HospitalInspections.org

Based on observation, interview, review of documentation in 4 of 4 medical records of patients who received hemodialysis treatments (Patients 1, 2, 3 and 4), and review of policies and procedures, and other documents, it was determined that the Governing Body failed to ensure that contracted services were provided in a manner that ensured the safety and well-being of all patients and the hospital's compliance with the Conditions of Participation.

These failures substantially limit the capacity of the hospital to furnish care in a safe setting.

Findings include:

Refer to Tag A83, CFR 482.12(e), Contracted Services.

Based on observation, interview, review of documentation in 4 of 4 medical records of patients who received hemodialysis treatments (Patients 1, 2, 3 and 4), and review of policies and procedures, and other documents, it was determined that the Governing Body failed to ensure that contracted services were provided in a manner that ensured the safety and well-being of all patients.

Findings include:

Refer to Tag A747, CFR 482.42, Condition of Participation: Infection Control. Those findings reflect that contracted hemodialysis services were not provided in accordance with policies and procedures and resulted in potential and actual harm to three patients.

Based on observation, interview, review of documentation in 4 of 4 medical records of patients who received hemodialysis treatments (Patients 1, 2, 3 and 4), and review of policies and procedures, and other documents, it was determined the hospital failed to fully develop and implement policies and procedures for infection prevention in the following areas:
* For 4 of 4 patients (Patients 1, 2, 3 and 4), evaluation of hepatitis status, including hepatitis lab results; disinfection and management of hemodialysis equipment; and patient post-exposure management.
* Disinfection and cleaning processes and services throughout the hospital;
* Management of disinfectants and cleaning supplies in accordance with manufacturer instructions and expiration dates;
* Isolation precautions;
* Labeling of injectable medications;
* Management of multi-dose vials of injectable medications;
* Management of clean/sterile patient care supplies;
* Management of personal items in patient procedure rooms;
* Hand hygiene practices;
* Management of furniture and patient care equipment in cleanable and good repair.

These failures resulted in Patients 2, 3 and 4 being potentially exposed to hepatitis B when they received hemodialysis treatments from a contaminated hemodialysis machine; and Patient 2 sustained an infection as a result of a treatment administered at the hospital to address the potential exposure.

The findings identified during the survey reflect the hospital's limited capacity to provide care and services and represent a Condition-level deficiency of CFR 482.42, Condition of Participation: Infection Control.

These failures substantially limit the capacity of the hospital to furnish care in a safe setting.

Findings include:

Refer to Tag A749, CFR 482.42(a), Infection Control standard. Those findings reflect that contracted hemodialysis services were not provided in accordance with policies and procedures and resulted in potential and actual harm to three patients.

Based on observation, interview, review of documentation in 4 of 4 medical records of patients who received hemodialysis treatments (Patients 1, 2, 3 and 4), and review of policies and procedures, and other documents, it was determined the hospital failed to fully develop and implement policies and procedures for infection prevention in the following areas:
* For 4 of 4 patients (Patients 1, 2, 3 and 4), evaluation of hepatitis status, including hepatitis lab results; disinfection and management of hemodialysis equipment; and patient post-exposure management.
* Disinfection and cleaning processes and services throughout the hospital;
* Management of disinfectants and cleaning supplies in accordance with manufacturer instructions and expiration dates;
* Isolation precautions;
* Labeling of injectable medications;
* Management of multi-dose vials of injectable medications;
* Management of clean/sterile patient care supplies;
* Management of personal items in patient procedure rooms;
* Hand hygiene practices;
* Management of furniture and patient care equipment in cleanable and good repair.

These failures resulted in Patients 2, 3 and 4 being potentially exposed to hepatitis B when they received hemodialysis treatments from a contaminated hemodialysis machine; and Patient 2 sustained an infection as a result of a treatment administered at the hospital to address the potential exposure.

The findings identified during the survey reflect the hospital's limited capacity to provide care in a safe environment and represents a Condition-level deficiency at: CFR 482.42, Condition of Participation: Infection Control.

These failures substantially limit the capacity of the hospital to furnish care in a safe setting.

Findings included:

1.a. The policy and procedure titled "Infection Prevention & Control Program Description and Plan" date last revised "1/2014" reflected the following: "...Activities of the Infection Prevention & Control Program...Recommend risk reduction strategies using evidence-based practice guidelines to reduce and eliminate HAIs, which include helping to strategize creative ideas for...Reducing exposure to pathogens, ..Reducing the transmission of infection associated with procedures, equipment, devices, and supplies...Lead cluster and outbreak investigations and assist in management of prevention and control measures in collaboration with...Infectious Diseases, Quality & Patient Safety, Unit Leaders and other departments as necessary...Authorization and Responsibility of IP&C...The IP&C Program and the Infection Control Committee are authorized by Legacy Health Administration to...In collaboration with operational leadership, responsibilities include, but are not limited to...Review and approval of all policies and procedures related to infection surveillance, prevention and control activities in all departments and services...Promote system-wide policies related to infection control involving isolation guidelines and procedures, disinfection and sterilization, infectious waste management and employee health...Develop and improve surveillance systems and data collection to identify, analyze and report clusters and outbreaks of infections, sentinel events...and to detect situations requiring special studies or reports..."

b. An interview was conducted with the IP on 07/22/2016 at 1215. The IP stated the hospital had recently experienced a "Hep B cluster." The IP stated that Patient 1 was identified as positive for Hepatitis B while at the hospital and Patients 2, 3 and 4, were potentially exposed to Hepatitis B after using a dialysis machine that was not appropriately disinfected with bleach after it was used to provide dialysis treatments to Patient 1. The IP stated Patient 1's Hepatitis B status was unknown when he/she was admitted to the hospital. The IP stated that "hepatitis labs" were drawn and the patient started dialysis treatments. The IP stated that the patient's hepatitis labs results were not available when the patient had his/her first dialysis treatment and therefore the patient's Hepatitis B status was unknown. The IP stated the patient had a second dialysis treatment "two or three" days later, and during that treatment, the RN who was providing the treatment reviewed the patient's hepatitis lab results. The IP stated the RN misread the lab results and thought they indicated the patient was "non-reactive" when in fact the lab results indicated the patient was "reactive." The IP stated that "reactive" lab results meant the patient had chronic Hepatitis B and was therefore infectious. The IP stated that as a result of the RN misreading Patient 1's hepatitis lab results, the dialysis machine that was used for Patient 1's dialysis treatment was not sequestered and was not disinfected with bleach after it was used as it should have been. The IP stated the same dialysis machine was then used for Patients 2, 3, and 4 for their dialysis treatments before the hospital became aware that Patient 1 was infectious, and therefore those three patients were potentially exposed to Hepatitis B.

c. The "First Amendment to Acute Dialysis and Therapeutic Apheresis Services Agreement" between the hospital and Fresenius Medical Care North America dated effective 06/04/2012 reflected that the hospital had an agreement with Fresenius Medical Care for the provision of hemodialysis services as follows: "...Hospital hereby engages Provider as Hospital's primary provider of acute dialysis and apheresis treatments...Provider acknowledges the Services provided under this Agreement are subject to monitoring by Hospital for quality and safety in accordance with performance expectations as set forth under...Hospital policies and procedures...Provider and Hospital shall jointly and mutually develop a written protocol governing specific responsibilities and procedures to be used by Provider Staff in rendering services to Patients. Provider shall provide policies, procedures, and techniques pertaining to the methods by which the Services are rendered...Provider shall provide equipment necessary to render acute dialysis, and apheresis services pursuant to this Agreement, including, but not limited to, portable dialysis machines, water treatment and ancillary equipment...Services shall be performed by non-physician employees or contractors of Provider..."

d. On 07/22/2016 at 1250 the Assistant Manager of Critical Care stated that hemodialysis services were provided at the hospital by "Fresenius RNs." The manager stated the "Fresenius RNs" performed the entire dialysis procedure and were responsible for cleaning and disinfecting the machines after the treatment was completed.

e. During an interview on 07/22/2016 at 1450, the A&CC stated that the hospital had no dialysis policies and procedures and had adopted Fresenius' policies and procedures for the provision of dialysis services.

f. The adopted Fresenius policy and procedure titled "Hepatitis Policy" date last revised "25-SEP-2013" reflected the following: "The purpose of this document is to guide FMS Inpatient Services Staff in the assessment and care of patients with Hepatitis B...Each FMS Inpatient Service program will adopt, approve and implement the following Bloodborne Pathogens and Infection Control Policies pertaining to Hepatitis B...Dialzying Patients with Positive Hepatitis B Antigen (HBsAg+): refer to the entire policy with exception to the home dialysis patient...The Hepatitis status should be evaluated and documented on the patient's treatment record prior to each treatment...If the Hepatitis status is not available; work with the patients' attending physician to ensure the HBV status of all patients are obtained prior to or during the first treatment. If results are utilized from another setting, the HbsAg results must be within the last month, or Hepatitis B surface antibody (anti-HBs)> 10 mIU/mL within one year. The anti-HBc result can be resulted from any date...Chemically disinfect the dialysis machine post treatment on any known HBsAg positive patient, and any patient with unknown HBsAg status...All staff will have documented evidence of competency and proficiency in understanding Hepatitis B infection and isolation requirements for patients with unknown HBsAg and known positive HBsAg status..."

* The adopted Fresenius policy and procedure titled "Cleaning the Inpatient Mobile Device" effective date "23-DEC-2015" reflected the following: "Follow the steps to clean the mobile device...Perform hand hygiene and don PPE...Make sure the device is unplugged...Dampen a cloth or paper towel in 1:100 bleach solution. Ensure there is no excess bleach solution...Wipe the entire mobile device and cover...with the dampened cloth, including the on/off switch, buttons, etc as applicable...Allow the mobile device to air dry...Remove gloves and dispose in the appropriate container. Perform hand hygiene."

* The adopted Fresenius policy and procedure titled "Fresenius 2008K Machine: Acid Clean and Heat Disinfection" date last revised "18-AUG-2010" reflected the following: "...Complete the Acid Cleaning...as directed...start the Heat Disinfect program...When the heat disinfect cycle is complete, turn off RO, water source and dialysis machine...Document acid cleaning and heat disinfection on the Dialysis Machine Check Log."

* The adopted Fresenius policy and procedure titled "Cleaning and Disinfection" date last revised "28-JAN-2015" reflected the following: "The purpose of this policy is to provide guidelines to prevent the spread of infectious disease in accordance with appropriate regulations, and to maintain a clean, safe, and aesthetically pleasant environment for patients, staff, and visitors...After use, all equipment and supplies must be considered as potentially blood contaminated, and should be separated, handled with caution and either disinfected or discarded...Externally disinfect the dialysis machine with 1:100 bleach solutions after each dialysis treatment. Give special attention to cleaning control panels on the dialysis machines and other surfaces that are frequently touched and potentially contaminated...Internally disinfect the dialysis machine as outlined below or per manufactures (sic) guidelines...Heat disinfect after the last treatment each day the machine is used...Bleach disinfect each week (at least every seven (7) days). Bleach disinfection can replace heat disinfection. When a patient's hepatitis status is unknown, the machine must be externally and internally disinfected with bleach."

* The adopted Fresenius policy and procedure titled "Dialyzing Patient with Positive Hepatitis B Antigen (HBsAG+)" date last revised "20-MAR-2013" was reviewed. The purpose of the policy was "To prevent transmission of Hepatitis B." The policy reflected the following: "Patients should not be dialyzed without a known hepatitis status...Caring for HBsAg positive patients requires adherence to strict guidelines. The hepatitis B virus is highly infectious because the concentration of virus particles in the blood is very high and the hepatitis B virus can live outside the body on surfaces for at least 7 (seven) days. Outbreaks of hepatitis B have been linked directly to poor infection control practices...If there are current HBsAg positive patients on census...Then...Equipment cannot be used for HBV negative patients on other shifts or days due to the risk of cross contamination. Equipment used for HBsAg positive patients should be reserved for the HBsAg positive patient unless repair or maintenance is needed...When the machine is no longer dedicated to an HBsAg positive patient, internal pathways of the machine can be disinfected using conventional protocols, external surfaces cleaned and surface disinfected and the machine may be returned to general use...Internally disinfect the dialysis machine with heat disinfect...Special attention shall be given to cleaning control knobs on dialysis machines and other surfaces that are frequently touched and potentially contaminated with the patient's blood."

g. During a tour of the dialysis equipment storage room on 07/26/2016 at 1230 with the Fresenius In-Patient Services Manager and A&CC, an observation of dialysis machine was made. The machine had a label affixed to the front of it indicating it was machine # 1KOS167387. The observation reflected the machine was approximately four feet tall and had numerous parts on the front of it including a touch screen, touch key pad, a round pressure gauge, control knobs, and multiple attached tubings and hoses. One side of the machine had a metal wire basket attached to it with a blood pressure cuff inside it. The other side of the machine had an IV pole attached to it. Interview with the Fresenius In-Patient Services Manager at the time of the observation reflected the dialysis machines used at the hospital were portable and were taken to patient rooms to be used. He/she stated that two dialysis machines were kept at the hospital and used for patient hemodialysis treatments. He/she said one other dialysis machine would be brought to the hospital from another location if a patient's condition required their machine be sequestered. He/she stated the dialysis machines were kept in the dialysis storage room when they were not being used. The Fresenius In-Patient Services Manager stated the exterior of the machine was to be disinfected with bleach while the machine was still in the patient room after every time it was used.

h. The medical record of Patient 1 was reviewed. Hemodialysis machine disinfection records provided titled "Fresenius Medical Care Mobile Machine Disinfection Calendar" for May 2016 were also reviewed.

The medical record reflected the patient was admitted to the hospital on 04/24/2016 at 1337 with diagnoses including severe asthma exacerbation, heart failure, atrial fibrillation and left sided chest pain.

Lab records reflected a "Hepatitis Chronic Panel" was ordered on 05/10/2014 at 1414 and was collected on 05/10/2016 at 1810.

The "Hemodialysis" flowsheet documentation reflected the patient started a dialysis treatment on 05/10/2016 at 2035 and the treatment was completed at 2330. The dialysis machine used for the treatment was recorded as machine # "3kos185787." There was no documentation reflecting:
* That the patient's hepatitis status was known or evaluated.
* That the dialysis machine was internally disinfected.
* That the dialysis machine was externally disinfected.

The 05/10/2016 the disinfection records for dialysis machine #3KOS185787 reflected the following:
* "Heat" with a blank space after it.
* "Bleach/Diasafe" (circled) with initials after it.
There was no time recorded reflecting when the machine was bleach disinfected and it was unclear what the circled entry meant.
It was unclear whether the machine was internally or externally disinfected with bleach, or both.

Lab records reflected the final results of the "Hepatitis Chronic Panel" on 05/11/2016 at 1420, were "Abnormal," and the "Hepatitis BsAg" result was "Reactive (A)." During an interview with the Fresenius In-Patient Services Manager at the time of the record review, he/she confirmed the lab results reflected the patient was positive for Hepatitis B and was infectious.

The "Hemodialysis" flowsheet documentation reflected the patient started a dialysis treatment on 05/12/2016 at 1200. The dialysis machine used for the treatment was recorded machine # "3KOS185787." The date and time the treatment was completed was not recorded. There was no documentation reflecting:
* That the patient's hepatitis status was known or evaluated.
* That the dialysis machine was internally disinfected with respect to the patient's infectious condition.
* That the dialysis machine was externally disinfected.
* That the dialysis machine was sequestered.

The 05/12/2016 disinfection records for dialysis machine # 3KOS185787 were reviewed and reflected the following:
* "Heat" with an individual's initials after it.
* "Bleach/Diasafe" with a blank space after it.
There was no time recorded reflecting when the machine was heat disinfected.
There was no documentation that the machine was internally or externally disinfected with bleach.
There was no documentation that the machine was sequestered.

The 05/13/2016 disinfection records for dialysis machine #3KOS185787 reflected the following:
* "Heat" with initials after it.
* "Bleach/Diasafe" with a blank space after it.
There was no time recorded reflecting when the machine was heat disinfected.
There was no documentation that the machine was internally or externally disinfected with bleach.
There was no documentation that the machine was sequestered.

The 05/14/2016 disinfection records for dialysis machine #3KOS185787 reflected the following:
* "Heat" with a blank space after it.
* "Bleach/Diasafe" with a blank space after it.
There was no documentation that the machine was internally or externally disinfected.
There was no documentation that the machine was sequestered.

The "Hemodialysis" flowsheet documentation reflected the patient started a dialysis treatment on 05/14/2016 at 2330. The dialysis machine used for the treatment was recorded machine # "3kos185787." The flowsheet reflected the treatment was completed on 05/15/2016 at 0320. There was no documentation reflecting:
* That the patient's hepatitis status was known or evaluated.
* That the dialysis machine was internally disinfected.
* That the dialysis machine was externally disinfected.
* That the dialysis machine was sequestered.

The 05/15/2016 disinfection records for dialysis machine #3KOS185787 reflected the following:
* "Heat" with a blank space after it.
* "Bleach/Diasafe" with an individual's initials after it.
This was the first documentation that reflected the machine was disinfected with bleach after the patient's hepatitis lab results on 05/11/2016 indicating he/she was infectious. However, there was no time recorded to reflect when the machine was bleach disinfected and it was unclear whether the machine was internally or externally disinfected with bleach, or both. In addition, there was no documentation that the machine was sequestered

The "Hemodialysis" flowsheet documentation reflected the patient started a dialysis treatment on 05/16/2016 at 0927. The dialysis machine used for the treatment was recorded machine # "3KOS185787." The date and time the treatment was completed was not recorded. There was no documentation reflecting the following:
* That the patient's hepatitis status was known or evaluated.
* That the dialysis machine was internally disinfected.
* That the dialysis machine was externally disinfected.
* That the dialysis machine was sequestered.

The 05/16/2016 the disinfection records for dialysis machine #3KOS185787 reflected the following:
* "Heat" with an individual's initials next to it.
* "Bleach/Diasafe" with a blank space after it.
There was no time recorded reflecting when the machine was heat disinfected.
There was no documentation that the machine was internally or externally disinfected with bleach.
There was no documentation that the machine was sequestered.

The "FMS Inpatient Services Dialysis Treatment Summary" documentation reflected the patient started a dialysis treatment on 05/18/2016 at 0920. The dialysis machine # was recorded "3k185787." The "Intra Procedure Vitals" section reflected "Tx started. Unable to run HD due to arterial pressure." The "Hep Status" section reflected the result of the "HBsAG" lab with draw date 05/10/2016 was "Positive." However, the "Machine Disinfection Requirement" section reflected "HBsAG+ machine bleached and isolated per policy" followed by "No." The "Hep B Status Unknown (HBsAG unknown and Antibody Neg or Unknown) machine bleached per policy" section was followed by "No." The documentation reflected the treatment was completed at 0922.
There was no documentation reflecting:
* That the dialysis machine was internally disinfected.
* That the dialysis machine was externally disinfected.
* That the dialysis machine was sequestered.
In addition, the evaluation of the patient's hepatitis status and lab results was unclear.

The "FMS Inpatient Services Dialysis Treatment Summary" documentation reflected a second dialysis treatment was started on 05/18/2016 at 1622. The dialysis machine # was recorded "3k185787." The "Hep Status" section reflected the result of the "HBsAG" lab with draw date 05/10/2016 was "Positive." However, the "Machine Disinfection Requirement" section reflected "HBsAG+ machine bleached and isolated per policy" followed by "No." The "Hep B Status Unknown (HBsAG unknown and Antibody Neg or Unknown) machine bleached per policy" section was followed by "No."
The documentation reflected the treatment was completed at 0922.
There was no documentation reflecting:
* That the dialysis machine was internally disinfected.
* That the dialysis machine was externally disinfected.
* That the dialysis machine was sequestered.
In addition, the evaluation of the patient's hepatitis status and lab results was unclear.

The 05/18/2016 disinfection records for dialysis machine #3KOS185787 reflected the following:
* "Heat" with an individual's initials after it.
* "Bleach/Diasafe" with a blank space after it.
There was no time recorded reflecting when the machine was heat disinfected.
There was no documentation that the machine was internally or externally disinfected with bleach.
There was no documentation that the machine was sequestered.

The 05/19/2016 disinfection records for dialysis machine #3KOS185787 reflected the following:
* "Heat" with a blank space after it.
* "Bleach/Diasafe" with a blank space after it.
There was no documentation that the machine was internally or externally disinfected.
There was no documentation that the machine was sequestered.

The 05/20/2016 "Hemodialysis" flowsheet at 1200 reflected "...Therapy Delivered...ICU Hemodialysis...Treatment status...Other (Comment)...Hemodialysis Intake...300" The time the treatment was started was not recorded. The machine # was not recorded. Numerous areas on the flowsheet were blank including but not limited to the following:
* "Gross Bleach Negative"
* "Machine #"
* "Machine log complete"
* "RO log complete"
* "Alarms verified"
* "Machine Temperature"
* "Dialyzer"
* "Access Visible"
* "Arteriovenous Lines Secure"
* "Reversed"
* "Blood Flow Rate (ml/min)"
* "Dialysate Flow Rate (ml/min)"
* "Net Hemodialysis"
* "Hemodialysis Output (ml)"
* "Treatment DC/Dialzer appearance"
The flowsheet reflected the treatment was completed at 1300.
There was no documentation reflecting:
* That the patient's hepatitis status was known or evaluated.
* That the dialysis machine was internally disinfected.
* That the dialysis machine was externally disinfected.
* That the dialysis machine was sequestered.

The 05/20/2016 and 05/21/2016 disinfection records for dialysis machine #3KOS185787 reflected the following:
* "Heat" with a blank space after it.
* "Bleach/Diasafe" with a blank space after it.
There was no documentation that the machine was internally or externally disinfected.
There was no documentation that the machine was sequestered.

The "Hemodialysis" flowsheet documentation reflected the patient started a dialysis treatment on 05/22/2016 at 1721. The dialysis machine used for the treatment was recorded machine # "3kos185787." The date and time the treatment was completed was not recorded.
There was no documentation reflecting:
* That the patient's hepatitis status was known or evaluated.
* That the dialysis machine was internally disinfected.
* That the dialysis machine was externally disinfected.
* That the dialysis machine was sequestered.

The 05/22/2016 disinfection records for dialysis machine #3KOS185787 reflected the following:
* "Heat" with a blank space after it.
* "Bleach/Diasafe" with an individual's initials after it.
There was no time recorded reflecting when the machine was bleach disinfected.
It was unclear whether the machine was internally or externally disinfected with bleach, or both.
There was no documentation that the machine was sequestered.

The "Hemodialysis" flowsheet documentation reflected the patient "Started" a dialysis treatment on 05/23/2016 at 1433. Another entry at 1440 reflected "HDTX initiated." The dialysis machine was recorded machine # "3kos185787." The flowsheet reflected the treatment was "terminated" at 1800.

The 05/23/2016 disinfection records for dialysis machine # 3KOS185787 were reviewed and reflected the following:
* "Heat" with a blank space after it.
* "Bleach/Diasafe" with an individual's initials after it.
There was no time recorded reflecting when the machine was bleach disinfected.
It was unclear whether the machine was internally or externally disinfected with bleach, or both.
There was no documentation that the machine was sequestered.

The "Hemodialysis" flowsheet documentation reflected the patient "Started" a dialysis treatment on 05/25/2016 at 1430. The dialysis machine # was recorded "3KOS185787." The flowsheet reflected the treatment was completed at 1800.
There was no documentation reflecting:
* That the patient's hepatitis status was known or evaluated.
* That the dialysis machine was internally disinfected.
* That the dialysis machine was externally disinfected.
* That the dialysis machine was sequestered.

The 05/25/2016 disinfection records for dialysis machine # 3KOS185787 reflected the following:
* "Heat" with a blank space after it.
* "Bleach/Diasafe" with an individual's initials after it.
There was no time recorded reflecting when the machine was bleach disinfected.
It was unclear whether the machine was internally or externally disinfected with bleach, or both.
There was no documentation that the machine was sequestered.

The "Hemodialysis" flowsheet documentation reflected the patient "Started" a dialysis treatment on 05/27/2016 at 1255. The dialysis machine # was recorded "3KOS185787." The flowsheet reflected the treatment was completed at 1320.
There was no documentation reflecting:
* That the patient's hepatitis status was known or evaluated.
* That the dialysis machine was internally disinfected.
* That the dialysis machine was externally disinfected.
* That the dialysis machine was sequestered.

The 05/27/2016 disinfection records for dialysis machine # 3KOS185787 reflected only the following:
* "Heat" with a blank space after it.
* "Bleach/Diasafe" with an individual's initials after it.
There was no time recorded reflecting when the machine was bleach disinfected.
It was unclear whether the machine was internally or externally disinfected with bleach, or both.
There was no documentation that the machine was sequestered.

The undated physician discharge summary was reviewed and reflected the following: "...Hepatitis B - Surface antigen positive X 2, hep B core antibody reactive, surface antibody negative. Suspect chronic infection. Not treated while inpatient." The discharge summary reflected the patient expired on 05/28/2016.

i. The medical record of Patient 2 was reviewed. Hemodialysis machine disinfection records provided titled "Fresenius Medical Care Mobile Machine Disinfection Calendar" for May 2016 were also reviewed.

The medical record reflected the patient was admitted to the hospital on 05/01/2016 at 2254 with diagnoses including acute kidney failure and urticaria.

Lab records reflected the final result of a "Hepatitis BsAg" lab was "Non React" on 05/02/2016 at 1404.

The "Hemodialysis" flowsheet documentation reflected the patient started a dialysis treatment on 05/04/2016 at 2000. The dialysis machine used for the treatment was recorded machine # "1kos167387." The date and time the treatment was completed was not recorded. The "Post-Hemodialysis Assessment" section was blank including but not limited to the following areas:
* "Treatment DC/Dialyzer appearance"
* "Duration of Treatment (hours)"
* "Patient response to Treatment"
There was no documentation reflecting the following:
* That the patient's hepatitis status was known or evaluated.
* That the dialysis machine was internally disinfected.
* That the dialysis machine was externally disinfected.

The 05/04/2016 the disinfection records for dialysis machine # 1KOS167387 reflected the following:
* "Heat" with initials after it.
* "Bleach/Diasafe" with a blank space after it.
There was no time recorded reflecting when the machine was heat disinfected.
There was no documentation that the machine was internally or externally disinfected with bleach.

The "FMS Inpatient Services Dialysis Treatment Summary" documentation reflected the patient started a dialysis treatment on 05/05/2016 at 1305. The dialysis machine # was recorded "3KOS185787." The treatment was completed at 1605.
There was no documentation reflecting:
* That the dialysis machine was internally disinfected.
* That the dialysis machine was externally disinfected.

The 05/05/2016 the disinfection records for dialysis machine # 3KOS185787 reflected the following:
* "Heat" with initials after it.
* "Bleach/Diasafe" with a blank space after it.
There was no time recorded reflecting when the machine was heat disinfected.
There was no documentation that the machine was internally or externally disinfected with bleach.

The "FMS Inpatient Services Dialysis Treatment Summary" documentation reflected the patient started a dialysis treatment on 05/06/2016 at 2300. The dialysis machine # was recorded "3kos185787." The treatment was completed on 05/07/2016 at 0310.
There was no documentation reflecting the following:
* That the dialysis machine was internally disinfected.
* That the dialysis machine was externally disinfected.

Review of the 05/07/2016 dialysis disinfection records for machine # 3KOS185787 reflected similar unclear and incomplete information related to internal and external disinfection, and time of disinfection.

The "FMS Inpatient Services Dialysis Treatment Summary" documentation reflected the patient started a dialysis treatment on 05/09/2016 at 0930. The dialysis machine # was recorded "1KOS167367." The treatment was completed on 05/09/2016 at 1315.
There was no documentation reflecting:
* That the dialysis machine was internally disinfected.
* That the dialysis machine was externally disinfected.

No disinfection records were provided for machine #1KOS167367.

The "FMS Inpatient Services Dialysis Treatment Summary" documentation reflected the patient started a dialysis treatment on 05/11/2016 at 0842. The dialysis machine # was recorded "[1KOS167387]." The treatment was completed on 05/11/2016 at 1245.
There was no documentation reflecting:
* That the dialysis machine was internally disinfected.
* That the dialysis machine was externally disinfected.

Review of the 05/11/2016 dialysis disinfection records for machine # 1KOS167387 reflected similar unclear and incomplete information related to internal and external disinfection, and time of disinfection.

The "Hemodialysis" flowsheet documentation reflected the patient started a dialysis treatment on 05/13/2016 at 0831. The dialysis machine # was not recorded. Numerous areas on the flowsheet were blank including but not limited to the following areas:
* "pH"
* "Gross Bleach Negative"
* "Machine #"
* "R.O. #"
* "Machine log complete"
* "RO log complete"
* "Alarms verified"
* "Machine Temperature"
* "Dialyzer"
* "Treatment DC/Dialyzer appearance"
The treatment was completed on 05/13/2016 at 1300.
There was no documentation reflecting:
* That the patient's hepatitis status was known or evaluated.
* That the dialysis machine was internally disinfected.
* That the dialysis machine was externally disinfected.

The "Hemodialysis" flowsheet documentation reflected the patient started a dialysis treatment on 05/16/2016 at 0815. The dialysis machine # was recorded "1kos167217." The treatment was completed on 1255.
There was no documentation reflecting:
* That the patient's hepatitis status was known or evaluated.
* That the dialysis machine was internally disinfected.
* That the dialysis machine was externally disinfected.

No disinfection records were provided for machine # "1kos167217."

The "Hemodialysis" flowsheet documentation reflected the patient started a dialysis treatment on 05/18/2016 at 0852. The dialysis machine # was recorded "1KOS167387." The treatment was completed on 05/18/2016 1252.
There was no documentation reflecting:
* That the patient's hepatitis status was known or evaluated.
* That the dialysis machine was internally disinfected.
* That the dialysis machine was externally disinfected.

Review of the 05/18/2016 dialysis d