Initial Comments:
Based on the findings of an onsite Medicare recertification survey conducted on April 5, 2022 through April 7, 2022, Franklin Commons Dialysis was identified to have the following standard level deficiency that was determined to be in substantial compliance with the following 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:
494.62(d)(3) STANDARD
ESRD Patient Orientation Training
Name - Component - 00
The dialysis facility must provide appropriate orientation and training to patients, including the areas specified in paragraph (d)(1) of this section.
Observations:
Based on a review of medical records (MR), facility policy, and an interview with the administrator, the facility did not conduct fire drills every quarter for patients and staff per policy for four (4) of six (6) MRs. MR# 1, 2, 4, and 6.
Findings include:
A review of policy 4-07-04 on January 19, 2018 at 11:45 AM states: "E. Fire Drills/ Exercises 2. fire Drills will be conducted quarterly on all treatment shifts."
A review of MRs was conducted on April 6, 2022 at 9:30 AM.
MR#1 admission date 9/13/16 did not have documentation of a fire drill conducted during the third quarter of 2021.
MR#2 admission date 2/28/21 did not have documentation of a fire drill conducted during the second quarter of 2021.
MR#4 admissions date 1/9/2020 did not have documentation of a fire drill conducted during the third quarter of 2021.
MR#6 admission date 9/19/13 did not have documentation of a fire drill conducted during the second quarter of 2021.
An interview with the administrator on April 7, 2022 at 11:30 AM confirmed the above findings.
Plan of Correction:E 040
The Facility Administrator (FA) or designee held mandatory meeting for all clinical teammates starting on 4/20/22. Surveyor observations were reviewed. Education included but was not limited to a review of Policy 4-07-01 "Facility Emergency Management Plan (EMP) (ICHD, HOME)", with emphasis on but not limited to: Fire Safety Drills: 1) Required on a quarterly basis; one drill to be conducted for each shift of patients. 2) Include patient emergency takeoff procedure, policy: Termination of Dialysis in an Emergency. 3) Document training for both teammates and patients. 4) Complete exercise evaluation and teammate attendance sheet. 5) Document in Governing Body and maintain with facility EMP. Verification of attendance is evidenced by teammate's signature on the in-service sheet. The Facility Administrator or designee will conduct quarterly fire drills for each shift of patients, to include emergency take off procedures. Teammate and patient education/participation will be documented with the appropriate forms per policy. The Facility Administrator or designee will audit fire drill documentation for three (3) quarters to verify compliance for all shifts of patients. Instances of non-compliance will be addressed immediately. The Facility Administrator or designee will review audit results with teammates during homeroom meetings, and with the Medical Director during the monthly Quality Assessment Performance Improvement meetings known as Facility Health Meetings, with supporting documentation included in the meeting minutes. The Facility Administrator is responsible for compliance with this plan of correction.
POC Completion Date 05/19/22
Initial Comments:
Based on the findings of an onsite Medicare recertification survey conducted on April 5, 2022 through April 7, 2022, Franklin Commons Dialysis 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 observation (Obs) of the clinical area, facility policy and an interview with the administrator, the facility did not follow its policy regarding glove removal and hand hygiene during the dialysis procedure for four (4) of ten (10) observations. Obs#1, 2, 3, and 4.
Findings include:
A review of facility policy 1-05-01 "Infection Control for Dialysis Facilties" on April 7, 2022 at 11:15 AM states: "Hand hygiene is to be performed upon entering the patient treatment area, prior to gloving, after removal of gloves...after patient and dialysis delivery system contact..."
Observation of the treatment area was conducted on April 5, 2022 9:10 AM-12:20 PM and April 6, 2022 10:50 AM-12:50 PM.
Obs#1 Station #1 after discontinuation of dialysis, reinfusion of the extracorporeal circuit, PCT#1 did not remove gloves and perform hand hygiene prior to disinfection of the catheter hubs.
Obs#2 Station#16 after discontinuation of dialysis, reinfusion of the extracorporeal circuit, PCT#1 did not remove gloves and perform hand hygiene prior to disinfection of the catheter hubs.
Obs#3 Station#15 after performing catheter exit site care, PCT #1 changed gloves without performing hand hygiene prior to disinfecting the catheter hubs at initiation of dialysis. Gloves were then changed without performing hand hygiene after initiation of treatment was completed.
Obs#4 Station#1 after performing catheter exit site care, PCT #4 changed gloves without performing hand hygiene prior to disinfecting the catheter hubs at initiation of dialysis. Gloves were then changed without performing hand hygiene after initiation of treatment was completed.
An interview with the administrator on April 7, 2022 at 11:30 AM confirmed the above findings.
Plan of Correction:The Facility Administrator or designee held mandatory in-services for all clinical teammates starting on 04/11/22. Surveyor observations were reviewed. Education included but was not limited to a review of Policy 1-05-01 "Infection Control for Dialysis Facilities" with emphasis on but not limited to: 1) Hand hygiene is to be performed upon entering the patient treatment area, prior to gloving, after removal of gloves, after contamination with blood or other infectious material, after patient and dialysis delivery system contact, between patients even if the contact is casual, before touching clean area... Verification of attendance is evidenced by teammate's signature on the in-service sheet. The Facility Administrator or designee will conduct infection control audits to verify teammate compliance with hand hygiene and infection control policy: daily for two (2) weeks, then weekly for two (2) weeks. Ongoing compliance will be monitored with monthly infection control audits. Instances of non-compliance will be addressed immediately. The Facility Administrator or designee will review the audit results with teammates during homeroom meetings, and with the Medical Director during monthly Quality Assessment Performance Improvement Meetings known as Facility Health Meetings, with supporting documentation included in the meeting minutes. The Facility Administrator is responsible for compliance with this plan of correction.
POC Completion 05/19/22
494.30(a)(4)(ii) STANDARD
IC-DISINFECT SURFACES/EQUIP/WRITTEN PROTOCOL
Name - Component - 00
[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.
Observations:
Based on observation (Obs) of the treatment area, facility policy and an interview with the administrator, the facility did not properly disinfect medical equipment for one (1) of one (1) observation. Obs#1.
Findings include:
Observation of the treatment area was conducted on April 5, 2022 9:10 AM-12:20 PM and April 6, 2022 10:50 AM-12:50 PM.
A review of Policy 1-05-01 "Infection Control For Dialysis Facilities" on April 7, 2022 at 11:15 AM states: "26. Stethoscopes will be disinfected with alcohol prep pad and/or 1:100 (one to one hundred) bleach solution..."
Policy 1-05-02 Hepatitis B Surveillance, Vaccination, Infection Control Measures and Isolation Guidance" states: "19.a. Dedicated ancillary supplies such as ...stethoscope...will be used. b. Such supplies will be labeled "isolation" and will remain in the isolation room..."
Obs#1 RN#1 observed in isolation room to wipe personal stethoscope with hand sanitizer after caring for a covid positive patient. When asked if isolation room had a dedicated stethoscope, RN replied "I can bring it out." A dedicated stethoscope was not observed to be in the isolation room. RN#1 brought a new dedicated stethoscope to the room.
An interview with the administrator on April 6, 2022 at 1:00PM stated that the isolation room disinfection procedure is the same for any isolation diagnosis using the room and that the facility does not currently have any hepatitis B positive patients.
An interview with the administrator on April 7, 2022 at 11:30 AM confirmed the above findings.
Plan of Correction:The Facility Administrator or designee held mandatory in-services for all clinical teammates starting on 04/19/22. Surveyor observations were reviewed. Education included but was not limited to a review of Policy 1-05-01 "Infection Control for Dialysis Facilities" and Policy 1-05-02 "Hepatitis B Surveillance, Vaccination, Infection Control Measures and Isolation Guidance" with emphasis on but not limited to: 1. Infection Control: 1) Non-disposable items are to be disinfected between patients. 2) Stethoscopes will be disinfected with alcohol prep pad and/or 1:100 (one to one hundred) bleach solution and if they are visibly contaminated with blood or body fluids should be disinfected with a 1:10 (one to ten) bleach solution. 2. Isolation Equipment / Supplies: 1) dedicated ancillary supplies such as ... stethoscope ... and non-disposable items will be used. 2) Such supplies will be labeled "isolation" and will remain in the isolation room/area or station and be disinfected after every patient use with a 1:100 (one to one hundred) bleach solution. 3) A facility may convert a designated isolation room or area once it is determined that the need for a dedicated station is no longer needed. a. The room/area will be terminally disinfected using conventional protocols... b. All non-disposable supplies will also be terminally disinfected and "isolation" labels removed. Verification of attendance at in-service will be evidenced by teammates signature on in-service sheet. The Isolation room was terminally cleaned 09/14/17. The Facility Administrator or designee will conduct infection control audits to verify compliance with cleaning stethoscopes appropriately in the clinic: daily for two (2) weeks then weekly for two (2) weeks. Ongoing compliance will be monitored with monthly infection control audits. Instances of non-compliance will be addressed immediately. The Facility Administrator or designee will review audit results with teammates during homeroom meetings and with the Medical Director during monthly Quality Assessment Performance Improvement meetings known as Facility Health Meetings, with supporting documentation included in the meeting minutes. The Facility Administrator is responsible for compliance with this plan of correction.
POC Completion 05/19/22
494.110(a)(2) STANDARD
QAPI-MEASURE/ANALYZE/TRACK QUAL INDICATORS
Name - Component - 00
The dialysis facility must measure, analyze, and track quality indicators or other aspects of performance that the facility adopts or develops that reflect processes of care and facility operations. These performance components must influence or relate to the desired outcomes or be the outcomes themselves.
Observations:
Based on a review of Quality Assessment Performance Improvement (QAPI) meeting minutes, medical records, and an interview with the administrator, the facility did not measure, analyze, and track quality indicators or other aspects of performance that reflect processes of care and facility operations.
Findings include:
A review of QAPI minutes from October, 2021 through March, 2022 was conducted on April 7, 2022 at 9:30 AM
The facility did not measure, analyze, and track mortality data. A review of QAPI census data (reflecting the month previous to the meeting) revealed the following deaths: October: 1 December: 3, January: 1, February: 2, March: 2. The minutes did not reflect any mention of these deaths including, trending, analysis or evaluation of the death.
The facility did not document, track and trend eligible patients' scores, the percent of eligible patients who complete and refuses the physical and mental functioning survey. A review of Medical Records on April 6, 2022 at 9:15 AM revealed that KDQOL( quality of life survey) and mental functioning surveys were completed. An interview with the social worker on April 7, 2022 at 11:00 AM revealed that there were no patient refusals for completing the surveys but that the above data was not reported in the QAPI meeting minutes.
An interview with the administrator on 12/23/2020 at 2:00 PM confirmed the above findings.
Plan of Correction:The Facility Administrator or designee held mandatory in-services for members of the Continuous Quality Improvement (CQI) Committee starting on 04/19/22. Surveyor observations were reviewed. Education included but was not limited to a review of Policy 1-14-06 "Continuous Quality Improvement Program" with emphasis on but not limited to the following: 1) the facility will measure, analyze, and track quality indicators or other aspects of performance. The program must include, but not be limited to, the following: Mortality – review of deaths ... Patient Satisfaction and Grievances, including KDQOL; Other indicators as reflected in the Facility Health Record application. 2) Continuous monitoring of the indicators will be reflected in the meeting minutes. Any area identified as underperforming will be reviewed to identify root causes for underperformance, will have an action plan identified that will results in performance improvement, and will track this change in performance over time to verify improvements are sustained. Verification of attendance at in-service will be evidenced by teammates signature on in-service sheet. The Manager of Clinical Services (MCS) and/or Regional Operations Director (ROD) will attend Quality Assessment Performance Improvement meetings known as Facility Health Meetings and /or review meeting minutes for three (3) months to provide coaching on effective Facility Health Meeting management and to review all documentation prior to submission, including but not limited to mortality analysis and review of KDQOL survey information. The Facility Administrator or designee will review the MCS/ROD feedback with the CQI Committee, and with the Medical Director during monthly Facility Health Meetings, with supporting documentation included in the meeting minutes. The Facility Administrator is responsible for compliance with this plan of correction.
POC Completion 05/19/22
494.150(c)(2)(i) STANDARD
MD RESP-ENSURE ALL ADHERE TO P&P
Name - Component - 00
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;
Observations:
Based on observation (Obs), a review of facility policy, and an interview with the administrator, the medical director did not ensure staff compliance to cannulation of the vascular access procedure for one (1) of two (2) observations. Obs#1.
Findings include:
A review of policy 1-04-01E "AV Fistula Or Graft Cannulation With Nipro Or Medisystems Safety Fistula Needles (SFN) And Administration of Heparin Loading Dose" on April 7, 2022 at 11:00 AM states: "24. Tape across butterfly wings but do not cover needle insertion site. Aseptically place sterile gauze or an adhesive type dressing over the needle insertion site..."
Observation of the treatment area was conducted on April 5, 2022 9:10 AM-12:20 PM and April 6, 2022 10:50 AM-12:50 PM.
Obs#1 PCT#1 at station 14 placed tape over the insertion site across the butterfly wings. The insertion site was covered by tape and not by the sterile gauze dressing.
An interview with the administrator on April 7, 2022 at 11:30 AM confirmed the above findings.
Plan of Correction:The Facility Administrator or designee held mandatory in-services for all for all clinical teammates starting 04/11/22. Surveyor observations were reviewed. Education included but was not limited to a review of Policy 1-04-01E "AV Fistula or Graft Cannulation with Nipro or Medisystems Safety Fistula Needles (SFN) and Administration of Heparin Loading Dose" with emphasis on but not limited to: 1) Tape across butterfly wings but do not cover needle insertion site. Aseptically place sterile gauze or an adhesive type dressing over the needle insertion site. Rationale: Avoid crossing tape over needle insertion or applying tape pressure at needle tip. Sterile dressing prevents contamination of needle insertion site. Verification of attendance is evidenced by teammate's signature on the in-service sheet. The Facility Administrator or designee will conduct audits to verify teammates are compliant with policy for proper cannulation and needle taping: daily for two (2) weeks, then weekly for two (2) weeks, and monthly for two (2) months. Instances of non-compliance will be addressed immediately. The Facility Administrator will review audit results with the Medical Director in the monthly Quality Assessment Performance Improvement meeting known as Facility Health Meeting, with supporting documentation included in the meeting minutes. On 04/19/22, a Governing Body meeting with the Medical Director, Facility Administrator, Director of Nursing and Regional Operations Director was held and reviewed the results of the survey ending on 04/07/22. The Governing Body reviewed Policy COMP-DD-017 "Medical Director Qualifications and Responsibilities" with the Medical Director, emphasizing the importance in executing his/her roles and responsibilities to verify that teammates adhere to the policies, procedures, and processes relative to cannulation and access care. The Medical Director acknowledges that he/she is responsible to ensure the facility teammates are trained and follow policy and procedure, and deficiencies identified need to be corrected timely with the support of the facility team. Plans of correction have been developed and initiated to correct identified deficiencies and to sustain compliance. The Medical Director will review progress as well as any barriers to maintaining compliance, with supporting documentation included in the meeting minutes. Action plans will be evaluated for effectiveness, new plans developed as applicable, in order to achieve compliance with teammates' adherence to policy and procedure. The Regional Operations Director (ROD) or designee will validate that the survey findings and plans of correction are being reviewed in Facility Health Meeting, monthly for three (3) months. The Facility Administrator on behalf of the Governing Body is responsible for compliance with the plan of correction.
POC Completion 05/19/22
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