QA Investigation Results

Pennsylvania Department of Health
ELIZABETH DIALYSIS
Health Inspection Results
ELIZABETH DIALYSIS
Health Inspection Results For:


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Initial Comments:


Based on the findings of an unannounced Medicare recertification survey conducted onsite November 14, 2022 through November 16, 2022 and completed offsite November 17, 2022, Elizabeth 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 Medicare recertification survey conducted onsite November 14, 2022 through November 16, 2022 and completed offsite November 17, 2022, Elizabeth 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(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 review of facility policy, observation and an interview with the facility administrator the facility failed to ensure infection control measures were followed for six (6) of six (6) observations made. (OBS#1, OBS#2, OBS#3, OBS#4, OBS#5, OBS#6).

Findings include:

Review of Policy: 1-05-01 last revised 10/2022 completed on 11/14/22 at approximately 10:40 a.m. revealed:
" TITLE: Infection Control for Dialysis Facilities, PURPOSE: To minimize the spread of infections or bloodborne pathogens in the dialysis facility environment., POLICY: The Centers for Disease Control (CDC) Recommendations for Preventing Transmission of Infections among Chronic Hemodialysis Patients.... Section: Teammate/Patient Safety,
#25, Non-disposable items are to be disinfected between patients...Section: Facility Hygiene, #46, Equipment including the dialysis delivery system... outside of sharps containers...as well as all work surfaces will be wiped clean with a bleach solution of the appropriate strength after completion of procedures, before being used on another patient... throughout the work day, and after each treatment...#49 The outside surfaces of all equipment will be wiped with a bleach solution prior to removal from treatment area."

Observations of dialysis treatment and care completed on 11/14/22 at approximately 9:30 a.m. and 3:15 p.m. revealed the following:

OBS#1 at 9:44 a.m., observation of 'Cleaning and Disinfection of the Dialysis Station' at station #11 revealed EMP2 failed to change the trash bag and wipe down the trash can located within station #11.

OBS#2 at 9:50 a.m., observation of 'Cleaning and Disinfection of the Dialysis Station' at station #8 revealed EMP3 failed to change the trash bag and wipe down the trash can located within station #8.

OBS#3 at 9:50 a.m., observation of EMP4 during 'Preparation of the Hemodialysis Machine/Extracorporeal Circuit.' at station #2. Set up for the next patient was present. Surveyor observed the trash can with trash remaining from previous patient after the station had been cleaned.

OBS#4 at 10:00 a.m. observation of EMP2 during 'Preparation of the Hemodialysis Machine/Extracorporeal Circuit.' at station #11. Set up for the next patient was present. Surveyor observed the trash can with trash remaining from previous patient after the station had been cleaned.

OBS#5 at 12:10 p.m., observation of station #12. Set up for the next patient was present. Surveyor observed the trash can with trash remaining from previous patient after the station had been cleaned.
.
OBS#6 at 12:20 p.m., observation of station #10. Set up for the next patient was present. Surveyor observed the trash can with trash remaining from previous patient after the station had been cleaned.

An interview was conducted with the facility administrator on 11/14/22 at approximately 3:30 p.m. Above findings were reviewed.
























Plan of Correction:

The Facility Administrator or designee held mandatory in-service for all clinical teammates starting on 11/21/22. Surveyor observations were reviewed. Education included but was not limited to a review of Policy 1-05-05 "Infection Control for Dialysis Facilities" with the emphasis on but not limited to: 1) Equipment including the dialysis delivery system ... outside of sharps containers ... as well as all work surfaces will be wiped clean with a bleach solution of the appropriate strength after completion of procedures, before being used on another patient ... throughout the work day, and after each treatment. Verification of attendance at in-service will be evidenced by teammates signature on in-service sheet. The Facility Administrator or designee will conduct a physical audit of the treatment floor to verify trash containers are emptied and cleaned between patients: daily for two (2) weeks, weekly for two (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 with teammates during homeroom meetings, and with the Medical Director during monthly Quality Assessment and Performance Improvement meetings known as Facility Health Meetings, with supporting documentation included in the meeting minutes. The Facility Administrator is responsible for compliance with this plan of correction.


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 facility policy, medical records (MR) and staff (EMP) interview, it was determined that the facility failed to ensure the nurse performed an assessment prior to the patient starting treatment for two (2) of five (5) In-Center Hemodialysis MRs reviewed (MR10, MR13).

Findings include:

Review of facility policy 1-03-07, revision date 10/2021 titled, "CWOW-Initial Patient Nursing Assessment for New Patients "on 11/15/22 at approximately 3:30 p.m. states: Policy "A registered nurse (RN) as required by federal regulation will perform an initial pre-treatment evaluation of all patients prior to the initiation of their first treatment at the facility."

Review of medical records (MRs) on 11/15/22 at approximately 1:00 p.m. to 3:30 p.m. revealed the following:

MR10, admission date of 9/23/22. Initial dialysis treatment was initiated on 9/23/22 at 12:49 p.m. Documentation indicated that the initial RN assessment was conducted on 9/23/22 at 15:26 p.m., 2 hours and 37 minutes after start of treatment.

MR13, admission date of 7/20/22. Initial dialysis treatment was initiated on 7/20/22 at 12:34 p.m. Documentation indicated that the initial RN assessment was conducted on 7/20/22 at 14:02 p.m., 1 hour and 28 minutes after start of treatment.

An interview with the facility administrator conducted on 11/15/22 at approximately 3:30 p.m. confirmed the above findings.



















Plan of Correction:

A Governing Body meeting was held on 12/20/22 with the Medical Director, Facility Administrator, Director of Nursing and Regional Operations Director to review the results of the survey ending on 11/17/22. The Governing Body reviewed Policy COMP-DD-017 "Medical Director Qualifications and Responsibilities" with the Medical Director, who acknowledges that he/she is responsible to ensure the facility teammates are trained and follow policy and procedure relative to patient admissions, patient care, infection control, and safety. Plans of correction have been developed and initiated to correct identified deficiencies and to sustain compliance. The Facility Administrator or designee held mandatory in-services for all clinical teammates starting on 11/21/22. Surveyor observations were reviewed. Education included but was not limited to a review of Policy 1-03-07 "New Patient Pre-treatment Evaluation" with emphasis on but not limited to: 1) A registered nurse (RN) as required by federal regulation will perform an initial pretreatment evaluation of all patients prior to the initiation of their first treatment at the facility. 2) This pre-treatment evaluation will be documented on the New Patient Pre-Treatment Initial Nurse Assessment" Policy 1-03-07A. Verification of attendance is evidenced by teammate's signature on the in-service sheet.
The Facility Administrator or designee will conduct an audit of one hundred percent (100%) new patient medical records to verify documentation of new patient pre-treatment evaluation: monthly for three (3) months. Ongoing compliance will be monitored with monthly ten percent (10%) medical records audit. Instances of non-compliance will be addressed immediately.
The Medical Director will review progress of teammate education, results of all audits, and adherence to this plan of correction during monthly Quality Assessment Performance Improvement meetings known as the Facility Health Meeting. The Facility Administrator will report progress, as well as any barriers to maintaining compliance, with supporting documentation included in the meeting minutes. Action plans will be evaluated for effectiveness, new plans developed as applicable to achieve compliance with teammate adherence to policy and procedure. The Facility Administrator on behalf of the Governing Body is responsible for compliance with this plan of correction.