specimen collection manual
TRANSCRIPT
SPECIMEN
COLLECTION MANUAL
Edward A Barker, M.D. Robert A Fouty, M.D. 206-623-3814 Toll Free 800-676-3814 Fax 206-623-4327
Your Lab for Life!
Medical Laboratory Associates
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About MLA What is MLA……………………………………………………………………………..3 How we serve you………………………………………………………………………..4 Customer relations………………………………………………………………………..5 Turnaround time………………………………………………………………………….6
Supplies and Procedures Surepath…………………………………………………………………………………..8 Thin Prep………………………………………………………………………………....9 Pap Pak………………………………………………………………………………….10 Surgical………………………………………………………………………………….11 HPV from Surepath……………………………………………………………………..12 HPV from Thin Prep……………………………………………………………………13 Neisseria Gonorrhea/Chlamydia Trachomatis swab…………..……………………….14 Neisseria Gonorrhea/Chlamydia Trachomatis urine…………………………………...15 Neisseria Gonorrhea/Chlamydia Trachomatis Surepath……………………………….16 Candida spp / Trichmonas Vaginalis / Gardnerella Vaginalis…………….…………...17 DES study….……………………………………………………………………………18 Fine needle and cyst aspiration………………………………………………………….19 Non-GYN discharge…………………………………………………………………….20 Non-GYN sputum……………………………………………………………………….21 Non-GYN other…………………………………………………………………………22 Immunocyt and Urine Cytology………………..……………………………………….23
MLA reports and requisitions Filling out a requisition……………………………………………………………….…25 Filling out an ABN………………………………………………………………………26 Reports - an overview…………………………………………………………………...27 Cytology reports………………………………………………………………………...28 Reports with attachments……………………………………………………………….29 Microbiology reports……………………………………………………………………30 Prostate reports………………………………………………………………………….31 Surgical reports………………………………………………………………………….32 Addendums ……………...………………………...……………………………………33 Monthly reports………………………………………………………………………....34 Physician reports………………………………………………………………………..35 Patient reminders………………………………………………………………………..35 Electronic reports……………………………………………………………………….37
Shipping regulations Shipping hazardous materials………………………………………………………..39-40 Shipping checklist…………………………………………………………………...41-42
Your Lab for Life!
Thank you for choosing MLA
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Medical Laboratory Associates Inc. PS is an independent medical laboratory directed and owned by renowned pathologist Edward A. Barker, MD, PhD. After a successful career as the Pathologist-in-Chief at Haborview Medical Center and a long association with the University of Washington as a Student, Fellow, and Professor, Dr. Barker recognized that there was need for a laboratory whose primary concern was for the client and the patients as opposed to corporate interests or a shareholder constituency. His vision was to run a laboratory under three principles; Integrity, Accountability, and Accuracy. He was able to fulfill his dream when he purchased Medical Laboratory Associates Inc. PS, from his friend Robert A. Fouty, MD. Dr. Fouty has a long history of dedication to creating the relationships that put the client and patient needs above all else, Your Lab for Life!
Founded in 1972, Medical Laboratory Associates is still defining what it means to be a high complexity laboratory today and in the future. We have seen other laboratories come and go during this time, which begs the question, “Why have we been able to establish long term suc-cess, when others have not?” Our belief is that being responsive to the needs of our clients and their patients is the purpose of a laboratory and we have made this belief the foundation of our business. We conduct our testing in such a way that Accuracy and Accountability come before the dollar. In this way we better serve you and the patients whose lives could be radically changed by the results of these tests. As a staff, we would like to thank you for choosing our laboratory to trust with your testing. We believe that our devotion to Integrity, Accountability, and Accuracy will prove to make you happy with your decision. Thank you for choosing us to be Your Lab for Life!
Your Lab for Life!
What is MLA?
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Medical Laboratory Associates performs a wide variety of services for our clients. For your convenience, these services are grouped into four categories.
CYTOLOGY
MICROBIOLOGY • Amplified Neisseria gonorrhea and Chlamydia trachomatis testing (Urine, Urethral, Cervical Swab,
Vaginal Swab, Liquid Based Pap) • HPV reflex testing (In-Situ Hybridization, from pap vial) • DNA probe based Microbial Identification via Affirm VPIII test for Candida spp, Trichomonas
Vaginalis, and Gardnerella Vaginalis
SURGICAL • Tissue Biopsies (GYN pathology, GI pathology, Uropathology, Other) • Special Stains (microorganism, mineral, other) • Cancer prognostic markers • Immunohistochemistry (Immunoperoxidase quantitative/non-quantitative) • Pathologist consults
• ER • PR • erB2(Her2/neu) • pS2 • Panels for lymphoma stratification
HISTOLOGY Samples of the many IHC stains available
• p53 • Cath-D • CK903 • p504S
• p16 • CD10 • Pan-Keratin • Ki-67
• Conventional Pap • Liquid Based Pap • Reflex Testing from liquid Pap for HPV if ASCUS Pap result • Computer driven primary image analysis of all conventional and Surepath slides prior to manual
screening using a Focal Point slide profiler • Non-gynecologic Cytology processing • Immunofluorescent (Immunocyt/uCyt+) / antibody (bladder cancer recurrence monitoring)
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How We Serve You
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Nancy Marshall, CMA General Manager
Dameon Pierce Laboratory Manager
Medical Lab Associates is not just ready to meet your laboratory needs, but offers additional benefits as a MLA customer.
• Reports that are easy to understand and color coded for convenience • Monthly report of statistical comparison and of patient summaries for pap and Gonorrhea/
Chlamydia tests • Rapid turn around time • Accessible Pathologists and staff • Pre-printed follow-up patient requisition included with Pap smear and Gonorrhea/
Chlamydia/HPV results • Follow up reminders so care is not compromised • “No Endocervical Cell” reports showing percentage compared to the lab as a whole • HPV reflex standing orders • Educational reports
You can feel secure with choosing our lab to serve you. If you have any questions about any of the services we provide, please call us. Our staff is
prepared assist you. We are proud to be Your Lab for Life!
Edward A Barker, MD, PhD Medical Director
Sue Maehren Billing Supervisor
Paul Unsworth Director of Client Relations
Business Hours: M-F 8am to 5pm Phone: 800-676-3814 or 206-623-3814 Billing: 866-519-3599 or 206-623-3817 Fax: 206-623-4327
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Customer Relations
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Medical Laboratory Associates has a clear and defined turnaround policy. Each provider sending a specimen to MLA will know what to expect and when to expect it. If, for any reason, there are delays in
processing, the provider will be notified promptly.
Histology
The majority of Histology reports are sent out within two working days of receiving the specimen. For those specimens that require more than seven working days from receipt to report, the provider will be notified. Certain specimens with immunohistochemistry stains, other requested special stains or additional consults may take longer to complete. In this case, the requirement for notification may be extended or waived at the discretion of the pathologist.
Cytology
The majority of Cytology reports are sent out within four working days of receiving the specimen. For specimens that require more than ten working days from receipt to report, the provider will be notified.
Molecular Microbiology
Affirm microbiology specimens are sent out the next business day. For affirm specimens that require more than four days the provider will be notified. Other microbiology specimens are to be sent out within four working days of receiving the specimen or the order for the test. For specimens that require more than seven working days from receipt to report, the provider will be notified.
HPV
The majority of HPV specimens are to be sent out within four working days of receiving the specimen or the order for the test. For specimens that require more than ten working days from receipt to report, the provider will be notified.
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Turnaround
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Surepath…………………………………..................…..8
Thin Prep……………………………..............................9
Pap Pak………………………..........................…….....10
Surgical………………......................................……….11
HPV from Surepath…………………………..………..12
HPV from Thin Prep..………………………………….13
Neisseria Gonorrhea/Chlamydia Trachomatis swab…………….14
Neisseria Gonorrhea/Chlamydia Trachomatis urine………….....15
Neisseria Gonorrhea/Chlamydia Trachomatis Surepath.…….....16 Candida spp / Trichomonas Vaginalis / Gardnerella Vaginalis……..17
DES study………….......................……………………18
Fine needle and cyst aspiration..................…………….19
Non-GYN discharge……..........................…………….20
Non-GYN sputum………….......................................…21
Non-GYN other……………......................................…22
Immunocyt...……………..................................……….23
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Supplies and Procedures
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Medical Laboratory Associates uses the Surepath Liquid-Based Pap Test offered by TriPath Care Technologies. Supplies for Surepath
such as testing vials and collection devices are provided by Medical Laboratory Associates.
STEP 1
STEP 2
STEP 3
STEP 4
Cervical Sample Collection - Insert the Rovers Cervex-Brush into the endocervical canal. Apply gentle pressure until the bristles form against the cervix. Maintaining gentle pressure, hold the stem between the thumb and forefinger. Rotate the brush five times in a clockwise direction.
Preserve the entire sample - Placing your thumb against the back of the brush pad, simply disconnect the entire brush from the stem into the SurePath preservative vial.
Cap and label vial - Place the cap on the vial and tighten. Label the vial with patient name using a peel-off sticker found on the Medical Laboratory Associates requisition form.
Send vial to lab -
Place the vial and requisition into a Medical Laboratory Associates specimen bag. Specimen is now ready for transport.
Your Lab for Life!
Liquid-Based Pap - Surepath
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Medical Laboratory Associates also uses the ThinPrep Liquid-Based Pap Test offered by Cytyc. Supplies for ThinPrep such as testing vials and
collection devices are provided by Medical Laboratory Associates.
STEP 1
STEP 2
STEP 3
STEP 4
Cervical Sample Collection - Insert the central bristles of the broom into the endocervical canal deep enough to allow the shorter bristles to fully contact the ectocervix. Push gently, and rotate the broom in a clock wise direction five times.
Cellular material transferred to vial - Rinse the broom into the ThinPrep vial by pushing the broom into the bottom of the vial 10 times, forcing the bristles apart. Swirl the broom vigorously to further release material. Discard the collection device.
Cap and label vial - Place the cap on the vial and tighten. Label the vial with patient name using a peel-off sticker found on the Medical Laboratory Associates requisition form.
Send vial to lab - Place the vial and requisition into a Medical Laboratory Associates specimen bag. Specimen is now ready for transport.
Your Lab for Life!
Liquid-Based Pap - ThinPrep
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Medical Lab Associates uses PAP-PAK Pap Smear Cytology Kits to collect conventional smears. Each kit contains all the necessary materials for preparation
and fixation in one convenient package. Instructions in each kit assist in standardizing collection techniques and assure properly fixed specimens. Kits contain the 8 inch CytoSoft cytology brush that enhances retrieval of endocervical cells and reduces the possibility of false negative smears, as well as one frosted end slide, one
modified Ayers spatula, and one alcohol fixative pouch.
• Open the PAP-PAK Kit and using a pencil label the frosted end of the slide with the patient’s name.
• Tear open the fixative pouch or uncap the fixative spray
bottle prior to preparing smears on the PAP-PAK kit. • Take a vaginal smear from the posterior fornix with the
spatula end of the cervical scraper. If an accurate hormonal evaluation is desired, obtain a specimen by lightly scraping the mid-lateral vaginal wall. Spread the material evenly on section “V”
• Take a cervical smear by rotating the scraper around the
ectocervix with special emphasis on the squamo-columnar junction. Keep the material on the cervical scraper.
• Take an endocervical smear by gently inserting CytoSoft
cytology brush into the endocervical canal past the squamo-columnar junction. Rotate the brush one-half turn (180 degrees). Gently remove brush without touching vaginal surfaces. Spread the material evenly on section “E” by rapidly rolling the cytology brush (clockwise) along the slide surface to ensure deposition of the cells. Bending brush bristles will help transfer cells to the slide.
• Spread the cervical material evenly on section “C.” • Immediately fix the preparations by flooding the entire
slide with cytology fixative.
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Conventional Pap - PAP-PAK Kit
• When slide is dry, fold the PAP-PAK Kit as illustrated. Write the patient’s name or attach a requisition ID number label to the outside of the PAP-PAK.
• Properly fill out a requisition and enclose it and the PAP-PAK in a specimen bag. Specimen is now ready for
transport to Medical Laboratory Associates.
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Medical Lab Associates Histology Department accepts a variety of tissue samples ranging from tiny needle biopsies to large resection specimens
and whole organs. Most radioactive tissues, however, will not be accepted. MLA will also only accept specimens collected properly by a trained provider. If you have any questions about a specific procedure,
our pathologists are available to answer any questions.
The majority of surgical specimens can be placed directly into a solution of 10% neutral buffered formalin for preservation and transport. Both the formalin and specimen bottles are provided by Medical Lab Associates.
• Place specimen in container sized to allow one part tissue to at least ten parts fixative by volume.
• Using the label provided on specimen bottle, label specimen bottle with patient
name, date, and specimen type. • Using a Medical Lab Associates Requisition sticker, label specimen bottle with
patient name and make sure to close lid tightly. • Place specimen bottle and requisition in specimen bag. Specimen is now ready for
transport. • If specimen is not arriving with a courier service, please see shipping information (pages 39-42).
WARNING: Neutral buffered formalin fixative is an eye and skin
irritant. It is toxic by ingestion, inhalation, and by direct contact. It
also has possible carcinogenic potential.
Each surgical specimen container is labeled with one
or both of these warnings.
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Surgical Specimens
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HPV testing may be done from the original Surepath vial. If a client or provider has sent in a Surepath pap, and later decides to test for HPV, Medical Laboratory Associates can accommodate you as long as the
request is made within four weeks of the collection date. Supplies for Surepath such as testing vials and collection devices are provided by
Medical Laboratory Associates. No additional supplies are required for HPV testing.
Send vial to lab -
Place the vial and requisition into a Medical Laboratory Associates specimen bag. Specimen is now ready for transport.
Your Lab for Life!
HPV - Surepath
To collect a sample please see instructions on page 8. NOTE: It is not necessary to collect an additional sample for HPV testing. Only one Surepath sample is needed for both the Pap and HPV. Be sure to check the appropriate box for HPV testing.
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HPV testing may be done from the original Thinprep vial. If a client or provider has sent in a ThinPrep pap, and later decides to test for HPV, Medical Laboratory Associates can accommodate you as long as the
request is made within four weeks of the collection date. Supplies for ThinPrep such as testing vials and collection devices are provided by
Medical Laboratory Associates. No additional supplies are required for HPV testing.
To collect a sample please see instructions on page 9.
NOTE: It is not necessary to collect an additional sample for HPV testing. Only one ThinPrep sample is needed for both the Pap and
HPV.
Be sure to check the appropriate box for HPV testing
Send vial to lab -
Place the vial and requisition into a Medical Laboratory Associates specimen bag. Specimen is now ready for transport.
Your Lab for Life!
HPV - ThinPrep
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Medical Laboratory Associates uses the Aptima unisex swab specimen collection kit for Neisseria gonorrhea and Chlamydia trachomatis testing. Directions for use
are provided both on the back of the tube and in an informational send-out (included in each box).
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Neisseria gonorrhea and Chlamydia trachomatis Test - Swab
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Medical Laboratory Associates uses the Aptima urine specimen collection kit for Neisseria gonorrhea and Chlamydia trachomatis testing. Directions for use are
provided both on the back of the specimen tube and in an informational send-out (included in each box).
Your Lab for Life!
Neisseria gonorrhea and Chlamydia trachomatis Test - Urine
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Neisseria gonorrhea and Chlamydia trachomatis testing may be done from the original Surepath vial. If a client or provider has sent in a
Surepath pap, and later decides to do additional tests, Medical Laboratory Associates can accommodate you as long as the request is made within ten days of the collection date. Supplies for Surepath such as testing vials and
collection devices are provided by Medical Laboratory Associates. No additional supplies are required for Neisseria gonorrhea and Chlamydia
trachomatis testing.
To collect a sample please see instructions on page 8.
NOTE: It is not necessary to collect an additional sample for Neisseria gonorrhea and Chlamydia trachomatis testing. Only one
Surepath sample is needed for both the Pap and Neisseria gonorrhea and Chlamydia trachomatis testing.
Be sure to check the boxes for STD tests as well as Pap Vial for specimen source
Send vial to lab -
Place the vial and requisition into a Medical Laboratory Associates specimen bag. Specimen is now ready for transport.
Your Lab for Life!
Neisseria gonorrhea and Chlamydia trachomatis Test - Surepath
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Medical Laboratory Associates uses the Affirm VPIII Microbial Identification test for Candida spp, Trichomonas Vaginalis, and Gardnerella Vaginalis.
Directions for use are on the back of each packet.
NOTE:Samples for testing Trichomonas, Gardnerella, and Candida using the Affirm method are for vaginal source only, and must be collected in the Ambient Temperature
Transport System tubes and sent to MLA as soon as possible. We ask that providers be aware of the 72 hour optimal testing window and make every effort to provide the sample to the
courier the same day the sample is collected.
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Affirm VPIII Microbial Identification
To Collect Sample: • Place the patient in position for a pelvic examination. Insert an UNLUBRICATED speculum
(WITHOUT JELLY OR WATER) into the vagina to permit visualization of the posterior vaginal fornix.
• Using the sterile polyester-tip swab, obtain a sample from the posterior vaginal fornix. Twist or roll the swab against the vaginal wall two or three times, ensuring the entire circumference of the swab has touched the vaginal wall. Swab the lateral vaginal wall while removing the swab.
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Medical Laboratory Associates can provide clients with a DES Study Kit. Each DES Study Kit consists of a large brown envelope affixed with a green sticker. All supplies are included in the brown envelope and a list of contents
and instructions are provided on the green sticker.
1. Label slide with a CX, A, P, R, or L (use pap pak slide for CX) along with patient name.
2. Take vaginal smear from the posterior vaginal
wall and spread the material on slide labeled “P.” Fix immediately to prevent air-drying.
3. Take a vaginal smear from the anterior vaginal
wall using a new spatula, spread the material on slide “A” and fix.
4. Take a vaginal smear from the right lateral
vaginal wall using a new spatula, spread the material on slide “R” and fix.
5. Take a vaginal smear from the left lateral vaginal wall using a new spatula, spread the material on slide “L” and fix.
6. Take a cervical smear by rotating the scraper around the ectocervix with special
emphasis on the squamo-columnar junction. Spread the material on the slide labeled “CX” and fix immediately.
7. Complete requisition (indicating the site of each specimen collected) and place
specimens into the large brown envelope (the vaginal smears placed in their containers and secured with rubber bands).
8. Specimen is now ready for transport to Medical Lab Associates.
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DES Study Kit Diethyl Stilbestrol
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Label slide with patient’s name.
1 2 Put one drop of specimen in center of one glass slide.
3 Open envelope of cytology fixative at
this point.
Place a second glass slide on top
of the first.
4 5 Pull slides apart gently.
Fix both slides immediately, using cytology fixative from envelope.
Allow slides to dry completely.
Submit remaining fluid as follows: 1. Put remaining specimen into specimen tube containing CytoRich Red fixative. 2. Rinse needle and syringe with fixative to obtain as much of the specimen as possible. 3. Replace cap on specimen tightly. 4. Gently shake contents. 5. Label specimen tube with patient information. 6. Fill out requisition (identify type of specimen on requisition). 7. Place slide container, specimen tube, and requisition into specimen bag. Specimen is now ready for transport.
Medical Laboratory Associates provides a Non-GYN kit consisting of two slides, an envelope of cytology fixative for
slides, a specimen tube filled with CytoRich Red fixative, and an instruction pamphlet.
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FINE NEEDLE AND CYST ASPIRATION
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1
Medical Laboratory Associates provides a Non-GYN kit consisting of two slides, an envelope of cytology fixative
for slides, a specimen tube filled with CytoRich Red fixative, and an instruction pamphlet.
Label slide with patient’s name.
Discard the first 2-3 drops of secretion and wipe surface of nipple
or fistula.
4
2
3
5
Obtain specimen by gently squeezing material
onto glass slide. Only put one or two drops on
the slide.
Place a second glass slide on top of the
first.
Open envelope of cytology fixative at this
point.
Pull slides apart gently.
Fix both slides immediately, using
cytology fixative from envelope. Allow slides
to dry completely.
4
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Non-GYN Kit DISCHARGES (Nipple, nasal, fistula, etc.)
.After slides have completely dried replace slides into slide container and secure with a rubber band. Place slide container and requisition (note: be sure to identify type of specimen on requisition) into Medical Laboratory Associates specimen bag. Specimen is now ready for transport.
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Medical Laboratory Associates provides a Non-GYN kit consisting of two slides, an envelope of cytology fixative for
slides, a specimen tube filled with CytoRich Red fixative, and an instruction pamphlet.
Instruct patient to rinse mouth
thoroughly with water to remove food or tobacco
particles
1 2 Have the patient cough deeply, then spit into specimen
tube. Saliva or nasal discharge material is NOT acceptable for
sputum cytology.
Replace specimen tube cap. Make sure cap is on
tightly.
Gently shake contents to disperse material
through fixative.
3
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Non-GYN Kit - Sputum Collection
Label specimen tube with patient information. Identify type of specimen on the requisition and fill out all remaining information. Place specimen and requisition in a Medical Lab Associates specimen bag. Specimen is now ready for transport.
4
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Medical Laboratory Associates provides a Non-GYN kit consisting of two slides, an envelope of cytology fixative
for slides, a specimen tube filled with CytoRich Red fixative, and an instruction pamphlet.
Other Non-GYN fluid specimens include urine, bronchial, gastric washings, brushings, and other body fluids. Please call Medical
Lab Associates if you have any questions about fluid for cytology.
1
2 Put fluid into specimen tube containing CytoRich Red fixative, from kit, as soon as collected. Ratio of fixative to a specimen must
be at least 1:1. If more fluid is collected than one tube can hold, please use more specimen tubes.
Replace specimen tube cap. Make sure cap is on tightly. Label tube with patient information. Be sure to
identify type of specimen on requisition.
3
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Place specimen and requisition in a Medical Lab Associates specimen bag. Specimen is now ready for transport.
Non-GYN Kit - Other Fluids
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Medical Lab Associates provides clients with supplies needed to collect and ship urine specimens. Urine cytology kits include a 90mL specimen bottle, foam specimen bottle holder, absorbent material to prevent possible leaks, lab-pack for transport, as well as pre-labeled boxes for shipping. If a small number of tests are ordered, 40% ethanol will be included in the kit. If a
large number of tests are ordered, 40% ethanol will be sent separately.
• Collect a "clean-catch" (midstream) urine sample. To obtain a clean-catch sample, men should wipe clean the head of the penis. Women need to wash the area between the lips of the vagina with soapy water and rinse well. As you start to urinate, allow a small amount to fall into the toilet bowl (this clears the urethra of contaminants). Then, in a clean container, catch about 1-2 ounces of urine and remove the container from the urine stream.
• Fill specimen bottle with 40mL of 40% ethanol. Add an equal
amount of urine for each specimen. • Tighten lid of specimen bottle securely after adding urine
alcohol solution and tape lid shut to prevent accidental leakage. • Label specimen bottle with patient name using urine cytology
requisition form stickers • Place specimen bottle into foam holder (foam holders may
contain up to six bottles) • Wrap foam holder in absorbent material and place inside
Lab-pack and seal • Lab-pack is then placed into pre-labeled box (provided) • All specimens are then shipped to Medical Lab Associates with
next day service. Note: Urine specimens must be received within five days of collection.
Specimen bottle
40 mL 40% ethanol 40 m
L Urin
e
Specimen bottle
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Urine Cytology Immunocyt Fluorescent Staining
TO: FROM:
Absorbent sheet Lab-Pack +
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Filling out a requisition……………….……..25 Filling out an ABN……………………......…26 Reports - an overview…………………..…...27 Cytology reports………………………..…....28 Reports with attachments …………..……….29 Microbiology reports……………………..…30 Prostate reports……………….…...……..….31 Surgical reports…………………...…...….…32 Addendums…………………….……....……33 Monthly reports……………….…………......34 Physician reports…………….........................35 Patient reminders…………......................…...36 Electronic reporting………………………….37
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MLA Reports and Requisitions
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If, for any reason you have a question regarding this form, our contact information is listed at the bottom of each requisition. Please feel free to contact us.
*For MLA use (MLA will provide pre-printed requisitions
with your business name, business address, doctor names,
MLA doctor codes and any additional information you
would like)
1
2
3 4 7
5
6
Please note that all required fields (such as patient name, date of birth, etc.) are printed in red
3. Pap Specimen
4. HPV Testing
7. Clinical Information and History
1. Patient information
2. Patient Insurance Information
5. Molecular Microbiology
6. Non-GYN And Surgcial Specimens
These stickers can be removed and affixed to specimen
container. Please include patient’s first and last name on
each sticker
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Filling out a requisition
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• The ABN should not be signed for services that Medicare never covers
• The ABN should not be
routinely signed by every Medicare patient
• The ABN must describe the
testing being done and why coverage may be denied
• The ABN is unnecessary
for a medically necessary pap smear (diagnostic)
The reverse side of the MLA requisition contains the Advanced Beneficiary Notice which applies only to Medicare Patients and then again only in
certain circumstances.
The ABN is a federal requirement and needs to be signed by a patient when she receives her screening pap smear if the provider believes that she may be receiving this service beyond the limits of Medicare coverage. This is referred to as a “frequency limitation.” It informs the patient that she will be responsible for payment if she exceeds Medicare’s limit of one or more
screening pap smear every two years.
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Filling out an ABN
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Medical Laboratory Associates provides a variety of reports to our clients. Not only will you receive the surgical, histology, cytology, or microbiology report, clients will also be given a monthly patient diagnosis summary report, patient alert notification, and an optional follow-up requisition for your records. These extra reports give our clients more than the results, helping to manage and track their patients.
What do I get?
How do I get it? Reports are delivered to your office by a courier service of your choice. Medical Laboratory Associates can also fax copies of reports directly to you, making our turn around time even faster.
What does it mean? MLA reports are color-coded and easy to understand. Each type of report and what it contains is presented in the following section. If you have any questions regarding reports, feel free to contact us.
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Reports (an overview)
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This is a typical Medical Laboratory Associates cytology report. Patient and doctor information is on top, followed by information from the requisition, diagnosis, comments, past history, and finally a pathologist signature (if reviewed by
pathologist).
• Client chart number for your convenience
• Information provided on
requisition • Result • Hormone comments • Maturation index
(optional) • HPV comment in
response to an HPV reflex or HPV order request
• Notation that the slide
has been read by image analysis on the Focal Point slide profiler (no extra charge)
• Denotes an additional
page is attached with important information
• Past record of specimens
from MLA Electronic Medical Record
• Date received • Date reported • Type of report
CYTOLOGY COLOR CODE: PINK
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Cytology Reports
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In some cases, additional information needs to be included in the report and is attached as an additional page. Cytology
attachments are similar to the report with the added information at the top of the page.
• Indicates an attachment • Important additional
information • Pathologist signature • Date received • Date reported
ATTACHMENTS HIGHLIGHTED IN RED
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Cytology Reports - Attachments
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• Client chart number for your convenience
• Information provided on
requisition • Result • Comments • Information summary of
last pap result • Past record of specimens
from MLA Electronic Medical Record
• Date received • Date reported • Type of report
MICROBIOLOGY COLOR CODE: GREEN
This is a typical Medical Laboratory Associates microbiology report. Patient and doctor information is on top, followed by information from the requisition, diagnosis, comments, past history, and finally a pathologist signature (if reviewed by
pathologist).
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Microbiology Reports
31
This is a typical Medical Laboratory Associates prostate report. Patient and doctor information is on top followed by a chart and
diagram of the prostate and the patient results. Below, the clinical data, gross and microscopic descriptions, and written
diagnosis precede the pathologist signature.
PROSTATE REPORT COLOR CODE: BLUE • Client chart number • Diagram and chart of
prostate • Clinical Data • Gross Description • Microscopic Description • Diagnosis • Date reported • Date received • Type of report
JOHN DOE
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Prostate Reports
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This is a typical Medical Laboratory Associates surgical report. Patient and doctor information is on top, followed by
information from the requisition, gross and microscopic description, stains (if performed) and their results. Directly below the report continues with diagnosis, comments, past
history, and a pathologist signature.
SURGICAL COLOR CODE: BLUE • Client chart number • Description of specimen • Information provided on
requisition • Gross description • Microscopic description • Diagnosis • Comments • Past history • Date reported • Type of report
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Surgical Reports
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If more information needs to be added to a report, or new information becomes available to us, Medical Laboratory Associates will send out an addendum to the report. An
addendum can be found at the end of the original report and will include all new information.
• Patient and doctor information
• Notification of
addendum • Addendum information • Type of report
ADDENDUM HIGHLIGHTED RED
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Addendums and Revisions
34
This is an example of a monthly test summary report. Each month, Medical Laboratory Associates will compile data from pap specimens and microbiology tests for each provider. This
information is then presented to the doctor, once a month, delivered along with the regular reports.
• Doctor name, location, and report dates
• List of patients and re-
sults for pap specimens and carcinogenic HPV results. Pap specimens are divided into classifi-cations for carcinoma, high grade squamous intraepithelial lesion, low grade intraepithelial lesion, and other atypi-cal, including ASC-US, ASC-H, AGUS, and ECUS.
• Date reported • Type of report
MONTHLY TEST SUMMARY COLOR: BLUE
Your Lab for Life!
Monthly Test Summary
35
This is an example of the Physician Diagnosis Summary. Each month Medical Laboratory Associates provides a statistical overview of pap results for our clients. The information is
presented in four columns, a monthly and yearly for our client and a monthly and yearly for MLA. This report is included
with the Monthly Test Summary.
Physician Diagnosis Summary is printed on blue paper
Your Lab for Life!
Physician Diagnosis Summary
• Date of report • Doctor name and
location • Monthly stats for
provider • Yearly stats for provider • Monthly stats for MLA • Yearly stats for MLA
(last twelve months)
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This is a typical Medical Laboratory Associates Patient Alert Notification. These reports are generated if a recommendation was made and we have not received an additional specimen or
result follow-up. This helps both Medical Laboratory Associates and their clients make sure that all patients needing
return care receive it.
• Doctor name and location
• Patient name and last
diagnosis • Section for addition of
updated information (if more information on this patient is available please fill out this form and return to MLA)
• Date reported • Type of report
Your Lab for Life!
Patient Alert Notification
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MLA has created a web-based electronic reporting method designed around a common standard web service. In order to provide flexibility and continuing operation, the electronic reporting system is designed to provide customized messaging to each remote site, with the expectation
that no two sites will be identical.
Web-Based In order to provide a client side application that is the least intrusive and simple to install, MLA is using a fully web-based transmission method. There is no requirement for difficult to configure and maintain VPN systems and uses very little memory and processing time. The transmission will use an established internet connection (DSL, Cable, T-1) in the office and the web-based system can simply reside on existing systems without the need for additional connections, hardware, or software. The client program uses port 443 (SSL) and this must be enabled on the client’s system. Most systems already have this open since port 443 and SSL is commonly used for secure browsing of the internet, such as shopping online and banking online. Client Program The Client Program for the electronic reporting system is a simple service that resides on the client’s (internet enabled) computer. By existing as a service, interaction with other programs or closing of programs will not affect the Client Program. To interface with the service, a simple executable provides any changes to the web service for maintenance, but closes after use. The service then is responsible for downloading and processing the messages in the back-ground. Peak memory and processing usage is minimal. The frequency of downloads may be scheduled to further minimize usage using off-peak hours. The peak bandwith usage is equivalent to browsing a website for less than one minute. Customized Communications To provide ultimate flexibility to the client, the transmission scheme is fully customizable. Most clients request HL7 formatted messages using either the MDM (TXA) or ORU (OBR) styles. We have default schemas for each message type, but due to the number of HL7 “flavors” out there, MLA had included the ability to fully customize the message schema for each clinician’s office. To do this, MLA installed a translation engine on the web side of the communication, allowing for each web user to receive a different customized message. Most customizations can be made within days, and Clients can request a message formatted as any HL7 scheme, or a delineated file of any configuration
Your Lab for Life!
Electronic Reports
38
Shipping hazardous materials……......39-40 Shipping checklist……………………41-42
* * * * * * * Shipping regulations are subject to change. Please check
with MLA or your preferred carrier if you have any questions regarding shipping.
Your Lab for Life!
Shipping regulations*
39
10% neutral buffered formalin is the solution commonly used to fix tissue samples for diagnosis. Diagnostic specimens are routinely shipped to offsite
labs by either ground or air transportation. Diagnostic specimens fixed in 10% formalin are not regulated as hazardous materials when shipped by air. However, they must be identified as “BIOLOGICAL SUBSTANCES
CATEGORY B” when shipping by air and comply with the rules specified on the accompanying checklist of requirements. Packaging and shipping
requirements for air are found in the International Air Transport Association (IATA) Dangerous Goods Regulations, packing instructions 650. Packaging
described below meets requirements for shipping by air or ground. Line items (see check list) are required by IATA regulations for shipping by air. Diagnostic
specimens are not considered infectious and do not need to meet require-ments regarding infectious materials.
• Specimen must be secured in a leak proof container capable of preventing leaks and escape of odor (fumes).
• Amount of formalin in any container must not exceed 500 liters (½ quart). Total amount of formalin allowed in any one shipment must not exceed 4 liters (1 gallon).
• Lid of each specimen container must be reinforced with tape (MLA will supply if
requested). Vacuum sealing of specimen containers is an excellent alternative. • Container should be stabilized to prevent movement during shipping (foam holders
provided by MLA will serve this purpose). • Specimen container(s) (and foam support if used) should be placed in a zip lock bag
with sufficient absorbent material (white sheets provided by MLA) to soak up an equivalent amount of liquid equal to or exceeding the volume of the liquid being shipped.
• The zip lock bag with container should be placed in a second zip lock bag for added
protection. *Continued on page 40*
Your Lab for Life!
Shipping Diagnostic Specimens
in 10% Formalin
40
a)
BIOLOGICAL SUBSTANCES CATEGORY B b)
To: Medical Lab Associates 13751 Lake City Way Ste 300 Seattle, WA 98125
From: Your Address
c)
(continued from page 39)
Your Lab for Life!
Shipping Diagnostic Specimens
in 10% Formalin (continued)
• All bagged specimens should be placed in a strong box or other type of shipping container for shipping. The shipping container does not have special requirements but must be capable of meeting shipment by air transport regulations (withstand a drop test from a height of 6 feet on all corners and sides without sustaining significant damage). Shipping container is required to be sealed with a strong shipping tape to secure the container.
• Shipping container must be labeled and marked according to IATA/ICOA
regulations for air. This includes: a) directional arrows on at least two (2) opposing sides of the box b) a marking label: BIOLOGICAL SUBSTABCES CATEGORY B. MLA shipping boxes will be marked appropriately by MLA. Additional marking labels will be supplied if other shipping boxes must be marked. c) a “to and from” label with shippers name, address, and phone number • Meet all requirements of the DIAGNOSTIC SPECIMEN SHIPPING CHECK
LIST that are applicable to your specimens. Please familiarize yourself with this checklist. If you have questions, contact Ken Pierce at MLA.
41
Before shipping any diagnostic specimens to Medical Lab Associates by air, please be sure to consult this checklist.
• Triple packaging; primary and secondary packaging (specimen bottle and zip lock bags) are leak-proof and vapor inhibiting. Actual shipping container is a strong container or box that can withstand handling and shipping without suffering significant damage to the shipping container or its contents.
• Screw caps on specimen bottles must be reinforced by use of tape.. • Quantities: Maximum volume of 10% formalin allowed for each
specimen container is 0.5 Liters (½ quart) and for total package is 4 Liters (1 gallon).
• All requisitions (paper work) are separated from the specimen by a plastic sleeve or bag.
• Absorbent material capable of containing an entire spill, placed between primary and secondary receptacles (around the specimen container inside the first zip lock bag).
• Multiple specimen containers may be placed in a single zip lock bag but each container must be sealed with tape or and sufficient absorbent material to contain spill of all containers in bag must be placed in the zip lock bag with the containers.
• Shipping box or container must be at least 100 mm (4” x 4” x 4”) in overall dimensions and meet the 6 ft drop test (shipping container when packed for shipping must be capable of being dropped from a height of 6 ft. on all corners and sides without sustaining significant damage to the integrity of the package and its contents).
• An itemized list of contents must be enclosed between the secon-dary and outer packaging (a list stating number of specimen con-tainers must be placed inside the shipping box separate from the specimens themselves)
PACKAGING
(Continued on page 42)
Your Lab for Life!
Shipping Diagnostic Specimens in 10% Formalin Checklist
42
LABELING • Orientation (Up) arrows (↑↑) on opposite sides of shipping container.
• Shipping container marked with “Biological Substance” label (shown on page 40).
• Name and telephone number of person responsible for shipping on shipping container and the destination (name and address, i.e. Med Lab Associates).
• On airbill, for line marked Nature and Quantity of Goods, write
in “Biological Substance Category B.” • You must keep your copy of the airbill for 375 days (file it in a
safe place) after acceptance of the shipment. Your copy needs to include the date the shipment was shipped.
If you have any questions about this checklist or any shipping questions please contact Ken Pierce at MLA.
AIRBILL
(continued from page 41)
Your Lab for Life!
Shipping Diagnostic Specimens in 10% Formalin Checklist (continued)