Bruce R Carlton Md Inc

Summary Statement of Deficiencies 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 Surveyor review of laboratory's patients test records and interview with the laboratory personnel on March 23, 2022, at 11:40 am, the laboratory failed to indicate the report date on the test report. The findings include: 1. The laboratory performed skin biopsies and later read the biopsied tissue slides that were prepared at the APMG laboratory. The laboratory generated the final test report after microscopic slide reading, however, did not indicate the report date on the test report, instead it indicated the service date (biopsy date) on the test report. The date of the test report is the date results were generated as a final report. On the other hand, the laboratory sent out the slides to another laboratory to verify its reading accuracy. Since the laboratory did not indicate the report date on the final test report, it can not be verified if the laboratory generated the report before sending out to the other laboratory or after receiving the results from the other laboratory. Therefore, the slide reading accuracy can not be assured. 2. The laboratory personnel on March 23, 2022, at 11:40 am, affirmed that the laboratory did not indicate the report date on the test report. 3. The laboratory's testing declaration form, signed by the laboratory director on 3/11/2022, stated that the laboratory performs approximately 173 tests, annually. 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 -- D6079 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(a)(b) The laboratory director is responsible for the overall operation and administration of the laboratory, including the employment of personnel who are competent to perform test procedures, record and report test results promptly, accurately and proficiently, and for assuring compliance with the applicable regulations. (a) The laboratory director, if qualified, may perform the duties of the technical supervisor, clinical consultant, general supervisor, and testing personnel, or delegate these responsibilities to personnel meeting the qualifications under 493.1447, 493.1453, 493.1459, and 493.1487 respectively. (b) If the laboratory director reapportions performance of his or her responsibilities, he or she remains responsible for ensuring that all duties are properly performed. This STANDARD is not met as evidenced by: Based on Surveyor review of laboratory's patients test records and interview with the laboratory personnel on March 23, 2022, at 11:40 am, the laboratory director failed to ensure the laboratory's compliance with the CLIA regulations. The findings include: See D5805. -- 2 of 2 --

Summary Statement of Deficiencies D5401 PROCEDURE MANUAL CFR(s): 493.1251(a) A written procedures manual for all tests, assays, and examinations performed by the laboratory must be available to, and followed by, laboratory personnel. Textbooks may supplement but not replace the laboratory's written procedures for testing or examining specimens. This STANDARD is not met as evidenced by: Based on observation of culture media for dermatophyte (fungal) cultures, the lack of laboratory written procedures and quality control documents, and interview with laboratory personnel and the Laboratory Director, the laboratory failed to have a written procedure addressing culture media. Findings include: a. The laboratory used DTM (Dermatophyte Test Medium) and Sabouraud Dextrose media to culture for dermatophytes and yeast. b. The laboratory was unable to provide for review written laboratory procedure addressing the use, quality assurance, and quality control for the media. c. The laboratory was unable to provide documents for quality assurance and quality control. See D5417 and D5477. d. Laboratory personnel and the Laboratory Director (Testing Person, Technical Consultant) affirmed the failure to establish a written laboratory procedure for the DTM and Sab-Dex culture media. . 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: 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 -- Based on observation of expired Sabouraud Dextrose media in use, review of patients test records, and interview with laboratory personnel and the Testing Person (Laboratory Director), the laboratory used expired culture media. Fingings include: a. For Sab-Dex cultures in progress, 3 out of 5 vials inoculated in January 2018 were Lot # S-54-0615 with expiration date 6/22/17. b. Laboratory personnel and the Testing Person (Laboratory Director) affirmed the aforementioned use of expired culture media. c. The reliability and quality of the expired culture media used could not be assured for patients tested as follows: Date inoculated Sab-Dex Culture ID --------------------- ------------------- 1/12/18 ES 1/15/18 RM 1/17/18 NP d. Due to the lack of documentation it could not be determined if the expired media was used for other previous cultures. Based on the stated estimated annual test volume, the laboratory reported approximately 9 mycology tests each month during the timeframe June 2017 to January 2018, including culture and direct microscopic examination method (KOH). . 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 observation of DTM culture media in use, the lack of laboratory quality control documents, and interview with labortory personnel and the Testing Person (Laboratory Director, Technical Consultant), the laboratory failed to document all quality control and quality assurance procedures performed. Findings include: a. Cultures in progress included the following Lot numbers of media: Date in use ID Lot # Expiration ------------------- ------- ------------ --------------------- 12/13/17 RS D-1206- 1116 2018-11-15 1/15/18 MM D-1198-0916 2018-09-07 1/19/18 RR D-1206-1116 2018-11-15 b. The laboratory was unable to provide for review quality assurance documents verifying the physical conditions of each Lot number of DTM upon receipt for acceptable color, sterility, and absence of breakage. c. The laboratory was unable to provide for review quality control documents checking each lot number of media for its ability to support growth of dermatophyte. d. Laboratory personnel and the Testing Person (Laboratory Director) affirmed the aforementioned failure to document all quality assurance and quality control procedures performed. e. Based on the stated estimated annual test volume, the laboratory performed approximately 110 mycology tests annually, including culture and microscopic examination (KOH). -- 2 of 2 --