Initial Comments:
Based on the findings of an onsite unannounced Medicare Recertification survey completed on 8/8/2022, US Renal Care Bedford 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 8/8/2022, US Renal Care Bedford Dialysis was found to have the following standard level deficiencies that was/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:
494.40(a) STANDARD
ADDITIVES-MIXING SPIKES
Name - Component - 00
5.4.5 Additives: mixing spikes
Concentrate additives should be mixed with liquid acid concentrates according to the manufacturer's instructions, taking care to ensure that the additive is formulated for use in concentrates of the appropriate dilution ratio. When liquid additives are used, the volume contributed by the additive should be considered when calculating the effect of dilution on the concentration of the other components in the resulting concentrate. When powder additives are used, care should be taken to ensure that the additive is completely dissolved and mixed before the concentrate is used.
Observations:
Based on a review of facility policies and manufacture directions for use, observation (OBV) and staff (EMP) interviews, the facility failed to record the amount of additive in a permanent record for dialysate additive mixing for one (1) of one (1) observations conducted (OBV1).
Findings included:
Review of the agency policy on 8/3/2022 at approximately 3:00 PM revealed, Policy " Guidelines for Administration of Medication ...PROCEDURE: 1. Medications administered to patients will have a written or verbal/telephone order by a physician/physician extender duly licensed to prescribe medications ...14. When administering a medication, the following steps will be followed. Check the physician ' s order to verify dosing specifications ...f. Administer the medication to the patient. g. Record the time, name, dose and route of administration and signature on the flowsheet or administration documentation in the EMR ... "
Review of the manufactures direction for use was conducted on 8/2/2022 at approximately 1:20 PM revealed, " DIALYSATE ADDITIVE MIXING GUIDELINES ...Procedural Guidelines: 1. Verify physician ' s order for Potassium, Calcium and/or Magnesium Chloride in dialysate. 2 If required, have clinical staff member oversee use and mixing of additive. 3. Verify size of acid container used by your facility ...4. Determine electrolyte additive required (KCL, CaCl2, MgCl2 etc.) 5. Determine amount of milliequivalent increase required (0.5 mEq/L 1 mEq/L etc.) ... "
Per agency form " ACID CONCENTRATE ADDITIVE LOG " The following documented information was required " Patient Name or Jug number, Starting Concentration of the Acid Bath, Added Electrolyte, Volume Mixed, Manufacturer and Lot # of Additive, Date & Time Added, Final Concentration of the Acid Bath after the Electrolyte Added and Employee Signature. "
During a observation flash tour OBV1 on 8/1/2022 at approximately 1:45 PM in the facility storage room a container was labeled 4K. The surveyor confirmed this was not a premixed dialysate: a registered nurse was required to mix concentrate additives with liquid acid concentrates. Confirmed with EMP2 the additive was packets of Potassium Chloride 11.5 grams were used for mixing.
The surveyor was unable to confirm from the documentation available the amount Potassium Chloride in grams or the milliequivalent that was added to the dialysate from 12/31/2021 to 7/22/2022.
An interview was conducted with the director of clinical services, regional director for central, group facility administrator, home therapies manager, area biomedical manager, biomedical technician, and clinical specialist on 8/4/2022 at approximately 11:30 AM which confirmed the findings.
Plan of Correction:Additives-Mixing Spikes:
Facility staff will be educated on Policy C-MA-0010, Guidelines for Medication Administration and policy C-TI-0010, Initiation of Dialysis Treatment. Moving forward the facility will no longer utilize Acid Additives. All Acid baths utilized in the facility will be Granuflo or premixed acid concentrates.
494.50(b)(1) STANDARD
PERSONNEL HEALTH MONITORING RECORDS
Name - Component - 00
4 Records
4.4 Personnel health monitoring records
A file must be kept of the results of medical examinations of personnel that are required by OSHA or other regulatory agencies.
Observations:
Based on a review of the agency policy, and staff interview, the agency failed to conduct tuberculosis (TB) screening in accordance with agency policy for three (3) of three (3) PFs reviewed (PF1, PF2 and PF3).
Findings included:
Review of the agency policy on 8/3/2022 at approximately 3:00 PM revealed, Policy TB Surveillance Testing-Employee ...NEW HIRE (BASELINE) TESTING AND SCREENING: 1. Complete Employee/Medical Staff TB Risk Assessment and Surveillance Tool (C-EH-0080) upon hire. 2. Perform two step TST on or within 10 of hire date, unless employee provides evidence of negative TB ...4. If there is not acceptable evidence of negative TB infections within 12 months of hire, follow these steps: a. Baseline TST (1st of 2) within 10 days of hire; b. Read the baseline TST 48-72 hours after planted: i If TST is not read within 48-72 hours after planted, employee will need to receive another baseline TST. ii If result is positive (refer to " Classification of the Tuberculin Skin Test Reaction " chart on page 4). Refer to policy C-OS-0190 TB Exposure Guidelines l c. 2nd step TST will be completed 1-3 weeks after 1st TST if 1st step TST was negative 5. Employees with a positive TST result will require a chest x-ray to exclude a diagnosis of TB disease ... "
A review of PF1, date of hire 1/10/2022, was conducted on 8/3/2022 at approximately 1:25 PM. The initial TST was administered on 1/10/2022 the results were read 1/12/2022 with negative results. The second TST was administer on 1/22/2022 and read on 1/24/2022 with negative results. The agency failed to provide documentation to confirm the initial TST was administered timely within agency policy.
A review of PF2, date of hire 10/4/2021, was conducted on 8/3/2022 at approximately 1:45 PM. Initial TST was administered on 10/4/2021, read 10/6/2021 with negative results. The second TST was administered on 10/12/2021, read 10/14/2021 the results were negative. The agency failed to administer the second TST after a one-week period from the time the first TST result was read.
A review of PF3, date of hire 3/2/2020, was conducted on 8/3/2022 at approximately 1:55 PM. The initial TST was administered on 3/2/2020 the results were read 3/4/2020 with negative results. The second TST was administer on 3/9/2020 and read on 3/10/2020 with negative results. The agency failed to read the second TST after a 48-72-hour period.
An interview was conducted with the director of clinical services, regional director for central, group facility administrator, home therapies manager, area biomedical manager, biomedical technician, and clinical specialist on 8/4/2022 at approximately 11:30 AM which confirmed the findings.
Plan of Correction:Employee TB Testing:
CS will educate the Facility Administrator and Staff on Policy C-EH-0030, Employee TB Testing and Surveillance. FA or appropriate designee will review all new hire charts for completion of TB testing and Surveillance per policy. FA will review findings with Clinical Specialist x3 new hires to ensure testing is completed and documented correctly. Any identified noncompliance will be reviewed and reeducation will take place. Results will be reviewed with QAPI and Governing Body.
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