Community Medical Laboratory Inc

Summary Statement of Deficiencies D0000 A recertification survey was completed on June 30, 2026. The laboratory was found to be in compliance with condition level deficiencies. The following standard-level deficiencies were cited. D5205 COMPLAINT INVESTIGATIONS CFR(s): 493.1233 The laboratory must have a system in place to ensure that it documents all complaints and problems reported to the laboratory. The laboratory must conduct investigations of complaints, when appropriate. This STANDARD is not met as evidenced by: Based on direct observation, review of laboratory policies and procedures and confirmed in interview with the owner of the laboratory, the laboratory failed to have a mechanism in place to conduct investigation of complaints for 2 of 2 years (2024 and 2025). 1) In direct observation on 6/29/2026 at 1:45 PM in the laboratory manager's office, a verbal complaint was heard. The owner of the laboratory arrived stating there had just been a patient that complained to providers upstairs regarding services rendered at the laboratory that day, and that the laboratory may receive a call about it. 2) Review of the laboratory's policies and procedures did not reveal a component to address and investigate complaints from patients and providers. 3) The laboratory was unable to provide documentation of any complaints or grievances received by the laboratory in 2024 and 2025. 4) In an interview on 6/29/2026 at 1:45 PM, the owner of the laboratory confirmed that the laboratory received calls on occasion from patients or providers for miscellaneous complaints and handled these events expeditiously, but did not formally document or have policies/procedures specific to these events. D5209 PERSONNEL COMPETENCY ASSESSMENT POLICIES CFR(s): 493.1235 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 -- 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 the laboratory's submitted Form Centers for Medicare and Medicaid Services (CMS) 209, lack of supervisory competency assessment records, review of laboratory policies and interview with the General Supervisor (GS) #1, the laboratory failed to establish written policies and procedures to assess supervisor competency for 2 of 2 years (2024 and 2025). Findings Included: 1) Review of the laboratory's Form CMS 209 revealed 2 GSs listed. 2) The laboratory was unable to provide competency assessment records for the supervisors listed on the Form CMS 209. 3) Review of the laboratory's policies and procedures titled 'Community Medical Laboratory General Supervisor Responsibilities' revealed instructions on competencies for Testing Personnel (TP), but no components for consultant and/or supervisor competencies. 4) In an interview on 6/29/2026 at 10:00 AM, GS#1 confirmed the laboratory did not perform competencies for supervisors. D5311 SPECIMEN SUBMISSION, HANDLING, AND REFERRAL CFR(s): 493.1242(a) (a) The laboratory must establish and follow written policies and procedures for each of the following, if applicable: (a)(1) Patient preparation. (a)(2) Specimen collection. (a)(3) Specimen labeling, including patient name or unique patient identifier and, when appropriate, specimen source. (a)(4) Specimen storage and preservation. (a)(5) Conditions for specimen transportation. (a)(6) Specimen processing. (a)(7) Specimen acceptability and rejection. (a)(8) Specimen referral. This STANDARD is not met as evidenced by: Based on review of laboratory policies, review of test records, and interview with General Supervisor (GS) #1, according to the Form Centers for Medicare and Medicaid (CMS) 209, the laboratory failed to establish and follow written policies and procedures for conditions of specimen transportation for 133 of 133 patients in 2025. Findings Included: 1) Upon request, the laboratory could not provide policies and procedures for conditions of specimen transportation for patient specimens received from outside facilities for testing. 2) Review of the laboratory's test records titled 'Community Medial Laboratory' Order Choice Utilization Report-Totals' revealed a total of 133 patient specimens received from the laboratory's draw facility in Red Hook, via courier or staff, to the laboratory for testing in 2025. 3) In an interview on 6 /30/2026 at 11:51 AM, GS#1 confirmed the laboratory did not have policies and procedures outlining conditioning for specimen transportation. D5401 PROCEDURE MANUAL CFR(s): 493.1251(a) (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. -- 2 of 5 -- This STANDARD is not met as evidenced by: Based on direct observation, review of manufacturer's instructions, laboratory policy and procedures, test records, verification studies and established reference ranges, and interview with the General Supervisor (GS#1) according to the Form Centers for Medicare and Medicaid (CMS) 209, the laboratory failed to follow the policy in establishing a new patient normal mean for 1 of 2 new lots used of Dade Innovin reagents for the Sysmex CA-600 analyzer in 2024 and 2025 (random review). 1. Based on direct observation on July 1, 2026 at 11:50 AM, one Sysmex CA-600 (Serial Number 41533) analyzer was in use 2. Review of the manufacturer's instructions 'Siemens Healthineers Dade Innovin 11528733_en Rev. 13' stated the following instructions on page 4 of 9: "The mean normal Prothrombin Time (MNPT) is defined as the mean value of the normal range. It must be determined specifically for each thromboplastin lot using the method used to analyze the patient samples and, where appropriate, using the coagulation analyzer used for the analysis. Follow appropriate laboratory guidelines for establishing an MNPT, if applicable. Use of CLSI guideline is recommended." 3. Review of the laboratory's policy titled 'Community Medical Laboratory Establishing MNPT Range Procedure' stated the following: "The laboratory collects specimens from a minimum of 10 normal individuals (check the manufacturer's guidelines for the specific criteria and exclusions for the "normal" pool of individuals) and performs a PT using the new low of thromboplastic reagent. Procedure: Establishing MNPT 1. Phlebotomists are informed to collect an extra citrate tube on 10 patients that are NOT on anti-coagulant medications ("normal" patient population). 2. Once collected, the 10 sample are ran using the new lot of Innovin. 3. Calculate the mean of the 10 sample, this is the mean normal PT range (MNPT). 4. Document all results on the New Lot of Innovin Worksheet ..." The written procedure did not state the laboratory's verified established normal reference ranges ("normal" patient population range) for staff to follow as part of each new Innovin lot study. 3. Review of the laboratory's Validation on the Sysmex CA-600 and review of patient test reports revealed the laboratory's established PT reference interval for normal patients as 9.3 to 10.7. 4. Review of the laboratory's New Lot Studies in 2024 and 2025 (random review) revealed the following: a. Innovin Lot Number 564654, New Lot Study conducted 12/10/24 revealed the usage of patients with PT values greater than 10.7 for four out of ten patients used for MNPT calculations. The values greater than the laboratory's established normal reference range were 11.10, 11.20, 11.40, 11.50. b. Innovin Lot Number 564672, New Lot Study conducted 05/09/25 revealed the usage of all ten patients within the laboratory's established normal reference range of 9.3 to 10.7. 5. In an interview on June 30, 2026, at 10:40 AM, the GS#1 confirmed the normal pool of patients used for the new lot Innovin study on 12/10/24 were higher than the laboratory's established reference range, and did not have the established normal reference range in the MNPT range procedure for staff to follow. D5783

Summary Statement of Deficiencies D0000 The following deficiencies are a result of a desk review of proficiency testing scores obtained from the national database and verified with the proficiency testing company. The facility was found to be out of compliance with the conditions of the CLIA program. The following CONDITION LEVEL DEFICIENCIES were found to be out of compliance: D2016 - 42 C.F.R. 493.803 Condition: Successful participation [proficiency testing]. D6076 - 42 C.F.R. 493.1403 Condition: Laboratories performing high complexity testing; laboratory director. 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 a proficiency testing desk review of the Certification and Survey Provider 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 -- Enhanced Reporting (CASPER) 0153, CASPER 0155 reports and the College of American Pathologist (CAP) evaluation reports, the laboratory failed to successfully participate in the sub-specialty of Endocrinology for the Folate, serum analyte for two of three events in 2025. Refer to D2107. D2107 ENDOCRINOLOGY CFR(s): 493.843(f) (f) 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 a proficiency testing desk review of the Certification and Survey Provider Enhanced Reporting (CASPER) 0153, CASPER 0155 reports and the College of American Pathologist (CAP) evaluation reports, the laboratory failed to successfully participate to successfully participate in the sub-specialty of Endocrinology for the Folate, serum analyte for two of three events in 2025. Findings: 1. A review of CASPER 0153 and CASPER 0155 reports on February 4, 2026, revealed the following unsatisfactory scores: a. CAP - 2025- 2nd Event - 40% for Folate, serum. b. CAP - 2025- 3rd Event - 60% for Folate, serum. 2. A review of CAP 2025 proficiency testing records confirmed the laboratory received the above scores. D6076 LABORATORY DIRECTOR CFR(s): 493.1441 The laboratory must have a director who meets the qualification requirements of 493. 1443 of this subpart and provides overall management and direction in accordance with 493.1445 of this subpart. This CONDITION is not met as evidenced by: Based on a proficiency testing desk review of the Certification and Survey Provider Enhanced Reporting (CASPER) 0153, CASPER 0155 reports and the College of American Pathologist (CAP) evaluation reports, the laboratory director failed to provide overall management and direction of laboratory services. Refer to D6089. D6089 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(4)(i) (e)(4)(i) The proficiency testing samples are tested as required under subpart H of this part; This STANDARD is not met as evidenced by: Based on a proficiency testing desk review of the Certification and Survey Provider Enhanced Reporting (CASPER) 0153, CASPER 0155 reports and the College of American Pathologist (CAP) evaluation reports, the laboratory director failed to ensure successful participation in an HHS approved proficiency testing program and ensure the overall quality of the laboratory services provided. Refer to D2107. -- 2 of 2 --

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