City Medical Of Upper East Side Pllc

Summary Statement of Deficiencies D2001 ENROLLMENT CFR(s): 493.801(a)(1)(2)(i) The laboratory must-- (1) Notify HHS of the approved program or programs in which it chooses to participate to meet proficiency testing requirements of this subpart. (2)(i) Designate the program(s) to be used for each specialty, subspecialty, and analyte or test to determine compliance with this subpart if the laboratory participates in more than one proficiency testing program approved by CMS; This STANDARD is not met as evidenced by: Based on lack of proficiency testing (PT) records for the hematology and confirmed in an interview with the technical consultant/testing person, the laboratory failed to enroll in an approved PT program for the hematology testing after initiating patient testing on June 4, 2018. FINDINGS: The technical consultant confirmed on 1/4/2019 at approximately 12:00 PM that the laboratory failed to enroll in PT when initiated hematology testing on June 4, 2018. D2096 ROUTINE CHEMISTRY CFR(s): 493.841(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 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 the following analyte: The following scores were assigned: C-Reactive Protein: 2018 second event 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 -- = 50% 2018 third event - 50% This is considered repeatedly 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/testing person, the laboratory failed to evaluate, perform and document remedial action for the PT scores of less than 100% for the following analytes: 2018 first event: Vitamin D = 67% 2018 second event: Creatinine = 0% Free Triiodothyronine (FT3) = 80% Thyroxine = 80% Total CK = 0% Erythrocyte Sedimentation Rate (ESR) = 50% Urine dipstick blood = 50% Urine dipstick PH = 50% Urine dipstick Nitrate = 50% 2018 third event: FT3 = 80% Tyroxine = 80% Thyroid Stimulating Hormone (TSH) = 60% D5291 GENERAL LABORATORY SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1239(a) The laboratory must establish and follow written policies and procedures for an ongoing mechanism to monitor, assess, and, when indicated, correct problems identified in the general laboratory systems requirements specified at 493.1231 through 493.1236. This STANDARD is not met as evidenced by: Based on surveyor's review of the laboratory's Quality Assessment (QA) policies and procedures and confirmed in an interview with the technical consultant/testing person, at the time of this survey, the laboratory failed to follow their established QA policy and perform a QA review for the 2018 calendar year. D5437 CALIBRATION AND CALIBRATION VERIFICATION CFR(s): 493.1255(a) Unless otherwise specified in this subpart, for each applicable test system the laboratory must perform and document calibration procedures-- (1) Following the manufacturer's test system instructions, using calibration materials provided or specified, and with at least the frequency recommended by the manufacturer; (2) Using the criteria verified or established by the laboratory as specified in 493.1253(b) (3)-- (2)(i) Using calibration materials appropriate for the test system and, if possible, traceable to a reference method or reference material of known value; and (2)(ii) Including the number, type, and concentration of calibration materials, as well as acceptable limits for and the frequency of calibration; and (3) Whenever calibration verification fails to meet the laboratory's acceptable limits for calibration verification. This STANDARD is not met as evidenced by: Based on surveyor review of hematology calibration records and an interview with the technical consultant/testing person, calibration of the hematology analyzer was not -- 2 of 5 -- performed at the frequencies required by the manufacturer of the Coulter AcT Diff 5 diff AL hematology analyzer. FINDINGS: 1. The manufacturer of the Coulter AcT Diff 5 diff AL hematology analyzer requires analyzer calibration every six months. 2. On January 3, 2019 at approximately 12:30 PM the technical consultant confirmed surveyor findings that the documentation of the hematology analyzer calibration available for review was for calibrations performed on 6/4/18 during the validation of the new analyzer. The analyzer was therefore out of calibration from 12/5/2018 through the date of this survey. 3. Approximately 40 patient specimens were tested and reported for hematology during the above time frames when the analyzer was out of calibration. 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/testing person, the laboratory failed to perform calibration verification at least once every six months for chemistry testing on the AU 480 analyzer from November 2018 up to survey date. FINDINGS: 1. At approximately 1:00 PM on January 4, 2019, the technical consultant confirmed that the laboratory had not performed calibration verification on the AU 480 analyzer for all the chemistry analytes after the initial calibration verification in May 2018. The AU 480 analyzer was therefore out of calibration verification from November 2018 through the date of this survey. Calibration Verification is required because the chemistry analytes on the AU 480 analyzer have less than three point calibrators. 2. Approximately 200 patients were tested during this time period. 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 -- 3 of 5 -- with 493.1407 of this subpart. This CONDITION is not met as evidenced by: Based on surveyor findings and interview with the laboratory technical consultant /testing person, the laboratory director failed to provide overall management of the laboratory. The laboratory director failed to ensure that the laboratory: 1. successfully participate in PT. Refer to D6016 2. review the scored proficiency testing reports received from API. Refer to D6018 3. maintained the laboratory's established QA program for all phases of laboratory testing, refer to D6021. D6016 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(i) 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)(i) Ensure that the proficiency testing samples are tested as required under Subpart H of this part; This STANDARD is not met as evidenced by: Based on the surveyor's review of the API PT program records and confirmed with the technical consultant/testing person, the laboratory director failed to ensure that the laboratory successfully participated in a PT program for Hematology, Chemistry and Endocrinology. Refer to: D2096, D2001, D5211 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