Hot Clinic Inc

Summary Statement of Deficiencies D5401 PROCEDURE MANUAL CFR(s): 493.1251(a) (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 Surveyor review of laboratory's policy and procedure, instrument print-out, patient test results, and interview with the laboratory technical consultant on May 14, 2026, at 3:53 p.m., the laboratory testing person failed to follow the laboratory's policy & procedure in repeating the flagged test results for 1 patient out of 14 patients, reviewed. The findings include: 1. The laboratory used Micros ES60 automated CBC instrument from Horiba to measure platelet (plt). Instrument print-out showed SCH alert with an asterisk, (*) following the plt results for the sample 1019560. According to the laboratory's procedure the results should be verified by re-running the sample. However, the laboratory person reported the results without repeating the run. Therefore, the accuracy of the reported results cannot be assured and might have harmed the patient. 2. The laboratory technical consultant on May 14, 2026, at 3:53 p. m., affirmed that the laboratory testing person #1 did not follow the laboratory's procedure and repeat the test. 3. The laboratory's testing declaration form, signed by the laboratory director on 5/14/2026, stated that the laboratory performed approximately 200 plt tests, annually. D5787 TEST RECORDS CFR(s): 493.1283(a) (a) The laboratory must maintain an information or record system that includes the following: (a)(1) The positive identification of the specimen. (a)(2) The date and time 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 -- of specimen receipt into the laboratory. (a)(3) The condition and disposition of specimens that do not meet the laboratory's criteria for specimen acceptability. (a)(4) The records and dates of all specimen testing, including the identity of the personnel who performed the test(s). This STANDARD is not met as evidenced by: Based on Surveyor review of laboratory patients tests records, instrument print-out and interview with the laboratory technical consultant on May 14, 2026, at 3:20 p.m., the laboratory failed to document the identity of the testing person performing the routine chemistry and CBC tests. The findings include: 1. The laboratory had 1 licensed testing person and 2 unlicensed assistants. The assistants helped in loading the sample on the automated instrument; however, the testing person was not always present in the laboratory. It cannot be ruled out that the assistants may have performed tests since the laboratory did not document and keep any records. Therefore, the accuracy of the reported results cannot be assured and might have harmed the patient. 2. The laboratory technical consultant on May 14, 2026, at 3:20 p.m., affirmed that the laboratory did not record the identity of the person running the tests. 3. The laboratory's testing declaration form, signed by the laboratory director on 5/14/2026, stated that the laboratory performed approximately 2,400 tests, annually. D6004 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(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, and record and report test results promptly, accurate, and proficiently and for assuring compliance with the applicable regulations. (a) The laboratory director, if qualified, may perform the duties of the technical consultant, clinical consultant, and testing personnel, or delegate these responsibilities to personnel meeting the qualifications of 493.1409, 493.1415, and 493.1421, 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 policy and procedure, instrument print-out, patient test results and interview with the laboratory technical consultant on May 14, 2026, at 3:20 p.m., it was determined that the laboratory director failed to direct the overall operation and administration of the laboratory. The findings include: See D5401, D5787, D6014 and D6070. D6014 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(3)(iii) (e)(3)(iii) Laboratory personnel are performing the test methods as required for accurate and reliable results; This STANDARD is not met as evidenced by: Based on Surveyor review of laboratory's policy and procedure, instrument print-out, patient test results, and interview with the laboratory technical consultant on May 14, 2026, at 3:53 p.m., the laboratory director failed to assure that the testing personnel -- 2 of 3 -- were following the laboratory's procedure for repeating the flagged sample run. The findings include: See D5401. D6070 TESTING PERSONNEL RESPONSIBILITIES CFR(s): 493.1425(b)(1) (b) Each individual performing moderate complexity testing must-- (b)(1) Follow the laboratory's procedures for specimen handling and processing, test analyses, reporting and maintaining records of patient test results; This STANDARD is not met as evidenced by: Based on Surveyor review of laboratory's policy and procedure, instrument print-out, patient test results, and interview with the laboratory technical consultant on May 14, 2026, at 3:53 p.m., it was determined that the laboratory testing person #1 failed to follow the laboratory's procedure for repeating the flagged sample run for 1 patient out of 14 patients, reviewed. The findings include: See D5401. -- 3 of 3 --

Summary Statement of Deficiencies D0000 A proficiency testing desk review survey was performed on May 1, 2026, the laboratory was found not in compliance with the following CONDITION LEVEL DEFICIENCIES D2016 - 42 C.F.R. 493.803 Condition: Successful [proficiency testing] participation; and D6000 - 42 C.F.R. 493.1403 Condition: Laboratories performing moderate complexity testing; laboratory director. D2016 SUCCESSFUL PARTICIPATION CFR(s): 493.803(a)(b)(c) (a) Each laboratory performing nonwaived testing must successfully participate in a proficiency testing program approved by CMS, if applicable, as described in subpart I of this part for each specialty, subspecialty, and analyte or test in which the laboratory is certified under CLIA. (b) Except as specified in paragraph (c) of this section, if a laboratory fails to participate successfully in proficiency testing for a given specialty, subspecialty, analyte or test, as defined in this section, or fails to take remedial action when an individual fails gynecologic cytology, CMS imposes sanctions, as specified in subpart R of this part. (c) If a laboratory fails to perform successfully in a CMS- approved proficiency testing program, for the initial unsuccessful performance, CMS may direct the laboratory to undertake training of its personnel or to obtain technical assistance, or both, rather than imposing alternative or principle sanctions except when one or more of the following conditions exists: (1) There is immediate jeopardy to patient health and safety. (2) The laboratory fails to provide CMS or a CMS agent with satisfactory evidence that it has taken steps to correct the problem identified by the unsuccessful proficiency testing performance. (3) The laboratory has a poor compliance history. This CONDITION is not met as evidenced by: Based on review of the Certification and Survey Provider Enhanced Reporting (CASPER) - 0155D and the American Association of Bioanalysts - Medical Laboratory Evaluation (AAB-MLE) records (2025-2 and 2026-1), the laboratory 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 -- failed to successfully participate in a proficiency testing program approved by HHS for each specialty, subspecialty and analyte or test in which the laboratory is certified under CLIA, the laboratory failed to successfully participate in the Follicle Stimulating Hormone (FSH) and Hematocrit analytes resulting in unsuccessful performances. See D2107 and D2130. D2107 ENDOCRINOLOGY CFR(s): 493.843(f) (f) Failure to achieve satisfactory performance for the same analyte or test in two consecutive testing events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on review of the Certification and Survey Provider Enhanced Reporting (CASPER) Report 0155D Individual Laboratory Profile and American Association of Bioanalysts - Medical Laboratory Evaluation (AAB-MLE) report, the laboratory failed to achieve satisfactory performance for two consecutive events (2025-2 and 2026-1) for the analyte Follicle Stimulating Hormone (FSH) (subspecialty Endocrinology): The finding include: 1. FSH 0% - 2025 second testing event; FSH 0% - 2026 first testing event. A review of the 2025 & 2026 scores from American Association of Bioanalysts - Medical Laboratory Evaluation (AAB-MLE) confirmed the above findings. D2130 HEMATOLOGY CFR(s): 493.851(f) (f) Failure to achieve satisfactory performance for the same analyte in two consecutive events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on review of the Certification and Survey Provider Enhanced Reporting (CASPER) Report 0155D Individual Laboratory Profile and American Association of Bioanalysts - Medical Laboratory Evaluation (AAB-MLE) report, the laboratory failed to achieve satisfactory performance for two consecutive events (2025-2 and 2026-1) for the analyte Hematocrit (specialty Hematology): The finding include: 1. Hematocrit 60% - 2025 second testing event; Hematocrit 0% - 2026 first testing event. A review of the 2025 & 2026 scores from American Association of Bioanalysts - Medical Laboratory Evaluation (AAB-MLE) confirmed the above findings. D6000 MODERATE COMPLEXITY LABORATORY DIRECTOR CFR(s): 493.1403 The laboratory must have a director who meets the qualification requirements of 493. 1405 of this subpart and provides overall management and direction in accordance with 493.1407 of this subpart. This CONDITION is not met as evidenced by: Based on a proficiency testing desk review of the CASPER 0155D report and American Association of Bioanalysts - Medical Laboratory Evaluation (AAB-MLE) -- 2 of 3 -- records for 2025-2 and 2026-1 events, the laboratory director failed to provide overall management and direction of the laboratory services. Refer to D6016. D6016 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(i) (e)(4)(i) The proficiency testing samples are tested as required under Subpart H of this part; This STANDARD is not met as evidenced by: Based on a proficiency testing desk review of the CASPER 0155D report and American Association of Bioanalysts - Medical Laboratory Evaluation (AAB-MLE) records for 2025-2 and 2026-1 events, the laboratory director failed to ensure successful participation in an HHS proficiency testing program. The findings include: 1. The laboratory failed to achieve satisfactory performance for two out of three testing events in Endocrinology. See. D2107 2. The laboratory failed to achieve satisfactory performance for two out of three testing events in Hematology. See 2130 -- 3 of 3 --

Summary Statement of Deficiencies D0000 A proficiency testing desk review survey was performed on 11/21/2025, the laboratory was found not in compliance with the following CONDITION LEVEL DEFICIENCIES D2016 - 42 C.F.R. 493.803 Condition: Successful [proficiency testing] participation; and D6000 - 42 C.F.R. 493.1403 Condition: Laboratories performing moderate complexity testing; laboratory director. D2016 SUCCESSFUL PARTICIPATION CFR(s): 493.803(a)(b)(c) (a) Each laboratory performing nonwaived testing must successfully participate in a proficiency testing program approved by CMS, if applicable, as described in subpart I of this part for each specialty, subspecialty, and analyte or test in which the laboratory is certified under CLIA. (b) Except as specified in paragraph (c) of this section, if a laboratory fails to participate successfully in proficiency testing for a given specialty, subspecialty, analyte or test, as defined in this section, or fails to take remedial action when an individual fails gynecologic cytology, CMS imposes sanctions, as specified in subpart R of this part. (c) If a laboratory fails to perform successfully in a CMS- approved proficiency testing program, for the initial unsuccessful performance, CMS may direct the laboratory to undertake training of its personnel or to obtain technical assistance, or both, rather than imposing alternative or principle sanctions except when one or more of the following conditions exists: (1) There is immediate jeopardy to patient health and safety. (2) The laboratory fails to provide CMS or a CMS agent with satisfactory evidence that it has taken steps to correct the problem identified by the unsuccessful proficiency testing performance. (3) The laboratory has a poor compliance history. This CONDITION is not met as evidenced by: Based on review of the Certification and Survey Provider Enhanced Reporting (CASPER) - 0155D and AAB-Medical Laboratory Evaluation records (2025-2 and 2025-3), the laboratory failed to successfully participate in a proficiency testing 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 -- program approved by HHS for each specialty, subspecialty and analyte or test in which the laboratory is certified under CLIA, the laboratory failed to successfully participate - RBC testing, resulting in an unsuccessful performance. See D2130. D2130 HEMATOLOGY CFR(s): 493.851(f) (f) Failure to achieve satisfactory performance for the same analyte in two consecutive events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on review of the Certification and Survey Provider Enhanced Reporting (CASPER) Report 0155D Individual Laboratory Profile and AAB-Medical Laboratory Evaluation report, the laboratory failed to achieve satisfactory performance for two of three consecutive events (2025-2 and 2025-3) for the analyte Red Blood Cell (RBC): The finding include: RBC 60% - 2025 second testing event; RBC 60% - 2025 third testing event. A review of the 2025 scores from AAB-Medical Laboratory Evaluation confirmed the above findings. D6000 MODERATE COMPLEXITY LABORATORY DIRECTOR CFR(s): 493.1403 The laboratory must have a director who meets the qualification requirements of 493. 1405 of this subpart and provides overall management and direction in accordance with 493.1407 of this subpart. This CONDITION is not met as evidenced by: Based on a proficiency testing desk review of the CASPER 0155D report and (Proficiency Testing Programs) records for 2025-2 and 2025-3 events, the laboratory director failed to provide overall management and direction of the laboratory services. Refer to D6016. D6016 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(i) (e)(4)(i) The proficiency testing samples are tested as required under Subpart H of this part; This STANDARD is not met as evidenced by: Based on a proficiency testing desk review of the CASPER 0155D report and AAB- Medical Laboratory Evaluation records for 2025-2 and 2025-3 events, the laboratory director failed to ensure successful participation in an HHS proficiency testing program. Refer to D2130. -- 2 of 2 --