Kevin H Lapoff Dpm

Summary Statement of Deficiencies D0000 An announced recertification survey was conducted from 01/24/2023 to 01/31/2023 at KEVIN H LAPOFF DPM, a clinical laboratory in Lake Worth, Florida. KEVIN H LAPOFF DPM clinical laboratory is not in compliance with 42 CFR Part 493, Requirements for Laboratories. D3033 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(3)(i) In addition, the laboratory must retain records of test system performance specifications that the laboratory establishes or verifies under 493.1253 for the period of time the laboratory uses the test system but no less than 2 years. This STANDARD is not met as evidenced by: Based on record review and interview with laboratory director, the laboratory failed to retain daily room temperature records for 18 out of 24 months reviewed (2021 and 2022). Findings include: Review of laboratory temperature logs revealed that the laboratory failed to have room temperature logs during 2021 and during 2022 from January to June. During an interview on 01/24/2023 at 10:40 a.m., the laboratory director confirmed that the laboratory failed to have onsite the temperature records of reference. 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 D0000 An announced recertification survey was conducted on 11/4/20 at Kevin H. Lapoff DPM, a clinical laboratory in Lake Worth, Florida. Kevin H. Lapoff DPM is not in compliance with Code of Federal Regulations (CFR) 42, Part 493, Laboratory Requirements. 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 record review and staff interview with laboratory personnel, the temperature of the refrigerator used to store media for fungal cultures was not recorded. The findings included: Review of quality control records on 11/4/20 revealed there were no temperature charts for the refrigerator. The manufacturer specified that the media was to be stored at 2 to 8 degrees centigrade. During an interview with the laboratory director at 10:55 a.m., on 11/4/20, he confirmed that they did not record the refrigerator temperature. 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 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 -- 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 record review and staff interview with laboratory personnel, the laboratory did not do a positive and a negative control with each batch of fungal culture media to check that it produced the correct biochemical response. The findings included: On 11 /4/20, review of quality control records for the past two years revealed that the laboratory tested each batch of media with a known positive or negative organism, not with both. During an interview with the laboratory director at 10:55 a.m., on 11/4/20, he confirmed that they had not done a positive and a negative organism with each new batch of media. -- 2 of 2 --

Summary Statement of Deficiencies 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 record review and interview with laboratory personnel, the laboratory did not verify the accuracy of fungal cultures twice annually. Findings include: Review of proficiency testing records on 09/06/18 revealed that split samples were sent to a reference laboratory for fungal cultures in May, 2018 and before that in July of 2016. During an interview with the laboratory director at 10:10 a.m. on 09/06/18, he confirmed that accuracy had not been verified twice annually. 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 observation and interview with laboratory personnel, the laboratory used culture media that had expired. Findings include: The surveyor observed at 10:05 a.m. on 09/06/18 that two of twenty fungal cultures were on media, lot # 1715020, that expired on 05/30/18. One of the cultures was dated 08/21/18 and the other was 08/22 /18. During an interview with the laboratory director at 10:10 a.m. on 09/06/18, he confirmed that the two cultures were on expired media. 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 -- 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 record review and interview with laboratory personnel, the laboratory did not perform negative controls for each batch of media used for fungal cultures. Findings include: Review of quality control records for fungal cultures on 09/6/18 revealed that the laboratory did a positive control but no negative control to check for the correct biochemical response for each batch of media. During an interview with the laboratory director at 10:15 a.m. on 09/06/18, he confirmed that they did not do negative controls. -- 2 of 2 --