SMILE
Johns Hopkins University
Baltimore, MD USA
Author: SMILE Staff Document Number: Pro71-11
Effectie !or Po"t# Date: 7 Au$u"t %&&'
(eie) *i"tor+ Date of la"t reie): 1'-,an-1-
(eie)e. b+: *ei.i *ane"
SMILE /omment": 0hi" .ocument i" 1roi.e. a" an e2am1le onl+3 It mu"t be rei"e. to
accuratel+ reflect +our lab4" "1ecific 1roce""e" an.5or "1ecific 1rotocol re6uirement"3 U"er" are
.irecte. to counterchec7 fact" )hen con"i.erin$ their u"e in other a11lication"3 If +ou hae an+
6ue"tion" contact SMILE3
CHECKLIST FOR SITE SOP REQUIRED ELEMENTS:
S1ecimen Mana$ement
**Please note - Laboratory specimen management plans may be protocol specific and require
network approval.
Element
Present
CONTENT-SPECIFIC REQUIRED ELEMENTS
SPECIMEN COLLECTION
This informtion is lso !ontine" in the SPECIMEN COLLECTION SOP CHECKLIST# Refer to
the l$ortor%&s s'e!imen !olle!tion SOP s nee"e" to 're(ent ")'li!tion#
a#
b#
c#
.#
e#
f#
$#
h#
i#
8#
7#
l#
A description of the laboratorys specimen collection process, which includes, but is
not limited to, the following as applicable:
a) Personal Protection Equipment (PPE) worn by staff;
b) dentify who can draw the specimen;
c) !onsent and other paper wor" in order;
d) Proper identification of the patient;
e) Preparation of the sub#ect;
f) $ype of collection container and amount of specimen to be collected;
g) %pecial conditions (i&e&, time of day, etc&);
h) $ypes and amounts of preser'ati'es or anticoagulants;
i) %tep by step procedure for collecting specimens;
#) %pecial handling (mi(ing, refrigeration, separation, etc&) between collection
and time recei'ed by the laboratory;
") Proper specimen labeling; and
l) $ypes of containers to be used for transport of specimen&
)enous blood collection: %pecial steps as applicable to 'ein selection, needle
selection, procedures when )s are present, etc&
*eel %tic" or !apillary collection: %pecific step+wise collection procedures, patient
requirements (i&e&, infants or when 'enous collection is unsuccessful, etc&),
appropriate collection tubes (i&e&, pediatric tubes and 'olumes)
Arterial blood collection procedures are highly discouraged& *owe'er, if they are
included, instructions must be included to limit the conditions under which they are
collected& ,etailed precautions, limitations on collection personnel, special training
requirements, and emergency steps must also be included&
%9:':;9:93.oc <er"ion=: 131 Pa$e 1 of :
SMILE
Johns Hopkins University
Baltimore, MD USA
A description of the specimen collection process for unusual or non+blood specimens
(e&g&, urine specimens collected under aseptic or -clean+catch. conditions to ensure
quality and a'oid contamination of specimen)&
A description of policy or procedure when no specimen or an inadequate sample is
collected and must be re#ected&
A description of the laboratorys training requirements for personnel collecting
specimens&
!omments:
PREC*UTIONS
a#
b#
c#
.#
,escription of what to do for ad'erse reactions
a) /ainting&
b) E(cessi'e bleeding&
c) *ematoma&
d) 0ausea
!omments:
LIMIT*TIONS OR SOURCES OF ERROR
1imitations to the procedure&
Potential problems (sources of error) and appropriate action if those problems are
encountered&
!omments:
SPECIMEN CH*IN OF CUSTOD+
This informtion is lso !ontine" in the CH*IN OF CUSTOD+ SOP CHECKLIST# Refer to the
l$ortor%&s !hin of !)sto"% SOP s nee"e" to 're(ent ")'li!tion#
SPECIMEN TR*NSPORT FROM COLLECTION TO L*,OR*TOR+
%pecimen labeling requirements at collection point&
A description or list of appropriate storage temperature as applicable to each test for
transport from phlebotomy to laboratory recei'ing&
Policy on timeline from draw of specimen to receipt in laboratory as applicable to
each or all tests&
f specimens are collected from an off+site facility, include specimen processing
instructions to be completed prior to transport&
A description on how specimens are pac"aged for transport from phlebotomy to
laboratory recei'ing&
A description of the necessary paperwor", completion instructions, and specimen log
information that must remain at the collection point and accompany specimens&
nstructions on who is responsible for specimen transport from phlebotomy to
laboratory&
!omments:
SPECIMEN RECEIPT IN L*,OR*TOR+
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SMILE
Johns Hopkins University
Baltimore, MD USA
A description of the laboratorys process for identifying indi'idual specimens (e&g&,
Patient dentification (P,) number for each sub#ect, identification printed on
specimen labels match requisitions forms) upon receipt in the laboratory&
A description of the laboratorys process for documenting entry of specimens into the
laboratory (e&g&, specimens are logged into a database, 1%, or 1,2% system)&
A description of documentation of specimen condition upon receipt in the lab&
A description of the sample re#ection policy&
A description of the process to correct problems with specimens (collection amounts,
sample labeling, sample condition, issues during transport, etc&) and the process to
notify the collection facility&
A description of the laboratorys process for specimen accountability (e&g&, date, time,
name and signature of handler, record of when each sample was recei'ed or
dispatched, %ample dentification (%,) number assigned to each specimen)&
A list of the laboratorys specimen retention times& $he laboratorys policy should
meet or e(ceed ,A,% appro'ed regulations&
!omments:
SPECIMEN DELI-ER+ TO TESTIN. DEP*RMENT
,escription of how the laboratory deli'ers specimens from specimen receipt to the
testing departments (department logs, specimen bar coding, etc&)&
Policy on where and how long each specimen type is retained after testing&
1aboratory can reference other procedures if this information is found elsewhere&
,escription of how the specimen results are handled when testing is complete (e&g&,
how are results 'erified in the department, where do the results go to be included on
one report, etc&)& 1aboratory can reference other procedures if this information is
contained elsewhere&
!omments:
SPECIMEN TESTIN. DEP*RTMENT
,escribe the laboratory process for recei'ing specimens in the testing departments&
,escribe the laboratorys process for specimen accountability in the testing
department and the follow+up for lost or unaccounted for specimens&
,escribe the laboratorys policy on storage conditions and retention times for wet
specimens after testing is complete& $he policy should meet or e(ceed ,A,%
appro'ed regulations&
!omments:
RESULT REPORTIN.
,escription of how the specimen results are reported and entered into the laboratory
report (e&g&, manual or automated result entry, how result reports are 'erified and
signed off, where reports are stored until returned to clinic3sending laboratory, etc&)&
,escription of how result reports are reported and3or deli'ered to the clinic or
requisitioning laboratory&
%9:':;9:93.oc <er"ion=: 131 Pa$e - of :
SMILE
Johns Hopkins University
Baltimore, MD USA
!omments:
SPECIMEN PROCESSIN. / Plsm0 Ser)m0 Urine0 Cells
This informtion is lso !ontine" in the SPECIMEN PROCESSIN. *ND H*NDLIN. SOP
CHECKLIST# Refer to the l$ortor%&s 'ro!essin1 n" hn"lin1 SOP2s3 s nee"e" to 're(ent
")'li!tion#
a3#
b3#
c3#
.3#
e3#
%tep+by+step procedure is present for each specimen type the laboratory processes
for each specific laboratory test& $he information may be presented in a table format
and should include at least the following:
a&) centrifuge speeds and times,
b&) separation requirements, if necessary
c&) special material requirements
d&) any secondary containers requirements
e&) secondary containers or storage 'ials labeling requirements&
Processing procedures may be present in a protocol specific format, if required&
nclude special transport requirements as needed for specimens after processing or
refer to transport specific procedures& %ee the $ransport and %hipping %4P chec"list
for detailed requirements&
!omments:
RECORDIN. *ND TR*CKIN.
A description of the documentation that accompanies shipped specimens (e&g&, paper
or electronic requisition), including the components of the documentation (e&g&,
sub#ect identifier, name and address of physician ordering test, tests or assays
required)&
A description of the laboratorys process controls and documentation for the trac"ing
of specimens (e&g&, date, time of collection, transport, receipt, processing, testing,
storage)& 2ention any status reports generated&
A description of the laboratorys processes for correcting problems identified in
specimen transportation and for impro'ing performance of clients or offices that
frequently submit specimens improperly&
!omments:
STOR*.E
,escription of how the specimens are documented and stored for long term storage&
nclude how specimens are trac"ed, logged, and stored (1% system, 1,2%, E(cel
spreadsheets, etc&)&
,escription of how stored specimen data is retrie'ed&
!omments:
PREP*R*TION *ND P*CKIN.
This informtion is lso !ontine" in the SPECIMEN TR*NSPORT *ND SHIPPIN. SOP
CHECKLIST# Refer to the l$ortor%&s trns'ort n" shi''in1 SOP2s3 s nee"e" to 're(ent
")'li!tion#
%9:':;9:93.oc <er"ion=: 131 Pa$e 9 of :
SMILE
Johns Hopkins University
Baltimore, MD USA
A description of the regulations the laboratory follows 5e&g&, nternational Air
$ransportation Association (A$A)6 when pac"ing specimens for shipment&
A description of shipping training and documentation of training for staff&
A description of the shipping containers the laboratory uses to transport specimens&
A description of the laboratorys process for labeling, sealing, and pac"aging
specimens for shipment&
A description of the documentation that accompanies shipments&
!omments:
TR*NSPORT *ND SHIPPIN.
A description of the laboratorys trac"ing management system for transportation,
chain of custody, record "eeping and trac"ing for shipments of specimens to and
from the laboratory or reference laboratories& nclude a description of the electronic
system and3or description of paper system and any status reports generated&
A description of the couriers used by the laboratory for international or local
shipments of specimens to and from the laboratory&
A description of the national3local import and3or e(port requirements for the shipping
of specimens and a description of the laboratorys procedures for complying with
those requirements&
A description of the laboratorys notification procedures in case of accidents or spills
of specimens during transport&
A description of shipment notification to the recipient prior to shipping specimens&
A description of the laboratorys policy on how long shipping documentation is
retained&
!omments:
(eference":
>e.eral (e$i"ter, De1artment of 0ran"1ortation, 9? />( Part" 171, 17%, 17-, 177, an. 17':
*a@ar.ou" Material": (ei"ion" to Stan.ar." for Infectiou" Sub"tance": >inal (ule
-? />( Part 111: *a@ar.ou" Material": Pro1o"e. Dome"tic Mail Manual (ei"ion" for Dii"ion
;3% Infectiou" Sub"tance" an. Ather (elate. /han$e"
AS*A %? />( Part 1?1&31&-&: Bloo.borne Patho$en"
/LSI3 Proce.ure" for *an.lin$ an. Proce""in$ of Bloo. S1ecimen"B A11roe. Cui.eline D 0hir.
E.ition3 /LSI .ocument *1'-A- !ISBN 1-:;%-'-:::- /LSI, ?9& Ee"t <alle+ (oa., Suite
19&&, Ea+ne, Penn"+lania 1?&'7-1'?', USA, %&&93
/linical Laborator+ Im1roement Amen.ment !/LIA# Self- A""e""ment Fue"tionnaire
/olle$e of American Patholo$i"t" !/AP#, Laborator+ Ceneral /hec7li"t for Laborator+
Accre.itation Pro$ram
I/* E; Coo. /linical Practice: /on"oli.ate. Cui.ance !C/P#
%9:':;9:93.oc <er"ion=: 131 Pa$e : of :
