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Based on observation, record reviews and interviews, the Governing Body failed to ensure the health and safety of dialysis patients through a contracted service, in that, the hospital's contracted service did not reserve and maintain the equipment for One of One Patient (Patient #13) who was a hepatitis positive patient. This, in turn, failed to ensure all other patients' health and safety needs were met from possible cross-contamination that included hepatitis infection.

Findings Included

The hospital's Governing Board Bylaws, H-ML F 01-005 A, dated 4/22/15 revealed: "...Recognizing that the Governing Board of Kindred Healthcare Inc...Kindred is responsible for...the evaluation and supervision of the conduct of the Hospital, including the care and treatment of patients...Board members hereby accept and assume the responsibility to act in the best interest of the Hospital..."

Cross reference A-083 Contracted Services
Cross reference A-0749 Infection Control

Based on record review and interview, the hospital failed to provide a sanitary environment to avoid sources of infections, in that,

A) One of One hepatitis positive patient (Patient #13) did not have reserved and maintained equipment for his/her use only during his/her treatments from 8/18/15 through 9/9/15; and


B) 3 of 7 machines (Machine #86D, #99D, and #110D) used by the hepatitis positive patient had no documentation that they were disinfected (given intermediate level disinfection; bleached) prior to use by another patient on 8/21/15, 8/24/15, 8/26/15, 8/28/15, and 9/4/15; and

C) 5 of 7 hepatitis negative (susceptible) patients (Patient #14 on 9/7/15 and 9/9/15; Patient #15 on 8/28/15; Patient #17 on 9/4/15 and 9/7/15; Patient #18 on 8/22/15 and 9/7/15; and Patient #19 on 8/31/15, 9/7/15, and 9/9/15) were cared for by the same dialysis staff members who cared for the hepatitis positive patient (Patient #13) during his/her dialysis treatments from 8/22/15 through 9/9/15.


Findings Included

These practices placed all patients at risk for hepatitis infections. An Immediate Jeopardy (IJ) was discovered onsite the evening of 9/9/2015. The IJ was removed onsite and verified as removed by the surveyor on 9/10/15, prior to any further dialysis treatments being performed.

Cross refer to Tag A-749 Infection Control Program

Based on record reviews and interviews, the Governing Body failed to ensure contracted dialysis services were provided in a safe manner for all Hemodialysis patients, in that, One of One Patient (Patient #13) who was a hepatitis positive patient did not have reserved and maintained equipment for treatments. This, in turn, failed to ensure all other patients' health and safety was protected from possible cross-contamination that included hepatitis infection.


Findings Included:


During a tour of the Dialysis Suite on 9/8/15 at 2:45 PM, the machines and machine log books were observed. The daily "Billing Sheets" were reviewed. The 8/28/15 "Billing Sheet" reflected a hand-written comment, "+ hep B" for Patient #13. There were no machines tagged or labeled for the identification of a reserved machine for a hepatitis positive patient's use only.

During a tour of the Dialysis Suite on 9/9/15 at 12:50 PM with Staff #27, the surveyor observed a handwritten "+ hep," 8 inch by 11 inch copy paper sheet taped on Machine #93D.

During an interview on 9/9/15 at 12:50 PM, Staff #27 was asked about the hepatitis positive patient note on the "Billing Sheets." Staff #27 stated, "Yes, the patient is positive." Staff #27 was asked which machine had been used for the patient. Staff #27 pointed toward a machine and stated, "I was told (#93D) this one." Staff #27 was informed that the sign had not been on the machine the previous night when the surveyor observed the area. Staff #27 did not offer a comment.

The surveyor asked for and reviewed the treatment sheets for Patient #13. The treatment sheets revealed that Patient #13 had been treated on:

8/18/15 on Machine #110D/Serial #133110; 8/20/15 on Machine #86D/Serial #133211; 8/22/15 through 8/28/2015 on Machine #110D/Serial #139110; 8/31/15 on Machine #86D/Serial #133211; 9/3/15 on Machine #99D/Serial #139124; 9/4/15 on Machine #107D/Serial #139086; and 9/7/15 through 9/9/15 on Machine #93D/Serial #133462.

The 08/2015 "Hemodialysis and Hepatitis B Status and Communication" policy required, "If the patient is a known Hepatitis Surface Antigen Reactive...positive...patient, then the patient will be...dialyzed in their patient room using a dedicated dialysis machine for the duration of treatments...all hemodialysis machines used on HBsAG positive or HBsAG unknown patients will be chemically disinfected...bleached...post treatment to prevent blood borne transmission between patients."

The 3/20/13 Fresenius Medical Care Clinical Services "Dialyzing Patients with Positive Hepatitis B Antigen (HBsAg+)" policy required, "Patients that are HBsAg positive must dialyze in the separate room...If there are current HBsAg positive patients...equipment cannot be used for HBV negative patients on other shifts or days due to the risk of cross-contamination..."


The hospital's Governing Board Bylaws, H-ML F 01-005 A, dated 4/22/15 revealed, "...Recognizing that the Governing Board of Kindred Healthcare Inc...Kindred is responsible for...the evaluation and supervision of the conduct of the Hospital, including the care and treatment of patients...Board members hereby accept and assume the responsibility to act in the best interest of the Hospital..."


The Master In-Hospital Dialysis and Apheresis Services Agreement dated 12/19/14 (with signatures) between "...Fresenius Medical Care...and Kindred Healthcare...Provider Staff...maintain compliance with PROVIDER's Exposure Control Plan...Provider agrees to...continuous quality improvement...safety and infection control, and risk management...subject to monitoring by HOSPITAL for quality and safety in accordance with performance expectations as set forth under the requirements, recommendations and standards of...Centers for Medicare and Medicaid Services conditions of participation for hospitals...HOSPITAL, PROVIDER, and Provider Staff shall perform all of their respective duties and obligations set forth herein in accordance with all applicable federal and state laws and regulations...EXHIBIT E, Kindred Healthcare, Code of Conduct...Kindred recognizes that as a healthcare organization we must comply with all laws and regulations pertaining to the provision of healthcare services...We must make every effort to identify where there is risk for noncompliance..."


Cross reference A-0749 Infection Control

Based on record review and interview, the hospital failed to provide a sanitary environment to avoid sources of infections, in that,

A) One of One hepatitis positive patient (Patient #13) did not have reserved and maintained equipment for his/her use only during his/her treatments from 8/18/15 through 9/9/15; and


B) 3 of 7 machines (Machine #86D, #99D, and #110D) used by the hepatitis positive patient had no documentation that they were disinfected (given intermediate level disinfection; bleached) prior to use by another patient on 8/21/15, 8/24/15, 8/26/15, 8/28/15, and 9/4/15; and

C) 5 of 7 hepatitis negative (susceptible) patients (Patient #14 on 9/7/15 and 9/9/15; Patient #15 on 8/28/15; Patient #17 on 9/4/15 and 9/7/15; Patient #18 on 8/22/15 and 9/7/15; and Patient #19 on 8/31/15, 9/7/15, and 9/9/15) were cared for by the same dialysis staff members who cared for the hepatitis positive patient (Patient #13) during his/her dialysis treatments from 8/22/15 through 9/9/15.

Findings Included

A) During a tour of the Dialysis Suite on 9/8/15 at 2:45 PM, the machines and machine log books were observed. The daily "Billing Sheets" were reviewed. The 8/28/15 "Billing Sheet" reflected a hand-written comment, "+ hep B" for Patient #13. There were no machines tagged or labeled for the identification of a reserved machine for a hepatitis positive patient's use only.

During a tour of the Dialysis Suite on 9/9/15 at 12:50 PM with Staff #27, the surveyor observed a handwritten "+ hep," 8 inch by 11 inch copy paper sheet taped on Machine #93D.

During an interview on 9/9/15 at 12:50 PM, Staff #27 was asked about the hepatitis positive patient note on the "Billing Sheets." Staff #27 stated, "Yes, the patient is positive." Staff #27 was asked which machine had been used for the patient. Staff #27 pointed toward a machine and stated, "I was told (#93D) this one." Staff #27 was informed that the sign had not been on the machine the previous night when the surveyor observed the area. Staff #27 did not offer a comment.

The surveyor asked for and reviewed the treatment sheets for Patient #13. The treatment sheets revealed that Patient #13 had been treated on:

8/18/15 on Machine #110D/Serial #133110; 8/20/15 on Machine #86D/Serial #133211; 8/22/15 through 8/28/2015 on Machine #110D/Serial #139110; 8/31/15 on Machine #86D/Serial #133211; 9/3/15 on Machine #99D/Serial #139124; 9/4/15 on Machine #107D/Serial #139086; and 9/7/15 through 9/9/15 on Machine #93D/Serial #133462.

The 08/2015 "Hemodialysis and Hepatitis B Status and Communication" policy required, "If the patient is a known Hepatitis Surface Antigen Reactive...positive...patient, then the patient will be...dialyzed in their patient room using a dedicated dialysis machine for the duration of treatments...all hemodialysis machines used on HBsAG positive or HBsAG unknown patients will be chemically disinfected...bleached...post treatment to prevent blood borne transmission between patients."

The 3/20/13 Fresenius Medical Care Clinical Services "Dialyzing Patients with Positive Hepatitis B Antigen (HBsAg+)" policy required, "Patients that are HBsAg positive must dialyze in the separate room...If there are current HBsAg positive patients...equipment cannot be used for HBV negative patients on other shifts or days due to the risk of cross-contamination..."

B) The "Billing Sheets," the patient's treatment sheets, and the dialysis machine logs were reviewed. There was no documentation that a machine used by the hepatitis positive patient was disinfected prior to use by another patient. The following exposures occurred:

TX date Patient # Machine # (end time)
8/18/15 Hep+ Pt 110D...Not Bleached (8:20 PM)
8/21/15 Pt #19 110D...Exposure (1:33 PM)
8/22/15 Hep+ Pt 110D...Not Bleached (12:15 PM)
8/24/15 Pt #19 110D...Exposure (3:40 PM)
8/25/15 Hep + Pt 110D...Not Bleached (11:20 AM) 8/26/15 Pt #19 110D...Exposure (11:34 PM)
8/27/15 Hep+ Pt 110D...Not Bleached (8:27 AM)
8/28/15 Pt #19 110D...Exposure (11:15 AM)
8/31/15 Hep+ Pt 86D...Not Bleached (1:25 PM) 9/4/15 Pt #18 86D...Exposure (11:15 AM)
9/3/15 Hep+ Pt 99D...Not Bleached (5:11 PM) 9/4/15 Pt #19 99D...Exposure (10:53 AM)


During an interview on 9/9/15 ending at 4:30 PM, Staff #27 was asked if the hepatitis positive patient's machine had been bleached after each treatment/prior to use by another patient. Staff #27 stated, "No. We bleach weekly."

The 08/2015 "Hemodialysis and Hepatitis B Status and Communication" policy required, "...all hemodialysis machines used on HBsAG positive or HBsAG unknown patients will be chemically disinfected...bleached...post treatment to prevent blood borne transmission between patients."

The 3/20/13 Fresenius Medical Care Clinical Services "Dialyzing Patients with Positive Hepatitis B Antigen (HBsAg+)" policy required, "Caring for HBsAg positive patients requires adherence to strict guidelines...Outbreaks of hepatitis B have been linked directly to poor infection control practices...When the machine is no longer dedicated to an HBsAg positive patient, internal pathways of the machine can be disinfected using conventional protocols...equipment cannot be used for HBV negative patients on other shifts or days due to the risk of cross-contamination...if a separate machine is not possible, bleach disinfect internal components of the machine."


C) The "Billing Sheets" and the patient's treatment sheets were reviewed. The following patients were cared for by the same staff/during the same timeframe as the hepatitis positive patient (Patient #13) was cared for:

Date Patients (timeframe) (# of Staff) 8/22/15 Pt #13 and Pt #18 (8:56-12:15) (1) 8/28/15 Pt #13 and Pt #15 (12:41-4:00 PM) (2) 8/31/15 Pt #13 and Pt #19 (11:55-1:25 PM) (1) 9/4/15 Pt#13 and Pt #17 (10:54-1:20 PM) (3) 9/7/15 Pt #13, #14, #17, #18 and #19 (9:52-11:27) (3) 9/9/15 Pt#13, #14 and #19 (08:11-10:40) (1)

During an interview on 9/9/15 ending at 4:30 PM, Staff #27 was informed of multiple staff charting/caring for the hepatitis positive and hepatitis negative patients at the same time. Staff #27 offered no response.

The 08/2015 "Hemodialysis and Hepatitis B Status and Communication" policy required, "If the patient is a known Hepatitis Surface Antigen Reactive...positive...patient, then the patient will be placed in a private room and dialyzed in their patient room...for the duration of treatments...to prevent blood borne transmission between patients."

The 3/20/13 Fresenius Medical Care Clinical Services "Dialyzing Patients with Positive Hepatitis B Antigen (HBsAg+)" policy required, "Caring for HBsAg positive patients requires strict guidelines...Outbreaks of hepatitis B have been linked directly to poor infection control practices...Patients that are HBsAg positive must dialyze in the separate room...Ensure the staff caring for HBsAG positive patients care only for HBV antibody positive (immune) patients at the same time. This includes nurses and (Patient Care Technician) PCTs. Examples include, but are not limited to: a) the nurse who administers any medications...b) PCTs and/or nurses who perform machine set-up/tear down, treatment initiation/discontinuation with (Central Venous Catheter) CVC or other access, 30 minute checks or any other care of the antigen positive patient can only care for immune patients at the same time...c) only when the HBsAg positive patient has left...has been completely disinfected and there are no further tasks to be done...can these staff members care for susceptible patients...Staff having any contact with the HBsAg positive patient must at the same time have NO contact with susceptible patients...due to the risk of cross-contamination..."