NATIONAL ENVIRONMENTAL LABORATORY ACCREDITATION STANDARDS

Transcription

1 NATIONAL ENVIRONMENTAL LABORATORY ACCREDITATION STANDARDS Jerry L. Parr The NELAC Institute (TNI) A standard is an established nrm r requirement published as a frmal dcument that establishes unifrm technical criteria, methds, prcesses and practices. DISCLAIMER This dcument highlights changes t the varius standards used in the Natinal Envirnmental Labratry Accreditatin Prgram (NELAP). The gal f this dcument is t capture all changes, but if errrs are nted, please let us knw. Labratries and Accreditatin Bdies shuld nt rely n this dcument, but rather the standard itself. An imprtant factr in establishing the quality f envirnmental data and ensuring that the data are adequate fr the intended purpse is a cnsistent, stringent, cmprehensive and yet practical accreditatin prgram. Such a prgram, the Natinal Envirnmental Labratry Accreditatin Prgram (NELAP), is designed t ensure the cmpetency f all envirnmental testing labratries and related sampling and measurement rganizatins in the United States. The gal f NELAP is t fster cperatin amng the accreditatin activities f different states and t unify the state requirements int a single standard. Each f the recgnized accreditatin bdies must implement the standards, and must accept the accreditatin f labratries accredited by ther NELAP accreditatin bdies. Hwever, recgnizing the svereignty f state gvernments, NELAP des nt require every state t implement accreditatin standard in the same manner r at the same time. Currently, states participating in NELAP have tw chices fr an accreditatin standard, the 2003 NELAC standard r the 2009 TNI standard. A third standard, the 2016 standard, has been apprved by TNI s Cnsensus Standards Develpment Prgram but has nt been adpted int NELAP. Nte: These standards specify the requirements that envirnmental testing labratries must meet t demnstrate their cmpetence. They cver testing perfrmed using standard methds, nn-standard methds, and labratry-develped methds. The standards are applicable t all labratries regardless f the number f persnnel r the extent f the scpe f testing activities. When a labratry des nt undertake ne r mre f the activities cvered by these standards, such as sampling and the develpment f new methds, the requirements f thse clauses d nt apply. These standards are fr use by labratries in develping their management system fr quality, administrative and technical peratins. Labratry custmers, regulatry authrities and accreditatin bdies may als use them in cnfirming r recgnizing the cmpetence f labratries. Backgrund EPA, with the states as its implementatin partners, maintains requirements fr the certificatin f drinking water labratries and als establishes accreditatin requirements fr labratries that analyze lead (such as in paint) and asbests. Many states have independently established accreditatin prgrams cvering the analysis f waste waters, slid and hazardus wastes, and air. In the 1980 s, the cmmercial labratry cmmunity began t advcate a natinal accreditatin prgram that wuld cnslidate the multiple state prgrams cntaining divergent accreditatin requirements. A natinal prgram wuld prvide the fundatin fr ensuring the capability and cmpetence f labratries t fster the generatin f data f knwn and dcumented quality. Over thirty years ag, EPA recgnized the prblem TNI Standards Cmparisn

2 f uncrdinated, incnsistent and redundant state and federal labratry accreditatin prgrams. In a 1988 Reprt t Cngress n the cmparability f labratry test prcedures, the EPA recmmended that it explre the feasibility f establishing a unifrm natinal labratry accreditatin prgram. The 2003 NELAC Standard On February 16, 1995, state and federal fficials vted t apprve an interim Cnstitutin and Bylaws thus establishing the Natinal Envirnmental Labratry Accreditatin Cnference (NELAC), a standard setting rganizatin. The majr bjective f NELAC was t develp accreditatin standards, and in the perid between 1995 and 2003 it did s. Hwever, NELAC, in its riginal structure, did nt meet the definitin f a vluntary cnsensus standards bdy and thus the last NELAC standard was published in This standard was based n the 1997 versin f the internatinal standard ISO/IEC 17025, that describes the requirements labratries have t meet if they wish t demnstrate that they perate a management system, are technically cmpetent, and are able t generate technically valid results. In additin, the 2003 standard: Added specificity t imprve clarity and help with cnsistency fr envirnmental testing, Required cnfrmance t EPA mandated methds (where they exist,) but therwise allws flexibility in meeting requirements, Represented the best prfessinal practice f the envirnmental testing cmmunity, Allwed fr multiple Accreditatin Bdies t implement cnsistently, Cntained an apprpriate level f prficiency testing, and Included a data integrity cmpnent missing frm ISO/IEC The 2003 NELAC Standard has been used by NELAP-recgnized Accreditatin Bdies (ABs) since 2005, and as such, is very familiar t the ABs as well as the accredited labratry cmmunity and ther stakehlders. Hwever, the 2003 NELAC standard cntains language abut the peratin f an rganizatin that n lnger exists, cntains administrative detail that des nt pertain t the peratin f an accreditatin prgram, cntains language frm an bslete versin f ISO/IEC 17025, is very hard t read and understand by labratries that have nt been accredited, and is nt recgnized by the EPA as a cnsensus standard. The 2003 NELAC Standard is widely perceived as ne f the barriers t increasing the participatin f bth labratries and states in NELAP. Nnetheless, this standard is still in use by sme states and is an acceptable standard fr a state t use. The 2009 TNI Standard The NELAC Institute (TNI) was frmed n Nvember 6, 2006, t cntinue the effrts f NELAC, but as a vluntary cnsensus standards bdy. TNI is a 501(c)3 nn-prfit rganizatin whse missin is t fster the generatin f envirnmental data f knwn and dcumented quality thrugh an pen, inclusive, and transparent prcess that is respnsive t the needs f the cmmunity. Members f the rganizatin include individuals frm labratries, data users, federal and state agencies and anyne interested in prmting envirnmental data f knwn and dcumented quality. The 2009 TNI standards were develped t respnd t criticisms f the 2003 NELAC standard and represent a substantial imprvement ver the 2003 standard. It remved utdated language related t the Natinal Envirnmental Labratry Accreditatin TNI Standards Cmparisn

3 Cnference, an rganizatin that n lnger exists. It has incrprated the 2005 versin f ISO/IEC It has incrprated ISO/IEC 17011, the internatinal standard fr accreditatin bdies. It has a multi-vlume mdular apprach that simplifies reading and understanding the requirements and minimizes the cst f the standard fr labratries. It has imprved clarity n requirements, especially requirements related t methd validatin and demnstratin f capability. It has a strnger emphasis n the technical cmpetence f labratry assessrs. It is a true cnsensus standard 1. A cmparisn f the 2003 NELAC Standard and the 2009 TNI standard can be fund in Appendix 1. The NELAP Accreditatin Cuncil adpted this standard fr use in NELAP with an effective date f July 1, Hwever, due t state gvernmental changes and plitical realities (such as a freeze n regulatins by a new gvernr, fr example), nt all states were able t implement the standard as earlier agreed planned. The extent f such delays became bvius in early 2011, as new gvernrs were installed int ffice and began t make changes in state peratins. The NELAP Accreditatin Cuncil (AC) and each f its 14 NELAP ABs fully cmmit t maintaining reciprcal recgnitin regardless f which standard is in use by any individual AB. This is n different than when NELAC changed frm the 2001 t the 2003 Standard, and TNI s Bard f Directrs has accepted the AC s prpsal fr a rlling implementatin. Expectatins were that the change-ver culd be accmplished n a fixed date, but reality intervened, and a fixed date fr implementatin is simply nt feasible. The 2016 TNI Standard The 2016 standard is the result f effrts t cntinually imprve the requirements. This standard clarifies the prficiency testing requirements, imprves the sectins n methd validatin, instrument calibratin and detectin/quantitatin limits fr chemistry and cntains cmpletely rewritten sectins fr micrbilgy and radichemistry. Appendix 2 summarizes the key differences between the 2009 and 2016 standards. It is likely that the implementatin date fr this standard will be 2019 r later, althugh sme states (e.g., Flrida) may d s sner if they have changes t their regulatins underway. In summary, there are three natinal standards available. While each f these have different requirements, they all have the same quality system fundatin, the same frequency f prficiency testing, and similar technical requirements. While each revisin t a standard brings imprvement, TNI believes these standards are all equally effective t be used as the basic framewrk fr an accreditatin prgram. 1 The Office f Management and Budget Circular A-119 defines a vluntary cnsensus standards bdy as ne having the fllwing attributes: (i) penness; (ii) balance f interest; (iii) due prcess; (iv) an appeals prcess; and (v) cnsensus, which is general agreement, but nt necessarily unanimity, and includes a prcess fr attempting t reslve bjectins by interested parties, as lng as all cmments have been fairly cnsidered, each bjectr is advised f the dispsitin f his r her bjectin(s) and the reasn(s) why, and the cnsensus bdy members are given an pprtunity t change their vtes after reviewing the cmments. TNI Standards Cmparisn

4 Appendix 1: The 2009 TNI Standard The 2005 versin f ISO/IEC has sme additinal management and technical requirements that were nt in the bslete versin f ISO/IEC cntained in the 2003 NELAC standard. These new requirements, fund in Mdule 2, are summarized belw. Ensure persnnel are aware f the relevance and imprtance f their activities and hw they cntribute t the achievement f the bjectives f the management system. (4.1.5 (k)) Ensure that apprpriate cmmunicatin prcesses are established within the labratry and that cmmunicatin takes place regarding the effectiveness f the management system. ( 4.1.6) Ensure the integrity f the management system is maintained when changes t the management system are planned and implemented. (4.2.7) Seek feedback, bth psitive and negative, frm its custmers t imprve the management system, testing activities and custmer service. (4.7.2) Cntinually imprve the effectiveness f its management system thrugh the use f the quality plicy, quality bjectives, audit results, analysis f data, crrective and preventive actins and management review. (4.10) Analyze quality cntrl data and, where they are fund t be utside pre-defined criteria, take actin t crrect the prblem and t prevent incrrect results frm being reprted. (5.9.2) In additin, TNI s Quality System and Prficiency Testing (PT) expert cmmittees revised language frm the 2003 NELAC standard, and in sme cases added new language, that impse new labratry requirements. Fr example, Sectin f Mdule 1 requires PT samples t be analyzed every 5 t 7 mnths. The 2003 NELAC standard required PT samples t be analyzed apprximately six mnths apart. The 2009 standard is nt a change in the requirement, but increased clarity n apprximately six mnths. Sectin f Mdule 2 prvides the requirements fr a daily check f supprt equipment such as balances, vens and refrigeratrs. The 2003 NELAC standard (Sectin f Chapter 5) used the phrase prir t use n each wrking day. The 2009 TNI standard has revised this t read each day the equipment is used t clarify what was meant by wrking. Again, this is nt a new requirement. Sectin f Mdule 2 nw requires reagents t be traceable. This is a new requirement. In the 2003 standard, PT Prviders were required t evaluate reprted results t a PT Reprting Limit published in the TNI Fields f Prficiency Testing tables. This requirement frced many labratries t create specific reprting limits just fr PT sample analyses, which is cntrary t the requirement that PT samples be analyzed as rutine samples. The 2009 standard allws labratries t reprt results t their nrmal reprting limit fr that analyte/methd/matrix, and the PT Prvider must evaluate the result n that basis. This change will require labratries t prvide their LOQ when reprting PT results. Fr mre details, read sectin 5.2 f Mdule 1 and sectin 10.3 f Vlume 2, the requirements fr PT prviders. The TNI expert cmmittees that develped the 2009 standard carefully reviewed requirements in the 2003 NELAC standard relative t their imprtance t ensuring data quality and integrity. A number f requirements frm the 2003 standard have been mdified, r in sme cases deleted, t prvide mre flexibility in meeting the requirements r t allw labratries t stp perfrming nn-essential activities. Fr example, Sectin f the 2003 NELAC standard required labratries t have 23 specific items in their TNI Standards Cmparisn

5 Quality Manual and even specified what was t be n the cver page. Sectin f Mdule 2 requires the Quality Manual t have a title and 8 specific items. It then lists 20 items that can be in the Quality Manual r simply referenced. There are n requirements fr what must be n the cver page. Sectin f the NELAC standard required an expiratin date fr standards, reagents, reference materials and media. The 2009 TNI standard (sectin f Mdule 2) des nt require a labratry t fabricate an expiratin date that is nt prvided by the manufacturer r required by a methd. Sectin f Chapter 5 in the NELAC standard required a labratry t dcument a demnstratin f capability (DOC) using a frm fund in Appendix C and that infrmatin t be maintained in an emplyee training file fr each analyst. The requirements fr the DOC were very much riented twards labratries perfrming chemical analyses. In the 2009 TNI standard, the requirements fr DOC are fund in Mdules 3-7 and vary based n the scientific discipline (asbests, chemical, micrbilgical, etc.). The requirements fr what must be dcumented are nt changed, but labratries are nt required t use a specific frm, and the labratry can decide where and hw t stre this infrmatin. These three examples illustrate the increased flexibility allwed in the 2009 TNI standard. In each f these examples, a labratry culd cntinue their current practice and be in cmpliance with the 2009 standard. The table which fllws summarizes all f the changes between the 2003 and 2009 standard. TNI Standards Cmparisn

6 Summary f Changes frm 2003 NELAC t 2009 TNI Standard Vlume Mdule Sectin Change Discussin Labratry Impact Fr labratries applying fr accreditatin, last analysis f PT sample must be within 6 mnths f applicatin Prvisin t allw PT samples t be btained frm a nnaccredited prvider Prvisin t allw PT samples t be btained frm a nnaccredited prvider PT sample analyses must be at least 5 and n mre than 7 mnths apart Fr this t ccur, a) analyte wuld have t be apprved by PT EC and NELAP AC and b) n existing PT prviders are capable f prviding sample. Fr this t ccur, a) analyte wuld have t be apprved by PT EC and NELAP AC and b) n existing PT prviders are capable f prviding sample. Clarificatin f "apprximately six mnths" Prvisin t allw fr Experimental PTs Fr this t ccur, analyte wuld have t be apprved by PT EC and NELAP AC Crrective actin PT samples must be 15 days apart NELAC standard required 15 days frm Trivial clsing date f PT study. The 2009 TNI language uses analysis date, nt study clsing date Clarificatins n hw PT samples are t be analyzed. N change in intent frm 2003 NELAC N Impact Reprt PT data t LOQ. Significant change fr labs that reprted t PTRL Retain recrd f n-line submissin f PT results Trivial (k) ensure persnnel are aware f the relevance and imprtance f their activities and hw they cntribute t the achievement f the bjectives f the management system (h) Delete requirement that TD has t certify persnnel have educatin/technical knwledge t perfrm tests (NELAC h) New ISO language See Sectin Management shall authrize Ensure that apprpriate cmmunicatin prcesses are established within the labratry and that cmmunicatin takes place regarding the effectiveness f the management system Change requirement frm 65 days t 35 days fr reprting t AB when TD is absent New ISO language TNI Standards Cmparisn

7 Vlume Mdule Sectin Change Discussin Labratry Impact Cmmitment t cntinually imprving effectiveness f New ISO language management system Imprtance f meeting custmer and regulatry New ISO language requirements Ensure the integrity f the management system is New ISO language maintained when changes t the management system are planned and implemented Custmer feedback required. Feedback may be a survey r New ISO language New Activity a review f reprts with custmer The labratry shall cntinually imprve the effectiveness f New ISO language its management system thrugh the use f the quality plicy, quality bjectives, audit results, analysis f data, crrective and preventive actins and management review Increased emphasis n implementatin f crrective New ISO language actins Fllw-up required t verify crrective actins implemented New ISO language Quality cntrl data shall be analyzed and, where they are fund t be utside pre-defined criteria, planned actin shall be taken t crrect the prblem and t prevent incrrect results frm being reprted. New ISO language Infrmatin n uncertainty is needed in test reprts when it New ISO language is relevant t the validity r applicatin f the test results, when a custmer's instructin s requires, r when the uncertainty affects cmpliance t a specificatin limit; Requirements fr cntent f Quality Manual Only 9 items required t be in Quality Manual; ther items may be r may be referenced. N requirements fr cver page N requirement fr a "Methds Manual." Labs must have SOPs fr all test methds; they d nt have t be cnslidated int a "manual." 1 2 NA Demnstratin f Capability remved DOC is in mdules 3-7 and varies by scientific discipline Crrective actin rt cause analysis nw clarified t apply t systematic errrs Requires calibratin f supprt equipment t be checked each day the equipment is used Remved requirements fr date equipment was received, placed in service and cnditin when received 2003 NELAC had the phrase "prir t use n each wrking day" Clarificatin Clarificatin TNI Standards Cmparisn

8 Vlume Mdule Sectin Change Discussin Labratry Impact Expiratin dates fr reagents in riginal cntainers nt required unless prvided by manufacturer Expiratin dates fr prepared reagents and standards must be n cntainer 2003 NELAC allwed dates t be in Quality Manual New Activity New traceability requirement fr prepared reagents New Activity Date f test reprt nt required t be present Certificatin that the results meet all requirements r prvide reasns and/r justificatin if they d nt n lnger required "Reprt cannt be reprduced except in full is nw a Nte ISO language Establishes default reprting requirements as "as received." New language t allw fr additin f anlaytes t a reference methd Remved must have prcedures t relate LOD t LOQ Sets different requirements fr validatin f reference methds and nn-reference methds fr precisin and bias Initial DOC required fr all methds and analysts, except thse in effect ne year befre applying fr accreditatin Frm in Appendix C f 2003 NELAC nt required t be used fr DOC Dcumentatin must be maintained New Activity DOC Dcumentatin nt required t be in persnnel file Initial DOC required if analyst des nt perfrm methd within 12 mnths New Activity QC sample used fr DOC des nt have t be frm an utside surce replicates (e.g., the 2003 NELAC requirements) is ne ptin fr initial DOC but nt required It is the respnsibility f the labratry t dcument that ther appraches t initial DOC are adequate Optins frm NELAC still allwed: Single-blind sample, Initial DOC, r 4 LCSs TNI Standards Cmparisn

9 Vlume Mdule Sectin Change Discussin Labratry Impact Anther ptin fr n-ging DOC added: A dcumented prcess f analyst review using QC samples. QC samples can be reviewed t identify patterns fr individuals r grups f analysts and determine if crrective actin r retraining is necessary On-ging demnstratin f prficiency des nt have t cntain all analytes fr which lab/analyst is qualified; must calibrate fr all (V1M4, 1.6.3) See NELAC 2003 Analyte was never used in this sectin Clarificatin Read and understand requirements fr test methds and quality dcuments deleted (NELAC ) See M2 sectin and It may nt have the wrds read and understand but requires educatin, training, experience and demnstrated skills Lw standard must be at r belw LOQ New Activity Minimum number f calibratin standards changed frm 2 t 3 0 may be used as a calibratin pint Data must be qualified fr failed surrgate recveries NELAC said "shuld." New Activity 1 4 NA 2003 NELAC language relating t glassware cleaning remved Methd validatin required fr nn-reference methds Specific fr micrbilgy New Activity An acceptable apprach fr initial DOC described; ther ptins pssible Specific fr micrbilgy Optins fr n-ging DOC described; ther ptins pssible Specific fr micrbilgy Beginning and ending filtratin blank fr MF nw 1 per set per series, nt 1 set per filtratin unit There was a micr task grup which made significatin clarificatins t M5 Clarificatin Additinal specifics n media quality cntrl Clarificatin TOC and ammnia/rganic nitrgen added t micr water quality requirements Recrding f amunt f media received n lnger required Determinatin f time required t reestablish equilibrium in incubatrs deleted TNI Standards Cmparisn

10 Vlume Mdule Sectin Change Discussin Labratry Impact Thermal preservatin nt required if if analysis begins within 15 minutes f cllectin r samples refrigerated within 15 minutes n residual chlrine check New language makes it very clear n when this check needs t be perfrmed. Clarificatin TNI Standards Cmparisn

11 Appendix 2: Summary f Changes between the 2009 and 2016 Standards As summarized in the seven subsectins belw, TNI s Cnsensus Standards Develpment Prgram believes this 2016 Standard is a significant imprvement ver the 2009 standard in terms f clarity and cnsistency and represents the best prfessinal practices fr determining the cmpetency f envirnmental testing labratries. The table which fllws this summary shws all f the changes between the 2009 and 2016 standard. Mdule 1: Prficiency Testing Vlume 1, Mdule 1 f the 2009 TNI Standard was limited in detail and cntained requirements preventing its implementatin by sme TNI Accreditatin Bdies (ABs). Vlume 1, Mdule 1 f the 2016 TNI Standard cntains revisins t imprve the rganizatin, clarity and cntent f the standard allwing all TNI ABs t implement. The significant changes made t imprve and prvide a mre cmprehensive prficiency testing (PT) standard are listed belw: The definitins in Sectin 3.0 were remved, added, r revised t minimize redundancy with nrmative references and t ensure cnsistency. These definitins were remved as n lnger being applicable: Accreditatin Bdy Accreditatin Field f Prficiency Testing Analysis Date Experimental Field f Prficiency Testing (Experimental FPT) Supplemental Prficiency Testing Study TNI PT Bard The definitin fr Field f Prficiency Testing (FPT) was slightly revised t clarify that TNI s PT Prgram Executive Cmmittee establishes FPT. The definitins fr PT Study, PT Study Clsing Date, and PT Study Opening Date were revised t discuss bth scheduled and supplemental PT studies. A definitin fr Prficiency Testing Reprting Limit (PTRL) was added t reflect the change in Sectin 4.3. The Experimental Fields f Prficiency Testing requirements in Sectin f the 2009 standard were remved as they have been incrprated as Fields f Prficiency Testing r remved frm the PT Prgram. The cntent f Sectins 4.0 and 5.0 were rerganized fr clarity and flw f requirements. The Whle Effluent Txicity (WET) specific requirements were incrprated separately frm Chemical, Radilgical, Asbests and Micrbilgical t allw fr these differences t be clearly highlighted. New Radichemistry and Whle Effluent Txicity (WET) requirements were added t Sectins 4.0 and 5.0 t imprve cnsistency within these disciplines, including reprting radichemistry PTs as measured (zer, negative, r psitive values) and with their assciated measurement uncertainty and nly requiring 1 PT/year fr WET testing with the acceptance f DMR-QA PTs. TNI Standards Cmparisn

12 Sectin was added t require the labratry t analyze PT samples in accrdance with instructins prvided by the PT prvider. The reprting ptins and impacts relative t reprting by methd r by technlgy were explained in Sectin t help labratries understand the risks f reprting by ne r the ther. The standard nw ntes that if a labratry reprts PT results fr multiple methds using the same analytical technlgy, an evaluatin f nt acceptable fr ne methd will be applied t all methds reprted with that technlgy. The PT requirements in Sectin fr EPA drinking water analytes specified in 40 CFR 141 were clarified, nting that PT results fr these analytes are t be reprted fr each analytical methd rather than by a single analytical methd representative f a technlgy. Evaluating and reprting PT sample results dwn t the labratry s Limit f Quantitatin (LOQ) was changed back t evaluating and reprting PT sample results dwn t the prescribed Prficiency Testing Reprting Limit (PTRL). See Sectin 4.3. The 2009 TNI Standard allwed labratries t reprt PT results as less than (<) their LOQ even if the analyte was present in a PT sample, and be scred Acceptable, if the LOQ value reprted with the less than (<) sign was within the acceptance range. This was a majr bstacle fr sme TNI Accreditatin Bdies and prevented their implementatin f the 2009 TNI Standard. PTRL reprting, hwever, is smetimes difficult fr labratries t execute while still treating PT samples as rutine envirnmental samples. S, the 2016 TNI Standard als includes allwances fr labratries t deal with these difficulties, including calibrating lwer r reprting withut qualificatin fr results belw their rutine calibratin curve. PT frequency requirements were changed in Sectin frm 5-7 mnths apart t a maximum f 7 mnths apart with a minimum f 7 days between PT studies instead f 15 days t allw labratries t participate in PTs mre frequently, if they desired, and t regain r btain new fields f accreditatin mre quickly. The PT tracking requirement in Sectin was changed frm analysis date back t the PT Study clsing date as the analysis date was nerus fr bth Accreditatin Bdies and labratries t track. Using the clsing date prvides a mre streamlined prcess that is easier t maintain. The difference between an Acceptable PT scre frm a PT Prvider and a Successful PT evaluatin frm an Accreditatin Bdy was clarified in a Nte in Sectins and t ensure that labratries understand that there is mre t btaining a successful evaluatin than just reprting an acceptable result. Sectin in the 2009 standard n histrical recrds was deleted since the language in (4.4.1 in the 2016 standard), all recrds necessary, addresses this requirement. TNI Standards Cmparisn

13 The crrective actin requirements in Sectin 6.0 fr unsuccessful PTs were updated t include the submittal f the rt cause investigatin and crrective actin dcumentatin t the primary Accreditatin Bdy within 30 days f request frm the primary Accreditatin Bdy. In Vlume 2, Mdule 2, f the 2009 TNI standard, Accreditatin Bdies were required t suspend a labratry fr nt submitting a crrective actin reprt within 30 days f request, yet Vlume 1, Mdule 1, never cntained this crrespnding requirement fr labratries. This requirement eliminates that cntradictin. The allwance fr the analysis f anther PT sample t reestablish successful PT histry was remved frm the crrective actin requirements in Sectin 6.0. It is nt a requirement fr crrective actin and was n lnger needed with the change t the PT frequency nted abve allwing labs t analyze PTs at any frequency within the 7-mnth maximum. Mdule 2: Quality Systems General Requirements Added the fllwing new definitins: Analyte, Data Integrity, In-depth Data Mnitring, Lt, Physical Parameter, and Reference Methd. Mdules 3 thru 7 in the 2009 Standard used the wrd parameter t describe what is being measured, but the definitin f this term did nt reflect this purpse. The 2016 Standard added Analyte and Physical Parameter t clarify the difference and reflect cmmn practice. Sectin discusses data integrity training and in-depth data mnitring, but these terms were nt defined in the 2009 standard, which resulted in cnfusin amng sme labratries. ISO/IEC Sectin 5.4 discusses standard and nn-standard methds, but these terms are nt defined. The TNI standard uses the term reference methd t differentiate this frm the well-knwn Standard Methds in the US. Mdules 3-7 describe varius methd validatin activities t be carried ut fr reference methds and nn-reference methds. The definitin f lt was added t help clarify the requirements in Mdules 3-7 fr varius Quality Cntrl (QC) checks. Revised the definitins fr Demnstratin f Capability, Limit f Detectin, and Selectivity. The revised definitin fr Limit f Detectin is cnsistent with the definitin f Methd Detectin Limit in 40 CFR Part 136. The revised definitin fr Demnstratin f Capability fcuses n cmpetence f the analyst. The revised definitin fr Selectivity eliminated the inapprpriate use f the wrd parameter. As stated in ISO/IEC 17025, Ntes are nt enfrceable; they are guidance. Many Ntes were eliminated, r the wrd Nte was remved thus making the language part f the standard. TNI Standards Cmparisn

14 The ISO/IEC language stating that Ntes are guidance nly was added back in t Sectin 1.2. The Nte in Sectin relating t the technical manager and quality manager was remved and the text in the Nte was added t the beginning f the sectin, thus ensuring this ptin is available t labratries. The wrd Nte was remved frm the beginning f Sectin 5.5 and the language was revised t clarify that these calibratin requirements d apply t envirnmental labratries. The nte in (b) relating t labratry sample identificatin number (ID) was remved clarifying that ID numbers n sample cntainers are nt permanent recrds t eliminate cnfusin. Sectin n Data Integrity was revised t clarify that data integrity is nt a thing t be mnitred. Rather, Data Integrity is a system with varius cmpnents. Added back language cncerning nn-standard methds and methd validatin in Sectins and frm ISO/IEC The 2009 Standard had mved sme language frm these sectins int the Technical Mdules 3-7, but in an incnsistent manner and sme language frm ISO/IEC was mitted. The 2016 standard faithfully cntains all f the language in these sectins in Mdule 2, including a missing subsectin ( ) that requires labratries t assess the results frm methd validatin studies t custmer needs. Additinal language was added t sectins and t link these requirements t the methd validatin requirements in Technical Mdules 3-7. Sectin was significantly rerganized t: Require the labratry t establish specificatins fr calibratin f supprt equipment, Clarify that vlumetric checks nly apply t devices used fr quantitative analysis Add incubatrs t the list f supprt equipment requiring daily checks, Allw labratries t use a single-pint calibratin check fr temperature measuring devices that are used ver a range f 10 C r less, and Clarified subsectin (e) relative t verificatin checks fr vlumetric measuring devices. Added in missing sectins and frm ISO/IEC While these sectins primarily apply t calibratin labratries, the language is applicable t sme activities f testing labratries. The language in Sectin (a) n sample identificatin numbers was rewrded slightly fr clarity and expanded t include all sub-samples. Added in missing subsectins frm Sectin f ISO relating t calibratin certificates. Althugh this sectin des nt apply t testing labratries, the language was TNI Standards Cmparisn

15 included because f a requirement frm the American Natinal Standards Institute that all language frm ISO/IEC be included in the TNI Standard. Mdule 3: Quality Systems fr Asbests Testing Sectins 1.4 and 1.5 n Methd Selectin and Validatin were revised t be cnsistent with the ther mdules. Sectin 1.6, Demnstratin f Capability, was revised fr clarity and t allw fr mre ptins. The revised sectin reinfrces that this demnstratin applies t each individual that perfrms the test. Mdule 4: Quality Systems fr Chemistry Testing Sectins 1.4 and 1.5 n Methd Selectin and Validatin were revised t be cnsistent with ther mdules. The ISO/IEC language in these sectins was mved back int Mdule 2. The language in Sectin 1.4 abut adding analytes t reference methds was revised fr clarity. The language in sectin n validatin f reference and nn-reference methds was revised t link t Mdule 2. New language was added t require labratries t participate in PT studies. Sectin n detectin limits was significantly revised t be cnsistent with the EPA MDL prcedure in 40 CFR Part 136 and t reflect best prfessinal practice. A detectin limit study is required fr methds and analytes except where it is nt applicable (ph, clr, temperature, dr and disslved xygen). Cnsistent with the new EPA prcedure, the study must include bth spike and blank data and include results frm multiple days. Using the EPA prcedure is an ptin. On-ging quarterly verificatin analyses are required. Nte: The definitin f MDL in Mdule 2 as written des nt exactly equal the EPA definitin f an MDL, and the prcedure described in Mdule 4, while mre generic, is still different. This culd create cnfusin amng labratries n which prcedure t use, if bth prcedures use the same term. This sectin uses the term t Detectin Limit (DL) t clarify that when a lab uses the term MDL they are using the Part 136 prcedure. Sectin n Limit f Quantitatin (LOQ) was significantly revised t allw the detectin limit study in Sectin t be used t verify the LOQ and t imprve the prcedure. The verificatin criteria include bth qualitative and quantitative criteria The LOQ must be verified quarterly. Dcumentatin requirements were added. TNI Standards Cmparisn

16 Sectin 1.6, Demnstratin f Capability, was revised fr clarity and t allw fr mre ptins. The revised sectin reinfrces that this demnstratin applies t each individual that perfrms the test. Sectin n instrument calibratin has been extensively revised, describing varius calibratin ptins, discussing hw t drp calibratin pints, and intrducing a new quality cntrl measure fr evaluating calibratin curves. New sectin (e) n remval f calibratin pints was added based n vtes received in the cmment perid and reflects current data integrity practices designed t minimize inapprpriate calibratin practices. The new sectin (e) des allw replacement f calibratin pints under very limited circumstances. New sectin (f) was added t specify the minimum number f calibratin standards t ensure a minimum f three degrees f freedm. New sectin (k) was added t require labratries t use and dcument a measure f relative errr. This language was added t prevent pr calibratin practices based slely n crrelatin cefficient. The language in subsectin (h) (nw subsectin (p) was revised fr clarity and t require a linear check be perfrmed quarterly. New sectin (m) was added t address specific issues surrunding the analysis f Arclrs. New sectin (c) was added t require the calibratin check standard t be equal t r less than ne half f the highest level. Sectin (c) (nw sectin (d)) was revised t allw the secnd surce verificatin standard r a labratry cntrl sample t be used fr calibratin verificatin. The criteria fr calibratin verificatin in sectin (e) (nw sectin (f)) were revised t allw fr a secnd calibratin check standard t be used in limited circumstances. Mdule 5: Quality Systems fr Micrbilgy Testing This mdule was substantially revised t add clarity, reinfrce the cncept f minimum requirements and default t the use f the data. All prir Standard Interpretatin Requests (SIRs) were addressed as part f the revisin prcess. A definitin f surce water was added t sectin 1.3. The language in Sectin 1.4 n methd selectin was mved t Mdule 2. Sectin added language t clarify that DOCs need t be apprpriate fr data use and prgram, s that they need t mirrr what wuld be seen the specific prgram. Fr example, ttal clifrm by MF fr the DW prgram needs t have the same set f 10 aliquts as wuld be seen when ding P/A methds. A single sample with reprting a number is nt sufficient fr use in the Drinking Water prgram. TNI Standards Cmparisn

17 The Quality Cntrl sectin (1.7) was rerganized t separate the activities dne befre analysis frm thse dne during analysis, alng with many ther changes. The active vice is used thrughut the sectin. This clarificatin was made t ensure labs knw what is expected t be accmplished in the lab, by the lab. Sectin and clarify that sterility checks and methds blanks are nt the same. Sterility checks and perfrmance checks are dne n materials t be used during testing as part f the prcess. Blanks are fr methds and techniques. Sterility checks are t be dne n all materials that are part f the prcess if the sterility f an item wuld affect the test clarifies the individual requirements fr reagent water and dilutin water. This sectin als further clarifies that they are nt the same Reprducibility is clarified and made cnsistent acrss methds reprting qualitative results. If a lab must reprt a number, all analysts ding that test must be able t reprduce that number fr each test. Previusly this requirement nly applied t plate methds, but it will nw apply t all methds where a number is reprted. When verifying the selectivity f media, the prcess needs t be like fr like. If this media is t be used in a qualitative test, the selectivity must be determined with a qualitative analysis. Fr tests where P/A is reprted, P/A is sufficient fr the selectivity check. Thermmeters can be verified at a single pint as lng as they are checked at that single pint, such as in an incubatr. Vlumetric equipment is clarified and acceptance criteria is prvided. Sectin fr Incubatrs and water baths has clarified the equilibrium and unifrmity f temperature check. Als, there is sme allwance fr labs fr staffing issues, such as weekends and hlidays. Defined under test s that when needed labs may frg the secnd reading f an incubatr which is nw empty because the tests have been cmpleted and remved. This sectin has remved the requirement fr an annual Inhibitry Residue Test. It is nw nly required initially. Will nt be required again unless the sap is changed allws fr sme reasnable flexibility in sample acceptance fr samples nt quite dwn t temperature. Added a nte t clarify that the intent is t get the samples t the lab as sn as practical rather than hlding n t them until they have reached the acceptable temperature has remved the need t mnthly spt check fr chlrine remval. Hwever, language was added t clarify that this sectin is an exemptin and nt a requirement. The requirement is lcated in Mdule 2 and requires each sample be checked fr prper preservatin. As checking each sample is neither practical nr desirable as it can cmprmise the samples, this sectin spells ut what the labs must d as an alternate t a cmprehensive check. This sectin als has sme language t clarify that the labs are nt really lking fr chlrine per se, but are checking the efficacy f the sdium thisulfate. As chlrine is the mst frequent TNI Standards Cmparisn

18 type f disinfectin chemical there are still sme references, but ther types f disinfectin are mentined as well. Mdule 6: Quality Systems fr Radichemical Testing Mdule 6 was substantially revised by the Radichemistry Expert Cmmittee. While the substance f the 2009 standard was verall retained, the text underwent substantial rerganizatin and refrmulatin t add clarity and better address less well-develped cncepts. The revised standard nw better reflects current practices in envirnmental radichemistry labratries. Changes in the revised Mdule 6 include the fllwing: Definitins fr key terms were added t Sectin 1.3. Requirements fr methd validatin in Sectin 1.5 were refined t better address labratry-develped/mdified methds and t evaluate uncertainty and methd perfrmance at backgrund (zer) activity. Sectin 1.6 requirements fr Demnstratins f Capability include analysis f blanks, nce again t address methd perfrmance at backgrund activity. Technical requirements in Sectin 1.7 were rerganized t lgically parallel set-up, calibratin, calibratin verificatins, and quality cntrl f instrumentatin. Sectin prvides requirements fr mathematical calibratin methds, and fr several appraches t backgrund determinatin, bth f which are in cmmn use but neither f which are currently permitted. The mst substantial change t methd quality cntrls in Sectin 1.7.2, the Radiatin Measurements Batch, was intrduced t eliminate substantial cnfusin, and incnsistent implementatin f batch quality cntrls fr nn-destructive analyses such as gamma spectrmetry. Sectin cntains requirements fr evaluating chemical yield which were nt included in previus revisins. It als addresses reprting requirements fr uncertainty. Mdule 7: Quality Systems fr Whle Effluent Txicity Testing There are n new changes t mdule 7 at this pint. Hwever, the cmmittee wanted t mentin that they recmmended pstpning the adptin f the 2012 versin f mdule 7 because the 2009 versin better met the criteria and requirements f WET testing. The cmmittee had tw principal bjectins t the 2012 revisin as written. First, the initial demnstratin f capability fr each individual analyst, as required in f the 2012 versin, is nt representative f the way txicity labs perate and is therefre inapprpriate. TNI Standards Cmparisn

19 Secnd, requiring txicity labs t cmply with the requirements f f the chemistry mdule fr its supprt measurements is excessive, since the purpse f WET testing is nt t identify the individual cmpnents f the effluent mixture, but rather t establish whether that the effluent is sufficiently txic that it warrants further investigatin. These chemistry measurements are supprt measurements t the WET - which shuld be the primary fcus (nt the chemistry parameters). The cmmittee is currently wrking n addressing these tw tpics fr a future revisin. TNI Standards Cmparisn

20 Changes frm the 2009 t the 2016 TNI Standard Nte: Sectins number shwn in brackets. i.e. [x.x], refer t the 2009 standard. Vlume Mdule Sectin Change Discussin Labratry Impact TNI PT Bard changed t PT Prgram Executive Cmmittee This reflects an rganizatinal change in TNI that ccurred in [1.3.3] Sectin deleted. This sectin referred t an appendix that did nt exist. 1 1 [3.1] Deleted definitin fr Accreditatin Bdy. This term is defined in Vlume 2. NA 1 1 [3.2] Deleted definitin fr Accreditatin Field f Prficiency Testing This is the same as Field f Prficiency Testing and was duplicative. NA The definitin fr Field f Prficiency Testing (FPT) was slightly revised t clarify that TNI s PT Prgram Executive Cmmittee establishes FPT. 1 1 [3.3] Deleted definitin fr Analysis Date Analysis date is n lnger used fr tracking PT sample results. This was a prblematic issue fr labratries in the 2009 standard. 1 1 [3.4] Deleted definitin fr Experimental FPT Experimental FPT are n lnger allwed. Such FPTs were vluntary and thus subject t misinterpretatin Added definitin f PT Reprting Limit Definitin added t cnfrm t changes t sectin Revised definitin f PT Clsing Date t address bth scheduled and supplemental PT studies Revised definitin f PT Opening Date t address bth scheduled and supplemental PT studies Revised definitin f Study t include bth scheduled and supplemental PT studies NA NA NA NA NA NA 1 1 [3.18] Deleted definitin f Supplemental PT Study This term is nw included in 3.13 NA 1 1 [3.20] Deleted definitin f TNI PT Bard This grup n lnger exists. It has been replaced by the PT Prgram Executive Cmmittee. See Sectin New Sectin Sectin 4.0, Accreditatin Requirements, is a new sectin cntaining three subsectins. NA TNI Standards Cmparisn

21 Vlume Mdule Sectin Change Discussin Labratry Impact New Sectin cntaining General Requirements. The language in [5.1.2] regarding prhibited activities is nw New subsectin indicating the actins described in can be a cause fr revcatin. This sectin clarifies the types f PT samples required fr accreditatin referring t FPT tables, New sectin indicating these requirements can be super ceded by regulatins New sectin n Sample Handling, Preparatin and Analysis This sectin includes sme f the language frm [5.2.1] Nne, unless sme regulatin supercedes New subsectin requiring labratries t fllw instructins frm PT Prvider This was added t address issues surrunding diluting ampules t vlume 1 1 [4.2.2[ The Experimental FPT requirements in Sectin f the 2009 standard were remved as they have been incrprated as FPT r remved frm the PT Prgram The language frm 5.1.1, minus the Nte, was mved here. The Nte, rewrded, was mved t sectin New sectin requiring labratries t evaluate results t the PT Reprting Limit (PTRL) New sectin t allw labratries t reprt t their LOQ if their LOQ is less than the PTRL. This is a substantive change t [5.2.1]. The 2009 standard allwed reprting t the LOQ. TNI has develped extensive guidance t assist labratries with this issue and it will be discussed in a training curse scheduled fr later summer Significant issue fr labratries that test fr rganics New sectin that allws labratries t rescale their calibratin curve r reprt unqualified data belw the LOQ. Because f the language in 4.2.2, this language was added t allw flexibility in meeting PTRLs New sectin n Reprting Requirements Sme f the language frm [5.2] was mved here This is [5.1.1] with minr edits. Remved experimental PTs This is [5.1.2] with a sentence added abut initial accreditatin and ther minr edits New subsectin t link PT results t FPTs. TNI Standards Cmparisn

22 Vlume Mdule Sectin Change Discussin Labratry Impact This new subsectin takes the Nte in [5.1.1], remves the Nte thus making this sectin applicable, but then adds a Nte relative t multiple methds that use the same technlgy New subsectin emphasizing the reprting t PTRL requirement in and See and New subsectin n radichemistry PTs. Clarifies reprting radichemistry results as measured (zer, negative, r psitive values) and with their assciated measurement uncertainty New subsectin n reprting t PTRL. This sectin discusses varius reprting ptins based n results abve r belw the labratry LOQ and/r PTRL New subsectin fr slid PTs. The sectin states results are nt t be adjusted fr misture cntent. Significant issue fr labratries that test fr rganics. Significant issue fr labratries that test fr rganics Sectin [4] was renamed and renumbered t 5.0, PT Study Frequency Requirements fr Accreditatin. The sectin has been clarified and includes new sectins n PT testing fr Whle Effluent Txicity Sectin divided int 2 subsectins with fr asbests, chemistry, micrbilgy and radichemistry and fr txicity. A Nte was added t indicate acceptable perfrmance is mre than getting acceptable scres [4.1.1] rewrded t allw 2 ut f 3 passing fr initial accreditatin with a Nte that indicates a third PT is nt required if the first 2 pass. The 2 Ntes in [4.1.1] were deleted. The requirement t have the 2 initial PTs t be at least 15 days apart has been reduced t 7 days. [4.1.3] was rewrded t add a clause regarding semi-annual testing and defining this as n mre than 7 mnths apart. PT frequency requirements were changed frm 5-7 mnths apart t a maximum f 7 mnths apart with a minimum f 7 days between PT studies instead f 15 days t allw labratries t participate in PTs mre frequently, if they desired, and t regain r btain new fields f accreditatin mre quickly New subsectin n Whle Effluent Txicity testing. These types f PT samples were nt discussed in the 2009 standard Sectin divided int 2 subsectins with fr asbests, chemistry, micrbilgy and radichemistry and fr txicity. A Nte was added t indicate acceptable perfrmance is mre than getting acceptable scres. TNI Standards Cmparisn

23 Vlume Mdule Sectin Change Discussin Labratry Impact [4.2.1 a-c] rewrded but with n change in the requirement ther than the phrase at least 5 mnths apart was deleted and 15 days between PT samples was reduced t The PT tracking requirement in Sectin was changed frm analysis date back t the PT Study clsing date as the analysis date was nerus fr bth Accreditatin Bdies and labratries t track [4.2.1 d-e] rewrded with mre discussin abut DMRQA fr txicity testing, but the discussin n crrectin actin mved t New subsectin that indicating that nt analyzing PT samples in the required time frame cunts as a failure. Using the clsing date prvides a mre streamlined prcess that is easier t maintain. Easier prcess. 1 1 [5.3.2] This sectin in the 2009 standard n histrical recrds was deleted since the language in in the 2016 standard, all recrds necessary, addresses this requirement [6.1] rewrded t fcus n crrective actin and rt cause analysis. The language n supplemental studies remved New sectin that requires the labratry t prvide their AB with a crrective actin reprt when requested New sectin indicating failure t prvide a crrectin actin reprt is cause fr suspensin New subsectin cntaining sme f the language frm [4.1 d] n dcumentatin f crrective actin fr txicity testing. Althugh the sectin n lnger discusses supplemental PT samples t demnstrate cmpliance, there is n prhibitin frm ding s. In Vlume 2, Mdule 2, f the 2009 TNI standard, Accreditatin Bdies were required t suspend a labratry fr nt submitting a crrective actin reprt within 30 days f request, yet Vlume 1, Mdule 1, never cntained this requirement fr labratries. This requirement eliminates that cntradictin. Nte that sectins 6.1 thrugh 6.4 als apply t WET testing New sectin n submitting questins t an AB and 8.2 Tw sentences rewrded with n change in the requirements New sectin n suspensin relative t nt prviding a crrective actin reprt. While [6.1] required crrective actin fr failed PT samples, it did nt require this t be reprted t the AB. The revised 6.3 requires the labratry t prvide such a reprt if TNI Standards Cmparisn