Family Medicine Clinic Pa

Summary Statement of Deficiencies D3000 FACILITY ADMINISTRATION CFR(s): 493.1100 Each laboratory that performs nonwaived testing must meet the applicable requirements under 493.1101 through 493.1105, unless HHS approves a procedure that provides equivalent quality testing as specified in Appendix C of the State Operations Manual (CMS Pub. 7). (a) Reporting of SARS-CoV-2 test results During the Public Health Emergency, as defined in 400.200 of this chapter, each laboratory that performs a test that is intended to detect SARS-CoV-2 or to diagnose a possible case of COVID-19 (hereinafter referred to as a "SARS-CoV-2 test") must report SARS-CoV-2 test results to the Secretary in such form and manner, and at such timing and frequency, as the Secretary may prescribe. This CONDITION is not met as evidenced by: Based on review of the Ecotest COVID-19 IgG/IgM Rapid test instructions for use, patient records, and interview with facility personnel, the laboratory failed to report SARS-COV-2 test results as required for 15 of 15 days reviewed between October 1, 2020 and December 14, 2020. The findings included: 1. Based on review of the Ecotest COVID-19 IgG/IgM Rapid test instructions for use (Number 1110032033, REV 1.4 Effective date: 2020-09-22), under Condition of Authorization for the Laboratory on page 2 of 3, the instructions state "4. Authorized laboratories using your product will have a process in place for reporting test results to healthcare providers and relevant public health authorities, as appropriate. 2. Based on review of patient records, the laboratory performed patient tests on 7 days in October 2020 5 days in November 2020, and 3 day in December 2020. a. Eight patient tests in October 2020. Eight of eight patients were recorded to have negative results to the Ecotest COVID-19 IgG/IgM Rapid test. b. Seven patient tests were performed in November 2020. Five of seven patients were recorded to have negative results to the Ecotest COVID-19 IgG/IgM Rapid test. Two of seven patients were recorded to have positive results to the Ecotest COVID-19 IgG/IgM Rapid test. c. Five patients were 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 -- test in December 2020. Four of five patients were recorded to have negative results to the Ecotest COVID-19 IgG/IgM Rapid test. One of five patients were recorded to have positive results to the Ecotest COVID-19 IgG/IgM Rapid test. 3. In an interview on January 19, 2021 at 11:52 hours in the laboratory, the Technical Consultant stated the laboratory had not reported both positive and negative COVID-19 tests results to HHS. -- 2 of 2 --

Summary Statement of Deficiencies D0000 Based on a proficiency testing desk review survey performed on January 19, 2021, 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 D2017 - 42 C.F.R. 493.807 Condition: Reinstatement of laboratories performing non-waived testing 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 Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 5 -- Institute proficiency testing records, the facility failed to achieve successful performance in three of three consecutive testing events for the analyte White Blood Cell Differential (WBC Diff), resulting in unsuccessful performance in the specialty of Hematology. Refer to D2121 and D2130. D2017 REINSTATEMENT OF NONWAIVED LABORATORIES CFR(s): 493.807(a)(b) (a) If a laboratory's certificate is suspended or limited or its Medicare or Medicaid approval is cancelled or its Medicare or Medicaid payments are suspended because it fails to participate successfully in proficiency testing for one or more specialties, subspecialties, analyte or test, or voluntarily withdraws its certification under CLIA for the failed specialty, subspecialty, or analyte, the laboratory must then demonstrate sustained satisfactory performance on two consecutive proficiency testing events, one of which may be on site, before CMS will consider it for reinstatement for certification and Medicare or Medicaid approval in that specialty, subspecialty, analyte or test. (b) The cancellation period for Medicare and Medicaid approval or period for suspension of Medicare or Medicaid payments or suspension or limitation of certification under CLIA for the failed specialty, subspecialty, or analyte or test is for a period of not less than six months from the date of cancellation, limitation or suspension of the CLIA certificate. 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 facility failed to achieve successful performance in three of three consecutive testing events for the analyte White Blood Cell Differential, resulting in a non-initial proficiency testing failure in the specialty of Hematology. Findings include: 1. The laboratory received the following unsatisfactory scores (satisfactory is 80% or greater) for the analyte White Blood Cell Differential in the specialty of Hematology: 2019 API 3rd event 30% 2020 API 1st event 0% 2020 API 2nd event 53% 2. The three consecutive failures result in a second unsuccessful performance for the analyte White Blood Cell Differential. D2121 HEMATOLOGY CFR(s): 493.851(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 Certification and Survey Provider Enhanced Reporting (CASPER) Report 155 Individual Laboratory Profile and the American Proficiency Institute (API) Comparative Evaluations, the facility failed to attain a score of at least 80 percent for the analyte White Blood Cell Differential (WBC diff) in three consecutive testing events in 2019 and 2020. The findings included: 1. Based on review of the Certification and Survey Provider Enhanced Reporting (CASPER) Report 155 Individual Laboratory Profile, the laboratory received the following unsatisfactory scores (satisfactory is 80% or greater) for the analyte White Blood Cell Differential in the specialty of Hematology in three consecutive events: 2019 API 3rd event 30% 2020 API 1st event 0% 2020 API 2nd event 53% 2. Review of the API -- 2 of 5 -- Comparative Evaluation for the 2019 3rd Hematology testing event found the laboratory submitted unacceptable responses for Lymphocytes and Neut/Gran (Neutrophils/Granulocytes), comprising the WBC Diff. a. Review of the results for Lymphocytes % found the laboratory failed to obtain acceptable results in four of five specimens tested as follows: Specimen HSY-11 - The facility reported a value of 33.6%, with an expected result of 24.2 - 32.9%. Specimen HSY-12 -The facility reported a value of 27.4%, with an expected result of 17.8 - 27.2%. Specimen HSY-14 -The facility reported a value of 40.3%, with an expected result of 33.0 - 40.2%. Specimen HSY-15 -The facility reported a value of 34.2%, with an expected result of 24.5 - 33.5%. b. Review of Neut/Gran (Neutrophils/Granulocytes) % found the laboratory failed to submit acceptable responses for 3 of 5 samples tested as follows: Specimen HSY-11- The facility reported a value of 59.5 %, with an expected result of 60.7 - 69.9%. Specimen HSY-14-The facility reported a value of 51.6%, with an expected result of 51.8 - 59.8%. Specimen HSY-15 -The facility reported a value of 59.8%, with an expected result of range 59.9 - 70.0%. 3. Review of the API Comparative Evaluation for the 2020 Hematology 1st testing event found the laboratory submitted unacceptable responses for Lymphocytes and Neut/Gran (Neutrophils/Granulocytes), comprising the WBC Diff. a. Review of the Lymphocytes % results found the laboratory failed to submit acceptable responses for 5 of 5 samples tested as follows: Specimen HSY-01-The facility reported a value of 38.6%, with an expected result of 28.8 - 37.6%. Specimen HSY-02 -The facility reported a value of 31.4%, with an expected result of 21.1 - 30.6%. Specimen HSY-03- The facility reported a value of 26.3%, with an expected result of 13.9 - 23.6% Specimen HSY-04 -The facility reported a value of 39.6%, with an expected result of 29.4 - 38.6% Specimen HSY-05 -The facility reported a value of 33.3%, with an expected result of 20.0 - 29.9%. b. Review of Neut/Gran (Neutrophils/Granulocytes) % results found the laboratory failed to submit acceptable responses for 5 out of 5 samples tested as follows: Specimen HSY-01 - The facility reported a value of 50.8%, with an expected result of 54.5 - 63.4% Specimen HSY-02 -The facility reported a value of 60.1%, with an expected result of 62.3 - 72.3%. Specimen HSY-03 -The facility reported a value of 66.8%, with an expected result of 69.9 - 81.2% Specimen HSY-04 -The facility reported a value of 50.3%, with an expected result of 53.4 - 62.9% Specimen HSY-05 -The facility reported a value of 59.3%, with an expected result of 63.6 - 73.9%. 4. Review of the API Comparative Evaluation for the 2020 Hematology 2nd testing event found the laboratory submitted unacceptable responses for Lymphocytes and Neut/Gran (Neutrophils/Granulocytes), comprising the WBC Diff. a. Review of the Lymphocytes % results found the laboratory failed to submit acceptable responses for 2 of 5 samples tested as follows: Specimen HSY-07 -The facility reported a value of 27.1%, with an expected result of 11.6 - 23.1% Specimen HSY-10 - The facility reported a value of 32.3%, with an expected result of 16.6 - 28.6% b. Review of the Monocytes % results found the laboratory failed to submit acceptable responses for 2 of 5 samples tested as follows: Specimen HSY-07 -The facility reported a value of 15.7%, with an expected result of 3.4 - 7.4% Specimen HSY-10 -The facility reported a value of 12.7%, with an expected result of 4.5 - 8.2% c. Review of the Neut/Grans % results found the laboratory failed to submit acceptable responses for 3 of 5 samples tested as follows: Specimen HSY-07 -The facility reported a value of 57.2 %, with an expected result of 70.4 - 84.2 Specimen HSY-08 -The facility reported a value of 52.1 %, with an expected result of 52.4 - 65.5 Specimen HSY-10- The facility reported a value of 55.0%, with an expected result of 64.3 - 77.9 D2130 HEMATOLOGY CFR(s): 493.851(f) -- 3 of 5 -- 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: I. 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 facility failed to achieve satisfactory performance for the same analyte in three consecutive events the analyte White Blood Cell Differential (WBC diff) in 2019 and 2020. The findings included: 1. Based on review of the Certification and Survey Provider Enhanced Reporting (CASPER) Report 155 Individual Laboratory Profile, the laboratory received the following unsatisfactory scores (satisfactory is 80% or greater) for the analyte White Blood Cell Differential in the specialty of Hematology in three consecutive events: 2019 API 3rd event 30% 2020 API 1st event 0% 2020 API 2nd event 53% 2. Review of the API Comparative Evaluation for the 2019 3rd Hematology testing event found the laboratory submitted unacceptable responses for Lymphocytes and Neut/Gran (Neutrophils/Granulocytes), comprising the WBC Diff. a. Review of the results for Lymphocytes % found the laboratory failed to obtain acceptable results in four of five specimens tested as follows: Specimen HSY-11 -The facility reported a value of 33.6%, with an expected result of 24.2 - 32.9%. Specimen HSY-12 -The facility reported a value of 27.4%, with an expected result of 17.8 - 27.2%. Specimen HSY-14 -The facility reported a value of 40.3%, with an expected result of 33.0 - 40.2%. Specimen HSY-15 -The facility reported a value of 34.2%, with an expected result of 24.5 - 33.5%. b. Review of Neut/Gran (Neutrophils/Granulocytes) % found the laboratory failed to submit acceptable responses for 3 of 5 samples tested as follows: Specimen HSY-11 -The facility reported a value of 59.5 %, with an expected result of 60.7 - 69.9%. Specimen HSY-14 -The facility reported a value of 51.6%, with an expected result of 51.8 - 59.8%. Specimen HSY-15 -The facility reported a value of 59.8%, with an expected result of range 59.9 - 70.0%. 3. Review of the API Comparative Evaluation for the 2020 Hematology 1st testing event found the laboratory submitted unacceptable responses for Lymphocytes and Neut/Gran (Neutrophils/Granulocytes), comprising the WBC Diff. a. Review of the Lymphocytes % results found the laboratory failed to submit acceptable responses for 5 of 5 samples tested as follows: Specimen HSY-01 -The facility reported a value of 38.6%, with an expected result of 28.8 - 37.6%. Specimen HSY-02 -The facility reported a value of 31.4%, with an expected result of 21.1 - 30.6%. Specimen HSY-03 -The facility reported a value of 26.3%, with an expected result of 13.9 - 23.6% Specimen HSY-04 -The facility reported a value of 39.6%, with an expected result of 29.4 - 38.6% Specimen HSY-05 -The facility reported a value of 33.3%, with an expected result of 20.0 - 29.9%. b. Review of Neut/Gran (Neutrophils/Granulocytes) % results found the laboratory failed to submit acceptable responses for 5 out of 5 samples tested as follows: Specimen HSY-01 -The facility reported a value of 50.8%, with an expected result of 54.5 - 63.4% Specimen HSY-02 -The facility reported a value of 60.1%, with an expected result of 62.3 - 72.3%. Specimen HSY-03 -The facility reported a value of 66.8%, with an expected result of 69.9 - 81.2% Specimen HSY-04 -The facility reported a value of 50.3%, with an expected result of 53.4 - 62.9% Specimen HSY-05 -The facility reported a value of 59.3%, with an expected result of 63.6 - 73.9%. 4. Review of the API Comparative Evaluation for the 2020 Hematology 2nd testing event found the laboratory submitted unacceptable responses for Lymphocytes and Neut/Gran (Neutrophils/Granulocytes), comprising the WBC Diff. a. Review of the Lymphocytes % results found the laboratory failed to submit -- 4 of 5 -- acceptable responses for 2 of 5 samples tested as follows: Specimen HSY-07 -The facility reported a value of 27.1%, with an expected result of 11.6 - 23.1% Specimen HSY-10 -The facility reported a value of 32.3%, with an expected result of 16.6 - 28.6% b. Review of the Monocytes % results found the laboratory failed to submit acceptable responses for 2 of 5 samples tested as follows: Specimen HSY-07 -The facility reported a value of 15.7%, with an expected result of 3.4 - 7.4% Specimen HSY-10 -The facility reported a value of 12.7%, with an expected result of 4.5 - 8.2% c. Review of the Neut/Grans % results found the laboratory failed to submit acceptable responses for 3 of 5 samples tested as follows: Specimen HSY-07 -The facility reported a value of 57.2 %, with an expected result of 70.4 - 84.2 Specimen HSY-08 -The facility reported a value of 52.1 %, with an expected result of 52.4 - 65.5 Specimen HSY-10 - The facility reported a value of 55.0%, with an expected result of 64.3 - 77.9 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 Certification and Survey Provider Enhanced Reporting (CASPER) Report 155 Individual Laboratory Profile and American Proficiency Institute proficiency testing records quality control records, temperature records, maintenance records, and quality assessment records, the laboratory director failed to provide overall management and direction of the laboratory services. The findings included: 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 a HHS approved proficiency testing program for analytes White Blood Cell Differential. 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 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 a HHS approved proficiency testing program for analyte White Blood Cell Differential (WBC Diff). Refer to D2016 and D2017. -- 5 of 5 --

Summary Statement of Deficiencies D0000 The following deficiencies are a result of a desk review of proficiency testing scores obtained from the CMS (Center for Medicare Services) national database and verified with the proficiency testing company, API (American Proficiency Institute). The facility was found to be out of compliance with the conditions of the CLIA program. The conditions not met were: D2016 - 42 C.F.R. 493.803 Condition: Successful participation in a proficiency testing program 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 the CASPER Report 155 Individual Laboratory Profile and proficiency testing records, the facility failed to achieve successful performance 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 4 -- two of three consecutive testing events for the analyte White Blood Cell Differential, resulting in unsuccessful performance in the specialty of Hematology. (refer to D2130 and D2121 I) D2121 HEMATOLOGY CFR(s): 493.851(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: I. Based on review of the CASPER Report 155 Individual Laboratory Profile and the API (American Proficiency Institute) Comparative Evaluations, the facility failed to attain a score of at least 80 percent for the analyte White Blood Cell Differential (WBC diff) in two of four testing events in 2019 and 2020. The findings included: 1. Review of the CASPER Report 155 Individual Laboratory Profile found the laboratory received a score of 30% in the 2019 third testing event, and a score of 0% in the first testing event of 2020 for WBC Diff. 2. Review of the API Comparative Evaluation for the 2019 3rd Hematology testing event found the laboratory submitted unacceptable responses for Lymphocytes and Neut/Gran (Neutrophils/Granulocytes), comprising the WBC Diff. a. Review of the results for Lymphocytes % found the laboratory failed to obtain acceptable results in four of five specimens tested as follows: Specimen HSY-11 The facility reported a value of 33.6%, with an expected result of 24.2 - 32.9%. Specimen HSY-12 The facility reported a value of 27.4%, with an expected result of 17.8 - 27.2%. Specimen HSY-14 The facility reported a value of 40.3%, with an expected result of 33.0 - 40.2%. Specimen HSY-15 The facility reported a value of 34.2%, with an expected result of 24.5 - 33.5%. b. Review of Neut /Gran (Neutrophils/Granulocytes) % found the laboratory failed to submit acceptable responses for 3 of 5 samples tested as follows: Specimen HSY-11 The facility reported a value of 59.5 %, with an expected result of 60.7 - 69.9%. Specimen HSY- 14 The facility reported a value of 51.6%, with an expected result of 51.8 - 59.8%. Specimen HSY-15 The facility reported a value of 59.8%, with an expected result of range 59.9 - 70.0%. 3. Review of the API Comparative Evaluation for the 2020 Hematology 1st testing event found the laboratory submitted unacceptable responses for Lymphocytes and Neut/Gran (Neutrophils/Granulocytes), comprising the WBC Diff. a. Review of the Lymphocytes % results found the laboratory failed to submit acceptable responses for 5 of 5 samples tested as follows: Specimen HSY-01 The facility reported a value of 38.6%, with an expected result of 28.8 - 37.6%. Specimen HSY-02 The facility reported a value of 31.4%, with an expected result of 21.1 - 30.6%. Specimen HSY-03 The facility reported a value of 26.3%, with an expected result of 13.9 - 23.6% Specimen HSY-04 The facility reported a value of 39.6%, with an expected result of 29.4 - 38.6% Specimen HSY-05 The facility reported a value of 33.3%, with an expected result of 20.0 - 29.9%. b. Review of Neut/Gran (Neutrophils /Granulocytes) % results found the laboratory failed to submit acceptable responses for 5 out of 5 samples tested as follows: Specimen HSY-01 The facility reported a value of 50.8%, with an expected result of 54.5 - 63.4% Specimen HSY-02 The facility reported a value of 60.1%, with an expected result of 62.3 - 72.3%. Specimen HSY-03 The facility reported a value of 66.8%, with an expected result of 69.9 - 81.2% Specimen HSY-04 The facility reported a value of 50.3%, with an expected result of 53.4 - 62.9% Specimen HSY-05 The facility reported a value of 59.3%, with an expected result of 63.6 - 73.9%. II. Based on review of the Casper Report 155 Individual Laboratory Profile and API Comparative Evaluation, the facility failed to -- 2 of 4 -- attain a score of at least 80 percent in the 2020 Hematology 1st testing event for White Blood Cell (WBC) Count. 1. Review of the Casper Report 155 Individual Laboratory Profile showed a score of 40% in the 1st Hematology testing event of 2020 for WBC. 2. Review of the API Comparative Evaluation 1st Hematology event of 2020 showed failures in White [Blood] Cell Count for 3 out of 5 samples tested as follows: Specimen HSY-01 The facility reported a value of 18.5% with an expected result of 13.4 - 18.3% Specimen HSY-04 The facility reported a value of 13.0%, with an expected result of 9.2 - 12.5%. Specimen HSY-05 The facility reported a value of 8.2%, with an expected result of 5.9 - 8.1%. D2122 HEMATOLOGY CFR(s): 493.851(b) Failure to attain an overall testing event score of at least 80 percent is unsatisfactory performance. This STANDARD is not met as evidenced by: Based on review of the Casper Report 155 Individual Laboratory Profile and API (American Proficiency Institute) Comparative Evaluation, the facility failed to attain an overall testing event score of at least 80 percent in the first Hematology testing event of 2020. The findings included: 1. Review of the Casper Report 155 Individual Laboratory Profile showed an overall test event score of 70% in the 1st testing event of 2020 for the specialty of Hematology. 2. Review of the API Performance Summary for the 1st Hematology testing event of 2020 showed scores for individual analytes as follows: White Blood Cell Differential was 0% Erythrocyte Count (RBC) was 100%, Hematocrit was 80% Hemoglobin was 100% Leukocyte Count (WBC) was 40%, and Platelet Count was 100%. The average of these scores is 70%. 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 review of the Casper Report 155 Individual Laboratory Profile and the API (American Proficiency Institute) Comparative Evaluations, the facility failed to achieve satisfactory performance for the White Blood Cell Differential (WBC diff) in 2 of 3 consecutive testing events. The findings included: 1. Review of the of the Casper Report 155 Individual Laboratory Profile showed a score of 30% for WBC Diff in the 3rd Hematology testing event of 2019, and a score of 0% in the 1st Hematology testing event of 2020. 2. Review of the API Comparative Evaluation for the 2019 3rd Hematology testing event found the laboratory submitted unacceptable responses for Lymphocytes and Neut/Gran (Neutrophils/Granulocytes), comprising the WBC Diff. a. Review of the results for Lymphocytes % found the laboratory failed to obtain acceptable results in four of five specimens tested as follows: Specimen HSY-11 The facility reported a value of 33.6%, with an expected result of 24.2 - 32.9%. Specimen HSY-12 The facility reported a value of 27.4%, with an expected result of 17.8 - 27.2%. Specimen HSY-14 The facility reported a value of 40.3%, with an expected result of 33.0 - 40.2%. Specimen HSY-15 The facility reported a value of 34.2%, with an expected result of 24.5 - 33.5%. b. Review of Neut -- 3 of 4 -- /Gran (Neutrophils/Granulocytes) % found the laboratory failed to submit acceptable responses for 3 of 5 samples tested as follows: Specimen HSY-11 The facility reported a value of 59.5 %, with an expected result of 60.7 - 69.9%. Specimen HSY- 14 The facility reported a value of 51.6%, with an expected result of 51.8 - 59.8%. Specimen HSY-15 The facility reported a value of 59.8%, with an expected result of range 59.9 - 70.0%. 3. Review of the API Comparative Evaluation for the 2020 Hematology 1st testing event found the laboratory submitted unacceptable responses for Lymphocytes and Neut/Gran (Neutrophils/Granulocytes), comprising the WBC Diff. a. Review of the Lymphocytes % results found the laboratory failed to submit acceptable responses for 5 of 5 samples tested as follows: Specimen HSY-01 The facility reported a value of 38.6%, with an expected result of 28.8 - 37.6%. Specimen HSY-02 The facility reported a value of 31.4%, with an expected result of 21.1 - 30.6%. Specimen HSY-03 The facility reported a value of 26.3%, with an expected result of 13.9 - 23.6% Specimen HSY-04 The facility reported a value of 39.6%, with an expected result of 29.4 - 38.6% and 33.3 for Specimen HSY-05 The facility reported a value of 33.3%, with an expected result of 20.0 - 29.9%. b. Review of Neut /Gran (Neutrophils/Granulocytes) % results found the laboratory failed to submit acceptable responses for 5 out of 5 samples tested as follows: Specimen HSY-01 The facility reported a value of 50.8%, with an expected result of 54.5 - 63.4% Specimen HSY-02 The facility reported a value of 60.1%, with an expected result of 62.3 - 72.3%. Specimen HSY-03 The facility reported a value of 66.8%, with an expected result of 69.9 - 81.2% Specimen HSY-04 The facility reported a value of 50.3%, with an expected result of 53.4 - 62.9% Specimen HSY-05 The facility reported a value of 59.3%, with an expected result of 63.6 - 73.9%. 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 Casper Report 155 Individual Laboratory Profile and the API (American Proficiency Institute) Comparative Evaluations, the laboratory director failed to ensure the overall quality of the laboratory services provided. The laboratory director failed to ensure successful participation in a HHS approved proficiency testing program. Refer to D2016, D2121, D2122 and D2130. -- 4 of 4 --

Summary Statement of Deficiencies 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: Based on review of the Beckman Coulter Access 25(OH) Vitamin D Total assay instructions for use and interview with facility personnel, the laboratory failed to follow manufacturer instructions for preparing the reagent for patient testing for 10 of 10 months between January 2018 and October 2018. The findings included: 1. Based on review of the Beckman Coulter Access 25(OH) Vitamin D Total assay instructions for use (REF B24838), the document states the following: "To ensure that the paramagnetic particles in the regent pack are fully suspended, mix the pack using a vortex mixer immediately before loading the reagent pack on the instrument for the first time. To mix: * Use a vortex mixer with a continuous 'On' mode (i.e. not 'Auto' or 'Touch' mode) and a maximum speed between 2500 and 3200 rpm. *Start the vortex mixer in the continuous mode and set it to its maximum speed. *Hold the pack upright by the clip end and place the base of the particle well (R1a) on the vortex pad at a slight downward angle (See instruction for Use for addition detail). *Mix the reagent pack continuously (do not pulse) for 20 to 30 seconds. *It is not necessary to remix packs after loading. Do not mix a puncture pack. The requirement to mix the reagent pack by vortex mixer is unique to the Vitamin D assay. Do not mix other Access reagent packs using a vortex mixer:" 2. In an interview at 11:41 hours on 11/15 /2018 in the patient room, Testing Person 3 (as listed on the CMS-209 laboratory personnel report) stated the laboratory had not been using a vortex to mix Beckman Coulter Access 25(OH) Vitamin D Total reagent packs prior to loading them on the Access II analyzer. 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 -- D5431 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(a)(2) For unmodified manufacturer's equipment, instruments, or test systems, the laboratory must perform and document function checks as defined by the manufacturer and with at least the frequency specified by the manufacturer. Function checks must be within the manufacturer's established limits before patient testing is conducted. This STANDARD is not met as evidenced by: Based on review of Beckman Coulter Access II chemistry analyzer function check records, manufacturer instructions, and interview with facility personnel, the laboratory failed to performance function checks at the interval required by the manufacturer and ensure that 2 of 2 function checks were within the manufacturer's established limits before patient testing was performed between September 13, 2018 and November 5, 2018. The findings included: 1. Based on review of Beckman Coulter Access II chemistry analyzer function check records from September 24, 2018 and November 5, 2018, the following function checks failed to meet manufacturer's established limits before patient testing was performed: 9/13/2018 Substrate percent CV - 23.62 (High) Acceptable defined 0.00 - 5.00 percent 09/24/2018 Substrate percent CV - 22.32 (High) - Acceptable defined 0.00 - 5.00 percent Based on the "Substrate Check Troubleshooting Table": High percent CV from high values in 1 or 2 replicates may be due to the System Check solution diluted incorrectly or Sample Containers out of order in the maintenance rack. High percent CV throughout the run may be due to insufficient supply of substrate, air in the substrate line, leak in the substrate system tubing, bent substrate probe tip, substrate pump or valve failure, or a luminometer problem. 2. On the Beckman Coulter Access II Maintenance log, "Run System check" is listed as a weekly procedure. Based on review of maintenance logs from September 2018, October, 2018, and November 2018, the laboratory performed the "Run System Check" on the following dates: 9/13/2018 9/20/2018 9/24/2018 9/27 /2018 10/04/2018 10/08/2018 10/15/2018 10/22/2018 10/24/2018 11/05/2018 Based on the System check record printed on 9/16/2018, the previous system check was performed on 9/13/2018 and had failed the Substrate percent CV. For the record printed on 9/24/2018 at 10:00 a.m., the System Check had been performed on 9/24 /2018 at 09:29 a.m. and had failed the Substrate percent CV. For the record printed on 10/01/2018, the System Check had been performed on 9/24/2018 at 09:29 a.m. For the record printed out 10/15/2018, the System Check had been performed on 9/24/2018 at 09:29 a.m. For the record printed out 10/22/2018, the System Check had been performed on 9/24/2018 at 09:29 a.m. For the record printed out 10/29/2018, the System Check had been performed on 9/24/2018 at 09:29 a.m. 3. On the Beckman Coulter Access II Maintenance log, "Replace/Clean Aspirate Probes" is listed as a weekly procedure. Based on review of maintenance logs from September 2018, October, 2018, and November 2018, the laboratory performed the "Replace/Clean Aspirate Probes" on the following dates: 9/20/2018 9/24/2018 9/27/2018 10/04/2018 10/08/2018 10/15/2018 10/22/2018 10/24/2018 11/05/2018 4. In an interview at 11:46 hours on 11/15/2018, Testing Person 3 confirmed the laboratory had not been removing the aspirate probes and cleaning them per the manufacturer's instructions and the laboratory had not ensured function checks were within manufacturer established limits prior to reporting patients for the two function checks that could be verified on 9/13/2018 and 9/24/2018. D5435 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(b)(2) -- 2 of 3 -- For equipment, instruments, or test systems developed in-house, commercially available and modified by the laboratory, or maintenance and function check protocols are not provided by the manufacturer, the laboratory must: (i) Define a function check protocol that ensures equipment, instrument, and test system performance that is necessary for accurate and reliable test results and test result reporting. (ii) Perform and document the function checks, including background or baseline checks, specified in paragraph (b)(2)(i) of this section. Function checks must be within the laboratory's established limits before patient testing is conducted. This STANDARD is not met as evidenced by: Based on surveyor observations and interview with facility personnel, the laboratory failed to establish and follow a function check protocol for 2 of 2 VanGuard V6500 centrifuges used to process patient specimens between 2015 and November 15, 2018. The findings included: 1. At 12:32 hours on 11/15/2018 in the laboratory, the surveyor observed two VanGuard V6500 centrifuges used to process patient specimens. The centrifuge on the left had a sticker on the right side with the following information: Date: 3/20/2015 RPM: 3340 RPM The VanGuard V6500 centrifuge on the right had a sticker on the right side with the following information: Date: 8/20 /2015 RPM: 3415 RPM 2. In an interview at 12:32 hours on 11/15/2018 in the laboratory, the surveyor requested documentation that the laboratory had established and followed function check protocols to verify the speed and time setting of the VanGuard V6500 centrifuges. The Technical Consultant stated the laboratory had not yet defined a protocol for verifying the function of the two centrifuges and the last verification of the performance had been performed on 3/20/2015 and 8/202/2015, respectively. -- 3 of 3 --