HospitalInspections.org

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.

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.

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.




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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.

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.

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).