IN THE MATTER
OF
Howard A. Zucker, M.D., J.D., as First Deputy
Commissioner of Health, and Acting Commissioner,
to determine the action to be taken with respect to:
PACE ANALYTICAL SERVICES, INC.
STIPULA11ON
2190 Technology Drive
Schenectady, New York 12309
AND
Respondent,
ORDER
arising out of alleged violations of Article 5, Title I of the
Public Health Law of the State of New York and Title 10
(Health) of the Official Compilation of Codes, Rules and
Regulations of the State at New York (NYCRR).
WHEREAS, the New York State Department of Health (the Department) has made
findings based upon the investigation of Pace Analytical Services, Inc. (the Respondent);
and
WHEREAS, the Departments investigatory findings included alleged violations of
ArticJe 5. Titie I of the Public Health Law of the State of New York (PHL) and Part 55 of 10
NYCRR by the Respondent; and
WHEREAS, the Department and the Respondent have engaged ri settlement
discussions: and
WHEREAS, the parties wish to resolve this matter by means of a settlement instead
of an adversarial administrative hearing and/or litigation; and
WHEREAS, Respondert has ccoperated with the Department and, among other
things, is providing written notification to its customers with regard to the matters giving rise
to this settlement; and
I
WHEREAS, the Departments investigation found that acts gMng rise to the violations
were initially the result of practices of Paces predecessor, Northeast Analytical, Inc. (74EA).
NOW, THEREFORE 1 IT IS STIPULATED AND AGREED AS FOLLOWS:
1. The Respondent acknowledges that the Department has jurisdiction in this
matter.
2. This matter Is settled and discontinued with prejudice. The Department shall
not pursue further administrative or civil enforcement action against the Respondent in
connection with the allegations of violating 502(2) of the PHL and Part 55 of 10 NYCRR
as set forth in paragraph 3 below.
3. Investigative Findings:
a. The Department finds and the Respondent admits that in violation of
502(2) of the PHL and 10 NYCRR 55-22(c), the Respondent and NEA, which the
Respondent acquired on or about November 1, 2010, failed to ensure that their laboratory
examinations performed at 2190 Technology Drive, Schenectady, New York (Schenectady
slt&) conformed to certain conditions under which their certificates of approval were granted,
as evidenced by repeat non-conformance observed during on-site assessments held on
March 12. 2009, March 17, 2011, and May 2,2013.
b. These onsite assessments determined that NEA, between the dates of
February 9, 2006 and October 29, 2010, and the Respondent, between the dates of
November 1, 2010 through August 29, 2013, failed to employ the approved method EPA
SW846 3520, as listed on the laboratories certificates of approval for the Schenectady site,
to conduct analyses on samples reported by NEA on 1772 reports submitted to clients, and
by the Respondent on 941 reports submitted to clients.
a Spe&icaliy, the method EPA-SW846 3520 requires the use of a
2
water-misc4bsolvent (e.g., acetone or methanol) for a spiking solution to assess the efficacy
of the exiractiori procedure prior to performing extraction of the analytes. The Respondent
and NEA. however did not use a water miscible solvent in performing their EPA-5W646 3520
tests, but Instead used an Immiscible solvent (e.g., hexane), which may have resulted in an
under-reporting of the arialyte(s) recovered in the sample(s) NEA End the Respondent
reported to their clients.
4. Pursuant to