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 cytology proficiency testing (PT) enrollment records and interviews the laboratory failed to enroll in a CMS-approved cytology PT program for gynecologic examination (refer to D2001). 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; and This STANDARD is not met as evidenced by: Based on the lack of cytology PT enrollment records and interviews the laboratory failed to enroll in a CMS-approved cytology PT program for gynecologic examination Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 11 -- for 2023 prior to the date of the survey on January 8, 2025. Findings include: 1. The Survey Team requested and the laboratory failed to provide records of enrollment in a CMS-approved cytology PT program for 2023. 2. During an interview on January 6, 2025 at 3:45 PM, when asked if the laboratory had enrolled or was currently enrolled in a CMS-approved cytology PT program the Director of Compliance and Quality replied "no." 3. During an interview on January 8, 2025 at 12:15 PM, the Director of Cytology and Molecular confirmed the laboratory had not been enrolled prior to the survey, and stated the laboratory enrolled in a 2025 PT program during the survey. 4. The laboratory provided a record of enrollment in a CMS-approved PT program for 2024 post-survey, on January 16, 2025. D3011 FACILITIES CFR(s): 493.1101(d) Safety procedures must be established, accessible, and observed to ensure protection from physical, chemical, biochemical, and electrical hazards, and biohazardous materials. This STANDARD is not met as evidenced by: Based on the lack of laboratory policies and procedures and interviews the laboratory failed to establish and follow safety procedures to ensure protection from physical, chemical and electrical hazards. Findings include: 1. The Survey Team requested and the laboratory failed to provide written policies and procedures to ensure protection from physical, chemical and electrical hazards that were specific to the laboratory being surveyed. 2. During an interview on January 6, 2025 at 1:20 PM, the Director of Compliance and Quality stated "the laboratory uses policies and procedures from the main laboratory and the hospital." When asked if the laboratory had its own written policies and procedures that were specific to the laboratory site and operations, the Director of Compliance and Quality replied "no, we use the same procedures for all sites for training." 3. During an interview on January 6, 2025 at 3:45 PM, when asked if the laboratory had written safety procedures to ensure protection from physical, chemical and electrical hazards that were specific to the laboratory being surveyed, the Director of Compliance and Quality replied "the hospital safety person can get the hospital procedures." The Director of Compliance and Quality confirmed there were no written policies and procedures specific to the laboratory site and operations. 4. During a phone interview on January 7, 2025 at 9:30 AM, the Director of Compliance and Quality stated the laboratory "will redo the policies from the main laboratory so they are specific to the laboratory and each site." 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 the lack of laboratory policies and procedures and interviews the laboratory failed to establish and follow written policies and procedures that ensure positive identification and optimum integrity of a patient's specimen from the time of receipt -- 2 of 11 -- of the specimen through completion of testing and reporting of results. Findings include: 1. The Survey Team requested and the laboratory failed to provide written policies and procedures for the laboratory's process to ensure positive identification and optimum integrity of a patient's specimen from the time the specimen slides are transported and received through the completion of testing and reporting of results. 2. During an interview on January 6, 2025 at 1:20 PM, the Director of Compliance and Quality stated, "the laboratory uses policies and procedures from the main laboratory and the hospital." When asked if the laboratory had its own written policies and procedures that were specific to the laboratory site and operations, the Director of Compliance and Quality replied, "no, we use the same procedures for all sites for training." 3. During a phone interview on January 7, 2025 at 9:30 AM, the Director of Compliance and Quality stated the laboratory "will redo the policies from the main laboratory so they are specific to the laboratory and each site." The Director of Compliance and Quality confirmed there were no written policies and procedures for the laboratory's process to ensure positive identification and optimum integrity of a patient's specimen from the time of receipt of the specimen through completion of testing and reporting of results. D5403 PROCEDURE MANUAL CFR(s): 493.1251(b) (b) The procedure manual must include the following when applicable to the test procedure: (b)(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. (b)(2) Microscopic examination, including the detection of inadequately prepared slides. (b)(3) Step-by- step performance of the procedure, including test calculations and interpretation of results. (b)(4) Preparation of slides, solutions, calibrators, controls, reagents, stains, and other materials used in testing. (b)(5) Calibration and calibration verification procedures. (b)(6) The reportable range for test results for the test system as established or verified in 493.1253. (b)(7) Control procedures. (b)(8)