Initial Comments:
Based upon the findings of an unannounced onsite Medicare recertification survey conducted August 7-9, 2023, FMC Dialysis Services Lebanon County was identified to have the following standard level deficiencies that were determined to be in compliance with the requirements of 42 CFR, Part 494.62, Subpart B, Conditions for Coverage for End-Stage Renal Disease (ESRD) Facilities-Emergency Preparedness.
Plan of Correction:
494.62(a)(1)-(2) STANDARD
Plan Based on All Hazards Risk Assessment
Name - Component - 00
§403.748(a)(1)-(2), §416.54(a)(1)-(2), §418.113(a)(1)-(2), §441.184(a)(1)-(2), §460.84(a)(1)-(2), §482.15(a)(1)-(2), §483.73(a)(1)-(2), §483.475(a)(1)-(2), §484.102(a)(1)-(2), §485.68(a)(1)-(2), §485.542(a)(1)-(2), §485.625(a)(1)-(2), §485.727(a)(1)-(2), §485.920(a)(1)-(2), §486.360(a)(1)-(2), §491.12(a)(1)-(2), §494.62(a)(1)-(2)
[(a) Emergency Plan. The [facility] must develop and maintain an emergency preparedness plan that must be reviewed, and updated at least every 2 years. The plan must do the following:]
(1) Be based on and include a documented, facility-based and community-based risk assessment, utilizing an all-hazards approach.*
(2) Include strategies for addressing emergency events identified by the risk assessment.
* [For Hospices at §418.113(a):] Emergency Plan. The Hospice must develop and maintain an emergency preparedness plan that must be reviewed, and updated at least every 2 years. The plan must do the following:
(1) Be based on and include a documented, facility-based and community-based risk assessment, utilizing an all-hazards approach.
(2) Include strategies for addressing emergency events identified by the risk assessment, including the management of the consequences of power failures, natural disasters, and other emergencies that would affect the hospice's ability to provide care.
*[For LTC facilities at §483.73(a):] Emergency Plan. The LTC facility must develop and maintain an emergency preparedness plan that must be reviewed, and updated at least annually. The plan must do the following:
(1) Be based on and include a documented, facility-based and community-based risk assessment, utilizing an all-hazards approach, including missing residents.
(2) Include strategies for addressing emergency events identified by the risk assessment.
*[For ICF/IIDs at §483.475(a):] Emergency Plan. The ICF/IID must develop and maintain an emergency preparedness plan that must be reviewed, and updated at least every 2 years. The plan must do the following:
(1) Be based on and include a documented, facility-based and community-based risk assessment, utilizing an all-hazards approach, including missing clients.
(2) Include strategies for addressing emergency events identified by the risk assessment.
Observations:
Based on review of agency Emergency Preparedness documents and interview with clinic administrator, the agency failed to update and maintain an emergency preparedness facility-based and community-based risk assessment, utilizing an all-hazards approach document at least every two years in one (1) out of one (1) reviews. Review #1
Findings:
Review #1 conducted on August 9, 2023, at approximately 10:30 AM, of Emergency Preparedness documents revealed: Documentation of risk assessments completed in 2019 and 2020 utilizing an all hazards approach. No updated HVA documentation completed in 2021 or 2022.
Interview conducted on August 9, 2023, at approximately 11 AM, with agency facility administrator confirmed the above finding.
Plan of Correction:On August 25, 2023, the Facility Administrator (FA) and Director of Operations (DO) met to complete the Hazard Vulnerability Assessment (HVA) for the Palmyra facility. With the HVA completed, the Governing Body (GB) will meet by September 1, 2023, to inform the members of the identified findings and approve the HVA. A copy of the HAV will be included in the Emergency Preparedness manual.
By August 31, 2023, the FA held a staff meeting and informed all staff of the facility risks identified on the 2023 HVA. The staff will be informed of the determination of the HVA risks identified upon annual completion.
Documentation of the meetings will be on site at the facility.
The FA or designee will ensure that an annual HVA is completed per policy beginning January 2024. The Quality Assessment and Performance Improvement (QAPI) workbook schedule will be the tracker for the completion of the annual HVA.
The FA will be re-educated and counseled by the DO if found to be non-compliant.
The QAPI committee is responsible for reviewing the annual HVA and ensuring adoption by the GB.
Initial Comments:
Based on the findings of an on-site unannounced Medicare recertification survey conducted August 7-9, 2023, FMC Dialysis Services Lebanon County was identified to have the following standard level deficiencies that were determined to be in compliance with the 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 policies, employee files (EFs), interview and email communication with facility administrator, the agency failed to ensure dialysis staff, prior to patient contact, that the individual had been screened for and was free from active mycobacterium tuberculosis (TB) in one (1) of seven (7) EFs (EF#5); failed to require new staff to complete onhire TB Risk Assessment in one (1) of seven (7) (EF#5).
Finding includes:
Review conducted on August 8, 2023, at approximately 2 PM, CDC "Guidelines for Preventing the Transmission of Mycobacterium tuberculosis in Health-Care Settings, 2005," "...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 August 8, 2023, at approximately 2:05 PM, of agency policies revealed: "Employee Tuberculosis Testing" version 4 dated 4/5/2021, "TB testing using the two-step tuberculin skin test (TST) method is required upon hire. ... The Healthcare Personnel TB Baseline Risk Assessment and TB Risk Assessment Review Questionnaire (TB-RAQ) are required to be completed on all new employees (page 1)"; Human Resources Policy, "Medical Evaluation Requirements for New Hires/Rehires" version 2, updated 4/23/19, under section "TB, An Employee Baseline TB Assessment Form and TB Risk Assessment Questionnaire must be completed by all applicable new hires., A TB skin test is required upon hire using the two-step tuberculin skin test (TST) method (as applicable)."
Review conducted on August 8, 2023, at approximately 2:30 PM, of employee files revealed:
-EF#5, date of hire 7/24/23, no documentation of completed TB two-step TST results or onhire Personnel TB Baseline Risk Assessment.
Interview conducted on August 8, 2023, at approximately 3:00 PM, with facility administrator revealed confirmed the above findings.
Email communication received on August 10, 2023, at 10:43 AM, from facility administration confirmed no completed TB two-step TST results or onhire Personnel TB Baseline Risk Assessment for EF#5.
Plan of Correction:All employees' files will be reviewed for their tuberculosis (TB) status. If their medical record does not have evidence of a two-step Protein-Purified Derivative (PPD) completed upon hire, a two-step PPD will be administered. Documentation of the PPD test with the results will be available in the employees' personnel file. The employee files will also be reviewed for the TB Risk Assessment Review Questionnaire (TB-RAQ). If the staff are found not to have had a TB-RAQ upon hire, one will be completed and placed in their files. The audit of the employee files will be completed by August 31, 2023.
The DO will meet with the FA by August 25, 2023, to review the policy:
- Employee Tuberculosis Testing
The focus at the meeting will be on the importance of ensuring that all new employees receive a two-step tuberculin skin test upon hire. The training will also review the importance of ensuring that there is documentation of the testing in the employee's personnel file.
The inservice will be completed by August 25, 2023, with documentation on file at the facility.
Beginning September 1, 2023, the FA or designee will perform audits of all newly hired staff within two weeks of the new staffs' start date. The FA will report the findings of the new hire TB audit at the monthly QAPI schedule. A POC audit tool will be used for the audits.
Issues of non-compliance will be re-education and counseling by the DO.
Sustained compliance will be monitored by the QAPI committee. The QAPI committee is responsible for reviewing the findings, providing oversight, and taking action if indicated.
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 observations, agency policy review, and an interview with the facility administrator, it was determined the clinic failed to ensure the dialysis staff performed hand hygiene and glove changes per policy for one (1) of two (2) observations of initiation of dialysis treatment care for a patient with left AVF (Observation #1); and one (1) of two (2) observations of discontinuation of dialysis/post dialysis access care for a patient with an CVC access (Observation #2).
Findings include:
Review conducted on August 7, 2023, at approximately 2 pm, of Clinical Services "Hand Hygiene" policy version 7, 3/17/2023, revealed: "Hands Will Be ... (section 2, page 1) Decontaminated using alcohol-based hand rub or by washing hands with antimicrobial soap and water ..., When ... Before and after direct contact with patients, ... After contact with inanimate objects near the patient, ... After contact with other objects within the patient station or treatment space."
Observation #1: On August 7, 2023, at approximately 11:00 AM, at Station #15 during initiation of dialysis treatment procedure, PCT EF#4 was observed touching the hemodialysis machine screen/components with gloved hands, and then touching the patient's left AVF access tubing without a change of gloves or performing hand hygiene between glove changes.
Observation #2: On August 9, 2023, at approximately 8:54 AM, at Station #12, PCT EF#2 was observed preparing clean syringe supplies for a patient with CVC access for treatment discontinuation. EF#2's gloves touched the hemodialysis machine screen and keyboard, she obtained two clear packaged sterile normal saline syringes, opened the packaged syringes and placed them on the chair side table. PCT EF#2 did not perform a glove change and hand hygiene between glove changes.
Interview conducted on August 9, 2023, at approximately 4:30 PM, with facility administrator confirmed the above findings.
Plan of Correction:The FA or designee will in-service all DPC staff on policy:
- Hand Hygiene
The in-service will focus on the staff ensuring that hand hygiene is always performed per policy. This includes removing gloves and performing hand hygiene after touching the hemodialysis machine, keyboard and/or machine screen and before touching any other surface, equipment, or supplies. The meeting will reinforce that hand hygiene must be performed between all glove changes.
In-servicing will be completed by August 28, 2023, and the training documentation will be on file at the facility.
Starting September 1, 2023, the FA or designee will perform daily audits for two (2) weeks. At that time if one-hundred percent (100%) compliance is observed the audits will then be completed 2 times/week for 2 weeks. At that time, if compliance is maintained, the audits will then follow the monthly QAPI schedule. A POC specific auditing tool will be used for the audits.
Issues of non-compliance will be addressed with the staff member not following policy by the FA and/or change nurse with re-education and counseling.
The FA and charge nurse will review the audit results and report the findings at the monthly QAPI meetings for ongoing oversight and compliance.
494.30(a)(1)(i) STANDARD
IC-HBV-VACCINATE PTS/STAFF
Name - Component - 00
Hepatitis B Vaccination
Vaccinate all susceptible patients and staff members against hepatitis B.
Observations:
Based on Occupational Safety and Health Administration (OSHA) guidelines, agency policy, review of employee files (EFs), and interview with and communication with facility manager, the agency failed to complete and maintain new employee Hepatitis B vaccination acceptance or declination documentation in employee files for three (3) out of seven (7) EFs (EFs #3-5).
Findings include:
Review conducted August 9, 2023, at approximately 1 PM, OSHA guidelines, obtained via website www.osha.gov/publications/bbfact05, "Hepatitis B Vaccination Protection" revealed: HBV Vaccination - "The standard requires employers to offer the vaccination series to all workers who have occupational exposure. ... must ensure that all occupationally exposed workers are trained about the vaccine and vaccination, including efficacy, safety, method of administration, and benefits of vaccine. ... no cost to worker. ... Declining the Vaccination - Employers must ensure that workers who decline vaccination sign a declination form."
Review conducted on August 9, 2023, at approximately 1:15 PM, of Human Resources Policy "Medical Evaluation Requirements for New Hires/Rehires" version 2, 4/23/19 revealed: "Test Type - Hepatitis; Description - Upon hire, employee must be offered the hepatitis B vaccination. - The employee may: Opt for the vaccine ... or decline the vaccination."
Review conducted on August 9, 2023, at approximately 3:00 PM, of employee files revealed:
EF#3, date of hire (doh) 11/14/2022, no evidence of Hepatitis B vaccination or signed declination form.
EF#4, doh 5/1/2023, no evidence of Hepatitis B vaccination or signed declination form.
EF#5, doh 7/24/2023, no evidence of Hepatitis B vaccination or signed declination form.
Interview conducted on August 9, 2023, at approximately 3:15 PM, with facility manager confirmed no evidence of above items in these employees file.
Review conducted on August 10, 2023, at 10:43 AM of mail communication from facility manager confirming no electronic evidence of vaccination or signed declination for these employees.
Plan of Correction:All employees' files hired since November of 2022, will be reviewed for their Hepatitis status. Staff who are noted to be susceptible will be offered/re-offered the Hepatitis B vaccine. If they refuse, a declination will be signed and placed in their employee file. If the vaccination is accepted, the administration record will be placed in the employee's file. The audit of the employee files will be completed by August 31, 2023.
The DO or designee re-educated the FA on the following policy:
- Employee Requirements for Testing and Vaccination for Hepatitis B
Emphasis will be placed on ensuring that all new susceptible employees are offered the Hepatitis B vaccination upon hire based on the results of their employment Hepatitis B bloodwork. It the employee refuses the vaccination or has antibodies > 10, a declination will be signed and placed in their employee file.
The in-servicing by the DO will be completed by August 28, 2023, with documentation of the training on file at the facility.
Starting September 1, 2023, the FA or designee will perform Hepatitis B audits of all newly hired staff within two weeks of the start date. The FA and charge nurse will report the findings of the new hire audit at the monthly QAPI schedule. A POC audit tool will be used for the audits.
Issues of non-compliance will be re-education and counseling by the DO.
Sustained compliance and oversight will be monitored by the QAPI committee.
494.60(a) STANDARD
PE-BUILDING-CONSTRUCT/MAINTAIN FOR SAFETY
Name - Component - 00
The building in which dialysis services are furnished must be constructed and maintained to ensure the safety of the patients, the staff and the public.
Observations:
Based on observations, review of facility physical environment audit checklists, and interviews with Director of Operations, the agency failed to maintain the integrity of the lower treatment station walls within the dialysis treatment area for ten (10) of sixteen (16) observations (Observations Station #2, #3, #5-9, #11-12, #15).
Findings include:
Observations performed on August 7, 2023, at approximately 10:30 AM, during initial "Flash Tour" of dialysis treatment room revealed: Multiple dialysis stations' lower wall section directly under the dialysis machine water connection access ports showed signs of past water leakage affecting the wall panels' lower edges, with chipped and cracked/"bubbling" surfaces exposing whitish-brown frayed/underlying pressed board fibers; Observations stations #2-3, #6-7, #9, #11 were noted as minimal/visible surface damage, and #5, #8, #12, #15 as moderate surface damage.
Reviewed conducted on August 16, 2023, at approximately 2:15 PM, of monthly agency "Building Interior Physical Environment Inspection" audit checklist (6/8/2023 and 7/20/2023) by clinic facility manager revealed no documented observations of lower wall panel damage as indicated by the question "are the walls and baseboards intact and free from damage? Documented answer was 'Yes' - no observed damage."
Telephone interview conducted on August 16, 2023, at approximately 2:20 PM, with agency Director of Operations confirmed the above findings.
Plan of Correction:On August 9, 2023, after the state survey exit interview, the FA, DO, Area Technical Operations Manager (ATOM) and Biomedical Technician (BMT) met to review the Physical plant issues identified during the surveyor's flash tour. All the walls of the dialysis treatment room were inspected on the same date to ensure no additional walls were damaged. It was determined at the meeting an estimate would be obtained to have the dialysis station lower walls repaired. Once the estimate is obtained, it will be submitted to the DO for approval.
The ATOM will meet with the BMT and FA to review:
- Building Interior Physical Environment Inspection Audit
The meeting will focus on the importance of ensuring that the audit is completed per the QAPI schedule. The need to have complete and accurate input of the findings of the physical plant audit will be emphasized at the meeting. This includes any wall damage in any area of the facility. The CM and BMT will understand the importance of notification to the ATOM and DO of any damaged area found during the audit.
In-servicing will be completed by August 28, 2023, and the training documentation will be on file at the facility.
Beginning September 1, 2023, the ATOM or designee will perform bi-monthly audits for three (3) months. At that time if 100% compliance is maintained, the audits will then follow the monthly QAPI schedule. A POC specific auditing tool will be used for the audits.
Issues of non-compliance will be addressed by the ATOM with re-education and counseling.
The ATOM or designee will review the audit results and report the findings at the monthly QAPI meetings for ongoing oversight and compliance.
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