Blue Mountain Hospital

Summary Statement of Deficiencies D5807 TEST REPORT CFR(s): 493.1291(d) (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 review of patient final test result and interview with technical supervisor, the laboratory failed to ensure that the final patient test report had reference ranges available to the authorized person who ordered the test. Findings include: 1. Review of patient test report, encounter #86830568 ordered on 03/03/2025 on a female 69 year old patient for GXpert COVFLURSV panel revealed no reference range available. 2. Interview with technical supervisor on 06/25/2025 at 0915 confirmed these findings. 3. The laboratory reports performing 836 COVFLURSV tests per year. 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 --

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 proficiency testing (PT) desk review of the American Proficiency Institute (API) proficiency testing failure summary results, a review of the CASPER Report 0155D, and a phone interview with the general supervisor/technical supervisor (GS /TS) revealed the laboratory had unsuccessful participation for two (2) out of three (3) testing events for the specialty hematology. Refer to D2127 and D2130. D2127 HEMATOLOGY CFR(s): 493.851(d) 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 -- 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 a review of the American Proficiency Institute (API) proficiency testing performance summary reports, Casper Report 0155D, and a phone interview with the technical supervisor/general supervisor (TS/GS), the laboratory failed to submit proficiency testing (PT) results on time, resulting in zero scores for the second event of 2023 in hematology. Findings include: 1. API 2nd event 2023. a) Cell ID or WBC Diff = 0% b) Red Blood Cell = 0% c) Hematocrit = 0% d) Hemoglobin = 0% e) White Blood Cell = 0% f) Platelets = 0% 2. Casper Report 0155D. a) Cell ID or WBC Diff = 0% b) Red Blood Cell = 0% c) Hematocrit = 0% d) Hemoglobin = 0% e) White Blood Cell = 0% f) Platelets = 0% 3. A phone interview with the TS/GS on 05/07/2024 @ 10:45 AM confirmed that the laboratory failed to submit the PT results on time to the PT provider. D2130 HEMATOLOGY CFR(s): 493.851(f) Failure to achieve satisfactory performance for the same analyte in two consecutive events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on Proficiency Testing (PT) desk review of the American Proficiency Institute (API) performance summary results, a review of the Casper report 0155D, and a phone interview with the general supervisor/technical supervisor (GS/TS), the laboratory had unsuccessful performance in two (2) out of three (3) consecutive testing events for the following analytes in Hematology. Findings include. 1. API 2nd event 2023 a) Red Blood Cell - 0% b) Hematocrit- 0% c) Hemoglobin - 0% d) White Blood Cell - 0% e) Platelets - 0% 2. Casper Report 1055D 2nd event 2023 a) Red Blood Cell - 0% b) Hematocrit- 0% c) Hemoglobin - 0% d) White Blood Cell - 0% e) Platelets - 0% 3. API 1st event 2024 a) Red Blood Cell - 60% b) Hematocrit- 40% c) Hemoglobin - 60% d) White Blood Cell - 60% e) Platelets - 60% 4. Casper Report 0155D 1st event 2024 a) Red Blood Cell - 60% b) Hematocrit- 40% c) Hemoglobin - 60% d) White Blood Cell - 60% e) Platelets - 60% 5. A phone interview with the GS /TS on 05/07/2024 at 10:45 AM confirmed these findings. D6076 LABORATORY DIRECTOR CFR(s): 493.1441 The laboratory must have a director who meets the qualification requirements of 493. 1443 of this subpart and provides overall management and direction in accordance with 493.1445 of this subpart. This CONDITION is not met as evidenced by: Based on a Proficiency Testing (PT) desk review of the American Proficiency Institute (API) performance summary results, a review of the Casper report 0155D, -- 2 of 3 -- and a phone interview with the general supervisor/technical supervisor (GS/TS), the laboratory director failed to provide overall management and guidance to the laboratory staff, which resulted in multiple PT failures. Refer to D6090 and D6092. D6090 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(4)(ii) The laboratory director must ensure the results are returned within the timeframes established by the proficiency testing program. This STANDARD is not met as evidenced by: Based on a review of the American Proficiency Institute (API) proficiency testing performance summary reports, Casper Report 0155D, and a phone interview with the technical supervisor/general supervisor (TS/GS), the laboratory director failed to ensure that proficiency testing (PT) results were submitted on time to the PT provider. Findings include: 1. API 2nd event 2023. a) Cell ID or WBC Diff = 0% b) Red Blood Cell = 0% c) Hematocrit = 0% d) Hemoglobin = 0% e) White Blood Cell = 0% f) Platelets = 0% 2. Casper Report 0155D. a) Cell ID or WBC Diff = 0% b) Red Blood Cell = 0% c) Hematocrit = 0% d) Hemoglobin = 0% e) White Blood Cell = 0% f) Platelets = 0% 3. A phone interview with the TS/GS on 05/07/2024 @ 10:45 AM confirmed that the laboratory failed to submit the PT results on time to the PT provider. D6092 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(4)(iv) The laboratory director must ensure an approved

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 Proficiency Testing (PT) desk review of the American Proficiency Institute (API) proficiency testing and CASPER Report 0155D, and phone conversation with the Technical Supervisor (TS) revealed the laboratory had unsuccessful participation for two (2) consecutive testing events for the specialties Routine Chemistry, Endocrinology, and Toxicology in 2023. Findings include. 1. API 2nd event 2023 = Routine Chemistry 0% 2. API 2nd event 2023 = Endocrinology 0% 3. API 2nd event 2023 = Toxicology 0% 4. API 3rd event 2023 = Routine Chemistry 0% 5. API 3rd event 2023 = Endocrinology 0% 6. API 3rd event 2023 = Toxicology 0% 7. Phone conversation with the TS confirmed these findings on 10/16/2023 @ 11:15 AM. 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 -- 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 Proficiency Testing (PT) desk review of the American Proficiency Institute (API) proficiency testing and CASPER Report 0155D, and phone conversation with the Technical Supervisor (TS), revealed the laboratory failed to return the proficiency testing on time resulting in a zero (0) score for two (2) consecutive testing events for the specialty Routine Chemistry in 2023. Findings include. 1. API 2nd event 2023 = Routine Chemistry 0% 2. API 3rd event 2023 = Routine Chemistry 0% 3. Analytes in Routine Chemistry includes alanine aminotransferase, albumin, alkaline phospatase, amylase, aspartate aminotransferase, total bilirubin, pH blood gas, PO2 blood gas, PCO2 blood gas, calcium, chloride, cholesterol total, cholesterol high density lipoprotein, creatine kinase total, creatinine, glucose, lactate dehydrogenase, magnesium, potassium, sodium, total protein, triglycerides, urea nitrogen, and uric acid. 4. Phone conversation with the TS confirmed these findings on 10/16/2023 @ 11: 15 AM. D2104 ENDOCRINOLOGY CFR(s): 493.843(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 Proficiency Testing (PT) desk review of the American Proficiency Institute (API) proficiency testing and CASPER Report 0155D, and phone conversation with the Technical Supervisor (TS), revealed the laboratory failed to return the proficiency testing on time resulting in a zero (0) score for two (2) consecutive testing events for the specialty Endocrinology in 2023. Findings include. 1. API 2nd event 2023 = Endocrinology 0% 2. API 3rd event 2023 = Endocrinology 0% 3. Analytes in Endocrinology includes free thyroxine, human chorionic gonadotropin, and thyroid stimulating hormone. 4. Phone conversation with the TS confirmed these findings on 10/16/2023 @ 11:15 AM. D2115 TOXICOLOGY CFR(s): 493.845(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 Proficiency Testing (PT) desk review of the American Proficiency Institute (API) proficiency testing and CASPER Report 0155D, and phone conversation with -- 2 of 3 -- the Technical Supervisor (TS), revealed the laboratory failed to return the proficiency testing on time resulting in a zero (0) score for two (2) consecutive testing events for the specialty Toxicology in 2023. Findings include. 1. API 2nd event 2023 = Toxicology 0% 2. API 3rd event 2023 = Toxicology 0% 3. Analytes in Toxicology includes Alcohol and Digoxin. 4. Phone conversation with the TS confirmed these findings on 10/16/2023 @ 11:15 AM. -- 3 of 3 --

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: Review of the College of American Pathologists (Excel) (CAP) proficiency testing (PT) shows laboratory had unsuccessful participation for pO2 in Routine Chemistry. Refer to D2096 D2096 ROUTINE CHEMISTRY CFR(s): 493.841(f) Failure to achieve satisfactory performance for the same analyte or test in two consecutive testing events or two out of three consecutive testing events is 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 -- unsuccessful performance. This STANDARD is not met as evidenced by: Record review of the College of American Pathologist (CAP) Excel proficiency testing (PT) results reveals that your laboratory has had unsatisfactory performance on two consecutive PT events. Findings include: 1. CAP 2nd event 2019 , pO2 = 60% 2. CAP 3rd event 2019 , pO2 = 40% -- 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: Review of the College of American Pathologists (Excel) (CAP) proficiency testing (PT) shows laboratory had unsuccessful participation for Phenytoin in Toxicology. Refer to D2110 and D2111. D2110 TOXICOLOGY CFR(s): 493.845(b) Failure to attain an overall testing event score of at least 80 percent is unsatisfactory performance. 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: Review of the College of American Pathology (CAP) Proficiency Testing shows the laboratory had unsatisfactory overall performance in Toxicology. Findings include: 1. 1st event 2019 - Toxicology 66% 2. 2nd event 2019 - Toxicology 66% D2111 TOXICOLOGY CFR(s): 493.845(c) Failure to participate in a testing event is unsatisfactory performance and results in a score of 0 for the testing event. Consideration may be given to those laboratories failing to participate in a testing event only if-- (1) Patient testing was suspended during the time frame allotted for testing and reporting proficiency testing results; (2) The laboratory notifies the inspecting agency and the proficiency testing program within the time frame for submitting proficiency testing results of the suspension of patient testing and the circumstances associated with failure to perform tests on proficiency testing samples; and (3) The laboratory participated in the previous two proficiency testing events. This STANDARD is not met as evidenced by: Review of the College of American Pathology (CAP) Proficiency Testing shows the laboratory unsatisfactory performance for Phenytoin. Findings includes: 1st event 2019 Phenytoin - 0 % 2nd event 2019 Phenytoin - 0 % -- 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: Review of the College of American Pathologists (Excel) (CAP) proficiency testing (PT) shows laboratory had unsuccessful participation for in Immunohematology. Refer to D2182. D2182 ANTIBODY IDENTIFICATION CFR(s): 493.865(a) Failure to attain an overall testing event score of at least 80 percent is unsatisfactory performance. 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: Review of the College of American Pathologist (CAP) proficiency testing (PT) reveals that the laboratory has unsatisfactory performance in antibody identification. Finding include: 1. 2nd Event of 2018 - Antibody Identification - 0%. -- 2 of 2 --