36C24419R0074-007.pdf

CLINICAL

LABORATORY &

ANATOMIC

PATHOLOGY

MANUAL

2018 – 2019

Pathology & Laboratory Medicine VA Medical Center Erie, PA 16504

Attachment E

VETERANS AFFAIRS MEDICAL CENTER

Erie, Pennsylvania

CLINICAL LABORATORY MANUAL

Pathology & Laboratory Medicine

This manual has been prepared by the staff of Pathology & Laboratory Medicine in order to apprise you of general policies and procedures for procurement of specimens and services provided by the Laboratory. No part of this manual may be altered without the consent of the Medical Director, Pathology & Laboratory Medicine.

BERNADETTE HALL, MT(ASCP)

Supervisor, Pathology & Laboratory Medicine

RITU KHERA, MD

Medical Director, Pathology & Laboratory Medicine

TABLE OF CONTENTS

PATHOLOGY & LABORATORY MEDICINE DIRECTORY

I. General Information and Services

A. Location B. People Who Care C. Services Provided D. Laboratory Hours of Operation and Staffing E. Keeping You Informed F. Accreditation G. Quality Assurance (QA) and Quality Control (QC) H. Dedication to Excellence

Clinical Laboratory II. GENERAL INFORMATION - Clinical Laboratory

A. Ordering of Laboratory Tests

1. General Information/Ordering of Laboratory Tests

2. Laboratory Test Ordering Urgency

3. Laboratory Test Ordering During Computer Down

B. Specimen Collection and Handling

1. Patient Identification Procedure

2. Specimen Collection

a. Phlebotomy General Information

b. Blood Sample That Cannot be Collected by Phlebotomist

c. Vacutainer Tubes

d. Collection of Other Samples (Urine, Sputum, Stool, Swabs)

e. Specimen Labeling

3. Patient Identification Procedure for Phlebotomy

4. Vacutainer Chart and Other Test Collection Information C. Criteria for Handling/Rejecting Unacceptable Specimens D. Turnaround Time of Test Results E. Reporting of Test Results – General Information F. Specimen Retention Guidelines G. Reference Laboratory Testing

1. Selection of Reference Laboratory

2. Reference Laboratories Currently Used

III. DEPARTMENT INFORMATION – Clinical Laboratory A. Chemistry

1. General Information

2. Test Information

3. Specimen Collection and Storage

4. Reference Ranges

5. Additional Information Attachments:

Instructions for the Chemistry Special Tests 24-Hour Urine Testing: Preservative Quick Reference Chart Instructions for 24-hour Urine Collection Glucose Tolerance Test Lactose Tolerance Test Acetone, Iron, TIBC and Alcohol

B. Special Chemistry

1. General Information

2. Test Information

3. Specimen Collection and Storage

4. Reference Ranges

C. Toxicology

1. General Information

2. Test Information

3. Specimen Collection and Handling

4. Reference Ranges

5. Additional Information

D. Hematology

1. General Information

2. Test Information

3. Specimen Collection

4. Reference Ranges

E. Coagulation

1. General Information

2. Test Information

3. Specimen Collection

4. Reference Ranges

F. Microbiology

1. General Information

2. Test Information

3. Specimen Collection and Storage

4. Additional Information

A) Rejection of Microbiology Specimens B) Quantitation of Organisms and Cells C) Sensitivity Testing

D) Turnaround Time

Attachments:

Microbiology Test List

Microbiology Test Chart

G. Urinalysis

1. General Information

2. Test Information

3. Specimen Collection and Handling

4. Reference Ranges

H. Serology

1. General Information

2. Test Information

3. Specimen Collection and Handling

4. Reference Ranges

I. Arterial Blood Gas

1. General Information

2. Test Information

3. Specimen Collection and Storage

4. Reference Ranges

J. Blood Bank

1. General Information

2. Test Information

3. Specimen Collection

4. Reference Laboratories

5. Additional Blood Bank MCMs

K. Ancillary Testing – Point of Care Testing (Waived Testing)

1. General Information

2. Approved Ancillary Tests

3. Home Testing

4. Patient Self Testing

5. Additional Ancillary Testing MCMs

IV. TESTS AND REFERENCE RANGES

Reference Range Chart

V. GENERAL INFORMATION - Anatomic Pathology

VI. SURGICAL PATHOLOGY

Specimen Submission and Handling/Procurement and Transport Criteria for Acceptance/Rejection of Tissue Specimens Instructions for Specimen Procurement:

Routine Specimens Specimens Requiring Special Handling

Breast Tissue for Estrogen and Progesterone Receptor Assay Muscle Biopsy Open Lung Biopsy Procedure Lymph Node Biopsy Testicular Biopsy for Infertility

Bone Marrow Aspiration and Biopsy Cytogenetics Studies Immunophenotyping/Flow Cytometry Studies

VII. CYTOPATHOLOGY

General Information Specimen Procurement Policy Specimen Collection and Preservation - General Information Instructions for Collection/Preparation of Specimens Instructions for Collection/Preparation of Specimens from Various Body

Sites

Gynecologic Specimens (Female Genital Tract) Non-Gynecologic Specimens

Respiratory Tract Gastrointestinal Tract Urinary Tract Body Fluids Cerebrospinal Fluid Cytology Scrapings Nipple Discharge Cytology Cyst Fluid Cytology Other Special Studies

Aspiration Cytology Specimens Criteria for Unacceptable/Unsatisfactory Cytology Specimens

VIII. AUTOPSY SERVICE

Autopsy Service Performance of Autopsy Examination Post-Mortem Reports

Provisional Anatomic Diagnosis for Post-Mortem Examination Final Post-Mortem Examination Report Turnaround Time of Post-Mortem Reports

STAFF DIRECTORY

NAME TITLE/SECTION EXTENSION

Ritu Khera, MD Medical Director x2177

Bernadette Hall, MT(ASCP) Supervisor x2178

Carol Kendra Program Support Assistant x2176

Erin Skelly, MT(ASCP) Ancillary Testing Coord./BB x2190

Lisa Miller, MT(ASCP) Lab Information Manager x2955

Clinical Laboratory

NAME DEPARTMENT EXTENSION

Destiny Belle Phlebotomy x2776

Beverly Freeman, MT(ASCP) General Laboratory x2184

Sarah Hatcher, MT(ASCP) General Laboratory x2184

Stephanie Hess Phlebotomy x2274

Joseph Kisiel, MT(ASCP) Chemistry x2182

Jared Leonardi, MT(ASCP) Intermittent Med. Technologist x2176

Filicia Menendez, MT(ASCP) Microbiology x2187

Laura Merritt, MT(ASCP) Intermittent Med. Technologist x2176

Suzanne Parker, MT(ASCP) Intermittent Med. Technologist 460-4039

Gail Patterson, MT(ASCP) Histology/Cytology x2189

Donald Vicary, MT(ASCP) 3rd shift – General Laboratory 460-4039

Mark Wagner, MT(ASCP) Hematology/Coagulation x2181

Beth Wasielewski, MT(AMT) Urinalysis/ABG x2180

Kayla Watkins Phlebotomy x2191

Kelci Yousett General Laboratory x2184

I. General Information and Services

A. Location

B. People Who Care

C. Services Provided

D. Laboratory Hours of Operation and Staffing

E. Keeping You Informed

F. Accreditation

G. Quality Assurance (QA) and Quality Control (QC)

H. Dedication to Excellence

General Information -

Index II

I. General Information and Services

The Pathology & Laboratory Medicine performs a comprehensive range of Laboratory tests with our goal being to provide accurate and timely Laboratory test results in a cost effective manner.

A. LOCATION

Pathology & Laboratory Medicine is located on the first floor, east wing, E1-1A.

B. PEOPLE WHO CARE

The Laboratory is directed by a Pathologist and staffed by qualified Medical Technologists and support staff who are committed to provide the highest level of quality and service. The staff has broad based knowledge and technical expertise to assist with information regarding significance of test results, unusual cases, and technical matters.

C. SERVICES PROVIDED

Pathology & Laboratory Medicine provides Clinical and Anatomic Services.

The Clinical laboratory offers a wide variety of testing being performed with sufficient rapidity to support emergency, inpatient acute care, outpatient services, outreach clinics and long-term health care monitoring. The departments in the Clinical Laboratory include Chemistry, Special Chemistry, Therapeutic Drug Monitoring, Hematology, Coagulation, Blood Bank, Microbiology, Serology/Immunology, Urinalysis, and Blood Gases. Each department provides a comprehensive menu of testing.

Anatomic Pathology includes surgical pathology, intra-operative consultation, cytopathology, and post-mortem examination.

Ancillary Testing Program Services includes establishing policies, standards, operation, quality management and medical appropriateness for all bedside laboratory testing within the Medical Center and its outreach functions.

D. LABORATORY HOURS OF OPERATION AND STAFFING

Laboratory technical coverage is available 24 hours per day, assuring adequate coverage to meet the demands of the inpatient and outpatient services provided. The hours of operation are as follows:

1. Clinical Laboratory

Laboratory Testing………………………….Technologist on-site 24 hours every day

Outpatient Phlebotomy……………………...Mon - Fri 6:30am – 5pm, CLOSED Holidays

2. Anatomic Pathology

Weekdays (Monday - Friday) Surgical Pathology, Cytopathology, and Autopsy Pathology

On weekends and holidays, autopsy services are also available, if necessary.

E. KEEPING YOU INFORMED

The Laboratory will provide you with up-to-date information regarding current developments, new in-house tests, and any changes in test procedures.

F. ACCREDITATION

Pathology & Laboratory Medicine is accredited by Joint Commission and the Food and Drug Administration (FDA).

G. QUALITY ASSURANCE (QA) AND QUALITY CONTROL (QC)

Quality Assurance (QA) and Quality Control (QC) are an integral part of daily operation. The internal and external proficiencies are utilized to monitor the accuracy and precision of each patient run for every assay performed.

Laboratory Standard Operating Procedures (SOP’s) have been written to include when to repeat testing to assure that reported test values are accurate and precise.

H. DEDICATION TO EXCELLENCE

The Laboratory has state of the art, automated and computerized equipment and an efficient and motivated workforce to provide services that are of high quality and customer focused.

II. General Information -

A. Ordering of Laboratory Tests

2. Laboratory Test Ordering Urgency

3. Laboratory Test Ordering During Computer Down

B. Specimen Collection and Handling

1. Patient Identification

2. Specimen Collection

- Phlebotomy General Information

- Blood Sample that Cannot be Obtained by

Phlebotomist

- Vacutainer Tubes

- Collection of Other Samples (Urine, Sputum, Stool and Swabs)

3. Patient Identification Procedure During Phlebotomy

4. Vacutainer Chart & Other Test Collection Information

C. Criteria for Handling/Rejecting Unacceptable Specimens

D. Turnaround Time of Test Results

E. Reporting of Test Results

F. Specimen Retention Guidelines

G. Reference Lab Testing

1. Selection of Reference Laboratory

2. Reference Laboratories Currently Used

CLINICAL LABORATORY

Laboratory tests contribute vital information about a patient’s health. Correct diagnostic and therapeutic decisions rely, in part, on accuracy of test results. Adequate patient preparation, specimen collection, and specimen handling are essential prerequisites for accurate testing. The accuracy of test results depends on integrity of specimens.

This section provides information on the following:

A. Ordering of Laboratory Test(s) B. Specimen Collection and Handling C. Criteria for Handling/Rejecting Unacceptable Specimen(s) D. Turnaround Time of Test Results E. Reporting of Test Results F. Specimen Retention G. Reference Laboratory Testing

A. ORDERING OF LABORATORY TESTS

1. ORDERS - GENERAL INFORMATION

a. “Electronic” test(s) requests:

All requests for Clinical Laboratory tests are made electronically into the CPRS computer system by authorized healthcare providers. The Laboratory personnel are not authorized to place orders for Laboratory testing except under situations such as:

- Lab test orders that are cancelled and are required to be recollected.

- Reflex testing as designated per policy.

- During direct consultation with ordering provider who will electronically sign

- During emergency situations (e.g., Cardiac Alert or Surgery)

The following requests for testing should be phoned to the Laboratory in addition to electronically ordered:

- STAT test requests

- “Immediate Collect” orders

- Blood culture requests

Blood Bank testing – the physician CPRS order designating desired testing, type and quantity of product(s).

Special Procedure(s) requests: The following tests should be scheduled with the Laboratory.

- Glucose and Lactose tolerance tests – Chemistry (x2182)

- Bone marrow procedures – Histology (x2184)

- Therapeutic phlebotomies – Blood Bank (x2190 or x2184)

HIV testing is considered routine testing and no longer will require a written consent

(documented verbal patient consent only). Laboratory service staff will not request, require or verify consent per VHA Directive 1113 dated May 5, 2015.

b. Verbal/telephone test requests:

Telephoned or verbal orders for laboratory tests are not authorized except in emergency situations. Providers are required to enter the order into CPRS and then contact the lab to have the lab test collected or completed using previously drawn specimens.

In the event of an emergency request, the P&LM staff taking the verbal or telephone order for laboratory tests should write down the patient’s full name/identification and complete order or enter it into the computer as a “verbal” or “telephoned” order to prompt physician signature. The order should be read back to the provider to ensure accuracy. The P&LM will document in VistA under comment section for patient test accession number that “read back was performed for the test order.”

c. The Laboratory test order must be accurate and include the following information:

Patient’s full name and full social security number Test(s) required

Type of material to be analyzed (e.g., blood, urine, cerebrospinal fluid, etc.)

Ordering provider Date, and when relevant, time of specimen collection Any special handling required.

NOTE: The correct information is of paramount importance. Incorrect or incomplete information causes unnecessary delays, as all discrepancies must be resolved prior to processing the specimens.

2. LABORATORY TEST ORDERING URGENCY

An urgency status is defined as the priority given to each laboratory test that will indicate how quickly Laboratory personnel must perform that test.

The urgencies for the Laboratory tests are as follows:

Test Ordering Urgency

Definition Turnaround Time (TAT)

STAT The “STAT” as applied to Laboratory test requests means a request for information that has immediate implications for patient care.

The key elements of the definition are:

* Patient’s condition requires immediate action

* Results of the test are required before a decision about the type of action to be taken can be made The category should be confined to life threatening situations.

One (1) hour for most tests.

List of approved tests on STAT list is attached.

IMMEDIATE

COLLECT

“Immediate collect” applies to test requests that need to be collected at a specific time or right away, other than normal inpatient rounds.

* The lab needs to be called/ notified and an order needs completed.

* Immediate collect may also be used for outpatients; however, it would not be the recommended choice.

This ordering urgency should be used for special circumstances to include timed specimen collection for urgent care patients, drug/stimulation testing or serial cardiac monitoring.

Up to two (2) hours.

ROUTINE The “routine” category includes test request(s) that are required for routine treatment/follow-up of patients.

NOTE: If no urgency is given, the order will be entered as “routine”.

Dependent on test complexity

PRE-OP The “pre-op” status applies to pre-operative laboratory work-up for an elective surgery.

NOTE: Any delay in writing the order will not be considered enough justification to place it in the “STAT” category.

One (1) to two (2) hours

PATIENT

WAITING

The “patient waiting” category applies to outpatients who are waiting for the test results.

The tests will be performed ASAP.

Two (2) hours for routine tests

3. LABORATORY TEST ORDERING DURING COMPUTER DOWN

In the event of a scheduled computer downtime or failure, the following procedure should be implemented. Evaluate how widespread the outage is first – can another area’s rollabout or contingency computer be deployed?

PHLEBOTOMY:

INPATIENT:

1. If phlebotomy collection rounds are pending:

A. Contact all inpatient locations for identification of patients needing phlebotomy.

B. Request that the attached Laboratory Request Form (Computer Back-Up Sheet) be filled out for each patient with pending blood work. These sheets will be kept at the nurses’ station until the phlebotomist arrives. The phlebotomist will use these sheets to properly identify the patients and tests required.

-OR-

Provide specific, written details pertaining to previously-entered order.

C. Specimens will be hand-labeled with patient’s full name, full social security number, date and time of draw and phlebotomists’ initials in the presence of the patient.

NOTE: All nursing locations should routinely print a list of lab orders to be collected each morning to assist with scheduled and unscheduled computer downtimes.

OUTPATIENT:

1. Patients with existing lab order number:

A. Contact patient’s originating PACT team to obtain desired lab test(s).

B. Fill out Laboratory Request Form (Computer Back-Up Sheet) with appropriate test requests, lab order number and complete patient identification.

C. Obtain specimen and label with patient’s full name, full social security number, date and time of draw and phlebotomists’ initials in the presence of the patient.

2. Patients with Laboratory Request Form (Computer Back-Up Sheet):

A. Obtain specimen and label with patient’s full name, full social security number, date and time of draw and phlebotomists’ initials in the presence of the patient.

Save all Lab Request Forms with ward collection sheets. Deliver specimens to appropriate lab departments.

*When using the manual “computer back up” form for test requests, complete the following information on the Lab Request Forms:

1. Date of test

2. Patient’s full name

3. Patient’s full social security number

4. Provider ordering the test(s)

5. Laboratory test(s) requested

6. Request Date

7. Collection time/date

8. Person collecting the specimen

For further information, see department specific computer downtime procedures in the Computer Downtime Manual.

LABORATORY REQUEST FORM

(Computer Back-up Sheet)

TEST DATE: ________________ ROUTINE TESTING UNLESS INDICATED

Laboratory Tests:

HEMATOLOGY CHEMISTRY

_____ CBC & DIFF □ STAT _____ Glucose □ STAT _____ HGB & HCT □ STAT _____ Lipid Profile _____ ESR (Westergren/Sed Rate) _____ Liver Profile □ STAT _____ Retic Count _____ Chem 8 □ Fasting □ Nonfasting □ STAT _____ Other _____ Chem 14 □ Fasting □ Nonfasting □ STAT COAGULATION _____ Cardiac Profile □ STAT _____ PTT □ STAT (CPK/CK-MB, Troponin) _____ ProTime □ STAT _____ Troponin-I □ STAT _____ Other _______________________ _____ Magnesium □ STAT _____ Lipase □ STAT _____ Amylase □ STAT SEROLOGY _____ Calcium □ STAT _____ RPR _____ Other ________________________

_____ RA

_____ Other _______________________ THERAPEUTIC DRUGS _____ Digoxin (monitor/random) □ STAT URINALYSIS _____ Theophylline (monitor/random) □ STAT _____ Routine □ STAT _____ Dilantin □ STAT _____ Phenobarbital □ STAT MICROBIOLOGY _____ Valproic Acid □ STAT _____ Culture & Sensitivity _____ Lithium (sent out) □ STAT Site: ___________________________ _____ Other _______________________ _____Other_______________________ _____ Vancomycin PEAK time ____________

_____ Vancomycin TROUGH time _________ BLOOD BANK _____ Gentamycin PEAK time _____________ _____Specific Testing_______________ _____ Gentamycin TROUGH time __________ _____Product/Quantity_______________ _____ Tobramycin PEAK time _____________

MISCELLANEOUS _____ Tobramycin TROUGH time __________ _____ Test: ________________________ _____ Other__________PEAK time _________ _____ Test: ________________________ _____ Other __________ TROUGH time_____ _____ Dose to be given at _________ over UNIT: ___________________________ __________ hours.

Patient ID Stamp: DOCTOR: ________________________________

REQUEST DATE: _________________________

COLLECTION TIME: ______________________

COLLECTION DATE: ______________________

COLLECTED BY: _________________________

Revised 11/30/17

B. SPECIMEN COLLECTION AND HANDLING

An adequate specimen properly timed, collected, identified, preserved and stored is critical in achieving an accurate test result.

1. Patient Identification

Accurate patient identification, specimen labeling and maintaining the integrity of identification from specimen collection to accessioning within the Laboratory is essential. Each section of the Laboratory will maintain the identity of each specimen throughout all phases of testing and reporting of test results. For complete identification procedure, refer to “Patient Identification for Phlebotomy.”

2. Specimen Collection

All specimens will be collected using proper collection technique and appropriate specimen requirements for the test(s) requested.

PHLEBOTOMY SERVICES - GENERAL INFORMATION

The Laboratory provides phlebotomy service for all inpatients and outpatients. The phlebotomist will routinely perform venipunctures on the hand and arm. Phlebotomies in the foot can be performed with provider permission. Nursing personnel or physicians may draw blood specimens from in-line catheters.

Arterial blood draws are performed by Respiratory Therapy staff or physicians only.

a. Service Hours

Outpatients:

Phlebotomy service will be provided to outpatients in the Laboratory phlebotomy area from 6:30 a.m. to 5:00 p.m. Monday through Friday. Laboratory personnel are available for phlebotomy on the weekends and holidays for STAT and critical timed tests and for patients seen during extended clinic hours.

Inpatients:

An electronic order must be placed by the provider, or other authorized personnel, prior to scheduled phlebotomy rounds.

Pathology & Laboratory Medicine will routinely perform inpatient phlebotomy rounds at the following times:

Timing for Phlebotomy Rounds

6:00 AM

10:30 AM

3:00 PM

6:00 PM

8:30 PM

STAT, timed and Immediate Collect specimens will be collected as ordered. STAT requests should be limited to life threatening situations.

b. Blood Sample That Cannot Be Obtained by Phlebotomist

Pathology & Laboratory Medicine will make two (2) attempts to draw a blood specimen on a patient.

The phlebotomist will not attempt more than two (2) venipunctures on the same patient. After two attempts, an alternate phlebotomist will be requested to draw the patient. If the alternate phlebotomist is unable to obtain the specimen, the attending physician will be contacted for further direction.

c. Vacutainer Tubes

All Laboratory tests require different Vacutainer tubes containing anticoagulants and preservatives. For information, refer to “Vacutainer Chart & Other Test Collection Information.” For any Laboratory test(s) not listed or requiring special collection procedures, and/or special transportation, call the specific Laboratory section.

d. Other Specimens (Urine, Sputum, Stool and Swabs)

Prior to each collection, review the laboratory’s specimen requirements, including proper specimen to be collected, the amount, the procedure, collection materials, and the handling requirements.

Preparing the patient: Provide the patient in advance with appropriate collection and instructions when necessary. NOTE: Some 24-hour urine specimen containers may contain hazardous chemicals such as hydrochloric or boric acid. Collection containers containing these preservatives will be labeled accordingly in order to inform the patient of its content.

The specimens should be delivered to the Laboratory as soon as possible after collection.

e. Specimen Labeling

All specimens collected by Laboratory and hospital personnel must be labeled in the presence of the patient in accordance with hospital policy and contain the following information:

Patient’s full name and full social security number Date and time (if applicable) collected Initials of person collecting the specimen

“AVOID COMMON ERRORS DURING SPECIMEN COLLECTION”

Careful attention to routine procedures can eliminate most of the errors. The complete blood collection system and other collection materials provided by the Laboratory can maintain the integrity of the specimens only when they are used in strict accordance with the instructions provided.

Types of errors include:

Failure to label a specimen correctly and to provide all pertinent information Insufficient quantity of specimen to run test or QNS (quantity not sufficient) Failure to use the correct container or appropriate specimen preservation Inaccurate and incomplete patient instructions prior to collection Failure to tighten specimen container lids resulting in leakage and/or contamination of container

NOTE: Refer to the Specimen Rejection section of the General Lab Manual for detailed criteria for acceptance/rejection of Laboratory specimens

3. Patient Identification Procedure for Phlebotomy

Patient Safety Goal: Improve the accuracy of patient identification. NOTE: Properly identifying the patient is the most critical aspect of specimen collection.

Phlebotomy Recommendations Approved Patient Identifiers

Outpatient/ Inpatient Phlebotomy

Require two (2) approved patient identifiers (neither to be the patient’s location).

Patient(s) who can communicate adequately.

Active participation with patient stating two of the verbal identifiers (full name and SSN, DOB [optional]). The other identifiers are VA Identification Card, Driver’s License or their Patient Identification Band as necessary.

Patient(s) who cannot communicate.

Identifiers would include: VA Identification Card, Driver’s License or Patient Identification Band. The healthcare worker, family member or attendant could participate in the identification process.

Patient(s) in Emergency Room who are unresponsive. The attendant, family member or healthcare worker could participate in the identification process: NOTE: In case a temporary name and medical record number are assigned, these identifiers could be used to identify the patient and match against specimen labels.

NOTE: The patient’s identity should be re-established if the Phlebotomist leaves the patient’s location prior to initiating the phlebotomy.

Approved Patient Identifiers:

Patient’s Full Name Patient’s entire Social

Security Number Patient’s Date of

Birth Patient’s VA

Identification Card or Driver’s License

Patient’s Identification Band

Specimen Labeling

DO NOT pre-label tubes because this may cause patient specimen mix up.

Use preprinted computer-generated label or pen/marker for labeling tubes.

Use two (2) patient identifiers to label blood and other specimen collection tubes/containers in the presence of the patient.

Blood Bank Phlebotomy Specimens

In addition to the above guidelines for Blood Bank specimens:

Venipuncture: For Blood Bank specimens, phlebotomy will be performed only on one patient at a time to minimize the risk of error.

Specimen Labeling: Label the sample tube at patient’s bedside immediately after blood sample has been taken. The sample tube must be labeled with the minimum patient information of:

Patient’s Full Name (Last, First, Middle) Patient’s Social Security Number Date/time of collection Signature or initials of the person drawing the sample (or employee ID, code) Signature of the healthcare provider witnessing the patient identification and blood sample collection on

VBECS order.

(NOTE: Healthcare providers include nursing staff, CRNA, nurse practitioners, physicians and second

Laboratory medical technologist.)

4. Vacutainer Chart and Other Test Collection Information for Common Tests

NOTE: Minimum sample volumes are provided to minimize unnecessarily large blood draw volumes.

Questions or concerns about minimum blood volumes or turnaround times may be answered by contacting the appropriate Laboratory section or reference laboratory.

IN-HOUSE TESTS

Tube Turnaround Time (*offered as STAT with TAT ≤ 1 hour) Test Minimum

Sample Volume

Gold top with gel separator OR Red top/Silicone coated/no additive 10 ml/7 ml

* Daily Acetone 2 ml Daily Albumin

* Daily Alcohol (no alcohol cleanser on arm)

Daily Alk. Phos. Isoenzymes Daily Alkaline Phosphatase Daily ALT (SGTP)

* Daily Amylase Daily AST (SGOT)

* Daily Beta hCG Daily B12

* Daily Bicarbonate (CO2) Daily Bilirubin, Direct Daily Bilirubin, Total

* Daily BUN

* Daily Calcium Daily Chem 14

* Daily Chem 8

* Daily Chloride Daily Cholesterol

* Daily CPK

* Daily Creatinine Daily Ferritin Daily Folate Daily Free T4 Daily GGT

* Daily Glucose Daily HDL Daily Iron

* Daily LDH Daily LDL Cholesterol (calculated)

* Daily Lipase Daily Lipid Profile

* Daily Liver Profile

* Daily Magnesium Daily Osmolality, calculated Daily Phosphorus

* Daily Potassium

* Daily Pregnancy Daily PSA

* Daily Sodium Daily TIBC Daily Total Protein Daily Triglycerides Daily TSH Daily Uric Acid Daily Vitamin D

Tube Turnaround Time

(*offered as STAT with TAT ≤ 1 hour)

Test Minimum Sample Volume

Pink Top K2 EDTA * Daily Blood Bank Specimens 4 ml 2 hrs Direct Coombs

Red top Silicone coated/no additive

* Daily Digoxin 2 ml

* Daily Vancomycin

* Daily Phenobarbital

* Daily Theophylline

* Daily Phenytoin (Dilantin)

Lavender 5 ml

EDTA

* Daily CBC/Diff 2-4 hrs Eluate Daily HBA1C (Glycated HGB)

* Daily Platelet Count Daily Reticulocyte Daily Sed Rate 1.5 ml

Blue 3.2% Sodium Citrate

4.5 ml

* Daily PT/INR Tube filled to line

* Daily PTT

Dark Green Top Lithium Heparin 4 ml

Light Green Top PST gel Li Hep 4 ml

* Daily CK-MB Tube 2/3 Full

* Daily Troponin

NOTE: *** Cardiac Profile: (1) Light Green Top and (1) Gold Top

Vacutainer Tubes to be used with Urine Collection System Cup:

Tube Turnaround Time (*offered as STAT with

TAT ≤ 1 hour)

Test Minimum Sample Volume

Red/Yellow Speckled Top Conical 8 mL UA preservative

* Daily Urinalysis 4 ml

* Daily Urinalysis with Reflex

* Daily Diabetic Urinalysis

Gray Top 4 mL Urine C&S preservative

2 days Urinalysis with Reflex Urine C&S

2 ml

Clear Top 6 ml No Additive

* Daily Diabetic Urinalysis Microalbumin/Creatinine Ratio

6 ml

Yellow Top 10 ml UA No Additive

* Daily Urine Drug screen 10 ml

NOTE: ***Urinalysis with Reflex: collect Red/Yellow speckled & gray top Diabetic Urinalysis: collect Red/Yellow speckled and clear top

OTHER IN-HOUSE TESTS

Test Turnaround Time (*offered as STAT with

TAT ≤ 1 hr)

Collection Device Specimen Volume

Manual Differential (Peripheral Blood Smear)

2-4 hrs Microscope Slide 1 drop of capillary blood from

EDTA

tube

Blood Gas * 15 min Heparinized syringe – drawn by RTs or physician only

1 ml arterial blood

Fecal Immunochemical Testing

3 days Special FIT test device

Minute amount of stool

Culture and Sensitivity OR Other Microbiology Tests

2 days Sterile culture swab OR Other sterile collecting device and/or media

Refer to Microbiology Dept. section in General Lab Manual

MRSA

* Daily Red top culturette Refer to Microbiology Dept. section in General Lab

Blood Culture

5 days 1 bottle Bactec Plus Aerobic/F, 1 bottle Bactec Lytic/10 Anaerobic/F (8-10 mL whole blood per bottle)

Refer to Microbiology Dept. section in General Lab Manual

INFLUENZA A and B Antigen, PCR

* Daily Nasopharyngeal Collection Device

Refer to Microbiology Dept. section in General Lab Manual

Surgical Pathology/Cytology Tests

Daily/Weekly Refer to appropriate section in General Lab Manual

Refer to appropriate section in

General Lab

C. SPECIMEN REJECTION CRITERIA AND SUBOPTIMAL TEST REQUESTS

The criteria for accepting or rejecting laboratory specimens for analysis to limit the number of pre-analytical variables in testing and ultimately to ensure an uncompromised reliable sample for testing. The following are the criteria for acceptance/rejection of specimens for Laboratory testing;

1. Incorrect/Inadequate Specimen Identification:

The Laboratory personnel will not assume the responsibility for identification of unlabeled specimens. All specimens not properly labeled with full patient name and full patient social security number will not be processed until positive patient identification is made by the collector. If identification cannot be secured, the specimen will be rejected.

Specimen cups must have the identification label affixed to the side of the specimen container, not the lid.

Each individual specimen container (tube, cup, swab, etc.) must be properly labeled.

2. Inadequate Volume (QNS):

Certain minimum volumes are required for test analysis. Also, the amount of additive placed into a tube is intended for a defined volume of blood. If less blood is drawn, the excess additive has the potential to adversely affect the Laboratory results. The following criteria will apply for the rejection of "short draw" samples when the optimum volume is difficult to obtain:

Blood Bank specimens not containing at least 5 ml of blood will be rejected.

Coagulation specimens (drawn in blue sodium citrate tubes) must show 90% or greater expected fill or they will be rejected. FSP (Fibrinogen Split Products ) tubes must contain 1- 2 ml of blood. This tube cannot be overfilled and is obtained from the Coagulation depart-ment.

Hematology specimens must contain at least 1 ml of blood.

Urine specimens for routine Urinalysis must contain at least 1.5 ml of urine or they will not be accepted for analysis.

Please refer to specific test procedures for additional sample requirement information.

3. Hemolyzed Specimens:

Hemolysis can result from a difficult venipuncture or from improper handling of specimens. Hemolysis can also occur within the patient as a result of intravascular erythrocyte destruction caused by a disease state. Certain tests will be inaccurate when the specimen is "moderately" hemolyzed in vitro. The presence of a visible red pigmentation also interferes with spectrophotometric analysis and interpretation of blood banking procedures. Therefore:

Blood Bank specimens that are hemolyzed will be rejected.

Chemistry determination (especially LDH, K+, AST, ALT, and Iron) showing moderate to gross hemolysis will be rejected.

Specimens exhibiting slight hemolysis will be accepted for analysis. Results will be entered with a comment reflecting the presence of slight hemolysis.

4. Clotted Specimens:

EDTA (Lavender) and sodium citrate (Blue) tubes for Hematology and Coagulation that arrive in a clotted condition will be rejected.

5. Delays or Error in Transport:

Specimens must be transported in as short a time as possible. Unopened specimens for coagulation studies can remain uncentrifuged for up to 24 hours.

Tubes of blood are to be kept stoppered at all times and be transported in a vertical position when possible. Specimens requiring special transport include but are not limited to:

Ammonia-- Placed on wet ice and transported to lab immediately.

ACTH-- Draw into chilled lavender top (EDTA). Transport on wet ice, separate and freeze plasma.

Alcohol-- Arm must not be prepped with alcohol.

Blood cultures--Require special preparation to ensure a sterile venipuncture.

Fibrinogen Degradation (Split) Products: Use special tubes kept in Send Out refrigerator.

Carotene-- Draw serum; protect from light.

Further instructions can be obtained from the appropriate Laboratory department.

All samples arriving in the Laboratory not meeting specific sample transport requirements will be rejected.

6. Improper Collection:

Wrong collection tube: specific specimen requirements must be considered as indicated in the test chart section of the General Laboratory manual. In particular, tubes with additives cannot be used indiscriminately. An additive can interfere with the analyte to be determined.

EXAMPLE: (1) Sodium Fluoride interferes in BUN testing (urease method)

(2) Plasma collected when serum is needed (Amylase)

Specimens arriving in the wrong collection tube will be rejected. Notification of specimen rejection will be made to the collecting location.

24 hour Urine: Improper collection of 24 hour urine specimens, i.e., wrong preservative, wrong timing, wrong pH, and lack of patient information regarding volume, height, weight, will be rejected. Date and time period of collection must be noted.

7. Gross Contamination/Unsafe Submission of Specimens:

Specimens arriving in the Laboratory in an unsanitary condition will be discarded and a second specimen requested. Laboratory staff will notify appropriate collecting location when recollection is necessary.

EXAMPLE: (1) Gross contamination of the outside of the container with the specimen.

(2) Leakage of specimen from the container.

Specimens that arrive with needles attached will be returned to the collecting location for proper submission or recollection.

2. PROCEDURES FOR HANDLING SUBOPTIMAL TEST REQUESTS AND SPECIMENS

For detailed procedures for Handling of Suboptimal (Unsatisfactory) Test Requests and Specimens, refer to Pathology & Laboratory Medicine Operations Policy HANDLING OF SUBOPTIMAL

(UNSATISFACTORY) TEST REQUESTS AND SPECIMENS.

D. TURNAROUND TIME OF LABORATORY TESTS

The turnaround time (TAT) of Laboratory tests is the interval between specimen receipt in the Laboratory and reporting of test results. The TAT of each test depends on the urgency requested, complexity and testing location (in-house versus reference laboratory testing).

The TAT of routine in-house testing is defined in each section of Laboratory and updated as necessary.

The TAT of STAT in-house testing is defined in MCM 113-04 Laboratory Critical Test (STAT Testing).

The TAT for tests sent to reference laboratories is listed in the section “Reference Testing.”

Notification of Providers When Testing is Delayed: When unexpected delays in test resulting occurs due to situations such as computer down or instrument malfunction, providers will be notified based on the following criteria:

Delay in Testing Notification Procedure STAT Testing (TAT >1 hour)

Providers notified by section technologist of the reason for the delay. The STAT testing may be sent to local reference laboratory as necessary.

Routine Testing (instrument malfunctioning or computer down-time)

Notification of all providers via computer email or telephone by the Supervisor, P&LM or designee. The Supervisor, P&LM/Medical Director, P&LM, will make the decision to send specimens to reference laboratory depending upon the reason and expected length of delay.

TURNAROUND TIME OF ROUTINE IN-HOUSE LABORATORY TESTS

Tests Turnaround Time Chemistry

Chem 8 Chem 14

2-4 hours

Special Chemistry/Toxicology Troponin

60 minutes

Hematology

CBC

2-3 hours

Coagulation 2-3 hours Urinalysis 2-3 hours Microbiology 2-3 days Blood Bank 1-2 hours Serology 1-2 hours

E. REPORTING OF TEST RESULTS

1. GENERAL INFORMATION

The Clinical Laboratory test results are entered into the patient’s electronic record via the VistA computer system following verification. STAT test results will be reported as specified in MCM 113-04 Laboratory Critical Test (STAT Testing). Critical values will be called to patient’s healthcare provider and documented as specified in MCM 113-05 Communication of Critical Values for Laboratory Tests.

2. REPORTS: All Laboratory results will have adequate pertinent information and are available via the VistA/CPRS computer system (electronic record), which can be accessed by all appropriately privileged providers.

a. Interim Reports:

The interim reports are printed immediately at all inpatient and outpatient ordering locations after verification of the test results. The providers may also access all interim reports in the patient’s VistA and CPRS chart. The interim reports should not be charted.

b. Cumulative Reports:

The cumulative summary reports are no longer printed and distributed. Cumulative reports are found in CPRS under the Laboratory Section, which can be accessed by all privileged providers.

c. Anatomic Pathology Reports The tissue and cytology reports are entered into the patient’s electronic record

d. Reference Lab Reports The copies of all reference laboratory test results are retained in the Laboratory. All reference laboratory test results are entered into VistA upon receipt without alterations that would affect clinical interpretation. Exceptions to this would be complex test results, such as electrophoresis. These more complex reports are scanned into VistA Imaging. These results have a comment attached stating “SEE SEPARATE REPORT IN VISTA IMAGING” to indicate original test results appear on the patient chart.

e. Pending Lab Results

All inquiries concerning pending in-house Laboratory test results should be directed to the specific sections of the Laboratory.

3. CORRECTION OF ERRONEOUS RESULTS:

The Laboratory technical staff discovering the error is responsible for communicating the error to the Supervisor, P&LM or designee.

The error should be IMMEDIATELY communicated to the healthcare provider responsible for the patient.

The error should be corrected in the patient’s report as “corrected result.”

All errors, including major and minor errors, will be documented in P&LM as a part of Performance

Improvement activity with investigation of results and corrective action taken.

F. SPECIMEN RETENTION

SPECIMEN RETENTION CHART

Specimens are retained for a clinically acceptable period as defined below:

Specimen Type Retention Time Storage Requirements Chemistry 48 hours Chemistry refrigerator Special Chemistry Toxicology Serology

48 hours Chemistry refrigerator

Hematology CBC’s Peripheral Blood

Smears/Body Fluid Smears

48 hours 2 weeks

Hematology refrigerator Room temp

Coagulation 48 hours Room temperature Urinalysis 24 hours Room temperature Body Fluids 48 hours Room temp/refrigerate Hepatitis C (purple pearl) 1 month Chemistry freezer Urine Drug Screens 1 month Chemistry refrigerator Blood Bank 2 weeks Blood bank refrigerator Blood Gas 48 hours Room temperature Microbiology Culture plates Permanently Stained

Microbiology Slides (e.g., gram, trichrome, etc.)

+ Blood Culture

1 week 1 month

1 month

Room temperature in Microbiology section

Histology Gross Specimens

Paraffin Blocks Microscopic Slides

2 weeks after reporting

10 years 25 years

Room temp in preservative Room temp in morgue Room temp in morgue

Cytology CSF/Body Fluids Urine Cell Blocks Microscopic slides

48 hours 24 hours 10 years 25 years

Refrigerate Room temperature

Reference: National Enforcement Office Operations Manual, Record Retention Guidelines, v.2.2, 2015

G. REFERENCE TESTING – CLINICAL LABORATORY

The tests that cannot be performed in-house are sent to fully accredited (CLIA 88 certified) reference laboratories.

1. SELECTION OF REFERENCE LABORATORY:

The reference laboratory(ies) are selected for VISN 4 based on evaluation criteria which focuses on quality, turnaround time and customer satisfaction.

The selected reference laboratories are approved by the Medical Executive Council.

2. REFERENCE LABORATORIES CURRENTLY BEING USED

Non-VA/VA Reference Laboratories

Reference Laboratories Type of Tests Sent

Turnaround Time

Non-VA Reference Laboratories

Laboratory Corporation of America, Columbus, Ohio

Used for esoteric send out tests that cannot be performed in-house or by another VAMC

One (1) to two (2) days for routine specimens

One (1) to five (5) days for special routine tests, e.g.

5HIAA, ACTH.

ACL/Quest Erie, PA

STAT tests not done in-house

CSF/Body fluids Back up for instrument malfunction

2-3 hours for STATs

VA Reference Laboratories

VAMC Pittsburgh Routine tests with TATs >24 hours.

HIV

HCV RNA-PCR

HIV RNA, viral load CD4-CD8 Subset

Pap Smears

2-3 days, usually

2-3 weeks

3-10 days

VAMC Kentucky Mycoplasma Epstein Barr Farmers lung panel Toxoplasma Herpes Simplex Ag

Titer HCV Genotyping

1-2 weeks

VAMC Philadelphia, PA Vitamin D Testing

2-3 days

VAMC Baltimore, MD Depleted Uranium Toxic Embedded

Fragments

90 days

III. Department Information

CLINICAL LABORATORY

A. Chemistry

B. Special Chemistry

C. Toxicology

D. Hematology

E. Coagulation

F. Microbiology

G. Urinalysis

H. Serology

I. Arterial Blood Gas

J. Blood Bank

K. Ancillary Testing (Point of Care Testing – Waived Testing)

A. CHEMISTRY

2. Test Information

3. Specimen Collection and Storage

4. Reference Ranges

5. Additional Information

Attachments:

Instructions for the Chemistry Special Tests

A. CHEMISTRY

a. In-house Automated Tests: All automated chemistry procedures are performed during normal duty hours.

b. Reference Laboratories: Tests not performed in-house may be sent to Laboratory Corporation of America, Associated Clinical Laboratories or another VAMC for testing if approved by the Chief, Pathology & Laboratory Medicine Service. It may take a week or more to receive results for these tests.

Contact the Laboratory at x2184 for turnaround times of specimens sent to a Reference Lab.

c. All body fluid testing in chemistry is sent to a local reference lab for testing.

2. TEST INFORMATION

a. STAT TESTS: The following tests are available on a STAT basis (24 hours a day, 7 days a week).

The turnaround time is approximately one (1) hour:

Chem 8

Chem 14 Electrolyte Panel Liver Profile

CPK, LDH

Amylase Magnesium

Lipase Cardiac Profile Alcohol (Ethanol) Urine Drug Screen

b. ROUTINE TESTS:

TEST PROFILES: (NOTE: Any test may be ordered as a single analyte).

Liver Profile (Hepatic Function Panel) Chem 8 (fasting/nonfasting) Albumin (Basic Metabolic Profile) Total bilirubin Sodium Direct bilirubin Potassium Alk Phosphatase Chloride Total Protein CO2 ALT Glucose

AST BUN

Creatinine Lipid Panel Calcium Cholesterol, total eGFR HDL cholesterol Triglycerides Cardiac Profile LDL cholesterol, calculated CPK

CPK-MB

Troponin I

Electrolyte Panel Chem 14 (fasting/nonfasting) Sodium (Comprehensive Metabolic Profile) Potassium Creatinine Chloride BUN CO2 Sodium Potassium Urine Drug Screen Chloride Amphetamines CO2 Barbiturates Albumin Benzodiazepines Total Protein Cocaine Calcium Methadone Total bilirubin Opiates Alkaline phosphatase Oxycodone AST

THC ALT

Glucose eGFR

TPN Panel (for hyperal patients) Anemia Profile Chem 8 (fasting) Iron Total Protein TIBC Albumin Transferrin Cholesterol B12 Triglyceride Folate ALT Ferritin Alkaline phosphatase Magnesium Phosphorus

NOTE: Serum amylase, lipase, LDH, GGT and uric acid are available for testing, but must be ordered independently.

CHEMISTRY SPECIAL TESTS:

24 Hour Urine Testing:

Sodium, Potassium, Chloride, Creatinine, Creatinine Clearance, Amylase, Protein, Glucose, Calcium and Microalbumin are performed in house.

Glucose Tolerance Test – must be scheduled with Laboratory.

Lactose Tolerance Test – must be scheduled with Laboratory.

Serum Acetone Ethanol

(See attachment “Instructions for the Chemistry Special Tests” for specific instructions for these tests)

3. SPECIMEN COLLECTION AND STORAGE

a. Unless specified by lab order, fasting is not required for specimen collection.

b. Serum or plasma should be free of hemolysis and separated from the clot ASAP or within 2 hours of collection. If there is marked hemolysis, lipemia or icterus, the specimen should be noted as such on the final report. If gross hemolysis is present, a new specimen may be requested at the physician's discretion.

c. 24-hour urine should be collected with the appropriate preservative and preferably refrigerated during the collection period. See attachment “Instructions for the Chemistry Special Tests” regarding list of tests requiring preservatives.

d. Cerebrospinal fluid and other body fluids should be analyzed promptly or refrigerated at 2-8C. All body fluid testing is sent to a local reference lab for testing. Normal ranges are not available for most body fluid testing.

4. REFERENCE RANGES

Chemistry Routine, Glucose Tolerance Tests and Special Tests: Refer to "Test and Reference Range Chart"(Section IV).

5. ADDITIONAL INFORMATION

Drug Effect on Blood Chemistry:

It is important for the physician and laboratory technologist alike to be aware of the possible effect of drugs on laboratory test results. Communication between those concerned with patient care is essential since many of the drug interferences have been discovered through such cooperation.

Drugs may have physiological or pharmacological actions in addition to those for which they are prescribed; they may cause idiosyncrasies or hypersensitivities, which could lead to unusual test values;

they may have toxic effects particularly on the liver and kidneys; and finally they may interfere in test procedures. In most cases, the association between the drug and unexpected test results may be readily identified. Results become abnormal after the drug is given and return to normal after it is discontinued.

Please contact the Laboratory with any specific questions regarding drug interferences.

INSTRUCTIONS FOR CHEMISTRY SPECIAL TESTS

A. 24 HOUR URINE COLLECTION

Obtain the one gallon plastic urine collection container from the Laboratory.

DO NOT remove any tablets or other preservatives that may be in the bottle.

Note any warnings or instructions posted on the outside of the urine collection container.

***CAUTION: Do Not Urinate Directly into the 24 Hour Container if there are any warning labels or any additives to the container: A small urine cup or urinal will be provided to urinate into, and transfer the contents into the large container. ***

1. In the morning (for example 7:00 a.m.), completely empty the bladder and discard the urine specimen.

2. All urine which is voided subsequently, including the final specimen voided at the end of the 24 hour collection period (i.e., 7:00 a.m. the following day) is collected and added to the plastic container.

NOTE: If one gallon jug is not sufficient to hold all of the urine for a 24 hour period, a clean milk jug or other suitable container may be used to hold the additional urine. It is essential for accurate test results that all urine is collected for the 24 hour period.

3. Keep the 24 hour urine collection bottle in a cool place, preferably in the refrigerator, or in a bucket with ice around the container.

4. The container must be labeled with the patient's name, social security number, and date/time collection started and finished.

5. Return the 24 hour urine collection bottle as soon as possible to the Laboratory

6. CBOC only- record the total volume in mL on 24 hour urine container and wrap the screw-top lid with para-film before sending to main laboratory.

7. LABORATORY- verify the correct preservative was used for the test ordered. Record the total volume in mL onto a properly labeled aliquot cup. Shake 24 hour urine jug to mix the specimen and pour off approximately 100mL into aliquot cup.

NOTE: It is essential that this procedure be followed without any deviation, since the results provided to the physician depend upon the accuracy of timing and the collection of the entire 24 hour specimen.

** Creatinine Clearance and Urea Clearance tests MUST have a GOLD top tube drawn on the day the 24 hour sample is DELIVERED to the Lab **

Any deviation…