Department of State Health Services Laboratory Services Section Biochemistry & Genetics Branch...

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Department of State Health Services Laboratory Services Section Biochemistry & Genetics Branch Clinical Chemistry Laboratory

Transcript of Department of State Health Services Laboratory Services Section Biochemistry & Genetics Branch...

Page 1: Department of State Health Services Laboratory Services Section Biochemistry & Genetics Branch Clinical Chemistry Laboratory.

Department of State Health Services

Laboratory Services Section

Biochemistry & Genetics Branch

Clinical Chemistry Laboratory

Page 2: Department of State Health Services Laboratory Services Section Biochemistry & Genetics Branch Clinical Chemistry Laboratory.

DSHS Laboratory Services THSteps and Title V Program

Specimen Collection and Shipping/Mailing Supplies

Test results to service providers Telephone consultations

Page 3: Department of State Health Services Laboratory Services Section Biochemistry & Genetics Branch Clinical Chemistry Laboratory.

DSHS Laboratory Tests

Newborn Screening Total Hemoglobin Lead Screening Hemoglobinopathy Testing RPR Screening and Confirmation Cholesterol/Lipid Profile/Glucose/Triple Screen Hemolytic Disease of the Newborn Gonorrhea/Chlamydia Infection Screen HIV Screen Pap Screen

Page 4: Department of State Health Services Laboratory Services Section Biochemistry & Genetics Branch Clinical Chemistry Laboratory.

Newborn Screening

Testing for five possible disorders in newborns at birth and 10-14 days after birth Congenital Adrenal Hyperplasia (CAH) Phenylketonuria – (PKU) Galactosemia Hemoglobinopathy Congenital Hypothyroidism

Page 5: Department of State Health Services Laboratory Services Section Biochemistry & Genetics Branch Clinical Chemistry Laboratory.

Newborn Screening (NBS-3) Form

Page 6: Department of State Health Services Laboratory Services Section Biochemistry & Genetics Branch Clinical Chemistry Laboratory.

Newborn Screening (cont.)

Filter paper collection Wall Chart- collection technique Reference chart – Valid specimen Newborn Screening Program – “Guide to

Practitioners”

Page 7: Department of State Health Services Laboratory Services Section Biochemistry & Genetics Branch Clinical Chemistry Laboratory.

Total Hemoglobin Testing for evidence of anemia Required 6, 12, and 24 months and 6, 12 and 16 years

of age Laboratory procedure:

SLS-Hb (sodium lauryl sulfate –

metthemoglobin method)

Sysmex XT-1800i/KX-21N/pocHi Normal Range: 11-16 g/dL

Page 8: Department of State Health Services Laboratory Services Section Biochemistry & Genetics Branch Clinical Chemistry Laboratory.

Sysmex KX-21N

Page 9: Department of State Health Services Laboratory Services Section Biochemistry & Genetics Branch Clinical Chemistry Laboratory.

Sysmex XT-1800i

Page 10: Department of State Health Services Laboratory Services Section Biochemistry & Genetics Branch Clinical Chemistry Laboratory.

Lead Screening

Testing for possible lead intoxication Blood Lead screening required 12 and 24 months.

Lead questionnaire required at 6 and 18 months, and at 3, 4, 5, and 6 years of age.

Laboratory procedure Blood Lead (Pb)

Atomic Absorption Spectrophotometer Graphite Furnace (PE AA600/4100ZL)

Expected Results Pb < 10 μg/dL

Page 11: Department of State Health Services Laboratory Services Section Biochemistry & Genetics Branch Clinical Chemistry Laboratory.

PE AA600

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Hemoglobinopathy

Testing for sickle cell diseases and other hemoglobin disorders

Required at birth and 10 - 14 days after birth Laboratory procedure

Isoelectric Focusing (IEF) Citrate Agar Electrophoresis

Normal Result: A,A (homozygous) Hemoglobin F may be present in children under 1

year of age.

Page 13: Department of State Health Services Laboratory Services Section Biochemistry & Genetics Branch Clinical Chemistry Laboratory.

Isoelectric Focusing Electrophoresis

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Rapid Plasma Reagin (RPR)

Testing for presence of syphilis Optional – no longer required Laboratory procedure

18 mm RPR card test Normal result

non-reactive Any (+) RPR is submitted for confirmation

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RPR Card Test

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Glucose Testing

Testing for high levels of blood glucose. Laboratory procedure:

-Enzymatic measure by automated chemistry analyzer. Beckman Synchron CX4

Desired Results: Random 50-130 mg/dL 1-Hr GTT < 140mg/dL 2-Hr PP < 120 mg/dL 3-HR GTT: Fasting < 105 mg/dL 1-HR < 190 mg/dL 2-HR < 165 mg/dL 3-HR < 145 mg/dL

Page 17: Department of State Health Services Laboratory Services Section Biochemistry & Genetics Branch Clinical Chemistry Laboratory.

Cholesterol Screen & Lipid Profile Testing for potential development of coronary heart

disease Blood Cholesterol Screen

Children over 2 years of age: -with a parent having a cholesterol > 240 mg/dL

-with multiple risk factors (smoking, obesity, hypertension, diabetes, fatty diet) Lipid Profile

Test is done only for children over 2 years of age in

high risk category. (Family history of heart or vascular disease)

Page 18: Department of State Health Services Laboratory Services Section Biochemistry & Genetics Branch Clinical Chemistry Laboratory.

Cholesterol & Lipid Profile (cont.)

Laboratory procedure:

Enzymatic measure by automated chemistry analyzer. Beckman Synchron CX4

Desired Results: Cholesterol < 170 mg/dL

Triglycerides 30 – 190 mg/dL

HDL > 35 mg/dL

LDL < 110 mg/dL

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Beckman CX4

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Hemolytic Disease of the Newborn(HDN Testing)

Testing for blood type (ABO) and Rh factor. Antibody Screen

Performed to detect and titer clinically significant antibodies

Antibody Identification Antibody titer

Immucor Capture Solid Phase

Page 21: Department of State Health Services Laboratory Services Section Biochemistry & Genetics Branch Clinical Chemistry Laboratory.

Immucor Capture Solid Phase

Page 22: Department of State Health Services Laboratory Services Section Biochemistry & Genetics Branch Clinical Chemistry Laboratory.

Triple Screen Testing Testing for birth defects:

Down’s Syndrome, Open Neural Tube Defects – (Open Spina Bifida), Trisomy 18

Biochemical Tests include:• hCG - human chorionic gonadotropin AFP – alpha-fetoprotein uE3- unconjugated estriol All three are used for determining risk for Trisomy 18 and

21, while AFP alone is used to determine NTD risk.

Performed during 15-20 weeks and 6 days of gestation. Beckman Coulter - AccessII

Page 23: Department of State Health Services Laboratory Services Section Biochemistry & Genetics Branch Clinical Chemistry Laboratory.

Beckman Coulter Access II

Page 24: Department of State Health Services Laboratory Services Section Biochemistry & Genetics Branch Clinical Chemistry Laboratory.

Triple Screen Testing (cont.)

Factors used in the calculation of patient risks: Gestational age is determined by physical exam,

dating of last menstrual period, and/or ultrasound dating.

Maternal age Maternal weight Maternal non-gestational insulin-dependent diabetic

status Maternal race Number of fetuses

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Recalculation of Triple Screen Test Results

Fax request for recalculation using Request for Recalculation of Prenatal Screening report to 512-458-7139.

Recalculation of Prenatal Triple screen will be performed based on a change in the gestational age only if the change is 10 days or more.

Page 26: Department of State Health Services Laboratory Services Section Biochemistry & Genetics Branch Clinical Chemistry Laboratory.

Gonorrhea/Chlamydia Screen

Testing for presence of infection by Neiserria gonorrhoeae and Chlamydia trachomatis

Physician’s discretion Laboratory procedure

DNA probe technology Normal Result: Negative

Page 27: Department of State Health Services Laboratory Services Section Biochemistry & Genetics Branch Clinical Chemistry Laboratory.

HIV Screen Testing for presence of human immunodeficiency

virus Adolescents at risk for HIV infection –

CONSENT for confidential screening Include pre- and post test counseling Laboratory procedure

Enzymatic Immunoassay (EIA) Western Blot

Normal Result: Negative

Page 28: Department of State Health Services Laboratory Services Section Biochemistry & Genetics Branch Clinical Chemistry Laboratory.

Pap Screen Testing for the detection of malignant,

premalignant, and infectious disease of the uterine cervix.

Laboratory procedure

Pap stain technique Normal Result

Negative Specimens must be sent to DSHS Women’s

Health Laboratories in San Antonio.

(210) 531-4596 or Toll-free: 1-888-440-5002

Page 29: Department of State Health Services Laboratory Services Section Biochemistry & Genetics Branch Clinical Chemistry Laboratory.

Collection and Shipping Supplies

Supplies for Collection and Shipping of Specimens

Do’s and Don’ts of Specimen Collection Submission of Specimens Forms G-1B, G-2A, G-2B, and M-47

Page 30: Department of State Health Services Laboratory Services Section Biochemistry & Genetics Branch Clinical Chemistry Laboratory.

Tips for Successful Submission of Specimens

Fill out test request forms accurately and completely. Patient name on specimen must match name on test request

form. Purple top blood collection tubes should be filled according to

manufacturer package insert. Thoroughly mix blood collected in purple top tubes

immediately after collection to avoid specimen from clotting. Avoid lead contamination from skin when collecting blood

specimen for lead testing by washing the puncture site with soap and water.

Page 31: Department of State Health Services Laboratory Services Section Biochemistry & Genetics Branch Clinical Chemistry Laboratory.

Tips for Successful Submission of Specimens (cont.)

Purple top specimens submitted for lead, total hemoglobin, and hemoglobin type may be shipped at ambient temperature and tested 21 days from date of collection.

Do NOT freeze whole blood specimens. Mail specimens same day of collection. Pack tubes carefully and ensure they are properly capped

to avoid specimen leaking in transit. Place specimens in PLASTIC canister. Wrap plastic

canister with form/s and place in cardboard mailing container.

Tips for Successful Specimen Collection: http://www.dshs.state.tx.us/lab/refman.pdf

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Specimen Acceptability Criteria Update

Becton Dickinson (BD) Microtainer® 250 uL – 500 uL Tube

Page 33: Department of State Health Services Laboratory Services Section Biochemistry & Genetics Branch Clinical Chemistry Laboratory.

Specimen Acceptability Criteria Update

Becton-Dickinson (BD) 2mL Vacutainer® K2 EDTA 3.6mg Tube

Page 34: Department of State Health Services Laboratory Services Section Biochemistry & Genetics Branch Clinical Chemistry Laboratory.

RPR Specimen Submission and Shipping Instructions

Whole blood or serum specimens may be submitted at ambient temperature as long as the specimens are received within 5 days from the time of collection.

Day one is the day the specimen is collected, unless the time of collection is documented on the G-1B form. If the time of collection is provided, the five days are calculated from the actual time of collection.

If serum specimens will not arrive at the laboratory within 5 days: Specimens will be accepted if frozen, but must be shipped overnight on dry ice.

Record the date and time specimens are removed from the freezer on the G-1B form.

Do not ship specimens to the DSHS Laboratory on Friday or the day before a Federally observed holiday.

Page 35: Department of State Health Services Laboratory Services Section Biochemistry & Genetics Branch Clinical Chemistry Laboratory.

Cholesterol, Lipid Profile and Glucose Specimen Collection Guidelines

Collect specimens for lipid profile and cholesterol testing in red top tubes.• Serum must be separated from red cells within

2 hours from time of collection and frozen.

Collect specimens for glucose testing in gray top tubes.• Plasma must be separated from red cells within

24 hours from time of collection and frozen.

Page 36: Department of State Health Services Laboratory Services Section Biochemistry & Genetics Branch Clinical Chemistry Laboratory.

Cholesterol, Lipid Profile and Glucose Shipping Instructions

Record the date and time the specimen was removed from the freezer on each G-1B form.

Package and ship specimens overnight with enough cold packs or dry ice to maintain specimens at proper temperature until arrival at DSHS Laboratory.

Friday or the day before a Federally observed holiday.

Page 37: Department of State Health Services Laboratory Services Section Biochemistry & Genetics Branch Clinical Chemistry Laboratory.

Patient specimen Transport tube

Canister Freezer

IcePack

IcePack

Styrofoam Box

StyrofoamLid

Fiberboard BoxG-1BForms

Place two ice packs onthe top of the canister(s) inthe styrofoam box

G-1B forms go on top ofthe closed styrofoam box

in the fiberboard outer box

Record Date and timespecimen(s) were takenout of freezer on the G-1Bform

Styrofoam Box holds up to4 canisters

Airbill

Place Airbill insleeve located ontop of fiberboardbox

Cholesterol Lipid and Glucose Packing Diagram

Cholesterol, Lipid Profile, and Glucose Specimen Packing Diagram

Page 38: Department of State Health Services Laboratory Services Section Biochemistry & Genetics Branch Clinical Chemistry Laboratory.

Triple Screen Specimen Collection and Shipping Guidelines

Specimens must be collected during the 15–20 week and 6 days of pregnancy.

Collect specimens for triple screen testing in red top tubes.• Serum must be separated from red cells within 2 hours from

time of collection and frozen.• Record the date and time the specimen was removed from the

freezer on each G-1B form. Package and ship specimens overnight with enough cold packs or

dry ice to maintain specimens at proper temperature until arrival at DSHS Laboratory.

Please do not ship specimens to the DSHS Laboratory on Friday or the day before a Federally observed holiday.

Page 39: Department of State Health Services Laboratory Services Section Biochemistry & Genetics Branch Clinical Chemistry Laboratory.

Triple Screen Specimen Packing Diagram

Patient specimen Blue Top Tube

Canister Freezer

Ice PackIce Pack

Styrofoam Box

Styrofoam Lid

Fiberboard BoxG-1CForms

Place two ice packs on thetop of the canister(s) in thestyrofoam box

G-1C forms go on top of theclosed styrofoam box in the

fiberboard outer box

Record Date and timespecimen(s) were taken outof freezer on the G-1C form

Styrofoam Box holds up to4 canisters

Airbill

Place Airbill insleeve located ontop of fiberboardbox

Triple Screen Packing Diagram

Biohazard

Biohazard Bag

Page 40: Department of State Health Services Laboratory Services Section Biochemistry & Genetics Branch Clinical Chemistry Laboratory.

Hemolytic Disease of the Newborn Specimen Collection and Shipping Guidelines

Collect specimens for HDN testing in red top tubes. Ship specimens overnight at ambient temperature Specimens that cannot be received by DSHS laboratory within

24 hours from time of collection should be stored at 1-10ºC. Do not freeze specimens. Package and ship specimens, including enough cold packs to

maintain specimens at the proper temperature until arrival at the DSHS Laboratory, if cold shipment is required.

Do not ship specimens to the DSHS Laboratory on Friday or the day before a federally observed holiday.

Page 41: Department of State Health Services Laboratory Services Section Biochemistry & Genetics Branch Clinical Chemistry Laboratory.

The G-1B Laboratory Submission Form

Master form An instruction page for filling out the form Descriptions of the DSHS programs listed on

the submission form

Page 42: Department of State Health Services Laboratory Services Section Biochemistry & Genetics Branch Clinical Chemistry Laboratory.

Specimen Submission Form G-1B

Page 43: Department of State Health Services Laboratory Services Section Biochemistry & Genetics Branch Clinical Chemistry Laboratory.

Specimen Submission Form G-2A

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Specimen Submission Form G-2B

Page 45: Department of State Health Services Laboratory Services Section Biochemistry & Genetics Branch Clinical Chemistry Laboratory.

Specimen Submission Form G-1C

Page 46: Department of State Health Services Laboratory Services Section Biochemistry & Genetics Branch Clinical Chemistry Laboratory.

Specimen Submission Form M-47

Page 47: Department of State Health Services Laboratory Services Section Biochemistry & Genetics Branch Clinical Chemistry Laboratory.

To Order Master Forms or Change Submitter Information

Call 1-888-963-7111 or 512-458-7578

--OROR--

E-mail [email protected]

Page 48: Department of State Health Services Laboratory Services Section Biochemistry & Genetics Branch Clinical Chemistry Laboratory.

Laboratory Services SectionPhone Numbers

1-888-963-7111

Clinical Chemistry Laboratory Specimen Submission

(512) 458-7680 (512) 458-7598

Newborn Screening Laboratory Billing Information

(512) 458-7333 (512) 458-7318 x3819

Ask for Accounts Receivable Lab Reporting

(512) 458-7578 Test Results Triple ScreenTesting

(512) 458-7300 Newborn Screening 1-800-687-4363

(Voice Response System) (512) 458-7138

(512) 458-7533 fax (512) 458-7139 fax

Specimen Collection Supplies

(512) 458-7661 THSteps (EPSDT)

(512) 458-7331 Newborn Screening

(512) 458-7672 fax

Page 49: Department of State Health Services Laboratory Services Section Biochemistry & Genetics Branch Clinical Chemistry Laboratory.

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