Meritus Pulmonary Consultants

Summary Statement of Deficiencies 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. This STANDARD is not met as evidenced by: Based on review of the standard operating procedure manual (SOPM) and interview with the technical consultant (TC), the laboratory's SOPM listed two different reportable ranges for arterial blood gas (ABG) testing. Findings: 1. The SOPM contained two sections that defined the reportable ranges for ABG analytes. 2. The "Reportable Ranges" SOP listed the following reportable ranges: a. Potential of hydrogen (pH): 6.30-8.00 b. Partial pressure of carbon dioxide (pCO2): 5-250 c. Partial pressure of oxygen (pO2): 0-800 3. Section "11.0 Reportable Range of ABL 80 with CO-OX" of the SOPM listed the following reportable ranges: a. pH: 6.80-7.90 b. pCO2: 5-120 mmHg c. pO2: 0-730 mmHg 4. During the survey on 04/17/2024 at 1:30 PM, the TC confirmed that the laboratory's SOPM listed two different reportable ranges for ABG testing and that the laboratory would have to confirm which reportable ranges were accurate based on the verification of the manufacturer's performance specifications. D5807 TEST REPORT CFR(s): 493.1291(d) Pertinent "reference intervals" or "normal" values, as determined by the laboratory 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 -- 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 review of the standard operating procedure manual (SOPM), final test reports, and electronic medical record (EMR) results and interview with the technical consultant (TC), the laboratory's normal ranges were not consistent between the SOP, the final test report, and the EMR for arterial blood gas (ABG) testing. Findings: 1. Patient results for ABR testing were released in a hardcopy final test report (report) as well as in the patient's EMR. 2. Results were reviewed for patient ID 018110 tested on 03/28/2023. 3. Below were the normal ranges listed for partial pressure of carbon dioxide (pCO2): a. From the SOP: 35-45 Torr b. From the report: 36-47 mmHg c. From the EMR: 35.0-45.0 mmHg 4. Below were the normal ranges listed for partial pressure of oxygen (pO2): a. From the SOP: 80-90 Torr b. From the report: 65-95 mmHg c. From the EMR: 80-90 mmHg 5. Below were the normal ranges listed for oxygen saturation: a. From the SOP: 95-99% b. From the report: 93-97.5% c. From the EMR: 95.0-99.0% 6. Below were the normal ranges listed for base excess ABG (B. E.): a. From the SOP: -2 to +2 mEq/L b. From the report: -3 to +3 with no units c. From the EMR: no range was listed 7. Below were the normal ranges listed for bicarbonate (HCO3): a. From the SOP: 22-26 mEq/L b. From the report: 22-26 mEq /L c. From the EMR: no range was listed 8. During the survey on 04/17/2024 at 1:30 PM, the TC confirmed that the SOP, the final test report, and the EMR results listed different normal ranges for patient ABR results interpretation. D6015 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4) 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) Ensure that the laboratory is enrolled in an HHS approved proficiency testing program for the testing performed. This STANDARD is not met as evidenced by: Based on proficiency testing (PT) record and patient results review and interview with the technical consultant (TC), the laboratory director failed to ensure that the laboratory was enrolled in an approved PT program for the concentration of total hemoglobin (ctHb) when results were reported in the electronic medical record (EMR). Findings: 1. The laboratory performed patient testing on the ABL80 Flex CO- OX analyzer. 2. The ABL80 analyzer reported results for blood gases as well as ctHb, which included results for oxyhemoglobin, carboxyhemoglobin, and methemoglobin. 3. Prior to implementing an EMR system, the laboratory reported patient results in a hardcopy final report that only included the results for blood gases. Once the EMR was implemented, results from all analytes from the ABL80 analyzer were reported in the patient's EMR. 4. The laboratory currently reports patient results in a hardcopy final report as well as the EMR system. 5. The laboratory was enrolled in PT for blood gases only. When ctHb began being reported in the EMR, the laboratory did not enroll in an approved PT program. 6. During the survey on 04/17/2024 at 1:30 PM, the TC confirmed that the laboratory was not enrolled in PT for ctHb which was being reported in the EMR system. -- 2 of 2 --

Summary Statement of Deficiencies D2016 SUCCESSFUL PARTICIPATION CFR(s): 493.803(a)(b)(c) (a) Each laboratory performing nonwaived testing must successfully participate in a proficiency testing program approved by CMS, if applicable, as described in subpart I of this part for each specialty, subspecialty, and analyte or test in which the laboratory is certified under CLIA. (b) Except as specified in paragraph (c) of this section, if a laboratory fails to participate successfully in proficiency testing for a given specialty, subspecialty, analyte or test, as defined in this section, or fails to take remedial action when an individual fails gynecologic cytology, CMS imposes sanctions, as specified in subpart R of this part. (c) If a laboratory fails to perform successfully in a CMS- approved proficiency testing program, for the initial unsuccessful performance, CMS may direct the laboratory to undertake training of its personnel or to obtain technical assistance, or both, rather than imposing alternative or principle sanctions except when one or more of the following conditions exists: (1) There is immediate jeopardy to patient health and safety. (2) The laboratory fails to provide CMS or a CMS agent with satisfactory evidence that it has taken steps to correct the problem identified by the unsuccessful proficiency testing performance. (3) The laboratory has a poor compliance history. This CONDITION is not met as evidenced by: Based on review of the federal report for unsuccessful proficiency testing (PT) and review of the PT evaluation report from Wisconsin State Laboratory of Hygiene (WSLH), the laboratory failed to successfully participate in the WSLH PT program for blood gas testing (D2096). D2096 ROUTINE CHEMISTRY CFR(s): 493.841(f) Failure to achieve satisfactory performance for the same analyte or test in two 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 -- consecutive testing events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on review of the federal report for unsuccessful proficiency testing (PT) and review of the PT evaluation report from Wisconsin State Laboratory of Hygiene (WSLH), the laboratory failed to achieve satisfactory performance for the same analyte in two consecutive PT events for blood gases. Findings: 1. Failure to attain a score of at least 80% of acceptable responses for each analyte in each testing event is unsatisfactory performance. 2. The laboratory received the following scores from WSLH for partial pressure of carbon dioxide (pCO2): a. 60% in the 2023 2nd PT event b. 60% in the 2023 3rd PT event 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 federal report for unsuccessful proficiency testing (PT) and review of the PT evaluation report from Wisconsin State Laboratory of Hygiene (WSLH), the laboratory director failed to ensure an approved

Summary Statement of Deficiencies 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)

Summary Statement of Deficiencies 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)

Summary Statement of Deficiencies D2007 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) The samples must be examined or tested with the laboratory's regular patient workload by personnel who routinely perform the testing in the laboratory, using the laboratory's routine methods This STANDARD is not met as evidenced by: Based on proficiency testing (PT) record review and interview with the laboratory staff, the laboratory did not ensure that all the testing personnel that tested patient samples performed the PT. Findings: 1. The laboratory currently has 3 testing personnel listed on the "Laboratory Personnel Report (CMS-209)." 2. A review of hematology PT attestation worksheets from 2016 and 2017 showed that PT was not performed by 1 of the 3 testing personnel in 6 of 6 events. 3. During an interview on 2 /26/18 at 9:20 AM, a laboratory staff member stated that the testing person worked in another office and tested patient samples infrequently at this laboratory, and confirmed that PT samples were not tested each year by all the staff that perform patient testing to ensure accurate and reliable patient test results. 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 surveyor observation and interview with the laboratory staff, the laboratory did not ensure that an eye wash station was located in the laboratory area where 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 -- testing occurs. Findings: 1. During a tour of the laboratory, it was observed that there was no eye wash station available in the laboratory where laboratory testing is performed. 2. During an interview on 2/26/18 at 12:15 PM, the laboratory staff confirmed that the laboratory did not have an eye wash station in the room where laboratory testing is performed. D6011 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(2) 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)(2) and provide a safe environment in which employees are protected from physical, chemical, and biological hazards. This STANDARD is not met as evidenced by: Based on observation, and interview with the laboratory director (LD), the LD did not ensure the safety of the laboratory staff. Findings: 1. During a tour of the laboratory at 9:15 AM, it was observed that there was no emergency eye wash station available to laboratory staff. 2. During an interview on 2/26/18 at 12:15 PM, the LD confirmed that there was no emergency eye wash station in the laboratory. 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