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.

MIDWESTERN REGION MED CENTER 2520 ELISHA AVENUE ZION, IL 60099 July 18, 2012
VIOLATION: INFECTION CONTROL OFFICER RESPONSIBILITIES Tag No: A0749
A. Based on review of Hospital policy, observational tour, and staff interview, it was determined, that for 1 of 4 staff (E #1) in OR 3 and 4 of 6 staff (E # 2 - 5) in OR 2, the Hospital failed to ensure staff were compliant with the attire policy, to reduce potential patient infection.

Findings include:

1. Hospital policy #4002, revised 6/2012, titled, "Attire in the Operating Room" was reviewed. The policy required, "Operating Room Attire... should completely cover any personal clothing... All head and facial hair is to be covered... jewelry shall be totally confined within scrub attire or removed..."

2. On 7/16/12 between 9:55 AM and 11:30 AM, an observational tour was conducted in the Surgical Area and the following was found:

- At 9:55 AM, in OR 3 with open surgical instruments, a Certified Registered Nurse Anesthesiologist (E #1) was wearing uncovered earrings.

- At 10:15 AM, in OR 2 with a surgical case in progress, a Scrub Technician (E #2), a Surgical Technician (E #3), and a Surgeon (E #4) wore caps that did not fully cover all head hair and an Anesthesiologist (E #5) wore a blouse not covered at the neck by scrubs.

3. The observational tour was conducted with the Director of Surgical Services who stated, at the time of the findings, it is Hospital policy to cover jewelry, hair, and clothing.

B. Based on observational tour and staff interview, it was determined, that for 2 of 2 OR table arm boards in OR 1 & 4 and 1 of 10 genesis trays in the reprocessing area, the Hospital failed to ensure equipment was properly cleaned to reduce patient exposure from potential infections, potentially affecting 13 patients on the surgical schedule on 7/16/12.

Findings include:

1. On 7/16/12 between 9:55 AM and 11:30 AM, an observational tour was conducted in the Surgical Area and the following was found:

- In ORs 1 & 4, the OR table arms contained sticky tape reside.

- In the Reprocessing Area, 1 of 10 Genesis trays (Mastectomy, sterilized on 7/15/12) contained tape on the lid.

2. The observational tour was conducted with the Director of Surgical Services who stated, at the time of the findings, tape is not used on the arm boards.

C. Based on observational tour, Manufacturer's instructions, Endoscope log, and staff interview, it was determined, that for 2 of 2 high disinfection machines (Medivators Reprocessing System and Steris) receiving disinfectant solution testing before each load, the Hospital failed to ensure the lot numbers of the testing strips (Metricide OPA Plus Strips and Steris) were documented, potentially affecting 13 patients on the surgical schedule on 7/16/12.

Findings include:

1. On 7/16/12 between 9:55 AM and 11:30 AM, an observational tour was conducted in the Surgical Area. Two of 2 high disinfection machines (DSD - 201 Endoscope Preprocessor Medivators Reprocessing System and Steris System 1E) were seen in the Endoscopic Procedure Reprocessing Area.

2. Medivators Reprocessing System Manufacturer's instructions required, "The efficacy of a disinfection procedure is directly related to the disinfectant solution used and the amount of time the endoscope is exposed to that solution. Disinfectants must be monitored for potency on a daily basis. Consult the disinfectant manufacturer recommendations for monitoring guidelines..."

3. The Steris system did not require disinfection solution testing, but it was done by the Hospital as an added precaution.

4. For disinfectant testing, the Hospital used Metricide OPA Plus Strips for the Medivators Reprocessing System and Verify chemical indicator strips for Steris. Both Metricide and Verify testing solutions included lot numbers to identify the testing product. However, the Hospital did not have the Metricide or Verify Strips manufacturer's guidelines available.

5. The Endoscope processing log was reviewed for July 2012 and included disinfectant testing for both machines. However, for 14 machine loads between 7/9/10 and 7/13/10, the log lacked documentation of the test strip lot numbers used to validate the integrity of the disinfectant solution.

6. The observational tour was conducted with the Director of Surgical Services who stated, at the time of the findings, the lot number was missing.

D. Based on review of Hospital policy, observational tour, and staff interview, it was determined, that for 1 of 10 genesis trays, the Hospital failed to ensure the correct reprocessing date was recorded on the tray label, potentially affecting 13 patients on the surgical schedule on 7/16/12.

Findings include:

1. Hospital policy # , revised 9/1/11, titled, "Sterilization and Sterilization Control and Monitoring" required, "Apply sterility sticker directly onto sterile indicator tape of pack. Every OR pack shall be stickered with the following information: sterilization date..."

2. On 7/16/12 between 9:55 AM and 11:30 AM, an observational tour was conducted in the Surgical Area. In the Reprocessing Area, 1 of 3 Genesis trays (Mastectomy) on a cooling table was labeled ("stickered") 7/10/12.

3. An interview was conducted with a Reprocessing Technician (E #6) who stated that the Mastectomy Tray had been reprocessed yesterday (7/15/12) not on 7/10/12 and the label was incorrect.

E. Based on review of Hospital policy, observational tour, and staff interview, it was determined, that for 1 of 2 Certified Registered Nurse Anesthesiologists (E #7), the Hospital failed to ensure medications were handled in a safe manner to reduce the potential of contamination.

Findings include:

1. A Hospital policy titled, "Medication Administration" was undated and did not provide instruction proper methods of carrying pre-drawn medication.

2. On 7/17/12 between 9:00 AM and 10 AM, an observational tour was conducted in the Surgical Area. In OR 3 the Certified Registered Nurse Anesthesiologists (E #7) carried a filled medication syringe in her top pocket, potentially contaminating the medication.

3. On 7/17/12 at 9:10 AM, an interview was conducted with E #7. E #7 stated that the syringe contained Versed and was administered to Pt. #4 in the holding area "to take the edge off" and additional Versed [syringe from pocket] was administered in OR 3. E #7 stated that she had no where else to carry the syringe when she was accompanying the patient to the OR.