Initial Comments:
Based on the findings of an onsite unannounced recertification survey conducted on May 17, 2022, through May 20, 2022, Fresenius Medical Care of East Falls 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 conducted on May 17, 2022 through May 20, 2022, Fresenius Medical Care of East Falls, 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:
494.60 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 observations (OBS) and an interview with the agency clinical manager, the agency failed to remove expired supplies from the treatment area for three (3) of three (3) observations. Observation # 1, 2, and 3.
Findings include:
Observation tour of storage area was conducted on May 17, 2022 from approximately 11:10AM until approximately 12:30PM revealed:
Observation #1:
Pure Bright Germicidal Ultra Bleach (1gal) Bottle - Serial Number 5964721014 (used to disinfect hard non-porous surfaces and effective against C Difficile spores, MRSA, CA-MRSA, VRE, etc.)
One (1) bottle Lot: 21 013 11:37 V6 1672-PA-01 (expiration date 7/15/2021)
One (1) bottle Lot: 21 256 11:20 V6 1272-PA-01 (expiration date 3/15/2022)
One (1) bottle Lot: 21 021 12126 V6 1672-PA-01 (expiration date 7/23/2021)
One (1) bottle Lot: 20 335 12:11 V6 1672-PA-01 (expiration date 6/1/2021)
Two (2) bottles Lot: 21 119 09:07 V6 1672-PA-01 (expiration date 10/29/2021)
One (1) bottle Lot: 21 256 11:20 V6 1672-PA-01 (expiration date 3/15/2022)
One (1) bottle Lot: 21 256 10:45 V6 1672-PA-01 (expiration date 3/15/2022)
One (1) bottle Lot: 21 271 13:17 V6 1672-PA-01 (expiration date 3/30/2022)
Observation #2:
One (1) Yankauer Suction Instrument - Reference Number 0034910, Lot: 201605044 (expiration date 5/3/2021)
Observation tour of medication room was conducted on May 17, 2022 from approximately 2:05PM until approximately 2:30PM revealed:
Observation #3:
One (1) bottle of Sensipar Hydrochloride Tablets (30mg) - Lot: PB10272 (expiration date 4/2023). The medication bottle was opened and did not include the date for when the bottle was first opened.
One (1) bottle of Calcitriol Capsules (0.5mcg) - Lot: 7249001A (expiration date 9/2023). The medication bottle was opened and did not include the date for when the bottle was first opened.
Three (3) Suture Removal Tray Kits - Lot: (10) 19KBO198 (expiration date 4/302022). The expiration date on all three (3) kits were circled were circled, but not removed room from the medication drawer.
An interview with the agency clinical manager, facility administrator, assistant administrator, and quality assurance manager, on May 20, 2022 at approximately 1:30 PM confirmed the above the findings.
Plan of Correction:For immediate compliance all expired items found at the time of the survey were removed and discarded on May 17, 2022, by the clinic manager (CM).
For ongoing compliance, the CM or designee will in-service all direct patient care (DPC) staff on the following policy:
· Expiration Dates Sterile Supplies
Emphasis will be placed on ensuring that all medications and supplies, including bleach, Yankauer Suction Supplies, suture removal kits and Sensipar and Calcitrol, are all within the current date for use before being used. The meeting reviewed that medications and supplies must follow the manufacture's direction for use (MDU) and that stock must be rotated First In – First Out when restocking. The meeting will reinforce that staff must check the expiration date of medications and supplies before using them.
The inservice will be completed by June 10, 2022, and the education records will be on file in 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 Performance and 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: July 1, 2022
494.150(c)(2)(i) STANDARD
MD RESP-ENSURE ALL ADHERE TO P&P
Name - Component - 00
The medical director must-
(2) Ensure that-
(i) All policies and procedures relative to patient admissions, patient care, infection control, and safety are adhered to by all individuals who treat patients in the facility, including attending physicians and nonphysician providers;
Observations:
Based on review of medical records, agency policy and procedures, and interview with the clinical manager, it was determined that the facility failed to ensure patients were dialyzed according to their treatment orders for two (2) out of five (5) medical records (MR) reviewed. (MR1 and MR4)
Findings include:
Review of policy and procedure titled "Pre-Treatment Safety Checks Procedure " on May 20, 2022 at approximately 3:00PM, states, " Pre-Dialysis Safety Checks: Verify the following elements by two staff members prior to treatment initiation: ....Prescribed dialysate composition: Verify proper delivery of dialysate prescription verifying as follows: Machine is connected to an acid concentrate that matches prescription. Verify by matching label on valve panel or concentrate jug .... "
Review of policy and procedure titled "Physician Order Documentation " on May 20, 2022 at approximately 3:15PM, states, " Responsibility: It is the nurses ' responsibility to ensure that all treatments, medications, labs or any care provided to the patient have an accurately documented physician order ....General Policy: Nurse practice acts require nurses to carry out treatment care, medication administration, lab tests, procedures, and other treatments, based on physician orders ....Providing service without physician orders is in violation of nurse practice acts ... "
A review of medical records (MR) conducted on May 19, 2022 between approximately 9:22AM until approximately 12:50AM revealed:
MR #1, Admission Date: 2/22/2022: Treatment orders dated 2/3/2022 for EW: 75, Frequency: Three (3) days per week, Dialyzer: 180NRe Optiflux, Dialysate: 2.0 K, 2.5 Ca, 1.0 Mg 100 Dextrose (G2251), BFR: 450, DFR: 500mL/min, Treatment Duration: four (4) hours, Heparin/Anticoagulant: 2,000 Bolus, ESA dose: 75mcg/IVP, Frequency: Every two (2) weeks, Oxygen (2L) via nasal cannula.
Review of flowsheets on 5/19/2022 from approximately 1:22PM until approximately 3:15PM revealed:
Treatment Date: 5/12/2022 - MR1 began treatment at 10:27AM. At approximately 11:01AM RN1 noticed that the dialysate was incorrect. The acid line was connected to the 3K 2.5Ca in the wall box, instead of 2K 2.5Ca. RN1 switched to the correct acidified dialysate line in the wall box (2K 2.5Ca). RN1's note indicated that the patient denied any issues.
There was no documentation that the physician was notified that the patient received the incorrect dialysate for approximately thirty (30) minutes into her treatment.
MR #4, Admission Date: 9/21/2022: Treatment orders dated 5/14/2022 for EW: 91, Frequency: Three (3) days per week, Dialyzer: 180NRe Optiflux, Dialysate: 2.0 K, 2.5 Ca, 1.0 Mg 100 Dextrose (G2251), BFR: 400, DFR: 500mL/min, Treatment Duration: Four (4) hours, Heparin/Anticoagulant: 2,000 Bolus, ESA dose: 150mcg/IVP, Frequency: Every two (2) weeks, Vitamin D: 0.500mcg (by mouth every treatment), Sensipar 90mg (by mouth three (3) times per week), Oxygen (2L) via nasal cannula, Heparin 2.3mL (Red Port), Heparin 2.4mL (Blue Port).
Review of flowsheets on 5/19/2022 from approximately 1:22PM until approximately 3:15PM revealed:
Treatment Date: 5/7/2022 - MR4 began treatment at 6:07AM. At approximately 6:15AM RN1 administered Oxygen (4L) via nasal cannula. RN1's clinical note indicated that at 6:01AM, the patient complained of shortness of breath and the patient was placed on oxygen via nasal cannula.
There was no documentation of a physician ' s order for oxygen at 4 liters via nasal cannula.
An interview with the agency clinical manager, facility administrator, assistant administrator, and quality assurance manager, on May 20, 2022 at approximately 1:30 PM confirmed the above the findings.
Plan of Correction:V 715
By June 10, 2022, the Director of Operations (DO) and the CM will meet with the Medical Director to review the Medical Director Responsibilities as defined in the Conditions for Coverage. The meeting also reviewed the following policies:
· Pre-Treatment Safety Checks Procedure
· Physician Order Documentation
The meeting will focus on the importance of the staff always following the physician orders and Fresenius Medical Care (FMC) policies.
Minutes of the meeting with the Medical Director will be on file at the facility for review. The Medical Director will be informed at the meeting that the CM will hold a meeting with the DPC
staff on the above policies by the CM or designee by June 10, 2022. The Medical Director will be informed that the education will focus on ensuring that prior to the start of treatment, the proper delivery of the physician dialysate prescription is verified. The re-education will review the importance of physician notification of any incorrect treatment prescription that the patient may have received at any time during their treatment. The meeting will also inform staff that a physician order is needed for the administration of oxygen to a patient with the specific liter flow.
All training documentation will be on file at the facility.
The CM or designee will perform daily audits for covid screening for 2 weeks. At that time if 100% compliance is observed, the audits will then be completed 3 times/week for 2 weeks to ensure that compliance is maintained. Audit for post hospitalizations and new patient assessments will be completed weekly for 2 months. 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.
The Medical Director was informed that staff found to be non-compliant will be re-educated and counseled.
To ensure ongoing compliance the CM will review the audit findings with the Medical Director at the QAPI Committee monthly meeting. Sustained compliance will be monitored by the QAPI committee.
Completion date: July 1, 2022
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