Allen L Spires, Md, Amc

Summary Statement of Deficiencies D0000 A Certification survey was performed on November 30, 2023 at Allen Spires MD, APMC, CLIA ID # 19D0464385. The laboratory was found in compliance with 42 CFR 493 Requirements for Laboratories; however, standard level deficiencies were cited. 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 review of the laboratory policy, personnel records, and interview with personnel, the laboratory failed to ensure written policies and procedures to assess competency for Technical Consultant was complete. Findings: 1. Review of laboratory policy revealed the "Laboratory Director is responsible for ensuring that competency is assessed at least annually for laboratory staff". 2. Review of personnel records for 2022 and 2023 revealed the competency assessment for Personnel 2 who serves as Technical Consultant was not performed. 3. In interview on November 30, 2023 at 2:09 pm, Personnel 2 confirmed the Laboratory Director did not perform competency assessments in 2022 and 2023 for personnel serving as Technical Consultant. D5431 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(a)(2) For unmodified manufacturer's equipment, instruments, or test systems, the laboratory must perform and document function checks as defined by the manufacturer and with at least the frequency specified by the manufacturer. Function checks must be within Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 7 -- the manufacturer's established limits before patient testing is conducted. This STANDARD is not met as evidenced by: Based on observation by surveyor, review of manufacturer's user manual, laboratory's start up logs, patient records and interview with personnel, the laboratory failed to ensure the daily background checks for the Horiba Medical ABX Micros 60 analzyer were within the manufacturer's parameter limits prior to patient testing for one (1) of six (6) months reviewed in 2023. Findings: 1. Observation by surveyor during the laboratory tour on November 30, 2023 at 1:30 pm revealed the laboratory utilizes the Horiba Medical ABX Micros 60 analyzer for Complete Blood Count (CBC) testing in the specialty of Hematology. 2. Review of the manufacturer's user manual for the Horiba Medical ABX Micros 60 under "Startup" revealed the following "If Backgrounds are unacceptable, the ABX Micros 60 automatically performs a Second and Third count. If the counts are still unacceptable, perform a Concentrated Cleaning. Run another Startup. If the second Startup fails, call ABX Technical Support". 3. Review of the laboratory's startup logs from March 20, 2023 revealed the laboratory performed six (6) Startup checks from 3:57 pm through 4:06 pm with documentation of the status as "Failed". 4. Further review of the startup logs from March 20, 2023 revealed the background counts exceeded the acceptable parameter limits for the six (6) startup checks identified above. 5. Review of the laboratory's patient test records revealed the following three (3) patients were performed with no documentation of troubleshooting or maintenance performed prior to patient testing: a) Patient 25957: Complete Blood Count (CBC) performed at 4:23 pm b) Patient 6668: Complete Blood Count (CBC) performed at 4:25 pm c) Patient 7923: Complete Blood Count (CBC) performed at 5:06 pm 6. In interview on November 30, 2023 at 3: 45 pm, Personnel 2 confirmed the identified patients above were resulted after background checks failed multiple times with no documentation of troubleshooting by the laboratory. D5437 CALIBRATION AND CALIBRATION VERIFICATION CFR(s): 493.1255(a) Unless otherwise specified in this subpart, for each applicable test system the laboratory must perform and document calibration procedures-- (1) Following the manufacturer's test system instructions, using calibration materials provided or specified, and with at least the frequency recommended by the manufacturer; (2) Using the criteria verified or established by the laboratory as specified in 493.1253(b) (3)-- (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 (2)(ii) Including the number, type, and concentration of calibration materials, as well as acceptable limits for and the frequency of calibration; and (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 observation by surveyor, review of the manufacturer instructions and laboratory calibration records, and interview with personnel, the laboratory failed to perform calibrations as required by the manufacturer in 2022 and 2023 for the Horiba Medical ABX Micros 60 analyzer. Findings: 1. Observation by surveyor during the laboratory tour on November 30, 2023 at 1:30 pm revealed the laboratory utilizes the Horiba Medical ABX Micros 60 Hematology analzyer for the testing of Complete Blood Counts (CBC). 2. Review of the Horiba Medical ABX Micros 60 user manual -- 2 of 7 -- revealed that calibration procedures are to be performed every six (6) months per manufacturer instructions. 3. Review of the laboratory's calibration records from 2022 and 2023 revealed the laboratory did not perform a calibration in April 2022 and September 2023. 4. In interview on November 30, 2023 at 2:52 pm, Personnel 2 confirmed the Horiba ABX Micros 60 six (6) month calibrations were not performed as required. D5781

Summary Statement of Deficiencies D0000 A Certification Survey was performed on October 23, 2019 at Allen Spires MD, CLIA ID # 19D0464385. The laboratory was found in compliance with 42 CFR 493 Requirements for Laboratories; however, standard level deficiencies were cited. 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 observation, record review and interview with personnel, the laboratory failed to have complete performance specification verification studies for the Horiba Medical ABX Micros 60 Hematology analyzer. Findings: 1. Observation by surveyor during the laboratory tour on October 23, 2019 revealed the laboratory utilizes the Horiba Medical ABX Micros 60 Hematology analyzer for Complete Blood Count (CBC) testing. 2. Review of the laboratory's records revealed the laboratory did not have a policy for performance verification studies for new analyzers. 3. Review of the laboratory's performance verification studies revealed the laboratory did have studies to include accuracy, simple precision, reportable range, and reference range; however, the laboratory did not include complete precision studies (day-to-day and operator variance) and the raw data to support these studies. 4. In interview on October 23, 2019 at 02:40 pm, Testing Personnel 5 confirmed the installation studies did not include complete precision studies. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 4 -- D5781

Summary Statement of Deficiencies D0000 A Recertification Survey was performed at Allen Spires, M.D. - CLIA # 19D0464385 on January 8, 2018. Allen Spires, M.D. was found not in compliance with the following CONDITION LEVEL DEFICIENCIES: 42 CFR 493.801 CONDITION: Enrollment and testing of samples 42 CFR 493.1215 CONDITION: Hematology 42 CFR 493.1403 CONDITION: Laboratories Performing Moderate Complexity Testing; Laboratory Director 42 CFR 493.1409 CONDITION: Laboratories Performing Moderate Complexity Testing; Technical Consultant D2000 ENROLLMENT AND TESTING OF SAMPLES CFR(s): 493.801 Each laboratory must enroll in a proficiency testing (PT) program that meets the criteria in subpart I of this part and is approved by HHS. The laboratory must enroll in an approved program or programs for each of the specialties and subspecialties for which it seeks certification. The laboratory must test the samples in the same manner as patients' specimens. For laboratories subject to 42 CFR part 493 published on March 14, 1990 (55 FR 9538) prior to September 1, 1992, the rules of this subpart are effective on September 1, 1992. For all other laboratories, the rules of this subpart are effective January 1, 1994. This CONDITION is not met as evidenced by: Based on observation, record review, and interview with laboratory personnel, the laboratory failed to enroll in a HHS approved proficiency testing program for Complete Blood Count (CBC) with automated differential testing. Findings: 1. Observation by surveyor during laboratory tour on January 8, 2018 revealed the laboratory utilizes a Horiba ABX Micros 60 Hematology analyzer for the testing and reporting of Complete Blood Count (CBC) with automated differentials. 2. Review of Proficiency Testing (PT) records for 2016 and 2017 revealed the laboratory had enrolled in Hematology Proficiency Testing (PT) with the American Academy of Family Physicians (AAFP). 3. Further review of proficiency testing records revealed Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 11 -- the laboratory was not enrolled in PT for Hematology testing for 2018. 4. In interview on January 8, 2018, Personnel 6 verified that the laboratory was not enrolled in PT for Hematology testing for 2018. 5. Review of the laboratory's Task 1 and 3 forms revealed the laboratory performs 11,568 CBCs with automated differential tests annually. D5024 HEMATOLOGY CFR(s): 493.1215 If the laboratory provides services in the specialty of Hematology, the laboratory must meet the requirements specified in 493.1230 through 493.1256, 493.1269, and 493. 1281 through 493.1299. This CONDITION is not met as evidenced by: Based on observation, record review, and interview with personnel, the laboratory failed to ensure the quality of testing in the specialty of Hematology. Findings: 1. The laboratory failed to ensure written policies and procedures were established to assess competency for the laboratory's Technical Consultant. Refer to D5209 I. 2. The laboratory failed to establish and follow written policies and procedures to assess employee competency. Refer to D5209 II. 3. The laboratory failed to properly fill BD collection tubes to the quantity indicated as required by the maufacturer's instructions. Refer to D5311. 4. The laboratory failed to have a Quality Assurance Policy to identify any of the deficiencies identified with the preanalytic system. Refer to D5391. 5. The laboratory failed to ensure the policy and procedure manual contained a detailed policy and procedure for the mean and assay range verification of new lots of quality control. Refer to D5403. 6. The laboratory failed to perform calibration procedures on the Horiba ABX Micros 60 Hematology Analyzer utilized for Complete Blood Count (CBC) testing every 6 months. Refer to D5439. 7. The laboratory failed to verify the means for Quality Control (QC) material for Hematology testing prior to use. Refer to D5469. 8. The laboratory failed to establish written policies and procedures for an ongoing mechanism to monitor, assess, and when indicated, correct problems identified in the analytic systems. Refer to D5791. 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: ***REPEAT DEfICIENCY from survey date May 24, 2016*** I. Based on record review and interview with personnel, the laboratory failed to ensure written policies and procedures were established to assess competency for the laboratory's Technical Consultant. Findings: 1. Review of the laboratory's policy and procedure manual revealed the laboratory did not establish written policies and procedures for personnel competency assessments of the Technical Consultant. 2. Review of the laboratory's CMS 209 form (Laboratory Personnel Report) revealed Personnel 2 listed as Technical Consultant. 3. Review of personnel records revealed a competency assessment was not performed for the duties of Technical Consultant by the Laboratory Director for Personnel 2. 4. In interview on January 8, 2018, Personnel 6 -- 2 of 11 -- confirmed there was no competency assessment performed for the Technical Consultant. II. Based on review of laboratory policy and procedure manual, and interview with personnel, the laboratory failed to establish and follow written policies and procedures to assess employee competency. Findings: 1. Review of the Laboratory's Policy and Procedure Manual revealed the laboratory failed to establish written policies and procedures that include the following six (6) procedures as a minimal requirement for assessing the competency of all personnel involved in any phase of laboratory testing: a) Direct observations of routine patient test performance, including patient preparation, if applicable, specimen handling, processing and testing. b) Monitoring the recording and reporting or test results. c) Review of intermediate test results or worksheets, quality control records, proficiency testing results, and preventative maintenance records. d) Direct observation of performance of instrument maintenance and function checks. e) Assessment of test performance through testing previously analyzed specimens, internal blind testing samples or external proficiency testing samples. f) Assessment of problem solving skills. 2. Interview with Personnel 6 on January 8, 2018 confirmed the laboratory failed to have a detailed written policy and procedure that included the six (6) mandated items. D5311 SPECIMEN SUBMISSION, HANDLING, AND REFERRAL CFR(s): 493.1242(a) The laboratory must establish and follow written policies and procedures for each of the following, if applicable: (1) Patient preparation. (2) Specimen collection. (3) Specimen labeling, including patient name or unique patient identifier and, when appropriate, specimen source. (4) Specimen storage and preservation. (5) Conditions for specimen transportation. (6) Specimen processing. (7) Specimen acceptability and rejection. (8) Specimen referral. This STANDARD is not met as evidenced by: Based on observation, record review, and interview, the laboratory failed to properly fill BD collection tubes to the quantity indicated as required by the maufacturer's instructions. Findings: 1. Observation by surveyor on January 8, 2018 revealed the laboratory utilized the lavender BD vacutainer collection tubes for CBC testing. 2. Review of the Horiba ABX Micros 60 Hematology Analyzer users manual revealed the following: "specimen collection and mixing: The sample collection tube must be filled to the exact quantity of blood indicated on the tube itself. Any incorrectly measured blood sample collections will show a variation in results." 3. Further observation by surveyors revealed short samples in the BD collection tubes for one (1) of five (5) patient samples: Patient 11 - less than 1/10th full 4. In Interview with Personnel 3 on January 8, 2018, she stated that she was unaware of the manufacturer's requirements and confirmed the observation stated above. D5391 PREANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1249(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 preanalytic systems specified at 493.1241 through 493.1242. This STANDARD is not met as evidenced by: Based on record review and interview with personnel, the laboratory's system failed to -- 3 of 11 -- monitor, assess, and correct problems, identified with the preanalytic system. Findings: 1. Review of the laboratory's policy and procedure manual revealed the laboratory failed to have a Quality Assurance Policy to identify any of the deficiencies identified with the preanalytic system. 2. The laboratory failed to follow manufacturer requirements for specimen collection and mixing of tubes used for Complete Blood Count (CBC) testing. Refer to D5311. 4. In interview on January 8, 2018, Personnel 6 confirmed the laboratory's system failed to monitor, assess, and correct problems identified with the preanalytic system. D5403 PROCEDURE MANUAL CFR(s): 493.1251(b) The procedure manual must include the following when applicable to the test procedure: (1) Requirements for patient preparation; specimen collection, labeling, storage, preservation, transportation, processing, and referral; and criteria for specimen acceptability and rejection as described in 493.1242. (2) Microscopic examination, including the detection of inadequately prepared slides. (3) Step-by-step performance of the procedure, including test calculations and interpretation of results. (4) Preparation of slides, solutions, calibrators, controls, reagents, stains, and other materials used in testing. (5) Calibration and calibration verification procedures. (6) The reportable range for test results for the test system as established or verified in 493.1253. (7) Control procedures. (8)