Community Medical Laboratory Inc

Summary Statement of Deficiencies D0000 The Centers for Medicare & Medicaid Services (CMS) New York CLIA Branch Location federal surveyors conducted an announced CLIA recertification survey at the Community Medical Laboratory on March 23, 2023. The laboratory was surveyed under 42 CFR part 493 CLIA requirements the specific deficiencies are as follows: 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 a review of hematology critical values, lack of documentation, and staff interview the laboratory failed to conduct hematology manual differential for testing personnel. Findings include: 1. On March 23, 2023 at approximately 11:35 AM during a review of the critical value reference sheet, the document revealed that the laboratory performs manual hematology differentials for instrument flags for blasts, atypical lymphocytes and abnormal white/red blood cells. 2. The surveyor requested hematology competency records for manual differential performed by the testing personnel. TS#1 stated " I didn't know we had to perform those competencies". 3. During the exit interview at approximately 4:20 PM, the laboratory director (LD) confirmed the laboratory does not perform the hematology manual differential competency. D6103 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(13) The laboratory director must ensure that policies and procedures are established for monitoring individuals who conduct preanalytical, analytical, and postanalytical 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 -- phases of testing to assure that they are competent and maintain their competency to process specimens, perform test procedures and report test results promptly and proficiently, and whenever necessary, identify needs for remedial training or continuing education to improve skills. This STANDARD is not met as evidenced by: Refer to D5209 Based on a review of policy and procedures for the hematology section of the laboratory , lack of documentation, and staff interview the laboratory director failed to establish a policy for the hematology manual differential competency for testing personnel. Findings include: 1. On March 23, 2023, at approximately 4:20 PM during the exit interview, the surveyor requested hematology manual differential competency for testing personnel and the policy and procedure to determine the criteria for the diffential . 2. The laboratory director confirmed their is no established policy or procedure for hematology manual differentials for the laboratory testing personnel. -- 2 of 2 --

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 director failed to sign the attestation statement for ten out of ten proficiency testing events reviewed in 2021. 1. Record review of ten proficiency testing events (FH9-A, FH9-B, C-B, C-A, J1-A, J1- B, COVS-A, CGL-A, CGL-B, and CGL-C) in 2021 revealed the laboratory director did not sign the attestation statement. 2. On September 23, 2021 at approximately 2:00 PM, Testing Personnel #1 confirmed that the laboratory director did not sign the attestation. D2010 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(2) The laboratory must test samples the same number of times that it routinely tests patient samples. This STANDARD is not met as evidenced by: Based on record review and interview, the laboratory failed to test hematology proficiency samples the same number of times as patients in two of five hematology proficiency testing events reviewed. Findings: 1. Review of the procedure "Proficiency Testing" stated "(3) Run survey and evaluate same a a patient." 2. Review of hematology testing proficiency event FH9-A 2021 revealed all samples (FH9-1, FH9-2, FH9-3, FH9-4, FH9-5) were tested in duplicate. Review of event FH9- Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 7 -- B 2020 revealed samples FH9-07 and FH9-08 were tested in duplicate. 3. Review of procedure "Reporting Critical Results Procedure" stated "Any result that is flagged as a critical in the LIS (indicated by bold red print), or per the chart below must be repeated and noted in the LIS as "repeated and verified"". 4. Review of the hematology testing proficiency event FH9-A 2021 revealed samples FH9-1, FH9-2, and FH9-4 did not have any critical results as defined by the "Reporting Critical Results Procedure". Review of the hematology testing proficiency event FH9-B 2020 revealed sample FH9-7 did not have any critical results as defined by the "Reporting Critical Results Procedure". 5. On September 23, 2021 at approximately 2:00 PM, Testing Personnel #1 and Testing Personnel #2 confirmed the above proficiency testing was performed in duplicate. D3031 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(3) Analytic systems records. Retain quality control and patient test records (including 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 lack of documentation and interview, the laboratory failed to retain the documentation of the normal patient Prothrombin mean study for the International Normalized Ratio (INR) calculation for one of one lot of thromboplastin reagent reviewed. Findings: 1. During review of the INR calculation for the current lot of thromboplastin, the surveyor requested documentation of the normal patient Prothrombin mean study. 2. At approximately 2:00 PM on September 22, 2021, Testing Personnel #1 stated that the laboratory did not retain the documentation. 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 failed to review one of two analytes with unacceptable results for chemistry proficiency testing event C-A 2021. Findings: 1. Review of C-A 2021 revealed two analytes (Glucose and Carbon dioxide (CO2)) with unacceptable results. 2. Documentation of review was available for CO2. No documentation of review was found for the unacceptable glucose results. 3. On September 23, 2021 at approximately 2:00 PM, Testing Personnel #1 confirmed there was no documentation of the review for the unacceptable glucose results available. D5217 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(c)(1) At least twice annually, the laboratory must verify the accuracy of any test or procedure it performs that is not included in subpart I of this part. This STANDARD is not met as evidenced by: -- 2 of 7 -- Based on record review, lack of documentation, and interview, the laboratory failed to verify twice annual accuracy for one of 12 new tests added to the test menu in the last two years. Findings: 1. Proficiency testing records from 2020 and 2021 were reviewed for the new tests added to the laboratory's testing menu. 2. No twice annual verification of accuracy documentation was found for C-Reactive Protein (CRP). 3. On September 23, 2021 at approximately 2:35 PM, Testing Personnel #1 confirmed that there was no proficiency testing for CRP and the test was added to the laboratory's test menu in late 2020. D5407 PROCEDURE MANUAL CFR(s): 493.1251(d) Procedures and changes in procedures must be approved, signed, and dated by the current laboratory director before use. This STANDARD is not met as evidenced by: Based on record review and interview, the laboratory director failed to sign and date one of three procedure manuals reviewed. Findings: 1. Review of the Chemistry procedure manual "Revision and Review Signature Page" revealed two signatures. 2. On September 23, 2021 at approximately 12:45 PM, the owner confirmed that neither signature was the laboratory director. D5411 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(a) Test systems must be selected by the laboratory. The testing must be performed following the manufacturer's instructions and in a manner that provides test results within the laboratory's stated performance specifications for each test system as determined under 493.1253. This STANDARD is not met as evidenced by: Based on record review and interview, the laboratory failed to follow the manufacturer's instructions for reporting for one of one SARS-CoV-2 tests reviewed. Findings: 1. Review of the package insert for the Dimension EXL SARS-CoV-2 Total antibody assay (CV2T) under "Conditions of Authorization for the Laboratory" stated "Authorized laboratories using the Dimension EXL CV2T assay will include with test result reports, all authorized Fact Sheets. Under exigent circumstances, other appropriate methods for disseminating these Fact Sheets may be used, which may include mass media." 2. Review of one of one patient report for CV2T revealed that the authorized Fact sheet was not included with the test result report. 3. On September 23, 2021 at approximately 12:09 PM, the owner confirmed that the authorized Fact sheet was not included with the test result report. 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) -- 3 of 7 -- 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 record review, lack of documentation, and interview, the laboratory failed to verify the manufacturer's reference intervals for 11 out of 14 verification of performance specifications reviewed. Findings: 1. Review of verification of performance specifications for C-Reactive Protein, Magnesium, Total Iron Binding Capacity, Iron, Vitamin B12, Folate, Ferritin, Urine Protein, Urine Sodium, Urine Potassium, and Urine Chloride revealed no documentation of verification of the manufacturer's reference intervals. 2. On September 23, 2021 at approximately 09:52 AM, testing personnel #1 confirmed the manufacturer's reference intervals were not verified. D5785