Select Laboratories - Marion County, Fl Llc

Summary Statement of Deficiencies D0000 An announced CLIA recertification survey was conducted at Select Laboratories- Marion County FL LLC on 07/09/2025 - 07/15/2025. The laboratory is not in compliance with 42 CFR Part 493, Requirement for Laboratories. The following Conditions were cited: D6168 493.1487 Condition: Testing Personnel D5481 CONTROL PROCEDURES CFR(s): 493.1256(f)(g) (f) Results of control materials must meet the laboratorys and, as applicable, the manufacturers test system criteria for acceptability before reporting patient test results. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on record review and interview, the Laboratory reported Patient test results when quality control (QC) was not in the normal range for Parathyroid Hormone (PTH) on 12/28/2023 and Alanine Aminotransferase (ALT) on 07/22/2024. Findings Included: 1. The QC was reviewed for 12/2023, 07/2024, and 03/2025 for all analytes tested. 2. Review of PTH QC revealed level 1 lower than the normal range with 1 Patient tested and reported. 3. Review of ALT controls revealed level 2 and level 3 both lower than the normal range with 8 Patients tested and reported. 4. Interview on 07/10/2025 at 2:00 PM the Technical Supervisor confirmed the unacceptable QC with Patients reported. D5805 TEST REPORT CFR(s): 493.1291(c) (c) The test report must indicate the following: (c)(1) For positive patient identification, either the patient's name and identification number, or a unique patient identifier and identification number. (c)(2) The name and address of the laboratory location where the test was performed. (c)(3) The test report date. (c)(4) The test 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 -- performed. (c)(5) Specimen source, when appropriate. (c)(6) The test result and, if applicable, the units of measurement or interpretation, or both. (c)(7) Any information regarding the condition and disposition of specimens that do not meet the laboratory's criteria for acceptability. This STANDARD is not met as evidenced by: Based on record review and interview, the Laboratory failed to have Patient reports that had an accurate date for testing and accurate reference Laboratory listed for send outs for 1 of 1 Patient record reviewed. Findings Included: 1. Review of Patient laboratory report from 12/08/2023 revealed that the Hematology, Chemistry, and the send out testing was all completed on 01/04/2025. 1a. Review of the Hematology and Chemistry analyzers revealed that the testing was performed 12/28/2023. 2. Review of the send out testing (Creatinine, Random Urine) revealed that it was performed by a sister laboratory in South Carolina and was performed by a reference laboratory in Virginia. 2a. Review of the send out results for Creatinine, Random Urine revealed that it was performed by the reference laboratory in Virginia. 3. Interview on 07/10 /2025 at 4:00 PM the Technical Supervisor confirmed that the testing date and location of send outs were incorrect. 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 had 1 (# B) out of 2 (#A and #B) Testing Personnel (TP) that did not qualify to perform High Complexity testing (See D6170). D6171 TESTING PERSONNEL QUALIFICATIONS CFR(s): 493.1489(b) (b) Meet one of the following requirements: (b)(1) 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 (b)(2)(i) Have earned a doctoral, master's, or bachelor's degree in a chemical, biological, clinical or medical laboratory science, or medical technology from an accredited institution; or (b)(2)(ii) Be qualified under the requirements of 493.1443(b)(3) or 493.1449(c)(4) or (5); or (b)(3)(i) Have earned an associate degree in a laboratory science or medical laboratory technology from an accredited institution or (b)(3)(ii) Have education and training equivalent to that specified in paragraph (b)(2)(i) of this section that includes (b)(3)(ii) (A) At least 60 semester hours, or equivalent, from an accredited institution that, at a minimum, includes either (b)(3)(ii)(A)(1) 24 semester hours of medical laboratory technology courses; or (b)(3)(ii)(A)(2) 24 semester hours of science courses that include (b)(3)(ii)(A)(2)(i) 6 semester hours of chemistry; (b)(3)(ii)(A)(2)(ii) 6 semester hours of biology; and (b)(3)(ii)(A)(2)(iii) 12 semester hours of chemistry, biology, or medical laboratory technology in any combination; and (b)(3)(ii)(B) Have laboratory training that includes: (b)(3)(ii)(B)(1) Completion of a clinical laboratory training program approved or accredited by the ABHES or the CAAHEP (this training -- 2 of 3 -- may be included in the 60 semester hours listed in paragraph (b)(3)(ii)(A) of this section); or (b)(3)(ii)(B)(2) At least 3 months documented laboratory training in each specialty in which the individual performs high complexity testing; or (b)(4) Successful completion of an official U.S. military medical laboratory procedures training course of at least 50 weeks duration and having held the military enlisted occupational specialty of Medical Laboratory Specialist (Laboratory Technician); or (b)(5) Notwithstanding any other provision of this section, an individual is considered qualified as a high complexity testing personnel under this section if they were qualified and serving as a high complexity testing personnel in a CLIA-certified laboratory as of December 28, 2024, and have done so continuously since December 28, 2024. (b)(6) For blood gas analysis (b)(6)(i) Be qualified under paragraph (b)(1), (2), (3), (4), or (5) of this section; or (b)(6)(ii) Have earned a bachelor's degree in respiratory therapy or cardiovascular technology from an accredited institution; or (b) (6)(iii) Have earned an associate degree related to pulmonary function from an accredited institution. (b)(7) For histopathology, meet the qualifications of 493.1449 (b) or (f) to perform tissue examinations. This STANDARD is not met as evidenced by: Based on record review and interview, the Laboratory had 1 (# B) out of 2 (#A and #B) Testing Personnel (TP) that did not qualify to perform High Complexity testing. Findings Included: 1. Review of the FORM CMS-209 signed and dated by the Laboratory Director 07/07/2025 revealed there were 2 TP who performed High Complexity Testing. 2. Review of TP#B employee file revealed they were hired on 10 /2024. He had a transcript from a Medical Clinical Laboratory Technician Program and a High School diploma. 3. Interview with the school on 07/09/2025 at 3:41 PM confirmed that the school did not issue an associates degree, but issues "career certificates". 4. Interview on 07/09/2025 at 4:00 PM TP#B confirmed that he did not have any other college classes, only his high school diploma and career certificate and that he performed High complexity Hematology and Chemistry testing in the Laboratory. -- 3 of 3 --

Summary Statement of Deficiencies D0000 A desk review survey of the laboratory's proficiency test results was performed on September 20, 2022 for Select Laboratories-Marion County. Select Laboratories- Marion County is not in compliance with the 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 2021 and 2022, the laboratory did not have successful performance in proficiency testing for analyte in the subspecialty of endocrinology. Refer to D2108. Findings include: Review of the American Association of Bioanalysts (AAB) proficiency testing records and 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 -- review of the Centers for Medicare & Medicaid Services (CMS) 153 and 155 reports, on September 20, 2022 on or about 10:00 AM, showed that the laboratory had unsatisfactory testing scores for the analyte, liothyronine, T3, for two out of three testing events in 2021 and 2022. D2108 ENDOCRINOLOGY CFR(s): 493.843(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 performance in proficiency testing for an analyte in the subspecialty of endocrinology. Findings include: On September 20, 2022 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, T3, as shown below. Event #3, 2021 T3-20% Event #2, 2022 T3-60% 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 in proficiency testing for analytes found in the subspecialty of endocrinology. Findings include: On September 20, 2022, 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, T3, in the subspecialty of endocrinology. The laboratory director is responsible for ensuring that the laboratory maintains successful participation in proficiency testing. Refer to D2108. 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 -- 2 of 3 -- manner as to achieve and maintain successful participation in proficiency testing for analyte(s) found in the subspecialty of endocrinology. 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 Septmeber 20, 2022, on or about 10:00 AM showed that the laboratory received unsatisfactory proficiency testing scores for two out of three testing events for the analytes shown below. Event #3, 2021 T3-20 % Event #2 2022 T3-60%. -- 3 of 3 --

Summary Statement of Deficiencies D0000 A desk review survey of the laboratory's proficiency test results was performed January 25, 2021 for Select Laboratories-Marion. Select Laboratories-Marion 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 endocrinology. Refer to D2107 Findings include: Review of the American Associates of Bioanalysts (AAB) proficiency testing records and the review 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 -- of the Centers for Medicare & Medicaid Services (CMS) 153 and 155 reports, on January 25, 2021 on or about 10:00 AM, showed that the laboratory had unsatisfactory testing scores for the analyte, human chorionic gonadotropin, HCG, for two consecutive testing events in 2020. D2107 ENDOCRINOLOGY CFR(s): 493.843(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 subspeciality of endocrinology. Findings include: On January 25, 2021 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, human chorionic gonadotropin, HCG, as shown below. Event #2, 2020 HCG-0% Event #3, 2020 HCG-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 endocrinology. Findings include: On January 25, 2021 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, human chorionic gonadotropin, HCG, in the subspeciality of endocrinology. The laboratory director is responsible for ensuring that the laboratory maintains successful participation in proficiency testing. Refer to D2107. 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 -- 2 of 3 -- manner as to achieve and maintain successful participation in proficiency testing for the analyte, human chorionic gonadotropin, HCG, in the subspecialty of endocrinology. 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 25, 2021 on or about 10:00 AM showed that the laboratory received unsatisfactory proficiency testing scores as shown below. Event #2, 2020 HCG-0% Event #3, 2020 HCG-0% -- 3 of 3 --

Summary Statement of Deficiencies D0000 An announced recertification survey was conducted on 12/21/20 at Select Laboratories - Marion County, a clinical laboratory in Ocala, Florida. Select Laboratories - Marion County is NOT in compliance with Code of Federal Regulations (CFR) 42, Part 493, Laboratory Requirements. . D2094 ROUTINE CHEMISTRY CFR(s): 493.841(e) (1) For any unsatisfactory analyte or test performance or testing event for reasons other than a failure to participate, the laboratory must undertake appropriate training and employ the technical assistance necessary to correct problems associated with a proficiency testing failure. (2) For any unacceptable analyte or testing event score, remedial action must be taken and documented, and the documentation must be maintained by the laboratory for two years from the date of participation in the proficiency testing event. This STANDARD is not met as evidenced by: Based on record review and interview with staff, the laboratory did not maintain complete proficiency testing records when remedial actions were performed for unsatisfactory test results for one of two chemistry testing events reviewed in 2019. Findings include: On 12/21/20, the laboratory AAB (American Association of Bioanalysts) proficiency testing records were reviewed. During the review, it was determined that the laboratory had received unsatisfactory test scores. The records provided by the laboratory did not identify the cause of the error or describe the steps that the laboratory performed in order to ensure that the error did not reoccur. 2019, Testing event #3 PSA (Prostate-specific antigen)-50% The interview with the Technical Supervisor on 12/21/20 on or about 11:35am revealed there was an investigation performed but was unable to locate the documentation. . D2105 ENDOCRINOLOGY Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 2 -- CFR(s): 493.843(e) (1) For any unsatisfactory analyte or test performance or testing event for reasons other than a failure to participate, the laboratory must undertake appropriate training and employ the technical assistance necessary to correct problems associated with a proficiency testing failure. (2) For any unacceptable analyte or testing event score, remedial action must be taken and documented, and the documentation must be maintained by the laboratory for two years from the date of participation in the proficiency testing event. This STANDARD is not met as evidenced by: Based on record review and interview with staff, the laboratory did not maintain complete proficiency testing records when remedial actions were performed for unsatisfactory test results for one of two endocrinology testing events reviewed in 2020. Findings include: On 12/21/20, the laboratory AAB (American Association of Bioanalysts) proficiency testing records were reviewed. During the review, it was determined that the laboratory had received unsatisfactory test scores. The records provided by the laboratory did not identify the cause of the error or describe the steps that the laboratory performed in order to ensure that the error did not reoccur. 2020, Testing event #1 TT3 (Total Triiodothyronine)-60% The interview with the Technical Supervisor on 12/21/20 on or about 12:40pm revealed there was an investigation performed but was unable to locate the documentation. -- 2 of 2 --

Summary Statement of Deficiencies D0000 Initial survey conducted on 07/16/2019 found Condition at D-6063 out of compliance. D5415 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(c) Reagents, solutions, culture media, control materials, calibration materials, and other supplies, as appropriate, must be labeled to indicate the following: (1) Identity and when significant, titer, strength or concentration. (2) Storage requirements. (3) Preparation and expiration dates. (4) Other pertinent information required for proper use. This STANDARD is not met as evidenced by: Based on observation, and staff interview, the facility failed to ensure the glass jars used for the Wrights Stain procedure were labeled with the identity of the stain, preparation, and expiration date. Finding include: 1. During the tour of the laboratory on 7/16/19 at 12:50 pm, one jar with no label was observed on the counter in the hematology testing area with liquid inside. The interview with the testing person on 7 /16/19 at 12:50 pm confirmed the jar was used for making blood smears using the Wrights Stain procedure. D6063 LABORATORY TESTING PERSONNEL CFR(s): 493.1421 The laboratory must have a sufficient number of individuals who meet the qualification requirements of 493.1423, to perform the functions specified in 493. 1425 for the volume and complexity of tests performed. This CONDITION is not met as evidenced by: Based on record review and interview it was determined that the staff member who Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 2 -- performed the establishment of performance verification on the ACL 2000, IR 1200, and IR 500 does not possess a current license issued by the state of Florida to be compliance by state law. (Refer to D6064) D6064 TESTING PERSONNEL QUALIFICATIONS CFR(s): 493.1423(a) Each individual performing moderte 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 it was determined that the staff member who performed the establishment of performance verification on the ACL 2000, IR 1200, and IR 500 does not possess a current license issued by the state of Florida to be compliance by state law. Findings include: The review of instrument validation documentation showed the staff member who performed the validation studies for the ACL 2000, IR 1200, and IR 500 is not licensed in State of Florida as a clinical laboratory technologist or clinical laboratory technician. Since patient testing began in May 2019, 2 patients have been tested on the ACL 2000 for coagulation studies, 96 patients on the IR 1200 for Chemistry, and 0 patients tested on the IR 500 for Toxicology. During an interview with the general supervisor on 7/16/19 at 11:30am, it was confirmed the staff member is not licensed in State of Florida as clinical laboratory technologist or clinical laboratory technician. -- 2 of 2 --