Mar 7 2008 13:15 MAR-B7-2088 13:46 _— HCA STATE OF FLORIDA DEPARTMENT OF HEALTH DEPARTMENT OF HEALTH, PETITIONER, Vv. CASE NO. 2005-58388 DONNA MECHEL WHITAKER, RESPONDENT. Soe ADMINISTRATIVE COMPLAINT COMES NOW, Petitioner, Department of Health (Department), by and through its undersigned counsel, and files this Administrative Complaint before the Board of Clinical Laboratory Personnel (Board) against Respondent, Donna Mechel Whitaker, and in support thereof alleges: 4. Petitioner is the state 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. 2. At all times material to this Complaint, Respondent was a licensed clinical laboratory technologist within the state of Florida, having been issued license number JC 37034. ma:ot ¢t M : MAR-B?-2688 13:46 AHCA ar #2008 iss oy 3. Respondent’s address of record is 293 County Road 44, Hartford, Alabama, 36344. 4. At all times material to the allegations in this Administrative Complaint, Respondent was employed as a technologist at Doctor's Memorial Hospital (‘Memorial’) in Bonifay, Florida. Facts involvi otal ir in 5. In September 2004, Memorial utilized the Synchron CX9 to test the Total Bilirubin levels in patients. 6. Memorial utilized no back-up analyzer. As a result, the only way Total Bilirubin levels could be analyzed at Memorial was the Synchron Cx9, 7. On September 28, 2004, the on board calibration for Total Bilirubin for the Synchron CX9 expired and required recalibration. 8. It was determined that the reagent used for the calibration of the machine was improperly reconstituted. , 9. As a result, the Synchron CX9 could not be used for Total Bilirubin analysis until new reagent was acquired. 10. The machine would not have been able to run the test for Total Bilirubin without the appropriate reagent. DOH v, Whitaker, 2005-58388 2 Administrative Complaint J:\PSU\Nursing\Simon\Board-Ciinical Laboratory Personnel\Whitaker, Donna\AC.doc.doc M : MAR-S?-2688 13:47 AHCA ar #2008 iss oN 11. All patient samples were put aside in a refrigerator for a time when future Total Bilirubin testing could be conducted. 42. While the Synchron CX9 was unable to be utilized for Total Bilirubin analysis, Respondent reported analyzing the Total Bilirubin levels on at Jeast ten patients. | 13. Respondent was unable to have conducted the Total Bilirubin analysis on any patients in that the only machine utilized to perform this test at Memorial was inoperable for this test. 14. .As a result, Respondent reported test results on at least ten patients when the test had not been conducted. Facts involving Patient M.H. 145. On or about January 29, 2005, an order for a chemistry profile was initiated for. Patient M.H. 16. At approximately 6:00 a.m., on or about January 29, 2005, the chemistry profile for Patient M.H. was completed by Respondent. 17. The results of the chemistry profile weré questioned by nursing staff as the-patient-had_been.on hourly.glucose.monitoring and the results __teported included a glucose level inconsistent with prior reports. DOH v. Whitaker, 2005-58388 3 Administrative Complaint J:\PSU\Nursing\Simon\Board-Clinical Laboratory Personnel\Whitaker, Donna\AC.doc.doc MAR-G?-2888 12:47 AHCA Mere aone. teete 18. Asa result of the questionable levels, at approximately 6:45 a.m., on or about January 29, 2005, the Respondent re-drew blood from Patient M.H. and provided a new sample for the chemistry profile. 19. A report was submitted by another technologist, based upon the new sample, in approximately thirty minutes. 20. Respondent canceled the original report, which canceled the - results of the originally run chemical profile. 21. The policies and procedures at Memorial required a label of any cancelled order to be placed in the logbook. ) -22.. A label of the cancelled order was not placed in the patient logbook. 23. Respondent did not create a corrected report. . 24... The .policies. .and..procedures at the Clinical Laboratory at Memorial. indicate that that. Respondent. should have created a corrected report, and not canceled the original one. 25. A reasonably prudent technologist under similar conditions and __-elreurmstances—would -have_taken. the-original sample drawn from Patient M.H. and re-run the test and compared the results with the original report. DOH v. Whitaker, 2005-58388 4 Administrative Complaint J:\PSU\Nursing\SImon\Board-Clinieal Laboratory Personnel\Whitaker, Donna\AC.doc.doc Mar 7 2008 13:16 MAR-G?-2888 13:47 _ ARCA 26. A reasonably prudent technologist under similar conditions and circumstances would have provided a corrected/modified report with any discrepancies from a previous test and would have clearly labeled the test as a corrected report. Facts involving Patient K.G. 27, At approximately 11:30 a.m., on or about March 9, 2005, a Complete Blood Count (“CBC”) was ordered for Patient K.G. | 28. Onor about March 9, 2005, Respondent completed the CBC for Patient K.G. during her shift at Memorial. 29. The results of the CBC were reported and placed on Patient K.G/s chart. 30. On or about March 11, 2005, a new CBC was analyzed for _ Patient KG. _ 31. The new CBC resulted in an analysis of abnormal or immature cells, which indicated that Patient K.G. was seriously ill, . 32, The new CBC raised ‘questions among health care personnel at __.the facility_as to why the cells were not discovered when the first CBC was conducted. DOH v. Whitaker, 2005-58388 5 Administrative Complaint 2:\PSU\Nursing\Simon\Board-Clinical Laboratory Personnel\whltaker, Donna\AC.doc.dec Mar 7 2008 13:16 MAR-G?-2888 13:48 AHCA 33. At approximately 8:00 a.m., on or about March 11, 2005, after the results of abnormal or immature cells appeared, Respondent canceled the original order from March 9, 2005, for the CBC for Patient K.G. and created a new order. 34. A label-of the-cancelled “order ‘was not placed in the patient logbook. 35. Respondent then transferred the results from the March 9, 2005, CBC, to respond to Respondent's newly created order for a CBC on March 11, 2005. | 36. Respondent put another laboratory employee's name and password on the “modified” test results. 37. Respondent's actions resulted in the appearance of another laboratory employee analyzing the CBC for Patient K.G. on March 11, 2005, when, in fact, Respondent created the report. 38. Respondent intentionally placed another laboratory employee's nameé and password on the “modified” CBC to make it appear as if the other. laboratory employee analyzed the results. 39. Respondent removed the results of the original CBC from Patient K.G.’s chart and replaced them with the “modified” report DOH v. Whitaker, 2005-58388 6 Administrative Complaint 3:\PSU\Nursing\Simon\Board-Clinical Laboratory Personnel\Whitaker, Donna\AC.doc.doc Mar 7 2008 13:16 MAR-G?-2888 13:48 AHCA documented to have been completed at approximately 8:13 a.m. on March 11, 2005. 40. The policies and procedures at Memorial require Respondent not to have removed the report from Patient K.G,s chart. 41. The laboratory report containing the original CBC results analyzed on March 9, 2005, was subsequently found in various laboratory “shred” boxes. 42, The policies and procedures at Memorial indicate that an incorrect report should never be removed from a patient's record. COUNT ONE 43. Petitioner realleges and incorporates paragraphs one (1) through forty-two (42) as if fully set forth herein. 44. Section 483.825(1}(c), Florida Statutes (2004), provides that demonstrating incompetence or making consistent errors in the -performance of clinical laboratory examinations or procedures or erroneous reporting constitutes grounds for disciplinary action by the Board of Clinical Laboratory Personnel. DOH v. Whitaker, 2005-58388 7 Administrative Complaint © J:\P5U\Norsing\Simon\Board-Clinical Laboratory Personnel\Whitaker, Donna\AC.doc.doc Mar * 2008 13:17 MAR-@7-2668 13:48 AHCA on 45. Respondent demonstrated incompetence or made consistent errors in the performance of clinical laboratory examinations or procedures or erroneous reporting on one or more of the following occasions: a. Reporting that another laboratory employee had conducted a-CBC for Patient K,G.- when: the Respondent, herself, had analyzed the test; b. Reporting the results of Patient M.H.'s chemistry profile without reporting that the results were of a second test; c. Failing to identify Patient M.H.'s chemistry profile to indicate _ that the report was modified/corrected; d. Removing the results of the original CBC from Patient K.G.'s chart and replacing them with the “modified” report. 46. Based on the foregoing, Respondent has violated Section 483.825(1)(c), Florida Statutes (2004), by. demonstrating incompetence or making consistent errors in the performance of clinical laboratory éxaminations or procedures or érraneous reporting. __- __...... COUN 47. Petitioner realleges and incorporates paragraphs one (1) —through forty-two (42) as if fullyset forth herein: DOH v, Whitaker, 2005-58388 8 Administrative Complaint J:\PSU\Nursing\Simon\Board-Clinical Laboratory Personnel\Whitaker, Donna\AC.doc.doc Mar 7 2008 13:17 MAR-G?-2888 13:49 ak AHCA , P.1a 48. Section 483.825(1)(p), Florida Statutes (2004), provides that making or filing a report which the licensee knows to be false constitutes grounds for discipline by the Board of Clinical Laboratory Personnel. 49. Respondent made or filed a report which. she new to be false when she did one or more of the following: | a. Reported that another laboratory employee had conducted a CBC for Patient K.G. when the Respondent, herself, had analyzed the test; b. Reported the results of Patient M.H.s chemistry profile without reporting that the results were of a second test; c. Failed to identify Patient M.H.s chemistry profile to indicate that the report was modified/corrected. 50. Based on the foregoing, Respondent has violated Section 483.825(1)(p), Florida Statutes (2004), in that she made or filed a report which she knew to be false. COUNT THREE 51. Petitioner realleges and incorporates paragraphs one (1) through forty-two (42) as if fully set forth herein. DOH v, Whitaker, 2005-58388 9 Administrative Complaint 1.\PSU\Nursing\Simon\Board-Clinical Laboratory Personnel\Whitaker, Donna\AC.doc.doc Mar 7 2008 13:17 MAR-G?-2888 13:49 AHCA P.il 52. Section 483.825(1)(w), Florida Statutes (2004), provides that violating any provision of this chapter or chapter 456, or any rules adopted pursuant thereto, constitutes grounds for disciplinary action by the Board of Clinical Laboratory Personnel. 53. Rule 64B3-13.003(2)(b), Florida Administrative Code, provides that a licensee must follow the clinical laboratory's procedures for specimen handling and processing, test analyses, reporting and maintaining records of patient test results. 54. Respondent failed to follow the clinical laboratory's procedures for specimen handling and processing, test analyses, reporting and maintaining records of patient test results when she did one or more of the following: a. Failed to place a label of the canceled order regarding Patient K.G,; b. Failed to place a label of the canceled order regarding Patient M.H.; c, Removed the report from Patient K.G.’s record. 55. Based on the foregoing, Respondent has violated Section 483.825(1)(w), Florida Statutes (2004), in that she violated Rule 64B3- DOH v. Whitaker, 2005-58388 10 Administrative Complaint J;\PSU\Nursing\SImon\Board-Ginical Laboratory Personnel\Whitaker, Donna\aC.dac.doc MAR-?-26H8 13:49 AHCA fox Mar 7 2008 13:18 P.i2 13.003(2)(b), Florida Administrative Code by failing to follow the Memorial’s clinical laboratory's procedures for specimen handling and processing, test analyses, reporting or maintaining records of patient test results made. WHEREFORE, the 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 Respondent on probation, corrective action, refund of fees billed or collected, remedial education --and/or-any other relief-that-the Board-deems appropriate. le | SIGNED this__|\~_ day of (Sacem bet , 2004. PERE oxennshUnLO we 1220/2 DATE, DOH y, Whitaker, 2005-38388 Administrative Complaint M. Rony Frangois, M.D., M.S.P.H., Ph.D. Secretary, Department of Health 4 Ellen M. Simon Assistant General Counsel DOH Prosecution Services Unit 4052 Bald Cypress Way, Bin C-65 Tallahassee, FL. 32399-3265 Florida Bar # 0976792 (850) 245-4640--.. -— (850) 245-4683 FAX J:\PSU\Nursing\Stmon\Board-Clinical Laboratory Personnel\Whitaker, Donna\AC.doc.dac Mar 7 2008 13:18 MAR-G?-2888 13:49 AHCA pce: JA/I! /o b PCP Members: Tysihve Caold be i, 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 Respondent in addition to any other discipline imposed. DOH v. Whtiaker, 2005-58388 42 Administrative Complaint 7:\PSU\Nursing\Simon\Board-Clinical Laboratory Personnel\Whitaker, Donna\AC.doc.doc

Docket for Case No: 08-001156PL