Elayne K Garber Md A Medical Corp

Summary Statement of Deficiencies D2122 HEMATOLOGY CFR(s): 493.851(b) (b) Failure to attain an overall testing event score of at least 80 percent is unsatisfactory performance. This STANDARD is not met as evidenced by: Based on the surveyor's review of the laboratory's American Proficiency Institute (API) proficiency testing (PT) records and an interview with the laboratory director (LD); it was determined that the laboratory failed to attain a score of at least 80 percent of acceptable responses for Hematology on the first event of 2025 (Q1-2025) which was unsatisfactory performance for the testing event. The findings include: 1. The API proficiency program gave an unsatisfactory score of 40% for the Hematocrit and Red Blood Cell (RBC) analytes for Q1-2025. 2. The LD affirmed by interview on May 19, 2025, at approximately 10:30 a.m. that the laboratory received the unsatisfactory score as mentioned in statement #1. 3. The reliability and quality of Hematology results reported could not be assured when the laboratory failed to attain overall scores of at least 80% in proficiency testing. 4. According to the testing declaration form submitted at the time of survey, the laboratory performed and reported 8,900 tests in Hematology annually including the time when unsatisfactory scores were obtained. D5421 ESTABLISHMENT AND VERIFICATION OF PERFORMANCE CFR(s): 493.1253(b)(1) (b) Each laboratory that introduces an unmodified, FDA-cleared or approved test system must do the following before reporting patient test results: (b)(1)(i) Demonstrate that it can obtain performance specifications comparable to those established by the manufacturer for the following performance characteristics: (b)(1)(i) (A) Accuracy. (b)(1)(i)(B) Precision. (b)(1)(i)(C) Reportable range of test results 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 3 -- the test system. (b)(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 the lack of a complete laboratory verification of performance specifications for Hematology, proficiency testing records, and an interview with the laboratory director (LD) on May 19, 2025, it was determined that the laboratory failed to provide a complete documentation for performance specifications when a new instrument replacement was obtained. The findings include: 1. A review of the proficiency testing records showed that the laboratory failed the first testing event of 2025, resulting to an unsatisfactory score. The Mindray BC 1300 instrument, used for Complete Blood Count (CBC) testing, was replaced with another of the same make and model after the scores were obtained. 2. The surveyor ' s review of the laboratory's performance specifications documentation indicated that due to the unexpected instrument issue, the method correlation was modified and tested by an external laboratory but a Sysmex instrument was utilized instead. Consequently, due to the differing methodologies, this method correlation was deemed invalid. Therefore, the quality and reliability of the reported test results cannot be assured. 3. The LD stated on an interview on May 19, 2025, at approximately 10:35 a.m., that the previous instrument was considered irreparable and unfit for method correlation, as mentioned in statement #1. Rather than conducting a full performance specifications, an alternative method was performed as mentioned in statement #2. 4. Based on the testing declaration submitted at the time of survey, the laboratory performed and reported approximately 8,900 tests for Hematology annually that included CBC. 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 the lack of laboratory quality control (QC) documentation, surveyor's review of policy/procedure, patient records, and an interview with the laboratory director (LD), it was determined that the laboratory failed to document QC performed prior to patient testing for the years 2022, 2023, 2024, and 2025. The findings include: 1. The laboratory's policy/procedure was to perform QC for rheumatoid arthritis (RA) test prior to patient testing. However, documentation was consistent only until February 8, 2022. After this date, QC was recorded only when a new lot was used. 2. The laboratory failed to provide documentation of reviewed or performed QC results for acceptability on each day of testing prior to analyzing patients samples when patient records were reviewed for the years 2022, 2023, 2024 and 2025. 3. The LD affirmed in an interview on May 19, 2025, at approximately 11:00 a.m., that QC was performed but not documented prior to patient testing after initial run of each lot. 4. The reliability, accuracy, and quality of results reported could not be assured. According to the laboratory's estimated annual tests volumes, 100 tests were performed and reported for RA including the time when QC documentation was incomplete. D6013 LABORATORY DIRECTOR RESPONSIBILITIES -- 2 of 3 -- CFR(s): 493.1407(e)(3)(ii) (e)(3)(ii) Verification procedures used are adequate to determine the accuracy, precision, and other pertinent performance characteristics of the method; and This STANDARD is not met as evidenced by: Based on the deficiency found last survey on May 19, 2025, the laboratory director is herein cited for deficient practice in ensuring verification of performance specifications were valid prior to patient testing. See D5421. D6016 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(i) (e)(4)(i) 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 surveyor's review of the unsatisfactory proficiency testing score for the first event of 2025, the laboratory director is herein cited for failure to ensure that proficiency testing samples were tested as required under Subpart H of this part. See D2122. D6020 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(5) (e)(5) Ensure that the quality control and quality assessment programs are established and maintained to assure the quality of laboratory services provided and to identify failures in quality as they occur; This STANDARD is not met as evidenced by: Based on the surveyor's findings on May 19, 2025, and the lack of quality control documentation, the laboratory director is herein cited for the deficient practice of failure to ensure quality control programs were followed to assure and monitor the quality of laboratory services provided, and to identify issues as it occurred. See D5481. -- 3 of 3 --

Summary Statement of Deficiencies D3011 FACILITIES CFR(s): 493.1101(d) Safety procedures must be established, accessible, and observed to ensure protection from physical, chemical, biochemical, and electrical hazards, and biohazardous materials. This STANDARD is not met as evidenced by: Based on observation and interview with the laboratory director (LD); it was determined that the laboratory lacked an eye wash station and a fire extinguisher in the laboratory. The laboratory failed to observe safety procedures to ensure protection from biohazardous materials. The findings included: 1. On the day of the survey March 7, 2022, at approximately 2:00 p.m. the surveyor observed that the laboratory lacked an eye wash station in the area where samples are processed, neither could the LD locate the fire extinguisher. 2. The LD affirmed the lack of an eye wash station and a fire extinguisher in the laboratory. 3. Based on the laboratory's annual testing volume declaration signed by the LD on 2/27/2022, the laboratory processes and reports approximately 9,000 patients' samples annually. 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 the laboratory's policies and procedures, lack of documentation, and interview with the laboratory director (LD), it was determined that the 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 2 -- failed to perform and document maintenance and calibration of the microscopes as defined by the manufacturer and with at least the frequency specified by the manufacturer for the laboratory equipment. The findings included: 1. The laboratory's policies and procedures indicated that annual maintenance and calibration according to manufacturer's requirements be performed on the microscopes used in the laboratory (Zeiss). 2. The LD confirmed on 3/7/2021 at approximately 1:45 p.m. that the laboratory failed to follow policies and procedures for maintenance and calibration of the microscope for the years 2020 and 2021. 3. According to the annual test volume declared by the laboratory LD the laboratory performs approximately 9,000 tests annually D6084 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(2) The laboratory director must ensure that the physical plant and environmental conditions provide a safe environment in which employees are protected from physical, chemical, and biological hazards. This STANDARD is not met as evidenced by: Based on the survey findings and deficiencies cited, the Laboratory Director is herein cited for deficient practice in providing overall administration of the laboratory to ensure a safe environment in which personnel are protected from biohazardous materials. Findings include: See D3011 D6121 TECHNICAL SUPERVISOR RESPONSIBILITIES CFR(s): 493.1451(b)(8)(i) The procedures for evaluation of the competency of the staff must include, but are not limited to direct observations of routine patient test performance, including patient preparation, if applicable, specimen handling, processing and testing. This STANDARD is not met as evidenced by: Based on review of the laboratory's competency evaluation documentation for the testing personnel listed on the CMS-209 form and interview with the laboratory director (LD), it was determined that the laboratory's technical supervisor (same as LD) failed to evaluate and document direct observations and the performance of individuals responsible for routine patient testing performance, including patient preparation, if applicable, specimen handling, processing and testing. Findings include: 1. The laboratory did not have annual competency evaluation and documentation for the one testing person listed in the CMS 209 form for the years 2020 and 2021. 2. The LD affirmed on 3/7/2022 at approximately 2:30 p.m. having no records of documentation for competency of testing personnel for the years 2020 and 2021. 3. According to the annual test volume declared by the laboratory LD the laboratory performs approximately 9,000 tests annually -- 2 of 2 --