A Dahhan Md Fccp

Summary Statement of Deficiencies D0000 The following deficiencies are a result of a desk review of proficiency testing scores obtained from the national database and verified with the proficiency testing company. The laboratory was found to be out of compliance with the conditions of the CLIA program. The following CONDITION LEVEL DEFICIENCIES were found to be out of compliance: D2016 - 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 a proficiency testing desk review of the Certification and Survey Provider Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 3 -- Enhanced Reporting (CASPER)-0155 and American Proficiency Institute (API) 2022 records (2nd event) and 2023 records (1st event), the laboratory failed to successfully participate 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 Hematology for the Platelets analyte. (Refer to D2130) D2130 HEMATOLOGY CFR(s): 493.851(f) Failure to achieve satisfactory performance for the same analyte in two consecutive events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on a proficiency testing desk review of the CASPER-0155 and API records 2022 (2nd event) and 2023 (1st event), the laboratory failed to achieve satisfactory performance (80% or greater) for two (2) of three (3) testing events in the specialty of Hematology for the Platelets analyte. 1. A Review of the CASPER-0155 report revealed the following: Hematology 2022- 2nd Event The Laboratory received an unsatisfactory score of 60% for the Platelets analyte. Hematology 2023- 1st Event The Laboratory received an unsatisfactory score of 60% for the Platelets analyte. 2. A review of proficiency testing records from API 2022 and 2023 confirmed the above findings. 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 proficiency testing desk review of the CASPER-0155 Individual Laboratory Report and API 2022 records (2nd event) and 2023 records (1st event), 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 a proficiency testing desk review of the CASPER-0155 and API 2022 records (2nd event) and 2023 (1st event), the laboratory director failed to ensure -- 2 of 3 -- successful participation in an HHS approved proficiency testing program. (Refer to 2130) -- 3 of 3 --

Summary Statement of Deficiencies D0000 Based on desk review of proficiency testing (PT) from 2021 through 2022, the laboratory failed to meet the following conditions, resulting in a non-initial unsuccessful PT participation: D2016 - SUCCESSFUL PARTICIPATION CFR(s): 493.803(a)(b)(c) D6000 - MODERATE COMPLEXITY LABORATORY DIRECTOR CFR(s): 493.1403 D2016 SUCCESSFUL PARTICIPATION CFR(s): 493.803(a)(b)(c) (a) Each laboratory performing nonwaived testing must successfully participate in a proficiency testing program approved by CMS, if applicable, as described in subpart I of this part for each specialty, subspecialty, and analyte or test in which the laboratory is certified under CLIA. (b) Except as specified in paragraph (c) of this section, if a laboratory fails to participate successfully in proficiency testing for a given specialty, subspecialty, analyte or test, as defined in this section, or fails to take remedial action when an individual fails gynecologic cytology, CMS imposes sanctions, as specified in subpart R of this part. (c) If a laboratory fails to perform successfully in a CMS- approved proficiency testing program, for the initial unsuccessful performance, CMS may direct the laboratory to undertake training of its personnel or to obtain technical assistance, or both, rather than imposing alternative or principle sanctions except when one or more of the following conditions exists: (1) There is immediate jeopardy to patient health and safety. (2) The laboratory fails to provide CMS or a CMS agent with satisfactory evidence that it has taken steps to correct the problem identified by the unsuccessful proficiency testing performance. (3) The laboratory has a poor compliance history. This CONDITION is not met as evidenced by: Based on a desk review of proficiency testing (PT) records, the laboratory failed to successfully participate in a PT program approved by the Department of Health and Human Services (HHS), for each specialty, subspecialty, and analyte or test in which 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 -- the laboratory is certified under Clinical Laboratory Improvement Amendments (CLIA). The laboratory failed to successfully participate in the specialty of Hematology for the Hematocrit (HCT) analyte. (Refer to 2130) D2130 HEMATOLOGY CFR(s): 493.851(f) Failure to achieve satisfactory performance for the same analyte in two consecutive events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on a proficiency testing (PT) desk review of the Certification and Survey Provider Enhanced Reporting (CASPER)-0155 Report and American Proficiency Institute (API) 2021 records (2nd and 3rd event), the laboratory failed to achieve satisfactory performance (80% or greater) for the same analyte in three (3) of three (3) events in the specialty of Hematocrit (HCT). The findings include: 1. Review of the Casper-0155 report revealed the following: Hematology 2020- 3rd Event Laboratory received an unsatisfactory score of 40% for HCT Hematology 2021- 2nd Event Laboratory received an unsatisfactory score of 40% for the HCT Hematology 2021- 3rd Event Laboratory received an unsatisfactory score of 60% for the HCT 2. A proficiency testing (PT) desk review from API 2021 PT records confirmed the above findings. 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 (PT) 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: Based on a desk review of proficiency testing (PT) results, the laboratory director failed to ensure successful participation in a Department of Health and Human Services (HHS) approved PT program. (Refer to D2130) -- 2 of 2 --

Summary Statement of Deficiencies D0000 Based on desk review of proficiency testing (PT) in 2022, the laboratory failed to meet the following conditions, resulting in an initial PT participation: D2016 - SUCCESSFUL PARTICIPATION CFR(s): 493.803(a)(b)(c) D6000 - MODERATE COMPLEXITY LABORATORY DIRECTOR CFR(s): 493.1403 D2016 SUCCESSFUL PARTICIPATION CFR(s): 493.803(a)(b)(c) (a) Each laboratory performing nonwaived testing must successfully participate in a proficiency testing program approved by CMS, if applicable, as described in subpart I of this part for each specialty, subspecialty, and analyte or test in which the laboratory is certified under CLIA. (b) Except as specified in paragraph (c) of this section, if a laboratory fails to participate successfully in proficiency testing for a given specialty, subspecialty, analyte or test, as defined in this section, or fails to take remedial action when an individual fails gynecologic cytology, CMS imposes sanctions, as specified in subpart R of this part. (c) If a laboratory fails to perform successfully in a CMS- approved proficiency testing program, for the initial unsuccessful performance, CMS may direct the laboratory to undertake training of its personnel or to obtain technical assistance, or both, rather than imposing alternative or principle sanctions except when one or more of the following conditions exists: (1) There is immediate jeopardy to patient health and safety. (2) The laboratory fails to provide CMS or a CMS agent with satisfactory evidence that it has taken steps to correct the problem identified by the unsuccessful proficiency testing performance. (3) The laboratory has a poor compliance history. This CONDITION is not met as evidenced by: Based on a desk review of proficiency testing (PT) records, the laboratory failed to successfully participate in a PT program approved by the Department of Health and Human Services (HHS), for each specialty, subspecialty, and analyte or test in which the laboratory is certified under Clinical Laboratory Improvement Amendments 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 -- (CLIA). The laboratory failed to successfully participate in the specialty of Hematology for the Hemoglobin (HGB) and Red Blood Cell (RBC) analytes. (Refer to 2130 and 2131) D2130 HEMATOLOGY CFR(s): 493.851(f) Failure to achieve satisfactory performance for the same analyte in two consecutive events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on a proficiency testing (PT) desk review of the Certification and Survey Provider Enhanced Reporting (CASPER)-0155 Report and American Proficiency Institute (API) 2021 records (2nd and 3rd event), the laboratory failed to achieve satisfactory performance (80% or greater) for the same analyte in two (2) of two (2) consecutive testing events in the specialty of Hematology for the Hemoglobin (HGB) and Red Blood Cell (RBC) analytes. The findings include: 1. Review of the Casper- 0155 report revealed the following: Hematology 2021- 2nd Event Laboratory received an unsatisfactory score of 20% for the HGB analyte Hematology 2021- 3rd Event Laboratory received an unsatisfactory score of 20% for the HGB analyte Hematology 2021- 2nd Event Laboratory received an unsatisfactory score of 0% for the RBC analyte Hematology 2021- 3rd Event Laboratory received an unsatisfactory score of 20% for the RBC analyte 2. A proficiency testing desk review from API 2021 proficiency testing records confirmed the above findings. D2131 HEMATOLOGY CFR(s): 493.851(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 proficiency testing (PT) desk review of the Certification and Survey Provider Enhanced Reporting (CASPER)-0155 Report and American Proficiency Institute (API) 2021 records (2nd and 3rd event), the laboratory failed to achieve overall satisfactory performance (80% or greater) for two (2) of two (2) consecutive events in the specialty of Hematology. The findings include: 1. Review of the Casper- 0155 report revealed the following: Hematology 2021- 2nd Event Laboratory received an unsatisfactory score of 60% for the Hematology. Hematology 2021- 3rd Event Laboratory received an unsatisfactory score of 63% for the Hematology. 2. A proficiency testing desk review from API 2021 proficiency testing records confirmed the above findings. 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. -- 2 of 3 -- This CONDITION is not met as evidenced by: Based on a desk review of laboratory proficiency testing (PT) 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: Based on a desk review of proficiency testing (PT) results, the laboratory director failed to ensure successful participation in an HHS approved PT program. Refer to D2130 and D2131. -- 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 desk review of chemistry proficiency testing results from the American Proficiency Institute (API) on 03/31/2022, the laboratory failed to successfully participate in the Sodium (Na) certified analyte in two (2) consecutive testing events. See D2096 D2096 ROUTINE CHEMISTRY CFR(s): 493.841(f) Failure to achieve satisfactory performance for the same analyte or test in two 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 -- consecutive testing events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on desk review of Chemistry proficiency testing results from the American Proficiency Institute (API) testing agency on 03/31/2022, the laboratory failed to successfully achieve satisfactory performance for the sodium certified analyte in two (2) consecutive testing events. Findings include: 1. The laboratory failed to achieve a satisfactory performance for the Sodium (Na) analyte in the third (3rd) testing event of 2021 with a score of forty percent (40%). 2. The laboratory failed to achieve a satisfactory performance for the Sodium (Na) analyte in the first (1st) testing event of 2022 with a score of twenty percent (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 the desk review of hematology proficiency testing results from the American Proficiency Institute (API), the laboratory failed to successfully participate in two (2) consecutive hematology testing events for Hematocrit (HCT). See D2131. D2131 HEMATOLOGY CFR(s): 493.851(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 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 -- unsuccessful performance. This STANDARD is not met as evidenced by: Based on the desk review of proficiency testing results from the American Proficiency Institute (API) on 09/14/2021, the laboratory failed to achieve satisfactory overall Hematology testing event scores in two (2) consecutive testing events. Findings include: 1. The laboratory failed to achieve a satisfactory score for the hematocrit (HCT) in the third (3rd) event of 2020 with a score of forty percent (40%). 2. The laboratory failed to achieve a satisfactory score for the hematocrit (HCT) in the second (2nd) event of 2021 with a score of forty percent (40%). -- 2 of 2 --

Summary Statement of Deficiencies D5413 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(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: (1) Water quality. (2) Temperature. (3) Humidity. (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: Based on review of the TOSOH manufacturer's Operator's manual, review of Daily Environmental logs, and staff interview on 01/29/2019, the laboratory failed to follow established procedure in the daily recording of humidity readings. Findings include: Review of the Operator's manual revealed the manufacturer stated "Take refrigerator and room temperature readings along with relative humidity reading daily". Review of the Daily Environmental Log provided by the manufacturer revealed the facility failed to document humidity readings from 05/12/2017 through 01/28/2019. Interview with Testing personnel #1 at 2:40 PM on 01/29/2019, confirmed the laboratory failed to have a system in place to ensure policy was followed and humidity readings were documented each day of patient testing. D5421 ESTABLISHMENT AND VERIFICATION OF PERFORMANCE CFR(s): 493.1253(b)(1) Each laboratory that introduces an unmodified, FDA-cleared or approved test system must do the following before reporting patient test results: (1)(i) Demonstrate that it can obtain performance specifications comparable to those established by the manufacturer for the following performance characteristics: (1)(i)(A) Accuracy. (1)(i) 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 -- (B) Precision. (1)(i)(C) Reportable range of test results for the test system. (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 record review and staff interview on 01/29/2019, the laboratory failed to ensure the laboratory director review, approve, sign, and date the performance specifications for the TOSOH Chemistry analyzer prior to routine patient testing. Findings include: Record review revealed performance specifications (precision, accuracy, reportable range verification, reference range verification) were established for the TOSOH analyzer 04/17/2017. There was no documentation of review by the laboratory director prior to the start of patient testing on 05/12/2017. Interview with Testing Personnel #1 at 2:40 PM on 01/29/2019, confirmed the laboratory failed to have a policy in place to ensure performance specifications for each nonwaived unmodified test system were reviewed, approved, signed, and dated prior to reporting patient test results. -- 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 desk review of Chemistry proficiency testing results on 04/06/2018, the laboratory failed to successfully participate in the pO2 certified analyte in two of three consecutive testing events. See D2087 and 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. 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 -- This STANDARD is not met as evidenced by: Based on desk review of Chemistry proficiency testing results on 04/06/2018, the laboratory failed to attain a satisfactory score of at least 80 percent on the pO2 certified analyte. Findings include: The laboratory scored 60 percent in the second testing event of 2017 and scored 60 percent in the first testing event of 2018. D2096 ROUTINE CHEMISTRY CFR(s): 493.841(f) Failure to achieve satisfactory performance for the same analyte or test in two consecutive testing events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on desk review of Chemistry proficiency testing results 04/06/2018, the laboratory failed to successfully achieve satisfactory performance for the pO2 certified analyte in two of three consecutive testing events. Findings include: The laboratory had an unsatisfactory performance in the second event of 2017 with a score of 60 percent, and had an unsatisfactory performance in the first testing events of 2018 with a score of 60 percent. -- 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 desk review of Hematology proficiency testing results from the American Proficiency Institute on 03/02/2018, the laboratory failed to successfully participate in the Red Blood Cell and Hematocrit analytes in two (2) of three (3) consecutive testing events. See D2121 and D2130 D2121 HEMATOLOGY CFR(s): 493.851(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 2 -- in each testing event is unsatisfactory analyte performance for the testing event. This STANDARD is not met as evidenced by: Based on desk review of Hematology proficiency testing results from the American Proficiency Institute on 03/02/2018, the laboratory failed to attain a satisfactory score of at least eighty percent (80%) on the Red Blood Cell and Hematocrit analytes. The findings include: For Red Blood Cell, the laboratory scored an unsatisfactory zero percent (0%) in the first testing event of 2017 and scored an unsatisfactory sixty percent (60%) in the third testing event of 2017. For Hematocrit, the laboratory scored an unsatisfactory zero percent (0%) in the first testing event of 2017 and scored an unsatisfactory forty percent (40 %) in the third testing event of 2017. D2130 HEMATOLOGY CFR(s): 493.851(f) Failure to achieve satisfactory performance for the same analyte in two consecutive events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on desk review of Hematology proficiency test results from the American Proficiency Institute on 03/02/2018, the laboratory failed to successfully achieve satisfactory performance for the Red Blood Cell and Hematocrit analytes in two (2) of three (3) consecutive testing events. The findings include: For the Red Blood Cell, the laboratory scored zero percent (0%) in the first testing event of 2017 and scored sixty percent (60%) in the third testing event of 2017 for an unsuccessful performance. For the Hematocrit, the laboratory scored zero percent (0%) in the first testing event of 2017 and scored forty percent (40%) in the third testing event of 2017 for an unsuccessful performance. -- 2 of 2 --