QA Investigation Results

Pennsylvania Department of Health
ELLWOOD CITY DIALYSIS
Health Inspection Results
ELLWOOD CITY DIALYSIS
Health Inspection Results For:


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Initial Comments:
Based on the findings of an onsite unannounced Medicare recertification survey completed on July 20, 2020, Ellwood City 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 July 20, 2020, Ellwood City 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) 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 and procedure, observation (OBS), and staff (EMP) interview, the facility failed to ensure the patient performed hand hygiene after glove removal for one (1) of one (1) observation of patient holding access with gloved hand to stop bleeding (OBS# 5.1).

Findings included:

Review of facility policy on July 16, 2020, at 8 a.m. showed, "Procedure: 1-04-01B TITLE: POST DIALYSIS VASCULAR ACCESS CARE: FISTULA/GRAFT USING SAFETY FISTULA NEEDLES ... Procedure ... 9. The patient will be encouraged to hold their own sites if their condition permits. When the patient holds their cannulation [needle] sites, the patient will be offered gloves and performs hand hygiene when completed."

Review of facility policy on July 16, 2020, at 8:30 a.m. showed, "Policy: 1-05-01 ... TITLE: INFECTION CONTROL FOR DIALYSIS FACILITIES PURPOSE: To minimize the spread of infections or bloodborne pathogens in the dialysis facility environment. ... TEAMMATE/PATIENT SAFETY ... 35. Patients are encouraged to wash their hands and access extremity upon entering the treatment area prior to initiation of dialysis and wash their hands after treatment before leaving treatment area."

Observation of discontinuation of dialysis with arteriovenous fistula (AVF) on July 15, 2020, at 9:10 a.m. revealed EMP1 remove needles from patient's right arm AVF. EMP1 covered the sites with gauze dressings and taped them in place. The patient held pressure with gloved left hand. Once the patient thought bleeding had stopped, the patient stood up and walked to the scale. The patient removed the glove from his left hand and touched the scale-- no hand hygiene or hand washing was performed by patient. Patient took printed results from scale with left hand, gave it to EMP1, discarded glove and left the treatment area. Interview with EMP1 at 9:15 a.m. confirmed findings.










Plan of Correction:

The Facility Administrator (FA) held mandatory in-service(s) for all Clinical Teammates (TMs) starting on 7/24/2020. Surveyor observations were reviewed. Education included but was not limited to a review of Procedure: 1-04-01B Post Dialysis Vascular Access Care: Fistula/Graft Using Safety Fistula Needles with the emphasis on but not limited to: 1) the patient will be encouraged to hold their own sites if their condition permits. 2) When the patient holds their cannulation [needle] sites, the patient will be offered gloves and performs hand hygiene when completed. 3) Patients must be encouraged to perform hand hygiene after removal of gloves and after treatment before leaving the treatment area. 4)If patient is unable or refuses to perform hand hygiene after removal of gloves, vascular access clamps will be utilized. Verification of attendance at in-service will be evidenced by TMs signature on in-service sheet. Additionally, all patients will be educated on washing their hands and access extremity upon entering the treatment area prior to initiation of dialysis, upon removal of gloves, and perform hand hygiene after treatment before leaving treatment area by 8/15/2020. Evidence of education will be placed in the patient medical records. The FA or designee will conduct infection control audits daily for two (2) weeks then weekly for two (2) weeks then monthly during internal infection control audits to verify compliance. Instances of non-compliance will be addressed immediately. The FA will review the results of the audits with TMs during homeroom meetings and with Medical Director during monthly Facility Health Meetings (FHM-QAPI) with supporting documentation included in the meeting minutes. The FA is responsible for compliance with this plan of correction.


494.30(a)(1)(i) STANDARD
IC-SINKS AVAILABLE

Name - Component - 00
A sufficient number of sinks with warm water and soap should be available to facilitate hand washing.



Observations:


Based on review of facility policy, observation (OBS) and staff (EMP) interview, the facility failed to ensure hand washing sinks were only used for hand washing for one (1) one (1) observation of independent conductivity testing (OBS#7.1).

Findings included:

Review of facility policy on July 16, 2020, at 8:30 a.m. showed, "Policy: 1-05-01 ... TITLE: INFECTION CONTROL FOR DIALYSIS FACILITIES PURPOSE: To minimize the spread of infections or bloodborne pathogens in the dialysis facility environment. ... FACILITY HYGIENE 35. ... Clean sinks should be dedicated to clean activities such as hand washing and remain clean. Avoid placing, cleaning or draining dirty items in clean washing sinks. Used or contaminated items should be handled in designated utility sinks."

During observation of independent conductivity testing (OBS# 7.1) on July 17, 2020, at 9:52 a.m. EMP1 took small cup to station 3. At this time, a patient was at the station and EMP3 was initiating dialysis with one needle already in the patient's arm. EMP1 touched the hemodialysis machine with gloved hands, and took sample from the machine's dialysate port. EMP1 then took cup with dialysate sample to clean area and placed it down. EMP1 picked up independent conductivity meter located at same clean area, and took sample's conductivity reading. EMP1 placed now contaminated meter back down at clean area, and took cup with sample and dumped it into a sink labeled "Clean." EMP5 who was present at time of observation confirmed findings.

Another interview with EMP5 on July 17, 2020, at 1:45 p.m. confirmed the facility's "Clean" sinks are handwashing sinks.











Plan of Correction:

The FA held mandatory in-service(s) for all Clinical TMs starting on 07/24/2020. Surveyor observations were reviewed. Education included but was not limited to a review of Policy # 1-05-01 Infection Control for Dialysis Facilities with the emphasis on but not limited to: 1) Clean sinks are dedicated to clean activities such as hand washing and remain clean. 2) Used contaminate items such as dialysate samples to be handled in designated dirty sinks. 3) Contaminated items must be disinfected before returning to a clean area. Verification of attendance is evidenced by TM signature on in-service sheet. The FA or designee will conduct infection control audits daily for two (2) weeks then weekly for two (2) weeks then monthly during internal infection control audits to verify compliance. Instances of non-compliance will be addressed immediately. The FA will review the results of the audits with teammates during homeroom meetings and with the Medical Director during FHM-QAPI with supporting documentation included in the meeting minutes. The FA is responsible for compliance with this plan of correction.


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 and procedure, observations, and staff (EMP) interview, the facility failed to ensure staff wore personal protective equipment (PPE) only on the treatment floor for two (2) of two (2) staff observed (EMP1, & EMP3).

Findings included:

Review of facility policy on July 16, 2020, at 8:10 a.m. showed, "Policy: 1-05-01 TITLE: INFECTION CONTROL FOR DIALYSIS FACILITIES ... TEAMMATE/PATIENT SAFETY ... 16. ... PPE [gloves, mask, face shield, and gloves] is to be removed prior to leaving the treatment area. PPE is not to be worn in non-treatment areas."

Observations on the treatment floor on July 15, 2020, at 9:30 a.m. revealed EMP1 (patient care technician) providing care to patients while wearing face shield, mask, gown, and gloves. While wearing his/her PPE, EMP1 walked off treatment floor and into patient waiting area (non-treatment area), obtained the patients temperature, gave the patient a face mask, and then escorted patient into the treatment area. Interview with EMP1 at 9:34 a.m. confirmed findings, and that staff are not permitted to wear PPE in non-treatment areas.

Observations on treatment floor on July 15, 2020, at 9:50 a.m. revealed EMP3 (registered nurse) providing care to patients. While wearing his/her PPE, EMP3 walked into patient waiting area and obtained patients temperature while propping treatment floor door open with his/her left foot. EMP3 then escorted the patient into the treatment area. Interview with EMP3 at 9:52 a.m. confirmed findings. EMP3 noted there should be a dedicated person (social worker) wearing PPE who is not on the treatment floor who can screen the patients prior to patients entering the treatment area.

Interview with EMP5 (manager of clinical services) on July 15, 2020, at 11:07 a.m. confirmed the social worker should be screening the patients, or direct patient care staff should remove PPE prior to entering the patient waiting area.






Plan of Correction:

The FA held mandatory in-service(s) for all Clinical TMs starting on 07/24/2020. Surveyor observations were reviewed. Education included but was not limited to a review of Policy # 1-05-01 Infection Control for Dialysis Facilities with the emphasis on but not limited to: 1) Personal Protection Equipment (PPE) is to be removed prior to leaving the treatment area. 2) During the COVID-19 emergency, a dedicated teammate will come out to the waiting room with designated PPE to perform Entrance Interviews when the patient enters the waiting room using full PPE per COVID-19 Infection Control Guidance by Centers for Disease (CDC). Verification of attendance at in-service will be evidenced by TMs signature on in-service sheet. The FA or designee will conduct infection control audits daily for two (2) weeks then weekly for two (2) weeks then monthly during internal infection control audits. Instances of non-compliance will be addressed immediately. The FA will review the results of the audits with TMs during homeroom meetings and with Medical Director during monthly FHM-QAPI with supporting documentation included in the meeting minutes. The FA is responsible for compliance with this 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 and procedure, observation (OBS), and staff (EMP) interview, the facility failed to ensure items taken to the station were disposed of or cleaned and disinfected before being taken to a common clean area for one (1) of one (1) observation of independent conductivity testing (OBS# 7.1).

Findings included:

Review of facility policy on July 16, 2020, at 8:30 a.m. showed, "Policy: 1-05-01 ... TITLE: INFECTION CONTROL FOR DIALYSIS FACILITIES PURPOSE: To minimize the spread of infections or bloodborne pathogens in the dialysis facility environment. ... DIALYSIS STATION MANAGEMENT ... 65. Items taken to the station will be disposed of, ... or cleaned and disinfected before being taken to a common area."
Review of facility procedure on July 17, 2020, at 10:17 a.m. showed, "Procedure: 2-08-01G ... TITLE: MEASURING CONDUCTIVITY, TEMPERATURE AND/OR pH USING THE PHOENIX CONDUCTIVITY METER ... NOTES: ... The outside of the phoenix meter must be disinfected after use prior to returning the meter to the storage location. ... 8. When you are finished with the Phoenix Meter, ... Disinfect the exterior of the meter with 1:100 bleach solution before taking to a common clean area or used in another station."

During observation of independent conductivity testing (OBS# 7.1) on July 17, 2020, at 9:52 a.m. EMP1 took small cup to station 3. At this time, a patient was at the station and EMP3 was initiating dialysis with one needle already in the patient's arm. EMP1 touched the hemodialysis machine with gloved hands, and took sample from the machine's dialysate port. EMP1 then took contaminated cup with dialysate sample to clean area and placed it down. EMP1 picked up independent conductivity meter located at same clean area, and took sample's conductivity reading. EMP1 placed now contaminated meter back down on clean area counter. EMP5 who was present at time of observation confirmed findings.












Plan of Correction:

The FA held mandatory in-service(s) for all Clinical TMs starting on 07/24/2020. Surveyor observations were reviewed. Education included but was not limited to a review of Policy # 1-05-01 Infection Control for Dialysis Facilities and Procedure: # 2-08-01G Measuring Conductivity, Temperature and/or pH Using The Phoenix Conductivity Meter with the emphasis on but not limited to: 1) Clean sinks are dedicated to clean activities such as hand washing and remain clean. 2) Used contaminate items such as dialysate samples to be handled in designated dirty sinks. 3) The outside of the phoenix meter must be disinfected after use prior to returning the meter to the storage location. Verification of attendance at in-service will be evidenced by TMs signature on in-service sheet. The FA or designee will conduct infection control audits daily for two (2) weeks then weekly for two (2) weeks then monthly during internal infection control audits. Instances of non-compliance will be addressed immediately. The FA will review the results of the audits with TMs during homeroom meetings and with the Medical Director during monthly FHM-QAPI with supporting documentation included in the meeting minutes. The FA is responsible for compliance with this plan of correction.


494.40(a) STANDARD
CARBON ADSORP-MONITOR, TEST FREQUENCY

Name - Component - 00
6.2.5 Carbon adsorption: monitoring, testing freq
Testing for free chlorine, chloramine, or total chlorine should be performed at the beginning of each treatment day prior to patients initiating treatment and again prior to the beginning of each patient shift. If there are no set patient shifts, testing should be performed approximately every 4 hours.

Results of monitoring of free chlorine, chloramine, or total chlorine should be recorded in a log sheet.

Testing for free chlorine, chloramine, or total chlorine can be accomplished using the N.N-diethyl-p-phenylene-diamine (DPD) based test kits or dip-and-read test strips. On-line monitors can be used to measure chloramine concentrations. Whichever test system is used, it must have sufficient sensitivity and specificity to resolve the maximum levels described in [AAMI] 4.1.1 (Table 1) [which is a maximum level of 0.1 mg/L].
Samples should be drawn when the system has been operating for at least 15 minutes. The analysis should be performed on-site, since chloramine levels will decrease if the sample is not assayed promptly.


Observations:


Based on review of facility policy, patient schedule, water logs, and staff (EMP) interview, the facility failed to ensure the chlorine test was conducted every 4 hours while patients were on dialysis for 5 treatment days in June and July 2020.

Findings included:

Review of facility policy on July 20, 2020, at 10 a.m. showed, "Policy: 2-05-02 ... TITLE: DAILY WATER TREATMENT SYSTEM TOTAL CHLORINE MONITORING ... POLICY: ... 3. Total chlorine testing is done on a daily basis prior to the first patient treatment and every four (4) hours until all activities that require use of dialysis quality water are completed."

A review of "ROUTINE TOTAL CHLORINE TESTING LOG 2-05-02A," and patient schedule and chair assignments with EMP5 on July 17, 2020, at 9:30 a.m. showed:

On 6/17/2020 the chlorine test was conducted at 8:40 a.m., but a patient was on dialysis until 2:15 p.m (an additional chlorine test would have been needed to be done at 12:40 p.m.).

On 6/19/2020 the chlorine test was conducted at 8:40 a.m., but a patient was on dialysis until 2:15 p.m.

On 7/3/2020 the chlorine test was conducted at 8:40 a.m., but a patient was on dialysis until 12:50 p.m.

On 7/8/2020 the chlorine test was conducted at 8:40 a.m., but a patient was on dialysis until 1:16 p.m.

On 7/10/2020 the chlorine test was conducted at 8:40 a.m., but a patient was on dialysis until 12:50 p.m.

Interview with EMP5 at time of chlorine log review confirmed the findings.




Plan of Correction:

The FA held mandatory in-service(s) for all Clinical TMs starting on 07/24/2020. Surveyor observations were reviewed. Education included but was not limited to a review of Policy # 02-05-02 Daily Water System Total Chlorine Monitoring and Policy # 2-05-02H Total Chlorine Test using RPC Ultra Low Total Chlorine Test Strip. Education included but was not limited to: 1) Completing total chlorine check on a daily basis prior to the first patient treatment and every four hours until all activities that require use of dialysis quality water are completed. Due to recent clinic hour changes, additional alarm reminder was added. Verification of attendance at in-service will be evidenced by TMs signature on in-service sheet. The FA or designee will perform audits of chlorine testing log daily for two (2) weeks then weekly for two (2) weeks then ongoing monthly during internal biomedical audits to verify compliance. Instances of non-compliance will be addressed immediately. The FA will review the results of the audits with TMs during homeroom meetings and with the Medical Director during monthly FHM-QAPI with supporting documentation included in the meeting minutes. The FA is responsible for compliance with this plan of correction.


494.90(a)(5) STANDARD
POC-VASCULAR ACCESS-MONITOR/REFERRALS

Name - Component - 00
The interdisciplinary team must provide vascular access monitoring and appropriate, timely referrals to achieve and sustain vascular access. The hemodialysis patient must be evaluated for the appropriate vascular access type, taking into consideration co-morbid conditions, other risk factors, and whether the patient is a potential candidate for arteriovenous fistula placement.


Observations:

Based on review of facility policy and procedure, observations (OBS), and staff (EMP) and patient (CR) interviews, the facility failed to ensure two (2) of two (2) patients observed washed their access prior to initiation of dialysis with arteriovenous fistula (AVF) (OBS#4.1, & OBS#4.2). The facility failed to ensure one (1) of two (2) patients had their access checked to see if bleeding had stopped, and had new dressings applied during discontinuation of dialysis (OBS#5.1).

Findings included:

Review of facility policy on July 16, 2020, at 8 a.m. showed, "Procedure: 1-04-01B TITLE: POST DIALYSIS VASCULAR ACCESS CARE: FISTULA/GRAFT USING SAFETY FISTULA NEEDLES ... Procedure ... [remove needles from access site] ... 12. Hold site for at least 5-10 minutes before checking to see if bleeding has stopped. 13. Once bleeding has stopped, discard gauze or band-aid used to hold site. Inspect site for any trauma and for hemostasis [stopped bleeding]. 14. Apply band-aid type or sterile dressing over cannulation [needle] site."

Review of facility policy on July 16, 2020, at 8:30 a.m. showed, "Policy: 1-05-01 ... TITLE: INFECTION CONTROL FOR DIALYSIS FACILITIES PURPOSE: To minimize the spread of infections or bloodborne pathogens in the dialysis facility environment. ... TEAMMATE/PATIENT SAFETY ... 35. Patients are encouraged to wash their hands and access extremity upon entering the treatment area prior to initiation of dialysis ... Individually wrapped antimicrobial hand wipes should only [EMPHASIS] be used when a patient is unable to get to a sink to wash their access site."

Review of facility procedure on July 16, 2020, 8:35 a.m. showed, "Procedure: 1-04-01E ... TITLE: AV [arteriovenous] FISTULA [AVF] OR GRAFT CANNULATION WITH NIPRO OR MEDISYSTEMS SAFETY FISTULA NEEDLES (SFN) ... Procedure 1. Have patient wash access site with appropriate antibacterial soap, if able. If patient unable to wash access site, patient care teammate will clean access extremity with skin cleansing agent and pat dry."

During observation (OBS#4.1) on July 15, 2020, at 9:40 a.m., the patient walked onto treatment floor and weighed himself. The patient then walked past the sink and sat down at station 1. EMP1 wiped patient's access with a PAWS (large hand sanitizing wipe) and disinfected it with alcohol before inserting both needles into patient's AVF. Interview with patient and EMP1 at 9:45 a.m. confirmed patient did not was his access at sink with soap and water prior to disinfection and insertion of needles. The interview revealed the patient was mentally and physically capable of washing his access. The patient noted, "I know I am supposed to."

During observation (OBS#4.2) on July 15, 2020, at 10:00 a.m., the patient walked onto treatment floor and weighed herself. The patient then walked past the sink and sat down at station 3. EMP3 wiped patient's access with a PAWS and disinfected it with alcohol before inserting both needles into patient's AVF. Interview with patient and EMP3 at 10:05 a.m. confirmed she did not wash her access at the sink with soap and water. The interview revealed the patient was mentally and physically capable of washing her access and that she, "washed it at home."

During observation of discontinuation of dialysis with arteriovenous fistula (AVF) on July 15, 2020, at 9:10 a.m. EMP1 removed needles from patient's right arm AVF. EMP1 covered the sites with gauze dressings and taped them in place. The patient held pressure with gloved left hand. Once the patient thought bleeding had stopped, the patient stood up and walked to the scale. EMP1 did not check to see if bleeding had stopped and did not apply new clean dressing. Interview with EMP1 at 9:15 a.m. confirmed findings.





Plan of Correction:

The FA held mandatory in-service(s) for the Clinical TMs starting on 07/24/2020. Surveyor observations were reviewed. Education included but was not limited to a review of 1) Procedure: 1-04-01B Post Dialysis Vascular Access Care: Fistula/Graft Using Safety Fistula Needles emphasizing access site should be held for at least 5-10 minutes before checking to see if bleeding has stopped. Once bleeding has stopped, discard gauze or Band-Aid used to hold site. Inspect site for any trauma and for hemostasis then apply Band-Aid type or sterile dressing over cannulation site. 2) Policy: 1-05-01 Infection Control for Dialysis Facilities emphasizing that patients are encouraged to wash their hands and access extremity upon entering the treatment area prior to initiation of dialysis. Individually wrapped antimicrobial hand wipes should only be used when a patient is unable to get to a sink to wash their access site. 3) Procedure: 1-04-01E AV [arteriovenous] Fistula [AVF] Or AV Graft Cannulation with Nipro or Medisystems Safety Fistula Needles emphasizing that TMs should have patient wash access site with appropriate antibacterial soap, if able. If patient unable to wash access site, TM will clean access extremity with skin cleansing agent and pat dry. If patient refuses to follow facility policy for safety and infection control, re-education will be provided along with interdisciplinary team involvement and an updated patient plan of care to include interventions for compliance. Verification of attendance is evidenced by TM signature on in-service sheet. Signage placed in waiting area and by the scale to remind patients to wash hands and access. The FA or designee will verify all TMs have completed skills checklist by 07/29/2020. The FA or designee will perform observational audits daily for two (2) weeks then weekly for two (2) weeks then monthly to verify patient pre-treatment hand and access hygiene, patient hand hygiene prior to leaving the treatment area, and post treatment access care including dressing change is completed. Instances of non-compliance will be addressed immediately. The FA will review the results of the audits with TMs during homeroom meetings and with the Medical Director during monthly FHM-QAP with supporting documentation included in the meeting minutes. The FA 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 procedure, observation (OBS), and staff (EMP) interview, the facility failed to ensure staff followed procedure for independent conductivity testing for one (1) of one (1) observation of independent conductivity testing (OBS#7.1).

Findings included:

Review of facility procedure on July 17, 2020, at 10:17 a.m. showed, "Procedure: 2-08-01G ... TITLE: MEASURING CONDUCTIVITY, TEMPERATURE AND/OR pH USING THE PHOENIX CONDUCTIVITY METER ... NOTES: ... The outside of the phoenix meter must be disinfected after use prior to returning the meter to the storage location. Procedure ... 2. Insert male slip luer on the Phoenix Meter into the sample port of the dialysis machine. Connects Phoenix meter to dialysis machine dialysate sample port. 3. Pull the syringe and draw solution through the cell. ... 6. Rinse the cell and syringe interior by drawing dialysis quality water through the cell filling the syringe. ... The Phoenix meter should be rinsed free of dialysate between uses. ... 8. When you are finished with the Phoenix Meter, RINSE interior thoroughly with dialysis quality water. Disinfect the exterior of the meter with 1:100 bleach solution before taking to a common clean area or used in another station."

During observation independent conductivity (OBS# 7.1) testing on July 17, 2020, at 9:52 a.m. EMP1 took small cup to station 3. At this time, a patient was at the station and EMP3 was initiating dialysis with one needle already in the patient ' s arm. EMP1 touched the hemodialysis machine with gloved hands, and took sample from the machine's dialysate port. EMP1 then took contaminated cup with dialysate sample to clean area and placed it down. EMP1 picked up independent conductivity meter located at same clean area, and took sample's conductivity reading. EMP1 placed now contaminated meter back down on clean area counter. EMP1 did not rinse or disinfect the meter in accordance with facility procedure. EMP5 who was present at time of observation confirmed findings.

Another interview with EMP5 on July 17, 2020, at 10:15 a.m. confirmed facility procedure does not include the use of a cup taken to station to obtain dialysate sample.



Plan of Correction:

A Governing Body (GB) with the Medical Director (MD), FA, Director of Nursing and Regional Operations Director (ROD) was held upon receiving the results of the survey ending on 7/16/2020. The GB reviewed the document Medical Director Qualifications and Responsibilities. The MD acknowledges that he/she is responsible to ensure the facility TMs are trained and follow policy and procedure, and deficiencies identified need to be corrected timely with the support of the facility team. Plans of correction have been developed and initiated to correct identified deficiencies and sustain compliance. The FA held mandatory in-service(s) for the Clinical TMs starting on 07/24/2020. Surveyor observations were reviewed. Education included but was not limited to a review of Policy # 1-05-01 Infection Control for Dialysis Facilities and Procedure: # 2-08-01G Measuring Conductivity, Temperature and/or pH Using The Phoenix Conductivity Meter with the emphasis on but not limited to: 1) Clean sinks are dedicated to clean activities such as hand washing and remain clean. 2) Used contaminate items such as dialysate samples to be handled in designated dirty sinks. 3) The Phoenix meter should be rinsed free of dialysate between uses. 5) When you are finished with the Phoenix Meter, rinse interior thoroughly with dialysis quality water. Disinfect the exterior of the meter with 1:100 bleach solution before taking to a common clean area or used in another station. Verification of attendance is evidenced by TM signature on in-service sheet. The FA or designee will conduct infection control audits daily for two (2) weeks then weekly for two (2) weeks then monthly during internal infection control audits to verify compliance. Instances of non-compliance will be addressed immediately. The FA or designee will conduct infection control audits daily for two (2) weeks then weekly for two (2) weeks then monthly during internal infection control audits. Instances of non-compliance will be addressed immediately. The results of the audits will be reviewed with the Medical Director during FHM-QAPI with supporting documentation included in the meeting minutes The MD will review progress of TM education, results of audits, and adherence to this plan of correction during monthly FHM -QAPI. The FA 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 TM adherence to policy and procedure. The FA on behalf of the GB is responsible for compliance with this plan of correction.