Ascension St John Sapulpa

Summary Statement of Deficiencies D0000 The recertification survey was performed on 09/27,28,29,30/2022. The laboratory was found in compliance with standard-level deficiencies cited. The findings were reviewed with the director of laboratory quality and laboratory manager at the conclusion of the survey. D5403 PROCEDURE MANUAL CFR(s): 493.1251(b) The procedure manual must include the following when applicable to the test procedure: (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. (2) Microscopic examination, including the detection of inadequately prepared slides. (3) Step-by-step performance of the procedure, including test calculations and interpretation of results. (4) Preparation of slides, solutions, calibrators, controls, reagents, stains, and other materials used in testing. (5) Calibration and calibration verification procedures. (6) The reportable range for test results for the test system as established or verified in 493.1253. (7) Control procedures. (8)

Summary Statement of Deficiencies D0000 The recertification survey was performed on 01/11,12,13,2021. The findings were reviewed with the laboratory director (phone), laboratory manager, laboratory lead, and hospital president during an exit conference performed at the conclusion of the survey. The laboratory was found out of compliance with the following CLIA regulation: 493.1447; D6108: Technical Supervisor 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 attestation statements were signed by the laboratory director or designee for three of 84 events. Findings include: (1) On 01/11/2021, the surveyor reviewed 2019 and 2020 proficiency testing records, with the following identified: (a) Second 2019 Hematology Event (FH9-B) - The attestation statement had not been signed by the laboratory director or designee; (b) Second 2019 Virology Event (VR4-B) - The attestation statement had not been signed by the laboratory director or designee; (c) First 2020 Urine Drug Screen Event (UDS6-A) - The attestation statement had not been signed by the laboratory director or designee. (2) Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 12 -- The surveyor reviewed the records with the laboratory manager. The laboratory manager stated on 01/11/2021 at 11:05 am the attestation statements had not been signed by the laboratory director or designee 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, written policy, and interview with the laboratory manager, the laboratory failed to have a written technical supervisor and general supervisor competency policy based on the position responsibilities as listed in Subpart M. Findings include: (1) On 01/11/2021, the surveyor reviewed the competency assessment policy. It did not include guidance for assessing the competency of the technical supervisor and general supervisor; (2) The surveyor then reviewed personnel records for competency assessments performed during 2019 and 2020. There was no evidence of competencies performed for the technical supervisor #2 and general supervisor based on their job responsibilities; (3) The surveyor asked the laboratory manager if a written policy to evaluate the technical supervisor and general supervisor based on job responsibilities was available. The laboratory manager stated on 01/11/2021 at 10:35 am a policy had not been written and the above competencies had not been performed. D5217 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(c)(1) At least twice annually, the laboratory must verify the accuracy of any test or procedure it performs that is not included in subpart I of this part. This STANDARD is not met as evidenced by: Based on a review of records and interview with the laboratory manager, the laboratory failed to verify the accuracy urine specific gravity testing at least twice annually for two of two years. Findings include: (1) On 01/11/2021 at 10:00 am, the laboratory manager stated to the surveyor urine specific gravity testing using a refractometer was performed in the laboratory; (2) The surveyor reviewed 2018, 2019 and 2020 records, which showed the testing had not been verified for accuracy twice in 2019 and 2020. Urine specific gravity testing had not been verified for accuracy after 10/31/2018; (3) On 01/12/2021, the surveyor reviewed the records with the laboratory manager who stated on 01/12/2021 at 03:20 pm, urine specific gravity testing had not been verified for accuracy at least twice annually in 2019 and 2020. 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 12 -- 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 implementing coagulation quality control materials. Findings include: (1) On 01/11 /2021 at 09:55 am, the laboratory manager stated to the surveyor that D-Dimer testing was performed on the Stago STA Satellite analyzer; (2) On 01/13/2021 at 02:00 pm, the laboratory manager stated the following STA LiaTest D-Dimer quality controls (normal and abnormal lot# 256531) were put into use on 12/11/2020; (3) The surveyor reviewed the manufacturer's instructions for implementing new lot numbers of quality control materials, which were as follows: (a) Section titled "5.0 Total Precision (Quality Control)" stated, "5.1.2 A minimum of 30 data points for each level for each test is recommended to be run and results complied into a site specific range." (4) The surveyor reviewed quality control records and identified that quality control had been established using four data points for each level of control, instead of the required 30 data points for each level; (5) The surveyor reviewed the records with the laboratory manager who stated on 01/13/2021 at 02:55 pm the quality control ranges had been established using only four data points for each level of control. D5445 CONTROL PROCEDURES CFR(s): 493.1256(d)(1)(2)(g) Unless CMS Approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub. 7), that provides equivalent quality testing, the laboratory must-- (d)(1) Perform control procedures as defined in this section unless otherwise specified in the additional specialty and subspecialty requirements at 493.1261 through 493.1278. (d)(2) For each test system, perform control procedures using the number and frequency specified by the manufacturer or established by the laboratory when 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, written policies, and interview with the laboratory manager, the laboratory failed to follow written quality control policies for one of 24 months. Findings include: (1) On 01/12/2021 at 04:00 pm, the laboratory manager stated the following to the surveyor: (a) RSV (Respiratory syncytial virus) testing was performed in the laboratory using the Sofia analyzer (high complexity with a Copan Mini-Tip Rayon Flocked Swab); (b) An IQCP (Individualized Quality Control Plan) had been developed for the above test system. (2) The surveyor reviewed the IQCP that had been developed for the test system. The QCP (Quality Control Plan) portion of the IQCP required 2 levels of external quality control materials be tested once every 30 days; (3) The surveyor reviewed QC (quality control) records for 24 months (January 2019 through December 2020) and identified the laboratory failed to follow the written QCP of performing quality control testing every 30 days. Quality control testing had not been performed between 05/13/2020 and 07/07/2020; (4) The findings were reviewed with the laboratory manager who stated on 01/12/2021 at 05:05 pm, the laboratory had not performed quality control testing as required by the QCP. D5449 CONTROL PROCEDURES CFR(s): 493.1256(d)(3)(ii)(g) -- 3 of 12 -- 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-- At least once a day patient specimens are assayed or examined perform the following for-- Each qualitative procedure, include a negative and positive control material; (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 perform negative and positive control materials two of 36 days of patient serum ketone testing. Findings include: (1) On 01/12/2021 at 03:30 pm, the laboratory manager stated the following to the surveyor: (a) The laboratory performed serum ketone testing using the K-Check tablets: (i) Positive and negative serum quality control (QC) materials were performed each day of patient testing. (2) The surveyor reviewed QC and patient testing records between on 01/09/2019 through 05 /12/2019. The review showed that negative and positive QC materials had not been performed for two of 36 days of patient testing. The specific days were 04/03/2019 and 05/04/2019; (3) The surveyor reviewed the records with the laboratory manager, who stated on 01/12/2021 at 05:15 pm, negative and positive QC materials had not been performed 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 and interview with the laboratory manager, the laboratory failed to evaluate the relationship between test results using two different analyzers at least twice a year. Findings include: (1) On 01/13/2021 at 10:30 am, the laboratory manager stated to the surveyor Troponin I testing was performed using the Abbott Architect and the iSTAT 1 analyzer; (2) The surveyor reviewed the comparison records between 08/02/2018 through 11/30/2020 and identified the following: (a) The comparison between the two analyzers had not been performed between 08/02/2018 and 08/17/2019. (3) The surveyor asked the laboratory manager if the relationship between the analyzers for Troponin testing had been evaluated twice annually during the review period. The laboratory manager stated on 01/13 /2021 at 11:10 am the relationship between the analyzers had not been evaluated twice annually as indicated above. 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. -- 4 of 12 -- This STANDARD is not met as evidenced by: Based on a review of records and interview with the laboratory supervisor, the technical consultant failed to ensure evaluations included all moderate complexity testing performed for five of five testing persons. Findings include: (1) On 01/11/2021 at 10:00 am, the laboratory manager stated to the surveyor urine specific gravity testing using a refractometer was performed in the laboratory; (2) On 01/11/2021, the surveyor reviewed the 2019 and 2020 personnel records for five persons performing urine specific gravity testing in the laboratory. The records showed that evaluations had been performed as follows: (a) Testing Person #1 - Performed on 09/28/2020 (b) Testing Person #2 - Performed on 10/20/2020 (c) Testing Person #4 - Performed on 09 /19/2020 (d) Testing Person #5 - Performed on 10/15/2020 (e) Testing Person #8 - Performed on 09/30/2020 (3) There was no evidence the evaluations, performed for the above persons, included an assessment of the urine specific gravity testing; (4) The surveyor reviewed the findings with laboratory manager, who stated on 01/11 /2021 10:25 am, the above evaluations did not include urine specific gravity assessments. 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 laboratory manager, 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 -- 5 of 12 -- 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 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 -- 6 of 12 -- 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 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 -- 7 of 12 -- 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 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 -- 8 of 12 -- 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 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 -- 9 of 12 -- 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 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 -- 10 of 12 -- 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 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. -- 11 of 12 -- This STANDARD is not met as evidenced by: Based on a review of records and interview with the laboratory manager, the technical supervisor failed to ensure that individuals who performed the duties and responsibilities of the technical supervisor met the qualifications for two of two of semiannual competency assessments. Findings include: (1) On 01/11/2021, the surveyor reviewed records for two testing person who had been hired to perform high complexity testing (ABO/Rh, Antibody Screen and Compatibility testing) since the previous recertification survey performed 08/30/2018. The records indicated the semi- annual evaluation for the testing persons had been performed by an individual who did not meet the regulatory qualification requirements of the technical supervisor: (a) Testing Person #6 - The 12/13/2019 semi-annual evaluation had been performed by the laboratory manager (this person had earned a bachelor degree in applied science); (b) Testing Person #8 - The 03/25/2020 semi-annual evaluation had been performed by the laboratory manager. (2) The surveyor explained to the laboratory manager that all components of the semi-annual competency evaluations must be performed by a person who qualifies as a technical supervisor (493.1449 (q) an individual with an MD or DO with a current medical license in state of laboratory's location and certified in anatomic pathology by ABP or AOBP or equivalent qualifications or resident in a program leading to ABP or AOBP certification in anatomic and clinical pathology who performs duties delegated by the technical supervisor for histopathology). On 01 /11/2021 at 10:40 am, the laboratory manager stated to the surveyor the semi-annual evaluation had not been performed by an individual who met the qualifications of a technical supervisor as indicated above. NOTE: The regulations only allow for an individual qualifying as a general supervisor to perform initial training and annual competency evaluations as stated at 493.1463 "Standard; General supervisor responsibilities: (b)(3) Providing orientation to all testing personnel; and (b)(4) Annually evaluating and documenting the performance of all testing personnel" -- 12 of 12 --

Summary Statement of Deficiencies D0000 The recertification survey was performed 08/27/18-08/30/18. The laboratory was found to be in compliance with standard-level deficiencies cited. The findings were reviewed with the laboratory director, the laboratory manager, the executive director, the director of community hospital laboratories, the accrediting and compliance officer, and the hospital president during an exit conference performed at the conclusion of the survey. 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, interpretive guidelines, policies and procedures, and interview with technical consultant #2, the laboratory failed to establish a written policy/procedure for assessing the competency of the technical consultant as listed in Subpart M. Findings include: (1) On the first day of the survey, the surveyor reviewed the Laboratory Personnel Report (Form 209) completed by the laboratory prior to the survey. The form designated 4 individuals as technical consultants for the moderate complexity testing performed by the laboratory: (a) Technical consultant #1 /Laboratory Director (b) Technical consultant #2 (c) Technical consultant #3 (d) Technical consultant #4 (2) The surveyor then reviewed personnel records but could not find documentation competency assessments had been completed for the duties of the 4 technical consultants between 11/07/16 and the first day of the survey in 2018. The surveyor asked technical consultant #2 if a competency assessment had been completed for the duties of the technical consultants. Technical consultant #2 stated competency assessments had not been performed; (3) The surveyor asked technical consultant #2 if the laboratory had a written policy for performing an assessment of Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 3 -- the duties performed by the technical consultants. Technical consultant #2 stated to the surveyor a policy/procedure for competency assessment of the technical consultants had not been written. NOTE: The interpretive guidelines at 493.1235, states "Competency Assessment Guidelines: Technical consultant, clinical consultant, technical supervisor, general supervisor - Documented competency assessment is required for the following named positions on the Form 209: technical consultant clinical consultant, technical supervisor, general supervisor. The laboratory must have policies and procedures to assess competency based on the position responsibilities listed in Subpart M and these assessments must performed at a frequency determined by the laboratory. If these people perform testing on patient specimens, they are required to have the six required procedures in their competency assessment in addition to a competency assessment based on their federal regulatory responsibilities (see 493.1413(b)(8)/493.1451(b)(8)). 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 technical consultant #2, the laboratory failed to ensure the manufacturer's environmental requirements were met. Findings include: (1) On the first day of the survey, technical consultant #2 stated to the surveyor the laboratory used 2 Sysmex XS-1000i hematology analyzers to perform CBC's (Complete Blood Counts); (2) On the third day of the survey, the surveyor reviewed the operator's manual for the analyzers and identified the manufacturer required an operating humidity between 30% and 85%; (3) The surveyor then reviewed humidity logs from 12/01/16 through 07/31/18 and identified the humidity was documented as less than 30% on 199 days of the 546 days, reviewed, as follows: (a) December 2016 - 27 of 31 days: Days: 1,2, 3,5,6,7,8,9,10,11,12,13,14,15,16,18,19,20,21,22, 23,24,27,28,29,30,31 (b) January 2017 - 21 of 31 days: Days: 1,4, 5,6,7,8,9,11,13,15,17,18,21,23,24,25,27,28,29, 30,31 (c) February 2017 - 16 of 28 days: Days: 1,2,3, 4,5,8,9,10,13,14,15,16,17,25,26,27 (d) March 2017 - 12 of 31 days: Days: 2,3,4,7, 8,9,10,11,12,14,15,16 (e) April 2017 - 3 of 30 days: Days: 6,7,11 (f) May 2017 - 1 of 31 days: Day: 1 (g) October 2017 - 6 of 31 days: Days: 24,25, 27,28,29,31 (h) November 2017 - 15 of 30 days: Days: 1,8, 9,10,11,16,19,20,21,22,23,24,25,26,27 (i) December 2017 - 23 of 31 days: Days: 1,2,5, 6,7,8,9,10,11,12,13,14,15,16,23,24,25,26, 27,28, 29,30,31 (j) January 2018 - 25 of 31 days: Days: 1,2,3, 4,5,6,7,8,9,13,14,15,16,17,18,19,22,23,24,25,26,28, 29,30,31 (k) February 2018 - 19 of 28 days: Days: 1,2,3, 4,5,6,7,8,9,10,11,12,13,17,18,22,23,25,26 (l) March 2018 - 16 of 31 days: Days: 2,6,7, 8,9,12,13,14,15,17,18,19 21,22,25,31 (m) April 2018 - 15 of 30 days: Days: 1,2,4,5,6, 7,8,9,10,11,15,16,17,19,20 (4) The surveyor reviewed the findings with technical consultant #2 who agreed the laboratory failed to ensure the manufacturer's environmental specifications had been met for the Sysmex XS-1000i analyzers. -- 2 of 3 -- 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, policies and procedures, and interview with technical consultant #2, the laboratory failed to follow its policy and procedure for storage of blood components. Findings include: (1) On the third day of the survey, technical consultant #2 verified the laboratory performed crossmatch testing (i.e. ABO/Rh typing, Antibody Screen Testing, and Compatibility Testing); (2) The surveyor observed the laboratory and identified the Helmer refrigerator located in the blood bank. Inside units of PRBC's (Packed Red Blood Cells) were stored. Technical consultant #2 stated to the surveyor the units of PRBC's were for patient transfusions; (3) The surveyor then reviewed the "Testing Blood Bank Component/Reagent Storage Equipment Alarms" policy and procedure, which stated for the manual High alarm activation: (a) Fill a container with 240 ml of cool water for component refrigerators; (b) Ensure documentation of the NIST (National Institute for Standards and Technology) serial number of the thermometer in the log sheet. Allow the thermometer to equilibrate to the temperature of the water; (c) Place the sensor into the cup. With continuous stirring, slowly add room temperature water to cause a rise in temperature of about 0.5 degrees C (Centigrade)/minute; (d) The alarm should sound at 5.5 degrees C; (e) Record the NIST thermometer temperature and the refrigerator LCD reading at which the alarm sound; (f) Evaluate acceptability of the results. Document any problems or