Central Clinical Labs Incorporated

Summary Statement of Deficiencies D0000 A complaint survey was performed on February 4, 2026. The laboratory was found to be out of compliance based on the following CONDITION LEVEL DEFICIENCY: D6108 - 42 C.F.R. 493.1447 Condition: Laboratory Technical Supervisor, high complexity D6108 LABORATORY TECHNICAL SUPERVISOR CFR(s): 493.1447 The laboratory must have a technical supervisor who meets the qualification requirements of 493.1449 of this subpart and provides technical supervision in accordance with 493.1451 of this subpart. This CONDITION is not met as evidenced by: Based on review of personnel records and interview with Testing Personnel (TP-4) on February 4, 2026 at 11:15 AM, the laboratory failed to provide evidence of the required experience to qualify one of one Technical Supervisor (TS) for the specialty of Chemistry for high complexity testing. (Refer to D6111) D6111 TECHNICAL SUPERVISOR QUALIFICATIONS CFR(s): 493.1449 (a) The technical supervisor must possess a current license issued by the State in which the laboratory is located, if such licensing is required; and (b) The laboratory may perform anatomic and clinical laboratory procedures and tests in all specialties and subspecialties of services except histocompatibility and clinical cytogenetics services provided the individual functioning as the technical supervisor-- (b)(1) Is a doctor of medicine or doctor of osteopathy licensed to practice medicine or osteopathy in the State in which the laboratory is located; and (b)(2) Is certified in both anatomic and clinical pathology by the American Board of Pathology or the American Osteopathic Board of Pathology. (c) Bacteriology, Mycobacteriology, Mycology, 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 -- Parasitology or Virology- If the requirements of paragraph (b) of this section are not met and the laboratory performs tests in the subspecialty of bacteriology, mycobacteriology, mycology, parasitology, or virology, the individual functioning as the technical supervisor must- (c)(1)(i) Be a doctor of medicine or doctor of osteopathy licensed to practice medicine or osteopathy in the State in which the laboratory is located; and (c)(1)(ii) Be certified in clinical pathology by the American Board of Pathology or the American Osteopathic Board of Pathology; or (c)(2)(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; and (c)(2)(ii) Have at least 1 year of laboratory training or experience, or both, in high complexity testing within the specialty of microbiology with a minimum of 6 months of experience in high complexity testing within the applicable microbiology subspecialty; or (c)(3)(i)(A) Have an earned doctoral degree in a chemical, biological, clinical or medical laboratory science, or medical technology from an accredited institution; or (c)(3)(i)(B) Meet the requirements in 493.1443(b)(3) (i)(B); and(c)(4)(ii) Have at least 2 years of laboratory training or experience, or both, in high complexity testing within the specialty of microbiology with a minimum of 6 months experience in high complexity testing within the subspecialty of bacteriology; or (c)(3)(ii) Have at least 1 year of laboratory training or experience, or both, in high complexity testing within the specialty of microbiology with a minimum of 6 months of experience in high complexity testing within the applicable subspecialty; or (c)(4)(i) (A) Have earned a master's degree in a chemical, biological, clinical or medical laboratory science, or medical technology from an accredited institution; or (c)(4)(i) (B)(1) Meet bachelor's degree equivalency; and (c)(4)(i)(B)(2) Have at least 16 semester hours of additional graduate level coursework in chemical, biological, clinical or medical laboratory science, or medical technology; or (c)(4)(i)(C)(1) Meet bachelor's degree equivalency; and (c)(4)(i)(C)(2) Have at least 16 semester hours in a combination of graduate level coursework in biology, chemistry, medical technology, or clinical or medical laboratory science coursework and an approved thesis or research project related to laboratory testing for the diagnosis, prevention, or treatment of any disease or impairment of, or the assessment of the health of, human beings; and (c)(4)(ii) Have at least 2 years of laboratory training or experience, or both, in high complexity testing within the specialty of microbiology with a minimum of 6 months of experience in high complexity testing within the applicable subspecialty; or (c)(5)(i)(A) Have earned a bachelor's degree in a chemical, biological, clinical or medical laboratory science, or medical technology from an accredited institution; or (c)(5)(i)(B) Have at least 120 semester hours, or equivalent, from an accredited institution that, at a minimum, includes either- (c)(5)(i)(B)(1) 48 semester hours of medical laboratory technology courses; or (c)(5)(i)(B)(2) 48 semester hours of science courses that include- (c)(5)(i)(B)(2)(i) 12 semester hours of chemistry, which must include general chemistry and biochemistry or organic chemistry; (c)(5)(i) (B)(2)(ii) 12 semester hours of biology, which must include general biology and molecular biology, cell biology or genetics; and (c)(5)(i)(B)(2)(iii) 24 semester hours of chemistry, biology, or medical laboratory science or technology in any combination; and (c)(5)(ii) Have at least 4 years of laboratory training or experience, or both, in high complexity testing within the specialty of microbiology with a minimum of 6 months of experience in high complexity testing within the applicable subspecialty. (d) Diagnostic Immunology, Chemistry, Hematology, Radiobioassay, or Immunohematology - If the requirements of paragraph (b) of this section are not met and the laboratory performs tests in the specialty of diagnostic immunology, chemistry, hematology, radiobioassay, or immunohematology, the individual functioning as the technical supervisor must- (d)(1)(i) Be a doctor of medicine or a doctor of osteopathy licensed to practice medicine or osteopathy in the State in which -- 2 of 5 -- the laboratory is located; and (d)(1)(ii) Be certified in clinical pathology by the American Board of Pathology or the American Osteopathic Board of Pathology; or (d) (2)(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; and (d)(2)(ii) Have at least 1 year of laboratory training or experience, or both, in high complexity testing for the applicable specialty; or (d)(3)(i) (A) Have an earned doctoral degree in a chemical, biological, clinical or medical laboratory science, or medical technology from an accredited institution; or (d)(3)(i) (B) Meet the education requirement at 493.1443(b)(3)(i)(B); and (d)(3)(ii) Have at least 1 year of laboratory training or experience, or both, in high complexity testing within the applicable specialty; or (d)(4)(i)(A) Have earned a master's degree in a chemical, biological, clinical or medical laboratory science, or medical technology from an accredited institution; or (d)(4)(i)(B) Meet the education requirement at paragraphs (c)(4)(i)(B) or (C) of this section; and (d)(4)(ii) Have at least 2 years of laboratory training or experience, or both, in high complexity testing for the applicable specialty; or (d)(5)(i)(A) Have earned a bachelor's degree in a chemical, biological, clinical or medical laboratory science, or medical technology from an accredited institution; or (d)(5)(i)(B) Meet the education requirement at paragraph (c) (5)(i)(B) of this section; and (d)(5)(ii) Have at least 4 years of laboratory training or experience, or both, in high complexity testing for the applicable specialty. (e) Cytology- If the requirements of paragraph (b) of this section are not met and the laboratory performs tests in the subspecialty of cytology, the individual functioning as the technical supervisor must- (e)(1)(i) Be a doctor of medicine or a doctor of osteopathy licensed to practice medicine or osteopathy in the State in which the laboratory is located; and (e)(1)(ii) Be certified in anatomic pathology by the American Board of Pathology or the American Osteopathic Board of Pathology; or (e) (2) An individual qualified under paragraph (b) or (e)(1) of this section may delegate some of the cytology technical supervisor responsibilities to an individual who is in the final year of full-time training leading to certification specified in paragraph (b) or (e)(1)(ii) of this section provided the technical supervisor qualified under paragraph (b) or (e)(1) of this section remains ultimately responsible for ensuring that all of the responsibilities of the cytology technical supervisor are met. (f) Histopathology - If the requirements of paragraph (b) of this section are not met and the laboratory performs tests in the subspecialty of histopathology, the individual functioning as the technical supervisor must- (f)(1) Meet one of the following requirements: (f)(1)(i)(A) Be a doctor of medicine or a doctor of osteopathy licensed to practice medicine or osteopathy in the State in which the laboratory is located; and (f)(1)(i)(B) Be certified in anatomic pathology by the American Board of Pathology or the American Osteopathic Board of Pathology; or (f)(1)(ii) An individual qualified under paragraph (b) or (f)(1) of this section may delegate to an individual who is a resident in a training program leading to certification specified in paragraph (b) or (f)(1)(i)(B) of this section, the responsibility for examination and interpretation of histopathology specimens. (f)(2) For tests in dermatopathology, meet one of the following requirements: (f)(2)(i)(A) Be a doctor of medicine or doctor of osteopathy licensed to practice medicine or osteopathy in the State in which the laboratory is located; and (f) (2)(i)(B) Meet one of the following requirements: (f)(2)(i)(B)(1) Be certified in anatomic pathology by the American Board of Pathology or the American Osteopathic Board of Pathology; or (f)(2)(i)(B)(2) Be certified in dermatopathology by the American Board of Dermatology and the American Board of Pathology; or (f) (2)(i)(B)(3) Be certified in dermatology by the American Board of Dermatology; or (f) (2)(ii) An individual qualified under paragraph (b) or (f)(2)(i) of this section may delegate to an individual who is a resident in a training program leading to certification specified in paragraph (b) or (f)(2)(i)(B) of this section, the responsibility -- 3 of 5 -- for examination and interpretation of dermatopathology specimens. (f)(3) For tests in ophthalmic pathology, meet one of the following requirements: (f)(3)(i)(A) Be a doctor of medicine or doctor of osteopathy licensed to practice medicine or osteopathy in the State in which the laboratory is located; and (f)(3)(i)(B) Must meet one of the following requirements: (f)(3)(i)(B)(1) Be certified in anatomic pathology by the American Board of Pathology or the American Osteopathic Board of Pathology; or (f) (3)(i)(B)(2) Be certified by the American Board of Ophthalmology and have successfully completed at least 1 year of formal post-residency fellowship training in ophthalmic pathology; or (f)(3)(ii) An individual qualified under paragraph (b) or (f) (3)(i) of this section may delegate to an individual who is a resident in a training program leading to certification specified in paragraph (b) or (f)(3)(i)(B) of this section, the responsibility for examination and interpretation of ophthalmic specimens; or (g) Oral Pathology- If the requirements of paragraph (b) of this section are not met and the laboratory performs tests in the subspecialty of oral pathology, the individual functioning as the technical supervisor must meet one of the following requirements: (g)(1)(i) Be a doctor of medicine or a doctor of osteopathy licensed to practice medicine or osteopathy in the State in which the laboratory is located; and (g) (1)(ii) Be certified in anatomic pathology by the American Board of Pathology or the American Osteopathic Board of Pathology; or (g)(2) Be certified in oral pathology by the American Board of Oral Pathology; or (g)(3) An individual qualified under paragraph (b) or (g)(1) or (2) of this section may delegate to an individual who is a resident in a training program leading to certification specified in paragraph (b) or (g) (1) or (2) of this section, the responsibility for examination and interpretation of oral pathology specimens. (h) Histocompatibility - If the laboratory performs tests in the specialty of histocompatibility, the individual functioning as the technical supervisor must either- (h)(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; and (h)(1)(ii) Have training or experience that meets one of the following requirements: (h)(1)(ii)(A) Have 4 years of laboratory training or experience, or both, within the specialty of histocompatibility; or (h)(1)(ii) (B)(1) Have 2 years of laboratory training or experience, or both, in the specialty of general immunology; and (h)(1)(ii)(B)(2) Have 2 years of laboratory training or experience, or both, in the specialty of histocompatibility; or (h)(2)(i) Have an earned doctoral degree in a biological, clinical or medical laboratory science, or medical technology from an accredited institution; or meet the education requirement at 493.1443(b)(3)(i)(B); and (h)(2)(ii) Have training or experience that meets one of the following requirements: (h)(2)(ii)(A) Have 4 years of laboratory training or experience, or both, within the specialty of histocompatibility; or (h)(2)(ii)(B)(1) Have 2 years of laboratory training or experience, or both, in the specialty of general immunology; and (h)(2)(ii)(B)(2) Have 2 years of laboratory training or experience, or both, in the specialty of histocompatibility. (i) Clinical cytogenetics- If the laboratory performs tests in the specialty of clinical cytogenetics, the individual functioning as the technical supervisor must- (i)(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; and (i)(1)(ii) Have 4 years of laboratory training or experience, or both, in genetics, 2 of which have been in clinical cytogenetics; or (i)(2)(i) Hold an earned doctoral degree in a biological science, including biochemistry, clinical or medical laboratory science, or medical technology from an accredited institution; or meet the education requirement at 493.1443(b)(3)(i) (B); and (i)(2)(ii) Have 4 years of laboratory training or experience, or both, in genetics, 2 of which have been in clinical cytogenetics. (j) Notwithstanding any other provision of this section, an individual is considered qualified as a technical supervisor under this section if they were qualified and serving as a technical -- 4 of 5 -- supervisor for high complexity testing in a CLIA-certified laboratory as of December 28, 2024, and have done so continuously since December 28, 2024. This STANDARD is not met as evidenced by: Based on review of personnel records, review of the CMS-209, Laboratory Personnel Form, and interview with testing personnel (TP-4) on February 4, 2026 at 11:15 AM, the laboratory failed to employ one or more individuals who are qualified to provide technical supervision for high complexity testing performed under the specialty of Chemistry. Findings include: 1. The laboratory began LC/MS (Liquid Chromatography-Mass Spectrometry) urine drug confirmation testing utilizing the Agilent analyzer on 12/16/2024 with an estimated annual test volume of 14,400 under the subspecialty of Toxicology (speciality of Chemistry). 2. Interview with testing personnel (TP-4) on 2/4/26 at 11:15 AM confirmed the individual listed on the CMS- 209 Laboratory Personnel Form as Technical Supervisor for the specialty of Chemistry began overseeing LC/MS urine drug confirmation testing on 5/12/2025. 3. The personnel records reviewed during the survey failed to include evidence indicating the individual listed on the CMS-209, Laboratory Personnel form as Technical Supervisor has the required minimum of four years of training/experience in high complexity testing under the specialty of Chemistry. 4. TP-4 interviewed on 2 /4/26 at 11:15 AM confirmed the Technical Supervisor failed to meet the required minimum of four years of training/experience in high complexity testing under the specialty of Chemistry. D6120 TECHNICAL SUPERVISOR RESPONSIBILITIES CFR(s): 493.1451(b)(7)(8) (b)(7) 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; (b)(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 review of the semi-annual competency evaluation from 2025 for one out of one testing personnel (TP-1) and interview with testing personnel (TP-4) on February 4, 2026 at 11:30 AM, a qualified technical supervisor failed to perform the semi- annual competency evaluation for TP-1 for high complexity testing performed in the speciality of Chemistry. Findings include: 1. The LC/MS semi-annual competency evaluation reviewed during the survey for TP-1 from May 12, 2025 revealed the evaluation was performed by an individual who failed to meet the qualification requirements for technical supervisor for high-complexity testing performed in the specialty of Chemistry. 2. TP-4 interviewed on 2/4/26 at 11:30 AM confirmed a qualified technical supervisor failed to evaluate the semi-annual competency evaluation for TP-1 during 2025 as indicated above. 3. The facility performs LC/MS urine drug screen confirmations under the specialty of Chemistry with an estimated annual test volume of 14,400. -- 5 of 5 --

Summary Statement of Deficiencies D5393 PREANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1249(b)(c) The preanalytic systems assessment must include a review of the effectiveness of

Summary Statement of Deficiencies D3031 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(3) Analytic systems records. Retain quality control and patient test records (including instrument printouts, if applicable) and records documenting all analytic systems activities specified in 493.1252 through 493.1289 for at least 2 years. This STANDARD is not met as evidenced by: Based on lack of manufacturer's assay information sheets presented for review for C. Diff testing and interview with the facility personnel, the laboratory failed to retain the manufacturer's package insert for each lot of C. Diff test kits used by the laboratory. Findings include: 1. The laboratory began C. Diff testing on patient specimens using the Alere Techlab C. Diff test kit in March 2019, with an approximate annual test volume of 2,400. 2. During the survey conducted on March 10, 2020, the laboratory could not produce evidence of the manufacturer's package inserts for each lot of C. Diff test kit that was used for testing by the laboratory since March 2019. The manufacturer's package insert contains information specific to the lot number and expiration date of the test kit and external control material. 3. The facility personnel confirmed that the laboratory failed to retain the manufacturer's package insert for each lot of C. Diff test kit that was used by the laboratory for patient testing since March 2019. D5291 GENERAL LABORATORY SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1239(a) The laboratory must establish and follow written policies and procedures for an ongoing mechanism to monitor, assess, and, when indicated, correct problems identified in the general laboratory systems requirements specified at 493.1231 through 493.1236. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 4 -- This STANDARD is not met as evidenced by: Based on review of the laboratory's established Quality Assessment policies, review of employee competency records and interview with the facility personnel, the laboratory failed to identify errors found within the personnel competency process. Findings include: 1. The laboratory performs patient testing under the specialties of Microbiology, Diagnostic Immunology, Chemistry and Hematology, with an approximate annual test volume of 1,156,800. At the time of the survey conducted on March 10, 2020, the laboratory used approximately 7 different test systems for patient testing. 2. The laboratory utilized a personnel competency form titled, "Tech Competency 3 month - CCL AZ" during 2019 to document testing personnel competency evaluations. 3. The form indicated above failed to include information specific to each test system for which personnel competency was evaluated. 4. The facility personnel confirmed that the competency form used to document personnel competency during that time period failed to include information specific to each test system. D5401 PROCEDURE MANUAL CFR(s): 493.1251(a) A written procedures manual for all tests, assays, and examinations performed by the laboratory must be available to, and followed by, laboratory personnel. Textbooks may supplement but not replace the laboratory's written procedures for testing or examining specimens. This STANDARD is not met as evidenced by: Based on review of the laboratory's established procedure manual, review of patient test reports and interview with the facility personnel, the laboratory failed to follow their established test procedure for Ammonia testing. Findings include: 1. The laboratory performs patient testing, including Ammonia testing, in the specialty of Chemistry, with an approximate annual test volume of 876,000. 2. The laboratory's established test procedure, Policy# 6008, for Ammonia testing performed on the Siemens Atellica analyzer states, "Separated specimens may be stored for up to 2 hours at 2-8 degrees Celsius. The tube should be completely filled, stored tightly capped on ice and centrifuged without delay. Samples should be analyzed within 30 minutes of centrifugation. Concentrations may more than double in plasma when stored at room temperature for 6 hours". 3. Review of patient test results for ammonia testing on 03/02/2020 (Lab # 5423885) indicated the specimen was collected on 3/02 /20 at 04:40am, received on 3/02/20 at 12:50pm, resulted on 3/02/20 at 01:16pm and reported on 3/05/20 at 01:23pm. 4. The facility personnel acknowledged that the laboratory failed to follow the established procedure for Ammonia testing and failed to test the specimen within the acceptable timeframe. D5445 CONTROL PROCEDURES CFR(s): 493.1256(d)(1)(2)(g) Unless CMS Approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub. 7), that provides equivalent quality testing, the laboratory must-- (d)(1) Perform control procedures as defined in this section unless otherwise specified in the additional specialty and subspecialty requirements at 493.1261 through 493.1278. (d)(2) For each test system, perform control procedures using the number and frequency specified by the manufacturer or established by the laboratory when -- 2 of 4 -- they meet or exceed the requirements in paragraph (d)(3) of this section. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on lack of quality control (QC) documentation and interview with the facility personnel, the laboratory failed to perform and document control procedures using the number and frequency as required for testing performed in the specialty of Microbiology. Findings include: 1. The laboratory began C. Difficile (C Diff) testing on patient specimens in March 2019, using the Alere C Diff Techlab test kit under the specialty of Microbiology. On the date of the survey, March 10, 2020, the laboratory's quality control procedure consisted of performing two levels of external control material, each new kit or shipment. 2. No QC documentation was provided for review during the survey to indicate the laboratory performed two levels of control material of different concentrations, each day of patient testing as required since January 1, 2016. 3. During the survey, review of C Diff QC records indicated the laboratory performed and documented QC with the number and frequency described above (see #1), and as of January 1, 2016, the laboratory had not implemented an Individualized Quality Control Plan (IQCP) for this test system. 4. The facility personnel confirmed that the laboratory did not perform and document controls as required since January 1, 2016 and confirmed that the laboratory had not implemented an Individualized Quality Control Plan (IQCP) for testing performed on the Alere C Diff test kit. 5. Approximately 2400 patients were tested using the C Diff test kit. D5801 TEST REPORT CFR(s): 493.1291(a) The laboratory must have an adequate manual or electronic system(s) in place to ensure test results and other patient-specific data are accurately and reliably sent from the point of data entry (whether interfaced or entered manually) to final report destination, in a timely manner. This includes the following: (a)(1) Results reported from calculated data. (a)(2) Results and patient-specific data electronically reported to network or interfaced systems. (a)(3) Manually transcribed or electronically transmitted results and patient-specific information reported directly or upon receipt from outside referral laboratories, satellite or point-of-care testing locations. This STANDARD is not met as evidenced by: Based on review of the laboratory's policies and procedures and interview with the laboratory personnel, the laboratory failed to have a specific policy in place that addressed the accuracy of results sent to the LIS from both interfaced systems and manually entered test results. Findings include: 1. The laboratory presented a policy that outlined the monitoring for data entry accuracy of test orders, but no policy was presented that monitored the accuracy of test result entries into the LIS. 2. The laboratory did perform periodic monitoring of test results for all tests except for C. Diff test results for patient testing that began in July 2019. 3. The laboratory personnel acknowledged that the laboratory lacked a specific policy that outlined the monitoring of the accuracy of test results both interfaced and manually entered. D6053 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(9) The technical consultant is responsible for evaluating and documenting the -- 3 of 4 -- performance of individuals responsible for moderate complexity testing at least semiannually during the first year the individual tests patient specimens. This STANDARD is not met as evidenced by: Based on lack of performance evaluation documentation and interview with the facility personnel, the technical consultant failed to evaluate and document the performance of testing personnel, at least semiannually during the first year the individual tested patient specimens. Findings include: 1. No semiannual competency evaluation documentation was presented for review for one out of one testing personnel who began patient testing in March 2019. 2. No semiannual competency evaluation documentation specific to the Siemens Atellica analyzer was presented for review for two out of two testing personnel who began patient testing on the Atellica analyzer in May 2019. 3. No semiannual competency evaluation documentation specific to the LH500 Hematology analyzer was presented for review for one out of one testing personnel who began patient testing on the LH500 analyzer in March 2019. 4. No semiannual competency evaluation documentation specific to the DXH Hematology analyzer was presented for review for one out of one testing personnel who began patient testing on the DXH in March 2019. 5. The facility personnel confirmed that the laboratory did not have documentation of semiannual competency evaluations for the testing personnel indicated above. -- 4 of 4 --

Summary Statement of Deficiencies D5393 PREANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1249(b)(c) The preanalytic systems assessment must include a review of the effectiveness of