Summary:
Summary Statement of Deficiencies D2000 ENROLLMENT AND TESTING OF SAMPLES CFR(s): 493.801 Each laboratory must enroll in a proficiency testing (PT) program that meets the criteria in subpart I of this part and is approved by HHS. The laboratory must enroll in an approved program or programs for each of the specialties and subspecialties for which it seeks certification. The laboratory must test the samples in the same manner as patients' specimens. For laboratories subject to 42 CFR part 493 published on March 14, 1990 (55 FR 9538) prior to September 1, 1992, the rules of this subpart are effective on September 1, 1992. For all other laboratories, the rules of this subpart are effective January 1, 1994. This CONDITION is not met as evidenced by: Based on review of the laboratory test menu, laboratory policy and procedure manuals, proficiency testing records, and interviews with the technical consultant (TC) and Laboratory Director (LD), the laboratory failed to enroll in proficiency testing (PT) challenges in 2024 for one of one regulated endocrinology analyte, Human Chorionic Gonadotropin (HCG, 0555), affecting 42 patient results. Findings Include: 1. Review of the laboratory's test menu revealed the laboratory performed testing for the analyte HCG total serum quantitative in 2024 on a TOSOH Bioscience analyzer. 2. Interview with TC, on 11-14-2024, at 9:30 am, confirmed that the laboratory started testing patient samples in December 2023 for HCG. 3. Review of laboratory records found no PT was performed in 2024 for HCG. 4. Review of test volume records revealed from January of 2024 through November of 2024 that 42 HCG chemistry samples were analyzed in the subspecialty of endocrinology. 5. Interview with LD and TC, on 11-14-2024, at 9:30 am, confirmed that the laboratory failed to enroll in PT challenges in 2024 for HCG. D3031 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(3) Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 4 -- Analytic systems records. Retain quality control and patient test records (including instrument printouts, if applicable) and records documenting all analytic systems activities specified in 493.1252 through 493.1289 for at least 2 years. This STANDARD is not met as evidenced by: Based on review of the laboratory's policy and procedure manual, laboratory maintenance logs, and interview with Testing Personnel (TP)#1; the laboratory failed to retain maintenance logs for the Tosoh AIA - 360 analyzer for 2 of 11 months reviewed in 2024. Findings Include: 1. Review of the laboratory's policy and procedure manual identified the procedure, "Checklist of Maintenance Checks and Calibrations" which stated to do the following: "Daily: Tosoh AIA - 360 per Maintenance Log Weekly and Bi-Weekly: Eyewash Tosoh AIA - 360 per Maintenance Log Monthly: Tosoh AIA - 360per Maintenance Log" 2. Review of laboratory Tosoh AIA - 360 maintenance log revealed the records lacked daily, weekly, and monthly maintenance for 2 of 11 months reviewed in 2024. 3. During the survey on 11-14-2024 at 11:01 am, TP #1 confirmed the Tosoh AIA - 360 maintenance logs for January 2024 and February 2024 were not retained by the laboratory. D5200 GENERAL LABORATORY SYSTEMS CFR(s): 493.1230 Each laboratory that performs nonwaived testing must meet the applicable general laboratory systems requirements in 493.1231 through 493.1236, unless HHS approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub. 7), that provides equivalent quality testing. The laboratory must monitor and evaluate the overall quality of the general laboratory systems and correct identified problems specified in 493.1239 for each specialty and subspecialty of testing performed. This CONDITION is not met as evidenced by: Based on review of laboratory test menu, laboratory test volume records, lack of documentation, and interview with the laboratory director (LD) and technical consultant (TC); the laboratory failed to perform bi-annual method accuracy evaluations for endocrinology testing in 2024 for four of four non-regulated analytes: Estradiol, Follicle Stimulating Hormone (FSH), Luteinizing Hormone (LH), and Progesterone. (See D5217). D5217 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(c)(1) At least twice annually, the laboratory must verify the accuracy of any test or procedure it performs that is not included in subpart I of this part. This STANDARD is not met as evidenced by: Based on review of laboratory test menu, lack of documentation, laboratory test volume records and interview with the laboratory director (LD) and technical consultant (TC); the laboratory failed to perform bi-annual method accuracy evaluations for endocrinology testing in 2024 for four of four non-regulated analytes: Estradiol, Follicle Stimulating Hormone (FSH), Luteinizing Hormone (LH), and -- 2 of 4 -- Progesterone, affecting 418 patient results. Findings include: 1. Review of laboratory's test menu revealed the laboratory performed testing for the analytes Estradiol, Follicle Stimulating Hormone (FSH), Luteinizing Hormone (LH), and Progesterone in 2024. 2. Interview with TC, on 11-14-2024, at 9:30 am, confirmed that the laboratory started testing patient samples in December 2023 for estradiol, FSH, LH, and Progesterone. 3. Review of laboratory records revealed no documentation of bi-annual method accuracy evaluations or proficiency testing for the four non-regulated endocrinology analytes listed above in 2024 4. During the survey on 11-14-2024, at 9:30 am, the LD confirmed the laboratory failed to perform bi-annual method accuracy evaluations for 4 of 4 non-regulated analytes for 2024. 5. Review of test volume records revealed from January of 2024 through November of 2024 that the following samples were analyzed in the subspecialty of Endocrinology: A. 174 Estradiol B. 10 FSH C. 54 LH D. 180 Progesterone 6. Interview with LD and TC, on 11-14-2024, at 9:30 am, confirmed that the laboratory failed to perform bi-annual method accuracy evaluations for four of four non-regulated analytes in 2024. D5403 PROCEDURE MANUAL CFR(s): 493.1251(b) The procedure manual must include the following when applicable to the test procedure: (1) Requirements for patient preparation; specimen collection, labeling, storage, preservation, transportation, processing, and referral; and criteria for specimen acceptability and rejection as described in 493.1242. (2) Microscopic examination, including the detection of inadequately prepared slides. (3) Step-by-step performance of the procedure, including test calculations and interpretation of results. (4) Preparation of slides, solutions, calibrators, controls, reagents, stains, and other materials used in testing. (5) Calibration and calibration verification procedures. (6) The reportable range for test results for the test system as established or verified in 493.1253. (7) Control procedures. (8)