Prattville Medical Clinic

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 CMS (Centers for Medicare and Medicaid) CASPER reports, a review of API (American Proficiency Institute) proficiency testing evaluations, and a telephone interview with testing personnel, the surveyor determined the laboratory failed to successfully participate in proficiency testing for Hematocrit (HCT) for two consecutive testing events. These failures resulted in an initial unsuccessful participation. This affected Event #3, 2020 and Event #1, 2021. The findings include: 1. A review of the CASPER reports revealed the laboratory scored zero percent (0 %) for HCT for Event #3, 2020, due to an untimely submission (D2127 was cited on the onsite survey, conducted on 3/9/2021); and scored 60 % for 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 -- HCT for Event #1, 2021. These two consecutive failures of the same analyte resulted in an initial unsuccessful participation in proficiency testing. The laboratory also scored 60 % for MCH (Mean Corpuscular Hemoglobin), MCHC (Mean Corpuscular Hemoglobin Concentration) and RDW (Red Cell Distribution Width) for Event #1, 2021. 2. A review of the API testing evaluations confirmed the above noted findings. 3. In a telephone interview on May 21, 2021 at 9:30 AM, the testing personnel confirmed the testing results for Event #3, 2020, which were mailed, were not received by API by the submission date, and resulted in zero percent scores. The testing personnel also confirmed the failures of Event #1, 2021. . 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 CASPER reports, a review of API (American Proficiency Institute) proficiency testing evaluations, and a telephone interview with testing personnel, the surveyor determined the laboratory failed to successfully perform in proficiency testing for Hematocrit (HCT) for two consecutive testing events. These failures resulted in an initial unsuccessful participation. This affected Event #3, 2020 and Event #1, 2021. The findings include: 1. Refer to D2016. -- 2 of 2 --

Summary Statement of Deficiencies D2007 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) The samples must be examined or tested with the laboratory's regular patient workload by personnel who routinely perform the testing in the laboratory, using the laboratory's routine methods This STANDARD is not met as evidenced by: Based on a review of API (American Proficiency Institute) proficiency testing (PT) records, and an interview with Testing Personnel #2, the surveyor determined the laboratory failed to ensure proficiency testing samples were rotated between all personnel who performed patient testing. This was noted on seven out of eight Hematology surveys reviewed for 2018 (2nd and 3rd Event), 2019 (all three events), and 2020 (all three events). The findings include: 1. A review of API attestation statements revealed Testing Personnel #2 had performed all the testing on seven out of eight Hematology surveys reviewed. 2. During an interview on 03/09/2021 at 01:25 PM, Testing Personnel #2 confirmed the proficiency testing was not rotated to the other two testing personnel since 2nd Event 2018. . 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 review of the API (American Proficiency Institute) Proficiency Testing (PT) records and an interview with Testing Personnel #2, the surveyor determined the 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 -- laboratory failed to submit proficiency testing results by the submission deadlines for Hematology testing for Event #3 2020. The laboratory scored zero percent (0%) for this event, due to the failure to timely submit the results. The findings include: 1. A review of the PT records revealed the due date to submit API proficiency testing results for the 3rd Event 2020 was 11/24/2020. The samples were tested on 11/19 /2020, however the results were not postmarked until 11/27/2020 to be mailed into API. 2. During an interview on 03/09/2021 at 12:15 PM, Testing Personnel #2 confirmed the results were not mailed in by the due date of 11/24/2020. 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 interviews, the laboratory failed to report SARS-Co-V-2 (Severe Acute Respiratory Syndrome Coronovirus 2) test results for positive and negative Coronovirus Disease 2019 (COVID-19) performed on the Sofia COVID test kit from January 8, 2021 [the date State Surveyors received CMS guidance for surveying on this deficiency] to March 8, 2021. The laboratory failed to report or attempt to report SARS-Co-V-2 for the COVID-19 antigen test results to the Alabama Department of Public Health with the timing and frequency prescribed. Findings include: 1. A review of SARS-Co-V-2 test results in two handwritten notebooks revealed patients were tested for SARS-Co-V-2 using the Sofia COVID test kit, starting September 21, 2020 through March 09, 2021. Most of the entries in the notebooks did not include the date the test was performed; the testing personnel had only documented the names of 1410 patients, and occasionally the COVID-19 test results. 2. During an interview on March 09, 2021 at 10:45 AM, Testing Personnel #2 stated the facility had not known about the reporting requirements; the testing personnel were only recording COVID-19 results in each patient's paper chart. Testing Personnel #2 confirmed the laboratory had never reported or attempted to report positive and negative SARS-Co-V-2 patient test results to the Alabama Department of Public Health from the 1410 patient tests performed from September 21, 2020 through March 09, 2021. 3. During a phone interview on March 12, 2021 at 12:12 PM, the surveyor asked Testing Personnel #1 how many patients were tested for COVID-19 from January 08, 2021 [the date State Surveyors received CMS guidance for surveying on this deficiency] through March 09, 2021. Testing Personnel #1 inquired at the Billing Office, and stated 782 patients were tested. -- 2 of 2 --

Summary Statement of Deficiencies D2007 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) The samples must be examined or tested with the laboratory's regular patient workload by personnel who routinely perform the testing in the laboratory, using the laboratory's routine methods This STANDARD is not met as evidenced by: Based on a review of API (American Proficiency Institute) proficiency testing (PT) records, and an interview with Testing Personnel #2, the surveyor determined the laboratory failed to ensure proficiency testing samples were rotated between all personnel who performed patient testing. This was noted on seven out of eight Hematology surveys reviewed for 2018 (2nd and 3rd Event), 2019 (all three events), and 2020 (all three events). The findings include: 1. A review of API attestation statements revealed Testing Personnel #2 had performed all the testing on seven out of eight Hematology surveys reviewed. 2. During an interview on 03/09/2021 at 01:25 PM, Testing Personnel #2 confirmed the proficiency testing was not rotated to the other two testing personnel since 2nd Event 2018. . 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 review of the API (American Proficiency Institute) Proficiency Testing (PT) records and an interview with Testing Personnel #2, the surveyor determined the 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 -- laboratory failed to submit proficiency testing results by the submission deadlines for Hematology testing for Event #3 2020. The laboratory scored zero percent (0%) for this event, due to the failure to timely submit the results. The findings include: 1. A review of the PT records revealed the due date to submit API proficiency testing results for the 3rd Event 2020 was 11/24/2020. The samples were tested on 11/19 /2020, however the results were not postmarked until 11/27/2020 to be mailed into API. 2. During an interview on 03/09/2021 at 12:15 PM, Testing Personnel #2 confirmed the results were not mailed in by the due date of 11/24/2020. 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 interviews, the laboratory failed to report SARS-Co-V-2 (Severe Acute Respiratory Syndrome Coronovirus 2) test results for positive and negative Coronovirus Disease 2019 (COVID-19) performed on the Sofia COVID test kit from January 8, 2021 [the date State Surveyors received CMS guidance for surveying on this deficiency] to March 8, 2021. The laboratory failed to report or attempt to report SARS-Co-V-2 for the COVID-19 antigen test results to the Alabama Department of Public Health with the timing and frequency prescribed. Findings include: 1. A review of SARS-Co-V-2 test results in two handwritten notebooks revealed patients were tested for SARS-Co-V-2 using the Sofia COVID test kit, starting September 21, 2020 through March 09, 2021. Most of the entries in the notebooks did not include the date the test was performed; the testing personnel had only documented the names of 1410 patients, and occasionally the COVID-19 test results. 2. During an interview on March 09, 2021 at 10:45 AM, Testing Personnel #2 stated the facility had not known about the reporting requirements; the testing personnel were only recording COVID-19 results in each patient's paper chart. Testing Personnel #2 confirmed the laboratory had never reported or attempted to report positive and negative SARS-Co-V-2 patient test results to the Alabama Department of Public Health from the 1410 patient tests performed from September 21, 2020 through March 09, 2021. 3. During a phone interview on March 12, 2021 at 12:12 PM, the surveyor asked Testing Personnel #1 how many patients were tested for COVID-19 from January 08, 2021 [the date State Surveyors received CMS guidance for surveying on this deficiency] through March 09, 2021. Testing Personnel #1 inquired at the Billing Office, and stated 782 patients were tested. -- 2 of 2 --