Davita Montclair recert

"The cumulative effect of these systemic practices had the potential to transmit infectious diseases to all 118 hemodialysis patients and staff. The facility failed to ensure compliance with Federal Regulations for the Condition of Participation: Infection Control"

COMMENT:  The only thing that I can state here is that this supports my ongoing advocacy and beliefs that staff are not adequately trained and educated in areas such as full understanding of patient consequences when correct practices are not implemented e.g. infection, death from infection, increased costs, etc. Additionally, staff should understand that if they are not implementing correct practices, they might be bringing these nasty germs home to their own families. I have continually stated that there is ineffective unit-level supervision in many facilities. First, and, foremost, the unit-management team must fully understand all aspects of infection control in order to ensure that staff are conducting safe practices. Hence, this shows that there was a lack of staff adequate staff training and education and unit-level supervision.

".....the facility failed to ensure that corrective measures were taken promptly when test results of the product water used to prepare dialysate (solution used for dialysis treatment) indicated high microbial level above the allowable limit which had the potential to result in life threatening infection to 118 patients" (21/21 of 89 of survey)

COMMENT:  Again, a situation that is frightening. The bacteria levels were high enough to cause serious harm to patients. However, the "...facility policy did not indicate a time frame as to when to reculture when microbial results were high...." according to the staff.  UNFORTUNATELY, the survey does not state how many patients acquired an infection, or were ill during this time frame when microbial counts were high. Again, a concern regarding education, training and supervision of staff. However, what is even more concerning is the lack of a complete policy/procedure to address such.

"...... the facility failed to ensure health and safeaty of two (2) unsampled patients...................by failing to check identifying  information on the dialyzers and identifying the patient prior to the initiation of dialysis treatment which resulted in 2 patients being placed on dialysis using dialyzers that belonged to other patients" "During an interview tieh PCT 4 on 12/30/09, at 3:45 PM, the technician stated, "We're (PCT 4 and 5) suppose to verify identification of the dialyzer and the patient before initiating treatment and that's where we failed."
"... the Nurse Manager stated that part of the corrective action that was implemented was inservice training on identification of reuse dialyzers given to all patien care staff". HOWEVER, "........the Nurse Manager reviewed the inservice attendance record and failed to find documenation indicating that PCT 5 and 6) (staff involved in wrong dialzyers used on patients) had attended the inservice training."

COMMENT:  This is yet a problem that happens more than it should. And, it should NEVER happen if staff are adhering to their facility's policies and procedures. In fact, if staff are aware, and are not implementing, then one could ask "Is this an intentional act that places patients in harm's way?  When a providers use 'reuse' versus 'single-use' they must ensure that all staff understand thoroughly that their lack of implementing correct practices can result in patient harm. If a policy calls for two staff to check such, then one must ask why are these staff not doing such. I remember onc incident that made media attention and the provider stated that they were changing their policy to three staff checking. This is not necessary. In fact, providers and staff state how busy they are, not enough time. So, the question is, "Why have three staff be involved in a procedure that if done correctly only requires two staff?" This takes another staff away from patient duties. So, instead of looking at why this happened and asking staff, "Was there a reason you did not follow the facility policy", then, moving forward to correct 'why' the staff did not implement such

"The cumulative effect of these systemic practices had the potential to result in creating multiple risks to patients' health and safety. The facility failed to ensure compliance with the Conditions of Participation: Physical Environment."

The facility failed to:

(1) "Maintain an operative electrical outlet at a treatment station where patients received dialysis treatment services and ensure that trash cans within the facility were maintained clean and sanitary:

(2) "Ensure that sufficient space between patients was provided during dialysis treatments:

(3) "Maintain a comfortable temperature level and/or make reasonable accommodations for 3 unsampled patients who were not comfortable at the level of temperature of the facility".

(4) "Ensure that multiple patients receiving dialysis treatments had their vascular access (method used to gain access to the blood stream) sites exposed and able to be seen by staff members during dialysis treatments."

COMMENT: Temperature is a major problem for many patients and often I hear from patients that the room temperature is set more for staff convenience than patients. I have also heard from many patients, throughout the US, that they stop bringing forth such concerns regarding coldness because 'they (staff) do not do anything about it).

Often patients are labeled as 'noncompliant' because they will not keep their access site uncovered. However, the question that needs to be asked is 1. Have staff asked the patient why they cover their access, that is, if they are aware it is to be uncovered? 2. Have staff even explained the importance of such? 3. If the patient is cold, have staff helped the patient resolved such? Do patients have a clear understanding of the dangers of bleeding? Do staff remind patients to uncover access sites? Do staff check access sites?

Many times chairs in unit are so close that blood can splatter .. This is potentially very dangerous and supports an environment where there is a high level of potential for transmission of infectious agents.

"The facility failed to maintain a safe and functional treatment environment for a universe of 118 patients by failing to:"

1. "Maintain an operative electrical outlet at a treatment station where patients were received dialysis treatment services which had the potential to result in failure to use emergency equipment promptly delaying the delivery of care and further risking serious health problems or death in the event of an emergency."

2. Ensure that trash cans within the facility were maintained clean and sanitary which had the potential to result in the transmission of infectious diseases to all patients, staff and visitors.

COMMENT: It is apparent that staff do not under the importance of all aspects of infection prevention and control. Do they realize that they can bring these infectious agents home to their own families, as well as out into the community at large?

 "....the facility failed to ensure that sufficient space between patients was provided during dialysis treatments which had the potential to result in cross-contamination between patients and would potentially not allow space for emergency equipment and staff to provide care in time of emergency." 

COMMENT: Staff acknowleged that the patients were sitting too close to each other and the first question that comes to my mind is the following: Did the facility have more chairs in order to accomodate more patients, knowing that it would be unsafe to have dialysis chairs in such close proximity?

" ....the facility failed to maintain a comfortable temperature level and/or make reasonable accommodations........................"

COMMENT: Patients complaining of being cold is a common complaint. I have heard from many patients, throughout the US that they complain once and if nothing is done, they don't complain again, they just suffer with being cold. Many have told me that the their unit is kept to the comfort level of the staff and that often staff (technicians) do not even report to management that patients are complaining about being cold. This makes the dialysis treatment very uncomfortable to sit for three, or more, hours being freezing, even with blankets and heavy clothing. Perhaps staff need to sit in a dialysis chair, attached to the machine, without being able to move for several hours, in a cold, cold environment, in order to fully understand.

"...the facility failed to ensure that multiple patients receiving dialysis treatments had their vascular access (method used to gain access to the blood stream) sites exposed and able to be seen by staff members during dialysis treatments which had the potential to result in undetected accidental needle or blood line disconnections which could result in massive blood loss and death in minutes."

COMMENT: It appears, from the survey documentation, that staff were within close proximity to patients and knew their sites were covered and even with the surveyors present did not correct situation. Nothing was done, e.g. ensuring visibility of site, until brought to staff's attention. One must wonder how often this happens and how often patients bleed to death?

"....the facility failed to assess and provide interventions for severe hypertension for 1 of 11 sampled patients (Patient 8) prior to, during, and post hemodialysis treatment."

COMMENT: We must wonder how many other patients, out of the sample size had the same type of care, or lack thereof. Unfortunately, only a sample size is reviewed unless surveyors find various other problems. This is inexcusable --->the patient started treatment with an elevated blood pressure  - 212/126. Th RN assessed the patient, however, there was no evaluation or intervention for the elevated blood pressure.  The patient's treatment was terminated 40 minutes early with a post blood pressure 129/100. There was no post treatment assessment performed.  This happened three times - three different dialysis treatments. Once, the ending blood pressure was 157/129. NOTHING WAS DONE> The facility's policy/procedure was not followed e.g. '...obtain and document basic data on each patient post dialysis and compare to pre dialysis findings...:  Again, we ask, 'How often does this happen and how many times do patients have negative outcomes because of same? Obvious that the staff have not been adequately trained, or that they don't understand the importance of addressing elevated blood pressures. What is even more disturbing is that this patient had a physician's order for medication for high blood pressure, but did not receive it. Again, how often does this happen? Did this happen to others outside of the sample size? One must wonder. Chances are that if it happens to one patient in a unit it will be happening to another. Afterall, if the staff who are NOT implementing correct practices and aware of such are doing so with on patients, they are probably doing same with others.

"....facility failed to ensure that the Condition of Participation for Patient Plan of Care was met by failing to:

1. Develop a written comprehensive plan of care which included estimated timetables to achieve outcomes identified based on the comprehensive assessment for 12 of 12 sampled patients in a universe of 118 patients which resulted in failure to address the plan of care of 2 of 12 (Patient 12 and 2) sampled patients."

2. Re-evaluate, adjust and revise care plans of 3 of 12 sampled patients (Patients 2, 8 and 9) which resulted in a failure to achieve the specified goals.:

"The cumulative effect of these systemic practices had the potential to result in failure to identify and meet necessary care needs of all 118 patients. The facility failed to ensure compliance with the Condition of Participation: Patient Plan of Care.

COMMENT: Patients are suppose to be included in 'their' plan of care and provide information about their needs and wants.  Often patients are not included in meeting with the treatment team and often the staff will walk to their chair, during dialysis, and ask them to sign the treatment plan of care. Many patients have stated they do not even know what they are signing e.g. they might not feel well during dialysis

If there is no plan of care, how does a patient receive 'individualized patient care to meet their specific needs e.g. psychosocial, medical, etc.  (This might not apply in this situation).

"....the facility failed to adjust the care plan for non-compliance to dialysis treatments resulting in multiple missed treatments and frequent hosptializations." The patient missed a significant number of dialysis treatments, however the Social Worker documented "Pt has good compliance with his treatment."

Comment - Why was the patient non-compliant? Did the staff attempt to intervene to prevent such and prevent hospitalizations? Perhaps there was a reason for the patient's noncompliance.

" .... the facility failed to meet the Conditions of Participation for Quality Assessment and Performance Improvement (QAPI) by failing to:

1. Ensure that an effective data driven progam was implemented, maintained and evaluated which resulted in an ineffective prevention, identification and monitoring of health outcomes such as the prevention and reduction of medical errors.

2. "Develop an ongoing program which achieved measurable improvement in health outcomes by failing to identify or monitor trend outcomes and develop an improvement plan when needed."

3. "Measure, analyze and track aspects of performance that reflects processes of care and facility operations."

4."Ensure that an effective, date driven program identify the prevalence of occurrences, commonalities and causes of medical error identification and patient safety events such as wrong dialyzer usage which resulted in 2 patients being placed on dialysis using dialyzers that belonged to other patients.:

5. "Ensure that QAPI program analytzed and developed action plans to minimize infection transmission, promote immunization and perfrom trend analysis to reduce future incidents."

6. "Continuously monitor its outcome performance data, develop improvement action plans for identified issues, implement the action plan, evaluate and revise the action plan as indicated."

7. "Ensure that immediate corrective action took place when 2 patients were placed on dialysis using dialyzers that belonged to other patients threatening the helath and safety of other patients."

"The cumulative effect if these systemic practices had the potential to result in creating multiple risks to patients' health and safety. The facility failed to ensure compliance with the Condition of Participation: Quality Assessment and Performance Improvement."

Comment: This is why we need to have timely surveys. We must wonder how long and how many times there were preventable errors in this facility between survey times. This is also, again, what happens when staff are not adequately trained/education and supervised.

When facility staff faile to check and confirm the identity of the dialzyer and patient to ensure safety, knowing the correct practice, we must ask again, "Does this staff realize the potential dangerous situation they are placing patients in? If there is an ineffective QAPI, then the chances of preventable errors continuing is greatly possible. If the facility does not know 'why' this happened in order to correct. What is more disturbing is that the Facility Administrator '...acknowledged that the QAPI committee members should hae developed and documented including the implementation of a plan or correction in the QAPI minutes.:

In my review of surveys, even before a QAPI was mandated, facilities did not effectively implement their program. This is, yet, another reason for increased oversight. None of the signicant areas, as above, e.g. microbial counts, were addressed adequately in the QAPI. If a facility does not identify the problem, investigate to understand why the error occurred, and develop a plan so that errors don't continue, then patients continue to be placed in harm's way.

FOR MEDICAL INJURIES/ERRORS:

".......the faciity failed to ensure that an effective, data driven program identified the prevalence of occurrences, commonalities and causes of medical error identification and patient safety event such as wrong dialyzer usage, retesting product water when microbial levels were high and at unacceptable level in a universe of 118 patients.:"

COMMENT: All these identified preventable errors above place patients in situations of potential negative outcomes, including death. This is unacceptable. For a company who only does 'reuse', staff should be proficient in  the practices that support the entire reuse process. This also can be said for those who ensure that water is safe for dialysis treatment.

"The facility failed to ensure that the Condition of Participation for Responsibilities of the Medical Director was met by failing to ensure that the  oversight regarding the delivery of quality patient care was met....." (for all the above deficiencies cited on this page and in the actual survey document).

COMMENT:  A physician, Medical Director, should be able to trust his staff and trust that they are implementing correct facility policies and procedures. It is, I am sure, a difficult role for a Medical Director, especially when he/she is not present in the facility all the time. I am also betting that many Medical Directors are not aware of much of what happens in their faclities. I wonder how many physician orders have been written regarding medication for high blood pressure, etc that have not been administered? Again, something to think about.

This is why it is imperative to have ongoing oversight  --->because it is obvious that facilities left alone, this one for example, had some serious problems. If the state had not conducted the survey one must ask 'how long these preventable errors would have continued', or one must ask for' how long was this happening before the survey?'

AND, congratulations to this facility to have implemented their Plan of Correction --> the revisit showed no deficiencies. Now, let's see what happens when the next survey is conducted. Hopefully, it will be timely.