A Preferred Women's Health Center

Summary Statement of Deficiencies D6030 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(12) 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)(12) Ensure that policies and procedures are established for monitoring individuals who conduct preanalytical, analytical, and postanalytical phases of testing to assure that they are competent and maintain their competency to process specimens, perform test procedures and report test results promptly and proficiently, and whenever necessary, identify needs for remedial training or continuing education to improve skills; This STANDARD is not met as evidenced by: Based on review of laboratory procedures and records, absence of technical consultant (TC) competency assessment records and interview with clinic general manager 2/27 /24, the laboratory director (LD) failed to establish a competency procedure for evaluating the responsibilities and duties of the TC and failed to annually assess the competency of the TC since 2021, a period of approximately 3 years. Findings: Review of laboratory procedures revealed no procedure to assess the competency of the TC. Review of TC competency assessment records revealed no documentation of an annual TC competency assessment for 2021, 2022, and 2023. Interview with clinic general manager at approximately 11:30 a.m. confirmed there was no procedure for assessing the competency of the TC and also confirmed there was no documentation of an annual TC competency assessment. D6032 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(14) 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 -- 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)(14) Specify, in writing, the responsibilities and duties of each consultant and each person, engaged in the performance of the preanalytic, analytic, and postanalytic phases of testing, that identifies which examinations and procedures each individual is authorized to perform, whether supervision is required for specimen processing, test performance or results reporting, and whether consultant or director review is required prior to reporting patient test results. This STANDARD is not met as evidenced by: Based on review of laboratory records, review of contract agreement with technical consultant (TC) and interview with clinic general manager 2/27/24, the laboratory director (LD) failed to specify in writing the specific duties and responsibilities delegated to the TC. Findings: Review of laboratory records revealed no documentation of the specific duties and responsibilities delegated by the LD to the TC. Review of TC contract agreement with laboratory revealed the contract fails to state the specific duties and responsibilities of the TC. Interview with clinic general manager at approximately 10:30 a.m. confirmed the laboratory records failed to reveal a delegation of specific duties and responsibilities of the TC signed by the LD. D6046 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(8) (b) The technical consultant is responsible for-- (b)(8) Evaluating the competency of all testing personnel and assuring that the staff maintain their competency to perform test procedures and report test results promptly, accurately and proficiently. This STANDARD is not met as evidenced by: Based on review of 2021, 2022, 2023 and 2024 testing personnel (TP) competency records, absence of TP competency assessment records, review of 2021, 2022, 2023 and 2024 technical consultant (TC) site visit notes and interview with clinic general manager 2/27/24, the TC failed to evaluate the competency of 2 of 4 TP in 2021, 2 of 4 TP in 2022, 1 of 5 TP in 2023, and 1 TP in 2024. Findings: Review of 2021, 2022, 2023 and 2024 TP competency records, "APWHC Annual Laboratory Skills Evaluation" forms, revealed the following: a. 2021 - TP #1 competency assessment was signed by the office manager. No documentation of a competency assessment for TP #3. b. 2022 - No documentation of competency assessments for TP #2 and TP #3. c. 2023 - TP #2 competency assessment was signed by the clinic general manager. d. 2024 - TP #1 competency assessment was signed by the clinic general manager. Review of 2021, 2022, 2023 and 2024 TC site visit notes revealed no documentation the TC performed the competency assessment of TP #1 in 2021, TP #2 in 2023 and TP #1 in 2024. Interview with clinic general manager at approximately 10:15 a.m. confirmed the competency findings. She stated she thought someone other than the TC could perform TP competencies and the TC could sign off on the competencies that were accessed by other staff members. -- 2 of 2 --

Summary Statement of Deficiencies D3031 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(3) Analytic systems records. Retain quality control and patient test records (including instrument printouts, if applicable) and records documenting all analytic systems activities specified in 493.1252 through 493.1289 for at least 2 years. This STANDARD is not met as evidenced by: Based on review of 2019, 2020 and 2021 quality control (QC) records and abscence of manufacturer assay sheets for QC reagent, ALBAcyte Antibody Screening cells, 7 /16/21, the laboratory failed to retain all Rh(D) QC records for at least two years. Findings: Review of 2019, 2020 and 2021 QC records revealed only 2 manufacturer assay sheets for the ALBAcyte Antibody Screening cells had been retained, Lot # V221377 with an expiration date of 7/6/20 and Lot # V222157 with an expiration date of 8/3/20. Review of 2019, 2020 and 2021 QC records revealed a new lot # of ALBAcyte Antibody Screening cells was opened and put into use approximately every 30 days due to expiration date. Approximately 20 manufacturer assay sheets for the QC reagent were not retained, for example: Lot #V219400, Lot #V220494 and Lot #V223104. 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 review of laboratory personnel records, review of testing personnel (TP) 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 -- competency records and interview with Director of Patient Services 7/16/21, the technical consultant (laboratory director) failed to ensure the competency of TP#3 was accessed semiannually during their first year of testing. Findings: Review of laboratory personnel records revealed TP #3 was hired in 2/19. Review of laboratory competency records revealed TP #3 did not have their first competency assessment until 12/20, approximately 20 months in which competency was not accessed. During interview with Director of Patient Services at approximately 10:00, she stated all records should be in their file and if not in their file she was unsure where else it would be. 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 review of previous survey, 6/22/18, Laboratory Personnel Report (CMS- 209), review of TP competency records and interview with Director of Patient Services 7/16/21, the technical consultant (laboratory director) failed to ensure the competency of TP#5 was accessed annually. Findings: Review of previous surveys CMS-209 revealed TP #5 began employment prior to 6/22/18. Review of laboratory personnel records revealed TP #5 had competency assessments in 12/20 and 5/21, there was no documentation of a competency assessment performed in 2019. During interview with Director of Patient Services at approximately 10:00, she stated all records should be in their file and if not in their file she was unsure where else it would be. D6107 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(15) The laboratory director must specify, in writing, the responsibilities and duties of each consultant and each supervisor, as well as each person engaged in the performance of the preanalytic, analytic, and postanalytic phases of testing, that identifies which examinations and procedures each individual is authorized to perform, whether supervision is required for specimen processing, test performance or result reporting and whether supervisory or director review is required prior to reporting patient test results. This STANDARD is not met as evidenced by: Based on review of laboratory records, review of "AGREEMENT" document and interview with Director of Patient Services 7/16/21, the laboratory director (LD) failed to specify, in writing, the responsibilities and duties of the technical consultant (TC). Findings: Review of laboratory records revealed no delegation of responsibilities and duties for the TC hired in 1/21. Review of "AGREEMENT" submitted at time of survey revealed "Duties of ....1. To complete a quarterly lab audit...2. A report of all findings...3. Development of all needed procedures...5. Technical assistance...6. Training for the LD and staff for the items found during audits. The "AGREEMENT" fails to define the CLIA duties or responsibilities that a LD can delegate to a TC. For example; assessment of testing personnel competency, establishing a quality control -- 2 of 3 -- program, and enrollment and participation in proficiency testing. Interview with Director of Patient Services at approximately 12:00 p.m. confirmed there was no documentation other than the "AGREEMENT" to specify the responsibilities and duties of the TC. -- 3 of 3 --