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Laboratory Quality Assurance Policy Manual

Laboratory Quality Assurance Program
3475 Albert Street
Regina, Saskatchewan S4S 6X6
Phone: (306) 787-8239
Fax: (303) 787-7240
2004 Edition

SECTION I - Purpose
SECTION II - General
SECTION III - Anatomical Pathology
SECTION III (a) - Cytopathology
SECTION III (b) - Surgical Pathology
SECTION IV - Biochemistry
SECTION V - Hematology
SECTION VI - Microbiology
SECTION VII - Transfusion Medicine

Section I: PURPOSE

The College of Physicians & Surgeons of Saskatchewan, under the Medical Laboratory Licensing Act has the authority/mandate to administer the Laboratory Quality Assurance Program. As part of that responsibility, a policy manual has been developed to provide a framework for continuous improvements in laboratory service which may include, but not restricted to:

  1. Development and maintenance of standards/guidelines for laboratory practice;
  2. Monitoring of laboratory performance through external and internal proficiency testing;
  3. Accreditation of diagnostic medical laboratories through on-site and self-inspections;
  4. Creation of a resource base for information/networking regarding diagnostic lab services;
  5. Promotion of existing standards and processes;
  6. Liaison with other healthcare professional organizations.

Within the document, the following terms are approved as:

MAY indicates DISCRETIONARY
SHOULD indicates RECOMMENDED
SHALL/MUST indicates REQUIRED

Feedback from laboratories is welcome. This policy manual will undergo annual review and revisions will be implemented following a consultative process.

Section II: GENERAL

General Issue #1

ISSUE

Off-site testing

BACKGROUND

Off-site testing refers to laboratory tests performed outside of the traditional laboratory (for example: hospital wards, clinics or patient bedside). There is a potential for better patient care, but a potential for patient harm also exists if persons performing the testing do not receive technical training or are not proficient in quality control.

Point-of-care testing (POCT) refers to those analytical patient testing activities provided within the institution, but performed outside the physical facilities of the clinical laboratory. The central criterion of POCT is that it may not require permanent dedicated space. Examples include kits and instruments that are hand carried or otherwise transported to the vicinity of the patient for immediate testing at that site (e.g. capillary blood glucose), or analytic instruments that are temporarily brought to a patient care location (e.g. operating room, intensive care unit.)

POLICY

Off-site testing shall be held to the same standard as clinical laboratory testing. To ensure quality patient care, the laboratory is responsible for :

  1. Evaluation and selection of instrumentation and procedures,
    • The report must be identified as a POCT result

  2. Training and certification of personnel,
    • There shall be centralized coordination of the POCT program with designated qualified personnel who review testing procedures and quality control, as well as conduct training of the individuals who perform the tests.

  3. Establishment of quality control protocols,
    • Shall include external proficiency testing participation, where available
    • Controls to be run each day of use
    • Document accordingly

  4. Test protocols, equipment maintenance and troubleshooting records,

  5. Protocols for test requisitioning and result reporting, and active review of results by POCT director or designee,

  6. Setting up policies regarding instrument maintenance and supplies.
    • Establish schedules
    • Document activities

General Issue #2

ISSUE

Testing in non-licensed settings , such as malls, stores, pharmacies.

BACKGROUND

Tests often performed in non-traditional laboratory settings may include glucose, cholesterol, hemoglobin and dipstick urinalysis. Potential for harm to patients exists when strict quality assurance standards are not met. As new technology evolves, more tests will move from the traditional laboratory setting to convey near to patient testing. The deceptive ease with which some tests may be performed belies the complexities involved in actually producing a reliable result.

POLICY

Laboratory testing performed in non-licensed settings is not approved and may be in contravention of the Medical Laboratory Licensing Act.

Pharmacists who sell instruments or kits directly to customers may provide instructions as to their proper use.

General Issue #3

ISSUE

Supervision of grandfathered staff

BACKGROUND

Supervision, as defined in the Medical Laboratory Licensing Regulations, is the responsibility of the qualified professional. A further clarification of supervision is provided.

POLICY

  1. The supervisor must be accessible to provide on-site supervision to grandfathered staff who perform tests for which they are grandfathered. Work may be performed in the absence of on-site supervision provided that the work performed during those times is checked within 72 hours. In cases of unscheduled leave, a contingency plan must be in place or labwork must be referred.

  2. The supervisor is responsible for evaluating the competency of all grandfathered personnel and assuring that the staff maintain their competency to perform test procedures and report test results promptly, accurately and proficiently. The procedures for evaluation of competency of the staff must include:

    1. Direct observations of routine patient test performance, including patient preparation, if applicable, specimen handling, processing and testing;
    2. Monitoring the recording and reporting of test results;
    3. Review of test results or worksheets, quality control records, proficiency testing results, and preventative maintenance records;
    4. Direct observation of performance of instrument maintenance and function checks;
    5. Assessment of test performance through testing previously analyzed specimens, internal blind testing samples or external proficiency testing samples;
    6. Adherence to appropriate safety standards;
    7. Assessment of problem solving skills;
    8. Maintenance of records that pertain to competency of individuals

General Issue #4

ISSUE

Retention of Records

BACKGROUND

Laboratories vary in size, facility and extent of services provided. Clinical laboratories must maintain thorough, accessible records that can demonstrate an acceptable standard of care and compliance with the accreditation requirements.

The Laboratory Quality Assurance Program of the College of Physicians and Surgeons urges laboratories to retain records, materials, or both for a longer period of time than specified for educational and quality improvement needs.

POLICY

The following minimum requirements meet or exceed those recommended by professional and/or regulatory requirements.

RETENTION GUIDELINES

Record (Type) Storage Time Comments
  Hem Bio Micro Cyto Anat Path  
Accession record (log-in sheets) 1 yr 1 yr 1 yr 2 yrs 2 yrs  
Worksheets 1 yr 1 yr 1 yr 6 mo 6 mo  
Instrument print-outs 1 yr 1 yr 1 yr n/a n/a  
Copy of patient reports 3 mo 3 mo 3 mo indefinite indefinite *In-patient & out-patient reports are not differentiated
Quality control documents 2 yrs 2 yrs 2 yrs 2 yrs 2 yrs  
Maintenance/Service records Life Life Life Life Life of the instrument
Method/instrument evaluation Life Life Life Life Life  
Procedure Manual Indefinite  
Technologist ID & initials log/computer 1 yr 1 yr 1 yr 1 yr 1 yr  
Telephone logs 3 mo 3 mo 3 mo 3 mo 3 mo  
Physician Ordering Requisition 3 mo 3 mo 3 mo 5 years 5 yrs after ordering

Retention of Specimens Discretion of laboratory 5 yrs slides, reports
20 yrs - abn.		 20 yrs blocks & slides( adult)
50 yrs blocks & slides (children)
20 yrs autopsy

Biomedical Waste Manifests must be retained for a minimum of 1 year

Electronic Format Automatic transfers equivalent to paper retention - provision must be made to access/ retrieve reports as needed. (some provinces recommend 2 years)

General Issue #5

ISSUE

Qualifications of Staff

BACKGROUND

Qualifications, as defined by International Organization of Standardization (ISO) are the accomplishments necessary to fit a person for a position. Quality laboratory services can only result when appropriately trained, competent and motivated staff perform analysis/related tasks, evaluation, and reporting of results. Medical laboratory personnel require a wide skill set and a broad knowledge base that provides the ability to perform tasks as assigned.

For the effective, safe practice of medical laboratory activities in the changing health care system, policies need to encompass all medical laboratory specialities and any personnel performing testing in the Province. These policies will offer assessment tools that are able to fairly and consistently address quality of practice issues and the competencies of personnel providing laboratory testing. The focus should be on competencies, identified by discipline.

POLICY

Persons performing tests in a medical laboratory shall possess the qualifications as defined in the Medical Laboratory Licensing Act/Regulations, Section 9.

Laboratories employing persons who possess a bachelor's, master's or doctoral degree in a relevant science, shall adhere to the following process in assessing relevancy of a particular degree:

  1. Application to Lab Licensing which shall include a full job description, educational qualification achieved (including description of classes completed) as well as a description of related clinical experience. This application shall be submitted in sufficient time to permit assessment prior to the hiring of the individual.
  2. Laboratory Licensing shall refer the application to the Laboratory Quality Assurance Program, seeking, in its opinion, whether the degree is relevant to the stated position.
  3. The Laboratory Quality Assurance Program shall review all information and provide its written opinion to Lab Licensing. This opinion may include requirements for additional training or courses of study, as applicable.
  4. Lab Licensing shall determine relevancy and communicate such decision with both the laboratory and the Lab QA Program.

General Issue #6

ISSUE

Lab Assistant duties

BACKGROUND

The defined activities of a laboratory assistant are the ultimate responsibility of the Laboratory Director or designated qualified professional. Preference should be given to persons who receive certification from a recognized laboratory assistant training course, or those who have appropriate laboratory experience. On-site training must be documented.

POLICY

A laboratory assistant may, under the direct on-site supervision of the qualified laboratory professional, perform a list of tasks which do not require interpretation or assessment. Specific work assignments should only be undertaken subsequent to thorough, documented training and instruction by qualified supervisory personnel.

Examples of tasks may include:

Notwithstanding the defined tasks above, Transfusion Medicine testing is restricted to persons trained in Transfusion Medicine.

Section III ANATOMICAL PATHOLOGY

Section III (A) CYTOPATHOLOGY

Cytopathology Issue #1

ISSUE

Storage and retention of slides and files

BACKGROUND

The most recent edition of the Canadian Society of Cytology Guidelines for Quality Assurance Programs is followed.

POLICY

The Canadian Society of Cytology guidelines will be adopted as the target objective standard for cytology:

  1. Negative slides
    • retain for a minimum of 5 years

  2. Positive or abnormal slides
    • retain for a minimum of 20 years

  3. Negative reports
    • retain for a minimum of 5 years

  4. Positive or abnormal reports
    • retain for a minimum of 20 years

Cytopathology Issue #2

ISSUE

Specimen Collection

BACKGROUND

Specimens should be collected and accepted in a manner that provides access and follow up.

POLICY

  1. All procedures for specimen collection, preparation, staining, disposal and reporting should conform to currently accepted cytology practice, and shall be detailed in a written laboratory manual.

  2. Each specimen shall be uniquely identified and reported to provide access and follow-up.

Cytopathology Issue #3

ISSUE

Follow-up Program for Cytology

BACKGROUND

A follow-up mechanism must be in place to ensure that actions appropriate to abnormal findings are implemented.

POLICY

  1. All patients who are reported to have a significant abnormality should be followed up by the laboratory or other agency to whom this task may be delegated, to obtain final clinical or preferably tissue confirmation of the diagnosis.

  2. Statistical data should be maintained which would include the number of cases screened annually in each category, and all correlative follow-up data available. Discrepancies, if any, should be included with this information.

Cytopathology Issue #4

ISSUE

Number of slides to be screened by cytotechnologists

BACKGROUND

The most recent edition of the Canadian Society of Cytology Guidelines for Quality Assurance Programs is followed.

POLICY

It is the responsibility of the laboratory director to assure that the number and type of cytology slides to be screened does not, through fatigue, adversely affect the cytotechnologist's ability to find, recognize and interpret abnormal cells that may be representative of a disease process. A maximum of 90 slides in one 24 hour period per technologist is recommended.

Cytopathology Issue #5

ISSUE

Standards for providing gynaecological cytology services

  1. Staffing
  2. Volumes

BACKGROUND

Canadian studies published in the past have addressed the issue of quality performance in laboratories. However, the relationship of quality testing to volume of specimens processed has been rather vaguely established. The most recent report states in its recommendation that "for most efficient function in a mass screening program a laboratory should process a sufficient number of cases annually".

External proficiency testing is one of the recognized ways of assessing quality. Proficiency testing, not only provides performance evaluation, but also provides a forum for continuing education and improvement. Once a certain level of proficiency is reached the testing program allows maintenance of proficiency.

The Anatomical Pathology Quality Assurance Committee recommends:

  1. Gynaecological cytology testing in Saskatchewan be centralized, ideally in two locations.
  2. Until the above is achieved, laboratories with fewer than three qualified cytotechnologists or less than optimal volumes of workload be encouraged to associate with other laboratories to maintain adequate staffing levels, participate in educational and quality control activities and peer review or to refer all their work to a larger laboratory.
  3. An External QA Program for gynaecological cytology be established in Saskatchewan as soon as possible to closely monitor the quality of testing and also to provide education and improve performance.
  4. A common patient database be established in Saskatchewan which is accessible to the laboratories and other users.

POLICY

Cytology laboratories should process a sufficient Cytology volume (25,000 cases or more) annually to require minimum staffing of qualified full-time cytotechnologists, adequate support staff and a supervising cytopathologist.

Cytopathology Issue #6

ISSUE

Performance of non-gynecological cytology

BACKGROUND

Non-gynecological cytology comprises of fine needle aspiration biopsies (FNAB) of organs/tissues such as lungs and other visceral lesions, effusion cytology of pleural, peritoneal, pericardial fluids, cytology of urine, CSF, sputum, broncho-alveolar lavage (BAL), brush biopsies of endoscopic procedures, (gastrointestinal tract, etc). Scrapings of open lesions, nipple discharges may also be included along with cytology of transplant organs to test for rejection (kidneys), or for cyclosporin toxicity. BAL and transplant cytology is usually done in specialized centers as it requires specific interpretation and often special tests. Most of the other samples can be handled and processed in a routine surgical pathology/cytology lab equipped with basic facilities including a biological safety cabinet (fume hood), cyto-centrifuge and staining capability for H & E and PAP stains.

In contrast to gynecological cytology, non-gynecological cytology (NGC) does not necessarily require a screening step. If adequate diagnostic material is present the focus is on diagnosis of and interpretive correlation with the clinical setting. If cell block or cytospin samples are available, further testing with special procedures could be performed.

Some aspects of NGC require a rapid turnaround time such as FNAB performed under CT-scan or ultrasound guidance and intra-operative cytology requests.

It is important for institutions with CT scanner facilities to be able to provide cytology service in house. However, it is acceptable, if the lab does not have a cytology department, the technologists in the histology lab are trained in processing the specimens. Such training is simple and can be provided by way of short course of a half a day.

Most NGC procedures are performed on patients who are in-patient residents in a hospital/health care institution or are required to come in for a day procedure/ambulatory care. Due to the time factor involved in patients institution stay, a rapid turnaround time becomes a key factor in availability of the service. On the other hand, the patient in an acute care setting may have an infectious process or malignancy requiring rapid diagnosis and treatment.

POLICY

The final interpretation of non-gynecological cytology must be made by a pathologist.

Cytopathology Issue #7

ISSUE

Follow-up reports for gynecological cytology.

BACKGROUND

To ensure a quality cytology service, a follow-up mechanism must be in place to provide reports to the primary and/or consulting physician.

POLICY

In an attempt to eliminate LOST - TO FOLLOW reporting situation, the following require follow-up letters to the primary and/or consulting physician:

  1. A repeat smear was requested at the time of reporting and 3 months have lapsed since the date of request.

  2. A diagnosis is rendered requiring follow-up and none has occurred. For example:
    • HSIL required follow-up a.s.a.p. and if this has not occurred within 3 months, a letter is required.
    • LSIL (ASCUS, AGUS) within 6 months requires a letter in 9 months.
    • A malignant diagnosis with no apparent followup.

  3. A follow-up letter has been previously issued with no reply. These letters should be automatically generated by the computer system and then replies must be recorded and reviewed quarterly.

  4. A minimum laboratory requirement of a computer system used to report gynecological cytology must have the ability to generate automatic follow-up letters that are linked to diagnostic codes.

Section III(B): SURGICAL PATHOLOGY

Surgical Pathology Issue #1

ISSUE

Qualifications of technical staff in Surgical Pathology

BACKGROUND

It must be demonstrated that duly qualified staff are employed.

POLICY

Medical Laboratory Technologists or a subject MLT in histopathology are qualified technical staffing.

Technical support staff (aides) may be used to assist the gross cut area. In accordance with CCHFA (Canadian Council on Health Facilities Accreditation) and CAP (College of American Pathologists) requirements, technical aides, if they are permitted to do gross examinations of specimens, shall do so under the direct supervision of a qualified pathologist.

Surgical Pathology Issue #2

ISSUE

Retention and Storage of documents and specimens

BACKGROUND

The retention and storage requirements are based on the guidelines of the Canadian Association of Pathologists and the College of American Pathologists.

POLICY
  1. GROSS SPECIMEN
    • retain for a minimum of 8 weeks after the report is issued. In situations where the lesion is unusual or a delay for any reason such as consultation or additional testing, discretion should be exercised.
  2. BLOCKS AND SLIDES
    1. surgicals
      • adults retain for a minimum of 20 years
      • children retain for 50 yrs
    2. autopsy
      • retain for a minimum of 20 years
  3. WET AUTOPSY TISSUE
    • retain for 8 weeks after issuing report
  4. ALL REPORTS, MICROFILMED OR HARD COPY
    • retain indefinitely
  5. PHOTOGRAPHIC TRANSPARENCIES
    • indexed and kept indefinitely
  6. PREVENTATIVE MAINTENANCE AND REPAIR RECORDS
    • Major records should be kept for the life of the instrument
    • Minor records (temperature) should be kept for 2 years
  7. REPORTS
    1. Routine surgical Pathology Reports are to be completed within 2 working days.
      • Where additional procedures are being performed, another 24 hours is preferable.
      • If further delays are anticipated, the physician must be notified.
    2. Autopsy Reports
      • Written initial reports of gross pathological findings within 72 hrs.
      • Final report
        • 30 days for routine cases
        • 90 days for complicated cases
  8. REQUISITIONS
    • refer to Retention guidelines

Surgical Pathology Issue #3

ISSUE

Specimen Rejection

BACKGROUND

Procedures related to specimen procurement, transport and accessioning require:

This policy must specify:

The nature of surgical pathology specimens is unique and cannot always be recollected.

Records of rejected specimens should be reviewed, at least annually, to create corrective action plans for the identification, labelling and accessioning of specimens.

POLICY

Criteria for pathology/cytology specimen acceptance or rejection shall be developed, adopted and documented as per policy.

Section IV: BIOCHEMISTRY

Biochemistry Issue #1

ISSUE

Qualifications of Staff - CLXTs performing Biochemistry procedures

BACKGROUND

The revised Certified Combined Laboratory & X-ray Technician's curriculum in chemistry includes: Glucose, Sodium, Potassium, Chloride, Carbon Dioxide, Alkaline Phosphatase, Alanine Amino Transferase, Gamma Glutamyl Transferase, Creatine Kinase, CKMB/TNI, Aspartate Amino Transferase, Creatinine, Urea, Total Bilirubin, Direct and Indirect Bilirubin, Magnesium, Amylase, Albumin, Calcium and Phosphorus. The Biochemistry Quality Assurance Committee supports the principle that CLXTs perform testing within their scope of training; with the provision that CLXTs must have taken the upgrading courses to be approved for performing the revised CLXT curriculum.

POLICY

  1. Graduates from the CLXT training program, will be allowed to practice to the scope of training obtained.

    CLXT s graduating from 2000 forward are approved to practice the full scope of training, as provided above.

    Graduates, prior to 2000-2001, who successfully complete the Chem 198 and 199 (or the equivalent previous courses: ANLT 180 and Chem 197) will be allowed to perform the expanded scope of testing.

  2. Laboratory Results Correlation (PATH 181) and Quality Management (QC 194) are also recommended for equivalent educational standing.

  3. Refer to Biochemistry Issue # 3 regarding lipid testing.

Biochemistry Issue #2

ISSUE

Use of Glucose Meter for laboratories performing glucose tolerance tests.

BACKGROUND

The glucose meter is appropriate for monitoring treatment, but not suitable for diagnostic testing, specifically glucose tolerance testing (GTT).

POLICY

Glucose tolerance tests, including the gestational diabetic screen, shall not be performed using a glucose meter.

Biochemistry Issue #3

ISSUE

Cholesterol / Triglyceride / Lipid testing

BACKGROUND

Cholesterol results are based on optimal performance of testing. Considerations to be included:

  1. treatment/preparation of the patient
  2. the emergent or non-emergent nature of the test
  3. appropriate technical equipment
  4. adequate quality control

The accomplishment of treatment goals also demands accurate cholesterol measurements. This requires standardization of all cholesterol measurement for accuracy to minimize the method-specific biases. This can be achieved ONLY by standardizing the cholesterol measurements and ensuring accuracy that is traceable to the National Reference System for cholesterol (NRS/CHOL), National Cholesterol Education Program.

POLICY

Clinical protocols are well-established and should be followed by all testing sites.

Laboratories testing for lipids must be capable of performing the entire profile, to include: Cholesterol, Triglycerides, HDL and LDL, for diagnosis and assessment. All lipid measurements should be performed by the same methodology.

Only instrumentation capable of maintaining intralaboratory precision that is less than or equal to 3 % (C.V.); and can demonstrate an accuracy bias of less than 3 % from the true value may be used for cholesterol analysis.

For sites that employ a combination of CLXTs and MLTS, only CLXTs who have completed the Chem l98 and Chem l99 courses (enhanced curriculum) will be approved to run the lipid profile, under the direct on-site supervision of the MLT.

Biochemistry Issue #4

ISSUE

Urinalysis

BACKGROUND

Urinalysis, the most common diagnostic tool available, is provided in most laboratory settings. The need for a microscopic examination may be indicated in specific situations.

POLICY

Complete urinalysis shall include microscopic examination when an abnormal result is obtained for leukocyte esterase, blood, protein, nitrites or turbidity.

Biochemistry Issue #5

ISSUE

Performance of whole blood glucose testing

BACKGROUND

Glucose meters are a convenient, quick and simple means for clinicians and their patients to obtain a blood glucose estimation. Glucose meters are not designed to diagnose diabetes and should not be used to monitor seriously ill patients. The results from a properly used glucose meter are accurate enough to determine insulin dosage and dietary compliance. Glucose meters allow for frequent and rapid blood glucose estimations thereby improving the overall control of the diabetic state. Glucose meter testing is intended to supplement rather than substitute for clinical laboratory testing.

The basic requirements for whole blood glucose testing must include proper training to ensure consistent operating techniques and a quality control surveillance program to ensure proficiency. The National Committee for Clinical Laboratory Standards (NCCLS) serves as the reference for this document.

POLICY

All glucose meter testing, performed outside the traditional laboratory, excluding patient performing glucose in his place of residence, is required to meet the criteria of quality assurance to ensure acceptable performance. The components of glucose monitoring by glucose meters will include, but not restricted to the following:

  1. Choosing the meter
    Personnel at sites where glucose testing is performed by glucose meter will consider the following components when determining which meter to use:
    • evaluations by pathologist-supervised laboratories to include:
      • analytical proficiency,
      • user satisfaction,
      • cost,
      • ease of use.
    • review proficiency testing results to assess performance on that meter
    • review the number of users for that instrument
    • technical limitations of the meter to include:
      • hi/lo range,
      • technical service support

    CAUTION: very high hematocrits in newborns interfere with results, so specific instruments must be recommended for glucose estimations in newborns.

  2. Internal QC
    Daily controls ensure accurate performance of the meter. Internal QC includes running controls:
    • once/day of use/machine; alternating high and low levels; and meter-laboratory comparison of that meter; perform visual inspection, if applicable, for size of drop; comparison to package insert chart; and daily maintenance

    NOTE: It is a good quality assurance practice to ensure that simultaneous venous samples are run once/month/meter.
    • Assays should be performed on fasting specimens.
    • Expected levels of variation are 15% or less for results over 5.5 mmol/L and 10% for results equal to or less than 5.5 mmol/L. (serum/plasma equivalent meters)

  3. Proficiency testing
    Proficiency testing is an important aspect of quality assurance and requires participation in the recognized proficiency testing program designated/approved by the Accreditation Program.

  4. Training/Certification of Users
    Training of personnel to perform glucose meter testing is critical to a successful program and the following components are required:
    • establishment of a training/inservice program
    • initial certification on all meters in use (standardization of meters is highly recommended).
    • training program of users with on-going evaluation as established by an inservice program.

  5. Responsibility for Internal/External QC and certification/supervision of users
    • The criteria as stated in General Issue # 1 and # 2 must be followed.
    • It is the responsibility of the applicant to designate an affiliation with a reference laboratory for training, certification, supervision and overseeing the internal and external QC program of whole blood glucose testing.
    • Training must be supervised by a qualified professional.

Biochemistry Issue #6

ISSUE

Pregnancy Testing

BACKGROUND

In an effort to standardize pregnancy testing throughout the province, guidelines should be set to address the frequency of running controls and provide recommendations to establish sensitivities for testing performance.

POLICY

Pregnancy testing requires highly sensitive methodologies, which define a minimum sensitivity level of 50 mIU BHcG. Frequency of running positive controls should be in accordance with the manufacturer's recommendations, with a minimum of once/month and upon initiation of a new lot number or shipment.

Biochemistry Issue #7

ISSUE

Performance/measurement of Microalbuminuria

BACKGROUND

Microalbuminuria is considered an early predictor of the development of glomerular damage in the absence of overt nephropathy. Patients with diabetes and hypertension are the primary risk groups.

The American Diabetes Association recommends testing for microalbumin once/year after the onset of diabetes.

POLICY

The presence of Microalbumin in urine is detectable by dipstick methodologies, and is approved as a screen for renal damage in the known diabetes patient.

All positive results must be confirmed by quantitative analysis.

Biochemistry Issue #8

ISSUE

Use of Controls for automated analyzers

BACKGROUND

QC emphasizes statistical control procedures, but may also include non-statistical check procedures, such as linearity checks, reagent and calibration checks, etc.

The purpose of QC is to detect the problems early enough to prevent their consequences.

POLICY

Two or three different materials should be selected to provide concentrations that monitor performance at different levels of medical decision-making.

For quantitative tests, the use of two levels of control material must be run each day of use.

For qualitative tests, a positive and negative control must be performed a minimum of once per month and upon initiation of a new lot number and shipment.

Section V: HEMATOLOGY

Hematology Issue #1

ISSUE

Hemoglobin methodology

BACKGROUND

Nationally, the trend to discontinue performance of hemoglobins by visual filter methods has occurred. The International Hematology Authorities have recommended photoelectric methods for measuring hemoglobin because of the increased accuracy of such technology.

POLICY

  1. Hemoglobin determination must be performed by acceptable photoelectric methodology.

  2. Copper sulphate technology may be utilized to screen individuals as potential blood donors.

Hematology Issue #2

ISSUE

Performance of manual white blood cell counts and manual platelet counts.

BACKGROUND

There is an expectation that laboratories performing manual WBC and manual platelet counts require staff with formal training. Research has shown that laboratories performing manual methodologies have experienced difficulty in achieving the expected standard of performance.

POLICY

Manual WBC and platelet counts shall not be used as the primary method of evaluation, but may be acceptable for secondary purposes.

  1. Minimum staffing requirements include MLT or CLXT training.

  2. When doing manual white blood cell counts and manual platelet counts, a slide must be reviewed to correlate with results. A good quality microscope is required.

Hematology Issue #3

ISSUE

Blood film preparation and Stain; Differential and Morphology.

BACKGROUND

To provide accurate differential counts, properly stained blood films prepared and examined by adequately trained personnel are required.

POLICY

  1. A microscope capable of oil immersion is required for a differential count.

  2. When a blood film is to be sent out for review, both a stained and an unstained film should be referred.

  3. A policy must be in place to include specific criteria regarding referral of abnormal peripheral blood smears to a pathologist.

Hematology Issue #4

ISSUE

Bleeding Time

BACKGROUND

The Thrombosis Hemostasis Advisory Group recommends that bleeding times have a limited clinical utility, but in specific circumstances, such as von Willebrand's Disease, the bleeding time is still indicated.

POLICY

  1. The minimum staffing requirement to perform bleeding times is the MLT.

  2. This test should be performed utilizing a Template methodology.

Hematology Issue #5

ISSUE

Retention of Hematological slides

BACKGROUND

Variances in retention of hematological slides exist and the possibility to provide a uniform and consistent standard for the province is now available.

POLICY

  1. Normal peripheral blood smears should be maintained for a minimum of seven days.

  2. Abnormal peripheral blood smears should be retained for a minimum of one year. Abnormal blood films will be defined in each laboratory.

  3. All bone marrow slides and bone marrow reports should be kept for a minimum of twenty years.

Hematology Issue #6

ISSUE

Semen/Sperm analysis

BACKGROUND

Semen analysis is a key component in the evaluation of male fertility, which includes more complex testing.

The minimum WHO requirements for basic semen analysis for assuring good quality of a screening test for fertility include the evaluation of liquefaction, appearance, viscosity, volume, viability, count, motility and morphology. For fertility purposes, a screening count is considered a useless test.

POLICY

  1. Any technologist trained in counting cells (CLXT &/or MLT) may perform seminal counts in post-vasectomy cases.

  2. Tests for the evaluation of fertility shall include: sperm count, sperm motility, viability, sperm morphology and special stains, as required, according to the WHO criteria.

    When a physician specialist has experience in sperm analysis and can demonstrate competency for fertility investigations, then fertility testing may be performed.

  3. Proficiency testing is mandatory for all semen analysis testing, excluding post-vasectomy counts.

Hematology Issue #7

ISSUE

Manual Prothrombin and Activated Partial Thromboplastin Time

BACKGROUND

Manual procedures are not widely used and are difficult to standardize. Laboratories that are not licensed for PT/PTT may refer specimens to the nearest licensed laboratory. It is recommended that plasma be frozen and shipped frozen if it takes over four hours for the specimen to be shipped and tested; or liquid plasma may be shipped on ice if shipping is less than four hours. The reference is NCCLS Document H21-A3.

POLICY

Manual PT/PTT tests will not be approved as primary technology; but may be used as secondary technology.

Hematology Issue #8

ISSUE

Malarial Parasites

BACKGROUND

Definitive diagnosis of malaria is made by demonstration and identification of the malarial parasite in stained blood smears. Parasites in smears may be very difficult for the inexperienced worker to identify.

POLICY

The report of the RBC morphology screen (as found in the differential) should indicate malaria parasites present or suspicious with confirmation to follow.

Slides that are positive for malarial parasites must be confirmed for presence and speciation by referring to a center that has the expertise in the identification of malaria parasites. The reference center should be encouraged to report the degree of parasitemia, in percent.

Hematology Policy #9

ISSUE

Manual Reticulocyte Counts

BACKGROUND

Reticulocyte counts are low volume tests and are rarely required on an urgent basis. Therefore, reticulocyte counts may be referred to a center to ensure competence.

POLICY

Manual testing for reticulocyte counts is discouraged.

  1. Reticulocyte counts shall only be performed in laboratories that employ Medical Laboratory Technologists. Reticulocytes should be performed in duplicate, by methodologies that do not correct for hematocrit, and should be reported as an absolute count.

  2. In order to ensure competence, a minimum of six (6) patient reticulocytes/month must be performed. If these volumes are not met, it is recommended the reticulocyte counts should be referred to a laboratory that is capable of maintaining competency.

Revised May 20, 2003
Revised January 15, 2003

Hematology Policy #10

ISSUE

Flow Cytometry for the diagnosis of Lymphoma/Leukemia

BACKGROUND

Immunophenotypic analysis of hematological malignancies is crucial for accurate diagnosis and classification of these complex malignancies. Flow cytometric data should be interpreted in the context of additional information and correlation with other clinical findings, obtained through genetic studies, and through conventional morphologic and cytochemical methods. Flow cytometry by itself does not provide enough information for diagnosis.

"Flow cytometric analysis has become an acceptable medical practice in the diagnosis and characterization of hematologic neoplasia and its role in the management of patients with these diseases is well recognized. Despite its extraordinary power, there is great concern regarding the inconsistent practices and wide variation in styles among laboratories involved in the flow cytometric analysis of leukemias and lymphomas. Of particular importance are the deficiencies in standardization and validation of procedures used in the analysis, the manner by which the information is generated and reported to pathologists or treating physicians, and the appropriate utililzation of this technology in patient care." (US-Cdn Consensus Recommendations on the Immunophenotypic Analysis of Hematologic Neoplasia by Flow Cytometry)

POLICY

  1. An MLT with Hematology experience, and appropriate Immunology background, and training in Flow Cytometry is required for the performance of Flow Cytometry clinical testing of Lymphoma and Leukemia.

  2. Interpretation of Flow Cytometry results must be performed by a qualified Pathologist/Hematologist who has training in both Hematopathology and Flow Cytometry.

  3. Flow cytometry for clinical diagnostic purposes shall only be performed in pathologist - directed laboratories.

Hematology Policy #11

ISSUE

Differential Reporting in Absolute Values

BACKGROUND

Absolute values for reporting leukocytes are much preferred for patient care. Absolute counts are preferable because they do not rely on the number of other cell types. For example, a patient with 90% lymphocytes and 10% granulocytes could have lymphocytosis, neutropenia, or both. By themselves, these percentages are meaningless. Absolute counts would provide direct information as to whether these cell types are decreased or increased. An increase in absolute concentration is an absolute increase; an increase in percentage only is a relative increase. With a low total leukocyte count, for example, the neutrophil count may be relatively normal (normal percentage) but absolutely decreased. Reference Intervals are more useful if given as absolute concentrations rather than as percentages.

Current automated cell counters report these counts in absolute terms and percentages. However, if differential counts are manually performed using blood films to determine the leukocyte proportions, it is recommended that they also be reported in absolute terms. To obtain absolute leukocyte differential values when performing manual differentials, multiply the differential percentage by the total leukocyte (white blood cell) count provided.

In a move towards standardized reporting formats for complete blood counts including differential leukocyte counts, absolute values have been recommended by several other provinces.

POLICY

All differential leukocyte counts shall be reported in absolute values. Reporting percentages is optional, and would be in addition to absolute values.

REFERENCES

Diagnosis and Management by Laboratory Methods - John Bernard Henry, 19th edition
MLO - Tips from the Clinical Experts - John Koepke, M.D. Professor Duke University, ALQEP, QMPLS, CAP

Section VI: MICROBIOLOGY

Microbiology Issue #1

ISSUE

Standards of practice for Stool Parasitology

BACKGROUND

When there is no qualified person on hand, stool specimens for parasitology should be sent to a reference laboratory.

The recommended preservative for the stool specimen is SAF (sodium acetate, acetic acid, formalin). Specimens in SAF can be transported at room temperature.

POLICY

Parasitology procedures include fixation of specimen, examination of concentrate, and examination of permanent stained smear.

Laboratories wishing to establish diagnostic parasitology services must have at least one MLT, who has been trained in parasitology within one year prior to initiating the program; the training must include a recognized practical workshop conducted by an accredited person or organization.

Microbiology Issue #2

ISSUE

Qualifications of Staff - Analysis of specimens

BACKGROUND

Analysis of specimens requires appropriately trained staff to interpret and certify results.

POLICY

  1. CLXTs who have completed an acceptable microbiology training that is recognized by the accreditation program, may help in processing microbiology specimens, but may not release final results.

  2. A transfer of function procedure should be available to Registered Nurses performing Gram stains and limited microscopy.

Microbiology Issue #3

ISSUE

Quality Control

BACKGROUND

All laboratories performing microbiology must have appropriate internal quality control procedures using NCCLS guidelines for antibiotic susceptibility testing and quality control of media.

  1. The most recent update of the following NCCLS documents should be followed:

    1. M22 Quality Assurance for Commercially Prepared Microbiological Culture Media

    2. M100 Performance Standards for Antimicrobial Susceptibility Testing

    3. M2 Performance Standards for Antimicrobial Disk Susceptibility Tests

    4. M7 Methods for Dilution Antimicrobial Susceptibility Tests for Bacteria that Grow Aerobically

    5. M11 Methods for Antimicrobial Susceptibility Testing of Anaerobic Bacteria

  2. Identification panels should be quality controlled according to the manufacturer's recommendations.

  3. ATCC organisms must be used for proper quality control of media and of antimicrobial susceptibility testing.
    • NCCLS: National Committee for Clinical Laboratory Standards
    • ATCC: American Type Culture Collection

POLICY

All laboratories performing microbiology should have written documentation demonstrating their efforts to meet the standards established by NCCLS guidelines and quality control using appropriate organisms.

Microbiology Issue #4

ISSUE

Quality Control Records to be retained in Microbiology.

BACKGROUND

The storage/retention of quality control records must be in accordance with the Regulations.

POLICY

Documentation of records must be retained as per Retention guidelines. (refer to Retention Guideline Policy - General Issue #4). Some examples are incubator and refrigerator temperatures, internal quality control of media and antimicrobial susceptibility testing and monitoring of CO2 incubators. Major service and repair records should be kept for the life of the instrument.

Microbiology Issue #5

ISSUE

Culture of Throat Swabs

BACKGROUND

The primary cause of bacterial pharyngitis is S. pyogenes [Gp A Streptococcus]. Other organisms such as Beta-hemolytic Streptococci belonging to groups C and G, and Arcanobacterium hemolyticum are occasionally implicated as causative agents. And should be looked for when clinical conditions are indicated, such as recurring infections or outbreaks. Group C & G are found in significant numbers in recurring pharyngitis. Occasionally, N. gonorrheae or C. diphtheriae may be responsible for infections at this site. Streptococcus pneumoniae and Haemophilus sp.are considered part of the normal flora of the throat and are not responsible for infections at this site, therefore, should not be reported.

Culture for N.gonorrheae or C.diphtheriae should be done only at the specific request of a physician.

POLICY

Throat swabs should be routinely cultured to detect the presence of S. pyogenes only. Culture for other organisms shall be performed only at the request of the ordering physician. Culture for Group C & G Beta Hemolytic Strep is indicated in patients with recurrent pharyngitis.

Antimicrobial susceptibility testing of these isolates is not required, as S. pyogenes is universally susceptible to penicillin, unless the patient is known to be allergic to penicillin.

Revised September 22, 2003

Microbiology Issue #6

ISSUE

Direct antigen testing for Group A Strep in throats.

BACKGROUND

The direct antigen test such as the rapid latex test for identifying Group A Strep in pharyngitis may be helpful in situations where patient recall is difficult or in settings where laboratory services are not immediately available.

POLICY

When the direct antigen test is to be performed for detection of Group A Strep in throats, two specimens must be collected. One swab should be used for the antigen test and if negative, the second swab should be referred for culture.

Microbiology Issue #7

ISSUE

Cerebrospinal fluid (CSF) cell counts and Gram Stains.

BACKGROUND

Examination of a CSF is done to confirm or rule out a diagnosis of meningitis caused by an infectious agent prior to starting the patient on antibiotics. Examination must:

  1. differentiate between RBC and WBC.
  2. provide a differential count of WBCs when WBCs are increased.
  3. determine if microrganisms can be seen in the smear, and give a presumptive identification of the microganism.

POLICY

  1. When significantly increased white blood cell counts are present and identified in cerebrospinal fluid, cell morphology should always be verified with a Romanowsky stain (eg. Wright's).

  2. Safranin is to be used as the counter stain on CSF, because it demonstrates the best results when screening for intracellular microorganisms.

Microbiology Issue #8

ISSUE

Standards of practice for detection of Group B Streptococcus (GBS) for prenatal screen.

BACKGROUND

Vertical transmission of GBS to neonates occur in 40-70% of culture-positive women, but only about 1% of these infants develop early-onset disease. The intestinal tract may be the primary reservoir of GBS. Proper specimen collection and use of selective broth are critical for detection of GBS.

POLICY

When a clinician deems it necessary to screen for Group B Streptococcus (GBS) the following procedure is recommended:

  1. Submit a single swab; swab the vagina first and then the rectum.

  2. Use selective broth for optimal detection of GBS.

  3. No routine susceptibility testing for GBS is necessary.

Microbiology Issue #9

ISSUE

Use of Antistreptolysin O titre (ASOT) in diagnosis of Acute Rheumatic Fever

BACKGROUND

Infection with hemolytic Group A streptococcus may lead to poststreptococcal sequelae such as acute rheumatic fever (ARF) and glomerulonephritis. ARF is associated with prior group A streptococcal pharyngitis, where as glomerulonephritis is associated with prior pharyngeal or skin infection with the organism. Streptococcal infections are treated to prevent ARF. Onset of ARF occurs from 2-5 weeks after streptococcal pharyngitis.

The diagnosis of ARF requires supporting evidence of antecedent group A Streptococcal infection, such as:

ASOT is not a stat test. Laboratories that perform only a few tests should refer their specimens to a larger center for confirmation.

POLICY

  1. Throat culture remains the gold standard for confirming pharyngitis caused by Group A Streptococcus.

  2. Neither Streptozyme nor ASOT are appropriate for the diagnosis of acute streptococcal pharyngitis.

  3. ASOT is recommended for identifying elevated or rising streptococcal antibody titre for the diagnosis of acute rheumatic fever.

  4. The use of Streptozyme kits is not recommended based on the lack of sensitivity and specificity.

Microbiology Issue #10

ISSUE

Acute Conjunctivitis

BACKGROUND

Acute conjunctivitis may be caused by viruses and bacteria.

The major causes of bacterial conjunctivitis are H. influenzae and S. pneumoniae in children and S. aureus in adults.

In the majority of cases, cultures do not provide adequate information as:

  1. Most cases have a viral etiology.

  2. Bacterial agents isolated from these cultures are also part of the "normal flora" at this site, so unless a swab from the uninfected eye is also received for comparison of flora, the significance of a positive culture cannot be determined.

  3. Treatment of infections is empiric, and a prescription is given before culture results are available, so that bacteriological investigation does not significantly alter the management of these infections.

  4. Antimicrobial susceptibility testing is not available for topical agents used to treat these infections. Antibiotics used topically achieve very high concentrations so that the susceptibility testing results that are based on achievable serum levels are irrelevant.

POLICY

To facilitate interpretation, swabs from both eyes should be submitted for culture to compare the infected eye to the non-infected eye.

Susceptibility testing results are based on achievable serum levels and are used to determine choice of oral/parental agents. These antibiograms are of no value in the choice of topical antibiotics.

Microbiology Issue #11

ISSUE

Investigation of Infectious Diarrhea

BACKGROUND

Diarrheal illness is a significant health problem. Guidelines for testing of stool specimens in the investigation of infectious diarrhea are based on current literature and on guidelines from other Provinces. (Ontario, Alberta and British Columbia most recently).

POLICY

The most common guideline requires:

  1. Bacterial Infections
    1. Stool for C&S
      Initially a single stool should be ordered in patients with symptoms of < 5 days duration and where antibiotic associated diarrhea is not suspected. Stool for C&S will detect Shigella sp, Salmonella sp, Campylobacter sp, Aeromonas and E. coli 0157. If other pathogens e.g. Vibrio sp or Yersinia enterocolitica are suspected, the laboratory must be informed.
      If the first stool culture is negative, and symptoms persist, a second sample should be submitted. Stool for C & S should be submitted in enteric transport media or Carey Blair transport media.

    2. C. difficile toxin test should be ordered in patients who have diarrhea secondary to antimicrobial use. Antibiotic associated diarrhea may occur up to 8 weeks after antibiotics have been stopped. Again, a single sample should be submitted. If results are negative but symptoms persist, a second sample may be submitted 5-7 days after the first. C. difficile is the commonest cause of infectious diarrhea in hospitalized patients who develop diarrhea >3 days after admission. Stool for C. difficile toxin testing should be transported in a sterile container without preservative.

    3. Routine culture of stool, and O&P examination are not indicated in patients who develop diarrhea > 3 days after admission to the hospital.

  2. Ova and parasites investigation
    1. One stool sample is recommended for initial ova and parasite examination. Two stool samples may only be requested in the following high risk cases:
      • patients with chronic diarrhea
      • returning travellers with diarrhea
      • other high risk categories of patients (e.g. immunosuppressed patients, patients on steroids, male homosexuals)

    2. Additional samples may be examined, if clinically required, after the results of the first examination are known. In special circumstances, e.g. patients with history of travel to the tropics, immunocompromised patients, etc., please consult the laboratory. Specimens should be transported in SAF preservative.

  3. Exclusions
    These guidelines may not apply to the following:
    • patients involved in a community or institutional outbreak, ie. food handlers to whom Public Health regulations apply
    • where an infectious etiology is not a consideration

  4. If a laboratory is not able to perform these tests as part of the work-up, then the stool should be referred to a reference laboratory to perform this level of testing.

References:

  1. J. CLIN MICRO: Aug '93
    Application of Rejection Criteria for Stool Cultures for Bacterial Enteric Pathogens. Fan et al. Pages 2233-2235.

  2. JAMA Feb 16, 1990 Vol: 263 #7
    Inappropriate Testing for Diarrhoeal Diseases in the Hospital.
    Siegel D.K., Edelstein P.M.

  3. Am. J. of INFECTION CONTROL: Dec 88 Vol 16 #16
    Yield of Stool Culture, Ova and Parasite tests and C. difficile determinations in nosocomial diarrhoeas. Yanelli et at. Pages 246-249.

  4. Ayoub E.M and E. Harden; 1992
    Immune Response to Streptococcal Antigens: Diagnostic Methods.
    N.R. Rose et al (ed); Manual of Clinical Laboratory Immunology, 4th edition, American Society for Microbiology Washington, DC, Pages 427-434

Section VII: TRANSFUSION MEDICINE

Transfusion Medicine Issue #1

ISSUE

Qualifications of Staff - CLXTs performing crossmatch procedures

BACKGROUND

Transfusion Medicine is not part of the curriculum for the CLXT, but there are CLXTs trained in transfusion medicine that have been grandfathered to continue.

POLICY

A MLT shall monitor the accuracy of the reports of the cross-matches performed by CLXTs who have been trained in a recognized Transfusion Medicine course. The MLT will take appropriate action when deficiencies are identified.

Transfusion Medicine Issue #2

ISSUE

Minimum number of crossmatches a year to maintain competency

BACKGROUND

A low threshold for crossmatches has been set in an effort to continue to provide essential services.

POLICY

Technologists performing transfusion medicine procedures must maintain a minimum of 12 documented crossmatches/year. This number may reflect a minimum of 8 patient samples/year/technologist. Proficiency testing samples may be utilized to maintain competence. This practice must be documented and available.

Transfusion Medicine Issue #3

ISSUE

Equipment for Transfusion Medicine procedures

BACKGROUND

Minimum equipment required to perform transfusion medicine procedures using the tube methodology includes a microscope, a closed system centrifuge, a circulating bath or thermal block and a blood bank refrigerator.

For optimal antibody reactions to occur 37 degrees Celsius incubation must be ensured.

Laboratories using other methodologies must have the equipment recommended by the manufacturer.

POLICY

Those laboratories performing compatibility testing using tube technology must have a microscope, "a closed system" centrifuge, a circulating bath or thermal block and a blood bank refrigerator.

Transfusion Medicine Issue #4

ISSUE

Storage of red blood cells

BACKGROUND

A Laboratory or facility that stores red blood cell products for transfusion purposes, must ensure proper storage conditions are maintained at all times.

POLICY

  1. The Blood bank refrigerator must be maintained at 1 - 6 degrees Celsius at all times.

  2. Red blood cell products not maintained in a blood bank refrigerator must be stored at 1-6 degrees Celsius for a maximum 24 hours and monitored with a calibrated high/low thermometer.

Transfusion Medicine Issue #5

ISSUE

Storage of platelets

BACKGROUND

To maintain platelet viability storage criteria must be maintained.

POLICY

Institutions storing platelets must provide proper agitation (continuous gentle agitation) at 20 - 24 degrees Celsius for storage of up to 5 days from collection.

Transfusion Medicine Issue #6

ISSUE

Storage of fresh frozen plasma, cryosupernatant, and cryoprecipatate

BACKGROUND

Proper storage requirements must be maintained to ensure product safety.

POLICY

Fresh frozen blood components must be stored at -18 degrees Celsius for a maximum of 12 months from the time of donation.

Transfusion Medicine Issue #7

ISSUE

Storage of fractionated products

BACKGROUND

Fractionated products are products obtained from the fractionation of blood (plasma). This includes factor VIII & IX, albumin and Rh immune globulin as well as other immunoglobulins.

POLICY

All fractionated products must be stored according to the manufacturer's instructions.

Transfusion Medicine Issue #8

ISSUE

Retention of Transfusion Medicine Records

BACKGROUND

The most recently published standards of the Canadian Society for Transfusion Medicine are referenced.

POLICY

Each transfusion service shall have in place an established system for record-keeping that is written and abides by the following:

DOCUMENTS  
Issue Vouchers from CBS Indefinitely
Correspondence Related to Blood Components Indefinitely
Documents Related toTracebook or Look Back Indefinitely
Daily Records for issue of Blood Components/Products Indefinitely
Transfused Patient Data
  • includes antibody investigation & resolution
  • transfusion reaction investigation
 Indefinitely
Non-transfused patient data 5 years
Method Revision Indefinitely
Blood Component & Product Final Disposition Records Indefinitely
Tissue & Bone Banking Donor & Inventory Records Indefinitely
Quality Control Records
  • Include reagents, serological test controls, external proficiency testing
 5 years
Utilization Reports
  • Blood component product inventory
 5 years
Direct & Stores Inventory
  • Purchase & acquisition data
 5 years
Meeting & Related Documents 5 years
Computer Program Validation & Exception List 5 years
Workload Records/Reports 3 years
Inservice Education Documentation 3 years
Test & Blood Product Request Forms 25 months

SPECIMENS  
Donor Segments from transfused red cells 3 weeks
Clotted and/or EDTA specimens, serum/plasma from transfused patients (pre-transfusion) 1 to 3 weeks
Cord Blood 2 weeks
All Other Patient Specimens 1 week
Kleihauer-Betke Slides 1 year

Transfusion Medicine Issue #9

ISSUE

Centralized Prenatal Antibody Titrations

BACKGROUND

Prenatal serologic screening detects the presence of clinically significant red blood cell antibodies requiring titration. Reproducibility of titrations is difficult to maintain in low volume test situations. Centralized testing of prenatal specimens has the advantage of centralized patient information.

POLICY

In an effort to enhance and ensure quality service, all prenatal red blood cell antibody titrations shall be performed at centralized sites. NOTE: All positive prenatal antibody screens should be referred to the appropriate reference laboratory. The results of prenatal screening should be reported to the ordering physician and the hospital of delivery.

Revised December 22, 2003
Revised July 8, 2003
Revised May 28, 2003
Revised May 8, 2003

Transfusion Medicine Issue #10

ISSUE

Testing for weak D Antigen.

BACKGROUND

The purpose for weak D Antigen testing is to identify those patients who may require Win Rho (Rho immune globulin). The test for weak D (Du) is unnecessary in pre-transfusion testing of recipients.

POLICY

Laboratories shall either utilize reagents sensitive enough to detect the weak D phenotype on initial cord blood testing, or perform a separate Weak D test on babies, born to Rh negative mothers, where the cord blood initially tested negative with Anti-D.

Transfusion Medicine Issue #11

ISSUE

Direct Antiglobulin Test (DAT).

BACKGROUND

The purpose of the DAT is to determine the presence of immunoglobulin and/or complement on the red cells, which may be the cause of in vivo red cell hemolysis.

POLICY

The Direct Antiglobulin Test should be performed in the following situations:

Transfusion Medicine Issue #12

ISSUE

Documentation of disposition of blood components

BACKGROUND

It is a requirement under CSA Z-902, CSTM and AABB to trace any unit of blood or blood component from source to final disposition, and to recheck records applying to the specific unit, including investigation of reported adverse reactions.

POLICY

Every facility providing transfusion medicine services must have a documented process to trace and identify all units of blood/blood components from SOURCE TO FINAL DISPOSITION. This information must be retrievable within a 24-hour timeframe and documentation must be retained indefinitely.

Re: AABB Standards 16th Edition
AABB Technical Manual 13th Edition
CSTM Standards 6th Edition 1999
CSA Z902

Revised February 5/04
Revised December 22/03

  1. For transfusion medicine purposes, the following references are used:1. CSTM Standards for Transfusion Medicine, 6th edition

  2. AABB Standards for Blood Banks and Transfusion Services, most current edition

  3. AABB Technical Manual, 13th edition, pages 301-304; 659-660

  4. CBS Circular of Information, most current edition