#518 - 11 - 2010 - FINAL

INSPECTION REPORT ROUTING SHEET
To be attached to all inspection reports in-house only.
Laboratory Cert. #:
.518
Laboratory Name:
Baxter Healthcare Corp.
Inspection Type:
Industrial Maintenance
Inspector Name(s):
Jason Smith
Inspection Date:
November 9, 2010
Date Report Completed:
January 14, 2011
Date Forwarded to Reviewer:
January 14, 2011
Reviewed bv:
David Livingston
Date Review Completed:
January 19, 2011
Cover Letter to use:
lnsp..Initial X Insp. Reg_ Insp. No Finding Insp, CP
Unit Supervisor:
Gary Francies
Date Received:
1/19/2011
Date Forwarded to
Alberta:
1/20/11
Date Mailed:
01

Beverly Eaves Perdue
Governor
518
Mr. Stephen Taylor
Baxter Healthcare Corp.
P.O. Box 1390
Marion, NC 28752
i�
RCDENR
North Carolina Department of Environment and Natural Resources
Division of Water Quality
Coleen H. Sullins
Director
January 20, 2011
SUBJECT: North Carolina Wastewater/Groundwater Laboratory Certification (NC WW/GW LC)
Maintenance Inspection
Dear Mr. Taylor:
Dee Freeman
Secretary
Enclosed is a report for the inspection performed on November 9, 2010 by Jason Smith. I apologize for the
delay in getting this report to you. Where finding(s) are cited in this report, a response is required. Within 30
days of receipt, please supply this office with a written item for item description of how these finding(s) were
corrected. For certification maintenance, your laboratory must continue to carry out the requirements set forth
in 15A NCAC 2H .0800.
Copies of the checklists completed during the inspection may be requested from this office. Thank you for your
cooperation during the inspection. If you wish to obtain an electronic copy of this report by email or if you have
questions or need additional information please contact me at 828-296-4677.
Sincerely,
Gary Francies
Unit Supervisor
Laboratory Section
CC: Jason Smith
Gary Francies
Master files
DENR DWQ Laboratory Section NC Wastewater/Groundwater Laboratory Certification Branch One
1623 Mail Service Center, Raleigh, North Carolina 27699.1623 NQi hCarolina
Location, 4405 Reedy Creek Road, Raleigh, North Carolina 27607-6445 Phone: [phone] t FAX: [phone] Naturally
ly
Internet: mvw,dwglab,org
An Equal Opportunity t Affirmaliva Action Emptoyer Customer Service: 1-877-623-6748 v+vm.ncwaterquality.org

LABORATORY NAME:
NPDES PERMIT #:
ADDRESS:
CERTIFICATE #:
DATE OF INSPECTION:
TYPE OF INSPECTION:
AUDITOR(S):
LOCAL PERSON(S) CONTACTED:
j ,s s
Baxter Healthcare Corp.
NCO006564
P.O. Box 1390
Marion, NC 28752
518
November 9, 2010
Industrial Maintenance
Jason Smith
Stephen Taylor
This laboratory was inspected to verify its compliance with the requirements of 15A NCAC 2H .0800 for
the analysis of environmental samples.
GENERAL COMMENTS:
The facility has all the equipment necessary to perform the analyses, The laboratory adequately
addressed most of the Findings prior to the completion of this report in an email received on November
16, 2010. These Findings are documented in this report as comments with no further response required.
Finding A is a new policy that has been implemented by our program since the last inspection.
III. FINDINGS REQUIREMENTS COMMENTS AND RECOMMENDATIONS:
Documentation
Comment: The time of sample preservation in the laboratory was not documented to show that samples
were preserved within 15 minutes. The Code of Federal Regulations, Title 40, Part 136; Federal
Register.Vol. 72, No. 47,.March 12, 2007; Table 11, Footnote 2 states in part: preserve the grab sample,
composite sample, or aliquot split from a composite sample within 15 minutes of collection. The
laboratory submitted an updated benchsheet which includes the time of sample preservation in the
laboratory. No further response is necessary for this finding.
Comment: The.date that Fecal Coliform filters and media are put in use was not documented. The date
opened was documented, but this date was when the materials were opened to perform the comparison
testing. In order to accurately determine the lot numbers used on a daily basis, both the date opened
and : put in use ,are required if they are not the same. North Carolina Wastewater/Groundwater
Laboratory Certification Policy states in part: All chemicals, reagents, standards and consumables used
by the laboratorymust have the following information documented: Date received, Date Opened (in
use), Vendor, Lot Number, and Expiration Date (where specified). This is a new policy that has been
implemented by our program since the last inspection. The laboratory is now documenting the date put in
use in addition to the date opened for Fecal Coliform filters and media. No further response is
necessary for this finding.

Page 2
#518 Baxter Healthcare Corp.
Comment: The procedure and calculations for preparing reagents is not included in the reagent
preparation log. North Carolina Wastewater/Groundwater Laboratory Certification Policy states in part:
Documentation of solution preparation must include the analyst's initials, date of preparation, the
volume or weight of standard(s) used, the solvent and final volume of the solution. This information as
well as the vendor and/or manufacturer, lot number, and expiration date must be retained for primary
standards, chemicals, reagents, and materials used for a period of five years. This is a new policy that
has been implemented by our program since the last inspection. The procedure and calculations are now
included in the reagent preparation log. No further response is necessary for this finding.
General Laboratory
Comment: The analytical balance was last serviced on August 11, 2009. North Carolina Wastewater/
Groundwater Laboratory Certification Policy states: Laboratory analytical balance(s) must be serviced by
a qualified vendor/technician at a minimum every 12 months to ensure that the balance is functioning
within required tolerances. Documentation that this service has been performed must be available for
review upon request. If the operational capabilities of the balance are in question at any time during the
12-month period, corrective action must be taken. The analytical balance was serviced on December 7,
2010. No further response is necessary for this finding.
PH— Standard.Methods, 18th Edition, 4500 H" B
Comment: The laboratory was reporting pH results to two decimal places. Standard. Methods, 18th
Edition, 4500. H+ B. (6) states: A variance of ± 0.1 pH unit represents the limit of accuracy under normal
conditions, especially for measurement of water and poorly buffered solutions. For this reason, report
pH values to the nearest 0.1 pH unit. The laboratory is now reporting pH to one decimal place. No
further response is necessary for this finding.
Specific Conductance -Standard Methods, 18th Edition, 2510 B
Comment: The effluent collection/analysis time was not documented, 'Required Documentation for
Sampling -Preservation and Hold Time", North Carolina Wastewater/Groundwater Laboratory
Certification memorandum dated June 20, 2007 states in part: Sample identification must be associated
with the. date ,and time of sample collection and analysis. The time elapsed between sampling and
analysis must be documented to determine if hold times are met. Prior to the laboratory inspection, the
collection/analysis times .for the upstream and downstream samples were recorded on the pH and
Dissolved Oxygen ,benchsheets. Based upon a recommendation during the inspection, the
collection/analysis times of the effluent, upstream, and downstream samples are now recorded on the
Conductivity benchsheet. No further response is necessary for this finding.
Total Suspended Solids -- Standard Methods, 18th Edition, 2540 D
Comment: The laboratory was using a minimum weight gain of 1 mg to determine the reporting limit.
North Carolina Wastewater/Groundwater Laboratory Certification Policy based upon Standard Methods,
20th and 21s' Editions, 2540 D. (3) (b) states: The minimum reporting value is established at 2.5 mg/L
when 1000 mL of sample is analyzed. The minimum weight gain allowed by any approved method is 2.5
mg. In instances where the weight gain is less than the required 2.5 mg, the value must be reported as
- less ,than the: appropriate value based upon the volume used. For example, if 500 mL of sample is
analyzed and < 2.5 mg of dried residue is obtained, the value reported would be < 5 mg/L. This is a new
policy that has:been implemented by our program since the last inspection. The laboratory is now using a
minimum weight gain of 2.5 mg to determine the reporting limit. No further response is necessary for
this finding.: ..>

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#518 Baxter Healthcare Corp.
Chemical Oxygen Demand — Hach !Method 8000
Comment: Since the laboratory is using a preprogrammed internal curve that is verified annually, the
analysis of a second source standard is not required.
Comment: The laboratory was not analyzing a blank and calibration verification standard at the end of
the sample set. North Carolina Wastewater/Groundwater Laboratory Certification Policy states: The
calibration blank and calibration verification standard (mid -range) must be analyzed initially (i.e., prior to
sample analysis), after every tenth sample and at the end of each sample group to check for carry over
and calibration drift. If either fall outside established quality control acceptance criteria, corrective action
must be taken (e.g., repeating sample determinations since the last acceptable calibration verification,
repeating the initial calibration, etc.). This is a new policy that has been implemented by our program
since the last inspection. The blank and calibration verification standard are now analyzed as required by
this policy. No further response is necessary for this finding.
A. Finding: The laboratory is not analyzing matrix spikes.
Requirement: Unless the referenced method states a greater frequency, spike 5% of samples
on a monthly basis. Laboratories analyzing less than 20 samples per month must analyze at
...least one.,matrix spike each month samples are analyzed. Prepare the matrix spike from a
reference source different from that used for calibration unless otherwise stated in the method.
If matrix _spike results are out of control, the results must be qualified or the laboratory must
take corrective action to rectify the effect, use another method, or employ the method of
standard: additions.: When the method of choice specifies matrix spike performance acceptance
.criteria for;accuracy, and the laboratory chooses to develop statistically valid, laboratory -specific
limits, the laboratory -generated limits cannot be less stringent than the criteria stated in the
approved method. Ref: North Carolina Wastewater/Groundwater Laboratory Certification Policy.
Comment:, :Please see the attached technical assistance document. Additional technical
assistance will be provided.
IV. PAPER TRAIL INVESTIGATION:
No paper trail performed.
V. CONCLUSIONS:
Correcting the above -cited finding will help this lab to produce quality data and meet certification
requirements.' The' -inspector would like to thank the staff for its assistance during the inspection and
data review process. Please respond to all findings.
Report prepared by: Jason Smith Date: January 14, 2011
Report reviewed: by: David Livingston Date: January 19, 2011

North Carolina Wastewater/Groundwater Laboratory Certification
Matrix Spiking Policy and Technical Assistance (41612010)
Policy Statement
Unless the referenced method states a greater frequency, spike 5% of samples on a monthly basis.
Laboratories analyzing less than 20 samples per month must analyze at least one matrix spike (MS) each
month samples are analyzed. Prepare the MS from a reference source different from that used for
calibration unless otherwise stated in the method. If MS results are out of control, the results must be
qualified or the laboratory must take corrective action to rectify the effect, use another method, or employ
the method of standard additions. When the method of choice specifies MS performance acceptance
criteria for accuracy, and the laboratory chooses to develop statistically valid, laboratory -specific limits, the
laboratory -generated limits cannot be less stringent than the criteria stated in the approved method.
When spiking with multi -component standards, if the method does not specify the spiking components,
the Laboratory Control Spike (LCS) and MS must contain all analytes that are reported.
If the unspiked sample result is in the top 40% of the calibration range, the sample should be diluted and
the MS prepared using the diluted sample. The recovery of the MS samples must be bracketed by the
calibration range.
The volume of spike solution used in MS preparation must in all cases be s 10% of the total MS volume. It
is preferable that the spike solution constitutes s 1% of the total MS volume so that the MS can be
considered a whole- volume sample with no adjustment by calculation necessary. If the spike solution
volume constitutes >1% of the total sample volume, the sample concentration or spike concentration must
be adjusted by calculation.
Technical Assistance
Spike Preparation
The spike concentration may be set at either 5 to 50 times the Method Detection Limit (as determined by
the Method Detection' Limit or MDL study) for the analyte, or at 1 to 10 times the ambient level (average
concentration) of the analyte in samples. There are 3 options for preparing spikes:
Option 1 (Recommended - easiest) - If the spike solution volume is equal to 1% or less of the
`total sample volume;direct subtraction of the unspiked sample is allowed. When the volume of
the standard solution spiked into a sample or a sample extract is less than 1 % of the total volume
then the final concentration need not be adjusted (e.g., 10 pL of spike solution added to a 1 mL
final extract results in only a negligible 1 % change in the final extract volume).
Option 2 - Adjust spike solution to a known volume with sample. In this case the sample
concentration must be adjusted. When the volume of spike solution exceeds 1% of the total MS
volume the sample concentration must be adjusted prior to determining spike recovery.
Option 3 (Not recommended — most difficult) - Add spike solution to a full volume sample. In this
case, the spike concentration must be adjusted. When the volume of spike solution exceeds 1%
of the total MS volume the spike concentration must be adjusted prior to determining spike
recovery.

Spike Preparation Examples
Option 1 - If the spike solution volume is equal to 1% or less of the total sample volume, direct subtraction
of the unspiked sample is allowed.
Option 1 Example:
0.5 m(s of a 1000 mg/L standard spike added to 100 mis of sample has a theoretical value of 5
mg/L.
(A) The spiked sample recovery is 5.1 mg/L
(B) If the unspiked sample result is 0.5 mg/L
(C) Theoretical value is 5.0 mg/L
The Percent Recovery = spiked sample recovery (A) - unspiked sample result (B) divided by
theoretical value (C) X 100 or
5.1 - 0.5 X 100 = 92% recovery A - B X 100 = Percent recovery
5.0 C
Option 2 - Adjust spike solution to a known volume with sample. In this case the sample concentration
must be adjusted.
Option 2 Example 1:
10 mis of spike (concentration 50 mg/L) brought to 100 mis with sample the theoretical MS value is
5 mg/L.
(A) The spiked sample recovery is 5.1
(B) If the unspiked sample result is 0.5 mg/L
(C) % sample is 0.90 (sample volume used (90) divided by final volume (100))
(D) Theoretical value is 5.0 mg/L
The Percent Recovery = spiked sample recovery (A) -- (unspiked sample result (B) x % sample
(C)) divided by theoretical value (D) X 100 or
5.1 (0.5 x 0.9) X 100 = 93% recovery A - (B x C) X 100 = Percent recovery
5.0 D
Option 2 Example 2: Larger spike volume
25 mis of spike (concentration 50 mg/L) brought to 250 mis with sample the theoretical MS value
is 5 mg/L.
- (A) The spiked sample recovery is 5.6
(B) If the unspiked sample result is 0.5 mg/L
-= (C)' " %sample is 0.90 (sample volume used (225) divided by final volume (250))
(D) Theoretical value is 5.0 mg/L
The Percent Recovery = spiked sample recovery (A) - (unspiked sample result (B) x % sample
(C)) divided by theoretical value (D) X 100 or
5.6 - 0.5 x Q.M X 100 = 103% recovery A - S x C X 100 = Percent recovery
5.0 D
Option 3 - Add spike solution to a full volume sample. In this case the spike concentration must be
adjusted.

Option 3 Example:
5 mis of a spike (concentration 100 mg/L) is added to 100 mis of a sample (105 mis final volume).
(A) The spiked sample recovery is 5.1
(B) If unspiked sample result is 0.5 mg/L
(C) Spike cone. adjustment is 0.9524 (sample volume (100) divided by sample + spike
volume (105))
(D) Actual spike value is 4.7619 (Theoretical value (5 mg/L based on 100 ml sample) x C)
The Percent Recovery = spiked sample recovery (A) x (sample volume divided by sample volume
+ spike volume (C)) — unspiked sample result (B) divided by Actual spike value (D) X 100 or
(5.1 x 100 ) — 0.5
100+5
4,7619
(AxC —B X100=91.5%
X 100 = 91.5% recovery D
Corrective Action/Qualifications for MS
Spike accuracy is usually based on a range of percent recovery (e.g., 80-120%). Refer to the method of
choice for specific acceptance criteria for the matrix spikes until the laboratory develops or adopts
statistically :valid, laboratory -specific performance criteria for accuracy. If a MS fails, and the LCS is
acceptable,. qualify the data for the MS sample. Repeated failures for a specific matrix may require use of
an alternate method or method of standard addition. Base the sample batch acceptance on the results of
the LCS analyses (and other quality control results) rather than the MS alone, because the matrix of the
spiked sample may interfere with the method performance. If a MS and the associated LCS fail, re -
prepare and reanalyze affected samples.
Post Digestion Spikes (PDS)
Post Digestion Spikes (PDS) are used for some analyses (e.g., metals) to assess the ability of a method
to successfully recover target analytes from an actual sample matrix after the digestion process has been
performed. The PDS results are used with MS results to evaluate matrix interferences. The MS and PDS
should be prepared from the same environmental sample. A PDS is not to be analyzed in place of a MS.
Post Digestion Spikes must be reported as post -digested and must not be misrepresented as pre-
digested spikes. (Exception: TCLP and SPLP samples are always spiked post digestion.)
Corrective Action/Qualifications for Post Digestion Spikes
In general, if the MS recovery for an analyte does not fall within the quality control acceptance range but
the PDS recovery is acceptable, then a matrix affect (associated with the preparatory process) should be
suspected and the unspiked sample results must be qualified on the basis of the matrix spike recovery.
However, when historical, data for the effect does not exist, the laboratory would normally be expected to
perform:a second. digestion and reanalysis of the MS to confirm the result. The result would be confirmed
if the MS recoveries and PDS recoveries for both sets of analyses were similar in magnitude and bias.
When- both the MS recoveryand PDS recovery for a particular analyte falls outside of quality control
acceptance: range in the -same manner (i.e., the PDS and MS failures are of similar magnitude and the.
direction of bias is the.same), confirmatory analyses are unnecessary but the data must be qualified.

Parameters Excluded from MS Requirements
Acidity
BODtCBOD
Chlorophyll
Color — ADMI
Conductivity
Ignitability
Paint Filter Test
pH
J Salinity
Total Residual Chlorine
Alkalinity
Aquatic Humie Substances
All Bacteriological Parameters
Color - PtCo
Dissolved Oxygen
All Residues
Turbidity
Temperature
Sulfite
Vector Attraction Reduction (All Options)
(Field Laboratories and Field Setting analyses are exempt.)