Hamilton Hospital/Respiratory Therapy

Summary Statement of Deficiencies D0000 The laboratory was found to be in substantial compliance with CLIA regulations 42 CFR Part 493. Standard level deficiency was cited. D5445 CONTROL PROCEDURES CFR(s): 493.1256(d)(1)(2)(g) (d) Unless CMS Approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub. 7), that provides equivalent quality testing, the laboratory must-- (d)(1) Perform control procedures as defined in this section unless otherwise specified in the additional specialty and subspecialty requirements at 493. 1261 through 493.1278. (d)(2) For each test system, perform control procedures using the number and frequency specified by the manufacturer or established by the laboratory when they meet or exceed the requirements in paragraph (d)(3) of this section. (d)(3) At least once each day patient specimens are assayed or examined perform the following for: This STANDARD is not met as evidenced by: Based on surveyor observation, review of manufacturer's instructions, quality control (QC) results, patient final reports, and confirmed in interview, the laboratory failed to document performance of QC prior to patient testing for ten of ten randomly reviewed patients tested in December 2024. Findings Included: 1. During a tour of the facility on 02/05/2025 at 10:16 AM, the surveyor observed one Nova Prime blood gas analyzer available for patient testing (Serial Number: P07320120C). 2. Review of Nova Prime manufacturer's instructions (also serving as the laboratory's policy for blood gas QC), "Nova Biomedical Prime Instructions for Use Manual" (Version: 2014) revealed the following: "Appendix A A.1.1 Quality Control Healthcare facilities should follow federal, state, and local guidelines for testing quality control materials. At a minimum, Nova Biomedical recommends that each laboratory performs the following minimum QC procedures (Auto-Cartridge QC or External Ampule QC) on each analyzer: During each 8 hours of testing, analyze one level of 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 -- Control. Analyze all levels during each day of operation." 3. Review of laboratory QC records in 2024, revealed the laboratory performed all three levels of QC only once every 30 days. The laboratory was asked to provide documentation to support the reduction of QC from every eight hours to every 30 days, and none was provided. 4. Review of patient final reports revealed the following ten patients tested in December 2024, with no documented QC performed prior to patient testing: a. Patient 1 (See attached Patient Alias List) Date Performed: 12/18/2024; 10:28 b. Patient 2 Date Performed: 12/22/2024; 12:36 c. Patient 3 Date Performed: 12/22/2024; 14:47 d. Patient 4 Date Performed: 12/25/2024; 00:09 e. Patient 5 Date Performed: 12/25 /2024; 12:12 f. Patient 6 Date Performed: 12/25/2024; 15:31 g. Patient 7 Date Performed: 12/25/2024; 21:58 h. Patient 8 Date Performed: 12/26/2024; 17:01 i. Patient 9 Date Performed: 12/29/2024; 16:16 j. Patient 10 Date Performed: 12/30 /2024; 23:01 5. In an interview on 02/05/2025 in the facility chapel at 11:35 AM with the technical consultant (TC-1), TC-1 confirmed the laboratory failed to document performance of QC prior to patient testing for ten of ten randomly reviewed patients tested in December 2024. -- 2 of 2 --

Summary Statement of Deficiencies D0000 The following deficiencies are a result of a desk review of proficiency testing scores obtained from the CMS (Centers for Medicare and Medicaid Services) national database and verified with the proficiency testing company, American Proficiency Institute (API). The facility was found to be out of compliance with the conditions of participation of the CLIA program. The following CONDITION LEVEL DEFICIENCIES were found to be out of compliance: 493.803 Successful participation in a proficiency testing program 493.1403 Laboratory Director, Moderate Complexity 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: 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 -- Based on a proficiency testing desk review of Center for Medicare and Medicaid Services (CMS) form 0155 and American Proficiency Institute (API) records, it was determined the laboratory had not successfully participated in a proficiency testing program approved by HHS, for each specialty, subspecialty, and analyte or test in which the laboratory is certified under CLIA. The laboratory did not successfully participate in the specialty of Routine Chemistry for PCO2 blood gas analyte. Refer to D2096 and D2097. 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 unsuccessful performance. This STANDARD is not met as evidenced by: Based on a proficiency testing desk review of Center for Medicare and Medicaid Services (CMS) form 0155 and American Proficiency Institute (API) 2022 (2nd Event) and 2023 (1st Event) records, it was revealed that the laboratory failed to achieve satisfactory performance (80% or greater) for the same analyte in two out of three consecutive testing events in the specialty of Routine Chemistry for the partial pressure of carbon dioxide (PCO2) blood gas analyte. Two out of three consecutive unsatisfactory scores result in unsuccessful PT performance. Findings included: 1. Review of the CMS 0155 report revealed the following results: Routine Chemistry 2022 - 2nd Event laboratory received an unsatisfactory score of 20% for the PCO2 blood gas analyte. Routine Chemistry 2023 - 1st Event laboratory received an unsatisfactory score of 20% for PCO2 blood gas analyte. 2. A proficiency desk review from American Proficiency Institute (API) 2022 and 2023 proficiency testing records confirmed the above scores. D2097 ROUTINE CHEMISTRY CFR(s): 493.841(g) Failure to achieve an overall testing event score of satisfactory performance for two consecutive testing events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on a proficiency testing desk review of Center for Medicare and Medicaid Services (CMS) form 0155 and American Proficiency Institute (API) 2022 (2nd Event) and 2023 (1st Event) records, it was revealed the laboratory failed to achieve an overall testing event score of satisfactory performance (80% or greater) for two out of three consecutive testing events for the specialty of chemistry. Two out of three consecutive unsatisfactory scores result in unsuccessful PT performance. Findings included: 1. Review of the CMS 0155 report revealed the following results: Routine Chemistry 2022 - 2nd Event: The laboratory received an overall unsatisfactory score of 66% for Routine Chemistry. Routine Chemistry 2023- 1st Event: The laboratory received an overall unsatisfactory score of 66% for Routine Chemistry 2. A proficiency desk review from American Proficiency Institute (API) 2022 and 2023 proficiency testing records confirmed the above scores. -- 2 of 3 -- 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 a proficiency testing desk review of Center for Medicare and Medicaid Services (CMS) form 0155 and American Proficiency Institute (API) records, the Laboratory Director failed to fulfill their responsibilities. The Laboratory Director failed to ensure proficiency testing was tested as required under subpart H. Refer to D6016. D6016 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(i) 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)(i) Ensure that the proficiency testing samples are tested as required under Subpart H of this part; This STANDARD is not met as evidenced by: Based on a proficiency testing desk review of Center for Medicare and Medicaid Services (CMS) form 0155 and American Proficiency Institute (API) records, the Laboratory Director failed to ensure proficiency testing was tested as required. The laboratory failed to achieve satisfactory performance (80% or greater) for the same analyte in two out of three consecutive testing events in the specialty of Routine Chemistry for the partial pressure of carbon dioxide (PCO2) blood gas analyte, resulting in unsuccessful performance. The laboratory failed to achieve an overall testing event score of satisfactory performance (80% or greater) for two out of three consecutive testing events for the specialty of chemistry, resulting in unsuccessful performance. Refer to D2096 and 2097. -- 3 of 3 --

Summary Statement of Deficiencies D0000 An entrance conference was held with the laboratory representative. The survey process was discussed and survey forms were provided. An opportunity for questions and comments was given. Noted deficiencies and plans of correction were discussed with the laboratory representative at the exit conference. The laboratory representative was given an opportunity to provide evidence of compliance with the noted deficiencies, and no such evidence was provided prior to survey exit. The facility was found to be in COMPLIANCE with applicable Conditions of Participation in the CLIA program, and recertification is recommended. Note: The CMS-2567 (Statement of Deficiencies) is an official, legal document. All information must remain unchanged except for entering the

Summary Statement of Deficiencies D3031 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(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 review of laboratory quality control records (2018 through 06/2019) and confirmed in interview, the laboratory failed to retain package inserts for Stat Profile pHOx Oximeter quality control material for Arterial Blood Gases (ABG) for 17 of 17 lot numbers. The findings included: 1. Review of laboratory quality control records revealed the laboratory failed to retain the lot value assignment datasheets for the following QC (quality control) lot numbers for Stat Profile pHOx quality control material: Lot: 16351017 Lot: 16351018 Lot: 17005010 Lot: 17089034 Lot: 17097061 Lot: 17100084 Lot: 17100094 Lot: 17158033 Lot: 17289034 Lot: 17277013 Lot: 17361067 Lot: 18046030 Lot: 18062002 Lot: 18064054 Lot: 18064055 Lot: 18136029 Lot: 18298040 2. In an interview on 07/10/2019 at 1500 hours in the chapel, the Technical Consultant was asked to provide package inserts for the Stat Profile pHOx quality control material. The TC stated that the laboratory did not kept the package inserts. This confirmed the above findings. D5413 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(b) The laboratory must define criteria for those conditions that are essential for 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: (1) Water quality. (2) Temperature. (3) Humidity. 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 -- (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 review of manufacturer's instructions for the Nova Stat Profile pHOx Ultra blood gas analyzer (Serial number Z1315090), laboratory environmental records (2018 through 06/2019), and confirmed in interview, the laboratory failed to ensure room temperature and humidity ranges were within the operating specifications for the Nova Stat Profile pHOx Ultra blood gas analyzer for 18 of 18 months. Findings included: 1. The manufacturer's instructions for the Nova Stat Profile pHOx Ultra blood gas analyzer stated the following in the section titled "Working Area Requirements": "Ambient operating temperature is 15C to 30C (59F to 86F). Operate at humidity of 0 to 85% without condensation." 2. Review of the laboratory environmental log titled "Olney-Hamilton Hospital Respiratory Therapy" for 2018 through 06/2019 revealed an acceptable room temperature range of 2C to 25C and humidity range of 0% to 100%. The laboratory failed to ensure room temperature and humidity ranges were within the operating specifications for the Nova Stat Profile pHOx Ultra blood gas analyzer. 3. The above findings were confirmed by the Technical Consultatant on 07/10/2019 at 1500 hours in the hospital chapel. D5445 CONTROL PROCEDURES CFR(s): 493.1256(d)(1)(2)(g) Unless CMS Approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub. 7), that provides equivalent quality testing, the laboratory must-- (d)(1) Perform control procedures as defined in this section unless otherwise specified in the additional specialty and subspecialty requirements at 493.1261 through 493.1278. (d)(2) For each test system, perform control procedures using the number and frequency specified by the manufacturer or established by the laboratory when they meet or exceed the requirements in paragraph (d)(3) of this section. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on direct observation, review of the laboratory's Individualized Quality Control Plan (IQCP) for the modification of the frequency of quality control (QC) testing performed for the Nova Stat Profile pHOx Ultra blood gas analyzer, pHOx QC records, and staff interview, it was revealed the laboratory failed to identify risks and the frequency and impact for each risk for 5 of 5 categories for the pHOx Ultra blood gas analyzer. Findings included: 1. During a tour of the laboratory on 07/11/2019 at 0930 hours, a Nova Stat Profile pHOx Ultra blood gas analyzer (Serial Number Z31315090) was observed. The analyzer was used to test pH, PCO2, PO2, O2Sat, HbCO, THb, and OxyHb. 2. Risk assessment is the identification and evaluation of potential failures and sources of errors in a testing process. Risk assessments for IQCP must include, at a minimum, an evaluation of the following five components: *Specimen *Test System *Reagent *Environment *Testing Personnel The scope of the risk assessments must encompass the entire testing process - preanalytic, analytic, and post-analytic phases and include, at a minimum, the evaluation of the five risk assessment components listed above for each test for which the laboratory wishes to employ IQCP. To conduct a risk assessment, the laboratory must identify the sources of potential failures and errors for a testing process, and evaluate the frequency and impact of those failures and sources of error on test quality. In-house data, established -- 2 of 3 -- by the laboratory in its own environment and by its own personnel, must be utilized to demonstrated that the stability of the test system as it is used in that laboratory supports the number and frequency of the QC documented in the IQCP. 2. Review of the laboratory policy titled "Individualized Quality Control Plan Summary" (Approval date 12/05/2016) and QC records revealed the laboratory failed to identify risk, frequency of occurrence, severity of harm, measures to control risk and supporting documentation of the preanalytic, analytic and post-analytic phases of the five risk assessment components. Examples: For the category of Specimen, the laboratory identified "Written specimen collection procedures with defined acceptability criteria." The laboratory failed to identify the impact of test quality if the specimen collection did not follow procedures or if the specimen was unacceptable for testing. For the category of Test System, the laboratory identified "Two level of external QC every 30 days." The laboratory failed to provide data that supported or proved the rationale for the number, type and frequency of external quality control testing. 3. In an interview on 07/11/2019 at 0930 in the laboratory, testing person#2 was asked to provide documentation of data that supported or proved the rationale for the number, type and frequency of external quality control testing every 30 days and documentation of a more complete IQCP. No documentation was provided. The above findings were confirmed by laboratory representatives during an interview on 07 /11/2019 at 1500 hours in the Chief Operating Officer's office. Word Key: PCO2= Partial pressure of carbon dioxide PO2= Partial pressure of oxygen O2 Sat=Oxygen saturation HbCO=Carboxyhemoglobin THb=Total Hemoglobin OxyHb=Deoxyhemoglobin D6053 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(9) The technical consultant is responsible for evaluating and documenting the performance of individuals responsible for moderate complexity testing at least semiannually during the first year the individual tests patient specimens. This STANDARD is not met as evidenced by: Based on review of CMS (Centers for Medicare and Medicaid Services) 209 form, personnel records, and interview with staff, the Technical Consultant (TC) failed to evaluate and document performance for 1 of 1 Testing Persons responsible for moderate complexity testing at least semiannually during the first year testing persons analyze patient specimens in 2017 and 2018. Findings included: 1. Review of the submitted CMS 209 form revealed Testing Person #3 listed to perform moderate complexity blood gas analysis. 2. Review of personnel records from 2017 through 2019 revealed the following: Testing Person #3; Date of hire-06/22/2017 Training on 06/22/17 Competency Evaluation 05/21/2018 (11 months after initial training) Competency Evaluation 06/19/2019 (2 years after initial training) The TC failed to evaluate and document performance at least semiannually during the first year of patient testing. 3. In an interview on 07/09/2019 at 1000 hours in the hospital chapel, the TC was asked to provide documentation of semiannual competency assessment for Testing Person #3. No documentation was provided. This confirmed the above findings. -- 3 of 3 --

Summary Statement of Deficiencies D0000 D000The following deficiencies are a result of a desk review of proficiency testing scores obtained from the CMS (Center for Medicare Services) national database and verified with the proficiency testing company, American Proficiency Institute (API) . The facility was found to be out of compliance with the conditions of participation of the CLIA program. The following CONDITION LEVEL DEFICIENCIES were found to be out of compliance: 493.803 successful participation in a proficiency testing program 493.1403 laboratories performing moderate complexity testing; laboratory director 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: 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 -- Based on a desk review of proficiency testing records obtained from the CMS (Center for Medicare Services) national database and verified with the proficiency testing company, American Proficiency Institute (API), it was determined the laboratory had not successfully participated in a proficiency testing program approved by HHS, for each specialty, subspecialty, and analyte or test in which the laboratory is certified under CLIA. The laboratory did not successfully participate in the specialty of hematology for hemoblobin. Refer to D2130. 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: Based on a proficiency testing desk review of CMS form 155 and American Proficiency Institute records found that the laboratory failed to attain a score of at least 80% acceptable responses for each analyte in the subspecialty of hematology for the analyte hemoglobin (HGB). Findings: 1. API 2018 - 1st event the laboratory received an unsatisfactory score of 40% for HGB. 2. API 2018 - 2nd event the laboratory received an unsatisfactory score of 40% for HGB. D2122 HEMATOLOGY CFR(s): 493.851(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 a proficiency testing desk review of CMS form 155 and API records found that the laboratory failed to attain an overall score of at least 80% for each testing event in the specialty of hematology. Findings: 1. API 2018 - 1st event lab received a score of 40% for hematology testing event. 1. API 2018 - 2nd event lab received a score of 40% for hematology testing event. 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 desk review of proficiency testing records, it was determined the laboratory failed to achieve satisfactory performance (80% or greater) for the same analyte in two consecutive testing events or two out of three consecutive testing events in the specialty of Hematology. Two out of three unsatisfactory scores results in unsuccessful PT performance. Findings: 1. API 2018 - 1st event the laboratory received an unsatisfactory score of 40% for HGB. 2. API 2018 - 2nd event the laboratory received an unsatisfactory score of 40% for HGB. -- 2 of 3 -- D2131 HEMATOLOGY CFR(s): 493.851(g) Failure to achieve an overall testing event score of satisfactory performance for two consecutive testing events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on desk review of proficiency testing records, it was determined the laboratory failed to achieve satisfactory performance (80% or greater) for each event in two consecutive testing events or two out of three consecutive testing events in the specialty of Hematology. Two out of three unsatisfactory scores results in unsuccessful PT performance. Findings: 1. API 2018 - 1st event lab received a score of 40% for hematology testing event. 1. API 2018 - 2nd event lab received a score of 40% for hematology testing 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 a desk review of laboratory proficiency testing performance it was revealed that the laboratory director failed to provide overall management and direction of the laboratory services. Refer to D6016 D6016 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(i) 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)(i) Ensure that the proficiency testing samples are tested as required under Subpart H of this part; This STANDARD is not met as evidenced by: Based on a desk review of proficiency testing results it was revealed that the laboratory director failed to ensure the overall quality of the laboratory services provided. The laboratory director failed to ensure successful participation in a HHS approved proficiency testing program. Refer to D2130 and D2131 -- 3 of 3 --