Frederick P Smith, Md, Pc, Division Of Rcca

Summary Statement of Deficiencies D5211 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(a) The laboratory must review and evaluate the results obtained on proficiency testing performed as specified in subpart H of this part. This STANDARD is not met as evidenced by: Based on review of proficiency testing (PT) records and interview with the testing person (TP), the laboratory failed to ensure that PT results were reviewed by the laboratory director (LD) or designee for two of five PT events. Findings: 1. The records for five PT events were reviewed. 2. The results evaluations were not signed as reviewed by the LD or designee for two of five PT events (2024 2nd and 3rd). 3. During the exit interview on 07/11/2025 at 1:50 PM, the TP confirmed that two of five PT results were not reviewed by the LD or designee. D5407 PROCEDURE MANUAL CFR(s): 493.1251(d) (d) Procedures and changes in procedures must be approved, signed, and dated by the current laboratory director before use. This STANDARD is not met as evidenced by: Based on review of the procedure manual and interview with the testing person (TP), the new laboratory director failed to approve, sign, and date the procedure manual. Findings: 1. The new laboratory director began at the end of 02/2025. 2. During the exit interview on 07/11/2025 at 1:50 PM, the TP confirmed that the new laboratory director had not reviewed, approved, and signed the procedure manual. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 6 -- D5413 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(b) (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: (b)(1) Water quality. (b)(2) Temperature. (b)(3) Humidity. (b)(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 review of the procedure manual, temperature logs, quality assessment (QA) forms, and monthly maintenance logs, and interview with the testing person (TP), the laboratory failed to consistently document and monitor room temperature (RT), humidity, and refrigerator temperatures (FT) in 8 of 23 months reviewed. Findings: 1. The "Quality Assessment" procedure stated that the "Temperatures will be recorded for room temperature (RT), room humidity, and for all refrigerators and freezers used by the laboratory for storage of reagents, controls, and calibration materials. This information and any

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 review of proficiency test records and interview with staff, the hematology laboratory did not rotate proficiency testing among all testing staff. Findings: 1. Testing Person #2 performed the hematology proficiency testing (automated CBC) for the 1st, 2nd and 3rd events of 2022 and the 1st and 2nd events for 2023, the proficiency testing was not rotated among the other two testing persons. 2. This was confirmed during interview with staff on the afternoon of the day of survey. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 1 --

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 proficiency testing (PT) record review and interview with the testing personnel (TP), the laboratory did not ensure that all the testing personnel who tested patient samples performed the PT. Findings: 1. The laboratory currently has 4 testing personnel listed on the "Laboratory Personnel Report (CMS-209)" who perform hematology testing. 2. A review of hematology PT attestation worksheets for 6 PT events from 2019 through 2021 showed that PT was performed by the same testing person (TP #1) in 2 of 2 PT events. Attestation statements were not available for the other 4 of 6 events. 3. During an interview on 11/17/2021 at 10:00 AM, TP #1 stated that the other TP are not running the PT and confirmed that PT samples were not tested each year by all the staff who perform patient testing to ensure accurate and reliable patient test results. D2015 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(5)(6) (5) The laboratory must document the handling, preparation, processing, examination, and each step in the testing and reporting of results for all proficiency testing samples. The laboratory must maintain a copy of all records, including a copy of the proficiency testing program report forms used by the laboratory to record proficiency testing results including the attestation statement provided by the PT program, signed by the analyst and the laboratory director, documenting that proficiency testing Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 6 -- samples were tested in the same manner as patient specimens, for a minimum of two years from the date of the proficiency testing event. (6) PT is required for only the test system, assay, or examination used as the primary method for patient testing during the PT event. This STANDARD is not met as evidenced by: Based on review of proficiency testing (PT) records and interview with the testing personnel (TP), the laboratory did not ensure that the laboratory director (LD) signed the PT attestation statements, documenting that proficiency testing samples were tested in the same manner as patient specimens. Findings: 1. A review of hematology PT records from 2019 through 2021 showed that signed attestation statements were not available at the time of the survey for 4 out of 6 events reviewed. 2. Two out of 2 attestation statements reviewed were not signed by the LD, documenting that proficiency testing samples were tested in the same manner as patient specimens. 3. This was confirmed by the TP at the exit interview on 11/17/2021 at 1:00 PM. D3037 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(4) Proficiency testing records. Retain all proficiency testing records for at least 2 years. This STANDARD is not met as evidenced by: Based on proficiency testing (PT) record review and interview with the testing personnel (TP), the laboratory did not ensure that a copy of all PT documents was maintained by the laboratory for a minimum of two years from the date of the PT testing event. Findings: 1. A review of hematology PT records from 2019 through 2021 showed that signed attestation statements were not available at the time of the survey for 4 out of 6 events reviewed. 2. Hematology instrument printouts from 2 of 6 PT events were not available for review at the time of the survey. 3. The PT report form used by the laboratory to record PT results for hematology was not available for 6 out of 6 PT events. 4. No PT records were available at all for the 3rd event of 2020 in hematology. 5. During an interview on 11/17/2021 at 1:00 PM, the TP confirmed that the laboratory did not maintain all PT documents for a minimum of two years from the date of the PT testing event. 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). This STANDARD is not met as evidenced by: Based on proficiency testing (PT) record review and interview with the testing personnel (TP), the laboratory failed to verify the accuracy of hematology PT when the results were not evaluated by the PT provider because the laboratory submitted its PT results after the return deadline. Findings: 1. A review of PT records from 2019 through 2021 showed that the laboratory scored "0%" for hematology PT for the 3rd -- 2 of 6 -- event of 2020. During an interview at 11:00 AM on the day of the survey the TP stated that they'd missed the deadline to send results in but that they had performed a self-evaluation of PT. 2. Record review showed that there were no PT documents available for this PT event at the time of the survey, including documentation showing that this review had been performed. 3. During an interview on 11/17/2021 at 1:00 PM, the TP confirmed that the laboratory failed to verify the accuracy of hematology PT results which had not been evaluated by the PT provider. D5401 PROCEDURE MANUAL CFR(s): 493.1251(a) A written procedures manual for all tests, assays, and examinations performed by the laboratory must be available to, and followed by, laboratory personnel. Textbooks may supplement but not replace the laboratory's written procedures for testing or examining specimens. This STANDARD is not met as evidenced by: I. Based on procedure manual and proficiency testing (PT) record review and interview with the testing personnel (TP), the laboratory did not follow written procedures for performing PT. Findings: 1. The procedure "Proficiency Testing" states, "Proficiency testing will be rotated among the techs so that everyone working in a lab discipline participates in the testing throughout the year." Record review and interview with the TP showed that the laboratory did not ensure that all the TP who tested patient samples performed the PT. Cross-refer to D2007. 2. The procedure also states that "The Lab Director and all testing personnel must sign the Attestation Statement." The laboratory did not ensure that the laboratory director (LD) signed the PT attestation statements, documenting that proficiency testing samples were tested in the same manner as patient specimens. Cross-refer to D2015. 3. The procedure also states that "All documents relating to the testing (instrument printouts, data report forms, work notes, etc.) must be retained for a minimum of 2 years." The laboratory did not ensure that a copy of all PT documents was maintained by the laboratory for a minimum of two years from the date of the PT testing event. Cross-refer to D3037. 4. The procedure also states that "All ungraded challenges must be reviewed against the Participant Summary to evaluate the lab's performance, with comments made on the result form indicating acceptability of results." The laboratory failed to verify the accuracy of hematology PT when the results were not evaluated by the PT provider because the laboratory submitted its PT results after the return deadline. Cross-refer to D5215. 5. The procedure also states that "Passing results with grades less than 100% should be reviewed for cause of the failed result in the group." For the 2nd event of 2020 in hematology the laboratory scored "96%" for "Cell I.D. or WBC Diff." The laboratory did not document that a root cause analysis was performed to determine the cause of the imperfect score. 6. During an interview on 11/17/2021 at 1:00 PM, the TP confirmed that the written procedure for performing PT did not accurately reflect the actual practice of the laboratory. II. Based on procedure manual review and interview with the testing personnel (TP), the laboratory did not follow written procedures for performing quality control (QC). Findings: 1. The laboratory performs hematology testing on the Sysmex-1000i hematology analyzer. 2. The procedure, "General Lab Operational Policies" subsection "Analytical Testing" states, "At least 3 levels of control will be run and have values within acceptable ranges each day of testing for all non-waived procedures before patient values are tested and reported." 3. During an interview on 11/17/2021 at 12:30 PM the TP stated that if they are busy, they will run 2 levels of control in the morning and if the 2 controls are acceptable, will begin -- 3 of 6 -- testing patient samples. They run the 3rd level of control "later." The TP confirmed that this practice does match the laboratory's procedure for running hematology QC. 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)

Summary Statement of Deficiencies 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 review of the written procedure manual and interview with the testing person, the laboratory did not have written policies and procedures for identifying and labeling patient hematology specimens utilizing a unique identifier Findings: 1. The laboratory did not have a system in place when two specimens are received that have the same first and last name or date of birth. 2. The laboratory must have polices and procedures in place to process hematology specimens using distinct identifiers in order to distinguish between the specimens. 3. The testing person confirmed that a policy was not available to identify patients when the two specimens have the same first,and last name or date of birth. D5401 PROCEDURE MANUAL CFR(s): 493.1251(a) A written procedures manual for all tests, assays, and examinations performed by the laboratory must be available to, and followed by, laboratory personnel. Textbooks may supplement but not replace the laboratory's written procedures for testing or examining specimens. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 2 -- This STANDARD is not met as evidenced by: Based on review of the written procedure manual interview with the testing person, and the analyzer consultant, the laboratory did not follow written procedures for performing hematology testing. Findings: 1. Hematology specimens once collected were placed on a mechanical rocker prior to testing. The analyzer consultant stated that when the testing person is busy samples are rocked. 2. The written procedure states to not place samples on a mechanical rocker prior to patient testing. Constant rocking may cause platelet clumping and white cell membrane changes causing false patient result interpretations. 3. The testing person confirmed that hematology samples are rocked prior to performing patient testing. -- 2 of 2 --