Summary:
Summary Statement of Deficiencies D5203 SPECIMEN IDENTIFICATION AND INTEGRITY CFR(s): 493.1232 The laboratory must establish and follow written policies and procedures that ensure positive identification and optimum integrity of a patient's specimen from the time of collection or receipt of the specimen through completion of testing and reporting of results. This STANDARD is not met as evidenced by: Based on review of laboratory policies and procedures, nongynecologic specimen slides, observation and interviews the laboratory failed to establish and follow written policies and procedures to ensure patient specimens were labeled with a unique patient identifier during all phases of testing. Findings include: 1. The Survey Team requested and the laboratory failed to provide written policies and procedures to ensure patient specimens were labeled with a unique patient identifier during all phases of testing. a. The Survey Team reviewed 45 nongynecologic specimen slides for 40 consecutive patient specimens from October 2024. Forty-five of 45 nongynecologic specimen slides from the 40 patient specimens failed to be labeled with a unique patient identifier. Specimen slides include: Accession number Specimen slide(s) -N24-00901 -901 -N24-00902 -902 -N24-00903 -903 -N24-00904 -904 -N24- 00905 -905 -N24-00906 -906 -N24-00907 -907 -N24-00908 -908 -N24-00909 -909 - N24-00910 -910 -N24-00911 -911 (2 slides) -N24-00912 -912 -N24-00913 -913 (2 slides) -N24-00914 -914 -N24-00915 -915 -N24-00916 -916 -N24-00917 -917 -N24- 00918 -918 -N24-00919 -919 -N24-00920 -920 -N24-00921 -921 -N24-00922 -922 - N24-00923 -923 -N24-00924 -924 (2 slides) -N24-00925 -925 -N24-00926 -926 (2 slides) -N24-00927 -927 -N24-00928 -928 -N24-00929 -929 -N24-00930 -930 -N24- 00931 -931 -N24-00932 -932 (2 slides) -N24-00933 -933 -N24-00934 -934 -N24- 00935 -935 -N24-00936 -936 -N24-00937 -937 -N24-00938 -938 -N24-00939 -939 - N24-00940 -940 2. During an observation of nongynecologic specimen processing (specimen N24-01024) on November 19, 2024 at 8:45 AM, Staff A failed to label the Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 12 -- specimen container, centrifuge tube, Hologic PreservCyt Solution Vial and specimen slide with the unique patient identifier "N24-01024". a. Staff A labeled the specimen container, centrifuge tube, Hologic PreservCyt Solution Vial and specimen slide with the patient identifier "1024". 3. During an interview on November 19, 2024 at 9:35 AM, these findings were confirmed with the Cytotechnologist, Staff A and Staff B. 4. During an interview on November 20, 2024 at 11:00 AM, these findings were confirmed with Technical Supervisor B. 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 laboratory policies and procedures, lack of competency assessment records and interviews the laboratory failed to establish and follow written policies and procedures to assess the competency of the Technical Supervisors. The laboratory failed to assess the competency of two of two Technical Supervisors in 2022, 2023 and January 1, 2024 to the date of the survey in 2024. Findings include: 1. The Survey Team requested and the laboratory failed to provide written policies and procedures to describe the process for assessing the competency of the Technical Supervisors. 2. The Survey Team requested and the laboratory failed to provide documentation of competency assessments for two of two Technical Supervisors in 2022, 2023 and January 1, 2024 to the date of the survey in 2024. Technical Supervisors include: -Technical Supervisor A -Technical Supervisor B 3. During an interview on November 18, 2024 at 11:15 AM, the Cytotechnologist stated "we don't have that". 4. During an interview on November 19, 2024 at 2:00 PM, these findings were confirmed with the Cytotechnologist. 5. During an interview on November 20, 2024 at 11:00 AM, these findings were confirmed with Technical Supervisor B. D5291 GENERAL LABORATORY SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1239(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 general laboratory systems requirements specified at 493.1231 through 493.1236. This STANDARD is not met as evidenced by: Based on review of laboratory policies and procedures, lack of laboratory records, nongynecologic specimen slides, observation and interviews the laboratory failed to establish and follow written policies and procedures for an ongoing mechanism to monitor, assess and correct problems identified in the general laboratory systems. The laboratory failed to document general laboratory quality assessment activities during 2022, 2023 and January 1, 2024 to the date of the survey in 2024. Findings include: 1. The Survey Team requested and the laboratory failed to provide written policies and procedures for an ongoing program to monitor, assess and correct problems identified in the general laboratory systems. 2. The Survey Team requested and the laboratory failed to provide documentation of general laboratory quality assessment activities -- 2 of 12 -- during 2022, 2023 and January 1, 2024 to the date of the survey in 2024. a. The Survey Team requested and the laboratory failed to provide written policies and procedures for a mechanism to monitor and evaluate the labeling of patient specimens to ensure patient specimens were labeled with a unique patient identifier during all phases of testing. Refer to D5203 b. The Survey Team requested and the laboratory failed to provide written policies and procedures for a mechanism to monitor and evaluate the competency of the Technical Supervisors. Refer to D5209 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: Based on review of 34 laboratory policies and procedures, laboratory records and interviews the laboratory failed to follow one written policy and procedure. Findings include: 1. The laboratory failed to follow the procedure CORRECTION OF ERRORS, which stated: "In the laboratory, a copy of the original report is retained with the corrected report. When these are filed, notation is made on the original that corrected report was issued." 2. The Survey Team requested and the laboratory failed to provide a duplicate of the original final test report for one of one corrected test reports. Test report includes: -N24-00820 3. During an interview on November 18, 2024 at 3:40 PM, the Cytotechnologist stated that "corrected reports overwrite the original report". 4. During an interview on November 19, 2024 at 2:00, these findings were confirmed with the Cytotechnologist. 5. During an interview on November 20, 2024 at 11:00 AM, these findings were confirmed with Technical Supervisor B. 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)