DIAGNOSTIC SERVICES BRITISH COLUMBIA / YUKON YEAR IN REVIEW JANUARY DECEMBER 2014

Transcription

1 DIAGNOSTIC SERVICES BRITISH COLUMBIA / YUKON YEAR IN REVIEW JANUARY DECEMBER 2014 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 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 Laboratory Phone# Fax# Website Canadian Blood Services BRITISH COLUMBIA Page 2 of 26

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... 8 REFERENCE LABORATORY Support Provided - Level 1 Hospitals Support Provided - Level 2 Hospitals 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 Page 3 of 26

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. Automated Antibody Screen Investigation Algorithm B. Electronic Reporting CBY Access to Care Connect (PLIS) C. Transfer of HLA/HPA Testing from Vancouver to Platelet Immunology Laboratory D. cff DNA Testing Canadian Blood Services BRITISH COLUMBIA Page 4 of 26

5 Figures Figure 1: Total Perinatal Specimens Tested... 7 Figure 2: Total Number of Perinatal Antibodies... 9 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: Perinatal Rejection Reasons Figure 10: 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... 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 Page 5 of 26

6 PERINATAL LABORATORY The Perinatal Laboratory within 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 Page 6 of 26

7 # of Samples C. Specimens Tested The data includes all women tested, including referrals. Table 1: Perinatal Specimens Tested Specimen Type Test Type Maternal Type and Screen 59,204 59,692 61,262 60,933 63,994 Paternal ABO/Rh Total # of Specimens Tested 59,513 60,160 61,874 61,545 64,569 Total # of Patients Tested N/A 52,885 53,578 53,800 55,052 Figure 1: Total Perinatal Specimens Tested Maternal Type and Screen Paternal ABO/Rh Canadian Blood Services BRITISH COLUMBIA Page 7 of 26

8 D. Antibodies Identified In 2014, a total of 312 antibodies were reported (see Table 2). This is somewhat lower than 2013 where 457 women had antibodies identified during their pregnancies. Of 312 antibodies identified in 2014; fortyone 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, anti-c, and anti-jka (see Figure 3) which together represented 84.4% 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 10 of the clinically significant antibodies increased from non-critical to critical levels during the pregnancy with a total of 42 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 Maternal Antibodies Identified (Including Passive D) Clinically Significant Antibodies Antibody Anti-D Passive 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 2 1 Anti-M Anti-S Anti-Fy a Anti-Fy b Anti-Jk a Anti-Jk b Anti-Vw Canadian Blood Services BRITISH COLUMBIA Page 8 of 26

9 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-Fya Anti-Fyb Anti-Jka Anti-Jkb Anti-Vw Anti-Wra Anti-Jra Anti-Lub Anti-Inb Anti-Mg Anti-Jk3 Anti-Lu14 Anti-Dantu Anti-Wr a Anti-Jra Anti-Lub 1 2 Anti-Inb 1 1 Anti-Mg 1 Anti-Jk3 1 Anti-Lu14 1 Anti-Dantu 1 Table 3: Perinatal Patient Antibody Titres Antibody Critical Level Non-Critical Level Non-Critical to Critical Anti-D Anti-C Anti-E Anti-c Anti-e Anti-Fya Anti-Fyb Anti-Jka Anti-Jkb Anti-M Anti-S Figure 2: Total Number of Perinatal Antibodies Total Number of Perinatal Clinically Significant Antibodies Canadian Blood Services BRITISH COLUMBIA Page 9 of 26

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-Fya Anti-Fyb Anti-Jka Anti-Jkb Anti-Vw Anti-Wra Anti-Jra Anti-Lub Anti-Inb Anti-Mg Anti-Jk3 Anti-Lu14 Anti-Dantu Figure 3: Frequency of Clinically Significant Antibodies Frequency of Perinatal Clinically Significant Antibodies 35.0% 30.0% 25.0% 20.0% 15.0% 10.0% 5.0% 0.0% Table 4: Combination Antibodies Antibodies Number in 2014 Anti-C Anti-D 1 Anti-C Anti-D Anti-G 2 Anti-c Anti-E 5 Anti-C Anti-e 1 Anti-c Anti-E Anti-Fya Anti-Jkb 1 Anti-c Anti-E Anti-K 2 Anti-C Anti-E Anti-M 1 Anti-C Anti-e Anti-Wra 1 Anti-c Anti-Jka 1 Anti-c Anti-Jka 1 Anti-c Anti-Jkb 1 Anti-c Anti-K 1 Anti-c Anti-Wra 1 Anti-Cw Anti-P1 1 Anti-D Anti-P1 3 Anti-e Anti-Fyb 1 Anti-E Anti-P1 2 Anti-E Anti-Wra 1 Canadian Blood Services BRITISH COLUMBIA Page 10 of 26

11 Anti-K Anti-Lea 1 Anti-K Anti-P1 3 Anti-Lea Anti-Leb 5 Anti-Lea Anti-Leb Anti-Jka 1 Anti-Lea Anti-Leb Anti-P1 1 Anti-Lea Anti-P1 1 Anti-M Anti-P1 2 REFERENCE LABORATORY The Reference Laboratory within 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. 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. 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. Red Cell Antibody Investigations This year, hospitals have referred 640 requests for red cell antibody identification. provides support for all BC and Yukon hospitals. Since hospitals have different capabilities and expertise in resolving red cell antibody investigations, 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 Additional Methods: ABO and Rh Antibody detection Crossmatch Gel / SIAT / PEGIAT / LIAT Pre-warm Saline replacement Canadian Blood Services BRITISH COLUMBIA Page 11 of 26

12 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 Pre-warm Saline replacements Differential DAT 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: Canadian Blood Services BRITISH COLUMBIA Page 12 of 26

13 Routine Services ABO and Rh Antibody detection Crossmatch donor units SIAT/PEGIAT/LIAT 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 and an antibody wallet card to the patient s physician. Additional Methods Pre-warm Saline replacement Differential DAT Elution Auto/Alloadsorptions Inhibition/Neutralization 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 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. Canadian Blood Services BRITISH COLUMBIA Page 13 of 26

14 Table 5: Reference Specimens Tested Total Reference Antibody Investigations Figure 4: Total Reference Specimens Tested References Cases 2010 Number of Red Cell Reference Antibody Investigations References Cases 2011 References Cases 2012 References Cases 2013 References Cases 2014 B. Antibodies Identified In 2014, a total of 640 antibodies were reported (see Table 6). The total number of antibodies detected is slightly lower than in 2013, but the distribution of the most common antibodies remains consistent. Three hundred and ninety-seven patients had antibodies identified, of these; fifty eight patients had multiple antibodies. 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-c and anti-s (see Figure 5) which together represented 61.5% of the total antibodies identified. Canadian Blood Services BRITISH COLUMBIA Page 14 of 26

15 Table 6: Total Number of Reference Antibodies Identified Antibody Number Detected 2010 Number Detected 2011 Number Detected 2012 Number Detected 2013 Number Detected 2014 Anti-D Anti-C Anti-C w Anti-Ce 2 1 Anti-c Anti-E Anti-e Anti-f Anti-G Anti-K Anti-k Anti-Kp a Anti-Kp b Anti-Jsa Anti-M Anti-N 1 1 Anti-S Anti-s Anti-Fy a Anti-Fy b Anti-Fy3 1 1 Anti-Jk a Anti-Jk b Anti-Jk Anti-Le a Anti-Le b Anti-P Anti-Lu a Anti-Lu b Anti-Lu Anti-Sda Anti-A Anti-Wr a Anti-Di a 1 1 Anti-Goa 1 Canadian Blood Services BRITISH COLUMBIA Page 15 of 26

16 Anti-Ina 1 Anti-I (allo) 1 Anti-Vel 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 Anti-Kna Anti-McCd / Vil 1 1 Anti-Yka 1 1 Anti-JMH 1 Anti-McCa 1 Total Canadian Blood Services BRITISH COLUMBIA Page 16 of 26

17 Anti-D Anti-C Anti-Cw Anti-Ce Anti-c Anti-E Anti-e Anti-f Anti-G Anti-K Anti-k Anti-Kpa Anti-Kpb Anti-Jsa Anti-M Anti-N Anti-S Anti-s Anti-Fya Anti-Fyb Anti-Fy3 Anti-Jka Anti-Jkb Anti-Jk3 Anti-Lea Anti-Leb Anti-P1 Anti-Lua Anti-Lub Anti-Lu14 Anti-Sda Anti-A1 Figure 5: Total Number of Crossmatch Antibodies Number of Clinically Significant Antibodies (Part 1) Reference Number of Clinically Significant Antibodies (Part 2) Reference 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. Canadian Blood Services BRITISH COLUMBIA Page 17 of 26

18 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. 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. Table 7: Platelet Immunology Specimens Tested Results Anti-HLA Anti-HPA-1a Anti-HPA-1b Anti-HPA-5a Anti-HPA-5B None Detected TOTALS Figure 6: Total Platelet Immunology Donor Specimens Tested HLA/Platelet Testing Totals Year 2010 Year 2011 Year 2012 Year 2013 Year 2014 Canadian Blood Services BRITISH COLUMBIA Page 18 of 26

19 FETAL GENOTYPING Canadian Blood Services in BC has been referring out specimens recently for fetal genotyping to the International Blood Group Reference Laboratory (NHS) 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. Approval for funding and discussion with a Canadian Blood Services physician is required prior to submitting specimens for testing within this criterion. 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 NEO or Tube Test Anti-D S4 & S5 Rh Negative NEO or Tube Test Anti-D S4 & S5?/0 or 0/1+ or 2 grade difference NCT Prevous Results in Trace Line (TL) NO NCT Results in TL NCT or No NCT Results in TL Report as per Previous Results NCT Test Report as Rh Negative NCT Test Negative NCT Test Positive Tube Tests NCT Anti- D S4 and S5 (if initially tested on the NEO) NCT, Anti-D S4 and S5 Negative NCT or Anti-D S4 or S5 < 2+ NCT, Anti-D S4 and S5 2+ NCT < 2+ NCT 2+ Report as Rh Negative Indicate as Indeterminate Previously reported as Rh NEGATIVE Previously reported as Rh POSITIVE NCT DBL NovaClone Anti-D S4 and S5 Immucor Anti-D Series 4 and 5 Send for RHD Genotyping Report as Rh Positive Canadian Blood Services BRITISH COLUMBIA Page 19 of 26

20 Table 8: Patient # - RHD Type/Result Patient RHD Genotype Predicted Phenotype RHD Sequencing Rh Group 1 weak D type 1 weak D NO POSITIVE 2 DVII Type 1 Partial D YES NEGATIVE 3 DAU2 (RHD*10.2) Partial D NO NEGATIVE 4 weak D type 55 weak D YES NEGATIVE 5 DVII Type 1 Partial D YES NEGATIVE 6 weak D type 1 weak D NO POSITIVE 7 weak D type 2 weak D NO POSITIVE 8 weak D type 2 weak D NO POSITIVE 9 weak D type 2 weak D NO POSITIVE 10 weak D type 3 weak D NO POSITIVE 11 Variant RHD*731T Uncertain Yes NEGATIVE 12 RHD*01 (RHD+) RHD YES POSITIVE 13 DVII Type 1 Partial D YES NEGATIVE 14 variant RHD*208T Uncertain YES NEGATIVE 15 RHD*IV S8-31C / weak D type42 Partial D/ weak D YES NEGATIVE 16 Nucleotide change in RHD exon 6 Uncertain YES 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 Canadian Blood Services BRITISH COLUMBIA Page 20 of 26

21 % Specimens Tested Within 72 Hours 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 Table 10: Turnaround Time Routine Perinatal Specimens Turn Around Time (TAT) % of Specimens Tested within 72 hours 79% 85% 91% 91% % of Specimens Tested > 72 hours 21% 15% 8% 8% Figure 8: Perinatal Routine TAT 95 Perinatal Routine TAT Q1 Q2 Q3 Q Canadian Blood Services BRITISH COLUMBIA Page 21 of 26

22 % Specimens Tested Within 72 Hours Table 11: Reference TAT Turn Around Time (TAT) % of Specimens Tested within 72 hours 98% 98% 98% 99% % of Specimens Tested > 72 hours 2% 2% 2% 1% Figure 10: Turnaround Time Reference Specimens 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 perianal 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 Page 22 of 26

23 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 Total # specimens rejected Total # specimens received Rejections as a % of Total 0.3% 0.5% 0.5% 0.3% Figure 9: Perinatal Rejection Reasons Rejection Reasons - % of Totals 15% Requisition Specimen 59% 0% 22% 4% Discrepancies Between Requisition & Specimen Discrepancies Between Current Requisition & Historical Records Other Canadian Blood Services BRITISH COLUMBIA Page 23 of 26

24 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 Total # specimens rejected Total # specimens received Rejections as a % of Total 0.6% 0.6% 0.6% 0.7% Figure 10: Reference Rejection Reasons Rejection Reasons - % of Totals Requisition 0% 0% 25% 50% Specimen 25% Discrepancies Between Requisition & Specimen Discrepancies Between Current Requisition & Historical Records Canadian Blood Services BRITISH COLUMBIA Page 24 of 26

25 ACCOMPLISHMENTS IN 2014 A. Automated Testing Instrument Upgrade In 2013 the Red Cell Serology sites (Vancouver, Edmonton, Regina and Winnipeg) upgraded the Galileo instruments to the second generation Galileo Neo. This instrument is used for ABO/Rh typing, antibody screening and antibody identification. Vancouver s first instrument was validated and implemented in the Perinatal Laboratory in August 2013 and the second Galileo Neo was validated and implemented January B. Business Continuity Planning Canadian Blood Services continues to refine the business continuity plans for all sites. Vancouver plan is nearing completion and discussions are ongoing with internal and external stakeholders to ensure the 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, and the Associate Medical Director, Clinical Services for CBS. The Medical Officers and Managers for the CBS 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. Canadian Blood Services BRITISH COLUMBIA Page 25 of 26

26 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 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 (DS) on a project to provide electronic test results reports. BCY DS reports to transferred daily to a central BC repository (database) each week and our results would be immediately available to hospitals, physicians, health care providers and authorized users. BCY tests over 60,000 patients per year. The repository is the Provincial Laboratory Information System (PLIS). CBS will the first external facility outside of a BC Health Authority to transmit results electronically. GOALS FOR 2015 A. Automated Antibody Screen Investigation Algorithm All sites (Vancouver, Edmonton, Regina and Winnipeg) will participate in the post implementation review of the common algorithm for the investigation of positive antibody screens obtained on the Galileo Neo. B. Electronic Reporting CBY Access to Care Connect (PLIS) BC Ministry of Health is meeting with Canadian Blood Services to provide 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 , a team of BC Ministry of Health (MOH) representatives along with representatives from CBS will be conducting meetings to have BCY staff access to PLIS information. C. Transfer of HLA/HPA Testing from Vancouver to Platelet Immunology Laboratory Work will begin in 2015 to transfer HLA and HPA antibody screen testing currently being performed at Vancouver to the Platelet Immunology Laboratory D. cff DNA Testing A proposal is being developed by Canadian Blood Services, BCY 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.. Canadian Blood Services BRITISH COLUMBIA Page 26 of 26