Clinicore

Summary Statement of Deficiencies D0000 A Complaint survey (LA00079526) was performed at Clinicore, CLIA ID 19D2139173, on August 13, 2025. Clinicore was found not in compliance with the following CONDITION LEVEL DEFICIENCIES: 42 CFR 493.1441: CONDITION: Laboratories performing high complexity testing; Laboratory Director 42 CFR 493.1453: CONDITION: Laboratories performing high complexity testing; Clinical Consultant D5311 SPECIMEN SUBMISSION, HANDLING, AND REFERRAL CFR(s): 493.1242(a) (a) The laboratory must establish and follow written policies and procedures for each of the following, if applicable: (a)(1) Patient preparation. (a)(2) Specimen collection. (a)(3) Specimen labeling, including patient name or unique patient identifier and, when appropriate, specimen source. (a)(4) Specimen storage and preservation. (a)(5) Conditions for specimen transportation. (a)(6) Specimen processing. (a)(7) Specimen acceptability and rejection. (a)(8) Specimen referral. This STANDARD is not met as evidenced by: I. Based on review of the laboratory's policies and interview with personnel, the laboratory failed to establish a written policy for direct to consumer laboratory testing, in which laboratory tests are ordered directly by the patient not through a medical provider. Findings: 1. Review of the laboratory's policies revealed the laboratory did not include a written policy for direct to consumer patient testing including process for ordering, add-on testing, and transmission of results. 2. In interview on August 13, 2025 at 10:24 am, the Technical Supervisor stated the laboratory did not have a written policy related to direct to consumer laboratory testing. II. Based on review of the laboratory's sample receipt log and interview with personnel, the laboratory failed to document the temperature of samples received per laboratory policy for 148 of 148 days reviewed. Findings: 1. Review of the laboratory's "Off Site Sample Condition Log" revealed the laboratory had columns that included room temperature (15-30 Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 7 -- degrees Celsius), frozen (-20 degrees Celsius), and refrigerated (2-8 degrees Celsius). 2. Further review of the laboratory's "Off Site Sample Condition Log" for 2025, January 2025 through July 2025, revealed the laboratory staff documented the number of bags received at the applicable temperature and documented "yes, acceptable condition upon arrival" for 148 days reviewed, but the temperature at receipt was not documented. 3. In interview on August 13, 2025 at 10:30 am, the accessioning personnel stated she takes the temperature of the samples upon receipt and documents the number of samples received, not the actual temperature. 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 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 review of random selection of patient test reports and interview with personnel, the laboratory failed to include the name and address of the testing location for samples sent to reference laboratories for nine (9) of fourteen (14) patients reviewed. Findings: 1. In interview on August 13, 2025 at 12:07 pm, the Technical Supervisor stated some tests such as Complete Blood Counts (CBC ) and ANA testing are sent to another reference laboratory for testing. 2. Review of random selection of patient test reports revealed the following patients had testing performed at a reference laboratory without the name and address of the testing location listed: January 9, 2025: Patient 115678- CBC test February 19, 2025 Patient 117775 CBC test July 17, 2025 Patient 125032 CBC test July 24, 2025 Patient 125431 CBC test July 24, 2025 Patient 125414 CBC test July 24, 2025 Patient 125400 CBC test July 31, 2025 Patient 125648 CBC test August 2, 2025 Patient 125771 ANA test August 8, 2025 Patient 126003 CBC test 3. In further interview on August 13, 2025 at 12:33 pm, the Technical Supervisor stated he was not sure why the reference laboratory's information did not print out on the final reports. D5807 TEST REPORT CFR(s): 493.1291(d) (d) Pertinent "reference intervals" or "normal" values, as determined by the laboratory performing the tests, must be available to the authorized person who ordered the tests and, if applicable, the individual responsible for using the test results. This STANDARD is not met as evidenced by: Based on review of patient final test reports and interview with patients, the laboratory failed to report race-free values for the estimated glomerular filtration rate (eGFR) calculations for twelve (12) of fourteen (14) patients reviewed. Findings: 1. Review random selection of patient final reports revealed the following twelve (12) patients had race based eGFR results reported: January 8, 2025: Patient 115678 February 6, -- 2 of 7 -- 2025: Patient 117146 July 9, 2025: Patient 124714 July 15, 2025: Patient 124985 July 15, 2025: Patient 125032 July 23, 2025: Patient 125400 July 23, 2025: Patient 125431 July 23, 2025: Patient 125414 July 30, 2025: Patient 125648 July 31, 2025: Patient 125783 August 7, 2025: Patient 126003 August 8, 2025: Patient 126086 2.In interview on August 13, 2025 at 12:07 pm, the Technical Supervisor confirmed the laboratory reported eGFR results based on race. D6014 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(3)(iii) (e)(3)(iii) Laboratory personnel are performing the test methods as required for accurate and reliable results; This STANDARD is not met as evidenced by: Based on record review and interview with personnel, the Laboratory Director failed to ensure the laboratory personnel performed test methods as required. Refer to D5311 II. D6026 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(8) (e)(8) Ensure that reports of test results include pertinent information required for interpretation; This STANDARD is not met as evidenced by: Based on record review and interview with personnel, the Laboratory Director failed to ensure patient final reports included required pertinent information. Findings: 1. The laboratory failed to include the name and address of the testing location for samples sent to reference laboratories for nine (9) of fourteen (14) patients reviewed. Refer to D5805. 2. The laboratory failed to report race-free values for the estimated glomerular filtration rate (eGFR) calculations for twelve (12) of fourteen (14) patients reviewed. Refer to D5807. 3. The Clinical Consultant failed to ensure race-free estimated glomerular filtration rate (eGFR) calculations were reported. Refer to D6061. D6036 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413 The technical consultant is responsible for the technical and scientific oversight of the laboratory. The technical consultant is not required to be onsite at all times testing is performed; however, he or she must be available to the laboratory on an as needed basis to provide consultation, as specified in paragraph (a) of this section. This STANDARD is not met as evidenced by: Based on record review and interview with personnel, the Technical Consultant failed to provide technical and scientific oversight to the laboratory. Findings: 1. The laboratory failed to document the temperature of samples received per laboratory policy for 148 of 148 days reviewed. Refer to D5311 II. 2. The laboratory failed to include the name and address of the testing location for samples sent to reference laboratories for nine (9) of fourteen (14) patients reviewed. Refer to D5805. -- 3 of 7 -- D6061 CLINICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1419(c) (c) Ensure that reports of test results include pertinent information required for specific patient interpretation; and This STANDARD is not met as evidenced by: Based on review of random selection of patient final reports and interview with personnel, the Clinical Consultant failed to ensure race-free estimated glomerular filtration rate (eGFR) calculations were reported. Refer to D5807. 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 with personnel, the Laboratory Director failed to provide overall management and direction for the laboratory. Findings: 1. The Laboratory Director failed to ensure the laboratory personnel performed test methods as required. Refer to D6087. 2. The Laboratory Director failed to ensure patient final reports included required pertinent information. Refer to D6098. 3. The Laboratory Director failed to ensure personnel providing consultation met Clinical Consultant qualification requirements. Refer to D6101. 4. The Laboratory Director failed to ensure that an approved procedure manual was available to all personnel. Refer to D6106. D6087 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(3)(iii) (e)(3)(iii) Laboratory personnel are performing the test methods as required for accurate and reliable results; This STANDARD is not met as evidenced by: Based on record review and interview with personnel, the Laboratory Director failed to ensure the laboratory personnel performed test methods as required. Refer to D5311 II. D6098 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(8) (e)(8) Ensure that reports of test results include pertinent information required for interpretation; This STANDARD is not met as evidenced by: -- 4 of 7 -- Based on record review and interview with personnel, the Laboratory Director failed to ensure patient final reports included required pertinent information. Refer to D5805. D6101 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(11) (e)(11) 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: Based on record review and interview with personnel, the Laboratory Director failed to ensure personnel providing consultation met Clinical Consultant qualification requirements. Refer to D6135. D6106 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(14) (e)(14) Ensure that an approved procedure manual is available to all personnel responsible for any aspect of the testing process; and This STANDARD is not met as evidenced by: Based on record review and interview with personnel, the Laboratory Director failed to ensure that an approved procedure manual was available to all personnel. Refer to D5311 I. D6112 TECHNICAL SUPERVISOR RESPONSIBILITIES CFR(s): 493.1451 The technical supervisor is responsible for the technical and scientific oversight of the laboratory. The technical supervisor is not required to be on site at all times testing is performed; however, he or she must be available to the laboratory on an as needed basis to provide supervision as specified in (a) of this section. This STANDARD is not met as evidenced by: Based on record review and interview with personnel, the Technical Supervisor failed to provide technical and scientific oversight to the laboratory. Findings: 1. The laboratory failed to document the temperature of samples received per laboratory policy for 148 of 148 days reviewed. Refer to D5311 II. 2. The laboratory failed to include the name and address of the testing location for samples sent to reference laboratories for nine (9) of fourteen (14) patients reviewed. Refer to D5805. D6134 CLINICAL CONSULTANT CFR(s): 493.1453 The laboratory must have a clinical consultant who meets the requirements of 493. 1455 of this subpart and provides clinical consultation in accordance with 493.1457 of this subpart. -- 5 of 7 -- This CONDITION is not met as evidenced by: Based on review of the laboratory's CMS-209, review of patient final test reports, and interview with personnel, the laboratory failed to ensure personnel providing clinical consultation met Clinical Consultant qualifications. Findings: 1. The laboratory failed to ensure personnel providing consultation related to diagnosis, treatment, and management of patient care met Clinical Consultant qualifications. Refer to D6135. 2. The Clinical Consultant failed to provide consultation to five (5) of fourteen (14) patients reviewed. Refer to D6136. D6135 CLINICAL CONSULTANT QUALIFICATIONS CFR(s): 493.1455 The clinical consultant must be qualified to consult with and render opinions to the laboratory's clients concerning the diagnosis, treatment and management of patient care. The clinical consultant must-- (a) Be qualified as a laboratory director under 493. 1443(b)(1), (2), or (3) for the subspecialty of oral pathology, 493.1443(b)(5); or (b) Be a doctor of medicine, doctor of osteopathy, doctor of podiatric medicine licensed to practice medicine, osteopathy, or podiatry in the State in which the laboratory is located. This STANDARD is not met as evidenced by: Based on review of the laboratory's CMS-209 form, personnel records, review of direct to consumer patient final test reports, and interview with personnel, the laboratory failed to ensure personnel providing consultation related to diagnosis, treatment, and management of patient care met Clinical Consultant qualifications. Findings: 1. Review of the laboratory's CMS-208 form (Laboratory Personnel Report) revealed the Laboratory Director served as the laboratory's Clinical Consultant. 2. Review of the laboratory's personnel records revealed a "Delegation of Duties Form" and "Job Description: Clinical Consultant" completed for the Laboratory Director for his duties as Clinical Consultant. 3. In interview on August 13, 2025 at 10:40 am, the Technical Supervisor stated the laboratory's Director of Business Operations or the CEO transmitted final test reports to patients who received direct to consumer laboratory services. 4. Review of random selection of patient final test reports revealed the CEO, who did not meet the qualifications of Clinical Consultant, provided consultation concerning treatment and management of patient care. Refer to D6136. 5. In interview on August 13, 2025 at 10:48 am, the Technical Supervisor stated clinical questions and consultation are directed to the Laboratory Director, who serves as the Clinical Consultant. The Technical Supervisor confirmed the CEO was not the Clinical Consultant for the laboratory. D6136 CLINICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1457 The clinical consultant provides consultation regarding the appropriateness of the testing ordered and interpretation of test results. This STANDARD is not met as evidenced by: Based on review of the laboratory's personnel records, direct to consumer patient final test reports, and interview with personnel, the Clinical Consultant failed to provide -- 6 of 7 -- consultation to five (5) of fourteen (14) patients reviewed. Findings: 1. Review of the laboratory's personnel records revealed a "Delegation of Duties Form" and "Job Description: Clinical Consultant" completed for the Laboratory Director for his duties as Clinical Consultant. 2. Review of random selection of direct to consumer patient final test reports revealed the CEO provided consultation to the following five (5) patients: a) Reported July 18, 2025: Patient 125032 b) Reported July 28, 2025: Patient 125414 c) Reported August 4, 2025: Patient 125648, 125771 (same patient) d) Reported August 8, 2025: Patient 125783 e) Reported August 9, 2025: Patient 126003 3. In interview on August 13, 2025 at 2:46 pm, the Technical Supervisor confirmed the CEO, who was not a Clinical Consultant for the laboratory, provided consultation related to the identified patients' laboratory results. -- 7 of 7 --

Summary Statement of Deficiencies D0000 A Recertification survey was performed on March 25, 2024 at Clinicore, CLIA ID # 19D2139173. The laboratory was found in compliance with 42 CFR 493 Requirements for Laboratories; however, standard level deficiencies were cited. D5317 SPECIMEN SUBMISSION, HANDLING, AND REFERRAL CFR(s): 493.1242(d) If the laboratory accepts a referral specimen, written instructions must be available to the laboratory's clients and must include, as appropriate, the information specified in paragraphs (a)(1) through (a)(7) of this section. This STANDARD is not met as evidenced by: Based on review of the laboratory's test menu and client services manual as well as interview with personnel, the laboratory failed to include instructions for specimen handling, transport, and stability requirements for molecular microbiology and toxicology testing. Findings: 1. Review of the laboratory's test menu revealed the laboratory performed molecular microbiology and toxicology testing. 2. In interview on March 25, 2024 at 3:56 p.m., the Technical Supervisor stated the laboratory began testing molecular microbiology in March 2024 and toxicology in October 2023. 3. Review of the laboratory's client services manual revealed the laboratory did not include the testing identified above. 4. In interview on March 25, 2024 at 3:56 p.m., the Technical Supervisor confirmed the laboratory's client services manual was not updated to include molecular microbiology and toxicology requirements. 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) Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 7 -- Preparation and expiration dates. (4) Other pertinent information required for proper use. This STANDARD is not met as evidenced by: Based on observation, review of the manufacturer's package inserts, and interview with personnel, the laboratory failed to document the open expiration date for chemistry quality control (QC) material as required. Findings: 1. Observation by surveyors on March 25, 2024 at 10:15 a.m. revealed the following thawed chemistry quality control vials in the Insignia refrigerator. - BioRad Liquicheck Immunoassay Plus Control, Level 1, Lot: 85321, manufacturer's expiration date: 5/31/2024, Quantity: two (2) bottles - BioRad Liquicheck Immunoassay Plus Control, Level 2, Lot: 85322, manufacturer's expiration date: 5/31/2024, Quantity: one (1) bottle - BioRad Liquicheck Immunoassay Plus Control, Level 3, Lot: 85323, manufacturer's expiration date: 5/31/2024, Quantity: two (2) bottles - BioRad Liquicheck Specialty Immunoassay Control, Level 1, Lot 64991, manufacturer's expiration date: 5/31/2026: Quantity: one (1) bottle - BioRad Liquicheck Specialty Immunoassay Control, Level 3 Lot 64993, manufacturer's expiration date: 5/31/2026: Quantity: one (1) bottle 2. Further observation of the QC materials identified above revealed the bottles did not have an open expiration date documented. 3. Review of the manufacturer's package insert for BioRad Liquicheck Immunoassay Plus Control revealed the following storage and stability requirements: a) This product will be stable until the expiration date when stored unopened at -20 to -70 degrees Celsius. b) Thawed Unopened: When thawed and stored unopened at 2 to 8 degrees Celsius, this product is stable as follows: - All Analytes: 30 days Except: - Androstenedione: 25 days - Prolactin, PSA (Free) and PSA (Total): 14 days - Estradiol: 8 days - Folate: 4 days Date of thaw should be noted. c) Thawed opened: Once thawed, opened, and stored tightly capped at 2 to 8 degrees Celsius, this product will be stable as follows: - All Analytes: 14 days Except: - Estradiol: 5 days - Folate: 4 days 4. Review of the manufacturer's package insert for BioRad Liquicheck Specialty Immunoassay Control revealed the following storage and stability requirements: a) This product will be stable until the expiration date when stored unopened at -20 to -70 degrees Celsius. b) Thawed Opened: Once thawed, opened, and stored tightly capped at 2 to 8 degrees Celsius, this product will be stable as follows: - All Analytes: 30days Except: - PTH (Intact): 7 days c) Thawed Unopened: When thawed and stored unopened at 2 to 8 degrees Celsius, this product will be stable as follows: - All Analytes: 30days Except: - PTH (Intact): 7 days 5. In interview on March 25, 2024 at 10:45 a.m., the Technical Supervisor confirmed the laboratory did not document the open expiration date for the thawed QC materials identified above. D5417 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(d) Reagents, solutions, culture media, control materials, calibration materials, and other supplies must not be used when they have exceeded their expiration date, have deteriorated, or are of substandard quality. This STANDARD is not met as evidenced by: **Repeat deficiency from previous survey conducted on May 25, 2022.** Based on observation by surveyors and interview with personnel, the laboratory failed to ensure reagents did not exceed expiration dates. Findings: 1. Observation by surveyor on March 25, 2024 at 10:15 am during the laboratory tour revealed the following expired -- 2 of 7 -- items: a) Panasonic refrigerator: UTAK SSRI 7 Plus MR Serum Control, lot C8454, Expiration date: 2024-02-29, Quantity: one (1) bottle Drugs of Abuse Level 1 Whole Blood Control, lot C7674, Expiration date: 2023-11-30, Quantity: one (1) bottle PM 100 Whole Blood Control, lot C4306, Expiration date: 05/2022, Quantity: one (1) bottle UTAK SSRI 7 Plus MR Serum controls, lot 5704, Expiration date: 2024-02-29, Quantity: one (1) bottle Tricyclics VI MR Serum control, lot C8012, Expiration date: 2023-07-31, Quantity: one (1) box Applied Biosystems Array Card Spectral Calibration Dye Kit, Expiration date: 2022-12-13, Quantity: one (1) box Located in blue plastic bin labeled "UTI and STI In Use:" TaqMan Fast Advanced Master Mix, Expiration date: 2022-05-31, Quantity: one (1) bottle Located in blue plastic bin labeled "UTI and STI In Use:" More Diagnostics Clinical Chemistry Controls EV/Rap /Tac/CsA controls 1-4, lot 9148, Expiration date: 2023-05-27, Quantity: one (1) box b) pHcbi Freezer located in blue plastic bin labeld "UTI/STI opened:" Applied Biosystems TaqMan Vaginal Microbiota Amplification control, Expiration date: 2022- 05-07, Quantity: one (1) vial Applied Biosystems TaqMan Open Array Real-Time PCR Master Mix, 2022-01-31, Quantity: one (1) vial c) Insignia refrigerator: Access TPO Antibody Calibrators, Lot 389818, manufacturer's expiration date: 7/23/2024, open expiration date: 3/22/2024, Quantity: one (1) open box 2. In interview on March 25, 2024 at 10:48 am, the Technical Supervisor confirmed the identified items were expired. 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 by surveyors, review of the laboratory's performance specification studies, test menu, patient final reports, and interview with personnel, the laboratory failed to define the normal values (cut-offs) for therapeutic drug monitoring (TDM) testing. Findings: 1. Observation by surveyors during the laboratory tour on March 25, 2024 at 10:15 am and review of the laboratory's test menu revealed the laboratory utilizes the LCMS 8060 CC for TDM testing of the following drugs: Morphine, Acetaminophen, Oxymorphone, Hydromorphone, Cotinine, Amphetamine, Naloxone, Norhydrocodone, Codeine, 6-MAM, Norhydrocodone, MDA, Methamphetamine, O-desmethyltramadol, Oxycodone, Phetermine, Olanzapine *, Aripiprazole *, Hydrocodone, MDMA, Caffeine, Lamotrigine, Norfentanyl, Tapentadol, Benzoylecgonine, Tramadol, Meprobamate, Methylphenidate, Normeperidine, Meperidine, Bupropion, 7-Aminoclomazepam, Norbupropion, Citalopram, Fentanyl, Carisoprodol, Buprenorphine, Fluoxetine, PCP, Quetiapine, Desipramine, Imipramine, Cyclobenzaprine, Nortriptyline, EDDP, Amitriptyline, Lorazepam, Clonazepam, Oxazepam, Sertraline, Methadone, Alpha- OH-Alprazolam, Nordiazepam, Alprazolam, Temazepam, Diazepam, Zolpidem- -- 3 of 7 -- COOH, THC-COOH, Phenobarbital, Butalbital, and 7-OH-Mitragynine. *-only reported in blood samples 2. Review of the laboratory's performance specification studies for TDM testing revealed the laboratory did not include the cut-off values for the identified drugs. 3. In interview on March 25, 2024 at 5:33 pm, the Technical Supervisor stated the low cut-off values listed on the "TM2 Toxicology AMR" document were the same as the ones included on their patient final reports. The Technical Supervisor provided Surveyor 2 the "TM2 Toxicology AMR" document at the time of the interview. 4. Review of the "TM2 Toxicology AMR" document and random patient final test reports for blood and urine TDM testing revealed the cut-offs for Methamphetamine, Benzoylecgonine, Desipramine, Nortriptyline, Amitriptyline, and Lorazempam differed. Olanzapine, Aripiprazole, and Gabapentin were not included on the "TM2 Toxicology AMR" list. 5. In further interview on March 25, 2024 at 5:45 pm, the Technical Supervisor confirmed the laboratory's performance specification studies did not define the normal (cut-off) values that were in use by the laboratory. D5435 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(b)(2) For 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: (i) Define a function check protocol that ensures equipment, instrument, and test system performance that is necessary for accurate and reliable test results and test result reporting. (ii) Perform and document the function checks, including background or baseline checks, specified in paragraph (b)(2)(i) of this section. Function checks must be within the laboratory's established limits before patient testing is conducted. This STANDARD is not met as evidenced by: Based on review of the laboratory's policies and maintenance records, observation, and interview with laboratory personnel, the laboratory failed to perform pipet calibrations annually as required by the laboratory. Findings: 1. Review of the laboratory's policy "Maintenance and Safety" revealed the following: a) The following pipettes are used at CliniCORE: - Gilson Pipetman L P8X200L Multichannel pipette - Gilson Pipetman L P1000L 100 - 1000 uL - Gilson Pipetman L P200L 20 - 200 uL - Gilson Pipetman L P20L 2 - 20 uL b) Each pipette must be calibrated every year and the pipette calibration report/certificate must be stored in the Certificate of Analysis book. 2. Observation by surveyors during the laboratory tour on March 25, 2024 at 10: 15 a.m. revealed the pipettes had stickers stating calibration was due in June 2024. 3. Review of the laboratory's maintenance records revealed the laboratory did not have documentation of pipette calibrations performed in 2023. 3. In interview on March 25, 2024 at 6:13 p.m., the General Supervisor stated an outside vendor performed the calibrations. He confirmed the laboratory did not have documentation the pipet calibrations were performed in 2023. D5785

Summary Statement of Deficiencies D0000 A Recertification survey was performed on May 24, 2022 through May 25, 2022 at Clinicore, CLIA ID # 19D2139173. The laboratory was found in compliance with 42 CFR 493 Requirements for Laboratories; however, standard level deficiencies were cited. D5221 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(d) All proficiency testing evaluation and verification activities must be documented. This STANDARD is not met as evidenced by: Based on review of the laboratory's policies, proficiency test records, and interview with personnel, the laboratory failed to document the Laboratory Director's review of

Summary Statement of Deficiencies D0000 A Recertification Survey was performed at Clinicore, CLIA ID # 19D2139173 on January 16, 2020. Clinicore was found not in compliance with the following CONDITION LEVEL DEFICIENCIES: 42 CFR 493.803 CONDITION: Successful Participation 42 CFR 493.1250 CONDITION: Analytic systems 42 CFR 493.1441 CONDITION: Laboratories Peforming High Complexity Testing; Laboratory Director 42 CFR 493.1447 CONDITION: Laboratories Performing High Complexity Testing; Techncial Supervisor 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 test results from the College of American Pathologists 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 -- (CAP) , review of the CMS 155 D Casper Report, and interview with personnel, the laboratory failed to successfully participate in Endocrinology proficiency testing. Refer to D2107. 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 record review and interview with personnel, the laboratory failed to achieve satisfactory performance (attain a score of at least 80 percent of acceptable responses) for Endocrinology testing for 2 of 3 consecutive events resulting in an initial unsuccessful participation. Findings: 1. Review of College of American Pathologists (CAP) proficiency results for 2019 revealed the following unsuccessful participation for 2 of 3 consecutive events: 2019 2nd Event K-B Ligand General: Endocrinology overall score: 0% 2019 2nd Event K-B Ligand General: Free Thyroxine (Free T4): 0% 2019 2nd Event K-B Ligand General: TSH: 0% 2019 3rd Event K-C Ligand General: Endocrinology:76 % 2019 3rd Event K-C Ligand: Free Thyroxine (Free T4): 60 % 2019 3rd Event K-C Ligand: TSH: 60% 2. Further review of the laboratory's CAP proficiency results for 2019 revealed the laboratory had documentation of

Summary Statement of Deficiencies D0000 An Initial Survey was performed at Clinicore- CLIA ID # 19D2139173 on May 15, 2018. Clinicore was not in compliance with the following CONDITION LEVEL DEFICIENCIES: 42 CFR 493.1441 CONDITION: Laboratories performing high complexity testing, Laboratory Director 42 CFR 493.1459 CONDITION: Laboratories performing high complexity testing, General Supervisor 42 CFR 493.1487 CONDITION: Laboratories performing high complexity testing, Testing Personnel Instruments that are identified as "research only and/or forensic testing" are considered laboratory developed tests under CLIA. These instruments, as well as any FDA approved moderate complexity instrument that has been modified are considered high complexity and are subject to the CLIA regulations for Establishment and verification of performance specifications (42 CFR 493.1253(b)(2) and all other high complexity CLIA requirements. 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: I. Based on record review and interview with personnel, the laboratory failed to ensure written policies and procedures to assess competency for the Technical Supervisors and General Supervisor were complete. Findings: 1. Review of the laboratory's CMS-209 form (Laboratory Personnel Report) revealed Personnel 2 and Personnel 3 serve as the Technical Supervisors. Personnel 6 previously served as a Technical Supervisor, effective March 2018. 2. Further review of the laboratory's CMS-209 form revealed Personnel 4 serves as the General Supervisor. 3. Review of personnel records revealed competency assessments for the duties of Technical Supervisor and General Supervisor were not performed. 4. In interview on May 15, 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 -- 2018 at 10:40 am, Personnel 2 stated the laboratory did not perform competency assessments for the identified personnel for the duties of Technical Supervisor and General Supervisor. II. Based on record review and interview with personnel, the laboratory failed to follow their established policy to assess competency of Testing Personnel. Findings: 1. Review of the laboratory's CMS-209 form (Laboratory Personnel Report) revealed the following testing personnel: Personnel 3 Personnel 4 Personnel 5 2. Review of the laboratory's "Quality Assurance Plan" under section "QMS SOP # : CC.2009" revealed the following: "All employees must be evaluated periodically to ensure competency in all areas defined for their position. The evaluation includes assessments of their knowledge and performance through: 1. Direct observation of routine testing 2. Monitoring reporting of test results (if applicable) 3. Direct observation of maintenance procedures and function checks 4. Review of intermediate results and/or worksheets 5. Assessment through performance samples or proficiency testing sample and 6. Assessment of problem solving skills" 3. Review of personnel records revealed the laboratory utilizes the "Procedure Competency Evaluation CC.2004A" form for assessing competency of testing personnel. These forms did not include the identified six (6) procedures as the minimal requirement for assessing the competency of all personnel performing laboratory testing. 4. Further review of the "Procedure Competency Evaluation CC. 2004A" revealed the following procedures are assessed through observation: A." Sample Extraction: B. "MS Data" to include "Calibration curve and QC accuracy" 5. In interview on May 15, 2018 at 10:40 am, Personnel 2 stated the laboratory utilizes the "Competency Evaluation" form for assessing the competency of testing personnel. Personnel 2 confirmed the form did not include the minimal six (6) procedures as required and stated in their policy 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: I. Based on observation, record review, and interview with personnel, the laboratory failed to monitor the temperature of areas where laboratory supplies are stored per manufacturer requirements. Findings: 1. Observation by surveyor during laboratory tour on May 15, 2018 revealed the laboratory did not monitor the temperature for the following areas: Accession/Reagent Preparation Room and Storage Area 2. Review of the manufacturer requirements on the BD Vacutainer/Microtainer blood collection tubes and reagent bottles revealed the following: a) Blood collection tubes: storage requirement 4-25 degrees Celsius b) Ammonium Hydroxide Optima Grade: store at 15-25 degrees Celsius c) BD Microtainer blood collection tubes: storage requirement 4-25 degrees Celsius 3. Further observation by surveyor during laboratory tour revealed the following items stored without temperature monitors: a) Accession /Reagent Preparation Room BD Vacutainer Serum Blood Collection tubes, Lot # 7096932, Quantity: ninety (90) tubes BD Vacutainer Serum Blood Collection tubes, Lot # 6295839, Quantity: seventy (70) tubes Ammonium Hydroxide Optima Grade, 1 -- 2 of 9 -- L, Lot # 7217020, Quantity: one (1) bottle b) Storage Room BD Microtainer Z (no additive tubes), Lot # 7145781, Quantity: fifty one (51) tubes BD Microtainer Z (no additive tubes), Lot # 7145854, Quantity: one hundred fifty (150) tubes BD Microtainer Z (no additive tubes), Lot # 7248715, Quantity: one hundred (100) tubes 4. In interview on May 15, 2018 at 10:00 am , Personnel 2 stated the laboratory no longer uses the Vacutainer tubes. Personnel 2 confirmed the laboratory does not have a thermometer in the accession/reagent preparation room. 5. In interview on May 15, 2018 at 10:15 am, Personnel 4 stated the laboratory does not monitor the temperature of the storage room. Personnel 4 stated he was unaware blood collection tubes had a temperature requirement. II. Based on observation and interview with personnel, the laboratory failed to properly store ammonium formate as required by the manufacturer. Findings: 1. Observation by surveyor on May 15, 2018 revealed the ammonium formate (Lot # 173879, Quantity 1 bottle) was stored in the accession /reagent preparation room. The temperature in the accession/reagent preparation room was not monitored. 2. Further observation by surveyor on May 15, 2018 revealed the following storage requirement for the ammonium formate: "store at 4 degrees Celsius." 3. In interview on May 15, 2018 at 10:00 am, Personnel 2 stated the laboratory does not use the ammonium formate. Personnel 2 confirmed the laboratory did not store the Ammonium Formate per manufacturer requirements. D5417 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(d) Reagents, solutions, culture media, control materials, calibration materials, and other supplies must not be used when they have exceeded their expiration date, have deteriorated, or are of substandard quality. This STANDARD is not met as evidenced by: Based on observation and interview with personnel, the laboratory failed to ensure supplies and reagents have not exceeded their expiration date. Findings: 1. Observation by surveyor during laboratory tour on May 15, 2018 revealed the following expired items: Located in Panasonic Refrigerator a) Hormones Low QC unlabeled b) Hormones Mid QC 120180206-MQC, Expiration date: 05/06/18, Quantity: one (1) vial c) Hormones High QC 120180206-HQC, Expiration date: 05/06 /18, Quantity: one (1) vial Located in Accession/Reagent Prep Room a) K2EDTA Microtainer tubes, Lot # 5247603, Expiration date: 2017-02, Quantity: fifteen (15) tubes 2. In interview on May 15, 2018 at 9:48 am, Personnel 4 stated the expiration date for the hormone quality controls are listed on the batch sheets. Personnel 4 further stated the identified hormone quality controls were expired. Personnel 4 stated the expired quality controls were utilized for a stability study. 3. In interview on May 15, 2018 at 9:50 am, Personnel 2 stated the identified microtainer tubes are not used by the laboratory. 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 -- 3 of 9 -- 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 with personnel, the laboratory failed to establish reference ranges for Endocrinology and Vitamin D testing. Findings: 1. Observation by surveyor during laboratory tour on May 15, 2018 revealed the laboratory utilizes the Shimadzu LCMS-8060 for Endocrinology testing: Aldosterone, Androstenedione, Corticosterone, Cortisol, Cortisone, 11- Deoxycorticosterone, 21-Deoxycortisol, Dexamethasone, DHEA, DHEA-Sulfate, DHT, 17-beta-Estradiol, Estriol, Estrone, Pregnenolone, 17-alpha-OH-Progesterone, Progesterone, Testosterone, and 25-OH-Vitamin D3. 2. Review of the laboratory's performance verification studies revealed the laboratory utilizes reference ranges from the following sources, not a clinical reference: Aldosterone: Quest Diagnostics Androstenedione: Quest Diagnostics Corticosterone: Quest Diagnostics Cortisol: LabCorp Cortisone: ARUP 11-Deoxycorticosterone: Mayo Clinic 21-Deoxycortisol: Mayo Clinic Dexamethasone: Quest Diagnostics DHEA: LabCorp DHEA-Sulfate: Quest Diagnostics DHT: LabCorp 17-beta-Estradiol: Mayo Clinic Estriol: Quest Diagnostics Estrone: Quest Diagnostics Pregnenolone: Quest Diagnostics 17-alpha- OH-Progesterone: Quest Diagnostics Progesterone: Quest Diagnostics Testosterone: Quest Diagnostics 25-OH-Vitamin D: ARUP 3. In interview on May 15, 2018 at 1:40 pm, Personnel 2 stated the laboratory utilizes reference ranges from the identified laboratories until the laboratory can obtain enough samples to establish their own. Personnel 2 confirmed the laboratory did not establish their own reference range or utilize a reference range from a clinical literature source prior to patient testing. 4. Review of the laboratory's Task 1 and 3 form revealed the laboratory performs 18,200 Endocrinology and Vitamin D tests annually. D5435 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(b)(2) For 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: (i) Define a function check protocol that ensures equipment, instrument, and test system performance that is necessary for accurate and reliable test results and test result reporting. (ii) Perform and document the function checks, including background or baseline checks, specified in paragraph (b)(2)(i) of this section. Function checks must be within the laboratory's established limits before patient testing is conducted. This STANDARD is not met as evidenced by: Based on observation, record review, and interview with personnel, the laboratory failed to establish a protocol to verify performance of high performance liquid chromatography (HPLC) columns when changed. Findings: 1. Observation by surveyor during the laboratory tour on May 15, 2018 revealed the laboratory utilizes Phenomenex Kinetex columns on the Shimadzu LCMS-8060 for Endocrinology and Vitamin D testing. 2. Review of the Phenomenex HPLC column's Certificate of Quality Assurance package insert under the receipt of the column section revealed "Test the column to verify performance." 3. Review of the laboratory's policy and -- 4 of 9 -- procedure manual revealed the laboratory did not include a policy/procedure for HPLC column changes. 4. In interview on May 15, 2018 at 11:40 am, Personnel 2 stated when the column is changed the retention time is checked. Personnel 2 stated there is not a written procedure for column changes to verify its performance. 5. In further interview on May 15, 2018 at 11:45 am, Personnel 2 stated the laboratory currently marks on the box when a column is changed. Personnel 2 further stated the column in use has not been changed since the instrument's installation due to low volume. 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 observation, record review and interview with personnel, the Laboratory Director failed to provide overall management and direction to the laboratory. Findings: 1. The Laboratory Director failed to ensure the laboratory established reference ranges for Endicrinology and Vitamin D testing. Refer to D6086. 2. The Laboratory Director failed to ensure laboratory personnel performed test methods as required. Refer to D6087. 3. The Laboratory Director failed to ensure the establishment of maintenance procedures as required. Refer to D6095. 4. The Laboratory Director failed to ensure all personnel had the appropriate state licensure for performing high complexity testing. Refer to D6102. 5. The Laboratory Director failed to ensure policies and procedures were established for assessing personnel competency, and whenever necessary, identify needs for remedial training or continuing education to improve skills. Refer to D6103. 6. The Technical Supervisor failed to document the competency of one (1) of three (3) testing personnel prior to patient testing. Refer to D6120. 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 observation, record review, and interview with personnel, the Laboratory Director failed to ensure the laboratory established reference ranges for Endocrinology and Vitamin D testing. Refer to D5423. D6087 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(3)(iii) The laboratory director must ensure that laboratory personnel are performing the test methods as required for accurate and reliable results. -- 5 of 9 -- This STANDARD is not met as evidenced by: Based on observation, record review and interview with personnel, the Laboratory Director failed to ensure laboratory personnel performed test methods as required. Findings: 1. The laboratory failed to monitor the temperature of areas where laboratory supplies are stored per manufacturer requirements. Refer to D5413 I. 2. The laboratory failed to properly store ammonium formate as required by the manufacturer. Refer to D5413 II. 3. The laboratory failed to ensure supplies and reagents have not exceeded their expiration date. Refer to D5417. D6095 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(6) The laboratory director must ensure the establishment and maintenance of acceptable levels of analytical performance for each test system. This STANDARD is not met as evidenced by: Based on observation, record review, and interview with personnel, the Laboratory Director failed to ensure the establishment of maintenance procedures as required. Refer to D5435. D6102 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(12) The laboratory director must ensure that prior to testing patients' specimens, all personnel have the appropriate education and experience, receive the appropriate training for the type and complexity of the services offered, and have demonstrated that they can perform all testing operations reliably to provide and report accurate results. This STANDARD is not met as evidenced by: Based on record review and interview with personnel, the Laboratory Director failed to ensure all personnel had the appropriate state licensure for performing high complexity testing. Findings: 1. The laboratory failed to ensure the General Supervisor met State of Louisiana licensure requirements. Refer to D6143. 2. The laboratory failed to have current licenses issued by the State of Louisiana (R. S. 37: 131 - 1329 "Louisiana Clinical Laboratory Personnel Law"), that would allow one (1) of three (3) testing personnel to perform high complexity testing. Refer to D6170. D6103 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(13) The laboratory director must ensure that policies and procedures are established for monitoring individuals who conduct preanalytical, analytical, and postanalytical phases of testing to assure that they are competent and maintain their competency to process specimens, perform test procedures and report test results promptly and proficiently, and whenever necessary, identify needs for remedial training or continuing education to improve skills. This STANDARD is not met as evidenced by: Based on record review and interview with personnel, the Laboratory Director failed -- 6 of 9 -- to ensure policies and procedures were established for assessing personnel competency, and whenever necessary, identify needs for remedial training or continuing education to improve skills. Findings: 1. The laboratory failed to ensure written policies and procedures to assess competency for the Technical Supervisors and General Supervisor were complete. Refer to D5209 I. 2. The laboratory failed to follow their established policy to assess competency of Testing Personnel. Refer to D5209 II. 3. The Technical Supervisor failed to document the competency of one (1) of three (3) testing personnel prior to patient testing. Refer to D6120. D6120 TECHNICAL SUPERVISOR RESPONSIBILITIES CFR(s): 493.1451(b)(7)(8) (7) The technical supervisor is responsible for identifying training needs and assuring that each individual performing tests receives regular in-service training and education appropriate for the type and complexity of the laboratory services performed; (8) Evaluating the competency of all testing personnel and assuring that the staff maintain their competency to perform test procedures and report test results promptly, accurately and proficiently. This STANDARD is not met as evidenced by: Based on record review and interview with personnel, the Technical Supervisor failed to document the competency of one (1) of three (3) testing personnel prior to patient testing. Findings: 1. Review of the laboratory's "Quality Assurance Plan" under section "QMS: SOP# CC.2009" revealed "Education , experience, and competencies for each individual is documented in the employee's file. All employees must be evaluated periodically to ensure competency in all areas defined for their position." 2. Review of the laboratory's CMS-209 (Laboratory Personnel Report) revealed Personnel 4 was listed as testing personnel. 3. Review of Personnel 4's "Procedure Competency Evaluation 6 Month" form (completed March 22, 2018) revealed documentation of "PASS" of "FAIL" was not indicated. 4. In interview on May 15, 2018 at 10:40 am, Personnel 2 confirmed documentation of Personnel 4 passing or failing competency was not included. Personnel 2 stated it was an oversight. 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 with personnel, the laboratory failed to ensure the General Supervisor met licensure requirements. 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 -- 7 of 9 -- 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 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 interview with personnel, the laboratory failed to ensure the General Supervisor met State of Louisiana licensure requirement. Findings: 1. Review of the laboratory's CMS-209 form (Laboratory Personnel Report) revealed Personnel 4 is listed as General Supervisor. 2. Review of personnel records revealed Personnel 4 maintained a current State of Louisiana Specialist license for Specialty in -- 8 of 9 -- Molecular Biology (American Association of Bioanalysts). 3. Review of the laboratory's Task 1 and 3 form revealed the laboratory performs high complexity Routine Chemistry and Endocrinology (Chemistry) testing. 4. In interview on May 15, 2018 at 10:40 am, Personnel 2 confirmed Personnel 4's specialist license is in Molecular Biology. Personnel 2 stated he thought Personnel 4's current Louisiana State license was acceptable for testing. 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 with personnel, the laboratory failed to ensure testing personnel met licensure requirements to perform high complexity testing. Refer to 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 with personnel, the laboratory failed to have current licenses issued by the State of Louisiana (R. S. 37:131 - 1329 "Louisiana Clinical Laboratory Personnel Law"), that would allow one (1) of three (3) testing personnel to perform high complexity testing. Findings: 1. Review of the laboratory's CMS-209 form (Laboratory Personnel Report) revealed Personnel 4 is listed as Testing Personnel. 2. Review of personnel records revealed Personnel 4 maintained a current State of Louisiana Specialist license for Specialty in Molecular Biology (American Association of Bioanalysts). 3. Review of the laboratory's Task 1 and 3 form revealed the laboratory performs high complexity Routine Chemistry and Endocrinology (Chemistry) testing. 4. In interview on May 15, 2018 at 10:40 am, Personnel 2 confirmed Personnel 4's specialist license is in Molecular Biology. Personnel 2 stated he thought Personnel 4's current Louisiana State license was acceptable for testing. -- 9 of 9 --