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Summary Statement of Deficiencies D0000 A proficiency testing desk review survey was performed on December 4, 2024, the laboratory was found not in compliance with the following CONDITION LEVEL DEFICIENCIES D2016 - 42 C.F.R. 493.803 Condition: Successful participation [proficiency testing] D6000 - 42 C.F.R. 493.1403 Condition: 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 CASPER report 155 and graded results from the College of 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 -- American Pathologists (CAP), the laboratory failed to successfully particiapte in four out of five Proficiency Testing (PT) events in the subspecialty Routine Chemistry for the analyte Sodium (NA). 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 review of the CASPER 155 report and graded results from College of American Pathologists (CAP), the laboratory failed to achieve satisfactory performance (80% or greater) for four out of five events in the subspecialty Routine Chemistry for the analyte Sodium (NA).The findings include: 1) A Review of the CASPER 155 report revealed the following: a) The laboratory scored 0% for NA in event 2-2023. b) The laboratory scored 60% for NA in event 3-2023. c) The laboratory scored 60% for NA in event 2-2024. d) The laboratory scored 0% for NA in event 3-2024. 2. A review of CAP graded results confirmed the above failed PT events. 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 CASPER 155 report and graded results from College of American Pathologists (CAP) the Laboratory Director (LD) failed to provide overall management and direction to laboratory personnel to ensure that the Proficiency Testing (PT) surveys are performed satisfactorily and in compliance with Clinical Laboratory Improvement Amendments (CLIA) regulations. The findings include: 1. The LD failed to ensure PT surveys are performed satisfactorily and in compliance with CLIA regulations. 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 a review of the CASPER 155 report and graded results from College of -- 2 of 3 -- American Pathologist (CAP) the Laboratory Director (LD) failed to ensure successful participation in a Department of Health and Human Services (DHHS) approved Proficiency Testing (PT) program for four out of five PT events for the analyte Sodium (NA) resulting in subsequent unsuccessful performance. Refer to D2096. -- 3 of 3 --

Summary Statement of Deficiencies D0000 A proficiency testing desk review survey was performed on December 4, 2024, the laboratory was found not in compliance with the following CONDITION LEVEL DEFICIENCIES D2016 - 42 C.F.R. 493.803 Condition: Successful participation [proficiency testing] D6000 - 42 C.F.R. 493.1403 Condition: Laboratories performing moderate complexity testing; laboratory director D2016 Based on review of CASPER report 155 and graded results from the College of American Pathologists (CAP), the laboratory failed to achieve 80% or more in two out of three events for Routine Chemistry for the analytes Alanine Transaminase (ALT), Amylase (AMY), Aspartate Aminotransferase (AST), and Chloride (CL). D2096 Based on review of the CASPER 155 report and graded results from College of American Pathologists (CAP), the laboratory failed to achieve satisfactory performance (80% or greater) for four out of five events in the subspecialty Routine Chemistry for the analyte Sodium (NA).The findings include: 1) A Review of the CASPER 155 report revealed the following: a) The laboratory scored 0% for NA in event 2-2023. b) The laboratory scored 60% for NA in event 3-2023. c) The laboratory scored 60% for NA in event 2-2024. d) The laboratory scored 0% for NA in event 3-2024. 2. A review of CAP graded results confirmed the above failed PT events. D6000 Based on review of the CASPER 155 report and graded results from College of American Pathologists (CAP) the Laboratory Director (LD) failed to provide overall management and direction to laboratory personnel to ensure that the Proficiency Testing (PT) surveys are performed satisfactorily and in compliance with Clinical Laboratory Improvement Amendments (CLIA) regulations. The findings include: 1. The LD failed to ensure PT surveys are performed satisfactorily and in compliance with CLIA regulations. Refer to D6016. D6016 Based on a review of the CASPER 155 report and graded results from College of American Pathologist (CAP) the Laboratory Director (LD) failed to ensure successful participation in a Department of Health and Human Services (DHHS) approved 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 -- Proficiency Testing (PT) program for four out of five PT events for the analyte Sodium (NA) resulting in subsequent unsuccessful performance. Refer to D2096. -- 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 surveyor review of the Proficiency Testing (PT) evaluation records, work records and interview with Laboratory Manager (LM)) the laboratory failed to participate in PT events "K-B 2023 Ligand-General" and "C-B 2023 General Chemistry/Therapeutic Drugs" with the College of American Pathologists (CAP). D3029 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(2) Test procedures. Retain a copy of each test procedure for at least 2 years after 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 6 -- procedure has been discontinued. Each test procedure must include the dates of initial use and discontinuance. This STANDARD is not met as evidenced by: Based on surveyor review of the Procedure Manual (PM) and interview with the Laboratory Manager (LM), the laboratory failed to include the dates of initial use and discontinuance for "RPR Card Test N/A" procedure on 11/20/24. The finding includes: 1. The PM had a procedure for serology testing. 2. The laboratory does not performed Serology testing. 3. The LM stated "she did know why" the procedure was in the PM. 4. The PM for "RPR Card Test N/A" had no dates of initial use and discontinuance. 5. The LM confirmed on 11/20/24 at 1:00 pm that the laboratory failed to include the dates of initial use and discontinuance for the aforementioned procedure. D5211 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(a) The laboratory must review and evaluate the results obtained on proficiency testing performed as specified in subpart H of this part. This STANDARD is not met as evidenced by: Based on surveyor review of the Proficiency Testing (PT) records and interview with the Laboratory Manager (LM) it was revealed that the laboratory failed to review code 11 "Unable to Analyze. Documentation to be provided by laboratory" results obtained for Chemistry, endocrinology and Toxicology performed with the College of American Pathologists (CAP) in the calendar years 2023, and 2024 The finding includes: 1. Code 11 result were received for event "C-A 2024 General Chemistry /Therapeutic Drugs" as follows. a) Amylase, Serum specimens CHM-01, CHM-02, CHM-03, CHM-04, CHM-05 b) Creatine Kinae specimens CHM-01, CHM-02, CHM- 03, CHM-04, CHM-05. c) Pancreatic Amylase specimens CHM-01, CHM-02, CHM- 03, CHM-04, CHM-05. d) Triiodothyronine (T3) specimens CHM-01, CHM-02, CHM-03, CHM-04, CHM-05. 2. Code 11 result were received for event "C-B 2024 General Chemistry/Therapeutic Drugs" as follows. a) Pancreatic Amylase specimens CHM-06, CHM-07, CHM-08, CHM-09, CHM-10. 3. Code 11 result were received for event "K-B 2023 Ligand-General" as follows. a) Ferritin specimens K-06, K-07, K- 08, K-09, K-10. b) Folate specimens K-06, K-07, K-08, K-09, K-10. c) Vitamin B-12 specimens K-06, K-07, K-08, K-09, K-10. d) Prostate Specific Ag (PSA) specimens K-06, K-07, K-08, K-09, K-10. e) PSA, Free specimens K-06, K-07, K-08, K-09, K- 10. 3. Code 11 result were received for event "C-C 2023 General Chemistry /Therapeutic Drugs" as follows. a) Amylase, Serum specimens CHM-11, CHM-12, CHM-13, CHM-14, CHM-15 b) T3 specimens CHM-11, CHM-12, CHM-13, CHM- 14, CHM-15. 3. The LM confirmed on 11/20/24 at 10:30 am that the laboratory failed to evaluate code 11 PT results. Note: This was previously cited. 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 -- 2 of 6 -- for nonparticipation, or late return or results). This STANDARD is not met as evidenced by: Based on surveyor review of the Proficiency Testing (PT) records and interview with the Laboratory Manager (LM) laboratory failed to verify the accuracy of Chemistry and Endocrinology test results obtained from the College of American Pathologists (CAP) for the calendar years 2023 and 2024. The findings include: 1. The laboratory received a 100% but results were received a code 20 "response was not formally graded due to insufficient peer group data. Please see the participant summary for additional information". 2. There was no documented evidence the laboratory verified code 20 for event "C-A 2024 General Chemistry/Therapeutic Drugs" as follows: a) High-density lipoprotein (HDL) Cholesterol, specimens CHM-01, CHM-02, CHM- 03, CHM-04, CHM-05. b) Triglycerides, specimens CHM-01, CHM-02, CHM-03, CHM-04, CHM-05. c) Unsaturated iron-binding capacity (UIBC), specimens CHM- 01, CHM-02, CHM-03, CHM-04, CHM-05. 3. There was no documented evidence the laboratory verified code 20 for event "C-B 2024 General Chemistry/Therapeutic Drugs" as follows: a) HDL Cholesterol, specimens CHM-01, CHM-02, CHM-03, CHM-04, CHM-05. b) Triglycerides, specimens CHM-01, CHM-02, CHM-03, CHM- 04, CHM-05. c) UIBC, specimens CHM-01, CHM-02, CHM-03, CHM-04, CHM-05. 4. There was no documented evidence the laboratory verified code 20 for event "ESR- A 2024 Erythrocyte Sedimentaion Rate" as follows: a) Erythrocyte Sedimentation Rate (ESR) Specimens ESR-01, ESR-02, ERS-04. 5. There was no documented evidence the laboratory verified code 20 for event "S2-A 2024 Special Immunology" as follows: a) Anti-throglobulin,qu samples S2-03 an S2-04. b) Anti-thyroid perox, qu samples S2-03 an S2-04 6. There was no documented evidence the laboratory verified code 20 for event "S2-B 2024 Special Immunology" as follows: a) Anti-throglobulin, qu samples S2-21 an S2-22. b) Anti-thyroid perox, qu samples S2-21 an S2-22. 7. There was no documented evidence the laboratory verified code 20 for event "C-C 20234 General Chemistry/Therapeutic Drugs" as follows: a) HDL specimens CHM- 11, CHM-12, CHM-13, CHM-14, CHM-15. b) Triglycerides, specimens CHM-11, CHM-12, CHM-13, CHM-14, CHM-15. 8. The LM confirmed on 11/20/24 at 10:20 am accuracy of the PT results were not verified Note: This was previously 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: A) Based on surveyor review of the Procedure Manual (PM), and interview with the Laboratory Manager (LM), the laboratory failed to follow all procedures written for proficiency testing review 10/25/22 to the 11/20/24. The findings include: 1. There was no documented evidence the log in "Investigation of Proficiency test scores less than 100%" was used. 2. The LM confirmed on 11/20/24 at 10:30 am that the laboratory did not follow the PM. Note: This was previously cited. B) Based on surveyor review of the Procedure Manual (PM), and interview with the Laboratory Manager (LM), the laboratory failed to follow all procedures written for Quality Controls (QC) review 10/25/22 to the 11/20/24. The findings include: 1. The PM -- 3 of 6 -- states "Make sure there is no shifting in control" 2. There was no documented evidence that laboratory monitored shifts and trends in QC values. 3. The LM confirmed on 11/20/24 at 10:30 am that the laboratory did not follow the PM. C) Based on surveyor review of the PM and interview with the LM, the laboratory failed to maintain complete procedures written for QC review from 10/25/22 to the 11/20 /24. The findings include: 1. The PM did not define a time frame on how and when "Shifting in controls" are monitored. 2. The PM did not define who will review and accept the procedure "Make sure there is no shifting in control". 3. The LM confirmed on 11/20/24 at 10:30 am the laboratory failed to maintain complete procedures written for QC review. D5779

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 an office review of the CASPER reports 153 and 155 and proficiency testing provider reports, the laboratory failed to achieve 80% or more in two out of three events for Routine Chemistry and Toxicology testing with the College of American Pathologists (CAP). . D2087 ROUTINE CHEMISTRY CFR(s): 493.841(a) Failure to attain a score of at least 80 percent of acceptable responses for each analyte 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 -- in each testing event is unsatisfactory analyte performance for the testing event. This STANDARD is not met as evidenced by: Based on an office review of the CASPER reports 153 and 155 and Proficiency Testing (PT) provider reports, the laboratory failed to achieve at least 80% for the Lactate Dehydrogenase (LDH) and Sodium (NA) tests. The finding includes: 1) The laboratory scored 0% for Sodium in event C-2023 with the College of American Pathologists (CAP). 2) The laboratory scored 60% for Sodium in event B-2023 with the CAP. 3) The laboratory scored 0% for LDH in event C & B-2023 with the CAP. D2089 ROUTINE CHEMISTRY CFR(s): 493.841(c) Failure to participate in a testing event is unsatisfactory performance and results in a score of 0 for the testing event. Consideration may be given to those laboratories failing to participate in a testing event only if-- (1) Patient testing was suspended during the time frame allotted for testing and reporting proficiency testing results; (2) The laboratory notifies the inspecting agency and the proficiency testing program within the time frame for submitting proficiency testing results of the suspension of patient testing and the circumstances associated with failure to perform tests on proficiency testing samples; and (3)The laboratory participated in the previous two proficiency testing events. This STANDARD is not met as evidenced by: Based on an office review of the CASPER reports 153, 155 and the performance summary form College of American Pathologists (CAP), 2023 Rountine Chemistry tests event B. The laboratory failed to participate in CAP aforementioned Proficiency Testing (PT) event of 2023 for Routine Chemistry tests. D2111 TOXICOLOGY CFR(s): 493.845(c) Failure to participate in a testing event is unsatisfactory performance and results in a score of 0 for the testing event. Consideration may be given to those laboratories failing to participate in a testing event only if-- (1) Patient testing was suspended during the time frame allotted for testing and reporting proficiency testing results; (2) The laboratory notifies the inspecting agency and the proficiency testing program within the time frame for submitting proficiency testing results of the suspension of patient testing and the circumstances associated with failure to perform tests on proficiency testing samples; and (3) The laboratory participated in the previous two proficiency testing events. This STANDARD is not met as evidenced by: Based on an office review of the CASPER reports 153, 155 and the performance summary form College of American Pathologists (CAP), 2023 Toxicolgy test event C. The laboratory failed to participate in the CAP aforementioned Proficiency Testing (PT) event of 2023 for Toxicolgy test. D2118 TOXICOLOGY CFR(s): 493.845(f) -- 2 of 3 -- 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 an office review of the CASPER report 153 and 155 and Proficiency Testing (PT) provider reports, the laboratory failed to achieve a score of at least 80% or more for Lithium. The finding includes: The laboratory scored 0 % in event 2-2023 and 0% in event 3-2023 PT events with the College of American Pathologists. 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 an office review of the laboratory's performance in Proficiency Testing (PT) surveys, the laboratory director failed to provide appropriate direction to the laboratory personnel to ensure that the PT surveys are performed satisfactorily and compliance with the CLIA regulations are maintained. -- 3 of 3 --

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 surveyor review of the Proficiency Testing (PT) evaluation records, work records and interview with Techincal Consultant (TC) the laboratory failed to participate in PT for events A-B 2022 General Chemistry/Therapeutic Drugs and VITD-B 2021 25-OH Vitamin D with the College of American Pathologists. D3009 FACILITIES CFR(s): 493.1101(c) The laboratory must be in compliance with applicable Federal, State, and local 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 -- laboratory requirements. This STANDARD is not met as evidenced by: Based on surveyor review of the laboratories NJ State License, Proficiency Testing (PT) and interview with the State of New Jersey Proficiency Provider Program lead, the Laboratory Director (LD) failed to be in compliance with New Jersey Administrative code N.J.A.C. 8:44-2.5(b)3. The finding includes: 1. N.J.A.C. 8:44-2.5 (b)3. states Laboratories shall: iii. Maintain records of all proficiency testing results in surveys in which they participate and make such records, including results, interpretations and cumulative performance data routinely available to the Department of Health and Senior Services. 2. The LD failed to make PT data routinely available to the Department of Health and Senior Services. 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 surveyor review of the Competency Assessment (CA) records and interview with the Techincal Consultant (TC) the laboratory failed to follow its policies and procedures for assessing the competency of Testing Personnel (TP) who perform Endocrinology, Hematology, and routine chemistry testing from 11/12/16 to the date of survey. The findings include: 1. The laboratory failed to use all the required elements applicable to Endocrinology, Hematology and Routine Chemistry for assessing the competency of TP. The laboratory did not use: a. #4 assessment of test performance through proficiency testing, blind sampling or previously analyzed specimens 2. The CA did not include evaluation of TP specifically for Endocrinology, Hematology and Routine Chemistry. 3. The TC confirmed on 10/25/22 at 10:00 am the laboratory did not use the follow the CA procedure. D5211 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(a) The laboratory must review and evaluate the results obtained on proficiency testing performed as specified in subpart H of this part. This STANDARD is not met as evidenced by: a) Based on surveyor review of the Proficiency Testing (PT) records and interview with the Techincal Consultant (TC) it was revealed that the laboratory failed to review code 20 "No appropriate target/response could not be graded" results obtained for Chemistry, Hematology and Endocrinology PT performed with the College of American Pathologists (CAP) in the calendar years 2020, 2021 and 2022 The finding includes: 1. Code 20 results were received for all anayltes for "Hematology Auto Differentials,FH1" three events in 2021 and events FH1-A 2022 and FH1-B 2022. 2. Code 20 Results where received for Triglycerides Samples CHM-11 through 15 in event C-C 2021 General chemistry/therapeutic Drugs. 3. Code 20 results where received for Thyroid Stimulating Hormone samples CHM-06 through 10 in event C-B -- 2 of 8 -- 2021 General Chemistry/Therapeutic Dugs 4. The TC confirmed on 10/25/22 at 10:30 am that the laboratory failed to evaluate code 20 PT results. b) Based on surveyor review of the Proficiency Testing (PT) records and interview with the TC it was revealed that the laboratory failed to review code 11 "Unable to Analyze. Documentation to be provided by laboratory" results obtained for Chemistry performed with the College of American Pathologists (CAP) in the calendar years 2020, 2021 and 2022 The finding includes: 1. Code 11 result were received for Thyroid Stimulating Hormone samples CHM-01 through 05 event C-A 2021 General Chemistry/Therapeutic Drugs. 2. The TC confirmed on 10/25/22 at 10:30 am that the laboratory failed to evaluate code 11 PT results. 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 surveyor review of the Proficiency Testing (PT) records and interview with the Techincal Consultant (TC), the laboratory failed to verify the accuracy of Chemistry and Hematology test results obtained from the College of American Pathologists (CAP) for the calendar years 2021 and 2022. The findings include: 1. The laboratory received a 100 but results were received a code 20. 2. There was no documented evidence the laboratory verified: a. "Hematology Auto Differentials, FH1" three events in 2021 and events FH1-A 2022 and FH1-B 2022 all analytes. 3. There was no documented evidence the laboratory verified: a. Thyroid Stimulating Hormone event C-B 2021 General Chemistry/Therapeutic Dugs 4. The TC confirmed on 10/25/22 at 10:20 am accuracy of the PT results were not verified 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 surveyor review of the Procedure Manual (PM), and interview with the Technical Consultant (TC), the laboratory failed to follow all procedures written for proficiency testing review and review of unacceptable controls from 11/12/19 to the date of the survey. The findings include: 1. There was no documented evidence the logs in the PM labeled "Review of Controls for Unacceptable Results" and "Investigation of Proficiency test scores less than 100%" were used. 2. The TC confirmed on 10/25/22 at 10:30 am that the laboratory did not follow the PM. D5411 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(a) -- 3 of 8 -- 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: a) Based on surveyor review of the Bio-Rad Liquid Assayed Multiqual Instructions For Use (IFU), Quality Control records (QC) and interview with the Technical Consultant (TC), the laboratory failed to follow the IFU for Uric Acid and Magnesium from 12/9/21 to the date of survey. The findings include: 1. Uric Acid was coded with a for all three levels of QC on the Bio-Rad Liquid Assayed Multiqual assay sheet Lot # 45910. 2. The IFU for Uric Acid states " - The data required to establish the means and acceptable ranges for this assay were not obtained due to limited assignment participation. If your facility is interested in participating in the Value Assignment Program for this assay, please contact your local Bio-Rad office." 3. Magnesium was coded for all three levels of Bio-Rad Liquid Assayed Multiqual assay sheet Lot # 45910. 4. The IFU for Magnesium states "Data is not available at this time. Please inquire." 5. There was no documented evidence that the above mentioned procedures were performed. 6. The TC confirmed on 10/25/22 at 12:50 pm that the laboratory did not follow the IFU. b) Based on surveyor review of the Streck Para 12 Extend IFU, QC records and interview with the TC, the laboratory failed to follow the IFU for "Multi-parameter Assayed Hematology Control" from 8/18/22 to the date of survey. The findings include. 1. The IFU stated that the control materials matrix was not compatible with the Cell-Dyn 1700. 2. The TC confirmed on 10/25/22 at 1:50 pm that the laboratory did not follow the IFU. c) Based on surveyor review of the Streck Cal-Chex IFU, Calibration Verification record (CVR) and interview with the TC, the laboratory failed to follow the IFU for "Hematology Calibrator" from 1/27 /21 to the date of survey. The findings include. 1. The IFU stated that the Calibration materials matrix was not compatible with the Cell-Dyn 1700. 2. The TC confirmed on 10/25/22 at 1:50 pm that the laboratory did not follow the IFU. 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: a) Based on surveyor review of the Quality Control (QC) Records and interview with the Technical consultant (TC), the laboratory used expired QC material for Hematology testing from to 9/5/22 to the date of survey. The findings include: 1. QC material expiration date changes once opened. 2. The laboratory was unaware that Streck Paras 12 Extend QC material was stable for 30 days after opening. 3. Streck Para 12 Extend Level 1- Lot 21850422, 2 - 21850423, 3- 21850424 QC opened 7/8/22 expired 9/5/22. 4. Approximately ten patients were run per day. 5. The TC confirmed on 10/25/22 at 11:00 am that the laboratory used expired QC material. D5437 CALIBRATION AND CALIBRATION VERIFICATION CFR(s): 493.1255(a) -- 4 of 8 -- Unless otherwise specified in this subpart, for each applicable test system the laboratory must perform and document calibration procedures-- (1) Following the manufacturer's test system instructions, using calibration materials provided or specified, and with at least the frequency recommended by the manufacturer; (2) Using the criteria verified or established by the laboratory as specified in 493.1253(b) (3)-- (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 (2)(ii) Including the number, type, and concentration of calibration materials, as well as acceptable limits for and the frequency of calibration; and (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 surveyor review of Calibration (CAL) records, Procedure Manual (PM) and interview with the Technical Consultant (TC), the laboratory failed to perform Calibration at least once every six months for Hematology Tests performed on the Cell-Dyn 1700 analyzer in the calendar years 2021 and 2022. The findings include: 1. A review of Cal records revealed that the calibration material used was not designed for the Cell-Dyn 1700 for calibration performed in the second half of 2021 and all of 2021. 2. The TC confirmed on 10/25/22 at 10:32 am that the laboratory failed to perform Cal once every six months. D5779

Summary Statement of Deficiencies D2015 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(5)(6) (5) 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. (6) PT is required for only the test system, assay, or examination used as the primary method for patient testing during the PT event. This STANDARD is not met as evidenced by: Based on surveyor review of the Proficiency Testing (PT) records and interview with the Laboratory Consultant (LC), the laboratory director failed to maintain the Work Records (WR) and Attestation Statements (AS) signed by the analyst and laboratory director for Routine Chemistry, Endocrinology, Immunoassay and Hematology tests performed with the College of American Pathologists for events performed in 2018 and 2019. The findings include: 1. The laboratory did not document handling, processing and each step in the testing and reporting of PT sample for: a. General Chemistry - events A,B & C in 2018 and A-2019 b. Immunoassay - Ligand Special Y- B 2018 and Y-A 2019 c. Hematology - Auto Differential FH1 A, B & C 2019 d. Hemoglobin A1C - GHB2 - B2018 & B-2019 2. There were no WR to substantiate reported results for: a. General Chemistry - events A,B & C in 2018 and A-2019. b. Immunoassay - Ligand Special Y-B 2018 and Y-A & B 2019 c. Hematology - Auto Differential FH1 B & C 2018 and FH1 A & C 2019 d. Vitamin - A & B 201825-OH Vitamin D e. Hemoglobin A1C - GHB2 - B2018 & B-2019 3. The LC confirmed on 11/12/19 at 11:15 pm that the laboratory did not maintain all records for PT. 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 -- D5217 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(c)(1) At least twice annually, the laboratory must verify the accuracy of any test or procedure it performs that is not included in subpart I of this part. This STANDARD is not met as evidenced by: Based on surveyor review of the Proficiency Testing (PT) records and interview with the Laboratory Consultant (LC), the laboratory failed to verify the accuracy and reliability of Folate, Ferritin, and Vitamin B12 tests twice a year from 9/13/17 to the date of survey. The LC confirmed on 11/12/19 at 11:00 am that the laboratory did not verify the accuracy of above mentioned tests. 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 surveyor review of the Procedure Manual (PM) and interview with the Laboratory Consultant (LC), the laboratory failed to follow the procedure for reviewing results with flags obtained on the Cell Dyne 1700 analyzer used for Hematology testing from 9/13/17 to the date of the survey. The finding includes: 1. The PM stated to review a stained smear to confirm results but a review of ten patient results with flags revealed the laboratory did not make smears. 2. The Testing Personnel stated the laboratory never made blood smears. 3. The LC confirmed on 11 /12/19 at 11:40 am that the laboratory did not follow the procedure for flag review. D5781