Identification and Test Request Form: Complete a test request form that is provided by Delta Medical Laboratories for every patient. Ensure that all information is correctly filled; Patient full name, Age, Gender, Specimen Collection Date and Time, Type of Sample Collected, Sample Collected by.
Clinical Information: The clinical information must be attached for pathology samples and a consent form is required for all genetic tests.
Sample Temperature: Mark the temperature requirement on the biohazard bag (Ambient, Refrigerated, Frozen).
Tube labeling: Each sample tube should be labeled by the barcode number of the used test request form
Turn Around Time (TAT): Please refer to the test catalog for TAT. The mentioned TAT is from the time the sample is received by the lab
All samples for Delta Medical Laboratories analysis should be sealed in the appropriate containers at the temperature indicated in the test catalog. These samples should then be placed into the appropriate “Biohazard” labeled transport bags provided by Delta Medical Laboratories. The test request form should also be placed in the appropriate pocket of the transport bag.
ALL SPECIMENS SHOULD BE TREATED AS IF THEY ARE POTENTIALLY INFECTIOUS
In most cases, a Delta Medical Laboratories courier will pick up all specimens, appropriately pack & transport them at the required temperature. Make sure that the temperature of the specimen is marked on the biohazard bag (Room temperature, Refrigerated & Frozen), the courier will reserve the sample based on the marking of the biohazard bag. In the event that a courier cannot pick up a specimen, please ensure that the specimen is packed at the appropriate temperature, as follows:
Room temperature specimens should be packed in a container that prevents excess heat from affecting the specimen.
Refrigerated specimens should be stored in a refrigerator to maintain temperature until the specimen reaches Delta Medical Laboratories.
Frozen specimens should be stored in a freezer to maintain the frozen state until the specimen arrives at Delta Medical Laboratories.
The transportation time from the collecting institute to Delta Medical Laboratories should be kept to a minimum.
Delta Medical Laboratories will maintain all submitted samples based on the sample type. Should additional testing be requested on a sample during this time, notify Delta Lab. We will do our best to accommodate your needs provided a sufficient amount of the sample remains, and test stability is maintained.
Collecting Specimenss for Blood Sampling
Draw blood in the appropriate containers as recommended under the “Test Catalog”. Blood drawn for tests to be performed on serum should be allowed to clot for 30 min at room temperature. After clotting, if the specimen is drawn in an SST tube it should be centrifuged and the entire tube shipped to Delta Medical Laboratories. If the specimen is drawn in a red top tube the serum should be separated into an appropriate container and forwarded to Delta Medical Laboratories.
Please follow test directions as to whether the serum should be stored at room temperature, refrigerated, or frozen. If a centrifuge is not available the patient should be drawn at a facility where serum separation can be accomplished.
Samples for plasma analysis should be drawn in the appropriate tubes as indicated under “Test Catalog”. These will either be heparin tubes, EDTA tubes, or citrate tubes. The specimen should be centrifuged immediately after collection. The plasma should be separated into an appropriate tube and stored at the temperature indicated in the catalog.
Before performing any component of the phlebotomy procedure, the phlebotomist must properly verify the identity of the patient with the collection request using two distinct identifiers as follows:
Ask the patient to verbally state or spell their complete name. Do not ask the patient to confirm their identity by requesting a yes/no response. Compare this information with the name on the test request form.
A second identifier such as date of birth must also be verbally stated by the patient. Do not ask the patient to confirm this information by requesting a yes/no response. Compare this information with the birth date on the test request form.
Patients who are not capable of giving their name or children may be identified through verbal verification by another adult who can personally identify the patient. Compare this information with the name on the test request form.
Hands must be washed prior to and after all phlebotomy procedures. Using soap and warm water, scrub vigorously for 10 to 15 seconds, rinse well and repeat. A hand sanitizer product can be used in place of soap and water.
Gloves are to be worn when performing all phlebotomy procedures.
Inform the patient of the procedure(s) that you are about to perform and obtain their permission and cooperation. Perform phlebotomy only if approved by appropriate healthcare professional and/or approved by the patient or patient’s guardian.
Venipuncture Specimens
Prepare patient as mentioned in “Patient identification” and “Patient Preparation” sections.
Wash hands. Put on properly fitting gloves.
Position or instruct the patient so that the patient’s arm is comfortably extended.
Apply the tourniquet 3 to 4 inches above the venipuncture site with enough tension to compress the vein, but not the artery.
Palpate or feel for the vein even when it can be seen. If a vein is difficult to find, it may become easier to see after massaging the arm from the wrist to the elbow, which forces blood into the vein. A warm moist towel (warm to the touch, but not hot) can also be used. You may need to examine the patient’s other arm if you are having difficulty finding a vein.
Cleanse the area for venipuncture in a circular motion from the center outward with an alcohol swab and allow to air dry.
Anchor the vein by placing your free thumb below the venipuncture site where the needle is to enter and pull the skin taut.
Vacutainer
Introduce the vacutainer needle apparatus with the bevel up at a 15- to a 30-degree angle to the skin and parallel to the vein.
Once the needle is properly positioned in the vein, anchor the needle by grasping the holder with the thumb on top and other fingers under the holder, resting securely on the patient’s arm. Push the appropriate vacutainer tube into the holder with gentle pressure in order to puncture the cap. The tube will automatically fill with blood.
Watch the blood as it flows into the vacutainer tube until the collection is complete.
Release tourniquet within one minute.
When all tubes are filled, withdraw the tube, place gauze square over the site and withdraw the needle.
Discard the activated needle and holder into the sharps container. Never re-cap the needle.
Inspect the puncture wound. When bleeding has stopped, apply a bandage. If bleeding continues, apply pressure for an additional three-five minutes. Prolonged bleeding may be related to the patient’s disease or medication.
Label the specimen tubes with the barcode number of the test request form and/or the barcode used in your facility which includes the patient information, before leaving the patient.
Wash hands thoroughly after removing gloves.
(Butterfly) with Evacuated Tubes or Syringe
Holding the wings of the butterfly with your dominant hand, smoothly insert the needle with the bevel up, parallel to the vein, at approximately a 10- to a 15-degree angle.
Once the needle is properly positioned in the vein, hold one wing of the winged collection set and insert evacuated tubes using the vacutainer holder according to the order of draw. For syringe draws, gently pull on the plunger to allow blood to flow into the syringe. Pulling on the plunger too fast may cause a possible collapse of the vein and restrict blood flow into the syringe and/or hemolyze the sample.
Pulling on the plunger too fast may cause a possible collapse of the vein and restrict blood flow into the syringe and/or hemolyze the sample.
If a syringe was used with the butterfly, properly discard the butterfly device into a sharps container, and attach a transfer device to the syringe. Fill the appropriate tubes without applying force on the plunger
Adverse Reaction Management
Remove tourniquet and withdraw the needle from the arm.
Assist patient to lie down on bed provided in the Phlebotomy areas.
Symptoms
Weakness, sweating, dizziness, pallor, loss of consciousness, convulsions, cold skin, drop in blood pressure, slow pulse rate.
Procedure
Loosen tight clothing.
Raise the patient’s feet above the level of the /patient’s head.
Apply a cold compress to the forehead and back of the neck.
Administer aromatic spirits of ammonia by inhalation. The patient’s response by coughing may elevate the blood pressure.
Instruct patient to breathe slowly and deeply. Apply a cold compress to the forehead and back of the neck.
Provide receptacle for vomitus and tissues.
Provide a cup of water to rinse the mouth.
Symptoms
Swelling of skin at needle entry sight.
Procedures
Place three or four sterile gauze squares over the hematoma and apply firm pressure for 7-10 mins. With the patient’s arm held above the heart level. Apply the dressing cover firmly.
Collection of other Specimens
- Blood Specimen:
Draw blood in lavender top (EDTA) tube(s) and send 5 mL (for pediatric 0.5 mL) of EDTA whole blood refrigerated. DO NOT FREEZE. Maintain sterility and forward promptly.
– Lesions on skin specimens:
Send specimen refrigerated in a screw-capped, sterile container. DO NOT FREEZE. Maintain sterility and forward promptly.
– Sputum and Biopsy Specimen (Brain, Liver, or Lung):
Send specimen refrigerated. DO NOT FREEZE. Maintain sterility and forward promptly
– Spinal Fluid and Urine Specimens (Please contact Delta Lab before sending the sample)
Send 2mL (pediatric 0.5mL) of spinal fluid or urine. Send specimen refrigerated. DO NOT FREEZE. Maintain sterility & forward promptly.
– Swab Specimens of Cervix, Rectum, Urethra, Vagina & other Genital Sites (Please contact Delta Lab before sending the sample)
Collect specimen using Culture swab. Break medium ampoule to moisten swab. Send specimen refrigerated. DO NOT FREEZE
Feces (stool) collected for the examination should contain no water, urine, or blood. Feces should be caught in a clean container and stored or mixed with appropriate preservatives as indicated in the “Test Catalog”. Feces for stool culture analysis must be collected in a sterile container.
To collect a 24-hr feces sample, feces should be collected for a 24-hour period in a clean container whose empty weight has been noted. No urine, blood, or water should enter the container. The full container and feces should be weighed. The net weight of the feces should be indicated on the request form. The appropriate quantity of feces should be removed from the 24-hr collection and stored as indicated in the “Test Catalog”.
When multiple blood samples are scheduled for collection from one patient, the trace metal specimens should be collected first. Once the phlebotomy needle has punctured another rubber stopper, it is contaminated & should not be used for trace metal specimen collection.
Use an alcohol swab to clean the venipuncture site. Avoid iodine-containing disinfectants. Use stainless steel phlebotomy needles.
Blood specimens for serum testing should be collected in the Monoject (royal blue top) trace element blood collection tube ( if unavailable in your clinic or hospital, Delta Medical Laboratories can supply this item). Allow the specimen to clot for 30 min. Centrifuge the specimen to separate serum from the cellular fraction.
Remove the stopper and carefully pour the serum into a 5 mL metal-free, screw-capped, polypropylene vial. Avoid transfer of the cellular components of blood. Do not insert a pipette into the serum to accomplish the transfer, do not ream the sample with a wooden stick to assist with serum transfer. Place the cap on the polypropylene vial tightly, attach a specimen label, and send the specimen to the laboratory refrigerated or frozen.
Specimen for whole-blood testing should be collected in the blood collection tube, containing EDTA as an anticoagulant. Leave the specimen in the tube. Attach an identification label and send the specimen to the laboratory at a cool temperature. Alternatively, pediatric specimens can be drawn in a Becton-Dickinson Microtainer, with EDTA Anticoagulant. An absolute volume of 0.5 mL is required for testing for each analyte ordered.
– Chromosome Analysis for Congenital Disorders:
Use a green top (lithium heparin) tube. Collect 7-10 mL (for pediatric 2.5 – 5mL in a sodium heparin tube). Invert to mix. Refrigerate for shipping. DO NOT FREEZE.
– Products of Conception or Stillbirth (Please contact Delta Medical Laboratories before sending the sample)
Obtain 1 cc of muscle and fascia from the thigh or 1 cc of placental tissue. Place in a sterile screw-topped bottle with Hanks’s balanced salt solution. KEEP COOL. Delta Medical Laboratories can supply the required container.
– Skin Biopsy (Please contact Delta Medical Laboratories before sending the sample)
Wash skin with an antiseptic such as pHisoHex. Wash well with sterile water. Obtain a punch biopsy 3 mm x 5 mm. Place in tissue culture media. Keep refrigerated.
– Solid Tumors or Lymph Nodes (Please contact Delta Medical Laboratories before sending the sample)
Obtain a 0.5 cc piece of tissue and place it in the tissue culture medium. Refrigerate.
– Chromosome Breakage:
Obtain blood as in chromosome analysis for congenital Disorders (see above).
– Chromosome Analysis Consultation:
Offered on the basis of Fluorescent, in-Situ Hybridization (FISH) Techniques, and other methods. For specimen collection, call Delta Lab for special instruction.
– – Blood Specimen:
Draw blood in lavender top (EDTA) tube(s) and send 5 mL (for pediatric 0.5 mL) of EDTA whole blood refrigerated. DO NOT FREEZE. Maintain sterility and forward promptly.
– Lesions on skin specimens:
Send specimen refrigerated in a screw-capped, sterile container. DO NOT FREEZE. Maintain sterility and forward promptly.
– Sputum and Biopsy Specimen (Brain, Liver, or Lung):
Send specimen refrigerated. DO NOT FREEZE. Maintain sterility and forward promptly.
– Spinal Fluid and Urine Specimens (Please contact Delta Lab before sending the sample)
Send 2mL (pediatric 0.5mL) of spinal fluid or urine. Send specimen refrigerated. DO NOT FREEZE. Maintain sterility & forward promptly.
– Swab Specimens of Cervix, Rectum, Urethra, Vagina & other Genital Sites (Please contact Delta Lab before sending the sample)
Collect specimen using Culture swab. Break medium ampoule to moisten swab. Send specimen refrigerated. DO NOT FREEZE.
Sample Preparation – Anatomic Pathology
Specimen Collection for Cervico-Vaginal Smears (Please contact Delta Lab before sending the sample):
Introduction:
The importance of proper specimen collection and submission cannot be overemphasized. At least one half to two-thirds of false negatives are the result of patient conditions present at the time of sample collection and submission and the skill and knowledge of the individual who obtains the specimen. The clinical community is responsible for training health care personnel to assure that adequate cervical cytology samples are collected and submitted to the laboratory with appropriate clinical information. The laboratory provides feedback on sample adequacy via individual reports and may elect to provide summary information regarding patient sampling to its clients.
To optimize collection conditions, a woman should:
Schedule an appointment approximately two weeks (10-18 days) after the first day of her last menstrual period. Not douche 48 hours prior to the test.
Not use tampons, birth control foams, jellies or other vaginal creams or vaginal medications for 48 hours prior to the test. Refrain from intercourse 48 hours prior to the test
Under the supervision and guidance of the physician, a laboratory requisition must be legibly and accurately filled out before obtaining the cellular sample. The laboratory requisition is the main communication link between the physician and the laboratory (pathologist). The requisition should request the following information as a minimum. All entries must be in English and the date of the last menstrual period should preferably in Gregorian and not the Arabic calendar.
The patient’s name.
Age and/or date of birth.
Menstrual status (LMP, hysterectomy, pregnant, postpartum, hormone therapy).
Use a green top (lithium heparin) tube. Collect 7-10 mL (for pediatric 2.5 – 5mL in a sodium heparin tube). Invert to mix. Refrigerate for shipping. DO NOT FREEZE.
– Products of Conception or Stillbirth (Please contact Delta Medical Laboratories before sending the sample)
Obtain 1 cc of muscle and fascia from the thigh or 1 cc of placental tissue. Place in a sterile screw-topped bottle with Hanks’s balanced salt solution. KEEP COOL. Delta Medical Laboratories can supply the required container.
– Skin Biopsy (Please contact Delta Medical Laboratories before sending the sample)
Wash skin with an antiseptic such as pHisoHex. Wash well with sterile water. Obtain a punch biopsy 3 mm x 5 mm. Place in tissue culture media. Keep refrigerated.
– Solid Tumors or Lymph Nodes (Please contact Delta Medical Laboratories before sending the sample)
Obtain a 0.5 cc piece of tissue and place it in the tissue culture medium. Refrigerate.
– Chromosome Breakage:
Obtain blood as in chromosome analysis for congenital Disorders (see above).
– Chromosome Analysis Consultation:
Offered on the basis of Fluorescent, in-Situ Hybridization (FISH) Techniques, and other methods. For specimen collection, call Delta Lab for special instruction.
The glass slide (except specimen for the automated machine) must be labeled with a unique identifier, usually the patient’s first and last names, at the time of the collection of the cellular sample. The required information is written in solvent resistant pen or pencil on the frosted end of the slide.
Collection of a cervical cytology specimen is usually performed with the patient in the dorsolithotomy position. A sterile, or single-use bivalve speculum of appropriate size is inserted into the vagina without lubrication. Warm water may be used to facilitate the insertion of the speculum. The position of the speculum should allow for complete visualization of the os and ectocervix.
The transformation zone is the site of origin for most cervical neoplasia and should be the focus of cytology specimen collection. The transformation zone may be easily visualized or maybe high in the endocervical canal. Location varies not only from patient to patient but in an individual over time. Factors producing variation include changes in the vaginal pH, hormonal changes including pregnancy, childbirth, and menopausal status, and hormonal therapy. In postmenopausal patients or women who have received radiation therapy, cervical stenosis may prevent visualization of the transformation zone. It remains important to sample the Endocervix in these patients. This may require more extensive clinical procedures. If a patient has had a hysterectomy, a vaginal sample is sufficient, with particular attention to sampling the vaginal cuff.
There are a variety of collection devices available for sampling the endocervix, transformation zone, and ectocervix. They include endocervical brushes, wooden and plastic spatulas, and plastic “broom-type” samplers. Plastic spatulas are preferred over wooden since the wooden spatulas retain cellular material. The use of a cotton-tipped swab is NOT recommended, even if the swab is moistened. Cells adhere to the cotton and do not transfer well to the glass slide, which results in an incomplete specimen. Analysis of different sampling methods has shown that overall, the cytobrush and spatula together provide the best specimen for cervical cytology. However, the choice of a particular device is dependent on variations in the size and shape of the cervix and the clinical situation. As stated in D, age, parity, and hormonal status of the patient can affect the exposure of the transformation zone. Previous therapy, such as conization, laser therapy, or cryotherapy, can also change the features of the cervix. The clinician ought to consider these factors when choosing a collection device. (Liquid-based methods require the use of collection devices that have been approved by the FDA for use with the particular specimen preparation instrument).
– Collection of cervical/vaginal specimens for conventional smear preparation using a spatula and endocervical brush.
The vaginal fornix and ectocervix should be sampled before the endocervix/transformation zone. First, a sample of the ectocervix is taken using a plastic (or wooden) spatula. The notched end of the spatula that corresponds to the contour of the cervix is rotated 360 degrees around the circumference of the cervical os, retaining a sample on the upper surface of the spatula. Grossly visible lesions, including irregular, discolored, or friable areas should be directly sampled and can be placed on a separate slide, especially if the lesion is distant from other collection areas. The spatula is held with the specimen face up while the endocervical sample is collected.
A sampling of the endocervix requires the insertion of the endocervical brush into the endocervical canal until only the bristles closest to the hand are visible. The brush is rotated 45-90 degrees and removed. At this time, the sample on the spatula is spread evenly and thinly lengthwise down one half of the labeled slide surface, using a single uniform motion. The endocervical brush is then rolled along the remaining half of the labeled slide surface by turning the brush handle and slightly bending the bristles with gentle pressure. The brush should not be smeared with force or in multiple directions. The entire slide is then rapidly fixed by immersion or spray and the collection devices are discarded.
Note:use of the endocervical brush may be contraindicated in pregnant patients. Refer to package insert. If the above-described sampling order is reversed, bleeding secondary to abrasion from the brush may obscure the cellular material.
– Cell Fixation for Conventional Cervical Cytology
Immediate fixation of the cellular sample, within seconds of specimen collection, is necessary to prevent air-drying. Air-drying obscures cellular detail and compromises specimen evaluation. Immersing the slide in alcohol or spraying with fixative can prevent air-drying artifact.
If the specimen is immersed in alcohol, it may remain in the alcohol (absolute ethyl alcohol) for transport to the laboratory. Alternatively, the specimen can be immersed in alcohol for 20-30 minutes, removed and allowed to air dry, then placed in a container /mailer for transport to the laboratory. The immersion technique requires the use of a separate container for each specimen and changing or filtering the alcohol between specimens. Isopropyl or rubbing alcohol is not recommended to be used as a fixative.
If a specimen is spray-fixed, only quality controlled cytology fixatives should be used. Hair spray should NOT be used. Whether using a pump spray, aerosol fixative, or single application packet, the manufacturer’s instructions on the container and package insert should be followed. Generally, spray fixatives should be 6-10 inches (15-25 cm) from the glass slide when applied.
– Variability in Specimen Collection and Submission Practices
Variations in specimen collection include the use of conventional Pap smear collection on a glass slide/slides or collection in a liquid fixative. An additional variation is encountered in rinsing the collection devices and handling the devices after the specimen has been collected. Manufacturer’s instructions and/or package inserts should be consulted and recommendations followed.
Other variations include the use of different collection devices. The plastic spatula is preferred to the wooden spatula. The endocervical brush is preferred for sampling the endocervix. Clinical judgment is required to determine the appropriate device, as there is no single sampling device.
No consensus has been reached on the clinical benefit of one slide versus two slides for cervical cytology. Several comparative studies have been performed and concluded that the single slide method is an acceptable alternative to the double slide method. The single slide method decreases the number of slides screened in the laboratory reduces costs for glass slides and requires less space for storage.
While this section discusses the consensus of the cytologic community regarding the most appropriate methods of specimen collection and submission, it is not intended to supplant or establish the gynecologic community’s standard of care and practice regarding these issues. Nor is this Guideline intended to diminish the responsibility of clinicians to be aware of and apply the standards applicable to their medical specialty and they’re individual.
Sample Preparation – Tissue Biopsy
1. Specimen Preparation for Tissue Biopsy
Tissue specimens should be immersed in the fixative labeled formalin, which is provided. The ratio of fluid to tissue, ideally, is 10:1. For larger specimens use an appropriate size of the container. The sizes provided are 20 ml and 120ml. Fixation should be prompt. This includes skin and GYN specimens. For a testicular biopsy, Bovin’s solution is preferred but is not absolute. Ask Delta Medical Laboratories customer service for this fixative.
2. Preparation of Muscle Biopsy for Enzyme Histochemistry
Obtain the biopsy from a muscle that is definitely affected but not so severely affected that much of it is replaced by fatty or fibrous connective tissue. In addition, the involved muscle should not be the one that has been traumatized by injections or by electromyographic studies. Typically, the triceps or vastus lateral are chosen. Deltoid or gastrocnemius muscles are less satisfactory and more prone to the artifact.
Excise a specimen approximately 1.0 cm with minimal trauma by dissecting along the long axis of the muscle. Immediately, after removal. The specimen must be fresh-frozen. Plunge the specimen into a slurry of dry ice and absolute alcohol. It is important that at least 80% of the slurry should be dry ice. The slurry must be stirred constantly to assure that a uniform temperature of –70 °C is achieved. The immersion into the freezing solution is to last not more than is needed to completely freeze the specimen. During the period of immersion, the specimen should be swirled around in the slurry. The well-frozen specimen has a white chalky color. Prolonged immersion in the quenching mixture should be avoided, as the specimen can become permeated by alcohol or acetone. The total freezing time is usually 10 sec. Immediately, after this, the frozen specimen is removed and packed in dry ice or temporarily stored at –70 °C. Send specimen FROZEN on dry ice.
1. A Note on Estrogen-Progesterone Binding Receptor Sites
The presence of steroid receptor sites on certain tumors has been correlated with improved prognosis. In patients with breast cancer, endometrial cancer, or endometrioid carcinoma of the ovary, levels of estrogen receptor sites and progesterone receptor sites have been correlated with an improved response to estrogen therapy. These receptor sites are more likely to be present in menopausal patients. Seventy percent of tumors with estrogen receptors regress after hormonal manipulation, whereas only 5% of those that are negative responses to this treatment.
Steroid receptor hormones usually have been measured on fresh tissue using a radioactive ligand binding on cytosol preparations. This method was difficult to control because of the lack of information on the amount of tumor tissue versus normal tissue. Specimens were transported frozen, which was inconvenient and risked inaccurate results. With the development of antibodies to steroid receptor sites, it became possible to perform analyses on the tissue on tissue slides-both frozen sections and paraffin-embedded sections. Clinical studies have now shown that tissue sections stained by the immunoperoxidase technique give results with the same clinical significance as with the fresh-tissue cytosol method. Delta’s Lab reference laboratory, we use the immunoperoxidase technique on paraffin-embedded tissue.
2. Specimen Preparation:
Submit four unstained slides or a formalin-fixed tissue block containing areas of the well-preserved tumor. The tissue should be fixed in neutral-buffered formalin for a minimum of 6 hours and a maximum of 18 hours. The formalin should be less than one month old. If the tissue cannot be immediately embedded, place in 70% ethanol for storage after 18 hours in formalin.
3.Results:
The results of estrogen and progesterone receptor assays are reported as positive or negative for receptor sites. A positive result shows at least 20% of tumor cells stain for receptor sites.
Rejection Croteria
The discrepancy between specimen label barcode number and the test request form.
Inappropriate specimen tube or container.
Leaking or spilled specimens.
Incorrect sample temperature transportation.
Missing patient information (name, age, gender, clinical data). Overfilled or underfilled specimens.
Any other condition, which might compromise reliable analysis or create the possibility of unreliable results (i.e., QNS, gross hemolysis, leakage, contamination …etc).
Saliva specimen was received instead of deep cough sputum.
In case of rejection, the laboratory sends a rejection form mentioning the reason for rejection to the concerned clinic or hospital through the provided emails.
Critical Results
For reference laboratories, the telephone number of the referring facility written on the official referral form will be the contact number used, and any critical results will be reported directly to clinical personnel, or to the referring laboratory. Delta Lab must have a written agreement with the referring laboratory that indicates to whom the reference laboratory reports critical results.
The following are the list of critical results
Test
Unit
Critical Low
Critical High
WBC (Adults)
*10e9/L
2.0
30.0
Test
Unit
Critical Low
Critical High
WBC (Adults)
*10e9/L
2.0
30.0
Test
Unit
Critical Low
Critical High
WBC (Adults)
*10e9/L
2.0
30.0
Test
Critical Result
Hepatitis AblgM
Positive
Test
Critical Result
Clostridium Difficile Toxin
Positive
Test
Critical Result
Glucose, urine
1000 mg/dL
Test
Critical Result
NBS
Abnormal
sTAT Samples
To arrange for sTAT testing, please contact the pathologist or medical director of Delta Medical Laboratories to discuss the case. If mutually agreed on the need for processing the sample as sTAT, Delta Medical Laboratories makes necessary arrangements for processing the sample and result releasing.
General Requirements – Specimen Preparation
Identification and Test Request Form: Complete a test request form that is provided by Delta Medical Laboratories for every patient. Ensure that all information is correctly filled; Patient full name, Age, Gender, Specimen Collection Date and Time, Type of Sample Collected, Sample Collected by.
Clinical Information: The clinical information must be attached for pathology samples and a consent form is required for all genetic tests.
Sample Temperature: Mark the temperature requirement on the biohazard bag (Ambient, Refrigerated, Frozen).
Tube labeling: Each sample tube should be labeled by the barcode number of the used test request form
Turn Around Time (TAT): Please refer to the test catalog for TAT. The mentioned TAT is from the time the sample is received by the lab
All samples for Delta Medical Laboratories analysis should be sealed in the appropriate containers at the temperature indicated in the test catalog. These samples should then be placed into the appropriate “Biohazard” labeled transport bags provided by Delta Medical Laboratories. The test request form should also be placed in the appropriate pocket of the transport bag.
ALL SPECIMENS SHOULD BE TREATED AS IF THEY ARE POTENTIALLY INFECTIOUSIn most cases, a Delta Medical Laboratories courier will pick up all specimens, appropriately pack & transport them at the required temperature. Make sure that the temperature of the specimen is marked on the biohazard bag (Room temperature, Refrigerated & Frozen), the courier will reserve the sample based on the marking of the biohazard bag. In the event that a courier cannot pick up a specimen, please ensure that the specimen is packed at the appropriate temperature, as follows:
Room temperature specimens should be packed in a container that prevents excess heat from affecting the specimen.
Refrigerated specimens should be stored in a refrigerator to maintain temperature until the specimen reaches Delta Medical Laboratories.
Frozen specimens should be stored in a freezer to maintain the frozen state until the specimen arrives at Delta Medical Laboratories.
The transportation time from the collecting institute to Delta Medical Laboratories should be kept to a minimum.Delta Medical Laboratories will maintain all submitted samples based on the sample type. Should additional testing be requested on a sample during this time, notify Delta Lab. We will do our best to accommodate your needs provided a sufficient amount of the sample remains, and test stability is maintained.
Collecting Specimenss for Blood Sampling
Draw blood in the appropriate containers as recommended under the “Test Catalog”. Blood drawn for tests to be performed on serum should be allowed to clot for 30 min at room temperature. After clotting, if the specimen is drawn in an SST tube it should be centrifuged and the entire tube shipped to Delta Medical Laboratories. If the specimen is drawn in a red top tube the serum should be separated into an appropriate container and forwarded to Delta Medical Laboratories.
Please follow test directions as to whether the serum should be stored at room temperature, refrigerated, or frozen. If a centrifuge is not available the patient should be drawn at a facility where serum separation can be accomplished.
Samples for plasma analysis should be drawn in the appropriate tubes as indicated under “Test Catalog”. These will either be heparin tubes, EDTA tubes, or citrate tubes. The specimen should be centrifuged immediately after collection. The plasma should be separated into an appropriate tube and stored at the temperature indicated in the catalog.
Before performing any component of the phlebotomy procedure, the phlebotomist must properly verify the identity of the patient with the collection request using two distinct identifiers as follows:
Ask the patient to verbally state or spell their complete name. Do not ask the patient to confirm their identity by requesting a yes/no response. Compare this information with the name on the test request form.
A second identifier such as date of birth must also be verbally stated by the patient. Do not ask the patient to confirm this information by requesting a yes/no response. Compare this information with the birth date on the test request form.
Patients who are not capable of giving their name or children may be identified through verbal verification by another adult who can personally identify the patient. Compare this information with the name on the test request form.
Hands must be washed prior to and after all phlebotomy procedures. Using soap and warm water, scrub vigorously for 10 to 15 seconds, rinse well and repeat. A hand sanitizer product can be used in place of soap and water.
Gloves are to be worn when performing all phlebotomy procedures.
Inform the patient of the procedure(s) that you are about to perform and obtain their permission and cooperation. Perform phlebotomy only if approved by appropriate healthcare professional and/or approved by the patient or patient’s guardian.
Venipuncture Specimens
Prepare patient as mentioned in “Patient identification” and “Patient Preparation” sections.
Wash hands. Put on properly fitting gloves.
Position or instruct the patient so that the patient’s arm is comfortably extended.
Apply the tourniquet 3 to 4 inches above the venipuncture site with enough tension to compress the vein, but not the artery.
Palpate or feel for the vein even when it can be seen. If a vein is difficult to find, it may become easier to see after massaging the arm from the wrist to the elbow, which forces blood into the vein. A warm moist towel (warm to the touch, but not hot) can also be used. You may need to examine the patient’s other arm if you are having difficulty finding a vein.
Cleanse the area for venipuncture in a circular motion from the center outward with an alcohol swab and allow to air dry.
Anchor the vein by placing your free thumb below the venipuncture site where the needle is to enter and pull the skin taut.
Vacutainer
Introduce the vacutainer needle apparatus with the bevel up at a 15- to a 30-degree angle to the skin and parallel to the vein.
Once the needle is properly positioned in the vein, anchor the needle by grasping the holder with the thumb on top and other fingers under the holder, resting securely on the patient’s arm. Push the appropriate vacutainer tube into the holder with gentle pressure in order to puncture the cap. The tube will automatically fill with blood.
Watch the blood as it flows into the vacutainer tube until the collection is complete.
Release tourniquet within one minute.
When all tubes are filled, withdraw the tube, place gauze square over the site and withdraw the needle.
Discard the activated needle and holder into the sharps container. Never re-cap the needle.
Inspect the puncture wound. When bleeding has stopped, apply a bandage. If bleeding continues, apply pressure for an additional three-five minutes. Prolonged bleeding may be related to the patient’s disease or medication.
Label the specimen tubes with the barcode number of the test request form and/or the barcode used in your facility which includes the patient information, before leaving the patient.
Wash hands thoroughly after removing gloves.
(Butterfly) with Evacuated Tubes or Syringe
Holding the wings of the butterfly with your dominant hand, smoothly insert the needle with the bevel up, parallel to the vein, at approximately a 10- to a 15-degree angle.
Once the needle is properly positioned in the vein, hold one wing of the winged collection set and insert evacuated tubes using the vacutainer holder according to the order of draw. For syringe draws, gently pull on the plunger to allow blood to flow into the syringe. Pulling on the plunger too fast may cause a possible collapse of the vein and restrict blood flow into the syringe and/or hemolyze the sample.
Pulling on the plunger too fast may cause a possible collapse of the vein and restrict blood flow into the syringe and/or hemolyze the sample.
If a syringe was used with the butterfly, properly discard the butterfly device into a sharps container, and attach a transfer device to the syringe. Fill the appropriate tubes without applying force on the plunger
Adverse Reaction Management
Remove tourniquet and withdraw the needle from the arm.
Assist patient to lie down on bed provided in the Phlebotomy areas.
Symptoms
Weakness, sweating, dizziness, pallor, loss of consciousness, convulsions, cold skin, drop in blood pressure, slow pulse rate.
Procedure
Loosen tight clothing.
Raise the patient’s feet above the level of the /patient’s head.
Apply a cold compress to the forehead and back of the neck.
Administer aromatic spirits of ammonia by inhalation. The patient’s response by coughing may elevate the blood pressure.
Symptoms
Stomach pain, dizziness, sweating, cold skin, vomiting.
Procedures
Instruct patient to breathe slowly and deeply. Apply a cold compress to the forehead and back of the neck.
Provide receptacle for vomitus and tissues.
Provide a cup of water to rinse the mouth.
Symptoms
Swelling of skin at needle entry sight.
Procedures
Place three or four sterile gauze squares over the hematoma and apply firm pressure for 7-10 mins. With the patient’s arm held above the heart level. Apply the dressing cover firmly.
Collection of other Specimens
- Blood Specimen:
Draw blood in lavender top (EDTA) tube(s) and send 5 mL (for pediatric 0.5 mL) of EDTA whole blood refrigerated. DO NOT FREEZE. Maintain sterility and forward promptly.
– Lesions on skin specimens:
Send specimen refrigerated in a screw-capped, sterile container. DO NOT FREEZE. Maintain sterility and forward promptly.
– Sputum and Biopsy Specimen (Brain, Liver, or Lung):
Send specimen refrigerated. DO NOT FREEZE. Maintain sterility and forward promptly
– Spinal Fluid and Urine Specimens (Please contact Delta Lab before sending the sample)
Send 2mL (pediatric 0.5mL) of spinal fluid or urine. Send specimen refrigerated. DO NOT FREEZE. Maintain sterility & forward promptly.
– Swab Specimens of Cervix, Rectum, Urethra, Vagina & other Genital Sites (Please contact Delta Lab before sending the sample)
Collect specimen using Culture swab. Break medium ampoule to moisten swab. Send specimen refrigerated. DO NOT FREEZE
Feces (stool) collected for the examination should contain no water, urine, or blood. Feces should be caught in a clean container and stored or mixed with appropriate preservatives as indicated in the “Test Catalog”. Feces for stool culture analysis must be collected in a sterile container.
To collect a 24-hr feces sample, feces should be collected for a 24-hour period in a clean container whose empty weight has been noted. No urine, blood, or water should enter the container. The full container and feces should be weighed. The net weight of the feces should be indicated on the request form. The appropriate quantity of feces should be removed from the 24-hr collection and stored as indicated in the “Test Catalog”.
When multiple blood samples are scheduled for collection from one patient, the trace metal specimens should be collected first. Once the phlebotomy needle has punctured another rubber stopper, it is contaminated & should not be used for trace metal specimen collection.
Use an alcohol swab to clean the venipuncture site. Avoid iodine-containing disinfectants. Use stainless steel phlebotomy needles.
Blood specimens for serum testing should be collected in the Monoject (royal blue top) trace element blood collection tube ( if unavailable in your clinic or hospital, Delta Medical Laboratories can supply this item). Allow the specimen to clot for 30 min. Centrifuge the specimen to separate serum from the cellular fraction.
Remove the stopper and carefully pour the serum into a 5 mL metal-free, screw-capped, polypropylene vial. Avoid transfer of the cellular components of blood. Do not insert a pipette into the serum to accomplish the transfer, do not ream the sample with a wooden stick to assist with serum transfer. Place the cap on the polypropylene vial tightly, attach a specimen label, and send the specimen to the laboratory refrigerated or frozen.
Specimen for whole-blood testing should be collected in the blood collection tube, containing EDTA as an anticoagulant. Leave the specimen in the tube. Attach an identification label and send the specimen to the laboratory at a cool temperature. Alternatively, pediatric specimens can be drawn in a Becton-Dickinson Microtainer, with EDTA Anticoagulant. An absolute volume of 0.5 mL is required for testing for each analyte ordered.
– Chromosome Analysis for Congenital Disorders:
Use a green top (lithium heparin) tube. Collect 7-10 mL (for pediatric 2.5 – 5mL in a sodium heparin tube). Invert to mix. Refrigerate for shipping. DO NOT FREEZE.
– Products of Conception or Stillbirth (Please contact Delta Medical Laboratories before sending the sample)
Obtain 1 cc of muscle and fascia from the thigh or 1 cc of placental tissue. Place in a sterile screw-topped bottle with Hanks’s balanced salt solution. KEEP COOL. Delta Medical Laboratories can supply the required container.
– Skin Biopsy (Please contact Delta Medical Laboratories before sending the sample)
Wash skin with an antiseptic such as pHisoHex. Wash well with sterile water. Obtain a punch biopsy 3 mm x 5 mm. Place in tissue culture media. Keep refrigerated.
– Solid Tumors or Lymph Nodes (Please contact Delta Medical Laboratories before sending the sample)
Obtain a 0.5 cc piece of tissue and place it in the tissue culture medium. Refrigerate.
– Chromosome Breakage:
Obtain blood as in chromosome analysis for congenital Disorders (see above).
– Chromosome Analysis Consultation:
Offered on the basis of Fluorescent, in-Situ Hybridization (FISH) Techniques, and other methods. For specimen collection, call Delta Lab for special instruction.
– – Blood Specimen:
Draw blood in lavender top (EDTA) tube(s) and send 5 mL (for pediatric 0.5 mL) of EDTA whole blood refrigerated. DO NOT FREEZE. Maintain sterility and forward promptly.
– Lesions on skin specimens:
Send specimen refrigerated in a screw-capped, sterile container. DO NOT FREEZE. Maintain sterility and forward promptly.
– Sputum and Biopsy Specimen (Brain, Liver, or Lung):
Send specimen refrigerated. DO NOT FREEZE. Maintain sterility and forward promptly.
– Spinal Fluid and Urine Specimens (Please contact Delta Lab before sending the sample)
Send 2mL (pediatric 0.5mL) of spinal fluid or urine. Send specimen refrigerated. DO NOT FREEZE. Maintain sterility & forward promptly.
– Swab Specimens of Cervix, Rectum, Urethra, Vagina & other Genital Sites (Please contact Delta Lab before sending the sample)
Collect specimen using Culture swab. Break medium ampoule to moisten swab. Send specimen refrigerated. DO NOT FREEZE.
Sample Preparation – Anatomic Pathology
Specimen Collection for Cervico-Vaginal Smears (Please contact Delta Lab before sending the sample):
Introduction:
The importance of proper specimen collection and submission cannot be overemphasized. At least one half to two-thirds of false negatives are the result of patient conditions present at the time of sample collection and submission and the skill and knowledge of the individual who obtains the specimen. The clinical community is responsible for training health care personnel to assure that adequate cervical cytology samples are collected and submitted to the laboratory with appropriate clinical information. The laboratory provides feedback on sample adequacy via individual reports and may elect to provide summary information regarding patient sampling to its clients.
To optimize collection conditions, a woman should:
Schedule an appointment approximately two weeks (10-18 days) after the first day of her last menstrual period. Not douche 48 hours prior to the test.
Not use tampons, birth control foams, jellies or other vaginal creams or vaginal medications for 48 hours prior to the test. Refrain from intercourse 48 hours prior to the test
Under the supervision and guidance of the physician, a laboratory requisition must be legibly and accurately filled out before obtaining the cellular sample. The laboratory requisition is the main communication link between the physician and the laboratory (pathologist). The requisition should request the following information as a minimum. All entries must be in English and the date of the last menstrual period should preferably in Gregorian and not the Arabic calendar.
The patient’s name.
Age and/or date of birth.
Menstrual status (LMP, hysterectomy, pregnant, postpartum, hormone therapy).
Previous abnormal cervical cytology result, previous treatment, biopsy, or surgical procedure.
Patient’s risk status for developing cervical cancer (if clinically relevant).
Source of the specimen, e.g. cervical, vaginal.
Appropriate clinical history provided by the physician on the requisition should include:
Hormone/contraceptive use.
Relevant clinical findings (abnormal bleeding, grossly visible lesion, etc.)
– Chromosome Analysis for Congenital Disorders:
Use a green top (lithium heparin) tube. Collect 7-10 mL (for pediatric 2.5 – 5mL in a sodium heparin tube). Invert to mix. Refrigerate for shipping. DO NOT FREEZE.
– Products of Conception or Stillbirth (Please contact Delta Medical Laboratories before sending the sample)
Obtain 1 cc of muscle and fascia from the thigh or 1 cc of placental tissue. Place in a sterile screw-topped bottle with Hanks’s balanced salt solution. KEEP COOL. Delta Medical Laboratories can supply the required container.
– Skin Biopsy (Please contact Delta Medical Laboratories before sending the sample)
Wash skin with an antiseptic such as pHisoHex. Wash well with sterile water. Obtain a punch biopsy 3 mm x 5 mm. Place in tissue culture media. Keep refrigerated.
– Solid Tumors or Lymph Nodes (Please contact Delta Medical Laboratories before sending the sample)
Obtain a 0.5 cc piece of tissue and place it in the tissue culture medium. Refrigerate.
– Chromosome Breakage:
Obtain blood as in chromosome analysis for congenital Disorders (see above).
– Chromosome Analysis Consultation:
Offered on the basis of Fluorescent, in-Situ Hybridization (FISH) Techniques, and other methods. For specimen collection, call Delta Lab for special instruction.
The glass slide (except specimen for the automated machine) must be labeled with a unique identifier, usually the patient’s first and last names, at the time of the collection of the cellular sample. The required information is written in solvent resistant pen or pencil on the frosted end of the slide.
Collection of a cervical cytology specimen is usually performed with the patient in the dorsolithotomy position. A sterile, or single-use bivalve speculum of appropriate size is inserted into the vagina without lubrication. Warm water may be used to facilitate the insertion of the speculum. The position of the speculum should allow for complete visualization of the os and ectocervix.
The transformation zone is the site of origin for most cervical neoplasia and should be the focus of cytology specimen collection. The transformation zone may be easily visualized or maybe high in the endocervical canal. Location varies not only from patient to patient but in an individual over time. Factors producing variation include changes in the vaginal pH, hormonal changes including pregnancy, childbirth, and menopausal status, and hormonal therapy. In postmenopausal patients or women who have received radiation therapy, cervical stenosis may prevent visualization of the transformation zone. It remains important to sample the Endocervix in these patients. This may require more extensive clinical procedures. If a patient has had a hysterectomy, a vaginal sample is sufficient, with particular attention to sampling the vaginal cuff.
There are a variety of collection devices available for sampling the endocervix, transformation zone, and ectocervix. They include endocervical brushes, wooden and plastic spatulas, and plastic “broom-type” samplers. Plastic spatulas are preferred over wooden since the wooden spatulas retain cellular material. The use of a cotton-tipped swab is NOT recommended, even if the swab is moistened. Cells adhere to the cotton and do not transfer well to the glass slide, which results in an incomplete specimen. Analysis of different sampling methods has shown that overall, the cytobrush and spatula together provide the best specimen for cervical cytology. However, the choice of a particular device is dependent on variations in the size and shape of the cervix and the clinical situation. As stated in D, age, parity, and hormonal status of the patient can affect the exposure of the transformation zone. Previous therapy, such as conization, laser therapy, or cryotherapy, can also change the features of the cervix. The clinician ought to consider these factors when choosing a collection device. (Liquid-based methods require the use of collection devices that have been approved by the FDA for use with the particular specimen preparation instrument).
– Collection of cervical/vaginal specimens for conventional smear preparation using a spatula and endocervical brush.
The vaginal fornix and ectocervix should be sampled before the endocervix/transformation zone. First, a sample of the ectocervix is taken using a plastic (or wooden) spatula. The notched end of the spatula that corresponds to the contour of the cervix is rotated 360 degrees around the circumference of the cervical os, retaining a sample on the upper surface of the spatula. Grossly visible lesions, including irregular, discolored, or friable areas should be directly sampled and can be placed on a separate slide, especially if the lesion is distant from other collection areas. The spatula is held with the specimen face up while the endocervical sample is collected.
A sampling of the endocervix requires the insertion of the endocervical brush into the endocervical canal until only the bristles closest to the hand are visible. The brush is rotated 45-90 degrees and removed. At this time, the sample on the spatula is spread evenly and thinly lengthwise down one half of the labeled slide surface, using a single uniform motion. The endocervical brush is then rolled along the remaining half of the labeled slide surface by turning the brush handle and slightly bending the bristles with gentle pressure. The brush should not be smeared with force or in multiple directions. The entire slide is then rapidly fixed by immersion or spray and the collection devices are discarded.
Note:use of the endocervical brush may be contraindicated in pregnant patients. Refer to package insert. If the above-described sampling order is reversed, bleeding secondary to abrasion from the brush may obscure the cellular material.
– Cell Fixation for Conventional Cervical Cytology
Immediate fixation of the cellular sample, within seconds of specimen collection, is necessary to prevent air-drying. Air-drying obscures cellular detail and compromises specimen evaluation. Immersing the slide in alcohol or spraying with fixative can prevent air-drying artifact.
If the specimen is immersed in alcohol, it may remain in the alcohol (absolute ethyl alcohol) for transport to the laboratory. Alternatively, the specimen can be immersed in alcohol for 20-30 minutes, removed and allowed to air dry, then placed in a container /mailer for transport to the laboratory. The immersion technique requires the use of a separate container for each specimen and changing or filtering the alcohol between specimens. Isopropyl or rubbing alcohol is not recommended to be used as a fixative.
If a specimen is spray-fixed, only quality controlled cytology fixatives should be used. Hair spray should NOT be used. Whether using a pump spray, aerosol fixative, or single application packet, the manufacturer’s instructions on the container and package insert should be followed. Generally, spray fixatives should be 6-10 inches (15-25 cm) from the glass slide when applied.
– Variability in Specimen Collection and Submission Practices
Variations in specimen collection include the use of conventional Pap smear collection on a glass slide/slides or collection in a liquid fixative. An additional variation is encountered in rinsing the collection devices and handling the devices after the specimen has been collected. Manufacturer’s instructions and/or package inserts should be consulted and recommendations followed.
Other variations include the use of different collection devices. The plastic spatula is preferred to the wooden spatula. The endocervical brush is preferred for sampling the endocervix. Clinical judgment is required to determine the appropriate device, as there is no single sampling device.
No consensus has been reached on the clinical benefit of one slide versus two slides for cervical cytology. Several comparative studies have been performed and concluded that the single slide method is an acceptable alternative to the double slide method. The single slide method decreases the number of slides screened in the laboratory reduces costs for glass slides and requires less space for storage.
While this section discusses the consensus of the cytologic community regarding the most appropriate methods of specimen collection and submission, it is not intended to supplant or establish the gynecologic community’s standard of care and practice regarding these issues. Nor is this Guideline intended to diminish the responsibility of clinicians to be aware of and apply the standards applicable to their medical specialty and they’re individual.
Sample Preparation – Tissue Biopsy
1. Specimen Preparation for Tissue Biopsy
Tissue specimens should be immersed in the fixative labeled formalin, which is provided. The ratio of fluid to tissue, ideally, is 10:1. For larger specimens use an appropriate size of the container. The sizes provided are 20 ml and 120ml. Fixation should be prompt. This includes skin and GYN specimens. For a testicular biopsy, Bovin’s solution is preferred but is not absolute. Ask Delta Medical Laboratories customer service for this fixative.
2. Preparation of Muscle Biopsy for Enzyme Histochemistry
Obtain the biopsy from a muscle that is definitely affected but not so severely affected that much of it is replaced by fatty or fibrous connective tissue. In addition, the involved muscle should not be the one that has been traumatized by injections or by electromyographic studies. Typically, the triceps or vastus lateral are chosen. Deltoid or gastrocnemius muscles are less satisfactory and more prone to the artifact.
Excise a specimen approximately 1.0 cm with minimal trauma by dissecting along the long axis of the muscle. Immediately, after removal. The specimen must be fresh-frozen. Plunge the specimen into a slurry of dry ice and absolute alcohol. It is important that at least 80% of the slurry should be dry ice. The slurry must be stirred constantly to assure that a uniform temperature of –70 °C is achieved. The immersion into the freezing solution is to last not more than is needed to completely freeze the specimen. During the period of immersion, the specimen should be swirled around in the slurry. The well-frozen specimen has a white chalky color. Prolonged immersion in the quenching mixture should be avoided, as the specimen can become permeated by alcohol or acetone. The total freezing time is usually 10 sec. Immediately, after this, the frozen specimen is removed and packed in dry ice or temporarily stored at –70 °C. Send specimen FROZEN on dry ice.
1. A Note on Estrogen-Progesterone Binding Receptor Sites
The presence of steroid receptor sites on certain tumors has been correlated with improved prognosis. In patients with breast cancer, endometrial cancer, or endometrioid carcinoma of the ovary, levels of estrogen receptor sites and progesterone receptor sites have been correlated with an improved response to estrogen therapy. These receptor sites are more likely to be present in menopausal patients. Seventy percent of tumors with estrogen receptors regress after hormonal manipulation, whereas only 5% of those that are negative responses to this treatment.
Steroid receptor hormones usually have been measured on fresh tissue using a radioactive ligand binding on cytosol preparations. This method was difficult to control because of the lack of information on the amount of tumor tissue versus normal tissue. Specimens were transported frozen, which was inconvenient and risked inaccurate results. With the development of antibodies to steroid receptor sites, it became possible to perform analyses on the tissue on tissue slides-both frozen sections and paraffin-embedded sections. Clinical studies have now shown that tissue sections stained by the immunoperoxidase technique give results with the same clinical significance as with the fresh-tissue cytosol method. Delta’s Lab reference laboratory, we use the immunoperoxidase technique on paraffin-embedded tissue.
2. Specimen Preparation:
Submit four unstained slides or a formalin-fixed tissue block containing areas of the well-preserved tumor. The tissue should be fixed in neutral-buffered formalin for a minimum of 6 hours and a maximum of 18 hours. The formalin should be less than one month old. If the tissue cannot be immediately embedded, place in 70% ethanol for storage after 18 hours in formalin.
3.Results:
The results of estrogen and progesterone receptor assays are reported as positive or negative for receptor sites. A positive result shows at least 20% of tumor cells stain for receptor sites.
Rejection Croteria
The discrepancy between specimen label barcode number and the test request form.
Inappropriate specimen tube or container.
Leaking or spilled specimens.
Incorrect sample temperature transportation.
Missing patient information (name, age, gender, clinical data). Overfilled or underfilled specimens.
Any other condition, which might compromise reliable analysis or create the possibility of unreliable results (i.e., QNS, gross hemolysis, leakage, contamination …etc).
Saliva specimen was received instead of deep cough sputum.
In case of rejection, the laboratory sends a rejection form mentioning the reason for rejection to the concerned clinic or hospital through the provided emails.
Critical Results
For reference laboratories, the telephone number of the referring facility written on the official referral form will be the contact number used, and any critical results will be reported directly to clinical personnel, or to the referring laboratory. Delta Lab must have a written agreement with the referring laboratory that indicates to whom the reference laboratory reports critical results.
The following are the list of critical results
sTAT Samples
To arrange for sTAT testing, please contact the pathologist or medical director of Delta Medical Laboratories to discuss the case. If mutually agreed on the need for processing the sample as sTAT, Delta Medical Laboratories makes necessary arrangements for processing the sample and result releasing.