Park Place Healthcare, Llc

Summary Statement of Deficiencies D0000 The surveyor determined this laboratory is in substantial compliance with the requirements of the Clinical Laboratory Improvement Amendments of 1988 (CLIA'88). 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 record review and interview, the laboratory failed to report SARS-CoV-2 (Severe Acute Respiratory Syndrome Coronovirus 2) test results for positive and negative Coronovirus Disease 2019 (COVID-19) performed on the Access Bio, Inc. CareStart COVID-19 Antigen test kit from January 8, 2021 [the date State Surveyors received CMS guidance for surveying on this deficiency] to April 1, 2021. The laboratory failed to report negative results for SARS-CoV-2 for the COVID-19 antigen test results to the Alabama Department of Public Health and positive results were reported to the Report Card for Alabama Department of Public Health (which is not the mechanism to use to report a patient that has a reportable disease). Findings include: 1. A review of SARS-CoV-2 test results revealed patients were tested for SARS-CoV-2 using the Access Bio, Inc. CareStart COVID-19 Antigen test kit, 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 -- starting November 23, 2020 through April 1, 2021. A total of 528 test were performed (Positive 67 and Negative 461) during this time period. 2. During an interview on April 1, 2021 at 10:40 AM, Testing Personnel #2 stated positive results were reported to the Novel Coronavirus (COVID-19) Report Card to the Alabama Department of Public Health. The Report Card has the following statement "If you are a Laboratorian, reporting on behalf of a laboratory, blood bank, or plasma center, the REPORT Card is not the mechanism you should use to report a patient that has a reportable disease or health condition." Testing Personnel #2 confirmed the laboratory had reported only positives (to the Report Card) but none of the negative SARS-CoV- 2 patient test results to the Alabama Department of Public Health. -- 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 CMS CASPER reports and a review of the American Proficiency Institute (API) proficiency testing reports, the surveyor determined the laboratory failed to successfully participate in Hematology testing for two of three consecutive events (Event #1 and Event #3 of 2020). The failures resulted in an initial unsuccessful participation for the laboratory. The findings include: 1. A review of the CASPER reports for proficiency testing revealed the laboratory scored zero percent (0%) for Event #1 2020 and sixty percent (60%) for Event #3 2020 for both RBC and HCT (Non-Waived) (Hematology). 2. A review of the API proficiency testing records 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 -- revealed the laboratory failed to participate in testing, resulting in zero scores for the RBC and HCT (Non-Waived) for Event #1 of 2020. Also, the review revealed the laboratory failed to successfully participate in testing, resulting in a score of sixty in Event #3 2020 for RBC and HCT (Non-Waived). D2127 HEMATOLOGY CFR(s): 493.851(d) Failure to return proficiency testing results to the proficiency testing program within the time frame specified by the program is unsatisfactory performance and results in a score of 0 for the testing event. This STANDARD is not met as evidenced by: Based on the CMS CASPER reports and a review of the American Proficiency Institute (API) proficiency testing reports, the surveyor determined the laboratory failed to submit proficiency testing results by the submission deadlines for Hematology (RBC and HCT(Non-Waived)) testing for Event #1 2020. The laboratory scored zero percent (0%) for this event, due to the failure to timely submit the results (Failure to Participate). The findings include: 1. A review of the CASPER reports for proficiency testing revealed the laboratory scored zero percent (0%) for Event #1 2020 for RBC and HCT (Non-Waived) (Hematology). 2. A review of the API proficiency testing records revealed the laboratory failed to participate in testing, resulting in zero scores for the RBC and HCT (Non-Waived) for Event #1 of 2020. This failure to participate in testing resulted from the laboratory's failure to timely submit the results to API. 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 the CMS CASPER reports and a review of the American Proficiency Institute (API) proficiency testing reports, the surveyor determined the laboratory failed to successfully participate in Hematology testing for two of three consecutive events (Event #1 and Event #3 of 2020). The failures resulted in an initial unsuccessful participation for the laboratory. The findings include: 1. A review of the CASPER reports for proficiency testing revealed the laboratory scored zero percent (0%) for Event #1 2020 and sixty percent (60%) for Event #3 2020 for both RBC and HCT (Non-Waived) (Hematology). 2. A review of the API proficiency testing records revealed the laboratory failed to participate in testing, resulting in zero scores for the RBC and HCT (Non-Waived) for Event #1 of 2020. Also, the review revealed the laboratory failed to successfully participate in testing, resulting in a score of sixty in Event #3 2020 for RBC and HCT (Non-Waived). D6017 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(ii) The laboratory director is responsible for the overall operation and administration of the laboratory, including the employment of personnel who are competent to perform -- 2 of 3 -- 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)(ii) Ensure that results are returned within the timeframes established by the proficiency testing program. This STANDARD is not met as evidenced by: Based on the CMS CASPER reports and a review of the American Proficiency Institute (API) proficiency testing reports, the surveyor determined the Laboratory Director failed to ensure test results were submitted to API for grading. This affected Hematology testing (RBC and HCT (Non-Waived) ) for Event #1 2020. This failure along with D2121 resulted in an initial unsuccessful participation for the laboratory. The findings include: Refer to D2016. Refer to D2130. Refer to D2127. -- 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 the CMS CASPER reports, a review of the American Proficiency Institute (API) proficiency testing reports, and a telephone interview with the laboratory's testing personnel, the surveyor determined the laboratory failed to successfully participate in Routine Chemistry - Total Bilirubin testing for two of three consecutive events (Event #1 and #3 of 2020). These failures resulted in an initial unsuccessful participation for the laboratory. The findings include: 1. A review of the CASPER reports for proficiency testing revealed the laboratory scored zero percent (0 %) for Total Bilirubin (Chemistry) for Event #1 and Event #3, 2020. 2. A review of the API 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 -- proficiency testing records revealed the laboratory failed to participate in testing, resulting in zero scores for the Total Bilirubin for Events #1 and #3 of 2020. 3. During a telephone interview on 11/17/2020 at 11:00 AM, the testing personnel stated the office manager (also a testing personnel) is responsible for submitting the proficiency testing results for grading, however she failed to submit the results to API by the submission deadline to ensure grading for both events. The testing personnel further stated the laboratory staff had performed self-evaluations for the testing. D2093 ROUTINE CHEMISTRY CFR(s): 493.841(d) Failure to return proficiency testing results to the proficiency testing program within the time frame specified by the program is unsatisfactory performance and results in a score of 0 for the testing event. This STANDARD is not met as evidenced by: Based on the CMS CASPER reports, a review of the American Proficiency Institute (API) proficiency testing reports, and a telephone interview with the laboratory's testing personnel, the surveyor determined the laboratory failed to submit proficiency testing results by the submission deadlines for Routine Chemistry (Total Bilirubin) testing for two of three consecutive events (Event #1 and #3 of 2020). The laboratory scored zero percent (0 %) for both events, due to the failure to timely submit the results (Failure to Participate). These failures resulted in an initial unsuccessful participation for the laboratory. The findings include: 1. A review of the CASPER reports for proficiency testing revealed the laboratory scored zero percent (0 %) for Total Bilirubin (Chemistry) for Event #1 and Event #3, 2020. 2. A review of the API proficiency testing records revealed the laboratory failed to participate in testing, resulting in zero scores for the Total Bilirubin for Events #1 and #3 of 2020. 3. During a telephone interview on 11/17/2020 at 11:00 AM, the testing personnel stated the office manager (also a testing personnel) is responsible for submitting the proficiency testing results for grading, however she failed to submit the results to API by the submission deadline to ensure grading for both events. The testing personnel further stated the laboratory staff had performed self-evaluations for the testing. D6017 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(ii) 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)(ii) Ensure that results are returned within the timeframes established by the proficiency testing program. This STANDARD is not met as evidenced by: Based on the CMS CASPER reports, a review of the American Proficiency Institute (API) proficiency testing reports, and a telephone interview with the laboratory's testing personnel, the surveyor determined the Laboratory Director failed to ensure test results were submitted to API for grading. This affected Routine Chemistry -- 2 of 3 -- testing (Total Bilirubin) for two of three consecutive events (Event #1 and #3 of 2020). These failures resulted in an initial unsuccessful participation for the laboratory. The findings include: Refer to D2016. -- 3 of 3 --

Summary Statement of Deficiencies 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) (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 a lack of validation documentation for the Reichert Unistat Bilirubinometer analyzer, and interviews with the Laboratory Director, the surveyor determined the laboratory failed to ensure the verification of the manufacturer's performance specifications was performed, approved, signed and dated by the Laboratory Director before the instrument was used by the testing personnel for patient testing. The findings include: 1. During the entrance tour of the laboratory on 1/4/2019 at approximately 9:20 AM, the Laboratory Director included on the test menu Neonatal Bilirubins performed on the Reichert Unistat Bilirubinometer. 2. A review of the "BILIRUBIN" binder revealed two levels of Pediatric Bilirubin quality controls (QC) were performed on 12/13/2018; there was no other documentation of validation or testing procedures. 3. As the survey continued on 1/4/2019 at 11:40 AM, the surveyor requested the validation records for the Bilirubinometer to review the laboratory's verification procedures of the manufacturer's performance specifications. The Laboratory Director stated the only "validation" performed was to run the Calibrator cuvette and run QC in December. The Director further explained the manufacturer's instructions "were very vague" on any other requirements. 4. As the interview continued on 1/4/2019 at approximately 11:50 AM, the surveyor explained the CLIA 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 -- requirements for validation of precision, accuracy and reportable ranges of the tests as stated in the manufacturer's performance specifications, plus verification of the reference ranges for the laboratory's patient population. All validations must be reviewed and approved by the Laboratory Director before patient testing can begin. The surveyor then asked if the testing personnel had performed any patient bilirubins. The Director stated there was one patient tested on 12/13/2018, and two patients on 1/3 /2018; thus the above noted findings were confirmed. . D5481 CONTROL PROCEDURES CFR(s): 493.1256(f)(g) (f) Results of control materials must meet the laboratory's and, as applicable, the manufacturer's test system criteria for acceptability before reporting patient test results. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on a review of the Reichert Unistat Bilirubinometer analyzer procedures and quality control (QC) records, and an interview with the Laboratory Director, the surveyor determined the laboratory failed to ensure at least two levels of QC were run and within acceptable limits prior to analyzing patient specimens and reporting the results on 1/3/2019. The findings include: 1. A review of the Bilirubin Policy and Procedure revealed, "Analysis of at least a normal and abnormal level of a commercial serum control assayed for total bilirubin will be used for quality control ... each day that patient samples are analyzed...". 2. A review of the "BILIRUBIN" binder revealed two levels of Pediatric Bilirubin QC were run on 12/13/2018; there was no other documentation of QC performed on any other days. 3. In an interview on 1/4/2019 at 11:58 AM, the surveyor asked about the dates of patient testing on the Bilirubinometer. The Laboratory Director stated QC and one patient Neonatal Bilirubin was performed on 12/13/2018, and two Bilirubins "were run yesterday" [1/3 /2019]. When asked for the QC for 1/3/2019, the Director checked with Testing Personnel #2 who had performed the patient testing. Testing Personnel #2 stated she had not run any QC on 1/3/2018, thus the above noted findings were confirmed. SURVEYOR ID #32558 Licensure and Certification Surveyor -- 2 of 2 --