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Based on observation, interview and record review, the facility's Governing Body failed to ensure effective oversight for the safe operation of this facility.

The facility's Governing Body failed to monitor the services provided by the contracted dialysis service to facility's patients, to ensure that medical devices used to dialyze patients were safe for use.

The Governing Body failed to ensure medical devices used by facility's contracted services for hemodialysis were not expired and that manufacturer's recommendation were followed for the use of Diasafe filters that were attached to hemodialysis machines in use for patient's hemodialysis treatment.


The Governing Body failed to ensure that dialyzers on an Urgent Medical Device Recall list were not used on facility's patients;


This failed practice had the potential for causing harm to all patients that used the the recalled dialyzers. Citing 12 of 20 sampled patients #s 1-12

Based on observation, interview and record review, the facility's Governing Body failed to ensure effective oversight for the safe operation of this facility.

The facility's Governing Body failed to monitor effectively the services provided by the contracted dialysis services to the facility's patients.

The facility's Governing Body failed to ensure that medical devices used to dialyze patients were safe for use.

The facility's Governing Body failed to ensure that the medical devices used by facility's contracted services for hemodialysis were not expired and that manufacturer's recommendation were followed for the use of Diasafe filters that were attached to hemodialysis machines in use for patient's hemodialysis treatment.

The Governing Body failed to ensure that dialyzers on an Urgent Medical Device Recall list were not used on facility's patients.

This failed practice had the potential for causing harm to all patients that used the recalled dialyzers. Citing 12 of 20 sampled patients #s 1- 12

Findings:

Review on 07/10/2014, of the facility's Rules and Regulation of the Governing Board, revised May 16, 2012, stated: " The purpose of the Governing Board is to recommend and implement Hospital policy, promote patient safety and performance improvement, provide quality patient care , and provide for organizational management and planning of the Hospital. The Governing Board has ultimate responsibility and legal authority for safety and quality of care, treatment and services rendered in the Hospital , including all on and off - campus provider based entities."

During an interview on 07/09/2014, at 8:03 a.m., during the Entrance Conference, the Surveyor informed the Facility's Administrator, the Facility's Chief Nursing Officer and the Facility's Director of Quality of the nature of the complaint allegation (Use of recalled dialyzers on a facility's patient.) The administrative staff present informed the Surveyor that they were not aware of any recalled notice regarding medical device utilized by the contracted service provider for hemodialysis treatment of the facility's patients.

Interview on 07/09/2014, at 8:25 a.m., with the Director of Material Management revealed that she had received a call from the FDA regarding recalled dialysate solution but she was not notified of any recall notice for dialyzers. She said that the contracted dialysis provider did not notify them of a recall notice for certain dialyzers.

Interview on 07/09/2014, at 8:27 a.m., with the Facility's Liaison for dialysis services revealed that she is assigned as the Liaison between the facility and the contracted dialysis provider. She said that the contracted provider for dialysis service at the facility did not notify her of a recall of any medical devices in use in the facility for dialysis.

During an interview on 07/09/2014, at 9:10 a.m., with the Clinical Coordinator of the contracted dialysis service, the Surveyor asked the Clinical Coordinator if she was aware of a product recall notice for Revaclear and Revaclear Max Dialyzers and if the facility was notified of the product recall. The contracted service Clinical Coordinator said that she was aware of the product recall but the facility was not notified of the recall because she was waiting on the Regional Operation Director of the company to send the notice to the Facility. She said that the contracted service had initiated a product recall log but this was not shared with facility's staff.

Interview on 07/09/2014, at 10:15 a.m., with the Assistant Facility Administrator of the contracted dialysis service, she said that the facility's staff was not notified of the recall notice because she was waiting on "corporate" to come down to notify facility's staff.

Review on 07/09/2014, of the following recall notice from the manufacturer of the Revaclear and Revaclear Max dialyzer revealed the following notice:

"Urgent: Medical Device Recall ...Reference OPAL-2014-01...April 14, 2014 Revaclear / Revaclear Max Dialyzer's

Dear Customer,

Gambro is sending you this communication to advise you of the possibility of internal blood leaks occurring in certain Lots of Revaclear / Revaclear Max dialyzers distributed during the recent winter months (December 2013 - March 2014). This can be caused if a dialyzer case is handled roughly during transportation while simultaneously being exposed to freezing temperatures. The impact shock origination from rough handling may cause damage to a frozen membrane which could result in an internal blood leak.

If fibers are damaged in the dialyzer, minute amounts of blood could pass into the dialysate. When this happens during a treatment, the Dialysis Machine will automatically stop the blood pump and trigger a Blood Leak Alarm, thereby avoiding any blood loss.

Consecutive use of dialyzer's with damaged fibers on the same patient in combination with not returning the blood in the circuit to the patient may lead to an accumulation of blood loss that could require the administration of adequate solution to compensate for the blood loss.

Gambro takes its responsibilities to its customers and their patients very seriously and, in response to this situation, requests that you take the following actions:

If you have any remaining Revaclear / Revaclear Max dialyzers from the lots listed on the following page in your inventory, please remove them from inventory and place them in quarantine for collection and replacement.

Provide the request information in the attached Customer Reply Form and return it to Gambro Regulatory Affairs department as indicated on the Customer Reply Form.

Bring this notice to the attention of all who need to know or be aware of within your facility, and to any third party to which any products from the affected lots may have been transferred.
Maintain awareness of this notice internally until all actions have been completed within your facility.

If you take the actions recommended in this notice, there is no risk of any harm to the patient".

The List dated 4/14/2014, had the following information:

"Gambro has determined that single cases of the following lots of Revaclear and /or Revaclear Max dialyzer's may be affected." Revaclear Max Lot # C 414200701, C 413128101 and C413129101 were listed.

Review on 07/09/2014, of the following patients' clinical records (treatment sheet and physicians' orders) revealed that recalled dialyzers with lot #s C414200701, C413129101 and C413128101 were utilized to dialyze hemodialysis patients after they were recalled by the manufacturer:
Review of the patients' clinical records revealed multiple patients were dialyzed with the recalled dialyzers on more than one occasions.

The usages of the recalled dialyzers are as follows:

Between April 16, 2014 and May 21, 2014, a total of twelve (12) recalled Revaclear Max Dialyzers Lot # C414200710 were used to hemodialyze a total of eleven ( 11 ) patients.

Between April 18, 2014 and May 24, 2014, a total of two (2) recalled Revaclear Max Dialyzers Lot # C413128101 and Lot # C413129101 were used to hemodialyze a total of ( 2 ) patients.

Review of a sample of patients' clinical records revealed the following patients were dialyzed with recalled Revaclear and Revaclear Max dialyzers after the recalled notice was issued by the manufacturer:

Patient #1 utilized recalled dialyzers Lot # C 414200701 on 4/30/2014 and Lot # C 413128101 on 05/24/14 for hemodialysis treatment.

Patient #2 utilized recalled dialyzer Lot # C 414200701 on 05/06/2014

Patient #3 utilized recalled dialyzer Lot # C 414200701 on 05/02/2014 and on 05/19/2014

Patient #4 utilized recalled dialyzer Lot # C 414200701 on 05/21/2014

Patient #5 utilized recalled dialyzer Lot # C 414200701 on 05/14/2014

Patient #6 utilized recalled dialyzer Lot # C 414200701 on 05/20/2014

Patient #7 utilized recalled dialyzer Lot # C 414200701 on 05/05/2014

Patient #8 utilized recalled dialyzer Lot # C 414200701 on 05/13/2014

Patient #9 utilized recalled dialyzer Lot # C 414200701 on 05/03/2014

Patient #10 utilized recalled dialyzer Lot # C 414200701 on 04/30/2014

Patient #11 utilized recalled dialyzer Lot # C 414200701 on 04/28/2014

Patient #12 utilized recalled dialyzer Lot # C 413129101 on 04/18/2014

Review of the facility's Dialysis Contract revealed the listed responsibilities of the contract service to the facility did not include a responsibility to inform the facility when there was a recall notification on the equipment/supplies that the Contract service purchased

Expired medical supplies:

Observation on 07/09/2014, at 8:25 a.m., of the stock room of the contracted dialysis services revealed the following medical items that were observed co-mingled with medical items for use on patients during hemodialysis treatment:

Three Medisystems needles set, Lot # 9105F2, Code BH- 7006 16 X 1 back eye clamp expired January 2012.

One Medisystems needles set, Lot # 8Z09F2, Code BH- 7006 16 X 1 back eye clamp expired December 2011.

Diasafe filters

Observation on 07/09/2014, at 8:28 a.m., of the facility's contracted dialysis services stock/ equipment room revealed a Fresenius K2 hemodialysis # 172-3 kos-18706. Attached to the back of the hemodialysis machine was a Diasafe filter. The label on the filter indicated that the filter was last replaced on 02/10/2014.


During an interview on 07/09/2014, at 9:10 a.m., with contracted service Clinical Coordinator ( in the presence of the Facility's Director of Quality) revealed the hemodialysis machine stored in the room was a backup machine for patients' hemodialysis treatment.

The Surveyor notified her that the Diasafe filter on the hemodialysis machine was not replaced every 90 days as per the manufacturer's recommendation.

The Clinical Coordinator informed the Surveyor that the Diasafe filter should be changed every 6 months.

Patient #13
On 07/09/2014, at 9:4 0 a.m., Patient #13 was observed receiving hemodialysis treatment in the facility. The patient was using a Fresenius K2 hemodialysis machine. Attached to the back of the hemodialysis machine was a Diasafe filter. The label on the filter indicated that the filter was last replaced on 01/19/2014.

Review of the facility's current policy and procedure (contracted company policy and procedure adopted by the facility) on Fresenius A200K, K2 automated Diasafe Plus Filter integrity test post chemical rinse cycle, #2-02- 01Q directed staff as follows: "The use of a Diasafe Plus Filter is not to exceed 90 days. After replacing the Diasafe Plus filter, perform either the automated test function or a manual pressure holding test and then perform the Diasafe Plus filter integrity test. After replacing the Diasafe Plus filter, the delivery system needs to be heat disinfected prior to patient use."

Review on 07/09/2014, of the manufacture's preventative maintenance semi- annual maintenance checklist, (page # 65) directed users as follows: "Clean filters (replace if necessary, inspect Pre- UF pump filter Inspect UF Pump Check Valves (replace if necessary), Check High Voltage AC Connections, Calibrate UF pump, Check Conductivity with External Meter, Check Temperatures with External Meter, Check Alarm Operations and Pressure Holding Test, Check Power Failure Alarm."

Review on 07/09/2014, of the manufacture's package insert for Diasafe Plus Fluid Filter directed staff as follows: " Diasafe Plus Filter must be exchanged after 12 weeks or 100 treatments (ONLINE plus) or earlier if the filter fails the integrity test. "