Warren General Hospital

Summary Statement of Deficiencies D2007 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) The samples must be examined or tested with the laboratory's regular patient workload by personnel who routinely perform the testing in the laboratory, using the laboratory's routine methods This STANDARD is not met as evidenced by: Based on review of College of American Pathologists (CAP) proficiency testing (PT) records and interview with Technical Supervisor #2 (CMS 209 TS #2), the laboratory failed to interpret histology slides by a pathologist (CMS 209 TP #1) who routinely interpret Histology slides for 2 of 2 CAP PT events in 2023 and 2 of 2 CAP PT events in 2024. Findings include: 1. The laboratory's procedure "Surgical Pathology Services" states the following "All specimens for microscopic examination shall be performed by a board eligible/board certified anatomic pathologist who is to employ professional skills to render a proper diagnosis." 2. Interview with Technical Supervisor #3 (CMS 209 TS #3) revealed that the routine patient testing for interpretation of histology slides is only performed by TP #1. 3. Interview with TP #1 revealed that for proficiency testing, unqualified testing personnel (CMS 209 TP #17, #16, #10, or #7) would interpret the slides and he would review the PT results. 4. On the day of survey, 10/09/2024, review of CAP PT records revealed that interpretation of histology slides was not performed by the pathologist for 2 of 2 events in 2023 and 2 of 2 events in 2024: - PM3-A 2023 CD20 Immunohistochemistry Tissue Microarray survey. - PM3-B 2023 CD20 Immunohistochemistry Tissue Microarray survey. - PM3-A 2024 CD20 Immunohistochemistry Tissue Microarray survey. - PM3-B 2024 CD20 Immunohistochemistry Tissue Microarray survey. 5. Laboratory director confirmed the above findings on 10/10/2024 at 11:30 AM. D3031 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(3) Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 8 -- 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 lack of documentation and interview with the Techinical Supervisor #2 (CMS 209 form TS#2), the laboratory failed to retain quality control (QC) documents for virology testing performed in 2023 and 2024. Findings include: 1. On the day of the survey, 10/09/2024 at 10:00 am, the laboratory failed to provide QC documentation for the Cepheid XPERT GC/NG tests performed in the laboratory for 1 out of 9 months (September) in 2024. 2. On the day of the survey, 10/09/2024 at 10: 00 am, the laboratory failed to provide maintenance logs for the Cepheid GeneXpert for: - 12 out of 12 months of 2023 - 2 out of 9 months (August and September) of 2024 3. TS #2 confirmed the findings above on 10/10/2024 around 12:00 pm. 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 review of proficiency testing (PT) records and interview with Technical Supervisor #2 (CMS 209 TS #2), the laboratory failed to establish and maintain the accuracy of its testing procedures twice annually for histology testing performed in 2024. Findings Include: 1. On the day of survey, 10/09/2024 review of the laboratory's College of American Pathologist records revealed the laboratory failed to verify grossing and inking testing in Histology twice annually in 2024: - HQIP-A 2024 Histology Quality Improvement Program not performed in 2024. 2. TS #2 confirmed these findings on 10/09/2024 at 10:00 am. 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 D3013 FACILITIES CFR(s): 493.1101(e) Records and, as applicable, slides, blocks, and tissues must be maintained and stored under conditions that ensure proper preservation. This STANDARD is not met as evidenced by: Based on lack of documentation and interview with testing personnel (TP) #17, the laboratory failed to record the room temperature for paraffin block storage to ensure proper preservation from 10/21/2020 to the day of the survey. Findings include: 1. On the day of the survey, 01/10/2023 at 02:20 pm, the laboratory could not provide the room temperature records for paraffin blocks stored in the laboratory and in the morgue from 10/21/2020 to 01/10/2023. 2. TP #17 confirmed the finding above on 01 /10/2023 around 02:35 pm. 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 lack of documentation and interview with technical consultants #2 and # 4 (TC), the laboratory failed to provide room temperature records for chemistry, and 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 -- bioMerieux BacTAlert blood culture temperature records from 10/21/2020 to the day of survey. Findings include: 1. On the day of survey, 01/10/2023 at 12:25 pm, the laboratory could not provide the temperature records for the following from 10/21 /2020 to 01/10/2023: - 4 of 4 bioMerieux BacTAlert blood culture drawers - Room temperature Chemistry area where the following reagents are stored: - 16 of 16 bottles of Carbon Dioxide (CO2) Acid Reagent - 20 of 20 bottles of ISE Electrolyte Reference - 12 of 12 bottle of ISE Electrolyte Buffer - 3 of 3 bottles of CO2 Alkaline Buffer 2. TC #2 and #4 confirmed the findings above on 01/10/2023 around 02:35 pm. D5417 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(d) Reagents, solutions, culture media, control materials, calibration materials, and other supplies must not be used when they have exceeded their expiration date, have deteriorated, or are of substandard quality. This STANDARD is not met as evidenced by: Based on observation of the laboratory and interview with testing personnel (TP) #17, the laboratory failed to ensure that reagents used for histopathology examinations were not used beyond the expiration dates from 07/01/2022 to the date of the survey. Findings Include: 1. On the date of the survey, 01/10/2023 at 02:00 pm, the laboratory tour revealed that the following reagents used for histopathology examinations were expired: - McDonalds Gram Stain Kit: - Carbol Fuchsin Lot # 142138 Exp: 10/31 /2022 - Verhoff's Elastic Stain Kit: - Ferric Chloride Lot # 121462 Exp: 06/30/2022 - Sodium Thiosulfate Lot # 122714 Exp: 06/30/2022 - Iodine Solution Lot# 114832 Exp: 10/04/2022 - 5% Alcoholic Hematoxylin Lot# 117648 Exp: 07/31/2022 - Van Gieson Solution Lot # 121177 Exp: 11/30/2022 - Muci Plus Stain - Muci-10 Plus Lot # 121422 Exp: 07/31/2022 - Metanil Yellow Stain Lot # 124085 Exp: 07/31/2022 - Modified Mayer's Hematoxylin Lot # 120796 Exp: 05/31/2022 - Cancer Diagnostics - Tissue Marking Blue Ink Lot # 20199 Exp: 07/31/2022 - Tissue Marking Yellow Ink Lot # 20259 Exp: 09/30/2022 2. The laboratory performed 3,320 grossing and inking procedures from 08/01/2022 to 01/10/2023. 3. The laboratory performed 1 histopathology examination using Verfhoff's Elastic Stain from 06/30/2022 to 01/10 /2023. 4. TP #17 confirmed the findings above on 01/10/2023 around 02:35 pm. 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 review of the Beckman Coulter Access and DxH 900 validation records and interview with technical consultant (TC) #4 and technical supervisor #4 (TS), the laboratory failed to establish criteria for acceptable performance specifications for 1 -- 2 of 11 -- of 1 analytes performed on the Beckman Coulter Access chemistry analyzers and 15 of 15 analytes performed on the Beckman Coulter DxH 900 hematology analyzers from 04/07/2021 to the date of the survey. Findings Include: 1. On the day of the survey, 01/10/2023 at 10:55 am, review of the Beckman Coulter Access validation records revealed the validation performed on 03/04/2022 for procalcitonin testing did not include the laboratory's acceptable criteria for performance specifications for precision, accuracy, and reportable ranges. 2. Further review of the Beckman Coulter validation records revealed the validation performed on 04/07/2021 for the Beckman Coulter DxH 900 hematology analyzer did not include the laboratory's acceptable criteria for performance specifications for precision, accuracy, and reportable ranges for the following analytes: - White Blood Count (WBC) - Red Blood Count (RBC) - Hemoglobin (HGB) - Hematocrit (HCT) - Mean Corpuscular Volume (MCV) - Mean Corpuscular Hemoglobin (MCH) - Mean Corpuscular Hemoglobin Concentration (MCHC) - Mean Platelet Volume (MPV) - Red Blood Cell Distribution Weight (RDW) - Platelet (PLT) - Neutrophils (NEU) - Lymphocytes (LYM) - Monocytes (MON) - Eosinophils (EOS) - Basophils (BASO) 3. The laboratory could not provide documentation verifying that the manufacturer's reference intervals are appropriate for the laboratory's patient population. 4. The laboratory performed 76,655 hematology examinations from April 2021 to December 2022. 5. TS # 4 confirmed the findings above on 01/11/2023 around 12:00 pm. D5601 HISTOPATHOLOGY CFR(s): 493.1273(a)(f) (a) As specified in 493.1256(e)(3), fluorescent and immunohistochemical stains must be checked for positive and negative reactivity each time of use. For all other differential or special stains, a control slide of known reactivity must be stained with each patient slide or group of patient slides. Reactions of the control slide with each special stain must be documented. (f) The laboratory must document all control procedures performed, as specified in this section. This STANDARD is not met as evidenced by: Based on review of the laboratory's quality control (QC) staining records and interview with testing personnel (TP) #17, the laboratory failed to check for positive and negative staining reactivity each time of use for 34 of 34 immunohistochemical (IHC) stains performed from 10/21/2020 to the date of the survey. Findings include: 1. On the day of the survey, 01/10/2022 at 01:45 pm, review of the laboratory's IHC staining quality control records revealed that positive and negative staining reactivity for IHC stains was not documented for each use of the following 34 of 34 IHC stains used for histopathology examinations from 10/21/2020 to 01/10/2023: -CA125, CD45, Calponin, CD3, CD20, CDX-2, CEA, Chromograin A, CK7, CK20, CKPK, E- cadherin, ER, EMA, 6ATA3, 6CDFP15, H. pylori, HMB45, KI67, Mart-1, Muc-2, NKx3-1, P16, P63, P120, P504s, PAM, PIN4, D2-40, S100, Smoothelin, Synapto, TIF-1, T311. 2. In 2021 - 477 IHC stains were used for histopathology slide examinations. 3. In 2022 - 371 IHC stains were used for histopathology slide examinations. 4. TP #17 confirmed the findings above on 01/10/2023 around 02:35 pm. D5775 COMPARISON OF TEST RESULTS CFR(s): 493.1281(a)(c) (a) If a laboratory performs the same test using different methodologies or -- 3 of 11 -- 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 lack of documentation and interview with technical consultant (TC) #4 and technical supervisor (TS) #4, the laboratory failed to evaluate twice a year the relationship between test results using different methodologies and instruments in hematology, urinalysis, chemistry, and coagulation from 10/21/2020 to the date of the survey. Findings include: 1. On the dates of the survey, 01/10/2023 at 11:17 am and 01 /11/2023 at 08:57 am, the laboratory failed to provide documentation of the biannual comparison studies for the following tests from 10/21/2020 to 01/11/2023: - 2 of 2 Beckman Coulter DxH 900 (hematology) - 2 of 2 Beckman Coulter Access (endocrinology/immunology/chemistry) - 2 of 2 Beckman Coulter DxC (general chemistry) - 2 of 2 ACL TOPS 500 (coagulation) - manual differentials vs. automated differentials (Beckman Coulter DxH 900) - manual cell counts (hemacytometer) vs. automated cell counts (Beckman Coulter DxH 900) - manual microscopic urinalysis vs automated microscopic urinalysis (Iris) 2. The laboratory performed the following examinations: - 54,437 hematology examinations from April 2021 to June 2022. - 22,218 hematology examinations from July 2022 to December 2022. - 15,825 coagulation examinations in 2021. - 13,039 coagulation examinations in 2022. - 10,209 urine microscopic examinations in 2021. - 9,705 urine microscopics in 2022. - 767,365 chemistry examinations in 2022 (CMS 116 annual volume) 3. TS # 4 and TC # 4 confirmed the findings above on 01/11/2023 around 12:00 pm. D6108 LABORATORY TECHNICAL SUPERVISOR CFR(s): 493.1447 The laboratory must have a technical supervisor who meets the qualification requirements of 493.1449 of this subpart and provides technical supervision in accordance with 493.1451 of this subpart. This CONDITION is not met as evidenced by: Based on review of personnel qualification records and interview with technical supervisor #2 (TS), the laboratory failed to ensure that 1 of 2 TS meets the educational requirements ( 493.1449) to perform technical supervision for immunohematology testing from 10/21/2020 to the date of the survey. 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 -- 4 of 11 -- 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 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 -- 5 of 11 -- 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 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 -- 6 of 11 -- 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 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 -- 7 of 11 -- 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 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 -- 8 of 11 -- 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 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 -- 9 of 11 -- 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 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 -- 10 of 11 -- 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 review of personnel qualification records and interview with technical supervisor #2 (TS), the laboratory failed to ensure that 1 of 2 technical supervisors (TS) meets the requirements to perform technical supervision for immunohematology testing from 10/21/2020 to the date of the survey. Findings include: 1. On the day of the survey, 01/10/2023 at 08:20 am, review of personnel qualification records revealed that 1 of 2 TS (CMS 209 personnel #6) did not meet the required education requirements to perform technical supervision of testing performed in immunohematology. 2. TS #2 confirmed the finding above on 01/11/2023 around 12: 00 pm. D6120 TECHNICAL SUPERVISOR RESPONSIBILITIES CFR(s): 493.1451(b)(7)(8) (7) The technical supervisor is responsible for identifying training needs and assuring that each individual performing tests receives regular in-service training and education appropriate for the type and complexity of the laboratory services performed; (8) Evaluating the competency of all testing personnel and assuring that the staff maintain their competency to perform test procedures and report test results promptly, accurately and proficiently. This STANDARD is not met as evidenced by: Based on review of the laboratory competency assessment records and interview with technical supervisor #2 (TS), the laboratory failed to assess the competency of 4 of 18 testing personnel (TP) who performed the testing in chemistry, microbiology, immunology, urinalysis, hematology and immunohematology from 10/21/2020 to the day of survey. Findings include: 1. On the day of survey, 01/10/2023 at 08:51 am, the laboratory could not provide the following annual competency assessment records: - 2021 and 2022 Hematology Competency assessment for TP # 2 - 2021 and 2022 Immunohematology Competency assessment for TP # 4 - 2021 and 2022 Chemistry, Microbiology, Urinalysis, and Immunolgy Competency assessment for TP # 9 - 2021 Immunohematology Competency assessment for TP # 6 2. TS # 2 confirmed the findings above on 01/10/2023 around 02:35 pm. -- 11 of 11 --

Summary Statement of Deficiencies 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 review of the histology competency policy and interview with the testing personnel (TP) #17, the laboratory failed to follow their histology competency policy to assess the competency of 1 of 1 testing personnel (TP) who performed grossing and Inking of histology specimen from 08/13/2018 to the date of survey. Findings Include: 1. The histology competency policy states, " Once a year, each employee that works in Histology will perform competency." 2. On the day of survey 10/22/2020, TP #17 could not provide competency assessment records for 1 of 1 TP who performed grossing and Inking of histology specimen from 2018, 2019, and 2020. 4. TP# 17 confirmed the finding above on 10/22/2020 around 09:15 am. 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 peer review records and interview with the TP #17, the laboratory failed to verify the accuracy of the histology slides read on site in 2018 and 2019. Findings Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 4 -- include: 1. On the day of survey, 10/22/2020, TP #17 could not provide verification of accuracy of histology slides examined in 2018 and 2020. 2. TP #17 confirmed the finding above on 10/22/2020 at 10:00 am. 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 observation of the laboratory and interview with the Technical Consultant (TC), the laboratory failed to monitor and document room temperatures for the Cytology and Histopathology reagent and stain storage area from 08/13/2018 to the date of survey. Findings include: 1. On the day of survey, 10/22/2020, observation of the Cytology and Histopathology laboratory areas revealed, the storage area where 2 of 2 flammable cabinets reside, housed the Cytology and Histopathology reagents and stains were not monitored for temperature from 08/13/2018 to 10/22/2020. 2. The laboratory could not provide documentation of room temperature from 2018, 2019 and 2020. 3. The flammable cabinets housed the following reagents and stains on 10 /22/2020, stated to be stored at "15 to 30 degrees Celsius": - 1 of 1 pint of Richard Allen Scientific EA-36 Stain, Lot# 536261, expiration date: 4/2022. - 4 of 4 pints of Richard Allen Scientific EA-36 Stain, Lot# 539051, expiration date: 5/2022. - 1 of 1 pint of Richard Allen Scientific OG-6 Stain, Lot# 534458, expiration date: 4/2022. - 946 ml bottles of Richard Allen Scientific Thin Prep Cytological Solution: - 2 of 2 bottles of Lot# 9070EB, expiration date: 03/11/2021. - 3 of 3 bottles of Lot# 9157EA, expiration date: 06/03/2021. - 4 of 4 bottles of Lot# 9294EA, expiration date: 09/06 /2021. - 4 of 4 bottles of Lot# 0006EA, expiration date: 12/19/2021. 4. In 2018 (08/13 /2018 to 12/31/2018) the following number of slides were examined: - Cytology: 1163 - Histology: 9909 5. In the 2019 - Cytology: 3243 - Histology: 19451 6. In 2020 (01 /01/2020 to 10/22/2020) the following number of slides were examined. - Cytology: 2128 - Histology: 12478 7. The TC confirmed the findings above 10/22/2020 at 1:00 p.m. D5423 ESTABLISHMENT AND VERIFICATION OF PERFORMANCE CFR(s): 493.1253(b)(2) Each laboratory that modifies an FDA-cleared or approved test system, or introduces a test system not subject to FDA clearance or approval (including methods developed in-house and standardized methods such as text book procedures), or uses a test system in which performance specifications are not provided by the manufacturer must, before reporting patient test results, establish for each test system the performance specifications for the following performance characteristics, as applicable: (2)(i) Accuracy. (2)(ii) Precision. (2)(iii) Analytical sensitivity. (2)(iv) Analytical specificity to include interfering substances. (2)(v) Reportable range of test results for the test system. (2)(vi) Reference intervals (normal values). (2)(vii) Any other performance characteristic required for test performance. -- 2 of 4 -- This STANDARD is not met as evidenced by: Based on observation of laboratory test kits and interview with the Technical supervisor (TS) #2 and #3, the laboratory failed to establish verification of performance on the AIMTab substance reducing tablets that are not subject to FDA clearance or approval, before reporting patient test results in 2020. Findings include: The AIM Tab Substance Reducing Tablets box states, "for forensic use only". 2. On the day of survey, 10/22/2020, observation of laboratory kits revealed, the laboratory was performing diagnostics tests on the AIM Tab substance reducing tablets, meant to be used for forensic use only. 3. Before patient tests were analyzed, the laboratory did not establish and perform verification of performance of the AIMTab substance reducing tablets that have been cleared by the FDA for diagnostic use. 4. In 2020 (01 /01/2020 to 10/22/2020) The laboratory analyzed 96 patients for the AIMTab substance reducing tablets test. 5. The TS #2 and #3 confirmed the finishing above on 10/22/2020 around 1:00 pm. D5449 CONTROL PROCEDURES CFR(s): 493.1256(d)(3)(ii)(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-- 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 review of the Cepheid Xpert Xpress SARS-CoV-2 quality control (QC) records, and interview the technical supervisor (TS) #2 and #3, the laboratory failed to document QC procedures each day of patient testing for 724 patient specimens examined for SARS - CoV-2 in 2020. Findings Include: 1. The Cepheid Xpert Xpress SARS-CoV-2 emergency use authorization (EAU) states, "Your product also includes in the cartridge the following controls, or other authorized controls, that are processed along with the patient samples when tested with your product. The controls listed below must generate expected results in order for a test to be considered valid, as outlined in the Instructions for Use". 2. The Xpert Xpress SARS-CoV-2 Instructions for use, under 15.2 External controls, states, "External controls should be used in accordance with local, state, and federal accrediting organizations as applicable". 1. On the day of survey, 10/21/2020 to 10/22/2020, review of the Xpert Xpress SARS- CoV-2 QC records revealed, the laboratory did not perform QC each day of patient testing from 05/05/2020 to 10/22/2020. 2. In 2020, 724 Xpert Xpress SARS-CoV-2 tests were analyzed. 5. The TS #2 and #3 confirmed on 10/22/2020 around 12:00 PM. D6094 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(5) The laboratory director must ensure that the quality assessment programs are established and maintained to assure the quality of laboratory services provided and to identify failures in quality as they occur. This STANDARD is not met as evidenced by: -- 3 of 4 -- Based on review of the The Laboratory Quality Management (QM) Plan Policy, review of QM documents and interview with technical supervisor (TS) #2 and #3, the LD failed to ensure quality assessment (QA) programs were followed to assure the quality of laboratory services provided from 2018 to the day of survey. Findings Include: 1. The Laboratory Quality Management Plan Policy states, "The committee shall meet 3 times per year". 2. On the date of survey, 10/21/2020, review of the Quality Management Plan committee meeting minutes revealed, the committee did not meet 3 times a year in 2018, 2019 and 2020. In 2018 the committee met 2 of 3 times. In 2019, the committee met 2 of 3 times. In 2020, the committee met once. 3. The TS #2 and #3 confirmed the findings above on 10/06/2020 around 11:00 am. ** Repeat Deficiency*** -- 4 of 4 --

Summary Statement of Deficiencies D5221 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(d) All proficiency testing evaluation and verification activities must be documented. This STANDARD is not met as evidenced by: Based on review of laboratory quality assurance (QA) policy, College of American Pathologists (CAP) Non-Gynecologic Cytopathology (NGC) proficiency testing (PT) record, and interview with the cytology general supervisor (GS), the laboratory failed to record PT review in 2017. Findings include: 1. The laboratory QA policy, the laboratory director signed on 05/23/2018, states "Proficiency testing is important to keep a record of each screener's ability to diagnosis different cases ..." 2. The 2017 NGC-A PT report reads as follows: Cumulative Case 4 Response Individuals* Ref Interpretation Adenocarcinoma 55 Site/Your Answer Metastatic Malignancy 17 (other than those listed) *Total 94 participants 3. Of all participants, 59% (55 of 94) responded "Adenocarcinoma" (reference interpretation) versus 18% (17 of 94) responded "Metastatic Malignancy-Other than those listed" (your answer). 4. The laboratory did not document Case 4 PT evaluations in 2017. 5. The laboratory had no other 2017 PT Case 4 verification records. 6. The cytology GS confirmed above findings on 08/15/2018 at 09:00 AM. ====================================== D5791 ANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1289(a)(c) (a) The laboratory must establish and follow written policies and procedures for an ongoing mechanism to monitor, assess, and when indicated, correct problems identified in the analytic systems specified in 493.1251 through 493.1283. (c) The laboratory must document all analytic systems assessment activities. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 2 -- This STANDARD is not met as evidenced by: Based on review of laboratory quality assurance (QA) policy, Nitrazine/Actim PROM Correlation Study record, and interview with the technical consultant (TC) #3, the laboratory failed to look into uncorrelated test results in 2018. Findings include: 1. The laboratory QA policy, the laboratory director signed on 05/23/2018, states "Laboratory tests are systematically monitoring for any factor that would affect the accuracy ..." 2. The laboratory 03/10/2018 Nitrazine/Actim PROM correlation study reads as follows: Patient Test Result Number PROM Nitrazine Comparison 1 Positive Positive Agree 2 Positive Positive Agree 3 Positive Negative Disagree 4 Negative Positive Disagree 3. Of these 4 comparison analyses, 2 (patient 3 and 4) disagreed. 4. The laboratory did not address these (2 of 2) discordant test results in 2018. 5. The laboratory had no other follow-up records. 6. The TC # 3 confirmed above findings on 08/13/2018 at 02:30 PM. ====================================== D6094 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(5) The laboratory director must ensure that the quality assessment programs are established and maintained to assure the quality of laboratory services provided and to identify failures in quality as they occur. This STANDARD is not met as evidenced by: Based on review of laboratory quality assurance (QA) policy, quality management (QM) committee meeting record, and interview with the technical consultant (TC) #3, the laboratory director (LD) failed to ensure QM committee meetings take place bi- monthly in 2018. Findings include: 1. The laboratory QA policy, the LD signed on 05 /23/2018, states "This Committee shall meet 6 times per calendar year." 2. The laboratory did not hold any (4 of 4) QM committee meetings from January through August 2018. 3. The laboratory had no other 2018 QM committee gathering records. 4. The TC # 3 confirmed above findings on 08/14/2018 at 11:30 AM. ====================================== -- 2 of 2 --