Sparrow Healthcare

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 facility was found to be out of compliance with the conditions of participation of the CLIA program The following CONDITION LEVEL DEFICIENCIES were found to be out of compliance: D2016 - 42 C.F.R. 493.803 Condition: Successful participation [proficiency testing] D2017 - 42 C.F.R. 493.807 (a) - Reinstatement After Failure 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: 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 -- Based on a review of the CMS (Center for Medicare Services) national database and a proficiency desk review of the American Proficiency Institute (API) proficiency testing records from 2018-2019, it was determined the laboratory has not successfully participated in a proficiency testing program, for each specialty, subspecialty, and analyte or test in which the laboratory is certified under CLIA. The laboratory did not successfully participate in the specialty of hematology for the analyte Red Cell Count (RBC); Hematocrit (HCT); Hemaglobin (Hgb); White blood count (WBC); Platelet (PLT); and Cell ID. (Refer to D2130, D2131) 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 a review of the CMS (Center for Medicare Services) national database and a proficiency desk review of the American Proficiency Institute (API) proficiency testing (PT) records from 2018-2019, it was determined the laboratory had not successfully participated in proficiency testing for the satisfactory performance in the specialty of hematology for the analytes: analyte Red Cell Count (RBC), Hematocrit (HCT), Hemaglobin (Hgb), White blood count (WBC), Platelet (PLT), and Cell ID resulting in a non-initial PT failure. Findings were: 1. Review of CMS national database from 2018-2019 for Red Cell Count (RBC), Hematocrit (HCT), Hemaglobin (Hgb), White blood count (WBC), Platelet (PLT), and Cell ID revealed the laboratory received the following scores for the 2018 Hematology 3rd event, and 2019 1st and 3rd events: API 3rd event 2018 = 0% API 1st event 2019 = 0% API 3rd event 2019 = 0% 2. The laboratory must demonstrate sustained satisfactory performance (>/= 80%) on two consecutive testing events for reinstatement. 3. A review of the performance summary reports from API proficiency testing agency confirmed the laboratory failed to submit proficiency testing results which resulted in a grade of 0 for the analytes Red Cell Count (RBC), Hematocrit (HCT), Hemaglobin (Hgb), White blood count (WBC), Platelet (PLT), and Cell ID. API 3rd event 2018 = 0% API 1st event 2019 = 0% API 3rd event 2019 = 0% 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. -- 2 of 5 -- This STANDARD is not met as evidenced by: Based on a review of the CMS (Center for Medicare Services) national database and a proficiency desk review of the American Proficiency Institute (API) proficiency testing records from 2018-2019, it was determined the laboratory failed to achieve satisfactory performance (at least 80%) in the specialty of hematology for the analytes: Erythrocyte Count, Hematocrit, Hemoglobin, Leukocyte Count, Platelet Count and White Blood Cell Differential for 1 of 3 testing events 2018 and 2 of 3 testing events in 2019. Findings were: 1. A review of the CMS national proficiency testing database revealed a score of "0" for the analytes: Erythrocyte Count, Hematocrit, Hemoglobin, Leukocyte Count, Platelet Count and White Blood Cell Differential for the following testing events: 2018 API 3rd event 2019 API 1st & 3rd event 2. A proficiency desk review of the API proficiency testing records from 2018- 2019 confirmed that the laboratory received a hematology score of 0% on for the following analytes: Erythrocyte Count, Hematocrit, Hemoglobin, Leukocyte Count, Platelet Count and White Blood Cell Differential for the following testing events: 2018 API 3rd event 2019 API 1st & 3rd event 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 a review of the CMS (Center for Medicare Services) national database and a proficiency desk review of the American Proficiency Institute (API) proficiency testing records from 2018-2019, it was determined the laboratory failed to attain an overall testing event score of at least 80 % for each event which constitutes unsatisfactory performance. Findings were: 1. A proficiency desk review of 3 of 4 API proficiency testing records from 2018-2019 revealed a hematology event score of less than 80% (unsatisfactory performance) for the following testing events: 2018 API 3rd event Hematology: 0% 2019 API 1st & 3rd event Hematology: 0% D2123 HEMATOLOGY CFR(s): 493.851(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 a review of the CMS (Center for Medicare Services) national database and a proficiency desk review of the American Proficiency Institute (API) proficiency testing (PT) records from 2018 - 2019, it was revealed that the laboratory failed to -- 3 of 5 -- participate in the 3rd hematology testing events of 2018 and 1st and 3rd hematology event of 2019. Findings were: 1. A review of the CMS national proficiency testing database revealed a score of "0" on the 3rd event of 2018; 1st and 3rd hematology event of 2019 for this facility. 2. A proficiency desk review of API PT records revealed the laboratory received a 0% for the 2018-3rd event; 2019-1st and 2019-3rd event Hematology for "Failure to Participate." The PT summary was rated by the provider as unsatisfactory performance for all analytes for testing events 2018-3, 2019- 1; 2019-3 Hematology. 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 review of the CMS (Center for Medicare Services) national database and a proficiency desk review of the American Proficiency Institute (API) proficiency testing records from 2018-2019, it was determined the laboratory failed to achieve satisfactory performance for the same analyte in 3 of 4 consecutive testing events. The laboratory failed to achieve satisfactory performance (at least 80%) in the specialty of hematology for the analytes: Erythrocyte Count, Hematocrit, Hemoglobin, Leukocyte Count, Platelet Count and White Blood Cell Differential for 3 of 4 consecutive testing events in 2018 and 2019. Findings were: 1. A review of the CMS national proficiency testing database revealed a score of "0" for the analytes: Erythrocyte Count, Hematocrit, Hemoglobin, Leukocyte Count, Platelet Count and White Blood Cell Differential for 3 of 4 consecutive testing events in 2018 and 2019 for the following test events: 2018 API 3rd event 2019 API 1st & 3rd event 2. A proficiency desk review of the API proficiency testing records from 2018-2019 confirmed that the laboratory received a hematology score of 0% on for the following analytes: Erythrocyte Count, Hematocrit, Hemoglobin, Leukocyte Count, Platelet Count and White Blood Cell Differential for 3 of 4 consecutive testing events in 2018 and 2019 for the following test events: 2018 API 3rd event 2019 API 1st & 3rd event 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 review of the CMS (Center for Medicare Services) national database and a desk review of the American Proficiency Institute (API) proficiency testing records, it was determined the laboratory failed to achieve satisfactory performance (80% or greater) for the specialty of hematology in 3 of 4 consecutive testing events. Two out of three unsatisfactory scores results in unsuccessful PT performance. Findings were: 1. A review of the CMS national proficiency testing database revealed a score of "0" for 3 of 4 consecutive testing events in 2018 and 2019, and 2020 for the following test events: 2018 API 3rd event 2019 API 1st & 3rd event 2. A proficiency desk review of the API proficiency testing records from 2018-2020 confirmed that the laboratory -- 4 of 5 -- received a hematology score of 0% for 3 of 4 consecutive testing events in 2018 and 2019 for the following test events: 2018 API 3rd event 2019 API 1st & 3rd event D6000 MODERATE COMPLEXITY LABORATORY DIRECTOR CFR(s): 493.1403 The laboratory must have a director who meets the qualification requirements of 493. 1405 of this subpart and provides overall management and direction in accordance with 493.1407 of this subpart. This CONDITION is not met as evidenced by: Based on a desk review of laboratory proficiency testing performance it was revealed that the laboratory director failed to provide overall management and direction of the laboratory services. Findings were: 1. A review of the laboratory proficiency testing results revealed that the laboratory director failed to ensure that the laboratory participated successfully. (refer to D6016) By not providing overall management and direction of the laboratory, the laboratory director could not ensure the accuracy or reliability of all laboratory services provided by the facility. 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 results it was revealed that the laboratory director failed to ensure the overall quality of the laboratory services provided. The laboratory director failed to ensure successful participation in an approved proficiency testing program. (refer to D2130, D2131) -- 5 of 5 --

Summary Statement of Deficiencies D3045 RETENTION REQUIREMENTS CFR(s): 493.1105(b) If the laboratory ceases operation, the laboratory must make provisions to ensure that all records and, as applicable, slides, blocks, and tissue are retained and available for the time frames specified in this section. This STANDARD is not met as evidenced by: Based on review and laboratory records and interview with testing personnel (TP) #1 and #2, the laboratory failed to make provisions to ensure that all records are maintained and available for 2 years after the laboratory ceased operations on February of 2019. Findings Include: 1. On the day of survey, 07/18/2019, TP#1 and #2 revealed that the laboratory ceased patient testing February 2019 and resumed testing June 26th, 2019. 2. The laboratory was unable to provide the following documents from 07/18/2017 (last inspection date) to February 2019 (when lab stopped patient testing). - Laboratory test requisitions and test authorizations, including the patient's chart or medical records. - Laboratory quality control and patient test records. - Laboratory proficiency testing records. - Laboratory quality system assessment documents. - Original reports (including final, preliminary, and corrected reports) after the date of reporting. 3. TP #1 and #2 confirmed the findings above on 06/18 /2019 around 9:00 am. 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. 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 review of laboratory procedure manuals and interview testing personnel (TP) #1 and #2, the laboratory failed to establish a competency assessment procedure to assess the competency of consultants, supervisors and TP who performed hematology testing from 09/19/2017 to the date of survey. Findings Include: 1. On the day of survey, 07/18/2019, the laboratory could not provide a written procedure to assess the competency of consultants, supervisors and TP who performed complete blood count tests on the Abbott Diagnostics CELL-DYN Emerald analyzer from 09/19 /2017 to 07/18/2019. 2. The laboratory could not provide the annual competency assessment for 1 of 2 TP (TP #1). 3. The TP #1 and #2 confirmed the findings above on 07/18/2019 around 09:40 am. -- 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 a review of the CASPER Report 155 report and performance evaluations from the proficiency testing organization, American Proficiency Institute (API), the laboratory failed to successfully participate in a proficiency testing program approved by CMS for the specialty of Hematology. The laboratory had unsatisfactory scores for the 3rd event of 2018 and the 1st event of 2019. See D2130 D2130 HEMATOLOGY CFR(s): 493.851(f) 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 -- 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 review of the CASPER Report 155 report and performance evaluations from the proficiency testing organization, American Proficiency Institute (API), the laboratory failed to successfully participate in a proficiency testing program approved by CMS for the specialty of Hematology. The laboratory had unsatisfactory scores for the 3rd event of 2018 and the 1st event of 2019. Findings Include: 1. API 2018 Event 3 Hematology Analytes: a. Cell ID - 0% b. Red Blood Cells - 0% c. Hematocrit - 0% d. Hemoglobin - 0% e. White Blood Cells - 0% f. Platelets - 0% 2. API 2019 Event 1 Hematology Analytes: a. Cell ID - 0% b. Red Blood Cells - 0% c. Hematocrit - 0% d. Hemoglobin - 0% e. White Blood Cells - 0% f. Platelets - 0% -- 2 of 2 --