Summary:
Summary Statement of Deficiencies D3043 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(7) The laboratory must retain cytology slide preparations for at least 5 years from the date of examination (see 493.1274(f) for proficiency testing exception). The laboratory must retain histopathology slides for at least 10 years from the date of examination. The laboratory must retain pathology specimen blocks for at least 2 years from the date of examination. The laboratory must preserve remnants of tissue for pathology examination until a diagnosis is made on the specimen. This STANDARD is not met as evidenced by: Based on Surveyor review of laboratory's policy & procedure, random patient testing records, lack of histopathology slide, and interview with the laboratory administrative personnel, the laboratory failed to retain histopathology slides for at least 10 years from the date of examination. The findings include: a. The laboratory did not have histopathology slide for the patient 71398, slide G62403, examination date: 10/30 /2018. b. On February 1, 2019 at 12:14 pm laboratory administrative personnel affirmed that the laboratory did not have the histopathology slide in possession. c. The laboratory's testing declaration form, signed by the laboratory Director on January 7, 2019, stated that the laboratory performs 500 tests annually. D6087 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(3)(iii) The laboratory director must ensure that laboratory personnel are performing the test methods as required for accurate and reliable results. This STANDARD is not met as evidenced by: Based on Surveyor review of random patient testing records, laboratory's policy & 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 -- procedure, and interview with the laboratory administrative personnel, the laboratory Director failed to ensure that laboratory personnel are performing the test methods as required for accurate and reliable results. The findings include: a. The laboratory's test report for patient 62627, slide G62345 shows the specimen size was 0.3x0.3x0.04 mm, but the measurement of the tissue on the slide is 3x1 mm in size. The tissue size on the slide does not match with the specimen size that is reported. Therefore, the reported specimen size is not accurate. b. On February 1, 2019 at 12:22 pm laboratory testing personnel affirmed that the reported specimen size is not accurate. c. The laboratory's testing declaration form, signed by the laboratory Director on January 7, 2019, stated that the laboratory performs 500 tests annually. -- 2 of 2 --