James H. Nichols, Ph.D., DABCC, FACB is a Professor of Pathology at Tufts University School of Medicine and Medical Director, Clinical Chemistry for

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1 James H. Nichls, Ph.D., DABCC, FACB is a Prfessr f Pathlgy at Tufts University Schl f Medicine and Medical Directr, Clinical Chemistry fr Baystate Health in Springfield, MA. Jim received his B.A. in General Bilgy/Premedicine frm Revelle Cllege, University f Califrnia at San Dieg. He went n t cmplete a Masters and Dctrate in Bichemistry frm the University f Illinis, Urbana- Champaign. Dr. Nichls was a fellw in the Pstdctral Training Prgram in Clinical Chemistry at the May Clinic, Rchester, MN.

2 James H. Nichls, PhD, DABCC, FACB Prfessr f Pathlgy Tufts University Schl f Medicine Medical Directr, Clinical Chemistry Baystate Health james.nichls@baystatehealth.rg

3 Identify cmmn cmpliance issues with POCT prgrams Discuss strategies t imprve POCT cmpliance Describe ne way t develp a POCT website using Micrsft Wrd

4 Labratry POCT One site Limited instrumentatin t perfrm bulk f testing Limited staff, fcused n same equipment daily Staff trained in labratry skills Dzens f sites, hundreds f devices and thusands f peratrs Staff are clinically fcused n patient nt n equipment Staff d nt have labratry training backgrund

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6 Leading prvider f healthcare services in Western MA 8200 emplyees, Grss revenues >$1.1 billin Baystate Medical Center - tertiary care Hybrid Academic/Private Practice - >1000 physicians 615 beds; 3rd largest acute care in NE 4500 emplyees 40,000 discharges/200,000 inpatient days (4.5 mean LOS) 600,000 ambulatry visits 142,000 emergency visits Western Campus Tufts Schl f Medicine 240 residents Franklin (96 beds) and Mary Lane (31 beds) Hspitals

7 METHOD SITES DEVICES OPERATORS Abbtt PCx UriSys Pylritek 2 15 Quidel Pregnancy Quidel Strep 9 50 Hemccult 2 50 Nitrazine ph 9 50 HIV 2 20 i-stat DCA2000/Afinin ITC Signature Elite ACT ITC PrTime PT PPM 8 10

8 Critical Values Misinterpret results Results dn t match symptms Wrng units Pstanalytic Wrng test POCT vs Lab Misidentificatin Preanalytic Cltted bld Wrng Tube Delays Test Limitatins Shrtcuts Analytic N QC Device cmplexity Bubbles Sample vlume Errrs

9 Set plicy fr QA/QC strategies t minimize risk f errrs Establish quality gals Mnitr cmpliance with POCT plicies Dcument perfrmance imprvement

10 Successful QC QC dcumentatin Number f errrs where wrng QC analyzed QC statistics cmpared t hspital statistics Percent f QC that fail QC utliers with cmment Failed QC with apprpriate actin (patients nt tested) Utilizatin (number f tests/site r device) Tests billed vs tests purchased Single lts f test and QC in use at any time Cmpliance Untrained peratrs Clerical errrs r data entry errrs Medical recrd entry with reference ranges Expired reagents Refrigeratr temperature mnitred Prficiency testing successful Actin plan respnse t site cmpliance deficiencies

11 APTU Cardiac Cath CICU/PCU CSC Daly 4 Inf/Child Daly 5A Daly 6A 1 QC utlier withut a cmment cde. Ok. ACT pt vlume = 223; Liquid QC vlume = ACT Liquid QC fails/36 LQC tests = 11% fails. 1 QC utlier withut a cmment cde. ID errr rate = 1 PCx invalid patient ID/380 ttal tests = 0.2%. 1 QC utlier withut a cmment cde. ID errrs nt decreasing: 1 PCx invalid patient ID/76 ttal tests = 1.3%. QC/reagents expired. Manager ntified via 4/11/08. ID errr rate = 3 PCx invalid patient ID/1496 ttal tests = 0.2%. Ok. ID errr rate = 2 PCx invalid patient ID/1037 ttal tests = 0.19%. Daly 6B ID errrs nt decreasing: 7 PCx invalid patient ID/2212 ttal tests = 0.3%.

12 ID errrs the patient ID entered int the glucse meter r ther POCT device desn t match active patient r matches wrng patient n dwnlad Daily refrigeratr mnitring Perfrmance and dcumentatin f QC r QC exceptins and crrective actins Expired reagents f cntrls Site actin plans and fllw-up t cmpliance issues

13 Self-management System Changes Cmmunicatin Visibility and POCT representatin n unit

14 Every persn plays a rle and has respnsibility in patient utcme POCT is part f patient care nt an ancillary service Thse invlved in patient care have respnsibility t perfrm and maintain POCT Prmtes mutual respect and individual respnsibility Philsphy sets lab as resurce nt dictatr

15 Lab can t hld everyne s hand, 24 hurs a day Lab is a resurce in setting hspital plicy (tgether with nursing, physicians, etc) Lab knws the CLIA requirements and what needs t be dne Nursing/Clinicians knw hw the test will be used in patient management Mutual trust that this plicy will be fulfilled, it is a rle f the emplyee s jb Nursing nt the lab is respnsible fr discipline when actins nt fllwed.

16 Balance f all disciplines invlved Remember CLIA 88 and accreditatin agency regulatins indicate what has t be dne nt hw t d it Different nursing units have different wrkflw and peratinal aspects that can accmmdate the regulatins in different ways and still be cmpliant Institutinal plicies must allw nursing units t implement POCT in ways that fit their wrk, s plicies and prcedures must nt be s restrictive as t lead t failure and nncmpliance

17 Fr many POCT devices, tw levels f external liquid QC must be analyzed and dcumented every 24 hrs f patient testing Many ways this can be accmplished Lab can send a MT t perfrm QC each day Isn t cmpliant with spirit f law, shared respnsibility Units can schedule staff t rtate perfrmance Units can assign t ne shift and rtate staff (peridically change shifts 12 hur days easy t rtate requirement semi-annually) Weekday utpatient clinics nly need perfrm QC when pen. Other ptins pssible prvided nursing unit meets 2 levels every 24 hr and rtates staff. System change t devices with QC lckut features mandate the perfrmance f QC at defined schedule and autmatically dcument that QC was acceptable

18 When prblems ccur, ften easier t blame an peratr than the system fr an errr If we take nte f the airline industry, mst prblems are nt the cause f a persn, but a weakness in the system that allwed the errr t happen in the first place. Establish ur POCT plicies t prevent errrs in the first place, and setup cntrls and mnitrs arund weak steps that can t be engineered ut f the testing prcess (like QC lckuts).

19 CLIA and regulatry requirement t cntact the rdering physician r clinician wh can take actin ASAP after critical result Sme POCT require staff t repeat test r send cnfirmatin t the lab setup fr nncmpliance Our plicy nly indicates the varius ptins fr staff Repeat the test n same/different device OR Send a cnfirmatry venus sample t lab OR Treat clinically as result matches clinical symptms Cmmunicatin desn t need t be dcumented IF peratr is rdering physician r if nurse wh can take actin All nursing TA s must dcument critical results like ALL POCT results using the electrnic nursing ntes in the EMR. System integrates critical results int rutine peratin

20 ID errrs the patient ID entered int the glucse meter r ther POCT device desn t match active patient r matches wrng patient n dwnlad Clerical ID entry errrs mnitred Initial gal 8 years ag was <5% errrs, lwered 5 years ag t < 3% Bld gas analyzers set up fr duplicate data entry t help with clerical errrs CAP recmmended zer tlerance Attempted implementing peratr 3 strike rule

21 Prblem was a system prblem We were requiring a 5 digit peratr ID and 9 digit patient accunt number with every test Manual entry f 14 digits is surce f errrs Only means f achieving zer errrs - barcding

22 In practice, ne f the mre challenging prjects t implement in an institutin: Devices nly read specific barcde languages Wristbands vary in durability Ink isn t permanent (thermal vs inkjet) Devices dn t require barcde entry! Try t engineer arund manual entry by adding special characters r digits t ID These wrk-arunds lengthen the barcde and increase read failure if barcde nt flat n wrist. Hw t print? Wristbands nly r labels that an peratr can stick nt device r paper chart? What abut nenates?

23 During implementatin, peratrs cntinued t manually enter patient IDs due t the scanner failing n the 1 st attempt An investigatin was cnducted int why scanners fail i-stat scanners failed mre frequently than glucse Operatr interactin with the POCT device was the primary determinant in scanner failure

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29 P=0.014 P=0.0007

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31 Implemented new glucse meter, Abbtt Xceed Pr Imprved barcde scanner fewer scanning errrs Psitive patient ID ADT feed, psts patient name when ID scanned r manually entered Must manually cnfirm ID by entering patient birth date Few patient ID errrs pst implementatin Selectin f utpatient episde fr inpatient care ED dwntime 911 cdes withut fllw-up in 24 hr Change in system has taken us frm >5% ID errrs t <5 a mnth thrughut the health system

32 POCT website develped with all f the tls necessary t manage POCT POCT sites have necessary resurces, and have n ne t blame but themselves fr nt succeeding Separates the lab frm being respnsible and in the middle f a nursing care prcess. Lab is available, nursing is respnsible

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34 Many ways t accmplish Use IT resurces t design t specificatin (mst institutins dn t have staff availability) Recruit Lab Infrmatin Services staff t build the website (particularly if lab plicies and prcedures ging paperless) Build it yurself

35 Website sftware Website Studi 4.0 Adbe Dreamweaver CS4 Phtn FX Easy Website Pr EZGeneratr Web Page Maker Site Spinner WebEasy Prfessinal Flash Website Builder Facebk, Twitter, Blgs Ggle free sftware Ggle Page Creatr

36 I, like mst medical prfessinals have n web experience nr available staff resurces frm IT t build a site fr me POCT culd budget fr resurces, but the wait time is lng fr IT prjects and expensive even if we culd get budget t build a site Build it myself using existing sftware (Wrd)

37 .html is the universal webpage file extensin Micrsft wrd has templates and can walk yu thrugh a shrt tutrial. Once dne save the file as an.html rather than.dc Open Micrsft wrd Lad a template Fill in the page cntent Save the file as.html

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44 Basic pages with a few links are easy t build and manage As links grw, number f files t manage becmes a challenge Updating ne page, can lse links tied t that page, s need t check all links n a page after each revisin This is where the task f maintaining a website becmes resurce intensive Recmmend t keep all files with assciated links, pictures, etc. in a separate flder n yur hard-drive, the back-up, wrking cpy Simple task t cpy this flder t the live website server

45 Obviusly, this is nt as prfessinal nr des the website have as many features as a prfessinally develped site Website can be built in a few hurs frm existing files and educatinal materials Only requires IT assistance t prvide space n hspital server and a link t yur POCT cntent

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52 Prtect yur cntent Use.pdf versins r cpy prtected wrd dcs Only allw access behind yur institutinal firewalls Get IS invlved in serving yur cntent Becmes imprtant with separate physician ffices/hspitals under separate CLIA just adpting yur plicies

53 POCT staff mnthly site inspectins ED lw cmpliance with key benchmarks Frequent POCT identificatin errrs Missed days fr temperature mnitring Outdated reagents/cntrls Failure t cmment failed QC, ut f range result cmmunicatin, etc. Pr fllw-up and actin plans Leadership claims t be different than ther units POCT nt unique similar nursing rund results

54 Acute care need fr rapid respnse Level 1 trauma center High staff turnver and utside cverage Lse administrative cntinuity Frequent staff reeducatin f basics Less wnership than ther hspital sites

55 Tw champins f POCT n unit helped mtivate staff re: POCT challenges This staff prvided visibility f POCT n unit and ffered nging liaisn fr cmpliance Staff tired f same issues reccurring mnth after mnth Cllected a team f TA peratrs Redesigned the self-inspectin frm Delegated tasks Assigned POCT respnsibilities t all shifts 4 team leads all respnsible wkly cmpliance

56 Baystate Health Systems/Emergency Department POCT Site Inspectin Reprt Signature: Date: Glucse QC marked with Exp. Date Review OK Cmments r Actins The QC bttles are gd until manufacturers utdate r fr 90 days nce pened. There shuld be ne set pened and in the plastic bx in the lab rm. Urinalysis Review OK Cmments r Actins Reagents dated and nt expired? Caps tight n the multistix bttles? Crrect QC n lg? Crrect QC ranges nted n lg? QC perfrmed each day n all pen bttles? QC perfrmed when a new bttle is pened? QC failures repeated with remedial actin plan? Daily and weekly maintenance perfrmed n Clinitek 50? Temperature chart cmplete with actin taken when ut f range? Patient results lgged? MR # and initials n tape? Patient results charted with reference ranges? Urine cntrls are t be kept in the refrigeratr. They are gd until manufacturers utdate. They are gd at rm temperature fr 30 days. Each pen bttle must have QC dne. Multistix bttles are t be dated and initialed when pened. They are gd until manufacturers utdate unless the cap is left t lse r ff.

57 Dramatic shift in cmpliance bserved TA wnership f all staff New self-inspectin delineated respnsibility Defined wnership and jb descriptins Enhanced awareness f QC/exp dates/temp Staff turnver planned fr cntinuity Enhanced fllw-up with actin plans POCT ID errrs dwn Staff weren t waiting fr pt registratin prir t POCT Using dwntime 999 cdes w/ fllw-up in 24hr TA team wrked with the ED reg staff t get pts registered and banded faster upn admissin Key a prcess change led t enhanced utcmes

58 POCT cmpliance reflects successful ptimizatin f POCT quality Cmpliance requires plicies that allw individual flexibility in implementatin withut being t stringent in enfrcing a single view Sme strategies t imprve prgram cmpliance include: Prmting self-management and rle f each staff in patient care Implementing system changes t cmpliance issues (rather than blaming the peratr) Cmmunicatin f plicies, prgram gals and expectatins Onging visibility n the nursing unit thrugh lab visits and POCT cntacts n the unit.

59 Fr a list f all the ways that technlgy has failed t imprve the quality f life, please press three Alice Kahn