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.

BAYSTATE MEDICAL CENTER 759 CHESTNUT STREET SPRINGFIELD, MA 01199 Jan. 20, 2016
VIOLATION: PATIENT RIGHTS: CARE IN SAFE SETTING Tag No: A0144
Based on observation and interview, the facility failed to ensure patients received dialysis care in a safe setting. Findings include:

1. During observation on 1/7/16 at 12:20 P.M., the Surveyors observed there were Stations lettered from A to H (eight stations). Station H was labeled as being the "Isolation" Room and was empty.

Stations A, B and C were empty. Station D had an unidentified patient being dialyzed in a bed. Station E had an unidentified patient being dialyzed, and receiving a blood transfusion, seated in a recliner and Station F had an unidentified patient being dialyzed in a bed.

There was a sink between Stations B and C in one Bay, and a sink between Stations D and E in the second Bay area. Station G was in an alcove.

During interview on 1/7/16 at 12:30 P.M., Charge Nurse #1 said that the Dialysis Unit had 8 stations, but that the Facility could dialyze 10 patients, if needed for any one shift. Charge Nurse #1 said that 1 additional patient would be placed in front of the sink between Stations B and C, and the 2nd additional patient would be placed in front of the sink between Stations D and E. Charge Nurse #1 said that both additional patients would utilize portable Reverse Osmosis (RO) machines in the make-shift stations (requiring two machines. The dialysis machine and the portable RO).

The Surveyors observed that there would not be enough room/space to safely dialyze a patient in front of either sinks, with all required equipment, beds/recliners for the additional patients. In addition, neither of these sink areas/spaces were designated as patient stations. The limited space would increase the risk of cross-contamination during initiation, termination and patient's dialysis care.

Charge Nurse #1 said that on occasion, there were so many patients requiring dialysis, at the same time, that not all patients were able to receive the entire dialysis treatment. Charge Nurse #1 said that the Physician would order ultra filtration (UF) to remove excess fluid, and the patient would have to be rescheduled for a full dialysis treatment later in the week.

During interview on 1/8/16 at 7:18 A.M., the Medical Director said that the census in the hospital has been high, and that at times, the Dialysis Unit would dialyze 10 patients in the 8 Station unit, despite there were not 10 Stations. He said that the extra patients would be dialyzed on Portable RO machines in front of the sinks between Stations B and C, and between Stations D and E.

The Medical Director said that there was not adequate space to safely dialyze 10 patients in an 8 Station Dialysis Unit, but there had been no other alternative. After Surveyor inquiry, the Medical Director said that this practice would not continue from this day moving forward.

2. For Patient #101, the facility failed to ensure the access site remained uncovered to ensure safe delivery of dialysis.

During observation on 1/8/16 at 7:39 A.M., Registered Nurse (RN) #3 initiated dialysis via Patient #101's Central Venous Catheter (CVC). RN #3 obtained two blankets. She placed one over the patient's lap, and wrapped the second blanket around the patient's, shoulders, neck and CVC site. (CVC or any other access sites need to be uncovered to ensure safety, in the event the dialysis tubing becomes disconnected from the patient, and the patient exsanguinates(bleeds out) in minutes). Later, on 1/8/16 at 10:13 A.M., the patient's CVC site was still covered by the blanket.

3. For Patients #85, #92, #94 and #98, the facility failed to ensure safe dialysis, when the dialysis access sites were covered during dialysis treatments.

During observation on 1/8/16 at 10:14 A.M., the Surveyor observed Patient's #85, #92, #94 and #98 access sites were covered during dialysis.






4. The hospital failed to ensure a safe environment when 9 - 10 patients received dialysis treatments in a dialysis unit, with a capacity for 8 patients/designated stations. This practice increased the risk for cross-contamination of infectious organisms from potential splattering, spurting of blood and staff from inadvertently touching both machines or patients by being too close.

Observation of the acute dialysis unit indicated there were 8 designated stations.
Review of the Acute Dialysis Daily Census Sheets indicated that the facility dialyzed more than the 8 patient capacity, when patients were identified on the census sheets as being dialyzed in front of sink areas as follows:

- 1 patient (9 stations on the first shift for 12/7/15), exceeding the 8 station capacity.

- 3 patients (10 stations used on the first shift, then 9 stations used on the second shift for 12/12/15), exceeding the 8 station capacity.

- 1 patient (9 stations used on the second shift for 12/14/15), exceeding the 8 station capacity.

- 1 patient (9 stations used on the first shift for 12/26/15), exceeding the 8 station capacity.

- 1 patient (9 stations used on the second shift for 1/5/16), exceeding the 8 station capacity.

- 2 patients (10 stations used on the first shift for 1/6/16), exceeding the 8 station capacity.
VIOLATION: FACILITIES, SUPPLIES, EQUIPMENT MAINTENANCE Tag No: A0724
Based on observation and interview, the Hospital did not maintain the Dialysis Unit and Water Room Departments in a manner to ensure an acceptable level of safety and quality. Findings include:

1. For the Main Reverse Osmosis (RO) water machine (system for water filtration to purify water required for hemodialysis) room, the facility failed to ensure all mechanisms for operations of the RO were maintained.

Review of a document, dated 12/29/15, provided by the Clinical Engineer (CE), indicated that the Main RO system was noted to have a leak coming from the area of the membranes (filtration system that does not allow living bacteria to pass through to ensure purity of the water/permeate), and that the contracted "Vendor" was contacted and would be sending a part the next day.

The document indicated that the CE would set up the dialysis unit with portable RO machines (portable, compact automatic RO water system) for the next morning, and repair the Main RO as soon as the part arrived. This indicated the Main RO was not safe to use.

In another attachment to this document, dated 12/30/15, it was indicated that the parts had been installed on this date, and the RO unit was still leaking at the membrane. Upon closer scrutiny, the "leak" appeared to be coming from the stainless housing itself, either a pin-hole leak or small crack that was not visible to the naked eye. A request was then made to the Vendor for emergency service with the next possible date to review as being 1/4/16.

During interview on 1/7/16 at 1:00 P.M., the CE said that the Main RO could not be safely used until "1/6/16." The Surveyor inquired about routine maintenance and daily operations/functioning log documentation of the Main RO, to ensure the RO system functioned within the allowable parameters, prior to the leak.

On 1/7/16 at 1:20 P.M., the CE provided the Surveyor with 6 months of documentation entitled: "Daily Log for Osmo Machines." All pertinent areas on the daily logs for 6 months were blank (other than results documented for water hardness tests).

During interview and review of these daily log sheets, the CE said that he does check all required components/functioning/operations of the Main RO water system, but he does not document findings on the "Daily Log" sheets.

The pertinent components for checking the Main RO water system, that were left blank, included: Prefilter Pressure, Post Filter Pressure, Primary Pressure, Final Pressure, Temperature, Permeate Flow, Concentration Flow, Recovery Flow, Feed Conductivity, Concentration Conductivity, Average Conductivity, Permeate Conductivity, % Passage, pH meter, pH manual, Calibrated pH, Filter Change, Clean, Hour meter and Feed Chlorine.

Changes in the pre and post filter pressures can predict early when the membrane filter starts to fail and it can be change proactively before needing to shut the RO down and go the portable ROs. With no documentation of monitoring of the pre and post filter pressures, the CE could not prevent a failure in the filter and prevent the leaking in the filter membrane.

2. During an inspection of the Main RO water system room with the CE on 1/7/16 at 2:10 P.M., the Surveyor observed that the time on the digital Hour Meters were inaccurately displayed as being "3:10" P.M. (Should be accurately set with the correct time as 2:10 P.M. to ensure that during times when the system is being back-washed, that patients are not receiving dialysis). The Surveyor pointed this out to the CE. The CE said that the Hour Meters were set with the incorrect time.

During interview on 1/20/16 at 10:53 A.M., the Director of Clinical Engineering (DCE) said that he oversees the CE, and that data presented to him by the CE, are "outcome" based, for review at the Quality Improvement committee meetings. The DCE said that he does not review day to day operations/logs, therefore, he did not know they were not being completed, and should have been.

3. The facility failed to ensure dialysis machines had been disinfected.

During interview on 1/7/16 at 1:10 P.M., the CE said that the dialysis unit has 14 dialysis machines, 12 were Gambro and 2 were Fresenius 2008K machines. He also said that the dialysis unit has 12 Portable RO machines.

During interview on 1/20/16 at 10:50 A.M., the DCE, said that all machines should be disinfected as if they were Hepatitis B contaminated, and are supposed to be disinfected in accordance with the facility's policy. However, the policy indicated that each machine should be bleached twice, only after exposure with a Hepatitis B patient.

Please refer to A-0747

4. The facility failed to ensure that Chlorine/Chloramines testing was completed on the Main RO water system, either prior to each patient shift, or every 4 hours, if there was no designated patient shifts.

According to AAMI (Association for the Advancement of Medical Instrumentation) standards "6.2.5 Carbon adsorption: monitoring, testing freq (frequency):" Testing for free chlorine, chloramines, or total chlorine should be performed at the beginning of each treatment day prior to patients initiating treatment and again prior to the beginning of each patient shift. If there are no set patient shifts, testing should be performed approximately every 4 hours."

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

During interview on 1/7/16 at 12:35 P.M., Charge Nurse #1 said that the dialysis unit had 2 shifts, but no designated, timed shifts, due to the inconsistency when patients arrive to the dialysis units, either from the hospital units, the community or through the Emergency Department (ED).

Charge Nurse #1 said that the dialysis unit treats patients from all areas in the Hospital, as well as from the community, who do not have assigned outpatient dialysis centers yet. Charge Nurse #1 said that these patients come in via the ED, and depending on how busy the ED may be, depends on what time the patient arrives to the unit for their dialysis treatment.

Charge Nurse #1 said that staff work 12 hour shifts to accommodate the two patient shifts the dialysis unit handles. She said that if patients require dialysis after 6:00 P.M., then the facility has an on-call nurse who is available from 6:30 P.M. to 6:00 A.M. on the following day.

During interview on 1/7/16 at 2:10 P.M., Nurse #9 said that testing for Chlorine/Chloramines is done twice a day, before each of the two shifts. Nurse #9 said that the first test is done between 6:00 - 6:15 A.M., and the second test is done before the second shift, between 12:00 - 12:30 P.M.

Nurse #9 said that nurses obtain the first shift test, and the CE obtains the second shift test, if he is available. Nurse #9 said that today, there is a patient scheduled for dialysis at 5:00 P.M., and that this would be considered part of the second shift, so testing the Chlorine/Chloramines would not be done again.

This is an unsafe practice since the requirement is before each patient shift and if no set shifts at least every four hours. If the last test was at 12:30 P.M. and a patient is starting treatment at 5:00 P.M., the water would need to be tested prior to this patient's treatment as it is over four hours from the last test.

During interview on 1/7/16 at 2:15 P.M., the CE said that he completed the Chlorine/Chloramines test today "around 1:10 P.M. (after the second shift patients were put on dialysis)."

Review of the Main RO Daily Chlorine Log sheets, dated from 11/1/15 - 1/7/16, indicated Chlorine testing had been completed twice a day, once in the A.M., and once in the P.M. (all results were in normal range). However, there was no time documented to indicate what time each test had been conducted, to ensure the testing had been completed, prior to patient shifts, as required.

In the event there was a problem with chlorine breakthrough, patients receiving dialysis would be exposed to chlorine in their blood (increasing the risk of harm to patients).

5. The facility failed to ensure proper mixing of Bicarbonate (a component of the dialysate used during dialysis).

During interview on 1/7/16 at 1:30 P.M., the CE said that the facility had two dialysis machines that required nurses to mix Bicarbonate. The CE then showed the Surveyor a carton of "Dry Pack" Bicarbonate with instructions for use.

The instructions indicated that the temperature of the Bicarbonate solution, after mixing with pure water (RO), must be 24 degrees centigrade/75.2 degrees Fahrenheit, and that both pH and conductivity testing should be done, prior to running the solution through the dialysis circuit. Testing the solution after mixing ensures the Bicarbonate has not been over-mixed after preparation, which can alter the pH. In addition, use of overmixed Bicarbonate can result in a low calcium level in the dialysate and a concomitant drop in the patients' serum calcium levels.

During interview with Charge Nurse #1 and Nurse #3 on 1/8/16 at 10:30 A.M., both said that they were not aware of the instructions printed on the container of "Dry Pack" Bicarbonate used for patient's dialysis. Nurse #3 said that when the Bicarbonate is mixed, she agitates the container gently to mix the Bicarbonate. Nurse #3 said that the temperature, pH and conductivity are not tested , prior to being run through the dialysis machine, and mixed with the dialysate (Potassium and Calcium components).
VIOLATION: INFECTION CONTROL OFFICER RESPONSIBILITIES Tag No: A0749
Based on observations, review of policies and procedures and staff interviews, the Hospital failed to: (1) The Hospital failed to follow its own policies for Dialyzing Hepatitis B positive (+) patients, which state patients who are Hepatitis B + will have a dedicated dialysis machine (to decrease the risk of transmission of blood borne infections to other patients) for three sampled patients (#2, #3 and #89), (2) The Hospital failed to ensure dialysis machines were properly disinfected after use on Hepatitis B + patients (#2, #3 and #89), in accordance with hospital policy before use on three non-Hepatitis B immune patients (#13, #92 and #93) , placing the patients at risk for becoming infected with Hepatitis B . The hospital failed to follow its policies and national standards of care by not dedicating the isolation room, dialysis machine and equipment while Hepatitis B + patients were on census in the dialysis unit, to minimize the potential of cross contamination and spread of infectious disease for three patients (#2, #3 and #89). The hospital failed to (4) ensure infection control practices were adequate, as observed on the Dialysis Unit relative to staff failing to wear the required Personal Protective Equipment (PPE), such as gloves, protective gowns and protective eye wear, when touching patients and/or contaminated surfaces during initiation of dialysis and/or obtaining blood specimens for three of two Registered Nurses (RN #1 and RN #3) observed; staff failing to perform adequate disinfection of access sites for two RNs observed (RN #1 and RN #4); staff failing to provide adequate disinfection of end caps and catheter limbs when accessing a Central Venous Catheter (CVC) for one RN observed (RN #3); failed to ensure that infection control practices were adequate relative to storage of supplies/equipment in dialysis stations increasing the risk of cross-contamination to prevent the likelihood of cross-contamination and failure to perform hand hygiene when required for one RN observed,(RN #3), for 13 of 102 sampled patients (#1, #2, #3, #4, #13, #14, #88, #89, #90, #91, #92, #98, #99 and #102). Findings include:


According to the Centers of Disease Control and Prevention (CDC) publication: Recommendations for Preventing Transmission of Infections Among Chronic Hemodialysis Patients (April 27, 2001), which sets the current standards for care in hemodialysis units for Hemodialysis in Acute-Care Settings, patients with acute renal failure who receive hemodialysis in acute-care settings, Standard Precautions as applied in all healthcare settings are sufficient to prevent transmission of bloodborne 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. If both acute and chronic renal failure patients receiving hemodialysis in the same unit, these infection control precautions should be applied to all patients. Regardless of where in the acute-care setting chronic hemodialysis patients receive dialysis, the Hepatitis B Antigen (HBsAg) status of all such patients should be ascertained at the time of admission to the hospital, by either a written report from the referring center (including the most recent date testing was performed) or by a serologic test. The Hepatitis B Virus (HBV) serologic status should be prominently placed in patients' hospital records, and all health-care personnel assigned to these patients, as well as the infection control practitioner, should be aware of the patients' serologic status. While hospitalized , HBsAg-positive, chronic hemodialysis patients should undergo dialysis in a separate room and use separate machines, equipment, instruments, supplies, and medications designated only for HBsAg positive patients. While HBsAg positive patients are receiving dialysis, staff members who are caring for them should not care for susceptible patients.

1. Review of the Hospital's Policy, "Dialyzing the Hepatitis B Positive Patient..." indicated:

- Designated Machine - This machine can only be used to dialyze this Hepatitis B Patient. If 2 or more Hepatitis B + patients are admitted at the same time, each patient must have their own dialysis machine. The designated machine is to be labeled with patient initials. Disinfection procedures for end of day clearly state that hemodialysis machines for hepatitis B positive patients must be isolated for that specific patient.

- Off Unit treatments - Any treatment not done in the Acute room (isolation room in the dialysis unit), the dialysis machine must be designated to that patient, and if the patient is moved, the machine must move with them.

- At end of any dialysis treatment, including using a designated machine for a Hepatitis patient, the dialysis machine must go through 1 complete bleach disinfectant rinse.

2. Terminal Cleaning of Isolation Room.

- When the Hepatitis B Positive patient has been discharged from the dialysis unit, the dedicated dialysis machine must go through two bleach disinfection cycles (This procedure prepares the isolation room and the dialysis machine for safe use on the next patient).

- Call "clean line" to have the room cleaned.

3. Review of the policy and procedure entitled, "Hemodialysis Machines, End of Day Procedures..." indicated:

- For Gambro Phoenix machines, determine Hepatitis status of patient.

- If Hepatitis B +, follow machine isolation procedures, as noted in Hepatitis B + policy. "Machine must be isolated for specific patient."

4. Review of the 1/2015 Acute Dialysis Daily Census Sheets (Treatment Sheets) indicated the facility's policy for use of a dedicated dialysis machine for Hepatitis B positive patients was not followed as evidenced by:

a. on 1/8/15, Patient #3, who was Hepatitis B +, was dialyzed on Machine G2. Post treatment, Machine G2 was bleached once and not twice per policy. Patient #3 was a chronic community dialyzed patient who was readmitted to the hospital for treatment of pneumonia.
On 1/9/15, Patient #4 (immunity to Hepatitis B) was dialyzed on Machine G2. The machine was cleaned with vinegar after this treatment. Machine G2 was not dedicated to Patient #3 with Hepatitis according to the hospital policy and was not terminally cleaned per hospital policy before used on a non-hepatitis B positive patient, increasing the potential for cross contamination with blood borne pathogens.

b. On 1/26/15: Patient #2 (Hepatitis B +) was dialyzed on Machine G2. Post treatment, Machine G2 was rinsed with Vinegar and not bleached twice per policy.
On 1/26/15: Patient #14 (an immune patient) was dialyzed on Machine G2 the next shift. Machine G2 was bleached once after that treatment, increasing the risk of cross-contamination. Machine G2 was not dedicated to Patient #3 with Hepatitis according to the hospital policy and was not terminally cleaned per hospital policy before used on a non-hepatitis B + patient, increasing the potential for cross contamination with blood borne pathogens.

c. On 1/27/15, Patient #13 (susceptible for contracting the Hepatitis B infection) was dialyzed on Machine G2, which was not properly disinfected with bleach twice after being used Patient #2 (on 1/26/15), thus making it a possibility for Patient #13 to contract Hepatitis B virus infection. After Patient #13's treatment, Patient #15 (immune to Hepatitis B) was dialyzed on Machine G2. The Hospital did not follow its' policy for using a dedicated machine for Hepatitis B positive patients.

d. On 2/2/15: Patient #2 (Hepatitis B +) was dialyzed on Machine G2, for the first shift. Post treatment, Machine G2 was not bleached twice per policy. A vinegar rinse was done.
On 2/2/15: Patient #88 (immune status) was then dialyzed on Machine G2 for the next shift. A dedicated machine was not used per policy for Patient #2.

e. On 2/17/15, Patient #89 (Hepatitis B +) was dialyzed on Machine G3. Post treatment, Machine G3 was rinsed with Vinegar and not bleached twice per policy.
On 2/17/15, Patient #90 was then dialyzed on Machine G3 (susceptible for contracting Hepatitis B virus), increasing the risk for transmission of the Hepatitis B infection. Post treatment, Machine G3 was bleached once. The Hospital failed to follow its' policy for use of a dedicated machine for Patient #89, failed to follow its' disinfection procedures for a hepatitis B machine and placed Patient #90 at risk for contracting blood borne diseases.

f. On 1/2/16, Patient #2 was dialyzed in the Isolation Room for the first shift on Machine G11. Post dialysis, Machine G11 was rinsed with vinegar and descaled, then bleached once and not twice per policy.
On 1/2/16, Patient #91 (immune status) was dialyzed in the Isolation Room using Machine G11 for the second shift, after the machine had been improperly disinfected. The Hospital failed to follow its' own policy for using a dedicated machine for Patient #2 who had Hepatitis B infection.

d. On 1/5/16: Patient #2 ( hepatitis B positive) was again dialyzed in the Isolation Room on Machine G11. Post dialysis treatment, Machine G11 was disinfected twice with bleach, per policy.
On 1/5/16, Patient #93 (susceptible for contracting Hepatitis B) was dialyzed on the next shift in the Isolation Room, on machine G11. The Hospital failed to follow its' own policy for using a dedicated machine for Patient #2 who had Hepatitis B infection.


5. Review of machine disinfection logs indicated that between 5/2/15 and 10/27/15, 52 of approximately 116 patients' dialysis machines were not disinfected after use per hospital policy. This increased the risk to the 52 patients for transmission of blood borne diseases.

6. The hospital failed to follow national standards of care by not dedicating the isolation room, dialysis machine and equipment to Hepatitis B + patients, while on census in the dialysis unit, to minimize the potential of cross contamination and spread of infectious disease.

a. On 12/27/15, Patient #2, a hepatitis B positive patient, was dialyzed in the Isolation room on the dialysis unit. On 12/28/15, Patient #92 (non-Hepatitis B) was dialyzed in the Isolation Room, despite having Station E open.

b. On 12/29/15: Patient #2 (Hepatitis B +) was dialyzed in the Isolation Room. However, on 12/29/15, 12 of 14 patient dialysis machines had no indication the machines were disinfected, including Patient #2 (Hepatitis B +)who was dialyzed in the Isolation Room, using Machine G 11. This increased the risk to the 12 patients for transmission of blood borne diseases.

c. On 1/2/16, Patient #2 was dialyzed in the Isolation Room for the first shift on Machine G11. Post dialysis, Machine G11 was rinsed with vinegar and descaled, then bleached once.
On 1/2/16, Patient #91 (immune status) was dialyzed in the Isolation Room using Machine G11 for the second shift, after the machine had been improperly disinfected for use on a non-hepatitis B patient. Post dialysis treatment, Machine G11 was rinsed with vinegar and descaled. The Hospital failed to follow its' policies for disinfection of machines before using on a non-hepatitis B patient and failed to follow national standards for using a dedicated isolation room when a Hepatitis B patient is on census.

d. On 1/5/16: Patient #2 was again dialyzed in the Isolation Room on Machine G11. Post dialysis treatment, Machine G11 was disinfected twice with bleach, per policy.
On 1/5/16, Patient #93 (susceptible for contracting Hepatitis B) was dialyzed on the next shift in the Isolation Room, despite having a Hepatitis B + patient in that room the shift before.

7. Hepatitis B virus lives on surfaces up to seven days and is capable during that time of transmitting disease. Inadequate or improper cleaning with inadequate bleach contact time or storage of equipment on contaminated surfaces allows the virus to survive between patients and increases the likelihood that transmission will occur.

During observation on 1/7/16 at 12:35 P.M., the Surveyor observed Station H, labeled "Isolation." Inside the room was a portable Reverse Osmosis (RO) machine, propping the door open. Inside, was a dialysis machine ("Fresenius 2008K"), a metal, two-tiered shelf, which held cleaning/disinfectant solutions spray bottles (considered contaminated), an open, 16 ounce bottle of Betadine solution (skin disinfectant), dressing supplies, face masks (these cannot be disinfected and would have to be disposed of), and miscellaneous equipment. There was a blue-colored linen hamper which contained soiled linen and an open trash receptacle. Nothing inside the Isolation Room was labeled as being Isolation. There was no patient in the Isolation Room at this time. Proper infection control practices had not been provided as evidenced by cohorted clean/contaminated equipment on the same shelf, and storage of equipment in the Isolation Room which should be labeled Isolation to prevent cross-contamination.

During interview (on 1/7/16 at 1:18 P.M.), Charge Nurse #1 said that the Isolation Room is used for Hepatitis B patients, Tuberculosis (TB) patients, droplet and contact precaution patients and for patients with behaviors. Charge Nurse #1 said that the equipment is disinfected after each patient use, whether on precautions or not.

During interview on 1/20/16 at 10:50 A.M., the Director of Clinical Engineering (DCE) said that all dialysis machines should be disinfected as if they were Hepatitis B contaminated, and are supposed to be disinfected in accordance with the facility's policy. However, the policy indicated that each machine should be bleached twice, only after exposure with a Hepatitis B patient.

The hospital did not follow its own policies for use of a dedicated machine for hepatitis B positive patients or national standards of care by failing to dedicate the isolation room to Hepatitis B positive patients on census, risking exposure of Hep B non-immune patients to cross contamination with blood borne pathogens (Hepatitis B).


8. For two Registered Nurses (RN #1, and RN #3) observed, the RN's did not wear the required Personal Protective Equipment (PPE), such as gloves, protective gowns and protective eye wear, when touching patients, contaminated surfaces, for initiation of dialysis and obtaining blood specimens, Review of the policy entitled, "Personal Protective Equipment" (reviewed 3/2014) indicated:

- Eye protection is worn when health care personnel are conducting procedures that are likely to generate splashes or sprays of blood, body fluids and secretions (such as initiation and termination of treatment).

- Eye protection consists of goggles, face shield or eye shields attached to surgical masks.

a. On 1/8/16 at 6:35 A.M., the Surveyor observed RN #1 initiate dialysis for Patient #99, with a Central Venous Catheter, and conduct a blood draw (Risk of splashing blood). RN #1 had donned a gown, mask and gloves. However, Nurse #1 did not wear any eye protection, per policy.
b. On 1/7/16 at 12:47 P.M., the Surveyor observed as the dialysis machine's alarm sounded during dialysis for Patient #102 who was receiving dialysis. Registered Nurse (RN) #3 responded, and touched the dialysis machine with bare hands. RN #3 then touched and lifted the blanket from Patient #102 with bare hands, and touched the patient's arm. (Facility's policy indicated to wear gloves when touching dialysis equipment and patients).
c. For Patient #2,, wearing of eye protection when there was a potential for blood spurting/splashing during blood sampling, and initiation of hemodialysis.
On 1/8/16 at 7:28 A.M., the Surveyor observed RN #3 draw blood and initiate hemodialysis via a central line Patient #2. RN #3 performed hand hygiene, donned a gown and gloves but failed to wear any eye protection, per policy.


8. Review of the policy entitled, "Dialysis Initiation, Fistula/Graft Technique..." (reviewed 4/2008), indicated staff are to:

- Cleanse access sites with ChloraPrep antibacterial swabs. Scrub for 15-30 seconds.

- Locate sites to be used for arterial and venous cannulation.

- Remove needle cap from end of fistula needle. Insert arterial needle against the direction of the fistula bloodflow.

a. On 1/8/16 at 6:45 A.M., the Surveyor observed RN #4 initiating dialysis for Patient #98, with a right arm fistula. RN #4 donned clean gloves and palpated both upper and lower access sites. RN #4 did not change gloves after palpating the fistula, contaminated the access site after they had been disinfected, and did not properly disinfect the access sites, prior to cannulation (inserting needles).

RN #4 used contaminated gloved hands to disinfect the patient's lower access site with ChloraPrep (disinfecting agent) for 10 seconds, and not 15-30 seconds per policy. Then with the same contaminated gloves, RN #4 disinfected the upper access site for 20 seconds with ChloraPrep swabs. A tourniquet was applied to the upper arm. RN #4 then touched the access sites, contaminating them. She then cleaned her hands and changed gloves.

Prior to cannulating the upper site, RN #4 palpated the access sites again. RN #4 did not disinfect the area again, prior to inserting a needle and drawing blood. RN #4 touched the dialysis machine, obtained the dialysis tubing, and connected the patient to dialysis with contaminated hands.

During interview on 1/8/16 at 8:30 A.M., the Unit Manager and the Infection Control Officer said they would review the infection control practices on the unit, as well as review the policies.

b. For Patient #1, the facility failed to ensure infection control practices, relative to adequate disinfection of the patient's dialysis access site, and re-contamination of the access site, prior to cannulation (inserting needles).

On 1/8/16 at 6:57 A.M., the Surveyor observed RN #1 don a protective gown and a face shield. RN #1 then set up supplies on the bed side table for blood sampling and initiation of dialysis, and donned gloves.

RN #1 palpated the access site, opened a Chloraprep solution foil packet (without removing gloves after touching the patient), removed 1 swabstick, swiped around and across both access sites, briefly (3 - 4 seconds), obtained a second swabstick, swiped the same area, again for only 3 - 4 seconds, obtained a third swabstick, and wiped in the same manner, only for 3-4 seconds. RN #1 said, now it has to dry, and allowed the area to dry for 2 minutes.

Using the same contaminated gloves she used to palpate then disinfect the access site, RN #1 cannulated the distal, then the proximal access sites.






9. The hospital failed to ensure infection control practices were adequate on the dialysis unit relative to the care of central venous catheters (CVC) for Patient #2.

The Hospital policy/procedure for Dialysis initiation of a CVC indicated to apply mask to Patient #2 and the Registered Nurse (RN), don non-sterile gloves, place a sterile towel under catheter ends of holding ends in the air, soak Betadine into 3 -4 by 4 gauze pads and scrub catheter tips thoroughly (2 minutes scrub is preferred). Remove catheter end caps and place catheter on the sterile field, remove indwelling antibiotic lock with empty 3 cc syringes - pull back 3 cc's from each port.

On 1/8/16 at 7:28 A.M., the Surveyor observed RN #3 set up supplies on the bedside table for blood sampling and initiation of hemodialysis. RN #3 performed hand hygiene, donned a gown and gloves.

RN #3 reclined the dialysis chair, changed her gloves (after touching the patient, environmental surfaces, her personal uniform, a pen and paper treatment record), did not performed hand hygiene. RN #3 placed a face mask over her nose and mouth, then placed one on Patient #2. RN #3 did not wear any eye protection in the event blood spurting or splattering occurred.

RN #3 then walked over and pulled the privacy curtain around the patient. She then touched and lifted the patient's shirt, and removed an outer, soiled dressing that covered the entire CVC. She then removed the gauze that covered the limbs to the CVC. She did not change the CVC dressing. RN #3 said that she would do that afterwards. RN #3 removed gloves, performed hand hygiene, and donned clean gloves.

RN #3 opened a sterile kit and set up the supplies inside. RN #3 retrieved an open, 16 ounce bottle of Betadine Solution (stored on the counter, then brought into Station F) and placed it on the bed side table. This practice increases risk of cross-contamination when common supplies are stored in dialysis station and shared from patient to patient. RN #3 poured the solution over a stack of gauze pads, removed the gloves, and applied clean ones, without performing hand hygiene.

RN #3 picked up a few Betadine soaked gauze pads and wiped the red end cap and limb for 5 seconds, discarded this, picked up a second wet gauze pad from the pile, and wiped the same end cap and limb briefly, 2-3 seconds, reached over and obtained another wet gauze pad, and wiped the blue end cap and limb, only briefly 2-3 seconds, discarded this, picked up another gauze pad that had only spots of the Betadine Solution on it, and wiped the blue end cap and limb for 2 seconds, and discarded it (not ensuring the end caps and limbs were properly disinfected).

She placed a folded, sterile drape under both limbs, using the same contaminated gloved hands. Without changing gloves, she picked up a syringe and attached it to the red port, then attached a syringe to the blue port, aspirated blood, removed the syringe, attached a vacutainer, and collected five blood samples.

At 7:39 A.M., RN #3 removed the vacutainer, attached syringes filled with Normal Saline and flushed the ports to the CVC, all with the same contaminated gloves. RN #3 then removed gloves, performed hand hygiene, and donned clean gloves. She then primed the dialysis tubing into the prime waste receptacle, attached the dialysis tubing to the patient's CVC and initiated dialysis.

RN #3 removed gloves, did not perform hand hygiene, applied clean gloves, secured dialysis tubing to the blue drape that was under the limbs of the CVC, removed the patient's face mask, picked up the blood filled syringes, moved aside the privacy curtain with contaminated hands, and disposed of blood syringes into the biohazard waste.

RN #3 obtained two blankets, and placed one over the patient's lap. She took the second blanket and wrapped it around the patient's neck, shoulders and CVC site. (CVC or any other access sites need to be uncovered to ensure safety, in the event the dialysis tubing becomes disconnected from the patient, and the patient bleeds).


10. The hospital failed to ensure infection control practices were adequate, on the Dialysis Unit relative to storage of supplies/equipment in dialysis stations.

a. The Hospital policy for Infection Control in Hemodialysis, revised 2/2011, indicated that common supply storage will be separate from the dialysis unit patient care area. All items brought to the patient bedside for potential or actual use for dialysis services will be considered contaminated to that patient. Supplies will be discarded or cleaned and disinfected after use before returning to storage. No food or beverages will be consumed or stored in the dialysis unit.

b. During observation on 1/7/16 at 12:35 P.M., the Surveyor observed Station H, labeled "Isolation." Inside the room was a portable Reverse Osmosis (RO) machine, propping the door open. Inside, was a dialysis machine ("Fresenius 2008K"), a metal, two-tiered shelf, which held cleaning/disinfectant solutions spray bottles (considered contaminated), an open, 16 ounce bottle of Betadine solution (skin disinfectant), dressing supplies, face masks, and miscellaneous equipment. There was a blue-colored linen hamper which contained soiled linen and an open trash receptacle. Nothing inside the Isolation Room was labeled as being Isolation. There was no patient in the Isolation Room at this time. Proper infection control practices had not been provided by combining clean and contaminated equipment/supplies on the same shelf. Storage of equipment in the Isolation Room should be labeled Isolation to prevent cross-contamination and no supplies should be stored in room unless for isolation room only.

c. During interview (on 1/7/16 at 1:18 P.M.), Charge Nurse #1 said that the Isolation Room is used for Hepatitis B patients, Tuberculosis (TB) patients, droplet and contact precaution patients and for patients with behaviors. Charge Nurse #1 said that the equipment is disinfected after each patient use, whether on precautions or not.

d. During observation on 1/7/16 at 12:40 P.M., the Surveyor observed (just outside and to the immediate right of the Isolation Room), a small Kitchenette (left wall partition was the outside wall of the Isolation Room). To the right of the entrance into the Kitchenette was a beige-colored, metal, open shelf (approximately 4 feet high). The open shelf stored several gallons containing various dialysate solutions.

Inside, to the left, in the open-concept Kitchenette, was a small sink with dirty mugs soaking, a dish drainer with several dishes, cups and various utensils stored, a microwave and a portable coffee dispenser. There were coats hanging, with shoes, sneakers and satchels stored on the floor.

During interview on 1/7/16 at 12:40 P.M., Charge Nurse #1 said that the small Kitchenette, located openly on the dialysis unit, was where dialysis staff take breaks and eat, as the unit is so busy, they cannot leave it unattended. Charge Nurse #1 said that it probably wasn't proper infection control practices to eat and drink beverages in the open Kitchenette, just outside the Isolation Room and behind where dialysis supplies were stored for patient use, and would check into this.

e. On 1/7/16 at 12:42 P.M., the Surveyor observed Patient #102 being dialyzed in a bed at Station G. There were 6 white and blue pillows piled up on a counter, next to a wadded up, yellow protective gown behind the patient's bed. There were 2 bedside chairs, a large biohazard bin, a large, blue linen hamper, a sharps bucket and a bed side table, all stored inside the Station. A large, yellow-colored canvas bag was suspended from a hook with a stethoscope draped over it on the wall, to the right of the entrance into this Station. The Station was very crowded with extraneous supplies.

During interview, Charge Nurse #1 said that there was no place to store all the supplies, and that the pillows on the shelf in Station G could be used for any patient who needed an extra. She could not say if all equipment in the station was disinfected after each patient.

f. On 1/7/16 at 1:10 P.M., the Surveyors observed Oxygen and Suction machine equipment stored openly in bins, in open shelving at Dialysis Stations A, B, C, D, E and F. In addition, Station C had an Ambu-bag stored (used if resuscitation were required); Station E had two pillows stored on the windowsill. Station F had 4, two-gallon containers (used to mix Bicarbonate for patient's dialysis treatments. Isolation Room stored a dialysis machine which required prepared Bicarbonate solution for dialysis treatments).

On the counter at Stations A, B, C, E and F were 16 ounce bottles of opened Betadine Solution, and other various treatment supplies (storing treatment supplies, used on patients receiving dialysis should be stored in one central supply area, and not in patient's stations, which increase the risk of cross-contamination and violates hospital policy).

During observation (on 1/20/16 at 8:35 A.M.), the Surveyor observed open, red-colored bins which held various treatment supplies, stored in each station of the dialysis unit.

During interview (on 1/20/16 at 8:42 A.M.), the Assistant Clinical Manager and Charge Nurse #1 said that they did not know the facility could not store these types of supplies in each station, but understood the risk of cross-contamination, and would disinfect and re-locate the supplies to a common supply area.

g. There was a sink area between Stations E and F which stored solutions for testing/calibration of Phoenix Meters (devices used for testing pH and conductivity in dialysis machines). There was also an opaque faucet device, adjacent to the metal faucet, and a drain tube resting in the sink (coming from the testing solutions).

Charge Nurse #1 said that the Dialysis Unit did not have any "Dirty" or contaminated sinks, and that this sink was considered a "hand washing" clean sink. Charge Nurse #1 said that this is the sink used for Phoenix Meter testing/calibration, as well as, for mixing Bicarbonate solutions (mixed and prepared in this sink for use in the Isolation Room when the Fresenius 2008K was utilized) for dialysis treatments, and that the opaque faucet was RO water (required to mix bicarbonate solution). Charge Nurse #1 considered the supplies and use for the sink, then said, the sink should be labeled as being "Dirty," and should not be used as a hand washing sink.
VIOLATION: GOVERNING BODY Tag No: A0043
Based on observations, staff interview and review of documentation, the Hospital failed to have an effective governing body who is legally responsible for the conduct of the hospital. Finding include:

During interview on 1/20/16 at 1:30 P.M., Medical Doctor (MD) #1 said that the Board of Trustees (who is the Governing Body) are responsible for the overall conduct of the hospital.

The governing body failed to effectively ensure the hospital:

1. Had a program to ensure adequate Infection Control Practices in the acute renal dialysis unit

See A747.

2. Provided dialysis patients dialysis care in a safe setting.

See A044.

3. Performance Improvement Program/Committee were responsible and accountable for identifying, analyzing, and tracking issues of patient safety on the acute dialysis unit.

See A0286.

4. Maintained the Acute Renal Unit and Water Room Department in a manner to ensure an acceptable level of safety and quality.

See A0724.

5. The Infection Control Officer or Officers developed and implemented a system for identifying and controlling the spread of infections and communicable diseases relative to exposure of patients/personnel to the Hepatitis B Virus Infection.

See A0749.
VIOLATION: PATIENT SAFETY Tag No: A0286
Based on document review and staff interview, the facility failed to ensure that the Performance Improvement Program/Committee were responsible and accountable for identifying, analyzing, and tracking issues of patient safety on the acute dialysis unit. Findings include:

Review of the Acute Dialysis Daily Census Sheets from 1/2015 to 1/2016, indicated that the dialysis unit:

- Exceeded the limit of 8 available treatment stations for patients per shift by crowding patients between stations and using portable (Reverse Osmosis (RO) machines;

- Did not follow policy and procedure regarding initiation and termination of treatment;

- Did not follow hospital policy for hand hygiene and personal protective equipment;

- Did not follow hospital policy and procedure for treating Hepatitis B patients to include using a designated dialysis machine and equipment, and did not follow the policy for disinfection process of dialysis machines.

During discussion on 1/8/16 at 4:15 P.M., Charge Nurse #1 said the nursing practices on the unit has been the same for years, and that no one realized there was an issue.

During interview on 1/20/16 at 1:20 P.M., Medical Doctor (MD) #1 and the Chief Infection Control Officer (CICO) told the Surveyors that the Performance Improvement Committee (PIC) was not aware there were any issues/concerns on the acute dialysis unit, therefore, the Board of Trustees (Governing Body) were not aware of any issues/concerns either.

Please refer to A749.
VIOLATION: INFECTION CONTROL Tag No: A0747
Immediate Jeopardy


Based on observation, record review and interview, the Hospital was found to have immediate threat to health and safety for 14 of 102 sampled patients (#2, #3, #4, #13, #14, #88, #89, #90, #91, #92, #93, #98, #99 and #102) related to: (1) The Hospital failed to follow its own policies for Dialyzing Hepatitis B positive (+) patients, which state patients who are Hepatitis B + will have a dedicated dialysis machine (to decrease the risk of transmission of blood borne infections to other patients), and if the isolation room and dedicated machine are terminally disinfected (done when a hepatitis B + patient is no longer on the dialysis unit's census and the room and machine can be used by general patients again) , the dialysis machine will go through two bleach disinfection cycles and the environmental services "clean line" will terminally clean the isolation room. (2) The Hospital failed to ensure dialysis machines were properly disinfected after use on Hepatitis B + patients, in accordance with hospital policy before use on non-Hepatitis B immune patients, placing patients at risk for becoming infected with Hepatitis B. (3) The hospital failed to follow national standards of care by not dedicating the isolation room, dialysis machine and equipment to Hepatitis B + patients, while on census in the dialysis unit, to minimize the potential of cross contamination and spread of infectious disease.
Findings include:

According to the Centers of Disease Control and Prevention (CDC) publication: Recommendations for Preventing Transmission of Infections Among Chronic Hemodialysis Patients (April 27, 2001), which sets the current standards for care in hemodialysis units for Hemodialysis in Acute-Care Settings, patients with acute renal failure who receive hemodialysis in acute-care settings, Standard Precautions as applied in all healthcare settings are sufficient to prevent transmission of bloodborne 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. If both acute and chronic renal failure patients receiving hemodialysis in the same unit, these infection control precautions should be applied to all patients. Regardless of where in the acute-care setting chronic hemodialysis patients receive dialysis, the Hepatitis B Antigen (HBsAg) status of all such patients should be ascertained at the time of admission to the hospital, by either a written report from the referring center (including the most recent date testing was performed) or by a serologic test. The Hepatitis B Virus (HBV) serologic status should be prominently placed in patients' hospital records, and all health-care personnel assigned to these patients, as well as the infection control practitioner, should be aware of the patients' serologic status. While hospitalized , HBsAg-positive, chronic hemodialysis patients should undergo dialysis in a separate room and use separate machines, equipment, instruments, supplies, and medications designated only for HBsAg positive patients. While HBsAg positive patients are receiving dialysis, staff members who are caring for them should not care for susceptible patients.

1. Review of the Hospital's Policy, "Dialyzing the Hepatitis B Positive Patient..." indicated:

- Designated Machine - This machine can only be used to dialyze this Hepatitis B Patient. If 2 or more Hepatitis B + patients are admitted at the same time, each patient must have their own dialysis machine.

- Off Unit treatments - Any treatment not done in the Acute room (isolation room in the dialysis unit), the dialysis machine must be designated to that patient, and if the patient is moved, the machine must move with them.

- At end of any dialysis treatment, including using a designated machine for a Hepatitis patient, the dialysis machine must go through 1 complete bleach disinfectant rinse.

2. Terminal Cleaning of Isolation Room.

- When the Hepatitis B Positive patient has been discharged from the dialysis unit, the dedicated dialysis machine must go through two bleach disinfection cycles (This procedure prepares the isolation room and the dialysis machine for safe use on the next patient).

- Call "clean line" to have the room cleaned.

3. Review of the policy and procedure entitled, "Hemodialysis Machines, End of Day Procedures..." indicated:

- For Gambro Phoenix machines, determine Hepatitis status of patient.

- If Hepatitis B +, follow machine isolation procedures, as noted in Hepatitis B + policy. "Machine must be isolated for specific patient."

4. Review of the 1/2015 Acute Dialysis Daily Census Sheets (Treatment Sheets) indicated the facility's policy for use of a dedicated dialysis machine for Hepatitis B positive patients was not followed as evidenced by:

a. on 1/8/15, Patient #3, who was Hepatitis B +, was dialyzed on Machine G2. Post treatment, Machine G2 was bleached once and not twice per policy. Patient #3 was a chronic community dialyzed patient who was readmitted to the hospital for treatment of pneumonia.
On 1/9/15, Patient #4 (immunity to Hepatitis B) was dialyzed on Machine G2. The machine was cleaned with vinegar after this treatment. Machine G2 was not dedicated to Patient #3 with Hepatitis according to the hospital policy and was not terminally cleaned per hospital policy before used on a non-hepatitis B positive patient, increasing the potential for cross contamination with blood borne pathogens.

b. On 1/26/15: Patient #2 (Hepatitis B +) was dialyzed on Machine G2. Post treatment, Machine G2 was rinsed with Vinegar and not bleached twice per policy.
On 1/26/15: Patient #14 (an immune patient) was dialyzed on Machine G2 the next shift. Machine G2 was bleached once after that treatment, increasing the risk of cross-contamination. Machine G2 was not dedicated to Patient #2 with Hepatitis according to the hospital policy and was not terminally cleaned per hospital policy before used on a non-hepatitis B + patient, increasing the potential for cross contamination with blood borne pathogens.

c. On 1/27/15, Patient #13 (susceptible for contracting the Hepatitis B infection) was dialyzed on Machine G2, which was not properly disinfected with bleach twice after being used Patient #2 (on 1/26/15), thus making it a possibility for Patient #13 to contract Hepatitis B virus infection. After Patient #13's treatment, Patient #15 (immune to Hepatitis B) was dialyzed on Machine G2. The Hospital did not follow its' policy for using a dedicated machine for Hepatitis B positive patients.

d. On 2/2/15: Patient #2 (Hepatitis B +) was dialyzed on Machine G2, for the first shift. Post treatment, Machine G2 was not bleached twice per policy. A vinegar rinse was done.
On 2/2/15: Patient #88 (immune status) was then dialyzed on Machine G2 for the next shift. a dedicated machine was not used per policy for Patient #2.

e. On 2/17/15, Patient #89 (Hepatitis B +) was dialyzed on Machine G3. Post treatment, Machine G3 was rinsed with Vinegar and not bleached twice per policy.
On 2/17/15, Patient #90 was then dialyzed on Machine G3 (susceptible for contracting Hepatitis B virus), increasing the risk for transmission of the Hepatitis B infection. Post treatment, Machine G3 was bleached once. The Hospital failed to follow its' policy for use of a dedicated machine for Patient #89, failed to follow its' disinfection procedures for a hepatitis B machine and placed Patient #89 at risk for contracting blood borne diseases.

f. On 1/2/16, Patient #2 was dialyzed in the Isolation Room for the first shift on Machine G11. Post dialysis, Machine G11 was rinsed with vinegar and descaled, then bleached once and not twice per policy.
On 1/2/16, Patient #91 (immune status) was dialyzed in the Isolation Room using Machine G11 for the second shift, after the machine had been improperly disinfected. The Hospital failed to follow its' own policy for using a dedicated machine for Patient #2 who had Hepatitis B infection.

d. On 1/5/16: Patient #2 ( hepatitis B positive) was again dialyzed in the Isolation Room on Machine G11. Post dialysis treatment, Machine G11 was disinfected twice with bleach, per policy.
On 1/5/16, Patient #93 (susceptible for contracting Hepatitis B) was dialyzed on the next shift in the Isolation Room, on machine G11. The Hospital failed to follow its' own policy for using a dedicated machine for Patient #2 who had Hepatitis B infection.


5. Review of machine disinfection logs indicated that between 5/2/15 and 10/27/15, 52 of approximately 116 patients' dialysis machines were not disinfected after use per hospital policy. This increased the risk to the 52 patients for transmission of blood borne diseases.

6. The hospital failed to follow national standards of care by not dedicating the isolation room, dialysis machine and equipment to Hepatitis B + patients, while on census in the dialysis unit, to minimize the potential of cross contamination and spread of infectious disease.

a. On 12/27/15, Patient #2, a hepatitis B positive patient, was dialyzed in the Isolation room on the dialysis unit. On 12/28/15, Patient #92 (non-Hepatitis B) was dialyzed in the Isolation Room, despite having Station E open.

b. On 12/29/15: Patient #2 (Hepatitis B +) was dialyzed in the Isolation Room. However, on 12/29/15, 12 of 14 patient dialysis machines had no indication the machines were disinfected, including Patient #2 (Hepatitis B +)who was dialyzed in the Isolation Room, using Machine G 11. This increased the risk to the 12 patients for transmission of blood borne diseases.

c. On 1/2/16, Patient #2 was dialyzed in the Isolation Room for the first shift on Machine G11. Post dialysis, Machine G11 was rinsed with vinegar and descaled, then bleached once.
On 1/2/16, Patient #91 (immune status) was dialyzed in the Isolation Room using Machine G11 for the second shift, after the machine had been improperly disinfected for use on a non-hepatitis B patient. Post dialysis treatment, Machine G11 was rinsed with vinegar and descaled. The Hospital failed to follow its' policies for disinfection of machines before using on a non-hepatitis B patient and failed to follow national standards for using a dedicated isolation room when a Hepatitis B patient is on census.

d. On 1/5/16: Patient #2 was again dialyzed in the Isolation Room on Machine G11. Post dialysis treatment, Machine G11 was disinfected twice with bleach, per policy.
On 1/5/16, Patient #93 (susceptible for contracting Hepatitis B) was dialyzed on the next shift in the Isolation Room, despite having a Hepatitis B + patient in that room the shift before.

6. Hepatitis B virus lives on surfaces up to seven days and is capable during that time of transmitting disease. Inadequate or improper cleaning with inadequate bleach contact time or storage of equipment on contaminated surfaces allows the virus to survive between patients and increases the likelihood that transmission will occur.

During observation on 1/7/16 at 12:35 P.M., the Surveyor observed Station H, labeled "Isolation." Inside the room was a portable Reverse Osmosis (RO) machine, propping the door open. Inside, was a dialysis machine ("Fresenius 2008K"), a metal, two-tiered shelf, which held cleaning/disinfectant solutions spray bottles (considered contaminated), an open, 16 ounce bottle of Betadine solution (skin disinfectant), dressing supplies, face masks (these cannot be disinfected and would have to be disposed of), and miscellaneous equipment. There was a blue-colored linen hamper which contained soiled linen and an open trash receptacle. Nothing inside the Isolation Room was labeled as being Isolation. There was no patient in the Isolation Room at this time. Proper infection control practices had not been provided as evidenced by cohorted clean/contaminated equipment on the same shelf, and storage of equipment in the Isolation Room which should be labeled Isolation to prevent cross-contamination.

During interview (on 1/7/16 at 1:18 P.M.), Charge Nurse #1 said that the Isolation Room is used for Hepatitis B patients, Tuberculosis (TB) patients, droplet and contact precaution patients and for patients with behaviors. Charge Nurse #1 said that the equipment is disinfected after each patient use, whether on precautions or not.

During interview on 1/20/16 at 10:50 A.M., the Director of Clinical Engineering (DCE) said that all dialysis machines should be disinfected as if they were Hepatitis B contaminated, and are supposed to be disinfected in accordance with the facility's policy. However, the policy indicated that each machine should be bleached twice, only after exposure with a Hepatitis B patient.

The hospital did not follow its own policies for use of a dedicated machine for hepatitis B positive patients or national standards of care by failing to dedicate the isolation room to Hepatitis B positive patients on census, risking exposure of Hep B non-immune patients to cross contamination with blood borne pathogens (Hepatitis B).
VIOLATION: MEDICAL STAFF - ACCOUNTABILITY Tag No: A0049
Based on observation, staff interview and review of hospital documentation, the governing body failed to identify responsible conduct of the dialysis unit and the quality of care provided to patients. Findings include:

Review of the monthly Hospital's Board Meeting Minutes (Governing Body) indicated there was no documentation regarding infection control and patient safety issues on the dialysis unit.

Observation, review of the Dialysis Unit's policies and procedures, review of medical records and interview with staff indicated the dialysis unit staff were not following hospital policy and procedures regarding:
- Infection Control in Hemodialysis and Peritoneal Dialysis, which includes for hepatitis B positive patients the use of a separate room, dedicated dialysis machine and equipment while on census.
- Hand Hygiene
- Hemodialysis Machines, End of Day Procedures for disinfection including procedures for Hepatitis B positive patients.
- Initiation and Termination of Dialysis for Patients with a Fistula/Graft.
- Initiation and Termination of Dialysis Patients with a Central Venous Catheter.
- Dialyzing the Hepatitis B Positive Patient (nursing policy)
- Environmental Services Terminal Cleaning.
- Standard Body Substance Precautions (BSP).
- Personal Protective Equipment

Review of the Acute Dialysis Daily Census Sheets from 1/2015 to 1/2016, indicated that the dialysis unit was:
- Exceeding the limit of 8 available treatment stations by crowding patients between stations and using portable ROs (Reverse Osmosis machines) increasing the potential for cross contamination;
- Not following policy and procedure regarding initiation and termination of treatment;
- Not following hospital policy for hand hygiene and personal protective equipment;
- Not following hospital policy and procedure for treating Hepatitis B patients by use of designated machines, equipment, isolation room and the disinfection process of their machines.

During interview on 1/20/16 at 1:20 P.M., Medical Doctor (MD) #1 told the surveyors that if anyone had known of these issues, they would have been discussed at the Board Meeting and a plan discussed to resolve these issues.

Please refer to A749.