Initial Comments:
Based on the findings of an onsite unannounced Medicare recertification survey completed on May 3, 2023, Lebanon County Dialysis 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 onsite unannounced Medicare recertification survey completed on May 3, 2023, Lebanon County Dialysis, was identified to have the following standard level deficiencies, and 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:
494.30(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, policy and procedure review, and an interview with the ESRD administrator, it was determined the ESRD failed to ensure the patient care technician to change gloves and perform hand hygiene while performing tasks at separate stations (Observation #1) and failed to ensure the registered nurse to change gloves and perform hand hygiene for two (2) out of two medication observations conducted (Observation #2 and Observation #3).
Findings include:
Review of policy "Infection Control For Dialysis Facilities" on 5/2/23 at approximately 1:15 PM states "All teammates....will perform hand hygiene...b. prior to gloving and immediately after removal of gloves, c. after contamination with blood or other infectious material, d. after patient and dialysis delivery system contact ..f between patients even if the contact is casual.....7. gloves should be changed when ...iv after touching one patient or their dialysis delivery system and before arriving to care for another patient or touch another patient's dialysis delivery system.."
Review of policy "Preparation and Administration of Parental Medications" conducted on 5/02/2023 at approximately 1:30 PM states "...administration...3. Perform hand hygiene. Put on PPE..."
Observation #1: On 5/1/2023 at approximately 12:30 PM PCT #3 was observed cleaning the hemodialysis machine at Station #6, then proceeded to silence the machine alarm at Station #8, without first removing and donning new gloves and performing hand hygiene, then proceeded to open a food wrapper for Patient #1 at Station #8, removing one glove, not donning new gloves and performing handing hygiene prior.
Observation #2 : On 5/01/2023, at approximately 11:30 AM, RN#1 was observed preparing the medication for Patient #2/Station #2. RN#1 did not first change gloves and perform hand hygiene prior to administration of the medication.
Observation #3 : On 5/01/2023, at approximately 11:40 AM, RN#1 was observed preparing the medication for Patient #3/Station #15. RN#1 did not first change gloves and perform hand hygiene prior to administration of the medication.
An interview with the ESRD administrator on 5/03/2023 at approximately 1:15 PM confirmed the above findings.
Plan of Correction:The Facility Administrator or designee held mandatory in-services for all clinical teammates starting on 5/3/2023. Surveyor observations were reviewed. Education included but was not limited to a review of Policy 1-05-01 "Infection Control for Dialysis Facilities" rev. April 2023 and Policy 1-06-01A Preparation and Administration of Parenteral Medications (Non-Epo, Non-Parsabiv) with all Dialyzer Types" with the emphasis on but not limited to: A. Infection control: 1) All teammates, Physicians and Non-Physician (NPP) will perform hand hygiene ...prior to gloving and immediately 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... 2) Gloves should be changed when: after touching one patient or their dialysis delivery system and before arriving to care for another patient or touch another patient's dialysis delivery system. B. Medication ..."administration... 1) Step #3: Perform hand hygiene. Put on PPE. 2) Step #4: Prior to each dose administration, verify that the patient, the prepared medication label, and the prescription information ... match. 3) Remove needle and attach syringe... Verification of attendance at in-service will be evidenced by teammate's signature on the Training/In-service form.
The Facility Administrator or designee will conduct observation audits to verify hand hygiene and glove changes are completed per policies: daily for two (2) weeks, then weekly for (2) weeks. Ongoing compliance will be monitored with the 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 the monthly Quality Assessment and Performance Improvement meeting known as Facility Health Meeting, with supporting documentation included in the meeting minutes. The Facility Administrator is responsible for compliance with this plan of correction
494.30(a)(1)(i) STANDARD
IC-IF TO STATION=DISP/DEDICATE OR DISINFECT
Name - Component - 00
Items taken into the dialysis station should either be disposed of, dedicated for use only on a single patient, or cleaned and disinfected before being taken to a common clean area or used on another patient.
-- Nondisposable items that cannot be cleaned and disinfected (e.g., adhesive tape, cloth covered blood pressure cuffs) should be dedicated for use only on a single patient.
-- Unused medications (including multiple dose vials containing diluents) or supplies (syringes, alcohol swabs, etc.) taken to the patient's station should be used only for that patient and should not be returned to a common clean area or used on other patients.
Observations:
Based on observation, policy and procedure review, and an interview with the ESRD administrator, it was determined the ESRD failed to ensure the disinfection of non-disposable equipment after patient usage for two (2) of two (2) Nursing Assessment observations (Observation #4 and Observation #5) and failed to ensure the disinfection of an oxygen concentrator after usage at a patient station (observation #6).
Findings include:
Review of policy "Infection Control For Dialysis Facilities" on 5/2/23 at approximately 1:15 PM states "...14. Non-disposable items are to be disinfected after each patient use....a. stethoscopes will be disinfected with alcohol prep pad and/or 1:100 (one to one hundred) bleach solution..."
Review of policy "Use of oxygen Concentrators" on 5/2/23 at approximately 1:20 PM states "..5. the outside of the oxygen concentrator will be cleaned with an acceptable disinfectant solution between patients..."
Observation #4 and Observation #5: On 5/01/2023, at approximately 11:45 AM, RN#1 was observed performing a patient assessment at Station #6, utilizing a Stethoscope #1. RN#1 did not disinfect Stethoscope #1 upon completion of the patient assessment, then proceeded to perform a patient assessment at Station #12 utilizing Stethoscope #1 and then disinfected Stethoscope #1 upon completion of the patient assessment.
Observation #6: On 5/01/2023 at approximately 12:20 PM, PCT #3 was observed cleaning Station #6 and did not clean Oxygen Concentrator #1, which had been used during the prior treatment.
An interview with the ESRD administrator on 5/03/2023 at approximately 1:15 PM confirmed the above findings.
Plan of Correction:The Facility Administrator or designee held mandatory in-services for all clinical teammates starting on 5/3/2023. Surveyor observations were reviewed. Education included but was not limited to a review of Policy 1-05-01 "Infection Control for Dialysis Facilities" rev. April 2023 and Policy 1-02-04 "Use of Oxygen Concentrators" with emphasis on but not be limited to: A. Infection control: 1) Non-disposable items are to be disinfected after each patient use 2) Stethoscopes will be disinfected with alcohol prep pad and/or 1:100 (one to one hundred) bleach solution. B. Oxygen concentrators: 1) the outside of the oxygen concentrator will be cleaned with an acceptable disinfectant solution between patients. Verification of attendance at in-service will be evidenced by teammate's signature on the Training/In-service form.
Upon learning of surveyor's observations the Facility Administrator or designee directed teammates to immediately clean all stethoscopes and oxygen concentrator(s) and return them to clean storage locations. The Facility Administrator or designee will conduct observational audits to verify non-disposable items are disinfected between patient use, including stethoscopes and oxygen concentrators: daily for two (2) weeks, then weekly for (2) weeks. Ongoing compliance will be monitored with the 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 the monthly Quality Assessment and Performance Improvement meeting known as Facility Health Meeting, with supporting documentation included in the meeting minutes. The Facility Administrator is responsible for compliance with this plan of correction.
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 observation, policy and procedure review, and an interview with the ESRD administrator, it was determined the ESRD failed to ensure Clean Sink #1 to be separated from contaminated areas (Station #16) and failed to ensure Clean Sink #1 to be free from biohazard sharps containers (Observation #7).
Findings include:
Review of policy "Infection Control For Dialysis Facilities" on 5/2/23 at approximately 1:15 PM states "...clean areas should be clearly separated from contaminated areas where used supplied and equipment are handled...."
Observation #7: On 5/01/2023 at approximately 9:45 AM, Clean Sink #1 was observed to be adjacent to Station #16 with no barrier to prevent cross contamination. A tall biohazard sharps container was noted to be placed directly in front of Clean Sink #1.
An interview with the ESRD administrator on 5/03/2023 at approximately 1:15 PM confirmed the above findings.
Plan of Correction:The Facility Administrator or designee held mandatory in-services for all clinical teammates starting on 5/3/2023. Surveyor observations were reviewed. Education included but was not limited to a review of Policy 1-05-01 "Infection Control for Dialysis Facilities" rev. April 2023 with emphasis on but not be limited to: 1) clean areas should be clearly separated from contaminated areas where used supplied and equipment are handled. Verification of attendance is evidenced by teammate's signature on the Training/In-service form.
On 5/1/2023, the Facility Administrator or designee submitted Work Order #WEB-433701 for barrier installation from Station #16 to clean sink, with expected completion by 6/30/2023.
The Facility Administrator or designee will conduct physical plant audits to verify clean areas are clearly separated from contaminated areas per policy: daily for two (2) weeks, then weekly for (2) weeks, and continue weekly until barrier installation is completed. Ongoing compliance will be monitored with the Monthly OSHA and Safety Checklist. Issues requiring physical plant repair will be escalated to the Regional Operations Director and a timeline developed for completion of repairs.
The Facility Administrator or designee will review audit results of audits with the Medical Director during the monthly Quality Assessment and Performance Improvement meetings, known as Facility Health Meeting, and bi-weekly with the Governing Body members who which will review physical plant audits and oversee the physical plant repairs until all repairs have been completed. Supporting documentation will be included in the meeting minutes. The Facility Administrator is responsible for compliance with this plan of correction.
494.30(c)(2) STANDARD
IC-CATHETERS:GENERAL
Name - Component - 00
(2) The "Guidelines for the Prevention of Intravascular Catheter-Related Infections" entitled "Recommendations for Placement of Intravascular Catheters in Adults and Children" parts I - IV; and "Central Venous Catheters, Including PICCs, Hemodialysis, and Pulmonary Artery Catheters in Adult and Pediatric Patients," Morbidity and Mortality Weekly Report, volume 51 number RR-10, pages 16 through 18, August 9, 2002. The Director of the Federal Register approves this incorporation by reference in accordance with 5 U.S.C. 552(a) and 1 CFR Part 51. This publication is available for inspection as the CMS Information Resource Center, 7500 Security Boulevard, Central Building, Baltimore, MD or at the National Archives and Records Administration (NARA). Copies may be obtained at the CMS Information Resource Center. For information on the availability of this material at NARA, call 202-741-6030, or go to: http://www.archives.gov/federal_register/code_of_regulations/ibr_locations.html
Observations:
Based upon observation, policy and procedure review, and an interview with the facility administrator, it was determined the ESRD failed to ensure the changing of Central Venous Catheter (CVC) dressing, was conducted per ESRD policy, for one (1) of two (2) observations of CVC dressing changes. (Observation #8).
Findings include:
Review of policy "Central Venous Catheter (CVC) with Clearguard HD Antimicrobial End Caps Procedure" on 5/2/23 at approximately 2:00 PM states"....10. Remove gloves and discard, perform hand hygiene per procedure and re-glove. 11. Apply antibiotic ointment to exit site, if prescribed. 12. Place sterile 2 x 2 gauze over the catheter exit site...."
Observation #8: On 5/01/2023 at approximately 11:15 AM, PCT#1 was observed placing a sterile gauze over the catheter exit site at Station #16 without first changing gloves and performing hand hygiene.
An interview with the ESRD administrator on 5/03/2023 at approximately 1:15 PM confirmed the above findings.
Plan of Correction:The Facility Administrator or designee held mandatory in-services for all clinical teammates starting on 5/3/2023. Surveyor observations were reviewed. Education included but was not limited to a review of Procedure 1-04-02B "Central Venous Catheter (CVC) with Clearguard HD Antimicrobial End Caps Procedure" with emphasis on but not limited to: 1) Step #10: Remove gloves and discard, perform hand hygiene per procedure and re-glove. 2) Step #11: Apply antibiotic ointment to exit site, if prescribed. 3) Step #12: Place sterile 2x2 gauze over the catheter exit site... Verification of attendance at In-service will be evidenced by teammate's signature on the Training/In-service form.
The Facility Administrator or designee will conduct observational audits to verify CVC exit care is completed with glove changes and hand hygiene per policy steps: daily for two (2) weeks, then weekly for (2) weeks. Ongoing compliance will be monitored with the monthly infection control audit. Instances of non-compliance will be addressed immediately. The Facility Administrator or designee will review audit results of audits with the Medical Director during the monthly Quality Assessment and Performance Improvement meetings, known as Facility Health Meeting, with supporting documentation included in the meeting minutes. The Facility Administrator is responsible for compliance with this plan of correction.
494.40(a) STANDARD
RO-MEETS AAMI/MONITORED, RECORDED ON LOG
Name - Component - 00
5.2.7 Reverse osmosis: meets AAMI/monitored/recorded on log
Refer to RD62:2001, 4.3.7 Reverse osmosis: When used to prepare water for hemodialysis applications, either alone or as the last stage in a purification cascade, reverse osmosis systems shall be shown to be capable, at installation, of meeting the requirements of Table 1, when tested with the typical feed water of the user, in accordance with the methods of [AAMI] 5.2.2.
5.2.7 Reverse osmosis
Users should carefully follow the manufacturer's instructions for feed water treatment and monitoring to ensure that the RO is operated within its design parameters.
6.2.7 Reverse osmosis
All results of measurements of RO performance should be recorded daily in an operating log that permits trending and historical review.
Observations:
Based upon review of "Routine Total Chlorine Testing" logs (Log #1), review of "Daily Water Treatment System Monitoring" logs (Log #2), policy and procedure review, and an interview with the ESRD administrator, it was determined the ESRD failed to ensure documentation/recording of the date of Routing Chlorine Testing and Water Treatment Monitoring logs for one (1) out of two (2) months of Log #1 and Log #2 reviewed (February 2023).
Findings include:
Review of Policy "Daily Water System Total Chlorine Monitoring" on 5/2/2023 at approximately 1:05 PM states "...3. Total Chlorine Testing is done on a daily basis prior to the first patient treatment and every four (4) hours.....Document results on Routine Total Chlorine Testing Log..."
Review of Policy "Daily Water Treatment System Monitoring" on 5/2/2023 at approximately 1:10 PM states "...All observations and test results must be recorded on the approved Daily Water Treatment Log....Observations and Test results listed on the Daily Water Treatment Log....are entered each facility operating day...."
On 5/01/2023 at approximately 1:45 PM, review of "Routine Total Chlorine Testing Log" for February 2023 revealed the section to record the date of the testing was left blank for 2/06/2023, 2/07/2023, and 2/10/23.
On 5/01/2023 at approximately 1:55 PM, review of " Daily Water Treatment Log" for February 2023 revealed the section to record the date of the testing was left blank for 2/25/2023 and 2/26/2023.
An interview with the ESRD administrator on 5/03/2023 at approximately 1:15 PM confirmed the above findings.
Plan of Correction:The Facility Administrator or designee held mandatory in-services for all clinical teammates starting on 5/3/2023. Surveyor observations were reviewed. Education included but was not limited to a review of Policy 2-05-02 "Daily Water Treatment System Total Chlorine Monitoring" and Policy 2-05-02A "Routine Total Chlorine Testing Log" Policy 2-04-02 "Daily Water Treatment System Monitoring" with emphasis on but not limited to: A. Total chlorine testing: 1) Total Chlorine Testing is done on a daily basis prior to the first patient treatment and every four (4) hours. 2) Document results on Routine Total Chlorine Testing log. B. Water treatment monitoring: 1) All observations and test results must be recorded on the approved Daily Water Treatment Log... 2) Observations and test results listed on the Daily Water Treatment Log ... entered each facility operating day prior to the use of dialysis quality water for any process and the start of dialysis treatments... Verification of attendance at In-service will be evidenced by teammate's on the Training/In-service form.
The Facility Administrator or designee will conduct audits of the Routine Total Chlorine Testing Log and the Daily Water Treatment Log to verify observations and test results are recorded daily as required by policy: daily for two (2) weeks, then weekly for two (2) weeks and ongoing monthly. 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 and Performance Improvement meeting known as Facility Health Meeting, with supporting documentation included in the meeting minutes. The Facility Administrator is responsible for compliance with this plan of correction
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 upon review of Medication Refrigerator Temperature logs, observations, policy and procedure review, and an interview with the ESRD administrator, it was determined the ESRD failed to ensure twice daily Medication Refrigerator temperature checks during days the ESRD was open for one (1) out of two (2) Medication Refridgerators in current use for medication storage at the ESRD (Medication Fridge #1) for two (2) out of two (2) months of Medication Refrigerator Temperature logs reviewed (March 2023 and April 2023), failed to ensure documentation of weekly emergency equipment checks for one (1) out of nine (9) weeks reviewed ( Week #9), and failed to ensure the emergency cart to be free from dirt and dust (Observation #9.)
Findings include:
Review of facility policy "Medications Requiring Refrigeration" on 5/03/2023 at approximately 9:30 AM states "...3. The refrigerator is checked during facility normal operation hours, by a licensed nurse teammate of designee. Checks will be documented on the Medication Refrigerator Management Log.... a. Twice daily temperature checks located on the Digital Data Logger (DDL) display, at the beginning and end of the day..."
Observation #9: On 5/1/23 at approximately 12:00 PM, a layer of dust/dirt on the top of the ESRD emergency cart was noted.
Review of facility policy "Emergency Equipment Checks" on 5/02/2023 at approximately 1:00 PM states "...The following equipment checks will be performed by a licensed nurse teammate to verify the designated equipment is available and functional:.....weekly: oxygen supply...airways...suction....AED is operational and pads are compatible with AED device...ambu bag...emergency cart (crash cart) is clean, operational and supplies/medications have not expired...."
Review of the Weekly Emergency Equipment Check log revealed no documented of checks conducted the week of 4/24/2023.
Review of the "Medication Refrigerator Management Log" for Medication Fridge #1 on 5/2/2023 at approximately 1:30 PM revealed the following dates when the ESRD was open, to not have recorded temperatures: 3/2/23-3/4/23, 3/6/23, 3/8/23, 3/10/23, 3/11/23, 3/14/23 (no PM temperature recording), 3/16/23 (no PM temperature recording), 3/17/2023, 3/18/2023, 3/21/2023, 3/22/2023, 3/23/23 (no PM temperature recording), 3/24/23, 3/25/23, 4/1/23, 4/3/23, 4/5/23-4/8/23, 4/10/23, 4/11/23,4/13/23-4/15/23, 4/17/23, 4/21/23, 4/22/23, 4/25/23.
An interview with the ESRD administrator on 5/03/2023 at approximately 1:15 PM confirmed the above findings.
Plan of Correction:The Facility Administrator or designee held mandatory in-services for all clinical teammates starting on 5/3/2023. Surveyor observations were reviewed. Education included but was not limited to a review of Policy 8-04-01 "Physical Environment", Policy 1-06-06 "Medications Requiring Refrigeration" and Policy 1-02-08 "Emergency Equipment Check" with emphasis on but not limited to:
A. Physical Environment: 1) The dialysis facility will be designed, constructed, equipped, and maintained to provide dialysis patients, teammates, and the public a safe, functional, and comfortable treatment environment.
B. Medication Refrigerator: 1) the refrigerator is checked during facility normal operation hours, by a licensed nurse teammate or designee. Checks will be documented on the Medication Refrigerator Management Log. 2) Twice daily temperature checks located on the Digital Data Logger (DDL) display, at the beginning and end of the day.
C. Emergency Equipment: 1) The following equipment checks will be performed by a license nurse teammate to verify the designated equipment is available and functional: Weekly... Oxygen supply is adequate (at least one (1) tank either on or next to the emergency cart [crash cart]); Airways are available; Suction is operational; AED is operational and pads are compatible with AED device... Artificial resuscitator (ambu bag) is operational; Emergency cart (crash cart) is clean, operational and supplies/medications have not expired. Verification of attendance will be evidenced by teammate's signature on the Training/In-service form.
The Facility Administrator or designee will conduct two log audits:
1) Audit of the medication refrigerator log to verify temperatures are checked and recorded twice daily: daily for two (2) weeks, then weekly for two (2) weeks. Ongoing compliance will be monitored with monthly log audits.
2) Audit of the emergency cart checklist to verify weekly emergency equipment checks are being done and documented, and an observation audit of the cart to verify it is clean: weekly for four (4) weeks. Ongoing compliance will be monitored with monthly emergency equipment checks. Instances of non-compliance for all audits 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 and Performance Improvement meeting known as Facility Health Meeting, with supporting documentation included in the meeting minutes. The Facility Administrator is responsible for compliance with this plan of correction.
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 observation, policy and procedure review, and an interview with the ESRD administrator, it was determined the ESRD failed to ensure the countertops at the in-center hemodialysis patient stations to be free from damage for sixteen (16) out of sixteen (16) incenter hemodialysis stations (Station #1-Station #16) and failed to ensure the interior windowsill to be free from damage for one (1) out of sixteen (16) stations (Station #1)(Observation #10).
Findings include:
Review of policy PHYSICAL ENVIRONMENT states "1. The dialysis facility will be designed, constructed, equipped and maintained for the safety of the patients, teammates, and the public a safe, functional, and comfortable treatment environment. 2. The building in which dialysis services are furnished will be constructed and maintained for the safety of the patients, teammates, and public....."
Observation #10: On 5/1/23 at approximately 9:50 AM, Station #1-Station #16 were observed to have scratches and cracks on the countertops. Station #1 was observed to have a rusted area on the interior windowsill.
An interview with the ESRD administrator on 5/03/2023 at approximately 1:15 PM confirmed the above findings.
Plan of Correction:The Facility Administrator or designee held mandatory in-services for all clinical teammates starting on 5/3/2023. Surveyor observations were reviewed. Education included but was not limited to a review of Policy 8-04-01 "Physical Environment" with emphasis on but not limited to: 1) the dialysis facility will be designed, constructed, equipped, and maintained to provide dialysis patients, teammates, and the public a safe, functional, and comfortable treatment environment. 2) The building in which dialysis services are furnished will be constructed and maintained for the safety of the patient, teammates and public. Verification of attendance at In-service will be evidence by teammate's signature on the Training/In-service form.
On 5/1/2023, the Facility Administrator or designee submitted Work Order #WEB-433702 for repairs to counter top and #WEB-433704 for repairs to window sill, with expected completion by 6/30/2023.
The Facility Administrator or designee will conduct physical plant audits of counter tops and window sills: daily for two (2) weeks, then weekly for (2) weeks, and continue weekly until repairs are completed. Ongoing compliance will be monitored with the Monthly OSHA and Safety Checklist. Issues requiring physical plant repair will be escalated to the Regional Operations Director and a timeline developed for completion of repairs.
The Facility Administrator or designee will review audit results with the Medical Director during the monthly Quality Assessment and Performance Improvement meetings, known as Facility Health Meeting, and bi-weekly with the Governing Body members who will review physical plant audits and oversee the physical plant repairs until all repairs have been completed. Supporting documentation will be included in the meeting minutes. The Facility Administrator is responsible for compliance with this plan of correction.
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 upon observation, policy and procedure review, and an interview with the ESRD administrator, it was determined the ESRD failed to ensure preventative maintenance or replacement of one (1) out of two (2) Fisherbrand Temperature Probes (Fisherbrand Temperature Probe #1)/ (Observation #11).
Findings include:
Review of policy PHYSICAL ENVIRONMENT states "...4. The dialysis facility will implement and maintain a program to verify that all equipment, including emergency equipment, dialysis delivery systems and the water treatment systems are maintained and operated in accordance with the manufacturer's recommendations..."
Observation #11: On 5/2/23 at approximately 1:45 PM, the Fisherbrand Temperature Probe #1, located at Medication Fridge #1, revealed a sticker on the back stating "Due 28 May 2022".
Interview with the ESRD administrator on 5/2/2023 at approximately 1:50 PM confirmed the ESRD does not perform preventative maintenance on Fisherbrand Temperature Probes and instead replaces them due to cost.
Plan of Correction:The Facility Administrator or designee held mandatory in-services for all clinical teammates starting on 5/3/2023. Surveyor observations were reviewed. Education included but was not limited to a review of Policy 8-04-01 "Physical Environment" with emphasis on but not limited to: 1) the dialysis facility will implement and maintain a program to verify that all equipment, including emergency equipment, dialysis delivery systems and the water treatment systems are maintained and operated in accordance with the manufacturer's recommendations. Verification of attendance at In-service will be evidenced by teammate's signature on the Training/In-service form.
A new temperature probe was ordered on 5/1/2023, it was received on 5/8/2023 and installed on 5/9/2023. Verification of the expiration date of the thermometer will be documented on a daily basis with the temperature readings. When the thermometer expiration date is within 2 (two) months of expiration, a new thermometer probe will be ordered and replaced.
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