CoaguChek Outpatient Clinic: Quality Control Test Procedure. Action

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PHSA Labratries CW Site - Pint f Care Title: CWPC_INR_0130 CaguChek Outpatient Clinic Quality Cntrl Test Prcedure CaguChek Outpatient Clinic: Quality Cntrl Test Prcedure PURPOSE: This prcedure

REQUIRED MATERIALS: CaguChek XS Plus / Pr Instrument CaguChek XS PT Test Strips with supplied cde chip marked S and cde number CaguChek XS PT Lyphilized Cntrl with supplied cde chip marked C and cde

PLUS / XS PRO Actin Nte: Liquid Quality Cntrl is run at a minimum nce per week n the CaguChek XS System, r with a new vial f test strips 1. Assemble supplies.

1 PHSA Labratries CW Site - Pint f Care Title: CWPC_INR_0130 CaguChek Outpatient Clinic Quality Cntrl Test Prcedure CaguChek Outpatient Clinic: Quality Cntrl Test Prcedure PURPOSE: This prcedure prvides instructin n hw t perfrm the liquid quality cntrl testing fr PT INR using the CaguChek XS / XS Plus / Pr instruments. REQUIRED MATERIALS: CaguChek XS Plus / Pr Instrument CaguChek XS PT Test Strips with supplied cde chip marked S and cde number CaguChek XS PT Lyphilized Cntrl with supplied cde chip marked C and cde number, diluent-filled drpper Scissrs Glves Sharps cntainer Paper twel fr wrking surface Caviwipes disinfectant wipes Nte: One Level f Quality Cntrl Slutin is used at PHSA fr the Caguchek XS / XS PLUS / XS PRO Actin Nte: Liquid Quality Cntrl is run at a minimum nce per week n the CaguChek XS System, r with a new vial f test strips 1. Assemble supplies. Remve cntrl vial and diluent filled drpper frm refrigerated strage. Allw t sit at rm temperature fr 10 minutes. Quality cntrl (QC) cde chip supplied with the QC matches the number n the lyphilized cntrl bttle. 2. Check that the Test Strip Cde is Current. Each Lt number f Caguchek XS PT Test Strips has a specific Cde number. Each bx f test strips is supplied with a cde chip with the crrespnding cde number. Test strip cde chips are marked with an S. Dcuments CaguChek Outpatient Clinic: Appendix B - CaguChek XS PT Quality Cntrl 3. Test strip chip cde in the meter is current. When switching t a new lt number f test strips it is mandatry t insert the new cde chip int the meter befre yu perfrm the first test (patient r quality check). Insert the cde chip int the cde chip slt, with the S facing up, until it snaps int place. Nte: The manufacturer recmmends that a cde chip is left in the meter t prtect the electrical cntacts frm becming dirty. 4. Press the On/Off buttn. Instrument initializes and perfrms electrnic checks. 5. Check the battery level. Medical Apprval: Dr Benjamin Jung Medical Apprval Date: 28 Dec 2016 Versin: 1.4 Implementatin Date: 1/4/2017 9:27:47 AM Flder Name: CW\Pint f Care\PT INR This is a cntrlled dcument fr CW use nly. Any printed cpies are uncntrlled unless specified. Please refer t Lab QMS Page 1 f 7

PHSA Labratries CW Site - Pint f Care Title: CWPC_INR_0130 CaguChek Outpatient Clinic Quality Cntrl Test Prcedure 6.

Replace batteries fr next test r place n charger base nce testing is cmplete. If Dcuments Caguchek XS Prceed t step 9. Caguchek XS Plus Prceed t step 8. Caguchek XS Pr Prceed t next step. 7.

The meter beeps nce the barcde has been read successfully. 8. Main Menu screen appears Check that the date and time are crrect.

2 PHSA Labratries CW Site - Pint f Care Title: CWPC_INR_0130 CaguChek Outpatient Clinic Quality Cntrl Test Prcedure 6. Actin If battery level shws 1 bar left in battery icn prceed t the next step < 1 bar left in battery icn, yu can perfrm a patient test. Replace batteries fr next test r place n charger base nce testing is cmplete. If Dcuments Caguchek XS Prceed t step 9. Caguchek XS Plus Prceed t step 8. Caguchek XS Pr Prceed t next step. 7. Operatr ID entry page appears. Manually enter r scan POCT OPID. Press t accept if a manual entry. IR scanner n right side f meter. Scan frm a distance f apprximately 10 cm. The meter beeps nce the barcde has been read successfully. 8. Main Menu screen appears Check that the date and time are crrect. Make any crrectins t the date r time if required at this time, befre prceeding t the cntrl test. 9. T prepare CaguChek XS PT Cntrl - match cntrl cde chip with vial. CaguChek XS PT Cntrl is at rm temperature fr a minimum f 10 minutes. Open the lid f the cntrl vial and carefully remve the rubber stpper. Be careful nt t remve any f the lyphilized cntrl plasma. Set cap and rubber stpper aside n paper twel. D nt discard. Hld the pipette with the sealed pipette neck pinting upward. Ensure that the diluent cntents are in the bulb. Cut ff the end f the pipette cap with scissrs. Gently squeeze the bulb f the pipette t dispense the entire cntents f the drpper nt the lyphilized cntrl plasma. D nt allw the drpper t tuch the dried material. Set pipette aside n paper twel. D nt discard. Clse the cntainer. Swirl the vial 2 t 3 times using a circular mtin t cmpletely disslve all f the cntrl plasma. D nt shake the vial r turn it n its side Cntrl slutin is ready in ne minute. Use within 30 minutes. Medical Apprval: Dr Benjamin Jung Medical Apprval Date: 28 Dec 2016 Versin: 1.4 Implementatin Date: 1/4/2017 9:27:47 AM Flder Name: CW\Pint f Care\PT INR This is a cntrlled dcument fr CW use nly. Any printed cpies are uncntrlled unless specified. Please refer t Lab QMS Page 2 f 7

PHSA Labratries CW Site - Pint f Care Title: CWPC_INR_0130 CaguChek Outpatient Clinic Quality Cntrl Test Prcedure Actin Dcuments 10.

Caguchek XS Plus / Pr Prceed t next step 11. Press Cntrl Test Hurglass icn appears briefly fllwed by the Test Strip icn.

Place face up nt the paper twel t avid cntaminatin f the sample area. Immediately replace the cntainer lid.

Nte: Expsure t external influences such as humidity may deterirate the test strips and can lead t errr messages r incrrect results.

Insert the test strip int the meter CaguChek XS PT lettering n the test strip is facing upwards.

Beep tne detects that the test strip is in place. Nte: If test strip is nt detected, remve the test strip and reinsert int the meter. 13.

3 PHSA Labratries CW Site - Pint f Care Title: CWPC_INR_0130 CaguChek Outpatient Clinic Quality Cntrl Test Prcedure Actin Dcuments 10. Match Cntrl Cde Chip If Cut end f diluent pipette Add cntents f pipette Replace lid, swirl Allw t sit 1 minute Caguchek XS Prceed t step 12 Caguchek XS Plus / Pr Prceed t next step 11. Press Cntrl Test Hurglass icn appears briefly fllwed by the Test Strip icn. Test strip icn prmpts yu t insert a test strip. Remve test strip frm vial. Tuch nly the end f the test strip. Place face up nt the paper twel t avid cntaminatin f the sample area. Immediately replace the cntainer lid. Use the test strip within 10 minutes f remving it frm its cntainer. Nte: Expsure t external influences such as humidity may deterirate the test strips and can lead t errr messages r incrrect results. Always clse the strip cntainer immediately after remving a test strip. If a test strip vial is fund pen discard. D nt use. 12. Insert the test strip int the meter CaguChek XS PT lettering n the test strip is facing upwards. Test strip is inserted in the directin indicated by the arrws. Test strip is inserted as far as it will g. Beep tne detects that the test strip is in place. Nte: If test strip is nt detected, remve the test strip and reinsert int the meter. 13. If Caguchek XS Caguchek XS Plus / XS Pr Cnfirm Current Test Strip Cde is crrect. Press M buttn t accept. Prceed t step 16. Prceed t next step. Medical Apprval: Dr Benjamin Jung Medical Apprval Date: 28 Dec 2016 Versin: 1.4 Implementatin Date: 1/4/2017 9:27:47 AM Flder Name: CW\Pint f Care\PT INR This is a cntrlled dcument fr CW use nly. Any printed cpies are uncntrlled unless specified. Please refer t Lab QMS Page 3 f 7

Dcuments New Lt number and New Cntrl Cde Select New Cde when a new Lt number with new Cde Number f QC is being used. The Cntrl Chip icn prmpt will appear.

4 PHSA Labratries CW Site - Pint f Care Title: CWPC_INR_0130 CaguChek Outpatient Clinic Quality Cntrl Test Prcedure Actin 14. Cntrl Cde Chip Select the QC Cde Chip number frm the list n the screen The QC Cdes currently in the memry f the Caguchek XS Pr will be displayed. Dcuments New Lt number and New Cntrl Cde Select New Cde when a new Lt number with new Cde Number f QC is being used. The Cntrl Chip icn prmpt will appear. T prgram the Caguchek XS Pr meter with a new Cntrl Cde, remve the Test Strip Cde Chip currently in the meter. Replace with the new Cntrl Cde Chip. Nte: Cntrl Chips are marked C with the crrespnding cde number. Screen with Cntrl Cde Chip Icn. 15. QC Test screen appears QC lt number, QC Cde number, Level 1 and Operatr ID number appears at the tp f the screen. (Caguchek XS Plus / Pr instruments) The hurglass icn shws that the test strip is warming up. D nt apply Aqueus Cntrl slutin at this stage r an errr cde will appear and the cntrl test prcess will need t start frm the beginning with a new test strip. Nte: Once the warming-up prcess is cmplete, a further beep tne indicates the instrument is ready fr QC sample applicatin. 16. Apply cntrl slutin t the CaguChek XS PT test strip. Pipette icn flashes t indicate that the mnitr is ready. Simultaneusly a 180 secnd cuntdwn begins. Swirl the Cntrl slutin in the vial well 2 t 3 times in bth directins fr adequate mixing. Using the pipette, draw up the disslved cntents f the vial, and further mix the cntrl slutin by drawing up slutin int the pipette and dispensing int the vial. Perfrm this step at least twice. Apply a large hanging drp (apprximately 8 ul) f cntrl slutin frm the pipette t the sample applicatin area f the test strip. The mnitr beeps when enugh cntrl slutin is applied. The test cycle starts and the hurglass icn replaces the flashing pipette icn. Medical Apprval: Dr Benjamin Jung Medical Apprval Date: 28 Dec 2016 Versin: 1.4 Implementatin Date: 1/4/2017 9:27:47 AM Flder Name: CW\Pint f Care\PT INR This is a cntrlled dcument fr CW use nly. Any printed cpies are uncntrlled unless specified. Please refer t Lab QMS Page 4 f 7

Draw up cntrl cntents int pipette Apply large drp apprx.

There is n indicatr that this is a QC r a Patient Test result.

(chsen unit f measure) QC lt number, QC Cde number, Level 1 and Operatr ID number appears at the tp f the screen as

Review the QC Result If result is within QC range Then Reprt result n QC Recrd sheet.

5 PHSA Labratries CW Site - Pint f Care Title: CWPC_INR_0130 CaguChek Outpatient Clinic Quality Cntrl Test Prcedure Actin Dcuments secnd cunt dwn QC Result is displayed. Draw up cntrl cntents int pipette Apply large drp apprx. 8 ul required Test incubatin If Caguchek XS Caguchek XS Plus / XS Pr QC results is displayed n the screen. There is n indicatr that this is a QC r a Patient Test result. Refer t current QC range fr an indicatin f pass r fail. Prceed t step 18. See belw. INR units. (chsen unit f measure) QC lt number, QC Cde number, Level 1 and Operatr ID number appears at the tp f the screen as befre. QC range is displayed fr the specific Lt number f Cntrl slutin. QC test saved in memry with date and time. 18. Review the QC Result If result is within QC range Then Reprt result n QC Recrd sheet. CaguChek XS Pr is ready fr patient testing. Prceed t next step. Medical Apprval: Dr Benjamin Jung Medical Apprval Date: 28 Dec 2016 Versin: 1.4 Implementatin Date: 1/4/2017 9:27:47 AM Flder Name: CW\Pint f Care\PT INR This is a cntrlled dcument fr CW use nly. Any printed cpies are uncntrlled unless specified. Please refer t Lab QMS Page 5 f 7

PHSA Labratries CW Site - Pint f Care Title: CWPC_INR_0130 CaguChek Outpatient Clinic Quality Cntrl Test Prcedure Actin nt within Reprt result n QC Recrd sheet.

6 PHSA Labratries CW Site - Pint f Care Title: CWPC_INR_0130 CaguChek Outpatient Clinic Quality Cntrl Test Prcedure Actin nt within Reprt result n QC Recrd sheet. QC range Fr the Caguchek XS Pr, the displayed result flashes with an arrw up (t high) r arrw dwn (t lw). Review and cnfirm the fllwing: Is the cntrl material prperly stred? Was the cntrl material at rm temperature befre preparatin? steps taken t prepare the quality cntrl material. was the cntrl test perfrmed after 1 minute and within 30 minutes f cntrl slutin preparatin? Are the test strips stred crrectly? Is the test perfrmed within 10 minutes f remving the test strip frm the cntainer? Was the test strip stred in an air tight cntainer with the stpper n crrectly? Is the test strip guide dirty? Clean the test strip guide as per instructin if required. Repeat with a new test strip. Crrect any actins taken t perfrm QC testing as required. 19. T Add a Cmment ( Cagucheck XS PLUS / PRO) Nt mandatry T add a cmment d nt remve the test strip In the Test Screen tuch the bubble icn n the bttm right f the screen In the Cmments screen select the apprpriate canned cmment Tuch the checkmark t save Nte: Once the test strip is remved a cmment cannt be added r edited. 20. T Remve the test strip frm the meter Tuch the menu icn at the bttm f the patient result screen (Diagram Step 14) Yu will be prmpted t remve the test strip. Discard the test strip and lyphilized Cntrl slutin as per institutinal guidelines fr bihazardus waste dispsal. Dcuments Medical Apprval: Dr Benjamin Jung Medical Apprval Date: 28 Dec 2016 Versin: 1.4 Implementatin Date: 1/4/2017 9:27:47 AM Flder Name: CW\Pint f Care\PT INR This is a cntrlled dcument fr CW use nly. Any printed cpies are uncntrlled unless specified. Please refer t Lab QMS Page 6 f 7

7 PHSA Labratries CW Site - Pint f Care Title: CWPC_INR_0130 CaguChek Outpatient Clinic Quality Cntrl Test Prcedure 21. Turn the mnitr ff. 22. Replace the Cntrl Cde Chip if previusly inserted int the meter with the Test Strip Cntrl Cde. 23. Clean the surface f the meter with 2% Chlrhexidine in 70% isprpyl alchl prep pad r Caviwipe disinfectant Wipes. CaguChek Outpatient Clinic Appendix G - CaguChek XS Plus Meter Cleaning References: CaguChek XS Plus Operatr Manual, Rche Diagnstics GmbH D Mannheim, Germany CaguChek XS PRO Operatr Manual, Rche Diagnstics, 201 Bul, Armand-Frappier, Laval, Quebec, H7V 4A2 Canada CaguChek XS Operatr Manual, Rche Diagnstics, 201 Bul, Armand-Frappier, Laval, Quebec, H7V 4A2 Canada CaguChek XS PT Test Strip Directinal Insert, Rche Diagnstics, 201 Bul, Armand-Frappier, Laval, Quebec, H7V 4A2 Canada CaguChek XS PT Cntrls Directinal Insert, Rche Diagnstics, 201 Bul, Armand-Frappier, Laval, Quebec, H7V 4A2 Canada REVISION & APPROVAL LOG Versin Revisin Type Descriptin f Change Revisin Date Technical Apprval 1.0 New dcument Elvira Kzak 1.1 Minr Additin Caguchek XS PRO 1.2 Minr Manual review & update 1.3 Minr Dcument title and number change. Uplad t QMS dcument cntrl 23 Aug Sept Dec 2016 Elvira Kzak Elvira Kzak Medical Apprval Dr. Cathy Halstead Dr. Benjamin Jung Attentin: This dcument is published n the BCCW SharePint website Revisins made t this dcument require an update t the crrespnding dcument published n BCCW SharePint website Medical Apprval: Dr Benjamin Jung Medical Apprval Date: 28 Dec 2016 Versin: 1.4 Implementatin Date: 1/4/2017 9:27:47 AM Flder Name: CW\Pint f Care\PT INR This is a cntrlled dcument fr CW use nly. Any printed cpies are uncntrlled unless specified. Please refer t Lab QMS Page 7 f 7

Instructions for Use INTRON A (In-tron-aye) (Interferon alfa-2b, recombinant) Powder for Solution

Instructions for Use INTRON A (In-tron-aye) (Interferon alfa-2b, recombinant) Powder for Solution Instructins fr Use INTRON A (In-trn-aye) (Interfern alfa-2b, recmbinant) Pwder fr Slutin Be sure that yu read, understand, and fllw these instructins befre injecting INTRON A. Yur healthcare prvider shuld