HospitalInspections.org

Based on observation, document review and staff interview, the hospital staff failed to secure patient information from unauthorized access in the Cardiac Catheterization (Cath) Lab. The Cardiac Cath staff identified approximately 12 patients/procedures daily.

Failure to secure medical records placed patients at risk for identity theft and unauthorized people access to patient's sensitive personal and medical information.

Findings include:

1. Observation during a tour of the Cardiac Catheterization department on 10/19/10 at 10:30 AM revealed a medical record shelving unit with six three-ring-binders containing confidential patient information, that included: patient name; date of birth; procedure performed; and diagnosis, on a desk in Registered Nurse (RN) K's office. At the time of the observation, RN K reported storing patients' confidential information in their office. RN K stated, "I get the charts ready in advance every day, so we're up and running when the first patient arrives."

a. When interviewed on 10/19/10 at 10:45 AM, RN K stated housekeepers "have access to patient's medical records" and at times Cardiac Catheterization staff did not supervise housekeeping staff while housekeeping staff cleaned the office. Staff K stated, "[Staff M] is our regular housekeeper, ... this probably isn't good but this is what is done."

b. During an interview on 10/21/10 at 1:25 PM, Staff L, Accreditation Coordinator verified housekeeping staff have unauthorized access to patient's medical record information in the Cardiac Cath lab. Staff L stated, "They've identified that environmental [housekeeping] staff have unauthorized access to medical records before and nothing has been put into policy." Staff L reported there were "two ways" to address this, "we can either change the [housekeeping] schedule" or "lock up the records when staff are not in the area."

c. In a follow up interview, on 10/21/10 at 3:00 PM, Staff L reported that until July of 2010, the hospitals' Health Information Management (HIM) department had a policy that required restricted access to patient records to authorized staff. Authorized staff did not include environmental (housekeeping) employees. In July 2010, that policy "was merged" with another HIM policy and the decision "was made" not to restrict access to confidential patient information to unauthorized staff.

I. Based on review of policies, procedures, documents, observation and staff interview, the hospital failed to ensure CSA (Contracted Services A):

1. Had a system in place that provided guidance for the staff responsible for the water treatment system regarding the acceptable limit for the water quality alarm.
2. Staff flushed the portable RO (reverse osmosis) after each patient dialysis treatment in accordance with the manufacturer's recommendations.
3. Staff completed the final negative disinfection residual verification prior to use of the portable RO in accordance with CSA's procedure.
4. Staff consistently tested for residual disinfectant, for the secondary verification of negative residual, from the same sample ports/sites after disinfection of the multi-station water treatment system.

Failure to have a system in place that identifies the acceptable parameters for the water quality alarm could potentially cause staff to document an unacceptable result, then not recognize this as unacceptable and allow the dialysis treatment to continue and expose all the dialysis patients to unsafe water contaminants. Because of the massive amounts of water dialysis patients' encounter, if the water quality is outside the acceptable limits, patient illness and/or death could occur.

Failure to follow the manufacturer's recommendations and flush the portable RO after each patient treatment could potentially cause contaminants to foul the RO membrane. The RO membrane removes harmful contaminants from the water to provide dialysis quality water for the dialysis treatments. In the acute (hospitalized) patients setting staff frequently have to provide immediate dialysis treatments to prevent poor outcomes for very ill patients. If a fouled RO membrane causes malfunctions during the dialysis set up, delay to the dialysis treatments could occur. Delay to the dialysis treatments could potentially cause severe symptoms and/or death to the dialysis patient.

Failure to complete the final residual disinfectant procedure prior to use of the dialysis equipment could cause inadvertent patient exposure to the disinfectant, which could then cause hemolysis. Hemolysis ruptures the red blood cells and causes severe anemia and/or hyperkalemia. Hyperkalemia or high potassium can cause cardiac arrest.

The hospital's census was 9 acute hemodialysis and 2 peritoneal dialysis patients at the time of the survey. Findings for review of 1 of 1 water treatment system and 1 of 2 portable ROs include:

1. Review of CSA's policy titled "WATER QUALITY MONITORING FOR MULTI-STATION (NON-PORTABLE) WATER TREATMENT SYSTEMS" Policy: 7-12-28, dated September 2009, included in part, "... PURPOSE: To ensure the dialysis water system operates safely and produces dialysis quality water through observations and/or testing of specific component performance parameters. ...All observations and test results will be within the limits specified on the Daily Treatment Log. If observations or test results are found outside the specified limits, follow instructions given on the Daily Treatment Log for the parameter(s) in question. ..."

a. Review of the documents identified by CSA as the logs used by staff to document the daily acceptable limits for the water treatment system showed areas that identified the acceptable limits for all the water components and areas to document the actual results for the water components. The "Final Product Water Quality" acceptable limits were listed as "Green Light/Red Light".

b. The final product water quality shows staff the quality result for the water used for dialysis treatments. Observation during the course of the survey showed a final product water quality alarm located in the multi-station dialysis room. Further observation showed this alarm had 2 colors, green and red. The alarm remained green during the course of the survey.

c. During an interview on 10/15/10 at 10:20 AM, CSA's Area Biomed Supervisor reported the light turned green for acceptable quality and red for unacceptable quality. CSA's Area Biomed Supervisor went on to agree that the acceptable limit for the final water quality was green, not red and the log should provide staff with the acceptable limits to prevent confusion if the final product water quality changed from acceptable to unacceptable. CSA's Area Biomed Supervisor went on to report changing the log to identify the green light as the acceptable limit.

2. Review of CSA's policy titled "REVERSE OSMOSIS (RO) WATER TREATMENT SYSTEM MAINTENANCE AND REPAIR" Policy: 7-12-14, with a revision date of September 2009, included in part, "...To ensure optimal reverse osmosis (RO) water treatment system performance. ... RO systems will be maintained in accordance with manufacturer's recommendations ..."

a. Review of the manufacturer information for the 2 portable ROs that CSA staff used to provide dialysis quality water at the patient bedside titled "Better Water, Inc." showed the manufacturer recommended a 15-minute flush procedure following every treatment to remove suspended particles from the membrane surface. The manufacturer's recommendations went on to suggest this procedure would extend the membrane life.

b. Review of the documents titled "Better Water Portable R.O. Log", with a revision date of 8/11/09 from 6/2/10 through 10/13/10 for R.O. Serial number 27027 showed that 5 of 31 entries identified as documentation before, during and/or after patient treatments failed to reflect the completion of the 15-minute flush following the dialysis treatment.

c. The "Better Water Portable R.O. Log"s had an area where the staff documented if the entry reflected results obtained regarding use of that machine for a patient treatment. In addition, the logs included an area where staff documented if the 15-minute post patient treatment flush was completed. The document directed staff to either document yes or NA (not applicable). Review of the logs for the RO with the serial number 27027 from 6/2/10 through 10/13/10 showed the following:

On 7/7/10, a date identified as information documented for a patient treatment, the area where the 15-minute flush documentation should occur, remained blank.

On 9/25/10 at 9 AM, a date identified as information documented for a patient treatment, the area where the 15-minute flush documentation should occur, had NA.

On 9/25/10 at 2:50 PM, a date and time identified as information documented for a new patient treatment, the area where the 15-minute flush documentation should occur had documentation that remained illegible.

On 10/2/10, a date identified as information documented for a patient treatment, the area where the 15-minute flush documentation should occur, remained blank.

On 10/4/10, a date identified as information documented for a patient treatment, the area where the 15- minute flush documentation should occur, remained blank.

d. During an interview on 10/15/10 at 10:45 AM, RN (Registered Nurse) DE reported when staff used the Better Water ROs to perform bedside dialysis treatments, the documentation should reflect the completion of the 15-minute flush following each patient treatment.

During an interview on 10/15/10 at 3:00 PM, the CSA Facility Administrator acknowledged, the documentation on the Better Water RO logs did not always reflect the completion of the required 15- minute flush after the patient dialysis treatments.

3. CSA had documentation that reflected the disinfection process for the portable ROs. The documentation titled "Portable RO System Peracetic Acid Disinfection Log Sheet" had areas where staff documented the results of the negative residual disinfectant tests. The logs had 2 areas for staff to document the negative results on the date the disinfection occurred. In addition, the log had 1 area for staff to document negative residual disinfectant results prior to using the portable RO for a patient treatment. Staff could obtain negative residual disinfectant tests on the day of the disinfection, however the disinfectant could rebound to a positive result at a later time. The safe guard for the patient occurs when staff complete and document the residual disinfectant test just prior to using the equipment. If staff fail to ensure absence of the residual disinfectant, dialysis patients could be exposed to this disinfectant. Exposure to the disinfectant could cause severe illness and/or death.

a. Review of the disinfection logs for the portable ROs showed the area where the negative residual disinfectant test verification should occur. Further review showed the log included "NOTE: PATIENTS MAY NOT BE DIALYZED UNTIL NEGATIVE RESIDUAL TEST IS VERIFIED" just above where staff should document the final verification.

b. Review of the logs from 1/15/09 through 9/15/10 showed the log dated 7/7/10 remained blank in the area where the documentation should reflect a negative residual disinfection result just prior to use.

c. During an interview, on 10/15/10 at 3:00 PM, the CSA Facility Administrator acknowledged staff should always complete and document the negative residual disinfectant test prior to use of the equipment.

4. Interview with staff and review of the water treatment system disinfection logs for the acute inpatient dialysis unit showed the staff did not consistently test for residual disinfectant, for the secondary verification of negative residual, from the same sample ports/sites after disinfection of the multi-station water treatment system.

a. Review of the facility forms titled "Portable RO System Disinfection Log Sheet," from 4/2010-9/2010, and interview with the CSA's Area Biomed Supervisor on 10/15/10 at 10:20 AM showed Biomed staff disinfected the water treatment system and distribution loop, which included the water line to the bicarbonate mixing tank, at least every month. Continued review of the forms titled "Portable RO System Disinfection Log Sheet" and interview with the CSA's Area Biomed Supervisor showed Biomed staff tested for residual disinfectant with the disinfection rinsing procedure and that dialysis staff performed a secondary test for residual disinfectant, a secondary verification of negative residual, prior to using the RO water for preparing the bicarbonate concentrate solution in the mixing tank and for the patient dialysis treatments.

b. However, interview with dialysis staff showed staff did not consistently test for residual disinfectant, for the secondary verification of negative residual, from the same water ports/sites. For example, interview on 10/12/10 at 1:40 PM with RN DB and on 10/13/10 at 1:05 PM with PCT (Patient Care Technician) DH showed these staff did not perform the residual disinfectant test for the bicarbonate mixing tank. Interview on 10/13/10 at 10:15 AM with PCT DG showed PCT DG performed the residual disinfectant test for the bicarbonate mixing tank. In addition, interview on 10/13/10 at 1:05 PM with PCT DH showed staff used a pink hose connected to a RO water port in the water treatment system room to rinse the individual bicarbonate containers with RO water. Continued interview with PCT DH showed PCT DH did not test for residual disinfectant from the pink hose. Interview on 10/13/10 at 10:15 AM with PCT DG showed PCT DG tested for residual disinfectant from the pink hose in the water treatment system room.

c. Interview on 10/15/10 at 10:20 AM with the CSA's Area Biomed Supervisor showed dialysis staff should perform the secondary verification test for residual disinfectant from the same ports/sites, including testing for residual disinfectant for the bicarbonate mixing tank. During continued interview, the CSA's Area Biomed Supervisor reported prior to the survey the facility had a written procedure in place which addressed the disinfection procedure for the water treatment system and distribution loop, including the ports/sites to test for residual disinfectant. However, the CSA's Area Biomed Supervisor reported during the survey the facility could not find the written procedure and had re-written the procedure during the survey.



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II. Based on observation and staff interview, the hospital failed to ensure the storage of patient care supplies and items in manner that assured safety and quality with separation of clean and unclean supplies and items or areas, failed to ensure a clean storage area and room, and failed to ensure security of a storage room or supplies from unauthorized access.

Failure to separate clean from unclean items or supplies or to ensure a clean storage area could potentially cause contamination of the clean items or supplies used for the patient dialysis treatment which could cause patient illness.

Failure to secure a room containing supplies for the dialysis treatments could potentially allow unauthorized persons access to the room and allow tampering of the supplies by the unauthorized persons which could result in patient harm or illness if the facility used the tampered with supplies for the patient dialysis treatments.

The hospital's acute dialysis census was 9 hemodialysis patients and 2 peritoneal dialysis patients at the time of the survey. The facility had 5 storage rooms holding acute care dialysis supplies and items. Findings for 3 of 5 storage rooms (storage room #1, the fourth floor storage room, and the storage room on level C) and for 1 of 1 water treatment system room containing supplies and items used for dialysis include:

1. Observation and interview on 10/11/10 beginning at 3:00 PM during tour of the acute care dialysis areas with the CSA Facility Administrator and the Executive Director for Medical Surgical revealed the following:

a. Observation of storage room #1 showed a metal storage shelving unit holding supplies and items. The shelves of the unit had spaces between the metal pieces/strips which made up each shelf. Observation revealed the metal pieces/strips of the shelves had a buildup of white particles present. Further observation showed biomedical supplies, including a used short handled broom/sweeper, stored in an open container on a shelf. In addition, a container holding the biomedical supplies and 2 other containers, holding supplies to test the water used for the dialysis treatments, had dust buildup on the top edges of the containers. Continued observation revealed patient care supplies, such as 2 boxes of pediatric bloodlines and 2 boxes of continuous renal replacement solution, stored below the biomedical supplies and containers that had dust present.

b. Observation of the storage room on the fourth floor showed a metal storage shelving unit that held 6 bicarbonate containers. (When used for the dialysis treatment, bicarbonate containers hold bicarbonate concentrate solution.) Observation of the inside of the bicarbonate containers revealed the containers were dry with particles and clumps of white particles present. Observation showed patient care supplies and items such as boxes holding Prisma tubing (tubing used for the continuous renal replacement therapy dialysis treatment) stored on the same shelf as the bicarbonate containers.

c. Observation of the storage room on lower level C showed the storage room door, located in a public hallway, open and the room unsecured from unauthorized use. The storage room had 4 barrels of acid, boxes holding bottles of bicarbonate concentrate solution and packets of bicarbonate powder, boxes holding bottles of acid concentrate solution, and boxes holding bottles of 5% (percent) acetic acid. Observation revealed the boxes set on pallets however, the floor of the room had a heavy buildup of sand-like particles. In addition, the light colored wall behind the boxes holding the bottles of acetic acid and barrels of acid, had brown streaks down the wall, appearing as if a leak had occurred and a substance dripped/ran down the wall.

d. During tour of the facility on 10/11/10 beginning at 3:00 PM, the CSA Facility Administrator and Executive Director of Medical Surgical acknowledged and verified the findings. Interview with the CSA Facility Administrator on 10/13/10 at 4:05 PM showed the facility should separate the clean items and supplies or areas from the unclean items and supplies and that the facility should maintain secure and clean storage rooms.

2. Observation and interview in the water treatment system room showed the facility failed to separate or protect cleaned bicarbonate and acid wands from potential contamination from the splashes or spattering that could occur from the dirty sink/utility sink located directly next to the cleaned bicarbonate and acid wands.

a. Observation on 10/12/10 at 1:40 PM in the water treatment system room showed bicarbonate and acid wands stored in a vertical position on a unit directly next to the sink labeled "DIRTY SINK."

b. During interview on 10/13/10 at 11:30 PM, the CSA Facility Administrator and PCT DG reported that staff primarily used the dirty sink/utility sink for rinsing the bicarbonate containers and wands.

c. Interview on 10/12/10 at 1:40 PM with RN DB showed after use for patient treatments, the facility's procedure included rinsing the bicarbonate and acid wands with RO water and placing the wands on a holder, suspending the wands in a vertical position, directly next to the dirty sink/utility sink. In addition, interview on 10/12/10 at 2:20 PM with PCT DH showed once a week staff disinfected the bicarbonate containers and wands with a bleach solution, rinsed the containers and wands with RO water, and then placed them on the unit directly next to the dirty sink/utility sink. (Splashes and splatters from the sink during the disinfecting, cleaning, or rinsing of items in the sink could reach the bicarbonate and acid wands placed directly next to the sink and potentially contaminate the wands. During the dialysis treatment, staff placed the wands in the bicarbonate and acid solution and the dialysis machines pulled the solution into the dialysis machine for the dialysis treatment.)

d. During interview on 10/13/10 at 11:30 PM, the CSA Facility Administrator acknowledged the findings and showed the facility was evaluating a system to separate or move the cleaned wands from the dirty sink/utility sink.


III. Based on review of manufacturer's information, documentation, observation, and staff interview, the hospital failed to ensure:

1. The RO reading displayed for the product water quality occurred in accordance with the manufacturer's recommendations.
2. Completion of the preventive maintenance for the RO located in the water treatment system room in accordance with the manufacturer's information.
3. Evaluation of a quality control procedure for the water hardness test strips as indicated in the test strip manufacturer's information.
4. Completion of an annual preventive maintenance test for the backflow preventers for the acute inpatient unit's water treatment system in accordance with the facility's planned frequency.

RO machines are used in hemodialysis to purify the water needed for the patient dialysis treatment. Failure to complete the preventive maintenance for the RO or to have the product water quality reading displayed on the RO in accordance with the manufacturer's recommendations could potentially result in the facility's failure to identify a problem with the RO or the RO water, potentially allowing the use of faulty equipment or poor quality water during the dialysis treatments which could result in patient harm.

Water hardness test strips provide a means of testing the level of hardness of the water treatment process. Hard water deposits can damage sensitive RO membranes. RO machines are used in hemodialysis to purify the water needed for the patient dialysis treatment. If a facility's RO did not function, patient dialysis treatments could be delayed which could cause adverse patient outcomes. Performing quality control procedures can increase user proficiency, provide the user with a warning of a possible test strip error, potential use of outdated test strips, or improperly stored or handled test strips.

Backflow prevention devices prevent water from flowing backward into the incoming municipal water supply. Most cities require installation of a backflow preventer at the start of the water treatment system. Failure to complete the preventive maintenance test for the backflow preventers could potentially result in the facility's failure to identify a problem with the backflow preventers which could result in reduction of water flow and pressure to the RO, potentially resulting in the RO not functioning effectively to produce the water needed for the patient dialysis treatments.

The hospital's acute dialysis census was 9 hemodialysis patients and 2 peritoneal dialysis patients at the time of the survey. Findings for 1 of 1 acute inpatient dialysis unit multi-station water treatment system include:

1. Observation and staff interview showed the facility failed to ensure the RO reading displayed for the product water quality occurred in accordance with the manufacturer's recommendations.

a. Observation in the water treatment system room on 10/14/10 at 9:50 AM and review of the logs used by staff to document the daily monitoring and checks completed by staff for the water treatment system showed the product water quality reading displayed on the RO and documented on the log in ppm (parts per million).

b. Interview and observation on 10/14/10 at 9:50 AM with CSA's Area Biomed Supervisor showed the set point for the RO programmed in microsiemens and the displayed reading on the RO for the product water quality monitoring, documented by staff each treatment day on a log, was in ppm. Interview on 10/15/10 at 10:20 AM with CSA's Area Biomed Supervisor showed the CSA's Area Biomed Supervisor had contacted a representative for the RO manufacturer, after the interview on 10/14/10 at 9:50 AM with the surveyor, and the representative informed CSA's Area Biomed Supervisor that the RO product water quality reading needed to measure in microsiemens not ppm. Continued interview with the CSA Area Biomed Supervisor showed the manufacturer's representative instructed the CSA's Area Biomed Supervisor to change the RO product water quality measure/reading to microsiemens. Further interview with the CSA Area Biomed Supervisor showed the CSA Area Biomed Supervisor had changed the RO measure/reading to microsiemens, including changing the acceptable value for the product water quality to microsiemens on the log used by staff to document the daily water quality reading.

2. Review of the manufacturer's information for the RO in the acute inpatient dialysis unit and interview with staff showed the facility did not complete the preventive maintenance for the RO in accordance with the manufacturer's information.

a. Observation in the water treatment system room on 10/11/10 at 4:15 PM with the CSA Facility Administrator showed the acute inpatient dialysis unit had an AmeriWater RO. The manufacturer's information for the AmeriWater RO titled "AmeriWater PORTABLE RO+ OPERATION & MAINTENANCE MANUAL" included in part, "7.1 MAINTAINING THE SYSTEM... 8. The accuracy of the Conductivity display should be verified with a calibrated, hand-held meter at least annually... Conductivity may also be verified each time an AAMI (Association for the Advancement of Medical Instrumentation) analysis is done by noting the conductivity readings when the AAMI sample is drawn and verifying the reading with the AAMI results."

b. Interview on 10/15/10 at 2:30 PM with the CSA Area Biomed Supervisor verified the manufacturer's information and showed the facility completed preventive maintenance of the RO on a routine schedule. However, continued interview with the CSA Area Biomed Supervisor showed the facility's preventive maintenance did not include verifying the RO Conductivity display with a hand-held meter or comparing the conductivity readings with the AAMI results as specified in the manufacturer's information.

3. Observation, review of manufacturer's information, and staff interview showed the facility failed to evaluate a quality control procedure for the water hardness test strips as indicated in the test strip manufacturer's information.

a. Observation on 10/13/10 at 10:15 AM in the water treatment system room for the acute inpatient dialysis unit showed the facility used HACH SteriChek Sensitive Low-Range Water Hardness test strips to test the water, used for the patient dialysis treatments, for hardness.

b. The manufacturer's information for the "SteriChek Sensitive Low-Range Water Hardness Reagent Strips" included in part, "For Quality Control: Each facility should determine its own quality control procedure. Samples of untreated feed water and water at the post-treatment stage can be used as "reactive" controls. Typically, feed water will display high levels of hardness in contrast to the purified water at the post-treatment stage. Testing the two samples with several SteriChek Low-Range Water Hardness Test Strips will allow the user to observe and characterize the performance of the strips. Regular use of Quality Control procedures will increase user proficiency, and will provide the user with a warning of a possible test strip error, potential use of outdated test strips, or of improperly stored or handled test strips..."

c. Interview on 10/15/10 at 3:00 PM with the CSA Facility Administrator verified the manufacturer's information for the SteriChek Sensitive Low-Range Water Hardness Reagent Strips and showed the facility had not performed or evaluated a quality control procedure for the test strips as indicated in the manufacturer's information.

4. Review of documentation and staff interview showed the facility did not complete an annual preventive maintenance test for the backflow preventer for the acute inpatient unit water treatment system in accordance with the facility's planned frequency.

a. Observation in the water treatment system room on 10/13/10 at 10:15 AM showed the water treatment system had 2 backflow preventers.

b. Review of documentation showed the facility's plan included completing a preventive maintenance inspection annually. Documentation on the forms titled "Preventive - Asset" with "Orig: Date: 5/26/2009" showed preventive maintenance completed on 6/4/09 for the 2 backflow preventers. Documentation on the forms with "Orig: Date: 1/13/2010" included "ANNUAL BACKFLOW TEST - TEST DUE BY 01/30/2010," however documentation on the forms showed preventive maintenance completed for the 2 backflow preventers on 10/13/10.

c. During interview on 10/15/10 at 1:50 PM, the CSA Facility Administrator verified the facility plan included annual preventive maintenance for the backflow preventers and acknowledged that preventive maintenance did not occur annually.


IV. Based on review of manufacturer's information, documentation, observation, and staff interview, the hospital failed to ensure:

1. The facility's normal range for conductivity for the prepared bicarbonate concentrate solution matched the range specified by the bicarbonate manufacturer.
2. The second teammate (staff) verified the mixed/prepared bicarbonate concentrate solution as specified on the facility form.
3. Staff mixed the bicarbonate solution for the same amount of time when preparing/mixing the bicarbonate concentrate solution in the mixing tank and that the facility's written procedure specified an amount of time to mix the bicarbonate solution.

Bicarbonate concentrate solution is part of the dialysate used for the patient dialysis treatments. Failure to have a normal range specified for the bicarbonate concentrate solution that matched the manufacturer's information or failure to obtain a secondary verification could result in failure of staff to identify a concern with the bicarbonate concentrate solution used for the patient dialysis treatment which could cause the dialysis machine to malfunction, delays for the dialysis treatment, and harm to the patient or patient illness.

Over-agitation or mixing of bicarbonate concentrate solution may result in loss of carbon dioxide from the solution. Loss of carbon dioxide results in an increase in pH which can lead to precipitation of calcium and magnesium carbonate in the fluid pathways of the dialysis machine following dialysate preparation. Use of over-mixed bicarbonate concentrate solution can result in a low calcium level in the dialysate and cause a drop in the calcium level in the patient's blood which can result in patient harm, such as an irregular heartbeat and patient death.

The hospital's acute dialysis census was 9 hemodialysis patients and 2 peritoneal dialysis patients at the time of the survey. Findings for 1 of 1 acute inpatient dialysis unit bicarbonate mixing tank include:

1. Review of manufacturer's information, documentation, and staff interview revealed the facility's normal range for conductivity for the prepared bicarbonate concentrate solution did not match the range specified by the bicarbonate manufacturer.

a. Interview on 10/12/10 at 1:40 PM with RN DB and at 2:20 PM with PCT DH showed each patient treatment day staff mixed/prepared bicarbonate concentrate solution in a mixing tank for the patient dialysis treatments and documented the procedure on the form titled "Rockwell Bicarb Mixing Log-Conductivity and pH." Continued interviews with RN DB and PCT DH showed after mixing the bicarbonate concentrate solution, staff checked the conductivity and pH of the solution to ensure the conductivity and pH values were within the acceptable range.

b. Review of the forms used by staff to document preparation and mixing of the bicarbonate concentrate solution titled "Rockwell Bicarb Mixing Log-Conductivity and pH" showed the forms included acceptable normal ranges for the conductivity and pH of: "Bicarb Cond. (conductivity) (45.0-65.0 uS/cm) (microsiemens/centimeter)... Normal Range: 45.0-65.0 (uS/cm)" and "Bicarb pH (7.5 to 8.5 pH)... Normal Range:... 7.5 to 8.5 pH."

c. Review of documentation from the bicarbonate manufacturer, in a printed e-mail presented for review by the facility and dated 10/14/10 with the subject of Conductivity, showed the range for the prepared bicarbonate concentrate solution specified by the manufacturer was a smaller range than the normal range used by the facility. The e-mail included in part, "Subject: Conductivity The following ranges have been established for reconstituted bicarbonate concentrate:... Lower Limit (mS/cm) (millisiemens/centimeter)... 49.2... Upper Limit (mS/cm)... 52."

d. Interview on 10/15/10 at 10:20 AM with CSA's Area Biomed Supervisor verified the findings that the facility's normal range for conductivity for prepared bicarbonate concentrate solution did not match the acceptable ranges specified by the bicarbonate powder manufacturer. During the interview, CSA's Area Biomed Supervisor reported the facility's normal range should match the manufacturer's range.

2. Review of documentation and staff interview showed the staff failed to document the second teammate (staff) verification for the mixed/prepared bicarbonate concentrate solution as specified on the facility form.

a. The forms used by staff to document the mixing and preparation of the bicarbonate concentrate solution titled "Rockwell Bicarb Mixing Log-Conductivity and pH" included a column for staff to document "Second teammate verification." Review of the "Rockwell Bicarb Mixing Log-Conductivity and pH" forms, dated 7/2/10-10/14/10, showed staff had not completed documentation in the column "Second teammate verification" (the column remained blank).

b. Interview on 10/15/10 at 10:20 AM with CSA's Area Biomed Supervisor verified the lack of documentation in the column "Second teammate verification" on the facility form. Continued interview with the CSA's Area Biomed Supervisor showed a second teammate should verify the information specified on the log prior to using the bicarbonate concentrate solution for patient treatments and document the verification in the column "Second teammate verification."

3. Observation, review of manufacturer's information, and staff interview showed staff did not mix the bicarbonate solution for the same amount of time when preparing/mixing the bicarbonate concentrate solution in the mixing tank and that the facility's written procedure did not specify an amount of time to mix the bicarbonate solution.

a. I

II. Based on review of policies and procedures, observation and staff interview, the hospital failed to ensure the chairs at the nurses station had intact surfaces or remained free from rips and/or tears and that the hospital maintained the surfaces of the walls with intact surfaces to ensure cleaning and disinfection of the walls and chair surfaces. In addition, the hospital failed to ensure staff disinfected the inside of the dialysis machine prime container after every dialysis treatment in accordance with the facility's policy.

Failure to maintain the chair coverings and walls with intact surfaces failed to ensure adequate cleaning and disinfection of the chairs and walls and could potentially cause cross contamination to occur. Failure to disinfect the inside of the prime container could result in cross contamination to the patients receiving a dialysis treatment on that dialysis machine.

The hospital's acute dialysis census was 9 hemodialysis patients and 2 peritoneal dialysis patients at the time of the survey. Findings for 1 of 1 acute inpatient dialysis unit include:

1. Observations in the acute inpatient dialysis unit on 10/13/10 at 1:00 PM showed the following:

a. The wall by the side of station #5 had chipped and bubbled paint near the base of the wall, approximately 2 feet long and 2-3 inches high.

b. The wall by the side of station #1 had areas of chipped paint.

c. The wall by the dirty sink/utility sink in the water treatment system room had areas of chipped paint by the top and side area of the sink.

d. During interview on 10/13/10 at 4:05 PM, the CSA Facility Administrator acknowledged and verified the findings and that failure to maintain the chair covering and walls with intact surfaces did not ensure adequate cleaning and disinfection of the surfaces could occur.

2. Observation and review of policies and procedures revealed that staff did not disinfect the inside of the dialysis machine prime container after every dialysis treatment in accordance with the facility's policy.

a. The facility had a policy titled "INFECTION CONTROL IN THE HOSPITAL DIALYSIS SETTING" (Revision Date: 9/2010) which stated in part, "... 2. Teammates will thoroughly wipe down all non-disposable items and equipment such as... the inside and outside of the prime container... with an appropriate disinfectant after every treatment..."

b. However, observation in the acute inpatient dialysis unit showed staff did not consistently wipe the inside of the prime container with a disinfectant after every treatment in accordance with the facility's policy.

i.) Observation on 10/12/10 at 1:00 PM with PCT DH showed PCT DH disinfecting the dialysis machine after Patient D3's dialysis treatment. Observation showed PCT DH did not wipe the inside of the prime container with the disinfection procedure.

ii.) Observation on 10/12/10 at 1:15 PM with PCT DH showed PCT DH disinfecting the dialysis machine after Patient D6's dialysis treatment. Observation showed PCT DH did not wipe the inside of the prime container with the disinfection procedure.

c. During interview on 10/13/10 at 4:05 PM, the CSA Facility Administrator acknowledged and verified the findings and showed that staff should disinfect the inside of the prime container after every patient dialysis treatment.








Surveyor: Wendehl, Sandra E.
I. Based on review of policies and procedures, manufacturer's information, observation and staff interview, the facility failed to ensure CSA's (Contracted Services A's) policies and procedures reflected the manufacturer's recommendations regarding staff's use of the disinfectant used to cleanse the dialysis catheter connections prior to initiation of the dialysis treatment and prior to disconnection from the bloodlines following the dialysis treatment.

Failure to ensure the policies and procedures and staff practice reflect the manufacturer's recommendations for the disinfectants used for the dialysis catheter could potentially cause bacterial contaminants to remain on the dialysis catheter and then migrate to the interior of the dialysis catheter. The dialysis catheter provides direct access to the bloodstream. Bacterial contaminants that enter the patient's bloodstream could cause severe illness and/or death to the dialysis patient.

The hospital's acute dialysis census was 9 hemodialysis and 2 peritoneal dialysis patients at the time of the survey. Findings for 2 of 3 patient treatment days observed (10/12/10 and 10/13/10) include:

1. Review of CSA's procedure titled "POST DIALYSIS CENTRAL VENOUS CATHETER (CVC) CARE AND LOCKING SOLUTION INSTALLATION" Procedure: 7-04-02D, with a revision date of September 2009, and CSA's procedure titled "PREDIALYSIS CENTRAL VENOUS CATHETER (CVC) CARE," Procedure: 7-04-02A, with a revision date of September 2009, showed when the disinfectant "Alcavis 50%" was used to disinfect the dialysis catheter connections, an effective contact time was 60 seconds. Further review of this procedure showed staff should scrub and soak the bloodline connections in accordance with the manufacturer's recommendations.

2. Review of the manufacturer's information for "ALCAVIS 50", the disinfectant identified by CSA as the disinfectant used to disinfect the dialysis catheter lumens prior to connection and disconnection to and from the bloodlines, showed the manufacturer recommended staff to scrub the dialysis ports for 1 minute and then wrap and soak each port for 1 minute.

3. Observation on 10/13/10 at 10:40 AM showed RN (Registered Nurse) DE wearing a protective gown, gloves and mask returning the patient's blood following the hemodialysis treatment. The patient was lying in the bed next to the hemodialysis machine labeled as #6. Continued observation showed RN DE wrapped and soaked the dialysis catheter ports with "ALCAVIS 50" for greater than 2 minutes and then scrubbed the arterial port for 10 seconds and the venous port for 7 seconds.

Observation on 10/13/10 at 11:15 AM showed RN DE wearing a protective gown, gloves and mask returning the patient's blood following the hemodialysis treatment. The patient was lying in the bed next to the hemodialysis machine labeled as #5. Continued observation showed RN DE wrapped and soaked the dialysis catheter ports with "ALCAVIS 50" for greater than 2 minutes and then scrubbed the arterial port for 6 seconds and the venous port for 3 seconds.

Observation on 10/13/10 at 11:31 AM showed PCT (Patient Care Technician) DG wearing a protective gown, gloves and mask returning the patient's blood following the hemodialysis treatment. The patient was lying in the bed next to the hemodialysis machine labeled as #4. Continued observation showed PCT DG wrapped and soaked the dialysis catheter ports with "ALCAVIS 50" for greater than 2 minutes and then failed to complete any scrub to the dialysis catheter ports prior to disconnecting the dialysis catheter port from the bloodlines.

4. Observation on 10/12/10 at 11:25 AM showed PCT DH wearing a protective gown, gloves and mask preparing Patient D2's catheter for initiation of the hemodialysis treatment. Observation showed prior to removing each catheter cap for initiation of the dialysis treatment, PCT DH wrapped and soaked one catheter port and capped end with "ALCAVIS 50" for approximately 1 minute and 10 seconds and the other catheter port and capped end with "ALCAVIS 50" for approximately 45 seconds. Continued observation showed PCT DH did not scrub the catheter ports and capped ends with the procedure.

Observation on 10/12/10 at 12:43 PM showed PCT DH wearing a protective gown, gloves and mask returning the patient's blood at the end of Patient D6's hemodialysis treatment. Continued observation showed PCT DH wrapped and soaked each of the catheter port connections with "ALCAVIS 50" for approximately 1 minute prior to disconnecting the bloodlines from the dialysis catheter ports. Observation showed PCT DH did not scrub the catheter port connections with the procedure.

5. During an interview on 10/15/10 at 3:00 PM, CSA's Facility Administrator acknowledged staff practice and the procedure that staff use for guidance when completing dialysis catheter care did not correlate with the manufacturer's recommendations for the disinfectant used to disinfect the dialysis catheter ports. In addition, CSA's Facility Administrator agreed because of this, CSA's staff were not following manufacturer's recommendations.




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