City Medical Of Upper East Side

Summary Statement of Deficiencies D1001 CERTIFICATE OF WAIVER TESTS CFR(s): 493.15(e) Laboratories eligible for a certificate of waiver must-- (1) Follow manufacturers' instructions for performing the test; and (2) Meet the requirements in subpart B, Certificate of Waiver, of this part. This STANDARD is not met as evidenced by: Based on a quality control (QC) record, the laboratory failed to follow the manufacturer's instruction for testing and documenting QC material for the Siemens' Multistix reagent strips when a new vial is opened or every 30 days. Findings: 1. QC missing between 9/25/2020 through 11/3/2020 and 5/7/2021 through 11/16/2021. 2. Confirmed on an interview with technical consultant on 6/21/2022 about 12pm. 3. Approximately 100 patients test performed during this period. D5413 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(b) The laboratory must define criteria for those conditions that are essential for proper storage of reagents and specimens, accurate and reliable test system operation, and test result reporting. The criteria must be consistent with the manufacturer's instructions, if provided. These conditions must be monitored and documented and, if applicable, include the following: (1) Water quality. (2) Temperature. (3) Humidity. (4) Protection of equipment and instruments from fluctuations and interruptions in electrical current that adversely affect patient test results and test reports. This STANDARD is not met as evidenced by: Based on the review of Freezer #1 and #2 temperature log, the laboratory failed to 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 -- maintain established temperature range of Bio-Rad Control Leve 1 and Level 1 range of -20C to -70C. Finding: 1. Freezer #1 out of range 5/2020 through survey date. 2. Freezer #2 out of range 1/2020 through survey date. 3. Confirmed on an interview with technical consultant on 6/21/2022 about 3:30pm D5417 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(d) Reagents, solutions, culture media, control materials, calibration materials, and other supplies must not be used when they have exceeded their expiration date, have deteriorated, or are of substandard quality. This STANDARD is not met as evidenced by: Based on review of Siemens Multistix quality control records, the laboratory failed to review quality control material for expired dates. Finding: 1. 12/9/2020 and 1/12/2021 used Lot # 447808 Expiration date 11/30/2020 2. 5/17/2022 and 6/17/2022 used Lot#73040B Expiration date 4/30/2022 3. Confirmed on an interview with technical consultant on 6/21/2022 about 12:30pm 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 the laboratory's quality assurance reports, the laboratory director failed to maintain all phases for the general laboratory system. Refer to D1001, D5413, D5417, -- 2 of 2 --

Summary Statement of Deficiencies D5417 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(d) Reagents, solutions, culture media, control materials, calibration materials, and other supplies must not be used when they have exceeded their expiration date, have deteriorated, or are of substandard quality. This STANDARD is not met as evidenced by: Based on a surveyor's review of the Quality Control (QC) records and an interview with the technical consultant, the laboratory failed to discontinue the use of the expired QC materials. FINDINGS: 1. On October 30, 2019 at approximately 12:30 PM the technical consultant confirmed surveyor's findings that the laboratory used expired calibration materials for the following analytes: A. Parathyroid Hormone (PTH) was tested on 6/14/19 using the QC materials lot # 010181000 expired 6/7/19 B. Total PSA was tested on 6/17/19 using the QC materials lot # 89458FN00 expired 6 /14/19 2. Approximately 25 patients were tested for the above analytes using the expired QC materials during the above time frames. PLEASE NOTE: THIS IS A RECITE FROM THE SURVEY CONDUCTED ON AUGUST 6, 2019. D5429 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(a)(1) For unmodified manufacturer's equipment, instruments, or test systems, the laboratory must perform and document maintenance as defined by the manufacturer and with at least the frequency specified by the manufacturer. This STANDARD is not met as evidenced by: Based on surveyor's review of laboratory's equipment maintenance records and an 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 -- interview with the technical consultant and the testing person, the laboratory failed to follow the manufacturer's requirement to calibrate the pipette annually. Findings: On October 30, 2019 at approximately 12:30 PM the technical consultant confirmed surveyor's finding that the laboratory failed to follow the manufacturer's requirement to calibrate the 500 pipette used for QC and reagent preparation in calendar year 2018 and up to survey date. 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 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 surveyor's review of the laboratory's calibration verification records and an interview with the laboratory technical consultant and the testing person, the laboratory failed to perform calibration verification at least once every six months for endocrinology testing on the Abbott Architect Plus analyzer in calendar year 2018 and up to survey date. FINDINGS: At approximately 12:30 PM on October 30, 2019, the technical consultant confirmed that the only calibration verification records available for the Abbott Architect Plus was for September 2018 and July 2019. The laboratory had not performed calibration verification for all analytes on the Abbott Architect Plus at least once every six months as required. Approximately 300 patients were tested during this time period. PLEASE NOTE: THIS IS A RECITE FROM THE SURVEY CONDUCTED ON AUGUST 6, 2019. D5441 CONTROL PROCEDURES CFR(s): 493.1256(a)(b)(c)(g) (a) For each test system, the laboratory is responsible for having control procedures that monitor the accuracy and precision of the complete analytic process. (b) The laboratory must establish the number, type, and frequency of testing control materials using, if applicable, the performance specifications verified or established by the laboratory as specified in 493.1253(b)(3). (c) The control procedures must-- (c)(1) Detect immediate errors that occur due to test system failure, adverse environmental -- 2 of 4 -- conditions, and operator performance. (c)(2) Monitor over time the accuracy and precision of test performance that may be influenced by changes in test system performance and environmental conditions, and variance in operator performance. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on a surveyor's review of the Cell Dyn Emerald hematology QC records, manufacturer's QC requirements, the laboratory's QC procedure and an interview with the technical consultant and the testing person, the laboratory failed to follow their established written QC policy and perform three levels of controls each day of patient testing on September 8, 2018. FINDINGS: 1. The technical consultant confirmed on October 30, 2019 at approximately 12:30 PM the surveyor's findings that the laboratory failed to perform three levels of hematology QC following calibration and prior to patient testing on September 8, 2018. 2. Approximately 20 patients' samples were tested and reported for hematology on September 8, 2018. D5469 CONTROL PROCEDURES CFR(s): 493.1256(d)(10)(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-- Establish or verify the criteria for acceptability of all control materials. (i) When control materials providing quantitative results are used, statistical parameters (for example, mean and standard deviation) for each batch and lot number of control materials must be defined and available. (ii) The laboratory may use the stated value of a commercially assayed control material provided the stated value is for the methodology and instrumentation employed by the laboratory and is verified by the laboratory. (iii) Statistical parameters for unassayed control materials must be established over time by the laboratory through concurrent testing of control materials having previously determined statistical parameters. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on a surveyor's review of Quality Control (QC) records and an interview with the technical consultant and the testing person, the laboratory failed to program the manufacturer expected ranges, as defined on the QC assay sheets, into the Beckman Olympus AU 480 analyzer for chemistry testing from September 2019 through the survey date. FINDINGS: A) On 10/30/2019 at approximately 1:00 PM, the technical consultant and the testing person confirmed the surveyor's review of QC records finding that the laboratory failed to program the established QC ranges and expected means into the new Beckman Olympus AU 480 analyzer for the chemistry tests performed. B) Without the established QC limits, the surveyor could not determine if the quality control results were within the acceptable ranges for the chemistry analytes tested on the Beckman Olympus AU 480 analyzer. C) Approximately 35 patients' specimens were tested and reported for chemistry during this time period. PLEASE NOTE: THIS IS A RECITE FROM THE SURVEY CONDUCTED ON AUGUST 6, 2019. D6000 MODERATE COMPLEXITY LABORATORY DIRECTOR CFR(s): 493.1403 -- 3 of 4 -- 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 surveyor's findings and an interview with the technical consultant, the laboratory director failed to provide overall management of the laboratory. The laboratory director failed to ensure that the laboratory: 1. Maintained the

Summary Statement of Deficiencies D1001 CERTIFICATE OF WAIVER TESTS CFR(s): 493.15(e) Laboratories eligible for a certificate of waiver must-- (1) Follow manufacturers' instructions for performing the test; and (2) Meet the requirements in subpart B, Certificate of Waiver, of this part. This STANDARD is not met as evidenced by: Based on surveyor's review of the manufacturer's packet inserts for the Siemens Multistix and interview with the technical consultant, the laboratory failed to follow the manufacturer's requirements for performing external positive and negative controls with each new vial opened for the Siemens Multistix from January 2017 through April 2018. FINDINGS: 1. The packet insert for the Siemens Multistix requires that external controls be performed with each new vial of Multistix opened. On August 6, 2018 at approximately 1:30 PM the technical consultant confirmed surveyor's findings that documentation for the required external control testing was not available the Siemens Multistix from January 2017 through April 2018. 2. Approximately 200 patients specimens were tested and reported for urinalysis during the above time frame. D2107 ENDOCRINOLOGY CFR(s): 493.843(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: Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 8 -- Based on a review of American Proficiency Institute (API) Proficiency Testing (PT) test reports, the laboratory failed to successfully participate in a PT program approved by the Centers for Medicare and Medicaid Services (CMS) for the test analyte Parathyroid Hormone (PTH). The following scores were assigned: Parathyroid Hormone: 2017 first event = 67% 2017 second event = 33% 2018 first event = 100% (an artificial 100% was assigned) This is considered unsuccessful PT performance. 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 the surveyor's review of American Proficiency Institute (API) Proficiency Testing (PT) reports and an interview with the technical consultant, the laboratory failed to evaluate, perform and document remedial action for the PT scores of less than 100% for the following analytes: 2016 third event: BNP = 50% Chloride = 80% Potassium = 80% Granulocytes = 80% Lymphocytes = 80% 2017 first event: Thyroid Stimulating Hormone (TSH) = 80% Chloride = 60% Sodium = 60% 2017 second event: Platelets = 80% Red Blood Cells = 80% CO2 = 80% 2018 first event: BNP = 50% 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: Based on a surveyor review of the Quality Assurance (QA) records and an interview with the technical consultant, the laboratory failed to verify accuracy of interpretation of Allergy testing twice in calendar year 2017 and up to survey date. FINDINGS: The technical consultant confirmed on August 6, 2018 at approximately 1:30 PM that the accuracy of Allergy testing for 36 allergens was not performed in calendar year 2017. Approximately 31 patient specimens were tested and reported for allergy during this time period. D5400 ANALYTIC SYSTEMS CFR(s): 493.1250 Each laboratory that performs nonwaived testing must meet the applicable analytic systems requirements in 493.1251 through 493.1283, unless HHS approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub.7), that provides equivalent quality testing. The laboratory must monitor and evaluate the overall quality of the analytic systems and correct identified problems as specified in 493.1289 for each specialty and subspecialty of testing performed. This CONDITION is not met as evidenced by: Based on surveyor's review of records and an interview with the technical consultant, -- 2 of 8 -- the laboratory failed to: 1. Ensure that a comprehensive procedure manual is available for all aspect of the testing process. Refer to D5403; 2. Ensure that the laboratory discontinued the use of expired QC and calibrator materials. Refer to D5417; 3. Ensure that the laboratory followed the manufacturer maintenance requirement. Refer to D5429; 4. Perform and document calibration for hematology. Refer to D5437; 5. Perform and document calibration verification for analytes with less than 3 point calibrators. Refer to D5439; 7. Perform and document QC for Immunology. Refer to D5449; 8. Perform and document lot to lot QC verification. D5469. 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)