Initial Comments:
Based on the findings of an on-site, unannounced Medicare recertification survey conducted April 7, 2022 through April 8, 2022, Fresenius Dialysis State College, was found to be in 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 on-site, unannounced Medicare recertification survey conducted April 7, 2022 through April 8, 2022, Fresenius Dialysis Services State College, was found not to be in 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 patient treatment area observations and interview with the clinic manager (EMP# 1) and employee #5, it was determined the facility failed to ensure patient privacy was maintained for one (1) of one (1) observations. (Observation #4)
Findings:
Confidentiality policy was requested, but was not provided.
Observations conducted in the patient treatment area on April 7, 2022 between approximately 10:07 a.m. and 3:30 p.m. and on April 8, 2022 between approximately 12:05 p.m. and 1:50 p.m. revealed the following:
Observation #3: On April 7, 2022 at approximately 12:00 p.m. surveyor asked employee # 5 where the trash bag that was located right beside the medication station was thrown away. Employee #5 replied, "In the dumpster out back (pointed with index finger to the dumpster through the window). Surveyor observed in the inside of the trash bag patient sticker labels stuck to the inside of the trash bag. The labels contained the following information: patient name, date of birth, medication name, medication dosage, medication directions and current date.
Interview with the clinic manager on April 8, 2022 at approximately 3:00 p.m. confirmed the policy above as current and above findings.
Plan of Correction:V 101
For immediate compliance, on April 8, 2022, the Clinic Manager (CM) informed all direct patient care (DPC) present that day, not to throw any patient medication labels into the trash cans any longer.
The CM or designee will re-educate all the DPC staff on the following policy:
- Medical Records Guidelines
Special emphasis will be placed on ensuring that patient privacy is always protected. This includes the proper disposal of unused medication labels, which may not be discarded into trash cans. The meeting informed the staff that the unused medication labels will now be placed on a paper located at the nurse's station. The paper with that attached labels will be shredded at the end of the day.
The in-servicing of staff and patients will be completed by April 20, 2022, with documentation of the training on file at the facility.
The CM 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 to ensure that compliance is maintained. At that time, if compliance is sustained, the audits will then follow the monthly Quality Assessment Improvement (QAI) schedule. A Plan of Correction (POC) audit tool will be used for the audits.
Staff found to be non-compliant will be re-educated and referred for counseling. Patients found to be non-complaint will be referred to the CM or designee for re-education.
The CM will review the audit results and report the findings to the QAI Committee at the monthly meeting. Sustained compliance will be monitored by the QAI committee.
Completion Date: May 25, 2022
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 facility policies/procedures, patient treatment area observations and interview with the clinic manager (EMP# 1), it was determined the facility failed to ensure the staff followed infection control protocols, including but not limited to, ensuring staff performed hand hygiene/don clean gloves according to facility procedure, for one (1) of two (2) of 'Discontinuation of Dialysis with Central Venous Catheter' observations. (Observation #2) and for one (1) of two (2) of 'Discontinuation of Dialysis and Post Dialysis Access Care for AV Fistula or Graft' observations. (Observation #3)
Findings:
Review was conducted of facility policy on April 7, 2022 between approximately 11:00 a.m. Policy 'Termination of treatment using Arteriovenous Fistula or Graft and Optiflux Single Use Ebeam Dialyzer', section, 'Termination: Disconnecting the Patient', states, "1. Obtain the patient's sitting blood pressure...2. Complete the patient assessment...3. Disconnect the blood lines from the needle lines and remove the needle according to the Post Treatment Needle Removal Procedure...4. Refer to Post Treatment Emptying Program Procedure to prepare the extracorporeal system for disposal...5. Discard the extracorporeal circuit in an appropriate biohazard waste receptacle...6. Discard the gloves and perform hand hygiene...."
Observations conducted in the patient treatment area on April 7, 2022 between approximately 10:07 a.m. and 3:30 p.m. and on April 8, 2022 between approximately 12:05 p.m. and 1:50 p.m. revealed the following:
Observation #2 'Discontinuation of Dialysis with Central Venous Catheter': On April 7, 2022 at approximately 3:28 p.m., patient #8 at station #5, employee #5 failed to remove gloves, perform hand hygiene and don clean gloves after reinfusing the extracorporeal circuit and disconnecting bloodlines aseptically.
Observation #3 'Discontinuation of Dialysis and Post Dialysis Access Care for AV Fistula or Graft': On April 7, 2022 at approximately 10:25 a.m., patient #13 at station #1, employee #13 failed to remove gloves, perform hand hygiene and don clean gloves after reinfusing the extracorporeal circuit and disconnecting bloodlines aseptically.
Interview with the clinic manager on April 8, 2022 at approximately 3:00 p.m. confirmed the policy above as current and above findings.
Plan of Correction:V 113
The CM or designee re-educated all DPC staff on the following policies:
- Discontinuation of Dialysis with Central Venous Catheter
- Discontinuation of Dialysis and Post Dialysis Access Care for AV Fistula or Graft
- Post Treatment Fistula Needle Removal
- Post Treatment Emptying Program
Special emphasis was placed on ensuring that removing gloves, performing hand hygiene, and donning new gloves is always completed according to policy. This includes after reinfusing the extracorporeal system and disconnecting the bloodlines for patient with either a catheter or a fistula or graft.
The in-servicing will be completed by April 20, 2022, with documentation of the training on file at the facility.
The CM or designee will perform daily audits for 2 weeks. At that time if 100% compliance is observed, the audits will then be completed 2 times/week for 2 weeks to ensure that compliance is maintained. At that time, if compliance is sustained, the audits will then follow the monthly QAI schedule. A POC audit tool will be used for the audits.
Staff found to be non-compliant will be re-educated and referred for counseling.
The CM will review the audit results and report the findings to the QAI Committee at the monthly meeting. Sustained compliance will be monitored by the QAI committee.
Completion Date: May 25, 2022
494.40(a) STANDARD
SOFTENERS-AUTO REGENERATE/TIMERS/SALT LVL
Name - Component - 00
5.2.4 Softeners: auto regen/timers/salt/salt level
Prior to exhaustion, softeners should be restored; that is, new exchangeable sodium ions are placed on the resin by a process known as "regeneration," which involves exposure of the resin bed to a saturated sodium chloride solution.
5.2.4 Softeners
Refer to RD62:2001, 4.3.10
Automatically regenerated water softeners: Automatically regenerated water softeners shall be fitted with a mechanism to prevent water containing the high concentrations of sodium chloride used during regeneration from entering the product water line during regeneration.
The face of the timers used to control the regeneration cycle should be visible to the user.
6.2.4 Softeners
Timers should be checked at the beginning of each day and should be interlocked with the RO system so that the RO is stopped when a softener regeneration cycle is initiated.
The softener brine tank should be monitored daily to ensure that a saturated salt solution exists in the brine tank. Salt pellets should fill at least half the tank. Salt designated as rock salt should not be used for softener regeneration since it is not refined and typically contains sediments and other impurities that may damage O-rings and pistons and clog orifices in the softener control head.
Observations:
Based on review of facility policy, observation of the water treatment room and interview with the clinic manager, it was determined the facility failed to ensure the salt pellets filled at least half the brine tank in the water treatment room for one (1) of one (1) observations. (Observation #1).
Findings:
Review was conducted of facility policy on April 7, 2022 at approximately 9:00 a.m. Policy 'Water Softener', states "Salt levels inside brine tanks will be maintained at a minimum of half full"
Water treatment room observation was conducted on April 7, 2022 between approximately 9:00 a.m. - 9:30 a.m. revealed the following:
Observation #1: On April 7, 2022 at approximately 9:05 a.m., accompanied by the clinic manager, the surveyor observed the brine tank was less then half full.
Interview with the clinic manager on April 8, 2022 at approximately 3:00 p.m. confirmed the policy above as current and above findings.
Plan of Correction:V 190
For immediate compliance, on April 7, 2022, the CM filled the brine tank with salt so that the tank was half full.
The CM or designee re-educated all DPC staff on the following policy:
- Water Softener
Special emphasis was placed on ensuring that the salt pellets in the brine tank are filled at least halfway and maintained at a minimum of half full. Staff were informed that salt must be added to the tank if not at the minimum level when the tank is inspected daily
The in-servicing will be completed by April 20, 2022, with documentation of the training on file at the facility.
The CM or designee will perform daily audits for 2 weeks. At that time if 100% compliance is observed, the audits will then be completed 2 times/week for 2 weeks to ensure that compliance is maintained. At that time, if compliance is sustained, the audits will then follow the monthly QAI schedule. A POC audit tool will be used for the audits.
Staff found to be non-compliant will be re-educated and referred for counseling.
The CM will review the audit results and report the findings to the QAI Committee at the monthly meeting. Sustained compliance will be monitored by the QAI committee.
Completion Date: May 25, 2022
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 review of facility policy, review of medical records (MRs) and interview with the clinic manager, it was determined the facility failed to ensure patients had a minimal evaluation completed by a registered nurse (RN), prior to initiating treatment for immediate needs which contained the minimal elements of nursing standards of care for two (2) of seven (7) MRs reviewed. (MR #6 and MR #7)
Findings:
Review was conducted of facility policy on April 8, 2022 at approximately 11:00 a.m. Policy 'Comprehensive Interdisciplinary Assessment and Plan of Care', states "A registered nurse must perform an assessment on patients NEW to dialysis BEFORE initiation of their first treatment to determine immediate needs."
Review of MRs was conducted on April 8, 2022 between approximately 10:00 a.m. - 2:00 p.m. revealed the following:
MR #6 Date of admission: January 7, 2022: Initial treatment was on 1/7/2022 at 8:30 a.m. Initial registered nurse (RN) was completed on 1/7/2022 at 12:42 p.m. RN failed to complete an initial assessment prior to the patient's first dialysis treatment.
MR #7 Date of admission: June 28, 2021: Initial treatment was on 6/28/2021 at 8:26 a.m. Initial registered nurse (RN) was completed on 6/28/2021 at 2:26 p.m. RN failed to complete an initial assessment prior to the patient's first dialysis treatment.
Interview with the clinic manager on April 8, 2022 at approximately 3:00 p.m. confirmed the policy above as current and above findings.
Plan of Correction:V 715
By April 22, 2022, the Director of Operations (DO) and the CM will meet with the Medical Director to review the Medical Director Responsibilities as defined in the Conditions for Coverage. The meeting also reviewed the following policy:
- Comprehensive Interdisciplinary Assessment and Plan of Care
The meeting will focus on the importance of the staff always following Fresenius Medical Care (FMC) policies.
Minutes of the meeting with the Medical Director will be on file at the facility for review.
The Medical Director will be informed at the meeting that the CM or designee will hold a meeting with the DPC staff on the above policies by April 22, 2022. The Medical Director will be informed that the education will focus on ensuring that a nursing assessment must be completed by an RN on a patient new to dialysis per policy prior to the initiation of the first treatment to determine immediate needs.
All staff training documentation will be on file at the facility.
The CM or designee will perform audits for all new patient admitted for the next 2 months to ensure an assessments was completed prior to the start of the first treatment. At that time, if compliance is sustained, the audits will then follow the monthly QAI schedule. A POC audit tool will be used for the audits.
The Medical Director was informed that staff found to be non-compliant will be re-educated and counseled.
To ensure ongoing compliance the CM will review the audit findings with the Medical Director at the QAI Committee monthly meeting. Sustained compliance will be monitored by the QAI committee with oversight by the GB.
Completion date: May 25, 2022
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