ADMINISTRATIVE COMPLAINT
Petitioner, Department of Health, by and through undersigned counsel, files this Administrative Complaint before the Board of Clinical Laboratory Personnel against, Merdis Price, J.C., and in support thereof alleges:
Petitioner is the st.ate department charged with regulating the practice of clinical laboratory personnel pursuant to Section 20.43, Florida Statutes; Chapter 456, Florida Statutes; and Chapter 483, Florida Statutes.
At all times material to this Complaint, Respondent was a clinical laboratory technician (J.C.) and clinical laboratory supervisor within the state of Florida, having been issued license number JC 2745232 and SU 22356.
3, Respondent's address of record is P.O. Box 292515, Tampa, Florida
33687.
At all times material to this Complaint, Respondent was employed at the Florida Department of Health/Tampa Serology Department ("TSD") as a clinical
laboratory supervisor with qualifications in chemistry, hematology, and
. immunuohematology.
On or about April 28, 2008, Respondent was on duty at TSO and responsible for performing laboratory procedures.
On or about April 28, 2008, Respondent was the operator of the Gen-
Probe Tigris© DTS System employing nucleic acid testing for identification of neisseria gonorrhea and Chlamydia trachomatis in patient samples.
As part of the procedure for the operation of the Gen-Probe Tigris© DTS System, an inventory will stop (fails) when a reagent lot number is not correctly scanned into the system and the bar code is not recognized. When an error occurs, an error message will appear on the monitor to notify the operator of the error. With the alert, the operator of the Gen-Probe Tigris© DTS System may do a physical inventory of reagents to ascertain if the correct lot numbers from kits are employed.
On or about April 28, 2008, Respondent scanned in the new master
barcodes for the new lot of reagents because the barcodes of the reagents on the instruments were not recognized.
On or about April 29, 2008, TSD staff noticed that there was a discrepancy in the numbers of the reagents for the lots done on April 28, 2008.
On or about April 29, 2008, Respondent admitted to TSO staff that the discrepancy was due to the number of reagents in the new and old lots and that she mistakenly entered the new master lot code into the Gen-Probe Tigris© DTS System.
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Respondent was advised by her employer to contact the manufacturer for testing validity.
On or about April 29, 2008, Respondent informed TSD staff that the Gen-
Probe technical consultant stated that the "tests would be okay".
On or about April 29, 2008, TSD staff contacted Gen-Probe Tigris© DTS System manufacturer and was advised by the technical consultant that Gen-Probe could not guarantee testing reliability when testing occurs outside the manufacturer's recommended testing instructions.
TSD staff rejected and retested the 442 samples done on April 28, 2008, by the Respondent. Three (3) of the patient samples which were originally reported negative, with subsequent testing, tested positive.
COUNT I
Petitioner realleges and incorporates paragraphs one (1) through thirteen
(13) as if fully set forth herein.
Section 483.825(1)(c), Florida Statutes (2007), states that demonstrating incompetence or making consistent errors in the performance of clinical laboratory examinations or procedures or erroneous reporting, constitutes grounds for discipline.
Respondent failed to properly operate the Gen-Probe Tigris© DTS System, which resulted in testing result errors that could have affected the health and safety of patients.
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Based on the foregoing, Respondent violated Section 483.82S(l)(c), Florida Statutes (2007), for demonstrating incompetence or making consistent errors in the performance of clinical laboratory examinations or procedures or erroneous reporting.
COUNT II
Petitioner realleges and incorporates paragraphs one (1) through thirteen
(13) as if fully set forth herein.
Section 483.825(1)(p), Florida Statutes (2007), states making or filing a report which the licensee knows to be false, constitutes grounds for discipline.
Respondent reported testing results to TSD on patient samples performed on April 28, 2008, which the Respondent knew or should have known, to be in error or inaccurate.
Based on the foregoing, Respondent 483.825(1)(p), Florida Statutes (2007), for making or filing a report which the licensee knows to be false.
COUNT III
. 23. Petitioner realleges and incorporates paragraphs one (1) through thirteen
(13) as If fully set forth herein.
Section 483.825(1)(w), Florida Statutes (2007), states violating any provision of this chapter, or chapter 456, or any rules adopted pursuant thereto, is grounds for discipline.
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Rule 64B3-13.002(2)(i), F.A.C., provides that a licensee assures that all remedial actions are taken whenever test systems deviate from the clinical laboratory's established performance specifications.
Respondent failed to ensure remedial actions took place on April 28, 2008,
when there was an error with the Gen-Probe Tigris© DTS System.
Based on the foregoing, Respondent violated Section 483.825(1)(w), Florida Statutes (2007), for violating any provision of this chapter, or chapter 456, or any rules adopted pursuant thereto, by violating Rule 6483-13.002(2)(i), F.A.C., for failing to assure that all remedial actions are taken whenever test systems deviate from the clinical laboratory's established performance specifications.
Petitioner realleges and incorporates paragraphs one (1) through thirteen
(13) as if fully set forth herein.
Section 483.825(1)(w), Florida Statutes (2007), states violating any provision of this chapter, or chapter 456, or any rules adopted pursuant thereto, is grounds for discipline.
Rule 6483-13.003(2)0), F.A.C., provides that licensee should ensure that patient test results are not reported until all corrective actions have been taken and the test system is properly functioning.
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Respondent notified her employers at TSD that the patient sample test results of April 28, 2008 were properly reported, without making corrective actions with the Gen-Probe Tigris© DTS System.
Based on the foregoing, Respondent violated Section 483.825(1)(w), Florida Statutes (2007), by violating Rule 64B3-13.003(2)(.j), F.A.C., for failing to ensure that patient test results are not reported until all corrective actions have been taken and the test system is properly functioning.
WHEREFORE, Petitioner respectfully requests that the Board of Clinical Laboratory Personnel enter an order imposing one or more of the following penalties: permanent revocation or suspension of Respondent's license, restriction of practice, imposition of an administrative fine, issuance of a reprimand, placement of the license on probation, corrective action, refund of fees billed or collected, remedial education
and/or any other relief that the Board deems appropriate.
lwT.
1.u,\/\ - l'l
Dr. Ana M. Viamonte Ros, M.D., M.P.H. State Surgeon General
FILED
DEPARTMENT OF HEALTH
Anntionette Smith Assistant General Counsel
DOH Prosecution Services Unit 4052 Bald Cypress Way, Bin C-65 Tallahassee, FL 32399-3265
Florida Bar# 0615951
(850) 245,4640 PHONE
CLERK
DEPUTY CLERK
Rq,chcl,'Broo4,
(850) 245-4683 FAX
DATE / · d("; .QCj
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AKS
PCP; 1/ 11p/ ac1
PCP Memb rs:
Dohanue & Barr
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NOTICE OF RIGHTS
Respondent has the right to request a hearing to be conducted in accordance with Section 120.569 and 120.57, Florida Statutes, to be represented by counsel or other qualified representative, to present evidence and argument, to call and cross-examine witnesses and to have subpoena and subpoena duces tecum issued on his or her behalf if a hearing is requested.
NOTICE REGARDING ASSESSMENT OF COSTS
Respondent is placed on notice that Petitioner has incurred costs related to the investigation and prosecution .of this matter. Pursuant to Section 456.072(4), Florida Statutes, the Board shall assess costs related to the investigation and prosecution of a disciplinary matter, which may include attorney hours and costs, on the in addition to any other discipline imposed.
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