Initial Comments:
Based on the findings of an onsite unannounced Medicare recertification survey completed on August 23, 2018, Dialysis Center of Erie was found to be in substantial compliance with the requirements of 42 CFR, Part 494.62, Subpart B, Conditions for Coverage of Suppliers of End-Stage Renal Disease (ESRD) Services - Emergency Preparedness
Plan of Correction:
Initial Comments:
Based on the findings of an onsite unannounced Medicare recertification survey completed on August 23, 2018, Dialysis Center of Erie was identified to have the following standard level deficiencies that were determined to be in substantial compliance with the following requirements of 42 CFR, Part 494, Subparts A, B, C, and D, Conditions for Coverage of Suppliers of End-Stage Renal Disease (ESRD) Services.
Plan of Correction:
494.30(a)(1) STANDARD
IC-WEAR GLOVES/HAND HYGIENE
Name - Component - 00
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.
Observations:
Based on review of agency policy and procedure, observation (OBS), and staff (EMP) interview, the patient care technician (PCT) failed to change gloves when going from a dirty task to a clean task for one (1) of two (2) observations of discontinuation of dialysis with an arteriovenous fistula (AVF) (OBS#5.2).
Findings included:
Review of facility policy on August 23, 2018, at 10:28 a.m. showed, "Policy: 1-05-01 ... TITLE: INFECTION CONTROL FOR DIALYSIS FACILITIES PURPOSE: To minimize the spread of infections or bloodborne pathogens in the dialysis facility environment. ... TEAMMATE/PATIENT SAFETY ... 13. Gloves should be changed when: ... going from a "dirty" area or task to a "clean" area or task"
OBS#5.2 at station 25 on August 20, 2018, at 11:22 a.m. revealed EMP4 (PCT) remove tape from patient's top needle site. EMP4 then left the station to retrieve a red biohazard sharps container (dirty). EMP4 touched and brought the red biohazard sharps container back to the station with gloved hands. With the same gloved hands, EMP4 removed needles from patients arm and applied gauze dressing to both needle sites (clean task).
Interiew with EMP4 on August 20, 2018, at 11:24 a.m. confirmed above findings.
Repeat deficiency from Medicare recertification surveys completed on 5/26/2017, 8/5/2016, and 11/6/2009
Plan of Correction:Direct patient care teammates (TMs) will receive an in-service by 9/7/2018 by the Group Facility Administrator (GFA) on Policy 1-05-01 Infection Control for Dialysis Facilities. Focus placed on performing hand hygiene between clean and dirty activities, specifically upon bringing biohazard sharps container to chairside to remove gloves, perform hand hygiene replace gloves and continue with patient take-off procedure. An in-service form to be completed as evidence of attendance. The FA or designee will be conducted audits daily for ten (10) days, then weekly for four (4) weeks, then ongoing monthly during internal infection control audits (Clean Sweep audits) of hand hygiene to verify compliance. Any instance of non-compliance will be addressed immediately. Audit results will be reviewed with TMs during homeroom meetings and with the Medical Director monthly during Facility Health Meeting (FHM-QAPI) with supporting documentation included in the meeting minutes. The Governing Body (GB) will review the FHM-QAPI minutes to ensure minutes reflect, action plans initiated, evaluated for effectiveness, new plans developed as applicable. Once compliance is achieved, plan of correction will be monitored during GB meetings at a minimum of quarterly. This plan of correction will also be followed in FHM-QAPI and the FA will report progress, as well as any barriers to maintaining compliance, with supporting documentation included in the meeting minutes. The Facility Administrator (FA) is responsible for compliance with this plan of correction.
494.40(a) STANDARD
PERSONNEL-TRAINING PROGRAM/PERIODIC AUDITS
Name - Component - 00
9 Personnel: training program/periodic audits
A training program that includes quality testing, the risks and hazards of improperly prepared concentrate, and bacterial issues is mandatory.
Operators should be trained in the use of the equipment by the manufacturer or should be trained using materials provided by the manufacturer.
The training should be specific to the functions performed (i.e., mixing, disinfection, maintenance, and repairs).
Periodic audits of the operators' compliance with procedures should be performed.
The user should establish an ongoing training program designed to maintain the operator's knowledge and skills.
Observations:
Based on review of facility policy and procedure, personnel files (PF), logs, and staff (EMP) interview, the facility failed to ensure two (2) of three (3) staff responsible for mixing and verifying dialysate concentrate had a competency assessment completed to include direct observation of the work performed (PF2, & PF19).
Findings included:
Review of facility policy on August 23, 2018, at 10:30 a.m. showed, "Initial and Annual Training Requirements For Water And Dialysate Concentrate ... PURPOSE: To provide guidance for annual training requirements for nurses and patient care technicians. POLICY: 1. The ESRD Conditions for Coverage require the operators of the water/dialysate system equipment to be trained ... Initial training is to be done during New Teammate Training and annually thereafter. ... 3. Preparation of dialysate concentrates and performing dialysate system operations: Initial and annual training consists of the following ... skills checklists based on teammate responsibilities preparing dialysate concentrates and performing dialysate system operations: ... Teammates who will be performing the mixing of concentrates or rinsing, cleaning and disinfecting concentrate mixes including clinical preceptors, trainers and mix masters are to complete: ... Acid concentrate skills checklist ... Bicarbonate concentrate skills checklist ... 4. The ESRD Condition for Coverage require that each teammate performing the procedures listed below is observed performing the procedures at least annually or more frequent as needed. Ongoing observation should be completed after new hire or annual training. ... Preparing and testing bicarbonate concentrate ... Preparing and testing acid concentrate"
Review of facility policy on August 23, 2018, at 10:36 a.m. showed, "Policy: 2-07-04 ... TITLE: GRANUFLO CONCENTRATE DISSOLUTION UNIT [acid concentrate mixer] PURPOSE: To verify that the Granuflo Concentrate Dissolution Unit (Granuflo) is operated to produce liquid acid concentrate from commercially packaged dry powder in a safe and fully documented process that is consistent with instructions given by the manufacturer of the device. POLICY: 1. Only teammates who have been trained to operate the Granuflo may complete the procedures used to rinse, disinfect and prepare liquid acid concentrate with the device. 2. The Facility Administrator is responsible for verifying that those operating the Granuflo have received appropriate training and that documentation of this training is place in the teammates' personnel file. ... 11. The results ... of the test ... is recorded on the Granuflo Batch Production Record and is accompanied by the signature of the operator performing the test and the signature of a licensed nurse reviewing the test results."
Review of facility policy on August 23, 2018, at 10:37 a.m. showed, "Policy: 2-07-01 ... TITLE: BICARBONATE CONCENTRATE SYSTEM MIXING ... POLICY: ... 2. Only teammates who have been trained to operate the bicarbonate concentrate system mixer may complete the procedures used to rinse, clean, disinfect and prepare bicarbonate solution."
Review of acid concentrate mixing logs on August 23, 2018, at 10 a.m. showed a batch of acid mixed on 8/17/2018. The "License Nurse Signature" portion of the form was signed by PF19 (registered nurse) to indicate the batch was mixed correctly.
Review of "BICARB MIX LOG" on August 23, 2018, at 9:57 a.m. showed a batch of bicarb mixed on 8/22/2018 by PF2 (patient care technician).
Review of PF2 on August 23, 2018, at 9:40 a.m. showed no bicarb mixing competency skills checklist or observation of the work performed. PF2 was hired on 8/8/2016. Interview with EMP19 at time of review confirmed findings, "I don't see it."
Review of PF19 on August 23, 2018, at 9:50 a.m. showed no competency skills checklist for acid concentrate mixing or observation of the work performed. PF19 was hired on 1//3/2017. Interview with EMP19 at time of review confirmed findings. .
Repeat deficiency from Medicare recertification surveys completed on 5/26/2017, and 8/5/2016.
Plan of Correction:The GFA, and Medial Director will received an in-service by 8/29/2018 by CSS on Policy TR1-01-12 Initial and Annual Training Requirements for Water and Dialysate. The GFA will in-service direct patient care TMs on Policy 2-07-04 Granuflo Concentrate Dissolution Unit. Both in-service focus placed on the requirement for annual training of Acid and Bicarbonate Skills Verification Checklist for Teammates. An in-service form to be completed as evidence of attendance. PF2 and PF19 will completed water training by 9/7/2018 with documentation of such placed in the TM file. TMs will not perform activities related to acid and bicarb mixing until skills checklist is completed. An annual acid and Bicarbonate training Outlook Calendar Reminder has been placed on the facility calendar. The FA or designee will monitor for current documentation for annual skills checklists/competency for dialysate, during audit of 25% of TM files quarterly. Audit results will be reviewed with the TMs during homeroom meetings and with the Medical Director monthly during FHM-QAPI with supporting documentation included in the meeting minutes. The Governing Body will review the FHM-QAPI minutes to ensure minutes reflect, action plans initiated, evaluated for effectiveness, new plans developed as applicable. Once compliance is achieved, plan of correction will be monitored during GB meetings at a minimum of quarterly. This plan of correction will also be followed in FHM-QAPI and the FA will report progress, as well as any barriers to maintaining compliance, with supporting documentation included in the meeting minutes. The FA is responsible for compliance with this plan of correction.
494.90(a)(5) STANDARD
POC-VASCULAR ACCESS-MONITOR/REFERRALS
Name - Component - 00
The interdisciplinary team must provide vascular access monitoring and appropriate, timely referrals to achieve and sustain vascular access. The hemodialysis patient must be evaluated for the appropriate vascular access type, taking into consideration co-morbid conditions, other risk factors, and whether the patient is a potential candidate for arteriovenous fistula placement.
Observations:
Based on review of facility policy and procedure, clinical records (CR), observation (OBS), and patient and staff (EMP) interviews, the facility failed to ensure the patient's arteriovenous fistula (AVF) was washed with soap and water prior to disinfection and insertion of needles for two (2) of two (2) observations of initiation of dialysis with an AVF, (OBS#4.1, & OBS#4.2).
Findings included:
Review of facility policy and procedure on August 23, 2018, at 10:23 a.m. showed, "Policy: 1-04-01 ... TITLE: ARTERIOVENOUS FISTULA (AVF) AND ARTERIOVENOUS GRAFT (AVG) VASCULAR ACCESS CARE ... PURPOSE: To reduce the risk of infection in the patient, and to reduce trauma to the fistula or graft while minimizing blood loss and to maximize the lifetime of each access. POLICY: ... 4. Patients are encouraged to wash access extremity with soap and water upon arrival for dialysis, if able. If patient unable to wash access site, patient care teammate will clean access extremity with skin cleansing agent and pat dry."
Review of facility policy on August 23, 2018, at 10:28 a.m. showed, "Policy: 1-05-01 ... TITLE: INFECTION CONTROL FOR DIALYSIS FACILITIES PURPOSE: To minimize the spread of infections or bloodborne pathogens in the dialysis facility environment. ... TEAMMATE/PATIENT SAFETY ... 37. Patients are encouraged to wash their hands and access extremity upon entering the treatment area prior to the initiation of dialysis"
Review of facility policy and procedure on August 23, 2018, at 10:25 a.m. showed, "Procedure: 1-04-01E ... TITLE: AV FISTULA OR GRAFT CANNULATION ... Procedure 1. Have patient wash access site with appropriate antimicrobial soap, if able."
OBS#4.1 at station 18 on August 20, 2018, at 11:09 a.m. revealed EMP5 wipe patient's access site with an antimicrobial hand wipe followed by another wipe containing 70 % isopropyl alcohol. EMP5 inserted needles into patient's access and initiated dialysis.
Interview with EMP5 and patient at time of observation confirmed patient did not wash access at sink with soap and water, and that patient was also physically able to do so. The patient noted, "I did not know I was supposed to."
OBS#4.2 at station 6 on August 21, 2018, at 10:50 a.m. revealed EMP15 wipe patient's access with antimicrobial hand wipe followed by another wipe containing 70 % isopropyl alcohol. EMP15 inserted needles into patient's access and initiated dialysis.
Interview with EMP15 at time of observation confirmed patient was physically able to wash access site at sink with soap and water, "He is [able to wash access at sink] but he has a language barrier." Interview with EMP19 on August 22, 2018, at approximately 2:47 p.m. confirmed patient has a daughter who is available to interpret for the patient.
On August 21, 2018, at 11:15 a.m. surveyor observed a patient at facility sink attempting to wash his access. Patient (CR11) was unfamiliar with how to wash his access, and was unable to operate the sink's faucet (motion actuated), soap dispenser, or retrieve hand drying towels. Interview with the patient at time of observation confirmed he has never washed his access with soap and water at the sink.
Review of CR11 on August 22, 2018, at 2:47 p.m. showed, "Patient Infection Control Information Sheet" signed by the patient on 10/10/2017. Review of the sheet revealed, "Washing your access before your treatment--Your access must be clean before we place the needles directly into your blood stream." Review of "TIPS to keep your Vascular Access in TOP shape!" showed, "Wash your Vascular Access extremity (arm, leg, etc) before each dialysis treatment." Patient was admitted to facility on 6/19/2015.
Plan of Correction:Direct patient care TM will receive an in-service by 9/7/2018 by the GFA on Policy 1-04-01 Arteriovenous Fistula (AVF) and Arteriovenous Graft (AVG) Vascular Access Care and Policy 1-05-01 Infection Control for Dialysis Facilities with focus on reduction of risk of infection and encourage patients to wash access extremity with soap and water upon arrival for dialysis, if able. An in-service form to be completed as evidence of attendance. Patient having AVF or AVG will be provided education sheet titled" Infection Risks" with specific focus education on Always Wash your access just before your dialysis to be completed by 9/30/2018. An education sheet will provide documentation of patient education. The FA or designee will audit AVG/AVF patient chart for compliance of patient education by 9/30/2018. Audit will take place weekly for eight (8) weeks and then monthly during Clean Sweep audits to verify patients wash their access prior to treatment and TMs perform verification of patient washing access prior to treatment initiation. Audit results will be reviewed with the TMs during homeroom meetings and with the Medical Director monthly during FHM-QAPI with supporting documentation included in the meeting minutes. The Governing Body will review the FHM-QAPI minutes to ensure minutes reflect, action plans initiated, evaluated for effectiveness, new plans developed as applicable. Once compliance is achieved, plan of correction will be monitored during GB meetings at a minimum of quarterly. This plan of correction will also be followed in FHM-QAPI and the FA will report progress, as well as any barriers to maintaining compliance, with supporting documentation included in the meeting minutes. The FA is responsible for compliance with this plan of correction.
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