Autumn Road Family Practice, Pa

Summary Statement of Deficiencies D5413 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(b) The laboratory must define criteria for those conditions that are essential for proper storage of reagents and specimens, accurate and reliable test system operation, and test result reporting. The criteria must be consistent with the manufacturer's instructions, if provided. These conditions must be monitored and documented and, if applicable, include the following: (1) Water quality. (2) Temperature. (3) Humidity. (4) Protection of equipment and instruments from fluctuations and interruptions in electrical current that adversely affect patient test results and test reports. This STANDARD is not met as evidenced by: Based on review of policy and procedure manuals, manufacturer's instruction, temperature logs, and interview with staff, the laboratory failed to follow manufacturer's instructions for operational environment relative humidity for Sysmex XS-1000i. Findings follow: A) Review of the Sysmex XS-1000i instrument manual (XS-1000i / XZ-800i Instructions for Use, revision June 2013, Code No. 461-2629-2) revealed the operating environment for relative humidity is "30 to 85% ". B) Review of the laboratory humidity log revealed a target range of "20-80%." C) Review of the laboratory humidity log revealed humidity below 30% on 39 of 41 days of operation in January through March 2024. D) During an interview on 9/17/24 at 1:18 p.m. the lab director confirmed the operation of the Sysmex XS-1000i below 30% humidity and the incorrect range stated on the humidity log. D5417 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(d) Reagents, solutions, culture media, control materials, calibration materials, and other supplies must not be used when they have exceeded their expiration date, have deteriorated, or are of substandard quality. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 2 -- This STANDARD is not met as evidenced by: Through observation and interview with laboratory staff it was determined that the laboratory had supplies available for use after their expiration date. Findings follow: A) During a tour of the laboratory on 9/17/24 at 2:42 pm, one (of one) opened container of EKZ II CAL Reagent (lot 3HD136, expiration date 8/1/24) was observed in the laboratory, available for use beyond the expiraton date. B) During a tour of the laboratory on 9/17/24 at 2:42 pm, one (of one) opened container of ADHDL Calibrator (lot 4BD312, expiration date 9/1/2024) was observed in the laboratory, available for use beyond the expiraton date. C) Laboratory policy stated reagents are to be discarded upon their expiration. D) In an interview on 9/17/24 at 2:43 pm the technical consultant, confirmed that the items, identified above, had exceeded the expiration date and were available for use. -- 2 of 2 --

Summary Statement of Deficiencies D5311 SPECIMEN SUBMISSION, HANDLING, AND REFERRAL CFR(s): 493.1242(a) The laboratory must establish and follow written policies and procedures for each of the following, if applicable: (1) Patient preparation. (2) Specimen collection. (3) Specimen labeling, including patient name or unique patient identifier and, when appropriate, specimen source. (4) Specimen storage and preservation. (5) Conditions for specimen transportation. (6) Specimen processing. (7) Specimen acceptability and rejection. (8) Specimen referral. This STANDARD is not met as evidenced by: Based upon a review of the laboratory's policy and procedure manual, lack of documetnation and interview with laboratory staff it was determined that the laboratory failed to establish written policy and procedure for specimen collection, specimen labeling, and specimen storage and processing. Findings follow: A) During review of the laboratory's policy and procedure manual the surveyor found no written policy governing specimen collection, specimen labeling, or specimen storage and processing. B) Upon request, the laboratory was unable to provide written policies for the items identified above. C) In an interview on 2/6/23 at 10:40 a.m., when asked if their were written policies governing specimen collection, labeling, storage and processing, laboratory staff members (numbers 1 and 3 on the CMS 209 form) stated "we can't find them". Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 1 --

Summary Statement of Deficiencies D5469 CONTROL PROCEDURES CFR(s): 493.1256(d)(10)(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-- Establish or verify the criteria for acceptability of all control materials. (i) When control materials providing quantitative results are used, statistical parameters (for example, mean and standard deviation) for each batch and lot number of control materials must be defined and available. (ii) The laboratory may use the stated value of a commercially assayed control material provided the stated value is for the methodology and instrumentation employed by the laboratory and is verified by the laboratory. (iii) Statistical parameters for unassayed control materials must be established over time by the laboratory through concurrent testing of control materials having previously determined statistical parameters. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Through a review of quality control documentation, lack of documentation, and interviews with laboratory staff, it was determined the laboratory failed to establish statistical parameters over time for Bio-Rad Control Lot #26461 and Lot #26462. Survey findings include: A. During a review of July 2020, November 2020, and February 2021 quality control documentation for chemistry tests performed on the Dimension EXL 200, the surveyor observed the following 2 standard deviation (SD) ranges in use as acceptable ranges that didn't correlate with the Dimension EXL calculated 2 SD ranges from February 2021: Creatinine (Lot #26461) 2 SD in use 0.8 (calculated 2 SD 0.18); CPK (Lot #26461) 2 SD in use 15.1 (calculated 2 SD 3.82); Glucose (Lot #26461) 2 SD in use 8.6 (calculated 2 SD 2.2); Iron (Lot 26461) 2 SD in use 17.2 (calculated 2 SD 3.01); Creatinine (Lot #26462) 2 SD in use 1.0 (calculated 2 SD .23); Alkaline Phosphatase (Lot # 26462) 2 SD in use 78.0 (calculated 2 SD 15.8); CPK (Lot # 26462) 2 SD in use (calculated 2 SD 8.573); and Iron (Lot #26462) 2 SD Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 2 -- in use 6.24 (calculated 2 SD 1.79). B. During an interview with employee #4 (as listed on the form CMS-209), at 1:24 p.m. on 3/18/2021, the surveyor requested documentation of the establishment of the 2 SD ranges in use as acceptable ranges for chemistry quality control. Employee #4 was unable to provide the documentation and confirmed the documentation was not available. -- 2 of 2 --