Gw Medical Faculty Assc At Gwu

Summary Statement of Deficiencies 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 review of proficiency testing (PT) records and interview with the testing person (TP), the laboratory failed to maintain all PT documents that is required when performing PT. Findings: 1. The lab performs Prostatic Specific Antigen (PSA) testing on the FastPack analyzer. 2. The lab failed to maintain all worksheets and raw data for the API 2121 Chemistry PT 1st, 2nd, 3rd events. 3. The lab failed to maintain all worksheets and raw data for the American Proficiency Institute (API) 2020 Chemistry PT 1st and 2nd events 4. The TP confirmed on the day of the survey at 2: 20 PM that the lab failed to maintain all PT documents that is required when performing PT testing. D3031 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(3) Analytic systems records. Retain quality control and patient test records (including Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 5 -- instrument printouts, if applicable) and records documenting all analytic systems activities specified in 493.1252 through 493.1289 for at least 2 years. This STANDARD is not met as evidenced by: Based on review of quality control procedures (QC) and interview with the nursing director, the lab failed to retain all QC performed during chemistry testing. Findings: 1. The lab performs Prostatic Specific Antigen (PSA) testing on the FastPack analyzer. 2. On January 21, 2020, testing person (TP) "A" performed the PSA QC twice. 3. The TP failed to keep the QC that did not pass and retained only the repeated QC. 4. The nursing director confirmed on the day of the survey at 3:20 PM that theTP failed to keep the QC that did not pass and retained only the repeated QC. D5305 TEST REQUEST CFR(s): 493.1241(c) The laboratory must ensure the test requisition solicits the following information: (1) The name and address or other suitable identifiers of the authorized person requesting the test and, if appropriate, the individual responsible for using the test results, or the name and address of the laboratory submitting the specimen, including, as applicable, a contact person to enable the reporting of imminently life threatening laboratory results or panic or alert values. (2) The patient's name or unique patient identifier. (3) The sex and age or date of birth of the patient. (4) The test(s) to be performed. (5) The source of the specimen, when appropriate. (6) The date and, if appropriate, time of specimen collection. (7) For Pap smears, the patient's last menstrual period, and indication of whether the patient had a previous abnormal report, treatment, or biopsy. (8) Any additional information relevant and necessary for a specific test to ensure accurate and timely testing and reporting of results, including interpretation, if applicable. This STANDARD is not met as evidenced by: Based on review of the physician lab orders and interview with the director of nursing, the lab failed to ensure that patient test requisitions included the required identifiers needed for accurate and reliable Chemistry Prostatic Specific Antigen (PSA) testing. Findings: 1. Review of the physician lab order showed the order did not include the date of birth, sex, nor the age of the patient. 2. The physician lab order did not include the name of the test that was ordered nor the name and complete address where the test would be performed. 3. Review of the physician order showed the resulting agency as "Internal Lab, 123 Anywhere Street, Madison WI 53711". 4. The director of nursing confirmed on the day of the survey at 3:00 PM that the physician lab orders failed to include the required identifies needed for accurate and reliable Chemistry testing D5439 CALIBRATION AND CALIBRATION VERIFICATION CFR(s): 493.1255(b) Unless otherwise specified in this subpart, for each applicable test system the laboratory must do the following: Perform and document calibration verification procedure - (b)(1) Following the manufacturer's calibration verification instructions; (b)(2) Using the criteria verified or established by the laboratory under 493.1253(b)(3) -- (b)(2)(i) Including the number, type, and concentration of the materials, as well as acceptable limits for calibration verification; and (b)(2)(ii) Including at least a -- 2 of 5 -- minimal (or zero) value, a mid-point value, and a maximum value near the upper limit of the range to verify the laboratory's reportable range of test results for the test system; and (b)(3) At least once every 6 months and whenever any of the following occur: (b)(3)(i) A complete change of reagents for a procedure is introduced, unless the laboratory can demonstrate that changing reagent lot numbers does not affect the range used to report patient test results, and control values are not adversely affected by reagent lot number changes. (b)(3)(ii) There is major preventive maintenance or replacement of critical parts that may influence test performance. (b)(3)(iii) Control materials reflect an unusual trend or shift, or are outside of the laboratory's acceptable limits, and other means of assessing and correcting unacceptable control values fail to identify and correct the problem. (b)(3)(iv) The laboratory's established schedule for verifying the reportable range for patient test results requires more frequent calibration verification. This STANDARD is not met as evidenced by: Based on the review of the written procedure manual, laboratory records, interview with the testing person (TP), and the director of nursing, the laboratory failed to perform and maintain six month calibration verification (CV) on the chemistry analyzer. Findings: 1. The lab performs Prostatic Specific Antigen (PSA) testing on the FastPack analyzer. 2.The TP stated on the day of the survey at 11:00 AM the lab performs CV procedure every six months. The TP stated that the lab receives the calibration materials in the mail when CV procedures need to be performed. 3. Review of laboratory records did not show that CV procedures were performed for the year 2121. 4. The director of nursing confirmed on the day of the survey at 3:20 PM that CV were not available. D5775 COMPARISON OF TEST RESULTS CFR(s): 493.1281(a)(c) (a) If a laboratory performs the same test using different methodologies or instruments, or performs the same test at multiple testing sites, the laboratory must have a system that twice a year evaluates and defines the relationship between test results using the different methodologies, instruments, or testing sites. (c) The laboratory must document all test result comparison activities. This STANDARD is not met as evidenced by: Based on review of the written procedure manual and interview with the testing person (TP), the lab failed to perform comparison studies when performing chemistry testing. Findings: Repeat deficiency 1. The lab performs Prostatic Specific Antigen (PSA) testing on two different FastPack analyzers. 2. The lab written procedure for "Fastpack comparison of test results" states that the lab director will perform twice a year the comparison studies for the two analyzers. 3. The lab failed to perform the comparison studies for PSA testing. 4. The TP confirmed on the day of the survey at 2: 30 PM that the lab director failed to perform the comparison studies for PSA testing. D5805 TEST REPORT CFR(s): 493.1291(c) The test report must indicate the following: (c)(1) For positive patient identification, either the patient's name and identification number, or a unique patient identifier and identification number. (c)(2) The name and address of the laboratory location where -- 3 of 5 -- the test was performed. (c)(3) The test report date. (c)(4) The test performed. (c)(5) Specimen source, when appropriate. (c)(6) The test result and, if applicable, the units of measurement or interpretation, or both. (c)(7) Any information regarding the condition and disposition of specimens that do not meet the laboratory's criteria for acceptability. This STANDARD is not met as evidenced by: Based on review of the patient's final report and interview with the director of nursing, the lab failed to ensure that the final report included the required identifiers needed for accurate interpretation of patient lab results. Findings: 1. The lab performs Prostatic Specific Antigen testing. 2. Review of the patient final report showed that the location where testing was performed was LabCorp and GW Medical Faculty Associates. The address was 2150 Pennsylvania Ave NW, Washington DC. 3. The final report did not have a date and time in the "collection date and collection time" area of the final report. 4. The final report did not include the test report date nor the run time the report was printed. 5. The final report did not include the test result, nor the unit of measurement needed for interpretation of the PSA result. 6. The director of nursing confirmed on the day of the survey at 3:00 PM that the lab failed to ensure that the patient final report included the required identifiers needed for accurate interpretation of lab results. D6000 MODERATE COMPLEXITY LABORATORY DIRECTOR CFR(s): 493.1403 The laboratory must have a director who meets the qualification requirements of 493. 1405 of this subpart and provides overall management and direction in accordance with 493.1407 of this subpart. This CONDITION is not met as evidenced by: Based on review of the written procedure manual and interview with the testing person (TP), the laboratory director (LD) failed to perform comparison studies when performing chemistry testing. Findings: Refer to D5775 1. The lab performs Prostatic Specific Antigen (PSA) testing on two different FastPack analyzers. 2. The lab written procedure for "Fastpack comparison of test results" states that the lab director will perform twice a year the comparison studies for the two analyzers. 3. The lab failed to perform the comparison studies for PSA testing. 4. The TP confirmed on the day of the survey at 2:30 PM that the lab director failed to perform the comparison studies for PSA testing D6018 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(iii) 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)(iii) Ensure that all proficiency testing reports received are reviewed by the appropriate staff to evaluate the laboratory's performance and to identify any problems that require

Summary Statement of Deficiencies D2009 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) The individual testing or examining the samples and the laboratory director must attest to the routine integration of the samples into the patient workload using the laboratory's routine methods. This STANDARD is not met as evidenced by: Based on record review and interview, the laboratory (lab) did not ensure that proficiency attestation statements were signed to show that the testing person and lab director attests PSA testing was performed in the same manner as patient testing. Findings: 1. The lab is enrolled in a proficiency testing program with a provider. The provider sends the lab unknown samples to test, after testing the lab reports results to the provider to be evaluated (scored); 2. The lab director and testing person did not sign the attestation statement for PSA proficiency testing event one of 2019, event three of 2018 and event two of 2018; and 3. This was confirmed during interview with Lab Staff Member #1, in the afternoon, on the day of survey. D5211 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(a) The laboratory must review and evaluate the results obtained on proficiency testing performed as specified in subpart H of this part. This STANDARD is not met as evidenced by: Based on record review and interview, the laboratory (lab) did not ensure that PSA chemistry proficiency testing results were reviewed by the lab director and staff. Findings: 1. The lab is enrolled in a proficiency testing program with a provider. 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 4 -- provider sends the lab unknown samples to test, after testing the lab reports results to the provider to be evaluated (scored); 2. The lab director did not review, sign and date the scored results obtained from the proficiency test provider for the second event of 2018; 3. The lab did not maintain the proficiency test providers evaluation (showing each test result and the proficiency test providers score for each reported test result) for the first event of 2019; and 4. This was confirmed with Lab Staff Member #1 during interview in the afternoon on the day of survey. 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)