Florida Family Laboratory, Inc Dba

Summary Statement of Deficiencies D0000 An unannounced complaint survey (#2020014101) was conducted on 09/14/20 - 09/21 /20 at Florida Family Laboratory Inc. DBA Lab 24. The facility was not in compliance with 42 CFR 493, Requirement for clinical laboratories. The following Conditions were cited: D3000 Facility Administration 493.1100 D5300 Preanalytic Systems 493.1240 D5800 Postanalytic Systems 493.1290 D6076 Laboratory Director 493.1441 D3000 FACILITY ADMINISTRATION CFR(s): 493.1100 Each laboratory that performs nonwaived testing must meet the applicable requirements under 493.1101 through 493.1105, unless HHS approves a procedure that provides equivalent quality testing as specified in Appendix C of the State Operations Manual (CMS Pub. 7). This CONDITION is not met as evidenced by: Based on record review and interview with the Office Manager the laboratory failed to follow the State of Florida Emergency Rule to report all positive and negative COVID-19 test results immediately to the Department Of Health (DOH) for 27 out of 27 Patient reports reviewed (See D3009). D3005 FACILITIES CFR(s): 493.1101(a)(3) Molecular amplification procedures that are not contained in closed systems have a uni-directional workflow. This must include separate areas for specimen preparation, amplification and product detection, and, as applicable, reagent preparation. This STANDARD is not met as evidenced by: Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 8 -- Based on observation and interview with the Technical Supervisor the laboratory failed to have a uni-directional workflow for the molecular COVID-19 testing. Findings Included: During a tour of the laboratory on 09/15/20 at 10:28 AM it was observed the workflow of the molecular COVID-19 testing. The extraction was performed in one room, then carried thru 2 doors, the accessioning room, thru another door to the hood for the DNA mix. Then the specimens were carried back to the accessioning room to centrifuge then back thru a door to the instrument to read. This was not a uni-directional workflow. Interview on 09/17/20 at 5:30 PM the Technical Supervisor confirmed that the molecular COVID-19 testing did not have a uni- directional workflow. D3009 FACILITIES CFR(s): 493.1101(c) The laboratory must be in compliance with applicable Federal, State, and local laboratory requirements. This STANDARD is not met as evidenced by: Based on record review and interview with the Office Manager the laboratory failed to follow the State of Florida Emergency Rule to report all positive and negative COVID-19 test results immediately to the Department Of Health (DOH) for 27 out of 27 Patient reports reviewed. Findings Included: Review of the State of Florida Emergency Rule 64DER20-18 (64D-3.029) states that all positive and negative COVID-19 test results need to be reported immediately. According to 64D-3.029 Diseases or Conditions to be Reported, "Immediately" is defined as "Reportable condition of urgent public health importance. Report without delay upon the occurrence of any of the following: an indicative or confirmatory test, findings indicative thereof, or diagnosis. Reports that cannot timely be made during the County Health Department business day shall be made to the County Health Department after hours duty official." Review of 27 Patient reports revealed the following: 1- Patient tested on 08/11/20 and reported to the DOH on 08/24/20. 2- Patient tested on 08/13/20 and not reported to the DOH. 3- Patient tested on 08/13/20 and reported to the DOH on 08/24/20. 4- Patient tested on 08/17/20 and reported to the DOH on 08/24/20. 5- Patient tested on 08/17/20 and reported to the DOH on 08/24/20. 6- Patient tested on 08/17/20 and not reported to the DOH. 7- Patient tested on 08/17/20 and reported to the DOH on 08/24/20. 8- Patient tested on 08/17/20 and reported to the DOH on 08/24 /20. 9- Patient tested on 08/17/20 and reported to the DOH on 08/21/20. 10- Patient tested on 08/17/20 and reported to the DOH on 08/21/20. 11- Patient tested on 08/17 /20 and reported to the DOH on 08/26/20. 12- Patient tested on 08/17/20 and reported to the DOH on 08/25/20. 13- Patient tested on 08/19/20 and not reported to the DOH. 14- Patient tested on 08/19/20 and reported to the DOH on 08/24/20. 15- Patient tested on 08/17/20 and not reported to the DOH. 16- Patient tested on 08/17/20 and reported to the DOH on 08/25/20. 17- Patient tested on 08/18/20 and reported to the DOH on 08/25/20. 18- Patient tested on 08/24/20 and not reported to the DOH. 19- Patient tested on 08/20/20 and reported to the DOH on 08/25/20. 20- Patient tested on 08/20/20 and reported to the DOH on 08/25/20. 21- Patient tested on 08/21/20 and reported to the DOH on 08/25/20. 22- Patient tested on 08/21/20 and reported to the DOH on 08/25/20. 23- Patient tested on 08/21/20 and reported to the DOH on 08/25 /20. 24- Patient tested on 08/21/20 and reported to the DOH on 08/25/20. 25- Patient tested on 08/24/20 and reported to the DOH on 08/26/20. 26- Patient tested on 08/24 /20 and not reported to the DOH. 27- Patient tested on 08/24/20 and reported to the DOH on 08/26/20. Interview on 09/21/20 at 8:46 PM the Office Manager confirmed -- 2 of 8 -- the dates the tests were performed and on 09/16/20 at 3:00 PM confirmed the dates of faxing results to the DOH. D5300 PREANALYTIC SYSTEMS CFR(s): 493.1240 Each laboratory that performs nonwaived testing must meet the applicable preanalytic system(s) requirements in 493.1241 and 493.1242, unless HHS approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub. 7), that provides equivalent quality testing. The laboratory must monitor and evaluate the overall quality of the preanalytic systems and correct identified problems as specified in 493. 1249 for each specialty and subspecialty of testing performed. This CONDITION is not met as evidenced by: Based on record review, observations, and Staff interview the laboratory failed to ensure that COVID-19 specimens were stored and shipped within acceptable temperatures prior to testing since starting testing on 05/19/20 (See D5311), and failed to document the date and time it receives a COVID-19 specimen for 35 of 35 Patient reports reviewed (See D5313). D5311 SPECIMEN SUBMISSION, HANDLING, AND REFERRAL CFR(s): 493.1242(a) The laboratory must establish and follow written policies and procedures for each of the following, if applicable: (1) Patient preparation. (2) Specimen collection. (3) Specimen labeling, including patient name or unique patient identifier and, when appropriate, specimen source. (4) Specimen storage and preservation. (5) Conditions for specimen transportation. (6) Specimen processing. (7) Specimen acceptability and rejection. (8) Specimen referral. This STANDARD is not met as evidenced by: Based on record review, observations, and Staff interview the laboratory failed to ensure that COVID-19 specimens were stored and shipped within acceptable temperatures prior to testing since starting testing on 05/19/20. Findings Included: Review of Policy and Procedure signed by the Laboratory Director on 04/01/20 states that COVID-19 specimens must be stored "at 2-8 degrees Celsius for up to 72 hours after collection. If a delay in testing or shipping is expected, store specimens at -70 degrees Celsius or below." Observations on 09/15/20 at 10:00 AM revealed that local specimens are brought to laboratory by courier. Interview on 09/21/20 at 11:00 AM the Office Manager confirmed that the courier has a temperature regulated cooler that keeps the specimens 2-8 degrees Celsius, however, there is no documentation of the temperature. Other specimens are shipped to the laboratory. There is no temperature indicator in the shipping containers to ensure specimens were kept 2-8 degrees Celsius. Interview on 09/15/20 at 10:28 AM the Processing Staff member confirmed that there were no temperature indicators received with the specimens. She also confirmed that there is no documentation as to when each specimen was put into the -70 degree Celsius freezer to indicate it was greater than the required 72 hours. Review of the policy "Criteria for Specimen Rejection" reviewed by the Laboratory Director on 04/01/20 does not list specimens received outside of the acceptable range as a criteria for rejection, even though improper storage will result in a loss of efficacy. -- 3 of 8 -- D5313 SPECIMEN SUBMISSION, HANDLING, AND REFERRAL CFR(s): 493.1242(b) The laboratory must document the date and time it receives a specimen. This STANDARD is not met as evidenced by: Based on record review and interview with the Processing Staff the laboratory failed to document the date and time it receives a COVID-19 specimen for 35 of 35 Patient reports reviewed. Findings Included: Review of 35 Patient reports revealed a collected date/time, a received date/time, and a printed date/time. These were not accurate dates or times. Interview on 09/15/20 at 5:30 PM the Processing Staff confirmed that there is no collection time on the specimens. The received date/time and collected time is actually when the specimen is accessioned, not time collected or date/time received. These missing dates and times are not recorded anywhere else in the laboratory. She also confirmed that the printed date/time is when the results are uploaded into the system and not when the specimen is ran. This date and time is only found on the instrument print outs. D5403 PROCEDURE MANUAL CFR(s): 493.1251(b) The procedure manual must include the following when applicable to the test procedure: (1) Requirements for patient preparation; specimen collection, labeling, storage, preservation, transportation, processing, and referral; and criteria for specimen acceptability and rejection as described in 493.1242. (2) Microscopic examination, including the detection of inadequately prepared slides. (3) Step-by-step performance of the procedure, including test calculations and interpretation of results. (4) Preparation of slides, solutions, calibrators, controls, reagents, stains, and other materials used in testing. (5) Calibration and calibration verification procedures. (6) The reportable range for test results for the test system as established or verified in 493.1253. (7) Control procedures. (8)

Summary Statement of Deficiencies D2016 SUCCESSFUL PARTICIPATION CFR(s): 493.803(a)(b)(c) (a) Each laboratory performing nonwaived testing must successfully participate in a proficiency testing program approved by CMS, if applicable, as described in subpart I of this part for each specialty, subspecialty, and analyte or test in which the laboratory is certified under CLIA. (b) Except as specified in paragraph (c) of this section, if a laboratory fails to participate successfully in proficiency testing for a given specialty, subspecialty, analyte or test, as defined in this section, or fails to take remedial action when an individual fails gynecologic cytology, CMS imposes sanctions, as specified in subpart R of this part. (c) If a laboratory fails to perform successfully in a CMS- approved proficiency testing program, for the initial unsuccessful performance, CMS may direct the laboratory to undertake training of its personnel or to obtain technical assistance, or both, rather than imposing alternative or principle sanctions except when one or more of the following conditions exists: (1) There is immediate jeopardy to patient health and safety. (2) The laboratory fails to provide CMS or a CMS agent with satisfactory evidence that it has taken steps to correct the problem identified by the unsuccessful proficiency testing performance. (3) The laboratory has a poor compliance history. This CONDITION is not met as evidenced by: Based on review of the laboratory's proficiency testing records for 2018, the laboratory did not have successful performance in proficiency testing for the subspecialty of general immunology. Refer to D2084. Findings include: Review of the American Associates of Bioanalysts (AAB) proficiency testing records and the review of the Centers for Medicare & Medicaid Services (CMS) 153 and 155 reports, on January 14, 2019 on or about 10:00 AM, showed that the laboratory had unsatisfactory testing scores for the analyte, complement component 4 (C4) for two out of three testing events in 2018. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 3 -- D2084 GENERAL IMMUNOLOGY CFR(s): 493.837(f) Failure to achieve satisfactory performance for the same analyte or test in two consecutive testing events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on the review of the Centers for Medicare & Medicaid Services (CMS) 153 and 155 reports and the laboratory's proficiency testing records, the laboratory did not have successful participation in proficiency testing for the subspecialty of general immunology. Findings include: On January 14, 2019 on or about 10:00 AM the American Association of Bioanalysts (AAB) proficiency testing records and the CMS 153 and 155 reports were reviewed. The review showed that the laboratory failed to achieve satisfactory performance for the analyte, complement component 4 (C4), as shown below. Event #2, 2018 C4-0% Event #3, 2018 C4-0% D6076 LABORATORY DIRECTOR CFR(s): 493.1441 The laboratory must have a director who meets the qualification requirements of 493. 1443 of this subpart and provides overall management and direction in accordance with 493.1445 of this subpart. This CONDITION is not met as evidenced by: Based on the review of the laboratory's proficiency testing records, the laboratory director failed to ensure that the laboratory maintained a satisfactory score for proficiency testing in the subspecialty of general immunology. Findings include: On January 14, 2019, on or about 10:00 AM, the American Association of Bioanalysts (AAB) proficiency records and the Centers for Medicare & Medicaid Service (CMS) 153 and 155 reports were reviewed. The review showed that the laboratory had unsatisfactory testing scores for two out of three testing events for the analyte, complement component 4 (C4), in the subspecialty of general immunology. The laboratory director is responsible for ensuring that the laboratory maintains successful participation in proficiency testing. Refer to D2084. D6089 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(4)(i) The laboratory director must ensure the proficiency testing samples are tested as required under subpart H of this part. This STANDARD is not met as evidenced by: Based on the review of the laboratory's proficiency testing scores, the laboratory director failed to ensure that the laboratory performed proficiency testing in such a manner as to achieve and maintain successful participation in proficiency testing in the subspecialty of general immunology. Findings Include: The review of the American Association of Bioanalysts (AAB) proficiency testing records and the Centers for Medicare & Medicaid Services (CMS) 153 and 155 reports on January 14, 2019 on or about 10:00 AM showed that the laboratory received unsatisfactory -- 2 of 3 -- proficiency testing scores for the analyte complement component 4 (C4) as shown below. Event #2, 2018 C4-0 % Event #3, 2018 C4-0%. -- 3 of 3 --

Summary Statement of Deficiencies D2016 SUCCESSFUL PARTICIPATION CFR(s): 493.803(a)(b)(c) (a) Each laboratory performing nonwaived testing must successfully participate in a proficiency testing program approved by CMS, if applicable, as described in subpart I of this part for each specialty, subspecialty, and analyte or test in which the laboratory is certified under CLIA. (b) Except as specified in paragraph (c) of this section, if a laboratory fails to participate successfully in proficiency testing for a given specialty, subspecialty, analyte or test, as defined in this section, or fails to take remedial action when an individual fails gynecologic cytology, CMS imposes sanctions, as specified in subpart R of this part. (c) If a laboratory fails to perform successfully in a CMS- approved proficiency testing program, for the initial unsuccessful performance, CMS may direct the laboratory to undertake training of its personnel or to obtain technical assistance, or both, rather than imposing alternative or principle sanctions except when one or more of the following conditions exists: (1) There is immediate jeopardy to patient health and safety. (2) The laboratory fails to provide CMS or a CMS agent with satisfactory evidence that it has taken steps to correct the problem identified by the unsuccessful proficiency testing performance. (3) The laboratory has a poor compliance history. This CONDITION is not met as evidenced by: Based on review of the laboratory's proficiency testing records for 2017 and 2018, the laboratory did not have successful performance in proficiency testing for the specialty of general immunology. Refer to D2085. Findings include: Review of the American Association of Bioanalysts (AAB) proficiency testing records and the review of the Centers for Medicare & Medicaid Services (CMS) 153 and 155 reports, on August 13, 2018 on or about 3:00 PM, showed that the laboratory had unsatisfactory testing scores for the analyte, anti-nuclear antibodies, ANA for three consecutive testing events in 2017 and 2018 and for the analyte immunoglobulin E, IgE, for two consecutive testing events in 2017 and 2018. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 3 -- D2085 GENERAL IMMUNOLOGY CFR(s): 493.837(g) Failure to achieve an overall testing event score of satisfactory performance for two consecutive testing events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on the review of the Centers for Medicare & Medicaid Services (CMS) 153 and 155 reports and the laboratory's proficiency testing records, the laboratory did not have successful participation in proficiency testing for the specialty of general immunology. Findings include: On August 13, 2018 on or about 3:00 PM the American Association of Bioanalysts (AAB) proficiency testing records and the CMS 153 and 155 reports were reviewed. The review showed that the laboratory failed to achieve satisfactory performance for the following analytes anti-nuclear antibodies (ANA) and immunoglobulin E (IgE), as shown below. Anti-nuclear antibodies, ANA Event #2, 2017 ANA-0% Event #3, 2017 ANA-0% Event #1, 2018 ANA-0% Immunoglobulin E, IgE Event #3, 2017 IgE-0% Event #1, 2018 IgE-0% D6076 LABORATORY DIRECTOR CFR(s): 493.1441 The laboratory must have a director who meets the qualification requirements of 493. 1443 of this subpart and provides overall management and direction in accordance with 493.1445 of this subpart. This CONDITION is not met as evidenced by: Based on the review of the laboratory's proficiency testing records, the laboratory director failed to ensure that the laboratory maintained a satisfactory score for proficiency testing in the specialty of general immunology. Findings include: On August 13, 2018, on or about 3:00 PM, the American Association of Bioanalysts (AAB) proficiency records and the Centers for Medicare & Medicaid Service (CMS) 153 and 155 reports were reviewed. The review showed that the laboratory had unsatisfactory testing scores for three consecutive testing events for the analyte, anti- nuclear antibodies (ANA) and for two consecutive testing events for the analyte immunoglobulin E (IgE), in the specialty of general immunology. The laboratory director is responsible for ensuring that the laboratory maintains successful participation in proficiency testing. Refer to D2085. D6089 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(4)(i) The laboratory director must ensure the proficiency testing samples are tested as required under subpart H of this part. This STANDARD is not met as evidenced by: Based on the review of the laboratory's proficiency testing records, the laboratory director failed to ensure that the laboratory performed proficiency testing in such a manner as to achieve and maintain successful participation in proficiency testing in the specialty of general immunology. Findings include: On August 13, 2018 on or -- 2 of 3 -- about 3:00 PM the American Association of Bioanalysts (AAB) proficiency testing records and the CMS 153 and 155 reports were reviewed on August 13, 2018 on or about 3:00 PM. The review showed that the laboratory failed to achieve satisfactory performance for the following analytes anti-nuclear antibodies (ANA) and immunoglobulin E (IgE), as shown below. Anti-nuclear antibodies, ANA Event #2, 2017 ANA-0% Event #3, 2017 ANA-0% Event #1, 2018 ANA-0% Immunoglobulin E, IgE Event #3, 2017 IgE-0% Event #1, 2018 IgE-0% -- 3 of 3 --

Summary Statement of Deficiencies D5417 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(d) Reagents, solutions, culture media, control materials, calibration materials, and other supplies must not be used when they have exceeded their expiration date, have deteriorated, or are of substandard quality. This STANDARD is not met as evidenced by: Based on observation and record review it was determined that the laboratory did not ensure that expired controls were labeled as such, removed from premises or not used during the period 2016-2018. The findings are: A tour of the laboratory at approximately 10:00 AM on January 3rd 2018 revealed that the CBC controls in use normal control (lot 888900) has expired 1/2/2018 and abnormal control I (lot 878400) has expired 1/1/2018. Record review of CBC controls showed that during the period of 2016 till 2018 the following: year 2016 abnormal I lot 868900 expired 4/2/2016 used 4/4/2016 till 4/14/2016 year 2017 abnormal I lot 873100 expired 1/16/2017 used 1/15/2017 normal lot 884600 expired 1/17/2017 used 1/17/2017 abnormal I lot 875200 expired 4/24/2017 used 4/25/2017 normal lot 885800 expired 4/25/2017 used 4/26/2017 abnormal II lot 864300 expired 4/23/2017 used 4/24/2017 normal lot 886500 expired 6/20/2017 used 6/22/2017 abnormal II lot 865000 expired 6/18/2017 used 7/17/2017 abnormal II lot 866300 expired 9/30/2017 used 10/10/2017 till 11/1 /2017 abnormal II lot 866000 expired 9/10/2017 used 9/11/2017 till 9/29/2017 normal lot 887500 expired 9/12/2017 used 9/15/2017 till 9/24/2017 abnormal I lot 876900 expired 9/11/2017 used 9/12/2017 till 9/26/2017 normal lot 887800 expired 10/1/2017 used 10/10/2017 till 10/26/2017 abnormal I lot 877200 expired 10/2/2017 used 10/10 /2017 till 10/26/2017 normal lot 877900 expired 11/19/2017 used 11/20/2017 till 12/1 /2017 abnormal lot 866900 expired 11/20/2017 used 11/21/2017 till 12/4/2017 normal lot 888900 expired 1/2/2018 used 1/3/2018 year 2018 abnormal I lot 878400 expired 1 /1/2018 used 1/3/2018 normal lot 888900 has expired 1/2/2018 used 1/3/2018 Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 1 --