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 a proficiency testing (PT) record review, a procedure review, and an interview with the technical supervisor, the laboratory failed to properly enroll in PT for the types of cultures performed in the laboratory since the last survey on May 24, 2017. Findings: 1. A PT record review from the College of American Pathologists revealed the laboratory failed to enroll in PT for wound cultures performed in the laboratory. 2. A review of the procedure manual and the laboratory's test menu confirmed a procedure for wound cultures. 3. The laboratory performs approximately 1300 throat, urine, and wound cultures per year. 4. An interview on January 17, 2019 at 2:15 PM, with the technical supervisor, confirmed the laboratory was not enrolled in a CMS-approved PT program that included wound cultures since the last survey. 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 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 -- 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 patient record reviews, proficiency testing (PT) record reviews, and an interview with the technical supervisor, the laboratory testing personnel failed to indicate the dates of microbiology test performances and the testing personnel who performed routine urine and throat cultures, which includes media set-up, colony description and quantitation, inhibition zone sizes, and susceptibilities since the last survey on May 24, 2017. Findings: 1. A review of The College of American Pathologists bacteriology PT worksheets revealed the microbiology worksheets failed to include: a. the dates of each step of test performance; b. the colony description, quantitation, and morphology; c. the person performing each step of testing from streaking of the plate to final sensitivity. 2. The laboratory performs approximately 1300 bacteriology tests on throat and urine specimens. 3. A record review of 4 patient records from April 2, 2018 through April 30, 2018, revealed the laboratory failed to indicate the dates of each test performance and identify the testing personnel performing the tests. 4. An interview on January 17, 2019 at 3:00 P.M., with the technical supervisor, confirmed the laboratory bacteriology worksheets used as final patient reports failed to indicate all dates and steps of testing and the identity of testing personnel. D6120 TECHNICAL SUPERVISOR RESPONSIBILITIES CFR(s): 493.1451(b)(7)(8) (7) The technical supervisor is responsible for identifying training needs and assuring that each individual performing tests receives regular in-service training and education appropriate for the type and complexity of the laboratory services performed; (8) Evaluating the competency of all testing personnel and assuring that the staff maintain their competency to perform test procedures and report test results promptly, accurately and proficiently. This STANDARD is not met as evidenced by: Based on document reviews and an interview with the technical supervisor, the laboratory failed to perform competency assessments in 2018 on 4 out of 5 medical providers performing Potassium Hydroxide (KOH) testing on skin scrapings for the presence of fungal elements. This is a repeat deficiency from the last survey performed on May 24, 2017. Findings: 1. The laboratory performs approximately 10 KOH examinations from skin scrapings per year. 2. A review of competency assessment documents for 4 out of 5 medical providers revealed the laboratory failed to perform and document competency assessments for 2018. 3. An interview on January 17, 2019 at 1:45 P.M., with the technical supervisor, confirmed that competency assessments for the providers failed to be performed and documented for 2018. -- 2 of 2 --