Trinity Hospital Lab

Summary Statement of Deficiencies D0000 A proficiency testing desk review survey was performed on 11/8/2024, the laboratory was found not in compliance with the following CONDITION LEVEL DEFICIENCIES D2016 - C.F.R. 493.803 Conditions: Successful participation [proficiency testing] and D6000 - C.F.R. 493.1403 Condition: 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: Based on review of the Certification and Survey Provider Enhanced Reporting (CASPER) - 0155D and American Proficiency Institute (API) proficiency testing records (2024-2 and 2024-3), the laboratory failed to successfully participate in a 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 -- proficiency testing program approved by HHS, for each specialty, subspecialty or test which the laboratory is certified under CLIA. The laboratory failed to successfully participate in the specialty Toxicology for the analyte Alcohol (blood). Refer to D2118. D2118 TOXICOLOGY CFR(s): 493.845(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 review of the Certification and Survey Provider Enhanced Reporting (CASPER) Report 0155D Individual Laboratory Profile and API proficiency testing report, the laboratory failed to achieve satisfactory performance in two out of three consecutive events for the analyte Alcohol (Blood): The finding include: a. Alcohol - 60% on the 2024 second event, Alcohol - 20% onthe 2024 third event; b. A review of the 2024 Alcohol scores from API Proficiency Testing Confirmed the above scores. 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 prficiency testing desk review of the CASPER 0155D report and API Proficiency Testing records for 2024-2 and 2024-3 events, 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 proficiency testing desk review of the CASPER 0155D report and API Proficiency Testing records for 2024-2 and 2024-3 events, the laboratory director failed to ensure successful participation in an HHS approved proficiency testing program. Refer D2118. -- 2 of 2 --

Summary Statement of Deficiencies D2087 ROUTINE CHEMISTRY CFR(s): 493.841(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 review of the laboratory's records and the proficiency testing (PT) result reports, and interview with the laboratory personnel (TP), it was determined that the laboratory failed to attain a score of at least 80 percent of acceptable responses for each analyte in each testing event was unsatisfactory analyte performance for the testing event. The findings included: a. The laboratory is in an acute care hospital, performed various chemistry testing including but not limited to pCO2. b. To ensure the accuracy of the testing results, the laboratory enrolled the routine chemistry PT with American Proficiency Institute (API) PT program. c. The laboratory attained a score of 20% for pCO2 in the Q2 2021, which was unsatisfactory performance in the PT events. e. The laboratory staff affirmed (7/30/21) that the laboratory attained score of 20% for pCO2 in the Q2 2021 PT, which was unsatisfactory performance in that PT events. 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 review of the laboratory's records and the proficiency testing (PT) result reports, and interview with the laboratory personnel (TP), it was determined that the 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 -- laboratory failed to attain a score of at least 80 percent of acceptable responses for each analyte in each testing event was unsatisfactory analyte performance for the testing event. The findings included: a. The laboratory is in an acute care hospital, performed hematology including coagulation testing. b. To ensure the accuracy of the testing result, the laboratory enrolled its PT with American Proficiency Institute (API) PT programs for hematology testing performed. c. The laboratory attained a score of 0 % for Prothrombin Time (PTn) in the Q2 2020 PT event, which was unsatisfactory performance for the PT events. d. The laboratory personnel affirmed (7/30/21) that the laboratory attained a score of 0% for PTn in Q2 2020 PT event was unsatisfactory performance for that event. e. The laboratory performed and reported the PTn results in approximately 67 patient samples each month. D5217 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(c)(1) At least twice annually, the laboratory must verify the accuracy of any test or procedure it performs that is not included in subpart I of this part. This STANDARD is not met as evidenced by: Based on review of the laboratory's records and the proficiency testing (PT) result reports, and interview with the laboratory personnel (TP), it was determined that the laboratory, at least twice annually, failed to verify the accuracy of any test or procedure it performed that is not included in subpart I of 42 CFR part 493. The findings included: a. The laboratory is in an acute care hospital, performed various laboratory testing including but are not limited to the followings: Ammonia, CA-19-9, CRP (hs), HA1C, Lipase, Progesterone (Prog), Testosterone (TST), Troponin (Tpn), TIBC, which are NOT in the list of subpart I of 42 CFR of part 493. b. To ensure the accuracy of the testing results, the laboratory elected to enroll the analyte listed in the item (a) above, which the laboratory performed NOT in the list of subpart I of 42 CFR part 493, for the evaluation of proficiency testing performance with American Proficiency Institute (API) PT programs. c. The laboratory failed to attained scores of 80 % for the analyte listed in the item (d) below, were unsatisfactory performance for the PT events. d. The laboratory failed to attain at least 80% for each analyte in a PT event was unsatisfactory performance for that event, see below: Test/% = test name /graded score in % Qx/Event = Q1 thru Q3/year Qx/Event Test/% Test/% Test/% Q3 2019 CRP(hs)/50 Tpn/40 Q2 2020 Ammonia/67 Prog/50 Q3 2020 CA-19-9/60 TST /50 A1C/60 BNP/20 TIBC/60 Q1 2021 CA19-9/60 Q2 2021 Lipase/60 e. The laboratory performed the analyte identified in the item (d) above in approximately patient samples volume per month in the format of test/volume. CRP(hs)/1 Ammonia /7 Lipase /51 CA19-9/2 TST/11 A1C/82 BNP/45 Tpn/67 f. The laboratory staff affirmed (7/30/21) that the laboratory failed to attain a score of 80% for each analyte listed in the item (d) were unsatisfactory performance for the PT events. D5411 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(a) Test systems must be selected by the laboratory. The testing must be performed following the manufacturer's instructions and in a manner that provides test results within the laboratory's stated performance specifications for each test system as determined under 493.1253. -- 2 of 4 -- This STANDARD is not met as evidenced by: Based on touring the laboratory facility, review of the laboratory records, and interview with the laboratory personnel and the hospital contracted IT (Information Technology) personnel, it was determined that the laboratory must select the test (alarm for transfusion service) systems properly to ensure and provide the accuracy, reliability, and timely test (alarm for transfusion service) system operated and performed to meet the expectations. It was determined that the laboratory failed to establish a newly installed alarm system for Blood Bank's transfusion services including whom/what/how an alarm system to be activated, alerted, and warned, so to assure the laboratory personnel to take actions immediately and accordingly when the temperature of the storage equipment out of acceptable/optimal temperature range failed, and to ensure that the quality of blood products are maintained at all time, in a manner that provides test results (alarm system) operated within the laboratory's stated performance specifications and expectations. The findings included: a. The laboratory is in an acute hospital and provided various laboratory testing including transfusion services with quality blood products. b. The laboratory has newly installed an alarm system to provide immediate warning for the failure of the temperature-controlled storage equipment, and to assure the laboratory take immediately actions to maintain the quality of the blood products in storage. c. Based on interview with the laboratory personnel and the contracted IT personnel, currently the warning systems due to the failure of the temperature system is that the IT department would initiate and generate an email to notify a laboratory personnel, who may or may not in the laboratory, to take actions immediately and to correct the failure or provide alternative ways to assure the quality of the blood products are maintained. d. Based on interview with the laboratory personnel (TP), the better ways of warning of temperature failure is to have a warning system, activated directly to a nursing station which immediately alert the laboratory, (if the laboratory personnel was not aware), and/or plus generate an email by the IT department to designated personnel to assure an immediately and effective actions taken to ensure the quality of the blood products maintained. e. At the time of survey (7/30/21 @ 11:45 am) that there were no acceptable warning systems established and agreed within the concerned personnel including the hospital administration, the laboratory, and the IT, other than the IT send-out an "email" notification. f. The laboratory must select the effective, workable, and appropriate systems as how to immediately and effectively notify the personnel involved to take actions when the temperature of the blood products storage equipment failed and to assure the quality of the blood products maintained. 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 review of the laboratory's records and the proficiency testing (PT) result reports, and interview with the laboratory personnel (TP), it was determined that the laboratory director failed to ensure that the proficiency testing samples were tested as required. The findings included: a. The laboratory is in an acute care hospital, -- 3 of 4 -- performed various laboratory testing which are in the list or NOT in the list of subpart I of 42 CFR part 493. b. The laboratory enrolled its PT with American Proficiency Institute (API) PT programs for all its testing analyte c. The laboratory failed to attain a score of 80 % for analyte listed in 42 CFR part 493 which constitute an unsatisfactory performance for that PT events, see D-2089 and D-2121. d. The laboratory failed to attain a score of 80 % for analyte NOT listed in 42 CFR part 493 which constitute an unsatisfactory performance for the evaluation of proficiency testing performance by the PT events, see D-5217. D6023 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(6) 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)(6) Ensure the establishment and maintenance of acceptable levels of analytical performance for each test system; This STANDARD is not met as evidenced by: Based on touring the facility, review of the laboratory's records and the proficiency testing (PT) result reports, and interview with the laboratory personnel (TP) and the hospital contracted IT personnel, it was determined that the laboratory director failed to ensure the establishment and maintenance of acceptable levels of analytical performance for each test system. The findings included: a. 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 is, see D-2087, D-2121 and D-5217. b. The laboratory must select the testing systems which would provide and assure for accuracy, reliability and timely of the testing(alarm system in transfusion service) systems laboratory operated, see D-5411. -- 4 of 4 --

Summary Statement of Deficiencies D2164 UNEXPECTED ANTIBODY DETECTION CFR(s): 493.861(a) 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 first quarter (Q1-2016) of the American Proficiency Institute (API) proficiency testing records, random patient sampling test results and interview with the technical supervisor, it was determined that the laboratory failed to attain an overall testing event score of at least 80 percent performance. The findings included: a. API reported an unsatisfactory score of 60% for Unexpected Antibody Detection testing for Q1-2016. b. For one (1) out of two (2) random patient sampling test results reviewed covering from period 2/3/2016 to 3/15/2016, the laboratory analyzed and reported Unexpected Antibody tests even with the laboratory's failure in proficiency test. c. The technical supervisor affirmed (2/16/2018, 10AM), that the laboratory received the above unsatisfactory proficiency testing score of 60% for Unexpected Antibody test. D2173 COMPATIBILITY TESTING CFR(s): 493.863(a) Failure to attain an overall testing event score of at least 100 percent is unsatisfactory performance. This STANDARD is not met as evidenced by: Based on review of the second quarter (Q2-2017) of the American Proficiency Institute (API) proficiency testing records, random patient sampling test results and interview with the technical supervisor, it was determined that 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 5 -- attain an overall testing event score of at least 100 percent performance. The findings included: a. API reported an unsatisfactory score of 80% for Compatibility testing for Q2-2017. b. For one (1) out of two (2) random patient sampling test results reviewed covering from period 2/3/2016 to 3/15/2016, the laboratory analyzed and reported Compatibility tests even with the laboratory's failure in proficiency test. c. The technical supervisor affirmed (2/16/2018, 10AM), that the laboratory received the above unsatisfactory proficiency testing score of 80% for Compatibility test. 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 and the lack of documentation for International Normalized Ratio (INR) Mean PT (MNPT) calculation, random patient sampling test results, and interview with the technical consultant (testing personnel), it was determined that the laboratory failed to follow manufacturer's ( Siemens Healthcare Diagnostics )test system instructions regarding Prothrombin (PT, INR .) The findings included: a. The laboratory has no documentation of the PT INR, MNPT calculation based on the manufacturer's instruction stated on the Siemens Healthcare Diagnostics product insert page 1/8. b. For six (6) out of six (6) random patient test results reviewed covering period from 1/1/2016 to 2/2/2018, the laboratory analyzed and reported PT INR results without the MNPT calculation needed. c. The technical consultant (testing personnel) affirmed (2/16/2018, 10AM) that the laboratory has no MNPT calculation performance documentation to show. D5217 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(c)(1) At least twice annually, the laboratory must verify the accuracy of any test or procedure it performs that is not included in subpart I of this part. This STANDARD is not met as evidenced by: Based on review of the American Proficiency Institute (API) proficiency testing records, and interview with the technical consultant, it was determined that the laboratory failed to at least verify the accuracy of any test or procedure it performs that is not included in subpart I of this part. The findings included: General Immunology a. API reported an unsatisfactory score of 0% for Anti-HBc analyte for Q1-2017. b. Based on the laboratory's annual testing declaration submitted for 2017- 2017, the laboratory analyzed and reported 299 Anti-HBc tests. c. The technical supervisor affirmed (2/16/2018, 10AM), that the laboratory received the above unsatisfactory proficiency testing score of 0% for Anti-HBc analyte. Bacteriology a. API reported an unsatisfactory score of 0% for C. difficile Toxin for Q3-2017. b. Based on the laboratory's annual testing declaration submitted for 2017-2017, the laboratory analyzed and reported 61 C. difficile Toxin test. c. The technical supervisor affirmed (2/16/2018, 10AM), that the laboratory received the above unsatisfactory proficiency testing score of 0% for C. difficile Toxin. Chemistry a. API reported unsatisfactory scores for the following analytes. Analyte: Score: Event/Year: Vit B-12 -- 2 of 5 -- 50% 2/2016 Vit B-12 50% 3/2016 Vit B-12 67% 1/2017 PSA 50% 3/2016 25-OH Vit D 67% 3/2016 Ferritin 0% 3/2016 Folate 0% 3/2016 Ammonia 67% 2/2017 b. Based on the laboratory's annual testing declaration submitted for 2017-2017, the laboratory analyzed and reported 106,873 Routine Chemistry tests which included the above analytes. c. The technical supervisor affirmed (2/16/2018, 10AM), that the laboratory received the above unsatisfactory proficiency testing scores for the above analytes. Hematology a. API reported an unsatisfactory score of 50% Mononuclear (CSF/Body Fluid) for Q1-2017. b. Based on the laboratory's annual testing declaration submitted for 2017-2017, the laboratory analyzed and reported 6 Mononuclear (CSF/Body Fluid) tests. c. The technical supervisor affirmed (2/16/2018, 10AM), that the laboratory received the above unsatisfactory proficiency testing score of 50% for Mononuclear (CSF/Body Fluid) tests. D5405 PROCEDURE MANUAL CFR(s): 493.1251(c) Manufacturer's test system instructions or operator manuals may be used, when applicable, to meet the requirements of paragraphs (b)(1) through (b)(12) of this section. Any of the items under paragraphs (b)(1) through (b)(12) of this section not provided by the manufacturer must be provided by the laboratory. This STANDARD is not met as evidenced by: Based on review and the lack of documentation for International Normalized Ratio (INR) Mean PT (MNPT) calculation, random patient sampling test results, and interview with the technical consultant (testing personnel), it was determined that the laboratory failed to follow manufacturer's ( Siemens Healthcare Diagnostics )test system instructions regarding Prothrombin (PT, INR .) The findings included: a. The laboratory has no documentation of the PT INR, MNPT calculation based on the manufacturer's instruction stated on the Siemens Healthcare Diagnostics product insert page 1/8. b. For six (6) out of six (6) random patient test results reviewed covering period from 1/2/2016 to 2/2/2018, the laboratory analyzed and reported PT INR results without the MNPT calculation needed. c. The technical consultant (testing personnel) affirmed (2/16/2018, 10AM) that the laboratory has no MNPT calculation performance documentation to show. D5411 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(a) Test systems must be selected by the laboratory. The testing must be performed following the manufacturer's instructions and in a manner that provides test results within the laboratory's stated performance specifications for each test system as determined under 493.1253. This STANDARD is not met as evidenced by: Based on review and the lack of documentation for International Normalized Ratio (INR) Mean PT (MNPT) calculation, random patient sampling test results, and interview with the technical consultant (testing personnel), it was determined that the laboratory failed to follow manufacturer's ( Siemens Healthcare Diagnostics )test system instructions regarding Prothrombin (PT, INR .) See D5405. D5439 CALIBRATION AND CALIBRATION VERIFICATION -- 3 of 5 -- 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 and the lack of Serofuge calibration performance documents for (2016 and 2017), interview with the technical supervisor, it was determined that the laboratory failed to establish and follow written policies and procedures for the Serofuge calibration performance. The findings included: a. The laboratory' uses IEC Centra-W Cell washer for Blood Bank Serofuge. b. During the survey (2/15-2/16 /2018) there were no documentation shown for the Serofuge Calibration performances for the years 2016 and 2017. c. Based on the laboratory's annual testing declaration for 2016-2017, the laboratory analyzed and reported Unexpected antibody detection and Compatibility testing approximately 161 tests. d. The technical supervisor affirmed (2/16/2018, 10AM), that there was no performance documentation to show for the years 2016 and 2017 for the Serofuge Calibration. 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. (c) The laboratory must document all analytic systems assessment activities. This STANDARD is not met as evidenced by: Based on review and the lack of documentation for Serofuge calibration, PT/INR patient mean population data studies and interview with the technical consultant, 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 analytic systems. See D 5411 and D5439. D6021 LABORATORY DIRECTOR RESPONSIBILITIES -- 4 of 5 -- CFR(s): 493.1407(e)(5) 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)(5) Ensure that quality assessment programs are established and maintained to assure the quality of laboratory services provided. This STANDARD is not met as evidenced by: Based on review and the lack of documentation for Serofuge calibration (D 5439), PT /INR patient mean population data studies (D 5405), (D 5411), retention policy (D 3031) and interview with the technical consultant, it was determined that the laboratory director failed to ensure that quality assessment programs are established and maintained to assure the quality of laboratory services provided. -- 5 of 5 --