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 the surveyor's review of the laboratory's policies and procedures manual, a review of three randomly chosen Dermatopathology patient test records, and interviews with the office manager (OM) and medical assistant (MA), it was determined that the laboratory failed to have an approved written policy and procedure for documentation and slide retention and storage. The findings include: 1. Based on the survey at approximately 12:15 p.m. on July 29, 2024, no written policy and procedure manual was found for the retention and storage of documents and slides. 2. The deficient practice was affirmed by interviews with the OM and MA on July 29, 2024, at approximately 12:15 p.m. as mentioned on statement #1. 3. According to the laboratory's testing declaration form submitted at the time of the survey and a review of three randomly chosen Dermatopathology patient test records covering the period of January 2023 to January 2024, the laboratory performed 3,000 tests annually for Dermatopathology during the time the laboratory had no written and approved retention and storage policy and procedure for documentation and slides. D5209 PERSONNEL COMPETENCY ASSESSMENT POLICIES CFR(s): 493.1235 As specified in the personnel requirements in subpart M, the laboratory must establish Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 4 -- and follow written policies and procedures to assess employee and, if applicable, consultant competency. This STANDARD is not met as evidenced by: Based on the lack of documentation, review of testing personnel competency assessment records, patient records review, and interviews with the office manager (OM) and medical assistant (MA) on July 29, 2024, as specified in the personnel requirements in subpart M, it was determined that the laboratory failed to establish a written policy and procedure to assess the testing personnel competency for the years 2023 and 2024. Findings include: 1. Based on the lack of the laboratory's policy and procedure and competency evaluations' records, the laboratory failed to have an approved written policy and procedure for competency assessment of the testing personnel (TP) for the subspecialties of Mycology and Parasitology. 2. Based on the review of patient records, the laboratory failed to provide documentation of training and competency assessment for the TP who performed the tests for KOH and scabies consisting of sample processing, testing, and reporting at the laboratory for the years 2023 and 2024. 3. This deficient practice was affirmed by interviews with the OM and MA on July 29, 2024, at approximately 12:00 p.m. 4. According to the laboratory's testing declaration submitted at the time of the survey, the laboratory performed 50 KOH tests for the subspecialty of Mycology and 10 scabies tests for the subspecialty of Parasitology annually, for which the competencies of the testing personnel were not performed. D5435 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(b)(2) For equipment, instruments, or test systems developed in-house, commercially available and modified by the laboratory, or maintenance and function check protocols are not provided by the manufacturer, the laboratory must: (i) Define a function check protocol that ensures equipment, instrument, and test system performance that is necessary for accurate and reliable test results and test result reporting. (ii) Perform and document the function checks, including background or baseline checks, specified in paragraph (b)(2)(i) of this section. Function checks must be within the laboratory's established limits before patient testing is conducted. This STANDARD is not met as evidenced by: Based on the surveyor's review of the written policy and procedure manual for equipment quality control and maintenance, an interview with the medical assistant (MA), and a review of six (6) randomly selected patient test results for KOH, scabies, and Dermatopathology, it was determined that the laboratory had missed recording the microscope preventive maintenance (PM) since 2022. The findings include: 1. Based on the survey on July 29, 2024, at approximately 12:30 p.m. and the review of the laboratory's equipment quality control policy and procedure manual and PM log, the surveyor observed that since June 20, 2022, no record for the microscope PM was found. 2. The MA affirmed by interview on July 29, 2024, that although the microscope PM is performed every time there is a patient slide to be reviewed, the facility had missed recording the PM performed as mentioned in statement #1. 3. Based on the laboratory's testing declaration submitted on July 29, 2024, and review of 6 randomly selected patient test records for KOH, scabies, and Dermatopathology, the laboratory performed 3,060 tests annually during the time that no PM was recorded. -- 2 of 4 -- D5787 TEST RECORDS CFR(s): 493.1283(a) The laboratory must maintain an information or record system that includes the following: (a)(1) The positive identification of the specimen. (a)(2) The date and time of specimen receipt into the laboratory. (a)(3) The condition and disposition of specimens that do not meet the laboratory's criteria for specimen acceptability. (a)(4) The records and dates of all specimen testing, including the identity of the personnel who performed the test(s). This STANDARD is not met as evidenced by: Based on the surveyor's review of patient test records and interviews with the laboratory director (LD) and medical assistant (MA), the laboratory failed to maintain a system that identified the records and dates of all specimens tested, including the identities of the personnel who performed the test. Findings include: 1. Based on the interviews with the LD and MA at approximately 12:30 p.m. on July 29, 2024, it was determined that the practice of the laboratory is to directly enter the results upon patient visitation into the electronic health records (EHR) for those seen by the LD. 2. Based on the findings during the patient test record review, it was found that only the testing personnel (TP) kept records for KOH tests performed. However, no signature or initials of the TP who performed the test were found on the patient log sheet. Since most of the tests were performed by the LD, all tests performed for KOH and scabies in 2023 were not documented in the patient record log sheet. 3. The LD and MA affirmed by interview on July 29, 2024, at approximately 12:30 p.m. that the laboratory failed to keep documentation for every patient tested for KOH and scabies seen by the LD. 4. According to the laboratory testing declaration submitted at the time of the survey, the laboratory performed 50 KOH and 10 scabies tests annually during the time the laboratory failed to maintain a record system for all specimens tested, including the identities of the personnel who performed the test on the patient log sheet. D5793 ANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1289(b)(c) (b) The analytic systems quality assessment must include a review of the effectiveness of