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 surveyor review of the Proficiency Testing (PT) records and interview with the Owner and Technical Supervisor, the laboratory failed to tests the College of American Pathologists C-B 2018 General Chemistry/Therapeutic Drugs PT samples in the same manner as patients' specimens. Cross refer to D 2013. D2013 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(4) The laboratory must not send proficiency testing samples or portions of proficiency testing samples to another laboratory for any analysis for which it is certified to perform in its own laboratory. Any laboratory that CMS determines intentionally referred a proficiency testing sample to another laboratory for analysis may have its certification revoked for at least one year. If CMS determines that a proficiency testing sample was referred to another laboratory for analysis, but the requested testing was limited to reflex, distributive, or confirmatory testing that, if the sample were a patient specimen, would have been in full conformance with written, legally accurate and adequate standard operating procedures for the laboratory's testing 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 6 -- patient specimens, and if the proficiency testing referral is not a repeat proficiency testing referral, CMS will consider the referral to be improper and subject to alternative sanctions in accordance with 493.1804(c), but not intentional. Any laboratory that receives a proficiency testing sample from another laboratory for testing must notify CMS of the receipt of that sample regardless of whether the referral was made for reflex or confirmatory testing, or any other reason. This STANDARD is not met as evidenced by: Based on surveyor review of the Proficiency Test (PT) record, observation of Chemistry instrument, refrigerator and freezer and interview with the Owner, Technical Supervisor (TS) and Testing Personnel (TP), the laboratory failed to analyze Chemistry PT samples obtained from the College of American Pathologists (CAP) on the Advia 1800 analyzer for the 2nd event of 2018. The findings include: 1. The Instrument Printout (IP) had analyzer serial # CA 129100919090919 but serial # on the analyzer was CA 1291010621062. 2. The laboratory printed all PT sample results on the final report which had 'Quality Laboratory Service' (QLS) name and Brooklyn, NY address. 3. On the day of survey the TP # 2 listed on CMS form 209 stated general supervisor 'brings reagents and control material from QLS laboratory to perform PT samples.' 4. Observation of the refrigerator and freezer confirmed that the laboratory did not have any reagents or controls to perform chemistry testing. 5. The laboratory was not approved and was not performing serum chemistry tests for patients. 6. The owner and TS stated on 5/15/19 at 2:30 pm that general supervisor was out of the country and will discuss with him on his return. D2015 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(5)(6) (5) The laboratory must document the handling, preparation, processing, examination, and each step in the testing and reporting of results for all proficiency testing samples. The laboratory must maintain a copy of all records, including a copy of the proficiency testing program report forms used by the laboratory to record proficiency testing results including the attestation statement provided by the PT program, signed by the analyst and the laboratory director, documenting that proficiency testing samples were tested in the same manner as patient specimens, for a minimum of two years from the date of the proficiency testing event. (6) PT is required for only the test system, assay, or examination used as the primary method for patient testing during the PT event. This STANDARD is not met as evidenced by: Based on surveyor review of the Proficiency Testing (PT) records and interview with the Technical Supervisor (TS), the laboratory failed to maintain the Work Records (WR) and Attestation Statements (AS) signed by the analyst and laboratory director for Routine Chemistry, Endocrinology, Urinalysis, Coagulation and Hematology tests performed with the College of American Pathologists in 1-2019 events. The findings include: 1. The laboratory did not document handling, processing and each step in the testing and reporting of PT samples. 2. There were no printouts to substantiate reported results. 3. The Advia 1800-Chemistry, Centaur- Endocrinology, Atlas Clinitek-Urinalysis, Sysmex 1500-Coagulation and Advia 2120i-Hematology analyzers were checked to ensure PT was performed but no data was found in any of -- 2 of 6 -- the analyzers to verify PT was done. 4. The CAP evaluation sheets for all PT were signed off and reviewed by the general supervisor. 5. The TS confirmed on 5/15/19 at 2:15 pm that the laboratory did not maintain any records for PT. D5309 TEST REQUEST CFR(s): 493.1241(e) If the laboratory transcribes or enters test requisition or authorization information into a record system or a laboratory information system, the laboratory must ensure the information is transcribed or entered accurately. This STANDARD is not met as evidenced by: Based on review of Test Requisition (TR), and interview with the Owner, the laboratory failed to ensure that information from TR was transcribed accurately into the laboratory information system for all tests from 12/7/17 to the date of the survey. The Owner confirmed on 5/15/19 at 11:00 am that the laboratory did not ensure TR information was transcribed accurately. D5391 PREANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1249(a) The laboratory must establish and follow written policies and procedures for an ongoing mechanism to monitor, assess, and when indicated, correct problems identified in the preanalytic systems specified at 493.1241 through 493.1242. This STANDARD is not met as evidenced by: Based on surveyor review of the Procedure Manual (PM) and interview with the Owner, the laboratory failed to established a written procedure on how transcribed information from test requisition into the laboratory information system will be monitored from 12/7/17 to the date of survey. The Owner confirmed on 5/15/19 at 11: 30 am that the laboratory did not have the procedure mentioned above. D5403 PROCEDURE MANUAL CFR(s): 493.1251(b) The procedure manual must include the following when applicable to the test procedure: (1) Requirements for patient preparation; specimen collection, labeling, storage, preservation, transportation, processing, and referral; and criteria for specimen acceptability and rejection as described in 493.1242. (2) Microscopic examination, including the detection of inadequately prepared slides. (3) Step-by-step performance of the procedure, including test calculations and interpretation of results. (4) Preparation of slides, solutions, calibrators, controls, reagents, stains, and other materials used in testing. (5) Calibration and calibration verification procedures. (6) The reportable range for test results for the test system as established or verified in 493.1253. (7) Control procedures. (8)