Statement of Deficiencies

Statement of Deficiencies	(X1) Provider/Supplier/CLIA Identification Number 852550	(X3) Date Survey Completed 10/29/2019
Name of Provider or Supplier Dublin Kidney Institute	Street Address, City, State 207 Industrial Blvd Ste 2, Dublin, 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)
V0000	An onsite survey to investigate complaint #GA00200492, was initiated on October 28, 2019 and concluded on October 29, 2019. The complaint investigation revealed that the facility was not in compliance with 42 CFR Part 494.30, Infection Control and 42 CFR Part 494.180, Governance. The complaint was substantiated. On October 29, 2019, a determination was made that a situation in which the facility's noncompliance with 42 CFR 494.30, Infection Control, resulted in an Immediate Jeopardy with harm to one patient (P#1) and a potential harm to the health and safety of the other two patients (P#2 and P#3), who were under the care of this facility and who dialyzed at a Skilled Nursing Facility. The Facility Administrator was informed of the IJ finding on 10/29/19 at 10:05 a.m. The immediate jeopardy was abated during the survey on 10/29/19 at 4:30 p.m., when the facility 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.
V0110	CFC-INFECTION CONTROL CFR(s): 494.30 This CONDITION is not met as evidenced by: Based on observation and staff interview, it was determined that the facility failed to ensure that three of three Patient Care Staff (RN AA, RN BB, and LPN AA) observed, employed infection control techniques to prevent transmission of infectious pathogens in the home hemodialysis unit at a Skilled Nursing Facility (SNF). This deficient practice resulted in an immediate jeopardy (IJ) with harm to one patient (P#1) and a potential harm to the health and safety of the other two patients (P#2 and P#3), who were under the care of this facility and who dialyzed at the SNF. The Facility Administrator was informed of the IJ finding on 10/29/19 at 10:05 a.m. The immediate jeopardy was abated during the survey on 10/29/19 at 4:30 p.m., when the facility implemented a Credible Allegation of Compliance related to the Immediate Jeopardy. Findings were: Cross reference the following cited deficiencies: V 113 - Failure of the staff to perform hand hygiene when going from a "dirty" area or task; to a "clean" area or task and to wear and change gloves as appropriate. V 115 - Failure of the staff to wear personal protective equipment (PPE) when appropriate. V 117 - Failure of the staff to separate "clean" and "dirty" areas/items to prevent cross contamination. V 582 - Failure of the facility to provide sufficient training, supervision, and oversight to the staff who administered home hemodialyis treatments at the SNF.
V0113	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: Based on observation, staff interviews, a review of the Center for Disease Control and Prevention (CDC) recommendations, the facility's Policies and Procedures (P&P), and review of facility records, it was determined that the Infection Control Committee failed to ensure that two of three Patient Care Staff (RN BB and LPN AA), changed gloves and performed hand hygiene when going from a "dirty" task to a "clean" task, to prevent cross contamination. These breaches in infection control techniques could negatively affect the health and safety of two of two patients (P#2 and P#3) who dialyzed at the Skilled Nursing Facility (SNF). Findings include: During observation in the dialysis treatment room at the SNF on 10/29/19 between 11:10 a.m. and 12:45 p.m., the following was revealed: - RN BB did not change gloves and did not perform hand hygiene after flushing P#2's dialysis bloodlines ("dirty" task). While she wore the same contaminated gloves, RN BB checked P#2's temperature, then wrote on P#2's hard copy chart ("clean" task/item). - LPN AA donned a pair of gloves that was at P#2's bedside table (considered "dirty" area). Then LPN AA went to the clean supply area to get more gloves from the glove box. LPN AA also checked P#2's blood pressure (BP), and without removing contaminated gloves, LPN AA went to the clean supply area and took several pieces of clean gauze. - During interviews with LPN AA and RN BB on 10/29/19 between 12:35 p.m. and 12:40 p.m., both stated that they forgot to change their gloves and wash or sanitize their hands. These breaches in infection control techniques could potentially cause the spread of infection-causing pathogens through cross contamination. A review of CDC recommendations stated the following: - Hand hygiene is necessary after glove removal because hands can become contaminated through small defects in gloves and from the outer surface of gloves during glove removal. - Remove gloves and perform hand hygiene between each patient or station, and if moving from contaminated to clean area or task. A review of the facility's P & P titled, "Infection Control Manual" with an effective date of 09/2017 stated: ... to prevent cross-contamination, hands should be washed: a. Upon leaving the patient area b. Upon entering the patient area c. Before any medical aseptic procedure is done d. Before and after each patient contact 4. Examples of when fresh pair of gloves must be put on... When going from "dirty" area or task to a "clean" area or task... A review of the Department of Health's investigation result on 8/6/19 revealed that handwashing/hand hygiene was one of the infection control breaches that was identified during their investigation. There were no records regarding the facility conducting in-services about hand hygiene and glove use and changes. There were no records of the facility's observations and audits of RN AA, RN BB, AND LPN AA, to verify that these Patient Care Staff followed facility P & P regarding hand hygiene and glove changes. During an interview with the Facility Administrator on 10/29/19 at 12:45 p.m., she stated that she observed these same breaches in infection control also, and stated that staff should practice infection control techniques such as hand hygiene between glove changes and when going from dirty area/task to clean area/task.
V0115	IC-GOWNS, SHIELDS/MASKS-NO STAFF EAT/DRINK CFR(s): 494.30(a)(1)(i) Staff members should wear gowns, face shields, eye wear, or masks to protect themselves and prevent soiling of clothing when performing procedures during which spurting or spattering of blood might occur (e.g., during initiation and termination of dialysis, cleaning of dialyzers, and centrifugation of blood). Staff members should not eat, drink, or smoke in the dialysis treatment area or in the laboratory. This STANDARD is not met as evidenced by: Based on observation, a review of the facility's policies and procedures (P & P), and staff interview, it was determined that the facility failed to ensure that one of three Patient Care Staff (LPN AA), wore personal protective equipment (PPE) while disconnecting dialysis bloodlines, and cleaning/disinfecting patient's (P#2's) hemodialysis chair and station. This breach in infection control techniques could negatively affect the health and safety of two of two patients (P#2 and P#3), who dialyzed at the Skilled Nursing Facility (SNF) and three Patient Care Staff (RN AA, RN BB, and LPN AA), who administered home hemodialyis (HHD) treatments at the SNF, and who were under the supervision and oversight of this facility. Findings were: During observation in the patient's dialysis treatment room at the SNF on 10/29/19 between 11:10 a.m. and 12:45 p.m., the following was observed: - LPN AA was observed taking down (or removing) used bloodlines and dialyzer from P#2's hemodialysis station, without wearing a gown, a faceshield, or goggles with mask. The Facility Administrator, who was also observing, reminded LPN AA to wear a gown. LPN AA stopped doing her task, and proceeded to put on a gown, but did not wear a mask with goggles or a faceshield. - During an interview with LPN AA on 10/29/19 at 12:40 p.m., she stated that she forgot to wear her PPE. A review of the facility's P & P titled, "Infection Control Manual" with an effective date of 09/2017 stated: - Safety glasses and a disposable paper mask or face shield must be worn when performing invasive procedures, e.g., initiating or terminating dialysis, tubing changing, or anytime there is a possibility of a blood/body fluid splash... - Staff must wear scrub suits while working in the dialysis unit. A review of facility records showed that the facility conducted an in-service and re-training of staff regarding PPE on 9/13/19. However, the records did not show that the staff had been observed and audited to verify if the in-service was effective and the procedure was followed since 9/13/19 up to present time.
V0117	IC-CLEAN/DIRTY;MED PREP AREA;NO COMMON CARTS CFR(s): 494.30(a)(1)(i) Clean areas should be clearly designated for the preparation, handling and storage of medications and unused supplies and equipment. Clean areas should be clearly separated from contaminated areas where used supplies and equipment are handled. Do not handle and store medications or clean supplies in the same or an adjacent area to that where used equipment or blood samples are handled. When multiple dose medication vials are used (including vials containing diluents), prepare individual patient doses in a clean (centralized) area away from dialysis stations and deliver separately to each patient. Do not carry multiple dose medication vials from station to station. Do not use common medication carts to deliver medications to patients. If trays are used to deliver medications to individual patients, they must be cleaned between patients. This STANDARD is not met as evidenced by: Based on observation, a review of the Center for Disease Control and Prevention (CDC) guidelines, review of facility's Policies and Procedures (P & P), and staff interview, it was determined that the facility failed to ensure that one of three Patient Care Staff, (RN AA) observed, used alcohol wipe/swab to disinfect the contaminated arterial bloodline tip and the Normal Saline (NS) port, prior to the reinfusion of blood of a patient (P) (P#2), to prevent cross contamination. This breach in infection control technique could negatively affect the health and safety of one of two patients (P#2), who were dialyzing at a Skilled Nursing Facility (SNF) and who were under the care of this facility. Findings include: During observation in the dialysis treatment room at a SNF on 10/29/19 between 11:10 a.m. and 12:45 p.m., the following was observed: - RN AA was observed discontinuing dialysis treatment on P#2. She disconnected the arterial AVF needle (dialysis needle) from the arterial bloodline tubing and attempted to connect the arterial bloodline tip to the NS port (hanging freely from the pole) with one hand (right hand), while she held the arterial AVF needle with her left hand. It took four attempts to align and insert the tip of the bloodline tubing into the NS port. In the process, the tip of the arterial tubing accidentally touched the outside surfaces of the NS port with each attempt, that caused contamination to the arterial bloodline tip and the NS port. - RN AA did not use alcohol wipe/swab to disinfect the contaminated arterial bloodline tip and the NS port after each attempt and prior to the reinfusion of blood of P#2. According to the CDC, cross contaminating (going from dirty to clean equipment/tasks/area) without proper disinfection, could cause the spread of pathogens/infection. A review of the facility's P & P, titled, "Infection Control Manual" with effective date of 1/14, stated: Use Aseptic Technique. During an interview on 10/29/19 at 4:30 p.m., the Facility Administrator (FA) stated that she also saw RN AA's breach of infection control technique when she used a "one-hand technique" to connect the bloodline to the NS bag. The FA stated that she inquired RN AA about it and RN AA told her that she didn't know why she did it that way.
V0582	H-IDT OVERSEES HOME TRAINING CFR(s): 494.100(a) The interdisciplinary team must oversee training of the home dialysis patient, the designated caregiver, or self-dialysis patient before the initiation of home dialysis or self-dialysis (as defined in §494.10) and when the home dialysis caregiver or home dialysis modality changes. This STANDARD is not met as evidenced by: Based on a review of records and staff interview, it was determined that the facility failed to show documented evidence that infection control audits were completed by the facility for all Patient Care Staff (RN AA, RN BB, and LPN AA) who administered home hemodialyis (HHD) treatments at Skilled Nursing Facility (SNF), and who were under the supervision and oversight of this facility, after a patient's (P) (P#1's) Hepatitis C Seroconversion was discovered. Hepatitis C or Hep C, is a contagious liver disease caused by the hepatitis C virus (HCV), and can be transmitted via exposure to an infected person's blood/body fluids. Seroconversion is a change from seronegative to a seropositive condition. P#1 was also admitted to a local hospital on 9/12/19 due to shock and an altered mental status of unknown etiology, with sepsis (a life threatening condition that arises when the body's response to infection causes injury to its own tissues or organs.) as one of the possible causes. This deficient practice resulted in an immediate jeopardy (IJ) with harm to one patient (P#1) and a potential harm to the health and safety of the other two patients (P#2 and P#3), who were under the care of this facility and who dialyzed at the SNF. The Facility Administrator was informed of the IJ finding on 10/29/19 at 10:05 a.m. The immediate jeopardy was abated during the survey on 10/29/19 at 4:30 p.m., when the facility implemented a Credible Allegation of Compliance related to the Immediate Jeopardy. Findings include: During a review of facility records, the following was revealed: - There were three patients (P#1, P#2, and P#3) who were receiving HHD treatments at the SNF, who were under the care of this facility. - P#1 was admitted to the facility on 11/2018. A Hep C Antibody (Ab) Screen, (a test that looks for hepatitis C antibodies in the bloodstream. A reactive or positive antibody test means a person have been infected with the HCV), was collected from P#1 on 11/29/18, and the result was non-reactive or negative. Another Hep C Ab Screen was collected on 1/2/19, and the result was non-reactive. However, the Hep C Ab Screen lab result of P#1 that was collected on 7/2/19 and resulted on 7/4/19, was reactive (positive) for Hep C. And the subsequent Hep C Ab lab collected on 9/5/19 was also reactive. - P#2 and P#3 were both HCV positive upon admission. - A review of P#1's hospitalization record showed that he was admitted to the hospital on 9/12/19 due to shock and an altered mental status of unknown etiology. Sepsis was one of the possibilities and P#1 was treated with IV antibiotics. He expired on 9/13/19. A review of the facility records showed that the facility administered infection control in-service and re-training of staff on 7/12/19, 8/5/19, and 9/13/19, but there were no records that showed that the facility conducted unannounced observations, and audits of RN AA, RN BB, and LPN AA regarding infection control techniques before, during, and after administering home hemodialysis treatments to P#1, P#2, and P#3, to verify if their re-training or in-service was effective and infection control techniques were consistently followed. A review of the Department of Health's investigation on 8/6/19, revealed that handwashing/hand hygiene was one of the infection control breaches that was identified. There were no facility records regarding observations and audits about the staffs' hand hygiene practices and glove use and changes. During an interview with the Facility Administrator (FA) on 10/28/19 at approximately 3:00 p.m., the FA stated that she observed them but these observations were not recorded. She further stated that RN AA also observed RN BB and LPN AA, but there were no records of RN AA's audits and observations either. The IJ was abated during the survey on 10/29/19 at 4:30 p.m. when the FA conducted the following: - An unannounced infection control audit was conducted by the FA using the Center for Disease Control and Prevention (CDC) Infection Control Checklist. - The findings of the audits were discussed with RN AA, RN BB, and LPN AA individually. - The FA conducted a re-training/inservice on Infection Control Manual that included hand hygiene, PPE, and cross contamination.
V0713	MD RESP-STAFF ED, TRAINING & PERFORM CFR(s): 494.150(b) Medical director responsibilities include, but are not limited to, the following: (b) Staff education, training, and performance. This STANDARD is not met as evidenced by: Based on a review of records and staff interviews, it was determined that the Medical Director (MD) failed to ensure that three of three Patient Care Staff (RN AA, RN BB, and LPN AA), who administered home hemodialysis treatments to patients (P#1, P#2, and P#3) in a Skilled Nursing Facility (SNF), were audited, observed, and evaluated for re-training as needed regarding their infection control techniques and skills competencies. This deficient practice could negatively affect the health and safety of two of two patients (P#2 and P#3) who dialyzed at the SNF and who were under the care of this facility. Findings include: Cross reference the following cited deficiencies: V 113 - Failure of the Medical Director to ensure that staff followed P & P regarding hand hygiene and glove changes. V 115 - Failure of the Medical Director to ensure staff wear appropriate personal protective equipment during potential exposure to blood and body fluids. V 117 - Failure of the Medical Director to ensure staff followed P & P regarding infection control techniques to avoid cross contamination. V 582 - Failure of the facility to oversee training, re-training, evaluation and performance of licensed caregivers of home hemodialysis patients who resided in the SNF.
V0715	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: Based on a review of facility records and staff interviews, it was determined that the Medical Director (MD) failed to ensure that all three Patient Care Staff, (RN AA, RN BB, and LPN AA), who administered home hemodialysis treatments to patients, (P#1, P#2, and P#3), who were residents at a Skilled Nursing Facility, adhered to the facility's policy and procedure (P&P) relative to infection control techniques. This deficient practice had harmed P#1, and had the potential to negatively affect the health and safety of the other two patients (P#2 and P#3), after P#1's Hepatitis C Seroconversion was discovered. Findings include: Cross reference the following cited deficiencies: V 113 - Failure of the Medical Director to ensure that staff followed P & P regarding hand hygiene and glove use and glove changes. V 115 - Failure of the Medical Director to ensure staff followed P & P regarding wearing appropriate personal protective equipment (PPE) during potential exposure to blood and body fluids. V 117 - Failure of the Medical Director to ensure staff followed P & P regarding infection control techniques to avoid cross contamination.
V0750	CFC-GOVERNANCE CFR(s): 494.180 This CONDITION is not met as evidenced by: Based on a review of facility records and staff interviews, it was determined that the Governing Body (GB) failed to demonstrate oversight of the home hemodialysis (HHD) program. This deficient practice had the potential harm to the health and safety of the other two patients, (P#2 and P#3), who were dialyzing in a Skilled Nursing Facility (SNF), after P#1's Hepatitis C Seroconversion. Findings include: - A review of the GB meeting minutes revealed that the last documented GB meeting was on 5/11/18. There were no documentation that the GB members met after discovering P#1's seroconversion on 7/4/19. - Cross reference the following cited deficiencies: V 110 - Failure of the facility to ensure staff followed infection control practices to prevent cross contamination in the treatment room. V 582 - Failure of the facility to demonstrate oversight of the home hemodialysis (HHD) program. V 715 - Failure of the facility to implement policies and procedures.