Initial Comments:
Based on the findings of an unannounced onsite Medicare recertification survey completed on February 2, 2024, Lincoln Way 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 unannounced onsite Medicare recertification survey completed February 2, 2024, Lincoln Way Dialysis was found 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 STANDARD
IC-SANITARY ENVIRONMENT
Name - Component - 00
The dialysis facility must provide and monitor a sanitary environment to minimize the transmission of infectious agents within and between the unit and any adjacent hospital or other public areas.
Observations:
Based on observations of clinic area (OBS) and employee interviews (EMP) the facility failed to provide and monitor a sanitary environment for one (1) out of three (3) clinic observations (OBS1).
Findings include:
During an observation (OBS1) performed on 1/29/24 between approximately 9:00 - 11:30 am the following expired medical devices and medications were discovered:
Thirty (30) individual 250 mL bags of 0.9% Sodium Chloride injection Lot Y387545, expiration date August 2023.
Seven (7) individual Clearguard HD antimicrobial end caps blood access device Lot 6368, expiration date 3-25-23.
Four (4) individual RPC Item 7001-3902W, Lot 1800082, expiration date 8-31-2021.
Twenty-seven (27) individual BD 22-gauge sterile Precision Glide Needle ref. 305155, unable to determine expiration date.
Four (4) individual Curity Coviden Sponges, expiration date 6/2023.
Seventeen (17) individual Curity Coviden Sponges, expiration date 11/1/2023.
Fourteen (14) individual Criterion non-woven sponges, unable to discern expiration date.
Thirteen (13) individual Cavilon No Sting Barrier Film, expiration date 1/2022.
Sixteen (16) individual BD Safety-Lok 22-gauge 3mL syringes expiration date 7-31-23.
Nine (9) individual BD Safety Lok 25-gauge 1 mL unable to discern manufacturer or expiration date.
Two (2) bottles Fosrenol 1000 mg tablets expiration date 06/2023.
The above findings were reviewed with EMP1 (Facility Administrator) during the onsite observation on 1/29/24 at approximately 11:30 am.
Plan of Correction:The Facility Administrator took immediate action on 1/29/2024 after being notified by the state surveyor. The Facility Administrator completed an audit of all supplies and all expired supplies were discarded. A form was created to track all supplies and expiration dates to be completed monthly by the inventory technician.
The Facility Administrator or designee held mandatory in-services starting on 2/12/24 for all clinical teammates. Surveyor observations were reviewed. Education included a review of: 1) Policy 1-06-01 titled "Medication Policy" emphasizing all medications in the facility are checked monthly for expiration date. Medications are ordered and replaced prior to expiration. Disposal of expired medications ...are removed from the treatment and inventory areas and disposed of per state/local regulations. Teammates must check the expiration date on all medication and supplies prior to use. 2) Policy 8-04-01 Physical Environment emphasizing the dialysis facility will implement and maintain a program to verify that all equipment, (including supplies) are maintained and used in accordance with the manufacturer's recommendations. Lastly, the inventory technician was re-educated on the "first in, first out" process which includes rotating supplies, inspecting the integrity of packaging and checking for expiration dates. Verification of attendance is evidenced by teammate signature on in-service sheet.
The Facility Admiistrator or designee will complete audits of the supply tracking form bi-weekly for three (3) months to verify compliance with tracking. In addition,the Facility Admiistrator or designee will audit all supplies monthly for three (3) months to verify no expired items are present and available for use. Instance of non-compliance will be addressed immediately. The Facility Administrator will review the results of the audits with the inventory technician and with the Medical Director during montly Quality Assurance and Performance Improvment meetings known as Facility Health meetings. The Facility Administrator will report progress, as well as any barriers to maintaining compliance. Action plans will be evaluated for effectiveness and new plans developed when needed until sustained compliance is achieved, 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 on observations of the treatment area (OBS), reviews of policies, and employee interviews (EMP) the facility failed to maintain a program that ensured dialysis machines and ancillary equipment were maintained and operated in accordance with manufacturer ' s recommendations for two (2) of three (3) observation periods. (OBS1 and 2)
Findings include:
A review of agency policies on 1/29/24 at approximately 3:00 pm revealed:
Citric Acid Policy ... " Purpose: To provide guidelines for preparation and use of citric acid solution ...Policy: 2. A 2% citric acid solution must be used within seven (7) calendar days of preparation. 3. Follow dialysis delivery system ' s manufacturer ' s instructions for utilizing citric acid solution. 6. Citric acid concentrate is to be stored in a plastic container, labeled with preparer ' s name, date, time and Hazardous Materials Information Sheet ...label ...7. All citric acid containers, uptake wands, and caps will be rinsed and disinfected every seven (7) days ... "
Medications Requiring Refrigeration ... " To provide guidance for the storage and management of medications requiring refrigeration. ... 3. The refrigerator is checked during facility normal operating hours, by a licensed nurse teammate or 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 ...b. Daily checks will include: iv. DDL buffered probe placed near center of refrigerator ... "
During an observation (OBS1) performed on 1/29/24 between approximately 9:00 - 11:30 am the following was discovered:
1. Citric acid jugs labeled with dates of 1/4/24 and 1/11/24 were found stored in cupboards on the treatment floor. According to the labels, the citric acid was retained longer than the facility ' s seven day policy.
2. A Medication refrigerator temperature monitor was found with the alarm off and a blank screen.
An interview with EMP1 (Administrator) during OBS1 revealed that the temperature alarm was nonfunctioning and required a battery replacement. EMP1 was unsure of the LCD screen ' s readings or the function of the alarm. EMP1 was made aware of the dates on the citric acid jugs.
During an observation (OBS2) performed on 1/31/24 between approximately 9:30 am- 11:30 am the following was discovered:
1. A Citric Acid jug labeled 1/22/24 was found stored in a cupboard on the treatment floor. According to the label, the citric acid was retained longer than the facility ' s seven day policy.
2. The Medication refrigerator monitor alarm remained off and a temperature reading was not visible on the DDL display.
The findings were discussed with EMP1 (Administrator) during an exit interview on 2/2/24 at approximately 3:45pm.
Plan of Correction:The Facility Administrator or designee held mandatory in-services for all clinical teammates starting on 2/05/24. Surveyor findings were reviewed. Education included a review of: 1) Policy 2-10-03 Citric Acid Policy emphasizing a 2% citric acid solution must be used within 7 calendar days of preparation. 2) Policy 1-06-06 Medications Requiring Refrigeration emphasizing the refrigerator is checked during facility normal operating hours, by a licensed nurse teammate or designee. Checks will be documented o the Medication Refrigerator Management log. Twice daily temperature checks located on the Digital Data Logger(DDL) display at the beginning and end of the day. Daily checks will include: DDL buffered probe placed near center of refrigerator. Teammates were instructed to report any issues regarding the functionallity of the DDL immediately to the Charge Nurse. Verificatin of attendence is evidenced by teammate signature on in-service sheet. The Facility Administrator replaced battery at the time of the finding and Bio-med was made aware of the non-functioning DDL.
The Facility Administrator or designee will perform daily audits for two (2) weeks then weekly for two (2) weeks then monthly for two (2) months to verify: 1) citric acid is not expired and 2) the DDL is functioning and documentation is complete and accurate. Instances of non compliance will be addressed immediately. The results of the audits will be reviewed with the teammates during homeroom meetings and with the Medical Director during montlyFacility Health meetings with suoporting documentation included in the meeting minutes. The Facility Administrato will report progress, as well as any barriers to maintaining compliance. Action plans will be evaluated for effectiveness and new plans developed when needed until sustained compliance is achieved, Supporting documentation will be included in the meeting minutes. The Facility Administrato is responsible for compliance with this plan of correction.
494.90(a)(1) STANDARD
POC-MANAGE VOLUME STATUS
Name - Component - 00
The plan of care must address, but not be limited to, the following:
(1) Dose of dialysis. The interdisciplinary team must provide the necessary care and services to manage the patient's volume status;
Observations:
Based on a review of facility policy/procedure, medical records (MR), and staff (EMP) interviews, the facility failed to assess and/or manage a patient ' s blood pressure/volume status per facility policy for two (2) of six (6) MRs reviewed. (MRs 2 and 5)
Findings include:
Review of facility policy Pre-Intra-Post Treatment Data Collection, Monitoring and Nursing Assessment on 1/29/24 revealed: " INTRADIALYTIC DATA COLLECTION/ASSESSMENT ...10. If the dialysis prescription is not being met (including dialysis flow rate or change to/inability to obtain prescribed blood flow rate) the reason will be documented and the licensed nurse informed. 11. Abnormal findings or findings outside of any patient specific physician ordered parameters will be reported to the licensed nurse immediately ...ABNORMAL FINDINGS ...the following are considered abnormal findings and should be reported to the licensed nurse and documented in the patient ' s medical record. ...Blood Pressure-Intradialytic: Difference of 20 mmHg increase or decrease from patient ' s last intradialytic treatment BP reading ... "
Review of MR1-4 and MR6 on 2/1/24 between approximately 10:00 am to 3:00 pm revealed the following:
Review of MR2: Admission 8/18/23. Review of in-center Treatment Details Report between 1/15/24 - 1/31/24 Intradialytic monitoring revealed:
1/15/24: 7:34 entry by PCT4 BP 146/70. 8:04 entry by PCT5 BP 112/84 noted a greater than 20 point decrease from previous pressure, no documentation of RN notification per facility policy.
1/29/24: 7:34 timed entry by PCT4, Blood Pressure (BP) 146/74. 8:05 timed entry by PCT4, BP 117/68 noted a greater than 20 point increase from previous pressure, no documentation of RN notification per facility policy.
A review of MR5 on 2/2/24 revealed the following:
MR5: Admission: 6/9/21. Review of in-center Treatment Details Report between 1/15/24 - 1/31/24 Intradialytic monitoring revealed:
1/15/24: 9:32 am entry by PCT5 BP 150/83. 10:07 entry by PCT's BP 93/81 noted a greater than 20 point decrease from previous pressure, no documentation of RN notification per facility policy.
The findings were reviewed with EMP1 (Facility Administrator) during an exit interview on 2/2/24 at approximately 4:00 pm.
Plan of Correction:The Facility Administrator or designee held mandatory in-services for all clinical teammates starting on 2/05/24. Surveyor observations were reviewed. Education included a review of Policy 1-03-08 TITLE: Pre-Intra-Post Treatment Data Collection, Monitoring and Nursing Assessment emphasizing: 1) Abnormal findings or findings outside of any patient specific physician ordered parameters will be reported to the licensed nurse immediately (including a difference of 20 mm Hg increase or decrease from patient's last intradialytic treatment BP reading). 2)The licensed nurse will use his/her clinical judgment based on individual patient needs to determine if any clinical interventions are necessary. The licensed nurse notifies the physician (or NPP if applicable) as needed of changes in patient status. 3) All findings, interventions and patient response will be documented in the patient's medical record. Verification of attendance is evidenced by teammate signature on in-service sheet.
The Facility Administrator or designee will conduct audits on twenty five oercent (25%) of the flow sheets daily for two (2) weeks then weekly for two (2) weeks then ten percent (10%) monthly during medical record audits to verify compliance. Intances of non-compliance will be addressed immediately.
The Facility Administrator or designee will review results of the audits with teammates during homeroom meetings and with the Medical Director during montly Facility Health meetings. The Facility Administrato will report progress, as well as any barriers to maintaining compliance. Action plans will be evaluated for effectiveness and new plans developed when needed until sustained compliance is achieved, Supporting documentation will be included in the meeting minutes. The Facility Administrato is responsible for compliance with this plan of correction.
494.90(a)(1) STANDARD
POC-ACHIEVE ADEQUATE CLEARANCE
Name - Component - 00
Achieve and sustain the prescribed dose of dialysis to meet a hemodialysis Kt/V of at least 1.2 and a peritoneal dialysis weekly Kt/V of at least 1.7 or meet an alternative equivalent professionally-accepted clinical practice standard for adequacy of dialysis.
Observations:
Based on a review of facility policy/procedure, medical records (MR), and staff (EMP) interviews, the facility staff failed to assess and/or manage a patient ' s prescribed dose of dialysis as per facility policy for three (3) of six (6) medical records reviewed. (MRs 1, 3, and 4)
Findings include:
Review of facility policy Pre-Intra-Post Treatment Data Collection, Monitoring and Nursing Assessment on 1/29/24 revealed: " INTRADIALYTIC DATA COLLECTION/ASSESSMENT ...10. If the dialysis prescription is not being met (including dialysis flow rate or change to/inability to obtain prescribed blood flow rate) the reason will be documented and the licensed nurse informed. 11. Abnormal findings or findings outside of any patient specific physician ordered parameters will be reported to the licensed nurse immediately ...ABNORMAL FINDINGS ...the following are considered abnormal findings and should be reported to the licensed nurse and documented in the patient ' s medical record. ...Pre/Intra/Post Patient reports/complaints ...of: Pain ... "
A review of MR1-4 and MR6 on 2/1/24 between approximately 10:00 am to 3:00 pm revealed the following:
Review of MR1: Admission 1/3/23. Review of in-center Treatment Details Report from 1/16/24 to 1/30/24 Intradialytic monitoring revealed:
1/20/2024: Dialysis prescription read: Blood Flow Rate (BFR) 450 mL/min, verified by PCT1 (Patient Care Technician) at 9:51 am. 11:02 am entry by PCT1: BFR (Blood Filtration Rate) 450. 11:32 entry by PCT1 BFR 400. No documentation of RN notification or reason for BFR change per facility policy.
Review of MR3: Admission 3/11/20. Review of in-center Treatment Details Report between 1/15/24 - 1/31/24 Intradialytic monitoring revealed:
1/15/24: 6:47 timed entry by PCT4 read, " bf [blood flow rate] turned down to 400 due to pt [patient] saying [their] arm hurt ... " No documentation per facility policy that RN was notified of abnormal patient findings of pain.
Review of MR4: Admission 2/18/22. Review of in-center Treatment Details Report between 1/16/24 - 1/30/24 revealed:
1/23/24: Dialysis prescription read: Blood Flow Rate: 450 mL/min and was verified by PCT4 at 5:13. 6:02 timed entry by RN1 noted decrease of BFR from 450 to 400, no documentation of reason for BFR rate change as per facility policy.
The findings were reviewed with EMP1 (Facility Administrator) during an exit interview on 2/2/24 at approximately 4:00 pm.
Plan of Correction:The Facility Administrator or designee held mandatory in-services for all clinical teammates starting on 2/05/24. Surveyor observations were reviewed. Education included a review of Policy 1-03-08 TITLE: Pre-Intra-Post Treatment Data Collection, Monitoring and Nursing Assessment emphasizing: 1) If the dialysis prescription is not being met (including dialysis flow rate or change to /inability to obtain prescribed blood flow rate) the reason will be documented and the licensed nurse informed. 2) Abnormal findings or findings outside of any patient specific physician ordered parameters will be reported to the licensed nurse immediately. The licensed nurse will use his/her clinical judgment based on individual patient needs to determine if any clinical interventions are necessary.
The Facility Administrator or designee will conduct audits on twenty five oercent (25%) of the flow sheets daily for two (2) weeks then weekly for two (2) weeks then ten percent (10%) monthly during medical record audits to verify compliance. Intances of non-compliance will be addressed immediately.
The Facility Administrator or designee will review results of the audits with teammates during homeroom meetings and with the Medical Director during montly Facility Health meetings. The Facility Administrato will report progress, as well as any barriers to maintaining compliance. Action plans will be evaluated for effectiveness and new plans developed when needed until sustained compliance is achieved, Supporting documentation will be included in the meeting minutes. The Facility Administrator is responsible for compliance with this plan of correction.
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