Pulmonary Disease Specialists Pa

Summary Statement of Deficiencies D0000 A recertification survey was conducted on April 11, 2022. Pulmonary Disease Specialists PA clinical laboratory was not in compliance with 42 CFR 493, requirements for clinical laboratories. D2000 ENROLLMENT AND TESTING OF SAMPLES CFR(s): 493.801 Each laboratory must enroll in a proficiency testing (PT) program that meets the criteria in subpart I of this part and is approved by HHS. The laboratory must enroll in an approved program or programs for each of the specialties and subspecialties for which it seeks certification. The laboratory must test the samples in the same manner as patients' specimens. For laboratories subject to 42 CFR part 493 published on March 14, 1990 (55 FR 9538) prior to September 1, 1992, the rules of this subpart are effective on September 1, 1992. For all other laboratories, the rules of this subpart are effective January 1, 1994. This CONDITION is not met as evidenced by: Based on record review, and interview, the laboratory failed to enroll in Proficiency Testing (PT) with an approved Proficiency Testing program for the Blood Gases analyte Glucose in 2020 (1st, 2nd 3rd events), 2021 (1st, 2nd 3rd events), and 2022 (1st event). This is a repeat deficiency from the survey on 06/09/2020. Findings: Review of the College of American Pathologists (CAP) PT records showed there was not any proficiency testing performed on the analyte glucose in 2020 to 2022. During an interview on 04/11/2022 at 9:38 AM, Testing Personnel A stated they were not enrolled in proficiency testing for glucose. D5439 CALIBRATION AND CALIBRATION VERIFICATION CFR(s): 493.1255(b) Unless otherwise specified in this subpart, for each applicable test system the 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 -- 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 record review, and interview, the laboratory failed to perform calibration /linearity on the Nova Stat Profile Prime blood gases instrument at least once every 6 months from 04/11/2020 to 04/11/2022. Findings: Review of the laboratory's quality control records showed there was not any documentation of the calibration/linearity being performed. Review of the package insert for the Nova Linearity Levels 1 - 4 listed the intended use as "Use for in vitro diagnostic use to verify calibration, analytic linearity, estimate test imprecision, and detect systematic analytical deviations that may arise from calibrator cartridges or analytical instrument variations for pH (potential of Hydrogen), PCO2 (Partial Pressure of Carbon Dioxide), PO2 (Partial Pressure of Oxygen), Na (Sodium), K (Potassium), Cl (Chloride) , iCa (Ionized Calcium), iMg (Ionized Magnesium), Glu (Glucose), and Lac (Lactate)." The package insert also noted to "use as frequently as required by local regulatory and hospital requirements. On 04/11/2022 at 11:55 AM, Testing Personnel A stated they did not perform linearity. D5807 TEST REPORT CFR(s): 493.1291(d) Pertinent "reference intervals" or "normal" values, as determined by the laboratory performing the tests, must be available to the authorized person who ordered the tests and, if applicable, the individual responsible for using the test results. This STANDARD is not met as evidenced by: Based on record review and interview, the laboratory failed to list the normal values of the laboratory tests for two (#1, #2) of three (#1, #2, #3) patients' laboratory test reports. Findings: Review of the patients' laboratory pulmonary function laboratory report, instrument printout, and the pulmonary function testing (PFT) test results showed the normal values were not listed on the reports given to two of three patients, (#1 and #2) On 04/11/2022 at 12:30, the Office Manager stated they gave the patients who requested their laboratory results, copies of the pulmonary function laboratory report, instrument printout and the PFT results. On 04/11/2022 at 9:38 AM, Testing -- 2 of 3 -- Personnel A stated normal values were on the bottom of the instrument print out and were not on the copies given to two (#1, #2) of the patient's reports examined. -- 3 of 3 --

Summary Statement of Deficiencies D0000 A recertification survey was conducted on June 9, 2020. Pulmonary Disease Specialists PA clinical laboratory was not in compliance with 42 CFR 493, requirements for clinical laboratories. D2000 ENROLLMENT AND TESTING OF SAMPLES CFR(s): 493.801 Each laboratory must enroll in a proficiency testing (PT) program that meets the criteria in subpart I of this part and is approved by HHS. The laboratory must enroll in an approved program or programs for each of the specialties and subspecialties for which it seeks certification. The laboratory must test the samples in the same manner as patients' specimens. For laboratories subject to 42 CFR part 493 published on March 14, 1990 (55 FR 9538) prior to September 1, 1992, the rules of this subpart are effective on September 1, 1992. For all other laboratories, the rules of this subpart are effective January 1, 1994. This CONDITION is not met as evidenced by: Based on record review and interview, the laboratory failed to enroll in proficiency testing with an approved proficiency testing (PT) program for Blood Gases in 2019. Findings: Review of the College of American Pathologists (CAP) proficiency testing records showed there was not any proficiency testing performed in 2019. The laboratory performed testing on the following analytes in 2019: pH (hydrogen ion concentration), CO2 (carbon dioxide), PO2 (partial pressure of oxygen), hematocrit, sodium, potassium, chloride, and glucose. During an interview on 6/9/20 at 9:40 AM, Testing Personnel A stated they were not enrolled in proficiency testing for 2019 and reinstated their enrollment for 2020. D3031 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(3) 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 -- 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 record review and interview, the laboratory failed to retain quality control (QC) records for the Nova Biomedical Stat Profile Prime blood gas analyzer instrument. The laboratory performs blood gas analysis on approximately 200 patients per year. Findings: 1. Review of the laboratory's QC records showed that the blood gas analyzer instrument failed to retain the control records from 2/13/19 to 5/6/19. No printouts of the daily controls were available for review. During an interview on 6/9 /20 at 11:44 AM, Testing Personnel A stated she was unable to retrieve the control records and did not know how long the instrument kept the records. 2. Review of the laboratory's QC records showed the laboratory failed to maintain the package insert for controls and calibration reagents from 2/13/19 to 6/9/20. During an interview on 6 /9/20 at 12:30 PM, Testing Personnel A stated she was not aware they needed to keep the package inserts. 3. Review of the laboratory's QC records showed the blood gas analyzer instrument failed to retain the calibration records from 2/13/19 to 12/31/19. There were no printouts of the calibrations available for review. Review of the Stat Profile Prime Instructions for User Manual showed that automatic calibrations are preformed "30 minutes after being powered on." During an interview on 6/9/20 at 12: 45 PM, Testing Personnel A stated she was unable to retrieve the calibration records and did not know how long the instrument kept the records. 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 record review and interview, the laboratory failed to document competency assessments for 2 of 2 testing personnel, (A, B) from June 9, 2018 to June 9, 2020. Findings: Review of the Laboratory Personnel Report (CMS 209) signed and dated by the Laboratory Director on 6/9/2020, showed that there were two testing personnel. Review of personnel records showed there were no competency evaluations performed in 2018, 2019, and 2020. During an interview on 6/9/2020 at 10:28 AM, Testing Personnel A stated that competency assessments were not performed from 2018 to 2020. 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 record review and interview, the laboratory failed to verify the accuracy of ionized calcium and lactate at least twice annually in 2019. Findings: Review of the -- 2 of 3 -- College of American Pathologists (CAP) proficiency testing records showed that there was not any proficiency testing performed in 2019. The laboratory is using CAP proficiency testing in 2020 to verify ionized calcium and lactate. During an interview on 6/9/20 at 9:40 AM, Testing Personnel A stated they were not enrolled in proficiency testing in 2019 and had reinstated their enrollment for 2020. -- 3 of 3 --

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, the laboratory personnel failed to sign the attestation statement for their proficiency testing with College of American Pathologist (CAP) for three out of three events in 2017. Findings include: Review of the laboratory's proficiency testing for 2017 showed that the testing personnel and the laboratory director failed to sign the attestation statement. The laboratory is enrolled in proficiency testing with CAP. The following proficiency testing attestations for 2017 were not signed. AQ-A 2017 Crit Care / Aqueous Blood Gas AQ-B 2017 Crit Care / Aqueous Blood Gas AQ-C 2017 Crit Care / Aqueous Blood Gas During an interview on 4/12/18 at 9:40 AM, Testing Personnel #1 acknowledged that the attestations for 2017 were not signed. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 1 --