NC0006564_Performance Audit Inspection_20170426

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UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
REGION 4
ATLANTA FEDERAL CENTER
61 FORSYTH STREET
ATLANTA, GEORGIA 30303-8960
APR 2 6 2017
CERTIFIED MAIL 7016 1970 0000 8992 6793
RETURN RECEIPT REQUESTED
Mr. Jay Zimmerman
Director, Division of Water Resources
North Carolina Department of Environment and Natural Resources
1601 Mail Service Center
Raleigh, North Carolina 27699
Re: Performance Audit Inspection
National Pollutant Discharge Elimination System Permit No. NC0006564
Dear Mr. Zimmerman:
The purpose of this letter is to transmit the National Pollutant Discharge Elimination System (NPDES)
Performance Audit Inspection report for the Baxter Healthcare Corporation wastewater treatment
laboratory, which was conducted by staff from Region 4 of the U.S. Environmental Protection Agency's
Science and Ecosystem Support Division on February 23, 2017. The overall NPDES program was
determined to be satisfactory. A report documenting the performance audit is enclosed for your review.
If you should have any further questions regarding the enclosed report, please contact Ms. Mary Mattox at
[phone] or via email at [e-mail].
Sincerely4Hoeyy,
Mau ' e ,Chief
Municipal & Industrial Enforcement Section
NPDES Permitting and Enforcement Branch
Enclosure
cc: Mr. Jason Smith
North Carolina Department of Environmental _Quality
Internet Address (URL) • http://www.epa.gov
Recycled/Recyclable • Printed with Vegetable Oil Based Inks on Recycled Paper (Minimum 30% Postconsumer)

Project ID: 17-0252
Performance Audit InspectionLU %Q%''OO
Baxter Healthcare Corporation 0
NPDES Permit NC0006564
65 Pitts Station Road
Marion, North Carolina
Project Date: February 23, 2017
Report Date: February 28, 2017
_
Project Leader: Bill Simpson
Enforcement Section
Field Services Branch
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Science & Ecosystem Support Division
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USEPA — Region 4
980 College Station Road
Athens, Georgia 30605-2720
The activities depicted in this report are accredited under the US EPA Region 4 Science and
Ecosystem Support Division ISO/IEC 17025 accreditation issued by the ANSI-ASQ National
Accreditation Board. Refer to certificate and scope of accreditation AT -1644.
SESD Project ID Number: 17-0252
1 of 7

Request®r:
Maurice Horsey, Chief
Municipal and Industrial Enforcement Section
NPDES Permitting and Enforcement Branch
USEPA Region 4, 61 Forsyth St. SW
Atlanta, Georgia 303-8960
Approvals:
SESD Project Leader:
Bill Simpson
Enforcement Section
Field Services Branch
980 College Station Road
Athens, GA 30605-2720
Approving Official:
Mike Bowden, Chief
Enforcement Section
Field Services Branch
980 College Station Road
Athens, GA 30605-2720
Date
Date
SESD Project ID Number: 17-0252 2 of 7

1.0 INTRODUCTION
On February 23, 2017, the United States Environmental Protection Agency (U.S.EPA) and the North
Carolina Department of Environmental Quality (NCDEQ) performed an on-site evaluation of the Baxter
Healthcare Corporation wastewater treatment laboratory. The on-site evaluation consisted of discussions
with laboratory staff/analysts, an inspection of the facilities and equipment, record reviews, a review of '
operating procedures, and a review of quality assurance activities. Representing the EPA and NCDEQ
during the on-site evaluation included:
Mr. Bill Simpson, U.S.EPA, Physical Scientist
Mr. Jason Smith, NCDEQ, Chemist II
The on-site evaluation began with an opening conference that included a round of introductions of the
auditors and representative staff from Baxter Healthcare. An explanation of the goals and objectives of
the evaluation was made by EPA staff. Later the same day a closing conference was held between the
EPA and NCDEQ auditors and representative staff of Baxter Healthcare. The purpose of the post
assessment conference was for the auditors to summarize the general findings from the on-site
evaluation, discuss the schedule for the findings report and answer questions. This report presents the
findings and recommendations from the on-site evaluation. The key managerial staff from Baxter
Healthcare participating in the assessment included:
Mr. Stephen D. Taylor, WWTP Supervisor, EHS
Mr. Michael J. Pisarik, Senior Environmental Engineer, EHS.
2.0 GENERAL LABORATORY DISCUSSIONS AND FINDINGS
Observation
The wastewater treatment laboratory was staffed with qualified analysts and supervisory personnel. The
wastewater treatment laboratory was housed in acceptable facilities with adequate workspace. The
laboratory had ample equipment to perform day to day operations. Laboratory instrumentation appeared
to be in excellent operating condition. All analytical instrumentation necessary for performing analysis
associated with National Pollutant Discharge Elimination System (NPDES) Permit NC0006564 was
available for inspection. The laboratory water purification system for providing ASTM Type I water to
the laboratory was functioning properly at the time of the laboratory evaluation. It was observed that the
Quality Assurance Manual which contained the Standard Operating Procedures (SOPs) were kept in a
bound three ring binder. At the time of the audit, the laboratory was conducting all the analysis
associated with the permit except oil and grease and chronic toxicity. Pace Analytical Laboratories,
Huntersville, NC was analyzing oil and grease as a contract laboratory.
SESD Project ID Number: 17-0252 3 of 7

The current permit status is listed in Table 1.
TABLE 1
Current Permit Status
Parameter
Monthly Average
Measurement
Sample type
Sample
Frequency
Location
Influent and
Flow
1.2 MGD
Continuous
Recording
, Effluent
460.9 pounds/day
3/Week
Composite
Influent and
BODS
Effluent
COD
1,292.8 pounds/day
3/Week
Composite
Influent and
Effluent
TSS
278,0 pounds/day
3/Week
Composite
Effluent
Fecal Coliforms (MPN)
200/100 mL
3/Week
Grab
Effluent and
UandD
Total Residual Chlorine
Daily limit of 28 ug/L
3/Week
Grab
Effluent
Oil and Grease
47.7 pounds/day
Weekly
Grab
Effluent
Field Parameters: pH,
Effluent and
temperature, conductivity, and
U and D
dissolved oxygen
pH between 6.0 and
3/Week
Grab
9.0 standard units
Report only Parameters
2/Month for
Composite
Effluent
NH3-N
N113 -N, mg/L
No permitted limits
All others
Total Nitrogen, mg/L
monthly
Total Phosphorus, mg/L
Chronic Toxicity
SESD Project ID Number: 17-0252 4 of 7

Findings, for the EPA Region 4's NPDES laboratory assessments, are defined as factual, objective
statements which provide evidence of non-conformance with any of the following and which may
adversely affect the quality of the data. Findings are supported with the citations to applicable
regulations.
• The Current NPDES Permit NC0006564, effective date, September 1, 2016.
• Official agency mandates and policies i.e. Title 40 of the Code of. Federal Regulations (40
CFR) Part 122.41, conditions applicable to all permits, 40 CFR Part 136.3, identification of
test procedures, 40 CFR Part136.7 quality assurance and quality control.
• Standard Methods for the examination of water and wastewater.
Recommendations are those corrective measures that would enhance laboratory operations, but are
not mandatory. The EPA strongly encourages implementation of the recommendations to better
conform to standard laboratory practices currently employed within the environmental industry.
Corrective Actions are those actions initiated in response to an identified nonconformance, in order to
define a problem, attempt to identify the root cause and determine how to prevent the problem
from recurring.
FINDINGS/CORRECTIVE ACTIONS
The following discussions present the findings, corrective actions and recommendations based on the
on-site evaluation and review of the documents submitted by the laboratory.
3.0 GENERAL LABORATORY QUALITY AND DOCUMENTATION
3.1 Finding: The standard, operating procedures were incomplete, and in need of revision.
Corrective Action: 40 CFR 136.7 states "for example, Standard Methods contains
QA/QC procedures in the Part 1000 section of the Standard Methods Compendium."
In accordance with part 1020 of Standard Methods," Standard Operating Procedures
describe the analytical methods to be used in the laboratory in sufficient detail that a
competent analyst unfamiliar with the method can conduct a reliable review and/or obtain
acceptable results."
3.2 Finding: The use of dedicated glassware (for QC samples) was observed for the
biochemical oxygen demand test. This is considered an unacceptable laboratory practice.
Corrective Action: In accordance with'Standard Methods, part 5210B sect. 6c "Dilution
water blank serves as a check on quality of unseeded dilution water and cleanliness of
incubation bottles." The cleanliness of all bottles cannot be ascertained if only one bottle
is utilized for the blank. If the glassware is dedicated; and not rotated, there is no way to
demonstrate that the cleaning protocol is acceptable.
SESD Project ID Number: 17-0252 5 of 7

3.3 Finding: The method requires an additional Glucose -Glutamic acid check, for a total of
three quality control checks, per sample batch of 20, for BODS analysis.
Corrective Action: In accordance with Standard Methods, part 5210B sect. 6b "Add
sufficient amounts of standard glucose -glutamic acid solution (5210B.3h) to give 3.0 mg
glucose/L and 3.0 mg glutamic acid/L in each of three test bottles. The resulting average
BOD for the three bottles, after correction for dilution and seeding, must fall into the
range of 198 ± 30.5 mg/L."
4.0 CONCLUSIONS
In evaluating the Baxter Healthcare wastewater treatment laboratory, the facility is following the
analytical methods specified in 40 CFR part 136. The laboratory had appropriate safety
equipment and emergency equipment available. The laboratory conducts QC checks on
equipment, instrumentation calibration and standard solutions. The laboratory maintains
appropriate records of reagent preparation, instrument calibration and maintenance. The
laboratory is producing defensible data with a known precision and accuracy.
SESD Project ID Number: 17-0252 6 of 7

REFERENCES:
The following SESD field measurement and reference procedures were followed during this
Performance Audit Inspection, as applicable:
SESDPROC-306-R3
Wastewater Sampling
SESDPROC-109-R4
Wastewater Flow Sampling
SESDPROC-100-R4
Field pH
SESDPROC-106-R3
Field Measurement of Dissolved Oxygen
SESDPROC-102-R4
Field Temperature
SESDPROC-112-R4
Field Measurement of Total Residual Chlorine
SESDPROC-101-R6 Field Measurement of Specific Conductance
SESDPROC-110-R4 Global Positioning System
SESDPROC-111-R3 In-situ water quality monitoring
SESD Wastewater Checklist: method SM5210-B Rev 2001, BODS (CBOD)
SESD Wastewater Checklist: method SM5220D Chemical Oxygen Demand, Colorimetric
SESD Wastewater Checklist: method SM2540D-Determination of Non- Filterable Residue (TSS)
SESD Wastewater Checklist: method SM 4500-H+ B, rev 2000 Determination of pH electrometrically
SESD Wastewater Checklist: method EPA method 1664B Oil and Grease
SESD Wastewater Checklist: Sample Management Procedures
SESD Wastewater Checklist: method EPA Method 360.1 Determination of Dissolved Oxygen (DO)
SESD Wastewater Checklist: method SM 4500 -CL G, rev 2000 Total Residual Chlorine, DPD
Colorimetric Method
SESD Wastewater Checklist: method SM9222D Determination of Fecal Coliform Bacteria by Membrane
Filter Procedure
SESD Wastewater Checklist: method SM 4500 -CL G, rev 2000 Total Residual Chlorine, DPD
Colorimetric Method
END OF REPORT
SESD Project ID Number: 17-0252 7 of 7