All Women's Medical Office Based Surgery Pllc

Summary Statement of Deficiencies D5481 CONTROL PROCEDURES CFR(s): 493.1256(f)(g) (f) Results of control materials must meet the laboratory's and, as applicable, the manufacturer's 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 review of spun hematocrit quality control (QC) records, Bio-Rad Meter Trax control assay sheets, and an interview with the testing person, the laboratory failed to ensure the spun hematocrit hematology QC test results were not within acceptable range prior to testing patient specimens. FINDINGS: 1. Review of the spun hematocrit form titled, "Centrifuge Calibration Record" had established QC ranges without validating, the following: low level 20.2-23.6 ; mid-level 34.1/39.9 and high level 38.5-45.7. 2. Review of the Bio-Rad Meter Trax QC assay sheets for the spun hematocrit had different ranges for each lot tested. 3. The testing person confirmed August 17, 2023, at 10:00 AM that the assay sheets revealed the calculated ranges did not match the ranges recorded the lag sheet. The laboratory failed to calculate the ranges for each new lot of Bio-Rad Meter Trax hematocrit controls. The following QC ranges for the eight lots were not calculated from 710/2021 through current lot in use8 /17/2023 and no

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 surveyor's review of 2019, 2020 American Proficiency Institute (API) proficiency testing (PT) attestation statements and an interview with the practice manager, the laboratory failed to rotate the testing of PT samples among four personnel, who routinely perform ABO/RH testing. FINDINGS. The practice manager confirmed on June 8, 2021 at approximately 10:00 AM, the surveyor's findings that the attestation forms for 2019 and 2020 were not signed by the testing personnel, therefore the surveyor could not determine if the PT samples were rotated among the four testing personnel, who routinely perform ABO/RH testing. 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 surveyor's review of API Immunohematology PT records for 2019 and 2020 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 -- and confirmed in an interview with the practice manager, the four testing personnel failed to sign the attestation forms attesting that the PT samples were tested in the same manner as patient specimens. 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 surveyor's review of the laboratory's temperature logs for 2020, laboratory temperature procedure for the Slide Viewbox and an interview with the practice manager, the laboratory failed to follow the laboratory's temperature procedure to monitor and document the Slide Viewbox from August 1, 2020 through January 1, 2021. FINDINGS: The practice manger confirmed on June 8, 2020 at approximately 11:00 AM, the laboratory failed to follow their established temperature procedure for the Slide Viewbox to monitor and document the temperature from August 1, 2020 through January 1, 2021. a. The Slide Viewbox temperature procedure requires temperatures to be recorded each day of testing. b. The established temperature range is 40-50C. D5435 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(b)(2) For equipment, instruments, or test systems developed in-house, commercially available and modified by the laboratory, or maintenance and function check protocols are not provided by the manufacturer, the laboratory must: (i) Define a function check protocol that ensures equipment, instrument, and test system performance that is necessary for accurate and reliable test results and test result reporting. (ii) Perform and document the function checks, including background or baseline checks, specified in paragraph (b)(2)(i) of this section. Function checks must be within the laboratory's established limits before patient testing is conducted. This STANDARD is not met as evidenced by: Based on surveyor's review of the Clay Adams Hematocrit (Hct) Maintenance log sheets, the laboratory's maintenance procedures for the Hct centrifuge and an interview with the practice manager, the laboratory failed to followed their established maintenance procedures for the Hct centrifuge and perform and document monthly checks using the Biorad Meter Trax Controls for the calendar year 2020. FINDINGS: The practice manager confirmed on June 8, 20221 at approximately 11;00 AM, the surveyor's findings that the laboratory failed to followed their established maintenance procedures for the Hct centrifuge and perform and document monthly checks using the Biorad Meter Trax Controls for the calendar year 2020. a. The last date for the HCT checks was 12/11/19 and resumed again on 1/26/21. -- 2 of 2 --

Summary Statement of Deficiencies 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 a review of laboratory competency records and an interview with the laboratory Office Manager/testing person, the laboratory failed to follow their written policies and procedures to assess the competency of the laboratory testing personnel semi-annually for the first year of patient testing. Findings Include: It was confirmed by the laboratory office Manager/testing person on April 5, 2018, at approximately 11: 00 am, that the director acting as the technical consultant failed to have documentation of semi-annual competency for two of two testing personnel who perform ABO/RHO Blood Typing. 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 a review of American Proficiency Institute Proficiency Test( API PT) reports and an interview with the laboratory office manager/testing person, the laboratory did not evaluate, perform and document remedial action for the PT scores less than 100% for the 1st event in 2017 for ABO/RH Blood typing. Findings Include: 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 -- It was confirmed with the laboratory office manager/testing person at approximately 11:15 am, that the laboratory failed to evaluate the results received for: 2017 first event ABO/RHO = 80% D6029 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(11) 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)(11) Ensure that prior to testing patients' specimens, all personnel have the appropriate education and experience, receive the appropriate training for the type and complexity of the services offered, and have demonstrated that they can perform all testing operations reliably to provide and report accurate results. This STANDARD is not met as evidenced by: Based on a review of personnel records and an interview with the laboratory office manager/testing person, the laboratory director failed to ensure that appropriate training was documented for two of two new testing personnel who perform moderate complexity testing for ABO/RHO Blood Typing in year 2016. D6053 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 semiannually during the first year the individual tests patient specimens. This STANDARD is not met as evidenced by: Based on a review of the personnel records and an interview with the office manager /laboratory testing person, the laboratory director, acting as the technical consultant, failed to perform the semi-annual evaluation for the two of two testing personnel during the first year of patient testing in calendar year 2016. Refer to D5209. -- 2 of 2 --