Transfusion Error Surveillance System (TESS) - 2012-2013 Report

Table of Contents

• Executive summary
• Introduction
• Methods
  • a) Definition
  • b) Data collection
  • c) Error coding
  • d) Potential severity of transfusion error
  • e) Case validation
  • f) Statistical analysis
• Results
  • a) Geographical coverage of the TESS
  • b) Reported transfusion-related errors
  • c) Potential severity of reported transfusion-related errors
  • d) Transfusion-related errors that did not reach the patients
  • e) Transfusion-related errors that reached the patients (i.e. detected post transfusion)
• Conclusion and future work
• References
• Appendix 1: Transfusion-related errors discovered through quality assurrance review and audits of the inventory and transfusion documentation more than 2 days after the event had occurred
• Appendix 2: Specific event codes & corresponding descriptions.

Executive summary

Blood transfusions are an important component of Canada's health care system. Although Canada has one of the safest blood systems in the world, transfusion-related errors can occur at various points in the transfusion chain, which encompasses any point in the collection, labelling, testing, storing, handling, transfusion, etc. of blood components and products and during the collection, labelling, testing, storing and handling of pre-transfusion patient samples. Transfusion-related errors may occur in either clinical or laboratory settings and may result in ABO incompatibilities, administrative delays, product wastage, inappropriate transfusions and the possible need for sample re-collection. Limiting opportunities for transfusion errors is therefore an important aspect of public health safety.

This report offers an analysis of the Transfusion Error Surveillance System (TESS) data reported from 2012 to 2013. Findings are presented for all transfusion-related errors, including errors that were detected prior to blood transfusion as well as errors detected during and after blood transfusion.

The TESS was initiated in 2005 by the Public Health Agency of Canada (the Agency) to monitor errors occurring at any point in the transfusion chain. Currently, 15 hospitals participate in the surveillance as sentinel sites and report all transfusion-related errors to the Agency on a quarterly basis. By tracking transfusion-related errors it is possible to identify not only the the policy and procedure in the transfusion chain where errors most commonly occur, but also the points where changes can be implemented in order to ensure mechanisms are in place to detect errors before transfusion as well as to limit the likelihood for transfusion errors.

Overall, a total number of 17,344 transfusion-related errors were reported from 2012 (n=8,698) to 2013 (n=8,646) and, sample collection (36.2%) and sample handling (14.4%) errors constituted the most frequently reported of all the errors. Highest occurrence rates were recorded by medical/surgical wards (22.1%), emergency rooms (20.9%), Transfusion Services (18.3%), outpatient clinics (11.0%) and intensive care units (11.4%).

The robustness of the detection processes in hospitals participating in the TESS was once again demonstrated through the capturing of over 93% (n=16,193) of the errors before they reached the patients. Detection by the Transfusion Service alone accounted for 93.5% (n=15,140) of these errors also sometimes referred to as "near-miss".

Of the 1,151 errors that reached the patient, approximately 97% (n=1,117) caused no harm. The majority of the remaining 3% (n=34) that caused some harm to the patients were errors related to product request (n=26) and unit transfusion (n=6). These two categories of errors were linked to 22 cases of transfusion-associated circulatory overload (TACO), 6 cases of febrile non-hemolytic reactions, 3 cases of minor allergic reactions and 1 case of IVIG headache. The remaining two errors that resulted in harm to the patients were sample testing and product selection errors which were respectively linked to the development of an acute hemolytic reaction (n=1) and a delayed serologic reaction (n=1).

The TESS data demonstrate that blood transfusions are both safe and efficient in Canadian hospitals participating in the surveillance coordinated by the Agency. Only 0.2% of all transfusion errors reported to the TESS network resulted in harm to patients and none of these cases resulted in death. While these findings may undoubtedly be suggestive of very efficient transfusion error detection processes/ procedures within participating hospitals, they also highlight potential areas for improvement which are the processes from which the errors that escaped detection were generated, most notably, the product request and unit transfusion processes. Similarly, hospitals should regularly revise/update safety and detection processes in place in each of its units/wards, with each unit/ward/service paying particular attention to processes related to errors for which they were the source, but not the detectors.

Data collected through the TESS facilitate the identification and evaluation of preventive measures designed to optimize system efficiency and, most importantly, patient safety. For example, in one participating hospital, the TESS data facilitated the adoption of prospective auditing of all blood requests to ensure compliance with hospital transfusion guidelines for both indication and dose. This demonstrates the importance of surveillance of transfusion-related errors in Canadian hospitals providing transfusion services.

Introduction

Blood transfusions are an important component of Canada's health care system. Each year in Canada, transfusion of blood and blood products, which may be used to treat blood loss following trauma or surgery or to treat people suffering from conditions such as anemia and cancer, result in improved patient health and saving lives. Although the risk of an adverse event following transfusion is low in Canada due to robust precautionary measures, transfusion-related errors can and do occur. These errors may occur at any step along the transfusion chain, from the collection of blood at donor clinics to the transfusion of blood and blood products to the patient in a hospital setting. Transfusion-related errors can therefore occur in either the laboratory or clinical settings and may arise during the collection, labelling, testing, storing, handling or transfusion of blood and blood products. These errors may result in ABO or other antigen incompatibilities, administrative delays in transfusion or procedures, product wastage, inappropriate transfusions and the possible need for sample re-collection. Ultimately, these errors have the potential to impact patient safety and to increase costs incurred by the health care system. Mitigating the risk of transfusion errors is therefore a leading priority for the government of Canada.

Recognizing the importance of transfusion safety in Canada, the Public Health Agency of Canada (the Agency) developed the Transfusion Error Surveillance System (TESS) in 2005. The TESS was designed to monitor the frequency of all types of errors that can occur at any step in the transfusion chain. Initially implemented as a pilot study encompassing 11 hospitals, the TESS has evolved into a voluntary sentinel surveillance system involving 15 hospitals across 4 Canadian provinces and territories^{Footnote 1}. The TESS data serves as a complement to data collected through the Transfusion Transmitted Injuries Surveillance System (TTISS) which monitors the incidence of adverse reactions following blood transfusion in Canada (Transfusion Transmitted Injuries Surveillance System: 2006-2012 Report).

Participating hospitals provide data on a quarterly basis using a secure electronic web-based server maintained by the Agency; all data are captured anonymously to promote participation and complete reporting by all sites. In addition to data on transfusion errors, participating hospitals provide the number of blood components received, requested, prepared and issued, as well as the number of samples received and tests performed (by location of service whenever possible) for the purpose of calculating error rates.

The TESS is a unique blood safety surveillance system in terms of its comprehensiveness; at present, no other surveillance system in the world collects data on all errors occurring throughout the transfusion chain regardless of their potential outcome. However, by identifying the points in the transfusion chain where errors most commonly occur, including those that are detected prior to actual blood transfusion, it is possible to target these areas through corrective action and, ultimately, increase patient safety and reduce system inefficiencies. Following the implementation of measures to minimize opportunities for transfusion errors, the TESS data may be used to determine the efficacy of said measures. Findings may also provide comparable benchmarks for hospitals in Canada regardless of whether they participate or not in the TESS although those not participating will have to adhere to the TESS protocol to ensure validity of data comparisons. The same condition will apply if international comparisons are considered.

Methods

a) Definition

Transfusion errors reported through the TESS are defined as unexpected, unplanned deviations from standard operating procedures or applicable laws and regulations, usually attributable to a human or system problem, that could:

1. adversely affect the safety, efficacy or quality of blood and blood products (plasma derivatives) as well as the safety of recipients, or/and
2. result in inefficiencies or cost-ineffective care.

b) Data collection

From 2012 to 2013, data on transfusion-related errors were reported by a core group of 15 hospitals from 4 Canadian provinces/territories: six were of small transfusion capacity (less than 2,000 RBC units per year), five were of medium transfusion capacity (between 2,000 to 10,000 RBC units per year) and four were of large capacity as they transfused more than 10,000 RBC units per year.

Errors are detected within participating hospitals using various methods that include ongoing systematic quality control (chart audit, record review, real-time prospective transfusion audit), scheduled quality assurance, supervisory reports and reporting by any other individual. Since scheduled quality control or supervisory reports are not standardized across the participating hospitals and, their systematic implementation could not be ascertained, errors discovered through these processes were considered for the overall analysis only if they were detected within two days following their occurrence. Those that were discovered more than two days later were analysed separately and are presented in Appendix 1.

The reporting process begins with the individuals who discover the event, whether or not they were involved. Following detection of a transfusion related error at a hospital participating in the TESS, non-nominal data regarding the error are collected by the hospital site. Brief narrative of the error is used to determine the type and code to which the error correspond. This code, as well as other pieces of information such as the date, time and location of the error, the point in the transfusion chain at which the error occurred, the point in the transfusion chain at which the error was detected, and the potential/actual severity of the error and its consequences to the patient, are captured using an online reporting form. The data collected are validated and consolidated into a single file by the Provincial/Territorial Blood Coordinating Office (P/T BCO). The data elements required for the TESS are then extracted and exported to the Public Health Agency of Canada (the Agency) as per the agreement between the participating P/Ts and the Agency. Data exports occur every 3 months. A user's manual for the TESS web application was developed to assist the P/T BCO with the data transfer.

c) Error coding

Transfusion-related errors captured through the TESS are classified using a limited set of predefined, standardized alpha-numeric codes described in detail in the TESS User's manual. The letters in the codes indicate the category within which the error falls (Table 2) and the numeric value differentiates specific errors within each category. For instance all errors described with DC codes are errors that occurred at the level of the distributor/supplier of blood components or blood products; whereas those with UT codes occurred at the time of transfusion: for example, a wrong product/unit transfused to a patient or a wrong patient transfused (Table 2). An example of an error code would be: error coded as a DC 02 is a processing/testing error that occurred at the distributor level, a DC 03 would be a labelling error, etc. Complete listing of the error codes is provided in Appendix 1. Error coding was introduced to enhance the surveillance capabilities as the coding reduces dependence on unstructured narratives which are not made available to the Agency for confidentiality.

To ensure consistency of error coding across Provinces/Territories participating in the TESS, the Agency organises monthly error coding exercises where the P/T BCO staff and reporting sites are invited to discuss complex cases for which error coding may be difficult and may benefit from group discussions which promote standardized reporting. Also, baseline training for error coding is offered to sites aspiring to join the TESS.

The transfusion chain described in Figure 1 indicates where each category of errors occurs. There are errors that occur only in laboratory settings (Transfusion Services, blood suppliers, laboratory services and service providers) or clinical settings (i.e. hospital care units where patients receive transfusion care: operating rooms, emergency rooms, out-patient clinics, intensive care units, obstetrics clinics and units, etc.). Errors related to distributor codes (DC), product check-in (PC), inventory management (IM), unit storage (US), sample receipt (SR), sample testing (ST), product selection (PS), unit manipulation (UM) and unit issue (UI) occur only in laboratory setting while those related to product request (PR), sample collection (SC), request for pick-up (RP) and unit transfusion (UT) only occur in clinical setting (figure 1).

d) Potential severity of transfusion error

The potential severity is a measure of the harm that the error may cause to the patient if the error is not detected. High severity level is assigned to errors that have potential to cause serious injury (including fatal outcome), whereas low and medium severity levels are assigned to errors with potential to cause no or minor/transient injury, respectively. The national TESS working group identified errors that by definition are listed in Table 2 as errors of potential high severity.

e) Case validation

The P/Ts review all transfusion-related errors reported by participating hospitals from their respective jurisdictions before exporting the data to the Agency (via the TESS electronic web-based system), where a second round of review and validation for completeness and accuracy is conducted by an Agency epidemiologist and a clinical advisor.

f) Statistical analysis

For analytical purposes, data received from the P/Ts are extracted from the TESS electronic warehouse and consolidated into a single file in Microsoft Excel, then subjected to a pre-analytical review and validation. The file is once again transferred to another statistical software package (SAS or Stata) for final analysis, which is mainly focused on the:

• types of errors,
• occurrence and detection locations and,
• errors that caused harm to patient.

Rates of occurrence are calculated using corresponding denominator data (as defined in Table 1) and results given per 100,000 units of products received, requested, prepared and issued, or per 100,000 samples received depending on the error type. The number of samples received and tests performed, as well as the number of units of product received, requested, prepared and issued per one error are also calculated.

N.B.

For the calculation of the rate of unit transfusion errors, the denominator used was the total of units of products issued because of the non-availability of the total units of product transfused.

Results

a) Geographical coverage of the TESS

Transfusion Services of the 15 TESS hospitals issued a total of 424,714 units of blood and blood components to their corresponding clinical services (Table 3) in 2012 and 2013. There was a significant decrease in the number of units of products received (12.4%), requested (12.5%), prepared and issued from 2012 to 2013.

b) Reported transfusion-related errors

Overall, the TESS received reports on 17,344 transfusion-related errors that met the surveillance criteria in 2012 and 2013 from the 15 Canadian hospitals participating in the TESS and, over 80% (n=13,917) of these errors were reported from hospitals of large transfusion capacities (Tables 5 & 6).

Clinical services in which highest proportions of errors occurred included medical/surgical wards 22.1% (n=3,842), emergency rooms 20.9% (n=3,617), intensive care units 11.4% (n=1,970) and outpatient clinics 11.0% (n=1,912). Transfusion Services accounted for 18.3% (n=3,172) of all the errors (Table 9). The most common were errors related to sample collection 36.2% (n=6,278), sample handling 14.4% (n=2,489), unit transfusion 12.7% (n=2,202) and product request 7.5% (n=1,298) regardless of the transfusion capacity of reporting hospitals (Tables 6, 7 & 8)). These errors collectively account for almost 71% of all reported transfusion-related errors (Table 7). Errors that occurred the least included errors related to inventory management (IM), storage (US), product selection (PS) and which occurred respectively at a rate of 1 error per 2,889; 3,111 and 7,231 units of product received or prepared (Table s 7 & 8).

Table 10 highlights the effectiveness of error detection processes in place within each clinical and Transfusion Service. Transfusion Services demonstrated highest efficiency as they were able to detect the vast majority of errors that originated from within (94.4%) and from other services (92.3%).

c) Potential severity of reported transfusion-related errors

Transfusion-related errors most commonly reported in 2012 and 2013 were of low (n=12,845; 74.1%) potential severity (Tables 11 & 12). Those of medium and high potential severity represented 8.9% (n=1,536) and 17.1% (n=2,963), respectively (Table 12).

d) Transfusion-related errors that did not reach the patients

Approximately 93.4% (n=16,193) of the transfusion-related errors reported in 2012 and 2013 were detected before they reached the patients (Table 13). Planned detection procedures in place in hopitals participating in the TESS were credited with the detection of 97.7% (n=15,817) of these errors (Table 14a). The remaining 2.3% (n=376) were detected through unplanned procedures i.e. by chance.

Transfusion Services demonstrated highest efficiency for detecting not only from within the blood bank, but also from clinical areas. Transfusion Services detected 93.5% (n=15,140) of the transfusion-related errors that did not reach the patients; this included 95.7% (n=2,939) of their of their own errors (Table 13).

The overwhelming majority (97.7%; n=15,817) of transfusion-related errors that did not reach the patients was detected through planned detection procedures(Table 14a). of those that were discovered though uplanned procedures (n=376), the most commonly reported (Table 14b) were related to product request (10.9%; n=41), sample testing (16.8%; n=63) and unit transfusion (19.9%; n=75). Also, Transfusion Services accounted for 43.4% (n=163) of all these errors, followed by medical/surgical wards (n=67) and emergency rooms (n=45) which posted 17.8% and 12.0%, respectively (Table 14b).

Transfusion Services also showed high efficiency in detecting errors through unplanned procedures as they accounted for the detection of 79.8% (n=300) of all the errors that did not reach the patients including 95.1% (n=155) of theirs (Table 15).

e) Transfusion-related errors that reached the patients (i.e. detected post transfusion)

Of all the 17,344 transfusion-related errors reported in 2012 and 2013, only 6.6% (n=1,151) reached the patients (Tables 16 & 17). Of these, those related to product request (n=253), request for pick-up (n=388) and unit transfusions (n=113) were the most common as they accounted for about 22.0%, 33.7% and 9.8%, respectively (Tables 16 & 17).

Cases that originated from large capacity hospitals (i.e. transfusing more than 10,000 units of red blood cells annually) were about 3.6 times that from hospitals transfusing between 2,000 and 10,000 units per year, and over 35 times that reported by hospitals transfusing less than 2,000 units per year (Table 17).

Not all the errors that reached the patients resulted in harm to the patient. In 73.8% (n=850) of the cases, transfusion procedure was delayed (Table 18) without impact to the patients and, in an additional 19.1% (n=220), though the errors were discovered after the product had been transfused, there was no negative impact to the the patient. Only 3.0% (n=34) of the errors that reached the patients resulted in adverse transfusion reactions (Table 19). The most common of these reactions was transfusion-associated circulatory overload (TACO) with 22 cases (64.7%) followed by febrile non-hemolytic and minor allergic reactions. Errors that led to TACO were related to product request (PR 04, PR 06, and PR 99) and not following guidelines for infusion time (UT 25) as detailed in Table 19; whereas those that resulted in febrile non-hemolytic and minor allergic reactions included inappropriate order of blood product (PR 06), and not following guidelines for infusion time (UT 25) or transfusion reaction protocol (UT 26). Other adverse reactions that resulted from transfusion-related errors included two cases of acute hemolytic & delayed serologic transfusion reactions (Table 19) respectively from incorrect selection of product/unit (PS 01) and sample testing error (ST 99), as well as a case of IVIG-related headache from not following transfusion reaction protocol (UT 26).

In comparison, harmful errors from large (i.e. transfusing more than 10,000 RBC units per year) transfusion capacity hospitals (Tables 19 & 20) were related to product requests (n=26; 92.9%), product selection (n=1; 3.6%) and unit transfusion (n=1; 3.6%). These errors were determined to be associated with 21 cases of TACO, 4 cases of febrile non-hemolytic reactions (n=4), 2 cases of minor allergic reactions and one case of acute hemolytic reaction (Tables 19 & 20). The only harmful error detected in hospitals of small (i.e. transfusing less than 2,000 RBC units per year) transfusion capacity was non-adherence to transfusion reaction protocol (UT 26) which led to a case of febrile non-hemolytic reaction in an emergency room (Table 20).

About 91.2% (n=31) of the transfusion-related errors found to be associated with adverse transfusion reactions were of high potential severity (Table 21). Product request errors coded as PR 04, PR 06 and PR 99 were determined to be associated with 19 cases of TACO, 4 cases of febrile non-hemolytic transfusion reactions and 2 cases of minor allergic reactions. Additional cases of TACO and febrile non-hemolytic transfusion reactions (Table 21) were linked to not following either the guidelines for infusion time (UT 25) or the transfusion reaction protocol (UT 26). The other two errors deemed to be of high potential severity were related to product/unit selection (PS 01) and sample testing (ST 99) and were respectively determined to be linked to an acute hemolytic and a delayed serologic transfusion reactions. The remaining 8.2% (n=3) of the errors found to be associated with adverse transfusion reactions were of medium potential severity and were also related to incorrect /no ordering of blood or blood product (PR 04), not following the guidelines for infusion time (UT 25) and the transfusion reaction protocol (UT 26).

Conclusion and future work

Overall, sample collection (SC) and sample handling (SH) errors remain the most frequent transfusion-related errors. Transfusion Services, as well as Medical/Surgical Wards and Emergency Rooms continue to be the locations where most of the transfusion-related errors occur. However, unlike Medical/Surgical Wards and Emergency Rooms that have been able to detect only less than 10% of errors that occurred in their units, Transfusion Services' error detection processes captured the vast majority (over 94%) of these errors.

Although the total number of errors recorded remains substantially high (n=17,344), the proportion that reaches the patients undetected represents just 6.6% (n=1,151). Of the errors that reach the patients, only about 3% actually resulted in an adverse reaction. Nevertheless, continued monitoring and improvements of the transfusion safety processes are recommended as the potential for harm resulting from transfusion errors can be considerable not only for the patients, but for the hospitals as well. Clinical settings demonstrated inefficacy in capturing their own errors; therefore, it is recommended to audit/review and potentially update the transfusion error detection procedures currently in place. Particular attention should be given to procedures targeting errors related to product requests, requests for pick-up and unit transfusion since these errors collectively represented the bulk of the errors that reached the patients.

The TESS working group has shown that it is possible to improve error tracking within the clinical and transfusion areas even when there are existing SOPs, etc. Future work will target interventions to increase timely error tracking outside the Transfusion Services, particularly those related to sample collection and transfusion documentation (such as product requests and requests for pick-up). The Agency through the TESS working group will also assess the feasibility of partnering with the Canadian Patient Safety Institute (CPSI) in order to address the issues related to patient identification.

References

1. Public Health Agency of Canada. Transfusion Transmitted Injuries Surveillance System (TTISS): 2006-2012 Report. Centre for Communicable Diseases and Infection Control, Public Health Agency of Canada, 2014.

Appendix 1: Transfusion-related errors discovered through quality assurrance review and audits of the inventory and transfusion documentation more than 2 days after the event had occurred

Approximately 63.0% (n=3,777) of transfusion-related errors detected through quality assurance review and inventory audit and review of transfusion documentation more than two days after the events had occurred (Table 22) were discovered more than 30 days (41.3%; n=2,476) or between 15 to 30 days (21.7%; n=1,301) later. Errors related to sample collection, product storage, unit transfusion and unit issue account for 27.3% (n=1,636), 24.9% (n=1,494), 20.4% (n=1,221) and 14.3% (n=859), respectively (Table 22). The breakdown of the specific errors under these categories is summarized in Table 23 and the description of specific event codes provided in Appendix 2.

Specific transfusion-related errors most frequently discovered through quality assurance review and audits of inventories and transfusion documentations more than two days after occurrence included (Table 23) unnecessary sample collection (SC 08) which accounted for 54.8% (n=1,634), followed by inappropriate monitoring of storage devices (US 03), incomplete documentation (UT 23) and non-verification of receipts (UI 21) representing respectively 48.1% (n=1,450), 28.4% (n=846) and 24.4% (n=735). The overall predominant error types discovered through the above-mentioned procedures differed from one province to another (Table 24), but was consistent from one year to another with the exception of province "D" which posted a very high proportion of sample collection (SC) errors in 2013. Unit transfusion (UT) errors were the most commonly reported from province "B", compared to unit storage (US), unit issue (UI) and sample testing (ST) errors which accounted for the majority (89.4%) of province "C" reports (Table 24).

Appendix 2: Specific event codes & corresponding descriptions

Event code

Description of event

Errors related to Distributors (DC)

DC 00

Not specified

DC 01

Collection

DC 02

Processing/testing

DC 03

Labelling

DC 04

Packaging

DC 05

Transport

DC 06

Look-back traceback

DC 07

Recall Process

DC 08

Order incompletely / incorrectly filled

DC 99

Other

Errors related to Product Check-in (PC)

PC 00

Not specified

PC 01

Data entry incomplete/not performed/incorrect

PC 05

Inappropriate return to inventory

PC 06

Unit confirmation not done / incorrect

PC 07

Administrative check not done / incorrect

PC 99

Other

Errors related to Inventory Management (IM)

IM 00

Not specified

IM 01

Inventory audit not done / incorrect

IM 02

Product status not / incorrectly updated in computer-internal only (available / discard)

IM 03

Supplier recall / look back / trace back not addressed appropriately

IM 04

Product ordered incorrectly / not submitted to supplier

IM 99

Other

Errors related to Unit Storage (US)

US 00

Not specified

US 01

Incorrect storage of product in transfusion service

US 02

Expired product in stock

US 03

Inappropriate monitoring of storage device

US 04

Unit stored on incorrect shelf (Group / Autologous / Reserved)

US 99

Other

Errors related to Product Request (PR)

PR 00

Not specified

PR 01

Order for wrong patient

PR 02

Order incorrectly entered (online order entry)

PR 03

Special needs not indicated (e.g. Auto, CMV negative)

PR 04

Order not done / incorrect / incomplete

PR 06

Inappropriate order of a blood product

PR 07

Wrong product ordered (type)

PR 99

Other

Errors related to Sample Collection (SC)

SC 00

Not specified

SC 01

Sample labelled with wrong patient identification

SC 02

Not Labelled

SC 03

Wrong patient collected (not from intended patient)

SC 04

Collected in wrong tube type

SC 05

Sample NSQ (Non-Sufficient Quantity)

SC 06

Sample hemolysed

SC 07

Label incomplete /illegible for key patient identifiers (name, identification, birthdate)

SC 08

Sample collected unnecessarily

SC 09

Requisition arrives without samples

SC 10

Armband incorrect / not available

SC 12

Label incomplete / illegible for non-key patient identifiers

SC 99

Other

Errors related to Sample Handling (SH)

SH 00

Not specified

SH 01

Sample arrives without requisition

SH 02

Paperwork and sample ID do not match

SH 03

Patient ID incomplete/illegible on requisition

SH 04

No patient ID on requisition

SH 05

No phlebotomist / witness identification

SH 06

Sample arrives with incorrect type of requisition

SH 07

Patient information (other than ID) missing / incorrect on requisition

SH 10

Sample transport issues

SH 11

Incorrect test ordered / requested

SH 12

Test not ordered / requested

SH 99

Other

Errors related to Sample Receipt (SR)

SR 00

Not specified

SR 01

Sample accepted in error

SR 02

Historical review incorrect / not done

SR 03

Demographic review / entry incorrect / not done

SR 04

Sample incorrectly accessioned (test / product)

SR 99

Other

Errors related to Sample Testing (ST)

ST 00

Not Specified

ST 02

Appropriate sample check(s) not done / incorrect

ST 03

Computer warning overridden

ST 04

Data entry incomplete / not done

ST 05

Sample labelled with incorrect accession label

ST 06

Data entry incorrect

ST 09

Sample / test tubes mixed up / mislabelled

ST 12

Testing not done (ordered / confirmatory)

ST 13

Incorrect testing method chosen

ST 14

Testing performed incorrectly (did not follow SOP)

ST 15

Test result misinterpreted

ST 16

Inappropriate reagents used for testing

ST 19

Additional testing not performed

ST 20

Final check not done / incorrect

ST 21

Administrative check not done / incorrect (after the fact, record review, audit)

ST 22

Sample storage incorrect / inappropriate

ST 98

Quality control related (only to be used as 2nd event code)

ST 99

Other

Errors related to Request for Pick-up (RP)

RP 00

Not specified

RP 01

Request for pick-up on wrong patient

RP 02

Incorrect type / dose of product requested for pick-up

RP 03

Product requested prior to obtaining consent

RP 04

Product requested for pick-up, patient not ready / unavailable

RP 05

Product requested for pick-up IV not ready

RP 06

Request for pick-up incomplete (no Pt. Id, MRN / or product indicated)

RP 10

Product transport issues (internal)

RP 99

Other

Errors related to Product Selection (PS)

PS 00

Not specified

PS 01

Incorrect type / product / unit / dose selected

PS 07

Special needs not checked

PS 09

Special needs misinterpreted

PS 99

Other

Errors related to Unit Manipulation (UM)

UM 00

Not specified

UM 01

Data entry incomplete / incorrect

UM 04

Final check not done / incorrect

UM 05

Labelling incorrect

UM 09

Special processing not done / incorrectly done

UM 10

Administrative check not done / incorrect

UM 99

Other

Errors related to Unit Issue (UI)

UI 00

Not specified

UI 01

Data entry incomplete / incorrect

UI 04

Product issued to wrong patient

UI 06

LIS warning overridden (in error or outside SOP)

UI 09

Not checking/incorrect checking of unit and/or patient information)

UI 11

Product delivered to the incorrect location by the Transfusion Service (physical delivery)

UI 19

Wrong type / dose of product issued to right patient

UI 21

Receipt verification not done (pneumatic tube issue)

UI 22

Issue approval not obtained / documented

UI 99

Other

Errors related to Unit Transfusion (UT)

UT 00

Not specified

UT 01

Administered product to wrong patient

UT 02

Administered wrong type / dose of product to patient

UT 04

Incorrect storage of product on floor

UT 05

Bedside check not done / incorrect (unit/patient info)

UT 06

Administered product with incompatible IV fluid

UT 08

Wrong unit / product chosen from satellite refrigerator

UT 11

Appropriate monitoring of patient not done

UT 12

Floor/clinic did not check for existing units in their area

UT 13

Labelling incorrect

UT 22

Order / consent check not done / incorrect

UT 23

Documentation not complete / incorrect

UT 24

Documentation not returned

UT 25

Guidelines for infusion time not followed

UT 26

Transfusion reaction protocol not followed

UT 27

Monitoring of satellite fridge not done / incorrect

UT 28

Inappropriate preparation of product

UT 29

Product storage tracking incorrect / not done

UT 99

Other

Miscellaneous errors (MS)

MS 00

Not specified

MS 03

Patient registration incomplete/incorrect

MS 04

Equipment / computer failure

MS 05

Equipment QC not done/documented

MS 06

Reagent/material event

MS 07

Patient incurred event

MS 99

Other

Footnotes