36C26318R0288-022.pdf

BLACK HILLS HEALTH CARE SYSTEM

PATHOLOGY AND LABORATORY MEDICINE

Document #/Version #: 400/8 This document applies to the following location(s):

Author/Date Created:

Kristen Colwell 2006

Editor/ Date:

PHILLIP MONK 6/2018

Replaces Doc #/Version #: 400/7

X

FORT MEADE VAMC

113 Comanche Road, Fort

Meade, SD 57741 Effective Date: 06/06/18

TITLE: Specimen Collection Guidelines and Rejection Criteria X

HOT SPRINGS VAMC

500 North 5th Street, Hot Springs, SD 57747

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PURPOSE: To outline the expectations associated with the appropriate identification of patients, collection of samples, preservation of specimen integrity, and criteria for rejection of unacceptable specimens.

POLICY:

1. The SPECIMEN COLLECTION MANUAL distributed from Diagnostic Services – Laboratory, provides detailed collection and handling instructions to all client user[s] for laboratory specimens. The Manual is available in a catalog format and/or a

VISTA-printed alphabetical version. The Manual contains examples of testing information for the following:

a. General Alphabetical Testing Listing

b. Ancillary Testing

c. Transfusion Medicine – Blood Bank Practices

d. Hematology and Coagulation

e. Chemistry and Urinalysis

f. Microbiology

g. Contingency Plans with Sample Forms

2. The alphabetical test listing in the catalog (also in VISTA Lab Inquiry feature, ^INQ) presents:

a. TEST NAME or Synonym

b. SPECIMEN REQUIRED [Type of collection container / amount of specimen to be collected]

i. Need for special timing of collection

ii. Types / Amounts of Preservatives or Anticoagulants

iii. Special Handling needs [between time of collection and time received by the laboratory such as refrigeration, room temperature, immediate delivery]

iv. Proper patient identification and specimen labeling (not in VISTA)

c. NEED FOR APPROPRIATE CLINICAL DATA, when indicated

d. PATIENT PREPARATION

e. MEDICATION / DIET RESTRICTIONS

f. REPORTING

g. REFERENCE RANGES

h. METHODOLOGY (not in VISTA)

i. TURN AROUND TIME

j. COST / TEST (not in VISTA)

k. CPT CODE[S]; (Workload code cross-references in VISTA via the National VA lab codes)

l. COMPUTER CONTINGENCY FORM (catalog only)

3. The SPECIMEN COLLECTION MANUAL is reviewed and approved by the current Medical Laboratory Director or designee who reviews and approves changes to the procedure manual prior to implementation.

4. SPECIMEN COLLECTION MANUAL is distributed to all specimen collecting areas within the facility and the CBOC’s or

Outreach Clinics we serve. REFER to DISTRIBUTION LIST in Specimen Collection Manual for client / users.

5. For specimens sent to reference laboratories, the referring laboratory [BHHCS VAMC Labs] properly follows all requisition, collection and handling specifications detailed by the reference laboratory. These preanalytic variables are closely monitored to insure and maintain specimen integrity. The elements include:

a. Specimen Temperature

b. Transport time

c. Interval before separation of blood cells from serum / plasma

d. Proper filling of collection tube[s]

e. Use of waste tubes when coagulation tests collected with butterfly device

f. Flushing of line, if blood must be drawn from an indwelling line. When obtaining specimens from indwelling lines, that may contain heparin, the line should be flushed with 5 ml of saline. The first 5 mls of blood (or 6 times the line volume) should be drawn off and discarded before the coagulation tube is filled. From those samples collected from

Document # 400 Specimen Collection Guidelines and Rejection Criteria a normal saline lock (capped off venous port) twice the dead space volume of the catheter and extension set should be discarded.

g. Proper preservation: fixatives, refrigeration

h. Special preservatives for certain 24-hour urine specimens

i. Specific patient information required by testing reference laboratory to process test[s].

PURPOSE: To outline expectations associated with providing accurate and precise laboratory data that depends on properly performed Phlebotomy to obtain a high-quality specimen.

POLICY:

1. All laboratory technologist[s] / technician[s] know how to perform patient blood collection to include the proper selection / use of equipment, supplies, and collection techniques. This skill and ability is determined from direct observation and is included in their competency evaluation. The following steps are observed:

a. COMPETENCY: Performs Proper Venipuncture Safely

i. GREETS AND IDENTIFIES PATIENT CORDIALLY

ii. CHECKS COMPUTER [VISTA] FOR LAB ORDER # WITH PATIENT NAME / SS# PRIOR TO

ACCESSIONING.

iii. QUESTIONS PATIENT ON FASTING STATUS NOTING IF PATIENT UNDERSTANDS.

iv. DONS GLOVES, GATHERS APPROPRIATE TUBES, NEEDLE, ETC.

v. POSITIONS ARM, APPLIES TOURNIQUET, SELECTS / CLEANS VENIPUNCTURE SITE

vi. PERFORMS VENIPUNCTURE WITH PROPER TUBES – ORDER OF DRAW, VOLUME / MIXING OF

SAMPLE. See guide on last page.

vii. Order of Draw:

1. Blood culture tubes or containers

2. Plain tubes, non-additive (red-top) or Gel separator red-tops

3. Coagulation tubes (lighter blue-tops)

4. Heparin (green top)

5. EDTA (purple top)

6. Oxalate/fluoride (gray top)

7. Other miscellaneous tube colors

viii. Note: According to CLSI recommendations, if only a coagulation tube is to be drawn for routine coagulation tests (APTT and PTT) the first tube drawn, if blue, may be used for testing. For special coagulation tests such as Factor Assays, the second or third tube should be used.

ix. Note: To minimize the transfer of anticoagulants from tube to tube, holding the tube horizontally or slightly downward during blood collection is recommended.

x. Note: Gently invert tubes upon filling of tube contents.

xi. Note: If using a butterfly, ensure that at least 1 mL of blood is placed in a waste tube to avoid dead space in the butterfly tubing. Discard waste tubes immediately after 1mL fill in appropriate biohazard container.

xii. RELEASES TOURNIQUET / WITHDRAWS NEEDLE / APPLIES PRESSURE WHILE EXPEDITIOUSLY

DISPOSING OF USED NEEDLE IN SHARPS CONTAINER.

xiii. AFFIXES BAR CODE LABELS TO CORRECT CORRESPONDING TUBES. PLACED COLLECTOR

INITIALS ON EACH SAMPLE COLLECTED ON THE BARCODE LABEL MARGIN.

xiv. CHECKS SITE FOR BLEEDING / APPLIES PRESSURE COFLEX BAND

xv. THANKS PATIENT AND DIRECTS HIM/HER TO NEXT CLINIC STOP.

xvi. ENTERS PATIENT / SPECIMEN COMMENTS INTO VISTA PROCESS OPTION, AS IN THE CASE

PATIENT IF FASTING.

2. The specimen collector or phlebotomist POSITIVELY IDENTIFIES the patient before collecting a specimen to confirm their identity by checking two identifiers. For inpatients that are conscious and mentally alert, the phlebotomist asks the patient to verbalize complete name, social security number and/or date of birth and crosschecks the patient’s wristband for the same information prior to drawing. Room numbers may not be used as identifiers. For outpatients drawn in the laboratory or in the

CBOC [Outreach Clinics], phlebotomist asks the patient to verbalize complete name, social security number and/or date of birth.

Specimen Collection Guidelines and Rejection Criteria Document # 400

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3. Laboratory Order number is accessioned into the computer [VISTA] . The subsequent identifying bar code label is affixed to the specimen container at the time of collection in the presence of the patient. [REFER TO Laboratory Computer Users

Protocol for look up and accessioning order numbers].

1. VISUAL CHECK: Phlebotomist will VISUALLY check patient’s bar-coded wristband for the following:

a. Complete and Correct NAME and SOCIAL SECURITY NUMBER and/or DATE OF BIRTH.

b. Compare wristband to requisition and computer-generated orders.

c. NOTE: wristband must be on the patient’s limb.

i. Wristbands that have been removed and taped on bed rails / head boards are UNACCEPTABLE.

ii. Notify patient’s nurse, DO NOT DRAW patient until proper identification has been obtained and verified.

d. All inpatient EDTA tubes drawn will have the phlebotomist’s signature (not initials) in addition to the patient’s full

Name, SSN, Date of Birth and date/time of draw to facilitate EDTA tube use as a pilot tube for transfusion requests, if needed, and eliminate the need for another blood draw..

2. VERBAL CHECK: Phlebotomist will VERBALLY question patient [outpatients] for the following:

a. Complete first/last name and SOCIAL SECURITY NUMBER and/or DATE OF BIRTH.

i. Compare the requisition and computer-generated orders to information received.

ii. Inpatient and outpatient surgical patients will have wristband for proper identification.

iii. Request for Blood Bank procedures must be verified with FULL NAME and FULL SOCIAL SECURITY

NUMBER and DATE OF BIRTH before phlebotomy.

b. Question patient concerning eating before the sample is drawn and the time of their last therapeutic drug dosage.

3. UNCONSCIOUS PATIENT: If patient is incoherent or unconscious, phlebotomist will proceed as follows:

a. Question RN or attending personnel to POSITIVELY IDENTIFY the patient.

b. Requests for Blood Bank procedures will necessitate the signature of the attending personnel on the BTRF as

Verifier of the patient.

c. Once identification is complete, proceed with phlebotomy.

4. MISSING OR INCORRECT WRISTBAND: If patient has no wristband or an incorrect wristband, phlebotomist will proceed as follows:

a. Notify RN, attending personnel or primary care nurse of error.

b. Verify NAME and FULL SOCIAL SECURITY NUMBER and/or DATE OF BIRTH on new wristband.

c. Proceed with phlebotomy.

5. TRANSFUSION REQUEST: Procedure for transfusion request is as follows:

a. The patient must have on a wristband before collection can occur.

b. Compare request to patient wristband for further confirmation.

c. VERIFY correct NAME, FULL SOCIAL SECURITY NUMBER and DATE OF BIRTH.

d. Label the tube with full name, full SS#, date of birth, date/time drawn and signature of the phlebotomist. Note: Do not pre-label the tube directly from the patient’s armband.

e. On the BTRF (Blood Transfusion Request Form), the phlebotomist or specimen collector will WRITE in their name and the date and time of draw as verification that they did the draw.

6. ACCEPTABLE REQUISITION SUBMISSION (SURGICAL PATHOLOGY/CYTOLOGY) and CONSULTS: Procedure for surgical pathology/cytology/peripheral smear/bone marrow request is as follows:

a. VERIFY correct full name of patient, social security number and date of birth

b. VERIFY form-specific field requirements, such as

i. Location, Age, Sex, Race

ii. Date and time of collection

iii. Provider’s/Surgeon’s signature and title

iv. Type of specimen (source/site)

v. Pertinent clinical history—extremely important for Pathologist interpretation or genetic/molecular testing.

vi. Preoperative diagnosis

vii. Operative diagnosis

viii. Postoperative diagnosis

ix. Required qualifying tests prior to procedure

x. Current consult in use.

c. VA Form 515 Tissue Examination-used for Surgical Pathology Requests. Should be completed in all fields. Entry of field descriptions into VISTA accessioning must be EXACT in wording.

d. VA Form 10-2866, must have the patient’s full name, SSN, specimen source/site, number in series (if more than one specimen submitted on that patient), and date of collection.

e. For Bone Marrow and Molecular/Genetic/Flow Cytometry requests: Verify the EXACT tests required prior to retrieving specimen with provider or delegate. Tests are orderable in VISTA.

1. Pre-printed bar code computer generated labels will be removed from printer and affixed to sample withdrawn from patient.

PRESS LABEL FIRMLY onto specimen container.

2. Label Format: Label Format Includes:

PATIENT NAME [LAST, FIRST, MIDDLE]:

SOCIAL SECURITY NUMBER: WARD:

BAR CODE /////////// ///////// //////////// ///////////

UNIQUE IDENTIFICATION NUMBER

DATE: ACCESSION AREA with ACCESSION DATE and NUMBER

ORDER #: TUBE SPECIFICATIONS: [color of top]

TESTS REQUESTED:

3. Extra Labels:

a. Extra labels are printed for use on aliquoted samples to insure optimal specimen identity.

b. These labels will minimize sample mix-up, mislabeling or transcription errors.

c. NOTE: In the event of no computer-generated labels, proceed as follows:

i. Remove a blank label from printer and affix to patient sample.

ii. Print patient name, full social security number, tests requested and date drawn on the label, using a black pen or permanent marker pen.

SPECIMEN ALIQUOT

Aliquots of specimen sample will be processed as follows:

1. If a sample needs aliquoting, it will be aliquoted to a properly labeled aliquot tube / cup with [patient name, SS#, Accession

Number] depending on size of cup. Do not pour aliquot back into original tube.

2. The computer-generated ACCESSION number will be an identifier for extremely small sample cups.

3. Samples to be processed at a later date [will have another computer-generated label affixed to the pour off tube. Samples can then be stored in the freezer or refrigerator.

4. SEND OUT Samples will be poured into appropriate storage tubes or vials with another computer-generated label affixed.

Samples can then be stored in freezer or refrigerator awaiting transport.

a. Print a LONG FORM Worklist for the Accession Area which lists specimen information by accession number for each sample to be sent out.

b. Insure that the DOB for each patient has been printed on the LONG FORM Worklist.

5. Slides-Write name/last four of SSN/date/accession number on slide.

1. SAMPLE COLLECTION: Samples received in the Laboratory are collected as follows:

a. Phlebotomist collects samples from patients by utilizing one of the following elements:

i. COLLECTION LIST for inpatients;

ii. WARD COLLECTION for pick up specimens;

iii. SEND PATIENT: for outpatients and CBOC specimens

b. Nursing personnel collect samples from patient’s bedside and deliver to laboratory.

c. CBOC specimens (Pierre and Rapid City) come with shipping manifests. The manifests are signed/initialed and dated and kept for 2 years. Any problems with missing or inadequate samples are recorded on the manifest along with a corrective action if needed. These are filed in the Chemistry area after testing is performed and pending logs reviewed. CBOC deliveries generally come at 10am, noon, and 2pm on Weekdays. Small, Remote CBOC’s send their specimens with off-line hard-copy requisitions or already accessioned/barcoded samples.

d. Specimen transport containers (including CAP samples), such as boxes, coolers, etc., need to be opened immediately upon receipt and processed. Keep container lids visibly open as a check to ensure all contents removed.

e. REFERENCE: Specimen Collection Manual located on the respective units.

2. DATE AND TIME: Date and time of receipt is:

a. Automatically given at time of accessioning by accepting N for NOW.

b. Viewed on the printed order copy, particularly in MICROBIOLOGY, and techs should enter that specific time when accessioning.

c. Documented as required for send-out/reference test collection requirements.

3. SAMPLE ACQUISITION: All specimens received in the laboratory will be accompanied or acquired thus:

a. Collection list [for inpatients] by computer [PHLEBOTOMY MENU].

b. Ward Collection or Send Patient [for outpatients] by computer [WARD MENU]. Send Patient Orders (Outpatients and CBOC’s) are indicated on the daily Laboratory Appointment list for FM Lab Clinic. Go to VISTA option

^APPT, for print.

c. Standard requisition form.

i. Refer to CLINICAL LABORATORY – SPECIMEN COLLECTION MANUAL

ii. These requisition forms are used as the contingency plan for any or all extended computer DOWN TIMES.

iii. Wards will stock manual requisition forms in the case of downtimes. These forms are available as needed from the Warehouse and require a 3-day lead time on ordering.

*************SAMPLES WILL BE UNACCEPTABLE AND REJECTED FOR THE FOLLOWING REASONS. DOCUMENT

TRUE REJECTIONS ON THE SPECIMEN REJECTION LOG IN THE AREAS OF HEME/COAG, CHEMISTRY, MICRO, BLOOD BANK AND SURGICAL PATHOLOGY. REVIEW MONTHLY WITH QA REVIEW. DO CORRECTIVE ACTION

PER TREND (greater than or equal to 8) OF REJECTION INCIDENCES. MAP INCIDENCES TO A CA CATEGORY LISTED

ON THE SPECIMEN REJECTION LOG*************

SEE ASSIGNED TESTING SECTION PERSONNEL FOR LOCATION OF POSTED SPECIMEN REJECTION LOGS.

1. Examples of Specimen Rejections:

a. All unlabeled samples. If recollection is not practical or possible, specimen relabeling by the collector of the specimen will be allowed e.g. specimens that are difficult or impossible to recollect such as CSF, body fluids, cytology or surgical samples. All specimen labeling errors must be documented on the Specimen Rejection Form

Document # 879.

b. Contaminated, non-sterile, broken, cracked containers.

c. Spilled sample in biohazard bag.

d. Expired hemocccults, culturettes, vacutainers, Enteric or O & P kits.

e. Dry swabs or lack of transport media.

f. Inappropriate or inadequate preservatives or anticoagulants.

g. Inaccurate timing for collection.

h. Improper temperature storage.

i. Delayed delivery of wound cultures and anaerobes [exception: recoverable samples].

j. Inadequate volume of blood collected into a tube with anticoagulant [either overfilled or under filled affects results];

k. Sample diluted with intravenous fluids or heparin.

l. Clotting in tubes containing anticoagulants [lack of sufficient mixing].

m. Grossly hemolyzed or lipemic / chylous samples.

n. Delayed plasma or serum separation from cells.

o. Non-fasting specimens [cream] for those tests that must be fasting.

i. BHHCS VAMC LAB POLICY – Phlebotomist will ask patient if food has been ingested prior to

Venipuncture. WATER IS PERMISSIBLE and patient is encouraged to come to lab hydrated.

ii. If patient has not fasted, instruct patient to tell the provider that they did not fast.

iii. Providers must interpret results for appropriate care.

p. Environmental exposure: temperature extremes /changes, sunlight, air.

q. Improperly collected because of ‘no patient instructions’.

r. Medication interferences.

s. Misidentified patient samples.

t. Improper puncture site preparation [alcohols or blood cultures].

u. Pouring aliquot back into original tube.

v. Utilizing non-sterile equipment or expired items.

w. Samples received with attached sharp will be rejected, until removed by the collector or designee. Lab staff will not remove attached needles.

x. Any specimens in “brought from home” containers.

2. The following specimens will be rejected if these specific precautions are not observed:

a. Alcohol: Cleanse puncture site with providine. DO NOT USE alcohol skin preps.

b. Ammonia: Submerge heparinized tube in ice: freeze plasma or test immediately.

c. Calcium and Potassium: Must not be drawn in EDTA.

d. Lithium: Must not be drawn in lithium heparin tube.

e. Potassium: Serum must be free of hemolysis.

f. Sodium: Must not be drawn in EDTA.

g. Triglyceride & HDL: Lipemic samples: redraw patient after a 8-12 hour fast. Cannot calculate LDL when

Triglyceride is >400 mg/dL. A Direct LDL is performed on all specimens with a Triglyceride >400 mg/dL

h. Carotenes: Wrap tube in aluminum foil to protect tubes from light

i. Ionized Calcium: If tube has been opened

3. LAB POLICY REGARDING UNACCEPTABLE SPECIMENS:

a. Provider/Specimen collector will be notified if sample exhibits the above problems. This may be done by flagging the order in CPRS.

b. Provider will determine if sample is to be processed, regardless of problems,

i. Tech will enter into Comments, the condition of the sample [ie. hemolyzed]

ii. Sample will be processed.

iii. Provider will be notified of results.

c. Document rejections on the specimen rejection log in the appropriate area: Heme/Coag/Blood Bank, Chemistry, Microbiology, and Surgical Pathology.

d. Complete a Corrective Action in the Laboratory Database for all rejected specimens.

e. Microbiology samples are held for 48 hours, after notification of provider.

i. Provider must initiate collection of new sample

ii. If new sample doe not arrive, original will be rejected.

4. LAB POLICY REGARDING HANDLING OF SUB-OPTIMAL SAMPLES:

a. If the test is ordered and the sample exhibits evidence of specimen injury or is unacceptable as outlined above in

Specimen Rejection Criteria’, the requesting provider is notified by telephone.

b. The condition of the sample is noted and a comment is entered into the computer. The test will be run if requested by the ordering provider.

c. Rejected samples are held by the chemistry department for 7 days following collection.

d. Document rejections on the specimen rejection log in the appropriate area: Heme/Coag/Blood Bank, Chemistry, Microbiology, Surgical Pathology.

e. Notify Specimen Collector and Provider of suboptimal and rejected specimens.

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f. Complete a Corrective Action in the Laboratory Database for all rejected specimens.

g. Document sub-optimal reason in the “Comments” section of the DHCP report, such as “Hemolyzed”, etc., PRIOR to placing on the analyzer.

5. RECOMMENDATIONS:

a. Follow carefully the instructions outlined in the Specimen Collection Manual or VISTA Lab Test inquiry for acceptable specimen collection to insure specimen quality and the accuracy of our test reports.

b. Call Extension 7718 or 7715 if you have any questions prior to collection.

1. The paper or electronic requisition will include all of the following elements:

a. Adequate patient identification information [i.e., full name, social security number, and location]

b. Patient gender.

c. Patient date of birth or age;

d. Name and address [if different than the receiving laboratory] of physician or legally authorized person ordering the tests;

e. Tests requested;

f. Time and date of specimen collection when appropriate;

g. Source of Specimen, when appropriate;

h. Clinical Information, when appropriate.

i. Legible requests. Reject if requisition is unclear or illegible

2. Note: Non-VA lab orders (received in person/fax) should be forwarded to a Primary Care clerk for processing into VISTA.

3. Note: Consults & other specific requisitions may have other required fields. Ensure forms are complete and accurate prior to accessioning.

RESPONSIBILITIES:

1. The Lab Manager/supervisor is accountable for insuring that the appropriate supplies are available and that the staff is properly trained in the selection/use of venipuncture items and that their subsequent performance is monitored to protect the patients and staff.

2. The laboratory technologist[s]/technician[s] assigned to procure patient specimens are accountable for their actions and initiate prompt corrective action when problem situations arise.

REFERENCES:

1. BHHCS VAMC LAB SPECIMEN COLLECTION MANUAL

2. CAP LABORATORY GENERAL CHECKLIST

3. PHLEBOTOMY HANDBOOK, BLOOD COLLECTION ESSENTIALS. Diana Garza and Kathleen Becan-McBride, 6th

Edition, 2002

Phlebotomy Tube Guide

= 1 inversion

* Please call the lab at 7712 or 7716 with any questions or refer Doc 400 of the Laboratory PROQUIS database

Reference: http://www.bd.com/vacutainer

PT, PTT, d-dimer, fibrinogen

Drug levels (i.e. dilantin, theophylline, carbamazepine)

Vancomycin, gentamicin, digoxin, PSA, TSH, amylase, iron panel, glucose, electrolytes, creatinine, liver enzymes

Troponin, glucose, BUN/creatinine, electrolytes

CBC, hemoglobin & hematocrit

*BNP (draw 3 ml)

Tests Commonly Used with Each Tube

NOTE: All of the minimums listed here are absolute minimums. If more sample can be obtained, please fill the tubes.

Mix immediately by inversion

Must fill to top of label to the mark on the tube

Minimums

1 mL

Type & screen and crossmatch requires 3 lavender tubes or a minimum of 6 mL, plus see special patient identifying and tube labeling procedures

Fill to top of label

6 mL

4 mL

3 mL

3 mL http://www.bd.com/vacutainer/pdfs/plus_plastic_tubes_wallchart_orderofdraw_VS5729.pdf