Aqsa Laboratory, Inc

Summary Statement of Deficiencies D5016 ROUTINE CHEMISTRY CFR(s): 493.1210 If the laboratory provides services in the subspecialty of Routine Chemistry, the laboratory must meet the requirements specified in 493.1230 through 493.1256, 493. 1267, and 493.1281 through 493.1299. This CONDITION is not met as evidenced by: Based on review of laboratory records, direct observation, and interview with the technical consultant; the laboratory failed to meet the requirements specified in 493. 1230 through 493.1256, and 493.1281 through 493.1299 for routine chemistry testing. Findings Include: 1. The laboratory failed to have procedures in place for 14 of 14 analytes tested on the Medica EasyRA chemistry analyzer. See D5401. 2. The laboratory failed to verify the reportable range for 14 of 14 analytes tested on the Medica Easy RA prior to patient testing. See D5421. D5209 PERSONNEL COMPETENCY ASSESSMENT POLICIES CFR(s): 493.1235 As specified in the personnel requirements in subpart M, the laboratory must establish and follow written policies and procedures to assess employee and, if applicable, consultant competency. This STANDARD is not met as evidenced by: Based on review of laboratory records and interview with the laboratory's technical consultant (TC); the laboratory failed to follow policies and procedures to assess the competency of the technical consultant and the clinical consultant. Findings Include: 1. Review of the laboratory procedure manual identified the laboratory's competency assessment policy, "Clinical Staff Competency Assessment Policy". 2. Review of 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 5 -- competency assessment policy revealed that supervisors are to have competency assessments based on their federal responsibilities, which is to be completed annually. 3. Review of competency assessment records found no annual competency assessments for the technical consultant (TC) and Clinical Consultant (CC), as identified on the CMS-209 (Laboratory Personnel Report), were completed in 2017 through 2019. 4. On survey date 09-04-2019, at 5:50 pm the TC confirmed the surveyor's findings that no annual competency assessments were completed for the federal responsibilities of the TC and CC. 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: Based on review of laboratory records, direct observation, and interview with the technical consultant (TC); the laboratory failed to have a procedure manual for 14 of 14 analytes tested on the Medica EasyRA analyzer for the specialty of routine chemistry. Findings Include: 1. During a walkthrough of the laboratory on 9-4-2019 at 11:30 am the surveyor observed patients' specimens being tested on a Medica EasyRA chemistry analyzer. 2. Review of the laboratory test menu identified 14 analytes which are tested on the Medica EasyRA analyzer: Sodium, Potassium, Chloride, Carbon Dioxide, BUN (Blood Urea Nitrogen), Creatinine, Calcium, Glucose, Alkaline Phosphatase, AST (Aspartate Aminotransferase), ALT (Alanine Aminotransferase), Total Protein, Total Bilirubin, Albumin, Cholesterol, Triglyceride, and HDL (High- Density Lipoproteins) 3. Review of laboratory's policy and procedure manual revealed the laboratory failed to have procedures in place for 14 of 14 chemistry analytes ran on the Medica EasyRA analyzer. 4. On survey date 09-04-2019, at 5:50 pm, the surveyor's finding were confirmed by the TC. D5421 ESTABLISHMENT AND VERIFICATION OF PERFORMANCE CFR(s): 493.1253(b)(1) Each laboratory that introduces an unmodified, FDA-cleared or approved test system must do the following before reporting patient test results: (1)(i) Demonstrate that it can obtain performance specifications comparable to those established by the manufacturer for the following performance characteristics: (1)(i)(A) Accuracy. (1)(i) (B) Precision. (1)(i)(C) Reportable range of test results for the test system. (1)(ii) Verify that the manufacturer's reference intervals (normal values) are appropriate for the laboratory's patient population. This STANDARD is not met as evidenced by: Based on direct observation, review of laboratory records, and interview with the technical consultant (TC); the laboratory failed to demonstrate the reportable range for 14 of 14 chemistry analytes performed on the Medica EasyRA analyzer prior to reporting patient test results for 35 patients from 8-13-2019 to date of survey 9-4- 2019. Findings Include: 1. Direct observation of laboratory testing equipment during a walkthrough of the laboratory on 9-04-2019, at 11:30am, identified a Medica EasyRA -- 2 of 5 -- chemistry analyzer. 2. Review of the laboratory's test menu identified 14 analytes tested on the Medica EasyRA analyzer: Sodium, Potassium, Chloride, Carbon Dioxide, BUN (Blood Urea Nitrogen), Creatinine, Calcium, Glucose, Alkaline Phosphatase, AST (Aspartate Aminotransferase), ALT (Alanine Aminotransferase), Total Protein, Total Bilirubin, Albumin, Cholesterol, Triglyceride, and HDL (High- Density Lipoproteins) 3. Review of the verification of performance documentation for the Medica EasyRA analyzer revealed the laboratory failed to verify the reportable range for the 14 of 14 analytes. 4. Review of the verification of performance documentation revealed the laboratory put the Medica EasyRA in use for patient testing on 08-12-2019. 5. Review of patient testing logs identified 35 patients who had testing performed on the Medica EasyRA from 08-13-2019 to 9-4-2019 when the laboratory had failed to verify the reportable range for 14 of 14 routine chemistry analytes. 6. On survey date 09-04-2019, at 5:50 pm, the above findings were confirmed by the TC. 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 laboratory records and interview with the laboratory's technical consultant (TC); the laboratory director (LD) failed to provide the overall management and direction in accordance with 493.1407. Findings Include: 1. The LD failed to ensure proficiency testing failures were identified and a

Summary Statement of Deficiencies D2016 SUCCESSFUL PARTICIPATION CFR(s): 493.803(a)(b)(c) (a) Each laboratory performing nonwaived testing must successfully participate in a proficiency testing program approved by CMS, if applicable, as described in subpart I of this part for each specialty, subspecialty, and analyte or test in which the laboratory is certified under CLIA. (b) Except as specified in paragraph (c) of this section, if a laboratory fails to participate successfully in proficiency testing for a given specialty, subspecialty, analyte or test, as defined in this section, or fails to take remedial action when an individual fails gynecologic cytology, CMS imposes sanctions, as specified in subpart R of this part. (c) If a laboratory fails to perform successfully in a CMS- approved proficiency testing program, for the initial unsuccessful performance, CMS may direct the laboratory to undertake training of its personnel or to obtain technical assistance, or both, rather than imposing alternative or principle sanctions except when one or more of the following conditions exists: (1) There is immediate jeopardy to patient health and safety. (2) The laboratory fails to provide CMS or a CMS agent with satisfactory evidence that it has taken steps to correct the problem identified by the unsuccessful proficiency testing performance. (3) The laboratory has a poor compliance history. This CONDITION is not met as evidenced by: Based on surveyor review of CASPER Report 155 Proficiency Testing (PT) records; it was confirmed that the laboratory failed to successfully participate in the testing of PT samples under the Specialty of Chemistry for events 1 & 2 of 2018. Findings include: 1. Review of the CASPER Report 155 on August 02, 2018 revealed that the initial unsuccessful PT performance was under the Specialty of Chemistry for the analyte URIC ACID. See D-2096. D2096 ROUTINE CHEMISTRY CFR(s): 493.841(f) 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 -- Failure to achieve satisfactory performance for the same analyte or test in two consecutive testing events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on surveyor review of CASPER Report 155 Proficiency Testing (PT) records; it was confirmed that the laboratory failed to successfully participate in the testing of PT samples under the Specialty of Chemistry for events 1 & 2 of 2018. Findings include: 1. Review of the CASPER Report 155 revealed that the initial unsuccessful PT performance occurred under the Specialty of Chemistry as listed below: ROUTINE CHEMISTRY EVENT -1, 2018 URIC ACID = 60% Unsatisfactory EVENT -2, 2018 URIC ACID = 0% Unsatisfactory 2. During review of Proficiency Testing CASPER Report 155 on August 01, 2018 confirmed the PT failing scores. -- 2 of 2 --

Summary Statement of Deficiencies 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: Based on review of laboratory records and interview with the laboratory director (LD); the laboratory failed to have a procedure in place for microscopic urinalysis testing. Findings Include: 1. Review of laboratory's policy and procedure manual found the laboratory failed to have a procedure in place for microscopic urinalysis testing. 2. On survey date 3-21-2018, at 12:15 PM, the LD confirmed no written procedure for microscopic urinalysis had been established by the laboratory. D5421 ESTABLISHMENT AND VERIFICATION OF PERFORMANCE CFR(s): 493.1253(b)(1) Each laboratory that introduces an unmodified, FDA-cleared or approved test system must do the following before reporting patient test results: (1)(i) Demonstrate that it can obtain performance specifications comparable to those established by the manufacturer for the following performance characteristics: (1)(i)(A) Accuracy. (1)(i) (B) Precision. (1)(i)(C) Reportable range of test results for the test system. (1)(ii) Verify that the manufacturer's reference intervals (normal values) are appropriate for the laboratory's patient population. This STANDARD is not met as evidenced by: Based on review of laboratory records and interview with the lab director (LD); 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 demonstrate it can obtain performance specifications for microscopic urinalysis testing prior to reporting patient testing results. Findings Include: 1. Review of the laboratory's policy and procedure manual confirmed the laboratory performs "urinalysis with Microscope". 2. The surveyor requested verification of performance documentation for microscopic urinalysis on 03-21-2018 at 10:25 am from the LD and the LD confirmed no verification of performance for microscopic urinalysis had been performed. 3. Review of patient test records identified 3 of 4 patient test reports for microscopic urinalysis testing. Patient Identification Test Date P2 03-05-2018 P3 02-14-2018 P4 02-14-2018 4. On survey date 03-21-2018, at 12:15 pm, the above findings were confirmed by the LD. D5447 CONTROL PROCEDURES CFR(s): 493.1256(d)(3)(i)(g) Unless CMS Approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub. 7), that provides equivalent quality testing, the laboratory must-- At least once a day patient specimens are assayed or examined perform the following for-- Each quantitative procedure, include two control materials of different concentrations; (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on review of laboratory records and interview with the lab director (LD); the laboratory failed to ensure two levels of quality control (QC) materials were ran each day of testing before reporting patient test results for microscopic urinalysis. Findings include: 1. Interview with the lab director (LD) at 9:22 am, on 3-21-2018, confirmed no quality controls for microscopic urinalysis are performed. 2. Review of patient test reports for microscopic urinalysis found no documented quality control records for 3 of 3 patient testing dates reviewed. Patient Identification Test Date P2 03-05-2018 P3 02-14-2018 P4 02-14-2018 3. On survey date 03-21-2018, at 12:15 pm, the LD confirmed that two levels of quality control material were not performed each day of patient testing for microscopic urinalysis. 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 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 review of laboratory records and interview with the lab director (LD), the laboratory failed to identify the testing personnel who performed each laboratory test. Findings Include: 1. Review of 4 of 4 patient test reports found the laboratory had no way to identify the testing personnel for each test performed. Patient Identification Test Date P1 03-05-2018 P2 03-05-2018 P3 02-14-2018 P4 01-15-2018 2. Interview with the LD on 3-21-2018, at 12:15 pm, confirmed the laboratory had no way to identify the person performing each test. -- 2 of 3 -- D6021 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(5) 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)(5) Ensure that quality assessment programs are established and maintained to assure the quality of laboratory services provided. This STANDARD is not met as evidenced by: Based on review of laboratory records and interview with the laboratory director (LD), the LD failed to ensure that a quality assessment plan was established. Findings Include: 1. Review of the laboratory's policy and procedure manual found no quality assessment plan for the laboratory. 2. On survey date 03-21-2018, at 12:15 pm, the LD confirmed no quality assessment plan had been established for the laboratory. -- 3 of 3 --