Responding to a Deficiency

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Responding to a Deficiency

• Preparing Labs to Conduct Corrective Actions

2
This Talk Will

• Look at the basis for citing a deficiency
• Conducting the Corrective Action effort
• Preparing a Response
• Following through
• Is it a deficiency?

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What is a Deficiency?

• ELAP can only issue a certificate if it finds
  compliance with all its Statutes and Regulations
  - HSC 100859(a)
• A Deficiency is a failure to comply

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Applicable Statutes Regulations

• HSC 100825(b) and (c).(16) Regulatory Purposes
• HSC 100865 Authority to conduct audit
• CCR Title 22 section 64807 Site Visits
• analytical test methods, instrumentation and
  equipment, quality assurance and quality control
  procedures, application information.
• Deficiency letter and corrective action response
• HSC 100875 Ability to issue order directing
  compliance with statue or regulation

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Chain of Logic

• State regulations state DW methods (CCR 64415(a))
  by pointing to 40CFR 141.21 Regulatory Purposes
  and HSC 116390 stipulates the use of certified
  labs
• Does not list IDEXX Colilert but does list Std
  Methods 9223B Enzyme Substrate 18th, 19th, 20th,
  and on-line
• CCR 64881(a) requires the use of methods found in
  40CFR 141 for DW FoTs

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Chain continued

• CCR 64813(b) requires the equipment be maintained
  and operated per method requirements
• CCR 64815(a) requires implementation of a QA
  program and documenting the program in a QA Plan
• CCR 64815(b) requires the QA/QC procedures found
  in the method Std Methods 9223 points to 9020B

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Deficiency Noted
The incubator temperature is read once daily.
The temperature must be read twice daily when in
use.
Non compliance of CCR 64813(b) and/or 64815(b)
and/or (d) Std Methods 9223 points to 9020 for
QA 9020B.3.(n) 20th stipulates measurements
twice daily (morning and afternoon)
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Responding to the Deficiency

• Examine QA Plan and the method SOPs. Be sure
  they state temperature monitoring twice daily.
• Check temperature records to see if space
  allocated for second reading.
• Interview involved staff.
• Train or refresh training to all involved staff.
• Institute a check system to see no relapse.

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Example Response
We have examined our QA Plan, method SOPs, and
temperature records and find that the lapse was
not due to a failure to establish twice-daily
temperature readings. We find that the staff
person assigned to do the readings failed to tell
their vacation/sick-time replacement to make
twice-daily readings. We have provided training
to the assigned staff person and require that all
vacation/sick-time replacements be trained prior
to performing the duties. As a means of
assessing continued compliance, the Lab Director
will examine the records at random for the next
year.
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General Response to Deficiency

• Examine practices, documents and records
• Go back to the base method or regulation to see
  what is required
• Interview staff

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Writing a Response

• Clearly state your findings
• State what will be corrected
• Be sure to involve training or refresher training
• Set up a self-check system

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Followup

• Be sure to implement all actions described in the
  Corrective Action
• Follow through on training
• If the Corrective Action involves proof, provide
  it with the letter, or at a promised future time
• Be sure to do the self-audits!

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DONT !!

• Promise an action you cannot or will not deliver
  on
• Fail to follow through on the self-audit

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Why

• CCR 64807(b) calls for the actions cited in HSC
  1021 (now 100880) for failures to implement
  corrective actions.
• HSC 100880 in addition to denial, suspension, or
  revocation, can issues citations for a failure to
  implement any actions directed in an order
• HSC 100890(a) stipulates fines (up to
  5,000/day/instance) for filing a false document

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How Not to Respond
Spot checks on glassware for residue using
bromthymol blue must be performed. Submit your
SOP and results of your most recent test.
As discussed at the audit, because we purchase
pre-cleaned glassware for bacteriological
testing, we do not reuse (and hence do not wash)
microbiology glassware.
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Std Methods 9020B 4.a.1 20th does state the
need to spot-check glassware for detergent
residues that might be acidic or alkaline by the
bromthymol blue check. Std Methods does not have
any rule for single-use or disposable glassware.
If the glassware is pre-cleaned it is hoped that
the vendor is checking for residues, but if not
then the lab has to check. In addition the
laboratory overlooked glassware used for media
preparation, which is washed and reused.
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Is It a Deficiency???
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Deficiency?
Provide personnel qualifications for the new
analysts in microbiology and chemistry.
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NOT
There is no regulation that requires review of
personnel qualifications beyond those for the
Laboratory Director and Principle Analyst (CCR
64817). Qualifications are required for the new
chemistry analysts if they are to be designated
Principle Analysts and the tests they will do use
the stated sophisticated equipment (CCR
64801(k)). Principle Analysts are not required
for microbiology
20
Deficiency??
EPA method 300.1 prohibits the use of quadratic
model.
21
Maybe Not
The method does not even mention the quadratic
equation so it cannot prohibit. However the
method does establish very strict rules on the
range of standards to keep the calibration curve
linear
22
Deficiency??
The laboratory must meet the DLRs This is
accomplished by including a calibration standard
at the DLR level with the calibration curve.
Alternatively, the laboratory may analyze a
quality control check at the DLR levels with
recoveries from 60 to 140.
23
NOT
HSC 100827 stipulates that labs are to report
the results per the request for analysis but no
regulation stipulates how anyone is to
demonstrate attaining the DLRs or how the DLRs
are to be implemented. EPA mentions MDLs (40CFR
136 App. B)
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Deficiency??
For every batch, a midpoint standard at the
beginning, end and after every 9 samples (SM 3020
Quality Control 19th edition) is required and
not just every 10 samples. Corrective actions
must be taken if recovery is not within 10 of
the true value
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YES
3020B 19th States Analyze a midpoint check
standard and calibration blank at the beginning,
end and periodically (normally after each set of
nine unknowns) with each group of samples to
verify Initially as a guideline use the
following criteria check standard outside 95
to 105...suggests a potential problem. When a
value is outside 90 to 110... usually
considered out of control take corrective action.
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The 20th However
Calibration verification Verify calibration by
analyzing a midpoint calibration standard (check
standard) and calibration blank at the beginning
and end of a sample run, periodically during a
run (normally after each set of ten samples).
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Continued
A check standard determination outside 90 to 110
of the expected concentration indicates a
potential problem. If a check standard
determination is outside 80 to 120 of the
expected concentration, immediately cease sample
analyses and initiate corrective action. For
instrumental methods (3111, 3113, 3120, and
3125), cease analysis and initiate corrective
action if check standards exceed 90 to 110.
Repeat initial calibration and sample
determinations since the last acceptable
calibration verification
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Deficiency??
The temperature of the water bath is read only
once on each day of use. The temperature must be
read twice daily at no less than four hours
apart. Provide us with the temperature logs
showing compliance.
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Not Completely
9020B.2.o 18th and 19th states for water
baths record temperature daily
9020B.2.p 18th and 19th, 9020B.3.n and
9020B.3.o 20th states record temperature
twice daily (morning and afternoon)
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Where Did 4 Hours Come From?

• There is no requirement in Std Methods, State or
  Federal regulations stipulating readings at least
  4 hours apart
• It is in the non-regulatory EPA DW Lab Cert
  Manual 3.4.2

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Lab Cert Manual Disclaimer
This is a guidance manual and not a regulation.
It does not change or substitute for any legal
requirement. While EPA has made every effort to
ensure the accuracy of the manuals discussion,
the obligations of the regulated community are
determined by the relevant statutes, regulations
or other legally binding requirements. This
manual is not a rule, is not legally enforceable,
and does not confer legal rights or impose legal
requirements upon any member of the public,
States or any other Federal agency. In the event
of a conflict between the discussions in this
manual and any statute or regulation, this
document is not controlling.
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NIST Thermometers

• 9020B.2.a 18th and 19th or 9020B.3.a 20th
  requires calibration for micro work
• No other section in Standard Methods requires
  calibration, including solids and BOD except
  there is mention in 2550B Temperature which
  states, Periodically check the thermometer
  against a precision thermometer certified by the
  National Institute of Standards and Technology
  (NIST) that is used with its certificate and
  correction chart. But that is for measuring
  temperature in the field.

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Can You Say No to ELAP?

• You can challenge any deficiency BUT
• Be sure no regulation was violated
• That it is not a provision of the method
• It is not in your QA Plan

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Your QA Manual can Get You in Trouble

• 64815(a) calls for implementing and documenting a
  QA Plan
• 64815(d) calls for records of Plan
  implementation
• You can be in trouble if you wrote it in the Plan
  and dont implement and document

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The Message

• Be sure to know what is required by the method.
• Know something about ELAPs regulations
• Get a clear picture of the deficiency
• Examine your documents, records, QA Plan, and
  SOPs.
• Interview involved staff
• Make the changes
• Be sure what is fixed stays fixed.

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More

• Many practices cited as deficient - including
  QA - may be unstated in regulations or statutes,
  and even the methods.
• Your Lab QA document may be the source of the
  violation. If you dont need it then consider
  removing it.

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William (Bill) RayQuality Assurance Office
ManagerOffice of Information Management and
Analysis916-341-5583bray_at_waterboards.ca.gov