Summary:
Summary Statement of Deficiencies D0000 The laboratory was surveyed on April 20, 2018 and found to be in compliance with the CLIA regulations. D5217 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(c)(1) At least twice annually, the laboratory must verify the accuracy of any test or procedure it performs that is not included in subpart I of this part. This STANDARD is not met as evidenced by: Based on review of the laboratory's test menu, review of the laboratory's records, and staff interview, it was revealed the laboratory failed to have documentation of twice annual accuracy assessment for semen analysis. The findings were: 1. A review of the laboratory's test menu revealed the laboratory performed 100 semen analysis tests in 2017. 2. A review of the laboratory's records revealed the laboratory performed an accuracy assessment once in 2017. 3. The laboratory was asked to provide documentation performing twice annual accuracy assessments for semen analysis twice in 2017. No documentation was provided. 4. An interview with the technical supervisor on 04/20/2018 at 1015 hours in the break room confirmed the findings. 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: Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 3 -- Based on review of laboratory policy, review of quality control records, review of patient results, and confirmed in interview of facility personnel, the laboratory failed to follow its own policy for evaluating threshold limits for its quality control testing. The findings were: 1. The laboratory's quality control policy stated, "Threshold Limits: All embryologists should be within 10% of the mean." 2. Review of the manufacturer's established quality control ranges located on the outside of the packaging listed the following means and ranges: Level 1 Lot # 260218001 Mean: 48 (+/- 12.0) Level 2 Lot # 260218002 Mean: 26 (+/- 6.5) Level 3 Lot # 260218003 Mean: 0.0 3. Review of the laboratory's quality control records revealed the laboratory had established the following ranges: Level 1 (high) Lot # 260218001 36 - 58 Level 2 (low) Lot # 260218002 20 - 32 Level 3 (negative) Lot # 260218003 0 4. Review of the laboratory's quality control records from October 2016 to April 2018 revealed the laboratory ran each level of control in duplicate but failed to calculate the percent difference to determine if the quality control was acceptable prior to patient testing. 5. An interview with the technical supervisor on 04/20/2018 at 1045 hours in the hallway confirmed the findings. D5417 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(d) Reagents, solutions, culture media, control materials, calibration materials, and other supplies must not be used when they have exceeded their expiration date, have deteriorated, or are of substandard quality. This STANDARD is not met as evidenced by: Based on surveyor observations, review of manufacturer's instructions, and interview will facility personnel, the laboratory failed to ensure expired reagents and solutions were not available for use in patient testing. The findings included: 1. At 1030 hours on April 20, 2018 in the laboratory, the surveyor observed the following expired quality control material: wik heck beads Lot #260218001 (opened: 10-05-2016) Lot #260218002 (opened: 10-05-2016) Lot #260218003 (opened: 10-05-2016) 2. Review of the manufacturer's instructions for the wik heck beads (Rev. 22_NOV_2017) under, "For in-vitro use only" stated, "Open vial shelf life is 90 days." 3. Review of the laboratory's "Semen Log Sheet" revealed the laboratory performed 100 semen analysis tests annually. 4. In an interview at 1200 hours on 04/20/2018 in the break room, the technical supervisor confirmed that the quality control materials were expired. D5785