Choctaw Memorial Hospital

Summary Statement of Deficiencies D0000 The recertification survey was performed on 03/21/2025. The laboratory was found in compliance with standard-level deficiencies cited. The findings were reviewed with the chief executive officer and laboratory manager during an exit conference performed at the conclusion of the survey. D5403 PROCEDURE MANUAL CFR(s): 493.1251(b) (b) The procedure manual must include the following when applicable to the test procedure: (b)(1) Requirements for patient preparation; specimen collection, labeling, storage, preservation, transportation, processing, and referral; and criteria for specimen acceptability and rejection as described in 493.1242. (b)(2) Microscopic examination, including the detection of inadequately prepared slides. (b)(3) Step-by- step performance of the procedure, including test calculations and interpretation of results. (b)(4) Preparation of slides, solutions, calibrators, controls, reagents, stains, and other materials used in testing. (b)(5) Calibration and calibration verification procedures. (b)(6) The reportable range for test results for the test system as established or verified in 493.1253. (b)(7) Control procedures. (b)(8)

Summary Statement of Deficiencies D0000 The recertification survey was performed on 02/13,14,15/2023. The laboratory was found out of compliance with the following CLIA Condition: 493.1447; D6108: Technical Supervisor The findings were reviewed with the hospital administrator and technical consultant #2 during an exit conference performed at the conclusion of the survey. D5211 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(a) The laboratory must review and evaluate the results obtained on proficiency testing performed as specified in subpart H of this part. This STANDARD is not met as evidenced by: Based on a review of records and interview with technical consultant #2, the laboratory failed to review and evaluate proficiency testing results for one of five Hematology events reviewed. Findings include: BIASES (1) On 02/13/2023, a review of Hematology proficiency testing records for the second 2021, third 2021, first 2022, second 2022 and third 2022 events and identified the following biases (biases were identified using the SDI (Standard Deviation Index) values assigned by the proficiency program) for one of five events: (a) Hematology Third 2021 Event (i) MCH (Mean Corpuscular Hemoglobin) - three of five results exhibited a negative bias (aa) Sample XE-11 - SDI of -2.8 (bb) Sample XE-13 - SDI of -2.2 (cc) Sample XE-15 - SDI of -2.1 (2) There was no evidence in the records proving the biases had been identified and addressed; (3) The records were reviewed with technical consultant #2 who stated on 02/13/2023 at 04:00 pm the biases had not been addressed. FAILURES (1) On 02/13/2023, a review of Hematology proficiency testing records for the second 2021, third 2021, first 2022, second 2022 and third 2022 events identified the following failures for one of five events: (a) Hematology First 2022 Event (i) MCH - The laboratory received a score of 60%. The results for samples XE-02 and XE-03 had failed. There was no documentation to prove that remedial action had been taken Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 11 -- for the failures; (ii) MCHC - The laboratory received a score of 60%. The results for samples XE-02 and XE-03 had failed. There was no documentation to prove that remedial action had been taken for the failures. (2) The records were reviewed with technical consultant #2 who stated on 02/13/2023 at 04:00 pm, there was no evidence that remedial action had been taken for the failures. D5409 PROCEDURE MANUAL CFR(s): 493.1251(e) The laboratory must maintain a copy of each procedure with the dates of initial use and discontinuance as described in 493.1105(a)(2). This STANDARD is not met as evidenced by: Based on a review of the procedure manual and interview with technical consultant #2, the laboratory failed to ensure that two of two written procedures no longer in use had been discontinued. Findings include: (1) On 02/14/2023 a review of the manual titled, "Policy & Procedure Manual" identified the following procedures: (a) "Bleeding Time" (b) "Cerebrospinal Fluid Examination" (2) The procedures were reviewed with technical consultant #2 who stated on 02/14/2023 at 03:00 pm, the laboratory no longer performed the above procedures and they should have been indicated as discontinued. D5421 ESTABLISHMENT AND VERIFICATION OF PERFORMANCE CFR(s): 493.1253(b)(1) Each laboratory that introduces an unmodified, FDA-cleared or approved test system must do the following before reporting patient test results: (1)(i) Demonstrate that it can obtain performance specifications comparable to those established by the manufacturer for the following performance characteristics: (1)(i)(A) Accuracy. (1)(i) (B) Precision. (1)(i)(C) Reportable range of test results for the test system. (1)(ii) Verify that the manufacturer's reference intervals (normal values) are appropriate for the laboratory's patient population. This STANDARD is not met as evidenced by: Based on a review of records and interview with technical consultant #2, the laboratory failed to utilize the demonstrated reportable range for one of one new test method. Findings include: (1) On 02/13/2023 at 11:30 am, technical consultant #2 stated the laboratory began using the Biosite Triage Meter Pro to perform D-dimer testing on 04/22/2022; (2) On 02/14/2023, a review of the performance specification records identified the laboratory had demonstrated a reportable range of 260-4260 ng /ml for D-dimer; (3) Interview with technical consultant #2 on 02/14/2023 at 12:05 pm confirmed the laboratory was using the manufacturer's reportable range of 100- 5000 ng/ml instead of the reportable range that had been demonstrated by the laboratory. 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 -- 2 of 11 -- 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 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 a review of records and interview with technical consultant #2, the laboratory failed to ensure one of one IQCP (Individualized Quality Control Plan) included the required components. Findings include: (1) On 02/13/2023 at 11:30 am, technical consultant #2 stated following: (a) D-dimer testing was performed using the Biosite Triage Meter Pro; (b) An IQCP had been developed for the test system. (2) On 02/14/2023, a review of the IQCP identified a QCP (Quality Control Plan) and QA (Quality Assessment) plan had not been included in the IQCP (it consisted of a Risk Assessment only); (3) The records with the laboratory manager who stated on 02/14 /2023 at 12:22 pm, a QCP and QA plan had not been included in the IQCP. D5479 CONTROL PROCEDURES CFR(s): 493.1256(e)(5)(g) (e) For reagent, media, and supply checks, the laboratory must do the following: (e) (5) Follow the manufacturer's specifications for using reagents, media, and supplies and be responsible for results. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on a review of records, manufacturer's instructions, and interview with technical consultant #2, the laboratory failed to follow the manufacturer's specifications for the Bio-Rad Cardiac Markers Plus Control LT for two of two lot numbers and the Bio-Rad Liquid Assayed Multiqual control materials for two of two lot numbers. Findings include: (1) On 02/13/2023 at 12:05 pm, technical consultant #2 stated CKMB, Amylase, Glucose, and Magnesium testing were performed using two Siemens Dimension EXL analyzers (Serial numbers DE270463 and DR270411); (2) On 02/15/2023 at 09:30 am, technical consultant #2 stated the following for both analyzers: (a) For CKMB testing, two levels of Bio-Rad Liquichek Cardiac Markers Plus Control LT control materials were performed each day of patient testing; (b) For Amylase, Glucose, and Magnesium testing, two levels of Bio-Rad Liquid Assayed Multiqual controls materials were performed each day of patient testing. (3) A review of the manufacturer's instructions (package inserts) for the above control materials stated, "The mean values and the corresponding +/-3SD ranges in the Assignment of Values Data Charts were derived from replicate analyses and are specific for this lot of product. Data from Unity Interlaboratory Program are included in the determination of some ranges. The tests listed were performed by the manufacturer and/or independent laboratories using manufacturer supported reagents and a representative sampling of this lot of product. It is recommended that each laboratory establish its own acceptable ranges and use those provided only as guides"; (4) A review of QC (Quality Control) records for both analyzers for four lot numbers of control materials used during the review period of July 2022 through December 2022 identified the following : (a) Bio-Rad Liquichek Cardiac Markers Plus Control LT control materials, level one lot #67641 and level three lot #67643 (i) The laboratory had not established their own acceptable ranges and were using the manufacturer's guideline ranges as -- 3 of 11 -- follows: (aa) CKMB level one - 1.71-2.95 (bb) CKMB level three - 56.1-80.9 (b) Bio- Rad Liquid Assayed Multiqual controls materials, level one lot #45871 and level three lot #45873 (i) The laboratory had not established their own acceptable ranges and were using the manufacturer's guideline ranges as follows: (aa) Amylase level one - 38.5-46.7 (bb) Amylase level three - 300-437 (cc) Glucose level one - 53.3-64.4 (dd) Glucose level three - 325-377 (ee) Magnesium level one - 0.753-1.17 (ff) Magnesium level three - 3.56-4.31 (5) The records were reviewed with technical consultant #2 who stated on 02/15/2023 at 10:30 am, the laboratory had not followed the manufacturer's instructions for the control materials used for both of the analyzers. D6054 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(9) The technical consultant is responsible for evaluating and documenting the performance of individuals responsible for moderate complexity testing at least annually, after the first year. This STANDARD is not met as evidenced by: Based on a review of records and interview with technical consultant #2, the technical consultant failed to ensure competency evaluations included all moderate complexity testing for 10 of 10 persons receiving annual competencies in 2022. Findings include: (1) On 02/13/2023 at 11:20 am, technical consultant #2 stated qualitative serum pregnancy testing was performed using the Cardinal Health hCG Combo Rapid test and serum samples; (2) A review of personnel records for 12 persons identified that annual evaluations performed in 2022 did not include an assessment of qualitative serum pregnancy testing for ten of ten persons: (a) Testing Person #1 - Performed on 02/04/2022 (b) Testing Person #2 - Performed on 09/05/2022 (c) Testing Person #3 - Performed on 05/07/2022 (d) Testing Person #4 - Performed on 06/06/2022 (e) Testing Person #5 - Performed on 05/01/2022 (f) Testing Person #6 - Performed on 11 /05/2022 (g) Testing Person #7 - Performed on 11/26/2022 (h) Testing Person #8 - Performed on 11/07/2022 (i) Testing Person #9 - Performed on 08/05/2022 (j) Testing Person #10 - Performed on 11/20/2022 (3) The findings were reviewed with technical consultant #2 who stated on 02/13/2023 at 03:45 pm the above evaluations did not include an assessment of qualitative serum pregnancy testing. 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 a review of records and interview with technical consultant #2, the technical supervisor failed to provide technical supervision in accordance with 493.1447 of this subpart. Findings include: (1) The technical supervisor failed to ensure the individual who performed the duties and responsibilities of the technical supervisor met the educational qualifications. Refer to D6111. D6111 TECHNICAL SUPERVISOR QUALIFICATIONS CFR(s): 493.1449 -- 4 of 11 -- (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 or Possesses qualifications that are equivalent to those required for such certification. (c) If the requirements of paragraph (b) of this section are not met and the laboratory performs tests in the subspecialty of bacteriology, 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 possess qualifications that are equivalent to those required for such certification; 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 one year 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)(i) Have an earned doctoral degree in a chemical, physical, biological or clinical laboratory science from an accredited institution; and (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 experience in high complexity testing within the subspecialty of bacteriology; or (c)(4)(i) Have earned a master's degree in a chemical, physical, biological or clinical laboratory science or medical technology from an accredited institution; 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)(5)(i) Have earned a bachelor's degree in a chemical, physical, or biological science or medical technology from an accredited institution; 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 experience in high complexity testing within the subspecialty of bacteriology. (d) If the requirements of paragraph (b) of this section are not met and the laboratory performs tests in the subspecialty of mycobacteriology, the individual functioning as the technical supervisor must-- (d)(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 (d)(1)(ii) Be certified in clinical pathology by the American Board of Pathology or the American Osteopathic Board of Pathology or possess qualifications that are equivalent to those required for such certification; or (d) (2)(i) Be a doctor of medicine, doctor of osteopathy, or doctor or 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 within the specialty of microbiology with a minimum of 6 months experience in high complexity testing within the subspecialty of mycobacteriology; or (d)(3)(i) Have an earned doctoral degree in a chemical, physical, biological or clinical laboratory science from an accredited institution; and (d)(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 -- 5 of 11 -- of 6 months experience in high complexity testing within the subspecialty of mycobacteriology; or (d)(4)(i) Have earned a master's degree in a chemical, physical, biological or clinical laboratory science or medical technology from an accredited institution; and (d)(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 mycobacteriology; or (d)(5)(i) Have earned a bachelor's degree in a chemical, physical or biological science or medical technology from an accredited institution; and (d)(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 experience in high complexity testing within the subspecialty of mycobacteriology. (e) If the requirements of paragraph (b) of this section are not met and the laboratory performs tests in the subspecialty of mycology, the individual functioning as the technical supervisor must-- (e)(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 (e)(1)(ii) Be certified in clinical pathology by the American Board of Pathology or the American Osteopathic Board of Pathology or possess qualifications that are equivalent to those required for such certification; or (e) (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 (e)(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 experience in high complexity testing within the subspecialty of mycology; or (e)(3)(i) Have an earned doctoral degree in a chemical, physical, biological or clinical laboratory science from an accredited institution; and (e)(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 experience in high complexity testing within the subspecialty of mycology; or (e)(4) (i) Have earned a master's degree in a chemical, physical, biological or clinical laboratory science or medical technology from an accredited institution; and (e)(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 mycology; or (e)(5)(i) Have earned a bachelor's degree in a chemical, physical or biological science or medical technology from an accredited institution; and (e)(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 experience in high complexity testing within the subspecialty of mycology. (f) If the requirements of paragraph (b) of this section are not met and the laboratory performs tests in the subspecialty of parasitology, the individual functioning as the technical supervisor must-- (f)(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 (f)(1)(ii) Be certified in clinical pathology by the American Board of Pathology or the American Osteopathic Board of Pathology or possess qualifications that are equivalent to those required for such certification; or (f)(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 (f)(2)(ii) Have at least one year 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 parasitology; (f)(3)(i) Have an earned doctoral degree in a chemical, physical, biological or clinical laboratory science from an accredited institution; and (f)(3)(ii) Have at least 1 year of laboratory training or experience, or both, in high complexity testing within the specialty of microbiology -- 6 of 11 -- with a minimum of 6 months experience in high complexity testing within the subspecialty of parasitology; or (f)(4)(i) Have earned a master's degree in a chemical, physical, biological or clinical laboratory science or medical technology from an accredited institution; and (f)(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 parasitology; or (f)(5)(i) Have earned a bachelor's degree in a chemical, physical or biological science or medical technology from an accredited institution; and (f)(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 experience in high complexity testing within the subspecialty of parasitology. (g) If the requirements of paragraph (b) of this section are not met and the laboratory performs tests in the subspecialty of virology, the individual functioning as the technical supervisor must-- (g)(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 (g)(1)(ii) Be certified in clinical pathology by the American Board of Pathology or the American Osteopathic Board of Pathology or possess qualifications that are equivalent to those required for such certification; or (g) (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 (g)(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 experience in high complexity testing within the subspecialty of virology; or (g)(3)(i) Have an earned doctoral degree in a chemical, physical, biological or clinical laboratory science from an accredited institution; and (g)(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 experience in high complexity testing within the subspecialty of virology; or (g)(4)(i) Have earned a master's degree in a chemical, physical, biological or clinical laboratory science or medical technology from an accredited institution; and (g)(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 virology; or (g)(5)(i) Have earned a bachelor's degree in a chemical, physical or biological science or medical technology from an accredited institution; and (g)(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 experience in high complexity testing within the subspecialty of virology. (h) If the requirements of paragraph (b) of this section are not met and the laboratory performs tests in the specialty of diagnostic immunology, the individual functioning as the technical supervisor must- (h)(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 (h)(1)(ii) Be certified in clinical pathology by the American Board of Pathology or the American Osteopathic Board of Pathology or possess qualifications that are equivalent to those required for such certification; or (h)(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 (h)(2)(ii) Have at least 1 year of laboratory training or experience, or both, in high complexity testing for the specialty of diagnostic immunology; or (h)(3)(i) Have an earned doctoral degree in a chemical, physical, biological or clinical laboratory science from an accredited institution; and (h)(3)(ii) Have at least 1 year of laboratory training or experience, or both, in high complexity testing within the specialty of diagnostic immunology; or (h)(4)(i) Have earned a master's degree in a chemical, physical, biological or clinical laboratory -- 7 of 11 -- science or medical technology from an accredited institution; and (h)(4)(ii) Have at least 2 years of laboratory training or experience, or both, in high complexity testing for the specialty of diagnostic immunology; or (h)(5)(i) Have earned a bachelor's degree in a chemical, physical or biological science or medical technology from an accredited institution; and (h)(5)(ii) Have at least 4 years of laboratory training or experience, or both, in high complexity testing for the specialty of diagnostic immunology. (i) If the requirements of paragraph (b) of this section are not met and the laboratory performs tests in the specialty of chemistry, the individual functioning as the technical supervisor must-- (i)(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 (i)(1)(ii) Be certified in clinical pathology by the American Board of Pathology or the American Osteopathic Board of Pathology or possess qualifications that are equivalent to those required for such certification; or (i)(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 (i)(2)(ii) Have at least 1 year of laboratory training or experience, or both, in high complexity testing for the specialty of chemistry; or (i)(3)(i) Have an earned doctoral degree in a chemical, physical, biological or clinical laboratory science from an accredited institution; and (i)(3)(ii) Have at least 1 year of laboratory training or experience, or both, in high complexity testing within the specialty of chemistry; or (i) (4)(i) Have earned a master's degree in a chemical, physical, biological or clinical laboratory science or medical technology from an accredited institution; and (i)(4)(ii) Have at least 2 years of laboratory training or experience, or both, in high complexity testing for the specialty of chemistry; or (i)(5)(i) Have earned a bachelor's degree in a chemical, physical or biological science or medical technology from an accredited institution; and (i)(5)(ii) Have at least 4 years of laboratory training or experience, or both, in high complexity testing for the specialty of chemistry. (j) If the requirements of paragraph (b) of this section are not met and the laboratory performs tests in the specialty of hematology, the individual functioning as the technical supervisor must-- (j)(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 (j)(1)(ii) Be certified in clinical pathology by the American Board of Pathology or the American Osteopathic Board of Pathology or possess qualifications that are equivalent to those required for such certification; or (j)(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 (j)(2)(ii) Have at least one year of laboratory training or experience, or both, in high complexity testing for the specialty of hematology (for example, physicians certified either in hematology or hematology and medical oncology by the American Board of Internal Medicine); or (j) (3)(i) Have an earned doctoral degree in a chemical, physical, biological or clinical laboratory science from an accredited institution; and (j)(3)(ii) Have at least 1 year of laboratory training or experience, or both, in high complexity testing within the specialty of hematology; or (j)(4)(i) Have earned a master's degree in a chemical, physical, biological or clinical laboratory science or medical technology from an accredited institution; and (j)(4)(ii) Have at least 2 years of laboratory training or experience, or both, in high complexity testing for the specialty of hematology; or (j) (5)(i) Have earned a bachelor's degree in a chemical, physical or biological science or medical technology from an accredited institution; and (j)(5)(ii) Have at least 4 years of laboratory training or experience, or both, in high complexity testing for the specialty of hematology. (k)(1) 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-- (k)(1)(i) Be a doctor of medicine or a doctor of osteopathy licensed to practice medicine or osteopathy in the -- 8 of 11 -- State in which the laboratory is located; and (k)(1)(ii) Meet one of the following requirements-- (k)(1)(ii)(A) Be certified in anatomic pathology by the American Board of Pathology or the American Osteopathic Board of Pathology or possess qualifications that are equivalent to those required for such certification; or (k)(1)(ii) (B) Be certified by the American Society of Cytology to practice cytopathology or possess qualifications that are equivalent to those required for such certification; (l) 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-- (l)(1) Meet one of the following requirements: (l)(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 (l)(1)(i)(B) Be certified in anatomic pathology by the American Board of Pathology or the American Osteopathic Board of Pathology or possess qualifications that are equivalent to those required for such certification; (l)(1)(ii) An individual qualified under 493.1449(b) or paragraph (l)(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 (l)(1)(i)(B) of this section, the responsibility for examination and interpretation of histopathology specimens. (l)(2) For tests in dermatopathology, meet one of the following requirements: (l)(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-- (l) (2)(i)(B) Meet one of the following requirements: (l)(2)(i)(B)(1) Be certified in anatomic pathology by the American Board of Pathology or the American Osteopathic Board of Pathology or possess qualifications that are equivalent to those required for such certification; or (l)(2)(i)(B)(2) Be certified in dermatopathology by the American Board of Dermatology and the American Board of Pathology or possess qualifications that are equivalent to those required for such certification; or (l)(2)(i)(B) (3) Be certified in dermatology by the American Board of Dermatology or possess qualifications that are equivalent to those required for such certification; or (l)(2)(ii) An individual qualified under 493.1449(b) or paragraph (l)(2)(i) of this section may delegate to an individual who is a resident in a training program leading to certification specified in paragraphs (b) or (l)(2)(i)(B) of this section, the responsibility for examination and interpretation of dermatopathology specimens. (l) (3) For tests in ophthalmic pathology, meet one of the following requirements: (l)(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-- (l)(3)(i)(B) Must meet one of the following requirements: (l)(3)(i)(B)(1) Be certified in anatomic pathology by the American Board of Pathology or the American Osteopathic Board of Pathology or possess qualifications that are equivalent to those required for such certification; or (l)(3)(i)(B)(2) Be certified by the American Board of Ophthalmology or possess qualifications that are equivalent to those required for such certification and have successfully completed at least 1 year of formal post-residency fellowship training in ophthalmic pathology; or (l)(3)(ii) An individual qualified under 493.1449(b) or paragraph (1)(3)(i) of this section may delegate to an individual who is a resident in a training program leading to certification specified in paragraphs (b) or (1)(3)(i)(B) of this section, the responsibility for examination and interpretation of ophthalmic specimens; or (m) 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: (m)(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-- (m)(1)(ii) Be certified in anatomic pathology by the American Board of Pathology or the American Osteopathic Board of Pathology or possess qualifications that are equivalent to those required for such certification; or (m)(2) Be certified in oral -- 9 of 11 -- pathology by the American Board of Oral Pathology or possess qualifications for such certification; or (m)(3) An individual qualified under 493.1449(b) or paragraph (m)(1) or (2) of this section may delegate to an individual who is a resident in a training program leading to certification specified in paragraphs (b) or (m)(1) or (2) of this section, the responsibility for examination and interpretation of oral pathology specimens. (n) If the requirements of paragraph (b) of this section are not met and the laboratory performs tests in the specialty of radiobioassay, the individual functioning as the technical supervisor must-- (n)(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 (n)(1)(ii) Be certified in clinical pathology by the American Board of Pathology or the American Osteopathic Board of Pathology or possess qualifications that are equivalent to those required for such certification; or (n)(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 (n)(2)(ii) Have at least 1 year of laboratory training or experience, or both, in high complexity testing for the specialty of radiobioassay; or (n)(3)(i) Have an earned doctoral degree in a chemical, physical, biological or clinical laboratory science from an accredited institution; and (n)(3)(ii) Have at least 1 year of laboratory training or experience, or both, in high complexity testing within the specialty of radiobioassay; or (n)(4)(i) Have earned a master's degree in a chemical, physical, biological or clinical laboratory science or medical technology from an accredited institution; and (n)(4)(ii) Have at least 2 years of laboratory training or experience, or both, in high complexity testing for the specialty of radiobioassay; or (n)(5)(i) Have earned a bachelor's degree in a chemical, physical or biological science or medical technology from an accredited institution; and (n)(5)(ii) Have at least 4 years of laboratory training or experience, or both, in high complexity testing for the specialty of radiobioassay. (o) If the laboratory performs tests in the specialty of histocompatibility, the individual functioning as the technical supervisor must either-- (o)(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 (o)(1)(ii) Have training or experience that meets one of the following requirements: (o)(1)(ii)(A) Have 4 years of laboratory training or experience, or both, within the specialty of histocompatibility; or (o)(1)(ii)(B)(1) Have 2 years of laboratory training or experience, or both, in the specialty of general immunology; and (o)(1)(ii)(B)(2) Have 2 years of laboratory training or experience, or both, in the specialty of histocompatibility; or (o)(2)(i) Have an earned doctoral degree in a biological or clinical laboratory science from an accredited institution; and (o)(2)(ii) Have training or experience that meets one of the following requirements: (o) (2)(ii)(A) Have 4 years of laboratory training or experience, or both, within the specialty of histocompatibility; or (o)(2)(ii)(B)(1) Have 2 years of laboratory training or experience, or both, in the specialty of general immunology; and (o)(2)(ii)(B)(2) Have 2 years of laboratory training or experience, or both, in the specialty of histocompatibility. (p) If the laboratory performs tests in the specialty of clinical cytogenetics, the individual functioning as the technical supervisor must-- (p)(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 (p)(1)(ii) Have 4 years of training or experience, or both, in genetics, 2 of which have been in clinical cytogenetics; or (p)(2)(i) Hold an earned doctoral degree in a biological science, including biochemistry, or clinical laboratory science from an accredited institution; and (p)(2)(ii) Have 4 years of training or experience, or both, in genetics, 2 of which have been in clinical cytogenetics. (q) If the requirements of paragraph (b) of this section are not met and the laboratory performs tests in the specialty of immunohematology, the individual functioning as the technical supervisor -- 10 of 11 -- must-- (q)(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 (q)(1)(ii) Be certified in clinical pathology by the American Board of Pathology or the American Osteopathic Board of Pathology or possess qualifications that are equivalent to those required for such certification; or (q)(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 (q)(2)(ii) Have at least one year of laboratory training or experience, or both, in high complexity testing for the specialty of immunohematology. Note: The technical supervisor requirements for "laboratory training or experience, or both'' in each specialty or subspecialty may be acquired concurrently in more than one of the specialties or subspecialties of service. For example, an individual, who has a doctoral degree in chemistry and additionally has documentation of 1 year of laboratory experience working concurrently in high complexity testing in the specialties of microbiology and chemistry and 6 months of that work experience included high complexity testing in bacteriology, mycology, and mycobacteriology, would qualify as the technical supervisor for the specialty of chemistry and the subspecialties of bacteriology, mycology, and mycobacteriology. This STANDARD is not met as evidenced by: Based on a review of records and interview with technical consultant #2, the technical supervisor failed to ensure the individual who performed the duties and responsibilities of the technical supervisor met the qualifications to perform a semi- annual competency assessment for one of one testing person. Findings include: (1) On 02/13/2023, competency assessment records were reviewed for one testing person (testing person #11) who had been hired to perform high complexity testing (ABO /Rh, Antibody Screen and Compatibility testing) since the previous recertification survey; (2) The records revealed the semi-annual competency for the testing person had been performed by an individual who did not meet the regulatory qualification requirements of the technical supervisor: (a) Testing Person #11 - The 10/16/2021 semi-annual competency had been performed by technical consultant #2. (3) The findings were reviewed with technical consultant #2 who stated on 02/13/2022 at 03: 02 pm, the semi-annual evaluation had not been performed by an individual who met the qualifications of a technical supervisor as shown above. -- 11 of 11 --

Summary Statement of Deficiencies D0000 The recertification survey was performed on 05/26,27,28/2021. The laboratory was found out of compliance with the following CLIA regulations: 493.801; D2000: Enrollment and Testing of Samples 493.1447; D6109: Technical Supervisor The findings were reviewed with the director of laboratory services at the conclusion of the survey. D2000 ENROLLMENT AND TESTING OF SAMPLES CFR(s): 493.801 Each laboratory must enroll in a proficiency testing (PT) program that meets the criteria in subpart I of this part and is approved by HHS. The laboratory must enroll in an approved program or programs for each of the specialties and subspecialties for which it seeks certification. The laboratory must test the samples in the same manner as patients' specimens. For laboratories subject to 42 CFR part 493 published on March 14, 1990 (55 FR 9538) prior to September 1, 1992, the rules of this subpart are effective on September 1, 1992. For all other laboratories, the rules of this subpart are effective January 1, 1994. This CONDITION is not met as evidenced by: Based on a review of records and interview with the director of laboratory services, the laboratory failed to enroll in a proficiency testing program for qualitative serum pregnancy testing. Findings include: (1) On 05/25/2021 the surveyor reviewed proficiency testing records for 2019 (second and third event), 2020 (first, second, and third events), and to date in 2021 (first event). There was no evidence the laboratory was enrolled in proficiency testing for serum qualitative pregnancy testing for the third 2019 event, first, second, and third 2020 events, and the first 2021 event; (2) The surveyor reviewed the records with the director of laboratory services who stated on 05 /25/2021 at 09:50 am, the laboratory discontinued proficiency testing for serum qualitative pregnancy testing on 09/10/2019; (3) The following were examples of patient serum pregnancy testing performed when the laboratory was not enrolled in Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 13 -- proficiency testing: (a) Patient #10178312 - testing performed on 05/17/2020 (b) Patient #10178614 - testing performed on 05/26/2020 (c) Patient #10178736 - testing performed on 05/28/2020 (d) Patient #10180996 - testing performed on 08/06/2020 (e) Patient #10181052 - testing performed on 08/07/2020 (f) Patient #10181298 - testing performed on 08/14/2020 (g) Patient #10181307 - testing performed on 08/15 /2020 (h) Patient #10181519 - testing performed on 08/21/2020 (i) Patient #10185958 - testing performed on 01/16/2021 (j) Patient #10186120 - testing performed on 01/21 /2021 (k) Patient #10186265 - testing performed on 01/27/2021 (l) Patient #10186320 - testing performed on 01/29/2021 (m) Patient #10187736 - testing performed on 03/24 /2021 (n) Patient #10187931 - testing performed on 03/30/2021 (o) Patient #10188190 - testing performed on 04/06/2021 (p) Patient #10188202 - testing performed on 04/06 /2021 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 a review of records and interview with the director of laboratory services, the laboratory failed to maintain quality control records for at least 2 years. Findings include: (1) On 05/26/2021 at 09:30 am, the director of laboratory services stated to the surveyor CBC(Complete Blood Count) testing was performed on the Sysmex XS 1000i analyzer; (2) On 05/27/2021, the surveyor requested QC (Quality Control) records, which consisted of L-J (Levey Jennings) graphs. The director of laboratory services stated to the surveyor on 05/27/2021 at 04:30 pm, the records were maintained in the analyzer and printouts were not maintained; (3) While searching in the analyzer's memory, the director of laboratory services stated to the surveyor on 05 /27/2021 at 04:45 that QC data could not be retrieved prior to 12/03/2019; (4) The surveyor explained to the director of laboratory services that all records must be maintained for at least 2 years. D5411 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(a) Test systems must be selected by the laboratory. The testing must be performed following the manufacturer's instructions and in a manner that provides test results within the laboratory's stated performance specifications for each test system as determined under 493.1253. This STANDARD is not met as evidenced by: Based on a review of records, manufacturer's instructions, and interview with the director of laboratory services, the laboratory failed to follow the manufacturer's instructions for verifying flags obtained on the Hematology analyzer for 7 of 18 records and failed to follow the manufacturer's instructions for implementing coagulation reagents. Findings include: VERIFYING HEMATOLOGY FLAGS (1) On 05/26/2021 at 09:40 am, the director of laboratory services stated to the surveyor CBC (Complete Blood Count) testing was performed on the Sysmex XS 1000i analyzer; (2) On 05/27/2021 the surveyor reviewed the manufacturer's instructions for -- 2 of 13 -- verifying automated differential flags obtained on the analyzer. The following were examples of flags, with the corresponding instructions: (a) Microcytosis - "Verify RBC morphology on slide" (b) Leukocytopenia - "Review manual smear" (c) Immature Gran? - "Perform manual differential" (d) Left Shift? - "Perform manual differential" (e) Blasts? - "Perform manual differential" (f) Turbidity/HGB Interf? - "Check sample for interpering substnaces, i.e.,lipemia, icterus, cold agglutinin, and clotted sample" (3) The surveyor randomly reviewed 18 patient records which contained flags from CBC testing performed during May 2021. For 6 of the records, there was no evidence the laboratory followed the manufacturer's instructions for verifying the flags. The findings for the 6 records were: (a) Record #1 - Testing was performed on 05/06/2021 at 03:59 am, with an Immature Gran? flag obtained; (b) Record #2 - Testing was performed on 05/13/2021 at 04:37 am, with a Leukocytopenia flag obtained; (c) Record #3 - Testing was performed on 05/13/2021 at 04:42 am, with an Immature Gran? flag obtained; (d) Record #4 - Testing was performed on 05/19/2021 at 05:04 am, with Immature Gran? and Left Shift? flags obtained; (e) Record #5 - Testing was performed on 05/24/2021 at 11:04 pm, with Blasts? and Immature Gran? flags obtained; (f) Record #6 - Testing was performed on 05/25/2021 at 04:18 am with a Turbidity/HGB Interf? flag obtained; (g) Record #7 - Testing was performed on 05/26/2021 at 11:13 pm with a Microcytosis flag obtained. (4) The surveyor reviewed the records with the director of laboratory services who stated on 05/27/2021 at 05:30 pm the flags obtained for the above 7 patients had not been verified. IMPLEMENTING COAGULATION REAGENTS (1) On 05/26/2021 at 09:20 am, the director of laboratory services stated to the surveyor the Sysmex CA- 660 analyzer was used to perform PT/INR (Prothrombin Time/International Normalized Ratio) and PTT (Partial Thromboplastin Time) testing (the INR was calculated using the PT reference interval mean); (2) On 05/28/2021 at 11:00 am, the director of laboratory services stated to the surveyor the following reagents were put into use on 11/29/2020: (a) PT - Siemens Dade Innovin reagent, lot #549771 (b) PTT - Siemens Actin FSL reagent, lot #562637A (c) Siemens Ci-Trol control level 1, lot #564828A (d) Siemens Ci-Trol control level 3, lot #55654128 (3) On 05/04/2021, the surveyor reviewed the manufacturer's instructions for implementing new reagents, which stated, "The following recommendations should be used as a guideline when converting to new lots of reagents for Hemostasis analyzers. These procedures should be followed each year before new lots of reagents are put into use on the existing Hemostasis system". In addition, the manufacturer required the following: (b) Section titled, "Method Correlation" (i) "40 samples: 20 normal, 20 abnormal"; (ii) "Normal samples (Section I) may be used for the Method Correlation and Verification of Reference Range"; (iii) "Abnormal samples should span the Reportable Range of assay"; (iv) "Assay samples on current and new lot number reagents simultaneously or within 1 our of each other"; (v) "Calculate Linear Regression statistics". (c) Section titled, "Quality Control" (i) "Assay new lot number of QC material with the new lot of reagent in PTN and APTTN protocols"; (ii) Collect a minimum of 30 data points over multiple days and stability limits of control"; (iii) Calculate the mean, 2 SD and 3 SD range". (4) The surveyor reviewed the records for the changes with the following identified: (a) PT - Innovin reagent, lot #549771 (i) Although the laboratory performed the method correlation using 20 normal and 20 abnormal samples with the current and new lot number of reagents simultaneously, the comparison with the abnormal samples did not span the reportable range of 8.9-120. The specimens used by the laboratory ranged from 19.9-48.6. (b) PTT - Actin reagent, lot #562637A (i) Although the laboratory performed the method correlation using 20 normal and 20 abnormal samples with the current and new lot number of reagents simultaneously, the comparison with the abnormal samples did not span the reportable range of 17.8- 150. The specimens used by the laboratory ranged from 35-75.9. (c) Siemens Ci-Trol -- 3 of 13 -- control level 1 lot #564828A (i) The records showed the laboratory had assayed the new lot of quality control material using 20 data points instead of 30 data points as required. (d) Siemens Ci-Trol control level 3 lot #55654128 (i) The records showed the laboratory had assayed the new lot of quality control material using 20 data points instead of 30 data points as required. (4) The surveyor reviewed the records and the findings with the director of laboratory services. The director of laboratory services stated the following to the surveyor on 05/28/2021 at 11:40 am: (a) The laboratory did not span the reportable range for the method correlation for PT and PTT; (b) The laboratory had utilized 20 data points to assay the new lots of quality control materials for level 1 and level 3, instead of 30 data points; (c) The laboratory had not followed the manufacturer's instructions for implementing the coagulation reagents. D5413 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(b) The laboratory must define criteria for those conditions that are essential for proper storage of reagents and specimens, accurate and reliable test system operation, and test result reporting. The criteria must be consistent with the manufacturer's instructions, if provided. These conditions must be monitored and documented and, if applicable, include the following: (1) Water quality. (2) Temperature. (3) Humidity. (4) Protection of equipment and instruments from fluctuations and interruptions in electrical current that adversely affect patient test results and test reports. This STANDARD is not met as evidenced by: Based on a review of records, observation, and interview with the director of laboratory services, the laboratory failed to ensure materials were being stored as required. Findings include: (1) On 05/27/2021 at 01:00 pm, the surveyor observed the outpatient phlebotomy room, located in a separate room. The following examples of collection tubes, used by the laboratory to collect patient blood specimens, were observed in the room, with the manufacturer's storage requirements: (a) BD Vacutainer 9 NC Coagulation Sodium Citrate 3.2% tubes - 25 tubes of lot #454334; storage requirement of 4-25 degrees Centigrade (C); (b) BD Vacutainer Serum tubes - 8 tubes of lot #1034950; storage requirement of 4-25 degrees C; (c) BD Vacutainer K2 EDTA tubes - 15 tubes of lot #454246; storage requirement of 4-25 degrees C. (2) On 05/28/2021 at 09:24 am, the surveyor asked the director of laboratory services if the temperature of the phlebotomy room was being monitored. The director of laboratory services stated on 05/28/2021 at 09:30 am, the laboratory was not monitoring the temperature of the outpatient phlebotomy room. 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. -- 4 of 13 -- This STANDARD is not met as evidenced by: Based on a review of records and interview with the director of laboratory services, the laboratory failed to follow their written protocol to ensure the blood bank centrifuge was functioning properly. Findings include: (1) On 05/26/2021 at 09:00 am, the director of laboratory services stated to the surveyor ABO/Rh, Antibody Screen and Compatibility testing were performed using the Ortho MTS gel system. The specimens were processed in the Ortho MTS Workstation centrifuge at a speed of 1027-1037 rpm (revolutions per minute) for 10 minutes; (2) On 05/27/2021, the surveyor reviewed the function check protocol titled, "Centrifuge Function Check Protocol" which required speed and timer checks be performed annually; (3) The surveyor reviewed the MTS Workstation centrifuge records for 2019 and 2020. Although the speed and timer checks had been performed on 10/15/2019 and 10/06 /2020, the checks had been documented as "OK" for the speed checks and "OK" for the timer checks. There was no documentation to show the speed and time obtained during the checks; (4) The surveyor reviewed the records with the director of laboratory services who stated on 05/27/2021 at 02:00 pm, the checks did not show the speed and time the centrifuge was checked. D5555 IMMUNOHEMATOLOGY CFR(s): 493.1271(c)(f) (c) Blood and blood products storage. Blood and Blood products must be stored under appropriate conditions that include an adequate temperature alarm system that is regularly inspected. (c)(1) An audible alarm system must monitor proper blood and blood product storage temperature over a 24-hour period. (c)(2) Inspections of the alarm system must be documented. (f) Documentation. The laboratory must document all control procedures performed, as specified in this section. This STANDARD is not met as evidenced by: Based on a review of records and interview with the director of laboratory services, the laboratory failed to ensure units of blood were stored under appropriate conditions for 8 of 29 refrigerator temperature charts and 8 of 29 freezer temperature charts. Findings include: (1) On 05/26/2021 at 09:10 am, the director of laboratory services stated the following to the surveyor: (a) The laboratory stored units of packed red blood cells in the blood bank refrigerator; (b) The laboratory stored units of FFP (Fresh Frozen Plasma) in the blood bank freezer; (c) The above units were to be used for patient transfusions. (2) On 05/27/2021 at 11:30 am, the surveyor observed the thermograph temperature recorders for the blood bank refrigerator and freezer. They had recorders connected to them for continuously recording the temperature on thermograph charts (Note: units of packed cells must be stored at 1-6 degrees (C) Centigrade and units of FFP must be stored at -19 degrees C or colder). Each chart monitored the temperature for a 7 day period; (3) The surveyor reviewed 29 refrigerator charts and 29 freezer charts dated from 09/04/2020 through 05/18/2021. The review showed that 8 of 29 refrigerator charts and 8 of 29 freezer charts had not been changed by the 7th day of usage as follows: (a) Refrigerator (i) Chart #1 - The chart was put into use on 09/04/2020 and removed on 09/12/2020 (8 days); (ii) Chart #2 - The chart was put into use on 09/12/2020 and removed on 09/25/2020 (13 days); (iii) Chart #3 - The chart was put into use on 10/16/2020 and removed on 11/012020 (16 days); (iv) Chart #4 - The chart was put into use on 11/01/2020 and removed on 11 /17/2020 (16 days); (v) Chart #5 - The chart was put into use on 12/15/2020 and removed on 12/23/2020 (8 days); (vi) Chart #6 - The chart was put into use on 12/23 /2020 and removed on 01/12/2021 (20 days); (vii) Chart #7 - The chart was put into -- 5 of 13 -- use on 04/13/2021 and removed on 04/27/2021 (14 days); (viii) Chart #8 - The chart was put into use on 05/04/2021 and removed on 05/18/2021 (14 days). (b) Freezer (i) Chart #1 - The chart was put into use on 09/04/2020 and removed on 09/12/2020 (8 days); (ii) Chart #2 - The chart was put into use on 09/12/2020 and removed on 09/25 /2020 (13 days); (iii) Chart #3 - The chart was put into use on 10/16/2020 and removed on 11/012020 (16 days); (iv) Chart #4 - The chart was put into use on 11/01 /2020 and removed on 11/17/2020 (16 days); (v) Chart #5 - The chart was put into use on 12/15/2020 and removed on 12/23/2020 (8 days); (vi) Chart #6 - The chart was put into use on 12/23/2020 and removed on 01/12/2021 (20 days); (vii) Chart #7 - The chart was put into use on 04/13/2021 and removed on 04/27/2021 (14 days); (viii) Chart #8 - The chart was put into use on 05/04/2021 and removed on 05/18/2021 (14 days). (4) The surveyor reviewed the charts with the director of laboratory services who stated on 05/27/2021 at 03:00 pm, the charts had not been changed by the 7th day as stated above. D5775 COMPARISON OF TEST RESULTS CFR(s): 493.1281(a)(c) (a) If a laboratory performs the same test using different methodologies or instruments, or performs the same test at multiple testing sites, the laboratory must have a system that twice a year evaluates and defines the relationship between test results using the different methodologies, instruments, or testing sites. (c) The laboratory must document all test result comparison activities. This STANDARD is not met as evidenced by: Based on a review of records, and interview with the director of laboratory services, the laboratory failed to have a system that twice a year evaluated and defined the relationship between test results using different analyzers. Findings include: (1) On 05 /26/2021, the director of laboratory services stated to the surveyor Acetaminophen, Albumin, Alcohol, Alkaline Phosphatase, Amylase, ALT (Alanine Aminotransferase), AST (Aspartate Aminotransferase), BUN (Blood Urea Nitrogen), Calcium, Carbamazepine, Cholesterol, Chloride, CK (Creatine Kinase), CKMB (CK Isoenzyme), CO2, Creatinine, Digoxin, Dilantin, Direct Bilirubin, Gentamicin, GGT (Gamma Glutamyl transferase), Glucose, HCG (Human Chorionic Gonadotropin), Hemoglobin A1c, HDL (High Density Lipoprotein), Lipase, Magnesium, Phenobarbital, Phosphorus, Potassium, Salicylate, Sodium, Tobramycin, Total Bilirubin, Theophylline, Total Protein, Triglyceride, TSH (Thyroid Stimulating Hormone), Free T4 (Thyroxin), Vancomycin, and Uric Acid testing were performed on two analyzers as follows: (a) The Dimension EXL analyzer, denoted by the laboratory as EXL 2 was the primary analyzer; (b) The Dimension EXL analyzer, denoted by the laboratory as EXL 1 was the back-up analyzer. (2) On 05/28/2021 the surveyor reviewed the comparison data for the analyzers for testing performed from January 2020 through 05/28/2021. There was no evidence the relationship between the analyzers had been evaluated twice in 2020 and to date in 2021. The relationship between the analyzers had been evaluated on 12/30/2020 (not prior to that date and after that date): (3) The surveyor reviewed the records with the director of laboratory services who stated on 05/28/2021 at 11:45 am, the relationship between the analyzers had not been evaluated prior to 12/30/2020 and to date in 2021. D6108 LABORATORY TECHNICAL SUPERVISOR CFR(s): 493.1447 -- 6 of 13 -- 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 a review of records and interview with technical the director of laboratory services, the technical supervisor failed to provide technical supervision in accordance with 493.1447 of this subpart. Findings include: (1) The technical supervisor failed to ensure the individual who performed the duties and responsibilities of the technical supervisor met the educational qualifications. 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 or Possesses qualifications that are equivalent to those required for such certification. (c) If the requirements of paragraph (b) of this section are not met and the laboratory performs tests in the subspecialty of bacteriology, 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 possess qualifications that are equivalent to those required for such certification; 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 one year 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)(i) Have an earned doctoral degree in a chemical, physical, biological or clinical laboratory science from an accredited institution; and (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 experience in high complexity testing within the subspecialty of bacteriology; or (c)(4)(i) Have earned a master's degree in a chemical, physical, biological or clinical laboratory science or medical technology from an accredited institution; 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)(5)(i) Have earned a bachelor's degree in a chemical, physical, or biological science or medical technology from an accredited institution; 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 experience in high complexity testing within the subspecialty of bacteriology. (d) If the requirements of paragraph (b) of this section are not met and the laboratory performs tests in the subspecialty of mycobacteriology, the individual -- 7 of 13 -- functioning as the technical supervisor must-- (d)(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 (d)(1)(ii) Be certified in clinical pathology by the American Board of Pathology or the American Osteopathic Board of Pathology or possess qualifications that are equivalent to those required for such certification; or (d) (2)(i) Be a doctor of medicine, doctor of osteopathy, or doctor or 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 within the specialty of microbiology with a minimum of 6 months experience in high complexity testing within the subspecialty of mycobacteriology; or (d)(3)(i) Have an earned doctoral degree in a chemical, physical, biological or clinical laboratory science from an accredited institution; and (d)(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 experience in high complexity testing within the subspecialty of mycobacteriology; or (d)(4)(i) Have earned a master's degree in a chemical, physical, biological or clinical laboratory science or medical technology from an accredited institution; and (d)(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 mycobacteriology; or (d)(5)(i) Have earned a bachelor's degree in a chemical, physical or biological science or medical technology from an accredited institution; and (d)(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 experience in high complexity testing within the subspecialty of mycobacteriology. (e) If the requirements of paragraph (b) of this section are not met and the laboratory performs tests in the subspecialty of mycology, the individual functioning as the technical supervisor must-- (e)(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 (e)(1)(ii) Be certified in clinical pathology by the American Board of Pathology or the American Osteopathic Board of Pathology or possess qualifications that are equivalent to those required for such certification; or (e) (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 (e)(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 experience in high complexity testing within the subspecialty of mycology; or (e)(3)(i) Have an earned doctoral degree in a chemical, physical, biological or clinical laboratory science from an accredited institution; and (e)(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 experience in high complexity testing within the subspecialty of mycology; or (e)(4) (i) Have earned a master's degree in a chemical, physical, biological or clinical laboratory science or medical technology from an accredited institution; and (e)(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 mycology; or (e)(5)(i) Have earned a bachelor's degree in a chemical, physical or biological science or medical technology from an accredited institution; and (e)(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 experience in high complexity testing within the subspecialty of mycology. (f) If the requirements of paragraph (b) of this section are not met and the laboratory performs tests in the subspecialty of -- 8 of 13 -- parasitology, the individual functioning as the technical supervisor must-- (f)(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 (f)(1)(ii) Be certified in clinical pathology by the American Board of Pathology or the American Osteopathic Board of Pathology or possess qualifications that are equivalent to those required for such certification; or (f)(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 (f)(2)(ii) Have at least one year 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 parasitology; (f)(3)(i) Have an earned doctoral degree in a chemical, physical, biological or clinical laboratory science from an accredited institution; and (f)(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 experience in high complexity testing within the subspecialty of parasitology; or (f)(4)(i) Have earned a master's degree in a chemical, physical, biological or clinical laboratory science or medical technology from an accredited institution; and (f)(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 parasitology; or (f)(5)(i) Have earned a bachelor's degree in a chemical, physical or biological science or medical technology from an accredited institution; and (f)(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 experience in high complexity testing within the subspecialty of parasitology. (g) If the requirements of paragraph (b) of this section are not met and the laboratory performs tests in the subspecialty of virology, the individual functioning as the technical supervisor must-- (g)(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 (g)(1)(ii) Be certified in clinical pathology by the American Board of Pathology or the American Osteopathic Board of Pathology or possess qualifications that are equivalent to those required for such certification; or (g) (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 (g)(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 experience in high complexity testing within the subspecialty of virology; or (g)(3)(i) Have an earned doctoral degree in a chemical, physical, biological or clinical laboratory science from an accredited institution; and (g)(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 experience in high complexity testing within the subspecialty of virology; or (g)(4)(i) Have earned a master's degree in a chemical, physical, biological or clinical laboratory science or medical technology from an accredited institution; and (g)(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 virology; or (g)(5)(i) Have earned a bachelor's degree in a chemical, physical or biological science or medical technology from an accredited institution; and (g)(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 experience in high complexity testing within the subspecialty of virology. (h) If the requirements of paragraph (b) of this section are not met and the laboratory performs tests in the specialty of diagnostic -- 9 of 13 -- immunology, the individual functioning as the technical supervisor must- (h)(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 (h)(1)(ii) Be certified in clinical pathology by the American Board of Pathology or the American Osteopathic Board of Pathology or possess qualifications that are equivalent to those required for such certification; or (h)(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 (h)(2)(ii) Have at least 1 year of laboratory training or experience, or both, in high complexity testing for the specialty of diagnostic immunology; or (h)(3)(i) Have an earned doctoral degree in a chemical, physical, biological or clinical laboratory science from an accredited institution; and (h)(3)(ii) Have at least 1 year of laboratory training or experience, or both, in high complexity testing within the specialty of diagnostic immunology; or (h)(4)(i) Have earned a master's degree in a chemical, physical, biological or clinical laboratory science or medical technology from an accredited institution; and (h)(4)(ii) Have at least 2 years of laboratory training or experience, or both, in high complexity testing for the specialty of diagnostic immunology; or (h)(5)(i) Have earned a bachelor's degree in a chemical, physical or biological science or medical technology from an accredited institution; and (h)(5)(ii) Have at least 4 years of laboratory training or experience, or both, in high complexity testing for the specialty of diagnostic immunology. (i) If the requirements of paragraph (b) of this section are not met and the laboratory performs tests in the specialty of chemistry, the individual functioning as the technical supervisor must-- (i)(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 (i)(1)(ii) Be certified in clinical pathology by the American Board of Pathology or the American Osteopathic Board of Pathology or possess qualifications that are equivalent to those required for such certification; or (i)(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 (i)(2)(ii) Have at least 1 year of laboratory training or experience, or both, in high complexity testing for the specialty of chemistry; or (i)(3)(i) Have an earned doctoral degree in a chemical, physical, biological or clinical laboratory science from an accredited institution; and (i)(3)(ii) Have at least 1 year of laboratory training or experience, or both, in high complexity testing within the specialty of chemistry; or (i) (4)(i) Have earned a master's degree in a chemical, physical, biological or clinical laboratory science or medical technology from an accredited institution; and (i)(4)(ii) Have at least 2 years of laboratory training or experience, or both, in high complexity testing for the specialty of chemistry; or (i)(5)(i) Have earned a bachelor's degree in a chemical, physical or biological science or medical technology from an accredited institution; and (i)(5)(ii) Have at least 4 years of laboratory training or experience, or both, in high complexity testing for the specialty of chemistry. (j) If the requirements of paragraph (b) of this section are not met and the laboratory performs tests in the specialty of hematology, the individual functioning as the technical supervisor must-- (j)(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 (j)(1)(ii) Be certified in clinical pathology by the American Board of Pathology or the American Osteopathic Board of Pathology or possess qualifications that are equivalent to those required for such certification; or (j)(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 (j)(2)(ii) Have at least one year of laboratory training or experience, or both, in high complexity testing for the specialty of hematology (for example, physicians certified either in hematology or hematology and medical oncology by the American Board of Internal Medicine); or (j) -- 10 of 13 -- (3)(i) Have an earned doctoral degree in a chemical, physical, biological or clinical laboratory science from an accredited institution; and (j)(3)(ii) Have at least 1 year of laboratory training or experience, or both, in high complexity testing within the specialty of hematology; or (j)(4)(i) Have earned a master's degree in a chemical, physical, biological or clinical laboratory science or medical technology from an accredited institution; and (j)(4)(ii) Have at least 2 years of laboratory training or experience, or both, in high complexity testing for the specialty of hematology; or (j) (5)(i) Have earned a bachelor's degree in a chemical, physical or biological science or medical technology from an accredited institution; and (j)(5)(ii) Have at least 4 years of laboratory training or experience, or both, in high complexity testing for the specialty of hematology. (k)(1) 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-- (k)(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 (k)(1)(ii) Meet one of the following requirements-- (k)(1)(ii)(A) Be certified in anatomic pathology by the American Board of Pathology or the American Osteopathic Board of Pathology or possess qualifications that are equivalent to those required for such certification; or (k)(1)(ii) (B) Be certified by the American Society of Cytology to practice cytopathology or possess qualifications that are equivalent to those required for such certification; (l) 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-- (l)(1) Meet one of the following requirements: (l)(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 (l)(1)(i)(B) Be certified in anatomic pathology by the American Board of Pathology or the American Osteopathic Board of Pathology or possess qualifications that are equivalent to those required for such certification; (l)(1)(ii) An individual qualified under 493.1449(b) or paragraph (l)(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 (l)(1)(i)(B) of this section, the responsibility for examination and interpretation of histopathology specimens. (l)(2) For tests in dermatopathology, meet one of the following requirements: (l)(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-- (l) (2)(i)(B) Meet one of the following requirements: (l)(2)(i)(B)(1) Be certified in anatomic pathology by the American Board of Pathology or the American Osteopathic Board of Pathology or possess qualifications that are equivalent to those required for such certification; or (l)(2)(i)(B)(2) Be certified in dermatopathology by the American Board of Dermatology and the American Board of Pathology or possess qualifications that are equivalent to those required for such certification; or (l)(2)(i)(B) (3) Be certified in dermatology by the American Board of Dermatology or possess qualifications that are equivalent to those required for such certification; or (l)(2)(ii) An individual qualified under 493.1449(b) or paragraph (l)(2)(i) of this section may delegate to an individual who is a resident in a training program leading to certification specified in paragraphs (b) or (l)(2)(i)(B) of this section, the responsibility for examination and interpretation of dermatopathology specimens. (l) (3) For tests in ophthalmic pathology, meet one of the following requirements: (l)(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-- (l)(3)(i)(B) Must meet one of the following requirements: (l)(3)(i)(B)(1) Be certified in anatomic pathology by the American Board of Pathology or the American Osteopathic Board of Pathology or possess qualifications that are equivalent to those required for such certification; or (l)(3)(i)(B)(2) Be certified by the American Board of Ophthalmology or possess -- 11 of 13 -- qualifications that are equivalent to those required for such certification and have successfully completed at least 1 year of formal post-residency fellowship training in ophthalmic pathology; or (l)(3)(ii) An individual qualified under 493.1449(b) or paragraph (1)(3)(i) of this section may delegate to an individual who is a resident in a training program leading to certification specified in paragraphs (b) or (1)(3)(i)(B) of this section, the responsibility for examination and interpretation of ophthalmic specimens; or (m) 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: (m)(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-- (m)(1)(ii) Be certified in anatomic pathology by the American Board of Pathology or the American Osteopathic Board of Pathology or possess qualifications that are equivalent to those required for such certification; or (m)(2) Be certified in oral pathology by the American Board of Oral Pathology or possess qualifications for such certification; or (m)(3) An individual qualified under 493.1449(b) or paragraph (m)(1) or (2) of this section may delegate to an individual who is a resident in a training program leading to certification specified in paragraphs (b) or (m)(1) or (2) of this section, the responsibility for examination and interpretation of oral pathology specimens. (n) If the requirements of paragraph (b) of this section are not met and the laboratory performs tests in the specialty of radiobioassay, the individual functioning as the technical supervisor must-- (n)(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 (n)(1)(ii) Be certified in clinical pathology by the American Board of Pathology or the American Osteopathic Board of Pathology or possess qualifications that are equivalent to those required for such certification; or (n)(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 (n)(2)(ii) Have at least 1 year of laboratory training or experience, or both, in high complexity testing for the specialty of radiobioassay; or (n)(3)(i) Have an earned doctoral degree in a chemical, physical, biological or clinical laboratory science from an accredited institution; and (n)(3)(ii) Have at least 1 year of laboratory training or experience, or both, in high complexity testing within the specialty of radiobioassay; or (n)(4)(i) Have earned a master's degree in a chemical, physical, biological or clinical laboratory science or medical technology from an accredited institution; and (n)(4)(ii) Have at least 2 years of laboratory training or experience, or both, in high complexity testing for the specialty of radiobioassay; or (n)(5)(i) Have earned a bachelor's degree in a chemical, physical or biological science or medical technology from an accredited institution; and (n)(5)(ii) Have at least 4 years of laboratory training or experience, or both, in high complexity testing for the specialty of radiobioassay. (o) If the laboratory performs tests in the specialty of histocompatibility, the individual functioning as the technical supervisor must either-- (o)(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 (o)(1)(ii) Have training or experience that meets one of the following requirements: (o)(1)(ii)(A) Have 4 years of laboratory training or experience, or both, within the specialty of histocompatibility; or (o)(1)(ii)(B)(1) Have 2 years of laboratory training or experience, or both, in the specialty of general immunology; and (o)(1)(ii)(B)(2) Have 2 years of laboratory training or experience, or both, in the specialty of histocompatibility; or (o)(2)(i) Have an earned doctoral degree in a biological or clinical laboratory science from an accredited institution; and (o)(2)(ii) Have training or experience that meets one of the following requirements: (o) (2)(ii)(A) Have 4 years of laboratory training or experience, or both, within the -- 12 of 13 -- specialty of histocompatibility; or (o)(2)(ii)(B)(1) Have 2 years of laboratory training or experience, or both, in the specialty of general immunology; and (o)(2)(ii)(B)(2) Have 2 years of laboratory training or experience, or both, in the specialty of histocompatibility. (p) If the laboratory performs tests in the specialty of clinical cytogenetics, the individual functioning as the technical supervisor must-- (p)(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 (p)(1)(ii) Have 4 years of training or experience, or both, in genetics, 2 of which have been in clinical cytogenetics; or (p)(2)(i) Hold an earned doctoral degree in a biological science, including biochemistry, or clinical laboratory science from an accredited institution; and (p)(2)(ii) Have 4 years of training or experience, or both, in genetics, 2 of which have been in clinical cytogenetics. (q) If the requirements of paragraph (b) of this section are not met and the laboratory performs tests in the specialty of immunohematology, the individual functioning as the technical supervisor must-- (q)(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 (q)(1)(ii) Be certified in clinical pathology by the American Board of Pathology or the American Osteopathic Board of Pathology or possess qualifications that are equivalent to those required for such certification; or (q)(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 (q)(2)(ii) Have at least one year of laboratory training or experience, or both, in high complexity testing for the specialty of immunohematology. Note: The technical supervisor requirements for "laboratory training or experience, or both'' in each specialty or subspecialty may be acquired concurrently in more than one of the specialties or subspecialties of service. For example, an individual, who has a doctoral degree in chemistry and additionally has documentation of 1 year of laboratory experience working concurrently in high complexity testing in the specialties of microbiology and chemistry and 6 months of that work experience included high complexity testing in bacteriology, mycology, and mycobacteriology, would qualify as the technical supervisor for the specialty of chemistry and the subspecialties of bacteriology, mycology, and mycobacteriology. This STANDARD is not met as evidenced by: Based on a review of records and interview with the director of laboratory services, the technical supervisor failed to ensure that individuals who performed the duties and responsibilities of the technical supervisor, met the qualifications for 3 of 4 proficiency testing attestation forms. Findings include: (1) On 05/26/2021, the surveyor review

Summary Statement of Deficiencies D0000 The recertification survey was performed on 01/08/19 through 01/11/19. The findings were reviewed with the laboratory manager at the conclusion of the survey. The laboratory was found to be in compliance with standard-level deficiencies cited. D2015 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(5)(6) (5) The laboratory must document the handling, preparation, processing, examination, and each step in the testing and reporting of results for all proficiency testing samples. The laboratory must maintain a copy of all records, including a copy of the proficiency testing program report forms used by the laboratory to record proficiency testing results including the attestation statement provided by the PT program, signed by the analyst and the laboratory director, documenting that proficiency testing samples were tested in the same manner as patient specimens, for a minimum of two years from the date of the proficiency testing event. (6) PT is required for only the test system, assay, or examination used as the primary method for patient testing during the PT event. This STANDARD is not met as evidenced by: Based on a review of records and interview with the laboratory manager, the laboratory failed to ensure proficiency testing attestation statements had been signed by the laboratory director or designee. Findings include: (1) On the first day of the survey, the surveyor reviewed 2017 and 2018 proficiency testing records. The following was identified for 5 of 19 testing events: (a) Second 2017 Immunohematology Event (i) The attestation was not signed by the laboratory director or designee. (b) Third 2017 Immunohematology Event (i) The attestation was not signed by the laboratory director or designee. (c) First 2018 Immunohematology Event (i) The attestation was not signed by the laboratory director or designee. (d) 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 -- Second 2018 Immunohematology Event (i) The attestation was not signed by the laboratory director or designee. (2) The findings were reviewed with the laboratory manager who stated the attestations had not been signed as indicated above. D5209 PERSONNEL COMPETENCY ASSESSMENT POLICIES CFR(s): 493.1235 As specified in the personnel requirements in subpart M, the laboratory must establish and follow written policies and procedures to assess employee and, if applicable, consultant competency. This STANDARD is not met as evidenced by: Based on a review of records and interview with the laboratory manager, the laboratory failed to perform a technical consultant and general supervisor competency based on the position responsibilities as listed in Subpart M. Findings include: (1) On the first day of the survey, the surveyor reviewed personnel records for competency assessments performed during 2017 and 2018. There was no evidence competencies had been performed for the technical consultant and general supervisor, based on their job responsibilities; (2) The surveyor asked the laboratory manager if competencies had been performed for the technical consultant and gneral supervisor, based on job responsibilities. The laboratory manager stated the competencies had not been performed. D5211 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(a) The laboratory must review and evaluate the results obtained on proficiency testing performed as specified in subpart H of this part. This STANDARD is not met as evidenced by: Based on a review of records and interview with the laboratory manager, the laboratory failed to review and evaluate proficiency testing results. Findings include: (1) On the first day of the survey, the surveyor reviewed 2017 and 2018 proficiency testing records. The following biases were identified (biases were identified using the SDI (Standard Deviation Index) values assigned by the proficiency program): (a) Second 2017 Chemistry Core Event (i) Triglyceride - 3 of 5 results exhibited a positive bias (aa) Sample CH-07- SDI of 3.0 (bb) Sample CH-08 - SDI of 4.0 (cc) Sample CH-09 - SDI of 2.5 (b) Third 2017 Chemistry Core Event (i) Glycated Hemoglobin (%) - 2 of 2 results exhibited a positive bias (aa) Sample GLY-11- SDI of 4.3 (bb) Sample GLY-12 SDI of 3.0 (2) The surveyor could not locate evidence in the records proving the biases had been identified and addressed; (3) The records were reviewed with the laboratory manager who stated the biases had not been addressed. D5411 was cited on the recertification survey performed on 04/17,18,19/17 D5411 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(a) Test systems must be selected by the laboratory. The testing must be performed following the manufacturer's instructions and in a manner that provides test results within the laboratory's stated performance specifications for each test system as determined under 493.1253. -- 2 of 7 -- This STANDARD is not met as evidenced by: Based on a review of records, manufacturer's instructions, and interview with the clinical laboratory manager, the laboratory failed to follow the manufacturer's instructions. Findings include: PT REAGENT (1) On the third day of the survey, the laboratory manager stated the following to the surveyor: (a) The Sysmex CA-660 analyzer was used to perform PT/INR (Prothrombin Time/International Normalized Ratio) and PTT (Partial Thromboplastin Time) testing; (b) PT - Dade Innovin reagent, lot #549713C, was put into use on 03/28/18; (c) PTT - Siemens Actin FSL reagent, Lot# 556931A was put into use on 03/28/18. (2) The surveyor reviewed the manufacturer's instructions for implementing new lot numbers of reagents, which were as follows: (a) Section I titled "Verification of Reference Range," required 20 normal individuals using the following screening guidelines: (i) "10 males; 10 females representing reference population. 20 is the minimum requirement for a statistically valid study"; (ii) "Note medication history. After review of data, history may be used for excluding questionable results that can be contributed to medications"; (iii) "Assay samples on current and new lot number reagents simultaneously or within 1 hour of each other. This data can be used in Section II"; (iv) "Calculate mean and 2 SD range"; (v) "MNPT for INR calculation must be the geometric mean". (3) The implementation records were reviewed by the surveyor with the following identified: (a) There was no evidence the medication history had been documented (4) The surveyor review the manufacturer's instructions with the laboratory manager who stated the medication history had not been documented. D5413 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(b) The laboratory must define criteria for those conditions that are essential for proper storage of reagents and specimens, accurate and reliable test system operation, and test result reporting. The criteria must be consistent with the manufacturer's instructions, if provided. These conditions must be monitored and documented and, if applicable, include the following: (1) Water quality. (2) Temperature. (3) Humidity. (4) Protection of equipment and instruments from fluctuations and interruptions in electrical current that adversely affect patient test results and test reports. This STANDARD is not met as evidenced by: Based on a review of records, manufacturer's instructions, and interview with the laboratory manager, the laboratory failed to ensure analyzers were stored as required by the manufacturer. Findings include: (1) On the first day of the survey, the laboratory manager stated the following to the surveyor: (a) CBC (Complete Blood Count) testing was performed using the Sysmex XS 1000i analyzer; (b) Routine Chemistry testing was performed using the Siemens Dimension EXL 200 analyzer; (c) Arterial Blood Gas (pH, pCO2, pO2, O2 Saturation) testing was performed using Rapid Point 500. (d) Routine Coagulation (PT/INR (Prothrombin Time/International Normalized Ratio) and PTT (Partial Thromboplastin Time) testing was performed using the Sysmex CA 660 analyzer. (2) On the second day of the survey, the surveyor reviewed the manufacturer's environmental requirements for the analyzers. The manufacturer's required the relative humidity be maintained as follows: (a) Sysmex XS 1000i - range of 30-85%; (b) Siemen Dimension EXL 200 - range of 20-80% (c) Rapid Point 500 - range of 5-85% (d) Sysmex CA 660 - range 30-85% (3) The surveyor reviewed laboratory records from January 2018 through December 2018. -- 3 of 7 -- There was no evidence that the humidity of the room, where the analyzers were maintained, had been monitored at an acceptable range of 30-80% to accommodate all analyzers; (4) The surveyor asked the laboratory manager if the humidity of the room, where the hematology, chemistry, arterial blood gas, and coagulation analyzers were maintained, was being monitored. The laboratory manager stated the humidity was not being monitored. D5429 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(a)(1) For unmodified manufacturer's equipment, instruments, or test systems, the laboratory must perform and document maintenance as defined by the manufacturer and with at least the frequency specified by the manufacturer. This STANDARD is not met as evidenced by: Based on a review of records, manufacturer's instructions, and interview with the laboratory manager, the laboratory failed to follow the manufacturer's instructions for performing maintenance procedures. Findings include: (1) On the first day of the survey, the laboratory manager stated the following to the surveyor: (a) CBC (Complete Blood Count) testing was performed on the Sysmex XS-1000i analyzer; (b) Coagulation testing (PT/INR (Prothrombin Time/International Normalized Ratio and PTT (Partial Thromboplastin Time) was performed on the Sysmex CA 660 analyzer. (2) On the second day of the survey, the surveyor reviewed the manufacturer's maintenance requirements as stated on the manufacturer's maintenance logs: (a) Sysmex 1000i Weekly Maintenance (i) Power Down IPU (b) Sysmex CA 660 Quarterly Maintenance (i) Perform LED Calibration (ii) Clean DI Water Rinse Bottle With Alcohol (3) The surveyor then reviewed maintenance records for 19 months (June 2017 through December 2018). There was no evidence the following maintenance had been performed: (a) Sysmex 1000i Weekly Maintenance (i) Between 06/26/17 and 07/17/17 (ii) Between 12/25/17 and 01/08/18 (iii) Between 02/05/18 and 02/19/18 (iv) Between 06/25/18 and 07/16/18 (b) Sysmex CA 660 Quarterly Maintenance (i) Between 12/03/17 and 05/20/18 (ii) Between 11/06/18 and the second day of the survey (01/09/19) (4) The surveyor reviewed the records with the laboratory manager, who stated the maintenance had not been documented as performed as required. D5411 was cited on the recertification survey performed on 04 /17,18,19/17 D5465 CONTROL PROCEDURES CFR(s): 493.1256(d)(8)(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-- Test control materials in the same manner as patient specimens. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on a review of records and interview with the laboratory manager, the laboratory failed to use control materials of a similar matrix to that of patient specimens. Findings include: (1) On the first day of the survey, the laboratory manager stated to the surveyor serum human chorionic gonadotropin (HCG) testing was performed using the Cardinal Health SP hCG Combo Kit; (2) Later during the -- 4 of 7 -- survey, the surveyor reviewed quality control and patient HCG serum records for 4 months (May 2017, December 2017, March 2018 and November 2018) which identified the following: (a) For 2 of 4 patients tested, a negative and a positive urine control had been performed instead of blood based (serum/plasma) controls: (i) Patient tested 11/15/18 at 08:05 pm (ii) Patient tested 12/09/17 at 04:30 am (3) The surveyor reviewed the findings with the laboratory manager who stated urine controls had been used as indicated above. NOTE: The interpretive guidelines at D5465 (493.1256) state "Control materials of a similar matrix to that of patient specimens should be utilized, if available, and the control materials must be treated in the same manner as patient specimens and go through all analytic test phases." D5545 HEMATOLOGY CFR(s): 493.1269(b)(d) (b) For all nonmanual coagulation test systems, the laboratory must include two levels of control material each 8 hours of operation and each time a reagent is changed. (d) The laboratory must document all control procedures performed, as specified in this section. This STANDARD is not met as evidenced by: Based on a review of records and interview with the laboratory manager, the laboratory failed to perform two levels of quality control materials each eight hours of PT/INR (Prothrombin Time/International Normalized Ratio and PTT (Partial Thromboplastin Time) testing. Findings include: (1) On the first day of the survey, the laboratory manager stated to the surveyors PT/INR and PTT testing were performed on the Sysmex CA 660 analyzer; (2) On the third day of the survey, the laboratory manager stated to the surveyor two levels of quality control (QC) materials were performed each eight hours of patient testing; (3) The surveyor reviewed QC and patient testing records for testing performed in January 2018 and identified that two levels of QC testing had not been performed each eight hours of patient testing for 1 of 3 days of patient testing reviewed: (a) QC testing had been performed on 01/02/18 at 04:45 pm and patient testing had been performed on 01/03/18 at 01:30 am. (4) The surveyor reviewed the records with the laboratory manager, who stated two levels of QC materials had not been performed each eight hours of patient testing. D5555 IMMUNOHEMATOLOGY CFR(s): 493.1271(c)(f) (c) Blood and blood products storage. Blood and Blood products must be stored under appropriate conditions that include an adequate temperature alarm system that is regularly inspected. (c)(1) An audible alarm system must monitor proper blood and blood product storage temperature over a 24-hour period. (c)(2) Inspections of the alarm system must be documented. (f) Documentation. The laboratory must document all control procedures performed, as specified in this section. This STANDARD is not met as evidenced by: Based on a review of records and interview with the laboratory manager, the laboratory failed to ensure units of blood were stored under appropriate conditions. Findings include: (1) On the third day of the survey, the surveyor observed the thermograph temperature recorder for the blood bank refrigerator. The refrigerator had a recorder connected to it for continuously recording the temperature on -- 5 of 7 -- thermograph charts (Note: units of packed cells must be stored at 1-6 degrees Centigrade). Each chart monitored the temperature for a 7 day period; (2) The surveyor reviewed 16 refrigerator charts dated from August 2018 through November 2018. The review indicated that 1 of 16 charts had not been changed by the 7th day of usage as follows: (a) Chart #6 - The chart was put into use on 10/11/18 and removed on 10/23/18 (13 days). (3) The surveyor reviewed the charts with the laboratory manager, who stated the chart had not been changed by the 7th day of usage as indicated above. D5775 COMPARISON OF TEST RESULTS CFR(s): 493.1281(a)(c) (a) If a laboratory performs the same test using different methodologies or instruments, or performs the same test at multiple testing sites, the laboratory must have a system that twice a year evaluates and defines the relationship between test results using the different methodologies, instruments, or testing sites. (c) The laboratory must document all test result comparison activities. This STANDARD is not met as evidenced by: Based on a review of records, policies and procedures, and interview with the laboratory manager, the laboratory failed to evaluate the relationship of chemistry testing performed on two different analyzers at least twice a year. Findings include: (1) On the first day of the survey, the laboratory manager stated to the surveyor the laboratory performed routine chemistry using two Siemens Dimension analyzers interchangeably: (a) Siemens Dimension EXL 200 (denoted by the laboratory as #1) (b) Siemens Dimension EXL 200 (denoted by the laboratory as #2) (2) The surveyor then reviewed 2018 records and identified that, although the laboratory had performed comparison testing between the two analyzers twice in 2018, using Proficiency Testing Verification samples, there was no evidence the results had been evaluated by the laboratory for acceptability; (3) The surveyor reviewed the laboratory's policy and procedure manual. A policy could not be located that explained how the test results obtained from both analyzers were to be compared and evaluated; (4) The findings were reviewed with the laboratory manager. who stated the following to the surveyor: (a) The data had not been evaluated using defined criteria; (b) A comparison testing policy had not been written. D5807 TEST REPORT CFR(s): 493.1291(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 a review of records and interview with the laboratory manager, the laboratory failed to make appropriate reference ranges available. Findings include: (1) On the first day of the survey, the laboratory manager stated to the surveyor PT/INR (Prothrombin Time/International Normalized Ratio) and PTT (Partial Thromboplastin Time) testing were performed using the Sysmex CA 660 analyzer; (2) On the third day of the survey, the surveyor reviewed the implementation records for the current lot numbers of reagents. The following was identified for PT and PTT: (a) PT Reagent -- 6 of 7 -- (i) Siemens Dade Innovin reagent, lot #549713C put into use on 03/28/18; (ii) The normal reference range that had been established was 9.0-11.0 seconds. (b) PTT Reagent (i) Siemens Actin FSL reagent, lot #556931 put into use on 03/28/18; (ii) The normal reference range that had been established was 22.9-31.7 seconds. (3) The surveyor then reviewed a patient PT and PTT report: (a) Patient #1 - Testing performed on 01/10/19 with the following reference range: (i) PT reference range of 9.9-11.80 seconds. (b) Patient #2 - Testing performed on 01/09/19 with the following reference range: (i) PTT reference range of 25.0-31.30 seconds. (4) The surveyor reviewed the findings with the laboratory manager who stated the established normal reference ranges for PT and PTT were not included on the patient reports. D5411 was cited on the recertification survey performed on 04/17,18,19/17 -- 7 of 7 --