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Based on record review and interview the facility failed to measure, analyze, and track quality indicators that assess processes of care for high risk hepatitis B antigen negative patients being placed on the same hemodialysis machines as hepatitis B antigen positive patients; to collect and use data to identify opportunities for improvement that may affect health outcomes, patient safety and quality of care for high risk hepatitis B antigen negative patients being placed on the same hemodialysis machines as hepatitis B antigen positive patients for 11 of 11 sampled patients (SP) #1-11). The Governing Body failed to ensure the Quality Assurance Performance Improvement (QAPI) program reflects the complexity of the hospital's organization and services and to maintain evidence of its QAPI program for review for the inpatient dialysis unit. (Refer to A-273, and A-308).

Based on record review and interview the facility failed to measure, analyze, and track quality indicators that assess processes of care for high risk hepatitis B antigen negative patients being placed on the same (hemodialysis) HD machines as hepatitis B antigen positive patients for 10 of 11 sampled patients (SP) #2-11).



The findings include:

Review of the Daily Dialysis Schedule documented as follows:
On 11/26/2019, Census = 7 (3 patients dialyzed in the unit and 4 dialyzed at bedside)
On 11/27/2019, Census = 15 (7 patients dialyzed in the unit and 8 dialyzed at bedside)
On 12/03/2019, Census = 5 (3 patients dialyzed in the unit and 2 dialyzed at bedside)
On 12/04/2019, Census = 13 (6 patients dialyzed in the unit and 7 dialyzed at bedside)

Review of Hepatitis B Laboratory reports show negative results for sample patients: sample patient (SP) #2 (dated 11/26/2019), SP#4 (dated 09/12/2019), SP#5 (dated 07/10/2019), SP#6 (dated 10/18/2019), SP#7 (dated 07/29/2019), SP#8 (dated 10/21/2019) and SP#9 (dated 11/25/2019). SP #10 (dated 08/29/2019) patient is HepB antibody positive.

On 12/03/2019 at 11:10 AM during an interview, the Nursing Supervisor stated The hemodialysis (HD) machine are cleaned and disinfected as if every patient is HBsAg +(hepatitis B surface antigen positive). There is not a specific HD machine for HBsAg+ patients. The HbsAg positive patient dialyze on the same HD machine as the HbsAg susceptible and the HbsAg immune patients.


Interview with Quality Director on 12/03/2019 at 1:08 PM revealed the Weekly Dialysis Schedule for November 2019 identified 1 positive Hepatitis B (HbsAg positive) patient (SP#3) documented on 11/18/2019. Stated that SP#3 was the only positive person. Stated the Daily Dialysis Schedule is shredded daily. Stated the Weekly Dialysis Schedule for the month November 2019 is available because the month has just completed. Stated the Weekly Dialysis Schedule is also shredded.

The facility did not provide any evidence for dialysis performance improvement measures to audit hepatitis B antigen positive patients being placed on the same hemodialysis machines as those patients who are hepatitis antigen negative.

Facility failed to provide data and documentation of the cleaning and disinfecting of the hemodialysis machines for Hepatitis B antigen positive patients who were being dialyzed with other patients per Centers for Disease Control and Prevention (CDC) guidelines.

Interview with Director of Quality Improvement on 12/03/2019 at 1:08 PM revealed that the Performance Improvement Department and the Governing Board meet every month. Stated that this was a performance improvement project that was started the April 2018 and finished December 2018. Stated that significant data is requested from the departments and since the monthly reporting was at 100%, there was no need to continue the audits. Stated the performance improvement project to audit the dialysis patient's medical record began the 2nd quarter of 2018 for the following performance improvement measures:

1. Is this a new patient to the Nephrologist?
2. Hep B Status known or documented?
3. If No above: Was a Hepatitis Antigen profile ordered?
4. On patients with unknown status: was the machine bleached after?
5. On patients with known hepatitis B antigen positive status: was the machine bleached after?

The Audits were discontinued in January 2019.

Interview with Director of Quality on 12/04/2019 at 10:55AM revealed that in order to obtain a list for hepatitis B antigen positive patients that were dialyzed on a specific hemodialysis machine for any given time period, the facility would run a report from the electronic database system for hemodialysis charges of all patients, hospital-wide, that have received hemodialysis. Stated this is a database of cases for all hemodialysis treatments, so if the patient is logged more than once the data would need to be manually sorted to prevent duplication of patient identification. Stated next, a report that identifies hepatitis B antigen positive patients would be obtained from the lab and then filtered and sorted, by clicking on a computer screen within a spreadsheet, to identify hemodialysis patients. Stated this process is more efficient instead of going through papers to find the hepatitis B antigen positive patients. Stated to identify the specific hemodialysis machine used by the patient for any ordered hemodialysis, the facility would need to manually review each hemodialysis patient's medical record. Stated the machine number is documented on the hemodialysis flowsheet for each patient dialyzed.

After using the described process, the facility was only able to provide a list of dialyzed hepatitis B antigen positive patients for the period of January 2019 - December 2019 on Survey Day #4. The list did not identify which hemodialysis machines were used for each patient during each hemodialysis treatment. The facility did not provide the HD machine number from a manual record review of each hemodialysis patient's medical record from the list.

Based on interview, record review, the Governing Body failed to ensure the Quality Assurance Performance Improvement (QAPI) program reflects the complexity of the hospital's organization and services and to maintain evidence of its QAPI program for review for the inpatient dialysis unit.


The findings include:

Review of Governing Board Meeting Minutes dated 03/26/2019 documented Agenda Item:
Committee Reports: Dialysis PI on Hep B to be discontinued as all metrics have been met. The PIC committee approved the motion. Q3'18 and Q4'18 Three out of four metrics at 100%, 4th Metric 92%.
Conclusions/Recommendations: Motion was made by the Medical Executive Committee members, seconded and passed unanimously to approve the minutes of the Medical Operations Committee as submitted.



Interview with Quality Director on 12/03/2019 at 1:08PM revealed the Weekly Dialysis Schedule for November 2019 identified only 1 positive Hepatitis B patient (SP#3) documented on 11/18/2019. Stated that SP#3 was the only positive person.

Interview with Director of Quality Improvement on 12/03/2019 at 1:08 PM revealed that the Performance Improvement Department and the Governing Board meet every month. Stated that this was a performance improvement project that was started the April 2018 and finished December 2018. Stated that significant data is requested from the departments and since the monthly reporting was at 100%, there was no need to continue the audits. Stated the performance improvement project to audit the dialysis patient's medical record began the 2nd quarter of 2018 for the following performance improvement measures:
1. Is this a new patient to the Nephrologist?
2. Hep B Status known or documented?
3. If No above: Was a Hepatitis Antigen profile ordered?
4. On patients with unknown status: was the machine bleached after?
5. On patients with known hepatitis B antigen positive status: was the machine bleached after?

The facility did not provide any evidence for dialysis performance improvement measures to audit hepatitis B antigen positive patients being placed on the same hemodialysis machines as those patients who are hepatitis antigen negative for 2019.

The QAPI Govering body did not provide any documentation of determination that the systems in place would provide the needed information, previously provided by the audits.

Performance improvement audits were completed from the 2nd quarter to the fourth quarter of 2018 that identified 100% compliance with cleaning the dialysis machines routinely on Saturdays and directly after a hepatitis positive patient was dialyzed. The facility only performed audits from the 2nd quarter 2018 to the 4th quarter 2018. Per the Director of Quality, audits were discontinued for dialysis PI on hep B as all metrics have been met.

Based on observation, policy, record review and interview the facility failed to have a well-organized nursing services with a plan of administrative authority and delineation of responsibilities for patient care in the inpatient dialysis unit: failed to ensure the hemodialysis nursing personnel meet applicable standards for training and competency in the process of cleaning the hemodialysis machines in 10 of 10 nursing staff; and 2 of 10 nursing staff (C,K) had an initial performance evaluation within 90 days. Failed to have a policy for clinical staff cleaning of the dialysis machine, and review and update the policies for the inpatient dialysis unit. (Refer to A-386 and A-397)

Based on policy, record review and interview the facility failed to have a well-organized nursing services with a plan of administrative authority and delineation of responsibilities for patient care in the inpatient dialysis unit.

The findings include:

1. Personnel record review on 12/03/19 at 2:00 PM revealed nurse -Staff C date of hire was 2/12/19. The record review showed that the facility failed to complete an initial performance evaluation within the 90 days of hire as prescribed by the hospital policy.

Personnel record review on 12/03/19 at 2:15 PM, revealed nurse-Staff I date of hire was 6/4/19. The record review showed that the facility failed to complete an initial performance evaluation within 90 days of hire.

Interview on 12/03/19 at 2:30 PM, the Human Resources Manager confirmed that Staff C and I did not have an initial performance evaluation completed within the 90 days of hired.


Review of Policy Number HW.HR.4.3 dated 4/19/19, Title:" Performance Evaluation", states, "a formal performance evaluation must be conducted within an employee's initial 90 days of employment (the Introductory Period) or transfer or promotion into a new position".

2. Review of the policies related to the inpatient dialysis services showed 5 of the policies were not reviewed/revised since 2017: The policies: Informed Consent for Hemodialysis, Origin date: 11/07, last reviewed 4/17. Changing of the Dialysis Machine, Changing of, Origin date 12/81, reviewed 4/17. Dialyzing Patients Outside of the Dialysis Unit reviewed 11/12, last revised 4/17, Pre and Post Weights, origin date 4/09, reviewed 4/17. Conductivity & PH Monitoring revised date 3/09, reviewed 4/17.

Based on policy, record review and interview the hospital failed to ensure the hemodialysis nursing personnel meet applicable standards for training and competency in the process of cleaning the hemodialysis machines in 10 of 10 nursing staff (A, C, D, E, F, G, H, I, J and K.

The findings include:

Review of the hemodialysis nursing staff education files revealed no evidence of education/training/competency for 10 of 10 (Registered Nurses staff: A, C, D, E, F, G, H, I, J and K) nursing staff on the process of cleaning the hemodialysis machines.


Personnel record review on 12/03/19 at 2:15 PM, revealed Staff I date of hire was 6/4/19. The record review showed that the facility failed to complete three of the four dialysis initial competency assessments (Dialysis Infection Prevention, Dialysis Water System-Room 470, and Dialysis Water Systems- SCICU). The dialysis competencies forms were missing key information on the Dialysis Infection Prevention, the skill evaluator signature is missing and on both the Dialysis Water System-Room 470 and SCICU, and the skill evaluation tasks section has not been completed.

Interview on 12/03/19 at 2:30 PM, the Human Resources Manager confirmed that three of the initial competency assessments (Dialysis Infection Prevention, Dialysis Water System-Room 470, and Dialysis Water System-SCICU) were incomplete.


Review of Policy Number HW.HR 2.5 dated 4/19/19, Title: "Competence Assessment" states "Initially, during department orientation and as on-going process thereafter, staff will demonstrate their ability to perform their functions safely, effectively and efficiently in accordance with Hospital policies and procedures and standards established by the regulatory agencies (e.g. AHCA, JCAHO, HCFA) that oversee hospital operations". The policy also states, "the performance of all employees will be assessed and documented at the conclusion of their introductory period, promotion, and at least once every three (3) years".

Based on record review, review of the Infection Prevention and Control Annual Plan, and interviews, the hospital failed to provide a sanitary environment and develop a system for identifying, reporting, investigating, and controlling infections and communicable diseases of patients in 11 (SP #1-11) of 11 sampled patients (SP); dialyzing high-risk hemodialysis patients on the same hemodialysis machines as those patients who are hepatitis B antigen positive; unable to provide evidence of cleaning and disinfecting hemodialysis machines; unable to provide evidence to identify tracking of the hepatitis B antigen positive patients that were dialyzed on a specific hemodialysis machine for any given time period; unable to provide documentation of competencies of all nursing staff assigned to Dialysis Unit; unable to provide a policy approved by the governing board for the disinfection of hemodialysis machines creating a situation that is likely to result in serious injury and harm to patients and requires immediate corrective action on the part of the hospital. (Refer to A-0749)

Based on record review, review of the Infection Prevention and Control Annual Plan, and interviews the hospital failed to develop a system for identifying, reporting, investigating, and controlling infections and communicable diseases of patients in 11 (SP #1-11) of 11 sampled patients (SP), dialyzing high-risk hemodialysis patients on the same hemodialysis machines as those patients who are hepatitis B antigen positive; unable to provide evidence of cleaning and disinfecting hemodialysis machines; unable to provide evidence to identify tracking of the hepatitis B antigen positive patients that were dialyzed on a specific hemodialysis machine for any given time period. These findings created a situation that is likely to result in serious injury, and harm to patients and requires immediate corrective action on the part of the hospital.


The findings include:
An environmental tour of Dialysis Unit located on the fourth-floor room 470 was conducted on 12/3/2019 around 11:00 AM alongside the Biotech Engineer. Staffing: Two (2) RN (Registered Nurses) for up to four (4) patients per shift. At the time of the tour there was one patient in the Acute Dialysis unit receiving hemodialysis treatment.


Interview on 12/3/2019 at 11:10 AM the Nursing Supervisor states there is not a specific HD machine for HBsAg+( hepatitis B surface antigen positive) patients. The Nursing Supervisor stated HbsAg positive patient dialyze on the same HD machine as the HbsAg susceptible and the HbsAg immune patients.

Interview on 12/3/2019 at 11:45 AM with Staff K (Registered Nurse) - stated HbsAg positive patient dialyze on the same HD machine as the HbsAg susceptible and the HbsAg immune patients.

Interview on 12/3/2019 at 3:15 PM with Biotech Engineer and the CNO (Chief Nursing Officer) stated the facility does not have a policy for the cleaning and disinfecting of the HD machines, it goes by the manufactory recommendation only. Biotech Engineer provided a copy of the manufactory recommendation; 2008 K2 Operator's Manual Rev. E, Chapter 5, Disinfection and Maintenance. (page 109-110).

Review of the manufacturer's recommendation; 2008 K2 Operator's Manual Rev. E, Chapter 5, Disinfection and Maintenance provided showed no recommendations for cleaning the machine per CDC guidelines for use after Hepatitis B antigen positive patient.
Review of lab reports for SP#2 (dated 11/26/2019), SP#4 (dated 09/12/2019), SP#5 (dated 07/10/2019), SP#6 (dated 10/18/2019), SP#7 (dated 07/29/2019), SP#8 (dated 10/21/2019) and SP#9 (dated 11/25/2019) documented 7 of 11 sample patients (SP) that were hepatitis B antigen negative and should have been considered high-risk hemodialysis patients that should not have been placed on the same hemodialysis machines as those patients who are hepatitis B antigen positive.

Interview with Director Medical Surgical/Forensic Services/Dialysis on 11/26/2019 at 3:40PM revealed that the hepatitis results are documented on the hemodialysis flowsheet. Stated the hemodialysis nurses disinfect all of the hemodialysis machines with bleach and hi-level disinfectant every Saturday. Stated there are no separate machines for hepatitis B antigen positive patients. Stated that hepatitis B antigen positive patients are scheduled last and assigned to one nurse that will only take care of that patient. Stated the hemodialysis area is one room with 4 beds. Stated that a hepatitis B antigen negative patient can be dialyzed on the opposite side of the same room assigned to another nurse. Stated the hemodialysis machine used by the hepatitis B antigen positive patient is disinfected with bleach and hi-level disinfectant after use. Stated that if the hepatitis B status is unknown, the nurse will order a hepatitis panel and the patient is treated as if hepatitis B antigen positive pending the results. Stated that if the results are not obtained prior to the end of the hemodialysis treatment, the hemodialysis machine will be disinfected with bleach and hi-level disinfectant after use. Stated that prior to the start of the hemodialysis treatment the nurse will review the patient's labs to include the hepatitis panel.

Interview with Director of Infection Prevention on 11/27/2019 at 11:35AM revealed that the residual log documentation refers to the test that is done to the hemodialysis machines to check for any evidence of bleach remaining on the hemodialysis machines after the hemodialysis machines are disinfected. Stated the result should be negative to indicate that there is no residual of the cleaning solution on the hemodialysis machine prior to putting the hemodialysis machine back in service. Stated that this process is completed after every hemodialysis machine is used. Stated the hi-level cleaning process is the same regardless of patient's hepatitis status.

Interview with the Director of Quality on 11/27/2019 at 1:45PM acknowledged that there is no documentation for the residual cleaning of the hemodialysis machines used for SP#1 for the dates 01/25/2018 (Machine #1), 01/26/2018 (Machine #11), 01/27/2018 (Machine #1) and 1/29/2018 (Machine #12).

Interview with Quality Director on 12/03/2019 at 1:08 PM revealed the Daily Dialysis Schedules are shredded daily and the Daily Dialysis Schedule for January 2018 is not available for review. Stated the Weekly Dialysis Schedule for the month November 2019 is available because the month has just completed. Stated the Weekly Dialysis Schedule is shredded.

One Hep B positive sample patient (# 3) was identified who was dialyzed in November 2019 per the Dialysis Residual Log. Past medical history of Hep B and Hep C. Facility unable to identify any other patients as they do not keep logs/schedules.

The facility did not provide evidence to identify tracking of hepatitis B antigen positive patients that were dialyzed on a specific hemodialysis machine.

Facility failed to provide documentation or evidence of cleaning and disinfecting hemodialysis machines.
Unable to provide a policy for cleaning of the dialysis machines and document.
Review of the policies related to the inpatient dialysis services showed 5 of the policies were not reviewed/revised since 2017: The policies include- Infection Control- Patient Placement And Infection Surveillance, revised 4/17. Disinfectant, Checking for Residual, reviewed 4/17. Chloramine and Chlorine Levels, reviewed 4/17. Endotoxin Testing, reviewed 4/17. Chemical Water Analysis Dialysis Unit, 4/17. Surveillance of Water/ Dialysate, 4/17. Dialysis Water System Disinfection, revised 4/17. Bicarbonate Concentrate Container Cleaning Procedure, 4/17. Arterio-Venous Access, Initiation Of Fistula/ Graft Needles, 4/17. Dialysis Catheter; Multi-lumen Hemodialysis Cath, revised 4/17.Termination of treatment: Disconnecting Patient from the [named] Machine, revised 7/17.

Review of Policy No. IC-1, Section: Surveillance, Prevention and Control of Infection, Subject: Infection Control - Patient Placement and Infection Surveillance, last revised: 04/17, documented V. Procedure, 3. Hepatitis antigen negative dialysis patients should be considered high risk and should not be placed on same dialysis machine as those patients who are hepatitis antigen positive.

Review of Policy No. IC-1, Section: Surveillance, Prevention and Control of Infection, Subject: Infection Control - Patient Placement and Infection Surveillance, last revised: 04/17, documented V. Procedure, 7. Staff members who are caring for hepatitis antigen positive patients will follow the following guidelines: Patients will undergo dialysis isolated from the other patients, machine will be bleached and Hi Level disinfected prior to use on another patient.

Review of Infection Prevention and Control Annual Plan 2019 documented Authority and Responsibilities: The Infection Control and Prevention Committee members have the overall authority and responsibility for the Infection Prevention and Control Program. The Infection Control Department has primary responsibility for the daily management of infection prevention and control activities. This includes developing and implementing policies that govern control of infections and communicable diseases and developing a system for identifying, reporting, investigating and controlling infections and communicable diseases.

The Infection Control Department has authority to institute any surveillance, prevention, and control measures or studies when there is reason to believe that any patient or personnel may be in danger from a potential or actual outbreak of, or exposure, to infectious disease. All employees have responsibility for adherence to infection prevention and control processes/strategies.

Review of Infection Prevention and Control Annual Plan 2019 documented
Surveillance Activity: High Level Disinfection and Immediate-Use Steam Sterilization (IUSS)
2019 Surveillance Plan, Goal 2019: Continue same goal as 2018 (Goal 2018: Ensure compliance with both the process and documentation of high-level disinfection).
Program Priority: Low
Planned Actions for 2019: Continue monitoring high level disinfection and IUSS and reporting, as appropriate
Population: Items needing High Level Disinfection and IUSS
Analysis: Incidence rate, observations of process and documentation elements
Case Finding Methodology: Direct observation and review of documentation

Review of Infection Prevention and Control Annual Plan 2019 documented Strategies to Minimize, reduce and Eliminate Infection Risk, Strategies: Dialysis Testing, Plan: Continue dialysis and water testing per existing requirements and guidelines. Continue to monitor dialysis area to ensure compliance with IC standards.
During the tour of the Dialysis Unit, in the presence of Nursing Supervisor, while reviewing the water system, it was observed in the dialysis water room, there were two expired dialysate water testing supplies.

Blood Leak testing strips that are used to test for blood in dialysate water had an expired date documented on the container. The date documented was 03/01/2018.

Residual Chlorine strips used to test for residual chlorine in the dialysate water had no open/expired date documented on the container.
An interview was conducted with Nursing Supervisor who stated "they are old and should have been discarded. We don't even use the bicarb mixing machine".

The Policy "Testing for Chlorine Residual" revised date 4/17, states the purpose is to ensure safety of the patient after machine has been cleaned with bleach.
Photo evidence obtained.