Mackey Family Practice Pa

Summary Statement of Deficiencies D0000 An offsite Proficiency Testing Desk Review survey was conducted at Mackey Family Practice, PA on August 25, 2025. The laboratory was not in compliance with the Clinical Laboratory Improvement Amendments of 1988, at 42 CFR Part 493. The following CONDITION LEVEL DEFICIENCIES were found to be out of compliance: D2016-Successful Participation CFR(S): 493.803(a)(b)(c) D6000- Moderate Complexity Laboratory Director CFR(S): 493.1403 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 desk review of Certification and Survey Provider Enhanced Reporting (CASPER) 0155D report and American Proficiency Institute 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 -- Testing (API) 2025 (Events 1, and 2) records, the laboratory had not successfully participated 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 specialty of Chemistry for analytes Albumin, Aspartate Aminotransferase (AST). Refer to 2096. D2096 ROUTINE CHEMISTRY CFR(s): 493.841(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 a proficiency testing desk review of CASPER 0155D report and API Proficiency Testing 2025 Chem records (Events 1 and 2), revealed that the laboratory failed to achieve a satisfactory performance for the same analytes or test in two consecutive testing events or two out of three consecutive testing is unsuccessful performance in the specialty and subspecialty of Chemistry, Albumin and AST. Findings included: 1. A review of the laboratory's API PT evaluation for the 1st and 2nd event of 2025 revealed that the laboratory failed to achieve satisfactory scores in two consecutive testing events: Chemistry 2025-1st Event the laboratory received an unsatisfactory score of 20% for Albumin. Chemistry 2025-1st Event the laboratory received an unsatisfactory score of 40% for Aspartate Aminotransferase (AST). Chemistry 2025-2nd Event the laboratory received an unsatisfactory score of 40% for Albumin. Chemistry 2025-2nd Event the laboratory received an unsatisfactory score of 40% for Aspartate Aminotransferase (AST). 2. A review of the CASPER 0155D report confirmed the laboratory received the above results. 2025-Chemistry-1st and 2nd Event 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 proficiency testing desk review of CASPER 0155D report and API Proficiency Testing 2025 records, 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 proficiency testing desk review of CASPER 0155D report and API -- 2 of 3 -- Proficiency Testing 2025 records, the laboratory director failed to ensure that the overall quality of the laboratory services provided. The laboratory director failed to ensure successful participation in an HHS approved proficiency testing program. Refer to 2096. -- 3 of 3 --

Summary Statement of Deficiencies D0000 An announced CLIA recertification survey was conducted at Mackey Family Practice on 09/18/2024 by the South Carolina Department of Public Health (SC DPH). The laboratory was surveyed under 42 CFR Part 493 CLIA requirements. The facility was found to be out of compliance with the CONDITIONS of the CLIA program. The following CONDITION and STANDARD LEVEL DEFICIENCES were found to be out of compliance. D2007 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) The samples must be examined or tested with the laboratory's regular patient workload by personnel who routinely perform the testing in the laboratory, using the laboratory's routine methods This STANDARD is not met as evidenced by: During an onsite recertification survey on 09/18/2024, based on the records review (from Certification And Survey Provider Enhanced Reports (CASPER) and Laboratory Personnel Report CMS 209), and staff interview, the laboratory failed to ensure that proficiency testing (PT) samples were rotated among all testing personnel (TP) who routinely performed chemistry testing for 4 of 4 PT events reviewed from 2023 to 2024 (2023 Event 1,2, and 3; 2024, Event 1). Findings included: 1. The laboratory listed 2 testing personnel on the CMS 209 performed non-waived testing in the specialty and subspeciality of chemistry on the day of the survey. 2. Review of American Proficiency Institute (API) records revealed Events 1, 2, and 3 in 2023 were performed by TP1. 3. Review of API records revealed for 2024 Events 1, and 2 were also performed by TP1. TP 2 also routinely performed patient chemistry test; however, did not perform any chemistry proficiency tests during 2023, or for 1 event of 2024. 4. In an interview with TP1 on 09/18/2024 at 1:30 pm in the office the above findings were confirmed. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 5 -- 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 API proficiency testing records review, CASPER Report 0155D and staff interview, the laboratory failed to achieve 80% successful performance for specialty chemistry analyte aminotransferase (AST)/serum glutamic-oxaloacetic transaminase (SGOT) for two consecutive proficiency testing events reviewed (20203, Events 2; 2024, Event 1). See D2096 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 API proficiency testing records review, CASPER Report 0155D and staff interview, the laboratory failed to achieve satisfactory performance for chemistry analyte aspartate aminotransferase (AST)/ serum glutamic-oxaloacetic transaminase (SGOT) for two out of three events from 2023 to 2024. Findings included: 1. Review of laboratory records for American Proficiency Institute (API) revealed the following results: a. AST/SGOT, 2023, Event 2, score 40%, unacceptable b. AST/SGOT, 2024, Event 1, score 0%, unacceptable 2. Review of CASPER Report 0155D revealed unsuccessful proficiency testing for AST/SGOT. a. 2023 AST(SGOT), score 40% b. 2024 AST(SGOT), score 0% 3. In an interview with TP1 on 09/18/2024 at 3:56 pm in the office, the above findings were confirmed. D5209 PERSONNEL COMPETENCY ASSESSMENT POLICIES CFR(s): 493.1235 As specified in the personnel requirements in subpart M, the laboratory must establish and follow written policies and procedures to assess employee and, if applicable, -- 2 of 5 -- consultant competency. This STANDARD is not met as evidenced by: Based on procedure manual review, testing personnel record review and staff interview, the laboratory failed to establish and follow written policies and procedures to assess employee competency for 7 out of 8 moderate complexity testing personnel listed on the CMS 209 3 years reviewed (2022, 2023 2024). Findings included: 1. The laboratory's procedure manual did not have a policy or procedure for the frequency of performing employee competency. 2. Review of testing personnel's file revealed that initial, semi-annual, or annual assessment could not be identified. 3. Review of "Personal Performance Checklist" revealed the following: a. 2022 lack documentation for 8 out of 8 TP No documentation available on the day of the survey. 4. In an interview with TP 1 on 09/18/2024 at 1:30 pm in the office the above findings were confirmed. D5291 GENERAL LABORATORY SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1239(a) The laboratory must establish and follow written policies and procedures for an ongoing mechanism to monitor, assess, and, when indicated, correct problems identified in the general laboratory systems requirements specified at 493.1231 through 493.1236. This STANDARD is not met as evidenced by: Based on policy and procedures, records review and staff interview, the laboratory failed to follow written policies and procedures for an ongoing mechanism to monitor, assess and when indicated correct problems identified in the general laboratory systems as specified at 493.1231 through 493.1236. Findings included: 1. Review of policy titled "Laboratory Quality Assurance Plan For Mackey Family Practice" revealed that evaluation and documentation of quality assurance activities would be performed monthly. 2. Review of Mackey Family Practice records revealed a lack of documentation monitoring the activities and standards as stated in the "Laboratory Quality Assurance Plan for Mackey Family Practice". 3. In an interview with TP1 on 09/18/2024 at 1:30 pm in the office the above findings were confirmed. D5415 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(c) Reagents, solutions, culture media, control materials, calibration materials, and other supplies, as appropriate, must be labeled to indicate the following: (1) Identity and when significant, titer, strength or concentration. (2) Storage requirements. (3) Preparation and expiration dates. (4) Other pertinent information required for proper use. This STANDARD is not met as evidenced by: Based on direct observation, manufacturer instructions and staff interview, the laboratory failed to indicate open and expiration dates of controls in use for chemistry and hematology analyzers. 1. During a tour of the laboratory on 09/18/2024 at 3:35 pm the surveyor observed quality control material Difftrol Tri-Level for the Horiba Medical Hematology Devices. a. Level 1, Lot # DX449L, expiration (exp) date 11/05 -- 3 of 5 -- /2024 b. Level 2, Lot # DX449N, exp. date 11/05/2024 c. Level 3, Lot# DX449H, exp. date 11/05/2024 No open or expiration dates written on bottles in use. 2. Review of manufacturer package insert under "Stability and storage", opened tubes are stable for 15 days provided they are handled properly. 3. The surveyor observed quality control material multi-analyte Thermo Scientific used for the Siemens analyzer. a. Liquid Assayed Chemistry Control MAS ChemTrak H, Level 1, Lot#24081A, exp. date 08/31/2024. b. Liquid Assayed Chemistry Control MAS ChemTrak H, Level 2, Lot# CHA 25122A, exp. date 12/31/2025 c. Liquid Assayed Chemistry Control MAS ChemTrak H, Level 3, Lot# CHA25043A, exp. date 04/30/2025 d. Liquid Assayed Immunoassay Control MAS Liquimmune, Lot# LIA24091A, exp. date 09/30/2024 e. Liquid Assayed Immunoassay Control MAS Liquimmune, Lot# LIA24092A, exp. date 09/30/2024 f. MAS CardioImmune XL, Level 3, Lot# CXL23063A, exp. date 06 /30/2023 No open or expiration dates written on bottles in use. 4. In an interview with testing personnel on 09/18/2024 at 3:35 pm in the laboratory, the above findings were confirmed. D5435 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(b)(2) For equipment, instruments, or test systems developed in-house, commercially available and modified by the laboratory, or maintenance and function check protocols are not provided by the manufacturer, the laboratory must: (i) Define a function check protocol that ensures equipment, instrument, and test system performance that is necessary for accurate and reliable test results and test result reporting. (ii) Perform and document the function checks, including background or baseline checks, specified in paragraph (b)(2)(i) of this section. Function checks must be within the laboratory's established limits before patient testing is conducted. This STANDARD is not met as evidenced by: Based on direct observations, and staff interviews, that laboratory failed to perform function checks on traceable timers used in the laboratory. Findings included: 1. During the laboratory tour on 09/18/2024 at 3:35 pm with testing personnel, the surveyor observed two Mckesson traceable timers with expired dates. 2. Review of label for timers reveal no information of calibrations. 3. In an interview with TP 1 on 09/18/2024 at 3:35 pm in the laboratory, the above findings were confirmed. D6029 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(11) 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)(11) Ensure that prior to testing patients' specimens, all personnel have the appropriate education and experience, receive the appropriate training for the type and complexity of the services offered, and have demonstrated that they can perform all testing operations reliably to provide and report accurate results. This STANDARD is not met as evidenced by: Based on record review and interviews with testing personnel the laboratory failed to document training provided to personnel prior to testing patients. Two personnel have -- 4 of 5 -- been identified as new since the last survey. 2 out of 8 personnel records lack training documentation. Findings included: 1. Review of CMS 209 personnel report form, 7 personnel listed as testing personnel (TP) and one GS. 2. Competency forms provided a list of duties with no indication of initial training to date of hire for (TP3, TP7). 3. In an interview on 09/18/2024 at 1:30 pm in the office with TP 1, the above findings were confirmed. D6047 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b(8)(i) The procedures for evaluation of the competency of the staff must include, but are not limited to direct observations of routine patient test performance, including patient preparation, if applicable, specimen handling, processing and testing. This STANDARD is not met as evidenced by: Based on review of policy and procedures, records review, and staff interview, the laboratory failed to address all 6 components in the competency assessment policy. The laboratory lacks documentation of technical consultant (TC) assessment of TP problem solving skills, direct observations and proficiency testing samples. Findings included: 1. Review of policy and procedures lacks all six components and a timeline for personnel competency. 2. A review of policy titled "Laboratory Quality Assurance Plan for Mackey Family Practice" included section III. Areas of Quality Assurance Evaluation, E. Personnel assessment" lack semiannual assessment. 3. Review of competency records reveals "personal performance checklist" lack problem solving /troubleshooting skills and handling proficiency testing samples the same as patient samples. 4. In an interview on 09/18/2024 at 1:30 pm with TP 1 in the office, confirm the findings above. D6053 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(9) The technical consultant is responsible for evaluating and documenting the performance of individuals responsible for moderate complexity testing at least semiannually during the first year the individual tests patient specimens. This STANDARD is not met as evidenced by: Based on review of policy and procedures, records review, and staff interview, the laboratory failed to ensure that testing personnel were evaluated at least semiannually during the first year of testing patient specimens for 2 out of 2 new testing personnel (TP3, TP7) Findings included: 1. The laboratory listed 7 testing personnel on the CMS 209 on the day of the survey and 1 general supervisor. 2. Review of policy and procedure manual revealed a policy titled "Laboratory Quality Assurance Plan For Mackey Family Practice" included section III. Areas of Quality Assurance Evaluation, E. Personnel assessment" procedure did not include a semiannual evaluation for the first year of testing. 3. Documentation of initial training and evaluation at least seminannually during the first year of testing was unavailable for review on the day of the survey for 2 of 2 new employees (TP3, TP7). 4. In an interview on 09/18/2024 at 1:30 pm in the office with the testing personnel, the above findings were confirmed. -- 5 of 5 --

Summary Statement of Deficiencies D0000 The following deficiencies are the result of a desk review of proficiency testing scores obtained from the national database and verified with the proficiency testing company. The facility was found to be out of compliance with the conditions of the CLIA program. The following CONDITION LEVEL DEFICIENCIES were found to be out of compliance: D2016-SUCCESSFUL PARTICIPATION CFR(s):493.803(a) (b)(c) D6000-MODERATE COMPLEXITY LABORATORY DIRECTOR CFR(s): 493.1403 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 desk review of certification and Survey Provider 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 -- Enhanced Reporting (CASPER) 0155 report and American Proficiency Institute (API) 2023, 2024 records and the laboratory had not successfully participated in a proficiency testing program approved by HHS, for each specialty, subspecialty, and analyte in which the laboratory is certified under CLIA. The laboratory failed to successfully participate in the specialty of Chemistry for the Aspartate Aminotransferase (AST). Refer to D2096. 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 a proficiency testing desk review of CASPER 0155 report and API Testing 2023 (Event 2), 2024 (Event 1) records, the laboratory failed to achieve a satisfactory performance for the for the same analytes for two out of three consecutive testing events for Aspartate Aminotransferase (AST) chemistry analyte. Findings included: 1. Review of the CASPER 0155 report revealed the following results: Chemistry 2023- 2nd Event the laboratory received an unsatisfactory score of 40% for: Aspartate Aminotransferase (AST) Chemistry 2024-1st Event. The laboratory received an unsatisfactory score of 0% for Aspartate Aminotransferase (AST) 2. A review of American Proficiency Institute Testing records confirmed the laboratory received the above results. 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 proficiency testing desk review of CASPER 0155 report and API Proficiency Testing 2023 and 2024 records, 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) 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 proficiency testing desk review of CASPER 0155 report and API -- 2 of 3 -- Proficiency Testing 2023, and 2024 records, the laboratory director failed to ensure that the overall quality of the laboratory services provided. The laboratory director failed to ensure successful participation in an HHS approved proficiency testing program Refer to D2016 -- 3 of 3 --

Summary Statement of Deficiencies 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: During an onsite recertification survey on 10/31/2019, based on proficiency testing records review, lack of documentation, and testing personnel interview, it was determined that the laboratory failed to evaluate and verify the accuracy of vaginal wet prep (VWP) assigned an unsatisfactory score for 2 of 6 proficiency testing events reviewed from 2018 and 2019 (2018, Event 2 and 2019, Event 1). Findings include: 1. Review of graded reports from American Proficiency Institute (API) revealed the following scores: a. 2018, Event 2: 0% for VWP b. 2019, Event 1: 0% for VWP 2. There was no

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: During a proficiency testing desk review performed on 05/30/2019, based on review of CASPER report 155D and graded reports from American Proficiency Institute (API), it was determined that the laboratory failed to successfully participate in proficiency testing for the specialty of chemistry, the analyte total bilirubin (T-BILI) for two out of three consecutive proficiency testing events reviewed (2018, Event 2 and 2019, Event 1). See D2087, D2096 D2087 ROUTINE CHEMISTRY CFR(s): 493.841(a) 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 -- 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: During the proficiency testing desk review performed on 05/30/2019, based on review of CASPER report 155D and graded proficiency reports from American Proficiency Institute (API), it was determined that the laboratory failed to attain a satisfactory score of at least 80% for total bilirubin (T-BILI) on two out of three consecutive proficiency testing events (2018, Event 2 and 2019, Event 1). Findings include: 1. The CASPER 155D report revealed the following scores for your laboratory's T-BILI: a. 2018, Event 2: 40% b. 2019, Event 1: 60% 2. The scores were confirmed by review of the graded API results. Scores less than 80% for these analytes indicate failure or unsatisfactory performance. A failure of the analytes for two consecutive or two out of three testing events is scored as unsuccessful. A failure of the analyte for three consecutive or three out of four/five events is scored as a repeat unsuccessful. 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: During a proficiency testing desk review performed on 05/30/2019, based on review of the CASPER 155D report and graded report from American Proficiency Institute (API), it was determined that the laboratory failed to achieve satisfactory performance for total bilirubin (T-BILI) for two out of three consecutive testing events (2018, Event 2 and 2019, Event 1). See D2087. -- 2 of 2 --