Bhi Diagnostics

Summary Statement of Deficiencies D2087 ROUTINE CHEMISTRY CFR(s): 493.841(a) (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 the surveyor's review of the American Proficiency Institute (API) proficiency testing (PT) records and interviews with the testing personnel (TP) and technical consultant (TC), it was determined that the laboratory failed to attain at least 80 percent of the acceptable score in Routine Chemistry for the Uric acid analyte. The findings include: 1. The surveyor reviewed the PT records wherein API reported an unsatisfactory score of 60% for the Uric Acid analyte during the second event of 2025 (Q2-2025). The result are as followed: Sample Result Expected CH-06 2.5 1.9 - 2.5 CH-07 *10.1 7.9 - 9.8 CH-08 5.2 4.1 - 5.2 CH-09 7.8 6.3 - 7.8 CH-10 *14.1 9.9 - 12.2 Legend: * = unsatisfactory score 2. The TP and TC affirmed by interviews on January 27, 2026 at approximately 2:25 p.m. that the laboratory obtained the unsatisfactory PT score mentioned in statement #1. 3. The accuracy and reliability of patient tests reported cannot be determined. 4. According to the laboratory's testing declaration form (Lab-144) submitted on the day of the survey, the laboratory performed approximately 100,000 patient test samples annually for Routine CHemistry which included the Uric Acid analyte during the time the laboratory received the unsatisfactory PT score. . D2098 ENDOCRINOLOGY CFR(s): 493.843(a) (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 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 -- event. This STANDARD is not met as evidenced by: Based on the surveyor's review of the American Proficiency Institute (API) proficiency testing (PT) records, and interviews with the testing personnel (TP) and technical consultant (TC), the laboratory failed to attain at least 80 percent of the acceptable score in Endocrinology for the 25-OH Vitamin D analyte for the second event of 2025 (Q2-2025). The findings include: 1. The surveyor reviewed the API PT comparative evaluation documentation and found that the laboratory obtained an unsatisfactory score of 40% for the 25-OH Vitamin D analyte in Q2-2025 event. The report is as followed: Sample Result Expected IAS-06 *61 32 - 59 IAS-07 *78 37 - 75 IAS-08 26 13 - 34 IAS-09 12 6 - 21 IAS-10 *84 45-80 Legend: * = unsatisfactory score 2. The TP and TC affirmed by interviews on January 27, 2026, at approximately 2:25 p.m. that the laboratory obtained the unsatisfactory PT scores for the 25-OH Vitamin D analyte during the Q2-2025 event as mentioned in statement #1. 3. According to the laboratory's testing declaration, the laboratory performed and reported approximately 2,000 patient test samples for the 25-OH Vitamin D analyte annually including the time the laboratory received unsatisfactory proficiency testing scores. Thus, the accuracy and reliability of patient test reported cannot be determined. . D2121 HEMATOLOGY CFR(s): 493.851(a) (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 the surveyor's review of the American Proficiency Institute (API) proficiency testing (PT) records, and interviews with the testing personnel (TP) and technical consultant (TC), it was determined that the laboratory failed to attain at least 80 percent of the acceptable response resulting to an unsatisfactory performance for the Hematology second event in 2024 (Q2-2024) for the White Blood Cell (WBC) count analyte. The findings include: 1. The laboratory was enrolled in the API PT program and received an unsatisfactory score of 60% for the WBC count analyte in the Q2-2024 event. 2. The TP and TC affirmed by interviews on January 27, 2026, at approximately 2:35 p.m. that the laboratory obtained the PT unsatisfactory scores as mentioned in statement #1. 3. According to the laboratory testing declaration submitted on the day of the survey, the laboratory performed approximately 35,000 samples annually for Hematology that included the WBC count analyte. Thus, the reliability and quality of Hematology patient results reported could not be assured at the time when the laboratory obtained unsatisfactory scores. . D5221 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(d) All proficiency testing evaluation and verification activities must be documented. This STANDARD is not met as evidenced by: -- 2 of 3 -- Based on the review of the laboratory's policy and procedure, proficiency testing (PT) records and interviews with the testing personnel and technical consultant on January 27, 2026, it was determined that the laboratory failed to perform and document a

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 desk review of CMS proficiency testing (PT) records (i.e. CMS CASPER Reports 0155D entitled, "Individual Laboratory Profile" and CMS CASPER Report 0153D entitled, "Unsuccessful (2 of 3) Report"), it was determined that the laboratory failed to successfully participate in a PT program approved by CMS for each analyte or test in which the laboratory is certified under CLIA. The findings included: The laboratory failed to achieve satisfactory performance for the same analyte or test in two out of three consecutive testing events in the specialty of Routine Chemistry constituting unsuccessful PT performance. (See D2096) 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 -- D2096 ROUTINE CHEMISTRY CFR(s): 493.841(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 desk review of CMS PT records (CMS CASPER Report 0155D and 0153D, it was determined that the laboratory failed to achieve satisfactory performance for the same analyte or test in two out of three consecutive PT events for the analyte, Bilirubin, Total, as follows: 2020 Q3 2021 Q2 Bilirubin, total 60% 60% Q2 = Second testing event Q3 = Third testing event b. Failure to achieve satisfactory performance for the same analyte or test in two of three consecutive PT resulted in an initial unsuccessful performance for the analyte, Bilirubin, total. 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 the severity of the deficiencies cited herein, the Condition: Laboratories Performing Moderate Complexity Testing: Laboratory director was not met. The laboratory director, moderate complexity testing, failed to ensure that PT samples were tested as required under Subpart H of this part. (See 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 a desk review of CMS PT records, it was determined the laboratory director, moderate complexity testing, failed to ensure that PT samples were tested as required under subpart H. of this part. The findings included: For the analyte, Bilirubin, total the laboratory repeatedly failed to achieve satisfactory performance for the same analyte or test in two out of three consecutive testing events, resulting in unsuccessful PT performance. (See D2016 and D2096) -- 2 of 2 --