The information below comes from the statement of deficiencies compiled by health inspectors and provided to AHCJ by the Centers for Medicare and Medicaid Services. It does not include the steps the hospital plans to take to fix the problem, known as a plan of correction. For that information, you should contact the hospital, your state health department or CMS. Accessing the document may require you to file a Freedom of Information Request. Information on doing so is available here.

ADVENTHEALTH ORLANDO 601 E ROLLINS ST ORLANDO, FL 32803 Feb. 16, 2018
VIOLATION: GOVERNING BODY Tag No: A0043
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**


Based on interview and record review, the hospital's Governing Body failed to provide oversight and monitoring of the Contracted Dialysis Company to ensure that dialysis services provided complied with all Conditions of Participation and standards for contracted services.

Patient #4 was admitted on [DATE] with a history of chronic kidney disease stage IV and diabetes mellitus. His admitting diagnoses included generalized weakness, productive cough, fevers, abnormal electrolytes and worsening renal function. The patient had labs drawn on 01/23/2018 and was noted to be Hepatitis B surface antigen, (HBsAg) positive on 01/24/2018. On 01/25/2018, the nurse misread the HBsAg positive result and documented that the result was negative. The patient had hemodialysis treatments on 01/23/2018, 01/24/2018, 01/25/2018 and 01/27/2018 and 01/30/2018. The Contracted Dialysis Company failed to follow processes for communicable diseases thereby subjecting 5 of 19 susceptible patients to potential Hepatitis B infections.

As a result of this failure, Immediate Jeopardy was determined to exist from 01/24/2018 and was determined to be ongoing as of the exit date of 02/16/2018.

Findings:

A review of the contracted agreement between the Hospital and the Contracted Dialysis Company page 3 (f) read, "Hospital shall bill Medicare, Medicaid and all other third-party payors for the Services in accordance with all applicable laws, rules and regulations ...."

An interview with the Quality Systems Director/Lead Auditor on 02/16/2018 at 11:45 AM revealed that the Hospital had a functioning Governing Body and a Quality Assurance and Performance Improvement (QAPI) committee. She stated that the Contracted Dialysis Company was discussed annually under contracted services and was on the agenda for the November 2018 QAPI meeting. Every contracted service had an owner and for the Contracted Dialysis Company, it was the hospital's Director of Dialysis Systems. She stated that he was responsible for ensuring that the Contracted Dialysis Company was providing care and services according to the hospital's standards.

An interview with the hospital's Director of Dialysis Systems on 2/16/2018 at 1:00 PM revealed that he was responsible for the services provided by the Contracted Dialysis Company. It was noted that the Contracted Dialysis Company provided dialysis to 3 other campuses and the director was responsible for the service at all locations. He stated that he received quarterly performance indicators from the company regarding water cultures of all machines, and logs of daily disinfection and annual lab results of all dialysis machines. He stated that he did not do any audits to confirm that the reported indicators were factual. Although he was aware of some problems with the Contracted Dialysis Company staff not following proper infection control precautions, he had not provided any monitoring. He had solely relied on the Contracted Dialysis Company to self-monitor and disclose any concerns. He confirmed that it would have been, "good to do our own checks and audits."

An interview with the risk management team on 02/16/2018 at 3:45 PM noted that they were aware that the Contracted Dialysis Company was not monitored by any regulatory authority except by the providing hospital. The team confirmed that there was no other hospital staff designee responsible for providing monitoring of the Contracted Dialysis Company to evaluate the quality of services provided to patients receiving dialysis treatments.
VIOLATION: CONTRACTED SERVICES Tag No: A0084
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**


Based on interview and record review, the hospital's governing body through the Quality Assurance and Performance Improvement failed to assess and identify quality deficiencies and failed to implement appropriate corrective interventions to ensure the monitoring of the contracted dialysis company and patient safety. The hospital's lack of oversight of the dialysis program resulted in the potential hepatitis B transmission via hemodialysis from one Hepatitis B Surface Antigen positive patient, #4 to five susceptible patients out of a sample of 19 patients.

Patient #4 was admitted on [DATE] with a history of chronic kidney disease stage IV, and diabetes mellitus. His admitting diagnoses included generalized weakness, productive cough, fevers, abnormal electrolytes and worsening renal function. The patient had labs drawn on 1/23/18 and was noted to be Hepatitis B surface antigen positive on 1/24/18. On 1/25/18, the nurse misread the positive results and documented that the patient was negative. The patient had hemodialysis treatments on 1/23/18, 1/24/18, 1/25/18, 1/27/18 and 1/30/18. The contracted dialysis company failed to follow infection control processes for communicable diseases thereby potentially infecting 5 of 19 patients that were identified as susceptible to Hepatitis B infections.

As a result of this failure, the facility failed to ensure that the immediate threat was lifted which resulted in immediate jeopardy starting on 1/24/18, and was determined to be ongoing at the exit date of 2/16/18.

Findings:

A review of the Exclusive Dialysis Service Agreement revealed that the contract was last signed on 8/31/2017 with the hospital and the contracted dialysis company. The company provided dialysis services to the hospital including. On page 10 of the contract, under heading, Clinical Performance Improvement, it was noted that the contracted dialysis company would collaborate biannually with the hospital to determine Performance Indicators and goals for clinical quality measures and patient perception of safety and quality of care. "Quarterly audits will be performed by the contracted dialysis company with quarterly reporting. Action plans to be submitted quarterly to the hospital leadership for any measures that are below established standards."

An interview with the Quality Systems Director/ Lead Auditor done on 2/16/18 at 11:45 AM revealed that the QAPI committee met quarterly. The meetings generally lasted 3 hours and consisted of high leadership staff including the chief nursing officer and the vice president of support services. She stated that contracted dialysis company was discussed under contracted services annually and was on the agenda for the November 2018 QAPI meeting. She said that every contracted services had an owner and for hemodialysis, it was the hospital's director of dialysis systems. There were quality indicators that the contractor must meet to show that they were meeting performance standards. The contracted dialysis director was responsible for ensuring that the contracted dialysis company was submitting these quarterly reports. She stated that there had not been any measures that were below the established standards. She stated that her team consisting of critical care nurses had done an observational audit of a dialysis treatment approximately one year ago. She said that they audited a treatment being done. She could not provide any documentation of the dialysis observation audit that was completed. She stated that once the audits were completed, the manager of the particular unit was informed of the findings. When she was asked who was responsible for the daily oversight of the contracted dialysis company, she said that it was the director of dialysis systems. She stated that the hospital had 600 contracts and all must meet the hospital standards. She said that the contracted mobile company had been providing dialysis services since 2009 and had not had any past quality deficiencies.

An interview with the hospital's director of dialysis systems on 2/16/18 at 1:00 PM revealed that he was responsible for the contracted dialysis company. When he was asked about oversight of the services, he stated that he received quarterly performance indicators from the company. He also received results of water cultures monthly and annual lab requests of all dialysis machines. He stated that he was also informed of any delay in service, or any issues with the nurses or physicians. When he was asked if he did any audits to monitor what the contracted company was documenting, he stated no. He did not do any audits re infection control or any observations to ensure that dialysis was being done according to standards. He stated that the dialysis company did their own auditing and monitoring. He stated that he ensured nursing competencies were being validated but could not provide any documentation. When he was questioned about any issues with the contracted dialysis company, he said there were some problems with their staff not wearing proper personal protective equipment, (PPE) and delays with treatments but he had not done any random audits or monitoring. When he was asked how he assured that the services provided by the contracted dialysis company were within acceptable standards of practice, he stated that it would have been, "good to do our own checks and audits.

An interview with the director of critical care services on 2/16/18 at 1:30 PM revealed that he did not monitor the dialysis procedures. He stated that he may assess a dialysis patient if they had a central line dressing as he tracked all central line dressings in the hospital. He stated that he received all the quarterly reports that the contracted dialysis company sent. He confirmed that the contracted dialysis company was responsible for its own surveillance.

During an interview with the risk management team on 2/16/18 at 3:45 PM, they confirmed that no other hospital staff person was providing any oversight of the contracted dialysis company to ensure standards of practice were being met.
VIOLATION: PATIENT RIGHTS Tag No: A0115
Based on interview, record review, and a review of both hospital documentation and hospital contractor documentation, the hospital failed to ensure that policies governing the provision of patient care in a safe setting through measures designed to prevent the transmission of Hepatitis B through hemodialysis were followed with one Hepatitis B Surface Antigen (HBsAg) positive patient (#4), thus potentially exposing to Hepatitis B five other patients who were susceptible to Hepatitis B infections (#11, #14, #16, #18 & #19,) out of a sample of 19 patients (#1-19). Immediate Jeopardy was determined to exist from 1/24/18 to the present. The administrator of the hospital was notified of Immediate Jeopardy on February 16, 2018 at 5:05 PM.

Findings:

Cross Refer A144. Registered Nurses (RN) B, F and G were employed by the contracted dialysis company with the hospital to perform dialysis on patients in their hospital. The performance of dialysis requires that nurses follow specific steps involving the maintenance of a patient setting or environment which inhibits the transmission of Hepatitis B from any patient who is HBsAg positive to any other patients who may be susceptible to being infected with Hepatitis B. Important environmental factors which must be addressed concern the dialysis machine and the room in which dialysis is performed. Registered Nurses B, F and G failed to follow contractor policies, hospital policies, and the contract provisions between the contractor and the hospital which governed steps to be taken with dialysis machines and dialysis treatment areas upon the review of laboratory results concerning a patient #4's Hepatitis B Surface Antigen (HBsAg) status. As a result, the hospital failed to fulfill its own policy requirement of providing care in a safe environment.

The lack of compliance with the joint contract between the dialysis contractor and the hospital, established hospital policies and associated documentation covering actions to be taken in the patient care environment concerning the HBsAg status of patients resulted in five patients, #11, #14, #15, #18, and #19 who were susceptible to a Hepatitis B infection being exposed to Hepatitis B. As a result, the hospital failed to provide care in a safe setting and violated the requirement to provide care in a safe environment, as stated in facility policy. The facility also failed to comply with standard A0144, which reads: "The patient has the right to receive care in a safe setting."
VIOLATION: PATIENT RIGHTS: CARE IN SAFE SETTING Tag No: A0144
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**

Based on interview, record review and a review of hospital and contractor documentation, the hospital failed to provide care to patients in a safe setting by not implementing established policies concerning the prevention of Hepatitis B transmission via hemodialysis treatments from one Hepatitis B Surface Antigen positive patient (#4) to five other patients who were susceptible to Hepatitis B infections (#11, #14, #16, #18 & #19) out of a sample of 19 patients (#1-19).

Findings:

A review of the medical record of patient #4 was performed. The patient was admitted on [DATE] at 6:21 PM, through the emergency room . He had a medical history that included chronic kidney disease stage IV, hypertension and diabetes mellitus. He was admitted to the hospital for generalized weakness, cough, sputum production, fevers, abnormal electrolytes and a worsening renal function. He had laboratory blood work concerning his Hepatitis B status performed on 1/23/18. Staff became fully aware of the results on 1/30/18, which indicated that he was Hepatitis B Surface Antigen (HBsAg) positive. This finding means that he was at a risk of transmitting Hepatitis B to others from 1/23/18 to 1/30/18, when staff eventually staff implemented protective measures.

The physician ordered dialysis treatments on a one time basis for each of the following days: 1/23/18, 1/24/18, 1/25/18, 1/27/18 and 1/30/18. The treatments were performed by Registered Nurses (RN) of the contracted dialysis company with the hospital to perform dialysis treatments.

According to the Centers for Disease Control and Prevention (CDC), susceptibility to exposure to Hepatitis B requires that a patient have a Hepatitis B surface anti-body (anti-HBs) result of less than 10 milli-international units per milliliter (MIU/ML). This definition of susceptibility is stated in the document "Recommendation for Preventing Transmission of Infections Among Chronic Hemodialysis Patients", published by the CDC (4/27/01).

The "Patient Log Book" and "Machine Log Book" documentation revealed that patient #4 underwent the ordered dialysis treatment in the facility as described in the following. Dialysis treatments took place in either room 3702, which has two stations, in room 3704, a one bed room, or in the patient's room.

Orders for hepatitis blood work for 1/23/18 at 10:12 AM for patient #4 read "Hepatitis Panel".

The "Patient Log Book" indicated on 1/24/18 at 8:30 AM, patient #4 began a dialysis treatment when he was placed on a dialysis machine by RN F. A review of the pre-treatment sheet for 1/24/18 revealed that patient #4 was placed in room 3404, a one station room.

The "Machine Log Book" indicated on 1/24/18, machine 70 did not receive internal disinfection immediately after this treatment session, a task which is necessary where a patient's Hepatitis B Surface Antigen status is unknown or known to be positive. Patient #11, susceptible to Hepatitis B infection, was later placed on this machine on 1/25/18 at 7 PM and was at risk for being exposed to Hepatitis B. The "Machine Log Book" revealed that machine 70 eventually received internal cleaning which would have eliminated risk of Hepatitis B transmission on 1/26/18 in the morning, prior to the first treatment of the day.

Aside from using the same machine, any patient who was in the same room, 3704, from 1/24/18 at 8:30 AM to the time of its next terminal cleaning, would also have been at risk for exposure. The next terminal cleaning was revealed in Environmental Services documentation to have taken place in room 3702 on 1/24/18 at the end of the day. A terminal cleaning involves the use of approved disinfectant cleaning products on all accessible surfaces in the room. "Patients admitted to hospital rooms that previously were occupied by patients infected or colonized with such pathogens are at increased risk of infection from contaminated environmental surfaces and bedside equipment if they have not been cleaned and disinfected adequately." (cdc.gov).

Patient #4's result of the Hepatitis Panel laboratory blood work was reported on 1/24/18 at 11:11 AM. This was after the patient's treatment time of 8:30 AM on that day. The results indicated that the patient was "Hep B Surf Ag: reactive." Therefore, he was HBsAg positive and a definite risk for transmitting Hepatitis B to other patients.

The "Patient Log Book" indicated on 1/25/18 at 7:30 AM, patient #4 was placed on machine 134 in room 3702, a two station room, by RN B.

Aside from using the same machine as patient #4, any patient who was in the same room, 3702, from 1/25/18 at 7:30 AM to the time of its next terminal cleaning at the end of the day would also have been at risk for exposure. The next terminal cleaning was revealed in Environmental Services documentation to have taken place in room 3702 on 1/25/18 at the end of the day. A review of contracted dialysis company documentation which summarized the performance of dialysis in rooms after they had been used by patient #4 revealed that two patients, #14 and #16, who were susceptible to Hepatitis infection, received dialysis treatment in room 3702 on 1/25/18 either during or after patient #4 received his dialysis treatment. Patient's #14 and #16 had treatments at 7:10 AM on 1/25/18 and 12:30 PM on 1/25/18, respectively. These patients were at risk for exposure to Hepatitis B.

The "Machine Log Book" indicated on Friday 1/26/18, machine 134 was internally cleaned prior to the first treatment of the day.

The "Patient Log Book" indicated on 1/27/18 at 11:50 AM, patient #4 was placed on machine 95 in his own room by RN G. The "Machine Log Book" indicated on 1/27/18, this machine did not receive internal cleaning after this treatment session. Thus, patients who were later placed on this machine were at risk for being exposed to Hepatitis B.

A review of contracted dialysis company documentation which summarized the use of dialysis machines after they had been used on patient #4 revealed that patients #18 and #19, susceptible to Hepatitis B infection, used machine 95 after 1/27/18 at 3:15 PM, the time when patient #4's treatment ended, per the Patient Log, through patient #4's next treatment on 1/30/18 at 1:00 PM. Thus, these patients, #18 and #19, were also at risk for exposure to Hepatitis B.

Patient #14 and patient #16 had an increased risk due to having been in the same room as patient #4 after he had received a dialysis treatment, but before terminal cleaning of the room. They had treatments on 1/25/18 at 7:10 PM and 1/25/18 at 12:30 PM, respectively. Patients #11, #18 and #19 also had an increased risk for contracting Hepatitis B since they had used the same machine as patient #4, after patient #4 had used it, and before it received internal cleaning. They had treatments on 1/ 25/18 at 7 PM, 1/29/18 at 2:50 PM, and 1/28/18 at 6 PM, respectively

On 2/02/18 at 11 AM, the Director of Infection Prevention at Florida Hospital confirmed that patients #14, #16, #11, #18 and #19 were susceptible to Hepatitis B infection.

On 1/31/18 at 4:22 PM, the Director of Nursing for the contracted dialysis company stated that they became aware of the patient's HBsAg positive status on 1/30/18, prior to patient #4's scheduled treatment for that day. This was the day in which the complaint investigation had started.

Based on record review, patient #14 had laboratory results on 1/25/18. Her anti-HBs (Hepatitis B surface anti-body) results were less than 3.5 MLIU/ML, which was less than 10 MLIU/ML. Her HBsAg result was "nonreactive," and was susceptible to a Hepatitis B infection.

Based on record review, patient #16 had laboratory results on 1/20/18. Her HBsAg result was "nonreactive," and was susceptible to a Hepatitis B infection.

Based on record review, patient #11 had laboratory results on 1/19/18. His anti-HBs (Hepatitis B surface anti-body) results were less than 3.5 MLIU/ML, which was less than 10 MLIU/ML. His HBsAg result was "nonreactive," and was susceptible to a Hepatitis B infection.

Based on record review, patient #18 had laboratory results on 1/28/18. Her HBsAg result was "nonreactive," and was susceptible to a Hepatitis B infection.

Based on record review, patient #19 had laboratory results on file from 1/04/18. His anti-HBs (Hepatitis B surface anti-body) results were less than 3.5 MLIU/ML, which was less than 10 MLIU/ML. His HBsAg result was "nonreactive," and was susceptible to a Hepatitis B infection.

According to the CDC, a patient with a HBsAg positive status, either undiscovered or ultimately revealed in laboratory testing results, has an increased risk of transmitting Hepatitis B to other patients who are not HBsAg positive, and are thus susceptible to a Hepatitis B infection, if certain key actions are not taken. This increased propensity for disease transmission would arise specifically if a HBsAg positive patient continued with dialysis on machines that are subsequently shared with patients who are susceptible to Hepatitis B infections, if there is no performance on those involved machines of more extensive cleaning after each use by the HBsAg positive patient. The increased propensity for Hepatitis B transmission would also arise if a HBsAg positive patient used the same rooms for treatment as patients who are susceptible to Hepatitis B infection, where a sufficient distance is not maintained between the dialysis machine used by the HBsAg positive patient and machines used by patients who are not HBsAg positive. In addition to distance concerns in treating HBsAg positive patients, there would be an increased risk for transmission if the area used by an HBsAg patient is not designated solely for use by such patients, at least until the performance of a terminal cleaning at a degree which would address all vulnerable surfaces. Nearby surfaces pose a significant risk to being exposed to blood from dialysis patients. These conclusions are supported by the following documents: "Recommendations for Preventing Transmission of Infections Among Chronic Hemodialysis Patients", from the Centers for Disease Control and Prevention; the contracted dialysis company's policy "Infection Control and Hepatitis Policy"; the contracted dialysis company's "Internal Disinfection of the Dialysis Machine" policy; the contracted dialysis company's policy "Care of the HD Patient on Isolation Precautions"; the contracted dialysis company policy "Care of the HD Patient on Isolation Precautions" the contracted dialysis company's policy "Infection Control and Hepatitis Policy"; the facility's contract (10/6/17); and the hospital's policy "Isolation Precautions for Selected Infections and Procedures", which had references at the end for two CDC sources. The first one, "2007 Guidelines for Isolation Precautions: Preventing the Transmission of Infectious Agents in Healthcare Settings" lead to the following document: "Recommendations for Preventing Transmission of Infections Among Chronic Hemodialysis Patients."

During an interview of the Risk Manager on 2/02/18 at approximately 1:20 PM and on 2/16/18 at 5:00 PM, she confirmed the findings.

A review of hospital policy "Patient Rights and Responsibilities" revealed the following: "The patient has the right to receive care in a safe environment." Hepatitis B susceptible hemodialysis patient #14 received hemodialysis treatment in a room environment concurrent with HBsAg positive patient #4 and Hepatitis B susceptible patient #16's dialysis treatment was initiated after #4's hemodialysis treatment, also in the same room. These two hemodialysis treatments were done without the protection of intervening terminal disinfection which policies and standards indicated would offer significant protection from exposure to the Hepatitis B virus. Therefore, the rights of patients #14 and #16 to receive care in a safe environment were not honored. Hepatitis B susceptible patients #11, #18 and #19 received hemodialysis treatments on the same dialysis machine that HBsAg positive patient #4 had used, at points in time after patient #4's hemodialysis treatment but before the internal disinfection of the machine which policies and standards indicated would offer significant protection from exposure to the Hepatitis B virus Therefore, the rights of patients #11, #18 and #19 to receive care in a safe environment were not honored.
VIOLATION: QAPI Tag No: A0263
Based on interview and record review, the hospital failed to ensure that the Quality Assessment and Performance Improvement program provided oversight of the Contracted Dialysis Company for dialysis services.

As a result of this failure, Immediate Jeopardy was found to exist starting on 01/24/2018 and determined to be ongoing as of the exit date of 02/16/2018.

Findings:

Cross Reference A286. Based on interview and record review, the hospital's governing body through the Quality Assurance and Performance Improvement failed to assess and identify quality deficiencies and failed to implement appropriate corrective interventions to ensure the monitoring of the contracted dialysis company and patient safety. The hospital's lack of oversight of the dialysis program resulted in the potential hepatitis B transmission via hemodialysis from one Hepatitis B Surface Antigen positive patient, #4 to five susceptible patients out of a sample of 19 patients.
VIOLATION: PATIENT SAFETY Tag No: A0286
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**


Based on interview and record review, the hospital failed to provide safe care to patients receiving dialysis treatments by the Contracted Dialysis Company by not providing oversight through its Quality Assurance and Performance Improvement plan (QAPI).

As a result of this failure, Immediate Jeopardy was found to exist starting on 01/24/2018 and determined to be ongoing as of the exit date of 02/16/2018.

Findings:

Patient #4 was admitted on [DATE] with a history of chronic kidney disease stage IV and diabetes mellitus. His admitting diagnoses included generalized weakness, productive cough, fevers, abnormal electrolytes and worsening renal function. The patient had blood drawn for laboratory testing on 01/23/2018, and was reported back as Hepatitis B surface antigen, (HBsAg) positive on 01/24/2018. On 01/25/2018, the nurse misread the HBsAg positive result and documented that the result was negative. The patient had hemodialysis treatments on 01/23/2018, 01/24/2018, 01/25/2018 and 01/27/2018 and 01/30/2018. The Contracted Dialysis Company failed to follow processes for communicable diseases thereby subjecting 5 of 19 susceptible patients to potential Hepatitis B infections.

A review of the service agreement contract between the hospital and the Contracted Dialysis Company revealed that the company provided dialysis treatments. Page 10 of the contract read, "Quarterly audits will be performed by the Contracted Dialysis Company with quarterly reporting. Action plans to be submitted quarterly to the hospital leadership for any measures that are below established standards."

An interview with the Quality Systems Director/Lead Auditor on 02/16/2018 at 11:45 AM revealed that the QAPI committee met quarterly. The committee consisted of high leadership hospital staff including the Chief Nursing Officer and the Vice President of support services. She said that the Contracted Dialysis Company was discussed under contracted services annually and was on the agenda for the November 2018 QAPI meeting. She stated that the hospital Director of Dialysis Systems was responsible for the oversight of the Contracted Dialysis Company. There were quality indicators that the contracted company must meet to show that they are meeting performance standards. The Director of Dialysis Systems of was responsible for ensuring that the Contracted Dialysis Company was submitting these quarterly reports. She stated that the company did not have any measures below the established standards. When she was questioned as to whether they expected the Contracted Dialysis Company to report measures that were below standards, she did not provide an answer. She stated that her group did random audits twice per year and had conducted a random audit of a dialysis treatment being performed but could not provide any documentation of the audit. She stated that the Contracted Dialysis Company had been providing services since 2009 and had not had any past quality deficiencies. When she was questioned as to how they validated this, she stated that the Director of Dialysis Systems could provide validation.

An interview with the Director of Dialysis Systems on 02/16/2018 at 1:00 PM revealed that he was responsible for the oversight of the services provided by the Contracted Dialysis Company. He stated that he received results of the Quarterly Performance Indicators from the company including monthly water cultures, annual lab results of all dialysis machines, delays in service and any issues with nurses or physicians. When asked if he did any independent audits to verify that the results were factual, he stated, no. He could not provide any evidence of monitoring regarding patient safety such as infection control or any observational audits to ensure that dialysis treatments were being done according to standards. He stated that the Contracted Dialysis Company conducted their own auditing and monitoring. He stated that he validated nursing competencies but could not provide any documentation. When he was questioned about any concerns with the Contracted Dialysis Company, he said there were problems with the staff not wearing proper personal protective equipment (PPE) and delays in treatment but he could not provide any evidence of any corrective action plan. When he was questioned as to how care and services provided by the Contracted Dialysis Company were monitored, he stated it would have been, "good to do our own checks and audits."
VIOLATION: INFECTION CONTROL Tag No: A0747
Based on interview, record review, and a review of both hospital documentation and hospital contractor documentation, the hospital failed to ensure that policies governing the control of infections and communicable diseases in the form of Hepatitis B transmission through hemodialysis were followed with one Hepatitis B Surface Antigen (HBsAg) positive patient (#4), thus potentially exposing to Hepatitis B five other patients who were susceptible to Hepatitis B infections (#11, #14, #16, #18 & #19,) out of a sample of 19 patients (#1-19). Immediate Jeopardy was determined to exist from 1/24/18 to the present. The administrator of the hospital was notified of Immediate Jeopardy on February 16, 2018 at 5:05 PM.

Findings:

Registered Nurses (RN) B, F and G were employed by the contracted dialysis company with the hospital to perform dialysis on patients in their hospital. These nurse failed to follow contractor policies, hospital policies, and the contract provisions between the contractor and the hospital which governed steps to be taken upon the review of laboratory results concerning a patient #4's Hepatitis B Surface Antigen (HBsAg) status.

The policies or policy-referenced documents that were in violation are as follows: (1) "Infection Control and Hepatitis Policy" (contractor); (2) "Internal Disinfection of the Dialysis Machine" (contractor); (3) "Care of the HD Patient on Isolation Precautions (contractor); and (4) "Isolation Precautions for Selected Infections and Procedures" (Florida Hospital Altamonte). This immediately preceding policy referenced (5) "2007 Guidelines for Isolation Precautions: Preventing the Transmission of Infectious Agents in Healthcare Settings", which, in turn, referenced (6) "Recommendations for Preventing Transmission of Infections Among Chronic Hemodialysis Patients."

The preceding policies, referenced documents and contract requirements require that if a patient's HBsAg status is unknown, or if laboratory results reveal that the patient is HBsAg positive, protective measures must be taken to help limit the prospects of Hepatitis B being transmitted to other patients who might follow the HBsAg positive patient. The preventive measures involve the immediate performance of a post-dialysis treatment internal disinfection of a dialysis machine used by a HBsAg positive patient or by a patient with an unknown HBsAg status. The preventive measures require that the dialysis treatment for such a patient either be performed in an area dedicated solely to HBsAg positive patients or that the room in which a treatment on a HBsAg positive treatment was performed receive a terminal cleaning before it is used by a patient who may be susceptible to a Hepatitis B infection. A terminal cleaning involves the use of approved disinfectant cleaning products on all accessible surfaces in the room. "Patients admitted to hospital rooms that previously were occupied by patients infected or colonized with such pathogens are at increased risk of infection from contaminated environmental surfaces and bedside equipment if they have not been cleaned and disinfected adequately." (cdc.gov). The methods, thoroughness, and frequency of cleaning and the products used are determined by hospital policy. There was no evidence that patient #4's HBsAg results or pending status had been reviewed and acted upon for three successive treatments on 1/24/18, 1/25/18 and 1/27/18, either with regards to post-treatment internal cleaning, the selection of the site or room for dialysis treatment, or the terminal cleaning of a room prior to its use by patients who would be susceptible to being infected by Hepatitis B.

Based on clinical record review and the "Machine Log Book", which documented dialysis machine use, contractor RN F performed dialysis on patient #4 on 1/24/18, and did not internally disinfect the machine prior to its use with four subsequent patients, one of whom one was susceptible to Hepatitis B, patient #11.

Based on clinical record review and the "Machine Log Book" which documented dialysis machine use, contractor RN B performed dialysis on patient #4 on 1/25/18, and did not terminally clean the room prior to its use with patients #14 and #16, whom were susceptible to Hepatitis B.

Based on clinical record review and the "Machine Log Book", which documented dialysis machine use, contractor RN G performed dialysis on patient #4 on 1/27/18 and did not internally clean the machine prior to its use with two susceptible to Hepatitis B patients, #18 and #19.

The lack of compliance with the joint contract between dialysis contractor and the hospital established policies and the documentation referenced in policies covering actions to be taken with respect to the HBsAg status of patients resulted in five patients, #11, #14, #15, #18, and #19 who were susceptible to a Hepatitis B infection being exposed to Hepatitis B.
VIOLATION: INFECTION CONTROL OFFICER(S) Tag No: A0748
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**

Based on interview, record review and a review of hospital and contractor documentation, the hospital failed to implement infections control and communicable disease policies for Hepatitis B transmission through hemodialysis from one Hepatitis B Surface Antigen positive patient (#4) to five patients who were susceptible to Hepatitis B infections (#11, #14, #16, #18 & #19) out of a sample of nineteen patients (#1-19).

Findings:

A review of the medical record of patient #4 was performed. The patient was admitted on [DATE] at 6:21 PM, through the emergency room . He had a medical history that included chronic kidney disease stage IV, hypertension and diabetes mellitus. He was admitted to the hospital for generalized weakness, cough, sputum production, fevers, abnormal electrolytes and a worsening renal function. He had laboratory blood work performed on 1/23/18. Staff became fully aware of the results on 1/30/18, which indicated that he was Hepatitis B Surface Antigen positive. This finding means that he was at a risk of transmitting Hepatitis B to others.

The physician ordered dialysis treatments on a one time basis for each of the following days: 1/23/18,1/24/18, 1/25/18, 1/27/18 and 1/30/18. The treatments were performed by Registered Nurses (RN) of the contracted dialysis company with the hospital to perform dialysis treatments.

According to the Centers for Disease Control and Prevention (CDC), susceptibility to exposure to Hepatitis B requires that a patient have an Hepatitis B surface anti-body (anti-HBs) result of less than 10 milli-international units per milliliter (MIU/ML). This would generally be found in patients who have never been vaccinated or exposed to Hepatitis B. If a patient has a score of greater than or equal to 10 MLIU/ML, they would be considered immune. Such a score could result from a past vaccination against Hepatitis B or past exposure. This test is performed annually, or more frequently if someone has been recently vaccinated. Regarding HBsAg testing, this is usually performed on a monthly basis to see if a patient has converted and turned positive. If a patient has turned positive, there is an increased risk of transmission of Hepatitis B.

The document "Recommendation for Preventing Transmission of Infections Among Chronic Hemodialysis Patients", published by the CDC (4/27/01) indicates in "Table 1: Interpretation of serologic test results for hepatitis B virus infection" that if results of the antiHBs is greater than or equal to 10 MIU/ML, the patient is immune to Hepatitis B infection. Thus, if the results were less that 10 MIU/ML, the person would be susceptible. This document also read, "The presence of HBsAG is indicative of ongoing HBV infection and potential infectiousness." These conclusions on serologic test results for Hepatitis B were confirmed during an interview of the hospital's Infection Prevention on 2/02/18 at approximately 11 AM.

The "Patient Log Book" and "Machine Log Book" documentation revealed that patient #4 underwent the ordered dialysis treatment in the facility as described in the following. Dialysis treatments took place in either room 3702, which has two stations, in room 3704, a one bed room, or in the patient's room. During an interview of the Chief Nursing Officer for the contractor company on 2/01/18 at 10:45 AM, she confirmed that no part of room 3702 had been designated as an isolation area while it was used by patient #4 during his treatments and that 3704 customarily has only one station.

Orders for hepatitis blood work for 1/23/18 at 10:12 AM for patient #4 read "Hepatitis Panel".

The "Patient Log Book" indicated on 1/23/18 at 7:55 PM, patient #4 was placed on machine 127 in room 3702, a two station room, by RN H. The treatment record, the "Patient Care Plan Summary Sheet", started on 1/23/18 at 7:55 PM, per the "Patient Log Book" read, "Hepatitis status: drawn 1-23-18." The medical record did not reveal any HBsAg positive status at this point. The investigation revealed that there was no risk to other patients with respect to patient #4's treatment on 1/23/18.

The "Patient Log Book" indicated on 1/24/18 at 8:30 AM, patient #4 began dialysis treatment when he was placed on a dialysis machine by RN F. A review of the pre-treatment sheet for 1/24/18 revealed that patient #4 was placed in room 3404, a one station room. This was the only time during the patient's treatments that he used machine 70.

The treatment sheet "Patient Care Plan Summary Sheet", used by the contracted dialysis company for consecutive patient dialysis treatments, was reviewed. This document covered all days of patient #4's dialysis treatment. Although it had a "positive" indication next to the previously quoted text concerning "Hepatitis status," this "positive" statement was not signed, timed or dated. The "positive" determination did not become actively known to contracted company nurses until 1/30/18. The conclusion that the "positive" statement was added on 1/30/18 was confirmed during an interview of the Chief Nursing Officer of the contracted company on 2/01/18 at 12:57 PM. At that time, she stated that this "positive" notation was added on 1/30/18, the first day of the survey. The medical record did not reveal anything else regarding this matter.

The "Machine Log Book" indicated on 1/24/18, machine 70 did not receive internal disinfection immediately after this treatment session, a task which is necessary where a patient's Hepatitis B Surface Antigen status is unknown or known to be positive. Patient #11, susceptible to Hepatitis B infection, was later placed on this machine on 1/24/18 at 1:30 PM, 1/25/18 at 7 PM, 1/25/18 at 3:40 PM and 1/25/18 at 10 AM, respectively, and was at risk for being exposed to Hepatitis B. The "Machine Log Book" revealed that machine 70 eventually received internal cleaning which would have eliminated risk of Hepatitis B transmission on 1/26/18 in the morning, prior to the first treatment of the day. This cleaning was two days later, thus exposing patient #11 to Hepatitis B.

A review was performed of untitled contracted dialysis company documentation which was created after the survey had started. It drew together and summarized information from the "Machine Log Book" and "Patient Log Book" concerning the use of dialysis machines and rooms after they had been used by patient #4. This "summary document" was found to correctly correspond with the source log book documents. It showed that patient #11 used machine 70 after 1/24/18 at 11 AM, the time when patient #4's treatment ended, per the "Patient Log", through the last treatment on 1/25/18. Machine 70 was internally disinfected on 1/26/18, the first thing in the morning. Patient #11 also used machine 70 in the above mentioned time interval and was at risk for exposure to Hepatitis B. Being susceptible, this placed patient #11 at a risk for later development of Hepatitis B. Aside from using the same machine, any patient who was in the same room, 3704, from 1/24/18 at 8:30 AM to the time of its next terminal cleaning, would also have been at risk for exposure. The next terminal cleaning was revealed in Environmental Services documentation to have taken place in room 3702 on 1/24/18 at the end of the day. A terminal cleaning involves the use of approved disinfectant cleaning products on all accessible surfaces in the room. "Patients admitted to hospital rooms that previously were occupied by patients infected or colonized with such pathogens are at increased risk of infection from contaminated environmental surfaces and bedside equipment if they have not been cleaned and disinfected adequately." (cdc.gov).

Patient #4's result of the Hepatitis Panel laboratory blood work was reported on 1/24/18 at 11:11 AM. This was after the patient's treatment time of 8:30 AM on that day. The results indicated that the patient was "Hep B Surf Ag: reactive." Therefore, he was HBsAg positive and a definite risk for transmitting Hepatitis B to other patients. The copy of these results had a print date of 1/25/18 at 6:55 AM. Thus, the contracted dialysis company staff should have been aware of the HBsAg positive results at least by this print date. The results were available and accessible on 1/24/18 at 11:11 AM.

The "Patient Log Book" indicated on 1/25/18 at 7:30 AM, patient #4 was placed on machine 134 in room 3702, a two station room, by RN B. The treatment sheet, which covered all days of the patient's treatment, indicated no change from the unknown HBsAg status. The "Machine Log Book" indicated on 1/25/18, this machine did not receive internal cleaning immediately after this treatment session. If an patients had later been placed on machine 134 on 1/25/18, they would have been at risk for being exposed to Hepatitis B. However, no other patients used this machine on 1/25/18. The "Machine Log Book" revealed that machine 134 received internal cleaning on 1/26/18 in the morning, prior to the first treatment of the day.

Aside from using the same machine as patient #4, any patient who was in the same room, 3702, from 1/25/18 at 7:30 AM to the time of its next terminal cleaning at the end of the day would also have been at risk for exposure. The next terminal cleaning was revealed in Environmental Services documentation to have taken place in room 3702 on 1/25/18 at the end of the day. A review of contracted dialysis company documentation which summarized the performance of dialysis in rooms after they had been used by patient #4 revealed that two patients, #14 and #16, who were susceptible to Hepatitis infection, received dialysis treatment in room 3702 on 1/25/18 after patient #4 received his dialysis treatment. These patients, #14 and #16, were at risk for exposure to Hepatitis B.

During an interview of B-RN on 2/16/18 at 2:05 PM, she stated that before placing patient #4 on the dialysis machine, she checked the computer for HBsAg results and saw a notation that said "pending." She also stated that prior to taking #4 off of the machine, she checked the computer again and thought she saw that the HBsAg results had changed to "negative," or non-reactive. However, she stated that she learned on 1/30/18 that she had actually been looking at results for Hepatitis C. During an additional interview on 2/16/18 at 3:09 PM, she stated that when she had erroneously noted a negative HBsAg result, she circled a pre-printed "non-reactive" notation on the laboratory test results sheet which she had printed. In addition, she wrote "(neg)" next to "hepatitis status" on the "Patient Care Plan Summary Sheet." During an interview of B-RN on 2/16/18 at 2:05 PM, she confirmed that she did not internally disinfect the dialysis machine after patient #4 had used it, based on her understanding that the patient had been found to be HBsAg negative. She also stated that it was her understanding that any patient who had an unknown HBsAg status or a HBsAg positive status could be placed on a dialysis machine in the same room as other patients, irrespective of their HBsAg status, if they were at least three feet away from them. In addition, when such a patient finished their treatment, the area of the room which had been used by the patient would have an extensive cleaning of surfaces.

The "Machine Log Book" indicated on Friday 1/26/18, machine 134 was internally cleaned prior to the first treatment of the day.

The "Patient Log Book" indicated on 1/27/18 at 11:50 AM, patient #4 was placed on machine 95 in his own room by RN G. The treatment sheet, which covered all days of the patient's treatment, indicated no changes regarding the patient's HBsAg status. The "Machine Log Book" indicated on 1/27/18, this machine did not receive internal cleaning after this treatment session. Thus, patients who were later placed on this machine were at risk for being exposed to Hepatitis B.

A review of contracted dialysis company documentation which summarized the use of dialysis machines after they had been used on patient #4 revealed that patients #18 and #19, susceptible to Hepatitis B infection, used machine 95 after 1/27/18 at 3:15 PM, the time when patient #4's treatment ended, per the Patient Log, through patient #4's next treatment on 1/30/18 at 1:00 PM. The "Machine Log Book" revealed that machine 95 received internal cleaning at 4:00 PM on 1/30/18 which would have eliminated risk after his treatment on that day. Thus, these patients, #18 and #19, were also at risk for exposure to Hepatitis B. During an interview of RN G on 2/16/18 at 2:49 PM, he stated that before placing patient #4 on the dialysis machine, he saw on the pre-printed laboratory test results sheet that the words "non-reactive" had been circled. He stated that he had assumed this was a reference to HBsAG, but he had later learned, on 1/30/18, that it concerned Hepatitis C. He stated that he had also saw the "neg" circled on the "Patient Care Plan Summary Sheet." He stated that in light of these notations he presumed the patient was HBsAg negative and acted accordingly with the patient's treatment. He confirmed that he did not internally disinfect the dialysis machine after patient #4 had used it, based on his understanding that the patient had been found to be HBsAg negative. He confirmed that an internal disinfection is required immediately after the treatment of a patient with either a HBsAg unknown or positive status.

From 1/23/18 through 1/29/18, patient #4's medical record did not contain evidence of nurse awareness of the patient having a HBsAg positive status, as reported on 1/24/18.

On 1/31/18 at 4:22 PM, the Director of Nursing for the contracted dialysis company stated that they became aware of the patient's HBsAg positive status on 1/30/18, prior to his scheduled treatment for that day. This was the day in which the complaint investigation had started.

Patient #14 and patient #16 had an increased risk due to having been in the same room as patient #4 after he had received a dialysis treatment, but before terminal cleaning of the room. They had treatments on 1/ 25/18 at 7:10 PM and 1/25/18 at 12:30 PM, respectively. Patients #11, #18 and #19 also had an increased risk for contracting Hepatitis B due to the parameters discussed above and that they had used the same machine as patient #4, after patient #4 had used it, and before it received internal cleaning. They had treatments on 1/ 25/18 at 7 PM, 1/29/18 at 2:50 PM, and 1/28/18 at 6 M, respectively

On 2/02/18 at 11 AM, the Director of Infection Prevention at Florida Hospital confirmed that patients #14, #16, #11, #18 and #19 were susceptible to Hepatitis B infection.

Based on record review, patient #14 was admitted on [DATE]. She had a medical history which included hypertension, hyperlipidemia, type 2 diabetes and end-stage renal disease on hemodialysis. She was admitted for generalized weakness and fatigue. She had laboratory results on 1/25/18. Her anti-HBs (Hepatitis B surface anti-body) results were less than 3.5 MLIU/ML, which was less than 10 MLIU/ML. Her HBsAg result was "nonreactive," and was susceptible to a Hepatitis B infection.

Based on record review, patient #16 was admitted on [DATE]. She had a medical history which included a recent urinary tract infection diagnosis and end-stage renal disease on hemodialysis. She was admitted to the hospital for a change in mental status. She had laboratory results on 1/20/18. Her HBsAg result was "nonreactive," and was susceptible to a Hepatitis B infection.

Based on record review, patient #11 was admitted on [DATE]. He had a medical history which included hypertension, chronic obstructive pulmonary disease and chronic kidney disease stage IV (severe) on hemodialysis. He was admitted to the facility for increased confusion. He had laboratory results on 1/19/18. His anti-HBs (Hepatitis B surface anti-body) results were less than 3.5 MLIU/ML, which was less than 10 MLIU/ML. His HBsAg result was "nonreactive," and was susceptible to a Hepatitis B infection.

Based on record review, patient #18 was admitted on [DATE]. She had a history which included hypertension and bladder cancer. She was admitted to the hospital with a sepsis diagnosis and began dialysis while in the facility. She had laboratory results on 1/28/18. Her HBsAg result was "nonreactive," and was susceptible to a Hepatitis B infection.

Based on record review, patient #19 was admitted on [DATE]. He had a history of hypertension, end stage renal disease on hemodialysis and coronary artery disease. He was admitted for a low hemoglobin. He had laboratory results on file from 1/04/18. His anti-HBs (Hepatitis B surface anti-body) results were less than 3.5 MLIU/ML, which was less than 10 MLIU/ML. His HBsAg result was "nonreactive," and was susceptible to a Hepatitis B infection.

During an interview of the Director of Environmental Services on 2/1/18 at 11:19 AM, he stated that the documentation presented regarding the performance of cleaning in room 3702 and 3204 reflected terminal cleaning. He stated that all surfaces in the rooms were cleaned with Perisept Disinfectant Cleaner. The suitability of this cleaner was confirmed through a review of documentation from the manufacturer. Manufacturer documentation titled "Perisept Sporicidal Disinfectant Cleaner" read, "Perisept Sporicidal Disinfectant Cleaner is considered a High Level Disinfectant." This document's "Table 1" indicated that Hepatitis B virus requires "Low Level Disinfection," at a minimum. In a table titled "Efficacy Data," it indicated that Hepatitis B virus can be eliminated with use of the product.

According to the CDC, a patient with a HBsAg positive status, either undiscovered or ultimately revealed in laboratory testing results, has an increased risk of transmitting Hepatitis B to other patients who are not HBsAg positive, and are thus susceptible to a Hepatitis B infection, if certain key actions are not taken. This increased propensity for disease transmission would arise specifically if a HBsAg positive patient continued with dialysis on machines that are subsequently shared with patients who are susceptible to Hepatitis B infections, if there is no performance on those involved machines of more extensive cleaning after each use by the HBsAg positive patient. The increased propensity for Hepatitis B transmission would also arise if a HBsAg positive patient used the same rooms for treatment as patients who are susceptible to Hepatitis B infection, where a sufficient distance is not maintained between the dialysis machine used by the HBsAg positive patient and machines used by patients who are not HBsAg positive. In addition to distance concerns in treating HBsAg positive patients, there would be an increased risk for transmission if the area used by an HBsAg patient is not designated solely for use by such patients, at least until the performance of a terminal cleaning at a degree which would address all vulnerable surfaces. Nearby surfaces pose a significant risk to being exposed to blood from dialysis patients. The document "Recommendations for Preventing Transmission of Infections Among Chronic Hemodialysis Patients", from the Centers for Disease Control and Prevention read: "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." If staff members can be exposed to blood, so can nearby surfaces. This document also read, "To isolate HBsAg-positive patients, designate a separate room for their treatment and dedicate machines, equipment, instruments, supplies, and medications that will not be used by HBV-susceptible patients....HBsAg-positive patients should be separated from HBV-susceptible patients in an area removed from the mainstream of activity and should undergo dialysis on dedicated machines."

A review of the contracted dialysis company's policy "Infection Control and Hepatitis Policy" read, "Hepatitis B Surface Antigen Positive Patient: If testing indicates the patient is hepatitis B surface antigen (HBsAg) positive, the patient will be considered potentially infectious and cared for using strict isolation measures." Thus, if a patient has HBsAg positive results, the patient cannot be treated in the same room as other patients who may be susceptible. The contracted dialysis company was not in compliance with their own policy.

Contracted dialysis company's "Internal Disinfection of the Dialysis Machine" policy read, "It is the policy of (contractor company name) to disinfect the single pass dialysis machine internally between patients in the following circumstance....Patient known to be Hepatitis B positive." The contracted dialysis company was not in compliance with their own policy.

The contracted dialysis company's policy "Care of the HD Patient on Isolation Precautions" read, "Guidelines and precautions for the dialysis of an HBsAg positive patient....The dialysis machine will be terminally disinfected using the bleach cycle...." On 2/01/18 at 2:52 PM, the Chief Nursing Officer for the contracted dialysis company she stated that a bleach treatment is expected on machines after use by a HBsAg positive patient. The above mentioned requirement of internal disinfection of dialysis machines was not performed immediately after the patient #4's treatments or prior to their use on other patients on: 1/24/18, which exposed susceptible patient #11, on 1/25/18 and 1/27/18, which exposed susceptible patients #18 and #19. The contracted dialysis company was in violation of their own policy. There were instances where internal disinfection was not done after patient #4's dialysis treatment.

Contracted dialysis company policy "Care of the HD Patient on Isolation Precautions" read, "Guidelines and precautions for the dialysis of an HBsAg positive patient: Dialyze these patients in their own room or at the end of the day in a dialysis room by themselves. If a dialysis room is used, environmental services will need to be notified to terminally clean the room prior to any other patient being dialyzed in it. Leave the contact isolation sign hanging to show that the room needs to be terminally cleaned." The expectation for a patient who is HBsAg positive to not be treated in the presence of a susceptible patient was not followed. The contractor company was in violation of their policy.

The contracted dialysis company's policy "Infection Control and Hepatitis Policy" discussed Hepatitis B Serological Testing. It read, "Hepatitis B surface antigen (HBsAg) testing will be performed before or with the first treatment. These patients will be treated as unknown status until the results are received." This policy confirms the expectation that patient #4 should have been treated as a potential HBsAg patient from the time of his first treatment to the time in which staff actively became aware of him having HBsAg positive status.

The hospital's policy "Isolation Precautions for Selected Infections and Procedures" read, "Infection/Condition: Type B - HbsAg positive acute or chronic... See specific recommendations for care of patients in hemodialysis centers." Regarding these "specific recommendations", this document had references at the end for two CDC sources. The first one, "2007 Guidelines for Isolation Precautions: Preventing the Transmission of Infectious Agents in Healthcare Settings" lead to the following document: "Recommendations for Preventing Transmission of Infections Among Chronic Hemodialysis Patients." It read, "HBV is transmitted by percutaneous (i.e., puncture through the skin) or permucosal (i.e., direct contact with mucous membranes) exposure to infectious blood or body fluids that contain blood, and the chronically infected person is central to the epidemiology of HBV transmissions. All HBsAg-positive persons are infectious...HBV is relatively stable in the environment and remains viable for at least 7 days on environmental surfaces at room temperature. HBsAg has been detected in dialysis centers on clamps, scissors, dialysis machine control knobs, and doorknobs. Thus, blood-contaminated surfaces that are not routinely cleaned and disinfected represent a reservoir for HBV transmission....Once the factors that promote HBV transmission among hemodialysis patients were identified, recommendations for control were published in 1977. These recommendations included....isolation of HBsAg positive patients in a separate room....assignment of dialysis equipment to HBsAg-positive patients that is not shared by HBV-susceptible patients....The hemodialysis machine and its components also can be vehicles for patient-to-patient transmissions of blood borne viruses and pathogenic bacteria. The external surfaces of the machine are the most likely sources for contamination...Published methods should be used to clean and disinfect the water treatment and distribution system and the internal circuits of the dialysis machine....These methods....will also eliminate blood borne viruses....However, when chronic hemodialysis patients receive maintenance hemodialysis while hospitalized , infection control precautions specifically designed for chronic hemodialysis units... should be applied to these patients....Regardless of where in the acute-care chronic setting chronic hemodialysis patients receive dialysis, the HBsAg status of all such patients should be ascertained at the time of admission to the hospital....While hospitalized , HBsAg-positive chronic hemodialysis patients should undergo dialysis in a separate room....If a machine that has been used on an HBsAg-positive patient is needed for an HBV (Hepatitis B Virus)-susceptible patient, internal pathways of the machine can be disinfected using conventional protocols." The contracted dialysis company did not meet these expectations for patient isolation during treatment and internal cleaning of the machine after treatment on specific occasions.

A review of the facility's contract (10/6/17) read, "Vendor will follow the disinfection schedule....All dialysis machines that come in contact with patients that harbor hepatitis, blood borne MRSA (Methicillin-Resistant Staphylococcus Aureus) and other such diseases are bleached in between patients. All dialysis machines are bleached following any patients whose hepatitis profile is pending and not yet known." As indicated in prior text, the contractor company did not meet these expectations for internal cleaning of the machine after treatment on specific occasions.

During an interview of the Risk Manager on 2/02/18 at approximately 1:20 PM, she confirmed the findings.

"Hepatitis B FAQs (frequently asked questions) for Health Professionals" by the CDC read, "HBV (Hepatitis B Virus) is transmitted through....contact with blood or open sores of an infected person.... HBV can survive outside the body at least 7 days and still be capable of causing infection.... Any blood spills - including dried blood, which can still be infectious - should be cleansed using 1:10 dilution of one part household bleach to 10 parts of water for disinfecting the area....The following populations are at increased risk of becoming infected with HBV....hemodialysis patients....Persons who should be screened for HBV...persons with end-stage renal disease (including hemodialysis patients)....The presence of HBsAg, a protein on the surface of HBV indicates that the person is infectious."

An unawareness at the outset by a contracted dialysis provider of any patient's HBsAg status, as was the case with patient #4, would have required, per the policies and contract provisions, that the patient commence dialysis treatments as a potential HBsAg positive patient. While in an unknown HBsAg status, a patient would be deemed as having a potential, but not yet confirmed, risk for transmitting Hepatitis B to other patients. As a result, Hepatitis B susceptible patients, who used the same machine that a patient with an unknown HBsAg status had used, and used the same machine before it had undergone any internal cleaning, would have a potential risk for exposure to Hepatitis B. Susceptible patients who had been treated in the same room as a patient with an unknown HBsAg status, concurrent with or after the time of the treatment of the patient with an unknown HBsAg status and before any terminal room cleaning, would also have a potential risk for exposure to Hepatitis B.