Crl

Front 1

Drugs tested other than the 5 drug classes specified by HHs

Back 1

5 clients under NRC (Nuclear Regulatory Commission)
Blood EtOH incl in waiver

Front 2

change made by lab after last NLCP inspection

Back 2

Screening Lab - 2nd J57 4 dp-refractometer

Front 3

Ave # of specimens analyzed for past 6 mos

Back 3

Feb-July 2005
Total specimens 1475
Total specimen screened div by 156

Front 4

Ave # of speciments analyzed each day under HHS Guidelines

Back 4

Feb-Jul 2005
Total number of "SAMSHA" drug screens divided by 156

Front 5

Maximum # of specimens in an accessioning batch

Back 5

72

Front 6

Max # of specimens in an initial drug test batch

Back 6

72

Front 7

Average # of initial drug batches per day that contain one or more regualted specimens

Back 7

21

Front 8

Maximum # of specimens in a confirmation drug test batch

Back 8

43

Front 9

Ave # of confirmatory drug test batches per day that contain one or more regulated specimens

Back 9

7 batches

Front 10

who does RP report to ?
who rates performance of RP?

Back 10

Company President and Company CEO

Front 11

What staff administratively report directly to the RP

Back 11

Business Analyst, Tox Testing Mngr, Analytical Mngr,Ancillary Mngr, QA/QC, Administrative Asst., Tox Customer Service Project Mngr

Front 12

RP rates performance of which staff members

Back 12

All of above
All of
Tox personnel for review and approval

Front 13

Location of Tox Lab

Back 13

8355 Quivira, Lenexa KS 66215
Atronic Alams
RP & Facility Support Mngr

Front 14

Where do you keep the specimens that screened negative, how is it stored and for how long?

Back 14

locked SAMSHA refrigerator in the Specimen Mgt Room, stored by date and SID order, for at least 7 days before being discarded

Front 15

NN Specimens storage? How? How long?

Back 15

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

Front 16

Where do you keep Records?

Back 16

in Secured area -- accessioning, Data Entry, Cert ofc or in Specimen Mgmt Room. Only authorized persnnel have access to records.

Front 17

What Records are being kept?

Back 17

CCF, internal chain of custody, screening data, confirmation data, review documents

Front 18

Where are specimens delivered?

Back 18

In sort area of CRLs distribution center. Stover delivers in the accessioning dock

Front 19

What constitutes an administrative error and who stamps it?

Back 19

missing temp, date and collectors signature. Accessioning stamps and data entry puts it on A hold pending receipt of an MFR.

Front 20

What constitutes a Problem? How is it dealt with?

Back 20

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.

Front 21

What is a Fatal Flaw?

Back 21

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.

Front 22

How is specimen handling done?

Back 22

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.

Front 23

What amount is poured by accessioner for screening?

Back 23

1ml

Front 24

Aliquoting Procedures

Back 24

c-1

Front 25

Whats the ratio of pos to negs with regards to our blind controls?

Back 25

20% pos and 80% negs

Front 26

Where do we get our neg blind controls?

Back 26

Negs are from commercial source. Screened using FDA approved immunoassay technology. Urine should test negs.

Front 27

Where do we get our positive blind controls?

Back 27

From previously confirmed positive samples pooled togther or verified commercial blind specimens.

Front 28

What is the usual concentration of our pos blind?

Back 28

>/= 1.5x the screening cutoff concentration.

Front 29

How do you introduce a blind in your batch?

Back 29

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.

Front 30

How do we discard the specimes that screened negative.

Back 30

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.

Front 31

What is the ratio of a control in a screening batch?

Back 31

Number of controls must be >/= 10% of specimens plus QC samples in a batch.

Front 32

How do you accept a batch?

Back 32

if all QC (and the blind) are acc4eptable for all drugs and SVT analytes

Front 33

Acceptance criteria for each control: What if a control fails?

Back 33

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.

Front 34

Controls supplied by Microgenics

Back 34

Above 1, Below 1, THC 40, THC 60, ph 10, NITBLW, NITABV

Front 35

Source of Neg Control

Back 35

UTAK

Front 36

Source of ph04

Back 36

Orion

Front 37

Source of Blind

Back 37

QAS

Front 38

Source of Crt 23, 3, 1

Back 38

Axiom Diag

Front 39

Analytes in the Above 1 Contrl

Back 39

all drugs except THCA

Front 40

Analytes in the Below 1

Back 40

All drugs except THCA
ph
Nitrite

Front 41

Analytes in the negative control

Back 41

No drugs

Front 42

THCA Controls

Back 42

THC 40 , THC 60

Front 43

Crt Controls

Back 43

23,3,1

Front 44

ph Controls

Back 44

ph 04 and 10

Front 45

Concentration of Above 1 Control

Back 45

125% of cutoffs

Front 46

Conc of Below1 Cntrl

Back 46

75% of cutoffs
Normal ph
Negative Nitrite

Front 47

Conc of Neg (S) Cntrol

Back 47

0

Front 48

Conc of THC 40

Back 48

40

Front 49

Conc of THC 60

Back 49

60

Front 50

Conc of Crt23

Back 50

21 - 25 mg/dl

Front 51

Conc of Crt 3

Back 51

3 to 20 mg/dl;
3 to 4 mg/dl

Front 52

Conc of CRT1

Back 52

1.0 to 1.5 mg/dl

Front 53

Conc of ph 04

Back 53

ph 4.01 (<4.5)

Front 54

Conc of ph10

Back 54

ph 10(>8.5)

Front 55

Conc of NITBLW Cntrl

Back 55

200-300 ug/ml

Front 56

Conc of NITABV

Back 56

625 ug/ml

Front 57

Conc of Blind

Back 57

0 or
>/= cutoff for drug

Front 58

What controls use Urine Matrix

Back 58

ABOVE1, BELOW1, NEG, THC 40, THC60, CRT23, Blind

Front 59

Matrix for Crt 23

Back 59

Urine

Front 60

Matrix for Crt 3 and 1

Back 60

Aqueous

Front 61

Controls using Aqueous Matrix

Back 61

CRT3, CRT1,
PH04, PH10,
NITABV, NITBLW

Front 62

Matrix for Blind

Back 62

Urine

Front 63

Controls Using Aqueous matrix

Back 63

CRT3, CRT1, PH04, PH10 NITABV and NITBLW

Front 64

Acceptance Criteria for ABOVE1 (Above Threshold Control - except for THCA)

Back 64

≥ cutoffs

Front 65

Acceptance Criteria for BeLOW1 (Below Threshold Controls- except for THCA)

Back 65

Drugs>BELOW1 values <cutoffs
nitrite </= 50ug/dl
ph mean +- 0.5 ph unit

Front 66

Acceptance Criteria for Negative Control

Back 66

<BELOW1 values

Front 67

Acceptance Criteria for THC40 (THCA Below Threshold Control)

Back 67

<50 >Neg

Front 68

Acceptance criteria for THC60 (THCA Above Threshold Control)

Back 68

≥ 50

Front 69

Acceptance criteria for CRT1 CRT3 CRT23

Back 69

Mean +/- 20%

Front 70

Acceptance criteria for PH04 (ph<4.5)

Back 70

Mean +/- 0.5 ph unit

Front 71

Acceptance criteria for PH10 (ph > 8.5)

Back 71

Mean +/- 0.5 ph unit

Front 72

Acceptance criteria for NITBLW ( Nitrite 200-300 ug/ml)

Back 72

Mean +/- 20%

Front 73

Acceptance criteria for NITABV (Nitrite Above Threshold Control)

Back 73

>/=500ug/ml

Front 74

Acceptance criteria for blind

Back 74

>/= cutoff for positive drugs
< cutoffs for negative drugs

Front 75

Calibration procedure for intitial drug test

Back 75

single-point calibration, daily historical calibration

Front 76

procedure and acceptance criteria for calibration of instrument for initial drug test

Back 76

3-replicate analyses
drops high and low values
if controls are acceptable, calibration is successful

Front 77

describe the method used to calculate the concentrations/results of analytes for initial drug test

Back 77

Utlizes absorbance value of calibrator to calculate a RF (response factor) for calculation of control and donor results

Front 78

Describe how the instrumental software analyzes the results

Back 78

Instrument convers absorbance readings into quantitation (for control and donor results) based on absorbance of calibrator

Front 79

Immunoassay method used for Amp, BE. THC, Opt and PCP

Back 79

EIA

Front 80

Kit manufacturer for the 5 NIDA drugs

Back 80

Microgenics

Front 81

Test Kit name for Amp/Meth

Back 81

CEDIA DAU Amphetamines

Front 82

TEst Kit used for Cannab, Cocain, Opt, and PCP

Back 82

Canab EIA
Cocaine EIA
Opiate EIA
PEP EIA

Front 83

Concentration of Amp Calibrator (initial drug test)

Back 83

0
1000

Front 84

Conc of Cannabinoid calibrator

Back 84

0
50

Front 85

Conc of Cocaine calibrator (screening)

Back 85

0
300

Front 86

Conc of calib for opt (screening)

Back 86

0
2,000

Front 87

Conc of PCP calib (screening)

Back 87

0
25

Front 88

AMP Screening Controls

Back 88

O-Neg (calib: 1000)
O-750
O-1250
B-variable

Front 89

Cannabinoid Screening Controls

Back 89

O- Neg, 40, 60
B- variable (calib: 50)

Front 90

Cocaine Screening Controls

Back 90

O-Neg, 225, 375
B- variable (calib: 300)

Front 91

Screening method for CRT

Back 91

CLR

Front 92

Screenig method for Specific
Gravity

Back 92

dREF

Front 93

Screening method for ph

Back 93

PHM

Front 94

Screening method for nitrite

Back 94

CLR

Front 95

Kit manufacturer for CRT

Back 95

Bayer

Front 96

Manufacturer for Spec Gravity

Back 96

Rudolf

Front 97

Kit Manufacturer for pH

Back 97

Instr=IQ Scientific

Front 98

Kit manufacturer for nitrite

Back 98

microgenics

Front 99

Test Kit name for CRT

Back 99

Bayer Creatinine

Front 100

Test Kit name for Specific Gravity

Back 100

Model=J57

Front 101

Test Kit name for ph

Back 101

Model= IQ 150

Front 102

Test Kit name for Nitrite

Back 102

Nitrite-Detect Test

Front 103

Unit of measurement for Crt and Nitrite

Back 103

mg/dl

Front 104

Conc of Calubrator for Crt

Back 104

0, 2.0

Front 105

Conc of calibrator for Specific Gravity

Back 105

De-I water
RI = 1.22200
Calib. Oil
RI= calculated fer lot #

Front 106

Concentration of Calibrator for ph

Back 106

ph 4.0
ph 7.0
ph 10.0

Front 107

Conc of calibrator for nitrite

Back 107

0,
500 ug/ml

Front 108

Conc of CRT controls

Back 108

1.25
3.5
23

Front 109

Conc of controls for Specific Gravity

Back 109

1.000
1.0020
1.0110
1.0230

Front 110

Conc of controls for ph

Back 110

ph <3.0 & >3.0
pH<11.0 & >11

Front 111

Conc of Nitrite control

Back 111

Neg
250 ug/dl
625 ug/ml

Front 112

LOQ for CRT

Back 112

1

Front 113

LOQ for Nitrite

Back 113

25

Front 114

ULOL for CRT

Back 114

400

Front 115

ULOL for Nitrite

Back 115

750

Front 116

COL for CRT

Back 116

400

Front 117

COL for Nitrite

Back 117

750

Front 118

COL for Sp.Gr.

Back 118

N/a

Front 119

COL for ph

Back 119

N/A

Front 120

AA

Back 120

Atomic Absorption

Front 121

ISE Ion Selective Electrode

Back 121

Ion Selective Electrode

Front 122

CE

Back 122

Capillary Electrophoresis

Front 123

Manufacturer of CLR ph

Back 123

Microgenics

Front 124

Test kid name for CLR ph

Back 124

ph-Detect Test

Front 125

Conc of CLR ph calibrators

Back 125

ph 4.0
ph 9.0

Front 126

CLR ph Controls

Back 126

ph>/= 4.5 </=8.5
ph 4.01
ph 10

Front 127

COL for Clr ph

Back 127

Neg COL 9.0
Pos COL 4.0

Front 128

Qualitative aliqoting of specimen for GCMS is documented on:

Back 128

Specimen chain of custody

Front 129

Transfer of aliquot from accessioning to GC/MS is documented on

Back 129

GCMS Aliquot chain of custody

Front 130

Who assigns the BID

Back 130

prep chemist

Front 131

Contents of Prep Batch Worksheet/Batch Chain of Custody Form

Back 131

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

Front 132

How is placement of controls in a GC/Ms Batch worksheet dont

Back 132

random, at least one quantitative control or calibrator must be extracted in each manifold

Front 133

Max batch size

Back 133

48 for all except BE 40

Front 134

Where do we get most of our quantitative controls

Back 134

QASC

Front 135

Negative Control is purchased

Back 135

UTAK

Front 136

Target conc of Low Control

Back 136

target conc of 40% of cutoff

Front 137

Conc of Cutoff

Back 137

contains drugs at target conc of 125% of cutoff

Front 138

What are the controls that are made in-house?

Back 138

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

Front 139

Parameter in accepting of rejecting a GC/MS batch

Back 139

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.

Front 140

How to resolve qualitative failure

Back 140

A specimen, calibrator and/or control may be reinjected once, under the same autotune, in an attempt to resolve qualitative failure.

Front 141

When do you do IVD and reinjection?

Back 141

For speciments with very high conc of drug(s) in an attemptto rel=solve ion ratio failure(s) and to improve peak symmetry

Front 142

How do you do COC

Back 142

specimen whose concentration is >ULOL

Front 143

In the event of unresolved quantitative failure of a control:

Back 143

only "true" negative specimens may be reported. All other specimens must be reprepped and reanalyzed.

Front 144

In the event of unresolved Qualitative failure of a control:

Back 144

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.

Front 145

Acceptance Criteria for Negative Control (except Opt)

Back 145

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

Front 146

Acceptance criterian for Amphetamine Oxidation control

Back 146

any quantitation detected for drug must be present at < 10% cutoff concentration

Front 147

Acceptance Criteria for Low and Cutoff Control

Back 147

All qualitative criteris must be met and quantation of drug must be within =?- 20% of the mean

Front 148

Drug/Drug Class, Controls and Drugs used

Back 148

page C-5