCP cleaning solution from Surg Enz to a cleaning solution approved by Pentax? The memo included a response from Advocate's Contract Manager, "...We are in the process of converting over in... GI Lab for detergents and Enzymatic solutions..." A solution name and start date was not provided.