Nelson G N Kalil Md

Summary Statement of Deficiencies D5417 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(d) Reagents, solutions, culture media, control materials, calibration materials, and other supplies must not be used when they have exceeded their expiration date, have deteriorated, or are of substandard quality. This STANDARD is not met as evidenced by: Based on review of the procedure manual and interview with the technical consultant (TC) and testing person (TP), the laboratory failed to document lot numbers and expiration dates of the reagents used for hematology testing. Findings: 1. The "Reagent Tracking" section of the laboratory's procedure manual stated that "When opening new reagents, log on the Reagent Log indicating date opened, lot number, and expiration date" and contained a "Reagent Log" template. 2. During the survey on 10/10/2024 at 11:45 AM, the TC and TP confirmed that the hematology reagents had a document attached that contained the lot number and expiration date, but that these documents were discarded when the reagents ran out and the laboratory did not use the Reagent Log to keep track of reagent lot numbers and expiration dates used for patient testing. D5813 TEST REPORT CFR(s): 493.1291(g) The laboratory must immediately alert the individual or entity requesting the test and, if applicable, the individual responsible for using the test results when any test result indicates an imminently life-threatening condition, or panic or alert values. This STANDARD is not met as evidenced by: Based on review of the procedure manual and interview with the technical consultant 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 -- (TC), the laboratory failed to document notification of critical alert values for hematology results as stated in the procedure. Findings: 1. The laboratory's procedure manual listed hematology critical alert values for white blood cells, hemoglobin, and platelet results. The procedure stated to "Repeat testing to verify, immediately notify attending provider, and log all pertinent information in Critical Value notification log in the lab." 2. During the survey on 10/10/2024 at 11:40 AM, the TC confirmed that critical alert values were entered into the electronic medical record and a "Critical Value notification log" was not used as stated in the procedure. -- 2 of 2 --

Summary Statement of Deficiencies D2015 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(5)(6) (5) The laboratory must document the handling, preparation, processing, examination, and each step in the testing and reporting of results for all proficiency testing samples. The laboratory must maintain a copy of all records, including a copy of the proficiency testing program report forms used by the laboratory to record proficiency testing results including the attestation statement provided by the PT program, signed by the analyst and the laboratory director, documenting that proficiency testing samples were tested in the same manner as patient specimens, for a minimum of two years from the date of the proficiency testing event. (6) PT is required for only the test system, assay, or examination used as the primary method for patient testing during the PT event. This STANDARD is not met as evidenced by: Based on record review and interview with staff, the laboratory did not identify the testing person(s) who performed testing on proficiency samples. Findings: 1. Staff performing the proficiency testing for hematology on test event three for 2022 did not initial test records and did not identify the specimen(s) they tested on the proficiency testing attestation record provided by the proficiency test provider; 2. This was confirmed during interview with staff on the afternoon of the day of survey. D3011 FACILITIES CFR(s): 493.1101(d) Safety procedures must be established, accessible, and observed to ensure protection from physical, chemical, biochemical, and electrical hazards, and biohazardous materials. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 3 -- This STANDARD is not met as evidenced by: Based on record review and interview with staff, the laboratory did not perform checks on the eyewash safety equipment from January 2022 thru July 2022. From September 2022 thru December 2022 the eyewash records were initialed and dated by staff, but the required observations to determine acceptability of the eyewash were not recorded. 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 record review and interview with staff, the laboratory did not document the monthly cleaning maintenance and the start up and shut down for the hematology complete blood count analyzer. Findings: 1. In 2022 the laboratory did not document that the laboratory cleaned the hematology analyzer bath once a month as required by the manufacturer for January, February, March, April, June, July, September, October, November and December of 2022; 2. In 2022 the laboratory did not document that start up and shut down procedures were performed on the hematology analyzer a) The start up and shutdown activities were not documented for February 18 to February 28 of 2022 b) The shut down procedures were not documented from May 6 thru May 13, of 2022 c) The start up and shutdown activities were not documented from November 19 thru 31 of 2022 3. This was confirmed during interview with staff on the afternoon of the day of survey. D5783

Summary Statement of Deficiencies D5403 PROCEDURE MANUAL CFR(s): 493.1251(b) The procedure manual must include the following when applicable to the test procedure: (1) Requirements for patient preparation; specimen collection, labeling, storage, preservation, transportation, processing, and referral; and criteria for specimen acceptability and rejection as described in 493.1242. (2) Microscopic examination, including the detection of inadequately prepared slides. (3) Step-by-step performance of the procedure, including test calculations and interpretation of results. (4) Preparation of slides, solutions, calibrators, controls, reagents, stains, and other materials used in testing. (5) Calibration and calibration verification procedures. (6) The reportable range for test results for the test system as established or verified in 493.1253. (7) Control procedures. (8)

Summary Statement of Deficiencies 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)