Summary:
Summary Statement of Deficiencies D2000 ENROLLMENT AND TESTING OF SAMPLES CFR(s): 493.801 Each laboratory must enroll in a proficiency testing (PT) program that meets the criteria in subpart I of this part and is approved by HHS. The laboratory must enroll in an approved program or programs for each of the specialties and subspecialties for which it seeks certification. The laboratory must test the samples in the same manner as patients' specimens. For laboratories subject to 42 CFR part 493 published on March 14, 1990 (55 FR 9538) prior to September 1, 1992, the rules of this subpart are effective on September 1, 1992. For all other laboratories, the rules of this subpart are effective January 1, 1994. This CONDITION is not met as evidenced by: Based on the lack of laboratory records and interviews it was determined that Facility B (CLIA #45D0504523) failed to enroll in an approved cytology proficiency testing (PT) program for gynecologic examination. The cumulative effect of this systemic problem resulted in the laboratory's failure to meet certification requirements to accurately and reliably evaluate patients' gynecologic cytology specimen slides for 2016, 2017 and to the date of the survey in 2018. D2001 ENROLLMENT CFR(s): 493.801(a)(1)(2)(i) The laboratory must-- (1) Notify HHS of the approved program or programs in which it chooses to participate to meet proficiency testing requirements of this subpart. (2)(i) Designate the program(s) to be used for each specialty, subspecialty, and analyte or test to determine compliance with this subpart if the laboratory participates in more than one proficiency testing program approved by CMS; Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 8 -- This STANDARD is not met as evidenced by: Based on the lack of cytology PT enrollment records and interviews it was determined that Facility B (CLIA #45D0504523) failed to enroll in an approved cytology PT program for 2016, 2017 and to the date of the survey in 2018. Findings include: 1. The Survey Team requested and the Facility B (CLIA #45D0504523) failed to provide records of enrollment in an approved cytology PT program for 2016, 2017 and to the date of the survey in 2018. 2. During an interview on November 13, 2018 at 4:09 PM, the Anatomic Pathology Manager stated that Facility B (CLIA #45D0504523) was not enrolled in an approved cytology PT program for 2016, 2017 and to the date of the survey in 2018. The Anatomic Pathology Manager further stated that Facility B (CLIA #45D0504523) Technical Supervisors participated in the PT program at Facility E (CLIA #45D0505003). 3. During an interview on November 14, 2018 at 3:00 PM, the Laboratory Director/Technical Supervisor confirmed these findings. D5032 CYTOLOGY CFR(s): 493.1221 If the laboratory provides services in the subspecialty of Cytology, the laboratory must meet the requirements specified in 493.1230 through 493.1256, 493.1274, and 493.1281 through 493.1299. This CONDITION is not met as evidenced by: Based on review of laboratory policies and procedures, record review, observation and interviews it was determined that Facility B (CLIA #45D0504523) failed to establish written policies and procedures for the collection of Becton Dickinson (BD) SurePath and Hologic ThinPrep gynecologic specimens (refer to D5311); failed to establish written procedures for two laboratory processes (refer to D5403); failed to ensure that 16 written procedures were approved, signed, and dated by the Laboratory Director prior to the start of the survey on November 13, 2018 (refer to D5407); failed to follow written policies and procedures for the evaluation and comparison of six of six laboratory statistics, and failed to document six of six required annual statistics for 2016 and 2017 (refer to D5629); failed to follow written policies and procedures to ensure that unsatisfactory gynecologic cytology slide preparations were identified and reported as unsatisfactory and failed to identify and report one gynecologic cytology case from January 2018 as being "Unsatisfactory for Evaluation" (refer to D5655); and failed to establish written policies and procedures to ensure that corrected reports indicated the basis for the correction on the report (refer to D5659). The cumulative effect of these systemic problems resulted in the laboratory's inability to ensure the accuracy and reliability of patient test results in the subspecialty of Cytology. D5311 SPECIMEN SUBMISSION, HANDLING, AND REFERRAL CFR(s): 493.1242(a) The laboratory must establish and follow written policies and procedures for each of the following, if applicable: (1) Patient preparation. (2) Specimen collection. (3) Specimen labeling, including patient name or unique patient identifier and, when appropriate, specimen source. (4) Specimen storage and preservation. (5) Conditions for specimen transportation. (6) Specimen processing. (7) Specimen acceptability and rejection. (8) Specimen referral. -- 2 of 8 -- This STANDARD is not met as evidenced by: Based on review of laboratory policies and procedures and interviews it was determined that Facility B (CLIA #45D0504523) failed to establish written policies and procedures for the collection of BD SurePath and Hologic ThinPrep gynecologic specimens. Findings include: 1. The Survey Team requested and Facility B (CLIA #45D0504523) failed to provide written policies and procedures for the collection of BD SurePath gynecologic specimens. 2. The Survey Team requested and Facility B (CLIA #45D0504523) failed to provide written policies and procedures for the collection of Hologic ThinPrep gynecologic specimens. 3. During an interview on November 14, 2018 at 2:15 PM, the Anatomic Pathology Manager stated that there were no policies and procedures to describe how clinicians were to collect BD SurePath and Hologic ThinPrep gynecologic specimens. 4. During an interview on November 14, 2018 at 3:00 PM, the Laboratory Director/Technical Supervisor confirmed these findings. 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)