Hrc Fertility - Pasadena

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 a review of the CMS Casper report 096 and the lack of documentation related to proficiency testing (PT) program and an interview with the Technical Consultant (TC), it was determined that the laboratory failed to enroll in proficiency testing (PT) for Cycle 1 of 2020. The laboratory inspection occurred on 7/16/21 between 11 a.m. and 2 p.m. Findings include: 1. The Casper 096 report for the Cycle 1 2020 was reviewed, and there were no entries for any of the CMS specialties, including Bacteriology (110), General Immunology (220), Endocrinology (330), Toxicology (340), Hematology (400) and ABO and Rh type (510). 2. The TC indicated that they utilized the College of American Pathology (CAP) proficiency testing during the time periods of 2019 and 2020. 3. There were no CAP results for Cycle 1 2020 for any analytes. 4. At approximately 12:00 p.m. on 7/16/21, the TC affirmed that they did not enroll with CAP for Cycle 1 proficiency testing. 5. The estimated annual test volumes submitted on the CMS-116 report were: - Microbiology 3,000 - Immunology 16,500 - Chemistry 32,300 - Hematology 19,600 - ABO and Rh 4,000 D6015 LABORATORY DIRECTOR RESPONSIBILITIES Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 2 -- CFR(s): 493.1407(e)(4) The laboratory director is responsible for the overall operation and administration of the laboratory, including the employment of personnel who are competent to perform test procedures, and record and report test results promptly, accurate, and proficiently and for assuring compliance with the applicable regulations. (e) The laboratory director must-- (e)(4) Ensure that the laboratory is enrolled in an HHS approved proficiency testing program for the testing performed. This STANDARD is not met as evidenced by: Based on a review of the CMS Casper report 096 and the lack of documentation related to proficiency testing (PT) program and an interview with the Technical Consultant (TC), it was determined that the laboratory failed to enroll in proficiency testing (PT) for Cycle 1 of 2020. The laboratory inspection occurred on 7/16/21 between 11 a.m. and 2 p.m. Findings include: 1. The laboratory director did not ensure that the laboratory was enrolled in an HHS approved proficiency program for each testing cycle. 2. See D 2000. -- 2 of 2 --

Summary Statement of Deficiencies D2075 GENERAL IMMUNOLOGY CFR(s): 493.837(a) Failure to attain a score of at least 80 percent of acceptable responses for each analyte in each testing event is unsatisfactory analyte performance for the testing event. This STANDARD is not met as evidenced by: Based on reviews second quarter (Q2-2017) of the College of the American Pathologists (CAP) proficiency testing performance evaluation records, random patient sampling test results, and interview with the technical consultant, it was determined that the laboratory failed to attain a score of at least 80 percent of acceptable responses for Rubella Antibody, IgG analyte. The findings included: a. Q1- 2017, CAP reported a score of 60% for Rubella Antibody, IgG analyte. b. For seven (7) out of seven (7) random patient sampling test results reviewed covering period from 7/6//2017 to 8/29/2017, the laboratory analyzed and reported Rubella Antibody, IgG analyte approximately during the time the laboratory received the failed proficiency testing score. c. The technical consultant confirmed (4/25/2019, 1430) that the laboratory received that above unsatisfactory proficiency testing score. D2098 ENDOCRINOLOGY CFR(s): 493.843(a) Failure to attain a score of at least 80 percent of acceptable responses for each analyte in each testing event is unsatisfactory analyte performance for the testing event. This STANDARD is not met as evidenced by: Based on reviews first quarter (Q1-2017) of the College of the American Pathologists (CAP) proficiency testing performance evaluation records, random patient sampling test results, and interview with the technical consultant, it was determined that the 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 -- laboratory failed to attain a score of at least 80 percent of acceptable responses for Human Chorionic Gonadotropin (HCG) analyte. The findings included: a. Q1-2017, CAP reported a score of 0% for HCG analyte. b. For four (4) out of four (4) random patient sampling test results reviewed covering period from 5/4/2017 to 6/7/2017, the laboratory analyzed and reported HCG analyte approximately during the time the laboratory received the failed proficiency testing score. c. The technical consultant confirmed (4/25/2019, 1430) that the laboratory received that above unsatisfactory proficiency testing score. 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 reviews and the lack of documentation of the laboratory's 2018, and 2019 verification of accuracy twice a year records, random patient sampling test results, and interview with the technical consultant the laboratory failed to perform verification of accuracy twice a year for Retrograde Urine Sperm Analysis. The finding included: a. Based on reviews and the lack of documentation for verification of accuracy two times per year, random patient sampling test results reviewed covering period from 10 /5/2017 to 9/3/2018, the laboratory analyzed and reported Retrograde Urine Sperm Analysis analyte even though there was no verification of accuracy performed. b. The technical consultant confirmed (4/25/2019, 1430) that the laboratory failed to perform verification of accuracy two times per year for the above analyte. D5473 CONTROL PROCEDURES CFR(s): 493.1256(e)(2)(g) (e) For reagent, media, and supply checks, the laboratory must do the following: (e) (2) Each day of use (unless otherwise specified in this subpart), test staining materials for intended reactivity to ensure predictable staining characteristics. Control materials for both positive and negative reactivity must be included, as appropriate. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on review s and the lack of documentation for HEMA 3 stain set used for microscopic evaluation for Semen Morphology its stain reactivity, and interview with the technical supervisor, it was determined that the laboratory failed to each day of use (unless otherwise specified in this subpart), test staining materials for intended reactivity to ensure predictable staining characteristics. The findings included: a. Based on reviews and the lack of documentation for the HEMA 3 stain reactivity, the laboratory failed to document stain reactivity whenever it is being used. b. For eight (8) out of eight (8) random patient test results reviewed covering period from 1/21 /2019 to 4/15/2019,the laboratory lacked the documentation for HEMA3 stain reactivity whenever the stain is used for manual white blood cell count differential. c. The technical supervisor confirmed (4/25/2019, 1430) that the laboratory failed to document HEMA 3 stain kit for its reactivity whenever it is being used. D6019 LABORATORY DIRECTOR RESPONSIBILITIES -- 2 of 3 -- CFR(s): 493.1407(e)(4)(iv) The laboratory director is responsible for the overall operation and administration of the laboratory, including the employment of personnel who are competent to perform test procedures, and record and report test results promptly, accurate, and proficiently and for assuring compliance with the applicable regulations. (e) The laboratory director must-- (e)(4)(iv) Ensure that an approved