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Based on review of policies and procedures, manufacturer's information, documentation, observation, and staff interview, the facility failed to ensure the facility's policy and procedure for testing the conductivity of the dialysate was in accordance with the Myron L D-2 Dialysate Meter manufacturer's information.

Written policies and procedures provide for guidance and consistency among staff and serves as a resource for staff in the performance of procedures. A written policy and procedure that did not reflect the manufacturer's information regarding the conductivity test could result in failure of staff to identify a conductivity reading outside of the acceptable range which could potentially allow the use of a hemodialysis machine or use of dialysate for the patient treatment that did not have a conductivity within a range deemed safe for the patient treatment. Use of a dialysis machine with a conductivity measurement outside the acceptable range could potentially result in adverse patient outcomes and patient harm such as hemolysis (the rupture of red blood cells).

At the time of the survey, the facility staff reported a hemodialysis patient census of 4 and that the facility had 5 hemodialysis machines. Findings for 2 of 2 patient treatment days observed (2/23/12 and 2/24/12) for the conductivity testing of the dialysate from the dialysis machine include:

1. Interview and observation on 2/23/12 with RN (Registered Nurse) DD before Patient D1's dialysis treatment showed that staff tested the conductivity of the dialysate from the dialysis machine with a Myron L Dialysate Meter, a manual hand held conductivity meter, prior to each patient treatment.

2. Review of the policies and procedures, the manufacturer's information for the Myron L Dialysate Meter, observation and staff interview failed to ensure the facility's policy and procedure for checking the conductivity of the dialysate was in accordance with the Myron L D-2 Dialysate Meter's manufacturer's information and that all staff performed the conductivity test using the Myron L Dialysate Meter in accordance with the manufacturer's information.

a. The manufacturer's information for the Myron L D-2 Dialysate Meter titled "DUAL RANGE DIALYSATE METER Operation Instructions User Manuel for Models D-2" stated in part, "... USING YOUR METER NOTE: Before measuring dialysate samples, check the calibration of your meter using Myron L Company 14.0 millimhos Standard Solution... 2. Fill the cell cup... with a sample of the dialysate you want to test... 3. Drop the plunger into the cell cup. Lift it about half way out of the cell and drop it back in three or four times. Discard the sample. NOTE: This procedure must be conscientiously performed for samples at working (body) temperature to avoid artificially high readings. 4. Repeat steps 2 and 3 at least three times. 5. Take another sample, drop in the plunger, and press the black button. When the pointer stops, IMMEDIATELY read and release the button. 6. Repeat step 5 twice and record the last reading..."

b. The facility had a policy and procedure titled "CONDUCTIVITY METER: INSTRUMENTATION," with a facility revised date of 12/11, which stated in part, "PURPOSE To ensure patient safety, in respect to dialysate preparation, for hemodialysis treatments. POLICY The conductivity of the dialysate will be checked with the conductivity meter prior to initiating each hemodialysis treatment. Results of the manual conductivity test will be compared to the conductivity results measured by the HD [hemodialysis] machine, and serves as a "double-check" method... PROCEDURE... 4. Fill and discard disposable cup... with dialysate sample fluid three times... 5. Obtain final dialysate test sample... (this is the 4th sample)... 6. Fill cell cup with sample fluid... 7. Drop plunger end into cell cup. Agitate plunger with up and down motion, three times, then press button and read conductivity. 8. Repeat steps 6-7 four more times and record the last (5th) reading..."

c. Observation on 2/23/12 with RN DD before Patient D1's dialysis treatment and interview on 2/24/12 at 12:50 PM with RN DA showed staff performed the conductivity test of the dialysate in accordance with the facility's written procedure. However, review of the facility's procedure for testing the dialysate with the manufacturer's information for the Myron L Dialysate Meter showed differences in the facility's policy and procedure and the manufacturer's information regarding the number of times staff filled the cell cup of the Myron L Meter to obtain the conductivity reading. Interview on 2/24/12 at 2:30 PM with the Lead Dialysis Nurse and Biomed Technician DF regarding the above findings showed that staff would contact the manufacturer of the Myron L Meter to clarify the manufacturer's procedure. The Lead Dialysis Nurse verified the facility's policy and procedure should reflect the manufacturer's information. An e-mail received from the facility's Director of Compliance on 2/27/12 showed the Lead Dialysis Nurse had contacted the Myron L Company and verified the differences in the facility's policy and procedure and the manufacturer's information regarding repeating specific steps. The 2/27/12 e-mail included that the Lead Dialysis Nurse had changed the facility's policy and procedure to reflect the manufacturer's information.

During interview on 2/24/12 at 3:00 PM, the Manager reported the acute in-patient hemodialysis services followed the Conditions for Coverage for End-Stage Renal Disease (ESRD) Facilities. The Conditions for Coverage for ESRD Facilities incorporated by reference the recommendations (with the exception of screening for hepatitis C), found in the "Recommendations for Preventing Transmission of Infections Among Chronic Hemodialysis Patients," dated April 27, 2001, pages 18-28, and the practice guideline of the Association for the Advancement of Medical Instrumentation (AAMI) for "Dialysate for hemodialysis" (ANSI/AAMI RD52:2004).

Based on review of policies and procedures, the CDC (Centers for Disease Control and Prevention) MMWR (Morbidity and Mortality Weekly Report) Recommendations and Reports, AAMI requirements, observations, and staff interview, the facility staff failed to ensure:

- Staff rinsed the bicarbonate and acid wands (also known as pick-up tubes), used for the dialysis treatments with the portable RO (reverse osmosis), with treated RO water at the end of the treatment day and failed to ensure the staff's practice of rinsing the wands with RO water in the water treatment system room on 3 West, using a bucket to collect the rinse water, ensured a clean procedure.

- Staff disinfected the inside of the dialysis machine prime waste container at the end of the patient dialysis treatment.

Bicarbonate concentrate solution provides an excellent media (substance/environment) for bacteria to grow or increase by rapid production of new bacteria; bicarbonate concentrate supports bacterial growth. Bacterial growth could potentially occur from residual bicarbonate remaining on the wands and/or from the wands becoming contaminated during the rinsing procedure. Exposure to elevated bacteria or endotoxins during the dialysis treatment could potentially result in patient illness. When the wands are placed in the bicarbonate or acid concentrate solution, residual chemicals/substances remaining on the wands could potentially enter the solution and the dialysate used for the patient's dialysis treatment.

Failure to disinfect the entire surface of the prime waste container, attached to the side of the machine during the patient dialysis treatment, could potentially allow cross contamination to occur and potentially put patients and staff at risk for exposure to infectious agents causing adverse patient outcomes and patient illness.

At the time of the survey, the facility staff reported a hemodialysis patient census of 4. The facility had an acute hemodialysis in-patient treatment area with a water treatment system room on 3 West and 2 portable ROs to provide patient dialysis treatments. Findings for 2 of 2 patient treatment days observed (2/23/12 and 2/24/12) include:

1. Observation and staff interview showed staff did not rinse the bicarbonate and acid wands, used for the dialysis treatments with the portable RO, with treated RO water at the end of the treatment day and failed to ensure the staff's practice of rinsing the wands with RO water in the water treatment system room on 3 West, using a bucket to collect the rinse water, ensured a clean procedure.

a. The Conditions for Coverage for ESRD Facilities included the AAMI requirements that pick up tubes should be rinsed with treated water and allowed to air dry at the end of each treatment day.

b. The facility had a policy and procedure titled "CLEANING," with a facility revised date of 12/11, which stated in part, "... POLICY Cleaning will be done by a trained dialysis nurse to ensure optimum safety for the dialysis patient... PROCEDURE... 2. Rinse bicarbonate and acid wands with treated water from R/O (reverse osmosis) at the end of the day after treatment..."

c. Observation on 2/23/12 at 8:30 AM with RN (Registered Nurse) DC and RN DD, at different dialysis stations, showed the hemodialysis machine acid and bicarbonate wands in containers of acid and bicarbonate concentrate solution for the patient dialysis treatments. The wands, also known as pick-up tubes, were straw like tubes that staff placed in the concentrate containers to take up the concentrate solution from the containers into the dialysis machine for the patient dialysis treatment.

Interview on 2/23/12 at 11:40 AM with RN DB showed at the end of the patient dialysis treatment, staff removed the acid and bicarbonate wands from the containers of acid and bicarbonate concentrate solution and placed the ends of the wands in a container holding a vinegar solution for the procedure to clean the dialysis machines. (The vinegar solution went through the pick-up tubes into the dialysis machine as part of the cleaning procedure for the dialysis machine.) Continued interview with RN DB showed at the end of the vinegar procedure, staff placed the wands in a vertical position on the dialysis machine. During the interview, RN DB reported the facility's procedures did not include that staff rinsed the acid and bicarbonate wands, if used for dialysis treatment, with RO water at the end of the treatment day.

d. Observation on 2/24/12 at 11:40 AM with RN DA showed RN DA rinsed the bicarbonate and acid wands after a patient dialysis treatment with treated RO water from a RO water port in the acute in-patient water treatment room on 3 West. Observation showed RN DA held the wands in a bucket under the sample port, with the water flowing from the sample port over and through the wands, with the rinse water collected in the bucket. Observation did not ensure the rinse water collected in the bottom of bucket did not come into contact with the ends of the wands (potentially contaminating the wands). Interview on 2/24/12 in the afternoon with RN DA showed the facility did not have a system to clean/disinfect the inside of the bucket.

e. During observation of the portable ROs and hemodialysis machines and interview on 2/23/12 at 1:40 PM with RN DD and on 2/24/12 at 12:50 PM with RN DA, RN DD and RN DA reported that staff rinsed the acid and bicarbonate wands, used for the patient dialysis treatment, with water from the portable RO red RO drain line/hose at the end of the treatment day. At the time of the above interviews, observation showed the end section of the RO drain line/hose in the wall unit drain.

f. Interview on 2/24/12 at 2:30 PM with Biomed Technician DF showed the water from the red RO drain line/hose was not the product (treated) RO water used for the patient dialysis treatment and that the water from the RO drain line/hose included RO water rejected by the RO. During interview on 2/24/12 at 2:30 PM, the Biomed Technician and the Lead Dialysis Nurse verified staff should not use the RO water from the RO red line/hose to rinse the bicarbonate and acid wands.

2. Observation and staff interview showed staff did not disinfect the inside of the dialysis machine prime waste container at the end of the patient dialysis treatment.

a. The CDC MMWR Recommendations and Reports, titled "Recommendations for Preventing Transmission of Infections Among Chronic Hemodialysis Patents," dated April 27, 2001 included in part, "... Discard all fluid and clean and disinfect all surfaces and containers associated with the prime waste (including buckets attached to the machines)..."

b. The facility had a policy and procedure titled "CLEANING," with a facility revised date of 12/11, which stated in part, "... POLICY Cleaning will be done by a trained dialysis nurse to ensure optimum safety for the dialysis patient... PROCEDURE... 1. The exterior of the machine is cleaned with a ... bleach solution... All surfaces, including... all other equipment... on the dialysis machine..."

c. Observation and interview on 2/23/12 at 12:55 PM with RN DD showed RN DD did not disinfect the inside of the prime waste container at the end of the patient dialysis treatment. Interview with RN DD showed RN DD rinsed the prime waste container with RO water at the end of the patient dialysis treatment.

d. Observation and interview on 2/24/12 with RN DA showed RN DA did not disinfect the inside of the prime waste container at the end of the patient dialysis treatment. Interview with RN DA verified that staff did not disinfect the inside of the prime waste container.

e. During interview on 2/24/12 at 2:30 PM with the Lead Dialysis Nurse and Manager, the Lead Dialysis Nurse acknowledged the findings and that the observed practice did not ensure disinfection of all surfaces of the prime waste container.