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The facility failed to ensure an effective governing body that is legally responsible for the conduct of the hospital, as evidence by failing to ensure contracted dialysis services at the facility were provided in a safe and effective manner. The facility contracts with Axis/Core Dialysis for dialysis services at their Austin and Round Rock locations.

1. The facility failed to ensure that a safe and sanitary environment in the dialysis areas was maintained to minimize the risk of infections.

2. The facility failed to ensure that all equipment used by a facility, was operated within manufacturer's specifications, and maintained free of defects which could be a potential hazard to patients, staff, or visitors.

3. The facility failed to ensure that the physical space in which the water treatment system is located must be adequate to allow for maintenance, testing, and repair of equipment.

4. The facility failed to ensure that each major water system component shall be labeled in a manner that identifies the device, describes its function, how performance is verified, and actions to take in the event performance is not within an acceptable range.

5. The facility failed to ensure that testing a sample of the product water immediately prior to the final bed of carbon tanks was properly performed. The facility also failed to ensure that water from this port was tested for chlorine/chloramine levels immediately prior to each patient shift.

6. The facility failed to ensure that after chemical disinfection, means shall be provided to restore the equipment and the system in which it is installed to a safe condition relative to residual disinfectant prior to the product water being used for dialysis applications.

7. The facility failed to ensure there was evidence that the medical director has reviewed the results of the water quality testing.

8. The facility failed to ensure that only persons qualified by the education or experience may operate, repair, or replace components of the water treatment system.

Please cross refer to A0084.

The facility contracts with Axis/Core Dialysis for dialysis services at their Austin and Round Rock locations. Based on tour, observation, review of records, and interview, the facility failed to ensure that the contracted services were provided in a safe and effective manner.

Findings:

1. The facility failed to ensure that a safe and sanitary environment in the dialysis areas was maintained to minimize the risk of infections.

According to Healthcare Facilities Today found at https://www.healthcarefacilitiestoday.com/posts/QA-Corrugated-cardboard-boxes--13520, "Cardboard boxes are usually delivered to hospital receiving docks from other shipping dock locations on carts or pallets, prior to arriving into a health care facility. Mice, insects, vermin, dirt with pathogenic organisms can be carried into a hospital within the cardboard boxes used as external shipping cartons. Also, corrugated cardboard boxes can and do shed particles that contribute to dust in hospital environments, whereby microorganisms can hitch a ride. If corrugated cardboard becomes wet, it becomes a source for bacterial growth."


The Centers for Disease Control and Prevention (MMWR, No. RR-5) stated that "the hemodialysis machine and its components also can be vehicles for patient-to-patient transmission of blood borne viruses and pathogenic bacteria (24, 192). The external surfaces of the machine are the most likely sources for contamination. These include not only frequently touched surfaces (e.g., the control panel), but also attached waste containers used during the priming of the dialyzers, blood tubing draped or clipped to waste containers, and items placed on tops of machines for convenience. "


Facility based (contracted dialysis) policy entitled, "Infection Control" stated in part,

"GENERAL INFECTION CONTROL MEASURES:

1. Staff will wash hands before and after each patient contact, before gloving and after glove removal.

2. Handwashing

a. Indications for hand-washing and hand antisepsis

o When hands are visibly soiled

o If hands are not visibly soiled, use an alcohol based hand sanitizer

o Before direct contact with patients

o Before donning gloves for clean I aseptic procedures

o After body fluid exposure

o After contact with patients

o If moving from a contaminated- body site to a clean-body site during patient care

o After contact patient surroundings

o After removing gloves

3. Only the supplies and equipment needed for the current patient treatment will be placed on the delivery system ...

13. No dialysis supplies or medications are used after the expiration date printed on the package, label, or carton ..."


Facility based (contracted dialysis) policy entitled, "Cleaning and Disinfecting- Exterior Surfaces" stated in part,

"2. All exterior surfaces of all delivery systems will be disinfected at the end of each patient treatment before setting up the delivery system for the next patient treatment.

3. A bleach/water solution of 1:100 bleach/water concentration or bleach wipes will be used to disinfect machine surfaces between patients and whenever contaminated with blood or body fluids ...

6. Cleaning and disinfecting of equipment surfaces will be documented daily on the Daily Equipment Log. Completed logs are placed in the Master File."


Facility based (contracted dialysis) policy entitled, "Disinfection of Non-Delivery System Equipment" stated in part,

"6. Cloths or disposable bleach wipes will be utilized for cleaning. Cloths should be soaked in the 1:100 bleach/water solution and wrung out to avoid dripping.

7. All surfaces or reusable equipment that is frequently touched will be cleaned and disinfected daily."


During a tour of the Austin Cornerstone Dialysis storage area on 01/29/20 the following observations of infection control issues were made:

* The one bottle of Myron-L solution was being shared between both locations (Austin and Round Rock). According to staff member #1, another bottle had been ordered but was not available yet..

* 2 bleach containers were observed side by side on a rolling cart. Staff member stated that one was for dirty wands to be cleaned and the other one was to store the bleached/clean wands (labeled clean). The dirty container was not labeled as dirty. These two containers should be stored separately to minimize the risk of cross contamination between clean and dirty.

* 3 external shipping boxes were observed stored above open clean supplies. Storage of supplies in this manner could potentially allow for dirt, debris, and or pests from the outside shipping containers to contaminate clean supplies stored nearby.

* A water damaged cleaning tile, discolored black 1 X 1 foot was observed above the dialysis machine storage areas.

* No electrical outlet was available in this room to plug in and test machines or complete repair or maintenance. Staff member #1 stated that the machines had to be moved to the patient room to plug in to see if there were any issues.


During observation of patient care at the Cornerstone Round Rock dialysis unit on 01/30/20 the following infection control issues were noted:

* In the clean supply closet 2 used PPE gowns were observed hanging up. Staff member #6 placed one of the gowns on to use as PPE for patient care that day. It appeared this was a used PPE gown and that the clean and dirty supplies were not properly separated, increasing the risk for cross contamination.

* While testing for total chlorine, staff member #6 was asked how long they swish the test strip in the sample water for the total chlorine test. This staff member responded "15 seconds." The manufacturer recommendations, it should be exposed for 30 minutes.

* While observing patient care, it was observed that staff member #6 placed several item on top of the dialysis machine. This included 2 saline syringes, 2 empty syringes, and a patient mask for initiating treatment with a catheter.

* While observing patient care, staff member #2 did not consistently practice hand hygiene. During the initiation of dialysis, it was observed that staff did not remove gloves, perform hand hygiene, or don clean gloves between touching the machine and the patient. The staff member touched the machine and continued cleaning the patient's catheter, only changing gloves and not completing hand hygiene. Staff was also noted to directly touch the dialysis machine with a single gloved hand. That gloved hand was then used to apply a glove to the second hand, presenting a risk of contamination.

* During the termination of patient treatment, staff member #6 was observed wiping down the dialysis machine with bleach wipes. The staff member failed to wipe off the laminate forms attached to the IV pole on the machine.

Based on the above findings the facility failed to ensure that the services performed under a contract are provided in a safe and effective manner.


2. The facility failed to ensure that all equipment used by a facility, was operated within manufacturer's specifications, and maintained free of defects which could be a potential hazard to patients, staff, or visitors.

During a tour of the Austin Cornerstone Dialysis storage area on 01/29/20 the following observations were made:

* It was observed none of the 2 dialysis machines and 1 portable RO system had electrical safety test stickers present. Only 1 portable RO system #66495 had a sticker indicating that an electric test had been completed on 07/10/14.

* The portable ROs systems had conflicting dates for re-bedding labeled on the outside. In interview on 01/29/20 staff member #1 was unable identify when the tanks were last replaced or re-bedded at the facility. One portable RO (#105) carbon had a replacement date of 02/2014 noted on a sticker. The other tank had a sticker indicating re-bedding on 07/22/18


During observation of patient care at the Cornerstone Round Rock dialysis unit on 01/30/20 the following was noted:.

* The dialysis machines (#100, 101, 102, and 103) and RO's were labeled with electrical safety test stickers dated 12/2019.


Review of Preventative Maintenance for the facility revealed the following:

* The surveyor initially asked for Preventative Maintenance records for the dialysis machines and portable RO's on the afternoon 01/29/20. These records were not on site and were not provided for review until late in the day on 01/30/20 when personally delivered by biomedical staff #5.


Preventative Maintenance records for Dialysis services at both locations revealed following:

* At the Austin location that the 2 Phoenix Gambro machines had the Phoenix Preventive Maintenance PH 2 Checklist completed for the 2 machines on PH 30216 on 11/10/19 and PH 30215 on 11/12/19. Both under 4000 meter hours. The two RO's had electric leakage testing on 12/11/19.

* At the Round Rock location that the 5 Phoenix Gambro machines had the Phoenix Preventive Maintenance PH 2 Checklist were completed for the 5 machines on PH 29890 on 10/12/19, PH 30218 on 10/13/19, PH 29829 on 10/14/19, and PH 30242 on 10/15/19.

* In an interview on 01/29/20 staff member #5 verified that the carbon tanks on the portable RO's should be re-bedded every six months.

* The surveyor began asking for documentation of carbon tank replacement/or re-bedding dates at the start of the survey on 01/29/20. This was not obtained until prior to the exit conference on 01/31/20.

* The facility was only able to provide documentation that the two portable RO's in Austin were re-bedded on: 01/18/19 and 06/17/19. This means these tanks were overdue for re-bedding in December 2019.

* No documentation was provided by exit to determine when the ROs at Round Rock were re-bedded.

* In interview with staff member #5 (biomedical) on 01/30/2 they verified that the Gambro RO 300 requires the carbon block filter be replaced quarterly.

* The facility was only able to provide documentation that the carbon block filter was exchanged in June 2019. This means this filter was not changed quarterly per manufacturer recommendations.


Based on the above findings the facility failed to ensure that preventive maintenance records were available on site for dialysis staff to review. It took several days for the contracted services to provide the requested maintenance documentation and some was still not available by the time of exit on 01/31/20. Provided documentation supports that the contracted service were not maintaining the dialysis equipment per manufacturer recommendations. Machines and ROs must be properly maintained to provide effective and safe patient care.


3. The facility failed to ensure that the physical space in which the water treatment system is located must be adequate to allow for maintenance, testing, and repair of equipment.

During a tour of the Austin Cornerstone Dialysis storage area on 01/29/20 the following observations were made:

* No electrical outlet was available in this room to plug in and test machines or complete repair or maintenance. Staff member #1 stated that the machines had to be moved to the patient room to plug in to see if there were any issues.

Due to the above finding the facility did not have an electrical outlet to adequately test and repair the dialysis equipment.


4. The facility failed to ensure that each major water system component shall be labeled in a manner that identifies the device, describes its function, how performance is verified, and actions to take in the event performance is not within an acceptable range.

During a tour of the Austin Cornerstone Dialysis storage area on 01/29/20 the following observations were made:

* It was observed that the carbon tanks on the 2 portable RO systems were not labeled as primary and secondary. In an interview staff member #1 stated they thought the one on the left was the primary and the one on the right was the secondary for water test purposes.


During observation of patient care at the Cornerstone Round Rock dialysis unit on 01/30/20 the following was noted:

* The 2 portable ROs were properly labeled primary and secondary.


In an interview on 01/30/20 staff members #1 and #5 verified that without proper labeling of the portable RO carbon tanks it would be difficult for a new staff member to discern the difference, increasing the risk for improper testing of these water components.


5. The facility failed to ensure that testing a sample of the product water immediately prior to the final bed of carbon tanks was properly performed. The facility also failed to ensure that water from this port was tested for chlorine/chloramine levels immediately prior to each patient shift.

Facility based (contracted dialysis) policy entitled, "Residual Chlorine Testing, Serim Residual Chlorine Test Strips" stated in part,

"Procedure: Test strips must be used by the expiration date labeled on the bottle. Each bottle will be labeled with the date it was first opened.

Rationale: Test strips are sensitive to humidity and should be used within the stated time period.
Procedure: Bottles will not be used past manufacturer or labeled expiration dates."


According to manufacturer recommendations for Serim® GUARDIAN (Trademark) HiSENSE ULTRA 0.1 (Trademark) found at https://www.serim.com/docs/5167_HiSENSEUltra0_1ProductProfile.pd stated in part,

"Testing Feed Water:

The water system must be in full operation for at least 15 to 20 minutes before the water sample is collected and tested.

Sample: Fill sample cup with 20 ml of post-carbon water, discard and re-fill with another 20 ml of water.

Test Strip Technique: Immerse indicator pad in water sample and swish vigorously for 30 seconds.

Remove strip, shake off excess sample.

Store bottles of Serim GUARDIAN HiSENSE ULTRA 0.1 Test Strips at temperatures between 15°- 30°C (59°- 86°F). The lot number and expiration date are printed on the bottom of each bottle ...

Each bottle is clearly labeled with:

* Lot number

* Expiration date

* Traceability of product through manufacturing to final user

* Leaves no doubt as to age or integrity of the product"


During a tour of the Austin Cornerstone Dialysis storage area on 01/29/20 the following observations were made:

* It was observed that expired Serim Guardian Hi Sense Ultra 0.1 Total chlorine strips were available for use on the portable RO cart with a manufacturer expiration date of 12/31/19 imprinted on the bottle. In interview, staff member #1 stated, they had been told that strips could be used for a year after the opened date, regardless of manufacturer expiration dates. A bottle of Guardian brand Bicarb pH strips were also observed available that had the printed manufacture expiration dated obscured by permanent marker, therefore it is unknown when these strips expired per manufacturer dating.


During observation of patient care at the Cornerstone Round Rock dialysis unit on 01/30/20 the following was noted:

* While testing for total chlorine, staff member #6 was asked how long they swish the test strip in the sample water for the total chlorine test. This staff member responded "15 seconds" per manufacturer recommendations, this should be exposed for 30 minutes.


Facility based (contracted dialysis) policy entitled "Procedure - Flow Sheet Documentation" stated in part,

"PURPOSE:

To ensure that the patient record accurately reflects all patient data collected and caregiver activities at each treatment and to validate all required patient monitoring and care were provided in a timely manner.

POLICY:

1. Every patient flow sheet will be completed in its entirety. No lines should be skipped or left empty. Any space that does not apply should be filled in with a NA (to denote not applicable) or have a line drawn through the space."


Facility based (contracted dialysis) policy entitled, "Chlorine and Chloramine Monitoring" stated in part,

"PURPOSE:

To provide patient safety by ensuring proper function of chlorine/chloramine removal devices of the water system ...

3. Water testing for total chlorine levels must be done prior to each patient shift during hours of operation. The water system must run at least 15 minutes prior to obtaining the first sample to be tested ...

10. Test results are documented on the Total Chlorine: Water Checklist, which includes date, time, result and signature of the staff member performing the test. Any staff member who has been trained to do the testing may perform the test ...


Review of the water logs and patient treatment sheets revealed that at both locations there were issues with documentation of the total chlorine checks being completed/documented prior to initiating patient treatment.


At Austin Cornerstone Patient #7 had issues with 3 of 8 recent treatments:

* Patient #7 had a treatment started at 0500 on 01/08/20. The chlorine check for the RO was not documented as being done (water turned on) until 0900 after the treatment started.

* Patient #7 had a treatment started at 0500 on 01/10/20. The chlorine check for the RO was not documented as being done (water turned on) until 0830 after the treatment started.

* Patient #7 had a treatment started at 0500 on 01/20/20. The treatment sheet listed #105 machine but the RO was not noted. No total chlorine test was completed on RO#103. The chlorine check for the RO#66495 was not documented as being done (water turned on) until 0930 after the treatment started. It is unknown which RO was used for this patient's treatment.


At Round Rock Cornerstone Patient #7 had the following noted:

* Patient #1 had a treatment started at 0400 on 01/10/20. The chlorine check for the RO was not documented as being done (water turned on) until 0830 after the treatment started.


In an interview on 01/30/20 staff member #1 stated they had entered the above times in error and they conduct the tests prior to initiating patient treatment, however the documentation does not reflect this practice.


Based on the above findings the facility failed to ensure that that the water system was properly tested for chlorine, by using expired testing supplies and improperly conducting the test per interview. The facility also failed to ensure that the chlorine tests were being conducted immediately prior to each patient shift, placing patients at risk that chlorine could have been present during their treatment.


6. The facility failed to ensure that after chemical disinfection, means shall be provided to restore the equipment and the system in which it is installed to a safe condition relative to residual disinfectant prior to the product water being used for dialysis applications.

Facility based (contracted dialysis) policy entitled, "Residual Chlorine Testing" stated in part,

"PURPOSE:

To ensure that residual chlorine levels in hemodialysis delivery systems are below the manufacturer's recommended residual level.

POLICY:

1. After bleach cleaning, the hemodialysis delivery system will be tested to ensure that adequate rinsing has occurred and that residual chlorine levels meet manufacturer's guidelines ...

5. Residual chlorine levels will be documented on the Daily Equipment Log when the residual test is done."


Review of the Dialysis Machine Disinfection Log revealed the check for "Post Disinfect Chlorine Residual Check" was not consistently documented:

*At the Austin Cornerstones the following dates had bleach disinfection noted with no post disinfection residual chlorine check noted: 01/03/19, 01/18/19, 01/21/19, 01/24/19, 01/28/19, 02/27/19, 04/02/19, 08/30/19, 09/02/19, 09/04/19, 11/27/19, and 11/29/19.

By failing to document checking for residual bleach after disinfection, it is not known if the rinse cycle was effective and chlorine was acceptable level per policy. The above was verified in an interview with staff member #1 on 01/30/20.


7. The facility failed to ensure there was evidence that the medical director has reviewed the results of the water quality testing.

Facility based (contracted dialysis) policy entitled, "Monthly Cultures of Hemodialysis Machines" stated in part,

"PURPOSE: To ensure that dialysate levels in hemodialysis delivery systems are below the AAMI recommended residual level.

POLICY:

1. All water cultures will be obtained by Biomed Technician or trained personnel.

2. Water cultures will be done every month.

3. Water culture results will be given to the facility and Core Dialysis Medical Director."


Review of Water Cultures and AAMIs revealed the following:

* Water cultures (including LALs) had not been signed off by the Medical Director from 05/2019 through 07/2019 at both locations.

* All of the AAMIs conducted in 2019 at both locations did not have a signature from the Medical Director indicating they had reviewed the results.


Due to the Medical Director not signing off on the water cultures and AAMIs, it is unknown if they were properly reviewed by the contracted agency. The facility said, they received the results from the contacted company and reports that the water cultures were okay as reported to infection control.

* The facility was asked to provide the facility water culture and AAMIs on 01/29/20, the AAMI results were not available for review by the surveyor until 01/31/20.

* The facility should have easy access to both water culture and AAMIs results to ensure safe water quality.


In a phone interview on 01/30/20, staff member #7, water biomedical, verified they collect water samples for cultures and AAMIs. They stated "Sometimes I look at the results, but usually don't, they look at them in Houston. They can access the results in the Ascend (laboratory) site."


Based on the above findings, it is unknown if the facility medical director was routinely reviewing the results of the water quality testing. Per interview, the facility was relying on the contracted services and Medical Director to review these results. Timely review of water quality testing is important to ensure appropriate water quality for in dialysis services and equipment is safe for patient use.


8. The facility failed to ensure that only persons qualified by the education or experience may operate, repair, or replace components of the water treatment system.

Facility based (contracted dialysis) policy entitled, "Monthly Cultures of Hemodialysis Machines" stated in part,

"PURPOSE: To ensure that dialysate levels in hemodialysis delivery systems are below the AAMI recommended residual level.

POLICY:
1. All water cultures will be obtained by Biomed Technician or trained personnel."


In a phone interview on 01/30/20, staff member #7, water biomedical, stated, they were trained as a Biomedical Technician and trained by another dialysis company to perform water maintenance and testing. However, there was no personnel file for this staff member or any documentation that they had appropriate training, certification, or was designated by the medical director to do water maintenance for dialysis at the 2 sites.


At the time of the complaint survey, the facility also did not have personnel files available for the mechanic and/or water biomedical technicians that worked in the dialysis areas (staff members #5 and 7). All personnel files for dialysis contract staff were initially requested by the surveyor on 01/29/20. The contracting dialysis company had not provided any personnel files for these employees by the time of exit on 01/31/19. The mechanical biomedical technician (staff member #5) did personally provide the surveyor evidence of their training on Gambro and Phoenix machines (which are utilized at the facility) on 01/30/10 via a printed certificate. However, there was no training or competency documentation provided from the contracted service.


Facility based (contracted dialysis) policy entitled, "New Employee Orientation" stated in part, "4. Complete and timely documentation of training will be provided to the Manager and will include:

o Orientation tests and records

o Competency Checklists

o Annual exams

o Orientation Training Checklists"


Review of personnel records for the contracted dialysis services revealed the following:

* 2 nurses are employed that provide patient care at Austin and Round Rock, Staff members #1 and 6.

* Staff member #1 did not have documentation of initial training on the Phoenix machines or portable RO system available in their file.

* Staff member #6 did not have documentation of initial dialysis orientation, training on the Phoenix machines, or portable RO system in her file. Staff member #6 also did not have a competency checklist in dialysis prior to 01/10/20. This was verified with staff member #1, the Director of Dialysis services for Austin and Round Rock.

*According to the Director of Dialysis services for Austin and Round Rock, 2 assistants work in the dialysis areas at the 2 facilities. The assistants are Staff members #8 and 9. Staff member #1 on 01/29/20 stated, they mainly assist in transporting machines and patients for treatment. In an interview on 01/30/20, Staff member #6 stated that the assistants help disinfect the dialysis machines (disinfection logs indicate this practice with assistant initials present). However, the facility had no personnel files available for these two assistants or any documentation that they were trained or competent to operate/disinfect dialysis machines properly.


Based on the above findings at the time of the survey, the facility did not have documentation to support that only persons qualified by the education or experience may operate, repair, or replace components of the water treatment system.