Grace Community Health Center, Inc Dba

Summary Statement of Deficiencies D0000 A desk review of proficiency testing was performed on October 13, 2022. The laboratory was found to be not in compliance with the folloing conditions: 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 review of CMS database proficiency report (155D) and American Proficiency Institute (API) performance evaluation for 2022 the laboratory failed to 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 -- attain satisfactory performance scores for two consecutive testing events resulting in unsatisfactory participation for the analytes of RBC (red blood cell) , HCT (hematocrit), HGB (hemoglobin), WBC (white blood cell), and Platelets. (See 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 record review of CMS 155D and API performance evaluation for 2019 through 2022, the laboratory failed to attain satisfactory testing scores in four out of nine testing events resulting in non - initial unsuccessful performance for the analyte of Cell ID in 2019 Event3, 2020 Event 1, and 2022 Events 1 and 2. Findings: 1) A review of 155D showed the following results for Cell ID: 2019 Event 3, 0%, 2020 Event 1, 20%, 2022 Event 1,0% 2022 Event 2, 0% 2) A review of API showed the following results for Cell ID: 2019 Event 3, 0%, 2020 Event 1, 20% 2022 Event 1, 0%, 2022 Event 2, 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 review of CMS 155D and API performance evaluation for 2022 the laboratory director failed to provide overall management and direction to the lab for successful participation in proficiency testing. (See 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: Record review of CMS 155D and API performance evaluation for 2022 showed that the laboratory failed to attain satisfactory scores for two consecutive testing events resulting in unsuccessful performance for the analytes of RBC, HCT, HGB, WBC and Platelets for events 1 and 2. (See D2130) -- 2 of 2 --

Summary Statement of Deficiencies D0000 A desk review of proficiency testing was performed on October 13, 2022. The laboratory was found to be not in compliance with the folloing conditions: D2016 - SUCCESSFUL PARTICIPATION CFR(s): 493.803(a)(b)(c) D6000 - MODERATE COMPLEXITY LABORATORY DIRECTOR CFR(s): 493.1403 D2016 Based on review of CMS database proficiency report (155D) and American Proficiency Institute (API) performance evaluation from 2019 through 2022 the laboratory failed to successfully participate in four of nine testing events resulting in non-initial satisfactory participation for the specialty of Hematology for cell identification (Cell ID). (See D2130) D2130 Based on record review of CMS 155D and API performance evaluation for 2022 showed the laboratory failed to attain satisfactory testing scores for two consecutive testing events resulting in unsuccessful performance for the analytes of RBC, HCT, HGB, WBC and Platelets for Events 2022, 1 and 2. Findings: 1) Review of 155 D showed results for the following analytes: Analyte 2022 Event 1 2022 Event 2 RBC 0% 0% HCT 0% 0% HGB 0% 0% WBC 0% 0% Platelets 0% 0% 2) Review of API showed results for the following analytes: Analyte 2022 Event 1 2022 Event 2 RBC 0% 0% HCT 0% 0% HGB 0% 0% WBC 0% 0% Platelets 0% 0% D6000 Based on review of CMS 155D and API performance evaluation for 2022 the laboratory director failed to provide overall management and direction to the laboratory for successful participation in proficiency testing. (See D6016) D6016 Record review of CMS 155D and API performance evaluation for 2022 showed that the laboratory failed to attain satisfactory scores for two consecutive testing events resulting in unsuccessful performance for the analytes of RBC, HCT, HGB, WBC and Platelets for events 1 and 2. (See D2130) Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 1 --

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 (API) proficiency testing agency on 06/01/2020, the laboratory failed to successfully participate in the White Blood Cell Differential certified analyte in two 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 American Proficiency Institute (API) proficiency testing agency on 06/01/2020, the laboratory failed to attain a satisfactory score of at least 80 (eighty) percent for the White Blood Cell Differential in two consecutive testing events. Findings include: 1. The laboratory scored zero (0) percent in the third testing event of 2019. 2. The laboratory scored twenty (20) percent in the first testing event of 2020. 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 (API) proficiency testing agency on 06/01/2020, the laboratory failed to successfully achieve satisfactory performance for White Blood Cell Differential in two consecutive testing events. Findings include: 1. The laboratory scored zero (0) percent in the third testing event of 2019. 2. The laboratory scored twenty (20) percent in the first testing event of 2020. -- 2 of 2 --

Summary Statement of Deficiencies D5807 TEST REPORT CFR(s): 493.1291(d) Pertinent "reference intervals" or "normal" values, as determined by the laboratory performing the tests, must be available to the authorized person who ordered the tests and, if applicable, the individual responsible for using the test results. This STANDARD is not met as evidenced by: Based on record review and staff interview on 01/31/2018, the laboratory failed to ensure normal values were available to the authorized person for five (5) of six (6) patient Complete Blood Cell (CBC) test reports. The findings include: A CBC was reported on Patient #1 on 12/14/17. The report failed to include reference ranges for each analyte. A CBC was reported on Patient #2 on 07/29/16. The report failed to include reference ranges for each analyte. A CBC was reported on Patient #3 on 11/29 /16. The report failed to include reference ranges for each analyte. A CBC was reported on Patient #5 on 06/21/17. The report failed to include reference ranges for each analyte. A CBC was reported on Patient #6 on 09/19/17. The report failed to include reference ranges for each analyte. Testing personnel acknowledged in an interview at 9:45 AM on 02/22/2018, the laboratory failed to establish a system to ensure reference ranges were available for all analytes reported. 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: 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 -- Based on record review and staff interview on 02/22/18 , the Technical Consultant failed to perform and document annual competency assessments using the six (6) mandated competency assessment requirements for three (3) of eight (8) testing personnel in 2016 and 2017. The findings include: Record review revealed annual competency assessments failed to include direct observation of routine patient test performance, monitoring the recording and reporting of test results, review of worksheets, quality control records, proficiency test results, maintenance records, direct observation of maintenance and function checks, assessment of testing external proficiency testing samples, and assessing the skills for solving problems. Testing personnel acknowledged in an interview at 9:00 AM on 02/22/18, the laboratory failed to have a system in place to ensure competency evaluations were performed using the six (6) mandated competency assessment requirements. -- 2 of 2 --