Davita Dialysis Care of Rockingham County

“IC-WEAR GLOVES/HAND HYGIENE CFR(s): 494.30(a)(1) Wear disposable gloves when caring for the patient or touching the patient’s equipment at the dialysis station. Staff must remove gloves and wash hands between each patient or station. This Standard is not met as evidenced by: 32003 Based on observations and staff interview, the facility staff failed to ensure patients performed hand hygiene for 2 of 2 AVF/G discontinuations (Patients #7 and #10). The findings include: Review on July 17, 2025 of the facility’s policy, “INFECTION CONTROL FOR DIALYSIS FACILITIES” revised April 2023 revealed, “PURPOSE ...NOTES ...POLICY ...HAND HYGIENE [space] 1. ...2. [space] Patients and caregivers will be encouraged to a. ...b. Perform hand hygiene after treatment before leaving treatment area. 3. [space] Use of an alcohol-based hand rub may be substituted for handwashing. ...” 1. Observation on July 15, 2025 at 11:05 AM revealed, Patient #7 was located at Station #1 applying manual pressure, with a gloved hand, to a right AVF/G access site. Hemostasis was achieved and the patient removed the glove. PCT #1 applied more tape to finish securing the access site. The patient went to the scale, removed the glove, obtained a post-treatment weight and exited the ICHD without performing hand hygiene. Interview on July 15, 2025 at about 4:30 PM with the Facility Administrator revealed, three years of service with the organization and since assuming the current position, the administrator performed operational duties such as: staffing, audits, policy keeper and in-service of staff. Interview revealed, the administrator had plans to create a culture of staff retention, patient safety/advocacy by elevating thought processes, community focused and building strong relationships with the Medical Director and physicians. 2. Observation on July 16, 2025 at 11:0 AM revealed, Patient #10 was located at Station #3 applying manual pressure, with a gloved hand, to a left AVF/G access site. Hemostasis was achieved and the patient removed the glove. PCT #2 applied more tape to finish securing the access site. The patient went to the scale, removed the glove, obtained a post-treatment weight and exited the ICHD without performing hand hygiene. Interview on July 15, 2025 at about 4:30 PM with the Facility Administrator revealed, three years of service with the organization and since assuming the current position, the administrator performed operational duties such as: staffing, audits, policy keeper and in-service of staff. Interview revealed, the administrator had plans to create a culture of staff retention, patient safety/advocacy by elevating thought processes, community focused and building strong relationships with the Medical Director and physicians.”

“IC-SINKS AVAILABLE CFR(s): 494.30(a)(1)(i) A sufficient number of sinks with warm water and soap should be available to facilitate hand washing. This Standard is not met as evidenced by: 32003 Based on policy review, observations and interviews, the facility staff failed to prevent cross contamination by not ensuring 1 of 1 sink was labeled as clean or dirty (Laboratory sink). The findings included: Review on July 17, 2025 of the facility’s policy “INFECTION CONTROL FOR DIALYSIS FACILITIES” revised April 2023 revealed, “PURPOSE: To minimize the spread of infections or bloodborne pathogens in the dialysis facility environment. ...HAND HYGEINE ...PPE ...SUPPLIES ...DISINFECTION ...FACILITY HYGEINE: 16. Clean areas should be clearly designated for the preparation, handling, and storage of medications and unused supplies and equipment. ...19. Sinks should be easily accessible and readily available in the treatment area and in other appropriate areas such as the medication area, home training room, and isolation area/room. ...” Observation on July 17, 2025 at 9:15 AM of the laboratory revealed 1 of 1 sink was not labeled as clean or dirty and thereby not preventing cross-contamination. Interview on July 17, 2025 at 3:30 PM with the MCS revealed, the sink in the laboratory area was not labeled as clean or dirty.”

“IC-DISINFECT SURFACES/EQUIP/WRITTEN PROTOCOL CFR(s): 494.30(a)(4)(ii) [The facility must demonstrate that it follows standard infection control precautions by implementing- (4) And maintaining procedures, in accordance with applicable State and local laws and accepted public health procedures, for the-] (ii) Cleaning and disinfection of contaminated surfaces, medical devices, and equipment. This Standard is not met as evidenced by: 32003 Based on policy reviews, observations, Governing Body meeting minutes, staff interview and personnel file reviews, the facility staff failed to clean and disinfect the Hansen connectors for 3 of 3 HDM and station disinfections (Stations #1, #11 and #12) and failed to clean and disinfect the outside of the oxygen concentrators that remained at the chairside between patient treatments (Station #1 and Station #12). The findings include: Review on July 17, 2025 of the facility’s policy, “INFECTION CONTROL FOR DIALYSIS FACILITIES” revised April 2023 revealed, “PURPOSE ...NOTES ...POLICY ...HAND HYGIENE ... SUPPLIES ...DISINFECTION [space] 12. ...13. At the end of each treatment, the dialysis station will be cleaned and disinfected. a. Surfaces to disinfect include but are not necessarily limited to: all surfaces in contact with the patient or their belongings (e.g., dialysis chair, tray tables, blood pressure cuffs) and frequently contacted by healthcare personnel (e.g., control panel; top, front and sides of dialysis machine; touchscreens; countertops). ... 14. Non-disposable items are to be disinfected after each patient use, prior to removal from treatment area/station and if contaminated between uses. ...” Review on July 17, 2025 of the facility’s policy, “USE OF OXYGEN CONCENTRATORS” revised October 2023 revealed, “PURPOSE: ...POLICY: [space] 1. ...5. The outside of the oxygen concentrator will be cleaned with an acceptable disinfectant solution between patients. ...” 1. Observation on July 15, 2025 at 11:05 AM revealed, PCT #1 obtained 1:100 bleach cloths to clean and disinfect Station #1, HDM #10. The observation revealed, all non-disposable equipment was cleaned and disinfected except for oxygen concentrator #04G678763 that was at the chairside during Patient #7 treatment. 2. Observation on July 15, 2025 at 11:35 AM revealed, CCHT #1 obtained 1:100 bleach cloths to clean and disinfect Station #12, HDM #7. The observation revealed, all non-disposable equipment was cleaned and disinfected except for the Hansen connectors on the HDM and oxygen concentrator #2152265 which remained at the chairside between patient’s treatments. 3. Observation on July 16, 2025 at about 11:45 AM revealed, PCT #2 obtained 1:100 bleach cloths to clean and disinfect Station #11and the HDM. The observation revealed, all non-disposable equipment was cleaned and disinfected except for the Hansen connectors on the HDM. Review on July 17, 2025 of the December 16, 2024 Governing Body meeting minutes revealed, an audit was performed in 2024 and identified concerns with staff not following the policy for cleaning and disinfecting the dialysis machine. Review revealed, the concern was ongoing and monitoring was to occur two times a week for two weeks followed by weekly monitoring for 4-weeks but there was no documentation that monitoring continued weekly for the additional 4-weeks. Interview on July 15, 2025 at about 4:30 PM with the Facility Administrator revealed, three years of service with the organization and since assuming the current position, the administrator performed operational duties such as: staffing, audits, policy keeper and in-service of staff. Interview revealed, the administrator had plans to create a culture of staff retention, patient safety/advocacy by elevating thought processes, community focused and building strong relationships with the Medical Director and physicians.”

“CARBON ADSORPTION-IODINE #900/REPLACEMENT CFR(s): 494.40(a) 5.2.5 Carbon adsorption: Iodine #900/replacement Refer to RD62:2001, 4.3.9 Carbon adsorption media: Exhausted carbon adsorption media shall be discarded and replaced with new media according to a replacement schedule determined by regular monitoring. 5.2.5 Carbon adsorption When granular activated carbon is used as the media, it shall have a minimum iodine number of 900. Other forms of carbon should not be used unless there is performance data to demonstrate that each adsorption bed has the capacity to reduce the chloramine concentration in the feed water to less than 0.1 mg/L when operating at the maximum anticipated flow rate for the maximum time interval between scheduled testing of the product water for chloramines. Regenerated carbon shall not be used for hemodialysis applications. This Standard is not met as evidenced by: 32003 Based on policy review, observation and staff interview, the facility staff failed to post the re-bedding dates for the softener tank, primary and secondary carbon tanks for 1 of 1 water treatment system. The findings include: Review on July 17, 2025 of the facility’s policy, “CENTRAL WATER TREATMENT SYSTEMS MINIMUM COMPONENTS AND REQUIREMENT” revised April 2025 revealed, “PURPOSE ...POLICY [space] GENERAL REQUIREMENTS [space] 1. ...9. All media tanks will be labeled with the following information: [space] ...Date of installation or last re-bed ...” Observation on July 15, 2025 at about 2:00 PM with the covering biomedical technician revealed, the softener tank, primary carbon tank and secondary tanks were not labeled with the date of the last re-bedding. Interview on July 17, 2025 at 10:40 AM with the Biomedical Operations Manager revealed, an unawareness that the softener and primary/secondary carbon tanks were not labeled with the last re-bedding date.”

“MIXING SYSTEMS-PERM RECORD/VERIF TEST CFR(s): 494.40(a) 5.4.4.1 Mixing systems: perm record/verification testing In addition to container labeling, there should be permanent records of batches produced. These records should include the concentrate formula produced, the volume of the batch, the lot numbers of powdered concentrate packages, the manufacturer of the powdered concentrate, the date and time of mixing, any test results, the person performing the mixing, the person verifying mixing and test results, and the expiration date (if applicable). 6.4.1 Mixing systems Acid and bicarbonate concentrates may be tested by using conductivity or by using a hydrometer. Concentrates should not be used or transferred to holding tanks or distribution systems until all tests are completed. The test results and verification that they meet all applicable criteria should be recorded and signed by the individuals performing the tests. This Standard is not met as evidenced by: 32003 Based on policy review, acid log review, Governing Body meeting minutes and staff interview, the facility staff failed to complete the citric acid dry mixing batch mixing log by not documenting the date of the filter change, by not documenting the specific gravity reading and by not documenting the acceptable range for a high reading for 3 of 60 days (May and June 2025). The findings include: Review on July 17, 2025 of the facility’s policy, “CITRIC COMPLETE ® DRY ACID CONCENTRATE MIXING” revised November 2024 revealed, “PURPOSE ...POLICY [space] 1. ...15. A Citric Complete Batch Production Record is fully completed for each batch of dry acid concentrate that is produced. ...” Review on July 15, 2025 of the Citric CompleteTM Batch Production Record revealed on May 1, 2025, the facility staff mixed 2.0/2.5 acid but failed to document the date the filter was replaced and the specific gravity reading. On May 9, 2025, the facility staff mixed 2.0/2.5 acid but failed to document the acceptable range for a high reading. On June 28, 2025, the facility staff mixed 2.0/2.5 acid but failed to document the specific gravity reading. Review on July 17, 2025 of the December 16, 2024 Governing Body meeting minutes revealed, an audit was performed in 2024 and identified concerns with staff not following the policy for mixing concentrates. Review revealed, the concern was ongoing and monitoring was to occur but there was no documentation that monitoring of staff mixing concentrates had been initiated. Interview on July 15, 2025 at about 2:00 PM with the covering biomedical technician revealed, there were no dates for 2-specific gravity readings, 1-filter replacement date and 1-acceptable range for high reading. failed to document the time the bicarbonate system was rinsed for 1 of 12-days and failed to document the time the bicarbonate system was disinfected for 1 of 2 months reviewed (May and June 2025).”

“BICARB MIX SYS-EMPTY/DISINFECT/PREV CORROSION CFR(s): 494.40(a) 5.4.4.3 Bicarbonate concentrate mixing systems: empty/ disinfect/prevent corrosion Bicarbonate concentrate mixing tanks should be designed to drain completely. Mixing tanks should have a tight-fitting lid and should be designed to allow all internal surfaces to be disinfected and rinsed. Because concentrate solutions are highly corrosive, mixing systems should be designed and maintained to prevent corrosion. This Standard is not met as evidenced by: 32003 Based on policy review, bicarbonate mixing log review, Governing Body meeting minutes and staff interview, the facility staff failed to document the time of preparation for 1 of 12-days, failed to document the time the bicarbonate system was rinsed for 1 of 12-days and failed to document the time the bicarbonate system was disinfected for 1 of 2 months reviewed (May and June 2025). The findings include: Review on July 17, 2025 of the facility’s policy, “BICARBONATE CONCENTRATE SYSTEM MIXING” revised April 2024 revealed, “PURPOSE ...POLICY [space] 1. ...7 ....13. Preparation of bicarbonate concentrate is documented on a log at the time of the preparation and verified by a second teammate prior to dispensing. ...20. ...At a minimum, the central bicarbonate system should be rinsed free of bicarbonate daily, at the end of the treatment day ...” Review on July 15, 2025 of the bicarbonate mixing log revealed from May 26, 2025 through May 31, 2025, the time the bicarbonate system was rinsed was documented daily except for May 27, 2025. Continued review revealed, the time bicarbonate system was disinfected was not documented for May 27, 2025. Furthermore, review revealed from June 23, 2025 through June 28, 2025, the time bicarbonate was prepared was documented daily except for June 27, 2025. Review revealed times of preparation, daily rinse and weekly disinfection were not consistently documented. Review on July 17, 2025 of the December 16, 2024 Governing Body meeting minutes revealed, an audit was performed in 2024 and identified concerns with staff not following the policy for mixing concentrates. Review revealed, the concern was ongoing, monitoring was to occur for 2-weeks followed by weekly for 4-weeks but there was no documentation that monitoring continued weekly for the additional 4-weeks. Interview on July 15, 2025 at about 2:00 PM with the covering biomedical technician revealed the times of disinfection were missing on the bicarbonate logs.”

“DIALYS PROPORT-MONITOR PH/CONDUCTIVITY CFR(s): 494.40(a) 5.6 Dialysate proportioning: monitor pH/conductivity It is necessary for the operator to follow the manufacturer’s instructions regarding dialysate conductivity and to measure approximate pH with an independent method before starting the treatment of the next patient. This Standard is not met as evidenced by: 32003 Based on policy review, observations, Governing Body meeting minutes and staff interviews, the facility staff failed to verify the solutions for calibration of the Phoenix were not expired and available for use for 2 of 4 solutions (1.0 mS/cm and 100 mS/cm). The findings include: Review on July 17, 2025 of the facility’s policy, “PHOENIX XL METERS MONTHLY VERIFICATION/CALIBRATIONS” revised October 2023 revealed, “Materials required ...NOTES: [space] on a monthly basis, verify full range (pH 4.0, pH 10.0, 100 mS, 1 mS ...) and if not within specifications, calibrate meter. ...Under normal meter usage and storage conditions, the pH component is expected to last for 12 months. ...Procedure [space] NOTES: [space] 1. ...5. Confirm that the standard solutions expiration date has not been exceeded. ...” Observation on July 17, 2025 at 9:15 AM revealed in the laboratory room there were 2 of 2 conductivity calibration solutions for the Phoenix meter that was available for use, in which, H & S conductivity 1.0 mS/cm - recorder #10010 was opened May 1, 2024 and had a manufacturer expiration date of April 3, 2025. Additionally, H & S conductivity 100.0 mS/cm - recorder #10007 was opened April 4, 2024 and had a manufacturer expiration date of February 28, 2025. Observation revealed the conductivity solutions for the Phoenix were expired and still available for use. Review on July 17, 2025 of the December 16, 2024 Governing Body meeting minutes revealed, an audit was performed in 2024 and identified concerns with expired calibration solutions for Phoenix meters. Review revealed, the concern was considered resolved on November 22, 2024 and biomed was to perform monthly monitoring but there was no documentation that monthly monitoring occurred. Interview on July 17, 2025 at 10:40 AM with the Biomedical Operations Manager revealed, the conductivity solutions for the Phoenix should have been pulled from the biomedical side.”

“POC-ACHIEVE ADEQUATE CLEARANCE CFR(s): 494.90(a)(1) Achieve and sustain the prescribed dose of dialysis to meet a hemodialysis Kt/V of at least 1.2 and a peritoneal dialysis weekly Kt/V of at least 1.7 or meet an alternative equivalent professionally-accepted clinical practice standard for adequacy of dialysis. This Standard is not met as evidenced by: 32003 Based on policy review, medical record reviews, Governing Body meeting minutes and staff interview, the facility staff failed to follow the adequacy plan of care by not dialyzing 2 of 4 patients at the prescribed BFR (Patients #1 and #4). The findings include: Review on July 17, 2025 of the facility’s policy, “PRE-INTRA-POST TREATMENT DATA COLLECTION, MONITORING AND NURSING ASSESSMENT” revised April 2024 revealed, “NOTE ...PURPOSE ...POLICY: [space] 1. Patient data ...2. The Nursing assessment ...3. Patient identity, prescription and machine setting ...The prescription components are confirmed by a licensed nurse within one (1) hours of treatment initiation ...Prescription components include but are not necessarily limited to: a. ...f. Blood flow rate ... .” 1. Open medical record review on July 17, 2025 revealed Patient #1 was admitted to the ICHD in December 2024. Treatment sheet review from June 30, 2025 through July 12, 2025 (6-consecutive treatments) revealed, July 1, 2025, the patient was not dialyzed at the prescribed BFR for 350 mL/min for 180 of 225-minutes; on July 10, 2025, the patient was not dialyzed at the prescribed BFR for 350 mL/min for 139 of 225-minutes and on July 12, 2025, the patient was not dialyzed at the prescribed BFR of 350 mL/min, for treatment duration of 218 of 225-minutes. Review revealed there was no documentation as to why the patient was not dialyzed at the prescribed BFR for treatment duration for 3 of 6 dialysis treatments. 2. Open medical record review on July 17, 2025 revealed Patient #4 was admitted to the ICHD in April 2025. Treatment sheet review from June 30, 2025 through July 12, 2025 (6-consecutive treatments) revealed, July 1, 2025, the patient was not dialyzed at the prescribed BFR for 400 mL/min for 163 of 210-minutes and on July 10, 2025, the patient was not dialyzed at the prescribed BFR for 400 mL/min for 178 of 210-minutes. Review revealed there was no documentation as to why the patient was not dialyzed of the prescribed BFR for treatment duration for 2 of 6 dialysis treatments. Review on July 17, 2025 of the December 16, 2024 Governing Body meeting minutes revealed, an audit was performed in 2024 and identified concerns with treatment sheets not following policy for treatment verification. Review revealed, the concern was ongoing and monitoring was to occur two times weekly followed by weekly for 4-weeks but there was no documentation that monitoring continued weekly for the additional 4-weeks. Interview on July 17, 2025 at 3:30 PM with the MCS revealed there were no progress notes as to why the patient was not dialyzed at the prescribed BFR.”

“MD RESP-ENSURE ALL ADHERE TO P&P CFR(s): 494.150(c)(2)(i) The medical director must- (2) Ensure that- (i) All policies and procedures relative to patient admissions, patient care, infection control, and safety are adhered to by all individuals who treat patients in the facility, including attending physicians and nonphysician providers; This Standard is not met as evidenced by: 32003 Based on teammate policy review, observations, log review for peracetic acid/CM 130 reagent, log review for the weekly cleaning of the oxygen concentrator filter, and staff interview, the facility staff failed to ensure staff secured and wore long hair up for 2 of 2 observations (Technicians #1 and #3); failed to ensure peracetic acid was stored at the correct temperature by not documenting daily temperatures for 5 of 5 months in 2025 (March, April, May, June and July); failed to ensure weekly filter cleaning was performed for 7 of 7 concentrators ( calendar years 2024 and 2025); failed to ensure liquid protein solutions were not expired and available for use 2 of 2 containers and failed to ensure 6 of 6 transplant kits were not out-of-date. The findings included: A. Review on April 24, 2025 of the facility’s policy, “[organization] TEAMMATE POLICIES” effective February 24, 2025 revealed, “1. New Hire ...2. Employment ...3. Benefits ...4. Pay Practices ...5. Work Environment ... Hair must be clean and long hair must be worn up or otherwise secured to prevent hair from falling onto any clean or sterile field or from becoming accidentally entangled in equipment. ...” 1. Observation on July 15, 2025 at 11:05 AM revealed, PCT #1 long hair was pulled back into a pony-tail that was not secured and pass shoulder-length as the technician provided treatment discontinuation care to Patient #7. 2. Observation on July 15, 2025 at 11:25 AM revealed, PCT #1 long hair was pulled back into a pony-tail that was not secured and pass shoulder-length as the technician provided treatment discontinuation care to Patient #2. 3. Observation July 16, 2025 at 11:10 AM revealed, PCT #1 long hair was pulled back into a pony-tail that was not secured and pass shoulder-length as the technician provided treatment initiation care to Patient #11. Interview on July 16, 2025 at 3:15 PM with the MCS revealed, teammates with long-hair, pass shoulder-length, should wear their hair up and secured. B. Review on July 17, 2025 revealed, “CHEMICAL USE POLICY” revised October 2018 revealed, “PURPOSE ...POLICY: Peracetic Acid [space] 1. Peracetic acid is to be stored separately from other chemicals, especially bleach. It is to be stored in a cool, dry area (32°F-75°F). ...CM130 Performance Check Kit Reagent (PCK): 1. CM 130 PCK is to be stored separate from other chemicals, especially bleach. It is to be stored in a cool, dry area (32°F-75°F). ...Document location: Chemical Storage Area(s) daily ...” Review on July 15, 2025 of the log for peracetic acid and CM 130 reagent revealed, temperature was only documented for March 13, 2025 and there was no temperature documentation for the entire months of April, May, June, or July 2025. Interview on July 15, 2025 at about 2:00 PM with the visiting Biomedical technician revealed that temperatures were not documented for all of March 2025 and there was no documentation for April, May, June and July 2025. C. Review on July 17, 2025 of the facility’s policy, “USE OF OXYGEN CONCENTRATORS” revised October 2023 revealed, “PURPOSE: ...POLICY: [space] 1. ...6. Follow Manufacturer Instructions for Use regarding any additional cleaning/maintenance of the device and document on the Oxygen Concentrator Filter Cleaning Log, as applicable. [space] OPERATION: Follow Manufacturer Instructions for Use ...SECTION 6-MAINTENANCE [space] WARNING ...Cleaning the Cabinet Filter [space] CAUTION ...1. Remove each filter and clean at least once a week depending on environmental conditions. ...” Review on July 16, 2025 of the listing of oxygen concentrators revealed, the facility had seven (7) oxygen concentrators listed but only had weekly cleaning filter logs for five (5) concentrators, wherein there was only 1 of 5 logs for calendar year 2025 and 4 of 5 logs for calendar year 2024. Additionally, the logs did not have the serial number documented that was associated with the actual oxygen concentrator. Review revealed the facility failed to ensure filters for the oxygen concentrators were cleaned weekly. Interview on July 16, 2025 at 3:00 PM with the Biomedical technician revealed that there was no additional documentation for oxygen concentrators. D. Review on July 17, 2025 of the facility’s policy, “INFECTION CONTROL FOR DIALYSIS FACILITIES” revised April 2023 revealed, “PURPOSE ...NOTES ...POLICY ...HAND HYGEINE ...PPE ...SUPPLIES [space] 8. Supplies will be stored in a manner that maintains their integrity. [space] a. ...b. Expiration date and package integrity will be verified prior to use. ...” Observation on July 17, 2025 at 9:15 AM of the Medication area with Nurse #1 revealed, 2 of 2 bottles of liquid protein had expiration dates of January 2023 and June 2024. Further observation revealed 2-transplant kits had expiration dates of September 20, 2021 and 4-transplant kits had expiration dates of January 31, 2021. Observation revealed that patient supplies were expired. Interview on July 17, 2025 at 9:15 AM with Nurse #1 revealed that [brand] of liquid protein was no longer used by facility staff for patient use.”