STATE OF FLORIDA 10 tee AGENCY FOR HEALTH CARE ADMINISTRATION iny | STATE OF FLORIDA, OY D0 \ AGENCY FOR HEALTH CARE ADMINISTRATION, ‘Oo PH 3: 43 Petitioner, Case No.: 2008003638 vs. BERT FISH MEDICAL CENTER, INC., d/b/a BERT FISH MEDICAL CENTER CLINICAL LABORATORY, Respondent. ADMINISTRATIVE COMPLAINT COMES NOW the Agency for Health Care Administration (hereinafter Agency), by and through the undersigned counsel, and files this Administrative Complaint against, BERT FISH MEDICAL CENTER, INC., d/b/a BERT FISH MEDICAL CENTER CLINICAL LABORATORY (hereinafter “Respondent”) and alleges: NATURE OF THE ACTION This is an action to impose a fine in the amount of one thousand dollars ($1,000) pursuant to Section 483.221(1), Florida Statutes (2007) for one identified deficient practice. JURISDICTION AND VENUE 1. The Agency has jurisdiction pursuant to Section 120.569 and 120.57, Fla. Stat. (2007) and Chapter 28-106, Florida Administrative Code. 2. Venue lies in Volusia County pursuant to Fla. Admin. Code R. 28-106.207, and Chapter 28, Florida Administrative Code. PARTIES 3. The Agency is the regulatory authority responsible for licensure of clinical laboratories licensure law pursuant to Chapters 408, Part II and 483, Part I, Florida Statutes and Chapter 59A- 7, Florida Administrative Code. 4. Respondent is a facility located at 401 Palmetto Street, New Smyrna Beach, FL 32168. Respondent, is and was at all times material hereto, a licensed laboratory under Chapters 408, Part IT and 483, Part I, Florida Statutes and Chapter 59A-7, Florida Administrative Code, having been issued license number 800000132. 5. Respondent was at all times material hereto a licensed under the licensing authority of the Agency, and was required to comply with all applicable rules, and statutes COUNT I 6. The Agency re-alleges and incorporates (1) through (5) as if fully set forth herein. 7. That pursuant to Florida law, each laboratory performing testing must employ and maintain a system that provides for proper patient preparation; proper specimen collection, identification, preservation, transportation, and processing; and accurate result reporting. This system must assure patient specimen integrity and positive identification throughout the pre- analytic (pre-testing), analytic (testing), and post-analytic (post-testing) processes and must meet the standards of this subpart as they apply to the testing performed. Records, reports and test requisitions are authorized to be stored off the immediate laboratory premises so long as they are available to the laboratory within twenty four hours. Rule 59A-7.028(1), Florida Administrative Code. 8. That the Petitioner completed a Complaint Survey (CCR #2008000353) of the Respondent on January 11, 2008. 9. That based upon a review of records and staff interview, Respondent failed to ensure that proper specimen collection procedure was employed and maintained for a patient, said failure resulting in the patient receiving the wrong blood type during a transfusion, the same being contrary to the requirements of law. 10. That the Petitioner’s representative interviewed Respondent’s staff during the survey who indicated as follows: 11. a. That the process for collecting blood specimens for type and cross match in preparation for blood transfusion involves using two (2) patient identifiers such as name and date of birth and copying the medical record number from the patient identification band after the blood is drawn; That the rewriting or transcribing of the patient's medical record number from the identification band is used as a second check to ensure that the medical record number on the preprinted label matches the medical record number that is on the patient's arm band. That the Petitioner’s representative reviewed Respondent’s policy and procedure entitled “Blood Bank Specimen Collections,” revised October 15, 2007, which provides as follows: a. The phlebotomist will compare both the top label and the blood bank label against the patient's armband and that the phlebotomist will hand write the medical record number on the tube; The phlebotomist will take special care to identify the patient when drawing a blood bank specimen using a minimum of two identifiers; Two identifiers will be used to label sample collection containers in the presence of the patient. 12. That the Petitioner’s representative reviewed Respondent’s records regarding patient number one (1) during the survey and noted as follows: a. That the patient was transfused with the incorrect blood type following a surgical procedure; That Respondent was responsible for the collection of a blood sample from patient number one (1) on December 18, 2007, said sample to be typed and cross matched by Respondent for the identification of blood products to be transfused during a planned surgery of the patient on December 29, 2007; That the Respondent’s Policy and Procedure as above addressed was not followed by Respondent’s staff when a blood sample was obtained from patient number one (1) for blood type and cross match prior to the patient’s scheduled surgery; The Respondent’s staff person that drew the blood for the above-referenced testing for patient number one (1) did not transcribe the medical record number from the patient's armband to the blood tube label; Although the name on the blood collection tube was that of patient number one (1), the blood that was drawn, in the tube, and tested was actually drawn from another patient; That as a result of the collected sample not being that of patient number one (1), typing and cross match was incorrect and correspondingly incorrect blood product was obtained and utilized during the scheduled surgery of patient number one (1) on December 29, 2007; Patient number one (1) was transfused with blood that had been typed and cross matched by Respondent based upon testing results of blood that was drawn on December 18, 2007; h. Patient number one (1) suffered an adverse reaction to the blood transfusion as the blood type did not match that of the patient and the patient expired the day of surgery, December 29, 2007. 13. That the above reflects the Respondent’s failure to employ and maintain a system that provides for proper patient specimen collection, identification, preservation, transportation, and processing; and accurate result reporting assuring patient specimen integrity and positive identification throughout the pre-analytic (pre-testing), analytic (testing), and post-analytic (post- testing) processes where blood drawn for the purposes of blood type and cross matching for use in a planned surgical procedure was not drawn from the correct patient, where Respondent failed to employ its systems to provide for proper secimen collection thereby resulting in the incorrect type of blood being administered to the patient. 14. That the agency may impose an administrative fine, not to exceed one thousand dollars ($1,000.00) per violation, for the violation of applicable rules, with each day of violation constituting a separate violation and subject to a separate fine. Section 483.221(1), Fla. Stat. (2007). 15. That in determining the penalty to be imposed, the agency must consider, inter alia, the severity of the violation, actions taken by the licensee to correct the violation, any previous violations by the licensee, and the financial benefit to the licensee of committing or continuing the violation. Section 483.221(b), Fla. Stat. (2007). 16. That the above referenced violation constitutes grounds for the Petitioner agency to impose a fine against the Respondent. 17. That the Petitioner agency seeks to impose an administrative fine against the Respondent in accord with law. WHEREFORE, the Agency intends to impose an administrative fine in the amount of $1,000.00 against Respondent of the State of Florida, pursuant to § 438.221, Fla. Stat. (2007). Respectfully submitted this G day of April, 2008. LL / Counsel for Petitioner Agency for Health Care Administration 525 Mirror Lake Drive, 330G St. Petersburg, FL 33701 727.552.1525 (office) 727.552.1440 (fax) Respondent is notified that it has a right to request an administrative hearing pursuant to Section 120.569, Florida Statutes. Respondent has the right to retain, and be represented by an attorney in this matter. Specific options for administrative action are set out in the attached Election of Rights. All requests for hearing shall be made to the Agency for Health Care Administration, and delivered to Agency Clerk, Agency for Health Care Administration, 2727 Mahan Drive, Bldg #3,MS #3, Tallahassee, FL 32308;Telephone (850) 922-5873. RESPONDENT IS FURTHER NOTIFIED THAT THE FAILURE TO REQUEST A HEARING WITHIN 21 DAYS OF RECEIPT OF THIS COMPLAINT WILL RESULT IN AN ADMISSION OF THE FACTS ALLEGED IN THE COMPLAINT AND THE ENTRY OF A FINAL ORDER BY THE AGENCY. CERTIFICATE OF SERVICE I HEREBY CERTIFY that a true and correct copy of the foregoing has been served by U.S. Certified Mail, Return Receipt No. 7007 1490 0001 6979 0789 on April _{-€ 2008 to Arthur J. Botting, Administrator, Bert Fish Medical Center Clinical Laboratory, 401 Palmetto Street, New Smyrna Beach, FL 32168 and by U.S. Mail to James F. Heekin, Jr, Registered Agent, Bert Fish Medical Center, Inc., 215 North Eola Drive, Orlando, Florida 32701. g5. tes II, Esquire Copies furnished to: Arthur J. Botting, Administrator Bert Fish Medical Center Clinical Laboratory 401 Palmetto Street New Smyrna Beach, FL 32168 (U.S. Certified Mail) James F. Heekin, Jr, Registered Agent Bert Fish Medical Center, Inc. 215 North Eola Drive Orlando, Florida 32701 (U.S. Mail) Nancy Marsh, Field Office Manager Agency for Health Care Administration Building A, Suite 115 921 North Davis Street Jacksonville, Florida 32209 (U.S. Mail) Thomas J. Walsh, II, Esquire Agency for Health Care Admin. 525 Mirror Lake Drive, #330G St. Petersburg, FL 33701 (Interoffice Mail) COMPLETE THiS SECTION ON DELIVERY A. Signatur x OC Cth, By Received by Printed Name} ™ Complete items 1,2,a Also complete » _ item 4 if Restricted Delivery Is desired, ® Print your name and address on the reverse So that we can return the card to you. ™ Attach this card to the back of the mailpiece, Or on the front if space Permits. 1. Article Addressed to: on Date of Delivery “ aks Os” D. Is delivery address different from item 1? ‘DO Yed If YES, enter delivery address below: CINo Arthur J. Botting, Administrator Bert Fish Medical Center Clinical Laboratory 401 Palmetto Street New Smyrna Beach, FL 32168 3. Service Type . 0 Certified Mall express Mail Cl Registered O Return Receipt for Merchandise OC insured Mait Ocop. 4 Restricted Delivery? (Extra Fee) O Yes 2. Arti T (ira 7007-1490 ooo 6779 O784 , PS Form 3811, February 2004: Domestic Return Receipt 102595-02-M-1540

Docket for Case No: 08-002401