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148 Cards in this Set

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