Ocean Biosciences Llc

Summary Statement of Deficiencies D0000 A recertification survey conducted from 06/29/2023 to 07/07/2023 found that the OCEAN BIOSCIENCES LLC clinical laboratory was not in compliance with 42 CFR Part 493, Requirements for Laboratories. The following Conditions were cited: - D5300 Preanalytic Systems -D6076 Laboratory Director -D6141 General Supervisor 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 observation, record review, and interview, the laboratory failed to monitor and define the transport temperature of specimens delivered to the laboratory for TaqPath COVID-19 and COVID FLU AB TaqPath testing. Refer to D5311. 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. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 4 -- This STANDARD is not met as evidenced by: Based on observation, record review, and interview, the laboratory failed to monitor and define the transport temperature of specimens delivered to the lab for TaqPath COVID-19 PCR and COVID Flu AB TaqPath testing. Findings included: On 06/29 /2023 at 09:30 AM, there was no temperature gauge to monitor specimens arriving in the lab via courier to the accessioning area for TaqPath COVID-19 and COVID Flu AB TaqPath testing. Review of "Taqpath COVID-19 Assay Protocol" signed by laboratory director (LD) on 03/28/2023 read "Validated nasal sample kits collection tubes are stable at room temperature and 2-8 Celsius (C) for 7 days." (Written as seen) There was no documentation that defined room temperature. Review of "COVID Flu AB Taqpath Validation Report-MIA" signed by laboratory director (LD) on 02/14 /2023 read "Validated nasal sample kits collection tubes are stable at room temperature and 2-8 Celsius (C) for 7 days." (Written as seen) Review of "COVID Flu AB TaqPath Validation Report Medschenker Miami "(written as seen) policy signed by LD on 03/07/2023 stated that Medschenker STM: Smart Transport Medium is used as the nasal collection tube. The Stability study section was missing a temperature that was defined for room temperature in the study. Review of Temperature logs for accessioning area revealed no documentation of temperature logs for 2022 to 2023 for specimens arriving via courier for Covid-19 PCR testing. Review of Patient Reports revealed the following: a. Patient#1 delivered from Hialeah and had no courier temperature on 11/04/2022 for COVID-19. b. Patient#2 delivered from Los Angeles and had no courier temperature on 11/30/2022 for COVID-19. c. Patient#3 delivered from Hialeah and had no courier temperature on 11/30/2022 for COVID-19. On 07/05 /2023 at 01:30 PM, Director of Research and Development and Quality Compliance stated 4,343 COVID samples were from vendors (local clinics/shipped in). On 07/07 /2023 at 11:00 AM, the lab confirmed failure to monitor and define the transport temperature of specimen delivered to the lab for COVID-19 testing. 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 record review and interview, the Laboratory Director failed to ensure that the laboratory had a qualified General Supervisor. Refer to D6101. D6101 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(11) The laboratory director must employ a sufficient number of laboratory personnel with the appropriate education and either experience or training to provide appropriate consultation, properly supervise and accurately perform tests and report test results in accordance with the personnel responsibilities described in this subpart. This STANDARD is not met as evidenced by: -- 2 of 4 -- Based on record review and staff interviews, the Laboratory Director failed to ensure that the laboratory had a qualified General Supervisor from 01/01/2022 to 06/29/2023. Findings included: -Refer to D6143. D6141 GENERAL SUPERVISOR CFR(s): 493.1459 The laboratory must have one or more general supervisors who are qualified under 493.1461 of this subpart to provide general supervision in accordance with 493.1463 of this subpart. This CONDITION is not met as evidenced by: Based on record review and staff interview, the laboratory failed to have a qualified General Supervisor. Refer to D6143. D6143 GENERAL SUPERVISOR QUALIFICATIONS CFR(s): 493.1461 (a) The general supervisor must possess a current license issued by the State in which the laboratory is located, if such licensing is required; and (b) The general supervisor must be qualified as a-- (b)(1) Laboratory director under 493.1443; or (b)(2) Technical supervisor under 493.1449. (c) If the requirements of paragraph (b)(1) or paragraph (b)(2) of this section are not met, the individual functioning as the general supervisor must-- (c)(1)(i) Be a doctor of medicine, doctor of osteopathy, or doctor of podiatric medicine licensed to practice medicine, osteopathy, or podiatry in the State in which the laboratory is located or have earned a doctoral, master's, or bachelor's degree in a chemical, physical, biological or clinical laboratory science, or medical technology from an accredited institution; and (c)(1)(ii) Have at least 1 year of laboratory training or experience, or both, in high complexity testing; or (c)(2)(i) Qualify as testing personnel under 493.1489(b)(2); and (c)(2)(ii) Have at least 2 years of laboratory training or experience, or both, in high complexity testing; or (c)(3)(i) Except as specified in paragraph (3)(ii) of this section, have previously qualified as a general supervisor under 493.1462 on or before February 28, 1992. (c)(3)(ii) Exception. An individual who achieved a satisfactory grade in a proficiency examination for technologist given by HHS between March 1, 1986 and December 31, 1987, qualifies as a general supervisor if he or she meets the requirements of 493. 1462 on or before January 1, 1994. (c)(4) On or before September 1, 1992, have served as a general supervisor of high complexity testing and as of April 24, 1995-- (c) (4)(i) Meet one of the following requirements: (c)(4)(i)(A) Have graduated from a medical laboratory or clinical laboratory training program approved or accredited by the Accrediting Bureau of Health Education Schools (ABHES), the Commission on Allied Health Education Accreditation (CAHEA), or other organization approved by HHS. (c)(4)(i)(B) Be a high school graduate or equivalent and have successfully completed an official U.S. military medical laboratory procedures course of at least 50 weeks duration and have held the military enlisted occupational specialty of Medical Laboratory Specialist (Laboratory Technician). (c)(4)(ii) Have at least 2 years of clinical laboratory training, or experience, or both, in high complexity testing; or (c) (5) On or before September 1, 1992, have served as a general supervisor of high complexity testing and-- (c)(5)(i) Be a high school graduate or equivalent; and (c)(5) (ii) Have had at least 10 years of laboratory training or experience, or both, in high complexity testing, including at least 6 years of supervisory experience between September 1, 1982 and September 1, 1992. (d) For blood gas analysis, the individual -- 3 of 4 -- providing general supervision must-- (d)(1) Be qualified under 493.1461(b)(1) or (2), or 493.1461(c); or (d)(2)(i) Have earned a bachelor's degree in respiratory therapy or cardiovascular technology from an accredited institution; and (d)(2)(ii) Have at least one year of laboratory training or experience, or both, in blood gas analysis; or (d)(3) (i) Have earned an associate degree related to pulmonary function from an accredited institution; and (d)(3)(ii) Have at least two years of training or experience, or both in blood gas analysis. (e) The general supervisor requirement is met in histopathology, oral pathology, dermatopathology, and ophthalmic pathology because all tests and examinations, must be performed: (e)(1) In histopathology, by an individual who is qualified as a technical supervisor under 493.1449(b) or 493.1449(l)(1); (e)(2) In dermatopathology, by an individual who is qualified as a technical supervisor under 493.1449(b) or 493.1449(l) or (2); (e)(3) In ophthalmic pathology, by an individual who is qualified as a technical supervisor under 493.1449(b) or 493.1449(1)(3); and (e)(4) In oral pathology, by an individual who is qualified as a technical supervisor under 493.1449(b) or 493.1449(m). This STANDARD is not met as evidenced by: Based on record review and staff interview, the laboratory failed to have a General Supervisor with Supervisor Florida License from 01/01/2022 to present. Findings included: Review of FORM CMS-209 Laboratory Personnel Report dated and signed by the Laboratory Director on 06/27/2023 revealed that: a) The Laboratory Director (LD) was acting also as Clinical Consultant (CC) and Technical Supervisor (TS). b) There was one General Supervisor (GS)#A that was also Testing Personnel (TP)#A. c) There was a second TP, TP # B. -Review of "General Supervisor Job Description", reviewed by the LD on 03/08/2023 revealed the following: "The general supervisor must possess a current license issued by the State in which the laboratory is located, if such licensing is required." -Review of personnel records for GS#A revealed that she did not have a Supervisor License for Florida. -Review of "Delegation of Duties Laboratory Director to General Supervisor" letters records revealed that the LD signed three Delegation letters in the period reviewed with the following dates: 07/13/2022, 02/13/2023 in which was listed as GS that was no longer with the laboratory (GS#B) and 04/18/2023 for GS#A. -Review of personnel records for the person listed as GS in the letters for 07/13/2022 and 02/13/2023, revealed that she did not have the Supervisor license (GS #B). During an interview on 06/29/2023 at 04:30 PM, with the laboratory manager, she confirmed that the GS#A listed in the FORM CMS-209 and GS#B listed in the Delegation of Duties letters of 07/13/2022 and 02/13/2023 did not have a Florida License as Supervisor. -- 4 of 4 --

Summary Statement of Deficiencies D0000 An initial certification survey conducted on 10/21/2021-11/05/2021, found the Ocean Biosciences LLC clinical laboratory not in compliance with 42 CFR Part 493, Requirements for Laboratories. Based on the survey findings an Immediate Jeopardy situation was identified and the laboratory was notified of the Immediate Jeopardy on 11/01/2021 at 11:10 AM. The laboratory failed to validate their method of spraying bleach and then wiping with alcohol on COVID-19 nasal collection tubes that leaked or spilled in the bag for viability from 06/23/2021 to 10/25/2021 Polymerase chain reaction (PCR) testing. The laboratory failed to perform a stability study on nasal specimens for transportation at room temperature and storage for 2-8 Celsius (C) used in COVID-19 PCR testing from 06/23/2021 to 10/25/2021. The laboratory failed to perform a stability study on Saliva collection tubes stored in refrigerator for retesting of COVID-19 PCR up to 7 days from 06/23/2021 to 10/25/2021 (See D5311). The laboratory failed to store TaqPath COVID-19 Positive controls at -70 Celsius(C) as instructed by the manufacturer from 06/23/2021 to 10/25/2021 (see D5413). The laboratory failed to complete a validation for storing elution plates in fluctuating temperatures from -80 C to -70 C that contained extracted Ribonucleic acid (RNA), interfering substances, and unvaildated nasal and saliva collection tubes performing COVID-19 PCR testing with the out of Emergency Use Authoritaization TaqPath Combo Kit before patient testing from 06/23/2021 to 10/25/2021 (see D5423). The laboratory failed to establish and validate the method for using positive controls outside of manufacturer guidelines before patient testing starting on 06/23/2021 with the unvalidated TaqPath COVID-19 Combo Kit. (see D5425) The following Conditions were not met: D5300-Preanalytic Systems D5400-Analytic Systems D6076-Laboratory Director D6141-General Supervisor D6168-Testing Personnel 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 Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 9 -- 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 observation, record review and interview, the laboratory failed to validate their method of spraying bleach and then wiping with alcohol on COVID-19 nasal collection tubes that leaked or spilled in the bag for viability from 06/23/2021 to 10/25 /2021 Polymerase chain reaction (PCR) testing. The laboratory failed to perform a stability study on nasal specimens for transportation at room temperature and storage for 2-8 Celsius (C) used in COVID-19 PCR testing from 06/23/2021 to 10/25/2021. The laboratory failed to perform a stability study on Saliva collection tubes stored in refrigerator for retesting of COVID-19 PCR up to 7 days from 06/23/2021 to 10/25 /2021. (See D5311) 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 observation, record review and interview, the laboratory failed to validate their method of spraying bleach and then wiping with alcohol on COVID-19 nasal collection tubes that leaked or spilled in the bag to for viability before Polymerase chain reaction (PCR) testing from 06/23/2021 to 10/25/2021. The laboratory failed to perform a stability study on nasal specimens for transportation at room temperature and storage for 2-8 Celsius (C) used in COVID-19 PCR testing from 06/23/2021 to 10 /25/2021. The laboratory failed to perform a stability study on Saliva collection tubes stored in refrigerator for retesting of COVID-19 PCR up to 7 days from 06/23/2021 to 10/25/2021. Findings included: During an observation of the accessioning area on 10 /22/2021 at 11:22 AM revealed COVID-19 specimen collection tubes that had leaked in biohazard bags during transit were placed under the BSCII Hood. An accessioning technician removed a COVID-19 specimen collection tube from one of the bags. The tube was placed on a paper towel. The accessioning technician sprayed the tube with bleach and wiped with a paper towel covered in alcohol. This process was repeated with the other tubes. Review of Cleaning Procedure revealed there was no written cleaning procedure with bleach and alcohol for COVID-19 specimen collection tubes that had leaked. There was no written validation for this method to ensure COVID-19 specimens were not affected. An observation of COVID-19 specimen receiving area on 10/22/2021 at 10:51 AM revealed COVID-19 specimen collection tubes were received in the laboratory by courier boxes with no ice or temperature gauges. Review of the Sorfa Disposables Sample Collection Kit states "the transport medium has not been reviewed by the Food and Drug Administration (FDA). Optimum storage temperature of collection tubes are 5C to 25C." During an observation of the Molecular Testing Room on 10/22/2021 at 12:00 PM revealed K2-Scientific FH-04- 002 refrigerator was used to store COVID-19 Nasal and Saliva collection specimen -- 2 of 9 -- for first time testing and retesting in PCR up to 7days. Review of K2-Scientific FH-04- 002 Daily Recording log revealed temperature recordings of 1C to 7C for COVID-19 specimen storage from 06/23/2021 to 10/25/2021. Review of Taqpath COVID-19 Combo Kit procedure stated "Taqpath Combo Kit are only for use under the Food and Drug Administration's Emergency Use Authorization. Patient samples must be collected according to appropriate laboratory guidelines. Positive and negative test controls must be included to accurately interpret patient test results. Store patient samples according to CDC guidelines." Review of CDC guidelines states "Store respiratory specimens at 2-8C for up to 72 hours after collection. If a delay in testing or shipping is expected, store specimens at -70C or below. Store extracted nucleic acid samples at -70C or lower." Review of Stability Study for COVID-19 Specimen collection tubes revealed the was no written documentation of a stability study for Sorfa Disposables samples collection kit used for nasal collection and SDNA-1000 Spectrum DNA innovation Devices are used for saliva collection to be stored at 2C- 8C for 7days in refrigerator or transportation . During an interview on 10/27/2021 at 1: 00 PM, the Operations Manager stated 22,217 patients were tested by the unvalidated Taqpath COVID-19 Combo Kit from 06/23/2021 to10/25/2021. During an interview on 11/02/2021 at 10:15 AM, the Operations Manager, Technical Supervisor (TS) A and TS B confirmed the failure to validate the method of spraying bleach and alcohol on nasal collection tubes and perform a stability study on saliva collection and nasal collection kits. D5400 ANALYTIC SYSTEMS CFR(s): 493.1250 Each laboratory that performs nonwaived testing must meet the applicable analytic systems requirements in 493.1251 through 493.1283, 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 analytic systems and correct identified problems as specified in 493.1289 for each specialty and subspecialty of testing performed. This CONDITION is not met as evidenced by: Based on observation, record review and interview, the laboratory failed to store TaqPath COVID-19 Positive controls at -70 Celsius(C) as instructed by the manufacturer from 06/23/2021 to 10/25/2021. (see D5413) Based on observation, record review and interview, the laboratory failed to complete a validation for storing elution plates in fluctuating temperatures from -80 Celsius (C) to -70 C that contained extracted Ribonucleic acid (RNA), interfering substances, and unvaildated nasal and saliva collection tubes for performing COVID-19 PCR testing with the out of Emergency Use Authoritaization TaqPath Combo Kit before patient testing from 06/23 /2021 to 10/25/2021. (see D5423) Based on observation, record review and interview, the laboratory failed to establish and validate the method for using positive controls outside of manufacturer guidelines before starting patient testing on 06/23/2021 with the unvalidated TaqPath COVID-19 Combo Kit. (see D5425) D5413 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(b) The laboratory must define criteria for those conditions that are essential for proper storage of reagents and specimens, accurate and reliable test system operation, and test result reporting. The criteria must be consistent with the manufacturer's -- 3 of 9 -- instructions, if provided. These conditions must be monitored and documented and, if applicable, include the following: (1) Water quality. (2) Temperature. (3) Humidity. (4) Protection of equipment and instruments from fluctuations and interruptions in electrical current that adversely affect patient test results and test reports. This STANDARD is not met as evidenced by: Based on observation, record review and interview, the laboratory failed to store TaqPath COVID-19 Positive controls at -70 Celsius(C) as instructed by the manufacturer from 06/23/2021 to 10/25/2021. Findings Included: Review of Applied Biosystems TaqPath COVID-19 Positive Control package stated "store positive control at-70 C." During an observation of the Molecular Testing Room on 10/21 /2021 at 1:30 PM revealed the Extraction K2 Scientific Freezer FH80-001(Extraction Freezer) held TaqPath COVID-19 Positive Control boxes and elution plates. Review of Extraction FH80-001 Freezer Daily log displayed temperatures of above -70 C for 5 out of 130 days from 06/23/2021 to 10/25/2021 for the Extraction freezer. For 125 out 130 days temperatures were record below -70 C from 06/23/2021 to 10/25/2021 for the extraction freezer. During an interview on 11/02/2021 at 10:00 AM, the Operations Manager, Technical Supervisor (TS) A and TS B confirmed the TaqPath COVID-19 Positive Controls were not stored at -70 C. D5423 ESTABLISHMENT AND VERIFICATION OF PERFORMANCE CFR(s): 493.1253(b)(2) Each laboratory that modifies an FDA-cleared or approved test system, or introduces a test system not subject to FDA clearance or approval (including methods developed in-house and standardized methods such as text book procedures), or uses a test system in which performance specifications are not provided by the manufacturer must, before reporting patient test results, establish for each test system the performance specifications for the following performance characteristics, as applicable: (2)(i) Accuracy. (2)(ii) Precision. (2)(iii) Analytical sensitivity. (2)(iv) Analytical specificity to include interfering substances. (2)(v) Reportable range of test results for the test system. (2)(vi) Reference intervals (normal values). (2)(vii) Any other performance characteristic required for test performance. This STANDARD is not met as evidenced by: Based on observation, record review and interview, the laboratory failed to complete a validation for storing elution plates in fluctuating temperatures from -80 Celsius (C) to -70 C that contained extracted Ribonucleic acid (RNA), interfering substances, and unvaildated nasal and saliva collection tubes for performing COVID-19 PCR testing with the out of Emergency Use Authoritaization TaqPath Combo Kit before patient testing from 06/23/2021 to 10/25/2021. Findings included: Review of Taqpath COVID-19 Combo Kit FAQS stated "The TaqPath COVID-19 Combo kit is currently approved for use with viral RNA extracted from these six specimen types: bronchoalveolar lavage (BAL), mid-turbinate swabs, nasal swabs, nasopharyngeal swabs, nasopharyngeal aspirate (nasal aspirate), and oropharyngeal swabs. Samples must be collected, transported, and stored using appropriate procedures and conditions. Improper collection, transport, or storage of specimens may hinder the ability of the assay to detect the target sequences. We did not validate any specific transport and storage solution; your lab is responsible for choosing and verifying the transport media you have selected and complying with manufacturer guidance for the storage media and vial you intend to use. Any changes to the protocol are considered -- 4 of 9 -- off-label use and invalidate compliance with the IFU." During an observation of Molecular Testing Room on 10/21/2021 at 1:30 PM revealed the Extraction K2 Scientific Freezer FH80-001(Extraction Freezer) held TaqPath COVID--19 Positive Control boxes and elution plates. Review of Extraction FH80-001 Freezer Daily Log displayed temperatures of above -70 C for 5 out of 130 days from 06/23/2021 to 10/25 /2021 for the Extraction freezer. For 125 out 130 days temperatures were record below -70 C from 06/23/2021 to 10/25/2021 for the extraction freezer. Review of Nasal and Saliva Taqpath COVID-19 Combo Kit validations revealed no documentation of interfering substances done for the validation since 05/11/2021. Validation procedure stated that elution plates are stored at -80 C with extraction materials. Based on observation, record review and interview, the laboratory failed to validate their method of spraying bleach and then wiping with alcohol on COVID-19 nasal collection tubes that leaked or spilled in bag to for viability before Polymerase chain reaction (PCR) testing from 06/23/2021 to 10/25/2021. The laboratory failed to perform a stability study on nasal specimens for transportation at room temperature and storage for 2-8 Celsius (C) used in COVID-19 PCR testing from 06/23/2021 to 10 /25/2021. The laboratory failed to perform a stability study on Saliva collection tubes stored in refrigerator for retesting of COVID-19 PCR up to 7 days from 06/23/2021 to 10/25/2021.(See 5311) During an interview with Operations Manager on 10/25/2021 at 12:00 PM, She stated that 22,217 patients were tested with unvalidated TaqPath COVID-19 Combo Kit from 06/23/2021 to 10/25/2021. During an interview on 11/02 /2021 at 10:00AM, the Operations Manager, Technical Supervisor(TS) A and TS B confirmed failure to complete a validation for outside manufacturer guidelines usage of TaqPath COVID-19 Combo Kit for testing with specimen collection tubes with no stability study, storing elution plates below -80 C and missing interfering substances before patient testing. D5425 ESTABLISHMENT AND VERIFICATION OF PERFORMANCE CFR(s): 493.1253(b)(3) The laboratory must determine the test system's calibration procedures and control procedures based upon the performance specifications verified or established under paragraph (b)(1) or (b)(2) of this section. This STANDARD is not met as evidenced by: Based on observation, record review and interview, the laboratory failed to establish and validate the method for using positive controls outside of manufacturer guidelines before starting patient testing on 06/23/2021 with the unvalidated TaqPath COVID-19 Combo Kit. Findings included: Based on observation, record review and interview, the laboratory failed to store TaqPath COVID-19 Positive controls at -70 Celsius(C) as instructed by the manufacturer from 06/23/2021 to 10/25/2021. (See D5413) Review of Taqpath COVID-19 Combo Kit stated "TaqPath COVID 19 Control, not diluted (1 104 copies/L) is stored at 3.6-4.6C for 48 hours. TaqPath COVID 19 Control working concentration (25 copies/L) is stored at 3.6-4.6C (including in open tubes) for 48 hours." An observation of the Molecular Testing Room on 10/22/2021 at 12:00 PM revealed the K2-Scientific FH-20-0001 freezer was storing TaqPath COVID 19 Positive Control working concentration (the positive control with dilution buffer) from -10 to -21.5C past 48 hours for daily use. During interview with a Thermofisher technician on 10/27/2021 at 1:47 PM, the Thermofisher technician stated "upon dilution, the positive control material should be kept at 2-8C for up to 8 hours, and not subject to further freeze-thaw cycles." Review of K2-Scientific FH-20- 0001 freezer revealed freezer temperature log ranges from -10 C to -21.5 C from 6/1 -- 5 of 9 -- /2021 to 9/30/2021. Review of Nasal and Saliva TaqPath validation showed there was no documentation of validation for the positive control to be stored outside of -70 C used and then used to make diluted positive working concentrations stored in a -10 C to-20 C freezer past 48 hours for daily use. During an interview on 10/27/2021 at 1:00 PM, the Operations Manager stated 22,217 patients were tested by the unvalidated TaqPath COVID-19 Combo Kit from 06/23/2021 to 10/25/2021. During an interview on 11/02/2021 at 10:00 AM, the Operations Manager confirmed the laboratory failed to establish and validate the method for using positive controls outside of manufacturer guidelines before starting patient testing on 06/23/2021 with the unvalidated TaqPath COVID-19 Combo Kit. 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 record review and interview, the laboratory director failed to have 4(TP# E, TP #F,TP# G and TP# I) out of 11 testing personnel(TP) licensed by the State of Florida to perform unvalidated COVID-19 Polymerase chain reaction (PCR) testing. (See D6079) Based on record review and interview, the laboratory director failed to ensure the TaqPath COVID-19 Combo Kit along with the positive controls were validate before patient testing from 06/23/2021 to 10/25/2021. (See D6086) D6079 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(a)(b) The laboratory director is responsible for the overall operation and administration of the laboratory, including the employment of personnel who are competent to perform test procedures, record and report test results promptly, accurately and proficiently, and for assuring compliance with the applicable regulations. (a) The laboratory director, if qualified, may perform the duties of the technical supervisor, clinical consultant, general supervisor, and testing personnel, or delegate these responsibilities to personnel meeting the qualifications under 493.1447, 493.1453, 493.1459, and 493.1487 respectively. (b) If the laboratory director reapportions performance of his or her responsibilities, he or she remains responsible for ensuring that all duties are properly performed. This STANDARD is not met as evidenced by: Based on record review and interview, the laboratory director failed to have 4(TP#E, TP# F,TP# G and TP# I) out of 11 testing personnel(TP) licensed by the State of Florida to perform unvalidated COVID-19 Polymerase chain reaction (PCR) testing. Findings Included: Based on record review and interview, the laboratory failed to have 4(TP#E,TP# F,TP# G and TP# I) out of 11 testing personnel(TP) licensed by the State of Florida to perform unvalidated COVID-19 Polymerase chain reaction (PCR) testing. (See D6170) During an interview on 11/02/2021 at 10:06 AM, the Operations Manager confirmed the laboratory director failed to have 4 out of 11 TP licensed by the State of Florida to perform unvalidated COVID-19 PCR testing. -- 6 of 9 -- D6086 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(3)(ii) The laboratory director must ensure that verification procedures used are adequate to determine the accuracy, precision, and other pertinent performance characteristics of the method. This STANDARD is not met as evidenced by: Based on record review and interview, the laboratory director failed to ensure the TaqPath COVID-19 Combo Kit along with the positive controls were validated before patient testing from 06/23/2021 to 10/25/2021. Findings included: Based on observation, record review and interview, the laboratory failed to complete a validation storing elution plates in fluctuating temperatures from -80 Celsius (C) to -70 C that contained extracted Ribonucleic acid (RNA) , interfering substances, and unvaildated nasal and saliva collection tubes for performing COVID-19 PCR testing with the out of Emergency Use Authoritaization TaqPath Combo Kit before patient testing from 06/23/2021 to 10/25/2021. (See D5423) Based on observation, record review and interview, the laboratory failed to establish and validate the method for using positive controls outside of manufacturer guidelines before starting patient testing on 06/23/2021 with the unvalidated TaqPath COVID-19 Combo Kit. (See D5425) During an interview on 11/02/2021 at 10:07 AM, the Operations Manager confirmed the laboratory director failed to ensure the TaqPath COVID-19 Combo Kit along with the positive controls were validate before patient testing from 06/23/2021 to 10/25/2021. D6141 GENERAL SUPERVISOR CFR(s): 493.1459 The laboratory must have one or more general supervisors who are qualified under 493.1461 of this subpart to provide general supervision in accordance with 493.1463 of this subpart. This CONDITION is not met as evidenced by: Based on record review and interview, the general supervisor (GS) failed to sign COVID-19 temperature logs, COVID-19 extraction room maintenance logs and GS duties documents instead of the operations manager from 06/01/2021 to 09/30/2021. (See D6144) D6144 GENERAL SUPERVISOR RESPONSIBILITIES CFR(s): 493.1463 The general supervisor is responsible for day-to-day supervision or oversight of the laboratory operation and personnel performing testing and reporting test results. This STANDARD is not met as evidenced by: Based on record review and interview, the General Supervisor (GS) failed to sign COVID-19 temperature logs, COVID-19 extraction room maintenance logs and GS duties documents instead of the Operations Manager from 06/01/2021 to 9/30/2021. Findings included: Review of CMS-209 Laboratory Personnel Report showed GS listed as the GS. Review of Employee records revealed Operations Manager (OM) -- 7 of 9 -- with an associate degree in Health Administration and BS in Health Management. OM has no license from the State of Florida in Medical Technology. Review of Molecular Temperature logs shows OM signing and reviewing temperature logs from 06/1/2021 to 09/30/2021 with no GS a signature. Review of COVID-19 Extraction maintenance logs shows OM signing and reviewing temperature logs from 06/1/2021 to 09/30/2021 with no GS a signature. Review of General Supervisor Duties Sheet revealed a signatures by OM performing GS duties and no signature by GS A from 07 /24/2021 to 09/24/2021. During an interview on 11/02/2021 at 10:05 AM, the OM confirmed she was signing on GS signature required documents. D6168 TESTING PERSONNEL CFR(s): 493.1487 The laboratory has a sufficient number of individuals who meet the qualification requirements of 493.1489 of this subpart to perform the functions specified in 493. 1495 of this subpart for the volume and complexity of testing performed. This CONDITION is not met as evidenced by: Based on record review and interview, the laboratory failed to have 4(TP# E,TP# F, TP# G and TP# I) out of 11 testing personnel(TP) licensed by the State of Florida to perform unvalidated COVID-19 Polymerase Chain Reaction (PCR) testing. (See D6170) D6170 TESTING PERSONNEL QUALIFICATIONS CFR(s): 493.1489(a) Each individual performing high complexity testing must possess a current license issued by the State in which the laboratory is located, if such licensing is required. This STANDARD is not met as evidenced by: Based on record review and interview, the laboratory failed to have 4(TP# E,TP# F, TP# G and TP# I) out of 11 testing personnel(TP) licensed by the State of Florida as a Medical Technologist to perform unvalidated COVID-19 Polymerase chain reaction (PCR) testing. Findings included: Review of CMS-209 Laboratory Personnel Report showed TP# E, TP# F, TP# G and TP# I were TP. Review of Employee records exhibited TP# E has a Bachelor of Arts in Chemistry from Florida International University and no state of Florida license for Medical Technologist. TP# E was hired on 03/22/2021. TP# F has a Bachelor of Sciences from Florida International University, Public Health Technician license and no State of Florida Medical Technologist license to perform testing in an independent laboratory. TP# F was hired on 09/17/2021. TP# G has a Bachelor degree in Psychology with a minor in Chemistry, Public Health Technician license and no State of Florida Medical Technologist license to perform testing in an independent laboratory. TP# G was hired on 10/11/2021.TP# I has a Bachelor of Science in Chemistry from Florida International University and no State of Florida license for Medical Technologist. TP# I was hired on 09/26/2021. Review of Competency assessment records revealed TP# E was hired and has been performing COVID-19 PCR testing since 09/03/2021. TP#F has been performing COVID-19 molecular testing since 09/23/2021.TP# G has been performing COVID-19 molecular testing since 10/15/2021.TP# I has been performing COVID-19 molecular testing since 10/5/2021. During an interview on 11/02/2021 at 10:15 AM, the Operations Manager, Technical Supervisor (TS) A and TS B -- 8 of 9 -- confirmed 4 out of 11 TP did not have a State of Florida Medical Technologist license to perform COVID-19 PCR testing. -- 9 of 9 --