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 the surveyor's direct observation, review of the laboratory's records, and an interview with the technical consultant (TC), the laboratory failed to enroll in an approved program for each of the specialties and subspecialties for which it seeks certification, affecting 164 patients. Findings: 1. The laboratory failed to enroll in an approved program for the subspecialty of Bacteriology for which it seeks certification. See D2001 D2001 ENROLLMENT CFR(s): 493.801(a)(1)(2)(i) The laboratory must-- (1) Notify HHS of the approved program or programs in which it chooses to participate to meet proficiency testing requirements of this subpart. (2)(i) Designate the program(s) to be used for each specialty, subspecialty, and analyte or test to determine compliance with this subpart if the laboratory participates in more than one proficiency testing program approved by CMS; Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 8 -- This STANDARD is not met as evidenced by: Based on the surveyor's direct observation, review of the laboratory's proficiency testing (PT) documents, test volume worksheet, and an interview with the technical consultant (TC), the laboratory failed to enroll in an approved program for the subspecialty of Bacteriology for which it seeks certification, affecting 164 patients. Findings: 1. On 07/23/2018 at 11:30 AM during a tour of the laboratory, the surveyor observed media for both throat and urine cultures. 2. The PT documents presented showed that the laboratory is enrolled in the College of American Pathologists (CAP) PT program for the specialty of Hematology, but not Bacteriology. No other documented evidence was provided to show that the laboratory has enrolled in a CAP or any other PT program for the throat culture and Urine culture testing the laboratory performs. 3. The "Laboratory Non-waived CLIA Test Volume Worksheet" submitted by the laboratory documents that 4 patients have been tested for Urine culture colony counts, and 160 patients have been tested for Step Group A culture identification (ID) between the months of May and June of 2018. 4. On an Initial survey conducted on 07 /23/2018 at 1:45 PM, the TC and the laboratory director confirmed that the laboratory does perform Urine culture counts and Throat cultures for Strep Group A ID. D5400 ANALYTIC SYSTEMS CFR(s): 493.1250 Each laboratory that performs nonwaived testing must meet the applicable analytic systems requirements in 493.1251 through 493.1283, unless HHS approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub.7), that provides equivalent quality testing. The laboratory must monitor and evaluate the overall quality of the analytic systems and correct identified problems as specified in 493.1289 for each specialty and subspecialty of testing performed. This CONDITION is not met as evidenced by: Based on the surveyor's direct observations, manuals, records and an interview with the laboratory staff, the laboratory failed to meet the applicable analytic systems requirements in 493.1251 through 493.1283, that provides equivalent quality testing in the specialties of Hematology and Bacteriology. Findings: 1. The laboratory failed to have written procedures manual for all tests, assays, and examinations performed by the laboratory. See D5401. 2. The laboratory procedures' manual failed to include all the applicable requirements specified in 493.1251(b)(1) - (14), when using the operator's manual and the requirements are not provided by the manufacturer in the specialty of Hematology. See D5405. 3. The laboratory failed to establish control procedures that monitor the accuracy and precision of the complete analytic process for Bacteriology testing. See D5441. 4. The laboratory failed to perform checks for media and reagents used in Bacteriological testing. See D5471 and D5477. 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: -- 2 of 8 -- Based on the surveyor's review of the laboratory's procedures manual, direct observations, the Laboratory Non-waived CLIA Test Volume Worksheet, and an interview with the technical consultant (TC), the laboratory failed to have written procedures for all tests, assays, and examinations performed by the laboratory, affecting 164 patients. Findings: 1. On 07/23/2018 at 11:35 AM during a tour of the laboratory, the surveyor observed that the laboratory stored and stocked the following media and reagent: Selective Streptococcus Agar (SSA), Cystine-lactose-Electrolyte- Deficient (CLED) agar/ Eosin Methylene Blue (EMB) Agar paddles, and Bacitracin (Taxo A) Disks. 2. The laboratory's manual does not include the procedures for the Bacterial culture systems that uses the media and reagents listed in "Findings #1". 3. The laboratory documents on the "Laboratory Non-waived CLIA Test Volume Worksheet" that the laboratory has performed 4 Urine culture tests using the CLED /EMB agar, and 160 Strep Group A culture tests using the SSA agar and Taxo A disks. 4. On an Initial survey conducted on 07/23/2018 at 1:15 PM, the TC confirmed the above findings. D5405 PROCEDURE MANUAL CFR(s): 493.1251(c) Manufacturer's test system instructions or operator manuals may be used, when applicable, to meet the requirements of paragraphs (b)(1) through (b)(12) of this section. Any of the items under paragraphs (b)(1) through (b)(12) of this section not provided by the manufacturer must be provided by the laboratory. This STANDARD is not met as evidenced by: Based on the surveyor's review of the laboratory's operator's manual, records, and an interview with the technical consultant (TC) and laboratory director (LD), the laboratory's procedures' manual failed to include all the applicable requirements specified in 493.1251(b)(1) - (14), when using the operator's manual and the requirements are not provided by the manufacturer, for tests performed in the specialty of Hematology, affecting 359 patients. Findings: 1. The laboratory uses the manufacturer's operators manual as it's procedure manual for Cellular Blood Count (CBC) analysis. Review of the operator's manual revealed that the manufacturer does not include the following procedure requirements: (b)(5). Calibration procedures. (b) (8).