Seymour Hospital Laboratory

Summary Statement of Deficiencies D0000 The laboratory was found to be in substantial compliance with CLIA regulations 42 CFR Part 493. Standard level deficiencies were cited. 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 laboratory's verification records for the Siemens' Dimension EXL with LM analyzer, review of patient test records, and staff interview, the laboratory failed to have documentation of verifying 4 of 4 patient normal ranges established for 3 new assays. The findings included: 1. A review of the laboratory's verification records for the Siemens' Dimension EXL with LM analyzer identified 3 new assays were implemented in April 2023. They were: a) C-reactive protein b) Iron c) Total Iron Binding Capacity 2. A review of patient test records determined the following 4 patient normal ranges were in use for the new assays: a) C-reactive protein 0 - 3.0 mg/L b) Iron 65 - 175 ug/dL (Male) 50 - 170 ug/dL (Female) c) Total Iron Binding Capacity 250 - 450 ug/dL 3. The laboratory's verification studies did not have documentation of verifying the identified patient normal ranges. 4. General supervisor number 1 (as listed on Form CMS 209) confirmed the findings in an interview conducted on 09/17/2024 at 1015 hours in the conference room. Key mg/L - milligrams per liter ug/dL - micrograms per deciliter 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 -- D5439 CALIBRATION AND CALIBRATION VERIFICATION CFR(s): 493.1255(b) Unless otherwise specified in this subpart, for each applicable test system the laboratory must do the following: Perform and document calibration verification procedure - (b)(1) Following the manufacturer's calibration verification instructions; (b)(2) Using the criteria verified or established by the laboratory under 493.1253(b)(3) -- (b)(2)(i) Including the number, type, and concentration of the materials, as well as acceptable limits for calibration verification; and (b)(2)(ii) Including at least a minimal (or zero) value, a mid-point value, and a maximum value near the upper limit of the range to verify the laboratory's reportable range of test results for the test system; and (b)(3) At least once every 6 months and whenever any of the following occur: (b)(3)(i) A complete change of reagents for a procedure is introduced, unless the laboratory can demonstrate that changing reagent lot numbers does not affect the range used to report patient test results, and control values are not adversely affected by reagent lot number changes. (b)(3)(ii) There is major preventive maintenance or replacement of critical parts that may influence test performance. (b)(3)(iii) Control materials reflect an unusual trend or shift, or are outside of the laboratory's acceptable limits, and other means of assessing and correcting unacceptable control values fail to identify and correct the problem. (b)(3)(iv) The laboratory's established schedule for verifying the reportable range for patient test results requires more frequent calibration verification. This STANDARD is not met as evidenced by: Based on review of the laboratory's calibration verification records for the Siemens' EPOC Blood Analysis System from 2022, 2023 and 2024, and staff interview, the laboratory failed to have documentation of performing calibration verification every six months on 3 of 3 analytes. The findings included: 1. A review of the laboratory's calibration records for the Siemens' EPOC Blood Analysis System from 2022, 2023 and 2024 identified calibration verifications were performed on pH, PO2 and PCO2 on the following days: April 8, 2022 September 6, 2022 (5 months later) January 1, 2023 (4 months later) April 4, 2023 (3 months later) September 9, 2024 (19 months later) 2. Testing personnel number 5 (as listed on Form CMS 209) confirmed the findings in an interview on 09/17/2024 at 1130 hours in her office. D5781

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 CLIA regulations 42 CFR Part 493. CONDITION LEVEL DEFICIENCIES were found to be out of compliance: 493.803 Successful participation [proficiency testing] 493.1441 Laboratories performing high 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: Based on a desk review of proficiency testing records, it was revealed 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 3 -- 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 Immunohematology. Refer to D2162 and D2163. D2162 ABO GROUP AND D(RHO) TYPING CFR(s): 493.859(f) Failure to achieve satisfactory performance for the same analyte 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 the CASPER- 0155 Individual Laboratory Report obtained from the CMS national database and API 2023 (1st and 2nd event) records, the laboratory failed to achieve satisfactory performance (100%) for the same analyte in two out of two consecutive testing events in the specialty of Immunohematology for the D(RHO) analyte. Two of two consecutive unsatisfactory scores result in unsuccessful PT performance. The findings include: 1. Review of the CASPER- 0155 report revealed the following: Blood Bank (ABO/RH) 2023 - 1st Event Laboratory received an unsatisfactory score of 0% for the D(RHO) analyte Blood Bank (ABO/RH) 2023 - 2nd Event Laboratory received an unsatisfactory score of 80% for the D(RHO) analyte 2. A proficiency testing desk review from API 2022 and 2023 proficiency testing records confirmed the above findings. Key: CASPER: Certification and Survey Provider Enhanced Reporting CMS: Centers for Medicare and Medicaid API: American Proficiency Institute D2163 ABO GROUP AND D(RHO) TYPING CFR(s): 493.859(g) Failure to achieve an overall testing event score of satisfactory 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 the CASPER- 0155 Individual Laboratory Report obtained from the CMS national database and API 2023 (1st and 2nd event) records, it was revealed the laboratory failed to achieve an overall testing event score of satisfactory performance (100%) for two out of two consecutive testing events for the specialty of Immunohematology ABO/RHO. Two of two consecutive unsatisfactory scores result in unsuccessful PT performance. The findings include: 1. Review of the CASPER- 0155 report revealed the following: Blood Bank (ABO/RH) 2023 - 1st Event Laboratory received an unsatisfactory score of 0% for ABO/RHO Blood Bank (ABO/RH) 2023 - 2nd Event Laboratory received an unsatisfactory score of 90% for ABO/RHO 2. A proficiency testing desk review from API 2022 and 2023 proficiency testing records confirmed the above findings. Key: CASPER: Certification and Survey Provider Enhanced Reporting CMS: Centers for Medicare and Medicaid API: American Proficiency Institute D6076 LABORATORY DIRECTOR CFR(s): 493.1441 -- 2 of 3 -- 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 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 D6089. D6089 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(4)(i) The laboratory director must ensure 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 an HHS approved proficiency testing program. Refer to D2162 and D2163. -- 3 of 3 --

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 laboratory was found to be NOT in compliance with the conditions of participation of the CLIA program based on the following CONDITION LEVEL DEFICIENCIES: 493.803 Successful participation [proficiency testing] 493.1441 Laboratories performing high 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: Based on a desk review of proficiency testing records, the laboratory failed to 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 -- successfully participate 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 failed to successfully participate in the specialty of Immunohematology for Compatibility Testing. Refer to D2181. D2181 COMPATIBILITY TESTING CFR(s): 493.863(e) Failure to achieve an overall testing event score of satisfactory 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 the CASPER- 0155 Individual Laboratory Report obtained from the CMS national database and API 2022 (2nd and 3rd event) and 2023 (1st event) records, the laboratory failed to achieve satisfactory performance (100%) for the same analyte in three out of three consecutive testing events in the specialty of Immunohematology for Compatibility Testing. Three consecutive unsatisfactory scores result in unsuccessful PT performance. The findings include: 1. Review of the CASPER- 0155 report revealed the following: Compatibility Testing 2022 - 2nd Event Laboratory received an unsatisfactory score of 80% Compatibility Testing 2022 - 3rd Event Laboratory received an unsatisfactory score of 80% Compatibility Testing 2023 - 1st Event Laboratory received an unsatisfactory score of 0% 2. A proficiency testing desk review from API 2022 and 2023 proficiency testing records confirmed the above findings. Key: CASPER: Certification and Survey Provider Enhanced Reporting CMS: Centers for Medicare and Medicaid API: American Proficiency Institute 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 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 D6089. D6089 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(4)(i) The laboratory director must ensure 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 -- 2 of 3 -- laboratory director failed to ensure the overall quality of the laboratory services provided. The laboratory director failed to ensure successful participation in an HHS approved proficiency testing program. Refer to D2181. -- 3 of 3 --

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 laboratory was found to be NOT in compliance with the conditions of participation of the CLIA program based on the following CONDITION LEVEL DEFICIENCIES: 493.803 Successful participation [proficiency testing] 493.1441 Laboratories performing high complexity testing; laboratory director 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 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 review of American Proficiency Institute (API) records, analytic records, and interview with facility personnel, the laboratory director and the individual performing testing failed to attest to the routine integration of the samples into the patient workload for 1 of 3 Miscellaneous Chemistry events in 2017. The findings included: 1. Based on review of the attestation page for the 2nd Miscellaneous Chemistry event in 2017: "SIGNATURES REQUIRED - Testing personnel and the laboratory director must physically sign an attestation statement for all PT results, and retain the signed statement (or a copy) for a minimum of 2 years. either the attestation statement below or a printed copy of the form provided online can be used for this purpose." The attestation sheet was not signed by the testing personnel or the laboratory director. 2. Based on review of analytic records, Testing Person 9 (as listed on the CMS-209 laboratory personnel report) performed testing by the MedTox Scan toxicology method on the API samples on 10/30/2017. 3. In an interview at 12:50 hours on 8/28/2018 in the conference room, the Laboratory Manager confirmed the laboratory director and the testing person failed to sign the attestation to the routine integration of proficiency samples into the laboratory's workload using the laboratory's routine methods. D5209 PERSONNEL COMPETENCY ASSESSMENT POLICIES CFR(s): 493.1235 As specified in the personnel requirements in subpart M, the laboratory must establish Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 12 -- and follow written policies and procedures to assess employee and, if applicable, consultant competency. This STANDARD is not met as evidenced by: Based on review of laboratory policies and procedures, competency assessment documentation, and interview with facility personnel, the laboratory failed to establish and follow written policies to assess employee and consultant competency to ensure 4 of 12 testing personnel competency assessments were performed by a qualified Technical Consultant in 2017 and 2018. The findings included: 1. Based on review of policies and procedures, the laboratory had established a written policy titled "ANNUAL PERSONNEL COMPETENCY ASSESSMENT", effective February 24, 2009. The policy states the following: "All Clinical Laboratory technologists are to be tested annually for competency in all areas of Clinical Laboratory. These include: Blood Banking, Chemistry, Coagulation, Hematology, Urinalysis, Microbiology, and Miscellaneous areas. Competency testing will include CAP proficiency testing or other CMS approved Proficiency Testing Program on rotation schedule for all technologist. Clinical Laboratory in-house examinations will be done annually, on their anniversary dates for all technologists. A passing grade of at least 70 percent must be achieved. When a technologist fails an examination in any area of the Clinical Laboratory, he/she will be retested in that area after in-service by supervisor. If a second failure occurs, the technologist will be placed on probation for 30 days with additional in-servicing and then retested. If a third failure occurs, the technologist will be suspended." The policy failed to address the following requirements as required in the CLIA regulations at subpart M of 42 CFR part 493: 493.1413 Standard; Technical consultant responsibilities. The technical consultant is responsible for the technical and scientific oversight of the laboratory. The technical consultant is not required to be onsite at all times testing is performed; however, he or she must be available to the laboratory on an as needed basis to provide consultation, as specified in paragraph (a) of this section. (a) The technical consultant must be accessible to the laboratory to provide on-site, telephone, or electronic consultation; and (b) The technical consultant is responsible for - (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. The procedures for evaluation of the competency of the staff must include, but are not limited to - (i) Direct observations of routine patient test performance, including patient preparation, if applicable, specimen handling, processing and testing; (ii) Monitoring the recording and reporting of test results; (iii) Review of intermediate test results or worksheets, quality control records, proficiency testing results, and preventive maintenance records; (iv) Direct observation of performance of instrument maintenance and function checks; (v) Assessment of test performance through testing previously analyzed specimens, internal blind testing samples or external proficiency testing samples; and (vi) Assessment of problem solving skills; and (9) Evaluating and documenting the performance of individuals responsible for moderate complexity testing at least semiannually during the first year the individual tests patient specimens. Thereafter, evaluations must be performed at least annually unless test methodology or instrumentation changes, in which case, prior to reporting patient test results, the individual's performance must be reevaluated to include the use of the new test methodology or instrumentation. Refer to 493.1413(b)(8) and 493.1451(b)(8) for specific testing personnel competency requirements and refer to 493.1407(e)(12) and 493.1445(e)(13) for establishing policies to monitor each individual's competency and identify remedial training or continuing education needs. Documented competency assessment is required for the following named positions on the Form 209: technical -- 2 of 12 -- consultant, clinical consultant, technical supervisor, general supervisor. The laboratory must have policies and procedures to assess competency based on the position responsibilities listed in Subpart M and these assessments must be performed at a frequency determined by the laboratory. If these people (TC, CC, TS, GS) perform testing on patient specimens, they are required to have the six required procedures in their competency assessment in addition to a competency assessment based on their federal regulatory responsibilities. 2. Based on review of competency assessment documentation for respiratory therapy staff that before routine chemistry blood gas testing, the laboratory failed to ensure the individual assessing competency was qualified as a Technical Consultant for the routine chemistry specialty. The competency assessment for Testing Person 11 (as listed on the CMS-209) was signed by Testing Person 8 on 01/03/2017 and 01/08/2018. The competency assessment for Testing Person 12 (as listed on the CMS-209) was signed by Testing Person 8 on 01 /03/2017 and 01/08/2018. The competency assessment for Testing Person 8 (as listed on the CMS-209) was signed by Testing Person 10 on 01/03/2017 and 01/08/2018. The competency assessment for Testing Person 10 (as listed on the CMS-209) was signed by Testing Person 8 on 01/03/2017 and 01/08/2018. Testing Person 8 and Testing Person 10 do not meet the CLIA requirements in subpart M for qualification as a Technical Consultant in moderate complexity routine chemistry. 3. In an interview at 11:22 hours on 8/28/2018 in the break room, the Laboratory Manager stated the laboratory had developed a competency assessment policy and stated that some of the requirements listed above were missing from the laboratory's procedure. D5291 GENERAL LABORATORY SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1239(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 general laboratory systems requirements specified at 493.1231 through 493.1236. This STANDARD is not met as evidenced by: Based on review of policies and procedures, competency assessment documentation, and interview with facility personnel, the laboratory failed to establish and follow written policies and procedures for an ongoing mechanism to monitor, assess, and, when indicated, correct problems identified in the general laboratory systems requirements specified at 493.1231 through 493.1236 for 2016 and 2017. The findings included; 1. Based on review of laboratory policies and procedures, competency assessment documentation, and interview with facility personnel, the laboratory failed to establish and follow written policies to assess employee and consultant competency to ensure 4 of 12 testing personnel competency assessments were performed by a qualified Technical Consultant. Refer to D5209. Quality Assessment (QA) is an ongoing review process that encompasses all facets of the laboratory's technical and non-technical functions and all locations/sites where testing is performed. QA also extends to the laboratory's interactions with and responsibilities to patients, physicians, and other laboratories ordering tests, and other non-laboratory areas or departments of the facility of which it is a part. When the laboratory discovers an error or identifies a potential problem, actions must be taken to correct the situation. This correction process involves identification and resolution of the problem, and development of policies that will prevent recurrence. Policies for preventing problems that have been identified must be written as well as communicated to the laboratory personnel and other staff, clients, etc., as appropriate. Over time, the laboratory must -- 3 of 12 -- monitor the