Summary:
Summary Statement of Deficiencies D2003 ENROLLMENT CFR(s): 493.801(a)(2)(ii) For those tests performed by the laboratory that are not included in subpart I of this part, a laboratory must establish and maintain the accuracy of its testing procedures, in accordance with 493.1236(c)(1) This STANDARD is not met as evidenced by: Based on record review and staff interview the laboratory failed to enroll in an HHS approved proficiency testing (PT) program or maintain accuracy of its testing procedures in the specialty of Hematology in 2018. Findings include: 1. Record review of the laboratory's PT records on 2/21/19 revealed: a. No records of PT documents for 2018. b. No records for accuracy testing for semen analysis (SA) for 2018. 2. Staff interview with the laboratory director on 2/21/19 at 10:15 AM confirmed: a. The laboratory did not enroll in an HHS approved PT program in 2018. b. Accuracy testing for SA was not performed for 2018. 3. The laboratory performs 24 SA annually. D2128 HEMATOLOGY CFR(s): 493.851(e) (1) For any unsatisfactory analyte or test performance or testing event for reasons other than a failure to participate, the laboratory must undertake appropriate training and employ the technical assistance necessary to correct problems associated with a proficiency testing failure. (2) For any unacceptable analyte or testing event score, remedial action must be taken and documented, and the documentation must be maintained by the laboratory for two years from the date of participation in the proficiency testing event. 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 -- This STANDARD is not met as evidenced by: Based on record review and staff interview the laboratory failed to investigate or take remedial action when unsatisfactory and unacceptable Proficiency Testing (PT) scores are received. Findings include: 1. Record review of the laboratory's American Proficiency Institute (API) PT records on 2/21/19 for 2017 revealed: A. Unsatisfactory score of 0% was obtained for the following tests in the 1st event. a. Sperm count (post vasectomy) b. Sperm morphology (image) c. Sperm motility d. Sperm progressive motility B. Unsatisfactory score of 50% was obtained for the following tests in the 3rd event. a. Sperm classification b. Sperm motility c. Sperm progressive motility C. Unsatisfactory score of 0% was obtained for sperm count test in the 3rd event. D. Unacceptable PT scores were obtained for the following samples in the 1st event. a. Sample # PVS-02 for sperm count (post vasectomy) b. Sample # SCL-03 for sperm classification c. Sample # SM-02 for sperm morphology d. Sample# MOT-01 & MOT-02 for sperm motility (%) and sperm progressive motility (%) E. Unacceptable PT scores were obtained for the following samples in the 3rd event. a. Sample # SPC-03 and SPC-04 for sperm count b. Sample # SCL-16 through 20 for sperm morphology c. Sample# MOT-03 for sperm motility (%) and sperm progressive motility (%) 2. Staff interview with the laboratory director on 2/21/19 at 10:00 AM confirmed the laboratory did not investigate or take