QA Investigation Results

Pennsylvania Department of Health
RENAL CARE GROUP - HERMITAGE
Health Inspection Results
RENAL CARE GROUP - HERMITAGE
Health Inspection Results For:


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Initial Comments:

Based on the findings of an onsite unannounced Medicare recertification survey completed March 1, 2024, Renal Care Group - Hermitage 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 March 1, 2024, Renal Care Group - Hermitage was found to have the following standard level deficiencies that were determined to be in substantial compliance with the following requirement(s) 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 review of facility policy, observation, and staff (EMP) interview, the facility failed to ensure patients sanitized hands immediately after glove removal for two (2) two (2) observations (AVF1, & AVF2) of discontinuation of dialysis with an arteriovenous fistula (AVF).

Findings included:

Review of facility policy on February 15, 2024, at 12 p.m. showed:

"Post Treatment Fistula Needle Removal ... 12. Remove and discard gloves. Perform hand hygiene per policy. Instruct patient holding sites to perform hand hygiene."

"Hand Hygiene ... Hands Will Be ... Decontaminated using alcohol-based hand rub or by washing hands with antimicrobial soap and water ... Immediately after removing gloves."

Observation of AVF1 on February 13, 2024, at 11:05 a.m. revealed patient at station 11 holding pressure to AVF bandages to stop bleeding with gloved right hand. Once bleeding had stopped, the patient removed glove from their right hand and left the station without performing hand hygiene. Interview with EMP11 at the time of observation confirmed findings.

Observation of AVF2 on February 14, 2024, at 2:35 p.m. revealed patient at station 9 holding pressure to AVF bandages to stop bleeding with gloved right hand. Once bleeding had stopped, the patient removed glove from their right hand and left the station without performing hand hygiene. Interview with EMP16 at the time of observation confirmed findings.









Plan of Correction:

An approved Plan of Correction is not on file.


494.30(a)(1)(i) STANDARD
IC-GOWNS, SHIELDS/MASKS-NO STAFF EAT/DRINK

Name - Component - 00
Staff members should wear gowns, face shields, eye wear, or masks to protect themselves and prevent soiling of clothing when performing procedures during which spurting or spattering of blood might occur (e.g., during initiation and termination of dialysis, cleaning of dialyzers, and centrifugation of blood). Staff members should not eat, drink, or smoke in the dialysis treatment area or in the laboratory.


Observations:

Based on review of facility policy, observations, and staff (EMP) interview, the facility failed to ensure three (3) of three (3) employees with prescription eyeglasses (EMP5, EMP11, & EMP15), and one (1) of one (1) employee with a latex allergy (EMP11), wore appropriate personal protective equipment (PPE).

Findings included:

Review of facility policy on February 12, 2024, at 2:23 p.m. showed, "Personal protective equipment including a full-face shield or mask and protective eyewear with full side shield, fluid resistant gowns, and gloves, must be worn to protect employees from blood or other potentially infectious materials (OPIM). ... Protective eyewear ... must be designed under normal conditions of use to prevent blood and OPIM from reaching the eyes. Prescription corrective eyewear is not considered appropriate eye protection."

Observations of in-center hemodialysis patient care was conducted on February 12, 2024, from 10 a.m. to 2 p.m. During that time frame, EMP5, EMP11, and EMP15 were observed providing direct patient care in the form of initiation and discontinuation of dialysis during times when spurting and spattering of blood was likely. While providing care, these employees wore their personal prescription eyewear (not goggles and not in accordance with policy) with flexible plastic pieces slid over top of the eyewear's temples. There was nothing to protect the top or bottom portions to protect their eyes from blood or OPIM. Additionally, EMP11 wore a latex free gown that he/she had fashioned by cutting off both sleeves exposing his/her skin from his/her elbows to his/her wrists.

Interview with EMP11 and EMP10 on February 12, 2024, at 11:10 a.m. confirmed findings concerning EMP11's sleeveless gown.

Interview with EMP1 (clinic manager) on February 12, 2024, at approximately 2 p.m. confirmed that EMP5, EMP11, and EMP15 wore prescription eyewear as PPE during patient care as noted above.






Plan of Correction:

An approved Plan of Correction is not on file.


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, manufacturer directions for use, and staff (EMP) interview, the facility failed to ensure one (1) of one (1) nurse practitioner (EMP17) disinfected an item taken into the dialysis station.

Findings included:

Review of facility policy on February 15, 2024, at 11:35 a.m. showed, "Cleaning and Disinfecting the Dialysis Station ... The purpose of this policy is to provide guidelines to prevent the spread of infectious disease ... After use, any non-disposable equipment and supplies brought into the dialysis station (ex. Stethoscope) must be disinfected with 1:100 bleach or EPA registered disinfectant before being removed from the dialysis station."

Observation of EMP17 on February 12, 2024, at 11 a.m. revealed him/her rounding on multiple patients, and EMP17 would take his/her personal stethoscope into the stations to assess the patients. Specifically, EMP17 took his/her stethoscope to station 2 and touched the patient with it while the patient was dialyzing. EMP17 then left the station and wiped his/her stethoscope with a 4.5cm x 9cm (centimeter) 70% isopropyl alcohol wipe. Interview with EMP17 at time of observation confirmed this he/she uses an alcohol wipe on his/her stethoscope after assessing each patient.

Review of the alcohol wipe wrapper and its manufactuer's directions for use on February 15, 2024, at 2 p.m. showed, "ALCOHOL PREP PAD ... Directions ... apply topically as need to cleanse intended area."

Interview with EMP3 (administrator) on February 15, 2024, at approximately 1:30 p.m. confirmed the alcohol wipe used by EMP17 was not 1:100 bleach nor an EPA registered disinfectant for the purpose of disinfection within a hemodialysis facility.







Plan of Correction:

An approved Plan of Correction is not on file.


494.30(a)(1)(i) STANDARD
IC-HBV-VACCINATE PTS/STAFF

Name - Component - 00
Hepatitis B Vaccination

Vaccinate all susceptible patients and staff members against hepatitis B.


Observations:


Based on review of facility policy, OSHA standards, and personnel files (PF), and interviews with staff (EMP), the facility failed to maintain Hepatitis B virus (HBV) vaccination records for three (3) of four (4) personnel files (PF5, PF11, & PF12).

Findings:

Review of facility policy on February 15, 2024, at 11:40 a.m. showed, "Employee Requirements for Testing and Vaccinations for Hepatitis B ... Hepatitis B vaccination status shall be documented in the employee's vaccination record including: ... dates of all the hepatitis vaccinations."

Review of facility's "OSHA Bloodborne Pathogen Standards" on February 16, 2024, at 10:30 a.m., "1910.1030(f) Hepatitis B Vaccination and Post-Exposure Evaluation and Follow-up -- 1910.1030(f)(1) ... 1910.1030(f)(2) Hepatitis B Vaccination. 1910.1030(f)(2)(i) Hepatitis B vaccination shall be made available ... to all employees who have occupational exposure unless the employee has previously received the complete hepatitis vaccination series, antibody testing has revealed that the employee is immune, or the vaccine is contraindicated for medical reasons. ... 1910.1030(f)(6) Medical Recordkeeping. Medical records required by this standard shall be maintained in accordance with paragraph (h)(1) of this section. ... 1910.1030(h)(1) Medical Records. 1910.1030(h)(1)(i) The employer shall establish and maintain an accurate record for each employee with occupational exposure, in accordance with 29 CFR 1910.1020 [requires 30 year maintenance of HBV vaccination records]. ... 1910.1030(h)(1)(ii) This record shall include: ...1910.1030(h)(1)(ii)(B) A copy of the employee's hepatitis B vaccination status including the dates of all the hepatitis B vaccinations and any special records relative to the employee's ability to receive vaccinations as required by paragraph (f)(2);" Retrieved from https://www.osha.gov/laws-regs/regulations/standardnumber/1910/1910.1030

Review of direct patient care personnel files was conducted on February 15, 2024, at 12 p.m.

PF5 (registered nurse) was hired in May 2023. PF5 signed the "EMPLOYEE HEPATITIS B VACCINE DECLINATION" form on 5/10/2023 with a reason of, "immune/+ [positive] antibodies." PF5 did not contain dates when he/she received his/her complete hepatitis B vaccine series to ensure his/her immunity would be sustained.

PF11 (patient care technician) was hired September 2022. PF11 signed the "EMPLOYEE HEPATITIS B VACCINE DECLINATION" form on 10/7/2022. PF11's laboratory results showed that he/she had hepatitis B immunity. PF11 did not contain dates when he/she received his/her complete hepatitis B vaccine series to ensure his/her immunity would be sustained.

PF12 (patient care technician) was hired August 2022. PF12 signed the "EMPLOYEE HEPATITIS B VACCINE DECLINATION" form on 8/27/2022 with a reason for the reason, "declines/immune/+ [positive] antibodies." PF12 did not contain dates when he/she received his/her complete hepatitis B vaccine series to ensure his/her immunity would be sustained.

Interview with EMP1 on February 15, 2024, at approximately 12:30 p.m. confirmed above employees were vaccinated against hepatitis B at some point but that their files lacked dates when they received their vaccines.









Plan of Correction:

An approved Plan of Correction is not on file.


494.40(a) STANDARD
PERSONNEL-TRAINING PROGRAM/PERIODIC AUDITS

Name - Component - 00
9 Personnel: training program/periodic audits
A training program that includes quality testing, the risks and hazards of improperly prepared concentrate, and bacterial issues is mandatory.

Operators should be trained in the use of the equipment by the manufacturer or should be trained using materials provided by the manufacturer.

The training should be specific to the functions performed (i.e., mixing, disinfection, maintenance, and repairs).

Periodic audits of the operators' compliance with procedures should be performed.

The user should establish an ongoing training program designed to maintain the operator's knowledge and skills.




Observations:

Based on review of personnel files (PF), facility documentation, and staff (EMP) interview, the facility failed to ensure the training for operators of water/dialysate system equipment included actual observation of the work performed for eighteen (18) of eighteen (18) direct patient care staff (EMP1, 2, 5-11, 15, 16, & 19-25).

Findings included:

The facility implemented new dialysate testing technology sometime in August or September of 2023 (facility staff not sure of exact date).

An interview was conducted with EMP1 (clinic manager) on March 1, 2024, from 12:10 p.m. to 3:30 p.m., concerning staff education as it relates to facility's recent implementation of BlueStar technology. This technology allows the hemodialysis machine to perform its own conductivity testing. Conductivity must be in range prior to initiating hemodialysis. This range is measured between the machine's independent conductivity and the machine's theoretical conductivity (TCD). Additionally, staff are still required to obtain the machine's pH by applying some of the machine's dialysate to a test strip. This BlueStar procedure is different from what was previously used by the facility to test dialysate conductivity. According to EMP1 the facility went "live" with BlueStar sometime in August or September of 2023.

Review of facility documentation with EMP1 showed facility staff did a "read and sign" to review the new BlueStar policy and procedure on November 2022 and on June 2023. The November 2022 review was provided by EMP1 and not all staff attended. The June 2023 review included the new policy and procedure placed out in the patient treatment area for staff to read and initial.

A phone interview was conducted with EMP18 (technical manager) on March 1, 2024, at 2:45 p.m. According to EMP18, he/she provided an in-service to staff sometime during the summer of 2023 (not documented). He/she reviewed BlueStar procedure with staff and observed them using the technology, but he/she did not document the training to show staff understood the information he/she provided to them.

A review of direct patient care employee personnel files (EMP1, 2, 5-11, 15, 16, & 19-25) was conducted on March 1, 2024, from 12:10 p.m. to 3:30 p.m., with EMP1 and EMP18 (technical manager). The review showed that staff complete the "DPC [direct patient care] Water Skills Validation" checklist annually-- it was last done prior BlueStar implementation on February of 2023 and most recently during February of 2024. Review of the checklist for both years revealed it was completed by qualified technical personnel and included, "Able to demonstrate Usage of the following per Manufacturer's IFU and P&P ... pH Test Strips ... pHoenix XL Meter ... Use [and] Calibration." The aforementioned process outlined in the checklist was used prior to BlueStar implementation when the pHonenix XL meters were used to test conductivity.

EMP1 (RN [registered nurse]) completed his/her DPC Water Skills Validation on 2/2023 and 2/2024.
EMP2 (RN) completed his/her DPC Water Skills Validation on 2/2023 and 2/2024.
EMP5 (patient care technician [PCT]) completed his/her DPC Water Skills Validation on 2/2023 and 2/2024.
EMP6 (RN) completed his/her DPC Water Skills Validation on 5/2023 and 220/24.
EMP7 (RN) completed his/her DPC Water Skills Validation on 1/2024 and 2/2024.
EMP8 (PCT) completed his/her DPC Water Skills Validation on 1/2024 and 2/2024.
EMP9 (PCT) completed his/her DPC Water Skills Validation on 1020/23
EMP10 (PCT) completed his/her DPC Water Skills Validation on 11/2023
EMP11 (PCT) completed his/her DPC Water Skills Validation on 2/2023 and 2/24.
EMP15 (PCT) completed his/her DPC Water Skills Validation on 2/2023 and 2/2024.
EMP16 (PCT) completed his/her DPC Water Skills Validation on 11/2023 and 2/2024.
EMP19 (RN) completed his/her DPC Water Skills Validation on 2/2023 and 2/2024.
EMP20 (RN) completed his/her DPC Water Skills Validation on 2/2023 and 2/2024.
EMP21 (RN) completed his/her DPC Water Skills Validation on 2/2023 and 2/2024.
EMP22 (PCT) completed his/her DPC Water Skills Validation on 2/2023 and 2/2024.
EMP23 (PCT) completed his/her DPC Water Skills Validation on 2/2023 and 2/2024.
EMP24 (PCT) completed his/her DPC Water Skills Validation on 2/2023 and 2/2024.
EMP25 (PCT) completed his/her DPC Water Skills Validation on 2/2023 and 2/2024.

Review of the personnel file information for the above employees on March 1, 2024, from 12:10 p.m. to 3:30 p.m., did not show the BlueStar process was listed on the "DPC Water Skills Validation" checklist to show the skill was observed and validated.

An interview with EMP1 and EMP18 on March 1, 2024, at 2:45 p.m. confirmed the above findings.














Plan of Correction:

An approved Plan of Correction is not on file.


494.110(a)(2)(ix) STANDARD
QAPI-INDICATOR-INF CONT-TREND/PLAN/ACT

Name - Component - 00
The program must include, but not be limited to, the following:
(ix) Infection control; with respect to this component the facility must-
(A) Analyze and document the incidence of infection to identify trends and establish baseline information on infection incidence;
(B) Develop recommendations and action plans to minimize infection transmission, promote immunization; and
(C) Take actions to reduce future incidents.



Observations:


Based on review of facility policy, facility QAPI (quality assurance performance improvement) meeting minutes, hospitalization logs, and staff (EMP) interview, the facility failed to record and follow up on all patient infections in order to analyze and document the incidence of infections to identify trends and establish baseline information on infection incidence; develop recommendations and action plans to minimize infection transmission, promote immunization; and take actions to reduce future incidents for two (2) of two (2) patients with covid-19 infections (CR7, & CR8).

Findings included:

Review of facility policy on February 15, 2024, at 12:30 p.m. showed, "Quality Assessment and Performance Improvement Program [QAPI] ... QAPI requires the use of aggregate patient data to evaluate the facility patient outcomes. ... The QAPI Committee will monitor data/information ... Elements to be reviewed include: ... Infection Surveillance."

Review of "Absence and Hospitalization Report From Date: 8/13/2023" on February 14, 2024, at 10 a.m. showed two (2) patients (CR7, & CR8) were hospitalized for covid-19. CR2 was hospitalized on 12/19/2023 and CR5 on 1/29/2024.

Review of infection tracking logs for the above time frames with EMP1 (clinic manager) on February 14, 2024, at 11 a.m. confirmed CR7's and CR8's covid-19 infections were not documented in the log.
























Plan of Correction:

An approved Plan of Correction is not on file.


494.140 STANDARD
PQ-STAFF LIC AS REQ/QUAL/DEMO COMPETENCY

Name - Component - 00
All dialysis facility staff must meet the applicable scope of practice board and licensure requirements in effect in the State in which they are employed. The dialysis facility's staff (employee or contractor) must meet the personnel qualifications and demonstrated competencies necessary to serve collectively the comprehensive needs of the patients. The dialysis facility's staff must have the ability to demonstrate and sustain the skills needed to perform the specific duties of their positions.



Observations:

Based on review of personnel files (PF), LMS (learning management system), facility documentation, and staff (EMP) interview, the facility failed to ensure dialysis facility staff demonstrated competency necessary to perform specific duties of their position for five (5) of five (5) registered nurses. The facility failed to determine how each staff member would demonstrate competency.

Findings included:

Review of registered nurse job description on March 1, 2024, a 3:15 p.m. showed, "PRINCIPAL ... DUTIES ... Directs patient care technician's provision of safe and effective delivery of chronic hemodialysis therapy to patients in compliance with standards outlined in the facility policy and procedure manuals ... Routinely monitors patient care staff for appropriate techniques and adherence to facility policy and procedure."

An interview was conducted with EMP1 (clinic manager) on March 1, 2024, from 12:10 p.m. to 3:30 p.m., concerning staff education as it relates to facility's recent implementation of BlueStar technology. This technology allows the hemodialysis machine to perform its own conductivity testing. Conductivity must be in range prior to initiating hemodialysis. This range is measured between the machine's independent conductivity and the machine's theoretical conductivity (TCD). Additionally, staff are still required to obtain the machine's pH by applying some dialysate to a test strip. This BlueStar procedure is different than what was used previously by the facility to test conductivity. According to EMP1, the facility went "live" with BlueStar sometime in August or September of 2023 (not sure of exact date). EMP1 also noted that he/she conducted an in-service "Clinical Services P/P Update" during the month of November 2022 that included an updated policy but not all staff attended. During the month of June 2023, EMP1 placed a copy of the revised conductivity testing policy but not all staff initialed the policy. In both cases, there was nothing to show staff demonstrated their understanding of the revised policy. Interview with EMP1 at the time of the review confirmed findings. EMP1 was not able to produce a policy or process or clearly define what method the facility uses to determine staff competency.

A phone interview was conducted with EMP18 (technical manager) on March 1, 2024, at 2:45 p.m. According to EMP18, all staff should have completed the LMS BlueStar module, "they all had to take an LMS course." He/she provided an in-service to staff sometime during the summer of 2023 (not documented). He/she asserted that he/she reviewed BlueStar procedure with staff and observed them using the technology, but he/she did not document the training to show staff understood the information he/she provided to them.

A review of direct patient care staff personnel files was conducted on March 1, 2024, 12:10 p.m. to 3:30 p.m., with EMP1 and EMP18 (technical manager). At 12:15 p.m., EMP1 reviewed LMS records for BlueStar modules completed by staff. The review showed five (5) of five (5) direct patient care registered nurses (RN), who routinely provided care, did not complete the BlueStar LMS module which was a 3-minute video and a two page "fact sheet."

The above interviews showed how the facility failed to determine how each staff member would demonstrate competency: with an in-service that not all staff attended; with a read and sign not initialed by all staff, with an LMS module not completed by all staff and containing generic information; and with an undocumented in-service from EMP18 during the summer of 2023. In all cases, there was nothing to show staff understood (were competent) the information provided to them or that there was a process in place for how the new information was to be conveyed to staff.

During an interview with EMP2 (charge nurse) on March 1, 2024, at 1:30 p.m. he/she said "he doesn't remember" completing BlueStar training in LMS.



















Plan of Correction:

An approved Plan of Correction is not on file.


494.170(b)(2) STANDARD
MR-CENTRALIZE ALL INFO;IDT HAS ACCESS

Name - Component - 00
(2) All clinical information pertaining to a patient must be centralized in the patient's record, including whether the patient has executed an advance directive. These records must be maintained in a manner such that each member of the interdisciplinary team has access to current information regarding the patient's condition and prescribed treatment.



Observations:

Based on review of facility policy, manufacturer's directions for use, clinical records (CR), and staff (EMP) interview, the facility failed to ensure the patient (treatment) flow sheets contained machine parameters to show conductivity safety checks were completed and in range for seven (7) of seven (7) in-center hemodialysis clinical records reviewed (CR1 - CR7).

Findings included:

Review of facility policy on February 15, 2024, at 12:30 p.m. showed, "Checking Conductivity and pH of Final Dialysate ... Conductivity and pH of dialysate are measurements used to verify proper proportioning of acid concentrate, bicarbonate concentrate and treated water. ... Policy ... The final dialysate conductivity and pH must be tested prior to each patient's treatment. ... Treatments may not be initiated, or current treatment must be stopped. ... The conductivity falls outside of the +/- 0.5 mS/cm [the unit of conductivity] of TCD [theoretical conductivity] ... BlueStar machine software allows independent conductivity and pH readings to be enabled in Service Mode. Per manufacturer's Instructions For Use, the machine will verify conductivity and calculate the theoretical pH of dialysate while running self-tests. ... Staff/care partners must maintain limits at +/- 0.5 mS/cm of the TCD. Staff/care partners May Not Adjust them to any other position than +/- mS/cm of the TCD. ... Record conductivity ... readings in the FKC treatment record."

Review of manufacturer's directions for use for facility's hemodialysis machines with EMP3 (administrator), and EMP18 (technical manager) on February 15, 2023, at 12:15 p.m. showed the following safety check, "2008T Hemodialysis Machine Operator's Manual ... 490122 Rev AA ... Warning! Always verify the conductivity ... of the dialysate solution through independent means before initiating each dialysis treatment. ... Verify that the conductivity is within 0.4 mS/cm of the theoretical conductivity value (TCD)... If conductivity [is] not within these limits, do not initiate dialysis." Retrieved from https://fmcna.com/content/dam/fmcna/live/support/documents/operator%27s-manuals---hemodialysis-(hd)/2008t-operator%27s-manuals/490122_Rev_AA.pdf

Review of clinical records on February 15, 2024, at 9 a.m.

CR1 received eight (8) incenter hemodialysis treatment sheets from 1/27 to 2/13/2024. Review of CR1's treatment sheets for above dates did not show that the hemodialysis machine's TCD and conductivity were within normal safe limits to start treatment.

CR2 received nine (9) incenter hemodialysis treatment sheets from 1/25 to 2/13/2024. Review of CR2's treatment sheets for above dates did not show that the hemodialysis machine's TCD and conductivity were within normal safe limits to start treatment.

CR3 received nine (9) incenter hemodialysis treatment sheets 1/24 to 2/12/2024. Review of CR3's treatment sheets for above dates did not show that the hemodialysis machine's TCD and conductivity were within normal safe limits to start treatment.

CR4 received nine (9) incenter hemodialysis treatment sheets from 1/25 to 2/13/2024. Review of CR4's treatment sheets for above dates did not show that the hemodialysis machine's TCD and conductivity were within normal safe limits to start treatment.

CR5 received nine (9) incenter hemodialysis treatment sheet from 1/25 to 2/13/2024. Review of CR5's treatment sheets for above dates did not show that the hemodialysis machine's TCD and conductivity were within normal safe limits to start treatment.

CR6 received six (6) incenter hemodialysis treatment sheets from 1/27 to 2/13/2024. Review of CR6's treatment sheets for above dates did not show that the hemodialysis machine's TCD and conductivity were within normal safe limits to start treatment.

CR7 received nine (9) incenter hemodialysis treatment sheets from 1/24 to 2/12/2024. Review of CR7's treatment sheets for above dates did not show that the hemodialysis machine's TCD and conductivity were within normal safe limits to start treatment.

Note: BlueStar is a new technology and facility does not show it is monitoring the function of this new technology. The conductivity range that appeared on the patient treatment sheets did include TCD to show the hemodialysis machine's conductivity was in range or within normal limits. is no longer valid for determining.

Interview with EMP1 (clinic manager) and EMP3 (administrator) on February 15, 2024, at 1:45 p.m. confirmed above findings and that the hemodialysis machines used for the above patients did not show TCD was recorded to show the machine's conductivity was in a safe range prior to initiating treatment.



















Plan of Correction:

An approved Plan of Correction is not on file.