St. Mary Mercy Hospital Outpatient Pathology and Laboratory Services

St. Mary Mercy Hospital Outpatient Pathology and Laboratory Services A Local, Full Service Laboratory

LABORATORY SERVICES 36475 West Five Mile Rd. Livonia, MI 48154-1971 24 hours a day, 7 days a week 2012 Edition V2.0 CLIA Licensed CAP Accredited Phone: 734-655-2580 Fax: 734-655-2652 2

Table of Contents WELCOME... 5 MISSION STATEMENT... 6 LABORATORY COMPLIANCE... 6 LABORATORY PERSONNEL... 10 INFORMATION REQUIREMENTS... 11 QUALITY ASSURANCE/LICENSES... 15 OUTREACH STAT TESTING... 16 STAT PROCEDURES... 17 COURIER SERVICES... 18 SUPPLIES... 18 OUTPATIENT REGISTRATION... 19 REFERENCE LABORATORY... 19 REPORTING... 19 LABELING OF SPECIMENS... 20 SPECIMEN INTEGRITY... 20 REJECTION CRITERIA... 21 BILLING... 22 SPECIMEN COLLECTION AND HANDLING... 23 BLOOD:... 23 BLOOD BANK SPECIMENS:... 24 URINE:... 24 TISSUE:... 25 CYTOLOGY COLLECTION:... 25 GYNECOLOGIC COLLECTION... 27 MICROBIOLOGY:... 29 ALPHABETICAL LISTING OF TESTS... 34 CRITICAL VALUES..39 MICROBIOLOGY CRITICALS:... 40

PRETEST DIETS & INSTRUCTIONS... 41 TIMED URINE COLLECTION INSTRUCTIONS... 41 URINE VMA... 41 OCCULT BLOOD... 41 REFLEX PROCEDURES... 42 4

Welcome Welcome Dear Colleague: At SMMH Laboratory we believe in working closely with you and your patients to ensure quality care and customer satisfaction. Our primary goals are to offer superior testing and personalized service, and our organizational challenge is to continually improve our quality by making your laboratory experience better than expected. Our commitment to you and your patients is to provide the finest clinical laboratory information, delivered in an efficient, rapid, and clinically relevant manner. The staff of the laboratory, from pathologists, medical technologists to phlebotomists, are knowledgeable and experienced. They are more than happy to help with any questions or concerns. Please do not hesitate to call when needed. Joseph A. Tworek, M.D., Medical Director, and the SMMH Laboratory management staff. 5

Mission Statement/Compliance Mission Statement To provide high quality and efficient medical diagnostic laboratory services to physicians, medical providers and their patients at St. Mary Mercy Hospital and in the community. To improve the overall health of our community, while stewarding the health care resources entrusted to us. Laboratory Compliance MEDICAL NECESSITY Claims submitted for laboratory services will only be paid if the service is covered, reasonable and necessary for the beneficiary, given his or her medical condition. Upon request, a laboratory should be able to produce or obtain from the treating physician (test ordering) the documentation to support the medical necessity of the service the laboratory has provided and billed to a federal or private health care program. Laboratories do not and cannot treat patients or make medical necessity determinations, but steps can be taken to assure compliance with applicable statutes, regulations and the requirements of federal, state and private health plans. The OIG (Office of the Inspector General) recognizes that physicians or the other authorized individuals must be able to order any tests that they believe are appropriate for the treatment of their patients. However, Medicare will only pay for tests that meet the Medicare coverage criteria and are responsible and necessary to treat or diagnose an individual patient. Medicare may deny payment for a test that the physician believes is appropriate, but which does not meet the Medicare coverage criteria (e.g. done for screening purpose) or where documentation in the entire patient record, including that maintained in the physician s records, does not support that the tests were reasonable and necessary for a given patient. Tests submitted for Medicare reimbursement must meet program requirements or the claim may be denied. Medicare generally does not cover any routine physical checkups, including tests that are performed in the absence of signs and symptoms. ICD-9 CODES Due to requirements of third party payors such as Medicare and Blue Cross/Blue Shield, physicians must include the sign, symptom, or if known, the diagnosis that prompted the order for laboratory outpatient testing. When the actual numeric code is provided, there is less chance for transcription and coding errors. Diagnosis information must be submitted for all tests ordered as documentation of the medical necessity of the service. Medicare carriers and fiscal intermediaries have the authority to develop and implement Local Medical Review Policy (LMRPS) which specify when, and under what circumstances, a service will be considered covered, reasonable and necessary and what 6

Mission Statement/Compliance CONTINUED documentation will support the need for service. The lab must be able to support tests billed to Medicare with documentation obtained from the physician ordering the test. ICD-9 DIAGNOSIS CODING FOR SCREENING TESTS The diagnosis code placed on the claim should reflect the reason for the test. If the intent of the test is for screening purposes, use the appropriate V code in the ICD-9-CM coding system, regardless of the finding. For example, when a screening laboratory test gives in abnormal finding, the test should be assigned the ICD-9-CM diagnosis for why the test was ordered, not the diagnosis indicated by the finding. REFLEX TESTING Reflex testing occurs when initial test results are positive or outside normal parameters and indicate that a second related test is medically appropriate. Tests for which this reflexive follow-up is done will be noted in this manual. These tests have been approved by the hospital Medical Executive Committee. STANDING ORDERS Standing orders are effective for six months. To meet compliance regulations, all orders are required to have: 1. Date(include expiration date) 2. Physician signature 3. Diagnosis or ICD-9 code A written signed and dated standing order will expire after 6 months, the laboratory will be unable to provide services with an expired date. If a standing order does not meet the medical necessity criteria for the diagnosis provided, then appropriate ABN procedures must be followed. Your cooperation and compliance with this regulation is greatly appreciated. ADVANCED BENEFICIARY NOTICE (ABN) An ABN is a written notification required by Medicare. The form should be utilized before services are actually furnished, as Medicare is likely to deny payment. ABN s allow beneficiaries to make informed consumer decisions about receiving lab tests which they may have to pay out of pocket, and to be more active participants in their own health 7

Mission Statement/Compliance care treatment decisions. If it is expected that payment for laboratory tests (listed on ABN) will be denied by Medicare, you should advise the beneficiary that he/she will be personally and fully responsible for payment. An ABN should be used each and every time it is determined Medicare will deny payment. When using an ABN please indicate the test(s) that were ordered. An explanation should be rendered to the patient that Medicare may not pay. The patient should review the form select an option and then sign the form. One copy should be sent to the laboratory (attached to the request form) and the patient retains the other. Health Insurance Portability and Accountability Act of 1996 (HIPAA) St. Mary Mercy Hospital Laboratory as a covered entity * complies with all federal, state and local laws, rules and regulations, including HIPAA. To this end, St. Mary Mercy Hospital Laboratory and users of SMMH Laboratory services, desire to establish terms and conditions with respect to utilizing and disclosing patient protected health information (PHI). Such confidential information includes information that is subject to protection under the Health Insurance Portability and Accountability Act of 1996 (HIPAA). To protect the integrity and availability of PHI, and to protect against inadvertent release or disclosure both parties agree to maintain the other parties confidential information in strict confidence using at least the same degree of care and security it uses to maintain the confidentiality of its own confidential information. Laboratory users, providers, employees, subcontractors and other individuals permitted by the ordering medical provider to access any computer system, network, file, report, data or software owned by or licensed to St. Mary Mercy Hospital shall take all reasonable safeguard measures necessary to protect the security of patients protected health information. * A healthcare provider, health plan, or healthcare clearinghouse that transmit protected health information (PHI) in connection with standard transactions. 8

Mission Statement/Compliance HIPPA I agree to maintain the confidentiality of protected patient health information as related to laboratory testing, and follow HIPAA guidelines. Location: Name: Title: Date: 9

Laboratory Personnel Laboratory Personnel Pathologists. 734-712-3161 option 4 Joseph A. Tworek, M.D. Medical Director, Clinical Laboratories, Clinical Chemistry and Hematology G. Ann Alpern, M.D. Transfusion Medicine Samuel D. Hirsch, M.D. Stewart M. Knoepp, M.D. John D. Schaldenbrand, M.D. Clinical Chemistry, Hematology, Coagulation Paul Valentein, M.D Informatics, Microbiology Administration Director of Laboratory Services Mary Tocco,MS, MT(ASCP) ------------------------------------------------------------ 655-2563 Diagnostic Service Representative Mark Klisman.655-2508 Technical Service Representative Meg Modes MT (ASCP) ----------------------------------------------------------------- 655-2554 Laboratory Information Systems Nancy Marchel MT (ASCP) -------------------------------------------------------------655-2454 Department Laboratory Manager -------------------------------------------------------------------- 655-2580 Carol Shevach MT(ASCP), Blood Bank and Serology Chemistry and Hematology Microbiology Anatomical Pathology 10

Information Requirements Information Requirements The quality of processing laboratory samples is affected greatly by the quality of the samples and completeness and accuracy with which tests are ordered. Test results may be delayed or not reported at all if critical information is not provided. In addition, billing problems can be created if necessary information is not provided completely and accurately. Each request form should therefore include the following: patient s name (first and last) date and time of collection date of birth sex diagnosis (preferably diagnosis code) patient s address and phone number source of specimen ( if pathology & microbiology requisition) date of last menses, pregnancy status, surgical history, previous abnormal paps or biopsies ( if cytology requisition) requesting physicians(s) phone number(s) billing information tests requested, carefully marked additional tests written in space provided physician/provider signature AFP data sheet Blood Lead Analysis Form Request Forms The following request forms for outreach testing are available: Clinical Test Request Form (see Figure 1) Cytopathology / Histology Request Form (see Figure 2) These forms are illustrated on the following pages (continue ) 11

Information Requirements Figure 1: Clinical Test Request Form 12

Information Requirements Figure 2: Cytology/Histology Request Form 13

Information Requirements Please note on requisition forms if: The test is a STAT Results are to be called or faxed (please include phone number) A courtesy copy is to be given 14

Quality Assurance Quality Assurance/Licenses The clinical laboratory at St. Mary Mercy Hospital is licensed under the Clinical Laboratory Improvement Act of 1988, certified by the College of American Pathologists and accredited by the Joint Commission for the Accreditation of Health Care Organizations. The strictest quality assurance protocols are followed at St. Mary Mercy Hospital. The laboratory participates in both internal and external quality control programs, as well as continuing education. The laboratory participates in proficiency testing programs through the College of American Pathologists. Every department of the laboratory participates in quality assurance and control. Several levels of quality control are in place to ensure that accurate and reliable test results are reported. Laboratory results are reviewed by a Group Leader and referred to a Pathologist for further review if highly abnormal. The laboratory monitors turnaround times, patient satisfaction, critical value reporting and many other test management studies. The quality assurance programs are ongoing and are designed to eliminate any technical errors as well as non-technical errors. Figure 3: Laboratory accreditation certificate 15

Outreach Stat Testing Outreach Stat Testing St Mary Mercy Laboratory offers outreach stat testing to its clients. When a client orders a test on a stat basis, the laboratory will call results back to the ordering physician within 4 hours after the specimen is received by the laboratory; thus total turnaround time for stat specimens will range from 2-4 hours depending on time for transportation. While the laboratory provides stat testing for its clients on a wide range of tests (see following page), it is important to note that certain tests cannot be processed on a stat basis. Examples include microbiology and virology cultures, polymerase chain reaction (PCR) testing, many special chemistry tests and allergy tests. The process for ordering tests on a stat basis is as follows: Step 1: Client calls laboratory (734) 655-2580. It is critical that the client identify exact location, including office or suite numbers. Step 2: A courier is dispatched. Step 3: Processing of the stat specimens begins after specimens are received in laboratory. Step 4: The laboratory will phone the stat results to the ordering physician s office immediately after specimen testing is completed. 16

Stat Procedures Outreach Stat Testing Blood Bank Chemistry Microbiology Serology Urinalysis Hematology Toxicology ABO & Rh Antibody Screen Basic Metabolic Panel Creatinine Iron Urine Chemistries Comprehensive Profile Electrolytes TIBC Amylase ABG & COOX Glucose Lactic Acid Calcium Acetone LDH Ferritin- Creatinine ALB Lipase Glycosolated Hemoglobin Sodium Alk Phos Mg CRP Potassium Amylase Phos Cholesterol Chloride HCG(serum) AST(SGOT) HDL Magnesium Bilirubin T&D ALT(SGPT) Triglycerides Microalbumin BNP Troponin T4 Free Phosphorus BUN Uric Acid TSH Total Protein Calcium Myoglobin Pre Albumin BUN CK &CKMB Troponin Uric Acid Rapid Strep.Screen Flu Gram Stain RSV Mono Urinalysis UCG CBC CBC & Diff PLT PT PTT Reticulocyte count Sickle Screen D-Dimer Fibrinogen Acetaminophen Carbamezapine Digoxin Gentamicin Lithium Phenobarbital Dilantin Tobramycin Vancomycin Salicylate Theophylline Valproic Acid 17

Outreach Stat Testing Courier Services St. Mary Mercy Hospital Laboratory provides a courier service for routine and stat pickup service to physician offices and clinics. Every effort is made to arrange courier visits that are convenient to the doctor s office and also provide timely delivery to the lab for testing. A lock box can be provided for after hour pick-ups. Supplies The lab will supply all forms, blood collection tubes and related materials, specimen containers, cervical spatulas, brushes, glass slides and fixative for cytology specimens, formalin and formalin filled containers for biopsies and other supplies upon request. (See supply order form) The completed supply orders may be given directly to the courier. Figure 4: Lab Supply Order Form 18

Specimen Collection Outpatient Registration Patients referred to St Mary Mercy Hospital Outpatient Lab must register at the laboratory drawing area at the Pavilion entrance of the hospital. The patient must have a Laboratory Requisition Form with proper information filled out for identification and billing purposes. Please instruct the patient to bring all insurance and billing information with their form. Reference Laboratory To provide a greater array of tests for diagnostic purposes, St. Mary Mercy Laboratory may send specific tests to Warde Laboratory, or other properly licensed and accredited laboratories, for reference testing. Warde Lab is located in Ann Arbor and is fully licensed by the State of Michigan, U.S. Department of Human Services and accredited by the College of American Pathologists. Please note that tests sent to a reference lab might increase result turn around time. Reporting Most routine results are reported within 24 hours. Culture results and tests sent to the reference lab might take longer to report. Results are routinely sent to the referring physician. Additional copies will be sent to consulting physician(s) if indicated on the Test Requisition Form. Reports can be delivered to the physician s office by the courier, put in the physician s mailbox in the hospital, faxed or printed at the office. Results that are life threatening, and critical values will be called to the physician s office as soon as they are resulted. See the complete list of Critical Values in this manual. When contacting a physician with a panic value, the laboratory representative will provide the following information: The ordering physician s name Patient s name The results Patient s phone number Review the status of any other testing for that date of service 19

Specimen Collection Labeling of Specimens To ensure the proper specimen identification it is essential that each tube or container be legibly labeled with the following information: Patients first and last name Date and time of collection Initials of person collecting specimens Site and type of specimen (For tissue biopsies, excisions, and cytology) Cytology slide specimens require that the site and source be noted on the slide(s) in pencil. Specimen Integrity The intent of the laboratory is to provide the most accurate and reliable test results possible. This depends considerably on proper specimen collection, handling and transport. The laboratory makes every effort to provide a timely and accurate test result. If a specimen is unsatisfactory for testing, we will notify your office. Please note that any specimen submitted in unsanitary condition is dangerous to laboratory personnel and may not be accepted for testing. Be sure to follow the specimen guidelines for handling of specimens. These are found in the specimen collection section. 20

Specimen Collection Rejection Criteria SPECIMEN No specimen received Unlabeled specimen Misspelled name, or unable to read Clotted specimen QNS (insufficient specimen) Hemolyzed Blood Bank specimen Hemolyzed Chemistry specimen Specimen with needle still attached to collection device Specimen not collected properly (wrong tube) Specimen not transported properly (on ice) Normal or required times of collection exceeded Specimen inappropriate for test order REQUESTS No order slip received with specimen (may be sent or faxed to the lab within 24 hrs.) Unsigned Blood Bank slip Wrong orders with a specimen (may be sent or faxed to the lab within 24 hrs.) No diagnosis code given. 21

Billing Billing St. Mary Mercy Hospital Laboratory will directly bill the patient or the patient s insurance company for laboratory fees. It is essential for third party billing that a diagnosis is recorded on the laboratory requisition form. As a JVHL laboratory, we are a provider for most insurance companies, HMO S, PPO s, Medicare and Medicaid. The following is the information required for proper billing. MEDICARE MEDICAID BC/BS COMMERCIAL PATIENT Name X X X X X Sex X X X X X Date of Birth X X X X X Relationship to X X X X X subscriber Address X X X X X Phone number X X X X X Doctor Name X X X X X Doctor s Type (MD, DO) Medicare No. Physician UPIN No. Medicaid No. Physician Provider No. Contract/Policy No. X X X X X X Group No. X X X Insurance Co. Name Insurance Co. Address ICD9 Diagnosis Code X X X X X X X 22

Specimen Collection/Handling Specimen Collection and Handling The proper handling and preservation of specimens is critical for accurate reporting. A full range of collection kits for blood, urine, stool cultures, and probe technology are available from the laboratory. Blood: Collect blood specimens using proper phlebotomy protocol. Refer to the collection instruction list for the proper tube(s) to draw for a specific test. Gold top, gel tube (SST): Keep at room temperature for approximately 15 minutes before centrifugation to allow time for clotting. Samples should then be centrifuged for 10 minutes. Spun tubes should be refrigerated (2-8 degrees C) unless otherwise noted in the collection instructions. Purple (lavender), blue, green top tubes: Do not centrifuge blood drawn with an anticoagulant. Mix sample well by inversion- DO NOT SHAKE TUBE. Anticoagulant tubes should be refrigerated unless otherwise noted in the collection instructions. Tube Top Color Gold Top SST, Gel Red(plain) Royal Blue Light blue Green Gray Lavender Yellow Tube Additive Clot activator and gel for serum separation Number Tube Laboratory Use Inversions 8 Serum determinations in chemistry. None 0 Chemistry, Serology, Blood Bank, Immunogenetics Sodium heparin, NA2EDTA None Sodium Citrate(3.2%) [Separate and freeze] Sodium heparin Lithium heparin Potassium oxalate, Sodium Fluoride 8 8 0 Trace elements, Toxicology 8 Coagulation determinations on plasma specimens. 8 8 Plasma determinations in Chemistry and HLA determinations 8 Glucose determinations. K3EDTA 8 Whole blood Hematology determinations. ACD [Keep at room temp.] 8 Molecular Immunogenetics determinations. 23

Specimen Collection Guidelines Blood Bank Specimens Collection and Handling: Identification of tube: It is imperative that blood drawn for Blood Bank testing be labeled with the following information: Patient s full name (no abbreviations) Date and time drawn Initials of drawer. Special instructions for filling out Laboratory Test Request Form: Must use patient s full name (no abbreviations) Under the laboratory instruction area of the form, please fill out the date and time. Must sign (patient witness & drawer) the Laboratory Test Request Form. Note: The person collecting the blood for Blood Bank testing must sign the Laboratory Request Form at the bottom blank area. See the Laboratory Test Request Form in this manual for details and sample. (There is no stated area for signature, the blank area at the bottom of the form will serve as a signature area.) Specimens drawn in physicians offices will not be used for transfusion workups, or for surgical or regular Type and Screens where there is a potential for future transfusions. These samples are for diagnostic testing only. Urine: Routine or complete urinalysis requires no preparation of the patient. Collect 10-15 mls. (5 ml. minimum) midstream urine in a clean urine container with a sealable lid. Contain in a plastic bag and store it in the refrigerator. 24 Hour Urine Collection: At the beginning of the collection period the bladder should be emptied, that specimen discarded and the time noted. All urine specimens passed thereafter are collected and the ENTIRE urine specimen passed during the 24 hours is added to the container. Refrigerate the container during collection. At the end of the 24 hour collecting period, the bladder is emptied and this specimen is added to the container. The collection container is returned to the lab as instructed, as soon as possible after collection of the last specimen. 24

Specimen Collection Guidelines Tissue: Routine surgical pathology specimens should be collected in 10% formalin and must be accompanied by a Cyto/Histo Request Form that details pertinent medical history. See the request form in this manual for detailed instructions. The site or source of collection must be clearly stated including the right or left ( R or L ). Please include the pre-operative diagnosis and any other pertinent information. To ensure proper specimen identification, the specimen container (not outside bag or package) must be labeled with patient s full name, date, and time of collection, initials of individual who collected the sample and the exact source of collection. Labeled specimen containers must be placed into a plastic bag for transport. Store formalinized specimens at room temperature. Non-gyn Specimens testing includes: Flow Cytometry Studies Pneumocytis detection by direct fluorescent antibody Non-Gyn samples: Body Cavity Fluids, Cerebrospinal Fluids, Sputum, Urine, Washings, Brushings, Tzanck Smears, Needle Aspirations from cysts and solid masses. Cytology Collection: Cytopathology is the study of disease by examination of cells that have spontaneously exfoliated or been forcibly removed from tissues by scraping, brushing or aspiration. The cellular sample is applied to glass slides by smearing, membrane filtration, or cytocentrifugation and then rapidly fixed with ethanol, and stained. The Papanicolaou stain is most commonly used but other histochemical stains commonly employed in tissue pathology may be used. The stained slides are screened by a cytoechnologist and any abnormalities are evaluated by a pathologist. For many types of specimens, sections of paraffin embedded cells trapped in an in vitro fibrin clot, (i.e. cell blocks) are also examined by a pathologist. Samples include: Pap smears, Fine Needle Aspirations, Tzanck smears, Urine Cytology, etc. SMMH Laboratory does provide the supplies and accepts Thin Prep testing. Supplies Requisitions, Thin-prep Vials, Ayre s spatulas, cytobrushes, glass slides, spray fixative, and cardboard slide holders are provided without charge. Please call the St. Mary Mercy Hospital laboratory at (734) 655-2580 to order supplies, which are delivered by our couriers. 25

Specimen Collection Guidelines Thin Layer Pap Sampling Devices: A plastic spatula is used for ectocervical sampling. An endocervical brush or Papette (broom) is used for endocervical sampling. A cotton swab is not recommended for the adult cervix. Patient Preparation: The patient should not have had any recent intravaginal therapy of any kind or used any douches for 24 hours prior to the exam. Specimen Collection: In patients with a cervix, to obtain an adequate sample from the endocervical transformation zone. A separate cervical scraping and endocervical brush sample are recommended. The sample must be taken under direct visualization. Lubricant should not be used on the speculum unless the patient is a virgin or the introitus is stenosed. Cervical/ Ectocervical Sample Rotate the notched end of the spatula around the exocervix in a 360-degree rotation. Rinse the spatula in the preservative solution by swirling the spatula vigorously in the vial 10 times. Discard the spatula. Endocervical Sample Upon sufficient contact with the targeted area, rotate the endocervical brush one-quarter turn to obtain a sample. Over rotation may damage some cells, and often induces more capillary bleeding. Rinse the brush in the preservative solution by rotating the brush in the solution 10 times while pushing against the vial wall. Swirl the brush vigorously to further release material. Discard the brush. ***Reflex HPV DNA typing if ASC-US is available upon request.*** PAP Smear Requisition Requirements 1. Fill in all patient information (DOB, Full Name, SS# (if possible) are a must) 2. Date of Service must be entered. 3. Doctor s name must be checked. 4. For Liquid Based Paps choose a test to be ordered: Thin Layer Pap Reflex HPV if ASC-US, Thin Layer Pap, or HPV Typing only. 5. Choose whether the pap is Diagnostic or Screening. 6. If the pap is a screening then at least one ICD-9 code must be a V code (see shaded box on req) e.g. V76.2, for a diagnostic pap any ICD-9 code may be used except the V codes in the shaded box. 7. Choose a source from where the sample was taken e.g. Vaginal, Cervical, Endo Cervix or any combination. 8. LMP is helpful if you are able to get the information. 9. Any patient history is to be put on the requisition and not on the vial. 26

Specimen Collection Guidelines Specimen Requirements 1. First and Last Name must be on all lab specimens. 2. Do not leave cervical brushes in vial. Rub on the wall of the vial, then swirl the brush and the spatula in the solution to remove cells. 3. Double check to make sure the lid on vial is tight, to prevent leaks! 27

Microbiology Microbiology: Aerobic Culture: Collection: specimens are to be collected from a pre-cleaned site using sterile technique. Contamination with normal flora from skin, rectum, vaginal tract or other body surfaces must be avoided. Sampling of open lesions is enhanced by deep aspiration using a sterile plastic catheter. Aspirate specimen with a needle and syringe, being careful to sample deepest portion or active margin of wound. Wound cultures include a gram stain. If little fluid is present, inject sterile saline into site and re-aspirate. Place fluid in sterile container. Note: if syringe is used to transport specimen all air should be expelled, needle should be removed and syringe capped. Needle curetting of the base of an open lesion may also provide good yield. Pus is obtained by needle aspiration through an intact surface which has been aseptically prepared. Use culturette swab for collection of culture. (A second swab sample can be obtained for gram smear analysis.) Anaerobic Culture: Applies to any site from which an anaerobic culture is desired. Before sampling, it is recommended that the surface be cleaned with an antiseptic (alcohol or iodine) Aspirate specimen with a needle and syringe, being careful to sample deepest position or the active margin of the wound. If little fluid is present, inject sterile saline into the site and re-aspirate. Expel bubbles from the syringe. Place fluid in sterile container. Note: if syringe is used to transport specimen all air should expelled, needle should be removed and syringe capped. If specimen is tissue, it should be placed in a sterile, disposable, impermeable container with a screw cap or tight cork. An anaerobic swab should be used for collection of culture (second swab sample must be obtained for gram smear analysis) Inject some of the aspirate into an anaerobic culture tube and replace the needle sheath. Press down plunger in anaerobic tube. Label appropriately Bacterial Antigen: Obtain a clean sterile leak proof container or deliver fluid in syringe, collection bag or bottle. Withdraw fluid using sterile technique 10 ml fluid required for complete antigen testing (CSF has 2 ml minimum requirement) Aseptically transfer fluid to sterile container if possible. 28

Microbiology Brucella: Acceptable specimen sources: blood, tissue, fluid. Place tissue or fluid into a sterile container. On requisition, clearly indicate brucella detection. Deliver to lab as soon as possible. Catheter: Aseptically prepare insertion site (wipe with alcohol) Remove line without contact with adjacent skin and send only intra-arterial segment (5 cm distal tip of line) Aseptically place in sterile container. Label appropriately. NOTE: Foley caths are unacceptable specimens and will be rejected. Diphtheria: Both the throat and the nasopharynx should be cultured. Obtain an aerobic culturette and a NP swab (NP swabs obtained from lab). Throat specimen: use aerobic culturette and swab from tonsil to tonsil. If pseudomembrane is present, lift edge of membrane and swab underneath it to reach deeply located diptheria organisms. Nasopharynx specimen: use a sterile NP swab to reach deep into the posterior nares.. Eye: Do not take cultures within 4 hours after irrigation or installation of disinfectant solutions or ophthalmic medications. Conjunctiva/cornea: --a scraping of the conjunctiva material is preferred Inner eye fluid or pus: --aspirate specimen using needle and syringe. --expel air from the syringe and remove needle and replace needle sheath. Fungus: Applies to any site from which fungus culture is desired. Collection: skin scrapings, exudates, nail clippings, whole nail, debris under nails, hair, sputum, urine, tissue, fluid, blood etc. Collect sample in sterile container. Genital: Specimen: swab of vagina, cervix, discharge, aspirated endo-cervical, endometrial, prostatic fluid or urethral discharge. Use two swabs (remove any exudates with first swab). Sample area with second swab. 29

Microbiology Group B Strep Screen: Specimens: cerebrospinal fluid, serum, urine. Endo-cervical or endometrial material or amniotic fluid submit in sterile container or sample area with culturette collection swabs. DNA Probe -Chlamydia Trachomatis: Only swabs contained in the Gen Probe specimen collection kit can be used to collect patient specimens. Cervix-remove excess mucus from the cervical os and surrounding mucosa using one of the swabs provided in the collection kit and discard the swab. Insert the second swab into the endocervical canal, rotate 10-30 seconds, withdraw and place into transport tube found in kit. Urethral-patient should not have urinated for at least 1 hour prior to sample collection. Insert swab from the urethral/conjunctivae collection kit 2-4 cm into urethra using a rotating motion. Withdraw and place into transport tube in the kit. Urine- collect a urine specimen in clean preservative free container. Do not use gray vacutainer collector. DNA Probe-GC: Only swabs contained in the Gen Probe specimen collection kit can be used to collect patient specimens. Cervix-remove excess mucus from the cervical os and surrounding mucosa using one of the swabs provided in the collection kit and discard the swab. Insert the second swab into the endocervical canal, rotate 10-30 seconds, withdraw and place into transport tube found in the kit. Urethral-patient should not have urinated for at lease 1 hour prior to sample collection. Insert swab from the urethral/conjunctivae collection kit 2-4 cm into urethra using a rotating motion. Withdraw and place into transport tube found in the kit. Break swab at the score line to fit the tube and cap the tube tightly. Urine- collect a urine specimen in clean preservative free container. Do not use gray vacutainer collector. Herpes: Specimen depends on type of infection may be:vesicle fluid, lesion, endo-cervical, conjunctival, throat, CSF, genital. If vesicles are present, wash with sterile saline, carefully open several vesicles and soak up vesicular fluid with swab. If no vesicles are present, swab the area with enough pressure to obtain epithelial cells. Place sample into transport media (break swab into media) Influenza: Throat swabs, Nasopharyngeal Swabs, and Nasal Aspirates are acceptable. 30

Microbiology Legionella Antigen-Urinary: Obtain 5 cc urine minimally. Do not use gray vacutainer collector. Place in sterile container. Note: Available as STAT test on day shift. Mycobacterium Culture: Applies to any sample requiring analysis for presence of mycobacterium species. Collection: biopsy, blood, fluid, pus, tissue, urine, sputum or respiratory aspirate. Place in appropriate collection device: Sputum should be collected in AFB sputum collector. Respiratory aspirates should be placed in sterile luki-tube (provided by lab). Blood may be collected in green top heparin vacutainer tube. Biopsy or tissue should be placed in sterile container. Urine: see specific collection instructions. Mycoplasma-Genital: Sample cervix or urethra with culturette swab (break swab into Mycoplasma transport media. Mycoplasma-Respiratory: Specimen: throat or nasopharyngeal swabs (break swab into Mycoplasma media), sputum in sterile container(keep refrigerated) Parasite-ID Mites or scabies: Tease the mite from its burrow or papule with a needle or cut a tiny bit of skin with a Bard-Parker blade. Place the specimen between two slides and secure. Lice: Place louse and/or hair with nits attached in closed container. Ticks: Place tick in closed container. Pinworm: Obtain pinworm slides from lab. (slides must be prepared, so please call in advance.) The sample must be taken during the night or early am (2am-8am). Pull about ¾ of the tape off of the slide by the tab and pull it back so that the adhesive part of the tape is exposed 31

Microbiology Press the adhesive part of the tape against the anus, flattening the perianal folds. (gloves are recommended during this procedure). Replace the adhesive part of the tape back on the slide and label slide with a pencil. Two preps must be prepared for each order. Note: Stool samples not recommended for pinworm detection. Rapid Strep Antigen: Obtain 2 aerobic culturette swabs and a tongue depressor Arrange the patient such that the light best illuminates the throat. While depressing the patient s tongue with the tongue depressor, have the patient stick out the tongue and inhale deeply thus opening the area to be swabbed/sampled. Using 2 swabs rub firmly over the back of throat (posterior pharynx) both tonsils or consular fossae. Any areas of inflammation, exudation, or ulceration should be swabbed. When using 2 swabs make sure that each swab touches the important areas. Avoid touching other areas of the mouth such as tongue, cheeks or lips. Replace swabs into culturette holders and crush ampoule on one swab. Sputum: Sputum should be collected before antibiotic therapy is started. Ask the patient to expectorate into sterile container at the time of a deep cough. Label appropriately. Note: Note on requisition if sample is endotracheal aspirate. Stool: Have a patient defecate into container. Cover container tightly. If multiple samples are required, collect on consecutive days. Rejection: diaper, tissue paper, presence of urine, specimen container contaminated on outside. Note: Yersinia and Vibrio may not be recovered unless specifically requested on requisition. Stool O&P: Obtain appropriate ova and parasite stool collection container and transport vials from laboratory. Have patient defecate into container. Instruct patient to transfer stool samples into transport vials. Cover tightly. If multiple samples are required, please collect on consecutive days. Rejection: diaper, tissue paper, presence of urine, specimen container contaminated on the outside. Note: Non acceptable samples include contamination by barium (7-10 day post UGI/LGI),oily laxatives (castor oil), gastrograffin, metamucil. 32

Microbiology Throat: Obtain 1 aerobic culturette swab and a tongue depressor. Arrange the patient such that the light best illuminates the throat. Have the patient extend the tongue and take a deep breath in (causing the throat to open wide). Using a sterile culturette, firmly rub both tonsillar pillars and or the pharynx. Avoid touching other areas of the mouth such a tongue, cheek, or lips. Replace swab into culturette holder and crush ampoule. Trichomonas/Yeast: Specimens: vaginal, cervical or urethral swabs, prostatic fluid, urine sediment. Collect posterior vaginal sample using a speculum without lubricant. Urine-Acid Fast: Collect a first morning specimen (20 ml minimum) in sterile collection container. Make sure lid is securely fastened. Urine Midstream: Collect specimen prior to administration of antibiotics. Obtain sterile urine C & S transport kit from laboratory. Explain instructions from kit to the patient. Urine from collection receptacle is transferred via the transfer device to the VACUTAINER Brand Tube containing the lyophilized preservative. Shake tube vigorously. Viral Culture: Specimen: blood, CSF, dermal, ocular, genital, mucosa, oral, rectal, stool, respiratory, tissue, urine or biopsy. For swabs: obtain transport media from laboratory. Blood, lavender EDTA vacutainer tube. Sterile screw cap container for other samples. For swab specimens obtain sample with enough pressure to obtain epithelial cells (break swab into media). 33

Critical Values Alphabetical Listing of Tests Test Name Handling/Comments Affected Tube by: Requirements Basic AHDL ALBUMIN ALCOHOL KEEP CAPPED; USE NON-ALCOHOL SWABS ALKALINE (H) PHOSOHATASE ALT (H) AMYLASE (H) AST H BILIRUBIN, CORD AVOID EXPOSURE TO LIGHT BILIRUBIN, TOTAL AVOID EXPOSURE TO LIGHT BILIRUBIN, DIRECT AVOID EXPOSURE TO LIGHT H BLOOD GASES PUT ON ICE IF NOT RUN WITHIN 15 MIN LI HEPARIN SYRINGE SEALED SYRINGE BUN (H) CALCIUM (H) CALCIUM, IONIZED LI HEPARIN, NA HEPARIN CHOLESTEROL (H) (I) CK H, I CREATININE FERRITIN FREE T4 GLUCOSE - SST SEPARATE WITHIN 1 HOUR SST GLUCOSE - GRAY Not seperated NA FLUORIDE GLUCOSE - GREEN, Not seperated LI HEPARIN GGT HA1C WHOLE BLOOD FOR ANALYSIS EDTA HCG (BLOOD) IRON H. I IRON BINDING CAPACITY LACTATE (BLOOD) COLLECT ON ICE, SPIN H NA FLUORIDE and IMMEDIATELY, ANALYZE WITHIN 15 MINUTES K+OXALATE (GRAY) LDH DO NOT FREEZE H Test Name Handling/Comments Affected Tube 34

Critical Values by: Requirements LIPASE H LYTES: SODIUM POTASSIUM REMOVE FROM CELLS WITHIN 2 HR H CHLORIDE CO2 KEEP SPECIMEN TIGHTLY CAPPED MAGNESIUM H MMB MYOGLOBIN OSMOLALITY, KEEP SPECIMEN TIGHTLY CAPPED SERUM PHOSPHORUS SEPARATE PROMPTLY H, I, L PROTEIN, TOTAL H, I PSA PREALBUMIN TRIGLYCERIDE 12 HOUR FAST TROPONIN TSH URIC ACID ACETAMINOPHEN CARBAMAZEPINE DIGOXIN GENTAMICIN LITHIUM SEPARATE WITHIN 2 HOURS SST PHENOBARBITAL PHENYTOIN (DILANTIN) SALICYLATE THEOPHYLLINE TOBRAMYCIN VALPROIC ACID (DEPAKOTE) VANCOMYCIN Test Name Handling/Comments Affected Tube by: Requirements 35

Critical Values BODY FLUIDS: ALBUMIN AMYLASE CHOLESTEROL GLUCOSE LDH TOTAL PROTEIN TRIGLYCERIDE DO NOT FREEZE URINE AMYLASE RANDOM OR 24 HOUR SPECIMEN CALCIUM RANDOM OR 24 HOUR SPECIMEN CHLORIDE RANDOM OR 24 HOUR SPECIMEN CREATININE RANDOM OR 24 HOUR SPECIMEN MAGNESIUM RANDOM OR 24 HOUR SPECIMEN MICROALBUMIN Reported Microalbumin/creatinine ratio RANDOM OR 24 HOUR SPECIMEN OSMOLALITY KEEP SPECIMEN TIGHTLY CAPPED RANDOM OR 24 HOUR SPECIMEN PHOSPHORUS RANDOM OR 24 HOUR SPECIMEN POTASSIUM PROTEIN, URINE H RANDOM OR 24 HOUR SPECIMEN SODIUM RANDOM OR 24 HOUR SPECIMEN UREA NITROGEN RANDOM OR 24 HOUR SPECIMEN URIC ACID RANDOM OR 24 HOUR SPECIMEN AMPHETAMINES ANALYZE IMMEDIATELY RANDOM URINE BARBITURATES ANALYZE IMMEDIATELY RANDOM URINE BENZODIAZEPINES ANALYZE IMMEDIATELY RANDOM URINE CANNABINOIDS ANALYZE IMMEDIATELY RANDOM URINE COCAINE ANALYZE IMMEDIATELY RANDOM URINE OPIATES ANALYZE IMMEDIATELY RANDOM URINE U MACROU-MICRO RANDOM URINE Test Name Handling/Comments Affected Tube by: Requirements CBC Lavender 36

Critical Values CBCD WESR Sickle cell Retic Lavender Lavender Lavender Lavender COAGULATION PT Must be a full tube Light Blue PTT Must be a full tube Light Blue FIB Must be a full tube Light Blue Dimer Must be a full tube Light Blue BNP Lavender 37

Critical Values Critical Values The laboratory values that will be called 24 hours/day, 7 days/week are as follows: 24HR Notification TEST LESS THAN GREATER THAN Bilirubin, Total (<21 days of age) 18 Sodium 120 160 Potassium 3 6.5 Glucose (0-1 day of age) 25 500 (2-3 days of age) 30 500 (>3 days of age) 40 500 Magnesium (Maternity) 1 9.5 Troponin >1.5 Hemoglobin 8 20 Platelet 50,000 PT (INR only) 5 PTT 119.9 ST. MARY MERCY LABORATORY CRITICAL CALL LIST 38

Critical Values As of: 11/29/2011 8 AM -10 PM 24HR Notification TEST RANGE LESS THAN GREATER THAN Ammonia >49 Bilirubin, Total (<21 days of age) 8.0-18.0 18 BUN >100 Calcium Total (<1 year) < 7 >13 (> 1 year) <7 >12 Creatinine >5 Sodium n/a 120 160 Potassium n/a 3 6.5 Chloride <80 >115 CO2 <10 >40 Glucose (0-1 day of age) 25 500 (2-3 days of age) 30 500 (>3 days of age) 40-60 40 500 Lactate >4 Magnesium (Maternity) n/a 1 9.5 Osmolality,serum >320 Osmolality, urine >1400 Troponin n/a >1.5 Acetaminophen >50 Carbamazepine >15 Digoxin >2.5 Gentamicin >12 Lithium >1.5 Phenobarbital >50 Phenytoin >30 Salicylate >30 Theophylline >15 Tobramycin >12 Valproic Acid >175 Vancomycin >90 Alcohol >300 WBC (age <3 months) <4000 >30000 (age > 3 months) <2000 >30000 Hemoglobin n/a 8 20 (child 0-1yrs of age) <10 >20 Platelet 50,000 PT (INR only) 4.0-5.0 5 PTT 119.9 Fibrinogen D-Dimer >500 Malaria & other blood parasites any CSF's wbc's >5 rbc's >1000 Neutrophil Count <0.5 39

Critical Values Microbiology Criticals: Routine: VRE (Vancomycin Resistant Enterococcus) from any site GISA (Vancomycin Intermediate or resistant Staphylococcus) from any site CSF; all organisms Ears and Eyes; Staph. Aureus, Pseudomonas spp. Stool ; Salmonella spp., Shigella spp., Campylobacter spp., Vibrio spp. Yersinia spp., Plesiomonos spp., Aeromonas spp., Shiga toxin, Producing E. coli, Clostridium Difficile toxin Blood Cultures: All positive smears or cultures AFB: All positive AFB s (smear or culture) Respiratory: Neisseria meningitides Ova & Parasites: Any ova or parasite identified Fungus: Cryptococcus neoformans, Coccoides immitidis 40

Diets & Reflex Procedures Pretest Diets and Instructions TIMED URINE COLLECTION INSTRUCTIONS 1) At the beginning of the collection period completely empty your bladder into the toilet. DO NOT COLLECT THIS SAMPLE. Put the date and time this is done on the label on the collection container. This is the start time of the collection. 2) From this point on, until the end of the collection period (2 hours, 12 hours, 24 hours, etc.) all urine must be collected in the collection container. 3) The urine specimen must be refrigerated during the collection. 4) At the end of the collection period (that is exactly 2, 12, 24 hours from the time initially recorded on the container label), completely empty your bladder and add this last specimen to the container. Put the date and time this is done on the label on the container. This is the finish time of the collection. 5) Make sure the outside of the container is not contaminated with urine and that the cap is tightly screwed on, and that the container is labeled with your full name, doctor s name, and start and finish times of the collection. Then place the container in a leak proof plastic bag. 6) The container should be returned as quickly as possible to the Outpatient Laboratory. If there will be a delay, the specimen should be kept refrigerated. URINE VMA Three days prior to and during collection diet should not include coffee, any form of chocolate, fruits, vanilla, or caffeine. OCCULT BLOOD Two days prior to and during collection, the diet should not include rare red meat, turnips, horseradish, or melons. Diet should include well-cooked meats, poultry, and fish, bran cereal daily, cooked fruits and vegetables, peanut and popcorn. On the advice of the physician, the following medications should be suspended two days prior to and during the collection: aspirin or containing-containing products, anti-inflammatory drugs, supplements containing iron, and supplements containing vitamin C in excess of 250 mg/day. FASTING The deprivation of food and drink for a period of time (usually 8 or 12 hrs.), depending on the specific laboratory test. 41

Diets & Reflex Procedures Reflex Procedures TEST REFLEXED TEST CBC.. Differential count Adult 1) WBC : <1.0 5 slides are scanned no diff is ordered. WBC count too low for accurate differential comment is added to WBC. This is performed every 72 hours. 2) WBC: 1000 3000 a diff is added every 72 hours. 3) WBC: >30,000 a diff is added every 72 hours 4) MCV: >115 5) HGB: <7.0 slide is scanned, if schistocytes, bacteria or parasites are seen, a diff is performed. 6) PLT: >1000 7) PLT: <75 slide is scanned, if schistocytes are seen, a diff is performed. 8) NRBC: >5% 9) Any instrument flags slide is scanned, if immature cells or blasts are seen, a diff is performed. SYPHILIS SEROLOGY TESTING.Reflexed for confirmation to FTA-ABS and (RPRT) will be useful in following response to treatment. Group A Strep Rapid Screen Culture, when 2 swabs are received for antigen and the result is negative. Acid Fast Culture & Smear, Stool C& S,.. Identification and sensitivity if indicated. Urine C & S, Wound C & S, Throat C& S, Genital C & S Urinalysis(Chem. only)... If positive microscopic, Complete Urinalysis. Urinalysis Reflex Culture if Positive.. (When Ordered as U MAC/CUL) Positive leukocytes Positive Nitrates WBC >2/HPF for men WBC >11/HPF for female Hepatitis C Antibody.. Hepatitis C RIBA (HCV RIBA) Lipid Panel Reflex LDL. If ordered and Trig. is greater than 400 PSA, Diagnostic or Screening- Reflex PSA, free.. If requested by physician and on lab req. 42