Pulmonologists Pc

Summary Statement of Deficiencies D5439 CALIBRATION AND CALIBRATION VERIFICATION CFR(s): 493.1255(b) (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 procedure, review of calibration records, and interview with the testing person (TP), the laboratory failed to define the acceptable limits for calibration verification and record

Summary Statement of Deficiencies D3011 FACILITIES CFR(s): 493.1101(d) Safety procedures must be established, accessible, and observed to ensure protection from physical, chemical, biochemical, and electrical hazards, and biohazardous materials. This STANDARD is not met as evidenced by: Based on observation in the laboratory testing area and interview with the testing person (TP), the laboratory failed to provide an eyewash station within the work area. Findings: 1. Occupational Safety and Health Act (OSHA) regulation 29 CFR 1910.151 (c) requires that "where the eyes or body of any person may be exposed to injurious corrosive materials, suitable facilities for quick drenching or flushing of the eyes and body shall be provided within the work area for immediate emergency use." 2. The area where the TP was performing blood gas analysis was toured during the survey. There was no eyewash attached to the sink or the wall next to the sink. 3. During the survey on 07/06/2023 at 3:00 PM, the TP confirmed that there was no eyewash station within the laboratory where testing is performed. 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) Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 3 -- The reportable range for test results for the test system as established or verified in 493.1253. (7) Control procedures. (8)

Summary Statement of Deficiencies D2015 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(5)(6) (5) The laboratory must document the handling, preparation, processing, examination, and each step in the testing and reporting of results for all proficiency testing samples. The laboratory must maintain a copy of all records, including a copy of the proficiency testing program report forms used by the laboratory to record proficiency testing results including the attestation statement provided by the PT program, signed by the analyst and the laboratory director, documenting that proficiency testing samples were tested in the same manner as patient specimens, for a minimum of two years from the date of the proficiency testing event. (6) PT is required for only the test system, assay, or examination used as the primary method for patient testing during the PT event. This STANDARD is not met as evidenced by: Based on record review and interview with laboratory staff, the Blood gas (chemistry) laboratory did not ensure testing personnel signed the proficiency test providers attestation statement that proficiency testing samples are tested in the same manner as patient samples. Findings: 1. The proficiency testing company that the laboratory enrolled with for blood gas chemistry testing, sends unknown samples to the laboratory for testing, the test results are then submitted to the provider for performance evaluation. The proficiency test provider sends samples to the laboratory three times a year (three separate events); 2. The proficiency provider's attestation statement was not signed by the testing person and laboratory director for the second event of 2021, the first second and third event of 2020 and the third event of 2019; and 3. This was confirmed during interview with Testing Person #1 the afternoon of the day of survey. D5016 ROUTINE CHEMISTRY CFR(s): 493.1210 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 -- If the laboratory provides services in the subspecialty of Routine Chemistry, the laboratory must meet the requirements specified in 493.1230 through 493.1256, 493. 1267, and 493.1281 through 493.1299. This CONDITION is not met as evidenced by: Based on record review and interview with Testing Person #1, the blood gas (chemistry) laboratory failed to review and evaluate the results obtained on proficiency testing performed as specified in subpart H of this part (see D5211); failed to follow the manufacturer's test system instructions for calibration verification, using calibration materials provided or specified, and with at least the frequency recommended by the manufacturer (see D5437); failed to follow control procedures that monitor the accuracy and precision of the complete analytic process and detect immediate errors that occur due to test system failure, adverse environmental conditions, and operator performance (See D5441); and failed to 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 (See D5445). 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 with laboratory staff, the blood gas (chemistry) laboratory did not document that the proficiency test provider's evaluation of the laboratory performance was reviewed by the laboratory director. Findings: 1. The proficiency testing company that the laboratory enrolled with for blood gas chemistry testing, sends unknown samples to the laboratory for testing, the test results are then submitted to the provider for performance evaluation. The proficiency test provider sends samples to the laboratory three times a year (three separate events); 2. The proficiency provider's evaluation of the laboratory's performance was not reviewed by the laboratory director for the first, second and third events of 2020 and was not reviewed for the third event of 2019; and 3. This was confirmed during interview with Testing Person #1 the afternoon of the day of survey 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. -- 2 of 5 -- This STANDARD is not met as evidenced by: Based on record review and interview with laboratory staff, the blood gas (chemistry) laboratory did not perform calibration verification for chemistry blood gas testing ever six months as required by the manufacturer. Findings: 1. The manufacturer requires the laboratory to perform calibration verification at least every six months and with every test system update made by the manufacturer, using the calibration verification reagents provided by the manufacturer; 2. From the beginning of 2019 through the day of the onsite survey, the laboratory had documentation for performance of two calibration verifications and not five. The calibrations were performed on March 28, 2019 and May 14, 2021; 3. The laboratory also failed to use the five reagent calibration kit supplied by the manufacturer to perform the two calibration verification procedures; and 4. This was confirmed during interview with Testing Person #1 on the afternoon of the day of survey 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 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 record review and interview with laboratory staff, the blood gas (chemistry) laboratory did not follow quality control procedures to ensure that the evaluation of the laboratory's quality control results was performed using the correct range of acceptable quality control results published by the manufacturer. Findings 1. The manufacturer of the quality control reagents requires the laboratory to identify the expected quality control ranges for the lot number in use by going to a web site, selecting the correct letter from the test kit and use this letter along with the kit lot number to make sure that the acceptable ranges match the lot number of the quality control reagent in use; 2. The laboratory performs external liquid quality control testing using three levels of control (Level 1, Level 2 and Level 3) once each week (instead of daily liquid quality control checks each day of patient testing), under the laboratory's Internal Quality Control Plan; 3. The laboratory did not use the correct acceptable limits (assigned by the manufacturer) for the lot number of quality control reagents in use. It was observed by the surveyor in the afternoon of the day of survey that the lot numbers on the quality control test result printout did not agree with the lot number printed on the manufacturer's acceptable ranges used to evaluate the acceptability of the control results; 4. The laboratory failed to follow the manufacturer's procedures to obtain the correct published quality control ranges to evaluate the quality control and made copies of the previous ranges from expired lot numbers of quality control reagent; 5. On the following weeks of quality control testing the lot number of the liquid external control did not match the lot number -- 3 of 5 -- assigned to the manufacturer's published acceptable ranges and patient testing was performed these weeks: a) On November 5, 2021 all three levels (1,2 and 3) did not match B) On October 1, 2021 level one did not match ac) On October 8, 15, 25, 29, 2021 all three levels (1,2 and 3) did not match d) On April 1, 2021 all three levels (1,2 and 3) did not match e) On January 6, 2021 all three levels (1,2 and 3) did not match bf) On November 11, 2020 all three levels (1,2 and 3) did not match G) On July 28, 2021 all three levels (1,2 and 3) did not match H) On January 20, 2021 level 3 did not match. 7. Testing Person # 1 stated during interview on the day of the onsite survey that the laboratory written procedures were not clear that in the event of a quality control failure, a retrospective review of all patient testing for the previous week must be performed as part of the

Summary Statement of Deficiencies 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 review of the written procedure manual and interview with the technical consultant (TC), the laboratory director (LD) did perform annual competency procedures for the TC. Findings: 1. The TC did not have annual competency procedures for performing blood gas analysis. 2. The LD did not perform the required six pieces competency assessment that included direct observation, monitoring test results reporting, review of intermediate test results including quality control, proficiency testing and preventative maintenance, assessment of test performance, and problem solving skills. 3. The last annual competency performed for the TC was completed on 11/7/16 and signed by the LD on 3/1/17 4. TC confirmed that competency procedures were not performed during the years 2017 and 2018. 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 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 -- 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 written procedure manual and interview with the testing person, the laboratory did not perform six month calibration verification procedures on the blood gas analyzer. Findings: 1. Review of the written procedure manual showed procedures for performing calibration verification of the blood gas analyzer. 2. The calibration verification procedures were not performed for the years 2017 and 2018. 3. The testing person stated that he was not aware that calibration verification procedures were needed for the blood gas analyzer. -- 2 of 2 --