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.

AURORA BAYCARE MEDICAL CTR 2845 GREENBRIER RD GREEN BAY, WI 54311 Sept. 10, 2015
VIOLATION: FACILITIES, SUPPLIES, EQUIPMENT MAINTENANCE Tag No: A0724
Based on record review and interview, the hospital failed to ensure that dialysis water purification equipment was operated using safe product water per recommended practice standards, in the collection of 3 of 3 RO product water samples reviewed (Product water samples for RO machines 850, 845 and 849); and failed to ensure that water purification systems tests were documented to show safe and effective function of the RO machine before patient use, in 1 of 3 RO machines used (RO machine 850). This deficiency has the potential to affect a total of 4 acute care hemodialysis patients in the hospital.


Findings include:

1) The 9/3/15 at 12 p.m. record review of the The Association of the Advancement of Medical Instrumentation approved by the American National Standards Institute, Inc. (ANSI/AAMI RD 52:2004) states under "4.1.1 -Maximum level od chemical contaminants in water" and "4.1.1 - Table 1- list of contaminants" states "Product water used to prepare dialysate at a dialysis facility...shall not contain chemical contaminiants at concentrations in excess of those listed in ANSI/AAMI...reproduced in Table 1 below. The manufacturer or supplier of a complete water treatment (purification) system should recommend a system that is capable of meeting the requirements of this clause given the analysis of the feed water (water supply at the hospital)...Following installation of a water treatment...system, the user is responsible for the continued monitoring of the levels of chemical contaminants in the water and for complying with the requirements of this standard...Maximum allowable chemical contaminant levels in water used to prepare dialysate and concentrates from powder at a dialysis facility...shall not contain chemical contaminants at concentrations in excess of...maximum concentrations (mg/L) of:
Calcium 2 (0.1 mEq/L)
Magnesium 4 (0.3 mEq/L)
Potassium 8 (0.2 mEq/L)
Sodium 70 (3.0 mEq/L)
Antimony 0.006
Arsenic 0.005
Barium 0.10
Beryllium 0.0004
Cadmium 0.001
Chromium 0.014
Lead 0.005
Mercury 0.0002
Selenium 0.09
Silver 0.005
Aluminum 0.01
Chloramines 0.10
Free Chlorine 0.50
Copper 0.10
Fluoride 0.20
Nitrate (as N) 2.0
Sulfate 100
Thallium 0.002
Zinc 0.10

During interview with Chief Support Officer B on 9/2/15 at 11:15 a.m., B stated "Here are the water reports that we have. The dialysis machines were set up at the Summit hospital by Marcor (water treatment system installer) and then brought to this hospital."

Record review on 9/3/15 at 9 a.m. reveals that product water testing for the following chemical contaminants in the hospital's product water (water used to prepare dialysate for hemodialysis) was not conducted in this Green Bay, WI hospital, before patient hemodialysis was initiated on 6/29/15. The chemical contaminate product water analysis, provided by Chief Support Officer A on 9/2/15 at 11:15 a.m., for the 3 portable hemodialysis machines used at the Green Bay hospital was conducted with product water from another hospital (Aurora Medical Center in Summit, WI) approximately 122 miles away.

The 9/3/15 at 9 a.m. record review of "Policy No. 2096, effective date: 6/15, Hemodialysis Machine Start-up, Priming, Treatment Initiation and Termination" reveals that the hospital has no policy covering the evaluation of chemical contaminants of it's water used for patient hemodialysis.

During interview with Director of Quality A on 9/8/15 at 3:30 p.m., A verified that the hospital was unaware that the product water used for chemical contaminant testing had to come from the location where the hemodialysis dialysate was being made.

2) The 9/3/15 at 9 a.m. record review of "Policy No. 2096, effective date: 6/15, Hemodialysis Machine Start-up, Priming, Treatment Initiation and Termination" states under: "VI. RO water log documentation documents that the following parameters must be checked and documented "prior to each treatment" are "total chlorine test, primary carbon filter PG 1, secondary carbon filter PG 2, Delta pressure change difference PG 1 minus PG 2, post carbon filter PG 3, Delta pressure change difference PG 2 minus PG 3, outlet pressure filter PG 4, Delta pressure change difference PG 3 minus PG 4, product temperature, feed water condition (feed TDS), product TDS, percent rejection, calculated percent rejection, pump pressure, product pump pressure, drains line secured, leak alert used, time and date of last heat disinfection completed (minimum 72 hours noted in log screen) and staff ID number."

The 9/3/15 at 12 p.m. record review of the The Association of the Advancement of Medical Instrumentation approved by the American National Standards Institute, Inc. (ANSI/AAMI RD 52:2004) states under "5.2.7, RO systems should be fitted with a variety of sensors to monitor the systems performance. Conductivity or total dissolved solids (TDS) sensors in the feed water and the product water streams are used to monitor the membranes ability to remove dissolved inorganic solutes. Flowmeters, usually in the product water and the rejection water streams, are used to monitor the output of the RO system. RO systems are also fitted with gauges to monitor the pressure at various points in the system. Although not indicative of treated water quality, monitoring flow rates and pressures can help ensure that the system is operating within the manufacturer ' s specifications and thus will help ensure RO reliability."

The 9/3/15 at 1:30 p.m. record review of RO #850 reveals that on 7/3/15 the "calculated % rejection" was not documented before Patient #9's hemodialysis treatment.

The 9/3/15 at 1:30 p.m. record review of RO #850 reveals that on 7/3/15 the "Feed Water Condition (Feed TDS), Product TDS, % rejection, and calculated % rejection" was not recorded before Patient #10's hemodialysis treatment.

The 9/3/15 at 1:30 p.m. record review of RO #850 reveals that on 7/13/15 the "calculated % rejection" was not recorded before Patient #11's hemodialysis treatment.

The 9/3/15 at 1:30 p.m. record review of RO #850 reveals that on 7/15/15 the "calculated % rejection" was not recorded before Patient #12's hemodialysis treatment.

During interview with Director of Quality A on 9/10/15 at 10:17 a.m., A verified that information was not documented and stated there was no additional information regarding the above examples.
VIOLATION: INFECTION CONTROL OFFICER RESPONSIBILITIES Tag No: A0749
Based on record review and interview, the hospital's infection control officer failed to ensure that a system was developed for monitoring hemodialysis infection control, in 3 of 3 areas reviewed (dialysate water bacterial cultures, hemodialysis machine disinfection and Reverse Osmosis/water purification machine disinfection). This deficiency has the potential to affect a total of 4 acute care hemodialysis patients in the hospital.

Findings include:

1) The 9/3/15 at 9 a.m. record review of "Policy No. 2096, effective date: 6/15, Hemodialysis Machine Start-up, Priming, Treatment Initiation and Termination" states under: "V. Cultures /LAL ( for RO machine water), 1. Chemical Disinfection should be done biannually or more frequently as cultures require. 2. RO machine (water) cultures and LALs are taken monthly. 2.a. Results for cultures must be less than 200 CFUs. If greater than 200 CFUs, than the equipment should be removed from use, disinfected with chemical and re-cultured. Results must be less than 50 CFUs to be placed back in service. 2.b. Action level for the RO is 50 CFUs.
The 9/1/15 at 2 p.m. record review of "Aurora Bay Care MarCor purification 2-day colony count/ endotoxin test report for RO #1's (850) reveals the July 2015 RO water culture, collected on 7/23/15 and reported on 7/26/15, was "174 CFU/ml". There is no documented evidence to show that "action level" chemical disinfection was done before RO water re-culture was collected 7/27/15 and reported on 7/30/15 as "88 CFU/ml".

During interview with PCT C on 9/1/15 at 2 p.m., C stated that "I did the disinfection using the Minncare disinfectant after the second culture of 88".

Record review on 9/3/15 at 11 a.m. of the "RO #1/ #850" form reveals use on Patient #8 on 7/26/15, while having an action level bacterial count.

2) The 9/3/15 at 9 a.m. record review of "Policy No. 2096, effective date: 6/15, Hemodialysis Machine Start-up, Priming, Treatment Initiation and Termination" states under: "VI. RO water log documentation" that the following "acceptable parameters" must be checked and documented "prior to each treatment": "...time and date of last heat disinfection completed (minimum 72 hours noted on log screen) and staff ID number." Under "Appendix A: Use of the Millennium HX RO system...shut down and disinfection procedure" states "6. Note the time and the date of the last heat cycle (machine disinfection). The unit should not be dormant longer than 72 hours without heat disinfection. If the unit has not been use or disinfected within the last 72 hours it should not be used."

The 9/1/15 at 2:15 p.m. record review of dialysis machine #3's RO machine log/ #849 reveals the the RO machine was last disinfected on 7/14/15 (no time documented). Patient hemodialysis treatments were given with RO #3 on 7/16/15 at 11:45 a.m. and 7/17/15 at 7:15 a.m., with dialysis staff failing to document "last date and time heat disinfection completed" on 7/16/15 and 7/17/15. There is no documented evidence on RO #3's log that this RO was disinfected within the minimum 72 hour period or that it was disinfected before patient hemodialysis use on 7/18/15 at 2:15 p.m.

3) The 9/3/15 at 9 a.m. record review of "Policy No. 2096, effective date: 6/15, Hemodialysis Machine Start-up, Priming, Treatment Initiation and Termination" states under: "20. Disinfection of the machine, i. Citric Thermal Disinfection...Done at the end of every day if machine (used) or post hepatitis B known or unknown patient (used)." The hospital's log for dialysis machine disinfection states that "Citric thermal disinfect" is done at the end of patient treatment day or required when patient's Hepatitis B status is positive or Hepatitis B status is unknown.

The 9/3/15 at 10 a.m. record review of hemodialysis machine #3 reveals use on 7/14/15 at 3:35 p.m. for Patient #13. There is no documented evidence of citric thermal disinfection at "end of treatment day" per facility policy.

The 9/3/15 at 10 a.m. record review of hemodialysis machine #3 reveals use on 7/16/15 at 11:45 a.m. for Patient #14. There is no documented evidence of citric thermal disinfection at "end of treatment day" per facility policy.

During interview with Director of Quality A on 9/10/15 at 10:17 a.m., A verified that information was not documented and stated there was no additional information regarding the above examples.
VIOLATION: PHYSICAL ENVIRONMENT Tag No: A0700
Based on record review and interview, the hospital failed to ensure that Reverse Osmosis (RO) water purification equipment used for hemodialysis patients was maintained by medical equipment practice standards and facility policy to ensure patient safety, in review of 3 of 3 RO product water samples (Product water samples for RO machines 850, 845 and 849); and in review of 1 of 3 RO machines used (RO machine 850). This deficiency has the potential to affect a total of 4 acute care hemodialysis patients in the hospital.

Findings Include:

1) Record review on 9/3/15 from 9 a.m. through 12 p.m. reveals the hospital failed to ensure that the RO water purification equipment was operated using safe product water per recommendations of the Association of the Advancement of Medical Instrumentation approved by the American National Standards Institute, Inc. (ANSI/AAMI ) practice standards, in the collection of 3 of 3 RO product water samples reviewed (Product water samples for RO machines 850, 845 and 849). The hospital failed to have a policy defining the guidelines for monitoring product water contaminants.

During interview with Director of Quality A on 9/8/15 at 3:30 p.m., A verified that the hospital was unaware that the product water used for chemical contaminant testing had to come from the location where the hemodialysis dialysate was being made. (Reference A-0724)

2) Record review on 9/3/15 from 9 a.m. through 12 p.m. reveals the hospital failed to ensure that water purification systems tests were documented to show safe and effective function of the RO machine before patient use per recommendations of the Association of the Advancement of Medical Instrumentation approved by the American National Standards Institute, Inc. (ANSI/AAMI ) practice standards and facility policy, in 1 of 3 RO machines used (RO machine 850).

During interview with Director of Quality A on 9/10/15 at 10:17 a.m., A verified that information was not documented and stated there was no additional information regarding the above examples. (Reference A-0724)

The cumulative effect of this failure to maintain hemodialysis water purification equipment resulted in the hospital's inability to ensure a safe environment for the patients.
VIOLATION: INFECTION CONTROL Tag No: A0747
Based on record review and interview, the hospital failed to ensure that it had an active program for prevention and control of hemodialysis- based patient infections, in 3 of 3 areas reviewed (dialysate water bacterial cultures, hemodialysis machine disinfection and Reverse Osmosis/water purification machine disinfection). This deficiency has the potential to affect a total of 4 acute care hemodialysis patients in the hospital.

Findings include:

1) The 9/1/15 record review from 9 a.m. through 2 p.m. and 9/3/15 record review at 11 a.m. reveals that the hospital failed to follow facility policy regarding the disinfection of dialysis RO equipment with bacteria levels in dialysate water, greater or equal to 50 CFU/ ml., that are used for patient hemodialysis, resulting in Patient #8's exposure to bacterial contaminants during dialysis.

During interview with PCT C on 9/1/15 at 2 p.m., C stated that "I did the disinfection using the Minncare disinfectant after the second culture of 88". (Reference A-0749)

2) The 9/1/15 at 2:15 p.m. record review and the 9/3/15 at 9 a.m. record review reveals that the hospital failed to ensure that 1 of 3 water purification systems (RO #3) was disinfected within a minimum 72 hour period or before the next patient hemodialysis treatment per facility policy.

During interview with Director of Quality A on 9/10/15 at 10:17 a.m., A verified that information was not documented and stated there was no additional information regarding the above example. (Reference A-0749)


3) The 9/3/15 at 9 a.m. through 10 a.m. record review reveals the hospital failed to ensure that 1 of 3 hemodialysis machines (Machine #3) was disinfected, per facility policy, at the end of the treatment day.

During interview with Director of Quality A on 9/10/15 at 10:17 a.m., A verified that information was not documented and stated there was no additional information regarding the above example. (Reference A-0749)

The cumulative effect of these failures to have an active program of hemodialysis infection control resulted in the hospital's inability to ensure a sanitary environment and prevent transmission of infections in their dialysis patients.