Dilip Elangbam

Summary Statement of Deficiencies D0000 A recertification survey was conducted by the Pennsylvania State Agency for Dilip Elangbam on 06/05/2025. The laboratory was found out of compliance with the following conditions: 493.1250 Condition: Analytic systems. D2014 TESTING OF PROFICIENCY TESTING SAMPLES (b)(6) The laboratory must document the handling, preparation, processing, examination, and each step in the testing and reporting of results for all proficiency testing samples. The laboratory must maintain a copy of all records, including a copy of the proficiency testing program report forms used by the laboratory to record proficiency testing results including the attestation statement provided by the PT program, signed by the analyst and the laboratory director, documenting that proficiency testing samples were tested in the same manner as patient specimens, for a minimum of two years from the date of the proficiency testing event. This STANDARD is not met as evidenced by: Based on review of the laboratory's American Proficiency Institute (API) proficiency testing (PT) records, and interview with the laboratory director (LD), the laboratory failed to provide 3 of 3 API PT Chemistry Core and 3 of 3 API PT Hematology /Coagulation attestation statements signed by the analyst for 2024. Findings include: 1. On the day of survey, 6/5/2025, the laboratory failed to provide attestation statements signed by the testing personnel (TP) for 3 of 3 API PT Chemistry Core and 3 of 3 API Hematology/Coagulation events performed in 2024. 2. The LD confirmed the finding above on 6/5/2025 at 1:30 pm. 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, Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 8 -- consultant competency. This STANDARD is not met as evidenced by: Based on lack of documentation and interview with Testing Personnel (TP) #1 and the laboratory director (LD), the laboratory failed to establish and follow a written policy or procedure to assess employee competency for 1 of 1 TP that performed chemistry and hematology testing from 06/14/2023 to 6/5/2025. Findings include: 1. On the day of survey, 6/5/2025 at 11:00 am, the laboratory failed to provide a written policy to assess the six required procedures of a competency assessment for 1 of 1 TP (CMS 209 TP#1) that performed moderate complexity hematology and chemistry testing from 06/14/2023 to 06/05/2025. 2. The laboratory performed 250 endocrinology examinations and 100 hematology examinations in 2024 (CMS 116, estimated annual volume). 3. The LD confirmed the above findings on 6/5/2025 at 1:00 pm. D5215 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(b)(2) The laboratory must verify the accuracy of any analyte, specialty or subspecialty assigned a proficiency testing score that does not reflect laboratory test performance (that is, when the proficiency testing program does not obtain the agreement required for scoring as specified in subpart I of this part, or the laboratory receives a zero score for nonparticipation, or late return or results). This STANDARD is not met as evidenced by: Based on review of the laboratory's American Proficiency Institute (API) proficiency testing (PT) records and interview with the laboratory director (LD), the laboratory failed to verify the accuracy of the PT results obtained for 1 of 3 API Hematology /Coagulation events in 2025 and 1 of 3 API Chemistry Core events in 2024. Findings: 1. On the day of survey, 6/5/2025 at 10:50 am., review of the laboratory's API PT results revealed the laboratory failed to verify the accuracy of PT results not graded by the PT agency for the following events: a. API Hematology/Coagulation: 2025 Event #1 b. API:Core Chemistry: 2024 Even t # 3 2. The LD confirmed the finding above on 6/5/2025 at 1:45 pm. D5311 SPECIMEN SUBMISSION, HANDLING, AND REFERRAL CFR(s): 493.1242(a) (a) The laboratory must establish and follow written policies and procedures for each of the following, if applicable: (a)(1) Patient preparation. (a)(2) Specimen collection. (a)(3) Specimen labeling, including patient name or unique patient identifier and, when appropriate, specimen source. (a)(4) Specimen storage and preservation. (a)(5) Conditions for specimen transportation. (a)(6) Specimen processing. (a)(7) Specimen acceptability and rejection. (a)(8) Specimen referral. This STANDARD is not met as evidenced by: Based on record review, observation of the laboratory, and interview with testing personnel (TP) #1, the laboratory failed to follow policies to ensure specimen integrity was maintained (collection, storage, and transport conditions) for specimens stored in 1 of 1 feezer to be used for endocrinology testing peformed at a later date from 06/14 /2023 to the date of the survey . Findings include: 1. The FastPack Systems Operating -- 2 of 8 -- manual states the following for Handling and Storing of Specimens: Remove serum or plasma from the cells prior to storage at 2-8 degrees Celcius. If not tested within 24 hours, samples should be frozen at -20 degrees Celcius or colder for up to 2 months. 2. On 6/5/2025, during observation in the laboratory, specimens stored for endocrinology testing did not have the serum or plasma removed from the cells prior to storage. 3. Interview with TP#1 on 6/5/2025 at 11:30 am revealed that endocrinology testing is performed every other week. 4. TP #1 confirmed the above findings on 6/5/2025 at 12:15 pm. D5400 ANALYTIC SYSTEMS CFR(s): 493.1250 Each laboratory that performs nonwaived testing must meet the applicable analytic systems requirements in 493.1251 through 493.1283, unless HHS approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub.7), that provides equivalent quality testing. The laboratory must monitor and evaluate the overall quality of the analytic systems and correct identified problems as specified in 493.1289 for each specialty and subspecialty of testing performed. This CONDITION is not met as evidenced by: Based on observation of the laboratory, record review, lack of documentation, and interview with the Laboratory Director (LD), the laboratory failed to meet applicable analytic systems requirements in 493.1251 through 493.1283 from 6/14/2023 to 6/5 /2025. Refer to 5413, 5421, 5437, 5439, 5477, and 5783. D5413 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(b) (b) The laboratory must define criteria for those conditions that are essential for proper storage of reagents and specimens, accurate and reliable test system operation, and test result reporting. The criteria must be consistent with the manufacturer's instructions, if provided. These conditions must be monitored and documented and, if applicable, include the following: (b)(1) Water quality. (b)(2) Temperature. (b)(3) Humidity. (b)(4) Protection of equipment and instruments from fluctuations and interruptions in electrical current that adversely affect patient test results and test reports. This STANDARD is not met as evidenced by: A. Based on observation in the laboratory, review of laboratory temperature records, and interview with Testing Personnel (TP) #1, the laboratory failed to monitor and document temperatures to ensure proper storage of reagents for 490 of 722 days from 6/14/2023 to 6/5/2025 when testing personnel are not present in the laboratory. Findings include: 1. On the day of survey, 6/5/2025, at 11:30 am, during the tour of the laboratory, the surveyor observed the following reagents stored in the following refrigerators currently in use in the laboratory: Reagent Refrigerator - 1 Beckman Coulter DxH 500 Series Calibrator. Storage requirements 2C to 8C. - 1 Beckman Coulter DxH 500 Series Quality Control. Storage requirements 2C to 8C. - 2 FastPack System TSH Calibrators. Storage requirements 2C to 8C. - 3 FastPack System FT4 Calibrators. Storage requirements 2C to 8C. - 2 FastPack System TSH Reagent Kits. Storage requirements 2C to 8C. - 2 FastPack System FT4 Reagent Kits. Storage requirements 2C to 8C. - 1 FastPack System PSA Reagent Kit. Storage requirements -- 3 of 8 -- 2C to 8C. Med Refrigerator - 1 FastPack System PSA Reagent Kit. Storage requirements 2C to 8C. - 1 FastPack System Vitamin D Reagent Kit. Storage requirements 2C to 8C. 2. Review of the laboratory's temperature records revealed the laboratory failed to monitor and document refrigerator/freezer temperatures for 490 of 722 days from 6/14/2023 to 6/5/2025. 3. TP #1 confirmed the findings above on 6/5 /2025 at 1:00 pm. B. Based on record review, lack of documentation, and interview with Testing Personnel (TP) #1, the laboratory failed to monitor and document daily humidity readings to ensure proper operating conditions were met for 1 of 1 FastPack System chemistry analyzer used for endocrinology examinations from 6/14/2023 to 6 /5/2025. Findings include: 1. On the day of survey, 6/5/2025 at 12:30 am, review of laboratory temperature records revealed the laboratory failed to monitor and document daily humidity readings to ensure operating conditions were met for 1 of 1 FastPack System analyzer used for endocrinology examinations from 6/14/2023 to 6/5/2025. 2. The manufacturer's acceptable temperature and humidity ranges for the FastPack System is as follows: - Temperature 15C to 32C - Humidity 10% to 90% Relative Humidity 3. TP#1 confirmed the findings above on 6/5/2025 at 1:00 pm. D5421 ESTABLISHMENT AND VERIFICATION OF PERFORMANCE CFR(s): 493.1253(b)(1) (b) Each laboratory that introduces an unmodified, FDA-cleared or approved test system must do the following before reporting patient test results: (b)(1)(i) Demonstrate that it can obtain performance specifications comparable to those established by the manufacturer for the following performance characteristics: (b)(1)(i) (A) Accuracy. (b)(1)(i)(B) Precision. (b)(1)(i)(C) Reportable range of test results for the test system. (b)(1)(ii) Verify that the manufacturer's reference intervals (normal values) are appropriate for the laboratory's patient population. This STANDARD is not met as evidenced by: Based on review of the laboratory's verification of performance specifications records, lack of documentation, and interview with the Laboratory Director (LD) and testing personnel (TP) #1, the laboratory failed to establish criteria for acceptable performance specifications for Complete Blood Count (CBC) testing performed on 1 of 1 Beckman Coulter DxH 520 hematology analyzer before reporting patient results from March 2024 to the date of survey. Findings Include: 1. On the day of the survey, 06/05/2025 at 11:00 am, review of the Beckman Coulter DxH 520 performance specification records revealed the validation performed in March 2024 for CBC testing did not include the laboratory's acceptable criteria for performance specifications for precision, accuracy, and reportable ranges. 2. The laboratory could not provide documentation for the verification of accuracy and that reference range /normal value are appropriate for the laboratory's patient population for the following hematology analytes performed on 1 of 1 Beckman Coulter DxH 520 hematology analyzer from March 2024 to the date of the survey: - White Blood Cell Count - Platelet Count - Red Blood Cell Count - Mean Platelet Volume - Hemoglobin - Neutrophil % - Hematocrit - Lymphocyte % - Mean Corpuscular Volume - Monocyte % - Mean Corpuscular Hemoglobin - Eosinophil % - Mean Corpuscular Hemoglobin Concentration - Basophil % - Red Cell distribution Width - Immature Granulocyte % 3. The LD confirmed the findings above on 6/5/2025 at 2:00 pm. D5437 CALIBRATION AND CALIBRATION VERIFICATION CFR(s): 493.1255(a) -- 4 of 8 -- (a )Unless otherwise specified in this subpart, for each applicable test system the laboratory must perform and document calibration procedures-- (a)(1) Following the manufacturer's test system instructions, using calibration materials provided or specified, and with at least the frequency recommended by the manufacturer; (a)(2) Using the criteria verified or established by the laboratory as specified in 493.1253(b) (3)-- (a)(2)(i) Using calibration materials appropriate for the test system and, if possible, traceable to a reference method or reference material of known value; and (a) (2)(ii) Including the number, type, and concentration of calibration materials, as well as acceptable limits for and the frequency of calibration; and (a)(3) Whenever calibration verification fails to meet the laboratory's acceptable limits for calibration verification. This STANDARD is not met as evidenced by: Based on record review, lack of documentation, and interview with testing personnel #1 (TP), the laboratory failed to perform calibrations on 1 of 1 Beckman Coulter DxH 520 hematology analyzer used to perform complete blood count (CBC) examinations from March 2024 to the date of the survey. Findings Include: 1. The Beckman Coulter DxH 520 manual stated, "calibration is performed every 6 months or when advised by Coulter representative". 2. On the day of the survey, 6/5/2025 at 12:30 pm, the laboratory failed to provide documentation for calibrations performed every 6 months on 1 of 1 Beckman Couler DxH 520 hematology analyzer from March 2024 to the date of the survey. 3. The laboratory performed 100 hematology (CBC) examinations (CMS 116, estimated annual volume). 4. TP #1 confirmed the finding above on 6/5 /2025 at 1:30 pm. D5439 CALIBRATION AND CALIBRATION VERIFICATION CFR(s): 493.1255(b) (b)(1) Following the manufacturer's calibration verification instructions; (b)(2) Using the criteria verified or established by the laboratory under 493.1253(b)(3)-- (b)(2)(i) Including the number, type, and concentration of the materials, as well as acceptable limits for calibration verification; and (b)(2)(ii) Including at least a minimal (or zero) value, a mid-point value, and a maximum value near the upper limit of the range to verify the laboratory's reportable range of test results for the test system; and (b)(3) At least once every 6 months and whenever any of the following occur: (b)(3)(i) A complete change of reagents for a procedure is introduced, unless the laboratory can demonstrate that changing reagent lot numbers does not affect the range used to report patient test results, and control values are not adversely affected by reagent lot number changes. (b)(3)(ii) There is major preventive maintenance or replacement of critical parts that may influence test performance. (b)(3)(iii) Control materials reflect an unusual trend or shift, or are outside of the laboratory's acceptable limits, and other means of assessing and correcting unacceptable control values fail to identify and correct the problem. (b)(3)(iv) The laboratory's established schedule for verifying the reportable range for patient test results requires more frequent calibration verification. This STANDARD is not met as evidenced by: Based on lack of documentation and interview with testing personnel (TP) #1, the laboratory failed to perform calibration verification at least once every six months for 1 of 1 Fast Pack IP chemistry analyzer from 6/14/2023 to the date of survey. Findings include: 1. On the date of survey, 06/05/2025 at 12:00 pm, the laboratory failed to provide calibration verification records performed at least once every 6 months for the -- 5 of 8 -- following analytes tested on 1 of 1 Fast Pack IP chemistry analyzer from 6/14/2023 to 06/05/2025: - Vitamin D - Prostrate Specific Antigen -Thyroid Stimulating Hormone - Free Thyroxine 2. The laboratory performed 250 chemistry examinations in 2024 (CMS 116, estimated annual volume). 3. TP #1 confirmed the findings above on 06/05 /2025 at 01:30 pm. ***REPEAT DEFICIENCY*** D5447 CONTROL PROCEDURES CFR(s): 493.1256(d)(3)(i)(g) (d)(3)(i) Each quantitative procedure, include two control materials of different concentrations; This STANDARD is not met as evidenced by: Based on lack of documentation and interview with Testing Personnel (TP) #1, the laboratory failed to include two control materials of different concentrations for endocrinology tests performed on 1 of 1 FastPack IP System chemistry analyzer , at least once each day of patient testing from 06/14/2023 to the date of survey. Findings include: 1. On the day of survey, 6/5/2025, the laboratory failed to provide documentation for the two control materials of different concentrations of QC run at least once a day for endocrinology testing performed on 1 of 1 FastPack IP System chemistry analyzer from 06/14/2023 to 6/05/2025. 2. The laboratory performed 250 chemistry examinations in 2024 (CMS 116 estimated annual volume). 3. TP#1 confirmed the finding above on 6/5/2025 at 12:05 pm. D5783

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 review of the CASPER 155 report and graded results from the proficiency testing organization American Proficiency Institute (API), the laboratory failed to successfully participate in proficiency testing for the analyte Red Blood Cell (RBC). Refer to D2130. D2130 HEMATOLOGY CFR(s): 493.851(f) Failure to achieve satisfactory performance for the same analyte in two consecutive 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 -- 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 CASPER 155 report and graded results from the proficiency testing organization American Proficiency Institute (API), the laboratory failed to successfully participate in proficiency testing for the analyte: Red Blood Cell (RBC). The laboratory had unsatisfactory scores for the 2nd event of 2023 and 1st event of 2024. Findings include: Analyte Year Event Score RBC 2023 2 40 % RBC 2024 1 0 % -- 2 of 2 --

Summary Statement of Deficiencies D5439 CALIBRATION AND CALIBRATION VERIFICATION CFR(s): 493.1255(b) Unless otherwise specified in this subpart, for each applicable test system the laboratory must do the following: Perform and document calibration verification procedure - (b)(1) Following the manufacturer's calibration verification instructions; (b)(2) Using the criteria verified or established by the laboratory under 493.1253(b)(3) -- (b)(2)(i) Including the number, type, and concentration of the materials, as well as acceptable limits for calibration verification; and (b)(2)(ii) Including at least a minimal (or zero) value, a mid-point value, and a maximum value near the upper limit of the range to verify the laboratory's reportable range of test results for the test system; and (b)(3) At least once every 6 months and whenever any of the following occur: (b)(3)(i) A complete change of reagents for a procedure is introduced, unless the laboratory can demonstrate that changing reagent lot numbers does not affect the range used to report patient test results, and control values are not adversely affected by reagent lot number changes. (b)(3)(ii) There is major preventive maintenance or replacement of critical parts that may influence test performance. (b)(3)(iii) Control materials reflect an unusual trend or shift, or are outside of the laboratory's acceptable limits, and other means of assessing and correcting unacceptable control values fail to identify and correct the problem. (b)(3)(iv) The laboratory's established schedule for verifying the reportable range for patient test results requires more frequent calibration verification. This STANDARD is not met as evidenced by: Based on lack of documentation and interview with testing personnel #1 (TP), the laboratory failed to perform calibration verification at least once every six months for 1 of 1 Fast Pack IP chemistry analyzer from 05/27/2021 to the date of survey. Findings include: 1. On the date of survey, 06/14/2023 at 02:00 pm, 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 -- could not provide calibration verification records for the required analytes tested on 1 of 1 Fast Pack IP chemistry analyzer from 05/27/2021 to 06/14/2023. 2. TP #1 confirmed the findings above on 06/14/2023 around 03:00 pm. 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 observation of the laboratory, review of laboratory records, and interview with the laboratory director (LD), the LD failed to provide overall management and direction of the laboratory in accordance with 493.1407 for a moderate complexity laboratory. Refer to 6018, 6022, 6054, and 5439. D6018 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(iii) 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)(iii) Ensure that all proficiency testing reports received are reviewed by the appropriate staff to evaluate the laboratory's performance and to identify any problems that require

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 review of the CASPER Report 155 report and graded results from the proficiency testing organization American Proficiency Institute (API), the laboratory failed to successfully participate in proficiency testing for the analyte Hemoglobin. Refer to D2130. D2130 HEMATOLOGY CFR(s): 493.851(f) Failure to achieve satisfactory performance for the same analyte in two consecutive 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 -- events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on a review of the CASPER 155 report and graded results from the proficiency testing organization American Proficiency Institute (API), the laboratory failed to successfully participate in proficiency testing for the analyte: Hemoglobin (HGB). The laboratory had unsatisfactory scores for the 3rd event of 2021, 1st event 2022 and 2nd event 2022. Findings include: Analyte Year Event Score HGB 2022 3 40% HGB 2022 1 0% HGB 2022 2 20% -- 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 review of the CASPER Report 155 report and graded results from the proficiency testing organization American Proficiency Institute (API), the laboratory failed to successfully participate in proficiency testing for the analyte Hemoglobin. Refer to D2130. D2130 HEMATOLOGY CFR(s): 493.851(f) Failure to achieve satisfactory performance for the same analyte in two consecutive 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 -- events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on a review of the CASPER 155 report and graded results from the proficiency testing organization American Proficiency Institute (API), the laboratory failed to successfully participate in proficiency testing for the analyte: Hemoglobin (HGB). The laboratory had unsatisfactory scores for the 3rd event of 2021, and 1st event 2022. Findings include: Analyte Year Event Score % HGB 2021 3 40 HGB 2022 1 0 -- 2 of 2 --

Summary Statement of Deficiencies 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, consultant competency. This STANDARD is not met as evidenced by: Based of review of the laboratory's procedure manuals and interview with laboratory director (LD), the laboratory failed to establish a procedure to assess the competency assessment of 1 of 1 testing personnel performing complete blood count (CBC) testing from 05/26/2019 to 05/26/2021. Findings include: 1. On the day of survey, 05/26 /2021, the LD could not provide a written policy and procedure to assess the competency assessment of 1 of 1 testing personnel performing complete blood count (CBC) testing from 05/26/2019 to 05/26/2021. 2. The LD confirmed the finding above on 05/26/2021 around 10:10 am. D5429 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(a)(1) For unmodified manufacturer's equipment, instruments, or test systems, the laboratory must perform and document maintenance as defined by the manufacturer and with at least the frequency specified by the manufacturer. This STANDARD is not met as evidenced by: Based on observation, lack of documentation and interview with the laboratory director (LD), the laboratory failed to document maintenance for 3 of 3 thermometers and 1 of 1 centrifuge from 05/26/2019 to 05/26/2021. Findings include: 1. On the day of survey, 05/26/2021, Observation of laboratory revealed: - A Thermo Scientific 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 -- thermometer on a large refrigerator service sticker stated, Due 1/24/2014. - A Fisher scientific traceable thermometer's service sticker stated, Due 2/20/2019. - A K2 Mini refrigerators internal thermometer was in use, but a service sticker was not available. - A PSS 602 centrifuge used for endocrinology was in use, but a service sticker was not available. 2. The laboratory was unable to provide a maintenance policy or documentation of maintenance performed on the 3 of 3 thermometers and 1 of 1 centrifuge. 3. The refrigerators stored reagents for the Fast pack IP system and the Beckman coulter Ac T diff 2 analyzer. 4. The LD confirmed the findings above round 1:45 pm. *** REPEAT DEFICIENCY*** 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 the review of patient test reports and interview with Laboratory Director (LD), the laboratory failed to include on patient endocrinology test reports either the patient's name and identification number, or a unique patient identifier and identification number from 05/26/2019 to the day of survey. Finding Include: 1. On the day of survey, 05/26/2021, a review of some test reports (3 of 3) revealed, the endocrinology test reports did not include a 2nd patient identifier or a unique patient identifier from 05/26/2019 to 05/26/2021. 2. The LD confirmed the finding above on 05/26/2021 around 1:30 pm. 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 observation of the laboratory, review of laboratory records, and interview with the laboratory director (LD), the LD failed to provide overall management and direction of the laboratory in accordance with 493.1407 for a moderate complexity laboratory. Refer to 6018 and 6022. D6018 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(iii) 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 -- 2 of 4 -- and for assuring compliance with the applicable regulations. (e) The laboratory director must-- (e)(4)(iii) Ensure that all proficiency testing reports received are reviewed by the appropriate staff to evaluate the laboratory's performance and to identify any problems that require

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 review of the CASPER Report 155 report and graded results from the proficiency testing organization American Association of Bioanalysts (AAB), the laboratory failed to successfully participate in proficiency testing for the analytes Hemogblobin and White Blood Cells (WBC). Refer to D2130. D2130 HEMATOLOGY CFR(s): 493.851(f) Failure to achieve satisfactory performance for the same analyte in two consecutive 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 -- events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on a review of the CASPER 155 report and graded results from the proficiency testing organization American Association of Bioanalysts (AAB), the laboratory failed to successfully participate in proficiency testing for the analyte: Hemoglobin (HGB). The laboratory had unsatisfactory scores for the 1st event of 2019, and 3rd event 2019. Findings include: Analyte Year Event Score HGB 2019 1 40 HGB 2019 3 60 Based on a review of the CASPER 155 report and graded results from the proficiency testing organization American Association of Bioanalysts (AAB), the laboratory failed to successfully participate in proficiency testing for the analyte: White Blood Cells (WBC). The laboratory had unsatisfactory scores for the 2nd event of 2019, and 3rd event 2019. Findings include: Analyte Year Event Score WBC 2019 2 40 WBC 2019 3 20 -- 2 of 2 --

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 Interview with Testing Personnel (TP) #2 and the American Association of Bioanalysts (AAB) Proficiency Testing (PT) record review, the laboratory failed to enroll in PT Hematology tests on the Beckman Coulter Act diff 2 Analyzer and Chemistry tests run on the Fast Pack IP system in 2018. Findings Include: 1. On the day of survey, 10/03/2018, when the surveyor asked to see ABB PT records, TP#2 stated, " PT has not yet been performed in 2018". Review of past AAB PT records revealed, the last PT performed onsite was event #3 of 2017. 2. Regulated analytes run on the Fast Pack IP system: Free Thyroxine and Thyroid Stimulating Hormone. 3. Regulated analytes run on the Act diff 2 Analyzer: Erythrocyte Count, Hematocrit, Hemoglobin, Platelets count and Cell Identification. 4. TP#2 confirmed that the laboratory was not enrolled in PT program for the tests listed above on 10/03/2018 around 10:15 am. D5209 PERSONNEL COMPETENCY ASSESSMENT POLICIES CFR(s): 493.1235 As specified in the personnel requirements in subpart M, the laboratory must establish Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 7 -- and follow written policies and procedures to assess employee and, if applicable, consultant competency. This STANDARD is not met as evidenced by: Based of review of laboratory's procedure manual and interview with the Testing Personnel (TP) #2, the laboratory failed to establish and follow written policy or procedure to assess employee competency from 06/08/2017 to the date of survey for 1 of 2 TP. Findings include: 1. On the day of survey, 10/03/2018, TP#2 could not produce a written policy and procedure to assess CLIA's 6 points of employee competency. 2. From 06/08/2018 to 10/03/2018, 1600 specimen were analyzed. 3. TP#2 confirmed on 10/03/2018 around 10:30 am that a competency assessment policy or procedure did not exist. D5403 PROCEDURE MANUAL CFR(s): 493.1251(b) The procedure manual must include the following when applicable to the test procedure: (1) Requirements for patient preparation; specimen collection, labeling, storage, preservation, transportation, processing, and referral; and criteria for specimen acceptability and rejection as described in 493.1242. (2) Microscopic examination, including the detection of inadequately prepared slides. (3) Step-by-step performance of the procedure, including test calculations and interpretation of results. (4) Preparation of slides, solutions, calibrators, controls, reagents, stains, and other materials used in testing. (5) Calibration and calibration verification procedures. (6) The reportable range for test results for the test system as established or verified in 493.1253. (7) Control procedures. (8)