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148 Cards in this Set
- Front
- Back
Drugs tested other than the 5 drug classes specified by HHs
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5 clients under NRC (Nuclear Regulatory Commission)
Blood EtOH incl in waiver |
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change made by lab after last NLCP inspection
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Screening Lab - 2nd J57 4 dp-refractometer
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Ave # of specimens analyzed for past 6 mos
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Feb-July 2005
Total specimens 1475 Total specimen screened div by 156 |
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Ave # of speciments analyzed each day under HHS Guidelines
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Feb-Jul 2005
Total number of "SAMSHA" drug screens divided by 156 |
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Maximum # of specimens in an accessioning batch
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72
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Max # of specimens in an initial drug test batch
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72
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Average # of initial drug batches per day that contain one or more regualted specimens
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21
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Maximum # of specimens in a confirmation drug test batch
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43
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Ave # of confirmatory drug test batches per day that contain one or more regulated specimens
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7 batches
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who does RP report to ?
who rates performance of RP? |
Company President and Company CEO
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What staff administratively report directly to the RP
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Business Analyst, Tox Testing Mngr, Analytical Mngr,Ancillary Mngr, QA/QC, Administrative Asst., Tox Customer Service Project Mngr
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RP rates performance of which staff members
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All of above
All of Tox personnel for review and approval |
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Location of Tox Lab
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8355 Quivira, Lenexa KS 66215
Atronic Alams RP & Facility Support Mngr |
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Where do you keep the specimens that screened negative, how is it stored and for how long?
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locked SAMSHA refrigerator in the Specimen Mgt Room, stored by date and SID order, for at least 7 days before being discarded
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NN Specimens storage? How? How long?
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NNSL are aliquoted for further testing in accessioning and transferred to Specimen Mgmt Room (segregated from negs) for short term storage, stored by SID and date of receipt, until confirmation/SVT is completed. Then stored in Long -term storage (>1yr) (Locked SAMSHA walk in freezer in the Specimen Mgmt Room
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Where do you keep Records?
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in Secured area -- accessioning, Data Entry, Cert ofc or in Specimen Mgmt Room. Only authorized persnnel have access to records.
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What Records are being kept?
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CCF, internal chain of custody, screening data, confirmation data, review documents
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Where are specimens delivered?
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In sort area of CRLs distribution center. Stover delivers in the accessioning dock
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What constitutes an administrative error and who stamps it?
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missing temp, date and collectors signature. Accessioning stamps and data entry puts it on A hold pending receipt of an MFR.
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What constitutes a Problem? How is it dealt with?
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Abn odor, A and B bottles different. Accessioner notes problem. aliquotes specimen, assigns a panel ID and placeholder panel and sends the SPECIMEN PROBLEM SHEET witht he CCF to Data Entry.
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What is a Fatal Flaw?
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Accessioner accessions specimen but does NOT aliquot. Completes a Specimen Rejection Sheet with the CCF to Data Entry and is stored/moved with other specimens in the batch.
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How is specimen handling done?
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Handle one CCF/specimen at a time, accessioner assigns matching, unique barcode labels to the CCF, specimen bottles, bottle lids and an aliquot tube. Enters SID and CCF# into system and verifies PSI of the bottle, aliquot tube, and the CCF.
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What amount is poured by accessioner for screening?
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1ml
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Aliquoting Procedures
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c-1
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Whats the ratio of pos to negs with regards to our blind controls?
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20% pos and 80% negs
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Where do we get our neg blind controls?
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Negs are from commercial source. Screened using FDA approved immunoassay technology. Urine should test negs.
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Where do we get our positive blind controls?
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From previously confirmed positive samples pooled togther or verified commercial blind specimens.
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What is the usual concentration of our pos blind?
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>/= 1.5x the screening cutoff concentration.
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How do you introduce a blind in your batch?
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c-2 accession the blind (do not place barcode on blind test tube) 2. place barcode assigned to Blind Log Sheed 3. write expected result in tul.blnd.scrn.---- 4. record the tube # for the blind. Singn, stamp/printnamde and date 5. send to Data Entryfor demographics. After pouring aliquot, put the blind specimen in the "Recycled Blinds" rack since this will be recycled 4-5 times.
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How do we discard the specimes that screened negative.
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Neg aliquots from screening are transferred to a rack. Documentation of discard of these aliquots is made on a Discard Log which is filed with the data in the certifiers' office at end of the day.
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What is the ratio of a control in a screening batch?
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Number of controls must be >/= 10% of specimens plus QC samples in a batch.
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How do you accept a batch?
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if all QC (and the blind) are acc4eptable for all drugs and SVT analytes
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Acceptance criteria for each control: What if a control fails?
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If failed drug is "too positive" - only positive specimens in the batch must be repeated with acceptable controls
If a failed drug is "too negative", all negative specimens in the batch must be repeated with acceptable controls. |
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Controls supplied by Microgenics
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Above 1, Below 1, THC 40, THC 60, ph 10, NITBLW, NITABV
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Source of Neg Control
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UTAK
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Source of ph04
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Orion
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Source of Blind
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QAS
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Source of Crt 23, 3, 1
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Axiom Diag
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Analytes in the Above 1 Contrl
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all drugs except THCA
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Analytes in the Below 1
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All drugs except THCA
ph Nitrite |
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Analytes in the negative control
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No drugs
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THCA Controls
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THC 40 , THC 60
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Crt Controls
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23,3,1
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ph Controls
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ph 04 and 10
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Concentration of Above 1 Control
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125% of cutoffs
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Conc of Below1 Cntrl
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75% of cutoffs
Normal ph Negative Nitrite |
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Conc of Neg (S) Cntrol
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0
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Conc of THC 40
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40
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Conc of THC 60
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60
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Conc of Crt23
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21 - 25 mg/dl
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Conc of Crt 3
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3 to 20 mg/dl;
3 to 4 mg/dl |
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Conc of CRT1
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1.0 to 1.5 mg/dl
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Conc of ph 04
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ph 4.01 (<4.5)
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Conc of ph10
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ph 10(>8.5)
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Conc of NITBLW Cntrl
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200-300 ug/ml
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Conc of NITABV
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625 ug/ml
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Conc of Blind
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0 or
>/= cutoff for drug |
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What controls use Urine Matrix
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ABOVE1, BELOW1, NEG, THC 40, THC60, CRT23, Blind
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Matrix for Crt 23
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Urine
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Matrix for Crt 3 and 1
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Aqueous
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Controls using Aqueous Matrix
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CRT3, CRT1,
PH04, PH10, NITABV, NITBLW |
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Matrix for Blind
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Urine
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Controls Using Aqueous matrix
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CRT3, CRT1, PH04, PH10 NITABV and NITBLW
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Acceptance Criteria for ABOVE1 (Above Threshold Control - except for THCA)
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≥ cutoffs
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Acceptance Criteria for BeLOW1 (Below Threshold Controls- except for THCA)
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Drugs>BELOW1 values <cutoffs
nitrite </= 50ug/dl ph mean +- 0.5 ph unit |
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Acceptance Criteria for Negative Control
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<BELOW1 values
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Acceptance Criteria for THC40 (THCA Below Threshold Control)
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<50 >Neg
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Acceptance criteria for THC60 (THCA Above Threshold Control)
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≥ 50
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Acceptance criteria for CRT1 CRT3 CRT23
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Mean +/- 20%
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Acceptance criteria for PH04 (ph<4.5)
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Mean +/- 0.5 ph unit
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Acceptance criteria for PH10 (ph > 8.5)
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Mean +/- 0.5 ph unit
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Acceptance criteria for NITBLW ( Nitrite 200-300 ug/ml)
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Mean +/- 20%
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Acceptance criteria for NITABV (Nitrite Above Threshold Control)
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>/=500ug/ml
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Acceptance criteria for blind
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>/= cutoff for positive drugs
< cutoffs for negative drugs |
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Calibration procedure for intitial drug test
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single-point calibration, daily historical calibration
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procedure and acceptance criteria for calibration of instrument for initial drug test
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3-replicate analyses
drops high and low values if controls are acceptable, calibration is successful |
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describe the method used to calculate the concentrations/results of analytes for initial drug test
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Utlizes absorbance value of calibrator to calculate a RF (response factor) for calculation of control and donor results
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Describe how the instrumental software analyzes the results
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Instrument convers absorbance readings into quantitation (for control and donor results) based on absorbance of calibrator
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Immunoassay method used for Amp, BE. THC, Opt and PCP
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EIA
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Kit manufacturer for the 5 NIDA drugs
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Microgenics
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Test Kit name for Amp/Meth
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CEDIA DAU Amphetamines
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TEst Kit used for Cannab, Cocain, Opt, and PCP
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Canab EIA
Cocaine EIA Opiate EIA PEP EIA |
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Concentration of Amp Calibrator (initial drug test)
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0
1000 |
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Conc of Cannabinoid calibrator
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0
50 |
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Conc of Cocaine calibrator (screening)
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0
300 |
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Conc of calib for opt (screening)
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0
2,000 |
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Conc of PCP calib (screening)
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0
25 |
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AMP Screening Controls
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O-Neg (calib: 1000)
O-750 O-1250 B-variable |
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Cannabinoid Screening Controls
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O- Neg, 40, 60
B- variable (calib: 50) |
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Cocaine Screening Controls
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O-Neg, 225, 375
B- variable (calib: 300) |
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Screening method for CRT
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CLR
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Screenig method for Specific
Gravity |
dREF
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Screening method for ph
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PHM
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Screening method for nitrite
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CLR
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Kit manufacturer for CRT
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Bayer
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Manufacturer for Spec Gravity
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Rudolf
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Kit Manufacturer for pH
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Instr=IQ Scientific
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Kit manufacturer for nitrite
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microgenics
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Test Kit name for CRT
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Bayer Creatinine
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Test Kit name for Specific Gravity
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Model=J57
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Test Kit name for ph
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Model= IQ 150
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Test Kit name for Nitrite
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Nitrite-Detect Test
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Unit of measurement for Crt and Nitrite
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mg/dl
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Conc of Calubrator for Crt
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0, 2.0
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Conc of calibrator for Specific Gravity
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De-I water
RI = 1.22200 Calib. Oil RI= calculated fer lot # |
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Concentration of Calibrator for ph
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ph 4.0
ph 7.0 ph 10.0 |
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Conc of calibrator for nitrite
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0,
500 ug/ml |
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Conc of CRT controls
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1.25
3.5 23 |
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Conc of controls for Specific Gravity
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1.000
1.0020 1.0110 1.0230 |
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Conc of controls for ph
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ph <3.0 & >3.0
pH<11.0 & >11 |
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Conc of Nitrite control
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Neg
250 ug/dl 625 ug/ml |
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LOQ for CRT
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1
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LOQ for Nitrite
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25
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ULOL for CRT
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400
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ULOL for Nitrite
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750
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COL for CRT
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400
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COL for Nitrite
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750
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COL for Sp.Gr.
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N/a
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COL for ph
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N/A
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AA
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Atomic Absorption
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ISE Ion Selective Electrode
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Ion Selective Electrode
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CE
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Capillary Electrophoresis
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Manufacturer of CLR ph
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Microgenics
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Test kid name for CLR ph
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ph-Detect Test
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Conc of CLR ph calibrators
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ph 4.0
ph 9.0 |
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CLR ph Controls
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ph>/= 4.5 </=8.5
ph 4.01 ph 10 |
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COL for Clr ph
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Neg COL 9.0
Pos COL 4.0 |
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Qualitative aliqoting of specimen for GCMS is documented on:
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Specimen chain of custody
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Transfer of aliquot from accessioning to GC/MS is documented on
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GCMS Aliquot chain of custody
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Who assigns the BID
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prep chemist
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Contents of Prep Batch Worksheet/Batch Chain of Custody Form
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handling of aliquots
transfer of aliquots in autosampler viials to GC/MS autosampler for analysis transfer of vials from one GC/MS to another verification of sequence table data review disposal of vials and excess aliquots |
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How is placement of controls in a GC/Ms Batch worksheet dont
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random, at least one quantitative control or calibrator must be extracted in each manifold
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Max batch size
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48 for all except BE 40
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Where do we get most of our quantitative controls
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QASC
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Negative Control is purchased
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UTAK
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Target conc of Low Control
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target conc of 40% of cutoff
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Conc of Cutoff
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contains drugs at target conc of 125% of cutoff
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What are the controls that are made in-house?
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THCA Hydrolysis - from pooled specimens that are >/= 1 year old and positive for THCA
Amphetamine Oxidation Control - contains 0.5 mg/ml each of (-)ephedrine, (=)pseudoephedrine and phenylpropanolamine |
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Parameter in accepting of rejecting a GC/MS batch
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Evaluation of carryover, IS recover, retention time, elution order, symmetry, resolution, qualifiers, and quantitaion. All qualitative and quantitative criteria must be met to report a specimen as positive.
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How to resolve qualitative failure
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A specimen, calibrator and/or control may be reinjected once, under the same autotune, in an attempt to resolve qualitative failure.
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When do you do IVD and reinjection?
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For speciments with very high conc of drug(s) in an attemptto rel=solve ion ratio failure(s) and to improve peak symmetry
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How do you do COC
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specimen whose concentration is >ULOL
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In the event of unresolved quantitative failure of a control:
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only "true" negative specimens may be reported. All other specimens must be reprepped and reanalyzed.
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In the event of unresolved Qualitative failure of a control:
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Specimens with analyte concentrations <cutoff mAY BE REPORTED AS "nEGATIVE" WHEN THE REASON FOR THE BAtch failure is known and con for the reported specimens are not affted by the problem. All other specimens must be reprepped and reanalyzed.
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Acceptance Criteria for Negative Control (except Opt)
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any quantitation ion detected for drug(s) should be present at <10% of cutoff concentration
For Opt: quantitation ion detected must be , 50 ng/ml |
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Acceptance criterian for Amphetamine Oxidation control
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any quantitation detected for drug must be present at < 10% cutoff concentration
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Acceptance Criteria for Low and Cutoff Control
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All qualitative criteris must be met and quantation of drug must be within =?- 20% of the mean
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Drug/Drug Class, Controls and Drugs used
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page C-5
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