Pelham Pkwy Professional Medical Services Of

Summary Statement of Deficiencies 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 review of I-Stat operations manual, laboratory QC and IQCP procedure manuals, calibration records, and an interview with the practice manager: The laboratory failed to ensure that the Risk Assessment (RA) section of the IQCP was maintained to identify issues and perform corrective/remedial action. The laboratory failed to ensure that: 1. The validation study was performed prior to implementation of patient testing. Refer to D5421. 2. The required calibration verification was performed every six-months. Refer to D5437. 3. The established QCP and IQCP were performed and maintained. Refer to D5445. 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. 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 -- This STANDARD is not met as evidenced by: Based on a review of the laboratory procedure manual, I-Stat operations manual, QC, and calibration records for the Abbott I-Stat, and an interview with the practice manager, the laboratory failed to perform and document a complete validation study to verify the performance specification for the Abbott I-Stat analyzer. Refer to D6013. FINDINGS: Patient log sheets documented that patient testing performed on the I-Stat was implemented on 1/4/21. However, the laboratory failed to perform and document a validation study for the Abbott I-Stat analyzer prior to commencement of patient testing. a. No validation documentation including accuracy, precision, and reportable ranges were available for review at the time of the survey. b. Approximately 200 patient samples were tested and results reported from 1/4/21 through 11/27/23. 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 review of the calibration verification records for the I-Stat, Abbott I-Stat operation's manual, observation of the calibration verification records in the admin program on the I-Stat, and an interview with the practice manager, the laboratory failed to perform and document the calibration verification every six-months. Refer to D6020. FINDINGS: 1. The Abbott I-Stat operations manual requires calibration verification every six months using the Trical (3 levels) material. 2. The Individual Quality Control Policy (IQCP) indicates that, "calibration verification is required every six months." 3. The laboratory failed to perform and document the six-month calibration for year 2021 and the first half of 2022. a. The laboratory did not perform the validation study prior to implementation of patient testing on 1/4/2021. b. Based on the admin program, documentation on the I-stat and log sheet, the surveyor verified that the laboratory performed a calibration verification on 12/7/2022. 4. Approximately 150 patients were tested and results reported for Cl, K, Na, CO2, Ca, Glucose, Creatine, and HCT from 1/4/2021 to 12/7/2022. -- 2 of 4 -- D5445 CONTROL PROCEDURES CFR(s): 493.1256(d)(1)(2)(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-- (d)(1) Perform control procedures as defined in this section unless otherwise specified in the additional specialty and subspecialty requirements at 493.1261 through 493.1278. (d)(2) For each test system, perform control procedures using the number and frequency specified by the manufacturer or established by the laboratory when they meet or exceed the requirements in paragraph (d)(3) of this section. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based review of the Abbott I-Stat operation's manual, the laboratory QC and IQCP procedures, and an interview with the practice manager, the laboratory failed to follow the established QCP section of the IQCP for the I-Stat analyzer. Refer to D6020 and D6021. FINDINGS: 1. The manufacturer's QC requires performance of both internal and external electronic simulator each day of testing to ensure that the cartridge signal and reading function are functioning properly. a. Surveyor could not determine if the laboratory performed the simulator controls due to the lack of documentation. 2. The laboratory QC and IQCP procedure require Tricontrol (only perform two levels 1 and 3 monthly) after calibration verifications, service preventative maintenance (PM), questionable results, and/or new cartridge/reagent lot. a. The laboratory failed to perform and document the external controls (level 1 & 3) from 1/4/21 through 12/1 /2022. b. The QC log sheet recorded 1/2/23 and 2/2/23 results for the two levels, lot #31151 expiration date 7/31/2023. 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 the laboratory procedure manual, QC and IQCP & calibration records, QA documentation, and confirmed in an interview with the practice manager, the director failed to provide overall management for all phases of moderate complexity testing. FINDINGS: The laboratory director failed to ensure that the laboratory: 1. Performed and documented the validation study for the I-Stat prior to implementing patient testing. Refer to D6013. 2. Maintained the QC program for hematology. Refer to D6020. 3. Maintained the written QA policy for all phases of laboratory testing. Refer to D6021. D6013 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(3)(ii) 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 -- 3 of 4 -- director must-- (e)(3) Ensure that-- (e)(3)(ii) Verification procedures used are adequate to determine the accuracy, precision, and other pertinent performance characteristics of the method; This STANDARD is not met as evidenced by: Based on lack of validation records for the I-Stat analyzer and confirmed in an interview with the practice manager, the laboratory director failed to ensure that validation studies were performed and documented for the I Stat analyzer prior to patient testing on 1/4/2021. Refer to D5421. D6020 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 the quality control program is established and maintained to assure the quality of laboratory services provided. This STANDARD is not met as evidenced by: This STANDARD is not met as evidenced by: Based on review of I-Stat operations manual, laboratory QC and IQCP procedure manuals, calibration records, and an interview with the practice manager, the laboratory director failed to maintain the I- Stat QC program to assure the quality of laboratory services. Refer to D5439 and D5445. 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 RA section of the IQCP policy, QA documentation and an interview the practice manager, the laboratory director failed to follow the establish RA procedure formaintining an ongoing mechanism to monitor, assess, and when indicated perform correct identified in the general laboratory system. Refer to D5421, D5439 and D5445 -- 4 of 4 --