Pediatric Associates Of Auburn

Summary Statement of Deficiencies D2007 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) (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 the American Proficiency Institute (API) Proficiency Test (PT) records, the CMS 209 Personnel document, and an interview with Testing Personnel #1 (TP1), the Laboratory failed to rotate all Testing Personnel in Proficiency Testing. This was noted for one of six Testing Personnel performing all eight PT events in 2023 through 2025. The findings include: 1. A review of the API PT records revealed TP1 performed all eight Hematology PT events in 2023 through 2025. 2. A further review of the CMS 209 Personnel document revealed five other qualified Testing Personnel performing moderate complexity testing in Hematology. 3. During an interview on 9-9-2025 at 10:30 AM, TP1 confirmed she was the only TP performing PT. D5437 CALIBRATION AND CALIBRATION VERIFICATION CFR(s): 493.1255(a) (a )Unless otherwise specified in this subpart, for each applicable test system the laboratory must perform and document calibration procedures-- (a)(1) Following the manufacturer's test system instructions, using calibration materials provided or specified, and with at least the frequency recommended by the manufacturer; (a)(2) Using the criteria verified or established by the laboratory as specified in 493.1253(b) (3)-- (a)(2)(i) Using calibration materials appropriate for the test system and, if possible, traceable to a reference method or reference material of known value; and (a) (2)(ii) Including the number, type, and concentration of calibration materials, as well 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 -- as acceptable limits for and the frequency of calibration; and (a)(3) Whenever calibration verification fails to meet the laboratory's acceptable limits for calibration verification. This STANDARD is not met as evidenced by: Based on a review of the Hematology records, the Quality Systems Assessment log, and an interview with Testing Personnel #1, the Laboratory failed to perform calibrations on the Abbott Emerald Cell Dyn Hematology analyzer every six months as per the QA policy. The laboratory failed to perform one of two calibrations due in 2023. The findings include: 1. A review of the Hematology calibration records revealed the Cell Dyn was calibrated 3/7/2023 and then almost twelve months later on 4/1/2024. There was no documentation of a calibration the second half of 2023. 2. A further review of the Quality Systems Assessment review revealed "...calibrations performed at least every six months." 3. During an interview on 9-9-2025, at 11:25 AM, Testing Personnel #1 confirmed the calibration due the second half of 2023 was not performed. D5481 CONTROL PROCEDURES CFR(s): 493.1256(f)(g) (f) Results of control materials must meet the laboratorys and, as applicable, the manufacturers 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 2023 Hematology quality control (QC) records for the Abbott Emerald Cell Dyn, the patient results log, and an interview with Testing Personnel #1, the laboratory failed to ensure at least two levels of quality control were run, acceptable and documented, prior to analyzing patient specimens and reporting the results. This was noted one day out of three months reviewed in 2023. The findings include: 1. A review of the QC records for the Emerald Cell Dyn Hematology analyzer revealed on 12/04/2023, there was no evidence of documented QC performed. 2. A review of the cumulative patient log printed from the instrument revealed two patient CBCs (Complete Blood Count) were performed on 12/4/2023. 3. During an interview on 9-9-2025 at 12:18 PM, Testing Personnel #1 confirmed QC documentation could not be located. D5781

Summary Statement of Deficiencies D2009 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) The individual testing or examining the samples and the laboratory director must attest to the routine integration of the samples into the patient workload using the laboratory's routine methods. This STANDARD is not met as evidenced by: Based on a review of the American Proficiency Institute (API) Proficiency Testing (PT) records and an interview with Testing Personnel #1, the laboratory failed to ensure the Laboratory Director signed the attestation statements for two of three events in 2022. The findings include: 1. A review of the API PT records revealed no signature by the Laboratory Director (or designee) on attestation statements for the following surveys: a) 2022 Hematology 1st Event. b) 2022 Hematology 3rd Event. 2. During an interview on February 28, 2022, at 9:43 AM, Testing Personnel #1 confirmed the above findings. D5413 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(b) The laboratory must define criteria for those conditions that are essential for proper storage of reagents and specimens, accurate and reliable test system operation, and test result reporting. The criteria must be consistent with the manufacturer's instructions, if provided. These conditions must be monitored and documented and, if applicable, include the following: (1) Water quality. (2) Temperature. (3) Humidity. (4) Protection of equipment and instruments from fluctuations and interruptions in electrical current that adversely affect patient test results and test reports. This STANDARD is not met as evidenced by: Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 2 -- Based on a review of the refrigerator temperature records, the Cell Dyn 18+ Quality Control package insert, and an interview with Testing Personnel #1, the Laboratory failed to document temperatures for the refrigerator in which the Hematology QC was stored since the previous survey on 5/11/2021 to the current survey on 2/28/2023. The findings include: 1. A review of the temperature records revealed the laboratory failed to document temperatures for the refrigerator in which the Cell Dyn+ Hematology Controls were stored since the previous survey on 5/11/2021. 2. A further review of the Cell Dyn 18+ Control package insert reveals, "Cell Dyn 18+ controls should be tightly capped and stored at 2-10 degrees Celsius." 3. During an interview on February 28th, 2023, at 12:19 PM, Testing Personnel #1 confirmed the above findings. D5429 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(a)(1) For unmodified manufacturer's equipment, instruments, or test systems, the laboratory must perform and document maintenance as defined by the manufacturer and with at least the frequency specified by the manufacturer. This STANDARD is not met as evidenced by: Based on a review of the Hematology maintenance records and an interview with Testing Personnel #1, the Laboratory failed to perform and document monthly maintenance on the Abbott Cell Dyn Emerald Hematology analyzer as per the manufacturer's requirements for 16 of 21 months reviewed from 2021 to 2023. The findings include: 1. A review of the Abbott Cell Dyn Emerald Hematology analyzer records revealed no documentation of monthly maintenance in: a) 2021: July, August, October through December b) 2022: February, March, May through December c) 2023: January 2. During an interview on February 28, 2023, at 12:45 AM, Testing Personnel #1 confirmed the above findings. -- 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 CMS CASPER Reports (#153 and #155) for Proficiency Testing (PT) and API (American Proficiency Institute) PT evaluations, the surveyor determined the laboratory failed to successfully participate in Hematology [Complete Blood Count (CBC)] for three out of three consecutive events Event #1 2021, Event #2 2021, and Event #3 2021. The failures of Hematology for these three out of three consecutive events resulted in a noninitial unsuccessful participation. The findings include: 1. Refer to D2130. 2. Refer to D2131. D2130 HEMATOLOGY 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 -- 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 (#153 and #155) and a review of the American Proficiency Institute (API) proficiency testing reports, the surveyor determined the laboratory failed to successfully participate in Hematology [Complete Blood Count (CBC)] testing for three of three consecutive events (Event #1, Event #2, and Event #3 of 2021). The failures resulted in an noninitial unsuccessful participation for the laboratory. The findings include: 1. A review of the CASPER reports revealed the following: a) the laboratory failed to participate in 2021 Events #1, resulting in zero scores for Hematology (CBC) b) the laboratory failed to participate in 2021 Events #2, resulting in zero scores for Hematology (CBC) c) the laboratory failed to successfully participate in 2021 Event #3, resulting in an overall score of seventy-one percent (71%) for Hematology (CBC). 2. A review of the API proficiency testing records revealed the laboratory failed to participate in the first and second testing events of 2021 resulting in 0% scores. The laboratory also failed to achieve satisfactory scores in the third event of 2021. The result of 3 of 3 testing event failures in 2021 is non-initial unsuccessful performance. See below: Testing Event Test Score 2021-1 Hematology 0% 2021-1 WBC Diff 0% 2021-1 RBC 0% 2021-1 Hematocrit 0% 2021-1 Platelets 0% 2021-2 Hematology 0% 2021-2 WBC Diff 0% 2021-2 RBC 0% 2021-2 Hematocrit 0% 2021-2 Platelets 0% 2021-3 Hematology 71% 2021-3 WBC Diff 67% 2021-3 RBC 60% 2021-3 Hematocrit 60% 2021-3 Platelets 60% 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 the CMS CASPER reports (#153 and #155) and a review of the American Proficiency Institute (API) proficiency testing reports, the surveyor determined the laboratory failed to successfully participate in Hematology [Complete Blood Count (CBC)] testing for three of three consecutive events (Event #1, Event #2, and Event #3 of 2021). The failures resulted in an noninitial unsuccessful participation for the laboratory. The findings include: 1. A review of the CASPER reports revealed the following: a) the laboratory failed to participate in 2021 Events #1, resulting in zero scores for Hematology (CBC) b) the laboratory failed to participate in 2021 Events #2, resulting in zero scores for Hematology (CBC) c) the laboratory failed to successfully participate in 2021 Event #3, resulting in an overall score of seventy-one percent (71%) for Hematology (CBC). 2. A review of the API proficiency testing records revealed the laboratory failed to participate in the first and second testing events of 2021 resulting in 0% scores. The laboratory also failed to achieve satisfactory scores in the third event of 2021. The result of 3 of 3 testing event failures in 2021 is non-initial unsuccessful performance. See below: Testing Event Test Score 2021-1 Hematology 0% 2021-1 WBC Diff 0% 2021-1 RBC 0% 2021-1 Hematocrit 0% 2021-1 Platelets 0% 2021-2 Hematology 0% 2021-2 WBC Diff 0% 2021-2 RBC -- 2 of 3 -- 0% 2021-2 Hematocrit 0% 2021-2 Platelets 0% 2021-3 Hematology 71% 2021-3 WBC Diff 67% 2021-3 RBC 60% 2021-3 Hematocrit 60% 2021-3 Platelets 60% 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 the CMS CASPER reports and a review of the American Proficiency Institute (API) proficiency testing reports, the surveyor determined the Laboratory Director failed to fulfill the Laboratory Director's responsibilities. The failures of Hematology for these three out of three consecutive events resulted in a noninitial unsuccessful participation. The findings include: 1. 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 the CMS CASPER reports and a review of the American Proficiency Institute (API) proficiency testing reports, the surveyor determined the Laboratory Director failed to fulfill the Laboratory Director's responsibilities. The failures of Hematology for these three out of three consecutive events resulted in a noninitial unsuccessful participation. The findings include: 1. Refer to D2130. 2. Refer to D2131. -- 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 a review of the CMS (Centers for Medicare and Medicaid Services) Casper reports, a review of the API (American Proficiency Institute) proficiency testing records, and a telephone interview with testing personnel, the surveyor determined the laboratory failed to successfully participate in Hematology testing for two consecutive testing events, Events #1 and #2, 2021. These failures resulted in an initial unsuccessful participation for the laboratory. The finding include: 1. A review of the CMS Casper reports revealed the laboratory failed to participate in Events #1 and #2, 2021, resulting in zero scores for Hematology [Complete Blood Count (CBC) testing]. 2. A review of the API proficiency testing confirmed the above noted findings. 3. 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 -- During a telephone interview on 9/21/2021 at 8:20 AM, the testing personnel explained she was, at the time of testing Event #1, the only testing personnel to perform Proficiency Testing (PT), and was out of the office, due to a medical emergency. She further explained that while other testing personnel continued to run patient CBC specimens, they had not been trained to test proficiency samples. The surveyor discussed with the testing personnel the importance of rotating PT samples among all personnel who test patient specimens. The testing personnel stated this had also been explained by the surveyor, during her last on-site survey. The testing personnel stated the PT samples for Event #2 were tested late, one day past the submission deadline, simply because the PT was forgotten. 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 (Centers for Medicare and Medicaid Services) Casper reports, a review of the API (American Proficiency Institute) proficiency testing records, and a telephone interview with testing personnel, the surveyor determined the laboratory failed to satisfactorily perform in Hematology testing for two consecutive testing events, Events #1 and #2, 2021. The laboratory did not participate in the proficiency testing, resulting in an initial unsuccessful participation for the laboratory. The finding include: 1. A review of the CMS Casper reports revealed the laboratory failed to participate in Events #1 and #2, 2021, resulting in zero scores for Hematology [Complete Blood Count (CBC) testing]. 2. A review of the API proficiency testing confirmed the above noted findings. 3. During a telephone interview on 9/21/2021 at 8:20 AM, the testing personnel explained she was, at the time of testing Event #1, the only testing personnel to perform Proficiency Testing (PT), and was out of the office, due to a medical emergency. She further explained that while other testing personnel continued to run patient CBC specimens, they had not been trained to test proficiency samples. The surveyor discussed with the testing personnel the importance of rotating PT samples among all personnel who test patient specimens. The testing personnel stated this had also been explained by the surveyor, during her last on-site survey. The testing personnel stated the PT samples for Event #2 were tested late, one day past the submission deadline, simply because the PT was forgotten. -- 2 of 2 --

Summary Statement of Deficiencies 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 #1, the surveyor determined the laboratory failed to submit proficiency testing results by the submission deadlines for Hematology testing for Event #1 2021. The laboratory scored zero percent (0%) for this event, due to the failure to timely submit the results. This affected one of seven PT events reviewed by the surveyor. The findings include: 1. A review of the PT records revealed the due date to submit API proficiency testing results for the 1st Event 2021 was 03/31/2021. The API Performance Summary for 1st Event 2021 revealed zero percent (0%) for Hematology Complete Blood Count (CBC) failure to participate. 2. During an interview on 05/11/2021 at 12:15 PM, Testing Personnel #1 confirmed the 1st Event 2021 was not performed due to Testing Personnel #1 being off work for an extended period of time. Also, Testing Personnel #1 confirmed patient testing was still being performed during this time period by other Testing Personnel. 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 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 -- 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 an interview, the laboratory failed to report SARS-CoV-2 (Severe Acute Respiratory Syndrome Coronovirus 2) test results for negative Coronovirus Disease 2019 (COVID-19) performed on the Quidel Sofia2 SARS Antigen FIA and COVID-19 IgG/IgM Rapid Test Cassette from January 8, 2021 [the date State Surveyors received CMS guidance for surveying on this deficiency] to May 11, 2021. The laboratory failed to report negative results for SARS-CoV-2 for the COVID-19 antigen and antibody test results to the Alabama Department of Public Health. Findings include: 1. A review of SARS-CoV-2 test results revealed patients were tested for SARS-CoV-2 using the Quidel Sofia2 SARS Antigen FIA, starting July 27, 2020 through May 11, 2021. A total of 1815 test were performed (87 Positives and 1728 Negatives) during this time period. A review of SARS-CoV-2 test results revealed patients were tested for SARS-CoV-2 using COVID-19 IgG/IgM Rapid Test Cassette, starting July 27, 2020 through May 11, 2021. A total of 25 test were performed (0 Positives and 25 Negatives) during this time period. 2. During an interview on May 11, 2021 at 10:40 AM, the Clinical Consultant #1 stated positive results were reported to the Alabama ALNBS Base system and negative results were not reported due to lack of manpower. 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. This STANDARD is not met as evidenced by: Based on lack of laboratory procedures, and an interview with Testing Personnel #1, the laboratory failed to establish written policies and procedures to assess the competency of the employees. The findings include: 1. A review of the Laboratory Procedures revealed the laboratory had one procedure for performing Complete Blood Counts (CBCs) and no other policies and procedures. 2. During an interview on 05/11 /2021 at 12:20 PM, Testing Personnel #1 confirmed the procedure for performing Complete Blood Counts (CBCs) was the only policy and procedure the laboratory had. D5215 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(b)(2) The laboratory must verify the accuracy of any analyte, specialty or subspecialty assigned a proficiency testing score that does not reflect laboratory test performance (that is, when the proficiency testing program does not obtain the agreement required for scoring as specified in subpart I of this part, or the laboratory receives a zero score for nonparticipation, or late return or results). -- 2 of 5 -- 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 #1, the surveyor determined the laboratory failed to submit proficiency testing results by the submission deadlines for Hematology testing for Event #1 2021 and verify the accuracy. The laboratory scored zero percent (0%) for this event, due to the failure to timely submit the results and did not perform a self evaluation when results were received. This affected one of seven PT events reviewed by the surveyor. The findings include: 1. A review of the PT records revealed the due date to submit API proficiency testing results for the 1st Event 2021 was 03/31/2021. The API Performance Summary for 1st Event 2021 revealed zero percent (0%) for Hematology Complete Blood Count (CBC) failure to participate. 2. During an interview on 05/11/2021 at 12:15 PM, Testing Personnel #1 confirmed the 1st Event 2021 was not performed due to Testing Personnel #1 being off work for an extended period of time. Also, Testing Personnel #1 confirmed patient testing was still being performed during this time period by other Testing Personnel and a self evaluation was not performed. D5291 GENERAL LABORATORY SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1239(a) The laboratory must establish and follow written policies and procedures for an ongoing mechanism to monitor, assess, and, when indicated, correct problems identified in the general laboratory systems requirements specified at 493.1231 through 493.1236. This STANDARD is not met as evidenced by: Based on the lack of the laboratory procedures, review of Quality Assessment (QA) records, and an interview with Testing Personnel #1, the laboratory failed to establish policies and procedures for an ongoing mechanism to monitor, assess, and correct problems identified. This was noted from 01/17/2019 to 05/11/2021. The findings include: 1. A review of the Laboratory Procedures revealed the laboratory had one procedure for performing Complete Blood Counts (CBCs) and no other policies and procedures. 2. A review of the Quality Assurance (QA) records revealed January 2019 to December 2019 QA forms covered Safety Policies, Proficiency Testing, and Preanalytic Systems. January 2020 to April 2021 QA forms covered Specimen Collection, Reporting Specimen Results, and Quality Control. 3. During an interview on 05/11/2021 at 1:50 PM, Testing Personnel #1 confirmed the Quality Assurance forms did not include all the practices/issues related to: Patient Confidentiality, Specimen identification and integrity, Complaint investigations, Communications, Personnel competency, and Proficiency testing performance. Testing Personnel #1 also confirmed the laboratory did not have an established procedure for QA. D5429 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(a)(1) For unmodified manufacturer's equipment, instruments, or test systems, the laboratory must perform and document maintenance as defined by the manufacturer and with at least the frequency specified by the manufacturer. This STANDARD is not met as evidenced by: Based on a review of the Hematology Cell Dyn Emerald maintenance records, a -- 3 of 5 -- review of the Cell-Dyn Emerald Operator's Manual, and an interview with Testing Personnel #1, the laboratory failed to document monthly maintenance. This was noted on 12 months out of 29 months for monthly maintenance reviewed by the surveyor. Also, for semi-annual maintenance this was noted from the previous survey 01/17 /2019 to 05/11/2021. The findings include: 1. A review of the Hematology maintenance records revealed that January 2019, February 2019, February 2020 - June 2020, August 2020, September 2020, December 2020, February 2021, and March 2021 the monthly cleaning was not documented on the Maintenance log. A review of the Hematology maintenance records also revealed the semi-annual maintenance was not documented from the pervious survey 01/17/2019 to 05/11/2021. 2. A review of the Cell-Dyn Emerald Operator's Manual revealed in section 9 page 9-11 under Monthly Maintenance the procedure for Bleach Cleaning to be performed monthly. A review of the Cell-Dyn Emerald Operator's Manual revealed in section 9 page 9-13 under Semi-Annual Maintenance the procedure for Lubricating the Pistons to be performed every six months. 3. During an interview on 05/11/2021 at 2:15 PM, Testing Personnel #1 confirmed monthly and semi-annual maintenance was not documented for the timeframe mention above. 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 review of the API (American Proficiency Institute) Proficiency Testing (PT) records and an interview with Testing Personnel #1, the surveyor determined the Laboratory Director failed to ensure test results were submitted to API for grading for Hematology testing for Event #1 2021. The laboratory scored zero percent (0%) for this event, due to the failure to timely submit the results and did not perform a self evaulation when results were received. This affected one of seven PT events reviewed by the surveyor. The findings include: Refer to D2127. D6054 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(9) The technical consultant is responsible for evaluating and documenting the performance of individuals responsible for moderate complexity testing at least annually, after the first year. This STANDARD is not met as evidenced by: Based on a review of personnel evaluation records and an interview with Testing Personnel #1, the Technical Consultant failed to assure annual evaluations were performed by a qualified personnel for Hematology Complete Blood Count (CBC). This was noted on two out of five employees since the previous survey, conducted 1 /17/2019. The findings include: 1. A review of the personnel records revealed that Testing Personnel #2 and # 3 had annual evaluations performed on 01/11/2019, 01/17 -- 4 of 5 -- /2020, and 10/13/2020. These evaluations were performed and reviewed by Testing Personnel #1, except Testing Personnel #2's evaluation on 01/17/2020 was not reviewed, as evidenced by lack of signature. 2. During an interview on 05/11/2021 at 11:40 AM, Testing Personnel #1 confirmed the above findings, and the Technical Consultant responsibilities were not delegated to Testing Personnel #1. D6065 TESTING PERSONNEL QUALIFICATIONS CFR(s): 493.1423(b)(1)(2)(3)(4)(i) (b) Meet one of the following requirements: (b)(1) Be a doctor of medicine or doctor of osteopathy licensed to practice medicine or osteopathy in the State in which the laboratory is located or have earned a doctoral, master's, or bachelor's degree in a chemical, physical, biological or clinical laboratory science, or medical technology from an accredited institution; or (b)(2) Have earned an associate degree in a chemical, physical or biological science or medical laboratory technology from an accredited institution; or (b)(3) Be a high school graduate or equivalent and have successfully completed an official military medical laboratory procedures course of at least 50 weeks duration and have held the military enlisted occupational specialty of Medical Laboratory Specialist (Laboratory Technician); or (b)(4)(i) Have earned a high school diploma or equivalent; and This STANDARD is not met as evidenced by: Based on a review of personnel records and an interview with Testing Personnel #1, the laboratory failed to have a diploma on file for Testing Personnel #4. This affected one of two new testing personnel reviewed by the surveyor. The findings include: 1. A review of personnel records revealed that Testing Personnel #4 had no education records on file. 2. During an interview on 05/11/2021 at 02:45 PM, Testing Personnel #1 confirmed the above finding. -- 5 of 5 --

Summary Statement of Deficiencies 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 #1, the surveyor determined the laboratory failed to submit proficiency testing results by the submission deadlines for Hematology testing for Event #1 2021. The laboratory scored zero percent (0%) for this event, due to the failure to timely submit the results. This affected one of seven PT events reviewed by the surveyor. The findings include: 1. A review of the PT records revealed the due date to submit API proficiency testing results for the 1st Event 2021 was 03/31/2021. The API Performance Summary for 1st Event 2021 revealed zero percent (0%) for Hematology Complete Blood Count (CBC) failure to participate. 2. During an interview on 05/11/2021 at 12:15 PM, Testing Personnel #1 confirmed the 1st Event 2021 was not performed due to Testing Personnel #1 being off work for an extended period of time. Also, Testing Personnel #1 confirmed patient testing was still being performed during this time period by other Testing Personnel. 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 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 -- 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 an interview, the laboratory failed to report SARS-CoV-2 (Severe Acute Respiratory Syndrome Coronovirus 2) test results for negative Coronovirus Disease 2019 (COVID-19) performed on the Quidel Sofia2 SARS Antigen FIA and COVID-19 IgG/IgM Rapid Test Cassette from January 8, 2021 [the date State Surveyors received CMS guidance for surveying on this deficiency] to May 11, 2021. The laboratory failed to report negative results for SARS-CoV-2 for the COVID-19 antigen and antibody test results to the Alabama Department of Public Health. Findings include: 1. A review of SARS-CoV-2 test results revealed patients were tested for SARS-CoV-2 using the Quidel Sofia2 SARS Antigen FIA, starting July 27, 2020 through May 11, 2021. A total of 1815 test were performed (87 Positives and 1728 Negatives) during this time period. A review of SARS-CoV-2 test results revealed patients were tested for SARS-CoV-2 using COVID-19 IgG/IgM Rapid Test Cassette, starting July 27, 2020 through May 11, 2021. A total of 25 test were performed (0 Positives and 25 Negatives) during this time period. 2. During an interview on May 11, 2021 at 10:40 AM, the Clinical Consultant #1 stated positive results were reported to the Alabama ALNBS Base system and negative results were not reported due to lack of manpower. 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. This STANDARD is not met as evidenced by: Based on lack of laboratory procedures, and an interview with Testing Personnel #1, the laboratory failed to establish written policies and procedures to assess the competency of the employees. The findings include: 1. A review of the Laboratory Procedures revealed the laboratory had one procedure for performing Complete Blood Counts (CBCs) and no other policies and procedures. 2. During an interview on 05/11 /2021 at 12:20 PM, Testing Personnel #1 confirmed the procedure for performing Complete Blood Counts (CBCs) was the only policy and procedure the laboratory had. D5215 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(b)(2) The laboratory must verify the accuracy of any analyte, specialty or subspecialty assigned a proficiency testing score that does not reflect laboratory test performance (that is, when the proficiency testing program does not obtain the agreement required for scoring as specified in subpart I of this part, or the laboratory receives a zero score for nonparticipation, or late return or results). -- 2 of 5 -- 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 #1, the surveyor determined the laboratory failed to submit proficiency testing results by the submission deadlines for Hematology testing for Event #1 2021 and verify the accuracy. The laboratory scored zero percent (0%) for this event, due to the failure to timely submit the results and did not perform a self evaluation when results were received. This affected one of seven PT events reviewed by the surveyor. The findings include: 1. A review of the PT records revealed the due date to submit API proficiency testing results for the 1st Event 2021 was 03/31/2021. The API Performance Summary for 1st Event 2021 revealed zero percent (0%) for Hematology Complete Blood Count (CBC) failure to participate. 2. During an interview on 05/11/2021 at 12:15 PM, Testing Personnel #1 confirmed the 1st Event 2021 was not performed due to Testing Personnel #1 being off work for an extended period of time. Also, Testing Personnel #1 confirmed patient testing was still being performed during this time period by other Testing Personnel and a self evaluation was not performed. D5291 GENERAL LABORATORY SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1239(a) The laboratory must establish and follow written policies and procedures for an ongoing mechanism to monitor, assess, and, when indicated, correct problems identified in the general laboratory systems requirements specified at 493.1231 through 493.1236. This STANDARD is not met as evidenced by: Based on the lack of the laboratory procedures, review of Quality Assessment (QA) records, and an interview with Testing Personnel #1, the laboratory failed to establish policies and procedures for an ongoing mechanism to monitor, assess, and correct problems identified. This was noted from 01/17/2019 to 05/11/2021. The findings include: 1. A review of the Laboratory Procedures revealed the laboratory had one procedure for performing Complete Blood Counts (CBCs) and no other policies and procedures. 2. A review of the Quality Assurance (QA) records revealed January 2019 to December 2019 QA forms covered Safety Policies, Proficiency Testing, and Preanalytic Systems. January 2020 to April 2021 QA forms covered Specimen Collection, Reporting Specimen Results, and Quality Control. 3. During an interview on 05/11/2021 at 1:50 PM, Testing Personnel #1 confirmed the Quality Assurance forms did not include all the practices/issues related to: Patient Confidentiality, Specimen identification and integrity, Complaint investigations, Communications, Personnel competency, and Proficiency testing performance. Testing Personnel #1 also confirmed the laboratory did not have an established procedure for QA. D5429 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(a)(1) For unmodified manufacturer's equipment, instruments, or test systems, the laboratory must perform and document maintenance as defined by the manufacturer and with at least the frequency specified by the manufacturer. This STANDARD is not met as evidenced by: Based on a review of the Hematology Cell Dyn Emerald maintenance records, a -- 3 of 5 -- review of the Cell-Dyn Emerald Operator's Manual, and an interview with Testing Personnel #1, the laboratory failed to document monthly maintenance. This was noted on 12 months out of 29 months for monthly maintenance reviewed by the surveyor. Also, for semi-annual maintenance this was noted from the previous survey 01/17 /2019 to 05/11/2021. The findings include: 1. A review of the Hematology maintenance records revealed that January 2019, February 2019, February 2020 - June 2020, August 2020, September 2020, December 2020, February 2021, and March 2021 the monthly cleaning was not documented on the Maintenance log. A review of the Hematology maintenance records also revealed the semi-annual maintenance was not documented from the pervious survey 01/17/2019 to 05/11/2021. 2. A review of the Cell-Dyn Emerald Operator's Manual revealed in section 9 page 9-11 under Monthly Maintenance the procedure for Bleach Cleaning to be performed monthly. A review of the Cell-Dyn Emerald Operator's Manual revealed in section 9 page 9-13 under Semi-Annual Maintenance the procedure for Lubricating the Pistons to be performed every six months. 3. During an interview on 05/11/2021 at 2:15 PM, Testing Personnel #1 confirmed monthly and semi-annual maintenance was not documented for the timeframe mention above. 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 review of the API (American Proficiency Institute) Proficiency Testing (PT) records and an interview with Testing Personnel #1, the surveyor determined the Laboratory Director failed to ensure test results were submitted to API for grading for Hematology testing for Event #1 2021. The laboratory scored zero percent (0%) for this event, due to the failure to timely submit the results and did not perform a self evaulation when results were received. This affected one of seven PT events reviewed by the surveyor. The findings include: Refer to D2127. D6054 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(9) The technical consultant is responsible for evaluating and documenting the performance of individuals responsible for moderate complexity testing at least annually, after the first year. This STANDARD is not met as evidenced by: Based on a review of personnel evaluation records and an interview with Testing Personnel #1, the Technical Consultant failed to assure annual evaluations were performed by a qualified personnel for Hematology Complete Blood Count (CBC). This was noted on two out of five employees since the previous survey, conducted 1 /17/2019. The findings include: 1. A review of the personnel records revealed that Testing Personnel #2 and # 3 had annual evaluations performed on 01/11/2019, 01/17 -- 4 of 5 -- /2020, and 10/13/2020. These evaluations were performed and reviewed by Testing Personnel #1, except Testing Personnel #2's evaluation on 01/17/2020 was not reviewed, as evidenced by lack of signature. 2. During an interview on 05/11/2021 at 11:40 AM, Testing Personnel #1 confirmed the above findings, and the Technical Consultant responsibilities were not delegated to Testing Personnel #1. D6065 TESTING PERSONNEL QUALIFICATIONS CFR(s): 493.1423(b)(1)(2)(3)(4)(i) (b) Meet one of the following requirements: (b)(1) Be a doctor of medicine or doctor of osteopathy licensed to practice medicine or osteopathy in the State in which the laboratory is located or have earned a doctoral, master's, or bachelor's degree in a chemical, physical, biological or clinical laboratory science, or medical technology from an accredited institution; or (b)(2) Have earned an associate degree in a chemical, physical or biological science or medical laboratory technology from an accredited institution; or (b)(3) Be a high school graduate or equivalent and have successfully completed an official military medical laboratory procedures course of at least 50 weeks duration and have held the military enlisted occupational specialty of Medical Laboratory Specialist (Laboratory Technician); or (b)(4)(i) Have earned a high school diploma or equivalent; and This STANDARD is not met as evidenced by: Based on a review of personnel records and an interview with Testing Personnel #1, the laboratory failed to have a diploma on file for Testing Personnel #4. This affected one of two new testing personnel reviewed by the surveyor. The findings include: 1. A review of personnel records revealed that Testing Personnel #4 had no education records on file. 2. During an interview on 05/11/2021 at 02:45 PM, Testing Personnel #1 confirmed the above finding. -- 5 of 5 --

Summary Statement of Deficiencies D5413 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(b) The laboratory must define criteria for those conditions that are essential for proper storage of reagents and specimens, accurate and reliable test system operation, and test result reporting. The criteria must be consistent with the manufacturer's instructions, if provided. These conditions must be monitored and documented and, if applicable, include the following: (1) Water quality. (2) Temperature. (3) Humidity. (4) Protection of equipment and instruments from fluctuations and interruptions in electrical current that adversely affect patient test results and test reports. This STANDARD is not met as evidenced by: Based on a review of the room temperature logs, a lack of humidity records, a review of environmental requirements for the Abbott Cell Dyn Emerald Hematology analyzer, and an interview with Testing Personnel (TP) #1, the surveyor determined the laboratory failed to: 1) establish acceptable room temperature ranges as per manufacturer's requirements, 2) ensure the Hematology analyzer was operated within the established environmental parameter specified by Abbott, and 3) monitor and document room humidity in the area of operation since the previous survey on 1/6 /2017. The findings include: 1. A review of the Cell Dyn Emerald Operator's Manual on page 2-4 revealed, "Installation Environment The following are environmental requirements: ... Temperature range: 64 - 90 degrees F (Fahrenheit) ... Maximum relative humidity 80% (percent) for temperatures up 90 degrees F". 2. A review of the 2017-2018 environmental logs revealed the testing personnel recorded room temperature each day of patient testing, however the acceptable "Range" at the top of the log was "10-85%". The surveyor further noted temperatures were less than 64 degrees F (colder than the environmental requirements specified by the manufacturer) sixteen days in January 2018 with no documentation of