Community Hospital

Summary Statement of Deficiencies D0000 The recertification survey was performed on 11/28/2023 through 12/01/2023. The laboratory was found in compliance with standard-level deficiencies cited. The findings were reviewed with the laboratory director, laboratory supervisor, laboratory consultant, director of nursing, laboratory manager, and quality assurance specialist during an exit conference performed at the conclusion of the survey. 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 and interview with the laboratory supervisor, the laboratory failed to ensure blood collection tubes were stored as required by the manufacturer, in three of three supply rooms. Findings include: (1) Observation of the supply rooms on 11/28/2023 at 11:45 am, identified the following: (a) Nursing Medical Surgery room - East i. 28 BD Vacutainer serum, lot # 2200887, storage temperature of 4-25 degrees C (Centigrade); ii. 10 BD Vacutainer SST, lot # 3206576, storage temperature of 4-25 degrees C; iii. 24 BD Vacutainer K2 EDTA tubes 7.2mg, lot # 2321385, storage temperature of 4-25 degrees C; iv. 10 BD Vacutainer buffered Na Citrate, 0.109M, 3.2%, lot # 3074232, storage temperature of 4-25 degrees C; v. 15 BD Vacutainer PST Gel and Lithium Heparin 83 Units, lot # 3163707, storage temperature of 4-25 degrees C. (b) Nursing Medical Surgery room - West i. 50 BD Vacutainer PST Gel and Lithium Heparin 83 Units, lot # 3194806, storage temperature of 4-25 degrees C; 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 -- ii. 75 BD Vacutainer K2 EDTA tubes 7.2mg, lot # 3163678, storage temperature of 4- 25 degrees C; iii. 19 BD Vacutainer K2 EDTA tubes 10.8mg, lot # 2200157, storage temperature of 4-25 degrees C. (c) Material Management room i. 160 BD Vacutainer Na Fluoride Potassium Oxalate 10mg/8mg, lot # 3163696, storage temperature of 4- 25 degrees C; ii. 133 BD Vacutainer SST tubes, lot # 3206576, storage temperature of 4-25 degrees C; iii. 920 BD Vacutainer Gel and Lithium Heparin tubes 83 Units, lot # 3222769, storage temperature of 4-25 degrees C. (2) Interview with the laboratory supervisor on 11/28/2023 at 12:37 pm confirmed the temperatures were not being monitored in the supply rooms. D5421 ESTABLISHMENT AND VERIFICATION OF PERFORMANCE CFR(s): 493.1253(b)(1) Each laboratory that introduces an unmodified, FDA-cleared or approved test system must do the following before reporting patient test results: (1)(i) Demonstrate that it can obtain performance specifications comparable to those established by the manufacturer for the following performance characteristics: (1)(i)(A) Accuracy. (1)(i) (B) Precision. (1)(i)(C) Reportable range of test results for the test system. (1)(ii) Verify that the manufacturer's reference intervals (normal values) are appropriate for the laboratory's patient population. This STANDARD is not met as evidenced by: Based on a review of records and interview with the laboratory consultant and the laboratory supervisor, the laboratory failed to utilize the demonstrated reportable ranges for one of one new test method. Findings include: (1) On 11/28/2023 at 11:00 am, the laboratory consultant and the laboratory supervisor stated the laboratory began performing glucose, BUN (blood Urea Nitrogen), Chloride, Sodium, and CO2 testing using the CHEM 8+ cartridge and the iSTAT1 analyzer on 03/07/2023; (2) A review of the performance specification records identified the laboratory had demonstrated the following reportable ranges: (a) Glucose - 30.0 - 587.0 mg/dL (b) BUN - 5.0 -134.0 mg/dL (c) CO2 - 9.0 - 42.0 mmol/L (3) Interview with the laboratory consultant and the laboratory supervisor on 11/28/2023 at 4:23 pm confirmed the laboratory was using the following manufacturer's reportable ranges: (a) Glucose - 20.0 - 700.0 mg/dL (b) BUN - 3.0 -140.0 mg/dL (c) CO2 - 5.0 - 50.0 mmol/L -- 2 of 2 --

Summary Statement of Deficiencies D0000 The recertification survey was performed on 11/01,02,03,04,05/2021. The findings were reviewed with the laboratory director, laboratory manager, laboratory supervisor, and QA manager 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 D5411 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(a) Test systems must be selected by the laboratory. The testing must be performed following the manufacturer's instructions and in a manner that provides test results within the laboratory's stated performance specifications for each test system as determined under 493.1253. This STANDARD is not met as evidenced by: Based on a review of records, manufacturer's instructions, and interview with the laboratory supervisor, the laboratory failed to follow the manufacturer's instructions for centrifuging specimens for two of six patient Ammonia specimens. Findings include: (1) On 11/02/2021 at 10:30 am, the laboratory supervisor stated to the surveyor Ammonia testing was performed in the laboratory using the Ortho Virtros 5600 analyzer; (2) The surveyor reviewed the manufacturer's instructions under the section titled, "Special Precautions" for Ammonia testing which stated: (a) Ammonia testing - "Centrifuge specimens and remove the plasma from the cellular material within 15 minutes of collection". (3) The surveyor randomly reviewed 6 patient records for Ammonia testing performed between 02/09/2021 through 10/03/2021: (a) For 2 of 6 records, there was no evidence the laboratory followed the manufacturer's instructions for centrifuging Ammonia patient specimens within 15 minutes as follows: (i) Patient testing was performed on 02/09/2021 at 03:38 pm. The specimen was collected on 02/09/2021 at 02:53 pm and received into the laboratory on 02/09 /2021 at 03:19 pm (26 minutes later); (ii) Patient testing was performed on 06/19/2021 Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 10 -- at 04:10 pm. The specimen was collected on 06/19/2021 at 03:30 pm and received into the laboratory on 06/19/2021 at 03:52 pm (22 minutes later). (4) The surveyor reviewed the records with the laboratory supervisor who stated on 11/04/2021 at 02: 30 pm that although the laboratory could not prove the specimens were centrifuged within 15 minutes as required by the manufacturer, the laboratory processed Ammonia patient specimens upon receipt in the laboratory. D5421 ESTABLISHMENT AND VERIFICATION OF PERFORMANCE CFR(s): 493.1253(b)(1) Each laboratory that introduces an unmodified, FDA-cleared or approved test system must do the following before reporting patient test results: (1)(i) Demonstrate that it can obtain performance specifications comparable to those established by the manufacturer for the following performance characteristics: (1)(i)(A) Accuracy. (1)(i) (B) Precision. (1)(i)(C) Reportable range of test results for the test system. (1)(ii) Verify that the manufacturer's reference intervals (normal values) are appropriate for the laboratory's patient population. This STANDARD is not met as evidenced by: Based on a review of records, written procedures, manufacturer's reportable ranges, and interview with the laboratory supervisor, the laboratory failed to ensure the reportable ranges were utilized for four of four new test methods. Findings include: BECKMAN COULTER DxH520 (1) On 11/02/2021 at 10:20 am, the laboratory supervisor stated to the surveyor two Beckman Coulter DxH 520 analyzers (serial number BC050677 and serial number BC050678) were available for patient use on 12 /20/2019; (2) On 11/03/2021, The surveyor reviewed the performance specification records for the two new analyzers and identified the laboratory had demonstrated the following reportable ranges: (a) Beckman Coulter DxH 520 Serial Number BC050677 (i) Hemoglobin - 0.0 - 22.9 g/dL (ii) Platelets - 0.2 - 1977 X 10^3/L (b) Beckman Coulter DxH 520 Serial Number BC050678 (i) Hemoglobin - 0.01 - 23.47 g/dL (ii) Platelets - 0.4 - 1955 X 10^3/L (3) The surveyor then reviewed the laboratory's written procedure titled, "Beckman Coulter DxH 520 Operation for Complete Blood Count and Single Automated Tests" to show the reportable ranges that were being utilized by the laboratory. The laboratory was using the following manufacturer's reportable ranges: (a) Hemoglobin - 0.2 - 25.0 g/dL (b) Platelets - 7.0 - 2000 X 10^3/L (4) The surveyor reviewed the findings with the general supervisor, who stated on 11 /03/2021 at 01:30 pm, the laboratory was not using the reportable ranges that had been demonstrated by the laboratory as shown above. CG8+ CARTRIDGE AND EC8+ CARTRIDGE (1) On 11/04/2021 at 11:30 am, the laboratory supervisor stated the following to the surveyor: (a) The iSTAT 1 analyzer and the EC8+ cartridge were used to perform Blood Gas (pH and pCO2) testing and Chemistry (BUN, Chloride, Glucose, Sodium, Potassium, and TCO2) testing. The system was available for patient testing on 01/29/2020; (b) The iSTAT 1 analyzer and CG8+ cartridge were used to perform Blood Gas (pH, pCO2, and PO2) testing and Chemistry (Glucose, Ionized Calcium, Sodium, and Potassium) testing. The system was available for patient testing on 02/03/2021. (2) The surveyor reviewed the performance specification records for the two new test systems and identified the laboratory had demonstrated the following reportable ranges for the following: (a) EC8+ (i) pCO2 - 23.6 - 105.9 mmHg (ii) BUN - 4 - 134 mg/dL (iii) Chloride - 60 - 125 mmol/L (iv) Glucose - 30 - 572 mg/dL (v) Sodium - 100 - 177 mmol/L (vi) Potassium - 2.3 - 7.9 mmol/L (vii) TCO2 - 11 - 42 mmol/L (b) CG8+ (i) pH - 6.544 - 7.912 (ii) pCO2 - 19.5 - 85.8 mmHg (iii) pO2 - 56 - 427 mmHg (iv) Glucose - 31 - 578 mg/dL (v) Ionized Calcium - 0.35 - 2.23 mmol/L -- 2 of 10 -- (vi) Sodium - 102 - 178 mmol/L (vii) Potassium - 2.3 - 7.9 mmol/L (3) The surveyor then reviewed the manufacturer's reportable ranges, which were being used by the laboratory. The manufacturer's reportable ranges were as follows: (a) EC8+ (i) pCO2 - 5.0 - 130.0 mmHg (ii) BUN - 3 - 140 mg/dL (iii) Chloride - 65 - 140 mmol/L (iv) Glucose - 20 - 700 mg/dL (v) Sodium - 100 - 180 mmol/L (vi) Potassium - 2.0 - 9.0 mmol/L (vii) TCO2 - 5 - 50 mmol/L (b) CG8+ (i) pH - 6.50 - 8.20 (ii) pCO2 - 5.0 - 130.0 mmHg (iii) pO2 - 5 - 800 mmHg (iv) Glucose - 20 - 700 mg/dL (v) Ionized Calcium - 0.25 - 2.50 mmol/L (vi) Sodium - 100 - 180 mmol/L (vii) Potassium - 2.0 - 9.0 mmol/L (4) The surveyor reviewed the findings with the laboratory supervisor, who stated on 11/04/2021 at 02:45 pm, the laboratory was not using the reportable ranges that had been demonstrated by the laboratory as shown above. 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 supervisor, the technical supervisor failed to provide technical supervision in accordance with 493.1447 of this subpart. Findings include: (1) The technical supervisor failed to ensure the individual who performed the duties and responsibilities of the technical supervisor met the educational qualifications. Refer to D6111. D6111 TECHNICAL SUPERVISOR QUALIFICATIONS CFR(s): 493.1449 (a) The technical supervisor must possess a current license issued by the State in which the laboratory is located, if such licensing is required; and (b) The laboratory may perform anatomic and clinical laboratory procedures and tests in all specialties and subspecialties of services except histocompatibility and clinical cytogenetics services provided the individual functioning as the technical supervisor-- (b)(1) Is a doctor of medicine or doctor of osteopathy licensed to practice medicine or osteopathy in the State in which the laboratory is located; and (b)(2) Is certified in both anatomic and clinical pathology by the American Board of Pathology or the American Osteopathic Board of Pathology or Possesses qualifications that are equivalent to those required for such certification. (c) If the requirements of paragraph (b) of this section are not met and the laboratory performs tests in the subspecialty of bacteriology, the individual functioning as the technical supervisor must-- (c)(1)(i) Be a doctor of medicine or doctor of osteopathy licensed to practice medicine or osteopathy in the State in which the laboratory is located; and (c)(1)(ii) Be certified in clinical pathology by the American Board of Pathology or the American Osteopathic Board of Pathology or possess qualifications that are equivalent to those required for such certification; or (c)(2)(i) Be a doctor of medicine, doctor of osteopathy, or doctor of podiatric medicine licensed to practice medicine, osteopathy, or podiatry in the State in which the laboratory is located; and (c)(2)(ii) Have at least one year of laboratory training or experience, or both, in high complexity testing within the specialty of microbiology with a minimum of 6 months experience in high complexity testing within the subspecialty of bacteriology; or (c)(3)(i) Have an earned doctoral degree in a chemical, physical, biological or clinical laboratory science from an -- 3 of 10 -- 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 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, -- 4 of 10 -- 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 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, -- 5 of 10 -- 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 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 -- 6 of 10 -- 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 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 -- 7 of 10 -- 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 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 -- 8 of 10 -- 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. This STANDARD is not met as evidenced by: Based on a review of records and interview with the laboratory supervisor, the technical supervisor failed to ensure that individuals who performed the duties and responsibilities of the technical supervisor met the qualifications for 2 of 2 of -- 9 of 10 -- semiannual competency assessments. Findings include: (1) On 11/02/2021, the surveyor reviewed records for 2 testing person who had been hired to perform high complexity testing (ABO/Rh, Antibody Screen and Compatibility testing) since the previous recertification survey performed. The records indicated the semi-annual evaluation for the testing person had been performed by an individual who did not meet the regulatory qualification requirements of the technical supervisor: (a) Testing Person #3 - The 02/19/2021 semi-annual evaluation had been performed by the laboratory supervisor (this person had earned a bachelor degree in applied science); (b) Testing Person #4 - The 04/23/2021 semi-annual evaluation had been performed by the laboratory supervisor. (2) The surveyor explained to the laboratory supervisor 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 11 /02/2021 at 12:25 pm, the laboratory supervisor stated to the surveyor the semi-annual evaluation had not been performed by someone 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" -- 10 of 10 --

Summary Statement of Deficiencies D0000 A recertification survey was performed on 11/18/19 through 11/21/19. The findings were reviewed with the laboratory director, chief operating officer, quality assurance manager, laboratory manager, laboratory supervisor, vice-president clinical service /system chief nursing officer, chief quality officer, and vice-president ancillary and support services during an exit conference performed at the conclusion of the survey. The laboratory was found out of compliance with the following CLIA regulation: 493.1409; D6033: Technical Consultant 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 quality assurance manager, laboratory manager and laboratory supervisor, the laboratory failed to ensure attestation statements were signed by the laboratory director or designee for 6 of 90 events. Findings include: (1) On the seond day of the survey, surveyor #3 reviewed 2018 and 2019 proficiency testing records, which included the attestation statements. The attestation statements had not been signed by the laboratory director or designee for 6 of 90 events reviewed as follows: (a) 2018 Therapeutic Drug Monitoring Survey Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 15 -- (LN3-B) Event - The attestation had not been signed by the laboratory director or designee; (b) 2018 Second Aqueous Blood Gas (AQI-B) Event -The attestation had not been signed by the laboratory director or designee; (c) 2018 Rapid Strep A Antigen (D6-B) Event - The attestation had not been signed by the laboratory director or designee; (d) 2018 Erythrocyte Sedimentation Rate (ESR-A) Event - The attestation had not been signed by the laboratory director or designee; (e) 2018 Alcohol/Volatiles (AL2-B) Event - The attestation had not been signed by the laboratory director or designee; (f) 2018 Coagulation, Limited (CGL-B) - The attestation had not been signed by the laboratory director or designee. (2) Surveyor #3 reviewed the findings with the quality assurance manager, laboratory manager and laboratory supervisor and explained that attestation statements must be signed by the laboratory director or designee. D3025 REQUIREMENTS FOR TRANSFUSION SERVICES CFR(s): 493.1103(d) Investigation of transfusion reactions. The facility must have procedures for preventing transfusion reactions and when necessary, promptly identify, investigate, and report blood and blood product transfusion reactions to the laboratory and, as appropriate, to Federal and State authorities. This STANDARD is not met as evidenced by: Based on a review of records, nursing policy, and interview with the quality assurance manager, laboratory manager, laboratory supervisor, chief quality officer, and vice- president clinical service/system chief nursing officer the laboratory failed to ensure written policies were established and followed for preventing transfusion reactions for 4 of 6 patients. Findings include: (1) On the fourth day of the survey, the laboratory manager stated to surveyor #3 the laboratory performed Crossmatch Testing, which consisted of ABO/Rh, Antibody Screen, and Compatibility testing (performed between the patient and red blood cell donor unit(s)); (2) Surveyor #3 reviewed the hospital policy regarding transfusion reactions. The policy "Blood and Blood Products Administration" defined the parameters of issuing blood products from the blood bank; (3) The surveyor further reviewed the policy which stated: (a) "Blood/blood components must be infused over a time period not to exceed four (4) hours." (b) "PROCEDURE" (i) "3. Verify transfusion consent." (ii) "4. Verify the physician's order to transfuse." (iii) "6. Complete blood requistion slip in its entirety." (iv) "9. The nurse will place a Typenex sticker from the patient's blood band (pt. armband) on the Transfusion Record (beside the blood bank identification number printed on the Transfusion Record) prior to removing blood product from the Blood Bank." (v). "13. Vital signs for baseline data, including blood pressure, pulse, respiratory rate, and temperature. Record vital signs on the Transfusion Record at Pre Transfusion (within 30 minutes before transfusion begins), 5 minutes from the START TIME, 15 minutes from the START TIME, 30 minutes from the START TIME, then every 30 minutes until the transfusion is complete. A separate set of post infusion vital signs must also be documented 30 minutes to 1 hour after the transfusion is complete." (4) Surveyor #3 then reviewed transfusion records for 6 patients with the quality assurance manager, laboratory manager, laboratory supervisor, chief quality officer, and vice- president clinical service/system chief nursing officer. For 4 of the 6 units transfused the policy was not followed by nursing personnel: (a) Unit #W091018331648 - The unit was checked out from the blood bank on 11/01/19 at 01:49 pm with the transfusion completed at 02:35 pm on 11/01/19. (i) There was no documentation the patient's transfusion consent or physician's order had been verified; (ii) There was no -- 2 of 15 -- documentation in the designated area for the transfused volume of packed red blood cells. (b) Unit #W091018287062 - The unit was checked out from the blood bank on 11/29/18 at 11:55 am with the transfusion completed at 02:45 pm on 11/29/18. (i) There was no documentation of the patient's Typenex sticker from the patient's blood band; (ii) There was no documentation of the donor unit number; (iii) The transfusion record documentation showed the transfusion completion date and time was 11/29/19 at 02:45 pm. The post transfusion time that was documentatied on the record was 02: 30 pm (10 minute prior to the completion time). (c) Unit #W091019158797 - The unit was checked out from the blood bank on 04/10/19 at 05:25 pm with the transfusion completed at 09:50 pm on 04/10/19. (i) The documentation showed the transfusion started at 05:00 pm (25 minutes before the checking the unit out of the blood bank); (ii) The documentation showed the transfusion started at 05:00 pm and was completed at 09:50 pm, which exceeded the maximum infusion time limit of 4 hours (at total of 4 hours and 50 minutes); (iii) The documentation showed the transfusion was stopped at 06:30 pm on 04/10/19 for antibiotic adminstration and a CT (Computerized Tomography) scan, then started again at 08:45 pm. (d) Unit #W091019166062 - The unit was checked out from the blood bank on 04/26/19 at 09:40 am with the transfusion completed at 11:50 am on 04/26/19. (i) The documentation showed the post transfusion vitals were taken at 12:00 pm, which was 10 minutes after the completion of the transfusion (the policy required post-transfusion vitals taken 30 minutes to 1 hour after completion). (5) Surveyor #3 explained to the quality assurance manager, laboratory manager, laboratory supervisor, chief quality officer, and vice-president clinical service/system chief nursing officer that in order to ensure a transfusion reaction is promptly identified, nursing personnel must follow their policy. D5211 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(a) The laboratory must review and evaluate the results obtained on proficiency testing performed as specified in subpart H of this part. This STANDARD is not met as evidenced by: Based on a review of records and interview with the quality assurance manager, laboratory manager and laboratory supervisor, the laboratory failed to review and evaluate proficiency testing results for 1 of 90 events. Findings include: (1) On the second day of the survey, surveyor #3 reviewed 2018 and 2019 proficiency testing records and identified the following failures: (a) 2018 Hematology Auto Differentials (FH3-A) Event (i) Monocytes - The laboratory failed the result for 1 of 5 samples (FH#-03) and attained a 80% score. (2) The records were then reviewed further by the surveyor. There was no evidence

Summary Statement of Deficiencies D0000 The following deficiencies are a result of a desk review of proficiency testing scores obtained from the national database. D2016 SUCCESSFUL PARTICIPATION CFR(s): 493.803(a)(b)(c) (a) Each laboratory performing nonwaived testing must successfully participate in a proficiency testing program approved by CMS, if applicable, as described in subpart I of this part for each specialty, subspecialty, and analyte or test in which the laboratory is certified under CLIA. (b) Except as specified in paragraph (c) of this section, if a laboratory fails to participate successfully in proficiency testing for a given specialty, subspecialty, analyte or test, as defined in this section, or fails to take remedial action when an individual fails gynecologic cytology, CMS imposes sanctions, as specified in subpart R of this part. (c) If a laboratory fails to perform successfully in a CMS- approved proficiency testing program, for the initial unsuccessful performance, CMS may direct the laboratory to undertake training of its personnel or to obtain technical assistance, or both, rather than imposing alternative or principle sanctions except when one or more of the following conditions exists: (1) There is immediate jeopardy to patient health and safety. (2) The laboratory fails to provide CMS or a CMS agent with satisfactory evidence that it has taken steps to correct the problem identified by the unsuccessful proficiency testing performance. (3) The laboratory has a poor compliance history. This CONDITION is not met as evidenced by: Based on a desk review of proficiency testing scores, the laboratory failed to successfully participate in a proficiency testing program for the subspecialty of Routine Chemistry. Findings include: (1) The laboratory failed to achieve satisfactory performance for two consecutive testing events for the analyte CK (Creatine Kinase). Refer to D2094 and D2096. 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 -- D2094 ROUTINE CHEMISTRY CFR(s): 493.841(e) (1) For any unsatisfactory analyte or test performance or testing event for reasons other than a failure to participate, the laboratory must undertake appropriate training and employ the technical assistance necessary to correct problems associated with a proficiency testing failure. (2) For any unacceptable analyte or testing event score, remedial action must be taken and documented, and the documentation must be maintained by the laboratory for two years from the date of participation in the proficiency testing event. This STANDARD is not met as evidenced by: Based on a desk review of proficiency testing scores, the laboratory failed to achieve a successful performance for the analyte CK. Findings include: (1) The laboratory failed to achieve satisfactory performance on the second 2018 and third 2018 events. NOTE: The only acceptable

Summary Statement of Deficiencies D0000 The following deficiencies are a result of a desk review of proficiency testing scores obtained from the national database. D2016 SUCCESSFUL PARTICIPATION CFR(s): 493.803(a)(b)(c) (a) Each laboratory performing nonwaived testing must successfully participate in a proficiency testing program approved by CMS, if applicable, as described in subpart I of this part for each specialty, subspecialty, and analyte or test in which the laboratory is certified under CLIA. (b) Except as specified in paragraph (c) of this section, if a laboratory fails to participate successfully in proficiency testing for a given specialty, subspecialty, analyte or test, as defined in this section, or fails to take remedial action when an individual fails gynecologic cytology, CMS imposes sanctions, as specified in subpart R of this part. (c) If a laboratory fails to perform successfully in a CMS- approved proficiency testing program, for the initial unsuccessful performance, CMS may direct the laboratory to undertake training of its personnel or to obtain technical assistance, or both, rather than imposing alternative or principle sanctions except when one or more of the following conditions exists: (1) There is immediate jeopardy to patient health and safety. (2) The laboratory fails to provide CMS or a CMS agent with satisfactory evidence that it has taken steps to correct the problem identified by the unsuccessful proficiency testing performance. (3) The laboratory has a poor compliance history. This CONDITION is not met as evidenced by: Based on a desk review of proficiency testing scores, the laboratory failed to successfully participate in a proficiency testing program for the subspecialty of Routine Chemistry. Findings include: (1) The laboratory failed to achieve satisfactory performance for two consecutive testing events for the analyte Total Iron. Refer to D2094 and D2096; 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 -- D2094 ROUTINE CHEMISTRY CFR(s): 493.841(e) (1) For any unsatisfactory analyte or test performance or testing event for reasons other than a failure to participate, the laboratory must undertake appropriate training and employ the technical assistance necessary to correct problems associated with a proficiency testing failure. (2) For any unacceptable analyte or testing event score, remedial action must be taken and documented, and the documentation must be maintained by the laboratory for two years from the date of participation in the proficiency testing event. This STANDARD is not met as evidenced by: Based on a desk review of proficiency testing scores, the laboratory failed to achieve a successful performance for the analyte Total Iron. Findings include: (1) The laboratory failed to achieve satisfactory performance on the First 2018 and Second 2018 events. NOTE: The only acceptable

Summary Statement of Deficiencies D0000 The following deficiencies are a result of a desk review of proficiency testing scores obtained from the national database. D2016 SUCCESSFUL PARTICIPATION CFR(s): 493.803(a)(b)(c) (a) Each laboratory performing nonwaived testing must successfully participate in a proficiency testing program approved by CMS, if applicable, as described in subpart I of this part for each specialty, subspecialty, and analyte or test in which the laboratory is certified under CLIA. (b) Except as specified in paragraph (c) of this section, if a laboratory fails to participate successfully in proficiency testing for a given specialty, subspecialty, analyte or test, as defined in this section, or fails to take remedial action when an individual fails gynecologic cytology, CMS imposes sanctions, as specified in subpart R of this part. (c) If a laboratory fails to perform successfully in a CMS- approved proficiency testing program, for the initial unsuccessful performance, CMS may direct the laboratory to undertake training of its personnel or to obtain technical assistance, or both, rather than imposing alternative or principle sanctions except when one or more of the following conditions exists: (1) There is immediate jeopardy to patient health and safety. (2) The laboratory fails to provide CMS or a CMS agent with satisfactory evidence that it has taken steps to correct the problem identified by the unsuccessful proficiency testing performance. (3) The laboratory has a poor compliance history. This CONDITION is not met as evidenced by: Based on a desk review of proficiency testing scores, the laboratory failed to successfully participate in a proficiency testing program for the subspecialty of Routine Chemistry. Findings include: (1) The laboratory failed to achieve satisfactory performance for two consecutive testing events for the analyte Creatine Kinase, Isoenzyme. Refer to D2094 and D2096; . 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 -- D2094 ROUTINE CHEMISTRY CFR(s): 493.841(e) (1) For any unsatisfactory analyte or test performance or testing event for reasons other than a failure to participate, the laboratory must undertake appropriate training and employ the technical assistance necessary to correct problems associated with a proficiency testing failure. (2) For any unacceptable analyte or testing event score, remedial action must be taken and documented, and the documentation must be maintained by the laboratory for two years from the date of participation in the proficiency testing event. This STANDARD is not met as evidenced by: Based on a desk review of proficiency testing scores, the laboratory failed to achieve a successful performance for the analyte Creatine Kinase, Isoenzyme. Findings include: (1) The laboratory failed to achieve satisfactory performance on the second event of 2017 and first event of 2018. NOTE: The only acceptable

Summary Statement of Deficiencies No Tags No deficiency details available. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 1 --