Initial Comments:
Based on the findings of an unannounced onsite Medicare recertification survey completed January 24, 2023, Fresenius Kidney Care Stroudsburg was identified to be in compliance with the following requirements of 42 CFR, Part 494.62, Subpart B, Conditions for Coverage for End-Stage Renal Disease (ESRD) Facilities-Emergency Preparedness.
Plan of Correction:
Initial Comments:
Based on the findings of an unannounced onsite Medicare recertification survey completed January 24, 2023, Fresenius Kidney Care Stroudsburg 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 a review of facility policy/procedure, observations, and an interview with the facility Administrator, the facility failed to ensure the staff followed infection control protocols, included but not limited to, performing hand hygiene/donning clean gloves, for one (1) of two (2) 'Central Venous Catheter Exit Site Care' observations and one (1) of two (2) 'Initiation of Dialysis with Central Venous Catheter' observations (Observation #1), for one (1) of two (2) 'Discontinuation of Dialysis and Post Dialysis Access Care for AV Fistula or Graft' observations (Observations #1), and for one (1) of two (2) 'Parenteral Medication Preparation and Administration' observations (Observation #2).
Findings include:
A review was conducted of facility policy/procedure on January 24, 2022 at approximately 5:40 p.m.. Clinical Services' 'Initiation of Treatment Using a Central Venous Catheter and Optiflux Single Use Ebeam Dialyzer' 'Prior to Initiation: Assessment and Machine Parameters' Step (1):"Perform hand hygiene and don full PPE." Step (9): Put mask on patient, doff (remove) gloves, perform hand hygiene then don new gloves." 'Preparing the Catheter: Dressing Change' "Refer to 'Changing the Catheter Dressing' procedure." 'Changing the Catheter Dressing Procedure' section 'Applying the Dressing' (2) "Remove backing of adhesive dressing or apply tape to edges of gauze dressing." (Note: There is no handwashing step noted in the procedure after applying the dressing to the site). 'Initiation of Treatment Using a Central Venous Catheter and Optiflux Single Use Ebeam Dialyzer' 'Preparing the Catheter: Disinfection of Catheter Connections, Heparin removal, Flushing the Catheter and Heparin Administration' step (1) "Check to make sure catheter clamps are closed. (2) Remove cap from clamped arterial limb. (3) Using a sterile alcohol pad .....scrub sides (threads) and end of hub ...." (Note: There is no handwashing step noted in the procedure prior to beginning step (1), after applying the sterile dressing).
Observation conducted in the patient treatment area on January 20, 2023 between approximately 9:20 a.m. and 1:30 p.m. revealed the following:
Observation #1: Observation #1 of two (2) 'Central Venous Catheter Exit Site Care' and 'Initiation of Dialysis with Central Venous Catheter' observations' on 01/20/23 at approximately 10:20 a.m., of patient #8, station #5, Employee #8 did not remove gloves/perform hand hygiene after applying the sterile dressing to the CVC site and prior to initiating dialysis (placing clean field under CVC ports/closing the catheter clamps and disinfecting CVC hubs).
'Clinical Services' 'Post Treatment Fistula Needle Removal' 'Procedure' step (2): "Person removing needles perform hand hygiene and don clean gloves."
Observation #1: Observation #1 of two (2) 'Discontinuation of Dialysis and Post Dialysis Access Care for AV Fistula or Graft' on 01/20/23 at approximately 9:20 a.m., of patient #9 at station #5, employee #8 removed the first needle and applied clean gauze. Employee #8 proceeded to remove the patients blood pressure cuff, removed the patients blanket and placed in patients bag, removed bloodlines from the dialysis machine/discarded and emptied the prime waste receptacle. Employee #8 did not perform hand hygiene/don clean gloves prior to removing the second needle.
'Clinical Services' 'Medication Preparation and Administration Procedure' 'Drawing Medications from a Vial' step (8) "Label syringe per policy and administer per procedure." "medication Administration Procedure' step (1) "Wash hands. Apply PPE." .... (3) Take the medication to the patients chair or bedside."
Observation #2: Observation #2 of two (2) 'Parenteral Medication Preparation and Administration' observations on 01/20/23 at approximately 1:30 p.m., of patient #10 at station #8, employee #4 did not perform hand hygiene prior to donning gloves after preparing patient medication and prior to administering the medication.
An interview with the facility Administrator on January 24, 2023 at approximately 5:30 p.m. confirmed the above findings.
Plan of Correction:V 113
The clinic manager (CM) or designee re-educated all the direct patient care (DPC) staff on the following policy:
- Initiation of Treatment Using a Central Venous Catheter and Optiflux Single Use Ebeam Dialyzer
- Central Venous Catheter Exit Site Care
- Discontinuation of Dialysis and Post Dialysis Access Care for AV Fistula or Graft
- Medication Preparation and Administration
Special emphasis will be placed on ensuring that hand hygiene is performed per policy at all times. This includes after applying a new dressing to the catheter site, after touching inanimate objects such as blood pressure (BP) cuffs and/or blankets. The meeting will also review the importance of performing hand hygiene any time gloves are removed and before donning new gloves. This also includes when preparing medications for the patients.
The in-servicing of staff will be completed by February 14, 2023, 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 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 and Performance Improvement (QAPI) 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.
The CM will review the audit results and report the findings to the QAPI Committee at the monthly meeting. Sustained compliance will be monitored by the QAPI committee.
Completion Date: March 17, 2023
494.30(a)(1)(i) STANDARD
IC-CLEAN/DIRTY;MED PREP AREA;NO COMMON CARTS
Name - Component - 00
Clean areas should be clearly designated for the preparation, handling and storage of medications and unused supplies and equipment. Clean areas should be clearly separated from contaminated areas where used supplies and equipment are handled. Do not handle and store medications or clean supplies in the same or an adjacent area to that where used equipment or blood samples are handled.
When multiple dose medication vials are used (including vials containing diluents), prepare individual patient doses in a clean (centralized) area away from dialysis stations and deliver separately to each patient. Do not carry multiple dose medication vials from station to station.
Do not use common medication carts to deliver medications to patients. If trays are used to deliver medications to individual patients, they must be cleaned between patients.
Observations:
Based on policy/procedure review, observations, and an interview with the facility Administrator, the facility failed to clearly separate clean areas from dirty areas for one (1) of one (1) observations (Observation#1).
Findings include:
A review was conducted of facility policy/procedure on January 24, 2022 at approximately 5:40 p.m.. 'Clinical Services' 'Dialysis Precautions'' 'Clean Versus Dirty Areas' "Clean Area: An area designated for clean and unused equipment, supplies, and medications." "Dirty Area: An area where this is a potential for contamination with blood or body fluids and areas where contaminated or used supplies, equipment, blood supplies, or biohazard containers are stored or handled." "Clean areas should be clearly designated for the preparation and handling and storage of medications and unused supplies and equipment." "Clean areas should be clearly separated from dirty areas where used supplies, equipment or blood samples are handled or stored."
Observations conducted in the patient treatment area on January 20, 2023 between approximately 9:20 a.m. and 1:30 p.m. revealed the following:
Observation #1: Patient treatment room observations on January 20, 2023 at approximately 10:30 a.m. The treatment area (8) countertops include a hole in the countertop which leads to a trash receptacle (not visible from above).
Countertop #1 (starting from the patient waiting room entrance and moving clockwise) had clean supplies which included saline bags, gloves, pre-packaged dialysis station patient kits, and 10 ml packaged saline syringes sitting close (within approximately 2"-12") to the hole in the countertop.
Countertop #2 had clean supplies which included gloves sitting close (within approximately 2"-12") to the hole in the countertop.
Countertop #3 had clean supplies which included hemostats in bin and pre-packaged dialysis station patient kits sitting close (within approximately 3"-12") to the hole in the countertop.
Countertop #4 had clean supplies which included gloves and pre-packaged dialysis station patient kits sitting close (within approximately 3"-12") to the hole in the countertop. A tray containing clean hemostats (drying after disinfection) sitting approximately 2" over the hole in the countertop.
Countertop #5 had clean supplies which included gloves sitting close (within approximately 2"-12") to the hole in the countertop.
Countertop #6 had clean supplies which included gloves and pre-packaged dialysis station patient kits sitting close (within approximately 3"-12") to the hole in the countertop.
Countertop #7 had clean supplies which included gloves sitting close (within approximately 2"-12") to the hole in the countertop.
Countertop #8 had clean supplies which included clean hemostats on a tray, clamps, and a and a Myron Meter sitting close (within approximately 2"-12") to the hole in the countertop.
An interview with the facility Administrator on January 24, 2023 at approximately 5:30 p.m. confirmed the above findings.
Plan of Correction:V 117
For ongoing compliance, the CM or designee re-educated all the DPC staff on the following policy:
- Dialysis Precautions
Special emphasis will be placed on ensuring that all equipment and supplies are stored in a designated clean area. This includes that clean supplies being stored on countertops in the treatment area are clearly separated and not located close to the to the dirty area where the trash is disposed of in the countertop. Clean versus dirty areas are to be clearly labeled to prevent any risk of contamination.
The in-servicing of staff will be completed by February 14, 2023, 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 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 QAPI 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 QAPI Committee at the monthly meeting. Sustained compliance will be monitored by the QAPI committee.
Completion Date: March 17, 2023
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 review of facility policy/procedure, observations, and an interview with the facility Administrator, the facility failed to ensure the staff followed infection control protocols, included but not limited to, cleaning and disinfecting surfaces and equipment, for two (2) of four (4) treatment area observations (Observation #2, Observation #3).
Findings include:
A review was conducted of facility policy/procedure on January 24, 2022 at approximately 5:40 p.m.. 'Clinical Services' 'Priming Bucket Disinfection' 'Procedure' step (1) "Dispose of saline solution down any marker dirty sink or utility room hopper." Step (3) " Clean all surfaces of the priming bucket or approved receptacle, with a wipe that has been wetted with 1:100 bleach solution as per facility surface disinfection procedures."
Observations conducted in the patient treatment area on January 20, 2023 between approximately 9:20 a.m. and 1:30 p.m. revealed the following:
Observation #2: The observation on 01/20/23 at approximately 10:08 a.m. of 'Cleaning and Disinfection of the Dialysis Station' for station #11, employee #8 emptied the prime waste receptacle down the dirty sink, placed the prime waste receptacle inside the container that contained 1:100 bleach mixture and moved the receptacle back and forth. Employee #8 then rinsed the receptacle with water.
Observation #3: The observation on 01/20/23 at approximately 10:50 a.m. of 'Cleaning and Disinfection of the Dialysis Station' for station #6, employee #8 emptied the prime waste receptacle down the dirty sink, placed the prime waste receptacle inside the container that contained 1:100 bleach mixture and moved the receptacle back and forth. Employee #8 then rinsed the receptacle with water.
An interview with the facility Administrator on January 24, 2023 at approximately 5:30 p.m. confirmed the above findings.
Plan of Correction:V 122
To ensure compliance the CM or designee will in-service all DPC staff on the following policies:
- Cleaning and Disinfection of the Dialysis Station
- Priming Bucket Disinfection
The meeting will focus on ensuring that all prime buckets are emptied, cleaned and disinfected per policy. The meeting will review that a 1:100 bleach wipe is used to clean all surfaces of the prime bucket before being placed back on the machine.
In-servicing will be completed by February 14, 2023. All training documentation is on file at the facility.
The CM or designee will perform daily audits for 2 weeks. At that time if compliance is observed the audits will then be completed 2/week for 2 weeks to ensure that compliance is maintained. At that time, the audits will then follow the monthly QAPI schedule. A POC specific 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 QAPI Committee at the monthly meeting. Sustained compliance will be monitored by the QAPI committee.
Completion Date: March 17, 2023
494.30(a)(1)(i) STANDARD
IC-HBV-ISOLATION-MACHINES/EQUIP/SUPPLIES
Name - Component - 00
Isolation of HBV+ Patients
To isolate HBsAg positive patients, ... dedicate machines, equipment, instruments, supplies, and medications that will not be used by HBV susceptible patients.
Observations:
Based on a review of facility policy/procedure, observations, and an interview with the Administrator, facility failed to label supplies/equipment that are dedicated for use in the isolation area for one (1) of one (1) isolation room observations (Observation #1).
Findings:
A review was conducted of facility policy/procedure on January 24, 2022 at approximately 5:40 p.m. 'Clinical Services' 'Dialyzing Patients with Positive Hepatitis B Antigen (HBsAg)' 'Equipment and Supplies' "Separated dedicated supplies and equipment,including blood glucose monitors, must be used to provide care to the HBsAg positive patient: .....Equipment used for HBsAg positive patients should be reserved for the HBsAg positive patient unless repair or maintenance is needed." "All supplies used in the isolation room/area such as clamps, blood pressure cuffs, testing reagents, etc. should be labeled "isolation" and not routinely removed."
Observations conducted in the patient treatment area on January 20, 2023 between approximately 9:20 a.m. and 1:30 p.m. revealed the following:
Observation #1: On 01/20/23 at approximately 12:15 p.m. the isolation room was inspected during the treatment of a HBsAg positive patient. Employee #11 assisted. One (1) stethoscope, one (1) dialysis chair, one (1) dialysis machine, and one (1) medication pole were found to be not labeled "isolation".
An interview with the facility Administrator on January 24, 2023 at approximately 5:30 p.m. confirmed the above findings.
Plan of Correction:V 130
The CM or designee will reeducate all DPC staff on:
- Dialyzing Patients with Positive Hepatitis B Antigen (HbAg+)
With special emphasis on ensuring that all items taken into and stored in the isolation room are labeled as isolation and not removed from the isolation room. These items include stethoscopes, the dialysis chair and machine and medication poles.
In-servicing will be completed by February 14, 2023. All training documentation is on file at the facility.
The CM or designee will perform daily audits for 2 weeks. At that time if compliance is observed the audits will then be completed 2/week for 2 weeks to ensure that compliance is maintained. At that time, the audits will then follow the monthly QAPI schedule. A POC specific 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 QAPI Committee at the monthly meeting. Sustained compliance will be monitored by the QAPI committee.
Completion Date: March 17, 2023
494.40(a) STANDARD
CARBON ADSORP-MONITOR, TEST FREQUENCY
Name - Component - 00
6.2.5 Carbon adsorption: monitoring, testing freq
Testing for free chlorine, chloramine, or total chlorine should be performed at the beginning of each treatment day prior to patients initiating treatment and again prior to the beginning of each patient shift. If there are no set patient shifts, testing should be performed approximately every 4 hours.
Results of monitoring of free chlorine, chloramine, or total chlorine should be recorded in a log sheet.
Testing for free chlorine, chloramine, or total chlorine can be accomplished using the N.N-diethyl-p-phenylene-diamine (DPD) based test kits or dip-and-read test strips. On-line monitors can be used to measure chloramine concentrations. Whichever test system is used, it must have sufficient sensitivity and specificity to resolve the maximum levels described in [AAMI] 4.1.1 (Table 1) [which is a maximum level of 0.1 mg/L].
Samples should be drawn when the system has been operating for at least 15 minutes. The analysis should be performed on-site, since chloramine levels will decrease if the sample is not assayed promptly.
Observations:
Based on a review of facility policy/procedure, observations, and an interview with the Administrator, facility failed to ensure total chlorine testing was performed at a minimum of every 4 hours, per policy, for one (1) of one (1) water testing logs reviewed (Water Testing Log #1).
Findings:
A review was conducted of facility policy/procedure on January 24, 2022 at approximately 5:40 p.m. 'Clinical Services' 'Carbon Filtration Monitoring for Incenter Central Water Systems Policy' 'Tests Rationale' "Total chlorine testing will be the only testing methodology used ....." 'Testing Locations and Frequency'
What to Test' 'Worker Carbon Filter' 'When to Test' "Prior to the initiation of the first patient treatment of the day and at a minimum of every four hours."
A review conducted of the facility water logs on January 23, 2023 at approximately 10:00 a.m. revealed the following:
Water Testing Log #1: The "FKC Log Readings Report for Total Chlorine(TCL)' was reviewed for the time period of November 2022, December 2022, and January 2023.
On November 25, 2022, the 'Time Reading 1' was 05:15. The next reading was conducted at 09:25. ( > four hours).
On November 30, 2022, the 'Time Reading 1' was 05:10. The next reading was conducted at 09:40. ( > four hours).
On December 5, 2022, the 'Time Reading 1' was 05:10. The next reading was conducted at 09:15. ( > four hours).
On December 20, 2022, the 'Time Reading 1' was 04:30. The next reading was conducted at 08:50. ( > four hours).
An interview with the facility Administrator on January 24, 2023 at approximately 5:30 p.m. confirmed the above findings.
Plan of Correction:V 196
To ensure compliance the CM or designee will reeducate all DPC staff on the following policy:
- Carbon Filtration Monitoring for Incenter Central Water Systems
With special emphasis on ensuring that chlorine testing is always completed per policy. The meeting will review that the testing is to be completed prior to the initiation of the 1st treatment of the day and a minimum of every four (4) hours. The meeting reinforced that the testing must be documented after each test is completed and must not be greater than 4 hours between testing.
In-servicing will be completed by February 14, 2023. All training documentation is on file at the facility.
The CM or designee will perform daily audits for 2 weeks. At that time if compliance is observed the audits will then be completed 2/week for 2 weeks to ensure that compliance is maintained. At that time, the audits will then follow the monthly QAPI schedule. A POC specific 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 QAPI Committee at the monthly meeting. Sustained compliance will be monitored by the QAPI committee.
Completion Date: March 17, 2023
494.40(a) STANDARD
RO-CHEMICAL ANALYSIS-FREQUENCY
Name - Component - 00
6.2.7 Reverse osmosis: Chemical analysis: frequency
Chemical analysis for the contaminants listed in 4.1.1 (Table 1) should be done when the RO system is installed, when membranes are replaced, and at not less than annual intervals thereafter to ensure that the limits specified in 4.1.1 are met (see Table 1). Chemical analyses should be done when seasonal variations in source water suggest worsening quality or when rejection rates fall below 90 %.
Observations:
Based on review of facility policy/procedure, review of water logs, and an interview with the facility Administrator, the facility failed to ensure chemical analysis testing was conducted quarterly, per policy, for one (1) of one (1) water log reviews (Water Log Review #1).
Findings include:
A review was conducted of facility policy/procedure on January 24, 2022 at approximately 5:40 p.m. 'Biomedical Support Services' 'AAMI Chemical Analysis of Water for Dialysis Policy' 'Purpose' "To define Fresenius Kidney Care (FKC) policy for AAMI Chemical Analysis samples in water used for dialysis purposes." 'Definitions' 'Term' 'Quarterly' 'Definition' "Quarterly is defined as every 3 months." 'Scheduled Sampling' 'Scheduled Sample Frequency' "An AAMI Chemical Analysis will be collected and sent to (laboratory) for testing at a minimum of quarterly." 'Obtaining Results' "The biomedical staff will review the electronic records within the Korus system at a minimum of quarterly for the following: ...... To assure samples have been collected, interpreted and action taken in accordance with this policy."
A review conducted of the facility water logs on January 23, 2023 at approximately 10:00 a.m. revealed the following:
Water Log Review #1: Documentation provided of the facility 'Environmental Tests Report' 'Sample tested to AAMI Standards'.
Sample ID: 'R.O 2, Permeate', 'R.O 3, Permeate', 'H2O Softener 2, Outlet', 'Source-Untreated H2O' collected 11/29/21.
Sample ID: 'R.O 2, Permeate', 'R.O 3, Permeate', 'H2O Softener 2, Outlet', 'Source-Untreated H2O' collected 03/07/22. ( > 3 months).
Sample ID: 'R.O 2, Permeate', 'R.O 3, Permeate', 'H2O Softener 2, Outlet', 'Source-Untreated H2O' collected 08/29/22. ( > 3 months).
An interview with the facility Administrator on January 24, 2023 at approximately 5:30 p.m. confirmed the above findings.
Plan of Correction:V 201
To ensure compliance the Area Technical Operations Manager (ATOM) or designee will reeducate the CM and biomedical technician (BMT) on the following policy:
- AAMI Chemical Analysis of Water for Dialysis
Special emphasis will be placed on ensuring that all water samples are drawn timely per policy and results reviewed when received with documentation.
In-servicing will be completed by February 14, 2023. All training documentation is on file at the facility.
For ongoing compliance, the BMT and CM will review the results of all monthly cultures prior to the QAPI meetings. The ATOM or designee will perform monthly audits for three (3) months. At that time if compliance is observed the audits will then follow the monthly QAPI schedule with review of water samples at the monthly QAPI meetings. A POC specific 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 QAPI Committee at the monthly meeting. Sustained compliance will be monitored by the QAPI committee.
Completion Date: March 17, 2023
494.60 STANDARD
PE-SAFE/FUNCTIONAL/COMFORTABLE ENVIRONMENT
Name - Component - 00
The dialysis facility must be designed, constructed, equipped, and maintained to provide dialysis patients, staff, and the public a safe, functional, and comfortable treatment environment.
Observations:
Based on review of facility policy, observations, and an interview with the facility Administrator, the facility failed to label/date the bleach mixture, used for disinfecting items, with sufficient information to differentiate the contents, for two (2) out of two (2) observations (Observation #1, Observation #2).
A review was conducted of facility policy/procedure on January 24, 2022 at approximately 5:40 p.m. "Clinical Services' Mixing Bleach' 'Procedure' "Follow the steps below for mixing bleach: step (2) "..... Measuring ensures proper concentration: 1:100 ....... 1:10 ......." Step (4) Label opaque container with "Bleach Solution", strength of bleach, date and time prepared with your initials." Step (6) "Discard solution at end of treatment day or more often if needed."
Observations conducted in the patient treatment area on January 20, 2023 between approximately 9:20 a.m. and 1:30 p.m. revealed the following:
Observation #1: On 01/20/23 at approximately 10:40 a.m. a small blue and white (not opaque) container (1 of 2) with bleach, labeled 1:100, dated 01/17/23 was observed sitting on the counter. Per employee #6, the container contained 1:10 bleach mixture. Employee #4 confirmed the container should be labeled 1:10 and the date was not marked as the current date.
Observation #2: On 01/20/23 at approximately 11:00 a.m. a small blue and white (not opaque) container (2 of 2) with bleach, labeled 1:10, dated 09/11/22 was observed sitting on the counter. Employee #8 stated "We never use this bin, we use the other (blue and white) bin."
An interview with the facility Administrator on January 24, 2023 at approximately 5:30 p.m. confirmed the above findings.
Plan of Correction:V 401
The CM or designee will reeducate all DPC staff on the following policy:
- Mixing Bleach
The meeting will place emphasis on ensuring that the bleach is labeled correctly every time it is mixed, with the proper concentration, date and time mixed. The meeting also reviewed that the bleach container must be an opaque container
In-servicing will be completed by February 14, 2023. All training documentation is on file at the facility.
The CM or designee will perform daily audits for 2 weeks. At that time if compliance is observed the audits will then be completed 2/week for 2 weeks to ensure that compliance is maintained. At that time, the audits will then follow the monthly QAPI schedule. A POC specific 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 QAPI Committee at the monthly meeting. Sustained compliance will be monitored by the QAPI committee.
Completion Date: March 17, 2023
494.60(b) STANDARD
PE-EQUIPMENT MAINTENANCE-MANUFACTURER'S DFU
Name - Component - 00
The dialysis facility must implement and maintain a program to ensure that all equipment (including emergency equipment, dialysis machines and equipment, and the water treatment system) are maintained and operated in accordance with the manufacturer's recommendations.
Observations:
Based on a review of facility policy/procedure, observations, and an interview with the Administrator, facility failed to ensure testing equipment was calibrated, per manufacturers directions for use, for one (1) of one (1) equipment calibration logs reviewed (Calibration Log #1).
Findings:
Policy for calibrating the 'Bio-Tek Instruments, Inc. Digital Safety Analyzer Model 170' was requested on January 24, 2022 at approximately 5:40 p.m. no specific policy provided.
A review was conducted of testing equipment 'Operators Manual' on January 24, 2022 at approximately 5:40 p.m. 'Bio-Tek Instruments, Inc.' 'Digital Safety Analyzer Model 170' 'Calibration' states "...Recommended recalibration once a year. ......"
A review conducted of the facility calibration logs on January 23, 2023 at approximately 10:00 a.m. revealed the following:
Calibration Log #1: Documentation was provided of the 'Calibration Certificates' for the '170 B Digital Safety Analyzer Model 170, Bio-Tek Instruments, Inc.' The most recent 'Calibration Certificates' was dated 07/19/22. No documentation was provided of the equipment being calibrated according in 2021 nor 2020.
An interview with the facility Administrator on January 24, 2023 at approximately 5:30 p.m. confirmed the above findings.
Plan of Correction:V 403
To ensure compliance the ATOM or designee will reeducate the CM and BMT on the following Operators Manual:
- Bio-Tek Instruments, Inc.
Special emphasis will be placed on ensuring that all equipment is tested and calibrated per manufacturer's directions for use. This includes annual testing of the 170 B Digital Safety Analyzer Model 170, Bio-Tek Instruments, Inc. The meeting will also review that the testing is documented in the facility calibration log upon completion. The ATOM will review the annual equipment testing and monitoring schedule with the BMT.
In-servicing will be completed by February 14, 2023. All training documentation is on file at the facility.
For ongoing compliance, the BMT and CM will review the results of all testing and calibrations when completed and review the results at the QAPI meetings. The ATOM will audit the testing and calibration of the equipment based on the calendar for six (6) months. At that time if compliance is observed the audits will then follow the monthly QAPI schedule with review at the monthly QAPI meetings. A POC specific 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 QAPI Committee at the monthly meeting. Sustained compliance will be monitored by the QAPI committee.
Completion Date: March 17, 2023
494.60(c)(4) STANDARD
PE-HD PTS IN VIEW DURING TREATMENTS
Name - Component - 00
Patients must be in view of staff during hemodialysis treatment to ensure patient safety, (video surveillance will not meet this requirement).
Observations:
Based on a review of facility policy/procedure, observations, and an interview with the facility Administrator, the facility failed to ensure the patients vascular access site and bloodline connections were visible by staff members throughout the dialysis treatment for two (2) of two (2) observations (Observation #1, Observation #2).
Findings:
A review was conducted of facility policy/procedure on January 24, 2022 at approximately 5:40 p.m.. 'Clinical Services' 'Patient Assessment and Monitoring' 'Monitoring During Treatment' 'Access' "Observe connections are secure and visible."
Observations conducted in the patient treatment area on January 20, 2023 between approximately 9:20 a.m. and 1:30 p.m. revealed the following:
Observation #1: On 01/20/23 at approximately 09:35 a.m., station #20, patient #11's long tee shirt and hooded jacket was placed over the access site and bloodline connections. The access site and bloodline connections were not visible from 9:35 a.m. to 10:05 a.m. At approximately 10:05 a.m. facility staff ensured the access was visible.
Observation #2: On 01/20/23 at approximately 09:35 a.m., station #14, patient #2 had a blanket placed over the access site and bloodline connections. The access site and bloodline connections were not visible from 9:35 a.m. to 9:55 a.m.
An interview with the facility Administrator on January 24, 2023 at approximately 5:30 p.m. confirmed the above findings.
Plan of Correction:V 407
To ensure compliance, the CM or designee re-educated all the DPC staff on the following policy:
- Patient Assessment and Monitoring
The meeting will place special emphasis on ensuring that the patient's access site must be visible throughout their treatment. The meeting will also reinforce the importance of verification and documentation that the access is uncovered when monitoring the patient every 30-45 minutes.
All patients will receive re-education by the DPC staff on the need to keep their access uncovered during treatment for safety reasons. Documentation of the access training will be completed in the patient's clinical note.
The in-servicing will be completed by February 14, 2023, with documentation of the training on file at the facility.
The CM or designee will perform daily audits on the DPC staff for 2 weeks. At that time if 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 QAPI 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 audits and report the findings to the QAPI Committee at the monthly meeting. Sustained compliance will be monitored by the QAPI committee.
Completion Date: March 17, 2023
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 a review of facility policy/procedure, clinical record review, and an interview with the facility Administrator, it was determined the facility failed to ensure an initial registered nurse evaluation was conducted, prior to the initiation of first treatment, for three (3) of seven (7) patient medical records (MR) reviewed (MR #3, MR#4, MR#5).
Findings include:
A review was conducted of facility policy/procedure on January 24, 2022 at approximately 5:40 p.m.. 'Clinical Services' policy 'Comprehensive Interdisciplinary Assessment and Plan of Care' 'Prior to Initiation of the patients first treatment for Patients New to Dialysis' states "A registered nurse must perform an assessment on patients NEW to dialysis BEFORE initiation of their first treatment to determine immediate needs. The RN must document the assessment. The assessment may be documented on the CIA in eCC, evaluation cascade in Chairside or multidisciplinary notes and should include at a minimum: *Neurologic: level of alertness/mental status, orientation, identification of sensory deficits. *Subjective complaints. *Rest and comfort: pain status. *Activity: ambulation status, support needs, fall risk. *Access: assessment. *Respiratory: respirations description, lung sounds. *Cardiovascular: heart rate and rhythm; presence and location of edema. *Fluid gains, blood pressure and temperature pre-treatment. *Integumentary: skin color, temperature and as needed, type/location of wounds."
MR#3 Date of Admission 10/27/22: Patient's first treatment flowsheet dated 10/27/22 was reviewed. Treatment initiated at 9:25 a.m. No documentation provided of a registered nurse patient evaluation containing all (9) required elements, prior to the initiation of the first dialysis treatment.
MR#4 Date of Admission 12/20/22: Patient's first treatment flowsheet dated 12/20/22 was reviewed. Treatment initiated at 6:46 a.m. No documentation provided of a registered nurse patient evaluation containing all (9) required elements, prior to the initiation of the first dialysis treatment.
MR#5 Date of Admission 07/06/22: Patient's first treatment flowsheet dated 07/06/22 was reviewed. Treatment initiated at 12:05 p.m. No documentation provided of a registered nurse patient evaluation containing all (9) required elements, prior to the initiation of the first dialysis treatment.
An interview with the facility Administrator on January 24, 2023 at approximately 5:30 p.m. confirmed the above findings.
Plan of Correction:V 715
To ensure compliance, the CM or designee will in-service all Registered Nursing (RN) staff on the following policy:
- Comprehensive Interdisciplinary Assessment and Plan of Care
The in-service will provide re-education 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 dialysis treatment to determine immediate needs.
The RN training will be completed by February 14, 2023, with documentation on file at the facility.
The CM or designee will perform audits for all new patient admitted for the next four (4) months to ensure an assessment was completed prior to the start of the first treatment. At that time, if compliance is sustained, the audits will then follow the monthly QAPI 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 QAPI Committee at the monthly meeting. Sustained compliance will be monitored by the QAPI committee.
Completion Date: March 17, 2023
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