Medical Associates Of Brownsville Pa

Summary Statement of Deficiencies D0000 The laboratory was found to be in substantial compliance with CLIA regulations 42 CFR Part 493. Standard level deficiencies were cited. D5401 PROCEDURE MANUAL CFR(s): 493.1251(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 review of the manufacturer's instructions for the Medonic M-series hematology analyzer, review of the laboratory's procedures, review of patient test records from April 2024 to May 2024, and staff interview, the laboratory failed to have documentation of following its procedure for addressing flagged white blood cell differential flags on 4 of 4 patient results. The findings included: 1. A review of the manufacturer's instructions for the Medonic M-series hematology analyzer (July 2019, Article no. 1504547) under the section titled "WBC Differential Abnormalities" determined the manufacturer identified the following flags: BD NM OM TM The manufacturer also included the following instructions for resolving the identified flags: "Blood sample too old or pathological sample. Follow laboratory's protocol for verification of results." 2. A review of the laboratory's procedure titled "Policy for Handling Flagged CBC Differentials" determined: "It will be the policy of this laboratory to rerun flagged CBC results. If the second run still shows flags, then the lab will evaluate flagged differentials according to the procedures in the unite's operator manual. See that the sample requirements are met, that the unit is in good working order, and that the testing procedure is correctly followed. If the flags disappear, then report that result. If the flags persist, then it will be considered an abnormal differential and will be invalidated and/or should be sent out for analysis." 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 -- 3. A review of patient test records from April 2024 to May 2024 identified the following 4 patient results with flags where the laboratory failed to invalidate the results or send the sample out for analysis: a) Test date: 04/01/2024 Patient: 37055 Flag: OM b) Test date: 04/01/2024 Patient: 73810 Flag: OM c) Test date: 04/01/2024 Patient: 74529 Flag: OM d) Test date: 05/30/2024 Patient: 74466 Flag: OM 4. The technical consultant confirmed the findings in an interview conducted 06/26/2024 at 1330 hours in the conference room. D5417 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(d) Reagents, solutions, culture media, control materials, calibration materials, and other supplies must not be used when they have exceeded their expiration date, have deteriorated, or are of substandard quality. This STANDARD is not met as evidenced by: Based on surveyor observation, review of manufacturer's instructions and staff interview, the laboratory failed to ensure expired reagent grade water was not available for use in the laboratory. The findings included: 1. Surveyor observation of laboratory supplies currently in use on 06/26/2024 at 1300 hours in the laboratory identified the following reagent grade water currently in use: EKI High Purity Reagent Grade Water 1- 20 Liter Box Lot: 2321601 Opened date: 10-27-2023 2. Review of the manufacturer's instructions for the EKI High Purity Reagent Grade Water determined: "Prolonged storage may have an adverse affect on the quality of this product. To reduce the risk of microbial contamination, consume entire contents within 30 days of opening. Thus, the water expired on 11-26-2023. It was in use for 7 months past its expiration. 3. The technical consultant confirmed the findings in an interview conducted on 06/26/2024 at 1330 in the conference room. D5813 TEST REPORT CFR(s): 493.1291(g) The laboratory must immediately alert the individual or entity requesting the test and, if applicable, the individual responsible for using the test results when any test result indicates an imminently life-threatening condition, or panic or alert values. This STANDARD is not met as evidenced by: Based on review of the laboratory's procedures, review of patient test records from 02 /01/2024 to 02/16/2024, review of the laboratory's critical value logs from February 2024 and staff interview, the laboratory failed to document the notification of 3 of 3 panic values. The findings included: 1. A review of the laboratory's policy titled "Panic Values" determined: "The Laboratory Personnel will immediately notify the requester or user about lab results in the 'Panic Range'. The laboratory's policy then defined the following Panic Ranges: Hemoglobin: 7.5 - 18 Hematocrit: 25 - 55 2. A review of the laboratory's policy titled "Reporting Panic Values" determined: "It is the policy of this lab to document the reporting of panic values. Document: who was notified, when that person was notified by whom" 3. A review of patient test records from 02/01/2024 to 02/16/2024 identified the following panic values: a) Test date: 02 /01/2024 Patient: 74136 Hematocrit: 23.8 b) Test date: 02/16/2024 Patient: 62436 Hemoglobin: 18.6 Hematocrit: 56.6 4. A review of the laboratory's critical value log from February 2024 determined the notification of the 3 critical values was not -- 2 of 3 -- documented. 5. The technical consultant confirmed the findings in an interview conducted on 06/26/2024 at 1440 hours in the conference room. -- 3 of 3 --

Summary Statement of Deficiencies D0000 The following deficiencies are a result of a desk review of proficiency testing scores obtained from the CMS (Centers for Medicare and Medicaid Services) national database and verified with the proficiency testing company, American Proficiency Institute (API). The laboratory was found to be NOT in compliance with the conditions of participation of the CLIA program based on the following CONDITION LEVEL DEFICIENCIES: 493.803 Successful participation [proficiency testing] 493.1403 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 a desk review of proficiency testing records obtained from the CMS (Center 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 -- for Medicare Services) national database and verified with the proficiency testing company, American Proficiency Institute (API), it was determined the laboratory failed to 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 immunology for the analyte of antinuclear antibody (refer to D2085). D2085 GENERAL IMMUNOLOGY CFR(s): 493.837(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 desk review of the CMS 155 report and proficiency testing records from American Proficiency Institute (API), it was determined the laboratory failed to achieve satisfactory performance for the same analyte in three of five testing events for the analyte of antinuclear antibody (ANA) resulting in an unsuccessful performance. The findings include: 1. A review of the CMS 155 report revealed the laboratory received the following unsatisfactory scores (passing = >80%) for the analyte antinuclear antibody: Third testing event 2021: 60% Second testing event 2022: 40% First testing event 2023: 0% 2. A desk review of the laboratory's American Proficiency Institute's results from the third event of 2021, the second event of 2022, and first event of 2023 revealed the following scores: Third testing event 2021: 60% Second testing event 2022: 40% First testing event 2023: 0% 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 desk review of laboratory proficiency testing performance it was revealed that 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: -- 2 of 3 -- Based on a desk review of proficiency testing results it was revealed that the laboratory director failed to ensure 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 D2085). -- 3 of 3 --

Summary Statement of Deficiencies D0000 Based on a proficiency testing desk review survey performed on September 23, 2022, the laboratory was found to be out of compliance based on the following CONDITION LEVEL DEFICIENCIES: D2016 - 42 C.F.R. 493.803 Condition: Successful participation D6000 - 42 C.F.R. 493.1403 Condition: Laboratory Director, moderate complexity 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) Report 155 Individual Laboratory Profile and American Proficiency Institute proficiency testing records, the laboratory failed to successfully participate in 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 -- two of three testing events for the analyte ANA (Anti-nuclear antibodies) in 2021 and 2022, resulting in unsuccessful performance. Refer to D2084. D2084 GENERAL IMMUNOLOGY CFR(s): 493.837(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 155 Individual Laboratory Profile and the American Proficiency Institute (API) Comparative Evaluations, the laboratory failed to achieve satisfactory performance for the analyte ANA (Anti-nuclear antibodies) in two of three testing events in 2021 and 2022. The findings included: 1. Based on review of the Certification and Survey Provider Enhanced Reporting (CASPER) Report 155 Individual Laboratory Profile and the American Proficiency Institute (API) Comparative Evaluations, the laboratory received the following unsuccessful performance for the analyte ANA (Anti-nuclear antibodies) in the specialty of General Immunology in two of three events: 2021 API (event 3) ANA (analyte #0095) 60% 2022 API (event 2) ANA (analyte #0095) 40% Failure to achieve satisfactory performance for the same analyte in two of three testing events is unsuccessful 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: Based on desk review of the Certification and Survey Provider Enhanced Reporting (CASPER) Report 155 Individual Laboratory Profile and American Proficiency Institute (API) proficiency testing records, the laboratory director failed to ensure successful participation in an HHS approved proficiency testing program for the analyte ANA (Anti-nuclear antibodies) in the specialty of General Immunology. 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; -- 2 of 3 -- This STANDARD is not met as evidenced by: Based on desk review of the Certification and Survey Provider Enhanced Reporting (CASPER) Report 155 Individual Laboratory Profile and American Proficiency Institute (API) proficiency testing records, the laboratory director failed to ensure successful participation in an HHS approved proficiency testing program for analyte ANA (Anti-nuclear antibodies) in the specialty of General Immunology. Refer to D2084. -- 3 of 3 --

Summary Statement of Deficiencies D0000 The facility was found to be out of compliance with the conditions of participation of the CLIA program. The following CONDITION LEVEL DEFICIENCIES were found to be out of compliance: 493.803 successful participation in a proficiency testing program 493.1403 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 laboratory's American Proficiency Institute (API) proficiency testing records, and confirmed in interview of facility personnel, it was determined that laboratory has not successfully participated in a proficiency testing program 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 -- approved by HHS, for each specialty, subspecialty, and analyte or test in which the laboratory is certified under CLIA. The laboratory did not successfully participate in the specialty of chemistry for the analyte Sodium (refer to D2096). D2087 ROUTINE CHEMISTRY CFR(s): 493.841(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 review of the laboratory's American Proficiency Institute (API) proficiency testing records, and confirmed in interview of facility personnel, it was determined the laboratory failed to attain a score of at least 80% acceptable responses for each analyte in the subspecialty of chemistry. The findings were: 1. Review of the laboratory's API proficiency testing records for Chemistry 2019 (events 1, 2, and 3) and Chemistry 2020 (events 1, 2, and 3) revealed the following failures for Sodium: 2020 (event 2): laboratory scored 60% 2020 (event 3): laboratory scored 60% 2. The findings were confirmed in interview of the technical consultant and the primary testing person on October 21, 2020 at 10:30 hours in the conference room. 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 review of the laboratory's American Proficiency Institute (API) proficiency testing records, and confirmed in interview of facility personnel, it was determined the laboratory failed to achieve satisfactory performance (80% or greater) for the same analyte in two consecutive testing events in the specialty of Chemistry for the analyte Sodium (NA). Two out of three unsatisfactory scores results in unsuccessful PT performance. The findings were: 1. Review of the laboratory's API proficiency testing records for Chemistry 2019 (events 1, 2, and 3) and Chemistry 2020 (events 1, 2, and 3) revealed the following failures for Sodium: 2020 (event 2): laboratory scored 60% 2020 (event 3): laboratory scored 60% 2. The findings were confirmed in interview of the technical consultant and the primary testing person on October 21, 2020 at 10:30 hours in the conference room. D5411 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(a) Test systems must be selected by the laboratory. The testing must be performed following the manufacturer's instructions and in a manner that provides test results within the laboratory's stated performance specifications for each test system as determined under 493.1253. This STANDARD is not met as evidenced by: -- 2 of 4 -- Based on review of manufacturer's instructions, review of patient test records, and confirmed in interview of facility personnel, the laboratory failed to follow the manufacturer's instructions for test performance on the In vitro Nano-Check AMI 3 IN 1 Cardiac Marker Test cTNI, CK-MB, and Myoglobin test kit. The findings were: 1. Review of the manufacturer's instructions for the In vitro Nano-Check AMI 3 IN 1 Cardiac Marker Test cTNI, CK-MB, and Myoglobin test kit (P/N EP-2401 R1 /052015) stated under the 2nd bullet point of Limitations, "A positive test result may only be used as an indicator of myocardial damage and requires further confirmation. Serial sampling of patients suspected of AMI at multiple time points is also recommended due to the delay between onset of symptoms and the release of cardiac marker proteins into the blood stream." 2. Random review of patient test records from January 2019 to October 20, 2020, the date of the survey found the following patient samples that were not confirmed as required by the manufacturer: Last 3 digits of Account Number: 003 Date Tested: 09-18-2020 Myoglobin Result: Abnormal Last 3 digits of Account Number: 832 Date Tested: 06-04-2020 CK-MB Result: Abnormal Myoglobin Result: Abnormal Last 3 digits of Account Number: 787 Date Tested: 04- 30-2020 CK-MB Result: Abnormal Myoglobin Result: Abnormal Last 3 digits of Account Number: 679 Date Tested: 08-26-2019 Myoglobin Result: Abnormal Last 3 digits of Account Number: 832 Date Tested: 05-15-2019 CK-MB Result: Abnormal Myoglobin Result: Abnormal Last 3 digits of Account Number: 269 Date Tested: 04- 29-2019 Troponin I Result: Abnormal CK-MB Result: Abnormal Myoglobin Result: Abnormal Last 3 digits of Account Number: 696 Date Tested: 04-16-2019 CK-MB Result: Abnormal Myoglobin Result: Abnormal Last 3 digits of Account Number: 162 Date Tested: 04-01-2019 CK-MB Result: Abnormal Last 3 digits of Account number: 265 Date Tested: 03-25-2019 CK-MB Result: Abnormal Last 3 digits of Account number: 997 Date Tested: 03-21-2019 CK-MB Result: Abnormal Myoglobin Result: Abnormal Last 3 digits of Account Number: 295 Date Tested: 02-15-2018 CK- MB Result: Abnormal Myoglobin Result: Abnormal Last 3 digits of Account Number: 296 Date Tested: 02-15-2019 CK-MB Result: Abnormal Myoglobin Result: Abnormal Last 3 digits of Account Number: 260 Date Tested: 02-11-2019 CK-MB Result: Abnormal 3. The laboratory was asked to provide documentation of confirming the results as required by the manufacturer. No documentation was provided. 4. An interview with the technical consultant and the primary testing person on October 21, 2020 at 14:00 hours in the conference room confirmed the findings. Key: CK-MB - creatine kinase primarily found in heart muscle TnI - troponin AMI - acute myocardial infarction D5469 CONTROL PROCEDURES CFR(s): 493.1256(d)(10)(g) Unless CMS Approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub. 7), that provides equivalent quality testing, the laboratory must-- Establish or verify the criteria for acceptability of all control materials. (i) When control materials providing quantitative results are used, statistical parameters (for example, mean and standard deviation) for each batch and lot number of control materials must be defined and available. (ii) The laboratory may use the stated value of a commercially assayed control material provided the stated value is for the methodology and instrumentation employed by the laboratory and is verified by the laboratory. (iii) Statistical parameters for unassayed control materials must be established over time by the laboratory through concurrent testing of control materials having previously determined statistical parameters. (g) The laboratory must document all control procedures performed. -- 3 of 4 -- This STANDARD is not met as evidenced by: Based on review of the manufacturer's instructions for the AIA-Pack 25-OH Vitamin D Control Set, and staff interview, it was revealed the laboratory failed to have documentation of establishing its own means and ranges as required by the manufacturer. The findings were: 1. A review of the manufacturer's instructions for the AIA-Pack 25-OH Vitamin D Control Set (Document No. 100B774001-115D, Rev. 11/15) under the section titled "Assignment of Values" revealed, "The AIA-Pack 25-OH Vitamin D Control Set contains assigned concentration range of 25-OH Vitamin D. The assigned value is determined on a lot-by-lot basis and is designed to provide target control levels of approximately 17 and 66 ng/mL of 25-OH vitamin D. Since the assay values are dependent upon assay procedures as well as several other factors, each laboratory should established its own range for the assay procedure being monitored." 2. The laboratory was asked to provide documentation of establishing the ranges for the AIA-Pack 25-OH Vitamin D Control Set Lot #s A64B745, J24B737, and J84B740. No documentation was provided. 3. An interview with the technical consultant and the primary testing person on October 21, 2020 at 13: 30 hours in the conference room confirmed the findings. Key: OH - hydroxide ng/mL - nanograms per milliliter 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 review of the laboratory's American Proficiency Institute (API) proficiency testing records and confirmed in interview of facility personnel, it was revealed that 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 review of the laboratory's American Proficiency Institute (API) proficiency testing records and confirmed in interview of facility pesonnel, it was revealed that the laboratory director failed to ensure successful participation in a HHS approved proficiency testing program. Refer to D2096. -- 4 of 4 --

Summary Statement of Deficiencies D0000 The laboratory was surveyed on July 24, 2018 and found to be in compliance with the CLIA regulations and recertification is recommended. 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 on review of personnel records and confirmed in interview of facility personnel, the laboratory failed to provide documentation of a competency assessment for each of its technical consultants. The findings were: 1. Review of the laboratory's submitted Form CMS-209 revealed the laboratory director identified two technical consultants. 2. Review of personnel records revealed no competency assessment was available for review for technical consultant one (as listed on Form CMS-209). 3. The above findings were confirmed in interview of technical consultant two (as listed on Form CMS-209) on July 24, 2018 at 10:15 hours in the conference room. Key: CMS - Centers for Medicare and Medicaid Services D5213 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(b)(1) The laboratory must verify the accuracy of any analyte or subspecialty without analytes listed in subpart I of this part that is not evaluated or scored by a CMS- approved proficiency testing program. This STANDARD is not met as evidenced by: 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 -- Based on review of the laboratory's American Proficiency Institute (API) proficiency testing results from 2016, 2017, and 2018, and confirmed in interview of facility personnel, the laboratory failed to provide documentation of evaluating proficiency testing results returned as 'not graded' by the proficiency testing agency. The findings included: 1. A review of the laboratory's API proficiency testing results from 2016 (events 2 and 3), 2017 (events 1, 2, and 3), and 2018 (event 1) revealed the proficiency agency returned the following results as "Not Graded": 2016 Immunology /Immunohematology (event 2) Analyte: Anti-RNP/Sm Sample ID: ANA-06 Grade: Not Graded-2 2016 Immunology/Immunohematology (event 2) Analyte: Antinuclear Antibody Sample ID: ANA-08 Grade: Not Graded-2 2016 Immunology /Immunohematology (event 2) Analyte: Antinuclear Antibody Sample ID: ANA-10 Grade: Not Graded-2 2016 Immunology/Immunohematology (event 3) Analyte: Anti- RNP/Sm Sample ID: ANA-14 Grade: Not Graded-2 2016 Immunology /Immunohematology (event 3) Analyte: Antinuclear Antibody Sample ID: ANA-12 Grade: Not Graded-2 2016 Immunology/Immunohematology (event 3) Analyte: Antinuclear Antibody Sample ID: ANA-13 Grade: Not Graded-2 2. The proficiency testing agency defined code "2" as: No Consensus. 3. An interview with technical consultant two (as listed on Form CMS-209) on July 24, 2018 at 10:29 hours in the conference room confirmed the findings. 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 laboratory policy, review of the laboratory's calibration verification records for analytes tested on the Ace Alera chemistry analyzer for 2017 and 2018, and confirmed in interview of facility personnel, it was revealed the laboratory failed to have documentation of performing the calibration verification every 6 months. The findings were: 1. Review of the laboratory's policy titled, "Instrument Operation and Maintenance" approved by the laboratory director on August 17, 2005 stated, "Calibration of all laboratory instruments will be every six months, every time there is a complete change in lot numbers, or when controls don't give desired results ..." 2. A -- 2 of 4 -- review of the laboratory's calibration verification records for analytes performed on the Ace Alera chemistry analyzer in 2016, 2017, and 2018 revealed the laboratory had documentation of performing calibration verification at the following times: June 2016 December 2016 June 2017 December 2017 3. The calibration verification performed in December 2016 and June 2017 were incomplete. The documentation provided had not been evaluated to ensure the continued accuracy of the analytes throughout the instrument's reportable range. 4. An interview with the technical consultant on July 24, 2018 at 13:10 hours in the conference room confirmed the findings. She reviewed and approved the calibration verifications during the onsite recertification survey. D5445 CONTROL PROCEDURES CFR(s): 493.1256(d)(1)(2)(g) Unless CMS Approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub. 7), that provides equivalent quality testing, the laboratory must-- (d)(1) Perform control procedures as defined in this section unless otherwise specified in the additional specialty and subspecialty requirements at 493.1261 through 493.1278. (d)(2) For each test system, perform control procedures using the number and frequency specified by the manufacturer or established by the laboratory when they meet or exceed the requirements in paragraph (d)(3) of this section. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on review of the laboratory's Individualized Quality Control Plan (IQCP), and confirmed in interview of facility personnel, the laboratory failed to provide documentation that the QA (quality assessment) portion of the IQCP included procedures for ongoing monitoring of the effectiveness of its IQCP. The findings were: 1. Review of the laboratory's IQCP revealed it was approved by the laboratory director on January 4, 2016. 2. Further review of the study revealed, "B.___The IQCP continues to be sufficient to mitigate risk in my laboratory." This portion was also signed on January 4, 2016. 3. Review of the quality assessment portion of the IQCP failed to include procedures for ongoing monitoring of the IQCP. 4. The above findings were confirmed in interview of the technical consultant on July 24, 2018 at 11:30 hours in the conference room. D6046 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(8) (b) The technical consultant is responsible for-- (b)(8) Evaluating the competency of all testing personnel and assuring that the staff maintain their competency to perform test procedures and report test results promptly, accurately and proficiently. This STANDARD is not met as evidenced by: Based on review of the laboratory's personnel records, and confirmed in interview of facility personnel, the technical consultant failed to perform a complete competency assessment for testing personnel two (as listed on Form CMS-209). The findings were: 1. Review of the laboratory's personnel files revealed testing personnel two (as listed on Form CMS-209) had assigned testing responsibilities for moderate complexity testing to include cardiac testing (Troponin, Myoglobin, and CKMB), CBC (Complete Blood Count), and chemistry testing on the Ace Alera chemistry -- 3 of 4 -- analyzer. 2. An interview with testing personnel two on July 24, 2018 at 09:50 hours in the laboratory confirmed his moderate complexity testing assignments. When asked if he performs patient cardiac testing and testing on the Ace Alera, he stated, "Yes." He went on to confirm he did not test patient samples on the TOSOH analyzer. 3. Review of the competency assessment for testing personnel two (as listed on Form CMS-209) revealed no tests were listed under, "Testing System(s)." 4. In an interview with the technical consultant on July 24, 2018 at 09:55 hours in the conference room, she revealed she only evaluated him for hematology testing. This confirmed the findings. Key: CMS - Centers for Medicare and Medicaid CKMB - creatine kinase muscle brain -- 4 of 4 --