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ST JOHN'S EPISCOPAL HOSPITAL AT SOUTH SHORE 327 BEACH 19TH STREET FAR ROCKAWAY, NY 11691 Sept. 28, 2012
VIOLATION: CONTRACTED SERVICES Tag No: A0083
Based on review of the contract, QA data, and interview, it was determined that the governing body did not ensure that the blood bank services (laboratory), provided under a contractual agreement, were effectively and consistently provided.

Findings include:Review of the contract between the facility and NSUH -LIJ (North Shore-Long Island Jewish ) laboratory found that the contract stipulated the responsibilities of both parties. There was evidence that the SOP (Standard Operating Procedures ) were not adequately modified prior to the implementation of the contract to minimize errors that may result from affiliation.

There were two (2) incidents on 6/17/12 and 7/4/12 regarding the blood bank which had potential for patient harm. These were reported to the Wadsworth Laboratories.

Specifically, on 6/17/12 there was an incident where a technician from the hospital lab (St. John's Episcopal ) requested that Unit # W 70 be crossmatched (apheresis unit ) for a SJEH patient by NSUH-LIJ. The unit selected was an apheresis unit and the requesting SJE technologist indicated container #2 on the specimen crossmatch result form.

The LIJ tech crossmatched container #1 instead of #2 as was indicated on the form with the volume of 318 ml. The immediate spin crossmatch was performed and the negative reaction and compatible interpretation was faxed to SJEH . The tech at SJ entered the 13 digit ISBT unit number W 070 in the Meditech system and both container #1 and #2 was displayed. The SJH tech entered the crossmatch result for container #1 into the field for container #2 and contunued to generate the transfusion slip. The transfusion slip for container #2 with the unit # W 0 container #2 went into the refrigerator waiting to be picked up for transfusion.

Since both containers were from the same unit (donation) and the transfusion slip matched the unit, both the issuing tech and the RN transfusing the units would not have detected this clerical error. The clerical error was discovered on 6/28/12 when the LIJ and SJE reconciliation of inventory was performed and it was found that the status of the container numbers were not in agreement. There was no negative effect or outcome to the patient.

The LIJ tech did not notice that the request was for container #2 and assumed it was for container #1. Container #1 was released for transfusion but the LIJ tech recorded that container #2 was released. The inventory discrepancy was not noted until 6/28/12 during a reconciliation of inventory. The existing SOP (standard operating procedure ) did not contain specific references to container numbers or handling of apheresis units.
It was further discovered that the Meditech computer system does not use the product ISBT - E codes for crossmatching units.

On 7/4/12, 2 units of PRC's (packed red cells ) were requested for SJEH for a patient.
The crossmatch request form was sent with units W 69 (unit 1) O positive and W 49 (unit 2 ) O positive on the form by the SJE tech. The LIJ receiving tech retrieved the request form and could not find the segments for the above referenced unit number ( unit #1 ) and called the SJH tech.
It was decided that another unit would be selected and the LIJMC tech would crossmatch unit # W 86 O- positive instead. The unit was crossmatched at 1:35 and the and the results for the 2 units was faxed at 1:38 to SJH .

At 1515 unit # W 86 was requested by SJH to be crossmatched for another patient and it was discovered at that time that it was on crossmatch and reserved for a patient by the LIJ tech. Upon further investigation , it was determined that the original unit requested for crossmatch W 69 whose segments could not be found and was replaced by unit #W 86 and was issued to the patient.

When the LIJ tech found the segments for unit #: W 9, the unit was immediately crossmatched for the patient to whom it was already released for transfusion. The immediate spin crossmatch result was found compatible.

It was determined that the SJH tech did not switch units when unit #W 69 segments could not be found. The LIJMC tech did not include the crossmatch request form when faxing the results to SJH tech.

The LIJMC Meditech crossmatch results which included unit #W 86 were not reviewed and verified when results were being entered into SJH Blood Bank Meditech system by SJH tech.

The potential for misidentification of specimens increases when there is outsourcing of a portion of a laboratory to another hospital.

The facility took corrective action which included that the reconciliation of inventory between SJH and LIJMC will be performed on a more timely basis and not exceed 48 hours.

The SOP 6-67 Interim LIJMC Testing Workflow Process will include the entry of the container number on the form and the handling of omitted or incorrect unit numbers by LIJMC staff.

The SOP 6-67 Interim LIJMC Testing Workflow Process will include a technical double verification process of the unit and container number on bag, LIJMC crossmatch result form, Meditech system display and generated transfusion slip.

A revision to the crossmatch form with a column for final review of the above 3 unique identifiers will be performed prior to attaching transfusion slip to the crossmatch unit.

The Meditech computer system does not utilize International Society for Blood Transfusions (ISBT) "E" product codes to differentiate the container numbers.

The existing SOP did not contain specific references to container numbers or handling of apheresis units.

During investigation of the incident of 6 /17/12 it was discovered that the Meditech computer system does not use the product ISBT E codes for crossmatching of units.

This information should have been noted during the transition process.