Cbs Labs Of Tampa Llc

Summary Statement of Deficiencies D0000 An announced CLIA recertification survey was conducted at CBS Labs of Tampa on 09/09/2025-09/10/2025. The laboratory is not in compliance with 42 CFR Part 493, Requirement for Laboratories. The following Condition was cited: D2016 493.803 (a) (b)(c) Condition: Successful Participation 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 proficiency testing records and staff interview, the lab failed to successfully participate in proficiency testing for creatinine (test event 3 of 2024 and 1 of 2025) and urine sediment (test event 3 of 2024 and 1 of 2025) for the specialty of Chemistry. See D2096. 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 -- D2096 ROUTINE CHEMISTRY CFR(s): 493.841(f) (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 record review and staff interview, the laboratory had unsuccessful performance for two out of three test event for the analytes creatinine (test event #3 of 2024 and #1 of 2025) and urine sediment (test event #3 of 2024 and #1 of 2025) for the specialty of Chemistry (subspecialties of Routine Chemistry and Urinalysis). Findings included: 1. Proficiency testing Performance Summary documents were reviewed for the specialty of Chemistry. The results for the analyte creatinine (Routine Chemistry) reflected a score of 20% for test event (TE) #3 for 2024 and 60% for TE #1 of 2025. The results for the analyte urine sediment (Urinalysis) reflected a score of 50% for TE #3 for 2024 and 50% for TE #1 for 2025. 2. The Technical Consultant confirmed the above data on 09/09/2025 at 12:10 p.m. D3005 FACILITIES CFR(s): 493.1101(a)(3) (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: Based on observation, record review and interview, the laboratory failed to have a uni- directional workflow for molecular amplification procedures from 02/14/2024 to 09 /2025. Findings included: 1. A tour of the lab was conducted on 09/09/2025 at 9:55 a. m. The layout of the lab failed to allow for uni-directional flow. 2. Review of validation binder for Molecular revealed testing was approved to begin, by Lab Director signature, 02/15/2024. 3. The Laboratory's Policy and Procedure Manual, policy titled "Do's and Don'ts, signed by the Laboratory Director on 08/03/2023 was reviewed. The policy stated, under Organization of workspace and equipment, that the workspace should be organized to ensure work flows in one direction. There was no layout/map of how the workspace and equipment would be organized to ensure uni- directional flow. 4. Interview with the Technical Supervisor on 09/09/2025 at 11:10 a. m. confirmed the above. D5431 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(a)(2) (a)(2) Function checks as defined by the manufacturer and with at least the frequency specified by the manufacturer. Function checks must be within the manufacturers established limits before patient testing is conducted. (b) Equipment, instruments, or test systems developed in-house, commercially available and modified by the laboratory, or maintenance and function check protocols are not provided by the manufacturer. The laboratory must do the following: -- 2 of 4 -- This STANDARD is not met as evidenced by: Based on record review and interview, the laboratory failed to perform and document function checks as defined by the manufacturer and with at least the frequency specified by the manufacturer for sub-speciality Syphilis Serology for 2023-2025. Findings included: 1. The laboratory performed qualitative Syphilis Serology using Arlington Scientific Rapid Plasma Reagin (RPR) card testing. The manufacturer instructions stated the accuracy of the needle dispensing reagent was to be checked to ensure 30 plus or minus 1 drop in 0.5 ml and the automatic rotator speed of 100 plus or minus 5 rpm each day of testing. 2. The RPR Quality Control Daily records for 3 /2025, 4/2025, and 5/2025 failed to document the accuracy of the needle dispensing reagent was checked to ensure 30 plus or minus 1 drop in 0.5 ml each day of testing and for 5/2025 the automatic rotator speed was 100 plus or minus 5 rpm each day of testing. 3. The Technical Consultant on 9/10/2025 at 1:00 p.m., confirmed the laboratory had not been documenting following the RPR manufacturer instructions for accuracy of reagent needle volume and automatic rotor speed. D5469 CONTROL PROCEDURES CFR(s): 493.1256(d)(10)(g) (d)(10) Establish or verify the criteria for acceptability of all control materials. (d)(10) (i) When control materials providing quantitative results are used, statistical parameters (for example, mean and standard deviation) for each batch and lot number of control materials must be defined and available. (d)(10)(ii) The laboratory may use the stated value of a commercially assayed control material provided the stated value is for the methodology and instrumentation employed by the laboratory and is verified by the laboratory. (d)(10)(iii) Statistical parameters for unassayed control materials must be established over time by the laboratory through concurrent testing of control materials having previously determined statistical parameters. This STANDARD is not met as evidenced by: Based on record review and interview the laboratory failed to, for commercially assayed control material, verify the stated value by the laboratory prior to being put into use for General Immunology, Routine Chemistry, Endocrinology, Toxicology, and Hematology Complete Blood Count (CBC) for 2023 to 2025. Findings included: 1. Quality Control (QC) Records for 2023-2025 for General Immunology, Routine Chemistry, Endocrinology, Toxicology, and CBC failed to include documentation of verifying the assayed commercial control material's stated values prior to use. 2. The Policy and Procedure Manual with an approval date of 08/02/2023, was reviewed. No policy was found regarding verifying assayed control material prior to use. 3. The Technical Consultant on 9/10/2025 at 11:00 a.m. confirmed the laboratory did not have documentation or a policy to verify the stated values of assayed commercial QC material for the General Immunology, Routine Chemistry, Endocrinology, Toxicology, and Hematology CBC for 2023 to 2025. D6080 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(c) (c) The laboratory director must: (c)(1) Be onsite at least once every 6 months, with at least 4 months between the minimum two on-site visits. Laboratory directors may elect to be on-site more frequently and must continue to be accessible to the laboratory to provide telephone or electronic consultation as needed; and (c)(2) -- 3 of 4 -- Provide documentation of these visits, including evidence of performing activities that are part of the laboratory director responsibilities. This STANDARD is not met as evidenced by: Based on record review and interview, the Laboratory Director failed to establish a policy or to reflect the requirement of being onsite once every 6 months to include evidence of performing activities that were part of the Laboratory Director's responsibilities. The Laboratory Director failed to document a 6 month onsite visit from 1/2025 to 9/2025. Findings included: 1. The Policy and Procedure Manual, which had an approval date of 08/02/2023 was reviewed. No policy was found regarding documenting the Laboratory Director being on site every 6 months to include evidence of performing activities that were part of the Laboratory Director's responsibilities. 2. The Laboratory Director confirmed on 09/10/2025 at 2:30 p.m., via phone, that he was not aware of this requirement to add a procedure or to perform and document an onsite visit at least every 6 months. -- 4 of 4 --

Summary Statement of Deficiencies D0000 An onsite recertification survey was conducted on 09/11/2023 to 09/12/2023 at CBS Labs of Tampa LLC. The clinical laboratory was not in compliance with 42 CFR 493, requirements for clinical laboratories. The following Standard level deficiency was cited: D5209 PERSONNEL COMPETENCY ASSESSMENT POLICIES CFR(s): 493.1235 As specified in the personnel requirements in subpart M, the laboratory must establish and follow written policies and procedures to assess employee and, if applicable, consultant competency. This STANDARD is not met as evidenced by: Based on review of personnel records, procedure manual, and interview, the laboratory failed to perform the initial training and semi-annual training for one (B) of three Testing Personnel (A-C). Findings Included: Review of the CMS 209, Laboratory Personnel Report, signed by the Laboratory Director on 09/10/2023 revealed there were three Testing Personnel (A-C). Review of Testing Personnel B's personnel record revealed no documentation of the initial training and 6 month competency evaluation. Review of the procedure manual showed the laboratory Competency Evaluation had a place to document if the evaluation was for Initial Training, Semiannual Training, or Annual Training. Review of the Quality Assurance policy stated "Ensure personnel records reflect training of personnel." On 09/11/2023 at 12:30 PM, the Technical Supervisor confirmed that Testing Personnel B started at the end of July 2022, and the initial training and 6th month competency assessment had not been performed. 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 --

Summary Statement of Deficiencies D0000 An announced CLIA recertification survey was conducted at CBS Labs of Tampa, LLC on 06/21/2021. The laboratory is not in compliance with 42 CFR Part 493, Requirements for Laboratories. The following is a description of the standard level deficiencies: D5411 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(a) Test systems must be selected by the laboratory. The testing must be performed following the manufacturer's instructions and in a manner that provides test results within the laboratory's stated performance specifications for each test system as determined under 493.1253. This STANDARD is not met as evidenced by: Based on observation, record review, and interview with the Technical Consultant the laboratory failed to record the open date and expiration date on the CBC (Complete Blood Count) and Retic Controls. Findings Included: Observations during the tour of the laboratory on 06/21/2021 at 2:17 PM revealed that the open CBC controls (Level 1-Lot#123173760, Level 2-Lot#1331183760, and Level 3-143193760) and the open Retic Controls (Level 1-Lot # 153202230, Level 2-Lot#163212230, and Level 3- Lot#17322223) did not have an open date written on them or the date of amended expiration. Review of the manufacturers' instructions for the CBC and Retic controls stated that once open, the controls are only good for 16 days. On 06/21/21 at 3:00 PM, the Technical Consultant confirmed that the open date was not recorded or the new expiration date 16 days post opening on the CBC or Retic controls. D5413 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(b) The laboratory must define criteria for those conditions that are essential for proper 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 -- storage of reagents and specimens, accurate and reliable test system operation, and test result reporting. The criteria must be consistent with the manufacturer's 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 observations, record review, and interview with the Technical Consultant the laboratory failed to store Chemistry controls and calibrators per the manufacturers' instructions for 192 out of 373 days in 2020 and 2021. Findings Included: During a tour of the laboratory on 06/21/21 at 3:00 PM a freezer was observed with a temperature of -19 degrees Celsius. The acceptable range on the temperature log was -20 degrees Celsius/-5 degrees Celsius. Observations of the chemistry controls and calibrators stored in the freezer revealed that they should be stored between -20 and -70 degrees Celsius. Review of temperature logs for 2021 and 2020 revealed 192 days out of 373 days the temperature was warmer than the acceptable range for storage of -20 to -70 degrees Celsius. In January 2020 the temperature was out of acceptable range 21 out of 23 days: 2 (-18), 3(-18), 6(-19), 7(-19), 9(-19), 10(-19), 13(-18), 14 (-19), 15(-18), 16(-18), 17(-19), 20(-18), 21(-18), 22(-19), 23(-19), 24(-19), 27(-19), 28(-18), 29(-18), 30(-18), and 31(-19). In February 2020 the temperature was out of acceptable range 20 out of 21 days: 3(-18), 4(-19), 6(-18), 7(-18), 10(-19), 11(-19), 12 (-18), 13(-18), 14(-18), 17(-17), 18(-18), 19(-18), 20(-19), 21(-18), 24(-17), 25(-17), 26(-17), 27(-18), and 28(-18). In March 2020 the temperature was out of acceptable range 21 out of 21 days: 2(-18), 3(-17), 4(-18), 5(-18), 6(-17), 8(-18), 9(-18), 10(-17), 11(-17), 12(-19), 15(-18), 16(-18), 17(-19), 18(-19), 19(-19), 22(-18), 23(-18), 24 (-18), 27(-18), 30(-18), and 31(-18). In April 2020 the temperature was out of acceptable range 22 out of 22 days: 1(-18), 2(-18), 3(-18), 6(-19), 7(-19), 8(-18), 9 (-18), 10(-18), 13(-18), 14(-18), 15(-19), 16(-19), 17(-19), 20(-18), 21(-19), 22(-18), 23(-19), 24(-18), 27(-18), 28(-18), 29(-18), and 30(-18). In May 2020 the temperature was out of acceptable range 21 out of 21 days: 1(-18), 4(-19), 5(-18), 6(-19), 7(-19), 8 (-18), 11(-18), 12(-18), 13(-18), 14(-19), 15(-18), 18(-18), 19(-18), 20(-18), 21(-18), 22(-18), 25(-19), 26(-18), 27(-18), 28(-18), and 29(-18). In June 2020 the temperature was out of acceptable range 22 out of 22 days: 1(-18), 2(-18), 3(-18), 4(-18), 5(-18), 8 (-18), 9(-18), 10(-18), 11(-18), 12(-18), 15(-18), 16(-18), 17(-18), 18(-18), 19(-18), 22 (-18), 23(-18), 24(-18), 25(-18), 26(-18), 29(-18), and 30(-18). In July 2020 the temperature was out of acceptable range 18 out of 23 days: 1(-18), 2(-18), 3(-18), 6 (-18), 7(-18), 8(-18), 9(-18), 10(-18), 13(-18), 14(-18), 15(-18), 16(-19), 17(-18), 23 (-19), 24(-19), 29(-19), 30(-19), and 31(-19). In August 2020 the temperature was out of acceptable range 20 out of 21 days: 3(-18), 4(-18), 5(-18), 6(-18), 7(-18), 11(-19), 12(-18), 13(-18), 14(-18), 17(-19), 18(-19), 19(-18), 20(-18), 21(-18), 24(-18), 25 (-18), 26(-18), 27(-18), 28(-18), and 31(-18). In September 2020 the temperature was out of acceptable range 22 out of 22 days: 1(-19), 2(-19), 3(-19), 4(-19), 7(-19), 8 (-19), 9(-18), 10(-19), 11(-18), 14(-19), 15(-19), 16(-19), 17(-19), 18(-19), 21(-19), 22 (-19), 23(-19), 24(-18), 25(-19), 28(-19), 29(-19), and 30(-19). In February 2021 the temperature was out of acceptable range 1 out of 20 days: 8(-19). In April 2021 the temperature was out of acceptable range 2 out of 19 days: 2(-19) and 8(-19). In June 2021 the temperature was out of acceptable range 2 out of 15 days: 8(-19) and 16 (-18). Interview on 06/21/21 at 2:45 PM with the Technical Consultant confirmed that the temperature was not in accordance with the manufacturer's temperature range for storage of the Chemistry controls and calibrators. -- 2 of 3 -- D5779

Summary Statement of Deficiencies D0000 A desk review survey of the laboratory's proficiency test results was performed on September 28, 2020 for CBS Labs of Tampa. The laboratory, CBS Labs of Tampa, is not in compliance with Code of Federal Regulations (CFR), Part 493, Laboratory Requirements. 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 2019 and 2020, the laboratory did not have successful performance in proficiency testing for the subspecialty of routine chemistry. Refer to D 2096. Findings include: Review of the American Proficiency Institute (API) proficiency testing records and the review of the 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 -- Centers for Medicare & Medicaid Services (CMS) 153 and 155 reports, on September 28, 2020 on or about 10:00 AM, showed that the laboratory had unsatisfactory testing scores for the analyte, total cholesterol for two consecutive testing events in 2020. D2096 ROUTINE CHEMISTRY CFR(s): 493.841(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 performance in proficiency testing in the sub-specialty of routine chemistry. Findings include: On September 28, 2020 on or about 10:00 AM the American Proficiency Institute (API) 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, total cholesterol, as shown below. Event #1, 2020 total cholesterol-60% Event #2, 2020 total cholesterol-0% D6000 MODERATE COMPLEXITY LABORATORY DIRECTOR CFR(s): 493.1403 The laboratory must have a director who meets the qualification requirements of 493. 1405 of this subpart and provides overall management and direction in accordance with 493.1407 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 routine chemistry. Findings include: On September 28, 2020, on or about 10:00 AM, the American Proficiency Institute (API) 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 consecutive testing events for the analyte, total cholesterol, in the sub-specialty of routine chemistry. The laboratory director is responsible for ensuring that the laboratory maintains successful participation in proficiency testing. Refer to D 2130. D6016 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(i) 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, and record and report test results promptly, accurate, and proficiently and for assuring compliance with the applicable regulations. (e) The laboratory director must-- (e)(4)(i) Ensure that the proficiency testing samples are tested as required under Subpart H of this part; -- 2 of 3 -- 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 for the analyte, total cholesterol, in the sub-specialty of routine chemistry. Findings Include: The review of the American Proficiency Institute (API) proficiency testing records and the Centers for Medicare & Medicaid Services (CMS) 153 and 155 reports on September 28, 2020 on or about 10:00 AM showed that the laboratory received unsatisfactory proficiency testing scores as shown below. Event #1, 2020 total cholesterol-60% Event #2, 2020 total cholesterol-0% -- 3 of 3 --

Summary Statement of Deficiencies D0000 An announced CLIA recertification survey was conducted at CBS Labs of Tampa on 05/14/2019 - 05/20/2019. The laboratory is not in compliance with 42 CFR Part 493, Requirement for Laboratories. An Immediate Jeopardy situation was identified and the laboratory was notified at 02:00 PM on 05/20/19. The laboratory failed to complete performance verification for Bio - Rad D-10 Hemoglobin A1C instrument and to have the performance verification for Bio - Rad D-10 Hemoglobin A1C instrument and the Beckman Coulter Unicel DxI 600 instrument that performs testing for prostate specific antigen(PSA)horionic gonatropin(HCG), folate, Vitamin B12, thyroxine (T4), free thryoxine (FT4), triiodothyronine (T3), free triidothyronine (FT3), tridothyronine uptake (T3 uptake), and thyroid stimulating hormone (TSH) approved by the Laboratory Director. (See D5400) The following Conditions were cited: D5400 Analytic Systems 493.1250 D6000 Moderate Complexity Laboratory Director 493.1403 D2121 HEMATOLOGY CFR(s): 493.851(a) Failure to attain a score of at least 80 percent of acceptable responses for each analyte in each testing event is unsatisfactory analyte performance for the testing event. This STANDARD is not met as evidenced by: Based on review of American Proficiency Institute (API) proficiency testing results and interview with the Technical Consultant #B, the laboratory failed to score at least 80% for White Blood Cell in 1 (2018 Hematology 2nd Event) Event out of 5 (3rd testing event 2017, 2018 1st, 2nd, 3rd Events, and 2019 1st Event) testing events reviewed in the specialty of Hematology. Findings Included: Review of API Hematology proficiency testing results revealed a score of 60% for White Blood Cell for the 2nd Event for 2018. Interview on 05/15/16 at 10:15 AM the Technical Consultant #B confirmed the proficiency testing failure. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 5 -- D5217 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(c)(1) At least twice annually, the laboratory must verify the accuracy of any test or procedure it performs that is not included in subpart I of this part. This STANDARD is not met as evidenced by: Based on review of American Proficiency Institute (API) proficiency testing , and interview with the Technical Consultant #B, the laboratory failed to ensure the accuracy of ammonia and hemoglobin A1C testing twice a year for 2018 for the subspecialty of Routine Chemistry. Findings Included: Review of API proficiency testing results for 2018 revealed that ammonia and hemoglobin A1C results were not included in the 2018 proficiency testing records. Interview on 05/15/19 at 10:00 AM, Technical Consultant #B confirmed that the laboratory did not enroll ammonia and hemoglobin A1C analytes for 2018 API proficiency or verify twice annually to confirm accuracy. 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 record review and interview with the Technical Consultant, the laboratory failed to follow Beckman Coulter manufacturer's instructions for the Unicel DxI 600 maintenance requirements (See D5411), failed to define the acceptable range for the measure of resistance (Ohms) for the de-ionized water, (See D5413), and failed to have completed the Bio-Rad D-10 Hemoglobin A1C performance verification and to have the performance verification for the Bio-Rad D-10 Hemoglobin A1c and the Beckman Coulter Unicel DxI 600 aprroved by the Laboratory Director. (See D5421) D5411 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(a) Test systems must be selected by the laboratory. The testing must be performed following the manufacturer's instructions and in a manner that provides test results within the laboratory's stated performance specifications for each test system as determined under 493.1253. This STANDARD is not met as evidenced by: Based on record review and interview with the Technical Consultant #B, the laboratory failed to follow Beckman Coulter manufacturer's instructions regarding the maintenance requirements for the Beckman Coulter Unicel DxI 600 chemistry analyzer . Findings included: Record review of the Beckman Coulter Maintenance logs for the Beckman Coulter Unicel DxI 600 analyzer revealed that the maintenance -- 2 of 5 -- logs included a 5000 test interval maintenance and a 10,000 test interval maintenance. The maintenance records showed that the 5000 tests was reached 12/07/18 and the 10000 tests was reached 03/13/19. As of 5/16/19 the maintenance for 5000 tests and 10000 tests had not been performed and the number of tests was 12,825. Interview on 05/16/19 at 2:00 PM, the Technical Consultant confirmed the 5000 test interval maintenance and 10000 test interval maintenance had not been performed. 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 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 record review, lack of documentation, and interview with Testing Personnel #D, the laboratory failed to define the acceptable range for the measure of resistance (which is measured in Ohms) for the De-ionized water for the Beckman Coulter AU680 from 11/18 to 05/15/19. Findings Included: Review of De-ionized Water Check logs for the laboratory found that there was not a defined range for the Ohms for the de-ionized water but the Ohms had been documented. Review of de-ionized water procedures revealed that the laboratory did not have manufacturer's instructions available at time of survey. Review of the laboratory's "Chemistry Distilled Water Q. C. procedure did not include the acceptable range for the Ohms for the de-ionized water. Interview on 05/16/19 at 12:30 PM Testing Personnel #D confirmed that the De-ionized Water Check logs and the "Chemistry Distilled Water Q.C. procedure did not include the acceptable range. D5421 ESTABLISHMENT AND VERIFICATION OF PERFORMANCE CFR(s): 493.1253(b)(1) Each laboratory that introduces an unmodified, FDA-cleared or approved test system must do the following before reporting patient test results: (1)(i) Demonstrate that it can obtain performance specifications comparable to those established by the manufacturer for the following performance characteristics: (1)(i)(A) Accuracy. (1)(i) (B) Precision. (1)(i)(C) Reportable range of test results for the test system. (1)(ii) Verify that the manufacturer's reference intervals (normal values) are appropriate for the laboratory's patient population. This STANDARD is not met as evidenced by: Based on record review and interview with the Technical Consultant #B, the laboratory failed to complete the performance verification for the Bio - Rad D-10 Hemoglobin A1C instrument performed 09/27/18 and failed to have the Laboratory Director approve the Bio - Rad D-10 Hemoglobin A1C instrument performance verification and the performance verification performed 09/18/18 on the Beckman Coulter Unicel DxI 600 instrument. Findings included: A. Record review of the performance verification performed 09/27/18 for the Bio - Rad Hemoglobin A1C -- 3 of 5 -- instrument revealed that the linearity verfication data had not been calculated and all sections of the performance verification for the Bio - Rad D-10 Hemoglobin A1C had not been approved by the Laboratory Director. Review of the Patient's Hemoglobin A1C result log revealed 1379 patient Hemoglobin A1C results were reported after 09 /27/18. Interview on 05/15/19 at 02:00 PM, the Technical Consultant #B confirmed that the laboratory started patient testing 09/28/18 before the Laboratory Director aprroved the performance verification. The Technical consultant #B also stated that all abnormal hemoglobins were repeated and glucose values looked up before reporting but these steps were not in the Bio - Rad D-10 Hemoglobin A1C procedure. B. Review of the performance verification performed 09/18/18 for the Beckman Coulter Unicel DxI 600 revealed that the Laboratory Director had not approved the performance verification and the T3 uptake linearity study had only 1 data point. The laboratory has been testing patients since 10/2018. In the performance verification binder for the Beckman Coulter Unicel DxI 600 was a manufacturer instruction for T3 Uptake that stated the laboratory had to find their own specimens to determine linearity which had not been done at the time of survey. Review of the patient result log for T3 Uptake revealed the laboratory had tested 43 patients. Interview on 05/20 /19 at 12:00 PM, the Technical Consultant #B confirmed that the laboratory had not performed a linearity study on T3 Uptake and did not have the Laboratory Director approve the completed performance verifications for the Beckman Coulter Unicel DxI 600. D6000 MODERATE COMPLEXITY LABORATORY DIRECTOR CFR(s): 493.1403 The laboratory must have a director who meets the qualification requirements of 493. 1405 of this subpart and provides overall management and direction in accordance with 493.1407 of this subpart. This CONDITION is not met as evidenced by: Based on record review and interview with the Laboratory Director, the Laboratory Director failed to ensure that testing systems used in the laboratory provided quality laboratory services for all aspects of testing performance from 05/18 to 10/18. (See 6007) and to sign and approve the perfomance verification procedures for the Bio - Rad D-10 Hemoglobin A1C instrument and Beckman Coulter Unicel DxI 600 instrument. (See D6013), D6007 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(1) 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, and record and report test results promptly, accurate, and proficiently and for assuring compliance with the applicable regulations. (E) The laboratory director must-- (E)(1) Ensure that testing systems developed and used for each of the tests performed in the laboratory provide quality laboratory services for all aspects of test performance, which includes the preanalytic, analytic, and postanalytic phases of testing; This STANDARD is not met as evidenced by: Based on record review and interview with the Laboratory Director, the Laboratory -- 4 of 5 -- Director failed to ensure that testing systems used in the laboratory provided quality laboratory services for all aspects of testing performance, preanalytic and analytic from 05/18 to 10/18. Findings included: A. Review of the laboratory's procedure manual revealed a job description for the General Supervisor which included Technical Consultant responsibilities and evaluation criteria for assessment of employee training and competency. Interview on 05/14/19 at 0230, the Technical Consultant confirmed that the Laboratory Director did not document training and competencies for the Technical Consultants, #B. B. Record review of performance verifications revealed that the Bio - Rad D-Hemoglobin A1C instrument performance verifcation was performed 09/27/18 but had not been completed and the performance verification for the Bio - Rad Hemoglobin A1C instrument and Beckman Coulter Unicel DxI testing had not been approved by the Laboratory Director. Hemoglobin A1C patient testing had started 09/28/18 and patient testing on the Beckman Coulter Unicel DxI had started 10/23/18. Interview on 05/15/2019 at 02:00 PM the Technical Consultant #B confirmed the Bio-Rad D-10 Hemoglobin A1C instrument performance verification had not been completed. or approved by the Laboratory Director Interview on 05/20/19 at 12:00 PM the Technical Conultant #B confirmed the Beckman Coulter Unicel DxI 600had not been appproved by the Laboratory Director. D6013 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(3)(ii) 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, and record and report test results promptly, accurate, and proficiently and for assuring compliance with the applicable regulations. (e) The laboratory director must-- (e)(3) Ensure that-- (e)(3)(ii) 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 with the Laboratory Director, the Laboratory Director failed to approve the performance verification procedures for the Bio - Rad D-10 Hemoglobin A1C instrument and Beckman Coulter Unicel DxI 600. Findings included: Record review of the performance verification performed 09/27/18 for the Bio - Rad D-10 Hemoglobin A1C instrument revealed that the linearity verification data had not been calculated and all sections of the performance verification for the Hemoglobin A1C had not been approved by the Laboratory Director. Review of the performance verification performed 09/18/18 for the Beckman Coulter Unicel DxI 600 showed the Laboratory Director had not signed and approved. Interview on 05/20 /19 at 04:20 PM, Laboratory Director was unaware that the performance verifications had not been finished and approved. -- 5 of 5 --