Salerno Complementary Medicine Pllc

Summary Statement of Deficiencies D2000 ENROLLMENT AND TESTING OF SAMPLES CFR(s): 493.801 Each laboratory must enroll in a proficiency testing (PT) program that meets the criteria in subpart I of this part and is approved by HHS. The laboratory must enroll in an approved program or programs for each of the specialties and subspecialties for which it seeks certification. The laboratory must test the samples in the same manner as patients' specimens. For laboratories subject to 42 CFR part 493 published on March 14, 1990 (55 FR 9538) prior to September 1, 1992, the rules of this subpart are effective on September 1, 1992. For all other laboratories, the rules of this subpart are effective January 1, 1994. This CONDITION is not met as evidenced by: Based on review of Centers for Medicare & Medicaid Services (CMS) Proficiency Testing (PT) Certification and Survey Provider Enhanced Reporting system (CASPER 0155D), Standard Operating Procedures (SOPs), lack of proficiency testing (PT) records as well as interview with Testing Personnel (TP), the laboratory failed to enroll in an approved PT program for the general immunology specialty. FINDINGS: 1. The laboratory performed on-site allergy panel laboratory testing and result reporting. 2. There was no documentation of general immunology PT performance or results for calendar years 2023 and 2024. 3. The current, approved SOPs did not include instructions for performing such activity. 4. The TP confirmed the findings on December 23, 2024, at approximately 3:30 P.M. 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. 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 CONDITION is not met as evidenced by: Based on review of CMS PT CASPER 0155D, SOPs, lack of PT records, and interview with the TP, the laboratory director (LD) 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) 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. (e) The laboratory director must-- (e)(4)(i) Ensure that the proficiency testing samples are tested as required under Subpart H of this part; This STANDARD is not met as evidenced by: Based on review of CMS PT CASPER 0155D, SOPs, lack of PT records, and interview with the TP, the LD failed to ensure successful participation in an HHS approved proficiency testing program. -- 2 of 2 --

Summary Statement of Deficiencies 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 a proficiency testing (PT) desk review of the Center for Medicare and Medicaid Services (CMS) PT reports and PT records from the American Proficiency Institute (API) PT program, the laboratory failed to participate and perform successfully in a PT program, approved by CMS, for the sub-specialty Endocrinology and the test analytes Free Thyroxine (FT4) and Thyroid Stimulating Hormone (TSH) The following scores were assigned: sub-speciality Endocrinology 2019 first event = 0% [non-participation] 2019 second event = 100% 2019 third event = 60% FT4 2019 first event = 0% [non-participation] 2019 second event = 100% 2019 third event = 0% TSH 2019 first event = 0% [non-participation] 2019 second event = 100% 2019 third Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 4 -- event = 20% This is considered unsuccessful PT performance. Refer to D2107 and 2108. D2075 GENERAL IMMUNOLOGY CFR(s): 493.837(a) Failure to attain a score of at least 80 percent of acceptable responses for each analyte in each testing event is unsatisfactory analyte performance for the testing event. This STANDARD is not met as evidenced by: Based on a PT desk review of the CMS PT reports and PT records from the API PT program, the laboratory failed to participate and perform successfully in a PT program, approved by CMS, for the test analyte AFP (Tumor Marker). The following scores were assigned: 2019 first event = 0% [non-participation] This is considered unsatisfactory PT performance D2076 GENERAL IMMUNOLOGY CFR(s): 493.837(b) Failure to attain an overall testing event score of at least 80 percent is unsatisfactory performance. This STANDARD is not met as evidenced by: Based on a PT desk review of the CMS PT reports and PT records from the API PT program, the laboratory failed to participate and perform successfully in a PT program, approved by CMS, for the test analytes specialty General Immunology. The following scores were assigned: 2019 first event = 50% This is considered unsatisfactory PT performance D2093 ROUTINE CHEMISTRY CFR(s): 493.841(d) Failure to return proficiency testing results to the proficiency testing program within the time frame specified by the program is unsatisfactory performance and results in a score of 0 for the testing event. This STANDARD is not met as evidenced by: Based on a PT desk review of the CMS PT reports and PT records from the API PT program, the laboratory failed to participate and perform successfully in a PT program, approved by CMS, for the speciality Chemistry and the test analytes Creatine Kinase Isoenzyme (CK-MB) and Total Iron (T Fe),. The following scores were assigned: 2019 first event = 0% [non-participation] This is considered unsatisfactory PT performance. D2104 ENDOCRINOLOGY CFR(s): 493.843(d) Failure to return proficiency testing results to the proficiency testing program within the time frame specified by the program is unsatisfactory performance and results in a score of 0 for the testing event. -- 2 of 4 -- This STANDARD is not met as evidenced by: Based on a PT desk review of the CMS PT reports and PT records from the API PT program, the laboratory failed to participate and perform successfully in a PT program, approved by CMS, for the test analytes Cortisol and HCG. The following scores were assigned: 2019 first event = 0% [non-participation] This is considered unsatisfactory PT performance D2107 ENDOCRINOLOGY CFR(s): 493.843(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 a proficiency testing (PT) desk review of the Center for Medicare and Medicaid Services (CMS) PT reports and PT records from the American Proficiency Institute (API) PT program, the laboratory failed to participate and perform successfully in a PT program, approved by CMS, for the test analytes Free Thyroxine (FT4) and Thyroid Stimulating Hormone (TSH) The following scores were assigned: FT4 2019 first event = 0% [non-participation] 2019 second event = 100% 2019 third event = 0% TSH 2019 first event = 0% [non-participation] 2019 second event = 100% 2019 third event = 20% This is considered unsuccessful PT performance. D2108 ENDOCRINOLOGY CFR(s): 493.843(g) Failure to achieve an overall testing event score of satisfactory performance for 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 a proficiency testing (PT) desk review of the Center for Medicare and Medicaid Services (CMS) PT reports and PT records from the American Proficiency Institute (API) PT program, the laboratory failed to participate and perform successfully in a PT program, approved by CMS, for the sub-specialty Endocrinology. The following scores were assigned: sub-speciality Endocrinology 2019 first event = 0% [non-participation] 2019 second event = 100% 2019 third event = 60% This is considered unsuccessful PT performance. 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: -- 3 of 4 -- Based on PT desk review of the PT CMS data reports and API PT program records, the laboratory director failed to fulfill the laboratory director's responsibilities and ensure that the laboratory achieved a satisfactory performance and successfully participate in a PT program, for the specialties General Immunology, Chemistry and sub-specialty Endocrinology and the test analytes FT4, TSH, Cortisol, HCG, AFP (Tumor Marker), TIBC, T Fe and CK-MB. Refer to D6016. D6016 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(i) 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. (e) The laboratory director must-- (e)(4)(i) Ensure that the proficiency testing samples are tested as required under Subpart H of this part; This STANDARD is not met as evidenced by: Based on PT desk review of the PT CMS data reports and API PT program records, the laboratory director failed to fulfill the laboratory director's responsibilities and ensure that the laboratory achieved a satisfactory performance and successfully participate in a PT program, for the test analytes FT4, TSH, Cortisol, , HCG, CK-MB, T Fe, TIBC, AFP (Tumor Marker) and the specialties General Immunology, Chemistry and sub-specialty Endocrinology. The following scores were assigned: sub- specialty Endocrinology 2019 first event = 0% [non-participation] 2019 second event = 100% 2019 third event = 60% FT4 2019 first event = 0% [non-participation] 2019 second event = 100% 2019 third event = 0% TSH 2019 first event = 0% [non- participation] 2019 second event = 100% 2019 third event = 20% This is considered unsuccessful PT performance. General Immunology 2019 first event = 50% AFP (Tumor Marker) 2019 first event = 0% [non-participation] Cortisol and HCG 2019 first event = 0% [non-participation] Chemistry and CK-MB, T Fe and TIBC 2019 first event = 0% [non-participation This is considered unsatisfactory PT performance -- 4 of 4 --