Contents: POCT Program Massachusetts General Hospital - Pathology Service 55 Fruit Street, Boston, MA 02114

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1 Title: GEM OPL Prcedure Crss References: Gem OPL Initial Training and Assessment Recrd Gem OPL Cmpetency Dcumentatin - 6 mnth and annual Gem OPL Crrective Actin Lg Gem OPL Instrument Replacement Lg MGH POCT Inter-Labratry Crrelatin Prcedure POCT Prficiency Testing Prcedure POCT Prficiency Testing Evaluatin Wrksheet POCT Prgram Massachusetts General Hspital - Pathlgy Service 55 Fruit Street, Bstn, MA Cntents: Purpse... 2 Scpe... 2 Plicy and Prcedure Statement... 2 Test Principle... 2 Prficiency Testing... 2 Regulatry Requirements... 3 Cmpetency Assessment... 4 Critical Elements... 4 Limitatins and Interferences... 4 Test Kit/Supplies/Equipment... 5 Calibratin... 5 Calibratin Verificatin/Crrelatins... 5 Quality Cntrl Mnitring... 6 Specimen Cllectin... 7 Patient Test Prcedure... 7 Instrument Replacement / Majr Maintenance... 9 Reference Ranges... 9 Technical Supprt... 9 References... 9 Crss-References... 9 Written by: Paul Pappagianpuls Date: 6/1/2005 Updated by: Paul Pappagianpuls Date: 07/12/2010 Reviewed/Apprved by: Kent Lewandrwski, MD Date: 9/30/2010 1

2 Purpse This dcument utlines plicies and prcedures that deal with Ttal Hemglbin and %O2Hgb testing. In an effrt t be cncise sme infrmatin may be excluded frm the manufacturer s recmmended prcedure. It is recmmended that peratrs familiarize themselves with the manufacturer s prduct infrmatin that accmpanies each package and their manual if ne exists. Scpe Level f Persnnel: Pulmnary Functin & CPET Technicians Testing Site: Pulmnary Functin CCU Labratry Plicy and Prcedure Statement The Gem OPL is a mderately cmplex instrument that perfrms definitive whle bld analysis f ttal hemglbin cncentratin, xyhemglbin fractin and the xygen cntent. These analytes are measured using specific and multiple wavelengths t btain results. Physicians may give a verbal rder fr xygen saturatin measurement. Reasns may include, but are nt limited t: Cardiac utput calculatin (FICK) ASD, VSD, PFO studies Verificatin f arterial/venus access Respiratry cmprmise Test Principle The ttal hemglbin cncentratin measured by the Gem OPL includes xy-, dexy-, met-, and carbxyhemglbin: [THb] = [HbO2] + [Hb] + [MetHb] + [HbCO]. Similarly, the percentage f xyhemglbin reprted by the Gem OPL is the s-called fractinal saturatin: %O2Hb = [HbO2] 100 [HbO2] + [Hb] + [MetHb] + [HbCO] The xygen cntent f the sample is [O2] = 1.39 THb %HbO2 / 100, if disslved xygen is ignred, THb is expressed in g/dl, and [O2] is expressed in ml/dl. N sample preparatin is required. Analysis is quickly accmplished by injecting the sample int a dispsable cuvette and inserting the cuvette int the instrument. The Gem OPL then illuminates the sample with multiple wavelengths, recrds the ptical density f the sample at each f the wavelengths, and cmputes the results. In less than 10 secnds, the xyhemglbin fractin, the ttal hemglbin cncentratin, and the xygen cntent f the sample are shwn in apprpriate units n the liquid-crystal display n the frnt panel. Prficiency Testing The Cllege f American Pathlgists (CAP) sends unknwn samples t the labratry fr analysis several times per year. Results are submitted t the CAP within 10 days f survey receipt. If a site fails 2 ut f 3 events r tw cnsecutive events, accrding t federal law, it may be required t discntinue testing. All Survey results are t be handled and reprted in the same manner as clinical results fllwing the directins n the CAP Survey package insert. The samples are nt t be analyzed in duplicate unless clinical specimens are analyzed in duplicate. Actins r decisins must be dcumented. 2

3 Participatin must be randm and nt assigned t specific individuals. Successful participatin may be used as demnstrating successful cmpetency fr that year. Upn receiving the survey: The POCT prgram will cntact the participating departments regarding the survey and the timeline f the survey t be perfrmed. The departments must be available within the perid identified by POCT. The Key peratrs must make sure f the fllwing: Instruments are in gd wrking rder. Randmly select staff t participate. Maintain riginal CAP survey frm with the results dcumented. Maintain the signed Attestatin frm. In additin, retain cpies f abve in the files f testing persnnel. Once results are btained, they shuld be reprted t CAP via mail, fax r electrnic entry n the CAP website. Site Directr and CLIA certificate Directr r designees shall review survey results t assess perfrmance and ensure cmpliance with the standard and cmment. Scres f 100 % minimally requires dcumentatin f review by the Directr r designee. Scres between 100% and 80% requires a cmprehensive investigatin and remedial actin dcumented f unsuccessful challenges. Scres less than 80% requires a cmprehensive investigatin and dcumentatin f remedial actin f unsuccessful challenges. Scres f less than 80 percent may jepardize a sites ability t cntinue t perfrm testing. Shuld a site fail prficiency, they will be required t immediately perfrm a cmprehensive investigatin and dcument remedial actin. Operatr re-training may be required. In rder t avid cessatin f testing a site failing a challenge will be expected t develp and implement a mre aggressive plan fr perfrmance imprvement. Each site is respnsible fr cmpleting survey challenges when they arrive. Anticipated Survey Perids: SO (Oximetry) Prduct Receipt April July Octber Evaluatin Receipt May August Nvember Regulatry Requirements I. Each testing site must have a dcumented quality cntrl prgram, which is develped in cllabratin with r has been apprved by the MGH Pathlgy Service. II. All test results must be maintained in patient recrds with all required infrmatin fr fur years Required infrmatin: 1. Patient s name 2. Medical Recrd Number 3. Patient s gender 4. Patient s age r date f birth 5. Date & time test cllected, perfrmed and reprted 3

4 6. Ordering Physician 7. Respnsible physician (if nt 6) 8. Reference r Target Range 9. Test Perfrmed 10. Test units 11. Lab name III. Additinal infrmatin that must be retained fr fur years: 1. Testing persnnel recrds 2. Quality cntrl results 3. Prduct infrmatin (i.e. serial number, lt numbers, expiratin dates, etc.), infrmatin n quality cntrl and any remedial actin 4. QC charts, maintenance sheets, reference and critical ranges IV. Other: 1. Universal precautins must be bserved when handling any patient specimen. 2. A physician s rder r standing rder is required is required prir t perfrming test. 3. The Hspital Hand Hygiene plicy must be adhered t at all times. V. Linearity/ Calibratin Verificatin The testing site will perfrm and dcument linearity/calibratin verificatin checks every six mnths. Cmpetency Assessment All peratrs must read the prcedure manual and cmplete the Operatr Training Checklist after initial training. Fr Ttal HGB and %O2Hb, the cmpetency assessment prcess is dne fllwing initial training, at 6 mnths during the first year, then annually thereafter. Cmpetency is assessed using six methds, examples f which are belw: 1. Successful perfrmance f rutine patient testing, verified by direct bservatin 2. Supervisr mnitring f the recrding and reprting f test results 3. Supervisr review f intermediate test results, QC, prficiency tests, and preventative maintenance perfrmance 4. Successful perfrmance f instrument maintenance functin checks and calibratin, verified by direct bservatin 5. Testing previusly analyzed samples, prficiency testing samples, r internal blind testing samples. 6. Assessment f prblem-slving skills Expired Operatrs: Operatrs that fail t meet cmpetency requirements within 365 days will be lcked ut f the system. They will be required t underg retraining and cmpetency assessment accrding t abve. Critical Elements 1. Never re-use a test cuvette nce it has been inserted int the analyzer. 2. D nt remve the syringe frm the cuvette until testing is cmplete. 3. Discard cuvette with trapped air bubbles and check fr bld clts frm patient specimen prir t injectin. 4. A delay in analysis f greater than 30 secnds may yield errneus results. 5. Air bubbles will yield errneus results. If any air bubbles are present in the light pathway, discard cuvette. 6. Overfilling f the testing cuvette is a cmmn surce f errr. This actin will cause bld t cver the ptics windw inside the instrument and affect results. Cntact the IL Tech Supprt if cntaminatin is suspected. Limitatins and Interferences 4

5 1. The Gem OPL is validated fr the range f %O2Hb frm 5.1 t 100%. The THb is validated frm 5.1 t 21 g/dl. Samples with results utside f these ranges shuld be cnfirmed with a repeat sample. 2. An incrrect THb value will be btained if the crrect pathlength fr the cuvettes in use is nt entered int the Gem OPL. Test Kit/Supplies/Equipment Prduct Vendr Manufacturer # Peple Sft# Strage Cuvettes IL IL RT tightly sealed Optical QC filters IL *Instrument serial Cntact RT Yellw and Orange number specific vendr Level-1 CO-Oximeter cntrl Level-2 CO-Oximeter cntrl IL IL IL IL RT (12 mnths) 2-8ºC (36 mnths) Level-3 CO-Oximeter cntrl IL IL RT (12 mnths) 2-8ºC (36 mnths) CO-Oximeter calibratin RNA Medical RNA CVC ºC (18 mnths) verificatin cntrls Syringes 1 ml BD RT Calibratin As the Gem OPL emplys highly stable state-f-the-art light surces, it des nt need t be re-calibrated frequently. The Gem OPL easily maintains its calibratin fr five r mre years. A. Cuvette Pathlength (THb calibratin): Each time a new bag f cuvettes is put int use, the pathlength value f the cuvettes must be entered int the Gem OPL. The prcedure is as fllws: 1. Press the Main Menu key, and select Optin 1 t reach the calibratin menu. 2. Select Chice 3 n the calibratin menu. 3. When prmpted t d s, enter the pathlength value n the bag f cuvettes currently in use int the Gem OPL. 4. After cnfirmatin that the value entered is crrect, the instrument will stre a new calibratin cnstant in nn-vlatile memry and use it in subsequent analyses. Calibratin Verificatin/Crrelatins Calibratin verificatin must be perfrmed: 1. Every six mnths by using RNA CVC 223 kit 2. If there is any majr maintenance r replacement f any critical parts that may influence test perfrmance. 3. Instrument replacement 4. Cntrl results indicate that there may be a prblem with the test system. Results will be entered int the nline prgram available frm RNA Medical t prvide a reprt n the linearity and calibratin verificatin f the Gem OPL alng with peer cmparisn. Results fr the calibratin verificatin will be reviewed and apprved by the POCT Site Crdinatr and the Medical Directr. Failure f any parameter will require an investigatin and pssibly re-calibratin f the instrument. Patient sample crrelatins may be perfrmed if required. Crrelatins between the Gem OPL and the Avximeter are perfrmed every six mnths. 5

6 Quality Cntrl Mnitring Daily: Tw QC filters are prvided fr verificatin f the calibratin f the instrument. Autmatic QC lckut requires that bth filters be run every 8 hurs f patient testing and electrnically dcumented in IMPACT. Filters are serial number specific and may nly be used with assigned instrument. The fllwing QC results shuld fall within the fllwing ranges: THb %HbO2 Yellw QC filter 7.8 t 8.2 g/dl 93.7 t 96.3% Orange QC filter 16.7 t 17.3 g/dl 37.8 t 40.2% Running a QC filter: 1. Insert ne f the QC filters int the Gem OPL. 2. Enter yur Operatr ID int the instrument as requested. 3. Dcument results n QC lg sheet. Patient testing shuld nt be perfrmed if any ne f the fur QC values is ut f range. Any values ut f range may indicate dirty ptics. The ptics shuld be cleaned accrding t the manufacturer s directins (see Trubleshting Sectin in Operatr s and Service manual ). The QC filters must be repeated after cleaning the dirty ptics. If the prblem persists, cntact the IL Tech Supprt Weekly: Three levels f liquid QC are perfrmed weekly t verify calibratin f the system. 1. Fllw hand hygiene prtcl and use glves. 2. Enter yur Operatr ID number using the numeric keypad and press ENTER. 3. Shake the cntrl sample Level 1 accrding t the manufacturer's recmmendatins, apprximately ten secnds. 4. Restre liquid t the bttm f the ampule with gentle tapping. If fam r small bubbles are present, allw ampule t stand until these have cme t the surface. 5. With fingers prtected, carefully snap pen the ampule. 6. Cntents shuld be sampled as sn as the ampule is pened. It is necessary t transfer liquid frm the ampule t a syringe. Use a 1 ml nn heparinized syringe. Insert tip f syringe int the ampule, lift the bttm f ampule up and slwly draw liquid int the syringe withut sample air. 7. Remve the syringe and insert the syringe tip int the cuvette syringe prt n the cuvette and inject the QC sample hlding cuvette dwn at a 45 angle. Inject QC material int the cuvette until the sample reaches the vent patch. Leave syringe attached t cuvette. Nte: Over injectin f QC material will cause the vent patch t bulge utward. If this happens, pull back slightly n the syringe plunger just until the patch flattens. 8. Check that n air bubbles are present in the sample light path. Nte: Air bubbles will yield errneus results. If air bubbles are present in the light pathway, discard cuvette. 9. Hlding the cuvette by the black cap, gently insert it int the slt f the instrument's frnt panel. 10. Insert the cuvette within 30 secnds f filling it. Nte: A delay f analysis greater than 30 secnds may yield errneus results. 11. Quality Cntrl data will be displayed. Data is saved electrnically in Gem IMPACT. Nte: If a result is utside f the range limits, this represents an unsuccessful quality cntrl test. a. Verify that the Cuvette pathlength is crrect fr the cuvettes in use, b. Check the desiccant's indicatr in the cuvette package, c. Perfrm the ptical QC using the yellw and range filters, d. Repeat the cntrl with a new ampule. If the results are within range, prceed with patient testing, e. If results are still utside f acceptable range limits, cntact the IL Tech Supprt f. D nt use instrument. 12. Discard the cuvette in an apprpriate bihazard cntainer 13. Repeat steps 1-10 fr Level 2 & Level 3cntrls. 6

7 14. Data saved in Gem IMPACT. Specimen Cllectin Heparinized whle bld is used. The sample shuld be btained frm an arterial cath, an arterial puncture, venus cath r venipuncture. Sample shuld be labeled with tw patient identifiers accrding t hspital plicy. 1. Use apprpriate precautins fr handling pssibly infectius bld. 2. Withdraw 10cc f bld int a syringe and discard. Fr a PA line, apprximately 2cc f waste is necessary. Withdraw 0.5cc f bld fr testing. 3. The required sample size fr the Gem OPL is 50 μl. Prir t analysis the sample shuld be free f any air bubbles and mixed by rlling the syringe between the utstretched palms f bth hands fr 10 secnds. Invert the syringe and repeat mixing. Expel a small amunt f bld sample int an absrbent surface. Care shuld be taken t prevent the intrductin f air int the sample when it is drawn. Expel all air bubbles frm the syringe and cap r seal the end f the syringe. Patient Test Prcedure 1. Patient testing can nly be dne if all quality cntrl results are within acceptable limits. 2. The instrument indicated that it is ready t analyze samples by displaying the fllwing message: 3. Fllw hand hygiene prtcl and use glves 4. Cllect the bld sample in a heparinized syringe ensuring prper waste t avid cntaminatin. 5. Rll the syringe cntaining the bld sample between hands peridically inverting the syringe t mix the sample thrughly. The sample must be mixed fr a full ten-secnd interval just prir t injectin int the cuvette. Nte: Prly mixed samples r thse cntaining clts may cause inaccurate results. 6. Expel a small amunt f sample frm the syringe. 7. NEVER INJECT BLOOD INTO THE INSTRUMENT ITSELF. 8. Attach a dispsable cuvette t the luer tip f the syringe, and inject the bld int the cuvette fllwing the directins fr Crrect Cuvette Technique. Crrect Cuvette Technique: a. Cnnect bld-filled, plastic syringe t a new dispsable cuvette. b. Hld cuvette dwnward at a 45 angle and express bld int cuvette until sample fills cuvette up t the vent patch at the ppsite end. CAUTION: Never frce bld int cuvette. If cuvette des nt fill easily, discard it and use anther ne. 7

8 c. Observing the cuvette clsely, make sure that the light path at the widest prtin f the sample chamber is cmpletely filled with bld and that bld reaches the air vent at the ppsite end f the cuvette. Nte: Over injectin f bld will cause the vent patch t bulge utward. If this happens, pull back slightly n the syringe plunger t flatten patch. d. Check that n air bubbles are present in the sample light path. Nte: Air bubbles will yield errneus results. If air bubbles are present in the light pathway, discard cuvette. e. If any bld is n the exterir surface f the cuvette, wipe it ff with gauze. 9. Leaving the syringe attached t the cuvette, and hlding the cuvette firmly by its black cap, insert the cuvette int the slt in the frnt panel f the instrument within 30 secnds f filling. Nte: A delay in analysis f greater than 30 secnds may yield errneus results. 10. Enter patient medical recrd number and press Yes. 11. Enter yur 9 digit peratr ID number (nly valid peratrs are allwed t perfrm testing) and press Yes. 12. Observe the LCD display. D nt disturb the Gem OPL while it is busy. Within 10 secnds, the results will be displayed. 13. Withdraw the cuvette as sn as the sample has been analyzed. Data will stay n the display until the cuvette is remved. A printut f the results is available n the attached printer and data will remain in nn-vlatile memry until deleted. 14. T analyze the next sample, discard the previusly used cuvette int an apprpriate bihazard cntainer, btain a fresh cuvette frm the bx and repeat the prcess frm step 1. 8

9 15. In the event f a test result that appears incnsistent with the patient s clinical status, send a sample t the Stat ABG lab. Instrument Replacement / Majr Maintenance A. The replacement instrument plicy must be fllwed when: The instrument is remved fr service Replaced by anther instrument Returned t service B. Dcumentatin: All the infrmatin shuld be dcumented cncurrently n the Gem OPL Crrective Actin Lg. C. Befre putting the analyzer int service: 1. Enter the cuvette pathlength f the currently used cuvette int the instrument, 2. Perfrm QC by using the yellw and range ptical filters, 3. Run three levels f liquid QC, 4. Perfrm the Calibratin Verificatin, 5. Dcument the Cal Verificatin results n the RNA Medical sheet and enter int the web site, 6. Dcument all steps perfrmed n the Instrument Replacement Lg. 7. Send a cpy f the calibratin verificatin t the POCT prgram fr review and apprval by the POCT Directr r designee prir t putting the analyzer int service. Reference Ranges A. Hemglbin: B. %O2hgb: Age Female g/dl Male g/dl 18 years years years years mnths mnths mnths mnth days days days days Arterial: Mixed venus: 60-80% C. Curtesy critical values fr hemglbin: < 9 g/dl Technical Supprt Call Tech Supprt fr questins r trubleshting assistance at References Gem OPL Operatr s Manual, Instrumentatin Labratry CVC 223 C-Oximeter Calibratin Verificatin Cntrls package insert, RNA Medical, Devens, MA 1/06 Multi 4 C-Oximeter cntrls package insert Levels (L1, L2, L3); Instrumentatin Labratry, Lexingtn, MA Crss-References Gem OPL Cmpetency Dcumentatin - 6 mnth and annual Gem OPL Instrument Replacement Lg Gem OPL Initial Training and Assessment Recrd Gem OPL Crrective Actin Lg 9