| Statement of Deficiencies | (X1) Provider/Supplier/CLIA Identification Number 852553 | (X3) Date Survey Completed 06/13/2019 |
| Name of Provider or Supplier Flint River Dialysis | Street Address, City, State 700 Gordon Avenue, Bainbridge, GA | |
| For information on the provider's plan to correct this deficiency, please contact the provider or the state survey agency. | ||
| (X4) ID Prefix Tag | Summary Statement of Deficiencies
(Each deficiency should be preceded by full regulatory or LSC identifying information) |
| E0000 | A recertification survey was conducted at Flint River Dialysis from June 11, 2019 through June 13, 2019. The survey revealed that the facility was in compliance with 42 CFR Part 494.62, Conditions for Coverage for Emergency Preparedness Plan for End Stage Renal Disease facilities. No deficiencies were cited. |
| V0000 | {CORE} A recertification survey was conducted at Flint River Dialysis from June 11, 2019 through June 13, 2019. The survey revealed that the facility was not in compliance with 42 CFR Part 494.40, Water and Dialysate Quality and 42 CFR Part 494.180, Governance. On 6/12/19, a determination was made that a situation in which the facility's noncompliance with 42 CFR Part 494.40(a) -Dialys Proport-Monitor pH/Conductivity, resulted in an Immediate Jeopardy with potential harm to the health and safety of one of 15 patients (P) (P#1), who were receiving dialysis treatment at the time of observation. The Facility Administrator and Clinical Service Specialist, were informed of the immediate jeopardy finding on 6/12/19 at 10:55 a..m. The noncompliance related to the immediate jeopardy was identified to have existed on 6/12/19 at 10:55 a.m. The immediate jeopardy was removed on 6/12/19 at 3:15 p.m., when the facilty implemented a Credible Allegation of Compliance related to the immediate jeopardy. However, the Conditions remained out of compliance. Also, the following standard level deficiencies were cited resulting from the facility's noncompliance related to the survey: |
| V0122 | 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: Based on observation, a review of Centers for Disease Control and Prevention (CDC) guidelines and facility's policy and procedure, and staff interviews, it was determined that the Infection Control Committee failed to ensure that the facility followed appropriate infection control measures, to prevent cross contamination and the spread of infection. This deficient practice had the potential to negatively affect the health and safety of all 60 in-center hemodialysis (ICHD) patients who dialyze at this facility. Findings include: - During a tour of the facility with the Facility Administrator on 6/11/19 between 10:30 a.m. and 1:00 p.m., the following was revealed: There were dried blood splatters of different sizes and shapes approximately 1 cm - 2 cm in diameter on the walls between stations (S) S3 & S4, S6 & S7, S7 & S8, S12 & S13, S13 & S14, and S16 & S17. - During observation in the treatment room on 6/12/19 between 9:30 a.m. and 10:30 a.m., the following was observed: Licensed Practical Nurse (LPN) CC, LPN DD and Patient Care Technician (PCT) BB were observed using Phoenix Meter [a device used to measure pH (acidity) and conductivity (ability of the dialysate to conduct electricity)] at S5, S14, and S8 respectively. They all returned the Phoenix Meters to a common clean area without cleaning and disinfecting after each use to prevent cross contamination. According to CDC, failures in environmental cleaning and disinfection have led to transmission of bloodborne pathogens (e.g., Hepatitis B virus) and other infections from one patient to another in hemodialysis units. Correct cleaning and disinfection of environmental surfaces (including patient chair or bed surfaces, dialysis equipment surfaces, adjacent tables and work surfaces) must be performed between patients uses to prevent transmission of dangerous pathogens. A review of the P & P #1-05-10 titled "Infection Control for Dialysis Facilities" stated: 50. Cleaning and/or disinfection of equipment and work surfaces will be performed as soon as possible following exposure to blood or other potentially infectious materials. 43. Items taken into the dialysis station will be disposed of, dedicated for use only on a single patient, or cleaned and disinfected before taken to a common clean area or used on another patient. 77. Any areas contaminated with visible blood or bloody fluids are cleaned promptly with a well wrung out wipe using 1:10 (one to ten) bleach solution. During an interview with the Facility Administrator (FA) and the Clinical Service Specialist (CSS) on 6/13/19 at 3:25 p.m., FA stated that all staff had been trained in infection control and the P & P should be implemented. |
| V0175 | CFC-WATER & DIALYSATE QUALITY CFR(s): 494.40 This CONDITION is not met as evidenced by: Based on observation, staff interviews, and a review of facility policy and procedure, it was determined that the facility failed to ensure that the dialysate (fluid used on the other side of the membrane to remove impurities) used for dialysis was safe prior to the start of dialysis treatment. On 6/12/19, a determination was made that a situation in which the facility's noncompliance with 42 CFR Part 494.40(a) -Dialys Proport-Monitor pH/Conductivity, resulted in an Immediate Jeopardy with potential harm to the health and safety of one of 15 patients (P) (P#10), who were receiving dialysis treatment at the time of observation. The Facility Administrator and Clinical Service Specialist, were informed of the immediate jeopardy finding on 6/12/19 at 10:55 a..m. The noncompliance related to the immediate jeopardy was identified to have existed on 6/12/19 at 10:55 a.m. The immediate jeopardy was removed on 6/12/19 at 3:15 p.m., when the facilty implemented a Credible Allegation of Compliance related to the immediate jeopardy. Findings include: Cross Reference: V 250 - Failure of the facility to test the pH (acidity) and conductivity (ability of the dialysate to conduct electricity) of dialysate prior to the start of dialysis treatment. |
| V0250 | 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: Based on observation, staff interviews, and a review of the facility policy and procedure (P & P), it was determined that the facility failed to ensure that the dialysate (fluid used on the other side of the membrane to remove impurities) used for dialysis was safe prior to the start of dialysis treatment. On 6/12/19, a determination was made that a situation in which the facility's noncompliance resulted in an Immediate Jeopardy with potential harm to the health and safety of one of 15 patients (P) (P#1), who were receiving dialysis treatment at the time of observation. The Facility Administrator (FA) and Clinical Service Specialist (CSS), were informed of the immediate jeopardy finding on 6/12/19 at 10:55 a..m. The noncompliance related to the immediate jeopardy was identified to have existed on 6/12/19 at 10:55 a.m. The immediate jeopardy was removed on 6/12/19 at 3:15 p.m., when the facilty implemented a Credible Allegation of Compliance related to the immediate jeopardy. The immediate jeopardy is outlined as follows: During observation in the treatment room on 6/12/19 between 9:30 a.m. and 10:55 a.m., the following was observed: The hemodialysis (HD) machine #12 at Station (S) 8 showed "test complete" on the screen. LPN AA then connected the hansen couplings (a connector device) to the dialyzer and recirculated the system. At 10:55 a.m., LPN AA initiated dialysis treatment on P #1 at S8 using HD machine #12. The pH (acidity) and conductivity (ability of the dialysate to conduct electricity) of the dialysate were not measured with an independent method prior to the start of P#1's dialysis treatment, to ensure patient safety. During an interview with LPN AA on 6/12/19 at 10:58 a.m., she stated she could not find the Phoenix Meter (a device used to measure the pH and conductivity). During an interview on 6/12/19 at 11:10 a.m., Biomedical Technician AA stated that the Phoenix Meter is used to verify the reading level of the HD machine and to check the accuracy of the dialysate solution distributed by the HD machine. A review of P & P #1-03-02 titled "Testing pH and Conductivity of Proportioned Dialysate and Verification of Temperature of Proportioned Dialysate" stated: 1. Trained teammates will test pH and conductivity of final dialysate utilizing appropriate test strips and/or meters prior to each patient treatment. 5. The final dialysate conductivity should be checked with an approved independent meter ... 6. Independent conductivity and pH is required to be performed prior to each treatment. On 6/12/19 at 1:45 p.m., the FA stated that staff should always test dialysate's pH and conductivity with an independent meter prior to each dialysis treatment. The immediate jeopardy was removed on 6/12/19 at 3:15 p.m., when the facilty implemented a Credible Allegation of Compliance related to the immediate jeopardy. The FA checked P#1 and was found asymptomatic. LPN AA discontinued P#1's dialysis treatment and tested HD machine #12 per facility's P & P and was found to be safe to use for dialysis. P#1's dialysis treatment was then resumed on 6/12/19 at 1:41 p.m. The Governing Body met on 6/12/19 at 3:00 p.m. and all clinical employees were in-serviced on P & P #1-03-02 titled "Testing pH and Conductivity of Proportioned Dialysate and Verification of Temperature of Proportioned Dialysate" on 6/12/19 at 3:15 p.m. |
| V0403 | PE-EQUIPMENT MAINTENANCE-MANUFACTURER'S DFU CFR(s): 494.60(b) The dialysis facility must implement and maintain a program to ensure that all equipment (including emergency equipment, dialysis machines and equipment, and the water treatment system) are maintained and operated in accordance with the manufacturer's recommendations. This STANDARD is not met as evidenced by: Based on record review and staff interview, it was determined that the facility failed to ensure that three of three Phoenix Meters [device used to measure pH (acidity) and conductivity (ability of the dialysate to conduct electricity)] were calibrated. This deficient practice had the potential to negatively affect the health and safety of all 60 in-center hemodialysis patients who dialyze at the facility. Findings include: A review of Phoenix Meter Calibration Logs from April 2019 to May 2019 revealed that during the month of May 2019, three of three Phoenix Meters had no documentation of the Phoenix Meter's serial number (used for identification and inventory) recorded in the Calibration Log. Therefore, there was no specific identification of which Phoenix Meter was calibrated, logged, used, or out of service. During an interview with Biomedical Technician AA on 6/12/19 at 11:00 a.m., he stated that all three Phoenix Meters needed to be identified with serial number and recorded in the Calibration Log for proper identification. |
| V0750 | CFC-GOVERNANCE CFR(s): 494.180 This CONDITION is not met as evidenced by: Based on observation, staff interviews, and a review of facility policy and procedure, it was determined that the Governing Body failed to ensure that the dialysate (fluid used on the other side of the membrane to remove impurities) used for dialysis was safe prior to the start of dialysis treatment. On 6/12/19, a determination was made that a situation in which the facility's noncompliance with 42 CFR Part 494.40(a) -Dialys Proport-Monitor pH/Conductivity, resulted in an Immediate Jeopardy with potential harm to the health and safety of one of 15 patients (P) (P#10), who were receiving dialysis treatment at the time of observation. The Facility Administrator and Clinical Service Specialist were informed of the immediate jeopardy finding on 6/12/19 at 10:55 a..m. The noncompliance related to the immediate jeopardy was identified to have existed on 6/12/19 at 10:55 a.m. The immediate jeopardy was removed on 6/12/19 at 3:15 p.m., when the facilty implemented a Credible Allegation of Compliance related to the immediate jeopardy. Findings include: Cross Reference: V 250 - Failure of the facility to test the pH (acidity) and conductivity (ability of the dialysate to conduct electricity) of dialysate prior to the start of dialysis treatment. . |