Clarification of Basis and Procedures for Downgrading/Suspending
Approval

 for Laboratories for the Analysis of Cryptosporidium Under the Long
Term 2 Enhanced Surface Water Treatment Rule 

The U.S. Environmental Protection Agency’s (EPA’s) Office of Ground
Water and Drinking Water, in the Office of Water, prepared this
document.  EPA intends to use this document for its own use in approving
laboratories for analysis of drinking water contaminants.  In order to
assume primary enforcement responsibility for the drinking water
regulations, a State must either have available laboratory facilities,
approved by the Administrator, capable of conducting analytical
measurements of drinking water contaminants, or establish and maintain
its own program for approval of laboratories.   States wishing to adapt
the procedures and criteria of this document for their own approval
program should revise it to accurately reflect their State approval
program.

This is a protocol that is intended to clarify EPA’s intended practice
and procedures for laboratory approval and to reflect good laboratory
practice and standard proficiency evaluation in the industry; it is not
a regulation.  While EPA intends generally to follow the procedures laid
out in this document, not every situation is reflected in these
procedures and EPA may need to address case-specific situations in ways
that differ from the procedures spelled out here.  This document is not
a rule, is not legally enforceable, and does not confer legal rights or
impose legal requirements upon anyone.  EPA welcomes comment on this
protocol and may decide to revise this document without public notice to
reflect changes to its approach or to clarify and update the text.

 “Approved Laboratories” have demonstrated, and continue to
demonstrate, proficient and reliable detection and enumeration of
Cryptosporidium in surface water sources for public water systems.  They
have passed all elements in the Laboratory Quality Assurance Evaluation
Program for Analysis of Cryptosporidium under the Safe Drinking Water
Act (Lab QA Program) and continue to successfully participate in all
program activities.  Approved Laboratories notify the Approval Authority
(EPA individual(s) administering the program or State individual(s)
administering an equivalent laboratory certification program) of loss of
key personnel or essential equipment, change in policies or procedures
that directly affect the validity of data, and any other change
affecting the capability of the laboratory, including change in
location.

“Provisionally Approved Laboratories” have deficiencies, but
demonstrate their ability to consistently produce data of known quality.
 They continue to successfully participate in all Lab QA Program
activities.  A Provisionally Approved Laboratory may analyze drinking
water samples for Long Term 2 Enhanced Surface Water Treatment Rule
(LT2ESWTR) compliance purposes if the laboratory has identified
themselves as Provisionally Approved to their clients and any reports
clearly state that the laboratory’s status is “Provisionally
Approved.”

“Not Approved” designates a laboratory that has either not
participated in the Lab QA Program, or has applied to the program, but
possesses deficiencies and, in the opinion of the Approval Authority,
does not consistently produce data that have met all applicable method
quality control (QC) requirements or has falsified data. 

Basis for Downgrading to “Provisionally Approved” Status

An Approved Laboratory (referred to as “laboratory”) may be
downgraded to “Provisionally Approved” status for Cryptosporidium
for any of the following reasons:

Failure to analyze samples for the LT2ESWTR according to the December
2005 version of EPA Method 1623 or EPA Method 1622, including all QA/QC
criteria;  

Failure to document a minimum of 22 percent for on-going precision and
recovery (OPR) values in an updated QC chart prior to analysis of
LT2ESWTR samples at the frequency required in Section 9.7 of the method;

Failure to demonstrate proficiency based upon acceptable matrix spike
recoveries for all modifications of the method procedures per Section
9.1.2 of the method;

Failure to submit valid Proficiency Test (PT) results or meet PT
acceptance limits described by the Approval Authority for the first two
initial testing events, or two out of three regular testing events
administered by a vendor authorized by the Approval Authority. 

 Acceptance Limits: laboratory mean recovery between ±2 standard
deviations (SD) of the mean recovery for all approved laboratories in a
given test event. 

Recoveries below the mean recovery minus 2 SD will fail the PT test
event.  

Recoveries higher than the mean recovery plus 2 SD trigger additional
evaluation, which may include one or more of the following:  

On-site evaluation 

Presence of a proctor when processing PT samples during the next test
event 

Submission of PT microscope slides to the Approval Authority  before the
expiration of holding time during the next test event;

Failure to submit PT slides within three weeks of PT test event when
requested by the Approval Authority;

Failure to maintain records of method modifications per Section 9.1.2.2
of the method;

Failure to notify the Approval Authority of loss of key personnel or
essential equipment, change in policies or procedures that directly
affect the validity of data, or other changes affecting the capability
of the laboratory, including change in location.  Laboratory approval
does not automatically survive such changes; the Approval Authority may
request an on-site or off-site evaluation and/or further proof of
compliance with all applicable method requirements;

Failure to submit on-site evaluation materials and any other requested
information within the time period requested by the Approval Authority; 

Failure to participate satisfactorily in the Approval Authority Lab QA
Program and demonstrate proficiency based upon: 

Sample and method holding time records; 

Analyst verification skills; 

Relative quality of positive staining control and OPR slides; 

Acceptable performance of QC checks, including but not limited to, blind
slide counts; and 

Acceptable precision and recovery values for all method variations.

Procedures for Downgrading to “Provisionally Approved” Status

The Approval Authority will notify the laboratory director or owner of
its intent to downgrade after becoming aware of the situation warranting
downgrading;  

The laboratory director should review the problems cited, and within 30
days of receipt of the letter, send a letter to the Approval Authority
specifying immediate corrective actions that are being taken;

The Approval Authority will consider the adequacy of the response and
notify the laboratory in writing of its approval status, generally
within 14 days of receipt of the laboratory’s response; 

After the Approval Authority notifies a laboratory, the Approval
Authority will post the laboratory’s status on the Web site list of
laboratories and may schedule an on-site evaluation of the laboratory;

The laboratory should identify and correct its problem(s) to the
Approval Authority’s satisfaction within 30 days of being notified of
the downgrade or have approval status suspended;  

A Provisionally Approved laboratory may continue to analyze samples for
compliance purposes, but must identify its status as Provisionally
Approved on any report;  

A laboratory may request that the Approval Authority or State provide
technical assistance to help identify and resolve any problem; however,
adequate performance is the laboratory’s responsibility and Approval
Authority assistance should not delay the downgrading procedure.

Basis for Suspending Approval Status

A laboratory may be downgraded from Approved or Provisionally Approved
status to “Not Approved” for any of the following reasons:

Repeated verification that all applicable method QC requirements have
been followed, when in fact they have not all been met;

Repeated failure to document acceptable OPR values prior to analysis of
LT2ESWTR samples;

Reporting PT data from another laboratory as its own;

Falsification of data or other deceptive practices, including false
verification that data submitted to the Data Collection and Tracking
System (DCTS) were generated using approved methods and met all method
QA/QC criteria; 

Refusal or failure to participate in on-site or off-site evaluations
conducted by the Approval Authority.

Basis for Suspending Provisionally Approved Status

Failure to provide a letter to the Approval Authority within 30 days
that adequately explains what immediate corrective actions were taken;

Failure to identify and correct problems in response to downgrade within
30 days;

Failure to provide accurate OPR control charts to the Approval
Authority;

Failure to submit valid PT results for the next two consecutive
authorized PT test events within the acceptance limits specified;

Continued failure to use the analytical methodology specified in the
regulations;

Failure to correct deviations identified during an on-site evaluation
within 30 days; 

Failure to provide requested demonstration, materials and documentation
within 30 days, including: 

Acceptable matrix spike recoveries for all method variations per Section
9.1.2 of the method; 

Bench sheets, examination forms or OPR charts for any samples requested;


Remote analyst verification; 

Recent positive staining control and OPR microscope slides, one of each;


Blind slide counts for each analyst.

Procedures for Suspension

The Approval Authority will notify the laboratory, in writing, of its
intent to suspend approval.  If the laboratory wishes to request
reconsideration of this decision, it should submit such a request in
writing to the Approval Authority within 30 days of receipt of the
notice of intent to suspend approval.  The laboratory will generally be
downgraded immediately to “Provisional Approval” in the interim
while the suspension is being considered.  If no request for
reconsideration is filed, approval will be suspended. 

The request for reconsideration should be supported with an explanation
of the reasons for the challenge and should be signed by a responsible
official from the laboratory, such as the president/owner for a
commercial laboratory, the laboratory supervisor of a municipal
laboratory, or the laboratory director for a State or Regional
laboratory.

The Approval Authority will make a decision and notify the laboratory in
writing, generally within 30 days of receipt of the request for
reconsideration.  If the request is determined to be valid, the Approval
Authority will take appropriate measures to reevaluate the facility and
notify the laboratory, in writing, of its decision, generally within 60
days of the reevaluation. 

Denial of the request will generally result in suspension of the
laboratory’s approval.  Once approval is suspended, a public water
system may not use the laboratory to analyze source water samples for
compliance with LT2ESWTR source water monitoring requirements.  The
laboratory should notify its clients that it is no longer approved and
will not accept any more LT2ESWTR samples for analysis.

Upgrading or Reinstatement of Approval

Subject to the availability of resources, the Approval Authority will
consider written requests from the laboratory to seek upgrading or
reinstatement of approval.  Requests should state the reasons why the
laboratory should regain its approval status. The laboratory should
demonstrate that all deficiencies have been corrected and successfully
complete two consecutive authorized PT test events within acceptance
limits for Provisionally Approved laboratories or three consecutive
authorized PT test events within acceptance limits for suspended
laboratories.  The authorized PT test events being described here are
those submitted to all laboratories in the Lab QA Program, not special
issue blind samples purchased independently from the vendor.  The
laboratory should provide evidence why the reasons for downgrading or
suspension are no longer applicable and explain its technical
competence.  Acceptable demonstration of technical competence may
include an on-site evaluation and/or any other measure the Approval
Authority deems appropriate.  The Approval Authority will consider
compliance history, corrective actions implemented by the laboratory,
effectiveness of corrective actions, and professional judgment of the
Approval Authority.

Grievances

Laboratories with grievances during the authorized PT events or
regarding participation in the Lab QA Program should immediately contact
the Program Manager at the Approving Authority and try to remedy the
problem.  When the laboratory feels they have not gotten immediate or
satisfactory results, they should contact the supervisor at the
Approving Authority.  The management at the Approving Authority will
work with the Program Manager to quickly address grievances.  A final
decision for all grievances will be made generally within 30 days of
contacting the Approving Authority. 

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