Initial Comments:
Based on the findings of an onsite unannounced Medicare recertification survey completed December 4, 2023 through December 7, 2023, Willow Lakes 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 review of medical records (MRs), agency policy review, and interview with facility administrator, agency failed to maintain documentation of completed emergency preparedness (EP) fire safety quarterly patient education in three (3) out of eight (8) medical records reviewed (MR #6-8).
Findings include:
Review conducted on December 6, 2023, at approximately 9:00 AM to 3:00 PM, of medical records revealed:
MR#6 soc 11/17/22, no documentation of EP Fire Safety Preparedness training for 2023 quarters 1 and 3.
MR#7 soc 7/29/20, no documentation of annual emergency training for 2021;
no documentation of EP Fire Safety Preparedness training for 2021 quarter 1, 2022 quarters 1 and 3, and 2023 quarters 1 and 3.
MR#8 soc 7/27/22, no documentation of EP Fire Safety Preparedness training for 2023 quarters 1 and 3.
Review conducted on December 7, 2023, at approximately 1:00 PM, of agency policy "4-07-01 Facility Emergency Management Plan (ICD, HOME) pages 25-28 of 38, b. Patients: ... ii. Quarterly 1. Fire Safety Preparedness. ... v. Document training on applicable forms."
Interview conducted on December 7, 2023, at approximately 1:30 PM, with facility administrator confirmed above findings.
Plan of Correction:E 040
The Facility Administrator or designee held mandatory in-services for all clinical teammates starting on 12/14/23. Surveyor observations were reviewed. Education included but was not limited to a review of Policy 4-07-01 "Facility Emergency Management Plan (EMP)" with emphasis on but not limited to: 1) The Facility Administrator or designee, is responsible to: Conduct and review quarterly fire safety and evacuation training and drills for compliance, identify additional training and education needs. 2) Fire safety drills: a. Required on a quarterly basis; one drill to be conducted for each shift of patients; b. Include patient emergency takeoff procedure, policy: Termination of Dialysis in an Emergency; c. Document training for both teammates and patients i. Patients use Reggie form Emergency Evacuation Acknowledgement Form; ii. Teammates use policy: Training/In-service Documentation Form iii. Identify patients requiring assistance in an evacuation. d. Complete exercise evaluation and teammate attendance sheet; e. Document in Governing Body and maintain with facility EMP. Verification of attendance is evidenced by teammate's signature on in-service sheet.
The Facility Administrator or designee will complete a one hundred percent (100%) audit of patient fire drill documentation by 12/21/23. Missing documentation for any patients, including for those identified by the surveyor will be completed by 12/31/23. All emergency preparedness training and documentation will be completed and recorded by 12/31/23.
The Facility Administrator or designee has established a schedule for quarterly fire drills and annual emergency training. The Facility Administrator or designee will audit fire drill documentation for three (3) quarters to verify compliance for all shifts of patients. The Facility Administrator or designee will monitor ongoing compliance with a quarterly review of documentation for patient fire drill participation and emergency takeoff education. Instances of non-compliance will be addressed immediately.
The Facility Administrator or designee will review fire drills and emergency training schedule and evaluations, along with audit results 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.
Initial Comments:
Based on the findings of an onsite unannounced Medicare recertification survey completed December 4, 2023 through December 7, 2023, Willow Lakes 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, Subparts A, B, C, and D, Conditions for Coverage of Suppliers of End-Stage Renal Disease (ESRD) Services.
Plan of Correction:
494.20 STANDARD
COMPLIANCE WITH FED/STATE/LOCAL LAWS
Name - Component - 00
The facility and its staff must operate and furnish services in compliance with applicable Federal, State, and local laws and regulations pertaining to licensure and any other relevant health and safety requirements.
Observations:
Based on a review of Centers for Disease Control (CDC) guidelines, agency personnel files (PFs) and policy, and interview with agency administrator, it was determined the agency failed to ensure direct care workers, prior to patient contact, that the individual had been screened for and was free from active mycobacterium tuberculosis (TB) for two (2) of three (3) PFs reviewed (PF1, PF3).
Findings Included:
Review conducted on December 4, 2023, at approximately 1 PM, of personnel files (PFs) revealed:
PF#1 date of hire (doh) 12/27/22, #1 tuberculin skin test (TST) negative test result; #2 TST never completed.
PF#3 doh 3/22/23, no TSTs performed.
Review conducted on December 4, 2023, at approximately 1:30 PM, of CDC Guidelines for Preventing the Transmission of Mycobacterium tuberculosis in Health-Care Settings, 2005 revealed: "...Baseline testing for M. Tuberculosis infection is recommended for all newly hired health care workers [HCWs]...If TST [tuberculin skin testing] is used for baseline testing, two-step testing is recommended for HCWs whose initial TST results are negative...If the first-step TST result is negative, the second-step TST should be administered 1--3 weeks after the first TST result was read...A second TST is not needed if the HCW has a documented TST result from any time during the previous 12 months. If a newly employed HCW has had a documented negative TST result within the previous 12 months, a single TST can be administered in the new setting...This additional TST represents the second stage of the two-step testing... ."
*Baseline (preplacement) screening and testing, in addition to the IGRA (interferon-gamma release assay) or TST, shall include a symptom screen questionnaire and an individual TB risk assessment. Serial screening and testing not routinely recommended. Annual TB education is recommended. (CDC/MMWR/May 17, 2019/Vol. 68/No. 19).
Review conducted on December 4, 2023, at approximately 1:35 PM, of agency policy 4-06-05 Tuberculosis Monitoring and Follow-up revealed: "Baseline new hire requirements for all new teammates ... will complete the following: 3c. Testing options (any one of the following): If exemption criteria for TST is not met, the following testing options are available: Baseline TST using a two step Purified Protein Derivative (PPD) Mantoux test (a *second TST repeated one to three weeks after the first if the initial test is negative). Test results will be recorded on the Teammate Health Monitoring Record."
Interview conducted on December 4, 2023, at approximately 1:45 PM, with agency administrator revealed confirmation of the above findings. Administrator immediately contacted PF#3 and performed TST #1 on 12/4/23. PF#3 #1 TST result was read on 12/6/23 Negative. TST #2 will be performed in 2-3 weeks.
Plan of Correction:V 101
The Facility Administrator or designee held mandatory in-services for all clinical teammates starting on 12/14/23. Surveyor observations were reviewed. Education included but was not limited to a review of Policy 4-06-05 "Tuberculosis (TB) Monitoring and Follow Up" with emphasis on but not limited to: 1) NOTE: Teammates will adhere to requirements related to initial and annual testing if required by their institution or local/state health departments. 2) Baseline new hire requirements for all new teammates including volunteers, per diem teammates, non-agency personnel and teammates will complete the following: 1. TN-Risk Assessment and Symptom Evaluation Questionnaire. 2. Successful completion of Tuberculosis Education for New Teammates course. 3. Testing options ... c. If exemption criteria for TST is not met, the following testing options are available: i. Baseline TST using a two-step Purified Protein Derivative (PPD) Mantoux test (a second TST repeated one to three weeks after the first, if the initial test is negative). Test results will be recorded on the Teammate Health Monitoring Record. Verification of attendance at in-service will be evidenced by teammate's signature on in-service sheet.
Facility Administrator completed a one hundred percent (100%) audit of teammate files for completed TB screening on hire on 12/12/23. Any missing documentation is scheduled for completion by 12/31/23. Missing documentation as identified by surveyor's observation, will be completed for both teammates by 12/22/23.
The Facility Administrator will audit one hundred percent (100%) of new teammate's medical records monthly for two (2) months to verify TB screening is completed and documentation is recorded per policy. Instances of non-compliance will be addressed immediately. Ongoing compliance will be monitored with a monthly audit of the teammate file spreadsheet by Facility Administrator or designee, with outstanding items completed by each month end.
The Facility Administrator or designee will review audit results 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.
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