Hillcrest Hospital Claremore

Summary Statement of Deficiencies D0000 The recertification survey was performed on 06/07,08,09,10/2022. The laboratory was found out of compliance with the following CLIA regulation: 493.1449; D6108: Technical Supervisor The findings were reviewed with the laboratory director, director RML, chief executive officer, chief nursing officer/chief operating officer, quality coordinator, laboratory manager and laboratory supervisor during an exit conference performed at the conclusion of the survey. D5209 PERSONNEL COMPETENCY ASSESSMENT POLICIES CFR(s): 493.1235 As specified in the personnel requirements in subpart M, the laboratory must establish and follow written policies and procedures to assess employee and, if applicable, consultant competency. This STANDARD is not met as evidenced by: Based on a review of records, written policy, and interview with the laboratory supervisor, the laboratory failed to follow their policy for performing general supervisor competencies based on the position responsibilities as listed in Subpart M for one of one general supervisor. Findings include: (1) On 06/08/2022, a review of the competency assessment policy and interview with the laboratory supervisor at 12: 05 pm, revealed that competencies for the general supervisor, based on the position responsibilites were required to be performed annually; (2) A review of personnel records for competency assessments performed during 2021 and to date in 2022 revealed no evidence of competencies performed for the general supervisor, based on job responsibilities; (3) The findings were reviewed with the laboratory supervisor who stated on 06/08/2022 at 12:15 pm, the competencies had not been documented as performed. D5415 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(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 11 -- Reagents, solutions, culture media, control materials, calibration materials, and other supplies, as appropriate, must be labeled to indicate the following: (1) Identity and when significant, titer, strength or concentration. (2) Storage requirements. (3) Preparation and expiration dates. (4) Other pertinent information required for proper use. This STANDARD is not met as evidenced by: Based on a review of the manufacturer's package insert, observation, and interview with the laboratory supervisor, the laboratory failed to document the open date on two of two ESR quality control vials. Findings include: (1) On 06/07/2022 at 11:50 am, the laboratory supervisor stated the following: (a) ESR (Erythrocyte Sedimentation Rate) testing was performed using the Excyte Mini analyzer; (b) Two levels (normal and abnormal) of QC (Quality Control) materials were performed each day of patient testing. (2) Observation of the current QC materials (ELI Tech Group Acu-Sed Plus Normal ESR control lot #216010 and Abnormal control lot #217110) on 06/08/2022 at 04:38 pm revealed the vials had not been dated with the open date; (3) Review of the manufacturer's package insert under "Storage and Stability" showed the controls were stable for 31 days after opening; (4) The QC vials were shown to the laboratory supervisor who stated on 06/08/2022 at 04:40 pm, the vials had not been dated when opened. D5429 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(a)(1) For unmodified manufacturer's equipment, instruments, or test systems, the laboratory must perform and document maintenance as defined by the manufacturer and with at least the frequency specified by the manufacturer. This STANDARD is not met as evidenced by: Based on a review of records, manufacturer's instructions, and interview with the laboratory supervisor, the laboratory failed to follow the manufacturer's instructions for performing maintenance procedures for two of six analyzers. Findings include: SYSMEX XS 1000i (1) On 06/07/2022 at 12:00 pm, the laboratory supervisor stated the laboratory performed CBC (Complete Blood Count) testing using the Sysmex XS 1000i analyzer; (2) On 06/09/2022, a review of the manufacturer's maintenance log showed the following manufacturer required weekly maintenance procedure: (a) "Power Down IPU" (3) A review of maintenance logs from January 2021 through May 2022 revealed the weekly maintenance had not been documented as performed between: (a) 01/28/2021 and 02/11/2021 (b) 11/04/2021 and 11/18/2021 (c) 12/16 /2021 and 12/31/2021 (d) 03/25/2022 and 04/07/2022 (4) The records were reviewed with the laboratory supervisor who stated on 06/09/2022 at 03:00 pm, the weekly maintenance had not been documented as performed. BECKMAN COULTER AU480 (RIGHTY) (1) On 06/10/2022 at 11:30 am, the laboratory supervisor stated the laboratory performed CMP*, Lipid Profile*, Amylase, Direct Bilirubin, CK (Creatine Kinase), Ammonia, Lactic Acid, Lipase, Magnesium, Acetaminophen, Digoxin, Salicylate, Alcohol, Uric Acid, Iron, and Phosphorus testing using the Beckman Coulter AU480 analyzer, denoted by the laboratory as "Righty"; (2) A review of the manufacturer's maintenance log showed the following manufacturer required maintenance procedures: (a) Quarterly (i) Clean Air Filters (ii) Replace the Detergent Rolling Tube (b) ISE Weekly (i) Enhanced Cleaning of the Electrode Line (3) A -- 2 of 11 -- review of maintenance logs from January 2021 through May 2022 revealed the maintenance had not been documented as performed as follows: (a) Quarterly - Not performed between: (i) 05/18/2021 and 11/02/2021 (b) ISE Weekly - Not performed between: (i) 06/22/2021 and 07/16/2021 (ii) 11/02/2021 and 11/16/2021 (iii) 11/23 /2021 and 12/07 2021 (4) The records were reviewed with the laboratory supervisor who stated on 06/10/2022 at 12:54 pm, the above maintenance had not been documented as performed. *Comprehensive Metabolic Panel (CMP) - Albumin, Alkaline Phosphatase, ALT, AST, BUN, Calcium, Chloride, CO2, Creatinine, Glucose, Potassium, Sodium, Total Bilirubin and Total Protein *Lipid Profile - Total Cholesterol, HDL Cholesterol, Triglyceride D5445 CONTROL PROCEDURES CFR(s): 493.1256(d)(1)(2)(g) Unless CMS Approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub. 7), that provides equivalent quality testing, the laboratory must-- (d)(1) Perform control procedures as defined in this section unless otherwise specified in the additional specialty and subspecialty requirements at 493.1261 through 493.1278. (d)(2) For each test system, perform control procedures using the number and frequency specified by the manufacturer or established by the laboratory when they meet or exceed the requirements in paragraph (d)(3) of this section. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on a review of records and interview with the laboratory supervisor and laboratory manager, the laboratory failed to perform quality control as stated in the IQCP for the ROM Plus Rupture of Fetal Membranes testing for five of eight months. Findings include: (1) On 06/09/2022 at 10:30 am, the laboratory supervisor stated the following: (a) The laboratory used the ROM Plus fetal membrane rupture test; (b) Positive and negative QC (Quality Control) materials were tested each 30 days, according to the laboratory IQCP (Individualized Quality Control Plan), which had been dated as approved by the laboratory director on 11/23/2021. (2) A review of QC records from November 2021 though June 2022 revealed there was no documentation to prove QC had been performed as stated in the QCP (Quality Control Plan) for four of eight months. QC had not been performed between: (a) 11/19/2021 and 03/22/2022 (b) 04/28/2022 and 06/05/2022 (3) The records were reviewed with the laboratory manager and laboratory supervisor. Both stated on 06/09/2022 at 11:55 am, QC had not been performed as shown above. D5543 HEMATOLOGY CFR(s): 493.1269(a)(d) (a) For manual cell counts performed using a hemocytometer-- (a)(1) One control material must be tested each 8 hours of operation; and (a)(2) Patient specimens and control materials must be tested in duplicate. (d) The laboratory must document all control procedures performed, as specified in this section. This STANDARD is not met as evidenced by: Based on a review of records and interview with the laboratory supervisor, the laboratory failed to test one control material each eight hours when performing manual CSF cell counts using a hemacytometer for four of five patients tested. -- 3 of 11 -- Findings include: (1) On 06/07/2022 at 12:00 pm, the laboratory supervisor stated manual CSF (Cerebral Spinal Fluid) cell counts for White Blood Cells (WBC) and Red Blood Cells (RBC) were performed using a hemacytometer; (2) A review of patient and QC (Quality Control) records for testing performed from December 2021 through May 2022 revealed that QC had not been performed each eight hours of patient testing for four of five patients tested as follows: (a) Patient testing had been performed on 12/14/2021 at 01:50 pm. QC had not been documented as performed until 12/14/2021 at 08:48 pm; (b) Patient testing had been performed on 01/24/2022 at 09:30 pm. QC had not been documented as performed until 01/24/2022 at 10:35 pm; (c) Patient testing had been performed on 03/27/2022 at 07:35 pm and at 08:22 pm. QC had not been documented as performed until 03/27/2022 at 09:20 pm; (d) Patient testing had been performed on 05/27/2022 at 04:25 pm. QC had not been documented as performed until 05/27/2022 at 06:10 pm. (3) The records were reviewed with the laboratory supervisor who stated on 06/08/2022 at 04:25 pm, QC had not been performed each eight hours of patient testing 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 manager and 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 -- 4 of 11 -- State in which the laboratory is located; and (c)(2)(ii) Have at least one year of laboratory training or experience, or both, in high complexity testing within the specialty of microbiology with a minimum of 6 months experience in high complexity testing within the subspecialty of bacteriology; or (c)(3)(i) Have an earned doctoral degree in a chemical, physical, biological or clinical laboratory science from an accredited institution; and (c)(3)(ii) Have at least 1 year of laboratory training or experience, or both, in high complexity testing within the specialty of microbiology with a minimum of 6 months experience in high complexity testing within the subspecialty of bacteriology; or (c)(4)(i) Have earned a master's degree in a chemical, physical, biological or clinical laboratory science or medical technology from an accredited institution; and (c)(4)(ii) Have at least 2 years of laboratory training or experience, or both, in high complexity testing within the specialty of microbiology with a minimum of 6 months experience in high complexity testing within the subspecialty of bacteriology; or (c)(5)(i) Have earned a bachelor's degree in a chemical, physical, or biological science or medical technology from an accredited institution; and (c)(5)(ii) Have at least 4 years of laboratory training or experience, or both, in high complexity testing within the specialty of microbiology with a minimum of 6 months experience in high complexity testing within the subspecialty of bacteriology. (d) If the requirements of paragraph (b) of this section are not met and the laboratory performs tests in the subspecialty of mycobacteriology, the individual functioning as the technical supervisor must-- (d)(1)(i) Be a doctor of medicine or doctor of osteopathy licensed to practice medicine or osteopathy in the State in which the laboratory is located; and (d)(1)(ii) Be certified in clinical pathology by the American Board of Pathology or the American Osteopathic Board of Pathology or possess qualifications that are equivalent to those required for such certification; or (d) (2)(i) Be a doctor of medicine, doctor of osteopathy, or doctor or podiatric medicine licensed to practice medicine, osteopathy, or podiatry in the State in which the laboratory is located; and (d)(2)(ii) Have at least 1 year of laboratory training or experience, or both, in high complexity testing within the specialty of microbiology with a minimum of 6 months experience in high complexity testing within the subspecialty of mycobacteriology; or (d)(3)(i) Have an earned doctoral degree in a chemical, physical, biological or clinical laboratory science from an accredited institution; and (d)(3)(ii) Have at least 1 year of laboratory training or experience, or both, in high complexity testing within the specialty of microbiology with a minimum of 6 months experience in high complexity testing within the subspecialty of mycobacteriology; or (d)(4)(i) Have earned a master's degree in a chemical, physical, biological or clinical laboratory science or medical technology from an accredited institution; and (d)(4)(ii) Have at least 2 years of laboratory training or experience, or both, in high complexity testing within the specialty of microbiology with a minimum of 6 months experience in high complexity testing within the subspecialty of mycobacteriology; or (d)(5)(i) Have earned a bachelor's degree in a chemical, physical or biological science or medical technology from an accredited institution; and (d)(5)(ii) Have at least 4 years of laboratory training or experience, or both, in high complexity testing within the specialty of microbiology with a minimum of 6 months experience in high complexity testing within the subspecialty of mycobacteriology. (e) If the requirements of paragraph (b) of this section are not met and the laboratory performs tests in the subspecialty of mycology, the individual functioning as the technical supervisor must-- (e)(1)(i) Be a doctor of medicine or doctor of osteopathy licensed to practice medicine or osteopathy in the State in which the laboratory is located; and (e)(1)(ii) Be certified in clinical pathology by the American Board of Pathology or the American Osteopathic Board of Pathology or possess qualifications that are equivalent to those required for such certification; or (e) (2)(i) Be a doctor of medicine, doctor of osteopathy, or doctor of podiatric medicine -- 5 of 11 -- licensed to practice medicine, osteopathy, or podiatry in the State in which the laboratory is located; and (e)(2)(ii) Have at least 1 year of laboratory training or experience, or both, in high complexity testing within the specialty of microbiology with a minimum of 6 months experience in high complexity testing within the subspecialty of mycology; or (e)(3)(i) Have an earned doctoral degree in a chemical, physical, biological or clinical laboratory science from an accredited institution; and (e)(3)(ii) Have at least 1 year of laboratory training or experience, or both in high complexity testing within the specialty of microbiology with a minimum of 6 months experience in high complexity testing within the subspecialty of mycology; or (e)(4) (i) Have earned a master's degree in a chemical, physical, biological or clinical laboratory science or medical technology from an accredited institution; and (e)(4)(ii) Have at least 2 years of laboratory training or experience, or both, in high complexity testing within the specialty of microbiology with a minimum of 6 months experience in high complexity testing within the subspecialty of mycology; or (e)(5)(i) Have earned a bachelor's degree in a chemical, physical or biological science or medical technology from an accredited institution; and (e)(5)(ii) Have at least 4 years of laboratory training or experience, or both, in high complexity testing within the specialty of microbiology with a minimum of 6 months experience in high complexity testing within the subspecialty of mycology. (f) If the requirements of paragraph (b) of this section are not met and the laboratory performs tests in the subspecialty of parasitology, the individual functioning as the technical supervisor must-- (f)(1)(i) Be a doctor of medicine or a doctor of osteopathy licensed to practice medicine or osteopathy in the State in which the laboratory is located; and (f)(1)(ii) Be certified in clinical pathology by the American Board of Pathology or the American Osteopathic Board of Pathology or possess qualifications that are equivalent to those required for such certification; or (f)(2)(i) Be a doctor of medicine, doctor of osteopathy, or doctor of podiatric medicine licensed to practice medicine, osteopathy, or podiatry in the State in which the laboratory is located; and (f)(2)(ii) Have at least one year of laboratory training or experience, or both, in high complexity testing within the specialty of microbiology with a minimum of 6 months experience in high complexity testing within the subspecialty of parasitology; (f)(3)(i) Have an earned doctoral degree in a chemical, physical, biological or clinical laboratory science from an accredited institution; and (f)(3)(ii) Have at least 1 year of laboratory training or experience, or both, in high complexity testing within the specialty of microbiology with a minimum of 6 months experience in high complexity testing within the subspecialty of parasitology; or (f)(4)(i) Have earned a master's degree in a chemical, physical, biological or clinical laboratory science or medical technology from an accredited institution; and (f)(4)(ii) Have at least 2 years of laboratory training or experience, or both, in high complexity testing within the specialty of microbiology with a minimum of 6 months experience in high complexity testing within the subspecialty of parasitology; or (f)(5)(i) Have earned a bachelor's degree in a chemical, physical or biological science or medical technology from an accredited institution; and (f)(5)(ii) Have at least 4 years of laboratory training or experience, or both, in high complexity testing within the specialty of microbiology with a minimum of 6 months experience in high complexity testing within the subspecialty of parasitology. (g) If the requirements of paragraph (b) of this section are not met and the laboratory performs tests in the subspecialty of virology, the individual functioning as the technical supervisor must-- (g)(1)(i) Be a doctor of medicine or doctor of osteopathy licensed to practice medicine or osteopathy in the State in which the laboratory is located; and (g)(1)(ii) Be certified in clinical pathology by the American Board of Pathology or the American Osteopathic Board of Pathology or possess qualifications that are equivalent to those required for such certification; or (g) (2)(i) Be a doctor of medicine, doctor of osteopathy, or doctor of podiatric medicine -- 6 of 11 -- licensed to practice medicine, osteopathy, or podiatry in the State in which the laboratory is located; and (g)(2)(ii) Have at least 1 year of laboratory training or experience, or both, in high complexity testing within the specialty of microbiology with a minimum of 6 months experience in high complexity testing within the subspecialty of virology; or (g)(3)(i) Have an earned doctoral degree in a chemical, physical, biological or clinical laboratory science from an accredited institution; and (g)(3)(ii) Have at least 1 year of laboratory training or experience, or both, in high complexity testing within the specialty of microbiology with a minimum of 6 months experience in high complexity testing within the subspecialty of virology; or (g)(4)(i) Have earned a master's degree in a chemical, physical, biological or clinical laboratory science or medical technology from an accredited institution; and (g)(4)(ii) Have at least 2 years of laboratory training or experience, or both, in high complexity testing within the specialty of microbiology with a minimum of 6 months experience in high complexity testing within the subspecialty of virology; or (g)(5)(i) Have earned a bachelor's degree in a chemical, physical or biological science or medical technology from an accredited institution; and (g)(5)(ii) Have at least 4 years of laboratory training or experience, or both, in high complexity testing within the specialty of microbiology with a minimum of 6 months experience in high complexity testing within the subspecialty of virology. (h) If the requirements of paragraph (b) of this section are not met and the laboratory performs tests in the specialty of diagnostic immunology, the individual functioning as the technical supervisor must- (h)(1)(i) Be a doctor of medicine or a doctor of osteopathy licensed to practice medicine or osteopathy in the State in which the laboratory is located; and (h)(1)(ii) Be certified in clinical pathology by the American Board of Pathology or the American Osteopathic Board of Pathology or possess qualifications that are equivalent to those required for such certification; or (h)(2)(i) Be a doctor of medicine, doctor of osteopathy, or doctor of podiatric medicine licensed to practice medicine, osteopathy, or podiatry in the State in which the laboratory is located; and (h)(2)(ii) Have at least 1 year of laboratory training or experience, or both, in high complexity testing for the specialty of diagnostic immunology; or (h)(3)(i) Have an earned doctoral degree in a chemical, physical, biological or clinical laboratory science from an accredited institution; and (h)(3)(ii) Have at least 1 year of laboratory training or experience, or both, in high complexity testing within the specialty of diagnostic immunology; or (h)(4)(i) Have earned a master's degree in a chemical, physical, biological or clinical laboratory science or medical technology from an accredited institution; and (h)(4)(ii) Have at least 2 years of laboratory training or experience, or both, in high complexity testing for the specialty of diagnostic immunology; or (h)(5)(i) Have earned a bachelor's degree in a chemical, physical or biological science or medical technology from an accredited institution; and (h)(5)(ii) Have at least 4 years of laboratory training or experience, or both, in high complexity testing for the specialty of diagnostic immunology. (i) If the requirements of paragraph (b) of this section are not met and the laboratory performs tests in the specialty of chemistry, the individual functioning as the technical supervisor must-- (i)(1)(i) Be a doctor of medicine or doctor of osteopathy licensed to practice medicine or osteopathy in the State in which the laboratory is located; and (i)(1)(ii) Be certified in clinical pathology by the American Board of Pathology or the American Osteopathic Board of Pathology or possess qualifications that are equivalent to those required for such certification; or (i)(2)(i) Be a doctor of medicine, doctor of osteopathy, or doctor of podiatric medicine licensed to practice medicine, osteopathy, or podiatry in the State in which the laboratory is located; and (i)(2)(ii) Have at least 1 year of laboratory training or experience, or both, in high complexity testing for the specialty of chemistry; or (i)(3)(i) Have an earned doctoral degree in a chemical, physical, biological or clinical laboratory science from an accredited institution; and (i)(3)(ii) Have at least 1 year of laboratory training or -- 7 of 11 -- experience, or both, in high complexity testing within the specialty of chemistry; or (i) (4)(i) Have earned a master's degree in a chemical, physical, biological or clinical laboratory science or medical technology from an accredited institution; and (i)(4)(ii) Have at least 2 years of laboratory training or experience, or both, in high complexity testing for the specialty of chemistry; or (i)(5)(i) Have earned a bachelor's degree in a chemical, physical or biological science or medical technology from an accredited institution; and (i)(5)(ii) Have at least 4 years of laboratory training or experience, or both, in high complexity testing for the specialty of chemistry. (j) If the requirements of paragraph (b) of this section are not met and the laboratory performs tests in the specialty of hematology, the individual functioning as the technical supervisor must-- (j)(1)(i) Be a doctor of medicine or a doctor of osteopathy licensed to practice medicine or osteopathy in the State in which the laboratory is located; and (j)(1)(ii) Be certified in clinical pathology by the American Board of Pathology or the American Osteopathic Board of Pathology or possess qualifications that are equivalent to those required for such certification; or (j)(2)(i) Be a doctor of medicine, doctor of osteopathy, or doctor of podiatric medicine licensed to practice medicine, osteopathy, or podiatry in the State in which the laboratory is located; and (j)(2)(ii) Have at least one year of laboratory training or experience, or both, in high complexity testing for the specialty of hematology (for example, physicians certified either in hematology or hematology and medical oncology by the American Board of Internal Medicine); or (j) (3)(i) Have an earned doctoral degree in a chemical, physical, biological or clinical laboratory science from an accredited institution; and (j)(3)(ii) Have at least 1 year of laboratory training or experience, or both, in high complexity testing within the specialty of hematology; or (j)(4)(i) Have earned a master's degree in a chemical, physical, biological or clinical laboratory science or medical technology from an accredited institution; and (j)(4)(ii) Have at least 2 years of laboratory training or experience, or both, in high complexity testing for the specialty of hematology; or (j) (5)(i) Have earned a bachelor's degree in a chemical, physical or biological science or medical technology from an accredited institution; and (j)(5)(ii) Have at least 4 years of laboratory training or experience, or both, in high complexity testing for the specialty of hematology. (k)(1) If the requirements of paragraph (b) of this section are not met and the laboratory performs tests in the subspecialty of cytology, the individual functioning as the technical supervisor must-- (k)(1)(i) Be a doctor of medicine or a doctor of osteopathy licensed to practice medicine or osteopathy in the State in which the laboratory is located; and (k)(1)(ii) Meet one of the following requirements-- (k)(1)(ii)(A) Be certified in anatomic pathology by the American Board of Pathology or the American Osteopathic Board of Pathology or possess qualifications that are equivalent to those required for such certification; or (k)(1)(ii) (B) Be certified by the American Society of Cytology to practice cytopathology or possess qualifications that are equivalent to those required for such certification; (l) If the requirements of paragraph (b) of this section are not met and the laboratory performs tests in the subspecialty of histopathology, the individual functioning as the technical supervisor must-- (l)(1) Meet one of the following requirements: (l)(1)(i)(A) Be a doctor of medicine or a doctor of osteopathy licensed to practice medicine or osteopathy in the State in which the laboratory is located; and (l)(1)(i)(B) Be certified in anatomic pathology by the American Board of Pathology or the American Osteopathic Board of Pathology or possess qualifications that are equivalent to those required for such certification; (l)(1)(ii) An individual qualified under 493.1449(b) or paragraph (l)(1) of this section may delegate to an individual who is a resident in a training program leading to certification specified in paragraph (b) or (l)(1)(i)(B) of this section, the responsibility for examination and interpretation of histopathology specimens. (l)(2) For tests in dermatopathology, meet one of the following requirements: (l)(2)(i)(A) Be a doctor of medicine or doctor of osteopathy licensed to -- 8 of 11 -- practice medicine or osteopathy in the State in which the laboratory is located and-- (l) (2)(i)(B) Meet one of the following requirements: (l)(2)(i)(B)(1) Be certified in anatomic pathology by the American Board of Pathology or the American Osteopathic Board of Pathology or possess qualifications that are equivalent to those required for such certification; or (l)(2)(i)(B)(2) Be certified in dermatopathology by the American Board of Dermatology and the American Board of Pathology or possess qualifications that are equivalent to those required for such certification; or (l)(2)(i)(B) (3) Be certified in dermatology by the American Board of Dermatology or possess qualifications that are equivalent to those required for such certification; or (l)(2)(ii) An individual qualified under 493.1449(b) or paragraph (l)(2)(i) of this section may delegate to an individual who is a resident in a training program leading to certification specified in paragraphs (b) or (l)(2)(i)(B) of this section, the responsibility for examination and interpretation of dermatopathology specimens. (l) (3) For tests in ophthalmic pathology, meet one of the following requirements: (l)(3)(i) (A) Be a doctor of medicine or doctor of osteopathy licensed to practice medicine or osteopathy in the State in which the laboratory is located and-- (l)(3)(i)(B) Must meet one of the following requirements: (l)(3)(i)(B)(1) Be certified in anatomic pathology by the American Board of Pathology or the American Osteopathic Board of Pathology or possess qualifications that are equivalent to those required for such certification; or (l)(3)(i)(B)(2) Be certified by the American Board of Ophthalmology or possess qualifications that are equivalent to those required for such certification and have successfully completed at least 1 year of formal post-residency fellowship training in ophthalmic pathology; or (l)(3)(ii) An individual qualified under 493.1449(b) or paragraph (1)(3)(i) of this section may delegate to an individual who is a resident in a training program leading to certification specified in paragraphs (b) or (1)(3)(i)(B) of this section, the responsibility for examination and interpretation of ophthalmic specimens; or (m) If the requirements of paragraph (b) of this section are not met and the laboratory performs tests in the subspecialty of oral pathology, the individual functioning as the technical supervisor must meet one of the following requirements: (m)(1)(i) Be a doctor of medicine or a doctor of osteopathy licensed to practice medicine or osteopathy in the State in which the laboratory is located and-- (m)(1)(ii) Be certified in anatomic pathology by the American Board of Pathology or the American Osteopathic Board of Pathology or possess qualifications that are equivalent to those required for such certification; or (m)(2) Be certified in oral pathology by the American Board of Oral Pathology or possess qualifications for such certification; or (m)(3) An individual qualified under 493.1449(b) or paragraph (m)(1) or (2) of this section may delegate to an individual who is a resident in a training program leading to certification specified in paragraphs (b) or (m)(1) or (2) of this section, the responsibility for examination and interpretation of oral pathology specimens. (n) If the requirements of paragraph (b) of this section are not met and the laboratory performs tests in the specialty of radiobioassay, the individual functioning as the technical supervisor must-- (n)(1)(i) Be a doctor of medicine or a doctor of osteopathy licensed to practice medicine or osteopathy in the State in which the laboratory is located; and (n)(1)(ii) Be certified in clinical pathology by the American Board of Pathology or the American Osteopathic Board of Pathology or possess qualifications that are equivalent to those required for such certification; or (n)(2)(i) Be a doctor of medicine, doctor of osteopathy, or doctor of podiatric medicine licensed to practice medicine, osteopathy, or podiatry in the State in which the laboratory is located; and (n)(2)(ii) Have at least 1 year of laboratory training or experience, or both, in high complexity testing for the specialty of radiobioassay; or (n)(3)(i) Have an earned doctoral degree in a chemical, physical, biological or clinical laboratory science from an accredited institution; and (n)(3)(ii) Have at least 1 year of laboratory training or experience, or both, in high complexity testing within the -- 9 of 11 -- specialty of radiobioassay; or (n)(4)(i) Have earned a master's degree in a chemical, physical, biological or clinical laboratory science or medical technology from an accredited institution; and (n)(4)(ii) Have at least 2 years of laboratory training or experience, or both, in high complexity testing for the specialty of radiobioassay; or (n)(5)(i) Have earned a bachelor's degree in a chemical, physical or biological science or medical technology from an accredited institution; and (n)(5)(ii) Have at least 4 years of laboratory training or experience, or both, in high complexity testing for the specialty of radiobioassay. (o) If the laboratory performs tests in the specialty of histocompatibility, the individual functioning as the technical supervisor must either-- (o)(1)(i) Be a doctor of medicine, doctor of osteopathy, or doctor of podiatric medicine licensed to practice medicine, osteopathy, or podiatry in the State in which the laboratory is located; and (o)(1)(ii) Have training or experience that meets one of the following requirements: (o)(1)(ii)(A) Have 4 years of laboratory training or experience, or both, within the specialty of histocompatibility; or (o)(1)(ii)(B)(1) Have 2 years of laboratory training or experience, or both, in the specialty of general immunology; and (o)(1)(ii)(B)(2) Have 2 years of laboratory training or experience, or both, in the specialty of histocompatibility; or (o)(2)(i) Have an earned doctoral degree in a biological or clinical laboratory science from an accredited institution; and (o)(2)(ii) Have training or experience that meets one of the following requirements: (o) (2)(ii)(A) Have 4 years of laboratory training or experience, or both, within the specialty of histocompatibility; or (o)(2)(ii)(B)(1) Have 2 years of laboratory training or experience, or both, in the specialty of general immunology; and (o)(2)(ii)(B)(2) Have 2 years of laboratory training or experience, or both, in the specialty of histocompatibility. (p) If the laboratory performs tests in the specialty of clinical cytogenetics, the individual functioning as the technical supervisor must-- (p)(1)(i) Be a doctor of medicine, doctor of osteopathy, or doctor of podiatric medicine licensed to practice medicine, osteopathy, or podiatry in the State in which the laboratory is located; and (p)(1)(ii) Have 4 years of training or experience, or both, in genetics, 2 of which have been in clinical cytogenetics; or (p)(2)(i) Hold an earned doctoral degree in a biological science, including biochemistry, or clinical laboratory science from an accredited institution; and (p)(2)(ii) Have 4 years of training or experience, or both, in genetics, 2 of which have been in clinical cytogenetics. (q) If the requirements of paragraph (b) of this section are not met and the laboratory performs tests in the specialty of immunohematology, the individual functioning as the technical supervisor must-- (q)(1)(i) Be a doctor of medicine or a doctor of osteopathy licensed to practice medicine or osteopathy in the State in which the laboratory is located; and (q)(1)(ii) Be certified in clinical pathology by the American Board of Pathology or the American Osteopathic Board of Pathology or possess qualifications that are equivalent to those required for such certification; or (q)(2)(i) Be a doctor of medicine, doctor of osteopathy, or doctor of podiatric medicine licensed to practice medicine, osteopathy, or podiatry in the State in which the laboratory is located; and (q)(2)(ii) Have at least one year of laboratory training or experience, or both, in high complexity testing for the specialty of immunohematology. Note: The technical supervisor requirements for "laboratory training or experience, or both'' in each specialty or subspecialty may be acquired concurrently in more than one of the specialties or subspecialties of service. For example, an individual, who has a doctoral degree in chemistry and additionally has documentation of 1 year of laboratory experience working concurrently in high complexity testing in the specialties of microbiology and chemistry and 6 months of that work experience included high complexity testing in bacteriology, mycology, and mycobacteriology, would qualify as the technical supervisor for the specialty of chemistry and the subspecialties of bacteriology, mycology, and mycobacteriology. -- 10 of 11 -- This STANDARD is not met as evidenced by: Based on a review of records and interview with the laboratory manager and laboratory supervisor, the technical supervisor failed to ensure the individual who performed the duties and responsibilities of the technical supervisor met the qualifications to perform a semi-annual competency assessment for one of one testing person. Findings include: (1) On 06/07/2022, competency assessment records were reviewed for one testing person (testing person #8) who had been hired to perform high complexity testing (ABO/Rh, Antibody Screen and Compatibility testing) since the previous recertification survey; (2) The records revealed the semi-annual competency for the testing person had been performed by an individual who did not meet the regulatory qualification requirements of the technical supervisor: (a) Testing Person #8 - The 05/10/2021 semi-annual competency had been performed by the laboratory manager (this person had earned a bachelor's degree in science). (3) The findings were reviewed with the laboratory manager and laboratory supervisor. Both stated on 06/07/2022 at 03:15 pm, the semi-annual evaluation had not been performed by an individual who met the qualifications of a technical supervisor as shown above. -- 11 of 11 --

Summary Statement of Deficiencies D0000 The recertification survey was performed on 10/19,20,21/2020 The laboratory was found in compliance with standard-level deficiencies cited. The findings were reviewed with the laboratory director, director of quality, chief executive officer, human resource director, laboratory manager, and testing person #3 during an exit conference performed at the conclusion of the survey. 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 manager/technical consultant, the laboratory failed to follow the manufacturer's instructions for performing ACT testing for 2 of 6 patients. Findings include: (1) On 10/19/2020 at 11:30 am, the laboratory manager/technical consultant stated to surveyor #1 ACT (Activated Clotting Time) testing was performed on the iSTAT 1 analyzer, using the ACT Celite test cartridge; (2) On 10/20/2020, surveyor #2 reviewed the manufacturer's instructions for the assay. Under the heading "Time to Test" the instructions stated, "The sample must be immediately dispensed into the sample well of the cartridge and the cartridge must be inserted immediately into an analyzer"; (3) Survyeor #2 reviewed 6 patient ACT reports from 08/03/2020 through 09/24/2020 which confirmed the laboratory had not followed the manufacturer's instructions for testing the sample immediately for 2 of 6 patients as follows: (a) Patient tested on 08/11/2020 - The specimen had been collected at 01:31 pm and received at 01:51 pm (10 minutes); (b) Patient tested on 09/24/2020 - The specimen had been collected at 10:39 and received at 11:55 (76 minutes). (4) Surveyor #2 Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 7 -- reviewed the records with the laboratory manager/technical consultant, who stated on 10/20/2020 at 01:05 pm, the manufacturer's instructions had not been followed for the two patients above. 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 manager, the laboratory failed to demonstrate the reportable range for 1 of 1 new test systems. Findings include: (1) On 10/19/2020 at 11:30 am, the laboratory manager/technical consultant stated to surveyor #1 the laboratory began performing ACT (Activated Clotting Time) testing using the iSTAT 1 analyzer on 04/13/2019; (2) Surveyor #2 reviewed the performance specification records and could not locate evidence the reportable range had been demonstrated; (3) On 10/20/2020, surveyor #2 reviewed the records with the laboratory manager/technical consultant and asked if there was documentation to prove the reportable range had been demonstrated for the new test system. The laboratory manager/technical consultant stated on 10/2020 at 01:05 pm, there was no documentation to prove the reportable range had been demonstrated. D5429 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(a)(1) For unmodified manufacturer's equipment, instruments, or test systems, the laboratory must perform and document maintenance as defined by the manufacturer and with at least the frequency specified by the manufacturer. This STANDARD is not met as evidenced by: Based on a review of records, manufacturer's instructions, and interview with the laboratory manager/technical consultant, the laboratory failed to follow the manufacturer's instructions for performing maintenance procedures for 2 of 2 analyzers. Findings include: (1) On 10/19/2020 at 11:30 the laboratory manager /technical consultant stated the following to surveyor #1: (a) *CMP, Ammonia, Amylase, Cholesterol, Creatine Kinase, HDL (High Density Lipoprotein), Triglycerides, Alcohol, Iron, Lactate, Lipase, Magnesium, Uric Acid, UIBC (Iron Binding Capacity), Acetaminophen, Direct Bilirubin, Digoxin, and Salicylic Acid testing were performed on the Beckman Coulter AU 480 analyzer, denoted by the laboratory as Righty; (b) *CMP, Ammonia, Amylase, Cholesterol, Creatine Kinase, HDL (High Density Lipoprotein), Triglycerides, Lactate, Lipase, Magnesium, Uric Acid, Carbamazepine, Direct Bilirubin, Gentamicin, Phenytoin, Vancomycin,Valproic Acid,*Urine Drug Screen, CSF (Cerebral Spinal Fluid) Glucose, CSF Total Protein testing were performed on the Beckman Coulter AU 480 analyzer, denoted by the laboratory as Lefty. (2) On 10/20/2020, surveyor #2 reviewed the manufacturer's -- 2 of 7 -- maintenance requirements as stated on the manufacturer's maintenance logs. The following was required every three months: (a) Replace the Roller Tubes for MID Solution dispense and Mixture Aspiration (b) Replace the Pinch Valve Tubing (3) Surveyor #2 then reviewed maintenance records for both analyzers for 13 months (September 2019 through September 2020). The every three month maintenance had not been documented as performed as follows: (a) Righty - Between 11/04/2019 and 08/04/2020 (b) Lefty - Between 11/04/2019 and 08/04/2020 (4) Surveyor #2 reviewed the records with the laboratory manager/technical consultant, who stated on 10/20 /2020 at 04:03 pm, the above maintenance had not been documented as performed. *Comprehensive Metabolic Panel (CMP) - Albumin, Alkaline Phosphatase, ALT (Alanine Amino Transferase), AST (Aspartate Amino Transferase), BUN (Blood Urea Nitrogen), Calcium, Chloride, CO2, Creatinine, Glucose, Potassium, Sodium, Total Bilirubin and Total Protein *Urine Drug Screen - Amphetamine, Barbiturate, Benzodiazepine, Cannabinoid, Cocaine, Ecstasy, Methadone, Opiate, Phencyclidine D5435 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(b)(2) For equipment, instruments, or test systems developed in-house, commercially available and modified by the laboratory, or maintenance and function check protocols are not provided by the manufacturer, the laboratory must: (i) Define a function check protocol that ensures equipment, instrument, and test system performance that is necessary for accurate and reliable test results and test result reporting. (ii) Perform and document the function checks, including background or baseline checks, specified in paragraph (b)(2)(i) of this section. Function checks must be within the laboratory's established limits before patient testing is conducted. This STANDARD is not met as evidenced by: Based on a review of records, policies and procedures, and interview with the laboratory manager/technical consultant, the laboratory failed to ensure the urine, blood bank, and coagulation centrifuges were functioning properly. Findings include: URINE CENTRIFUGE (1) On 10/21/2020 at 10:00 am, the laboratory manager /technical consultant stated to surveyor #1 urine sediment examinations were performed in the laboratory. The specimens were processed in the Clay Adams Dynac centrifuge at a speed of 1500 rpm (revolutions per minute) for 5 minutes; (2) Surveyor #1 reviewed the function check policy which required speed and timer checks be performed on the centrifuge annually; (3) Surveyor #1 reviewed the centrifuge maintenance records for 2019 and to date in 2020, with the following identified: (a) There was no documentation to prove the centrifuge speed and timer had been checked in 2019; (b) Although the speed had been checked at 1414 rpm on 10/19 /2020, the timer check had been documented as "OK" and did not indicate that the timer was checked at 5 minutes, which was the time the laboratory processed urines. (4) Surveyor #1 reviewed the findings with the laboratory manager/technical consultant, who stated on 10/21/2020 at 2:30 pm, the centrifuge function checks had not been performed as indicated above. BLOODBANK CENTRIFUGE (1) On 10/21 /2020 at 10:15 am, the laboratory manager/technical consultant stated to surveyor #1 the laboratory used the Ortho MTS centrifuge for performing Antibody Screen testing at a speed of 895 +/-25 rpm for 10 minutes; (2) Surveyor #1 reviewed the function check policy which required speed and timer checks be performed on the centrifuge annually; (3) Surveyor #1 reviewed the centrifuge maintenance records for 2019 and to date in 2020, with the following identified: (a) There was no documentation to prove the centrifuge speed and timer had been checked in 2019; (b) Although the -- 3 of 7 -- speed had been checked at 923 rpm on 10/19/2020, the timer check had been documented as "OK" and did not indicate that the timer was checked at 10 minutes, which was the time the laboratory processed specimens. (4) Surveyor #1 reviewed the findings with the laboratory manager/technical consultant , who stated on 10/21/2020 at 3:00 pm, the centrifuge function checks had not been performed as indicated above. COAGULATION CENTRIFUGES (1) On 10/21/2020 at 10:30, the laboratory manager/technical consultant stated to surveyor #1 the following centrifuges were used to process patient specimens for PT/INR (Prothrombin Time/International Normalized Ratio) and PTT (Partial Thromboplastin Time) testing: (a) Heraeus Medical Megafuge - Specimens processed at a speed of 3600 rpm for 10 minutes; (b) Hettich Universal centrifuge - Specimens processed at a speed of 4500 rpm for 10 minutes; (c) Horizon Mini B centrifuge - Specimens processed at a speed of 3600 rpm for 10 minutes. (2) Surveyor #1 reviewed the function check policy which required speed and timer checks be performed on the centrifuge annually; (3) Surveyor #1 reviewed the centrifuge maintenance records for 2019 and to date in 2020, with the following identified: (a) There was no documentation to prove the speed and timer of the centrifuges had been checked in 2019; (b) Checks Performed 10/19/2020: (i) Heraeus Medical Megafuge - Although the speed had been checked at 3636 rpm, the timer check had been documented as "OK" and did not indicate that the timer was checked at 10 minutes, which was the time the laboratory processed specimens; (ii) Hettich Universal centrifuge - Although the speed had been checked at 4545 rpm, the timer check had been documented as "OK" and did not indicate that the timer was checked at 10 minutes, which was the time the laboratory processed specimens; (iii) Horizon 642 B centrifuge - Although the speed had been checked at 3400 rpm, the timer check had been documented as "OK" and did not indicate that the timer was checked at 10 minutes, which was the time the laboratory processed specimens. (4) Surveyor #1 reviewed the findings with the laboratory manager/technical consultant , who stated on 10/21/2020 at 3:10 pm, the centrifuge function checks had not been performed as indicated above. 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 a review of records and interview with the laboratory manager/technical consultant, the laboratory failed to perform a negative and positive control material 1 of 4 days of patient Mononucleosis testing. Findings include: (1) On 10/19/2020 at 11: 30 am, the laboratory manager/technical consultant stated the following to surveyor #1: (a) The laboratory began using the Cardinal Health Mono II Rapid test kit and serum or plasma samples to perform Mononucleosis testing on 04/16/2020; (b) Negative and Positive QC (Quality Control) materials were performed each day of patient testing. (2) Surveyor #2 reviewed QC and patient testing records from 08/05 /2020 through 10/13/2020. The review showed negative and positive QC materials had not been performed 1 of 4 days of patient testing reviewed. The specific day was -- 4 of 7 -- 09/24/2020; (4) Surveyor #2 reviewed the records with the laboratory manager /technical consultant, who stated negative and positive QC materials had not been performed each day of patient testing. D5465 CONTROL PROCEDURES CFR(s): 493.1256(d)(8)(g) Unless CMS Approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub. 7), that provides equivalent quality testing, the laboratory must-- Test control materials in the same manner as patient specimens. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on a review of records, manufacturer's instructions, and interview with the laboratoratory manager/technical consultant, the laboratory failed to ensure quality control was tested in the same manner as patient specimens for 36 of 36 days of negative AHG quality control testing. Findings include: (1) On 10/19/2020 at 11:30 am, the laboratory manager/technical consultant stated the following to surveyor #1: (a) Antibody Screen testing, to detect unexpected antibodies in patient plasma, was performed using the Ortho AHG (Anti Human Globulin) Anti-IgG gel card and 0.8% Selectogen Reagent Red Blood Cells I and II; (b) Positive and Negative QC (Quality Control) testing were performed each day for the AHG Anti-IgG gel card. (2) On 10 /20/2020, surveyor #2 reviewed QC records for 36 days of testing performed from 07 /17/2020 through 07/31/2020; and 09/03/2020 through 09/30/2020. The QC documentation for the negative AHG QC consisted of Selectogen Reagent Red Blood Cells I or II added to the AHG well of the gel card. There was no documenation a plasma based material had been added to the well in addition to the Selectogen Reagent Red Blood Cell I or II; (3) Surveyor #2 asked the laboratory manager /technical consultant to explain what was added to the wells of the gel card when a patient Antibody Screen was performed. The laboratory manager/technical consultant stated on 10/20/2020 at 02:30 pm patient Antibody Screen testing consisted of patient plasma and 0.8% Selectogen I or II added to the AHG gel card; (4) Surveyor #2 reviewed the QC records with the laboratory manager/technical consultant and asked if a plasma based material was utilized in the procedure when a negative AHG control was performed. The laboratory manager/technical consultant stated on 10/20/2020 at 02:45 pm, the negative AHG QC consisted of 0.8% Selectogen I or II added to the AHG gel card and did not include a plasma based material. Therefore, surveyor #2 determined QC had not been tested in the same manner as patient specimens for the following 36 days of QC testing: (a) July 2020 - days 17,18,19,20,28,29,30,31 (b) September 2020 - days 03,04,05,06,07,08,09,10,11,12,13,14,15,16,17,18,19,20,21,22,23,24,25,26,27,28,29,30 NOTE: The interpretive guidelines at D5465 (493.1256) state "Control materials of a similar matrix to that of patient specimens should be utilized, if available, and the control materials must be treated in the same manner as patient specimens and go through all analytic test phases." D5543 HEMATOLOGY CFR(s): 493.1269(a)(d) (a) For manual cell counts performed using a hemocytometer-- (a)(1) One control material must be tested each 8 hours of operation; and (a)(2) Patient specimens and control materials must be tested in duplicate. (d) The laboratory must document all -- 5 of 7 -- control procedures performed, as specified in this section. This STANDARD is not met as evidenced by: Based on a review of records, and interview with the laboratory manager/technical consultant, the laboratory failed to test one control material each 8 hours of operation when performing manual counts using a hemacytometer for 1 of 14 days. Findings include (1) On 10/19/2020 at 11:30 am, the laboratory manager/technical consultant stated to surveyor #1 spinal fluid cell counts for White Blood Cells and Red Blood Cells were performed in the laboratory using a hemacytometer; (2) Surveyor #1 reviewed the patient and quality control log for patient testing performed from 04/22 /2019 through 09/30/2020. There was no evidence a control material had been performed 1 of 14 days of patient testing. The specific day was 07/07/2019; (3) Surveyor #1 reviewed the records with the laboratory manager/technical consultant, who stated on 10/19/2020 at 1:00 pm, there was no evidence that a control had been tested on 07/07/2019. D5555 IMMUNOHEMATOLOGY CFR(s): 493.1271(c)(f) (c) Blood and blood products storage. Blood and Blood products must be stored under appropriate conditions that include an adequate temperature alarm system that is regularly inspected. (c)(1) An audible alarm system must monitor proper blood and blood product storage temperature over a 24-hour period. (c)(2) Inspections of the alarm system must be documented. (f) Documentation. The laboratory must document all control procedures performed, as specified in this section. This STANDARD is not met as evidenced by: Based on a review of records, policies and procedures,and interview with the laboratory manager, the laboratory failed to ensure that blood products were stored under appropriate conditions for 1 of 8 alarm checks. Findings include: (1) On 10/19 /2020 at 11:30 am, the laboratory manager/technical consultant stated to surveyor #1 units of packed red blood cells, which were stored in the blood bank refrigerator, were used for patient transfusions; (2) Surveyor #1 reviewed the policy titled, "Blood Bank Refrigerator Alarm Check" which stated, "High and Low temperatures of activation should be checked quarterly." (3) Surveyor #1 reviewed Blood Bank Refrigerator Alarm Check records between 01/25/2019 through 10/21/2020 (last day of the survey) and identified that quartely alarm checks had not been performed between 06/29/2020 and 10/21/2020; (4) Surveyor #1 reviewed the records with the laboratory manager /technical consultant who stated on 10/21/2020 at 10:45 the Blood Bank Refrigerator Alarm Checks had not been performed for as stated above. D5559 IMMUNOHEMATOLOGY CFR(s): 493.1271(e)(f) (e) Investigation of transfusion reactions. (e)(1) According to its established procedures, the laboratory that performs compatibility testing, or issues blood or blood products, must promptly investigate all transfusion reactions occurring in facilities for which it has investigational responsibility and make recommendations to the medical staff regarding improvements in transfusion procedures. (e)(2) The laboratory must document, as applicable, that all necessary remedial actions are taken to prevent recurrences of transfusion reactions and that all policies and procedures are reviewed -- 6 of 7 -- to assure they are adequate to ensure the safety of individuals being transfused. (f) Documentation. The laboratory must document all control procedures performed, as specified in this section. This STANDARD is not met as evidenced by: Based on a review of written policies and interview with the laboratory manager /technical consultant, the laboratory failed to ensure that written policies provided safety for individuals being transfused for 1 of 5 packed red blood cell units. Findings include: (1) On 10/19/2020 at 11:30 am, the laboratory manager/technical consultant stated to surveyor #1 units of packed red blood cells, which were stored in the blood bank refrigerator, were used for patient transfusions; (2) Surveyor #2 reviewed the Nursing Policy and Procedure regarding blood administration. The policy titled, "Blood Product Administration" stated the following: (a) "7. Obtain and document patient's temperature and vital signs (not more than 15 minutes) prior to administration, 15 minutes after initiation, then hourly until transfused. A final set of vitals signs will be obtained within 15 minutes after completion of transfusion." (3) Surveyor #2 reviewed transfusions on 01/03/2020, 02/03/2020, 02/25/2020, and 04/28 /2020 (a total of 5 units) and identified the following: (a) Stop time of the infusion (1) Patient # 0000257005 - Transfused with 1 unit of PRBCs (unit# W204920455535) on 02/25/2020. There was no documentation indicating the stop time of the infusion. (4) The above transfusion record was reviewed with the laboratory manager/technical consultant on 10/20/2020 who stated at 03:35 pm the record did not follow the blood administration policy as indicated above. -- 7 of 7 --

Summary Statement of Deficiencies D0000 The survey was performed on 05/07,08,09,10/18 The findings were reviewed with Regional Medical Laboratory support person, Regional Medical Laboratory executive director, testing person #9, testing person #11, director of quality, laboratory manager /technical consultant, human resource director, chief nursing officer/chief operating officer and chief executive officer of the hospital, during an exit conference performed at the conclusion of the survey. The laboratory was found out of compliance with the following CLIA regulations: 493.1409; D6033: Technical Consultant 493.1201; D5002: Bacteriology 493.1441; D6076: High Complexity Laboratory Director D5002 BACTERIOLOGY CFR(s): 493.1201 If the laboratory provides services in the subspecialty of Bacteriology, the laboratory must meet the requirements specified in 493.1230 through 493.1256, 493.1261, and 493.1281 through 493.1299. This CONDITION is not met as evidenced by: Based on a review of records, policies and procedures, and interview with the laboratory manager/technical consultant, the laboratory failed to ensure the requirements were met for the subspecialty of Bacteriology. Findings include: (1) The laboratory failed to have written policies and procedures for assessing employee competency. Refer to D5209; (2) The laboratory failed to check each batch of blood culture media for its ability to support growth. Refer to D5477. 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, 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 -- consultant competency. This STANDARD is not met as evidenced by: Based on a review of policies and procedures and interview with the laboratory manager/technical consultant, the laboratory failed to have written policies and procedures for assessing employee competency. Findings include: (1) On the first day of the survey, the surveyor reviewed the laboratory's policies and procedures. A policy that explained how employees were assessed for competency could not be located; (2) The surveyor asked the laboratory manager/technical consultant if a competency policy was available for review. The laboratory manager/technical consultant stated a policy had not been written. NOTE: For non-waived testing, the regulations require initial training, a semiannual evaluation during the first year, and an annual evaluation thereafter for each testing person for ensuring competency. The policy/procedure for evaluating competency must include, but is not limited to: *Direct observation of routine patient test performance, including patient preparation, if applicable, specimen handling, processing and testing *Monitoring the recording and reporting of test results *Review of intermediate test results or worksheets, quality control records, proficiency testing results, and preventive maintenance records *Direct observation of performance of instrument maintenance and function checks *Assessment of test performance through testing previously analyzed specimens, internal blind testing samples or external proficiency testing samples *Assessment of problem solving skills 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 laboratory manager/technical consultant, the laboratory failed to follow the manufacturer's instructions for method verification between a current and new coagulation analyzer. Findings include: (1) On the first day of the survey, the laboratory manager/technical consultant stated to the surveyor that the laboratory began using the Sysmex CA-660 on 08/04/17 for the following: (a) D-dimer testing (2) On the third day of the survey, the surveyor reviewed the manufacturer's instructions for method verification that defined the relationship between a previous system (Sysmex CA 560) and a new system; (a) "Best results for method verification studies require a minimum of 40 patient samples (20 normal and 20 abnormal). Range should be from below to substantially above the expected reference range. Studies should be performed over several days." (3) The surveyor reviewed the method verification records and identified the laboratory only used 33 patients instead of 40 patients as required by the manufacturer; (4) The surveyor reviewed the records with the laboratory manager/technical consultant who stated 40 patients had not been used to perform the method verification. D5413 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(b) -- 2 of 10 -- The laboratory must define criteria for those conditions that are essential for proper storage of reagents and specimens, accurate and reliable test system operation, and test result reporting. The criteria must be consistent with the manufacturer's instructions, if provided. These conditions must be monitored and documented and, if applicable, include the following: (1) Water quality. (2) Temperature. (3) Humidity. (4) Protection of equipment and instruments from fluctuations and interruptions in electrical current that adversely affect patient test results and test reports. This STANDARD is not met as evidenced by: Based on a review of records, manufacturer's instructions, and interview with the laboratory manager/technical consultant, the laboratory failed to ensure analyzers were stored as required by the manufacturer. Findings include: HEMATOLOGY DEPARTMENT (1) On the first day of the survey, the laboratory manager/technical consultant stated the following to the surveyor: (a) CBC (Complete Blood Count) testing was performed on the Sysmex 1000i analyzer; (b) PT (Prothrombin Time)/INR (International Normalized Ratio), PTT (Partial Prothromboplastin Time) and D-Dimer testing was performed on the Sysmex CA-600 Series analyzer; (c) (ESR) Erythrocyte Sedimentation Rate testing was performed on the Excyte Mini Automated EST analyzer. (2) On the second day of the survey, the surveyor reviewed the manufacturer's environmental requirements for the analyzers. The manufacturer required the relative humidity be maintained within the range of 30-85%; (3) The surveyor reviewed laboratory humidity records from January 2018 through March 2018 which verified the humidity readings were less than 30% for 3 of 3 months as follows: (a) January - 8 of 31 humidity readings were documented as less than 30% (days 1,2,3,4,5,16,17,18); (b) February 2018 - 1 of 28 humidity readings was documented as less than 30% (day 13); (c) March - 2 of 31 humidity readings were documented as less than 30% (days 8,14). (4) The surveyor reviewed the records with the laboratory manager/technical consultant who stated the humidity of the laboratory had been maintained below 30% as indicated above. PATHOLOGY DEPARTMENT (1) On the first day of the survey, the laboratory manager/technical consultant stated the following to the surveyor: (a) Frozen tissue samples were processed using the Thermo Scientific Cryostat Microm HM500. (2) On the second day of the survey, the surveyor reviewed the manufacturer's environmental requirements for the analyzer. The manufacturer required the relative maximum humidity of 60%; (3) The surveyor reviewed records from January 2018 through March 2018 which verified humidity readings were not documented. There was no evidence that the humidity of the laboratory had been monitored; (4) The surveyor asked the laboratory manager /technical consultant if the humidity in the Pathology department was being monitored. The laboratory manager/technical consultant stated it was not monitored. 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. -- 3 of 10 -- This STANDARD is not met as evidenced by: Based on a review of records, policy and procedures, and interview with the laboratory manager/technical consultant, the laboratory failed to verify the reportable range for a new test method. Findings include: (1) At the beginning of the survey, the laboratory manager/technical consultant stated to the surveyor the Excyte Mini-ESR analyzer was approved to perform ESR (Erythrocyte Sedimentation Rate) testing on 10 /31/17; (2) The surveyor then reviewed the installation records for the analyzer. The records indicated the laboratory had verified a reportable range of 2-74 mm/hr, however, they were utilizing the manufacturer's AMR (Analytical Measurement Range) of 1-140 mm/hr as the reportable range for ESR testing, as reflected in the laboratory policy and procedure; (3) The surveyor asked the laboratory manager /technical consultant if there was additional documentation to prove the reportable range had been verified beyond 2-74 mm/hr. The laboratory manager/technical consultant stated the reportable range had not been verified beyond 2-74 mm/hr. D5429 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(a)(1) For unmodified manufacturer's equipment, instruments, or test systems, the laboratory must perform and document maintenance as defined by the manufacturer and with at least the frequency specified by the manufacturer. This STANDARD is not met as evidenced by: Based on a review of records, manufacturer's instructions, and interview with the laboratory manager/technical consultant, the laboratory failed to follow the manufacturer's instructions for performing maintenance procedures. Findings include: BECKMAN COULTER AU 480 (1) At the beginning of the survey, the laboratory manager/technical consultant stated the following to the surveyor: (a) *CMP, Ammonia, Amylase, Cholesterol, Creatine Kinase, HDL (High Density Lipoprotein), Triglycerides, Ethyl Alcohol, Iron, Lactate, Lipase, Magnesium, Uric Acid, UIBC (Urine Iron Binding Capacity), Acetaminophen, Carbamazepine, Direct Bilirubin, Gentamicin, Phenytoin, Salicylic Acid, Vancomycin and Valproic Acid testing were performed on the Beckman Coulter AU 480 analyzer, denoted as Righty; (b) *CMP, Ammonia, Amylase, Cholesterol, Creatine Kinase, HDL (High Density Lipoprotein), Triglycerides, Ethyl Alcohol, Iron, Lactate, Lipase, Magnesium, Uric Acid, UIBC (Urine Iron Binding Capacity), Acetaminophen, Carbamazepine, Direct Bilirubin, Gentamicin, Phenytoin, Salicylic Acid, Vancomycin,Valproic Acid,*Urine Drug Screen, CSF (Cerebral Spinal Fluid) Glucose, CSF Total Protein testing were performed on the Beckman Coulter AU 480 analyzer, denoted as Lefty; (2) On the second day of the survey, the surveyor reviewed the manufacturer's maintenance requirements as stated on the manufacturer's maintenance logs. The requirements for weekly maintenance were as follows: (a) Weekly (i) Clean the Sample Probe and Mix Bars (ii) Perform a W2 (iii) Perform a Photocal (iv) Clean the Pre-dilution Bottle (v) Enhanced Cleaning of the ISE Electrode Line (3) The surveyor then reviewed maintenance records for both analyzers for 16 months (January 2017 through April 2018 ). The following weekly maintenance had not performed as follows: (a) Righty (i) Perform a W2, Perform a Photocal, Clean the Pre-dilution Bottle not documented as performed between: (aa) 09/04/17 and 09/16/17 (ii) Perform an Enhanced Cleaning of the ISE Electrode Line not documented as performed between: (aa) 02/20/17 and 03 /06/17 (bb) 05/31/17 and 06/12/17 (cc) 06/12/17 and 06/25/17 (dd) 08/07/17 and 08/20 /17 (ee) 08/20/17 and 09/04/17 (ff) 09/04/17 and 09/16/17 (b) Lefty (i) Perform a W2, -- 4 of 10 -- Perform a Photocal, Clean the Pre-dilution Bottle not documented as performed between: (aa) 09/05/17 and 09/17/17 (ii) Perform an Enhanced Cleaning of the ISE Electrode Line not documented as performed between: (aa) 01/27/17 and 02/08/17 (bb) 08/07/17 and 08/20/17 (4) The surveyor reviewed the records with the laboratory manager/technical consultant, who stated the maintenance had not been documented as performed as required. *Comprehensive Metabolic Panel (CMP) - Albumin, Alkaline Phosphatase, ALT (Alanine Amino Transferase), AST (Aspartate Amino Transferase), BUN (Blood Urea Nitrogen), Calcium, Chloride, CO2, Creatinine, Glucose, Potassium, Sodium, Total Bilirubin and Total Protein *UDS - Amphetamine, Barbiturate, Benzodiazepine, Cannabinoid, Cocaine, Ecstasy, Methadone, Opiate, Phencyclidine BECKMAN COULTER ACCESS 2 (1) At the beginning of the survey, the laboratory manager/technical consultant stated the following to the surveyor: (a) BNP (B-Type Natriuretic Peptide), Beta HCG (Human Chorionic Gonadatropin), CKMB, Troponin I and TSH (Thyroid Stimulating Hormone) testing were performed on the Beckman Coulter Access 2 analyzer. (2) On the second day of the survey, the surveyor reviewed the manufacturer's maintenance requirements as stated on the manufacturer's maintenance logs. The requirements for weekly maintenance were as follows: (a) Weekly - System Check Results (i) Washed RLU/%CV (ii) Substrate RLU /%CV (iii) Unwashed RLU/%CV (iv) Wash Efficiency PPM (v) Substrate Ratio (vi) Substrate: Washed Ratio (b) Weekly - Maintenance (i) Clean Instrument Exterior (ii) Inspect Liquid Waste Bottle (iii) Check Waste Filter Bottle (iv) Inspect/Clean Primary Probe (v) Replace/Clean Aspirate Probes (vi) Run Daily Maintenance (vii) Run System Check (3) The surveyor then reviewed maintenance records for the analyzers for 16 months (January 2017 through April 2018 ). The following was identified: (a) Weekly - System Check Results had not been documented as performed between: (i) 07/17/17 and 08/03/17 (ii) 08/20/17 and 09/01/17 (b) Weekly - Maintenance had not documented as performed between: (i) 08/20/17 and 09/01/17 (4) The surveyor reviewed the records with the laboratory manager/technical consultant, who stated the maintenance had not been documented as performed as required. SYSMEX XS 1000i (1) At the beginning of the survey, the laboratory manager/technical consultant stated the following to the surveyor: (a) CBC (Complete Blood Count) testing were performed on the Sysmex XS 1000i analyzer. (2) On the second day of the survey, the surveyor reviewed the manufacturer's maintenance requirements as stated on the manufacturer's maintenance logs. The requirements for weekly maintenance were as follows: (a) Weekly (i) Power Down IPU (ii) Perform Rinse (1,2000 cycles) (3) The surveyor then reviewed maintenance records for the analyzer for 16 months (January 2017 through April 2018 ). The following was identified: (a) Weekly - System Check Results had not been documented as performed between: (i) 05/11/17 and 05/25/17 (4) The surveyor reviewed the records with the laboratory manager/technical consultant, who stated the maintenance had not been documented as performed as required. SIEMENS CLINITEK ADVANTUS (1) At the beginning of the survey, the laboratory manager/technical consultant stated the following to the surveyor: (a) Routine Urinalysis testing was performed on the Clinitek Advantus analyzer. (2) On the second day of the survey, the surveyor reviewed the manufacturer's maintenance requirements as stated on the manufacturer's maintenance logs. The requirements for daily maintenance were as follows: (a) Daily (i) Clean Push Bar (ii) Clean Fixed Platform (iii) Clean Moving Table (iv) Clean Strip Holddown Plate (v) Clean Display Screen (3) The surveyor then reviewed maintenance records for the analyzers for 16 months (January 2017 through April 2018 ). The following was identified: (a) Daily maintenance had not been documented as performed between: (i) 12/09/17 and 12/11 /17 (ii) 12/24/17 and 12/26/17 (iii) 01/20/18 and 01/22/18 (iv) 02/16/18 and 02/18/18 (4) The surveyor reviewed the records with the laboratory manager/technical consultant, who stated the maintenance had not been documented as performed as -- 5 of 10 -- required. NOTE: D5429 was cited on the recertification survey performed on 04/12, 13,14/16 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 a review of records and interview with the laboratory manager/technical consultant, the laboratory failed to perform a negative and positive control each day of patient Serum HCG (Human Chorionic Gonadotropin) screen testing. Findings include: SERUM QUALITATIVE PREGNANCY TEST (1) On the first day of the survey, the laboratory manager/technical consultant stated to the surveyor the laboratory performed HCG screen testing using the Quidel HCG Combo test kit (a non-waived test kit); (2) On the second day of the survey, the surveyor reviewed records of patient testing from June 2017 through March 2018 and identified the following during 1 of the 10 months: (a) Negative and positive quality control testing had not been perform for 1 day of the review period: (a) Testing performed on 05/10 /17 (3) The surveyor reviewed the records with the laboratory manager/technical consultant, who believed the control testing had been performed, but had not been documented. IMMUNOHEMATOLOGY (1) On the first day of the survey, the laboratory manager/technical consultant stated to the surveyor the laboratory performed ABO/Rh and Antibody Screen testing using the Ortho MTS Gel System. (2) On the fourth day of the survey, the surveyor reviewed records of patient testing from January 2017 through May 2017 and identified the following during 3 of the 5 months: (a) Negative and positive quality control testing had not been perform for 3 days of the review period: (i) Testing performed on 02/24/17 (ii) Testing performed on 04/01/17 (iii) Testing performed on 05/12/17 (3) The surveyor reviewed the records with the laboratory manager/technical consultant, who believed the control testing had been performed, but had not been documented. D5477 CONTROL PROCEDURES CFR(s): 493.1256(e)(4)(g) (e) For reagent, media, and supply checks, the laboratory must do the following: (e) (4) Before, or concurrent with the initial use-- (e)(4)(i) Check each batch of media for sterility if sterility is required for testing; (e)(4)(ii) Check each batch of media for its ability to support growth and, as appropriate, select or inhibit specific organisms or produce a biochemical response; and (e)(4)(iii) Document the physical characteristics of the media when compromised and report any deterioration in the media to the manufacturer. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on a review of records and interview with the laboratory manager/technical consultant, the laboratory failed to check each batch of blood culture media for its ability to support growth. Findings include: (1) At the beginning of the survey, the -- 6 of 10 -- laboratory manager/technical consultant stated the following to the surveyor: (a) Automated microbial detection was performed using the bioMerieux BackT/Alert 3D system; (b) A gram stain was performed and reported on any positive growth; (c) Culture workup sent to the reference laboratory. (2) On the third day of the survey, the surveyor asked the laboratory manager/technical consultant if quality control (QC) checks (the ability to support growth or no growth) were performed on each batch of blood culture media, received into the laboratory from March 2018 through May 2018. The laboratory manager/technical consultant stated QC testing had not been performed. The surveyor then asked the laboratory manager/technical consultant if an IQCP (Individualized Quality Control Plan) had been developed for each type of blood culture media used in the laboratory. The supervisor stated an IQCP had not been developed. Therefore, the surveyor determined QC checks must be performed on each batch of blood culture media received, as appropriate; (4) Examples of patient testing using the media were: (a) Blood Culture Media: (i) Patient #1 - Verified on 03 /07/18 (ii) Patient #2 - Verified on 03/09/18 (iii) Patient #3 - Verified on 03/11/18 (iv) Patient #4 - Verified on 03/13/18 (v) Patient #5 - Verified on 03/16/18 (vi) Patient #6 - Verified on 03/21/18 (vii) Patient #7 - Verified on 03/29/18 (viii) Patient #8 - Verified on 04/01/18 (ix) Patient #9 - Verified on 04/03/18 (x) Patient #10 - Verified on 04/05/18 (xi) Patient #11 - Verified on 04/08/18 (xii) Patient #12 - Verified on 04 /16/18 (xiii) Patient #13 - Verified on 04/18/18 (xiv) Patient #14 - Verified on 04/24 /18 (xv) Patient #15 - Verified on 04/30/18 (xvi) Patient #16 - Verified on 05/06/18 (xvii) Patient #17 - Verified on 05/07/18 (xviii) Patient #18 - Verified on 05/08/18 (xix) Patient #19 - Verified on 05/08/18 D5805 TEST REPORT CFR(s): 493.1291(c) The test report must indicate the following: (c)(1) For positive patient identification, either the patient's name and identification number, or a unique patient identifier and identification number. (c)(2) The name and address of the laboratory location where the test was performed. (c)(3) The test report date. (c)(4) The test performed. (c)(5) Specimen source, when appropriate. (c)(6) The test result and, if applicable, the units of measurement or interpretation, or both. (c)(7) Any information regarding the condition and disposition of specimens that do not meet the laboratory's criteria for acceptability. This STANDARD is not met as evidenced by: Based on a review of patient test reports and interview with the laboratory manager /technical consultant, the laboratory failed to ensure patient test reports included the name of the laboratory. Findings include: (1) On the fourth day of the survey, the surveyor reviewed 2 patient test reports as follows: (a) Report #1 - ABO/Rh and Antibody Screen testing was performed with the results reported on 04/01/18; (b) Report #2 - Cord Blood testing was performed with the results reported on 02/24/18. (2) The surveyor identified that the name of the laboratory on the reports was "Hillcrest Hospital Claremore", which did not match the name on the CLIA certificate. The name on the CLIA certificate was "Regional Medical Lab-Hillcrest Hospital Claremore"; (3) The surveyor reviewed the reports with the laboratory manager/technical consultant, who stated the name on the reports did not match the name on the CLIA certificate. D6033 TECHNICAL CONSULTANT-MODERATE COMPEXITY CFR(s): 493.1409 -- 7 of 10 -- The laboratory must have a technical consultant who meets the qualification requirements of 493.1411 of this subpart and provides technical oversight in accordance with 493.1413 of this subpart. This CONDITION is not met as evidenced by: Based on a review of records and interview with the laboratory manager/technical consultant, the technical consultant failed to provide technical oversight in accordance with 493.1413 of this subpart. Findings include: (1) The technical consultant failed to ensure the individuals who performed the duties and responsibilities of the technical consultant, met the qualifications. Refer to D6035. D6035 TECHNICAL CONSULTANT QUALIFICATIONS CFR(s): 493.1411 (a) The technical consultant must be qualified and must possess a current license issued by the State in which the laboratory is located, if such licensing is required. (b) The technical consultant must-- (b)(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 (b)(1)(ii) Be certified in anatomic or clinical pathology, or both, 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 (b)(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 (b)(2)(ii) Have at least one year of laboratory training or experience, or both in non-waived testing, in the designated specialty or subspecialty areas of service for which the technical consultant is responsible (for example, physicians certified either in hematology or hematology and medical oncology by the American Board of Internal Medicine are qualified to serve as the technical consultant in hematology); or (b)(3)(i) Hold an earned doctoral or master's degree in a chemical, physical, biological or clinical laboratory science or medical technology from an accredited institution; and (b)(3)(ii) Have at least one year of laboratory training or experience, or both in non-waived testing, in the designated specialty or subspecialty areas of service for which the technical consultant is responsible; or (b)(4)(i) Have earned a bachelor's degree in a chemical, physical or biological science or medical technology from an accredited institution; and (b)(4)(ii) Have at least 2 years of laboratory training or experience, or both in non-waived testing, in the designated specialty or subspecialty areas of service for which the technical consultant is responsible. Note: The technical consultant 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, excluding waived tests. For example, an individual who has a bachelor's degree in biology and additionally has documentation of 2 years of work experience performing tests of moderate complexity in all specialties and subspecialties of service, would be qualified as a technical consultant in a laboratory performing moderate complexity testing in all specialties and subspecialties of service. This STANDARD is not met as evidenced by: Based on a review of records and interview with the laboratory manager/technical consultant, the technical consultant failed to ensure the individuals who performed the duties and responsibilities of the technical consultant, met the qualifications. Findings -- 8 of 10 -- include: (1) On the first day of the survey, the surveyor reviewed records for testing persons performing moderate complexity testing in 2016, 2017 and 2018. The records verified the evaluations had been performed by individuals who did not meet the regulatory qualification requirements of the technical consultant: (a) Bleeding Time - 9 of 9 testing persons (i) Laboratory manager/technical consultant (aa) The 05/26/16 annual evaluation had been performed by testing person #11 (this person had earned an associate degree) (bb) The 05/19/17 annual evaluation had been performed by testing person #11 (ii) Testing Person #1 (aa) The 05/06/16 semi-annual evaluation had been performed by testing person #11 (bb) The 04/10/17 annual evaluation had been performed by testing person #11 (iii) Testing Person #2 (aa) The 03/01/18 semi- annual evaluation had been performed by testing person #5 (this person had earned a high school diploma) (iv) Testing Person #3 (aa) The 05/23/16 annual evaluation had been performed by testing person #12 (this person had earned an associate degree) (bb) The 04/13/17 annual evaluation had been performed by testing person #9 (this person had earned an associate degree) (v) Testing Person #4 (aa) The 03/09/18 annual evaluation had been performed by testing person #6 (this person had earned a high school degree) (vi) Testing Person #6 (aa) The 04/13/17 annual evaluation had been performed by testing person #11 (vii) Testing Person #11 (aa) The 05/06/16 annual evaluation had been performed by previous testing person #1 (this person had earned an associate degree) (bb) The 04/17/17 annual evaluation had been performed by previous testing person #2 (this person had earned an associate degree) (viii) Testing Person #12 (aa) The 05/03/16 semi-annual evaluation had been performed by testing person #11 (bb) The 04/18/17 annual evaluation had been performed by previous testing person #2 (ix) Testing Person #17 (aa) The 05/22/16 annual evaluation had been performed by previous testing person #3 (this person had earned an associate degree) (bb) The 05/26/17 annual evaluation had been performed by previous testing person #4 (this person had earned an associate degree) (b) Moderate Complexity Testing (i.e. Routine Chemistry performed on the Beckman Coulter AU480, Microscopic Urinalysis, Wet Prep Analysis, CBC (Complete Blood Count) performed on the Sysmex XS1000i) - 4 of 4 testing persons (i) Testing Person #1 (aa) The 05/03/16 annual evaluation had been performed by testing person #11 (this person had earned an associate degree) (bb) The 04/07/17 annual evaluation had been performed by testing person #11 (ii) Testing Person #11 (aa) The 05/03/16 annual evaluation had been performed by pervious testing person #1 (this person had earned an associate degree) (bb) The 04/17/17 annual evaluation had been performed by previous testing person #2 (this person had earned an associate degree) (iii) Testing Person #12 (aa) The 05/03/16 annual evaluation had been performed by testing person #11 (bb) The 04/18/17 annual evaluation had been performed by previous testing person #2 (iv) Testing Person #17 (aa) The 05/16/16 annual evaluation had been performed by previous testing person #3 (this person had earned an associate degree) (bb) The 05/26/17 annual evaluation had been performed by previous testing person #4 (this person had earned an associate degree) (2) The surveyor explained to the laboratory manager/technical consultant that all components of the competency evaluations must be performed by a person who qualifies as a technical consultant (an individual with a minimum of a bachelor's degree in a chemical, physical or biological science or medical technology from an accredited institution, and at least 2 years of laboratory training or experience, or both in non-waived testing, in the designated specialty or subspecialty areas of service). D6076 LABORATORY DIRECTOR CFR(s): 493.1441 The laboratory must have a director who meets the qualification requirements of 493. -- 9 of 10 -- 1443 of this subpart and provides overall management and direction in accordance with 493.1445 of this subpart. This CONDITION is not met as evidenced by: Based on a review of records, policies and procedures and interview with laboratory manager/technical consultant, the laboratory director failed to provide overall management and direction for high complexity testing. Findings include: (1) The laboratory director failed to ensure that quality control programs were established and maintained. Refer to D6093; (2) The laboratory director failed to ensure policies and procedures were established for monitoring the competency of testing persons. Refer to D6103. D6093 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(5) The laboratory director must ensure that the quality control 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 a review of records and interview with the laboratory manager/technical consultant, the laboratory director failed to ensure that quality control programs were established and maintained. Findings include: (1) The laboratory director failed to ensure each batch of blood culture media was checked for its ability to support growth. Refer to D5477. D6103 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(13) The laboratory director must ensure that policies and procedures are established for monitoring individuals who conduct preanalytical, analytical, and postanalytical phases of testing to assure that they are competent and maintain their competency to process specimens, perform test procedures and report test results promptly and proficiently, and whenever necessary, identify needs for remedial training or continuing education to improve skills. This STANDARD is not met as evidenced by: Based on a review of policies and procedures, and interview with the laboratory manager/technical consultant, the laboratory director failed to ensure policies and procedures were established for monitoring the competency of testing persons. Findings include: (1) The laboratory director failed to ensure the laboratory had written policies and procedures for assessing employee competency. Refer to D5209. -- 10 of 10 --