Alveoli Corpporation Dba Lungs At Work

Summary Statement of Deficiencies D0000 A recertification survey was conducted by the Pennsylvania State Agency at Alveoli Corporation dba Lungs at Work on 03/11/2026. The laboratory was found out of compliance with the following condition: 493.1409 Condition: Laboratories performing moderate complexity testing; technical consultant. D2009 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) (b)(1) The individual testing or examining the samples and the laboratory director must attest to the routine integration of the samples into the patient workload using the laboratory's routine methods. This STANDARD is not met as evidenced by: Based on review of the American Proficiency Institute (API) proficiency testing (PT) records and interview with the Patient Care and Office Coordinator (PCOC), the Laboratory Director (LD)/designee failed to sign 2 of 4 API PT attestation statements for blood gas testing performed from 07/18/2024 to 03/11/2026. Findings include: 1. The API PT attestation form stated, "The undersigned certify that, as closely as possible, these proficiency testing samples were tested in the same manner as patient specimens." 2. On the day of the survey, 03/11/2026 at 10:30 am, the laboratory failed to provide attestation statements signed by the LD/designee for the following 2 of 4 API PT events performed from 07/18/2024 to 03/11/2026: - 2025 Chemistry - Core - 2nd Event - 2025 Chemistry - Core - 3rd Event 3. The PCOC confirmed the findings above on 03/11/2026 at 11:36 am. D5413 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(b) (b) The laboratory must define criteria for those conditions that are essential for 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 -- proper storage of reagents and specimens, accurate and reliable test system operation, and test result reporting. The criteria must be consistent with the manufacturer's instructions, if provided. These conditions must be monitored and documented and, if applicable, include the following: (b)(1) Water quality. (b)(2) Temperature. (b)(3) Humidity. (b)(4) Protection of equipment and instruments from fluctuations and interruptions in electrical current that adversely affect patient test results and test reports. This STANDARD is not met as evidenced by: Based on record review, lack of documentation, and interview with the Patient Care and Office Coordinator (PCOC), the laboratory failed to monitor and document relative humidity for 601 of 601 days to ensure operating conditions were met for reliable test system operation and test result reporting of blood gas testing performed from 07/18/2024 to 03/11/2026. Findings Include: 1. The GEM Premier 5000 Operations Manual stated, "Ambient Environmental Requirements: Relative Humidity Limits 15 to 85 % RH (non-condensing)." 2. On the day of survey, 03/11/2026 at 10: 39 am, review of the laboratory's temperature and humidity control logs revealed the laboratory failed to monitor and document relative humidity when blood gas testing was performed on the GEM Premier 5000 analyzer for 601 of 601 days from 07/18 /2024 to 03/11/2026. 3. The laboratory performed 208 blood gas tests in 2025 (CMS 116, estimated annual volume, dated 03/10/2026). 4. The PCOC confirmed the findings above on 03/11/2026 at 11:36 am. D5435 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(b)(2) (b)(2)(i) Define a function check protocol that ensures equipment, instrument, and test system performance that is necessary for accurate and reliable test results and test result reporting. (b)(2)(ii) Perform and document the function checks, including background or baseline checks, specified in paragraph (b)(2)(i) of this section. Function checks must be within the laboratory's established limits before patient testing is conducted. This STANDARD is not met as evidenced by: Based on record review, lack of documentation, and interview with the Patient Care and Office Coordinator (PCOC), the laboratory failed to establish and maintain a maintenance/function check policy for 2 of 2 thermometers used to ensure acceptable storage and operating temperatures were met in the laboratory for blood gas testing performed from 07/18/2024 to 03/11/2026. Findings include: 1. On the day of survey, 03/11/2026 at 10:52 am, the surveyor observed the following thermometers used in the laboratory to monitor acceptable storage and operating temperatures of equipment, reagents, and supplies: - Taylor refrigerator thermometer. - Ambient Weather room temperature monitor. 2. Review of laboratory procedures revealed the laboratory failed to establish and maintain a maintenance/function check policy for 2 of 2 thermometers used to ensure acceptable storage and operating temperatures were met in the laboratory for blood gas testing performed from 07/18/2024 to 03/11/2026. 3. The PCOC confirmed the findings above on 03/11/2026 at 11:36 am. D6033 TECHNICAL CONSULTANT-MODERATE COMPLEXITY CFR(s): 493.1409 -- 2 of 4 -- The laboratory must have a technical consultant who meets the qualification requirements of 493.1411 of this subpart and provides technical oversight in accordance with 493.1413 of this subpart. This CONDITION is not met as evidenced by: Based on record review and interview with the Patient Care and Office Coordinator (PCOC), the laboratory failed to ensure 1 of 1 testing personnel (TP) (CMS 209, TP #1, dated 03/10/2026) that performed the duties of a technical consultant met the minimum education requirements listed under 493.1411 to provide technical oversight for moderate complexity blood gas analysis in 2024 and 2025. Refer to D6035 D6035 TECHNICAL CONSULTANT QUALIFICATIONS CFR(s): 493.1411 (a) The technical consultant must be qualified and must possess a current license issued by the State in which the laboratory is located, if such licensing is required. (b) The technical consultant must-- (b)(1)(i) Be a doctor of medicine or doctor of osteopathy licensed to practice medicine or osteopathy in the State in which the laboratory is located; and (b)(1)(ii) Be certified in anatomic or clinical pathology, or both, by the American Board of Pathology or the American Osteopathic Board of Pathology; or (b)(2)(i) Be a doctor of medicine, doctor of osteopathy, or doctor of podiatric medicine licensed to practice medicine, osteopathy, or podiatry in the State in which the laboratory is located; AND (b)(2)(ii) Have at least 1 year of laboratory training or experience, or both, in nonwaived testing, in the designated specialty or subspecialty areas of service for which the technical consultant is responsible (for example, physicians certified either in hematology or hematology and medical oncology by the American Board of Internal Medicine are qualified to serve as the technical consultant in hematology); or (b)(3)(i)(A) Hold an earned doctoral or master's degree in a chemical, biological, clinical or medical laboratory science, or medical technology from an accredited institution; or (b)(3)(i)(B) Meet either requirements in 493.1405(b)(3)(i)(B) or (b)(4)(i)(B) or (C); AND (b)(3)(ii) Have at least 1 year of laboratory training or experience, or both, in nonwaived testing, in the designated specialty or subspecialty areas of service for which the technical consultant is responsible; or (b)(4)(i)(A) Have earned a bachelor's degree in a chemical, biological, clinical or medical laboratory science, or medical technology from an accredited institution; or (b)(4)(i)(B) Meet 493.1405(b)(5)(i)(B); and (b)(4)(ii) Have at least 2 years of laboratory training or experience, or both, in nonwaived testing, in the designated specialty or subspecialty areas of service for which the technical consultant is responsible; or (b)(5)(i) Have earned an associate degree in medical laboratory technology, medical laboratory science, or clinical laboratory science; and (b)(5)(ii) Have at least 4 years of laboratory training or experience, or both, in nonwaived testing, in the designated specialty or subspecialty areas of service for which the technical consultant is responsible. (b)(6) For blood gas analysis, the individual must- (b)(6)(i) Be qualified under paragraph (b)(1), (2), (3) or (4) of this section; or (b)(6)(ii)(A) Have earned a bachelor's degree in respiratory therapy or cardiovascular technology from an accredited institution; and (b)(6)(ii)(B) Have at least 2 years of laboratory training or experience, or both, in blood gas analysis; or (b) (7) Notwithstanding any other provision of this section, an individual is considered qualified as a technical consultant under this section if they were qualified and serving as a technical consultant for moderate complexity testing in a CLIA-certified laboratory as of December 28, 2024, and have done so continuously since December 28, 2024. -- 3 of 4 -- This STANDARD is not met as evidenced by: Based on record review and interview with the Patient Care and Office Coordinator (PCOC), the laboratory failed to ensure that 1 of 1 Testing Personnel (TP) who performed the responsibilities of a technical consultant (TC) met the minimum education requirements listed under 493.1411 to provide technical oversight for moderate complexity blood gas analysis from 07/18/2024 to 03/11/2026. Findings include: 1. On the day of the survey, 03/16/2026 at 09:20 am, review of personnel credentials revealed TP #1 obtained an Associate Degree in Respiratory Therapy. 2. Further review of the laboratory's competency assessment (CA) and Quality Assurance (QA) records revealed the laboratory failed to ensure that 1 of 1 TP (CMS 209, TP #1, dated 03/10/2026) met the minimum educational requirements to perform the following duties of a TC listed under C.F.R. 493.1413 from 07/18/2024 to 03/11 /2026: - Direct observations and sign-off of CA records for TP #1 and TP #2 in 2024 and 2025 - QA monthly review in 2024 and 2025 3. The Form CMS-209, signed by the laboratory director (LD) on 3/10/2026, did not list TP # 1 as a TC. 4. The laboratory performed 208 blood gas tests in 2025 (CMS 116, estimated annual volume, dated 03/10/2026). 5. The PCOC confirmed the findings above on 03/11 /2026 at 11:36 am. -- 4 of 4 --

Summary Statement of Deficiencies D2088 ROUTINE CHEMISTRY CFR(s): 493.841(b) Failure to attain an overall testing event score of at least 80 percent is unsatisfactory performance. This STANDARD is not met as evidenced by: Based on review of the laboratory's American Proficiency Institute (API) proficiency testing (PT) records and interview with Testing Personnel (TP) #2, the laboratory failed to attain an overall testing event score of at least 80 percent for 1 of 3 chemistry testing events in 2023. Findings include: 1. On the day of survey 7/18/2024 at 12:30 pm, review of the laboratory's API PT records revealed the laboratory scored a zero percent (0%) for each of the following analytes in the 2nd event of 2023: - pCO2, pH, pO2, Carboxyhemoglobin, Hemoglobin, Methemoglobin and Oxyhemoglobin. 2. The laboratory failed to obtain an overall testing event score of at least 80 percent and resulted in unsatisfactory performance for the 2nd API PT event of blood gas analysis in 2023. 3. TP #2 confirmed the findings above on 7/18/2024 at 1:05 pm. D2093 ROUTINE CHEMISTRY CFR(s): 493.841(d) Failure to return proficiency testing results to the proficiency testing program within the time frame specified by the program is unsatisfactory performance and results in a score of 0 for the testing event. This STANDARD is not met as evidenced by: Based on review of the laboratory's American Proficiency Institute (API) proficiency testing (PT) records and interview with Testing Personnel (TP) #2, 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 -- failed to return PT results to API within the timeframe specified for 1 of 3 chemistry testing events in 2023. Findings include: 1. On the day of survey 7/18/2024 at 12:30 pm, review of the laboratory's API PT records revealed the laboratory failed to participate and resulted in an unsatisfactory performance score of zero for the 2nd event of blood gas analysis in 2023. 2. Interview with TP #2 on 7/18/2024 at 1:05 pm confirmed the laboratory failed to return PT results to API within the specified timeframe for the 2nd event in 2023. -- 2 of 2 --

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 Gem 5000 Blood Gas analyzer validation records and interview with Testing Personnel (TP)#1, the laboratory failed to establish criteria for acceptable performance specifications for the Gem 5000 Blood Gas analyzer validation used for routine chemistry specimens from December 17, 2021 to December 06, 2022. Findings Include: 1. On the day of the survey, 12/06/2022 at 12: 35pm, review of the Gem 5000 Blood Gas analyzer validation records revealed that the validation performed on 12/17/2021 did not include criteria for acceptable precision, accuracy, and reportable range. 2. TP#1 confirmed the findings above on 12 /06/2022 around 01:25pm. D6046 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(8) (b) The technical consultant is responsible for-- (b)(8) Evaluating the competency of all testing personnel and assuring that the staff maintain their competency to perform test procedures and report test results promptly, accurately and proficiently. 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 -- This STANDARD is not met as evidenced by: Based on review of the laboratory competency assessment records and interview with Testing Personnel (TP)#1, the Technical Consultant (TC) failed to evaluate the competency assessment of 2 of 2 Testing Personnel (TP) who performed Blood Gas examinations in 2021 and 2022. Findings include: 1. On the day of survey 12/06/2022 at 11:51 am, the laboratory could not provide competency assessment records performed by the TC for 2 of 2 TP (CMS 209 personnel #2 and#3) who performed Blood Gases in 2021 and 2022. 2. TP#1 confirmed the finding above on 12/06/2022 at 01:25 pm. -- 2 of 2 --