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$ortor%&s !hin of !)sto"% SOP s nee"e" to 're(ent ")'li!tion# SPECIMEN TR*NSPORT FROM COLLECTION TO L*,OR*TOR+ %pecimen labeling requirements at collection point& A description or list of appropriate storage temperature as applicable to each test for transport from phlebotomy to laboratory recei'ing& Policy on timeline from draw of specimen to receipt in laboratory as applicable to each or all tests& f specimens are collected from an off+site facility, include specimen processing instructions to be completed prior to transport& A description on how specimens are pac"aged for transport from phlebotomy to laboratory recei'ing& A description of the necessary paperwor", completion instructions, and specimen log information that must remain at the collection point and accompany specimens& nstructions on who is responsible for specimen transport from phlebotomy to laboratory& !omments: SPECIMEN RECEIPT IN L*,OR*TOR+ %9:':;9:93.oc <er"ion=: 131 Pa$e % of : 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 :