Altitude Pulmonary And

Summary Statement of Deficiencies D2087 ROUTINE CHEMISTRY CFR(s): 493.841(a) (a) Failure to attain a score of at least 80 percent of acceptable responses for each analyte in each testing event is unsatisfactory analyte performance for the testing event. This STANDARD is not met as evidenced by: Based on the surveyor's review of the laboratory's policy and procedure, College of American Pathologists (CAP) proficiency testing (PT) records, and an interview with the medical assistant (MA), it was determined that the laboratory failed to attain at least 80 percent of the acceptable score in Routine Chemistry for the Partial pressure of Oxygen (pO2) analyte in the second event of 2024 (Q2-2024). The findings include: 1. The surveyor reviewed the PT records for Q2-2024, where CAP reported an unsatisfactory score. The results were as follows: a. pO2 PT Q2-2024 Overall score: 20% Specimen Reported Expected AQ-06 *158 65 - 87 AQ-07 *113 82 - 109 AQ-08 87 78 - 99 AQ-09 *100 104 - 128 AQ-10 *75 136 - 169 Legend: * = unsatisfactory score reported 2. The MA affirmed by interview on May 1, 2025, at approximately 11:50 a.m. that the laboratory obtained the PT scores mentioned in statement #1. 3. According to the laboratory's testing declaration submitted on the day of the survey, the laboratory performed approximately 1,500 pO2 patient test samples during the time the laboratory received an unsatisfactory proficiency testing score. Thus, the accuracy and reliability of patient test reported cannot be determined. 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. 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 the lack of a laboratory safety procedure, surveyor's observations during the tour, and an interview with medical assistant (MA); it was determined that the laboratory failed to establish safety procedures to ensure protection from physical, chemical, biochemical, and biohazardous materials. The findings include: 1. The laboratory lacked an established and approved safety policy and procedure to provide protection from physical, chemical, biochemical, and biohazardous materials as needed based on the laboratory's risk assessment. 2. The laboratory had an eye wash station, as observed and noted by the surveyor during the facility tour on May 1, 2025 at approximately 12:40 p.m. However, no documentation was available to review that it was checked. 3. The MA affirmed by interview on May 1, 2025, at approximately 12:40 p.m., that the laboratory lacked a safety policy and procedure and failed to check the eye wash station in the laboratory area. The MA also added that until the day of the survey, she was uncertain that the eye wash station was working. 4. The safety of laboratory personnel could not be assured. 5. The annual testing declaration form (Lab-144) signed by the director on April 24, 2025, stated that the laboratory processed and reported approximately 5,700 patient tests for Routine Chemistry and Hematology during the time when neither a safety protocol nor an eye wash station documentation log was in place. D5791 ANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1289(a)(c) (a) The laboratory must establish and follow written policies and procedures for an ongoing mechanism to monitor, assess, and when indicated, correct problems identified in the analytic systems specified in 493.1251 through 493.1283. This STANDARD is not met as evidenced by: Based on the surveyor's review of an incomplete quality assessment policy and procedure, proficiency testing records, five randomly chosen patient results and an interview with the medical assistant (MA) on May 1, 2025, it was determined that the laboratory failed to have a complete policy and procedure for an ongoing mechanism to monitor and assess, and when indicated, correct problems identified in the all phases of the testing system. The findings include: 1. The laboratory's current protocol was limited to competency assessment, quality control logs, and maintenance and function check log. 2. The incomplete quality assessment policy and procedure found lacked a risk assessment, safety protocol, criteria for rejection of samples, any documentation tracking to show comparison of test results. 3. The MA affirmed by interview on May 1, 2025, at approximately 11:40 a.m., that the laboratory had an incomplete system to monitor, assess, or correct problems, when identified in any phase of their processes. 4. The laboratory's testing declaration form submitted at the day of the survey stated approximately 5,700 patient test samples were processed and reported for Blood Gas Analysis, including the Hematocrit tests annually during the time the laboratory had an incomplete quality assessment protocol in place. D6011 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(2) (e)(2) provide a safe environment in which employees are protected from physical, chemical, and biological hazards; -- 2 of 4 -- This STANDARD is not met as evidenced by: Based on the surveyor's direct observations during the tour of the laboratory and an interview with the medical assistant; it was determined that the laboratory director failed to provide a safety protocol to ensure a safe environment in which employees and patients are protected from physical, chemical, and biological hazards. See D3011. D6016 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(i) (e)(4)(i) The proficiency testing samples are tested as required under Subpart H of this part; This STANDARD is not met as evidenced by: Based on the surveyor's review of proficiency testing (PT) event scores on May 1, 2025, at approximately 11:50 a.m., and an interview with the medical assitant, the laboratory director is herein cited for failure to ensure that proficiency testing samples were tested as required under Subpart H of this part. The findings include: 1. The laboratory received an unsatisfactory PT score of 20 percent in Blood Gas analysis. See. D2087. D6018 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(iii) (e)(4)(iii) All proficiency testing reports received are reviewed by the appropriate staff to evaluate the laboratorys performance and to identify any problems that require

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 interview with the laboratory staff, review of laboratory personnel reports (CMS209, LAB116), patient test reports, College of American Pathologists (CAP) Blood Gas Analysis proficiency testing (PT) records from 2018 to 2019, for 6 out of 6 testing events results reviewed from the 1st testing event of 2018 through the 3rd testing event of 2019, it was determined that proficiency testing samples had not been tested by personnel routinely testing patients specimen. The findings included: 1. Based on interview with the laboratory staff on 02/28/2020, review of the laboratory's CAP (account # 7197025-01) PT records from the 1st testing event of 2018 through the 3rd testing event of 2019, there were four testing personnel who routinely perform blood gas analysis, but only one testing person and the Laboratory Director not listed in CMS 209 and LAB 116 performed the proficiency testing samples. 2. Random patient sampling covering the period from 03/06/2018 to 07/15/2019, the laboratory tested and reported 15 out of 15 blood gas patient test results (pH, pCO2, pO2), Sodium (Na+), Potassium ( K+), Calcium (Ca +2), and Hematocrit (Hct) which the laboratory failed to utilize personnel who routinely test patient specimens to perform PT samples. Q1, 2018 Q2, 2018 Q2, 2019 03/06/2018 06/29/2018 07/11/2019 Accession # Accession # Accession # 4889 16722 49485 8649 5090 07/15/2019 1413 4644 Accession # 4494 49238 24437 49897 49192 30407 13116 5408 3. Based on the annual test volume reported (CMS 116 and LAB 144a Testing Declaration, signed and dated by the Laboratory Director on 02/21/2020), the laboratory performed and reported approximately 4,412 tests for the subspecialty of Routine Chemistry (ph, pCO2, pO2, Na+, K+, Ca +2), and 1,103 tests for the subspecialty of Hematology Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 17 -- (Hct). 4. The laboratory staff affirmed (02/28/2020 at approximately 9:00 a.m.) that only 1 out 4 testing personnel for blood gas and the Laboratory Director not performing routine patient specimens performed all PT samples for 6 out of 6 testing events. D2009 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(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 interview with the laboratory staff on February 28, 2020, review of the laboratory's College of American Pathologists (CAP) proficiency testing (PT) records from 2018 to 2019, for 6 out of 6 testing events results reviewed from the 1st testing event of 2018 through the 3rd testing event of 2019, it was determined that the laboratory failed to document that the individual testing or examining the PTsamples and the Laboratory Director attested to the routine integration of the Blood Gas PT samples into the patient workload utilizing the laboratory's routine methods. The findings included: 1. Based on interview with the laboratory staff on 02/28/2020, the laboratory participated in CAP (account # 7197025-01) Blood Gas (pH, pCO2, pO2), Na +, K+, Ca +2, and Hematocrit) PT program from the 1st testing event of 2018 through the 3rd testing event of 2019. 2. Review of 6 out 6 Blood Gas PT events reviewed from 2018 to 2019 indicated that the Laboratory Director and testing staff did not sign the attestation page to document they attested to the routine integration of PT samples in routine patient workload utilizing the laboratory's routine methods. 3. Random patient sampling covering the period from 03/06/2018 to 07/15/2019, the laboratory tested and reported 15 out of 15 blood gas patient test results (pH, pCO2, pO2, Na+, K+, Ca +2, Hematocrit (Hct) which the Laboratory Director and testing staff failed to sign the attestation page to document they attested the routine integration of PT samples in routine patient workload utilizing the laboratory's routine methods. Q1, 2018 Q2, 2018 Q2, 2019 03/06/2018 06/29/2018 07/11/2019 Accession # Accession # Accession # 4889 16722 49485 8649 5090 07/15/2019 1413 4644 Accession # 4494 49238 24437 49897 49192 30407 13116 5408 4. Based on the annual test volume reported (CMS 116 and LAB 144a Testing Declaration, signed and dated by the Laboratory Director on 02/21/2020), the laboratory performed and reported approximately 4,412 tests for the subspecialty of Routine Chemistry (ph, pCO2, pO2, Na+, K+, Ca +2), and 1,103 tests for the subspecialty of Hematology (Hct). 5. The laboratory staff affirmed (02/28/2020 at approximately 9:00 a.m.) that the Laboratory Director and testing staff failed to sign the attestation page to document the routine integration of PT samples in routine patient workload utilizing the laboratory's routine methods. D2121 HEMATOLOGY CFR(s): 493.851(a) Failure to attain a score of at least 80 percent of acceptable responses for each analyte in each testing event is unsatisfactory analyte performance for the testing event. This STANDARD is not met as evidenced by: -- 2 of 17 -- Based on interview with the laboratory staff, review of College of American Pathologists (CAP) Blood Gas Analysis proficiency testing (PT) records from 2018 to 2019, for 6 out of 6 testing events results reviewed from the 1st testing event of 2018 through the 3rd testing event of 2019, it was determined that the laboratory failed to attain a score of at least 80% for Hematocrit (Hct), a subspecialty of Hematology, 2nd PT event of 2018. The findings included: 1. Based on interview with the laboratory staff on 02/28/2020, review of the laboratory's CAP (account # 7197025-01) PT records from the 1st testing event of 2018 through the 3rd testing event of 2019, the laboratory failed to maintain satisfactory performance with the PT program by failing to obtain a score of at least 80% acceptable response. 2nd testing event of 2018, Hct (20%) Kit # 31250072 CAP Result Mean Expected Spec # Result HCT-06 42 32.2 30- 35 HCT-07 25 19.8 18-21 HCT-08 43 42.1 39-45 HCT-09 20 24.8 23-27 HCT-10 32 41.3 38-44 2. The laboratory tested and reported 3 out of 3 Hct patient test results (Q2, 2018) on 06/29/2018, the day the laboratory failed the Hct proficiency testing. Accession # 16722 5090 4644 3. Based on the annual test volume reported (CMS 116 and LAB 144a Testing Declaration, signed and dated by the Laboratory Director on 02 /21/2020), the laboratory performed and reported approximately 1,103 tests for the subspecialty of Hematology (Hct). 4. The laboratory staff affirmed (02/28/2020 at approximately 9:00 a.m.) the unsatisfactory PT performance for Hct, Q2, 2018. D5221 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(d) All proficiency testing evaluation and verification activities must be documented. This STANDARD is not met as evidenced by: Based on interview with the laboratory staff, review of College of American Pathologists (CAP) Blood Gas Analysis proficiency testing (PT) records from 2018 to 2019, for 6 out of 6 testing events results reviewed from the 1st testing event of 2018 through the 3rd testing event of 2019, it was determined that the laboratory failed to document the evaluation and verification of the unacceptable responses to evaluate the laboratory's performance and to identify any problems that required