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Based on observation, interview and record review the facility's Governing Body failed to effectively monitor contract dialysis services to ensure medical devices used to dialyze patients were safe for use;

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

The facility failed to ensure the recalled dialyzers and outdated blood collection tubes were not available for continued use by the Contract Dialysis Service at there facility.

(c) The Governing Body failed to ensure the facility's Quality Assurance Performance Improvement (QAPI) Program have systems in place that informs them when there is a Recall on medical equipment/supplies purchased by all Contracted Services in the facility. Dialyzers on an Urgent Medical Device Recall list were used on multiple facility's patients and were made available for continued use by the Contract Dialysis Service without the facility's staff having any knowledge of the recall.

This failed practice had the potential for wide spread harm to the facility's patients who receive care through contract services.

Refer to 482.12(e).
Refer to 482.21(a),(c),(2),(e),(3)

Based on observation, interview and record review the facility's Governing Body failed to effectively monitor contract dialysis services to ensure medical devices used to dialyze patients were safe for use;

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

(c) The facility failed to ensure the recalled dialyzers and outdated blood collection tubes were not available for continued use by the Contract Dialysis Service at there facility.

(d) The facility failed to ensure the recalled dialyzers and outdated blood collection tubes were not available for continued use by the Contract Dialysis Service at there facility.

This failed practice had the potential for causing harm to all patients that used the the recalled dialyzers. Citing 22 of 24 sampled patients #s 1-22 and random observations on the Acute Dialysis Unit.

Findings:

Observation at the hospital on 5/27/2014 at 11:15 am on the Acute Dialysis care unit revealed Staff (G) who stated her job title was Transporter was stocking a cupboard shelf with Revaclear (R) dialyzers. The staff was asked if the cupboard was the storage for supplies in use, and she replied "yes." She further stated supplies were stocked so that the older ones were used first.

Observation revealed a small quantity of Revaclear Max dialyzers on the supply cupboard shelf.

According to Staff (J) Registered Nurse who was present at the time of the observation, the unit chiefly use Revaclear Regular (R) Dialyzers but there were a few physicians who occasionally order the Revaclear Max.

During an interview on 5/27/2014 at 11:30 am in the Acute Dialysis Unit with Staff (B) who identified herself as the Group Administrator for the Contract Dialysis Service ,she was asked if she had knowledge of a recent recall on some Revaclear Dialyzers. Staff (B) stated she received an email with the dialyzer recall information on 4/14/2014 and they had no dialyzers with the recall numbers in stock. When asked, the Administrator presented a copy of the recall letter to the Surveyor.

Review of the Recall Notice presented revealed there was a letter and an attachment with lot numbers of Revaclear and Revaclear Max Dialyzers that were on the recall list. The letter and list revealed the following information:

"Urgent: Medical Device Recall ...Reference OPL-2014-01...April 14,2014
Revaclear / Revaclear Max Dialyzers

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 dialyzers 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 dialyzers may be affected." Revaclear Max Lot # C 414200701 was listed.

Inspection on 5/27/2014 at 11: 25 am in the Acute dialysis unit of lot numbers and expiration dates on randomly selected dialyzers and other supplies in the supply cupboard revealed eleven (11) Revaclear Max Dialyzers with the lot # C 414200701 listed on the Urgent: Medical Device Recall list-- Reference OPL-2014-01 dated April 14, 2014 was in the unit's supply cupboard amongst supplies that were available for use.

Further observation at that time revealed a carton containing 100 unopened Buffered Sodium Citrate blood collecting tubes in the cupboard had an expiration date of April ,2014.

The recalled dialyzers and expired blood collection tubes were brought to the attention of Staff (Q) the facility's Director of Quality who was present on the Dialysis Unit during the inspection.

During an interview on 5/27/2014 at 11:45 am with the Staff (B) Group Administrator of the contracted dialysis service regarding the recall information, she was asked if the dialysis staff were informed of the recall notice , she stated "no" because she was informed by their Area Manager on 4/16/2014 that none of the recalled dialyzers were in their stock. The Area Administrator stated none of the staff at the hospital physically checked to verify that there were no recalled dialyzers in their stock.

During an interview on 5/27/2014 at 12:12 pm with Staff (Q) the facility's Quality Director who was present on the Acute Dialysis Unit regarding the facility's knowledge of the recall dialyzers, she stated the facility was not notified by the contract agency that there was a recall notification.
.
Review of a list of patients who had hemodialysis treatment in the facility after the recall notice was released April 14, 2014, revealed the following information :

During the months of April, 2014 and May 2014 a total of thirty-one (31) dialyzers with the Lot number C 414200701 on the medical device recall list was used in the facility to hemodialyze twenty-two (22) patients as late as May 20,2014, more than a month after the facility received the recall notice.

Review of the clinical records revealed multiple patients were dialyzed with the recalled dialyzers on more than one occasion.

The usage of the recall dialyzers is broken down as follows:

Between April 16, 2014 and April 30,2014 a total of nineteen (19) Revaclear Max Dialyzers Lot # C 414200710 were used to hemodialyze a total of fourteen (15 ) patients.

Between May 1,2014 and May 20,2014 a total of twelve (12) Revaclear Max Dialyzer with the recall lot number C 414200701 was used on seven (7) patients.

The number of Patient who had the recalled dialyzers used for their hemodialysis treatment on multiple days were as follows:

Patient (# 1) two dialyzers,
Patient (# 3) two dialyzers,
Patient (# 9) three dialyzers,
Patient (#4) , three dialyzers
Patient (# 8) two dialyzers,
Patient # 16 two dialyzers, and
Patient # 18 two dialyzers.


Review of the facility's Dialysis Contract effective July 7, 2013 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.


Review of the facility's Bylaws of the Board of Trustees dated 2011 that was presented during the investigation revealed information that: "The Hospital shall retain overall responsibility and authority for services furnished under a contract".

Based on observation, interview and record review the facility's Quality Assurance Performance Improvement (QAPI) Program failed to have systems in place to prevent medical errors and maintain patient safety;

(c) The facility's Quality Assurance Performance Improvement (QAPI) Program failed to have systems in place that informs the hospital when there is a recall on medical equipment/supplies purchased by all Contracted Services in the facility. Dialyzers on an Urgent Medical Device Recall list were used on multiple facility's patients and were made available for continued use by the Contract Dialysis Service without the facility's staff having any knowledge of the recall.

This failed practice had the potential for wide spread harm to the facility's patients who receive care through contract service.

(Refer to 482.21(a),(c),(2),(e),(3)).

Based on observation, interview and record review the facility failed to have systems in place to prevent medical errors and maintain patient safety;

(c) The facility's Quality Assurance Performance Improvement (QAPI) Program failed to have systems in place that informs the hospital when there is a Recall on medical equipment/supplies purchased by all Contracted Services in the facility .Dialyzers on an Urgent Medical Device Recall list were used on multiple facility's patients and were made available for continued use by the Contract Dialysis Service without the facility's staff having knowledge of the recall.


This failed practice had the potential for wide spread harm to the facility's patients who receive care through contract service. Citing 22 of 24 sampled patients #s 1-22 and random observations on the Acute Dialysis Unit.


Findings:

Observation at the hospital on 5/27/2014 at 11:15 am on the Acute Dialysis care unit revealed Staff (G) who stated her job title was Transporter was stocking a cupboard shelf with Revaclear.. (R) dialyzers. The staff was asked if the cupboard was the storage for supplies in use, and , she replied "yes." She further stated supplies were stocked so that the older ones were used first.

Observation revealed a small quantity of Revaclear Max dialyzers on the supply cupboard shelf.

According to Staff (J) Registered Nurse who was present at the time of the observation, the unit chiefly use Revaclear Regular (R) Dialyzers but there were a few physicians who occasionally order the Revaclear Max.

During an interview on 5/27/2014 at 11:30 am in the Acute Dialysis Unit with Staff (B) who identified herself as the Group Administrator for the Contract Dialysis Service ,she was asked if she had knowledge of a recent recall on some Revaclear Dialyzers. Staff (B) stated she received an email with the dialyzer recall information on 4/14/2014 and they had no dialyzers with the recall numbers in stock. When asked, the Administrator presented a copy of the recall letter to the Surveyor.

Review of the Recall Notice presented revealed there was a letter and an attachment with lot numbers of Revaclear and Revaclear Max Dialyzers that were on the recall list. The letter and list revealed the following information:

"Urgent: Medical Device Recall ...Reference OPL-2014-01...April 14,2014
Revaclear / Revaclear Max Dialyzers

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 dialyzers 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 dialyzers may be affected."
Revaclear Max Lot # C 414200701 was listed.

Inspection on 5/27/2014 at 11: 25 am in the Acute dialysis unit of lot numbers and expiration dates on randomly selected dialyzers and other supplies in the supply cupboard revealed eleven (11) Revaclear Max Dialyzers with the lot # C 414200701 listed on the Urgent: Medical Device Recall list-- Reference OPL-2014-01 dated April 14, 2014 was in the unit's supply cupboard amongst supplies that were available for use.

Further observation at that time revealed a carton containing 100 unopened Buffered Sodium Citrate blood collecting tubes in the cupboard had an expiration date of April ,2014.

The recalled dialyzers and expired blood collection tubes were brought to the attention of Staff (Q) the facility's Director of Quality who was present on the Dialysis Unit during the inspection.

During an interview on 5/27/2014 at 11:45 am with the Staff (B) Group Administrator of the contracted dialysis service regarding the recall information, she was asked if the dialysis staff were informed of the recall notice , she stated "no" because she was informed by their Area Manager on 4/16/2014 that none of the recalled dialyzers were in their stock. The Area Administrator stated none of the staff at the hospital physically checked to verify that there were no recalled dialyzers in their stock.

During an interview on 5/27/2014 at 12:12 pm with Staff (Q) the facility's Quality Director who was present on the Acute Dialysis Unit regarding the facility's knowledge of the recall dialyzers, she stated the facility was not notified by the contract agency that there was a recall notification.
.
Review of a list of patients who had hemodialysis treatment in the facility after the recall notice was released April 14, 2014, revealed the following information :

During the months of April, 2014 and May 2014 a total of thirty-one (31) dialyzers with the Lot number C 414200701 on the medical device recall list was used in the facility to hemodialyze twenty-two (22) patients as late as May 20,2014, more than a month after the facility received the recall notice.

Review of the clinical records revealed multiple patients were dialyzed with the recalled dialyzers on more than one occasion.
The usage of the recall dialyzers is broken down as follows:

Between April 16, 2014 and April 30,2014 a total of nineteen (19) Revaclear Max Dialyzers Lot # C 414200710 were used to hemodialyze a total of fourteen (15 ) patients.

Between May 1,2014 and May 20,2014 a total of twelve (12) Revaclear Max Dialyzer with the recall lot number C 414200701 was used on seven (7) patients.

The number of Patient who had the recalled dialyzers used for their hemodialysis treatment on multiple days were as follows:

Patient (# 1) two dialyzers,
Patient (# 3) two dialyzers,
Patient (# 9) three dialyzers,
Patient (#4) , three dialyzers ,
Patient (# 8) two dialyzers,
Patient # 16 two dialyzers, and
Patient # 18 two dialyzers.

Review of the facility's Bylaws of the Board of Trustees dated 2011 that was presented during the investigation revealed information that:

"The Hospital shall retain overall responsibility and authority for services furnished under a contract .

The Board is ultimately responsible for the quality of patient care and services provided by the hospital.

The Board shall oversee and recommend resources and support for an effective, Hospital -wide quality assessment and quality assessment and performance improvement program.

The Board shall ensure that the program reflects the complexity of the hospitals organization and services; involves all hospital departments and services (including services furnished under contract or arrangement); and focuses on indicators related to improved health outcomes and the prevention and reduction of medical errors"

During an interview on 5/27/2014 at 2:15 pm with the Group Administrator(B) of the Contract Dialysis Service she stated she did not inform the facility because she was told by her Area Manager that there were no dialyzers with the recall lot numbers in store, she did not see the need to inform the facility.

During an interview on 5/28/2014 at 10:30 am at the facility with Staff (D) Chief Nursing Officer (CNO) she was asked what systems the facility had in place to ensure recall information was passed on to the facility from contract services, she stated at present there was no official systems in place. She stated because the contract agency orders their own supplies/equipment recall notices on those supplies go through the contract agency and not to the hospital. The facility relies on the contract service to make a "good faith" effort to inform them of any recall notices.

During an interview on 5/28/2014 at 11:05 am with Staff (B) Contract Service Group Administrator she stated her contract agency provide dialysis services to thirty - four (34) other hospitals in the region and staff were out pulling recall dialyzers from those facilities as a result of the current State investigation. Later that day Staff (B) reported to the Surveyor that there were dialyzers from the recall list found in multiple facilities and they were all removed and the facilities triple checked to verify.

During exit interview on 5/28/2014 at 3:00 pm the Chief Operations Officer stated there were no systems in place to get recall information from any of the hospital's contract services that purchase their own medical equipment or supplies, however, systems will now be implemented to ensure the facility is notified.