#683_2016_0913_BS_FINAL

INSPECTION REPORT ROUTING SHEET
To be attached to all inspection reports in-house only.
Laboratory Cert. #: 683
LaboratoryName: ame: Biota Diagnostics, LLC
Inspection Type: Commercial Initial
Inspector Name(s): Beth Swanson, Gary Francies, Anna
Ostendorff, Nick Jones, Todd Crawford
and Jason Smith
Inspection Date:
Date Report Completed:
Date Forwarded to Reviewer:
Reviewed by:
Date Review Completed:
Cover Letter to use:
Unit Supervisor/Chemist III:
Date Received:
Date Forwarded to Admin:
Date Mailed:
September 13, 2016
September 27, 2016
October 7, 2016
Jason Smith
10/31 /2016
® Insp. Initial
❑ Insp. No Finding
❑ Corrected
Gary Francies
10/31 /2016
2/2/2016
12/5/2016
❑ Insp. Reg.
❑ Insp. CP
❑ Insp. Reg. Delay
Special Mailing Instructions: mail copy to Wes Bell in MRO @ wes.bellO—ncdenr.gov

Water Resource.
Er€vIRON MEN I AL QUAL#' V
December 5, 2016
683
Mr. Keith D Hambright
Biota Diagnostics, LLC
2401 Whitehall Park Drive, Suite 700
Charlotte, NC 28273
PAT MCCRORY
DONALD R. VAN DER VAART
S. JAY ZIMMERMAN
Subject: North Carolina Wastewater/Groundwater Laboratory Certification (NC WW/GW LC)
Maintenance Inspection
Dear Mr. Hambright:
Enclosed is a report for the inspection performed on September 13, 2016 by Beth Swanson, Anna
Ostendorff, Nick Jones, Todd Crawford, Jason Smith and myself. I apologize for the delay in getting this
report to you. Where Finding(s) are cited in this report, a response is required. Within thirty days of
receipt, please supply this office with a written item for item description of how these Finding(s) were
corrected. Please describe the steps taken to prevent recurrence and include an implementation date for
each corrective action. If the Finding(s) cited in the enclosed report are not corrected, enforcement
actions may be recommended. 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 [phone].
Sincerely,
Gt
Gary Francies, Technical Assistance/Compliance Specialist
Division of Water Resources
Attachment
Cc: master file
Beth Swanson
Water Sciences Section
NC WastewaterlGroundwater Laboratory Certification Branch
1623 Mail Service Center, Raleigh, North Carolina 27699-1623
Location: 4405 Reedy Creek Road, Raleigh, North Carolina 27607
Phone: [phone] FAX: [phone]
Internet: http3ldeg nc govlabouUdivisions(water-resources(water-resources-datalwater•scien ces-home-pageltaboratory-certification-branch

LABORATORY NAME:
ADDRESS:
CERTIFICATE #:
DATE OF INSPECTION:
TYPE OF INSPECTION:
AUDITOR(S):
LOCAL PERSON(S) CONTACTED:
INTRODUCTION:
• • 0 ' • • _.
Biota Diagnostics, LLC
2401 Whitehall Park Drive, Suite 700
Charlotte NC, 28273
683
September 13, 2016
Commercial Initial
Beth Swanson, Gary Francies, Anna
Ostendorff, Nick Jones, Todd Crawford
and Jason Smith
Keith Hambright and Jason Robinson
This laboratory was inspected by a representative of the North Carolina Wastewater/Groundwater
Laboratory Certification (NC WW/GW LC) program to verify its compliance with the requirements
of 15A NCAC 2H .0800 for the analysis of environmental samples.
GENERAL COMMENTS:
This was an initial inspection conducted at the request of the laboratory. Many parameters are not
yet analyzed and reported to clients. Those parameters with compliance data were fully audited.
The rest of the laboratory's Certified parameters were audited through Proficiency Test or internal
laboratory data with the exception of Anions (EPA 300.0, Rev. 2.1, 1993), Dissolved Oxygen
(Standard Methods, 4500 O G-2001), Total Residual Chlorine (Standard Methods, 4500 Cl G-
2000) and BOD/CBOD (Standard Methods 5210 B-2001).
The facility is spacious and clean. Laboratory personnel were forthcoming and engaged in the
inspection process.
All required Proficiency Testing (PT) samples for the 2016 PT calendar year have been analyzed,
but remedial PTs and Corrective Action Reports (CARs) are pending for unacceptable results.
The laboratory is reminded that any time changes are made to laboratory procedures; the
laboratory must update the QA/SOP document(s) and inform relevant staff. Any changes made
in response to the pre -audit review or to Findings, Recommendations or Comments listed in this
report must be incorporated to insure the method is being performed as stated, references to
methods are accurate, and the QA and/or SOP document(s) is in agreement with each
approved practice, test, analysis, measurement, monitoring procedure or regulatory
requirement being used in the laboratory. In some instances, the laboratory may need to create
an SOP to document how new functions or policies will be implemented.
The laboratory is also reminded that SOPs are intended to describe procedures exactly as they
are to be performed. Use of the word "should" is not appropriate when describing requirements

Page 2
#683 Biota Diagnostics, LLC
(e.g. Quality Control (QC) frequency, acceptance criteria, etc.). Evaluate all SOPS for the proper
use of the word "should".
Requirements that reference 15A NCAC 2H .0805 (a) (7) (A), stating "All analytical data pertinent
to each certified analysis must be filed in an orderly manner so as to be readily available for
inspection upon request", are intended to be a requirement to document information pertinent to
reconstructing final results and demonstrating method compliance. Use of this requirement is not
intended to imply that existing records are not adequately maintained unless the Finding speaks
directly to that.
Contracted analyses are primarily performed by Analytical Environmental Services, Inc.
(Certification #562), Pace Analytical Services, Inc. — Huntersville (Certification #12) and
TestAmerica Laboratories, Inc. Nashville (Certification #387).
Approved Procedure documents for the analysis of the facility's currently certified Field
Parameters were provided at the time of the inspection.
III. FINDINGS, REQUIREMENTS, COMMENTS AND RECOMMENDATIONS:
Documentation
Recommendation: It is recommended that all benchsheets include the method name being used
for analysis and that the client reports include the full method reference. Most benchsheets
included the parameter but not method title, and the client reports did not consistently include the
method approval year or version (e.g., SM 2540 D-1997 or SW-846 Method 6020 B).
A. Finding: Error corrections are not always properly performed.
Requirement: All documentation errors must be corrected by drawing a single line
through the error so that the original entry remains legible. Entries shall not be obliterated
by erasures or markings. Wite-Out®, correction tape or similar products designed to
obliterate documentation are not to be used. Write the correction adjacent to the error.
The correction must be initialed by the responsible individual and the date of change
documented. All data and log entries must be written in indelible ink. Pencil entries are not
acceptable. Ref: NC WW/GW LC Policy.
Comment: The data contained some write-overs and corrections that were not initialed
and dated by the responsible individual.
Recommendation: It is recommended that when any documentation correction that
affects the final reported sample result is made, the lab also note the reason the change
was made. For example, changing an original sample absorbance or weight observation
due to further stabilization of the spectrophotometer or balance, the lid to the
spectrophotometer was left open in error during sample measurement, etc.
B. Finding: The preservation acid used and pH of preserved samples upon receipt are not
consistently documented.
Requirement: A record of date collected, time collected, sample collector, and use of
proper preservatives must be maintained. Ref: 15 NCAC 2H .0805 (a) (7) (M).
Comment: The laboratory employs two forms for each sample, the Chain of Custody
(COC) and Cooler Receipt Form. When used correctly in conjunction, all the necessary

Page 3
#683 Biota Diagnostics, LLC
information for sample preservation appears to be documented. However, the forms
reviewed contained no linkage of the samples between the COC and Cooler Receipt Form
and some documentation was also missing from the COC where a space to enter that
information was provided.
C. Finding: The preparation of some standards are not documented in such a way as to
provide traceability from preparation to analysis.
Requirement: A system (e.g., traceable identifiers) must be in place that links
standard/reagent preparation information to analytical batches in which the solutions are
used. 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. Ref: NC WW/GW LC Policy.
Comment: The laboratory's system of traceability was effective and easy to follow for
stock standards, reagents and consumables. The missing elements are documentation of
some standard preparations. Stock standards were traceable, but matrix spikes and
standards prepared from the stock must be documented.
Proficiency Testing
D. Finding: The preparation of Proficiency Testing (PT) samples is not documented.
Requirement: PT samples received as ampules must be diluted according to the PT
provider's instructions. The preparation of PT samples must be documented in a traceable
log or other traceable format. The diluted PT sample becomes a routine environmental
sample and is added to a routine sample batch for analysis. Ref: Proficiency Testing
Requirements, February 20, 2012, Revision 1.2.
Comment: Dating and initialing the instruction sheet for the preparation of PTs not
received as whole volume samples would satisfy the documentation requirement.
E. Finding: The laboratory is not analyzing Proficiency Testing (PT) samples in the same
manner as compliance samples.
Requirement: All PT samples are to be analyzed and the results reported in a manner
consistent with the routine analysis and reporting requirements of compliance samples
and any other samples analyzed according to the requirements of 15A NCAC 2H .0800.
Ref: Proficiency Testing Requirements, February 20, 2012, Revision 1.2.
Comment: A calibration verification standard was not analyzed at the beginning and end
of the analytical sequence for the SW-846 8260 B PT samples or at the end of the
analytical sequence for SW-846 8270 D PT samples.
Comment: The calibration curves utilized to assess the SW-846 8260 B and SW-846
8270 D PT samples were not valid because the initial calibration verifications were not
from a second source standard.

Page 4
#683 Biota Diagnostics, LLC
General
F. Finding: Thermal preservation is not performed on all applicable samples within 15
minutes.
Requirement: Except where noted in this Table II and the method for the parameter,
preserve each grab sample within 15 minutes of collection. Ref: Code of Federal
Regulations, Title 40, Part 136; Federal Register Vol. 72, No. 47, March 12, 2007; Table II,
Footnote 2.
Requirement: A 15-minute limit to thermally or chemically preserve samples is allowed.
The temperature of a temperature blank or of a representative sample from each cooler
must be recorded upon receipt in the laboratory. Occasionally, samples that are collected
and delivered to the lab within a short period of time may not have time to cool to less than
or equal to 6 °C (less than 10 °C for Bacteriological analyses) before they arrive at the
laboratory. If these samples are placed in ice immediately after collection and are shipped
on ice or in ice slurry (NOTE: frozen or blue ice packs are not acceptable), the sample
collectors have complied with these requirements to the best of their ability and the
samples will be accepted. Documentation of the actual sample temperature at the time of
collection and upon receipt at the laboratory must exhibit a downward trend and will
complete the preservation documentation requirements. Ref: NC WW/GW LC Policy.
Comment: There is a nearby location where the samples are collected by the client and
picked up by the laboratory to be brought back for analysis. These samples are
transported to the laboratory quickly, but not within 15 minutes and often have
temperatures upon receipt of >6 'C. The samples are not placed on ice. Once the
laboratory begins the process of placing the samples on ice, the temperature of the
sample upon collection must be documented to show that there was a downward trend in
the event that there is not enough time to reduce the sample temperature to s6°C.
Quality Control
G. Finding: The temperature sensor used to record sample temperature upon receipt has
not been verified within the last 12 months.
Requirement: All thermometers must meet National Institute of Standards and
Technology (NIST) specifications for accuracy or be checked, at a minimum annually,
against a NIST traceable thermometer and proper corrections made. Ref: 15 NCAC 2H
.0805 (a) (7) (0).
Comment: All other thermometers and temperature sensors had been verified, but the
sensor on the pH meter used to check sample temperatures was inadvertently overlooked.
H. Finding: Auto-pipettors are not calibrated twice per year.
Requirement: Mechanical volumetric liquid -dispensing devices (e.g., fixed and adjustable
auto-pipettors, bottle -top dispensers, etc.), used for critical measurements, must be
calibrated at least twice per year, approximately six months apart and documented. Each
liquid -dispensing device must meet the manufacturer's statement of accuracy. Ref: NC
WW/GW LC Policy.
Comment: The auto-pipettors are calibrated every 12 months.

Page 5
#683 Biota Diagnostics, LLC
COD — Standard Methods, 5220 D-1997 (Aqueous)
Comment: No data pertinent to NC WW/GW LC has been analyzed at this time. PT data was
reviewed.
Finding: The laboratory is not documenting the temperature of the reactor during
digestion. This is considered pertinent information.
Requirement: All analytical data pertinent to each certified analysis must be filed in an
orderly manner so as to be readily available for inspection upon request. Ref: 15 NCAC
2H .0805 (a) (7) (A).
J. Finding: The laboratory is not analyzing a final Continuing Calibration Verification
standard or blank.
Requirement: 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. Ref: NC WW/GW LC
Policy.
K. Finding: The laboratory has not analyzed a method reporting limit (MRL) standard initially
and quarterly thereafter.
Requirement: Verify quantitation at the MRL initially and at least quarterly (preferably
daily) by analyzing a QC sample (subjected to all sample -preparation steps) spiked at a
level 1 to2 times the MRL. Ref: Standard Methods, 5020 B-2010. (1) (c).
L. Finding: The laboratory is not preparing a new calibration curve when standards differ >_
5% from the calibration curve.
Requirement: Prepare calibration curve for each new lot of tubes or ampules or when
standards prepared in ¶ a above differ by >_ 5% from calibration curve. Ref: Standard
Methods, 5220 D-1997. (4) (c).
Comment: This requirement applies to all standards analyzed. The LFB analyzed with the
PT data had a 93.2% recovery.
pH — Standard Methods, 4500 H+B-2000 (Aqueous)
M. Finding: Values were reported that exceed the method specified accuracy of 0.1 units.
Requirement: By careful use of a laboratory pH meter with good electrodes, a precision
of ±0.02 unit and an accuracy of ±0.05 unit can be achieved. However, ± 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. Ref: Standard Methods, 4500 H+ B-2000. (6).
N. Finding: The true value of the check buffer is not documented.
Requirement: The following must be documented in indelible ink whenever sample
analysis is performed: True value for the check standard buffer, true value and value

Page 6
#683 Biota Diagnostics, LLC
obtained for the post analysis calibration verification(s), where applicable. Ref: NC
WW/GW LC Approved Procedure for the Analysis of pH.
Comment: The laboratory performs a post analysis verification.
Residue, Suspended — Standard Methods, 2540 D-1997 (Aqueous)
Recommendation: Although the required traceability information for filters are documented in the
laboratory's consumables material log, it is recommended the filter lot # be documented on the
benchsheet.
O. Finding: Client reports state the practical quantitation limit (PQL) is 1 mg/L.
Requirement: The minimum weight gain allowed by any approved method is 2.5 mg.
Choose sample volume to yield between 2.5 and 200 mg dried residue. This establishes a
minimum reporting value of 2.5 mg/L when 1000 mL of sample is analyzed. Ref: NC
WW/GW LC Policy.
Temperature — Standard Methods, 2550 B-2000 (Aqueous)
P. Finding: Documentation is not available to verify that the NIST thermometer used for
Temperature sensor verification is accurate within ± 0.5 °C.
Requirement: NIST traceable temperature measuring devices used for this verification
must have a stated accuracy of at least ± 0.5 °C. Document the verification data and keep
on file. Ref: NC WW/GW LC Approved Procedure for the Analysis of Temperature.
TCLP Metals — SW846-1311 (Aqueous) (Non -Aqueous)
Q. Finding: The benchsheet does not document all units of measure.
Requirement: All laboratories must use printed laboratory bench worksheets that include
a space to enter the signature or initials of the analyst, date of analyses, sample
identification, volume of sample analyzed, value from the measurement system, factor and
final value to be reported and each item must be recorded each time samples are
analyzed. Ref: 15A NCAC 2H .0805 (a) (7) (H).
Comment: The benchsheet lacks units for the "extraction fluid selection" and "maximum
pressure on filter" columns.
R. Finding: The amount of time the sample is held at 50 °C is not documented. This is
considered pertinent data.
Requirement: All analytical data pertinent to each certified analysis must be filed in an
orderly manner so as to be readily available for inspection upon request. Ref: 15 NCAC
21-1.0805 (a) (7) (A).
Requirement: If the pH from Section 7.1.4.2 is >5.0, add 3.5 mL 1 N HCI, slurry briefly,
cover with a watchglass, heat to 50 °C, and hold at 50 °C for 10 minutes. Ref: SW-846
Test Methods for Evaluating Solid Waste, Physical/Chemical Methods; 31d Edition, Method
1311, July 1992, Section 7.1.4.3.

Page 7
#683 Biota Diagnostics, LLC
TCLP Metals — SW846-1311 (Aqueous)
Comment: The benchsheet does not include a space to document the volume of filtrate obtained
after tumbling. Only one sample, non -aqueous, has been analyzed and the volume of filtrate is not
applicable in this instance. It will apply if aqueous samples are analyzed.
Metals — EPA 200.8, Rev. 5.4, 1994 (Aqueous)
Metals — SW-846 6020 B (Aqueous)
Comment: Aqueous samples were not being digested prior to analysis. EPA Method 200.8, Rev.
5.4, 1994 states: For the determination of total recoverable analytes in aqueous and solid samples
a digestion/extraction is required prior to analysis when the elements are not in solution (e.g.,
soils, sludges, sediments and aqueous samples that may contain particulate and suspended
solids).EPA SW-846 Test Methods for Evaluating Solid Waste, Physical/Chemical Methods; 3rd
Edition, Method 6020 B, Rev. 2, July 2014, Section 1.1 states: Acid digestion prior to filtration and
analysis is required for groundwater, aqueous samples, industrial wastes, soils, sludges,
sediments, and other solid wastes for which total (acid -leachable) elements are required.
Acceptable corrective action (i.e., a notice for immediate response was issued during the
inspection and the laboratory agreed to begin digesting all samples immediately upon receipt of
the next aqueous samples) was performed by the laboratory and approved by the auditor during
the inspection. No further response is necessary for this Finding.
Metals — EPA 200.8, Rev. 5.4, 1994 (Aqueous) and (Non -Aqueous)
Metals — SW-846 6020 B (Aqueous) and (Non -Aqueous)
Comment: When a combined run with the two methods is performed, the digestion procedure
must either follow EPA 200.2, Rev. 2.8, 1994 or EPA 200.8, Rev. 5.4, 1994.
Comment: The laboratory is reminded that the digestion procedure in EPA 200.8, Rev. 5.4, 1994
includes a correction factor of 1.25 that must be applied if the chloride interference dilution is
performed. This dilution may not be necessary if the kinetic energy discrimination (KED)
technology in the instrument is utilized.
Base Neutral/Acid Organics — SW-846 8270 D (Aqueous)
Comment: The laboratory does not currently analyze compliance data for NC clients for this
parameter.
Recommendation: It is recommended that the laboratory request additional sample from their
clients. This will ensure there will be sufficient volume of sample to analyze the parent samples, a
matrix spike, and sample or matrix spike duplicate without having to elevate the laboratory's
reporting level.
Purgeable, Organics — SW-846 8260 B (Aqueous) (Non -Aqueous)
Comment: The laboratory does not currently analyze compliance data for NC clients for this
parameter.
Recommendation: Internal standard responses were relatively low which likely contributed to
erroneously high reported concentrations of target analytes and false positives in the Proficiency
Testing sample. It is recommended that area counts of the internal standard peaks be between

Page 8
#683 Biota Diagnostics, LLC
50-200% of the areas of the target analytes in the mid -point calibration analysis, as recommended
in Section 5.10 of the method,
Recommendation: It is recommended that aqueous standards be prepared daily. Section 7.3.2.1
of the method states: Aqueous standards are not stable and should be prepared daily. The
analyst indicated on the checklist that this was not current practice but would be carried out going
forward. Employing the standard reservoirs on the auto -sampler would be the easiest way to
accomplish this.
Recommendation: According to Section 5.10 of the method, it is recommended that the
secondary dilution standard be prepared at a concentration of 25 mg/L of each internal standard
compound. Addition of 10 pL of this standard to 5.0 mL of sample or calibration standard would be
the equivalent of 50 pg/L. If a more sensitive mass spectrometer is employed to achieve lower
detection levels, then more dilute internal standard solutions may be required. The concentration
of surrogate and internal standards are currently 10 pg/L, recommended by a Perkin Elmer
analyst, instead of the method prescribed 50 pg/L. During the inspection, it was noted that the
laboratory was having a problem with low recovery of internal and surrogate standards. The lower
concentration of the standards may be a contributing factor to this problem.
Recommendation: Currently, the laboratory analyzes six calibration standards (in an attempt to
bracket the range of concentrations found in typical samples), and utilizes a six -standard linear
regression for all target analytes. Because this extends the calibration range beyond the specified
linear working range of the analytical system for some analytes (i.e., they exceed the Relative
Standard Deviation acceptance criterion of 15%), it is recommended that the laboratory
(depending upon the analyte), take advantage of one of the two following options.
Option 1: The laboratory may only use five of the standards instead of all six in the linear
regression for that analyte. If one of the calibration standards is discarded, it must be the lowest or
highest concentration standard and the linear working range or practical quantitation limit must be
adjusted accordingly.
Option 2: In situations where the analyst knows the instrument response does not follow a linear
model over a sufficiently wide calibration range, a non -linear calibration model may be employed.
At least six calibration levels are recommended to construct a quadratic (second -order) calibration
curve, and at least seven levels should be used for a cubic (third -order) curve.
Comment: The lab was not analyzing a second source standard each day. NC WW/GW LC
Policy states: When a standard curve is manually prepared (as opposed to a factory -set
calibration verification), it is required to analyze one known standard in addition to calibration
standards each day samples are analyzed to document accuracy. This standard must be
prepared from materials obtained from a source independent from the one used for preparing the
calibration standards (often referred to as a second source standard or external reference
standard). A second source standard may be:
® a quality control standard obtained from a vendor,
® a standard prepared from primary standards obtained from a second vendor, or
® a standard made from primary standards from the same vendor but from a different lot
number (i.e., an independent lot) as those used to make the calibration standards.
Laboratory control standards are evaluated to assess whether the lab is in control of the
processes involved in the preparation and analysis of specific tests. Laboratory control standards
must be similar in composition to the environmental samples. They must contain known

Page 9
#683 Biota Diagnostics, LLC
concentrations of all analytes of interest and undergo the same preparatory and determinative
`procedures as the environmental samples.
Second source standards must be evaluated using one of the following: vendor supplied criteria,
method -defined acceptance criteria, in-house calculated acceptance limits that are statistically -
derived from historical data based on three standard deviations from the mean in the detectable
range or other statistically viable evaluation criterion. If the results fall outside of acceptance limits,
the analysis is out of control. The analysis must be terminated and the problem corrected prior to
sample analysis. Notification of acceptable corrective action (i.e., a statement that a second
source standard had been purchased and was put into use as of October 27, 2016) was received
by email on October 27, 2016. No further response is necessary for this Finding.
IV. PAPER TRAIL INVESTIGATION:
The paper trail consisted of comparing original records (e.g., laboratory benchsheets, logbooks,
COCs, etc.) and client reports. Data were reviewed for the following project numbers BD-0069,
BD-0070, BD-0074, BD-0075, BD-0080, BD-0101 and BD-0105. No transcription errors were
detected. The facility appears to be doing a good job of accurately transcribing data.
V. CONCLUSIONS:
Correcting the above -cited Findings and implementing the Recommendations will help this
laboratory to produce quality data and meet Certification requirements. The inspector would like
to thank the staff for their assistance during the inspection and data review process. Please
respond to all Findings and include supporting documentation and implementation
dates for each corrective action.
Report prepared by: Beth Swanson Date: October 7, 2016
Report reviewed by: Jason Smith Date: October 10, 2016