D.33 LABORTORY MANUAL.pdf

D.33 LABORATORY MANUAL

36C25922R0102

Department of Veterans Affairs Medical Center

Pathology and Laboratory Medicine Service (P&LMS)

Directory of Services and Policies

VAMC, Oklahoma City, Oklahoma

Directory of Services

Department of Veterans Affairs Medical Center

Pathology and Laboratory Medicine Service (P&LMS)

Oklahoma City, Oklahoma

CAP #2035901 - CLIA #37D0988002

A. SUPERVISORY PERSONNEL

Extension

Chief, Pathology & Laboratory Medicine Service Ravindranauth Sawh, M.D. 65338

Chief, Clinical Pathology Richard Marlar, Ph.D. 65261

Administrative Office

Administrative Officer Lisa Meyers 65348

Chief Technologist Lisa Foster, MT (ASCP) 65330

Laboratory Information Manager/QA Coordinator Donna Taylor, MT (ASCP) 65233

Ancillary Testing/Compliance Coordinator Trenda Brown, MT (ASCP) 65243

EOC/GEMS Coordinator Donna Downard, MT (ASCP) 65254

Blood Bank/Transfusion Medicine

Medical Director Susan Weiss, M.D. 65222/65019

Supervisor Sheila Galliart, MT (ASCP) 65350/65014

Clinical Chemistry, Toxicology, Urinalysis

Supervisor Joseph Legault, MT (ASCP) 63187

Processing and Phlebotomy

Supervisor Raymond (Mike) Showalter 65327/65244

Hematology

Medical Director William F. Kern, III, M.D. 65019

Supervisor Jana Gausman, MT (ASCP) 65642

Flow Cytometry

Medical Director William F. Kern, III, M.D. 65019

Technical Consultant Linda Archer, Ph.D. 65260

Special Coagulation

Director/Technical Consultant Richard Marlar, Ph.D. 65261

Supervisor Jana Gausman, MT (ASCP) 65642

Molecular Pathology

Director/Technical Consultant Richard Marlar, Ph.D. 65261

Supervisor Michelle Vincent, MT(ASCP) 65505

Microbiology

Supervisor Uyen Tran, MT(ASCP) 65257

Department of Veterans Affairs Medical Center

Pathology and Laboratory Medicine Service (P&LMS)

Directory of Services and Policies

VAMC, Oklahoma City, Oklahoma

Evening/Night Shift

Supervisor Alan Clark, MT (ASCP) 65232

Anatomic Pathology/Cytology/Surgical Pathology

Medical Director Ravindranauth Sawh, M.D. 65338

Supervisor (Acting) Lisa Foster, MT (ASCP) 65330

Supervisor, Cytology Ravindranauth Sawh, M.D. 65338

Anatomic Pathology Clerical Staff

Office Automation/Transcription Carol Reed 65019

LaDean Navarro 65341

Ancillary Testing Laboratories

Director Ravindranauth Sawh, M.D. 65338

Technical Consultant Richard Marlar, Ph.D. 65261

Ancillary Testing Coordinator Trenda Brown, MT (ASCP) 65243

Special Hematology Catherine O’Connor, MT (ASCP) 63326/63327

Pathologists

Ravindranauth Sawh, M.D. Surgical Pathology/Cytology 65338

Barbara Shideler, M.D. Surgical Pathology/Cytology 65253

Ranjana Gottipati, M.D. Surgical Pathology/Cytology 65339

Jan V. Pitha, M.D., Ph.D. Surgical Pathology 65012

Elizabeth Gillies, M.D. Surgical Pathology 65019

Kar-Ming Fung, M.D., Ph.D. . Neuropathology 65019

William F. Kern, III, M.D. Hematopathology 65019

Bradley Gehrs, M.D. Hematopathology 65019

Susan Weiss, M.D. Transfusion Medicine 65222/65019

B. General Policies and Procedures

1. Location: Fourth Floor, Clinical Addition, Veterans Affairs Medical Center, 921 N.E. 13th Street, Oklahoma City, Oklahoma, 73104.

2. Hours and Staffing: Pathology and Laboratory Medicine Service provides services seven days week, 24-hours a day, 365 days a year as follows:

a. Full staff and services 0800 to 1600 - Monday through Friday.

b. Reduced staff and services 1600 to 0800 - Monday through Friday.

c. Reduced staff and services All hours, weekends and holidays.

3. Emergency Services:

a. CRASH tests, patients in life-threatening situations, are available 24 hours a day, 7 days a week, 365 days a year. Results of CRASH testing are reported by laboratory personnel directly to the appropriate physician or nurse. Reports are also entered in the computer as soon as completed.

CRASH tests available and target turn-around times:

Department of Veterans Affairs Medical Center

Pathology and Laboratory Medicine Service (P&LMS)

Directory of Services and Policies

VAMC, Oklahoma City, Oklahoma

BMP 45 minutes from receipt of specimen in laboratory

CBC 20 minutes from receipt of specimen in laboratory

PT/PTT 45 minutes from receipt of specimen in laboratory

b. URGENT (STAT) tests are available 24 hours a day, 7 days a week, 365 days a year. These tests are performed as quickly as staffing and methodology permit. Results of URGENT testing are available in the computer as soon as completed. In an emergency, if procedures that are not listed below are needed, consultation with a pathologist is required.

Most urgent tests will be completed within 1 hour. Due to the workload and waiting time for outpatient phlebotomy, urgent requests drawn by laboratory on outpatients will be completed as soon as possible, but likely will not be completed within the target times listed.

URGENT tests available and target turn-around times (from the time of the specimen receipt in the laboratory until the completed report is verified in the computer):

URGENT Tests with 45 minute Target TAT

CBC

URGENT Tests with 1 hour Target TAT

Acetone Alkaline Phosphatase AST ALT

Ammonia Amylase Blood Alcohol BMP

Calcium Creatinine CK Panel CPK

Fluid Cell Count Fluid Chemistry Glucose Gram Stain*

Lactate LDH Lipase Lithium

Magnesium Osmolality Phosphorous PT-INR/PTT

Total Protein Troponin I Urinalysis

*requires verbal notification of microbiology laboratory personnel, ext. 65257

Tests with 2 hour Target TAT

Aminoglycosides BNP D-Dimer Digoxin

Fibrinogen Phenytoin Phenobarbital Theophylline

Urine Drug Screen

4. Routine Services (CM 113-10, Availability of Clinical Laboratory Services)

a. All routine laboratory procedures will be performed during normal working hours (0070 to 1530).

Routine cultures should be in the laboratory no later than 1500 hours. Results on specimens for culture received after that time may be delayed by 24 hours due to insufficient incubation time.

b. Preoperative blood workup. Results of routine pre-op blood work should be available within three hours of the arrival of the specimen in the lab. Pre-op transfusion requests or type and antibody screen should be received in the lab by 1500 the day preceding surgery whenever possible. Blood bank specimens on patients scheduled for Monday surgery should be in the lab no later than noon on Sunday preceding the

Monday surgery whenever possible. Failure to comply could delay scheduled surgery if unexpected antibodies are encountered.

c. Patients undergoing cardiac catheterization as potential candidates for open heart surgery may have blood samples submitted prior to the time of cardiac catheterization for blood type and antibody

Department of Veterans Affairs Medical Center

Pathology and Laboratory Medicine Service (P&LMS)

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VAMC, Oklahoma City, Oklahoma screening. The presence of unexpected antibodies could significant delay in the availability of compatible blood and must be taken into account when scheduling patient procedures and blood work.

d. Test information including specimen collection, patient preparation, special handling, normal values, availability, and expected turnaround times is available in VISTA (Veterans Health Information

Systems and Technology Architecture) and CPRS (Computerized Patient Record System), and on the

Oklahoma City VAMC webpage.

e. Current test methods, including performance specifications, will be made available upon request to the laboratory (extension 65330) or section supervisors.

5. Blood Availability (Transfusion Service). Blood compatibility testing (crossmatching) is performed to minimize the incidence of potentially fatal hemolytic transfusion reactions and requires approximately an hour to complete. The following list gives the usual times for obtaining blood components, in order of greatest safety and longest response times. These times are determined by the technical procedures involved and cannot be reduced.

Preparation Level Component # of units Response Time

Crossmatched Packed Red Blood Cells 4 60 minutes from receipt of specimen

Type specific Packed Red Blood Cells 4 20 minutes from receipt of specimen

Type O * Packed Red Blood Cells 2 15 minutes from receipt of specimen

Platelet Single Donor (apheresis) 1 1 hour

Plasma Fresh Frozen (apheresis) 1 20 minutes

Cryoprecipitate Single Donor (apheresis) 1 20 minutes

*Universal Donor

Emergency Transfusion:

The occasional need to replace blood, to prevent exsanguination, can occur. In this situation waiting on crossmatched blood could further jeopardize the patient. Justification, in the chart, for the use of uncrossmatched or incompletely crossmatched blood should be documented. Documentation should include that the hazard of transfusing uncrossmatched or incompletely crossmatched blood is less of a risk to the patient than waiting for fully crossmatched blood.

Contact the blood bank (65350), providing them with the patients full name, full identification and date of birth. Inform them of the need for uncrossmatched blood. Send a person to the blood bank to wait for the blood. The blood bank personnel will prepare the blood* and any additional documentation for the physician to sign. Both will be sent, with the person waiting for the blood.

A blood bank specimen should be obtained and sent to blood bank (pink EDTA or red top tube, no gel) prior to starting any emergency transfusion.

*In cases of emergency transfusions, Group O, Rh Positive packed red blood cells may be given in place of Group O, Rh Negative, packed red blood cells if the patient has a negative antibody screen and if female, the woman is >50 years of age.

6. Blood Collection and Requisition Information.

a. Routine Phlebotomy Protocol.

1. Laboratory phlebotomists draw blood inpatient wards at the following scheduled times:

a. All wards, daily, starting at: morning (0500 - 0900), afternoon (1300 - 1400), evening (1930 - 2130)

Department of Veterans Affairs Medical Center

Pathology and Laboratory Medicine Service (P&LMS)

Directory of Services and Policies

VAMC, Oklahoma City, Oklahoma

b. Blood cultures, daily: 0900-2300 only.

2. All requests for routine morning ward rounds must to be ordered in the computer prior to 0430.

3. Laboratory personnel will draw blood from outpatients and ambulatory inpatients in the

Laboratory Outpatient Phlebotomy Area, room 4F-107, from 0700 to 1800 (or whenever the last clinic closes), Monday through Friday and for additional Saturday clinics.

4. Blood for crash or urgent tests should be drawn by house staff (nurses, physicians, medical students, and physician assistants).

b. Patient Identification.

All personnel collecting blood or other laboratory specimens must carefully confirm patient identity by asking the patient to state his/her full name and full Social Security number (SSN) and examining the patient's armband or photo identification card before performing the collection. Two forms of identification must be used. Use of room or bed number is not acceptable. If conditions require, the patient may be offered the opportunity to write their SSN on one of the collection tubes or a slip of paper rather than verbally repeating it.

Collection tubes must be labeled in the patient’s presence with the patient name, full social security number and laboratory order number, and initialed/timed/dated by the phlebotomist (required for

Blood Bank samples).

c. Ordering Protocol.

Laboratory tests will be performed only if ordered by a facility-approved provider of care either by electronic or written order. Tests may be added by verbal request provided there is a written/electronic order in the patient chart. When ordering tests in the computer, it is important to ensure that the work is ordered for the proper patient and that the correct sample name and collection date/time are indicated. If the computer system is down, a completed computer downtime form should be submitted with the sample. The following information should be on each electronic or written requisition:

1. Name of patient

2. Patient's full social security number

3. Name of ordering physician

4. Ward or location to which the completed report should be forwarded

5. Lab test requested

6. Collection date and time*

7. Clinical information (surgical and cytopathology samples) and sex (if pertinent)

*NOTE: If specimen is to be drawn by laboratory personnel, be sure to indicate appropriate collection time.

If a particular test is not available for ordering in the computer contact Laboratory Client Services (65277).

d. Sharing and Fee Basis Tests.

Some testing and procedures are performed outside the Oklahoma City VA Laboratory. Requests for these tests and or procedures must be made in CPRS or through Pathology and Laboratory Medicine

Service. This allows for proper arrangements for payment and performance of these tests. Requests for

Department of Veterans Affairs Medical Center

Pathology and Laboratory Medicine Service (P&LMS)

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VAMC, Oklahoma City, Oklahoma procedures not included in the sharing agreement must be purchased on a fee basis and must also be made through P&LMS. These requests, if costing over $400, may require review and approved by the concerned

Clinical Service Chief and/or a pathologist.

7. Computer System CPRS organizes and presents patient data in a manner that directly supports clinical decision-making. This data includes medical history and conditions, problems and diagnoses, diagnostic and therapeutic procedures, tests and interventions. Comprehensive information on the system capabilities can be obtained from the Computerized Patient Record System (CRPS) User Guide, v.28. If you experience difficulty accessing laboratory functions in CPRS, please call your Clinical Applications Coordinator (CAC), or laboratory staff at extension 65233 or 65330.

8. Specimen Requirements Special patient preparation information, and dates of scheduled batched testing are also available in CPRS by clicking on Tools on the top tool bar and on the OKC VAMC homepage at.

https://vaww.visn16.portal.va.gov/sites/okl/default.aspx by clicking on Service Information and then

Pathology & Laboratory Test Menu.

9. Processing of Laboratory Specimens All patient specimens received in the laboratory, whether collected by laboratory or ward personnel, will be accessioned into the computer. Clinical pathology specimens are accessioned in the central processing area (4F102), microbiology specimens are accessioned in microbiology

(4F115) and anatomic pathology specimens are accessioned in the histology (4F142). Lab personnel will log in, process, and store or distribute specimens to the proper departments for testing. Specimens requiring priority handling should be so indicated and a technologist notified.

10. Distribution of Results All results will be recorded in Vista, or a copy of the requisition/results forwarded to the ordering provider if the ordered test is not available through the computer. Laboratory results can be viewed or printed from CPRS. The computer system maintains records of all laboratory test results performed or manually entered, indefinitely.

11. Notification “Critical” Values ‘Notification’ or ‘Critical Values’ are test values are defined as, ‘results abnormal enough to require prompt medical evaluation’. These, critical test values, will be communicated as soon as possible, directly to the ordering provider. These results will also generate an automatic computer

‘view alert’ in CPRS. The following values were developed by the P&LMS and submitted to the medical staff for review and approval. They are intended as guidelines to alert the medical technologist to critical medical situations in which the provider should be notified as soon as possible. Repeat critical results on tests other than potassium and glucose may be called at the discretion of the technologist. Notification values on referred tests will also be called when instructed by the referral laboratory.

When critical results are verbally communicated the clinical staff will be asked to confirm the accuracy of the results received by reading back their recorded values. This read back is required by Joint Commission standards. The call and read back will be documented in Vista in the result comment field.

Some laboratory tests will generate a view alert, but are not considered critical and do not require verbal notification to the ordering provider.

The following values were developed by the P&LMS and submitted to the medical staff for review and approval.

NOTIFICATION (CRITICAL) VALUES

https://vaww.visn16.portal.va.gov/sites/okl/default.aspx

Department of Veterans Affairs Medical Center

Pathology and Laboratory Medicine Service (P&LMS)

Directory of Services and Policies

VAMC, Oklahoma City, Oklahoma

CHEMISTRY LESS THAN GREATER THAN

CO2 (Bicarbonate) 10 mmol/L 40 mmol/L

Calcium --- 13 mg/dL

Creatinine --- 7.5 mg/dL (excludes dialysis patients)

CSF Glucose 40 mg/dL ---

CSF Protein --- 100 mg/dL

Glucose 40 mg/dL 500 mg/dL* Perform Acetone

Ionized Calcium 0.4 mmol/L ---

Lactate --- 4.0 mmol/L

Magnesium 1.1 mg/dL 3.5 mg/dL

Osmolality (blood) 250 mOsm/kg 320 mOsm/kg

Phosphorus, Inorganic 1.0 mg/dL ---

Potassium 2.7 mmol/L 6.5 mmol/L

Sodium 120 meq/L 158 meq/L

NOTIFICATION (CRITICAL) VALUES (continued)

HEMATOLOGY LESS THAN GREATER THAN

Hemoglobin 6 g/dL 20 g/dL or 3 gm decrease in <24 hours

Hematocrit 18% 65%

WBC 1,500/cu mm

25,000/cu mm (excludes history of CLL, CML, CMML, myeloproliferative disorder)

>100,000/cm mm (excludes known CLL)

>200,000/cm mm no exclusions

Department of Veterans Affairs Medical Center

Pathology and Laboratory Medicine Service (P&LMS)

Directory of Services and Policies

VAMC, Oklahoma City, Oklahoma

Platelet Count

20.0 K/cmm (excludes patients

undergoing treatment for leukemia, lymphoma or chronic thrombocytopenia with previous

20 count)

50.0 K/cmm if prior count >150

K/cmm

1,000 K/c mm

Sterile Body Fluids --- Bacteria or yeast observed and/or malignant cells

Peripheral Smear/Differential --- Initial presence of blasts, presence of parasites

COAGULATION LESS THAN GREATER THAN

INR (no therapy) --- 4.0

INR (anticoagulation therapy) --- 6.0

PTT (no heparin) --- 80 seconds

PTT (heparin therapy) --- 130 seconds

Fibrinogen 100 mg/dL ---

TOXICOLOGY LESS THAN GREATER THAN

Acetaminophen --- 50 ug/mL

Amikacin – Peak --- 50 ug/mL

Carbamazepine --- 12 ug/mL

Cyclosporine --- 500 ng/mL

Digoxin --- 2.1 ng/mL

Ethanol, Blood --- 300 mg/dL

Ethylene glycol --- 10 mg/dL

Gentamicin - Peak --- 18 ug/mL

Lidocaine --- 7 ug/mL

Lithium --- 1.6 mmol/L

Methanol --- 10 mg/dL

Phenobarbital --- 50 ug/mL

NOTIFICATION (CRITICAL) VALUES (continued)

TOXICOLOGY LESS THAN GREATER THAN

Phenytoin --- 25 ug/mL

Primidone --- 15 ug/mL

Quinidine --- 7 ug/mL

Department of Veterans Affairs Medical Center

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Salicylate --- 300 mg/L

Theophylline --- 25 ug/mL

Tobramycin Peak --- 18 ug/mL

Tricyclics --- 500 ng/mL

Valproic Acid --- 125 ug/mL

Vancomycin Peak --- 80 ug/mL

ARTERIAL BLOOD

GASES LESS THAN GREATER THAN

pH 7.20 7.60

PCO2 20 60

PO2 50 ---

MICROBIOLOGY

Blood Culture Positive

India Ink Positive

Normally sterile

Tissues/Body Fluids Positive stain or growth on culture

Catheter Tip Cultures Significant growth (>15 colonies)

Acid Fast Bacillus Positive smears or culture

VRE Present in cultures from any source

Cryptococcal, Histo Antigen Positive

14-3-3 When test request and specimen are received.

BLOOD

BANK/TRANSFUSION

SERVICE

Any problem that may delay products requested.

Presence of unidentified antibody or positive DAT.

Results suggestive of hemolytic transfusion reaction.

CYTOPATHOLOGY and

SURGICAL PATHOLOGY

First time diagnosis of cancer and/or cancer at a new site (excluding non-melanoma skin cancers).

Significant/Unexpected findings.

High grade squamous intraepithelial lesion (HSIL) or more advanced lesions on

GYN specimens.

REFERRAL TESTING

Any critical high or low result called to OKC lab staff or provided on result printout by referral laboratory staff.

12. Criteria for Rejection of Laboratory Specimens For any specimen identified as unacceptable, the physician or nurse will be notified. If pertinent, a Mislabeled Specimen and Problem Specimen Form will be filled out and action documented. If the specimen is inadequately identified, the responsible nurse or

Department of Veterans Affairs Medical Center

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VAMC, Oklahoma City, Oklahoma physician will be asked to fill out the misidentified section of the form. If the problem is not resolved, the reasons for rejection will be recorded and the specimen discarded. Irreplaceable specimens such as CSF, body fluids, and surgical specimens will not be discarded until a full inquiry into the problem has been completed.

a. Blood specimens - reasons for rejection:

1. Unlabeled specimen with or without order number and or requisition.

2. Specimen label and order number do not match (are not on the same patient).

3. Method of specimen collection is incorrect

a. Specimen clotted

b. Wrong collection tube used

c. Wrong anticoagulant used

d. Quantity of specimen submitted is insufficient to allow for accurate testing

e. Timed tests were improperly collected

4. Air bubbles in specimens for blood gases

5. Gross hemolysis. This criterion applies only to those tests that are adversely affected by hemolysis.

A partial list follows:

a. Hematology tests: Hemoglobin, Hematocrit, Reticulocyte count

b. Coagulation tests: PT, INR, Aptt, Fibrinogen, platelet aggregation

c. Chemistry tests: Alkaline phosphatase, ALT, AST, CPK, CSF Protein, Direct bilirubin, GGT, Iron, LDH, Magnesium, Phosphorus, Potassium, Serum protein electrophoresis, Total bilirubin.

d. Serology tests: Adenovirus, ANA, anti-DNA, ASO, Blastomyces, Chlamydia, CMV, Coccidioides, Epstein-Barr virus, FTA, Herpes, Histoplasma, Mumps, Mycoplasma, Parainfluenza (1,2,3), Respiratory Syncytial Virus, RPR, Rubella, Rubeola, Toxoplasma, Varicella Zoster.

e. Blood Bank: Hemolyzed specimens should not be used for any serum testing except in the case of a transfusion reaction. Specimens with slight to moderate hemolysis may be used when a redraw is not feasible; however, hemolytic crossmatch reactions will not be detected.

f. Miscellaneous tests: ACTH, alpha 1-antitrypsin, beta 2-microglobulin, CEA, Digoxin, Ferritin, FSH, LH, Gastrin, Growth hormone, HCG, Hepatitis, Insulin panels, Prolactin, Thyroid function tests.

b. Urine specimens - reasons for rejection:

1. Unlabeled specimen with or without an order number and/or requisition.

2. Specimen label and order number do not match (are not on the same patient).

3. Improper collection/storage of special or timed tests.

4. Improper container.

c. Blood Bank specimens - reasons for rejection: (Center Memorandum 113-6, Blood Bank Policies and Procedures).

1. Unlabeled specimen with or without an order number and/or requisition.

2. Incorrect collection sample (Wrong collection tube used).

3. Requisition and/or tube do not contain the signature of the person collecting the specimen.

4. Requisition does not identify the ordering physician. Both #2 and 3 constitute a temporary rejection. The crossmatch may proceed; however, the essential information must be obtained before the blood is allowed to leave the laboratory.

5. No order.

d. Microbiology specimens - reasons for rejection:

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1. Unlabeled specimen with or without an order number and/or requisition.

2. Specimen label and order number do not match (are not on the same patient).

3. Method of specimen collection is incorrect:

a. Wrong container.

b. Insufficient quantity or quality.

c. Improper collection/storage.

4. Improper or inadequate specimen for culture.

5. Inappropriate duplicate specimens.

e. Molecular Pathology specimens – reasons for rejection:

1. Unlabeled specimen with or without an order number and/or requisition.

2. Specimen label and order number do not match (are not on the same patient).

3. Method of specimen collection is incorrect:

a. Wrong container.

b. Insufficient quantity or quality.

c. Improper collection/storage.

f. Pathology specimens (Cytology or Surgical Pathology). Because of the unusual and usually irreplaceable nature of most pathology tissue specimens, no specimen will be discarded until a full inquiry into the problem has been completed.

g. Flow Cytometry specimens - reasons for rejection:

1. Unlabeled specimen with or without an order number and/or requisition.

2. Specimen label and order number do not match (are not on the same patient).

3. Improper collection/storage of specimens (i.e., blood should never be stored in a refrigerator, whereas tissue in RPMI or saline should).

4. A blood specimen is >48 hours old.

5. An inadequate number of cells in the specimen (i.e., <500 cells per mL).

6. A clot in peripheral blood, although a bone marrow with a clot will be accepted and run with a comment subject to interpretation by the physician.

7. The number of viable cells is less than 80%.

a. Viability is tested on all lymphoma/leukemia panel specimens.

b. If a specimen is less than 80% viable, testing may be done and a diagnosis rendered.

Both are subject to the Medical Director’s discretion.

8. The scatter pattern represented by histogram fails to define any cell population, thus accurate gating cannot be assured.

h. Cytology specimens - reasons for rejection:

1. Unlabeled specimen with or without an order number and/or requisition.

2. Improper identification of specimens.

a. Name on SF515 or computer order and specimen do not match (are not on the same patient).

b. Specimen not identified with patient name and social security number or source of specimen.

3. Specimen collected into the wrong fixative or no fixative.

4. Specimens collected for some time and allowed to degenerate before submitting to laboratory.

5. Inappropriate request for examination.

13. Specimen and Labeling Policy Only properly labeled specimens will be accepted for processing and testing.

Department of Veterans Affairs Medical Center

Pathology and Laboratory Medicine Service (P&LMS)

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VAMC, Oklahoma City, Oklahoma

a. Blood Bank specimen (CM113-6, Blood bank Policies & Procedures)

1. Verification of the patient’s identity must be assured prior to obtaining the specimen. This will be accomplished by checking the inpatient wristband for name and Social Security number and by asking the patient to state his/her full name and SSN. If the patient is non-responsive, identification verification and signature of the verifier is required. Outpatients may be identified by use of a photo ID card and having the patient repeat his/her full name and SSN. The patient may elect to write their name and personal SSN on a tube or a slip of paper rather than verbally report it.

2. The individual collecting the specimen must label the specimen in the presence of the patient.

The tube must be labeled with the patients’ full name, full Social Security number, date/time of phlebotomy, and initials of the person drawing the blood. This information must be recorded on the label AT THE TIME OF VENIPUNCTURE and in the presence of the patient to avoid misidentification of specimens. They must also initial, date and time SF-518, Blood or Blood

Component Transfusion Form. This information must be recorded on the label AT THE TIME

OF VENIPUNCTURE and in the presence of the patient. To summarize:

a. Properly complete one SF-518.

b. Identify the patient by checking the wristband (or photo id) and asking him/her to repeat full name and full SSN. Compare that all are accurate and match.

c. Collect the proper specimen, a Pink EDTA tube. Label it with the patient’s name, full

SSN, date, time and initials of the person collecting the blood.

d. The person collecting the blood must now sign, date and time an SF-518 form.

3. Completed paperwork with all required signatures should accompany the specimen. In an emergency, paperwork can follow the delivery of a properly labeled specimen, but must be received and appropriately completed before blood is released for transfusion.

* If an error is made on a blood bank specimen, a new specimen MUST be drawn (no exceptions) *

b. All other laboratory specimens Patient identity and full SSN should be confirmed verbally and by checking the armband or photo id prior to specimen collection (see a.1 above). A properly labeled specimen must display at least the following information and will be accepted for testing provided all information matches:

1. First and last name

2. Full Social Security number

3. Order number

c. Once a mislabeled specimen is recognized in the lab, a Mislabeled Specimen/Variance Form should be completed. This form documents the nature of the problem, who was informed, and the action taken. If a specimen is mislabeled (incorrect patient name), the person who obtained the specimen will be required to sign the release statement on the form. If the collector is not able to complete this, the specimen will not be accepted for testing.

* No mislabeled specimen will be allowed to leave the laboratory.*

Mislabeled specimens will be held for a period not to exceed 8 hours or until the time past which test results will be invalid. Spinal fluid, miscellaneous body fluids and all histology specimens will be considered irreplaceable specimens and will not be discarded until a full inquiry into the problem has been completed.

Department of Veterans Affairs Medical Center

Pathology and Laboratory Medicine Service (P&LMS)

Directory of Services and Policies

VAMC, Oklahoma City, Oklahoma

d. Exceptions to the labeling policy. In an extreme emergency, the testing will be completed and results reported orally, as per name and identification number appearing on the specimen. No written report is to be released or entered into the computer until the standard release procedure has been carried out. An incident report will be completed if the release procedure is not followed exactly. If discrepancies on CSF specimens cannot be completed quickly, the cell count, differential, glucose, protein, and cultures must be performed as per identification on the specimen.

14. Referral Testing The Oklahoma City VA Laboratory test menu provides complete and cost-effective service for our patient population. Some tests will be referred to a reference laboratory. Most are orderable in

CPRS. If a particular test is not available for ordering in the computer contact Laboratory Client Services

(65277).

Reference laboratories will be chosen based on (in decreasing order of importance) accuracy and precision, test menu and availability, turnaround time, convenience and cost. All laboratories used will comply with

CLIA 88 regulations and will be inspected and accredited by either the College of American Pathologists or

Joint Commission.

15. Ancillary Testing Ancillary tests are defined as, ‘Laboratory testing within a VA Medical Center or its outreach functions (community based outpatient clinics) performed outside the physical facilities of the main clinical laboratory.’ All testing performed for the purposes of patient diagnosis or treatment is expected to comply with CLIA 88 regulations, including test method evaluation, procedure manuals, authorization and competence of personnel, quality control, and proficiency testing. Requests for any new point of care testing must be submitted to the Ancillary Testing Coordinator. For further information, refer to the Center

Memorandum CM 113-14, Ancillary testing Policy.