Statement of Deficiencies

Statement of Deficiencies	(X1) Provider/Supplier/CLIA Identification Number 852550	(X3) Date Survey Completed 06/09/2022
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)
E0000	A recertification survey was conducted at Dublin Kidney Institute on June 7, 2022 through June 9, 2022. The survey revealed that the facility was in substantial compliance with 42 CFR Part 494.62, Conditions for Coverage for Emergency Preparedness Plan for End Stage Renal Disease facilities. A standard level deficiency was cited.
E0028	Dialysis Emergency Equipment §494.62(b)(9) Condition for Coverage: [(b) Policies and procedures. The dialysis facility must develop and implement emergency preparedness policies and procedures, based on the emergency plan set forth in paragraph (a) of this section, risk assessment at paragraph (a)(1) of this section, and the communication plan at paragraph (c) of this section. The policies and procedures must be reviewed and updated at least every 2 years. At a minimum, the policies and procedures must address the following:] (9) A process by which the staff can confirm that emergency equipment, including, but not limited to, oxygen, airways, suction, defibrillator or automated external defibrillator, artificial resuscitator, and emergency drugs, are on the premises at all times and immediately available. This STANDARD is not met as evidenced by: Based on observation, a review of facility records, a review of the Food and Drug Administration (FDA) recommendation, and staff interview, it was determined that the facility failed to ensure that all emergency drugs and other stored medications, should not be out of date and should be stored and maintained according to the manufacturer's instructions. This deficient practice had the potential to negatively affect the health and safety of all 16 Home Peritoneal Dialysis (PD) patients (P#1-P#4, P#6 - P#17) and one Home Hemodialysis (HHD) patient (P#5) who were under the care of this facility. Findings include: During a tour of the facility with Registered Nurse (RN AA) on 6/7/22 at 5:20 p.m., the following medications were expired, thus these were not suitable for use. At the Crash Cart: - Naloxone HCl Injection (medication used to rapidly reverse opioid overdose) 0.4 mg/mL (five vials) - expired 5/2022 - Epipen Abboject Injection (for the treatment of severe allergic reactions (including anaphylaxis) to insect bites or stings, medicines, food, or other substances) 1mg/10 mL glass Abboject (total of six) - expired 5/1/2022. RN AA acknowledged the expiry dates of these medications on 6/7/22 at 5:20 p.m. and she stated that she was unaware that the medications were expired. A review of facility records revealed that there was no available facility policy and procedure (P & P) regarding expired medications. According to FDA recommendation dated 2/8/2021, drug expiration dates reflect the time period during which the product is known to remain stable, which means it retains its strength, quality, and purity when it is stored according to its labeled storage conditions. Several potential harms may occur from taking an expired medicine... Once the expiration date has passed there is no guarantee that the medicine will be safe and effective.
V0000	A Recertification survey was conducted at Dublin Kidney Institute from June 7, 2022 through June 9, 2022. The survey revealed that the facility was not in compliance with 42-CFR Part 494.80 - Patient Assessment, 42-CFR Part 494.90 - Patient Plan of Care, 42 CFR Part 494.150 - Responsibilities of the Medical Director, and 42 CFR Part 494.180 - Governance, for End Stage Renal Disease Facilities. The following standard level deficiencies were also cited which resulted from the facility's noncompliance related to the survey:
V0500	CFC-PATIENT ASSESSMENT CFR(s): 494.80 This CONDITION is not met as evidenced by: Based on a review of facility records and staff interviews, it was determined that the facility failed to ensure that comprehensive assessments and re-assessments were completed by the entire Interdisciplinary Team (IDT) for four of four Peritoneal Dialysis (PD) patients (P#1 - P#4) sampled, and one of one Home Hemodialysis (HHD) patient (P#5) sampled, . This deficient practice had the potential to negatively affect the health and safety of all 16 Home Peritoneal Dialysis (PD) patients (P#1-P#4, P#6-P#17) and one Home Hemodialysis (HHD) patient (P#5), who were under the care of this facility. Findings include: 1. Cross reference V 501 - Failure of the facility to ensure that initial comprehensive assessments of patients were completed by the entire IDT. 2. Cross reference V 516 - Failure of the facility to complete an initial comprehensive assessment within 30 days of patient's (P#1's) admission or/ after 13 dialysis treatments.
V0501	PA-IDT MEMBERS/RESPONSIBILITIES CFR(s): 494.80 The facility's interdisciplinary team consists of, at a minimum, the patient or the patient's designee (if the patient chooses), a registered nurse, a physician treating the patient for ESRD, a social worker, and a dietitian. The interdisciplinary team is responsible for providing each patient with an individualized and comprehensive assessment of his or her needs. The comprehensive assessment must be used to develop the patient's treatment plan and expectations for care. This STANDARD is not met as evidenced by: Based on facility record review and staff interviews, it was determined that the facility failed to ensure that four of four Peritoneal Dialysis (PD) patients (P#1 - P#4) sampled, and one of one Home Hemodialysis (HHD) patient (P#5) sampled, had a current comprehensive Interdisciplinary Team (IDT) assessment that was used to develop the patient's treatment plan and expectations for care. This deficient practice had the potential to negatively affect the health and safety of all five patients sampled. The facility census was 16 PD patients and one HHD patient. Findings include: A review of the medical records of P#1 - P#5, revealed the following: - P#1 was admitted to this facility on 3/23/22. There was no documentary evidence that a comprehensive IDT initial assessment was completed. There was an incomplete assessment by the Registered Nurse (RN BB), and Social Worker (SW), with no dates, and no signatures from both disciplines. There was no documentary evidence of the Registered Dietitian's assessment nor of the Nephrologist's assessment. - P#2 was admitted to this facility on 1/15/20. There was no documentary evidence of a comprehensive IDT assessment. It was unknown if or when the last time P#2 had a comprehensive IDT assessment. In addition, P#2 had Peritonitis on 3/21/22 - 3/25/22 and again on 5/30/22 - 6/2/22. There was no documentary evidence of a re-assessment due to a change in P#2's condition. - P#3 was admitted to this facility on 6/10/20. There was no documentary evidence of a comprehensive IDT assessment. It was unknown if or when the last time P#3 had a comprehensive IDT assessment. - P#4 was admitted to this facility on 4/1/20. There was no documentary evidence of a comprehensive IDT assessment. It was unknown if or when the last time P#4 had a comprehensive IDT assessment except for an assessment by the SW, with no date and no SW signature. - P#5 was admitted to this facility on 2/18/19. There was no documentary evidence of a comprehensive IDT assessment. It was unknown if or when the last time P#4 had a comprehensive IDT assessment. A review of facility records revealed that there was no facility Policy and Procedures (P & P) regarding comprehensive IDT Assessments, except for a checklist, with a header, "Medical Record Audit". ... RN Assessment... complete RN assessment completed within 30 days. Assessment updated if treatment modality changes/as needed. Psychosocial/SW assessment - within 30 days of admission. Annually. Assessment updated if treatment modality changes/as needed. Nutrition Assessment - within 30 days of admission. Annually. Assessment updated if treatment modality changes/as needed. There was no mention of an Unstable Assessment Criteria. Registered Nurse (RN AA), also the new Administrator in training and Charge Nurse, stated on 6/9/22 at approximately 4:00 p.m., that she could not find any documentary evidence of the above patients' comprehensive IDT assessments. During a telephonic interview with the Medical Director on 6/10/22 at 9:17 a.m., he stated that whatever needed to be corrected will be corrected.
V0516	PA-FREQUENCY-INITIAL-30 DAYS/13 TX CFR(s): 494.80(b)(1) An initial comprehensive assessment must be conducted on all new patients (that is, all admissions to a dialysis facility), within the latter of 30 calendar days or 13 hemodialysis sessions beginning with the first dialysis session. This STANDARD is not met as evidenced by: Based on a review of medical records and staff interview, it was determined that the facility failed to complete a comprehensive interdisciplinary assessment that was conducted by the entire interdisciplinary team (IDT) within 30 calendar days of admission or after 13 dialysis treatments for one of one sampled new patient (P#1), who was admitted on 3/23/22. This failure had the potential to negatively affect the health and safety of P#1. The facility census was 16 Peritoneal Dialysis (PD) patients and one Home Hemodialysis (HHD) patient. A review of P#1's medical records revealed the following: - P#1 was admitted to this facility on 3/23/22. There was no documentary evidence that a comprehensive IDT initial assessment was completed. There was an incomplete assessment by the Registered Nurse (RN BB), and Social Worker (SW), with no dates, and no signatures from both disciplines. There was no documentary evidence of the Registered Dietitian's assessment nor of the Nephrologist's assessment. A review of facility records revealed that there was no facility Policy and Procedures (P & P) regarding comprehensive IDT Assessments, except for a checklist, with a header, "Medical Record Audit". ... RN Assessment... complete RN assessment completed within 30 days. Assessment updated if treatment modality changes/as needed. Psychosocial/SW assessment - within 30 days of admission. Annually. Assessment updated if treatment modality changes/as needed. Nutrition Assessment - within 30 days of admission. Annually. Assessment updated if treatment modality changes/as needed. - Registered Nurse (RN AA) stated on 6/9/22 at approximately 4:00 p.m., that she could not find any documentary evidence of an initial comprehensive IDT assessment completed for P#1.
V0540	CFC-PATIENT PLAN OF CARE CFR(s): 494.90 This CONDITION is not met as evidenced by: Based on a review of facility records and staff interviews, it was determined that the facility failed to develop or complete an individualized plan of care (POC) in collaboration with the entire Interdisciplinary Team (IDT) for five of five patients sampled (P#1 - P#5). This deficient practice had the potential to negatively affect the health and safety of all patients who were under the care of this facility. The facility had a census of 16 Peritoneal Dialysis (PD) patients and one Home Hemodialysis (HHD) patient. Findings include: Cross reference: V 0542 - Failure of the facility to ensure that the POC was completed by the entire IDT.
V0542	POC-IDT DEVELOPS PLAN OF CARE CFR(s): 494.90(a) The interdisciplinary team must develop a plan of care for each patient. This STANDARD is not met as evidenced by: Based on medical record review and staff interviews, it was determined that the facility failed to ensure that the Interdisciplinary Team (IDT) developed an effective, individualized Plan of Care (POC) for four of four Peritoneal Dialysis (PD) patients (P#1 - P#4), sampled and one of one Home Hemodialysis (HHD) patient (P#5), sampled. This deficient practice had the potential to negatively affect the health and safety of the five patients sampled and the other 12 PD patients who were under the care of this facility. Findings include: A review of the medical records of P#1 - P#5, revealed the following: - P#1 was admitted to this facility on 3/23/22. There was no documentary evidence that an individualized Plan of Care (POC) was developed and completed by the entire IDT. - P#2 was admitted to this facility on 1/15/20. There was no documentary evidence that an individualized Plan of Care (POC) was developed and completed by the entire IDT. In addition, P#2 had Peritonitis on 3/21/22 - 3/25/22 and again on 5/30/22 - 6/2/22. There was no documentary evidence of a re-assessment and revised POC due to a change in P#2's condition. - P#3 was admitted to this facility on 6/10/20. There was no documentary evidence that an individualized Plan of Care (POC) was developed and completed by the entire IDT. - P#4 was admitted to this facility on 4/1/20. There was no documentary evidence that an individualized Plan of Care (POC) was developed and completed by the entire IDT. - P#5 was admitted to this facility on 2/18/19. There was no documentary evidence that an individualized Plan of Care (POC) was developed and completed by the entire IDT, except for a comment by the Social Worker, but there was no date when the information was entered or developed. A review of facility records revealed that there was no facility Policy and Procedures (P & P) regarding patients' individualized POC based on a comprehensive IDT Assessments, except for a checklist, with a header, "Medical Record Audit". PLAN OF CARE FORM (POC) -Present in medical record. Complete, i.e. signed /dated by: Physician, RN, SW, RD, Patient (Family member/Guardian)... Registered Nurse (RN AA), who was also the new Administrator in training and Charge Nurse, stated on 6/9/22 at approximately 4:00 p.m., that she could not find any documentary evidence of the above patients' individualized POC. During a telephonic interview with the Medical Director on 6/10/22 at 9:17 a.m., he stated that whatever needed to be corrected will be corrected.
V0637	QAPI-INDICATOR-INF CONT-TREND/PLAN/ACT CFR(s): 494.110(a)(2)(ix) The program must include, but not be limited to, the following: (ix) Infection control; with respect to this component the facility must- (A) Analyze and document the incidence of infection to identify trends and establish baseline information on infection incidence; (B) Develop recommendations and action plans to minimize infection transmission, promote immunization; and (C) Take actions to reduce future incidents. This STANDARD is not met as evidenced by: Based on a review of the facility's quality assessment and performance improvement (QAPI) meeting minutes, and staff interview, it was determined that the Interdisciplinary Team (IDT) failed to identify and analyze trends, investigate all infections, develop recommendations, and take remedial actions to minimize the facility's infection rates, specifically Peritonitis (an inflammation of the abdominal membranes, most commonly due to bacterial infection), in seven of seven months (November 2021 - May 2022) of QAPI meeting minutes reviewed. This deficient practice had the potential to negatively affect the health and safety of all 16 Peritoneal Dialysis (PD) patients who were under the care of this facility. Findings include: A review of the facility's QAPI meeting minutes from November 2021 - May 2022 revealed that there was no documentary evidence that trends in Peritonitis infections were evaluated and investigated. - November 2021 - three patients out of 19 PD patients had Peritonitis. - December 2021 - one patient had Peritonitis. - March 2022 - one patient had Peritonitis. - May 2022 - two patients had Peritonitis. During a medical record review of patient (P#2), who was sampled for Peritonitis, it was revealed that P#2 had Peritonitis in March 21 to 25, 2022 and again on May 30 to June 2, 2022. There were no evidences of patient or caregiver re-training/re-education after the Peritonitis infection incidences and there were no home visits nor other evidences of analyzing root causes and interventions to avoid future infections. There was no documentary evidence of a comprehensive Interdisciplinary Team (IDT) assessments/re-assessments and care plans. P#2's initial PD training was completed on 3/6/20 and there were no documentary evidences of re-training nor evaluations. The last recorded home visit was on 11/11/21. Registered Nurse (RN AA) was unable to present any documentation of P#2's re-training, re-evaluation and follow up home visits after P#2's Peritonitis infections. RN AA stated on 6/9/22 at approximately 3:00 pm., that P#2 was transferred to in-center hemodialysis on 6/2/22 after his hospitalization.
V0710	CFC-RESPONSIBILITIES OF THE MEDICAL DIRECTOR CFR(s): 494.150 This CONDITION 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 demonstrate responsibility for the operations of the facility. This failure had the potential to negatively impact the health and safety of all 16 Peritoneal Dialysis patients and one Home Hemodialysis patient who were under the care of this facility. Findings include: Cross Reference the following cited deficiencies: V 501 - Failure of the facility to ensure that the entire Interdisciplinary Team (IDT) completed patients' comprehensive assessments. V 516 - Failure of the facility to ensure that the IDT completed a comprehensive interdisciplinary assessment that was conducted by the entire interdisciplinary team (IDT) within 30 calendar days of admission or after 13 dialysis treatments for one of one sampled new patient (P#1), who was admitted to the facility on 3/23/22. V 542 - Failure of the facility to ensure that the entire IDT completed patients' Plan of Care (POC). V 637 - Failure of the facility to identify and analyze trends, investigate all infections, develop recommendations, and take remedial actions to minimize the facility's infection rates, specifically Peritonitis (an inflammation of the abdominal membranes, most commonly due to bacterial infection). V 714 - Failure of the Medical Director to develop, review and approve facility Policies and Procedures for comprehensive IDT assessments and care plans. During a telephonic interview with the Medical Director on 6/10/22 at 9:17 a.m., he stated that whatever needed to be corrected will be corrected.
V0714	MD RESP-DEVELOP, REVIEW & APPROVE P&P CFR(s): 494.150(c)(1) The medical director must- (1) Participate in the development, periodic review and approval of a "patient care policies and procedures manual" for the facility; This STANDARD is not met as evidenced by: Based on a review of the facility's policies and procedures (P&P), and staff interview, it was determined that the Medical Director (MD) failed to establish, adopt and annually review facility (P & P) in accordance with acceptable standards of practice to ensure the safety of all 16 Peritoneal Dialysis (PD) patients and one Home Hemodialysis (HHD) patients who were were under the care of this facility. Findings include: A review of the facility's P & P for Comprehensive Interdisciplinary Team (IDT) Assessments and Care Plans, revealed that there were no established and adopted P & P, and there were no documentary evidences of annual reviews of P & P, updates nor revisions. Cross References: V 501 - Failure of the facility to ensure that the entire Interdisciplinary Team (IDT) completed patients' comprehensive assessments. V 516 - Failure of the facility to ensure that the IDT completed a comprehensive interdisciplinary assessment that was conducted by the entire interdisciplinary team (IDT) within 30 calendar days of admission or after 13 dialysis treatments for one of one sampled new patient (P#1), who was admitted to the facility on 3/23/22. V 542 - Failure of the facility to ensure that the entire IDT completed patients' Plan of Care (POC).
V0750	CFC-GOVERNANCE CFR(s): 494.180 This CONDITION is not met as evidenced by: Based on facility record review and staff interviews, it was determined that the Governing Body (GB) failed to demonstrate responsibility and accountability for the operations of the facility. This failure had the potential to negatively impact the health and safety of all 16 Peritoneal Dialysis patients and one Home Hemodialysis patient who were under the care of this facility. Findings include: Cross Reference the following cited deficiencies: V 501 - Failure of the facility to ensure that the entire Interdisciplinary Team (IDT) completed patients' comprehensive assessments. V 516 - Failure of the facility to ensure that the IDT completed a comprehensive interdisciplinary assessment that was conducted by the entire interdisciplinary team (IDT) within 30 calendar days of admission or after 13 dialysis treatments for one of one sampled new patient (P#1), who was admitted to the facility on 3/23/22. V 540 - Failure of the facility to ensure that the entire IDT completed patients' Plan of Care (POC). V 637 - Failure of the facility to identify and analyze trends, investigate all infections, develop recommendations, and take remedial actions to minimize the facility's infection rates, specifically Peritonitis (an inflammation of the abdominal membranes, most commonly due to bacterial infection).