DIAGNOSTIC SERVICES BRITISH COLUMBIA / YUKON YEAR IN REVIEW JANUARY DECEMBER 2015

Transcription

1 DIAGNOSTIC SERVICES BRITISH COLUMBIA / YUKON YEAR IN REVIEW JANUARY DECEMBER 2015 Diagnostic Services Year in Review statistics are based on a January to December calendar year. The calendar year provides better correlation with Health Canada birth statistics.

2 SENIOR STAFF AND CONTACT INFORMATION Associate Medical Director, Donor & Clinical Services Phone # Gwen Clarke, MD, FRCPC gwen.clarke@blood.ca Diagnostic Services Manager Tony Dolnik, MLT, BSc tony.dolnik@blood.ca Technical Supervisor, Testing Lhevinne Ciurcovich, MLT Lhevinne.ciurcovich@blood.ca Supervisor, Testing Vivian Stephens, MLT Vivian.stephens@blood.ca Diagnostic Services Laboratory Phone# Fax# Diagnostic Services Website Canadian Blood Services BRITISH COLUMBIA / YUKON Page 2 of 30

3 TABLE of CONTENTS SENIOR STAFF AND CONTACT INFORMATION... 2 PERINATAL LABORATORY... 6 A. Testing Performed... 6 ABO/Rh blood type... 6 Screen for red blood cell antibodies... 6 Antibody Identification, if antibodies are detected... 6 Antibody Identification referrals... 6 Antibody Titre, if a clinically significant antibody is identified... 6 Phenotyping... 6 B. Testing Frequency... 6 C. Specimens Tested... 7 D. Antibodies Identified... 7 REFERENCE LABORATORY Diagnostic Services Support Provided - Level 1 Hospitals Diagnostic Services Support Provided - Level 2 Hospitals Diagnostic Services Support - Level 3 Hospitals ABO/Rh blood type Screen for red blood cell antibodies Antibody Identification Phenotyping (patient and donor units) Transfusion Reaction Investigation Direct Antiglobulin Test Elution and Allo and Auto Absorptions Neutralization tests Referral genotype testing A. Specimens Tested B. Antibodies Identified FETAL GENOTYPING QUALITY INDICATORS A. Turnaround Times B. Rejected Specimens Canadian Blood Services BRITISH COLUMBIA / YUKON Page 3 of 30

4 ACCOMPLISHMENTS IN A. Automated Testing Instrument Upgrade B. Business Continuity Planning C. Genotyping Red Cell D. Perinatal Advisory Committee E. Electronic Reporting GOALS FOR A. Electronic Reporting CBY Diagnostic Services Access to Care Connect (PLIS) B. Transfer of HLA/HPA Testing from Vancouver Diagnostic Services to Platelet Immunology Laboratory C. Perinatal Advisory Committee D. cff DNA Testing Canadian Blood Services BRITISH COLUMBIA / YUKON Page 4 of 30

5 Figures Figure 1: Total Perinatal Specimens Tested... 7 Figure 2: Total Number of Perinatal Antibodies Figure 3: Frequency of Clinically Significant Antibodies Figure 4: Total Reference Specimens Tested Figure 5: Total Number of Crossmatch Antibodies Figure 6: Total Platelet Immunology Donor Specimens Tested Figure 7: Rh D Testing Algorithm Figure 8: Perinatal Routine TAT Figure 9: Turnaround Time Reference Specimens Figure 10: Perinatal Rejection Reasons Figure 11: Reference Rejection Reasons Tables Table 1: Perinatal Specimens Tested... 7 Table 2: Total Number of Perinatal Antibodies Detected... 8 Table 3: Perinatal Patient Antibody Titres (2015)... 9 Table 4: Combination Antibodies Table 5: Reference Specimens Tested Table 6: Total Number of Reference Antibodies Identified Table 7: Platelet Immunology Specimens Tested Table 8: Patient # - RHD Type/Result Table 9: Turnaround Time Routine Criteria by Specimen Type Table 10: Turnaround Time Routine Perinatal Specimens Table 11: Reference TAT Table 12: Quarterly Rejection Rates Perinatal Specimens Table 13: Quarterly Rejection Rates Reference Specimens Canadian Blood Services BRITISH COLUMBIA / YUKON Page 5 of 30

6 PERINATAL LABORATORY The Perinatal Laboratory within Diagnostic Services at Canadian Blood Services provides diagnostic testing of pregnant women for blood type and red blood cell antibodies. Results from this screening assist physicians, midwives and nurse practitioners in ensuring the appropriate management of a pregnancy for both the mother and baby. A. Testing Performed Canadian Blood Services Perinatal Laboratory routinely performs the following tests: ABO/Rh blood type Screen for red blood cell antibodies Antibody Identification, if antibodies are detected Antibody Identification referrals Antibody Titre, if a clinically significant antibody is identified Phenotyping B. Testing Frequency Mothers Initial Testing All women should be tested upon their first prenatal visit. Mothers Weeks Gestation All Rh negative women should be retested at weeks gestation. Rh positive women should also be retested at weeks gestation when there is only one blood group result available (usually first pregnancy) or if patient is at increased risk of allo-immunization (e.g. previous transfusion, fetal trauma or procedure, IV drug use). Mothers Antibody Present If the antibody is known to cause HDFN, it is recommended that specimens be submitted every three to four weeks for the duration of the pregnancy dependant on the specificity of the antibody and the strength of the antibody titre. More frequent testing may be indicated if the antibody titre rises rapidly or if clinical monitoring mandates that additional sampling would provide helpful information. Mothers Postnatal Following delivery, specimens from the mother and her baby should be tested if the Rh of the mother is unknown, the mother is Rh negative, the mother has a clinically significant antibody or if the baby shows signs of HDFN (i.e. anemia or jaundice). Partners When a woman has an antibody capable of causing HDFN, specimens from the partner will be requested for ABO/Rh and antigen phenotyping. This will assist in assessing the probability of the baby being affected by the antibody. Partners specimens may also be tested to assess Rh Immune Globulin (RhIG) eligibility of Rh negative mothers. Canadian Blood Services BRITISH COLUMBIA / YUKON Page 6 of 30

7 # of samples C. Specimens Tested The data includes all women tested, including referrals. Table 1: Perinatal Specimens Tested Specimen Test Type Maternal Type and Screen 59,692 61,262 60,933 63,994 65,595 Paternal ABO/Rh Total # of Specimens Tested 60,160 61,874 61,545 64,569 66,221 Total # of Patients Tested ,052 55,869 Figure 1: Total Perinatal Specimens Tested 70,000 60,000 50,000 40,000 30,000 20,000 10, Maternal type and screen 59,692 61,262 60,933 63,994 65,595 Paternal ABO/Rh D. Antibodies Identified In 2015, a total of 285 antibodies were reported (see Table 2). This is somewhat lower than 2013 where 312 women had antibodies identified during their pregnancies. Of 285 antibodies identified in 2015; fortyfive women had multiple antibodies. Passive anti-d data has been excluded from the preceding numbers. Antibodies identified were considered to be clinically significant if they have been reported to cause HDFN. The most common clinically significant antibodies identified were: anti-e, anti-d, anti-k, anti-m, Canadian Blood Services BRITISH COLUMBIA / YUKON Page 7 of 30

8 (see Figure 2`) which together represented 76% of the total antibodies identified. IgG Anti-M can be considered clinically significant as they may cause HDFN and/or delayed anemia in rare cases. Titres for 16 of the clinically significant antibodies increased from non-critical to critical levels during the pregnancy with a total of 35 antibody titres at critical levels (see Table 3). Recommendations were made for all patients with a critical titre level (current or previous pregnancy) and all Kell system antibodies to be referred to a High Risk Fetal Assessment Clinic for further follow-up and monitoring during pregnancy. Table 2: Total Number of Perinatal Antibodies Detected 2015 Maternal Antibodies Identified (Including Passive D) Anti-D Anti-C Anti-C w Anti-Ce Anti-c Anti-E Anti-e Anti-f Anti-G Anti-K Anti-Kp a 1 Anti-Lu b Anti-M Anti-S Anti-s 2 Anti-Fy a Anti-Fy b Anti-Jk a Anti-Jk b Anti-Vw Anti-Wr a Anti-Jra Anti-Lub 2 Anti-Inb 1 Anti-Sc1 1 Anti-Lua 1 Anti-Cob 1 Anti-Dantu 1 1 Canadian Blood Services BRITISH COLUMBIA / YUKON Page 8 of 30

9 Table 3: Perinatal Patient Antibody Titres (2015) Antibody Critical Level Non-Critical Level Non-Critical to Critical Anti-D Anti-C 10 Anti-E Anti-c Anti-e 5 Anti-Ec Anti-Ce 1 1 Anti-G 4 Anti-Fya Anti-Fyb 1 Anti-Jka 16 Anti-Jkb 1 Anti-M Anti-S 12 Anti-s 1 Canadian Blood Services BRITISH COLUMBIA / YUKON Page 9 of 30

10 Anti-D Anti-C Anti-Cw Anti-Ce Anti-c Anti-E Anti-e Anti-f Anti-G Anti-K Anti-Kpa Anti-Lub Anti-M Anti-S Anti-s Anti-Fya Anti-Fyb Anti-Jka Anti-Jkb Anti-Vw Anti-Wra Anti-Jra Anti-Lub Anti-Inb Anti-Sc1 Anti-Lua Anti-Cob Anti-Dantu Number of Antibodies Figure 2: Total Number of Perinatal Antibodies 120 Total Number of Perinatal Antibodies Figure 3: Frequency of Clinically Significant Antibodies Frequency of Perinatal Clinically Significant Antibodies 35% 30% 25% 20% 15% 10% 5% 0% Canadian Blood Services BRITISH COLUMBIA / YUKON Page 10 of 30

11 Table 4: Combination Antibodies Antibodies Number in 2015 Anti-c Anti-Cw Anti-E 1 Anti-c Anti-Cw Anti-K 1 Anti-C Anti-D 5 Anti-C Anti-D Anti-Dia 1 Anti-C Anti-D Anti-Fya 2 Anti-C Anti-D Anti-G 1 Anti-C Anti-E 2 Anti-c Anti-E 10 Anti-C Anti-G 2 Anti-c Anti-Jka 1 Anti-c Anti-K 1 Anti-D Anti-Jka 1 Anti-D Anti-Wra 1 Anti-E Anti-Jka 4 Anti-E Anti-K 1 Anti-E Anti-S 2 Anti-E Anti-Wra 1 Anti-Fya Anti-Jka 1 Anti-Fyb Anti-Jka 1 Anti-Jka Anti-s 2 Anti-Jkb Anti-S 1 Anti-K Anti-Kpa 1 Anti-K Anti-Lea 1 Anti-K Anti-M 1 REFERENCE LABORATORY The Reference Laboratory within Diagnostic Services provides testing for hospital transfusion medicine laboratories. Hospital patients who are repeatedly transfused may develop red cell and platelet antibodies and as a result may have difficulty in tolerating transfusions. Diagnostic Services has specialized and experienced technologists that assist and provide consultation to hospital transfusion medicine laboratories (24 hours, 7 days per week). The Reference Laboratory identifies red cell or platelet antibodies and provides transfusion recommendations. Diagnostic Services has a varied selection of specialized procedures and rare reagents to resolve more difficult red cell antibody cases. Staff within our department have published a number of papers, abstracts and posters and have collaborated with other reputable references laboratories such as the New York Blood Center and the National Immunohematology Reference laboratory (NIRL). Staff provide presentations at various conferences. Canadian Blood Services BRITISH COLUMBIA / YUKON Page 11 of 30

12 Diagnostic Services Red Cell Antibody Investigations In 2015, hospitals have referred 463 requests for red cell antibody identification. Diagnostic Services provides support for all BC and Yukon hospitals. Since hospitals have different capabilities and expertise in resolving red cell antibody investigations, Diagnostic Services has categorized hospitals into three levels Based on their capabilities. Level 1 Level 1 is defined by hospital transfusion medicine laboratories that do not have the resources for either antibody identification or phenotyping of patient and donor units prior to transfusion. Hospital transfusion medicine laboratories capabilities usually include the following methods: Routine Services ABO and Rh Antibody detection Crossmatch Additional Methods: Gel / SIAT / PEGIAT / LIAT / Solid Phase Pre-warm Saline replacement Diagnostic Services Support Provided - Level 1 Hospitals Consultation. Identifying and/or excluding antibodies to the major blood group antigens. Providing compatible/antigen negative donor units if applicable. Forwarding an interim report followed by the final antibody report and patient antibody wallet card (where applicable) to the hospital Transfusion Service. Level 2 Level 2 is defined by hospital transfusion medicine laboratories that have limited resources available for antibody identification. Level 2 hospitals generally have one in-date antibody panel and a small inventory of the common antisera to some of the major blood group antigens (eg. anti-c, -E, -c, -e, -K, -Fya, -Fyb, - Jka and -Jka). Hospital Transfusion Service capabilities usually include the following methods: Routine Services ABO and Rh Antibody detection Crossmatch Resolve antibody cases with exclusions of most single specificity antibodies base on an in-date panel Phenotype patient and donor units if antisera is available Resolve antibody cases with exclusions of most single specificity antibodies based on the in-date panel Phenotype patient and donor units if antisera available. Additional Methods Gel/SIAT/PEGIAT/LIAT/ Solid Phase Pre-warm Saline replacements Differential DAT Canadian Blood Services BRITISH COLUMBIA / YUKON Page 12 of 30

13 Diagnostic Services Support Provided - Level 2 Hospitals Consultation. Identifying and excluding antibodies to the major blood group antigens. Providing antigen negative donor units if the corresponding antisera is not routinely stocked at the hospital. Forwarding an interim report followed by the final antibody report and patient antibody wallet card (where applicable) to the hospital Transfusion Services. The hospital Transfusion Service should forward a copy of the report to the patient s physician (if indicated by hospital policy) as well as the antibody wallet card to the patient. Level 3 Level 3 is defined by Hospital transfusion medicine laboratories that have the resources to resolve the majority of serological problems. Resources would include two or more in-date panels and antisera to the major blood group antigens. Hospital Transfusion Service capabilities usually include the following methods: Routine Services ABO and Rh Antibody detection Crossmatch donor units SIAT/PEGIAT/LIAT// Solid Phase and/or Gel Identify or exclude most single/multiple/rare antibodies based on two or more in-date panels Phenotype patient/donor units as required Provide a written report to the patient s physician and an antibody wallet card to the patient. Additional Methods Pre-warm Saline replacement Differential DAT Elution Auto/Alloadsorptions Inhibition/Neutralization Diagnostic Services Support - Level 3 Hospitals Consultation Identifying and excluding antibodies to the major blood group antigens Providing antigen negative donor units if the corresponding antisera is not routinely stocked at the hospital Forwarding an interim report followed by the final antibody report to the hospital Transfusion Service Testing Performed The Reference Laboratory routinely performs the following tests: ABO/Rh blood type Screen for red blood cell antibodies Antibody Identification Phenotyping (patient and donor units) Transfusion Reaction Investigation Canadian Blood Services BRITISH COLUMBIA / YUKON Page 13 of 30

14 Direct Antiglobulin Test Elution and Allo and Auto Absorptions Neutralization tests Referral genotype testing Antibody Screening is routinely performed by solid phase testing. A combination of solid phase testing and indirect antiglobulin tube testing using PEG for enhancement is the primary antibody identification methods. PEG IAT is also the manual back-up method for antibody screening. A. Specimens Tested The data in this report reflects a calendar year period to enable better correlation to other government statistical data. Table 5: Reference Specimens Tested Specimen Type Total Reference Antibody Investigations References Cases 2011 References Cases 2012 References Cases 2013 References Cases 2014 References Cases Figure 4: Total Reference Specimens Tested Number of Reference Antibody Investigations 0 References Cases 2011 References Cases 2012 References Cases 2013 References Cases 2014 References Cases 2015 B. Antibodies Identified In 2015, a total of 374 antibodies were reported (see Table 6). The total number of antibodies detected is lower than in 2014, but the distribution of the most common antibodies remains consistent. Three hundred and fifty patients had antibodies identified, of these; fifty eight patients had multiple antibodies. Canadian Blood Services BRITISH COLUMBIA / YUKON Page 14 of 30

15 Antibodies identified were considered to be clinically significant if they have been reported to cause acute or delayed hemolytic transfusion reactions. The most common clinically significant antibodies identified were: anti-e, anti-k, anti-c, anti-d, anti-jka (see Figure 5) which together represented 65.1% of the total antibodies identified. Table 6: Total Number of Reference Antibodies Identified Antibody Number Detected 2011 Number Detected 2012 Number Detected 2013 Number Detected 2014 Number Detected 2015 Anti-D Anti-C Anti-C w Anti-Ce 1 Anti-c Anti-E Anti-e Anti-f Anti-G Anti-K Anti-k Anti-Kp a Anti-Kp b 1 1 Anti-Jsa Anti-M Anti-N Anti-S Anti-s Anti-Fy a Anti-Fy b Anti-Fy3 1 Anti-Jk a Anti-Jk b Anti-Jk Anti-Le a Anti-Le b Anti-P Anti-Lu a Anti-Lu b Anti-Lu14 1 Anti-Sda 4 3 Anti-A Canadian Blood Services BRITISH COLUMBIA / YUKON Page 15 of 30

16 Anti-Wr a Anti-Di a 1 Anti-Goa 1 Anti-Ina 1 Anti-Jra 1 Anti-Dantu 1 2 Anti-Mg 1 1 Anti-Co b Anti-Mta 1 Anti-V Anti-Vw 1 1 Anti-Yta Anti-Ytb 1 Anti-Rg 1 Anti-Csa 1 1 Anti-Ch 1 1 Anti-Kna Anti-McCd / Vil Anti-Yka 1 Anti-Lan 1 Anti-McCa 1 Canadian Blood Services BRITISH COLUMBIA / YUKON Page 16 of 30

17 Figure 5: Total Number of Crossmatch Antibodies Number of Clinically Significant Antibodies Reference (Part 1) Number Detected 2011 Number Detected 2012 Number Detected 2013 Number Detected 2014 Number Detected Number of Clinically Significant Antibodies Reference (Part 2) Number Detected 2011 Number Detected 2012 Number Detected 2013 Number Detected 2014 Number Detected 2015 Canadian Blood Services BRITISH COLUMBIA / YUKON Page 17 of 30

18 Number of Clinically Significant Antibodies Reference (Part 3) Number Detected 2011 Number Detected 2012 Number Detected 2013 Number Detected 2014 Diagnostic Services Platelet Immunology Neonatal Alloimmune Thrombocytopenia (NAIT) Platelet antibodies, usually anti-hpa-1a, in the plasma of a pregnant woman, may cause neonatal alloimmune thrombocytopenia, the platelet equivalent of hemolytic disease of the fetus and newborn (HDFN). It occurs with a frequency of 1 in 2000 to 3000 live births. Affected infants may be severely thrombocytopenic and at high risk, especially for intracranial bleeds. CBS Winnipeg Centre maintains a list of available platelet apheresis donors who type as HPA 1b/1b (HPA-1a negative) and others such as HPA-5a negative. Post-Transfusion Purpura (PTP) Post-transfusion purpura is a thrombocytopenia that develops after transfusion when platelet antibodies destroy autologous as well as transfused platelets. It is a rare complication characterized by acute thrombocytopenia occurring approximately 1 week after red cell transfusion. Most patients are multiparous women who have been sensitized to platelets through previous transfusions. Samples are tested by a Solid Phase ELISA method in Vancouver and by CBS Winnipeg. Diagnostic Services may refer samples to CBS Platelet Antibody Reference Laboratory in Winnipeg where more specific tests may be performed. Refer to Table 7 and Figure 6. Canadian Blood Services BRITISH COLUMBIA / YUKON Page 18 of 30

19 Table 7: Platelet Immunology Specimens Tested Results Anti-HLA Anti-HPA-1a Anti-HPA-1b Anti-HPA-3a Anti-HPA-5a Anti-HPA-5b None Detected Figure 6: Total Platelet Immunology Donor Specimens Tested HLA/Platelet Testing Totals 0 Year 2011 Year 2012 Year 2013 Year 2014 Year 2015 FETAL GENOTYPING Canadian Blood Services in BC has been referring out specimens recently for fetal red cell antigen genotyping to the International Blood Group Reference Laboratory (NHSBT) in Bristol, England, as they can detect fetal DNA in maternal plasma. Specimens are submitted through the Maternal Fetal Medicine clinics and are accepted if they meet the following criteria: The mother has an antibody capable of causing hemolytic disease of the fetus/newborn (HDFN), AND The father is heterozygous for the corresponding antigen (or unknown), AND The antibody titre has reached a critical level, OR There has been a previous fetus/newborn affected by HDFN, OR The antibody is anti-k. Canadian Blood Services BRITISH COLUMBIA / YUKON Page 19 of 30

20 Approval for funding and discussion with a Canadian Blood Services physician is required prior to submitting specimens for testing within these criteria. Based on the following testing algorithm (figure 7) patients with a serologically variable Rh D typing results may have a genetic testing for the RHD gene. For 2014, the following results (table 9) were obtained in patients using one of the two Red Cell antigen genotyping platforms available at CBS: Figure 7: Rh D Testing Algorithm Canadian Blood Services BRITISH COLUMBIA / YUKON Page 20 of 30

21 Table 8: Patient # - RHD Type/Result Patient RHD Genotype Predicted Phenotype RHD Sequencing Rh Group 1 weak D type 3 weak D NO POSITIVE 2 weak D type 3 weak D NO POSITIVE 3 weak D type 1 weak D NO POSITIVE 4 weak D type 3 weak D NO POSITIVE 5 weak D type 8 weak D YES NEGATIVE 6 weak D type 4.0 or 4.3 weak D NO POSITIVE 7 weak D type 3 weak D NO POSITIVE 8 weak D type 3 weak D NO POSITIVE 9 weak D type 3 weak D NO POSITIVE 10 DAU4 or DV type 5 Partial D NO NEGATIVE 11 weak D type 1 weak D NO POSITIVE 12 weak D type 4.0 or 4.3 weak D NO POSITIVE 13 weak D type 2 weak D NO POSITIVE 14 weak D type 2 weak D NO POSITIVE 15 DHMi Partial D NO NEGATIVE 16 weak D type 3 weak D NO POSITIVE 17 weak D type 4.0 or 4.3 weak D NO POSITIVE 18 May possess a D variant D variant NO NEGATIVE 19 May possess a D variant D variant NO NEGATIVE 20 DOL or DOL 2 Partial D NO NEGATIVE 21 weak D type 3 weak D NO POSITIVE 22 weak D type 3 weak D NO POSITIVE 23 Weak D type 4.0 or 4.3 weak D NO POSITIVE 24 Weak D type 4.0 or 4.3 weak D NO POSITIVE 25 weak D type 3 weak D NO POSITIVE 26 weak D type 1 weak D NO POSITIVE 27 weak D type 3 weak D NO POSITIVE 28 weak D type 3 weak D NO POSITIVE 29 weak D type 1 weak D NO POSITIVE 30 May possess a D variant D variant NO NEGATIVE 31 weak D type 1 weak D NO POSITIVE 32 weak D type 3 weak D NO POSITIVE 33 May possess a D variant D variant NO NEGATIVE 34 weak D type 2 weak D NO POSITIVE 35 weak D type 2 weak D NO POSITIVE 36 weak D type 3 weak D NO POSITIVE Canadian Blood Services BRITISH COLUMBIA / YUKON Page 21 of 30

22 37 weak D type 2 weak D NO POSITIVE 38 weak D type 3 weak D NO POSITIVE 39 weak D type 2 weak D NO POSITIVE 40 weak D type3 weak D NO POSITIVE 41 weak D type 3 weak D NO POSITIVE 42 weak D type 4.0 or 4.3 weak D NO NEGATIVE 43 Weak D type 3 weak D NO POSITIVE 44 weak D type 1 weak D NO POSITIVE 45 Weak d type 3 weak D NO POSITIVE 46 Partial D DAR D variant NO NEGATIVE 47 weak D type 1 weak D NO POSITIVE 48 May possess a D variant D variant NO NEGATIVE 49 weak D type 1 weak D NO POSITIVE 50 weak D type 1 weak D NO POSITIVE 51 May possess a D variant D variant NO NEGATIVE 52 DAU2 phenotype D variant NO NEGATIVE 53 Weak D type 3 weak D NO POSITIVE 54 Weak D type 3 weak D NO POSITIVE 55 May possess a D variant D variant NO NEGATIVE 56 weak D type 3 weak D NO NEGATIVE 57 Weak D type 3 weak D NO POSITIVE 58 weak D type 4.1 weak D NO NEGATIVE 59 weak D type 1 weak D NO POSITIVE 60 weak D type 1 weak D NO POSITIVE 61 weak D type 4.0 or 4.03 weak D NO NEGATIVE 62 Partial D DNB Partial D NO NEGATIVE 63 Weak D Type 3 weak D NO POSITIVE 64 Weak D Type 3 weak D NO POSITIVE 65 May possess a D variant D variant NO POSITIVE 66 Weak D Type 1 weak D NO POSITIVE 67 May possess a D variant D variant NO NEGATIVE 68 May possess a D variant D variant NO NEGATIVE 69 May possess a D variant D variant NO NEGATIVE 70 weak D type 3 weak D NO POSITIVE 71 May possess a D variant D variant NO NEGATIVE 72 May possess a D variant D variant NO NEGATIVE 73 Weak D type 1 weak D NO POSITIVE 74 Weak D type 3 weak D NO POSITIVE 75 Weak D type 1 weak D NO POSITIVE Canadian Blood Services BRITISH COLUMBIA / YUKON Page 22 of 30

23 76 May possess a D variant D variant NO NEGATIVE 77 weak D type 3 weak D NO POSITIVE 78 weak D type 3 weak D NO POSITIVE 79 weak D type 3 weak D NO POSITIVE 80 weak D type 1 weak D NO POSITIVE 81 May possess a D variant D variant NO NEGATIVE 82 weak D type 2 weak D NO POSITIVE 83 weak D type 1 weak D NO POSITIVE 84 May possess a D variant D variant NO NEGATIVE 85 weak D type 3 weak D NO POSITIVE 86 weak D type 4.0 or 4.3 weak D NO NEGATIVE QUALITY INDICATORS The laboratories monitor many quality indicators and the two which are most relevant to this document are turnaround times and rejected specimens which are presented below. A. Turnaround Times To ensure timely reporting of patient test results, Canadian Blood Services monitors turn-around time (TAT) from when the specimen is received at Canadian Blood Services in Winnipeg to the time when the results are available. Since monitoring of this quality indicator began in 2008, the percentage of specimens has consistently exceeded the predefined TAT threshold. Samples whose testing exceeds the expected TAT are usually those where clinically significant antibodies are detected or where difficulty in finding compatible blood is encountered. TAT data for Platelet Immunology will be available commencing in Table 9: Turnaround Time Routine Criteria by Specimen Type Specimen Type Expected Turn-around Time Expected % of specimens to meet or exceed TAT Routine Perinatal < 72 hours Reference Testing < 72 hours Canadian Blood Services BRITISH COLUMBIA / YUKON Page 23 of 30

24 % Specimens Tested Within 72 Hours Table 10: Turnaround Time Routine Perinatal Specimens Turn Around Time (TAT) % of Specimens Tested within 72 hours % of Specimens Tested > 72 hours 79% 85% 91% 91% 89% 21% 15% 8% 8% 11% Figure 8: Perinatal Routine TAT 95 Perinatal Routine TAT Q1 Q2 Q3 Q Canadian Blood Services BRITISH COLUMBIA / YUKON Page 24 of 30

25 % Specimens Tested Within 72 Hours Table 11: Reference TAT Turn Around Time (TAT) % of Specimens Tested within 72 hours % of Specimens Tested > 72 hours 98% 99% 98% 99% 98% 2% 1% 2% 1% 2% Figure 9: Turnaround Time Reference Specimens 100 Reference TAT Q1 Q2 Q3 Q B. Rejected Specimens Each time a specimen is rejected, a reason for rejection is entered into our Laboratory Information System. This data is then retrieved and analysed on a quarterly basis. The number of rejected specimens is quite low for both perinatal and reference specimens. Reference specimens come from hospitals and perinatal samples are primarily collected at external collection sites. For perinatal specimens, the most common reason for rejecting a sample is that the sample is a duplicate. Samples are rejected if another sample from the patient was tested within the previous week. Often a duplicate sample is collected when the patient has seen their family physician and then sees their obstetrician shortly after. We do ensure that the report from the initial testing is sent to the second physician making the request. Health care professionals can access Canadian Blood Services reports for BC patients on PLIS, BC s Electronic Health Record. Canadian Blood Services BRITISH COLUMBIA / YUKON Page 25 of 30

26 Table 12: Quarterly Rejection Rates Perinatal Specimens Rejection Category Q1 Q2 Q3 Q4 Requisition Specimen Discrepancies Between Requisition & Specimen Discrepancies Between Current Requisition & Historical Records Other (Duplicates, etc.) Total # specimens rejected Total # specimens received Rejections as a % of Total 0.2% 0.3% 0.3% 0.3% Figure 10: Perinatal Rejection Reasons 2015 Rejection Reasons - % of Totals Requisition 74% 9% 15% 0% 2% Specimen Discrepancies Between Requisition & Specimen Discrepancies Between Current Requisition & Historical Records Other Canadian Blood Services BRITISH COLUMBIA / YUKON Page 26 of 30

27 Table 13: Quarterly Rejection Rates Reference Specimens Rejection Category Q1 Q2 Q3 Q4 Requisition Specimen Discrepancies Between Requisition & Specimen Discrepancies Between Current Requisition & Historical Records Other (Duplicates, etc.) Total # specimens rejected Total # specimens received % 0.6% 0.6% 0.7% Figure 11: Reference Rejection Reasons 2015 Rejection Reasons - % of Totals Requisition 0% 17% 0% 16% Specimen Discrepancies Between Requisition & Specimen 67% Discrepancies Between Current Requisition & Historical Records Other Canadian Blood Services BRITISH COLUMBIA / YUKON Page 27 of 30

28 ACCOMPLISHMENTS IN 2015 A. Automated Testing Instrument Upgrade In 2015 all Diagnostic Services sites (Vancouver, Edmonton, Regina and Winnipeg) participated in the post implementation review of the common algorithm for the investigation of positive antibody screens obtained on the Galileo Neo. B. Business Continuity Planning Canadian Blood Services continues to refine the business continuity plans for all sites. Vancouver Diagnostic Services plan is nearing completion and discussions are ongoing with internal and external stakeholders to ensure the Diagnostic Services plan meshes seamlessly with other plans. C. Genotyping Red Cell Canadian Blood Services is able to provide red cell antigen genotyping services through our National Immunohematology Reference Laboratory (NIRL). A process for the referral of perinatal and pretransfusion specimens to NIRL for genotyping was developed and implemented. This service is used to aid in resolving complex immunohematology cases. Molecular testing combined with hemagglutination testing can provide better resolution to serological problems and guide patient transfusion requirements in some circumstances, in particular for sickle cell patients and patients with frequent transfusion requirements. D. Perinatal Advisory Committee The PNAC held their annual meeting on April 29 and 30, 2015 in Edmonton. Attendees included the Director, Testing, the Associate Director, Diagnostic Services and the Associate Medical Director, Clinical Services for CBS. The Medical Officers and Managers for the CBS Diagnostic Services Laboratories across the country and representatives from the CBS National Reference Laboratory (NIRL) in Ottawa as well as guests from user hospitals were also in attendance. The meeting included an overview of Diagnostic Services activities over the past year, and discussion of procedures and quality issues affecting these laboratories. Highlights of the two day meeting include the following: Human platelet antigen and antibody testing has been consolidated in the CBS Platelet Immunology Laboratory in Winnipeg and subsequent to this, an increase in test volumes has been observed. This laboratory has obtained College of American Pathologists (CAP) accreditation. Roll-out of the Trace Line hospital module has been completed in Manitoba. All testing services operating under the CBS umbrella have been consolidated into a single management structure. Genotyping using the Immucor BioArray BeadChip system was implemented in June Discussion occurred around the reporting and management of patients with weak D types 4.0, 4.1 and 4.3 in the context of a recent article by S. G. Sandler on behalf of the AABB/CAP Working Group on RHD Genotyping (Sandler SG et al. Transfusion March 2015; 55: ). Discussion occurred around expanding availability of testing for fetal DNA using maternal blood samples to provinces outside Alberta where this process is already in place. Report comments for anti-m in pregnancy was discussed in light of a recent article suggesting that this antibody rarely causes severe hemolytic disease of the fetus and newborn (HDFN) and/or delayed Canadian Blood Services BRITISH COLUMBIA / YUKON Page 28 of 30

29 anemia in affected infants, particularly with patients of Asian extraction (Yasuda H et al. Transfusion Medicine Reviews 2014; 28: 1-6). E. Electronic Reporting BC Ministry of Health worked with CBS BCY Diagnostic Services (DS) on a project to provide electronic test results reports. As of March 2015, BCY DS reports are transferred daily to a central BC repository (database) and our results would be immediately available to hospitals, physicians, health care providers and authorized users. BCY Diagnostic Services tests over 65,000 patients per year. The repository is the Provincial Laboratory Information System (PLIS). CBS Diagnostic Services is the first external facility outside of a BC Health Authority to transmit results electronically. GOALS FOR 2016 A. Electronic Reporting CBY Diagnostic Services Access to Care Connect (PLIS) BC Ministry of Health is meeting with Canadian Blood Services to provide CBS BC Diagnostic Services staff access to the Provincial Laboratory Information System (PLIS) With the completion of BC Ministry of Health - CBS BCY Diagnostic Services on-boarding with provincial electronic reporting (PLIS) as of March 2015, a team of BC Ministry of Health (MOH) representatives along with representatives from CBS have been conducting meetings to have BCY Diagnostic Services staff access to PLIS information. Target date is set for June B. Transfer of HLA/HPA Testing from Vancouver Diagnostic Services to Platelet Immunology Laboratory A working group has consulted with Provincial stakeholders in the fall of 2015 to plan transfer HLA and HPA antibody screen testing currently being performed at Vancouver Diagnostic Services to the Platelet Immunology Laboratory. The target date for the transfer is set for January C. Perinatal Advisory Committee The annual Perinatal Advisory Committee meeting for 2016 is planned for June 13 and in Winnipeg MB. The PNAC meeting will be followed by an Educational Event sponsored by Grifols. Attendees will include Laboratory Directors, Associate Directors and Managers as well as perinatal supervisory staff and laboratory physicians who oversee perinatal testing. We will also welcome some hospital colleagues, both technologists and physicians, who are involved with perinatal testing laboratories. Ongoing work on standardization among our laboratories is a theme for this year. Our meeting plan and ongoing work plan for the remainder of 2016 will include: Discussion and consensus on appropriate follow up for perinatal patients with inconclusive antibodies. Planning for investigation of patients with possible antibodies to low prevalence antigens in the perinatal setting. We will discuss the development of a standard low prevalence panel of cells that will allow for investigation of antibodies to low prevalence antigens which may be clinically significant in pregnancy. Discussion and consensus on the timing of repeat samples for patients with clinically significant or potentially significant antibodies in the perinatal setting. Canadian Blood Services BRITISH COLUMBIA / YUKON Page 29 of 30

30 We will discuss the functionality of our standardized antibody investigation algorithm, including any necessary changes following one year of use. We will optimize and standardize the use of our algorithm used for RHD genotyping in perinatal patients with weak or variable Rh D serological typing. We will discuss the optimal serological evaluation for anti G, especially in the presence of passive anti D. We will discuss the results of an audit of Kell negative donor unit availability in transfusion of Kell negative (or Kell unknown) females of child bearing potential. We will have some updates and final discussions on completed projects including a study of anti Mia antisera in the BC perinatal testing lab as well as an update of testing and labeling strategies for platelet products in fetal/neonatal alloimmune thrombocytopenia. D. cff DNA Testing A proposal was developed by Canadian Blood Services, BCY Diagnostic Services laboratory for referring maternal plasma samples to an external reference laboratory for cell free fetal (cff) DNA assessment. This testing to be performed on selected patients, referred by the maternal fetal medicine physicians at BC Children and Women s hospital. These patients are selected based on clinically significant red cell allo antibodies known to cause hemolytic disease of the newborn. Results of this DNA testing will help to determine which patients require follow up in a high risk obstetrical clinic and which can return to routine prenatal care setting. The proposal is currently being reviewed by the BC Ministry of Health with a decision expected in Canadian Blood Services BRITISH COLUMBIA / YUKON Page 30 of 30