Mas quality control package inserts

Mas quality control package inserts DEFAULT

Editor's ChoiceFeatured

Abstract

Objectives

In the United States, minimum standards for quality control (QC) are specified in federal law under the Clinical Laboratory Improvement Amendment and its revisions. Beyond meeting this required standard, laboratories have flexibility to determine their overall QC program.

Methods

We surveyed chemistry and immunochemistry QC procedures at 21 clinical laboratories within leading academic medical centers to assess if standardized QC practices exist for chemistry and immunochemistry testing.

Results

We observed significant variation and unexpected similarities in practice across laboratories, including QC frequency, cutoffs, number of levels analyzed, and other features.

Conclusions

This variation in practice indicates an opportunity exists to establish an evidence-based approach to QC that can be generalized across institutions.

In order for a clinical test to be useful, it must be both accurate (reflect the actual concentration of the analyte in question) and precise (be reproducible). Quality control (QC) testing using measurements of QC samples (with known target analyte values) is a key component of the overall quality management process. In the United States, minimum acceptable standards for QC are specified in federal law under the Clinical Laboratory Improvement Amendment and its subsequent revisions.1 These standards are enforced through the laboratory accreditation process by the College of American Pathologists, The Joint Commission, and other organizations. The basic theoretical framework involved in the design of a laboratory QC program has been described in standard textbooks.2-4 These sources often emphasize the use of power function curves (which chart the probability of rejection vs the degree of systematic error for different QC rules) to determine the number and frequency of controls, as well as cutoff values.2 Furthermore, these power curves can also be used to calculate the probability of false negatives (accepting an out-of-control QC as valid) and false positives (rejecting QC that is actually valid), as well as to estimate the number of control measurements required to identify errors of varying magnitude.2

Some laboratories use a variation of the Westgard Multirule Chart.5,6 This chart uses a series of control rules that are employed to interpret QC data to determine if a result is either in or out of control. The rules were designed to be sensitive to both random and systematic errors.3 Typically, the rules are applied to a Levey-Jennings QC plot with control limits drawn to indicate varying degrees of deviation from the expected QC mean.6 Given that this statistically robust approach to QC has existed for several decades, one would expect that a consensus evidence-based best practice guideline for quality control in clinical chemistry (CHEM) and immunochemistry (IM) would have been developed during this time. However, to our knowledge, no national pathology/laboratory professional organization has issued detailed guidance statements regarding QC programs. Logically, one may assume that similar laboratories performing the same tests on comparable types of patients would have similar approaches to QC with minor variations due to differing volumes, instruments, and local practices. We surveyed 21 leading academic medical centers regarding their QC approaches to assess similarities and differences in QC practice across different organizations.

Materials and Methods

A six-question survey about QC practices Table 1 was distributed to laboratory directors at 21 large academic medical centers Table 2. These centers were chosen for their size and national reputation based on the US News & World Report 2016 to 2017 hospital top 20 honor roll.7 Because of their separate locations and laboratory management schemas, NewYork-Presbyterian Cornell and Columbia were considered separate, bringing the total to 21 instead of 20. For the purpose of this analysis, the results from individual laboratories were kept anonymous such that the QC program used at individual centers would not be identified. The questions were deliberately phrased in an open-ended fashion to collect as much data possible, with additional communication via email used to elucidate any ambiguities. The responses of the laboratories were tabulated to give a semiquantitative picture of QC practices among the participating hospitals. The instruments used were stratified by vendor company, with QC frequency stratified by number of QC levels and events per day (when “per shift” was used, three shifts/day were assumed, and startup and shutdown were considered independent time points). QC materials were divided into manufacturer (ie, provided by the same vendor that produces the testing platform) and third party (which was further substratified by vendor). QC rules were generally defined as a number of standard deviations (SDs) of difference from the mean acceptable to call a value “in control” (ie, a 2-SD rule means that a QC value is considered “out of control” if it is 2 SD or more from the accepted average). We did not delineate how these SDs were derived (eg, from testing a QC sample multiple times to determine the SD vs manufacturer-designated SD ranges). QC rules were generally in the format of “if test X is out by Y SD, we take action Z.” These rules were simplified and streamlined to give short, easily interpretable responses of uniform format (these changes were supplied back to the laboratories to confirm accuracy). Finally, the utilization of moving averages was coded as yes or no, and any narrative comments (eg, utilization for nonclinical purposes, intent on implementation in the near future) were considered separately and mentioned where relevant.

Table 1

Questions Included on Surveys

What instrument do you use for automated chemistry and immunochemistry? 
For chemistry and immunochemistry, how do you perform QC (number of levels and frequency)? 
What QC material do you use (manufacturer supplied or third party)? 
How do you define your QC ranges? 
What are your QC rules (eg, Westgard rules, other)? 
Do you use moving averages? 
What instrument do you use for automated chemistry and immunochemistry? 
For chemistry and immunochemistry, how do you perform QC (number of levels and frequency)? 
What QC material do you use (manufacturer supplied or third party)? 
How do you define your QC ranges? 
What are your QC rules (eg, Westgard rules, other)? 
Do you use moving averages? 

Open in new tab

Table 1

Questions Included on Surveys

What instrument do you use for automated chemistry and immunochemistry? 
For chemistry and immunochemistry, how do you perform QC (number of levels and frequency)? 
What QC material do you use (manufacturer supplied or third party)? 
How do you define your QC ranges? 
What are your QC rules (eg, Westgard rules, other)? 
Do you use moving averages? 
What instrument do you use for automated chemistry and immunochemistry? 
For chemistry and immunochemistry, how do you perform QC (number of levels and frequency)? 
What QC material do you use (manufacturer supplied or third party)? 
How do you define your QC ranges? 
What are your QC rules (eg, Westgard rules, other)? 
Do you use moving averages? 

Open in new tab

Table 2

Hospitals Responding in Full

Barnes-Jewish Hospital/Washington University, St Louis 
Brigham and Women’s Hospital 
Cedars-Sinai Medical Center 
Duke University Hospital 
Hospitals of the University of Pennsylvania–Penn Presbyterian 
Houston Methodist Hospital 
Johns Hopkins Hospital 
Massachusetts General Hospital 
Mayo Clinic 
Mount Sinai Hospital 
New York-Presbyterian Columbia 
New York-Presbyterian Cornell 
Northwestern Memorial Hospital 
Ronald Reagan UCLA Medical Center 
Stanford Health Care–Stanford Hospital 
The Cleveland Clinic 
Tisch Hospital, NYU Langone Health 
University of California, San Francisco Medical Center 
University of Colorado Hospital 
University of Michigan Hospitals and Health Centers 
UPMC Presbyterian Shadyside, Pittsburgh 
Barnes-Jewish Hospital/Washington University, St Louis 
Brigham and Women’s Hospital 
Cedars-Sinai Medical Center 
Duke University Hospital 
Hospitals of the University of Pennsylvania–Penn Presbyterian 
Houston Methodist Hospital 
Johns Hopkins Hospital 
Massachusetts General Hospital 
Mayo Clinic 
Mount Sinai Hospital 
New York-Presbyterian Columbia 
New York-Presbyterian Cornell 
Northwestern Memorial Hospital 
Ronald Reagan UCLA Medical Center 
Stanford Health Care–Stanford Hospital 
The Cleveland Clinic 
Tisch Hospital, NYU Langone Health 
University of California, San Francisco Medical Center 
University of Colorado Hospital 
University of Michigan Hospitals and Health Centers 
UPMC Presbyterian Shadyside, Pittsburgh 

Open in new tab

Table 2

Hospitals Responding in Full

Barnes-Jewish Hospital/Washington University, St Louis 
Brigham and Women’s Hospital 
Cedars-Sinai Medical Center 
Duke University Hospital 
Hospitals of the University of Pennsylvania–Penn Presbyterian 
Houston Methodist Hospital 
Johns Hopkins Hospital 
Massachusetts General Hospital 
Mayo Clinic 
Mount Sinai Hospital 
New York-Presbyterian Columbia 
New York-Presbyterian Cornell 
Northwestern Memorial Hospital 
Ronald Reagan UCLA Medical Center 
Stanford Health Care–Stanford Hospital 
The Cleveland Clinic 
Tisch Hospital, NYU Langone Health 
University of California, San Francisco Medical Center 
University of Colorado Hospital 
University of Michigan Hospitals and Health Centers 
UPMC Presbyterian Shadyside, Pittsburgh 
Barnes-Jewish Hospital/Washington University, St Louis 
Brigham and Women’s Hospital 
Cedars-Sinai Medical Center 
Duke University Hospital 
Hospitals of the University of Pennsylvania–Penn Presbyterian 
Houston Methodist Hospital 
Johns Hopkins Hospital 
Massachusetts General Hospital 
Mayo Clinic 
Mount Sinai Hospital 
New York-Presbyterian Columbia 
New York-Presbyterian Cornell 
Northwestern Memorial Hospital 
Ronald Reagan UCLA Medical Center 
Stanford Health Care–Stanford Hospital 
The Cleveland Clinic 
Tisch Hospital, NYU Langone Health 
University of California, San Francisco Medical Center 
University of Colorado Hospital 
University of Michigan Hospitals and Health Centers 
UPMC Presbyterian Shadyside, Pittsburgh 

Open in new tab

Results

Results were collected from all 21 institutions (100% response rate). Although some responses required additional communication to further clarify answers, eventually all questions were adequately addressed by all institutions.

The instrument manufacturers used by the different institutions for routine CHEM and IM varied Table 3. For CHEM, only one institution used instruments from more than one vendor, whereas all other institutions used instruments from one vendor. The overall breakdown included Roche (Basel, Switzerland) (n = 10, 48%), Beckman Coulter (Brea, CA) (n = 6, 29%), Siemens (Berlin, Germany) (n = 4, 19%), and Abbott (Lake Bluff, IL) and Ortho (Raritan, NJ) (n = 1, 5% each) Table 3). In contrast, for IM, 10 (48%) of 21 institutions used instruments from multiple manufacturers (range, 1-5), including Roche (n = 13, 61.9%), Beckman Coulter (n = 10, 47.6%), Siemens (n = 9, 48.9%), Abbott (n = 7, 33.3%), Ortho (n = 1, 4.7%), and Bio-Rad (Hercules, CA) (n = 1, 4.7%).

Table 3

Instruments Used for Automated Chemistry and Immunochemistry

Hospital Chemistry Immunochemistry 
Roche Roche 
Siemens Siemens 
Roche Roche, Abbott 
Siemens Siemens 
Roche Roche 
Roche, Beckman Coulter Abbott, Roche, Beckman Coulter 
Ortho Ortho, Roche, Abbott 
Beckman Coulter Beckman Coulter, Roche 
Beckman Coulter Beckman Coulter, Siemens 
Beckman Coulter Roche, Abbott, Beckman Coulter, Siemens 
Abbott Abbott 
Roche Roche 
Roche Roche 
Roche Roche, Beckman Coulter, Siemens 
Roche Roche, Siemens, Beckman Coulter 
Beckman Coulter Beckman Coulter 
Roche Roche, Abbott, Beckman Coulter 
Siemens Siemens 
Siemens Siemens 
Roche Roche, Siemens, Bio-Rad, Abbott, Beckman Coulter 
Beckman Coulter Beckman Coulter 
Hospital Chemistry Immunochemistry 
Roche Roche 
Siemens Siemens 
Roche Roche, Abbott 
Siemens Siemens 
Roche Roche 
Roche, Beckman Coulter Abbott, Roche, Beckman Coulter 
Ortho Ortho, Roche, Abbott 
Beckman Coulter Beckman Coulter, Roche 
Beckman Coulter Beckman Coulter, Siemens 
Beckman Coulter Roche, Abbott, Beckman Coulter, Siemens 
Abbott Abbott 
Roche Roche 
Roche Roche 
Roche Roche, Beckman Coulter, Siemens 
Roche Roche, Siemens, Beckman Coulter 
Beckman Coulter Beckman Coulter 
Roche Roche, Abbott, Beckman Coulter 
Siemens Siemens 
Siemens Siemens 
Roche Roche, Siemens, Bio-Rad, Abbott, Beckman Coulter 
Beckman Coulter Beckman Coulter 

Open in new tab

Table 3

Instruments Used for Automated Chemistry and Immunochemistry

Hospital Chemistry Immunochemistry 
Roche Roche 
Siemens Siemens 
Roche Roche, Abbott 
Siemens Siemens 
Roche Roche 
Roche, Beckman Coulter Abbott, Roche, Beckman Coulter 
Ortho Ortho, Roche, Abbott 
Beckman Coulter Beckman Coulter, Roche 
Beckman Coulter Beckman Coulter, Siemens 
Beckman Coulter Roche, Abbott, Beckman Coulter, Siemens 
Abbott Abbott 
Roche Roche 
Roche Roche 
Roche Roche, Beckman Coulter, Siemens 
Roche Roche, Siemens, Beckman Coulter 
Beckman Coulter Beckman Coulter 
Roche Roche, Abbott, Beckman Coulter 
Siemens Siemens 
Siemens Siemens 
Roche Roche, Siemens, Bio-Rad, Abbott, Beckman Coulter 
Beckman Coulter Beckman Coulter 
Hospital Chemistry Immunochemistry 
Roche Roche 
Siemens Siemens 
Roche Roche, Abbott 
Siemens Siemens 
Roche Roche 
Roche, Beckman Coulter Abbott, Roche, Beckman Coulter 
Ortho Ortho, Roche, Abbott 
Beckman Coulter Beckman Coulter, Roche 
Beckman Coulter Beckman Coulter, Siemens 
Beckman Coulter Roche, Abbott, Beckman Coulter, Siemens 
Abbott Abbott 
Roche Roche 
Roche Roche 
Roche Roche, Beckman Coulter, Siemens 
Roche Roche, Siemens, Beckman Coulter 
Beckman Coulter Beckman Coulter 
Roche Roche, Abbott, Beckman Coulter 
Siemens Siemens 
Siemens Siemens 
Roche Roche, Siemens, Bio-Rad, Abbott, Beckman Coulter 
Beckman Coulter Beckman Coulter 

Open in new tab

There was wide variation in the frequency of running CHEM QC Table 4, ranging from daily (n = 3, 14%) to every 2 hours (n = 2, 10%); intermediate intervals included every 4 hours (n = 3, 14%), 6 hours (n = 1, 5%), 8 hours (n = 6, 29%), and 12 hours (n = 6, 29%). Two (10%) institutions used a different QC frequency for electrolytes vs other CHEM tests. The total number of QC “events” per analyte (defined as the total number of times QC was run on an analyzer regardless of the number of levels) in a 24-hour period varied from a minimum of one to a maximum of 12. Three (14%) institutions used only one level per shift or one alternating level on the nonday shift hours (eg, a high control in the morning, a low control in the afternoon, and medium control on the late-night shifts).

Table 4

Quality Control Frequency

QC Events/d . 
Hospital . CHEM . IM . Stat IM . CHEM . IM . Tn .  hCG . 
2-3 Lv qd (electrolytes q8h) 2-3 Lv qd 2-3 Lv qd, negative QC q8h for Tn and hCG 
2-3 Lv q8h 2-3 Lv q8h 2-3 Lv q8h 
1 Lv (alternating) q2h 2-3 Lv q8h cTn 4 Lv qd, 2 Lv alternating q2h, hCG 2 Lv q8h 12 12 
2 Lv q12h 2 Lv q12h 2 Lv q8h 
2 Lv q8h 2 Lv qd 2 Lv qd 
2 Lv q8h 2 Lv qd 2 Lv qd 
High control q12h, low control qd 2-3 Lv qd (medium Lv q12 for Lv 3 tests) or high Lv q12h/low Lv qd Tn/CKMB/NT-proBNP: 2 Lv q12h; hCG: high q12h, low qd 
2-3 Lv q12h 2-3 q12h 2-3 q12h 
2-3 Lv q8h or qd 2-3 Lv qd 2-3 Lv qd 
2 Lv q8h (q4h for electrolytes) 2-3 qd, 1 Lv (alternating) second/third shift 2-3 Lv day shift, 1 Lv (alternating) second/third shifts 
2 Lv qd 2-3 Lv qd Tn/hCG: 3 Lv qd 
2 Lv q6h, 2 Lv startup/shutdown 2-3 Lv q12h 5 Lv q8h; hCG 2-3 Lv q12h 
2 Lv at startup, 1 Lv (q4h alternating) 2-3 Lv at startup, 1 Lv at shutdown Tn/hCG 2/3 Lv at startup, 1 Lv (alternating) q4h 
3 Lv startup/shutdown, then 2 levels QC q2h 3 Lv startup/shutdown, plus 2 levels q8h 3 Lv q8h 12 
3 Lv qd 2-3 Lv qd Core laboratory: Tn/hCG 3 Lvq12h/q24 hours; ED laboratory: Tn/hCG 2 Lv qd 
2-3 Lv q12h 2 Lv q8h 2 Lv q8h 
3 Lv day shift, 2 Lv other shifts 3 Lv day shift, 2 Lv other shifts 3 Lv qd, 2 Lv q12h 
2 Lv q12h 2 Lv q12h 3 Lv q12h 
2-3 q12h q12h, certain tests once at start up q12h, some qd 
2 Lv qd 2 Lv qd 2 Lv qd 
3 Lv q8h 3 Lv qd 3 Lv qd 
QC Events/d . 
Hospital . CHEM . IM . Stat IM . CHEM . IM . Tn .  hCG . 
2-3 Lv qd (electrolytes q8h) 2-3 Lv qd 2-3 Lv qd, negative QC q8h for Tn and hCG 
2-3 Lv q8h 2-3 Lv q8h 2-3 Lv q8h 
1 Lv (alternating) q2h 2-3 Lv q8h cTn 4 Lv qd, 2 Lv alternating q2h, hCG 2 Lv q8h 12 12 
2 Lv q12h 2 Lv q12h 2 Lv q8h 
2 Lv q8h 2 Lv qd 2 Lv qd 
2 Lv q8h 2 Lv qd 2 Lv qd 
High control q12h, low control qd 2-3 Lv qd (medium Lv q12 for Lv 3 tests) or high Lv q12h/low Lv qd Tn/CKMB/NT-proBNP: 2 Lv q12h; hCG: high q12h, low qd 
2-3 Lv q12h 2-3 q12h 2-3 q12h 
2-3 Lv q8h or qd 2-3 Lv qd 2-3 Lv qd 
2 Lv q8h (q4h for electrolytes) 2-3 qd, 1 Lv (alternating) second/third shift 2-3 Lv day shift, 1 Lv (alternating) second/third shifts 
2 Lv qd 2-3 Lv qd Tn/hCG: 3 Lv qd 
2 Lv q6h, 2 Lv startup/shutdown 2-3 Lv q12h 5 Lv q8h; hCG 2-3 Lv q12h 
2 Lv at startup, 1 Lv (q4h alternating) 2-3 Lv at startup, 1 Lv at shutdown Tn/hCG 2/3 Lv at startup, 1 Lv (alternating) q4h 
3 Lv startup/shutdown, then 2 levels QC q2h 3 Lv startup/shutdown, plus 2 levels q8h 3 Lv q8h 12 
3 Lv qd 2-3 Lv qd Core laboratory: Tn/hCG 3 Lvq12h/q24 hours; ED laboratory: Tn/hCG 2 Lv qd 
2-3 Lv q12h 2 Lv q8h 2 Lv q8h 
3 Lv day shift, 2 Lv other shifts 3 Lv day shift, 2 Lv other shifts 3 Lv qd, 2 Lv q12h 
2 Lv q12h 2 Lv q12h 3 Lv q12h 
2-3 q12h q12h, certain tests once at start up q12h, some qd 
2 Lv qd 2 Lv qd 2 Lv qd 
3 Lv q8h 3 Lv qd 3 Lv qd 

Open in new tab

Table 4

Quality Control Frequency

QC Events/d . 
Hospital . CHEM . IM . Stat IM . CHEM . IM . Tn .  hCG . 
2-3 Lv qd (electrolytes q8h) 2-3 Lv qd 2-3 Lv qd, negative QC q8h for Tn and hCG 
2-3 Lv q8h 2-3 Lv q8h 2-3 Lv q8h 
1 Lv (alternating) q2h 2-3 Lv q8h cTn 4 Lv qd, 2 Lv alternating q2h, hCG 2 Lv q8h 12 12 
2 Lv q12h 2 Lv q12h 2 Lv q8h 
2 Lv q8h 2 Lv qd 2 Lv qd 
2 Lv q8h 2 Lv qd 2 Lv qd 
High control q12h, low control qd 2-3 Lv qd (medium Lv q12 for Lv 3 tests) or high Lv q12h/low Lv qd Tn/CKMB/NT-proBNP: 2 Lv q12h; hCG: high q12h, low qd 
2-3 Lv q12h 2-3 q12h 2-3 q12h 
2-3 Lv q8h or qd 2-3 Lv qd 2-3 Lv qd 
2 Lv q8h (q4h for electrolytes) 2-3 qd, 1 Lv (alternating) second/third shift 2-3 Lv day shift, 1 Lv (alternating) second/third shifts 
2 Lv qd 2-3 Lv qd Tn/hCG: 3 Lv qd 
2 Lv q6h, 2 Lv startup/shutdown 2-3 Lv q12h 5 Lv q8h; hCG 2-3 Lv q12h 
2 Lv at startup, 1 Lv (q4h alternating) 2-3 Lv at startup, 1 Lv at shutdown Tn/hCG 2/3 Lv at startup, 1 Lv (alternating) q4h 
3 Lv startup/shutdown, then 2 levels QC q2h 3 Lv startup/shutdown, plus 2 levels q8h 3 Lv q8h 12 
3 Lv qd 2-3 Lv qd Core laboratory: Tn/hCG 3 Lvq12h/q24 hours; ED laboratory: Tn/hCG 2 Lv qd 
2-3 Lv q12h 2 Lv q8h 2 Lv q8h 
3 Lv day shift, 2 Lv other shifts 3 Lv day shift, 2 Lv other shifts 3 Lv qd, 2 Lv q12h 
2 Lv q12h 2 Lv q12h 3 Lv q12h 
2-3 q12h q12h, certain tests once at start up q12h, some qd 
2 Lv qd 2 Lv qd 2 Lv qd 
3 Lv q8h 3 Lv qd 3 Lv qd 
QC Events/d . 
Hospital . CHEM . IM . Stat IM . CHEM . IM . Tn .  hCG . 
2-3 Lv qd (electrolytes q8h) 2-3 Lv qd 2-3 Lv qd, negative QC q8h for Tn and hCG 
2-3 Lv q8h 2-3 Lv q8h 2-3 Lv q8h 
1 Lv (alternating) q2h 2-3 Lv q8h cTn 4 Lv qd, 2 Lv alternating q2h, hCG 2 Lv q8h 12 12 
2 Lv q12h 2 Lv q12h 2 Lv q8h 
2 Lv q8h 2 Lv qd 2 Lv qd 
2 Lv q8h 2 Lv qd 2 Lv qd 
High control q12h, low control qd 2-3 Lv qd (medium Lv q12 for Lv 3 tests) or high Lv q12h/low Lv qd Tn/CKMB/NT-proBNP: 2 Lv q12h; hCG: high q12h, low qd 
2-3 Lv q12h 2-3 q12h 2-3 q12h 
2-3 Lv q8h or qd 2-3 Lv qd 2-3 Lv qd 
2 Lv q8h (q4h for electrolytes) 2-3 qd, 1 Lv (alternating) second/third shift 2-3 Lv day shift, 1 Lv (alternating) second/third shifts 
2 Lv qd 2-3 Lv qd Tn/hCG: 3 Lv qd 
2 Lv q6h, 2 Lv startup/shutdown 2-3 Lv q12h 5 Lv q8h; hCG 2-3 Lv q12h 
2 Lv at startup, 1 Lv (q4h alternating) 2-3 Lv at startup, 1 Lv at shutdown Tn/hCG 2/3 Lv at startup, 1 Lv (alternating) q4h 
3 Lv startup/shutdown, then 2 levels QC q2h 3 Lv startup/shutdown, plus 2 levels q8h 3 Lv q8h 12 
3 Lv qd 2-3 Lv qd Core laboratory: Tn/hCG 3 Lvq12h/q24 hours; ED laboratory: Tn/hCG 2 Lv qd 
2-3 Lv q12h 2 Lv q8h 2 Lv q8h 
3 Lv day shift, 2 Lv other shifts 3 Lv day shift, 2 Lv other shifts 3 Lv qd, 2 Lv q12h 
2 Lv q12h 2 Lv q12h 3 Lv q12h 
2-3 q12h q12h, certain tests once at start up q12h, some qd 
2 Lv qd 2 Lv qd 2 Lv qd 
3 Lv q8h 3 Lv qd 3 Lv qd 

Open in new tab

There was also variability in the frequency and number of QC for IM and STAT IM (eg, troponin and β–human chorionic gonadotropin [hCG]). The total number of non-STAT IM QC levels used per day varied between institutions from a minimum of two levels to a maximum of three different levels per day (Table 4). QC events per 24 hours were less varied than for CHEMs, ranging from one to seven. For STAT IMs, 19 laboratories used two or three levels, with one laboratory using four levels for troponin (which included a QC near the 99% cutoff), another laboratory using five levels for troponin, and four laboratories using alternating levels at different time points. QC events for STAT IM per 24 hours varied from one to 12 per day. As with CHEM, some hospitals used a single control level on select shifts.

For CHEM, many hospitals used QC materials from multiple sources (n = 8, 38%) Table 5. However, all respondents predominantly relied on third-party QC materials (n = 21, 100%). Of the third-party reagents, Bio-Rad was the most common (n = 19, 90%), with MAS ChemTrak (Thermo Fisher Scientific, Waltham, MA) less commonly used (n = 2, 10%). For IM, 12 (57%) laboratories used more than one source for control materials. Again, Bio-Rad QC materials were the most commonly used (n = 19, 90%), and two (10%) laboratories favored the use of manufacturer QC materials over third party.

Table 5

Quality Control Material Vendors

Hospital . Chemistry . Immunochemistry . 
MAS Chemtrak Bio-Rad 
Bio-Rad Bio-Rad 
Bio-Rad Bio-Rad 
Bio-Rad Bio-Rad 
Bio-Rad, manufacturer when necessary Bio-Rad, manufacturer QC when necessary 
Bio-Rad Bio-Rad 
Bio-Rad Bio-Rad 
Bio-Rad Bio-Rad 
Predominantly Bio- Rad QC and some manufacturer supplied (if available) Predominantly Bio-Rad QC and some manufacturer supplied (if available) 
Bio-Rad, MAS Chemtrak Automatic laboratory: manufacturer supplied when possible, third party when necessary (Bio-Rad). Special chemistry laboratory: Bio-Rad when possible, manufacturer when necessary; supplemented with patient pools 
Bio-Rad Bio-Rad, manufacturer QC when necessary 
Bio-Rad Bio-Rad, Roche, Randox 
MAS ChemTrack Manufacturer, third party when needed (Bio-Rad) 
Mostly Bio-Rad, also Stanbio, Thermo TDM, UTAK, Elsohly Mostly Bio-Rad, manufacturer control where necessary 
Bio-Rad, very few manufacturers or laboratory made Bio-Rad, very few manufacturers 
Bio-Rad Bio-Rad 
Bio-Rad, some Beckman Coulter, Abbott, and in-house prepared Bio-Rad, some Beckman Coulter, Abbott, and in-house prepared 
Bio-Rad Bio-Rad 
Bio-Rad Bio-Rad, some Beckman Coulter, Abbott, and in-house prepared 
Bio-Rad, some Roche Bio-Rad, some Roche, Abbott 
Bio-Rad, very few manufacturers Bio-Rad, very few manufacturers 
Hospital . Chemistry . Immunochemistry . 
MAS Chemtrak Bio-Rad 
Bio-Rad Bio-Rad 
Bio-Rad Bio-Rad 
Bio-Rad Bio-Rad 
Bio-Rad, manufacturer when necessary Bio-Rad, manufacturer QC when necessary 
Bio-Rad Bio-Rad 
Bio-Rad Bio-Rad 
Bio-Rad Bio-Rad 
Predominantly Bio- Rad QC and some manufacturer supplied (if available) Predominantly Bio-Rad QC and some manufacturer supplied (if available) 
Bio-Rad, MAS Chemtrak Automatic laboratory: manufacturer supplied when possible, third party when necessary (Bio-Rad). Special chemistry laboratory: Bio-Rad when possible, manufacturer when necessary; supplemented with patient pools 
Bio-Rad Bio-Rad, manufacturer QC when necessary 
Bio-Rad Bio-Rad, Roche, Randox 
MAS ChemTrack Manufacturer, third party when needed (Bio-Rad) 
Mostly Bio-Rad, also Stanbio, Thermo TDM, UTAK, Elsohly Mostly Bio-Rad, manufacturer control where necessary 
Bio-Rad, very few manufacturers or laboratory made Bio-Rad, very few manufacturers 
Bio-Rad Bio-Rad 
Bio-Rad, some Beckman Coulter, Abbott, and in-house prepared Bio-Rad, some Beckman Coulter, Abbott, and in-house prepared 
Bio-Rad Bio-Rad 
Bio-Rad Bio-Rad, some Beckman Coulter, Abbott, and in-house prepared 
Bio-Rad, some Roche Bio-Rad, some Roche, Abbott 
Bio-Rad, very few manufacturers Bio-Rad, very few manufacturers 

Open in new tab

Table 5

Quality Control Material Vendors

Hospital . Chemistry . Immunochemistry . 
MAS Chemtrak Bio-Rad 
Bio-Rad Bio-Rad 
Bio-Rad Bio-Rad 
Bio-Rad Bio-Rad 
Bio-Rad, manufacturer when necessary Bio-Rad, manufacturer QC when necessary 
Bio-Rad Bio-Rad 
Bio-Rad Bio-Rad 
Bio-Rad Bio-Rad 
Predominantly Bio- Rad QC and some manufacturer supplied (if available) Predominantly Bio-Rad QC and some manufacturer supplied (if available) 
Bio-Rad, MAS Chemtrak Automatic laboratory: manufacturer supplied when possible, third party when necessary (Bio-Rad). Special chemistry laboratory: Bio-Rad when possible, manufacturer when necessary; supplemented with patient pools 
Bio-Rad Bio-Rad, manufacturer QC when necessary 
Bio-Rad Bio-Rad, Roche, Randox 
MAS ChemTrack Manufacturer, third party when needed (Bio-Rad) 
Mostly Bio-Rad, also Stanbio, Thermo TDM, UTAK, Elsohly Mostly Bio-Rad, manufacturer control where necessary 
Bio-Rad, very few manufacturers or laboratory made Bio-Rad, very few manufacturers 
Bio-Rad Bio-Rad 
Bio-Rad, some Beckman Coulter, Abbott, and in-house prepared Bio-Rad, some Beckman Coulter, Abbott, and in-house prepared 
Bio-Rad Bio-Rad 
Bio-Rad Bio-Rad, some Beckman Coulter, Abbott, and in-house prepared 
Bio-Rad, some Roche Bio-Rad, some Roche, Abbott 
Bio-Rad, very few manufacturers Bio-Rad, very few manufacturers 
Hospital . Chemistry . Immunochemistry . 
MAS Chemtrak Bio-Rad 
Bio-Rad Bio-Rad 
Bio-Rad Bio-Rad 
Bio-Rad Bio-Rad 
Bio-Rad, manufacturer when necessary Bio-Rad, manufacturer QC when necessary 
Bio-Rad Bio-Rad 
Bio-Rad Bio-Rad 
Bio-Rad Bio-Rad 
Predominantly Bio- Rad QC and some manufacturer supplied (if available) Predominantly Bio-Rad QC and some manufacturer supplied (if available) 
Bio-Rad, MAS Chemtrak Automatic laboratory: manufacturer supplied when possible, third party when necessary (Bio-Rad). Special chemistry laboratory: Bio-Rad when possible, manufacturer when necessary; supplemented with patient pools 
Bio-Rad Bio-Rad, manufacturer QC when necessary 
Bio-Rad Bio-Rad, Roche, Randox 
MAS ChemTrack Manufacturer, third party when needed (Bio-Rad) 
Mostly Bio-Rad, also Stanbio, Thermo TDM, UTAK, Elsohly Mostly Bio-Rad, manufacturer control where necessary 
Bio-Rad, very few manufacturers or laboratory made Bio-Rad, very few manufacturers 
Bio-Rad Bio-Rad 
Bio-Rad, some Beckman Coulter, Abbott, and in-house prepared Bio-Rad, some Beckman Coulter, Abbott, and in-house prepared 
Bio-Rad Bio-Rad 
Bio-Rad Bio-Rad, some Beckman Coulter, Abbott, and in-house prepared 
Bio-Rad, some Roche Bio-Rad, some Roche, Abbott 
Bio-Rad, very few manufacturers Bio-Rad, very few manufacturers 

Open in new tab

Most hospitals used a QC rule of 2 SD (n = 16, 76%), two (10%) used variable rules (based on the test) between 2 and 3 SD, and one (5%) used a cutoff of 3 SD Table 6. Two (10%) hospitals used derivations of the Westgard rules depending on the assay. For IM, 17 (81%) hospitals chose a 2-SD rule, one (5%) chose 3 SD, and three (14%) chose some permutation of the Westgard rules.

Table 6

Quality Control Rules

Hospital . Chemistry . Immunochemistry . 
±2 SD ±2 SD 
±2 SD ±2 SD 
±2 SD ±2 SD 
±2 SD, some ±2.5 SD and ±3 SD ±2 SD 
±2 SD ±2 SD 
±2 SD ±2 SD 
±2 SD ±2 SD 
±2 SD ±2 SD 
Variable (1-3S, 1-3.5S, 1-4S, 1-5S, 2-2S, 2 of 3-2S, R-4S, 3-1S, 4-1S, or N-x, 1-2S, 1-2.5S) Variable (1-3S, 1-3.5S, 1-4S, 1-5S, 2-2S, 2 of 3-2S, R-4S, 3-1S, 4-1S, or N-x, 1-2S, 1-2.5S) 
±2 SD ±2 SD 
±2 SD ±2 SD 
±2 SD ±2 SD 
±2 SD ±2 SD 
±2 SD ±2 SD 
±2 SD ±2 SD 
±2 SD ±2 SD 
3 SD 3 SD 
±2 SD ±2 SD 
2-2S, 1-3S, R-4S, 10x 2-2S, 1-3S, R-4S, 10x 
2 or 3 SD Some 2 or 3 SD; others Westgard rules 
±2 SD ±2 SD 
Hospital . Chemistry . Immunochemistry . 
±2 SD ±2 SD 
±2 SD ±2 SD 
±2 SD ±2 SD 
±2 SD, some ±2.5 SD and ±3 SD ±2 SD 
±2 SD ±2 SD 
±2 SD ±2 SD 
±2 SD ±2 SD 
±2 SD ±2 SD 
Variable (1-3S, 1-3.5S, 1-4S, 1-5S, 2-2S, 2 of 3-2S, R-4S, 3-1S, 4-1S, or N-x, 1-2S, 1-2.5S) Variable (1-3S, 1-3.5S, 1-4S, 1-5S, 2-2S, 2 of 3-2S, R-4S, 3-1S, 4-1S, or N-x, 1-2S, 1-2.5S) 
±2 SD ±2 SD 
±2 SD ±2 SD 
±2 SD ±2 SD 
±2 SD ±2 SD 
±2 SD ±2 SD 
±2 SD ±2 SD 
±2 SD ±2 SD 
3 SD 3 SD 
±2 SD ±2 SD 
2-2S, 1-3S, R-4S, 10x 2-2S, 1-3S, R-4S, 10x 
2 or 3 SD Some 2 or 3 SD; others Westgard rules 
±2 SD ±2 SD 

Open in new tab

Table 6

Quality Control Rules

Hospital . Chemistry . Immunochemistry . 
±2 SD ±2 SD 
±2 SD ±2 SD 
±2 SD ±2 SD 
±2 SD, some ±2.5 SD and ±3 SD ±2 SD 
±2 SD ±2 SD 
±2 SD ±2 SD 
±2 SD ±2 SD 
±2 SD ±2 SD 
Variable (1-3S, 1-3.5S, 1-4S, 1-5S, 2-2S, 2 of 3-2S, R-4S, 3-1S, 4-1S, or N-x, 1-2S, 1-2.5S) Variable (1-3S, 1-3.5S, 1-4S, 1-5S, 2-2S, 2 of 3-2S, R-4S, 3-1S, 4-1S, or N-x, 1-2S, 1-2.5S) 
±2 SD ±2 SD 
±2 SD ±2 SD 
±2 SD ±2 SD 
±2 SD ±2 SD 
±2 SD ±2 SD 
±2 SD ±2 SD 
±2 SD ±2 SD 
3 SD 3 SD 
±2 SD ±2 SD 
2-2S, 1-3S, R-4S, 10x 2-2S, 1-3S, R-4S, 10x 
2 or 3 SD Some 2 or 3 SD; others Westgard rules 
±2 SD ±2 SD 
Hospital . Chemistry . Immunochemistry . 
±2 SD ±2 SD 
±2 SD ±2 SD 
±2 SD ±2 SD 
±2 SD, some ±2.5 SD and ±3 SD ±2 SD 
±2 SD ±2 SD 
±2 SD ±2 SD 
±2 SD ±2 SD 
±2 SD ±2 SD 
Variable (1-3S, 1-3.5S, 1-4S, 1-5S, 2-2S, 2 of 3-2S, R-4S, 3-1S, 4-1S, or N-x, 1-2S, 1-2.5S) Variable (1-3S, 1-3.5S, 1-4S, 1-5S, 2-2S, 2 of 3-2S, R-4S, 3-1S, 4-1S, or N-x, 1-2S, 1-2.5S) 
±2 SD ±2 SD 
±2 SD ±2 SD 
±2 SD ±2 SD 
±2 SD ±2 SD 
±2 SD ±2 SD 
±2 SD ±2 SD 
±2 SD ±2 SD 
3 SD 3 SD 
±2 SD ±2 SD 
2-2S, 1-3S, R-4S, 10x 2-2S, 1-3S, R-4S, 10x 
2 or 3 SD Some 2 or 3 SD; others Westgard rules 
±2 SD ±2 SD 

Open in new tab

When a QC was out of control, all but one hospital elected to repeat the control and accept results if the repeat came back into control (n = 20, 95%), although some had some minor variations (such as rejecting a run outright if a control was out by >4 SD; Table 7). One (5%) institution rejected runs if two controls were out 2 SD or if one was out 3 SD. Another institution (5%) repeated QC if one of the two levels was out 2 SD from target value but accepted the run if only one of three QC levels was out. This institution also rejected outright if the following rules were broken: 1- 2.5S, 2-2S, 2/3-2S, or R-4S. Only laboratory E made no provisions for repeating control(s); if one level exceeded 3 SD or two controls exceeded 2 SD, the run was rejected as being out of control.

Table 7

Quality Control Rules

Hospital . QC Rules . 
If control is out of range, it is repeated. If repeat is in range, the results are accepted. If still out of range, assay is recalibrated and/or additional troubleshooting occurs (eg, new reagent pack, new QC). Patient results may be repeated if it is determined that QC was out when patient results were reported. 
As “A.” 
As “A.” 
As “A.” 
Reject results if two QC values are out 2 SD or more or if one is out 3 SD. If QC fails, corrective action is taken. If one QC is out 2 SD, evaluate other QC in same run and in previous runs (warning only). 
As “A.” 
As “A.” 
As “A” if one QC out <4 SD. If two QCs are out 2 to 4 SD, both must be repeated and corrective action is taken if one or more are still out. If QC out >4 SD, stop analysis immediately and take corrective action before continuing testing. 
As “A.” 
As “A” 
As “A,” but if the QC results are acceptable after recalibration, 10 specimens analyzed within the last 24 hours are repeated. If they are within 10% of reported value, the assay is validated. If not, further corrective action is taken. 
As “A.” 
As “A.” 
As “A.” 
For analytes with two QC levels and troponin, as “A” but also rejected if 1-2.5S, 2-2S, 2/3-2S, or R-4S rules are violated. We also have a warning with the 7-T rule.
For analytes with three QC levels, if control is outside of 2 SD range (1-2S), it is a warning; repeat is not required and run is accepted. If two QC levels are outside of 2 SD range (2-2S), run is rejected, and controls are repeated using new vials/aliquots of controls. If QC is back into range, the run is accepted. If repeat is out of range, investigate/recalibrate. Reject run also if 1-2.5S, 2-2S, 2/3-2S, or R-4S rule is violated. We also have a warning with the 7-T rule. 
As “A.” 
If QC is out 3 SD, then QC failure; repeat once, and if it fails again, take corrective action. 
We use several Westgard rules (4-1S, 10x) to further investigate when a 2-SD flag occurs on QC. First step is to repeat QC; if it is in and no Westgard rules have triggered, accept and continue. If out, check QC on other analyzers and rerun at least five patients on a different analyzer. Notify supervisor if recalibration is warranted. 
If results are out by 2-2S or 1-3S, the QC is repeated and accepted if it comes in. If it is out, the system is recalibrated and QC is rerun. Any further problems are escalated to the lead in the area for further troubleshooting. 
As “A.” 
As “A”; if far outside of 2 SD, then may be worked up at coordinator’s discretion. 
Hospital . QC Rules . 
If control is out of range, it is repeated. If repeat is in range, the results are accepted. If still out of range, assay is recalibrated and/or additional troubleshooting occurs (eg, new reagent pack, new QC). Patient results may be repeated if it is determined that QC was out when patient results were reported. 
As “A.” 
As “A.” 
As “A.” 
Reject results if two QC values are out 2 SD or more or if one is out 3 SD. If QC fails, corrective action is taken. If one QC is out 2 SD, evaluate other QC in same run and in previous runs (warning only). 
As “A.” 
As “A.” 
As “A” if one QC out <4 SD. If two QCs are out 2 to 4 SD, both must be repeated and corrective action is taken if one or more are still out. If QC out >4 SD, stop analysis immediately and take corrective action before continuing testing. 
As “A.” 
As “A” 
As “A,” but if the QC results are acceptable after recalibration, 10 specimens analyzed within the last 24 hours are repeated. If they are within 10% of reported value, the assay is validated. If not, further corrective action is taken. 
As “A.” 
As “A.” 
As “A.” 
For analytes with two QC levels and troponin, as “A” but also rejected if 1-2.5S, 2-2S, 2/3-2S, or R-4S rules are violated. We also have a warning with the 7-T rule.
For analytes with three QC levels, if control is outside of 2 SD range (1-2S), it is a warning; repeat is not required and run is accepted. If two QC levels are outside of 2 SD range (2-2S), run is rejected, and controls are repeated using new vials/aliquots of controls. If QC is back into range, the run is accepted. If repeat is out of range, investigate/recalibrate. Reject run also if 1-2.5S, 2-2S, 2/3-2S, or R-4S rule is violated. We also have a warning with the 7-T rule. 
As “A.” 
If QC is out 3 SD, then QC failure; repeat once, and if it fails again, take corrective action. 
We use several Westgard rules (4-1S, 10x) to further investigate when a 2-SD flag occurs on QC. First step is to repeat QC; if it is in and no Westgard rules have triggered, accept and continue. If out, check QC on other analyzers and rerun at least five patients on a different analyzer. Notify supervisor if recalibration is warranted. 
If results are out by 2-2S or 1-3S, the QC is repeated and accepted if it comes in. If it is out, the system is recalibrated and QC is rerun. Any further problems are escalated to the lead in the area for further troubleshooting. 
As “A.” 
As “A”; if far outside of 2 SD, then may be worked up at coordinator’s discretion. 

Open in new tab

Table 7

Quality Control Rules

Hospital . QC Rules . 
If control is out of range, it is repeated. If repeat is in range, the results are accepted. If still out of range, assay is recalibrated and/or additional troubleshooting occurs (eg, new reagent pack, new QC). Patient results may be repeated if it is determined that QC was out when patient results were reported. 
As “A.” 
As “A.” 
As “A.” 
Reject results if two QC values are out 2 SD or more or if one is out 3 SD. If QC fails, corrective action is taken. If one QC is out 2 SD, evaluate other QC in same run and in previous runs (warning only). 
As “A.” 
As “A.” 
As “A” if one QC out <4 SD. If two QCs are out 2 to 4 SD, both must be repeated and corrective action is taken if one or more are still out. If QC out >4 SD, stop analysis immediately and take corrective action before continuing testing. 
As “A.” 
As “A” 
As “A,” but if the QC results are acceptable after recalibration, 10 specimens analyzed within the last 24 hours are repeated. If they are within 10% of reported value, the assay is validated. If not, further corrective action is taken. 
As “A.” 
As “A.” 
As “A.” 
For analytes with two QC levels and troponin, as “A” but also rejected if 1-2.5S, 2-2S, 2/3-2S, or R-4S rules are violated. We also have a warning with the 7-T rule.
For analytes with three QC levels, if control is outside of 2 SD range (1-2S), it is a warning; repeat is not required and run is accepted. If two QC levels are outside of 2 SD range (2-2S), run is rejected, and controls are repeated using new vials/aliquots of controls. If QC is back into range, the run is accepted. If repeat is out of range, investigate/recalibrate. Reject run also if 1-2.5S, 2-2S, 2/3-2S, or R-4S rule is violated. We also have a warning with the 7-T rule. 
As “A.” 
If QC is out 3 SD, then QC failure; repeat once, and if it fails again, take corrective action. 
We use several Westgard rules (4-1S, 10x) to further investigate when a 2-SD flag occurs on QC. First step is to repeat QC; if it is in and no Westgard rules have triggered, accept and continue. If out, check QC on other analyzers and rerun at least five patients on a different analyzer. Notify supervisor if recalibration is warranted. 
If results are out by 2-2S or 1-3S, the QC is repeated and accepted if it comes in. If it is out, the system is recalibrated and QC is rerun. Any further problems are escalated to the lead in the area for further troubleshooting. 
As “A.” 
As “A”; if far outside of 2 SD, then may be worked up at coordinator’s discretion. 
Hospital . QC Rules . 
If control is out of range, it is repeated. If repeat is in range, the results are accepted. If still out of range, assay is recalibrated and/or additional troubleshooting occurs (eg, new reagent pack, new QC). Patient results may be repeated if it is determined that QC was out when patient results were reported. 
As “A.” 
As “A.” 
As “A.” 
Reject results if two QC values are out 2 SD or more or if one is out 3 SD. If QC fails, corrective action is taken. If one QC is out 2 SD, evaluate other QC in same run and in previous runs (warning only). 
As “A.” 
As “A.” 
As “A” if one QC out <4 SD. If two QCs are out 2 to 4 SD, both must be repeated and corrective action is taken if one or more are still out. If QC out >4 SD, stop analysis immediately and take corrective action before continuing testing. 
As “A.” 
As “A” 
As “A,” but if the QC results are acceptable after recalibration, 10 specimens analyzed within the last 24 hours are repeated. If they are within 10% of reported value, the assay is validated. If not, further corrective action is taken. 
As “A.” 
As “A.” 
As “A.” 
For analytes with two QC levels and troponin, as “A” but also rejected if 1-2.5S, 2-2S, 2/3-2S, or R-4S rules are violated. We also have a warning with the 7-T rule.
For analytes with three QC levels, if control is outside of 2 SD range (1-2S), it is a warning; repeat is not required and run is accepted. If two QC levels are outside of 2 SD range (2-2S), run is rejected, and controls are repeated using new vials/aliquots of controls. If QC is back into range, the run is accepted. If repeat is out of range, investigate/recalibrate. Reject run also if 1-2.5S, 2-2S, 2/3-2S, or R-4S rule is violated. We also have a warning with the 7-T rule. 
As “A.” 
If QC is out 3 SD, then QC failure; repeat once, and if it fails again, take corrective action. 
We use several Westgard rules (4-1S, 10x) to further investigate when a 2-SD flag occurs on QC. First step is to repeat QC; if it is in and no Westgard rules have triggered, accept and continue. If out, check QC on other analyzers and rerun at least five patients on a different analyzer. Notify supervisor if recalibration is warranted. 
If results are out by 2-2S or 1-3S, the QC is repeated and accepted if it comes in. If it is out, the system is recalibrated and QC is rerun. Any further problems are escalated to the lead in the area for further troubleshooting. 
As “A.” 
As “A”; if far outside of 2 SD, then may be worked up at coordinator’s discretion. 

Open in new tab

Although most of the surveyed hospitals do not currently use moving averages (n = 19, 90%), four (19%) are hoping to implement moving averages in the near future Table 8. One (5%) institution runs moving averages in the background but does not use them for clinical metrics. Only one (5%) uses moving averages for clinical use and then only for a small number of assays. One of the institutions that did not use moving averages reported that it had previously implemented them but had not found them to be useful.

Hospital . Do You Use Moving Averages? . 
No 
No 
No 
No 
No 
Not yet, but planning to 
No 
No 
No 
No [but hopefully soon] 
No 
Not clinically, run for some in background to collect data 
No 
No, investigated but not useful 
No 
No 
No 
We do use moving averages routinely as QC point on six different assays and have the capability of turning it on for other assays if deemed necessary. 
We are collecting data currently and will be implementing spring/summer of 2017. 
No 
Not at this time, but planning to implement this year 
Hospital . Do You Use Moving Averages? . 
No 
No 
No 
No 
No 
Not yet, but planning to 
No 
No 
No 
No [but hopefully soon] 
No 
Not clinically, run for some in background to collect data 
No 
No, investigated but not useful 
No 
No 
No 
We do use moving averages routinely as QC point on six different assays and have the capability of turning it on for other assays if deemed necessary. 
We are collecting data currently and will be implementing spring/summer of 2017. 
No 
Not at this time, but planning to implement this year 

Open in new tab

Hospital . Do You Use Moving Averages? . 
No 
No 
No 
No 
No 
Not yet, but planning to 
No 
No 
No 
No [but hopefully soon] 
No 
Not clinically, run for some in background to collect data 
No 
No, investigated but not useful 
No 
No 
No 
We do use moving averages routinely as QC point on six different assays and have the capability of turning it on for other assays if deemed necessary. 
We are collecting data currently and will be implementing spring/summer of 2017. 
No 
Not at this time, but planning to implement this year 
Hospital . Do You Use Moving Averages? . 
No 
No 
No 
No 
No 
Not yet, but planning to 
No 
No 
No 
No [but hopefully soon] 
No 
Not clinically, run for some in background to collect data 
No 
No, investigated but not useful 
No 
No 
No 
We do use moving averages routinely as QC point on six different assays and have the capability of turning it on for other assays if deemed necessary. 
We are collecting data currently and will be implementing spring/summer of 2017. 
No 
Not at this time, but planning to implement this year 

Open in new tab

Discussion

QC is a critical aspect of laboratory management that laboratory directors take very seriously as it helps ensure we provide accurate results to guide clinical management. This is perhaps related to the high rate of response (100%) from our cohort. In this study, we were able to survey a wide range of highly regarded academic institutions comprising the entirety of the US News & World Report 2016 to 2017 honor roll list.7 This list consisted of 21 hospitals from 12 states. We selected this cohort as a group of high-performing academic institutions with diverse practice settings and distinct academic histories.

As expected, a variety of different instruments were used in the laboratories surveyed. Although some vendors were seen more frequently among respondents, no single vendor or platform had complete market dominance. Since QC rules are often related to actual assay performance, it makes sense that different platforms, which will have distinct methods, will perform somewhat differently and may require different QC rules. There were no apparent trends between QC frequency and manufacturer, and variation existed between laboratories using similar instruments. Therefore, it seems unlikely that platform choice alone would affect QC practices to a significant extent. A factor that supports this is that, in most institutions that used instruments from multiple manufacturers, QC rules did not vary notably between the instruments.

There was dramatic (ie, 12-fold) variation in QC frequency, ranging from once daily to every 2 hours. This was surprising because, although QC frequency may vary based on the device used, reagent stability, and test volume, the clinical risk associated with result errors should be more or less similar among the cohort, especially for routine CHEM/IM testing. Possible factors include assay method, test volume, economic constraints, and the difficulty of repeating patient samples in the event of QC failure. When QC fails, there is the possibility of needing to repeat all patient samples tested since the previous successful QC. For a high-volume test, potentially repeating all samples from the previous 24 hours would result in a very large number of samples that must be retrieved and retested. In addition, a significant delay before erroneous results are corrected has the potential to affect patient care. These are reasonable concerns, but increased frequency of QC may result in increased QC failures for purely statistical reasons, resulting in unnecessary corrective actions, delayed results, and increased costs.

Other QC practices were reported by several laboratories in the survey. At the time of surveying, three laboratories (C, J, and M) performed “alternating-level” QC testing—that is, instead of testing two levels of QC material at t = X hours after daily startup, one level was tested at t = X/2 hours and an alternate level tested at t = X hours. Laboratories C and M performed such “alternating” QC testing for CHEMs, all three for STAT IM (laboratory C did for troponin but not for hCG), and only laboratory J for IMs (in the time since surveying, laboratory J has ceased performing alternating-level QC). In theory, this practice reduces the time to detect an out-of-control situation compared with performing both QC levels at double the time interval. This practice assumes that all out-of-control situations will be detected equally well by testing either QC level, an assumption that may not apply in all analytical circumstances.

Several laboratories reduced the number of QC levels tested after daily startup; for example, if three levels of QC were tested to demonstrate an instrument test was “in control” at time t = 0 hours, subsequent QC testing events might only employ one or two QC levels over the subsequent 24 hours. Four laboratories (G, M, N, and Q) did this for CHEM, five for IM (G, J, M, N, and Q), and six for STAT IM (A, C [troponin only], G [hCG only], J, M, and Q). Two laboratories (A and J) performed QC testing for electrolytes (Na, K, and Cl) at a higher frequency than CHEM, likely due to the high volume of tests.

QC materials were overwhelmingly third party, with only a single laboratory relying predominantly on manufacturer-supplied QC materials (for IM only). Third-party materials have the theoretical advantage of providing a more independent verification of assay function and may have the option of QC material return to the parent company for further analysis if repeated failure occurs with a lot. On the other hand, manufacturer-produced materials have the potential benefit of being specifically designed for the system and test in question such that assay failures can be traced to a single manufacturer source, as opposed to having to query two separate vendors for QC material and machine issues. Despite these theoretical considerations, there has not been a systematic study into which method provides the most reliable approach for the selection of QC materials.

Most (n = 16, 76%) respondents used a QC range of 2 SD almost exclusively, and 14% (n = 3) used a combination of between 2 and 3 SD. This is an unexpected finding, as there is no standard Westgard rule for 1-2S, except as a warning. Assuming a normal distribution of values for QC materials on repeat analysis (ie, normal random variation and no systemic bias), a QC will be out of a 2-SD control range approximately 5% of the time compared with only 1% if a cutoff of 3 SD is used. Although a 2-SD QC rule has an increased chance of finding small analytical variations, one would expect lowered specificity, with numerous incidences of QC out-of-range results merely due to chance. In contrast, in laboratories where 3 SD or 2 × 2 SD are used, one would theoretically expect a potential 1% or 0.25% rate of QC out of control based on random error.

Of the 21 hospitals that responded to the survey, only two explicitly used Westgard rule derivations. These rules were introduced in the 1970s by James Westgard and colleagues in an effort to apply a mathematically rigorous approach to systematizing quality control. The Westgard rules are used to evaluate QC data and are designed to capture both increased variation (random error) and bias (systemic error) while minimizing both false negatives and false positives.8 Minimization of false negatives is especially critical, since these patients may be entirely missed or discharged without proper workup (as opposed to false positives, which may be revelated by further testing).

There are several iterations of the Westgard rules, but the process of flagging and repeating controls out at a 2-SD level is not one of the standard criteria. Assuming normal variation, approximately one in 20 QC results will be out of range, a high level of false positives. However, if run rejection requires two consecutive 2-SD errors, the base possibility of rejection is 0.25%, a lower percentage than that of the 3-SD cutoff. Relying on a QC to be abnormal and then repeat as abnormal requires a high level of systemic bias, and if the issue is increased variability, a repeated QC could very well be normal. Even if there is bias, the requirement for two consecutive QC measurements to be out at 2 SD may miss many low-lying biases that a 10x rule (which flags a run if 10 consecutive QC results are off by 1 SD in the same direction) would detect. In contrast, an increase in assay variability may be detected better by a 1-3S rule, which would flag a run where a single QC value is out by 3 SD. Of course, combining both of these rules would allow for detection of these two very different types of error. In this manner, multirule QC checks have the capacity to detect different errors at a higher sensitivity than a single blanket rule. Although not a large number of studies have validated the practice of repeating QC samples, a study in 2012 suggested that this process can provide performance on par with a 1-3S/2-2S/R-4S multirule, with the tradeoff of slightly increased cost of QC materials (due to increased rate of repetition).9 However, this study was limited by the use of a simple in silico model (that simulated differing levels of systemic error) and only compared with an abbreviated Westgard multirule.

An additional level of variation that was not captured in this survey is the method of SD derivation. The most common method for calculating SD for QC purposes is to run a control analyte numerous times (usually at least 20 times) and measure the SD of the results. Depending on the laboratory, machine, and analyte, the number of repeats used to calculate the SD may vary. In addition, many controls have manufacturer-recommended standard deviation ranges as part of their package insert.

The overwhelming majority of hospitals did not use moving averages (90%), although there was interest in implementing this in 19% of the hospitals. Only one hospital used moving averages as part of its QC practice (the other ran them in the background but did not fully use them), and one hospital had previously used moving averages but discontinued them due to perceived lack of utility. Overall, this is a surprising finding, as moving averages are theoretically useful, as well as inexpensive and simple to implement. The software to track these moving averages is included in commercially available software systems. Moving averages have the potential to detect low-level drifts in the values of measurements that would not ordinarily trigger normal QC flags.10-13

One laboratory mentioned that it used performance-driven QC methods, another proposed means of establishing QC goals.14 This involves using biological variation data to set goals for total allowable error and QC rules. For tests such as alanine aminotransferase, which have a high intraindividual and interindividual variation (24.3% and 41.6%, respectively),15 the goals for acceptable imprecision could theoretically be relaxed from ±2 SD to ±2.5 or even ±3 SD. This method may result in a reduction in the number of false rejections and maximize the number of true rejects.

Overall, our findings demonstrate a heterogenous but surprisingly similar grouping of QC practices at these academic laboratories. At least 75% of the hospitals used a QC range of 2 SD, and virtually all (90%) used the policy of repeating an out-of-control QC and accepting results if the repeat value comes into control. The method of repeating out-of-control QC at 2 SD has been shown to be effective at improving the performance of QC over simple multirule methods (in this case, 1-3SD, 2 of 3-2SD/R-4) in an in silico model.9 In comparison to these QC methods developed through mathematical analysis, most of these policies appear to have evolved in a fashion “validated by experience.” The 2 SD or similar cutoff with QC repetition was seen commonly in our cohort, demonstrating that it is likely deeply ingrained in clinical pathology.

Limitations of this study include the survey-based method: to ensure maximal compliance, we limited the number of items that we queried. Extremely detailed and granular information for each institution was not always available, so the data set used was not uniform, which creates the possibility of misinterpretation based on the answers. We attempted to minimize this by circulating the manuscript with the participating authors (each author was aware of which anonymized letter corresponded to his or her laboratory). Total quality management of a laboratory includes QC as a basic tenet but also a wide array of next-level practices to ensure test result quality. Future directions for this research include deeper-level inquiry into the heterogeneity of QC programs as well as investigating how these different practices affect result reporting and patient care.

In conclusion, this study demonstrated both similarities and differences among QC practices at academic hospitals. There appears to be no systematic approach to defining QC rules or frequency. The Westgard rules offer a systematic and thoroughly vetted approach for QC to detect errors while minimizing false-positive rates, and additional methods involving rules for QC-level repetition have also been mathematically studied. Interestingly, Westgard rules were used by a small minority of academic center laboratories. Most laboratories prefer home-validated QC rules, which may rely on the director’s experience and expertise rather than a rigorously validated statistical approach to designing QC rules. We believe that most academic medical center chemistry laboratories that have similar volumes and patient populations may benefit from a standardized approach to QC for routine chemistry/immunochemistry testing and that can withstand rigorous statistical validation. The survey results suggest an opportunity for laboratory professional organizations to convene a consensus panel to determine a best practice approach (or approaches) to QC in the chemistry laboratory. This would help to ensure quality testing by enhancing error detection and reduce the costs associated with excessive QC and the use of QC rules that create high (false-positive) run rejection rates.

References

5.

Westgard

JO

,

Barry

PL

,

Hunt

MR

, et al. 

A multi-rule Shewhart chart for quality control in clinical chemistry

.

Clin Chem

.

1981

;

27

:

493

-
Sours: https://academic.oup.com/ajcp/article/150/2/96/5023366
Value assignment is provided for key integrated instrument systems, including Abbott Architect, Beckman Coulter AU, Synchron and UniCel, Ortho Clinical Diagnostics Vitros, Roche Cobas and Elecsys systems and Siemens Advia, Dimension and Dimension Vista. Shelf life starts from the date of manufacture. Dropper Tips - Pkg 100 - MAS P/N 286-606 4 Thyroid Function Tests Thyroxine, Total (TT4) Thyroid-Stimulating Hormone (TSH) Thyroid Uptake (T-Uptake) Endocrine/Hormone Tests Cortisol Allergy Tests Immunoglobulin E (IgE) Serum Proteins/Serology Tests Alpha-1-Acid Glycoprotein Alpha-1-Antitrypsin Alpha-2-Macroglobulin Antistreptolysin O (ASO) Apolipoprotein A1 Apolipoprotein B Beta-2-Microglobulin C3 Complement C4 Complement Ceruloplasmin C-Reactive Protein (CRP) Haptoglobin Immunoglobulin A (IgA) Immunoglobulin G (IgG) Immunoglobulin M (IgM) Lipoprotein (a) Prealbumin Rheumatoid Factor MAS Omni•IMMUNE™ Thermo Scientific MAS Omni•IMMUNE &amp; Omni•IMMUNE PRO Controls provide consolidation for routine immunoassay, tumor marker and specialty immunoassay QC processing into a single product, offering three distinct levels. Value assignment is provided for key integrated instrument systems including Abbott Architect, Beckman Coulter Access and UniCel, Ortho Clinical Diagnostics Vitros, Roche Cobas and Elecsys systems and Siemens Centaur, Dimension, Dimension Vista and Immulite. Part Number Level OIM-101 1 OIM-202 2 OIM-303 3 Bottles &amp; Size Storage &amp; Stability Matrix 6 x 5 mL Assayed 36 month shelf life @ -25 to -15 &ordm;C 30 days open vial @ 2 to 8 &ordm;C Human Serum MAS Omni•IMMUNE PRO™ Thermo Scientific MAS Omni•IMMUNE PRO Control provides Anti-Thyroglobulin (Anti-Tg), Anti-Thyroid Peroxidase (Anti-TPO) and Sex Hormone Binding Globulin (SHBG), in addition to the same analyte panel provided in the MAS Omni•IMMUNE product. Shelf life starts from the date of manufacture. Dropper Tips - Pkg 100 - MAS P/N 286-606 5 Thermo Scientific MAS Serum Chemistry Controls MAS chemTRAK&reg;•H This is a comprehensive multi-analyte control, designed to monitor general chemistry and TDM methods. Available in an assayed or unassayed format. Both formats are liquid, ready-to-use and no additional preparation is required. Assayed values are available for most major platforms. Shelf life starts from the date of manufacture. * These constituent levels have not been adjusted but are at levels found in the source material used in preparation of the controls. No claim is made for expected values of these constituents. Dropper Tips - Pkg 100 - MAS P/N 286-606 6 Procainamide Pseudocholinesterase Quinidine Salicylate Sodium Theophylline Thyroid Stimulating Hormone Thyroid Uptake (T-Uptake) Thyroxine, Free (FT4)* Thyroxine, Total (TT4) Tobramycin Total Protein Transferrin* Tricyclic Antidepressants Triglycerides Triiodthyronine, Free (FT3)* Triiodthyronine, Total (TT3)* Uric Acid Valproic Acid Vancomycin MAS Alcohol/Ammonia An assayed, bi-level control for monitoring ethanol and ammonia levels in serum. This ready-to-use product is packed in convenient multipacks and has been assayed for most major instruments. Normal Ammonia values in Level 1. Part Number Level Bottles &amp; Size Storage &amp; Stability Matrix AAC-MP Bi-level, Multi-Pack 6 x 3.5 mL 24 month shelf life @ 2 to 8 &ordm;C 30 days open-vial @ 2 to 8 &ordm;C Human Serum Analytes Ammonia Ethanol MAS Bilirubin This assayed, tri-level control has been designed to monitor the performance of total, direct, conjugated, unconjugated and neonatal bilirubin. There are no additional preparation steps required for this liquid, ready-to-use product. An elevated Bilirubin is included in level 3 for neonatal applications. Part Number BC101 BC102 BC103 Level 1 2 3 Bottles &amp; Size 6 x 5 mL Storage &amp; Stability 24 month shelf life @ 2 to 8 &ordm;C 14 days open-vial @ 2 to 8 &ordm;C when stored in the dark Matrix Analytes Bilirubin, Conjugated Bilirubin, Direct (DBIL) Bilirubin, Neonatal Bilirubin, Total (TBIL) Bilirubin, Unconjugated Bovine Serum Refer to package insert for specific analyte and stability claims. Shelf life starts from the date of manufacture. Dropper Tips - Pkg 100 - MAS P/N 286-606 7 Thermo Scientific MAS Urine Chemistry Controls MAS UA Control A bi-level control that is liquid and ready-to-use with improved room temperature storage capability. This urine control was designed for monitoring urine dipstick and microscopic components and is assayed for most major reagent strips and strip systems. It includes ten commonly tested dipstick tests plus Microalbumin, Creatinine and hCG. Part Number UAB-115 UAB-160 UAB-215 UAB-260 UAB-MP Level Bottles &amp; Size 1 (normal) 2 (abnormal) Bi-level, Multi-Pack 6 x 15 mL 4 x 60 mL 6 x 15 mL 4 x 60 mL 6 x 15 mL Storage &amp; Stability Matrix 24 month shelf life @ 2 to 8 &ordm;C Open Vial: Refrigerated 3 months @ 2 to 8 &deg;C Room temperature 6 weeks @ 18 to 25 &deg;C Human Urine Analytes Bilirubin Blood Creatinine Crystals Glucose Human Chorionic Gonadotropin (hCG) Ketones Leukocyte Esterase Microalbumin Nitrite Osmolality pH Potassium Protein Red Blood Cells Sodium Specific Gravity Urobilinogen White Blood Cells MAS UA DipTube MAS UA product packed into convenient dip tubes to simplify manual testing of urinalysis strips. Part Number Level UAT-MP Bi-level, Multi-Pack Bottles &amp; Size Storage &amp; Stability Matrix 10 x 12 mL 24 months shelf life @ 2 to 8 &ordm;C Open Vial: Refrigerated 8 weeks or 20 dips @ 2 to 8 &ordm;C Room temp 2 weeks or 10 dips @ 18 to 30 &ordm;C Human Urine MAS Urinalysis A bi-level urine control designed for monitoring urine dipstick and microscopic components. This liquid control is assayed for most major reagent strips and strip systems. Part Number 024222 024225 024224 024227 Level Bottles &amp; Size Storage &amp; Stability Matrix 1 (abnormal) 3 (normal) 4 x 15 mL 4 x 60 mL 4 x 15 mL 4 x 60 mL 12 month shelf life @ 2 to 8 &ordm;C 30 days open-vial @ 2 to 8 &ordm;C 18 month shelf life @ 2 to 8 &ordm;C 30 days open-vial @ 2 to 8 &ordm;C Human Urine Refer to package insert for specific analyte and stability claims. Shelf life starts from the date of manufacture. Dropper Tips - Pkg 100 - MAS P/N 286-606 8 Analytes Bilirubin Blood Creatinine Crystals Glucose Human Chorionic Gonadotropin (hCG) Ketones Leukocyte Esterase Microalbumin Nitrite Osmolality pH Potassium Protein Red Blood Cells Sodium Specific Gravity Urobilinogen White Blood Cells Analytes Bilirubin Blood Creatinine Crystals Glucose Human Chorionic Gonadotropin (hCG) Ketones Leukocyte Esterase Microalbumin Nitrite Osmolality pH Potassium Protein Red Blood Cells Sodium Specific Gravity Urobilinogen White Blood Cells Sentry Urine Dipstick Control Ideal for use outside the clinical laboratory where refrigerated storage isn’t always available. The Sentry Urine Dipstick Control offers 12 months room temperature stability for an immediate, ready to use urinalysis strip control. Suitable for Mutistix, Chemstrips, Diascreen and other urinalysis strips as well as automated strip readers. Supplied in two levels, normal and abnormal. Part Number Level Bottles &amp; Size Storage &amp; Stability Matrix URN5005 Bi-level, Multi-Pack 4 x 25 mL 18 months shelf life 2 to 8 &ordm;C 12 months open-vial @ room temperature Synthetic Analytes Bilirubin Blood Glucose Human Chorionic Gonadotropin (hCG) Leukocytes Ketones Microalbumin Nitrite pH Protein Specific Gravity Urobilinogen MAS UrichemTRAK&reg; UrichemTRAK is designed to quantitatively monitor the most commonly tested urine chemistry analytes. This liquid, assayed control is ready-to-use, requires no additional preparation and the non-azide formulation will not interfere with ISEs. It includes general chemistry, physical properties and hCG tests. Part Number UR11001 UR22002 UR-MP Level Bottles &amp; Size Storage &amp; Stability Matrix 1 2 Bi-level, Multi-Pack 6 x 15 mL 24 month shelf life @ 2 to 8 &ordm;C opened and unopened Human Urine Analytes Amylase Calcium Chloride Cortisol Creatinine Glucose Human Chorionic Gonadotropin (hCG) Magnesium Microalbumin Osmolality pH Phosphorus Potassium Sodium Specific Gravity Total Protein Urea Nitrogen Uric Acid Refer to package insert for specific analyte and stability claims. Shelf life starts from the date of manufacture. Dropper Tips - Pkg 100 - MAS P/N 286-606 9 Thermo Scientific MAS Immunoassay Controls MAS Liquimmune&reg; This multi-analyte immunoassay control is liquid based and designed to monitor immunoassay test procedures on automated instruments. Provides coverage of fertility, thyroid, iron deficiency, endocrine and allergy parameters. Assayed values are provided for major instrument systems. Shelf life starts from the date of manufacture. Dropper Tips - Pkg 100 - MAS P/N 286-606 10 Testosterone Theophylline Thyroglobulin Thyroid Stimulating Hormone (TSH) Thyroid Uptake (T-Uptake) Thyroxine, Free (FT4) Thyroxine, Total (TT4) Tobramycin Tricyclic Antidepressants Triiodthyronine, Free (FT3) Triiodthyronine, Total (TT3) Valproic Acid Vancomycin Vitamin B12 MAS PTH Control PTH (Parathyroid Hormone) is commonly tested to assess Calcium regulation in blood. The MAS PTH Control offers three distinct PTH levels for evaluation of automated PTH methods across the assay range. Provided in a liquid format for ease of use, the MAS PTH Control offers 10 days open vial stability when stored at 2-8 &ordm;C. Value assignment is provided for the key automated PTH methods available in today’s clinical laboratory. Part Number Level PTH-MP Tri-level Multipack Bottles &amp; Size Storage &amp; Stability Matrix 6 x 3 mL 24 months @ -25 to 15 &ordm;C 10 days open-vial @ 2 to 8 &ordm;C Human Serum Analytes Parathyroid Hormone (PTH) MAS PAR TDM This liquid therapeutic drug control is a multi-analyte control with assayed values designed for therapeutic drugs and common immunoassay test procedures on most automated instruments. No additional preparation is required for this liquid, ready-to-use product that offers three significant levels. Part Number PTD1-1001 PTD2-2002 PTD3-3003 Level Bottles &amp; Size Storage &amp; Stability Matrix 1 2 3 6 x 5 mL 36 month shelf life @ 2 to 8 &ordm;C 30 days open-vial @ 2 to 8 &ordm;C Bovine Serum Analytes Acetaminophen Amikacin Caffeine Carbamazepine Digoxin Disopyramide Estriol Ethanol Ethosuximide Gentamicin Lidocaine Lithium Methotrexate N-acetylprocainamide (NAPA) Phenobarbital Phenytoin Primidone Procainamide Quinidine Salicylate Theophylline Thyroid Stimulating Hormone (TSH) Thyroxine, Total (TT4) Tobramycin Tricyclic Antidepressants Triiodthyronine, Total (TT3) Valproic Acid Vancomycin MAS T-Marker This liquid, assayed, multi-analyte control is designed to monitor performance of various cancer antigen tests on automated instruments, such as Abbott Architect&reg;, Beckman Access/Dxl&reg;, Ortho Vitros ECi&reg;, Roche Modular Elecsys&reg;, Siemens Advia Centaur&reg; and Immulite&reg;, and Tosoh AIA 600II&reg;. No additional preparation steps are required for these ready-to-use products. Part Number TUM-101 Level Bottles &amp; Size Storage &amp; Stability Matrix 6 x 3 mL 36 month shelf life @ -25 to -15 &ordm;C 90 days unopened @ 2 to 8 &ordm;C 30 days open-vial @ 2 to 8 &ordm;C Human Serum 1 TUM-202 2 TUM-303 3 Refer to package insert for specific analyte and stability claims. Shelf life starts from the date of manufacture. + Not cleared by FDA. No claims can be made. Dropper Tips - Pkg 100 - MAS P/N 286-606 Analytes ACTH+ Aldosterone Alpha-Fetoprotein (AFP) Beta Human Chorionic Gonadotroopin (beta-hCG) Beta-2-Microglobulin CA 125 CA 15-3 CA 19-9 CA 27-29 CA 72-4 Calcitonin Carcinoembryonic Antigen (CEA) Cortisol CyFRA 21-1+ Estradiol Ferritin Gastrin Human Chorionic Gonadotroopin (hCG) Insulin NSE+ Prolactin Prostate Specific Antigen, Total (TPSA) Prostate Specific Antigen, Free (FPSA) Prostatic Acid Phosphatase (PAP) Thyroglobulin 11 Thermo Scientific MAS Cardiac &amp; Diabetes Controls MAS CardioImmune&reg;•XL This multi-analyte control is designed to monitor serum cardiac marker test methods. No additional preparation is required for this liquid, ready-to-use product. It offers four distinct levels, and is also available in a tri-level multipack. Part Number CAI-XLL CAI-XL1 CAI-XL2 CAI-XL3 CAI-XL4 Level Bottles &amp; Size L 1 2 6 x 3 mL 3 Tri-level Multi-Pack Storage &amp; Stability Matrix 36 month shelf life @ -25 to- 15 &deg;C 30 days open-vial @ 2 to 8 &deg;C (for hsCRP, Digitoxin, Troponin I and Homocysteine) 15 days open-vial @ 2 to 8 &deg;C for BNP32, Myoglobin (when a dropper tip is used), NT-proBNP, Troponin T, CK-MB Human Serum Analytes BNP 32 CK-MB Digitoxin Homocysteine C-Reactive Protein high sensitivity (hs-CRP) Myoglobin NT-pro BNP Troponin I Troponin T MAS Diabetes This liquid assayed diabetes control is a bi-level control designed to monitor hemoglobin A1c methods. Assayed for most major instrument systems. The liquid, ready-to-use product requires no additional preparation. Part Number Level Bottles &amp; Size DBCL-MP Bi-level Multi-Pack 6 x 1 mL Storage &amp; Stability 24 month shelf life @ -25 to -15 &ordm;C 60 days unopened @ 2 to 8 &deg;C 30 days open-vial @ 2 to 8 &ordm;C Refer to package insert for specific analyte and stability claims. Shelf life starts from the date of manufacture. Dropper Tips - Pkg 100 - MAS P/N 286-606 12 Matrix Human Whole Blood Analytes Hemoglobin A1c (HbA1c) Thermo Scientific MAS Immunology &amp; Protein Controls MAS Immunology This multi-analyte immunology liquid assayed control is designed to monitor the performance of various serum protein and serology test procedures including Antistreptolysin O, C-Reactive Protein, Prealbumin and Rheumatoid Factor. It is assayed for major instrument systems and is ready-to-use, requiring no additional preparation. Three levels provide monitoring of the full assay range. Part Number IC-101 Level 1 Bottles &amp; Size Storage &amp; Stability Matrix IC-202 2 6 x 3 mL Human Serum IC-303 3 24 month shelf life @ 2 to 8 &ordm;C 30 days open-vial @ 2 to 8 &ordm;C Analytes Albumin Alpha-1-Antitrypsin Alpha-2-Macroglobulin Antistreptolysin O Antithrombin III Apha-1-Acid-Glycoprotein Apolipoprotein A-1* Apolipoprotein B* Beta-2-Microglobulin C-Reactive Protein (CRP) C3 Complement C4 Complement Ceruloplasmin Ferritin* Haptoglobin Immunoglobulin A (IgA) Immunoglobulin E (IgE) Immunoglobulin G (IgG) Immunoglobulin M (IgM) Kappa Light Chain Lambda Light Chain Prealbumin Properdin Factor B Rheumatoid Factor (RF) Total Protein Transferrin MAS CSF This assayed, bi-level control is designed to monitor the performance of quantitative and manual chemical analysis of human cerebrospinal fluid. Multiple oligoclonal bands are present in Level 2. Assayed for major instrument systems as well as for cellulose acetate and agarose gel electrophoresis. These products are liquid, ready-to-use and require no additional preparation. Part Number CSF-MP Level Bi-level, Multi-Pack Bottles &amp; Size 6 x 3.5 mL Storage &amp; Stability 24 month shelf life @ 2 to 8 &ordm;C 30 days open-vial @ 2 to 8 &ordm;C Refer to package insert for specific analyte and stability claims. Shelf life starts from the date of manufacture. * These constituent levels have not been adjusted but are at levels found in the source material used in preparation of the controls. No claim is made for expected values of these constituents. Matrix Human Serum Analytes Albumin Alpha-1-Globulin Alpha-2-Globulin Beta-Globulin Chloride Gamma-Globulin Glucose Glutamine Immunoglobulin A (IgA) Immunoglobulin G (IgG) Immunoglobulin M (IgM) Lactate Dehydrogenase (LDH) Lactic Acid Oligoclonal Bands Potassium Prealbumin Sodium Total Protein Dropper Tips - Pkg 100 - MAS P/N 286-606 13 Thermo Scientific MAS Toxicology Controls MAS DOA TOTAL This multi-constituent urine toxicology control offers 19 analytes with 4 distinct levels at drug concentrations 25% below and above commonly used screening and SAMHSA* cutoffs. A drug-free level and high positive level are also available (6 levels total). The control is a liquid, ready-to-use product available for use on a variety of instrument platforms. Each level of control is individually packed which gives you the flexibility to choose your levels according to your drug screen panel cutoffs while keeping the number of control vials to a minimum. Part Number DOAT-1 DOAT-2 DOAT-3 DOAT-4 DOAT-5 DOAT-6 Level 1 2 3 4 5 6 DOAT-MP Multi Pack Bottles &amp; Size 6 x 18 mL Storage &amp; Stability Matrix 24 month shelf life @ 2 to 8 &ordm;C 30 days open vial @ 2 to 8 &ordm;C Human Urine Analytes 11-nor-9-COOH-D9-THC Benzoylecgonine Buprenorphine Cotinine d-Methamphetamine EDDP Ethanol Ethyl Glucuronide LSD Methadone Methaqualone Morphine, free Nitrazepam Nortriptyline Oxazepam Oxycodone Phencyclidine Propoxyphene Secobarbital 1 bottle per level, 18 mL each MAS TOX Control This multi-analyte control is developed for use with the Thermo Scientific MAS Toxicology immunoassays for the semiquantitative measurement of barbiturates, benzodiazepine, and tricyclic antidepressants in either serum or plasma. Part Number 10011608 Level Multi-Pack 3 levels Bottles &amp; Size 6 x 5 mL Storage &amp; Stability 24 months shelf life @ 2 to 8 &ordm;C 20 days open vial @ 2 to 8 &ordm;C Matrix Bovine Plasma Analytes Barbiturate (Secobarbital) Benzodiazepine (Diazepam) Tricyclic Antidepressants (Nortriptyline) (for use with DRI Reagents) MAS DOA-XSE&reg; This multi-analyte control is designed to monitor semi-quantitative drugs of abuse screening test methods for: Beckman Coulter, Siemens Healthcare Syva EMIT, DRI, CEDIA, Roche Diagnostics ONLINE reagent systems and a variety of other systems. No additional preparation is required for this liquid, ready-to-use product. It is available in 4 distinct levels and cut-offs are in accordance with SAMHSA* and leading manufacturer’s guidelines. MAS DOA-XSE contains the SAMHSA* 5, plus Barbiturates, Benzodiazepines, Ethanol, LSD, Methadone, Methaqualone, and Propoxyphene. Part Number SDOA-101 SDOA-202 SDOA-303 SDOA-404 Level 1: negative 2: 20-25% low challenge to immunoassay cut-off 3: 20-25% high challenge to immunoassay cut-off 4: high positive Bottles &amp; Size 6 x 18 mL Storage &amp; Stability 24 month shelf life @ 2 to 8 &ordm;C Human Urine 30 days open vial @ 2 to 8 &ordm;C Refer to package insert for specific analyte and stability claims. Shelf life starts from the date of manufacture. * Substance Abuse and Mental Health Services Administration (SAMHSA) Dropper Tips - Pkg 100 - MAS P/N 286-606 14 Matrix Analytes Benzoylecgonine Cannabinoid (11-nor-9-COOH-∆9-THC) d-Methamphetamine Ethanol LSD Methadone Methaqualone Morphine Oxazepam Phencyclidine Propoxyphene Secobarbital Thermo Scientific MAS Quality Control Solutions for Vista Designed for use with the Siemens DimensionVista&reg; instrumentation Thermo Scientific MAS quality control products are available in vials specifically designed for use with the Siemens Dimension Vista&reg; instrumentation. Fully validated onboard QC stability claims provide assurance that long-term quality assurance is maintained when performing routine quality control on the Dimension Vista instrument. Nine individual Thermo Scientific MAS quality control products are available in a Dimension Vista specific format covering the instrument assay portfolio. Six vials are provided in each kit for convenience. Shelf life starts from the date of manufacture. * These constituent levels have not been adjusted but are at levels found in the source material used in preparation of the controls. Shelf life starts from the date of manufacture. * These constituent levels have not been adjusted but are at levels found in the source material used in preparation of the controls. No claim is made for expected values of these constituents. 17 Thermo Scientific LabLink xL Quality Assurance Program Used in conjunction with the Thermo Scientific MAS quality controls, LabLink xL offers a 100% web-based quality assurance solution comprised of four integrated modules: LabLink xL Web, LabLink xL Communicator, LabLink xL Daily and LabLink Extra. • 100% Real-time QC data transfer to central LabLink xL database • Real-time peer comparison LabLink xL Web LabLink xL Web is an interlaboratory QC program that offers an external perspective on your internal day-to-day QC. LabLink Extra is an online information portal that works in unison with the LabLink xL Quality Assurance Program providing easy access to package inserts and other support documentation for QC products manufactured by Thermo Scientific. An enhancement of the existing LabLink communicator module. The LabLink xL Cloud Communicator offers fully automated connectivity for the real-time transfer of QC data from Data Innovations Instrument Manager™ to LabLink • Completely integrated module within LabLink xL - Easy and efficient installation and setup completed remotely by the LabLink xL support organization • Upload data from instrument, LIS or middleware • Hassle free automatic upload - Eliminates QC transcription error MAS LabLink xL Modules Part Number LLXLW LLXLC LLXLDM Module LabLink xL Web LabLink xL Communicator LabLink xL Daily - No manual data entry is necessary - Saves time and reduces cost • Real-time transfer of QC data Visit maslablink.com to view an online LabLink xL demo. - Instantaneous access to data in LabLink xL - Immediate comparison, review and approval of QC data 20 Instrument Manager is the trademark of Data Innovations Inc. , Brea, CA DiaSTAT&reg;, D-10&reg; and Variant/Variant&reg; II: Bio-Rad Laboratories, Hercules, CA Biovation&reg;: Biovation Inc., Hercules, CA Fisherbrand&reg;, UriSystem&reg; and Sure-Vue&reg;: Fisher Scientific, Pittsburgh, PA CONTRAST II&reg;, OSOM&reg; and Signify&reg;: Genzyme Corp. Cambridge, MA DiaScreen&reg; 10 and DiaScreen&reg; 50: Hyoguard, Minneapolis, MN iChem100&reg; and IQ100&reg;: International Remote Imaging Systems Inc., Chatsworth, CA Vitros&reg;, Vitros&reg; ECi, Vitros 5,1 FS and Vitros 5600&reg;: Ortho Clinical Diagnostics, Rochester, NY QuickVue&reg; and UrinQuick™: Quidel Corporation, San Diego, CA Cobas 6000™, Elecsys&reg;, Hitachi&reg; Series, Cobas Integra&reg;, Modular Analytics E170, Criterion 1/11&reg;, CUA/SUA, MiniUA&reg;, Chemstrip 101&reg;, Urisys 1100/1800&reg;, Urisys 2400 and Micral&reg;: Roche Diagnostics, Indianapolis, IN ACETEST&reg;, ACS180™, Advia Centuar&reg;, Advia 1650/2400&reg;, Atlas&reg;, BNA/BN II™, BN ProSpec™, Clinitek Series&reg;, Clinitest&reg;, DCA 2000&reg;, Dimension&reg;, Dimension&reg; VISTA, Dimension&reg; Xpand, Ictotest&reg;, Immulite&reg;/Immulite&reg;2000, Microbumintest&reg;, Status&reg; and Stratus&reg; CS: Siemens Healthcare Diagnostics, Los Angles, CA; Glasgow, DE; and Tarrytown, NY AIA&reg; Series, A1c 2.2 Plus and G7/G8: Tosoh Medics Inc., S. San Francisco, CA URiSCAN (Visual), URiSCAN Pro II, URiSCAN Optima II, URiSCAN Mini, URiSCAN Super: YD Diagnostics Corp. Songpa-ku, Seoul, Korea A1CNow&reg;: Bayer Healthcare, Tarrytown, NY. 30 Phone: 1-800-232-3342 - Press 1 for Customer Service. Fax: 1-800-829-8115 e-mail Orders:[email protected] e-mail or Fax: Required - Please indicate the following information on your purchase order: • Customer Account Number • Purchase Order Number • Shipping Address with Contact • Product Catalog Number • Quantity Desired • Contact Person &amp; Phone Number Mail: Thermo Fisher Scientific 46360 Fremont Blvd. Fremont, CA 94538 USA ATTN: Customer Service Hours: 7 a.m. - 4 p.m. Monday - Friday, pacific time Delivery: Domestic orders are shipped next-day air freight. International orders are shipped through a freight forwarder. Minimum Orders: We have a minimum order requirement of $100. Sales Support Phone: 1-800-232-3342 e-mail: [email protected] Technical Service &amp; Support In most cases, technical assistance is available, 24 hours a day, 7 days a week. Phone: 1-800-232-3342- press 2 for technical service options For non-urgent inquiries: e-mail: LabLink Support - [email protected] MAS- [email protected] Terms Payment: Payment terms are NET 30 days. Payment is expected within 30 days from the date of the invoice. Thermo Fisher Scientific reserves the right to require payment in advance, C.O.D., credit card or otherwise modify credit terms. Prices: Prices are subject to change without notice. Shipment: Shipping terms are Free on Board (FOB) shipping point. Customer is responsible for transportation costs from our facility to customer facility; freight is prepaid, then billed on invoice. Transfer of ownership occurs when the shipment leaves our facility. Damaged Goods: Be sure to inspect your shipment immediately upon arrival. Please notify the Thermo Fisher Scientific Customer Service Department of any product discrepancy or damage within 10 working days of shipment receipt. Product Claims: Failure to use the product as set forth in the product labeling and application sheets can affect performance. NOTE: Sales are subject to the other terms and conditions on Thermo Fisher Scientific invoice. All sales are final. Returned products require a Return Materials Authorization and may be subject to a Restocking Fee. Call Thermo Fisher Scientific prior to returning any material. 31 The value of innovation A history of quality Product availability may vary by country. thermoscientific.com/qc &copy; 2012 Thermo Fisher Scientific Inc. All rights reserved. Copyrights in and to portions of the illustrations are owned by a third party and licensed for limited use only to Thermo Fisher Scientific by Getty Images and Shutterstock. Instrument Manager is a trademark of Data Innovations. Refer to page 30 for additional trademark details used in this publications. All other trademarks are the property of Thermo Fisher Scientific and its subsidiaries. Diagnostics USA 46360 Fremont Blvd. Fremont, CA 94538 USA Tel. 800-232-3342 [email protected] Asia Pacific Fax + 61 2 9012 0023 [email protected] Australia Tel. + 61 1800 333 110 [email protected] MASQCCAT 2 8/2012 BN0518106 8/2012 Belgium, Netherlands &amp; Luxembourg Tel. + 31 34 156 0744 [email protected] Canada Tel. 905-286-4290 [email protected] China Tel. + 86 21 6865 4588 [email protected] France Tel. + 33 4 7289 4400 [email protected] Germany Tel. + 49 851 88689 0 [email protected] New Zealand Tel. + 61 3 9757 4486 [email protected] Nordic Tel. + 47 2 325 0433 [email protected] Spain, Portugal &amp; Italy Tel. + 34 93589 8338 [email protected] Switzerland &amp; Austria Tel. + 41 26 663 86 70 [email protected] United Kingdom &amp; Ireland Tel. + 44 1442 868 940 [email protected]
Sours: https://studylib.net/doc/8877786/mas-quality-control-products-lablink-xl-quality-assurance...
  1. Nelson county ky health department
  2. Off white sneakers used
  3. 2020 chevrolet silverado 1500 wheels

Increase confidence in your lab’s clinical results and improve the efficiency in your lab with quality controls that are built for your timeline.  Make your lab lean and efficient, streamlining your process without sacrificing quality or throughput.

Thermo Scientific™ MAS™ controls, with Thermo Scientific LabLink xL software empower you to optimize your quality control system, increase overall productivity, and efficiently manage demanding timelines. Talk to a Specialist about making your lab more efficient and productive with MAS QC.

Contact an Expert ›

30 days open vial stabilty

Optimize product utilization

Most MAS Quality Controls can be used for up to 30 days after opening the vials. Thanks to normalized stability across all analytes, they fit seamlessly into your lab’s existing timeline for quality control.

Ready to use

Increase daily throughput

MAS Quality Controls are ready to use straight from the fridge. Not having to wait for reconstitution means less downtime and more throughput at your lab.

3-5 years shelf life

Maximize time savings

With their long shelf life, MAS Quality Controls help reduce the amount of time you spend on lot-to-lot verification. This simplifies planning ahead and frees you up to focus on other essential lab tasks.

Get the most out of your products

MAS quality control analytes remain stable for up to 30 days after opening, featuring open vial stability that is higher than most comparable controls on the market. Open vial stability is normalized across the analytes present in the control, making it easier for labs to use one control with greater certainty knowing the stability remains the same for the analytes in the control.

Easy to use

Unlike other quality controls, MAS quality controls are ready to use immediately, right from the cold storage refrigerator.  MAS QC gives YOU the control, with no waiting for reconstitution. Your saves time and money and reduces the potential errors of reconstitution.

Save time

Calibrating new QC lot rolls is a tedious, but necessary, part of running the lab. MAS QC products offer controls with some of the longest shelf life available. Reduce the time spent having to recalibrate new QC lots by using MAS QC products with controls that offer extended shelf-life. Fewer lot roll changes means increased productivity and improved efficiency for your lab. As an example: Thermo Scientific™ MAS™ Liquimmune™ quality control has the longest shelf life (5 years) in the industry; other MAS quality controls typically have a 3-year shelf life.

LabLink xL with Real-Time Data

For In Vitro Diagnostic Use.

Sours: https://www.thermofisher.com/us/en/home/products-and-services/promotions/clinical/mas-productivity-quality-controls.html
Unit-Level Serialization - Packaging - Track and Trace - Quality Control - End-to-End Reporting

MAS Quality Controls - Thermo Fisher Scientiï¬c MAS Quality Controls ... a comprehensive menu of clinical laboratory controls for ... Elecsys , Siemens Advia

MAS Urine Chemistry Controls

Fisher P/N Part Number Level # bottles/size Storage & Stability Matrix23139109 UR11001 1

6 x 15 mL 24 month shelf life 2 to 8Copen and unopened Human Urine23139110 UR22002 2

23139108 UR-MP Bi-level, Multi-Pack

UrichemTRAK is designed to quantitatively monitor the most commonly tested urine chemistry analytes. This liquid, assayed control is ready-to-use, requires no additional preparation and the non-azide formulation will not interfere with ISEs. It includes general chemistry, physical properties and hCG tests.

Analytes*

UrichemTRAK

AmylaseCalciumChlorideCortisolCreatinineGlucosehCGMagnesiumMicroalbumin

OsmolalitypHPhosphorusPotassiumSodiumSpecific GravityTotal ProteinUrea NitrogenUric Acid

MAS Specialty Controls

* Refer to package insert for specific analyte and stability claims. Shelf life starts from the date of manufacture.

** These constituent levels have not been adjusted but are at levels found in the source material used in preparation of the controls. No claim is made for expected valiues of these constituents

Fisher P/N Part Number Level # bottles/size Storage & Stability Matrix

23100004 IC-101 1

6 x 3 mL 24 month shelf life 2 to 8C30 days open-vial 2 to 8C Human Serum23100005 IC-202 2

23100006 IC-303 3

Fisher P/N Part Number Level # bottles/size Storage &am

Sours: https://dokumen.tips/documents/mas-quality-controls-thermo-fisher-scientic-mas-quality-controls-a-comprehensive.html

Inserts control package mas quality

1 Simplifying yor qality controls Thermo Scientific MAS Qality Control Prodcts LabLink xl Qality Assrance Program

2 Experience or qality Improve yor reslts

3 Contents Thermo Scientific MAS Controls Omni Consolidated Controls 4-7 Serm Chemistries 8-9 Urine Chemistries Immnoassay Cardiac & Diabetes 14 Immnology & Protein 15 Toxicology 16 Dimension Vista Controls Thermo Scientific MAS Programs LabLink xl Qality Assrance Software Vale Assignment Program 28 Thermo Scientific MAS Control References Instrments General Ordering Information To Place An Order 39 Technical Service & Spport 39

4 Thermo Scientific MAS Omni Controls 4

5 Streamline yor workflow Consolidate mltiple QC prodcts Omni CARDIO Thermo Scientific MAS Omni CARDIO consolidates a comprehensive cardiac marker panel with the new generation of STAT analytes inclding D-Dimer, hcg, Myeloperoxidase and Procalcitonin. Vale assignment is provided for key instrment systems inclding Abbott Architect, Beckman Colter Access, AU and UniCel systems, Ortho Clinical Diagnostics VITROS, Roche Cobas and Elecsys systems and Siemens Advia, Dimension, Dimension Vista, Immlite and Strats systems. Part Nmber Level Bottles & Size Storage & Stability Matrix OCRD-UL Ultra Low OCRD-L Low OCRD OCRD OCRD OCRD-MP Tri-Level Mlti-Pack (2 vials each level 1/2/3) 6 x 3 ml Assayed to -15 ºC ºC (for BNP-32, CK-MB, D-Dimer, Digitoxin, hcg, hscrp, Myeloperoxidase, Procalcitonin, Total CK, Troponin-I and Troponin-T) ºC (for Myoglobin and NT-proBNP) Hman Serm Brain Natriretic Peptide-32 (BNP-32) Creatinine Kinase-MB (CK-MB) D-Dimer Digitoxin Hman Chorionic Gonadotropin (hcg) Beta Hman Chorionic Gonadotropin (b-hcg) High Sensitivity C-Reactive Protein (hscrp) Myeloperoxidase (MPO) Myoglobin N-Terminal Brain Natriretic Peptide (NT-proBNP) Procalcitonin (PCT) Total Creatinine Kinase (Total CK) Troponin I Troponin T 5

6 Thermo Scientific MAS Omni Controls Omni CORE Thermo Scientific MAS Omni CORE Control consolidates general chemistry and serm protein QC processing into a single prodct, offering three distinct levels. Vale assignment is provided for key integrated instrment systems, inclding Abbott Architect, Beckman Colter AU, Synchron and UniCel, Ortho Clinical Diagnostics Vitros, Roche Cobas and Elecsys systems and Siemens Advia, Dimension and Dimension Vista.

7 Omni IMMUNE Thermo Scientific MAS Omni IMMUNE & Omni IMMUNE PRO Controls provide consolidation for rotine immnoassay, tmor marker and specialty immnoassay QC processing into a single prodct, offering three distinct levels. Vale assignment is provided for key integrated instrment systems inclding Abbott Architect, Beckman Colter Access and UniCel, Ortho Clinical Diagnostics Vitros, Roche Cobas and Elecsys systems and Siemens Centar, Dimension, Dimension Vista and Immlite. Part Nmber Level Bottles & Size Storage & Stability Matrix OIM OIM OIM x 5 ml Assayed 36 month shelf -25 to -15 ºC 30 days open 2 to 8 ºC Hman Serm Omni IMMUNE PRO Thermo Scientific MAS Omni IMMUNE PRO Control provides Anti-Thyrogloblin (Anti-Tg), Anti-Thyroid Peroxidase (Anti-TPO) and Sex Hormone Binding Globlin (SHBG), in addition to the same analyte panel provided in the MAS Omni IMMUNE prodct. No claim is made for expected vales of these constitents. Refer to package insert for specific analyte and stability claims. Shelf life starts from the date of manfactre. Dropper Tips - Pkg MAS P/N

8 Thermo Scientific MAS Serm Chemistry Controls MAS chemtrak H This is a comprehensive mlti-analyte control, designed to monitor general chemistry and TDM methods. Available in an assayed or nassayed format. Both formats are liqid, ready-to-se and no additional preparation is reqired. Assayed vales are available for most major platforms. Part Nmber Level Bottles & Size Storage & Stability* Matrix CHA x 5 ml Assayed 30 month shelf -25 to -15 ºC CHA-2 2 CHA-3 3 CHU-1 1 CHU-2 2 CHU-3 3 Acetaminophen Alanine Aminotransferase (ALT) Albmin Alkaline Phosphatase Amikacin Amylase Amylase (Pancreatic) Apolipoprotein A Apolipoprotein B Aspartate Aminotransferase (AST) Bilirbin Unconjgated Bilirbin, Conjgated Bilirbin, Direct (DBIL) Bilirbin, Neonatal Bilirbin, Total (TBIL) Blood Urea Nitrogen (BUN) C3 Complement* C4 Complement* Caffeine Calcim Carbamazepine 10 x 15 ml Unassayed Carbon Dioxide (CO2) Chloride Cholesterol Creatine Kinase (CK) Creatinine Digoxin Disopyramide Ethanol Ethosximide Ferritin* Gamma-Gltamyl Transferase Gentamicin GLDH* Glcose Haptoglobin* HBDH* HDL Cholesterol Immnogloblin A (IgA)* Immnogloblin G (IgG)* Immnogloblin M (IgM)* Iron 14 days 2 to 8 ºC; nassayed 7 days 2 to 8 ºC; assayed Refer to package insert for specific analyte and stability claims. Shelf life starts from the date of manfactre. * These constitent levels have not been adjsted bt are at levels fond in the sorce material sed in preparation of the controls. No claim is made for expected vales of these constitents. Dropper Tips - Pkg MAS P/N Iron Binding Capacity, Total (TIBC) Iron Binding Capacity, Unsatrated (UIBC)* Lactate Dehydrogenase (LDH) Lactic Acid LDL Cholesterol Lidocaine Lipase Lipoprotein (a) Lithim Magnesim Methotrexate N-acetylprocainamide (NAPA) Osmolality Phenobarbital Phenytoin Phosphors Potassim Prealbmin Primidone Hman Serm Procainamide Psedocholinesterase Qinidine Salicylate Sodim Theophylline Thyroid Stimlating Hormone Thyroid Uptake (T-Uptake) Thyroxine, Free (FT4)* Thyroxine, Total (TT4) Tobramycin Total Protein Transferrin* Tricyclic Antidepressants Triglycerides Triiodthyronine, Free (FT3)* Triiodthyronine, Total (TT3)* Uric Acid Valproic Acid Vancomycin 8

9 MAS Alcohol/Ammonia An assayed, bi-level control for monitoring ethanol and ammonia levels in serm. This ready-to-se prodct is packed in convenient mltipacks and has been assayed for most major instrments. Normal Ammonia vales in Level 1. Part Nmber AAC-MP Level Bottles & Size Storage & Stability Matrix Bi-level, Mlti-Pack 6 x 3.5 ml 24 month shelf 2 to 8 ºC 30 days 2 to 8 ºC Hman Serm Ammonia Ethanol MAS Bilirbin This assayed, tri-level control has been designed to monitor the performance of total, direct, conjgated, nconjgated and neonatal bilirbin. There are no additional preparation steps reqired for this liqid, ready-to-se prodct. An elevated Bilirbin is inclded in level 3 for neonatal applications. Part Nmber Level Bottles & Size Storage & Stability Matrix BC month shelf 2 to 8 ºC BC x 5 ml 14 days 2 to 8 ºC Bovine Serm BC103 3 when stored in the dark Refer to package insert for specific analyte and stability claims. Shelf life starts from the date of manfactre. Bilirbin, Conjgated Bilirbin, Direct (DBIL) Bilirbin, Neonatal Bilirbin, Total (TBIL) Bilirbin, Unconjgated Dropper Tips - Pkg MAS P/N

10 Thermo Scientific MAS Urine Chemistry Controls MAS UA Control A bi-level control that is liqid and ready-to-se with improved room temperatre storage capability. This rine control was designed for monitoring rine dipstick and microscopic components and is assayed for most major reagent strips and strip systems. It incldes ten commonly tested dipstick tests pls Microalbmin, Creatinine and hcg. Part Nmber Level Bottles & Size Storage & Stability Matrix UAB x 15 ml UAB-160 (normal) 4 x 60 ml 24 month shelf 2 to 8 ºC UAB x 15 ml Open Vial: Hman UAB-260 (abnormal) 4 x 60 ml Refrigerated 3 2 to 8 C Urine UAB-MP Bi-level, Room temperatre 6 18 to 25 C 6 x 15 ml Mlti-Pack Bilirbin Blood Creatinine Crystals Glcose Hman Chorionic Gonadotropin (hcg) Ketones Lekocyte Esterase Microalbmin Nitrite Osmolality ph Potassim Protein Protein-to-creatinine ratio Red Blood Cells Sodim Specific Gravity Urobilinogen White Blood Cells MAS UA DipTbe MAS UA prodct packed into convenient dip tbes to simplify manal testing of rinalysis strips. Part Nmber UAT-MP Level Bottles & Size Storage & Stability Matrix Bi-level, Mlti-Pack 10 x 12 ml 24 months shelf 2 to 8 ºC Open Vial: Refrigerated 8 weeks or 20 2 to 8 ºC Room temp 2 weeks or to 30 ºC MAS Urinalysis A bi-level rine control designed for monitoring rine dipstick and microscopic components. This liqid control is assayed for most major reagent strips and strip systems. Hman Urine Part Nmber Level Bottles & Size Storage & Stability Matrix x 15 ml 12 month shelf 2 to 8 ºC (abnormal) 4 x 60 ml 30 days 2 to 8 ºC Hman x 15 ml 18 month shelf 2 to 8 ºC Urine (normal) 4 x 60 ml 30 days 2 to 8 ºC Refer to package insert for specific analyte and stability claims. Shelf life starts from the date of manfactre. Dropper Tips - Pkg MAS P/N Bilirbin Blood Creatinine Crystals Glcose Hman Chorionic Gonadotropin (hcg) Ketones Lekocyte Esterase Microalbmin Nitrite Bilirbin Blood Creatinine Crystals Glcose Hman Chorionic Gonadotropin (hcg) Ketones Lekocyte Esterase Microalbmin Nitrite Osmolality Osmolality ph Potassim Protein Protein-to-creatinine ratio Red Blood Cells Sodim Specific Gravity Urobilinogen White Blood Cells ph Potassim Protein Red Blood Cells Sodim Specific Gravity Urobilinogen White Blood Cells 10

11 Sentry Urine Dipstick Control Ideal for se otside the clinical laboratory where refrigerated storage isn t always available. The Sentry Urine Dipstick Control offers 12 months room temperatre stability for an immediate, ready to se rinalysis strip control. Sitable for Mtistix, Chemstrips, Diascreen and other rinalysis strips as well as atomated strip readers. Spplied in two levels, normal and abnormal. Part Nmber URN5005 Level Bottles & Size Storage & Stability Matrix Bi-level, Mlti-Pack 4 x 25 ml 18 months shelf life 2 to 8 ºC 12 months room temperatre Synthetic Bilirbin Blood Glcose Hman Chorionic Gonadotropin (hcg) Lekocytes Ketones Microalbmin Nitrite ph Protein Specific Gravity Urobilinogen MAS UrichemTRAK UrichemTRAK is designed to qantitatively monitor the most commonly tested rine chemistry analytes. This liqid, assayed control is ready-to-se, reqires no additional preparation and the non-azide formlation will not interfere with ISEs. It incldes general chemistry, physical properties and hcg tests. Part Nmber Level Bottles & Size Storage & Stability Matrix UR UR month shelf 2 to 8 ºC Hman 6 x 15 ml Bi-level, opened and nopened Urine UR-MP Mlti-Pack Refer to package insert for specific analyte and stability claims. Shelf life starts from the date of manfactre. Amylase Calcim Chloride Cortisol Creatinine Glcose Hman Chorionic Gonadotropin (hcg) Magnesim Microalbmin Osmolality ph Phosphors Potassim Sodim Specific Gravity Total Protein Urea Nitrogen Uric Acid Dropper Tips - Pkg MAS P/N

12 Thermo Scientific MAS Immnoassay Controls MAS Liqimmne Save time and extra costs associated with lot changes sing the MAS Liqimne controls now with an extended shelf life. This mlti-analyte immnoassay control is liqid based and designed to monitor immnoassay test procedres on atomated instrments. Provides coverage of fertility, thyroid, iron deficiency, endocrine and allergy parameters. Assayed vales are provided for major instrment systems. No claim is made for expected vales of these constitents. Refer to package insert for specific analyte and stability claims. Shelf life starts from the date of manfactre. Dropper Tips - Pkg MAS P/N

13 MAS PTH Control PTH (Parathyroid Hormone) is commonly tested to assess Calcim reglation in blood. The MAS PTH Control offers three distinct PTH levels for evalation of atomated PTH methods across the assay range. Provided in a liqid format for ease of se, the MAS PTH Control offers 10 days open vial stability when stored at 2-8 ºC. Vale assignment is provided for the key atomated PTH methods available in today s clinical laboratory. Part Nmber PTH-MP Level Bottles & Size Storage & Stability Matrix Tri-level Mltipack 6 x 3 ml to 15 ºC 10 days 2 to 8 ºC Hman Serm Parathyroid Hormone (PTH) MAS PAR TDM This liqid therapetic drg control is a mlti-analyte control with assayed vales designed for therapetic drgs and common immnoassay test procedres on most atomated instrments. No additional preparation is reqired for this liqid, ready-to-se prodct that offers three significant levels. Part Level Bottles & Size Storage & Stability Matrix Nmber PTD month shelf 2 to 8 ºC Bovine PTD x 5 ml 30 days 2 to 8 ºC Serm PTD MAS T-Marker This liqid, assayed, mlti-analyte control is designed to monitor performance of varios cancer antigen tests on atomated instrments, sch as Abbott Architect, Beckman Access/Dxl, Ortho Vitros ECi, Roche Modlar Elecsys, Siemens Advia Centar and Immlite, and Tosoh AIA 600II. No additional preparation steps are reqired for these ready-to-se prodcts. Part Nmber TUM TUM TUM Level Bottles & Size Storage & Stability Matrix 6 x 3 ml 36 month shelf -25 to -15 ºC 90 days 2 to 8 ºC 30 days 2 to 8 ºC Hman Serm Refer to package insert for specific analyte and stability claims. Shelf life starts from the date of manfactre. * Not cleared by FDA. No claims can be made. Dropper Tips - Pkg MAS P/N Acetaminophen Amikacin Caffeine Carbamazepine Digoxin Disopyramide Estriol Ethanol Ethosximide Gentamicin Lidocaine Lithim Methotrexate N-acetylprocainamide (NAPA) ACTH* Aldosterone Alpha-Fetoprotein (AFP) Beta Hman Chorionic Gonadotroopin (beta-hcg) Beta-2-Microgloblin CA 125 CA 15-3 CA 19-9 CA CA 72-4 Calcitonin Carcinoembryonic Antigen (CEA) Phenobarbital Phenytoin Primidone Procainamide Qinidine Salicylate Theophylline Thyroid Stimlating Hormone (TSH) Thyroxine, Total (TT4) Tobramycin Tricyclic Antidepressants Triiodthyronine, Total (TT3) Valproic Acid Vancomycin Cortisol CyFRA 21-1* Estradiol Ferritin Gastrin Hman Chorionic Gonadotroopin (hcg) Inslin NSE* Prolactin Prostate Specific Antigen, Total (TPSA) Prostate Specific Antigen, Free (FPSA) Prostatic Acid Phosphatase (PAP) Thyrogloblin 13

14 Thermo Scientific MAS Cardiac & Diabetes Controls MAS CardioImmne XL This mlti-analyte control is designed to monitor serm cardiac marker test methods. No additional preparation is reqired for this liqid, ready-to-se prodct. It offers for distinct levels, and is also available in a tri-level mltipack. Part Nmber Level Bottles & Size Storage & Stability Matrix CAI-XLL L 36 month shelf -25 to- 15 C CAI-XL days 2 to 8 C (for hscrp, CAI-XL2 2 Digitoxin, Troponin I and Homocysteine) 6 x 3 ml CAI-XL days 2 to 8 C Hman Serm CAI-XL4 Tri-level for BNP32, Myoglobin (when a dropper tip is Mlti-Pack sed), NT-proBNP, Troponin T, CK-MB BNP 32 CK-MB Digitoxin Homocysteine C-Reactive Protein high sensitivity (hs-crp) Myoglobin NT-pro BNP Troponin I Troponin T MAS CardioImmne Ultra Low A single analyte control designed to challenge the low end sensitivity of the next generation high sensitivity Troponin assays. Part Nmber Level Bottles & Size Storage & Stability Matrix CAI-UL UL 6 x 3 ml 36 month shelf -25 to -15 ºC 30 days 2 to 8 ºC Hman Serm MAS Diabetes This liqid assayed diabetes control is a bi-level control designed to monitor hemoglobin A1c methods. Assayed for most major instrment systems. The liqid, ready-to-se prodct reqires no additional preparation. Part Nmber Level Bottles & Size Storage & Stability Matrix 24 month shelf -25 to -15 ºC Bi-level Hman DBCL-MP 6 x 1 ml 60 days 2 to 8 C Mlti-Pack Whole Blood 30 days 2 to 8 ºC Troponin I Hemoglobin A1c (HbA1c) Refer to package insert for specific analyte and stability claims. Shelf life starts from the date of manfactre. Dropper Tips - Pkg MAS P/N

15 Immnology & Protein Controls MAS Immnology This mlti-analyte immnology liqid assayed control is designed to monitor the performance of varios serm protein and serology test procedres inclding Antistreptolysin O, C-Reactive Protein, Prealbmin and Rhematoid Factor. It is assayed for major instrment systems and is ready-to-se, reqiring no additional preparation. Three levels provide monitoring of the fll assay range. Part Nmber Level Bottles & Size Storage & Stability Matrix IC IC IC x 3 ml 24 month shelf 2 to 8 ºC 30 days 2 to 8 ºC Hman Serm Albmin Alpha-1-Antitrypsin Alpha-2-Macrogloblin Antistreptolysin O Antithrombin III Apha-1-Acid-Glycoprotein Apolipoprotein A-1* Apolipoprotein B* Beta-2-Microgloblin C-Reactive Protein (CRP) C3 Complement C4 Complement Cerloplasmin Ferritin* Haptoglobin Immnogloblin A (IgA) Immnogloblin E (IgE) Immnogloblin G (IgG) Immnogloblin M (IgM) Kappa Light Chain Lambda Light Chain Prealbmin Properdin Factor B Rhematoid Factor (RF) Total Protein Transferrin MAS CSF This assayed, bi-level control is designed to monitor the performance of qantitative and manal chemical analysis of hman cerebrospinal flid. Mltiple oligoclonal bands are present in Level 2. Assayed for major instrment systems as well as for celllose acetate and agarose gel electrophoresis. These prodcts are liqid, ready-to-se and reqire no additional preparation. Part Nmber Level Bottles & Size Storage & Stability Matrix Bi-level, 24 month shelf 2 to 8 ºC CSF-MP 6 x 3.5 ml Hman Serm Mlti-Pack 30 days 2 to 8 ºC Refer to package insert for specific analyte and stability claims. Shelf life starts from the date of manfactre. * These constitent levels have not been adjsted bt are at levels fond in the sorce material sed in preparation of the controls. No claim is made for expected vales of these constitents. Albmin Alpha-1-Globlin Alpha-2-Globlin Beta-Globlin Chloride Gamma-Globlin Glcose Gltamine Immnogloblin A (IgA)* Immnogloblin G (IgG)* Immnogloblin M (IgM)* Lactate Dehydrogenase (LDH) Lactic Acid Oligoclonal Bands Potassim Prealbmin Sodim Total Protein Dropper Tips - Pkg MAS P/N

16 Thermo Scientific MAS Toxicology Controls MAS DOA TOTAL This mlti-constitent rine toxicology control offers 19 analytes with 4 distinct levels at drg concentrations 25% below and above commonly sed screening and SAMHSA* ctoffs. A drg-free level and high positive level are also available (6 levels total). The control is a liqid, ready-to-se prodct available for se on a variety of instrment platforms. Each level of control is individally packed which gives yo the flexibility to choose yor levels according to yor drg screen panel ctoffs while keeping the nmber of control vials to a minimm. Part Nmber Level Bottles & Size Storage & Stability Matrix DOAT-1 1 DOAT-2 2 DOAT x 18 ml DOAT month shelf 2 to 8 ºC Hman Urine DOAT days open 2 to 8 ºC DOAT-6 6 DOAT-MP Mlti Pack 1 bottle per level, 18 ml each 11-nor-9-COOH-D9-THC Benzoylecgonine Bprenorphine Cotinine d-methamphetamine EDDP Ethanol Ethyl Glcronide LSD Methadone Methaqalone Morphine, free Nitrazepam Nortriptyline Oxazepam Oxycodone Phencyclidine Propoxyphene Secobarbital MAS TOX Control This mlti-analyte control is developed for se with the Thermo Scientific MAS Toxicology immnoassays for the semiqantitative measrement of barbitrates, benzodiazepine, and tricyclic antidepressants in either serm or plasma. Part Nmber Level Bottles & Size Storage & Stability Matrix Mlti-Pack 3 levels 6 x 5 ml 24 months shelf 2 to 8 ºC 20 days open 2 to 8 ºC Bovine Plasma Barbitrate (Secobarbital) Benzodiazepine (Diazepam) Tricyclic Antidepressants (Nortriptyline) (for se with DRI Serm Tox Reagents) Dropper Tips - Pkg MAS P/N

17 Qality Control Soltions for Vista Designed for se with the Siemens Dimension Vista instrmentation Thermo Scientific MAS qality control prodcts are available in vials specifically designed for se with the Siemens Dimension Vista instrmentation. Flly validated onboard QC stability claims provide assrance that longterm qality assrance is maintained when performing rotine qality control on the Dimension Vista instrment. Nine individal Thermo Scientific MAS qality control prodcts are available in a Dimension Vista specific format covering the instrment assay portfolio. Six vials are provided in each kit for convenience. MAS Alcohol/Ammonia Part Nmber Level Bottles & Size Storage & Stability Matrix Bi-level, 24 month shelf 2 to 8 ºC x 2 ml Hman Serm Mlti-Pack 7 days onboard instrment Ammonia Ethanol MAS CardioImmne XL Part Nmber Level Bottles & Size Storage & Stability Matrix L month shelf -25 to -15 ºC 6 x 2 ml days onboard instrment Hman Serm C-Reactive Protein high sensitivity (hscrp) CK-MB Digitoxin Homocysteine Myoglobin NT-pro BNP Troponin I 17

18Shelf life starts from the date of manfactre. * These constitent levels have not been adjsted bt are at levels fond in the sorce material sed in preparation of the controls. No claim is made for expected vales of these constitents. 18

19Shelf life starts from the date of manfactre. * These constitent levels have not been adjsted bt are at levels fond in the sorce material sed in preparation of the controls. No claim is made for expected vales of these constitents. 19

20 Thermo Scientific LabLink xl Qality Assrance Software Abot LabLink xl Monitor yor internal qality control while comparing reslts with other labs arond the globe in real-time with Thermo Scientific LabLink xl clod-based qality assrance software. Trly Real-Time Peer Comparison Software Peer data is pdated instantly Daily QC Integration for MAS and Other QC Prodcts All yor QC prodcts are in one place Simple and Intitive Interface Interactive Levey-Jennings charts, Westgard rles, and adit-friendly reports Atomated QC Data Transfer With select systems Clod-Based SSL encrypted. Atomatically receive ftre pdates No Sbmission Ctoff Dates Review data whenever yo want Sigma Score and Other Performance Metrics %Bias, SDI, CVI, Z score, and more Mltiple Lab Management Scalable software grows with yor organization Validated Software FDA and GAMP 5 compliance Mltilingal Capabilities Available in 15+ langages 20

21 Trobleshoot faster with real-time peer comparison Compare yor data with labs arond the globe or jst yor affiliated network. Determine if a worrisome reslt is an instrment problem, widespread isse, or acceptable vale. Peer data is pdated in real-time, so yo can identify trends and shifts sooner. Day-to-day QC all in one place Levey-Jennings Charts Westgard Sigma Rles Perform all yor daily QC activities inside LabLink xl with interactive charts and graphs. Compare Levey-Jennings charts for mltiple instrments. Select Westgard and RiliBÄK violation rles. Flag and comment on individal data points. Use with MAS prodcts or any other QC manfactrer* * Non-MAS prodcts are spported by or atoconnectivity and Daily QC featres sch as report generation, Levey-Jennings charts, Westgard rles, mltiple lab management, and affiliated lab comparison. Peer Data for non-mas Prodcts is not available at this time. 21

22 Thermo Scientific LabLink xl Qality Assrance Software Adit-friendly reports Visalize data the way yo want Easy-to-read reports help yo monitor individal lab performance by shift, day and month View peer data alongside yor laboratory data Internal Performance Peer Data Comparison Adit History Region Specific Comparison Affiliated Lab Adit Rilibak Data Smmary Levey-Jennings QC Smmary Condensed Interlab Drgs of Abse Individal Lab Point Data Sbmission Smmary Data Sbmission Rilibak NEW IN LABLINK XL 2.0 Errors and Exceptions Instrment Interlab Affliliated Exception Notes Method Performance Exception Notes Monthly Smmary Statistical Smmary Smmary Urinalysis Yoden Signatre Verification and Delivery Review and digitally sign reports (athorized sers only) Schedle reports to be atomatically delivered to yor inbox every month 22

23 Poplar reports Method Performance and Sigma Score See which instrments are performing the best for a particlar method and test. Choose between CLIA qality goals or cstom goals for total allowable error. Individal Lab Report Test-by-test listing of yor lab s statistics and yor peer grop s statistics for a given month. Total Error Graph compares yor lab s method to yor peer grop s mean and yor chosen total allowable error limits. Monthly Smmary Report Shows a histogram of yor lab s data alongside yor peer grop s data. Qickly identify shifts and trends with a month-bymonth snapshot of yor lab s performance. Levey-Jennings Report Displays individal daily QC reslts or the daily mean for a selected date range on a Levey-Jennings chart. View Levey-Jennings charts for a single level or mltiple levels at the same time for qick comparison. Statistical Smmary Report Displays a statistical analysis for each of yor lab s tests alongside yor peer grop s reslts for a given month. View performance metrics sch as Mean, SD, CV, SDI, CVI and % Bias all on one screen. Exception Notes Report Smmarizes which QC reslts and corresponding analytical methods fell otside the performance criteria in a given month. Designated vales are flagged as otliers with respect to the lab s mean, peer grop mean, total allowable error, or other limits for each test. 23

24 Thermo Scientific LabLink xl Qality Assrance Software Performance metrics inclding Sigma Score %Bias Percent difference between yor observed test reslts and yor lab s target mean. Coefficient of Variation (CVI) Compares yor lab s CV to yor target CV to evalate precision with respect to yor chosen target. Standard Deviation Index (SDI) Compares yor lab s mean to yor target mean to evalate accracy with respect to yor chosen target. Sigma Indicates how mch yor data varies from the total allowable error limit by calclating the nmber of standard deviations in a given test system that fit within yor chosen qality goals. Z Score Measres how many standard deviations away an individal QC reslt is from the target mean. 24

25 Mltiple lab management scalable software grows with yor organization View data from a specific lab, or all yor labs combined. Compare reslts within yor affiliated network. Permissions hierarchy with mltiple levels of ser access - Elite User: For administrators who need fll access to data across all labs. - Intermediate User: For Lab managers who need to review data and sign reports. - Basic User: For technologists who need to sbmit data. Visalize yor reslts in real time Levey-Jennings Instrment Comparison Global Peer Review 25

26 Thermo Scientific LabLink xl Qality Assrance Software Stay p-to-date with Resorce Center View the latest package inserts, spplements, MSDS, and Certificates of Analysis for MAS prodcts Receive prodct pdates and important notifications via Download additional docments sch as User Gide and QC handling gidelines 26

27 Freqently Asked Qestions Q: Is LabLink xl secre? A: Absoltely. LabLink xl ses SSL encryption to ensre yor data is protected. Q: Can I create niqe login credentials for each ser? A: Yes. Each ser can have a niqe login ID and password, and the lab administrator can set different levels of permission for each ser. For example, an administrative ser can sign reports while a lab technician can only view and enter data. Q: I have non-mas prodcts. Do I need to se other software? A: Non-MAS prodcts are spported by ato-connectivity and Daily QC featres sch as report generation, Levey-Jennings charts, Westgard rles, mltiple lab management, and affiliated lab review. Peer data for non-mas prodcts is not available at this time. Q: Does LabLink xl offer both manal and atomated data entry options? A: Yes. LabLink xl offers options for atomated data entry as well as manal data entry (individal points or smmary data). Q: Does LabLink xl have access to my patient data? A: No. Even with or atomated connectivity options, patient data never leaves yor lab, and is never seen by LabLink xl. Interested in learning more? Or specialists can provide a software demonstration, go over atoconnectivity options, and more. Visit maslablink.com or s at 27

28 Thermo Scientific MAS QC Vale Assignment Program Testing Gidelines Each new lot of QC will tilize a different grop of vale assignment partner laboratories as participants are not reqired to test every QC lot. Advance notification of when to expect samples will be sent ot prior to testing. Instrctions for testing and data entry forms are sent with all vale assignment samples. Most tests are rn in dplicate over three separate days. All testing mst to be completed within 4-6 weeks of receiving the samples. Vale assignment is an important reqirement when rolling over to a new lot of QC material. The ability to provide fll coverage of instrment target vales involves the partnership of Thermo Fisher Scientific with laboratories performing the reqired testing. Withot involvement of these external laboratories, the ability to provide vale assignment coverage is significantly redced. Thermo Fisher Scientific is actively looking for new laboratories that are willing to assist with MAS QC Vale Assignment in retrn for monetary compensation or free QC prodcts. The reslts received from the participating laboratories are sed to establish QC ranges in the lot specific package inserts for the MAS Qality Controls. Compensation Options Monetary: This is typically based pon a flat fee per data point pls reagent costs. As this varies between test systems and methods, there is no standard amont. The different reimbrsement options will be discssed prior to prodct shipment. Free of charge MAS QC prodct: This is based pon the nmber of tests and MAS prodcts being vale assigned. Free QC prodct is given at the discretion of yor sales representative. Frther details will be provided by a member of the vale assignment team. Participation Reqirements CLIA certification or eqivalent local accreditation. A completed W-9 form (US only). A completed srvey noting instrments and testing capabilities. Steps to follow if yo are interested in participating in the MAS Vale Assignment Program Step 1: Complete the form below. Step 2: Fax this page to or to Step 3: A vale assignment introdction pack will be sent via mail or . Please complete the forms and retrn to s. Step 4: Once the introdction pack is received, a member of the vale assignment team will notify yo to discss acceptance into the program and the different methods of compensation. Lab Name: Lab Address: Contact Name: Alternate Contact: Phone Nmber: Fax Nmber: Accreditation #: Fax to: to: 28

29 Reference and Ordering Instrments Order Placement Technical Service & Spport

30n - No claim is made for expected vales or the stability of these constitents. 30

31 Page Analyte Alcohol/Ammonia Bilirbin CardioImmne XL chemtrak H CSF Diabetes DOA TOTAL Immnology Liqimmne Omni CARDIO Omni CORE Omni Immne Omni Immne PRO PAR TDM PTH Control Sentry Urine Dipstick Control TOX Control T-Marker UA Control UA Dip Tbe Urinalysis UrichemTRAK Vista Alcohol/Ammonia Vista CardioImmne XL Vista chemtrak H Vista CSF Vista Diabetes Vista Immnology Vista Liqimmne Vista UrichemTRAK CA 19-9 CA CA 72-4 CA 125 Caffeine Calcitonin Calcim Cannabinoids (THC) Carbamazepine Carbamazepine (Free) n CEA (carcinoembryonic antigen) Cerloplasmin Chloramphenicol Chloride Cholesterol Creatine Kinase (CK) CK-MB Carbon Dioxide (CO2) Cocaine (Benzoylecgonine) Color Cortisol Cotinine Copper Creatinine Crystals CYFRA 21-1 n d-dimer d-methamphetamine Diazepam DHEA-Slfate Digitoxin Digoxin Disopyramide EDDP (Methadone Metabolite) Estradiol Estriol Estriol (Free) - Analyte present. n - No claim is made for expected vales or the stability of these constitents. 31

32n - No claim is made for expected vales or the stability of these constitents. 32

33n - No claim is made for expected vales or the stability of these constitents. 33

34n - No claim is made for expected vales or the stability of these constitents. 34

35 Page Instrment Alcohol/Ammonia Bilirbin CardioImmne XL chemtrak H CSF Diabetes DOA TOTAL Immnology Liqimmne Omni CARDIO Omni CORE Omni Immne Omni Immne PRO PAR TDM PTH Control Sentry Urine Dipstick Control TOX Control T-Marker UA Control UA Dip Tbe Urinalysis UrichemTRAK Vista Alcohol/Ammonia Vista CardioImmne XL Vista chemtrak H Vista CSF Vista Diabetes Vista Immnology Vista Liqimmne Vista UrichemTRAK ABBOTT Architect ACON INTERNATIONAL ACON Mission (Visal) Mission U120 Mission U500 BECKMAN-COULTER Access AU Series n ICON ICON/11/25/20 Immage Synchron CX/LX UniCel DxI UniCel DxC Synchron BIOLIS 24i Clinical Systems BIOMERIEUX Vidas Systems BIOVATION Biovation BIORAD DiaSTAT D-10 Variant/Variant II COLE TAYLOR MARKETING, INC. (VISUAL) Cole Taylor (on CT-120) Cole Taylor (on Clinitek) DFI DIAGNOSTICS DFI ComboStik (Visal) DFI ComboStik Series DFI ComboStik CYBOW (Visal) DFI ComboStick CYBOW Series DFI 10 +/ DUS (Visal) DFI DU Reader 300 DFI DUS R-300 ERBA DIAGNOSTICS ERBA Urodip (Visal) ERBA Urodipcheck Analyte present. n - No claim is made for expected vales or the stability of these constitents. 35

36n - No claim is made for expected vales or the stability of these constitents. 36

37 Page Instrment Alcohol/Ammonia Bilirbin CardioImmne XL chemtrak H CSF Diabetes DOA TOTAL Immnology Liqimmne Omni CARDIO Omni CORE Omni Immne Omni Immne PRO PAR TDM PTH Control Sentry Urine Dipstick Control TOX Control T-Marker UA Control UA Dip Tbe Urinalysis UrichemTRAK Vista Alcohol/Ammonia Vista CardioImmne XL Vista chemtrak H Vista CSF Vista Diabetes Vista Immnology Vista Liqimmne Vista UrichemTRAK SIEMENS HEALTHCARE Acetest Advia 1650/2400 n n Advia Centar Altas BNA BN II/Prospec n n Clinitek Series Clinitest DCA 2000/Vantage n Dimension Series Dimension VISTA Ictotest Immlite/Immlite 2000 Micro-Bmintest Reagent Strip (visal) Stats Strats CS Viva Systems THERMO FISHER SCIENTIFIC Konelab Systems B R A H M S Kryptor MGC240 TOSOH BIOSCIENCES AIA Series A1c 2.2 Pls G7/G8 YD DIAGNOSTICS Uriscan (Visal) Uriscan Pro II Uriscan Optima II Uriscan Mini Uriscan Sper - Analyte present. n - No claim is made for expected vales or the stability of these constitents. 37

38 References Page Instrment OTHER Alcohol/Ammonia Bilirbin CardioImmne XL chemtrak H CSF Diabetes DOA TOTAL Immnology Liqimmne Omni CARDIO Omni CORE Omni Immne Omni Immne PRO PAR TDM PTH Control Sentry Urine Dipstick Control TOX Control T-Marker UA Control UA Dip Tbe Urinalysis UrichemTRAK Vista Alcohol/Ammonia Vista CardioImmne XL Vista chemtrak H Vista CSF Vista Diabetes Vista Immnology Vista Liqimmne Vista UrichemTRAK Arteray Monarini Bilirbinometer Coverslip Diastix (Bayer) Emit Flame Photometer n A1CNow Osmometer ph Meter Refractometer Thermo Electron Pocketchem - Analyte present. n - No claim is made for expected vales or the stability of these constitents. Architect, Abbott Laboratories, Abbott Park, IL Access, AU Series, Immage, CX/LX, ICON, ICON 11/25/20, SYNCHRON UniCel Dxl and UniCel DxC : Beckman Colter Inc., Brea, CA DiaSTAT, D-10 and Variant/Variant II: Bio-Rad Laboratories, Hercles, CA Biovation : Biovation Inc., Hercles, CA SPApls ; The Binding Site Grop Ltd, Birmingham, UK Add after Biovation in the list above Fisherbrand, UriSystem and Sre-Ve : Fisher Scientific, Pittsbrgh, PA CONTRAST II, OSOM and Signify : Genzyme Corp. Cambridge, MA DiaScreen 10 and DiaScreen 50: Hyogard, Minneapolis, MN ichem100 and IQ200 : International Remote Imaging Systems Inc., Chatsworth, CA Vitros, Vitros ECi, Vitros 5,1 FS and Vitros 5600 : Ortho Clinical Diagnostics, Rochester, NY QickVe and UrinQick : Qidel Corporation, San Diego, CA Cobas 6000, Elecsys, Hitachi Series, Cobas Integra, Modlar Analytics E170, Criterion 1/11, CUA/SUA, MiniUA, Chemstrip 101, Urisys 1100/1800, Urisys 2400 and Micral : Roche Diagnostics, Indianapolis, IN ACETEST, Advia Centar, Advia 1650/2400, Atlas, BNA/BN II, BN ProSpec, Clinitek Series, Clinitest, DCA 2000, Dimension, Dimension VISTA, Dimension Xpand, Ictotest, Immlite /Immlite 200, Microbmintest, Stats and Strats CS: Siemens Healthcare Diagnostics, Los Angles, CA; Glasgow, DE; and Tarrytown, NY AIA Series, A1c 2.2 Pls and G7/G8: Tosoh Medics Inc., S. San Francisco, CA URiSCAN (Visal), URiSCAN Pro II, URiSCAN Optima II, URiSCAN Mini, URiSCAN Sper: YD Diagnostics Corp. Songpa-k, Seol, Korea A1CNow : PTS Diagnostics, Tarrytown, NY. Now owned and distribted by PTS Diagnostics, Snnyvale, CA 38

View more

Sours: https://docplayer.net/52078503-Simplifying-your-quality-controls-thermo-scientific-mas-quality-control-products-lablink-xl-quality-assurance-program.html
HSE \u0026 SOP of Quality Control

Apparently then I decided to get used to the role of a whore one hundred percent. Maxim's member was much larger than Angela's. Hot flesh, smelling of an assortment of lubricant, sperm and wife juices, almost completely filled my mouth.

Now discussing:

And then it even became ashamed that she started all this. - Ashamed, but not very. - added Diana - No, not really, - Maria laughed. Opening the door of her jeep, Diana pulled out the bag of white powder that started it all, tossed it several times and asked her partner.

- With this, what are you going to do.



1716 1717 1718 1719 1720