Chi Lisbon Health

Summary Statement of Deficiencies D2006 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b) (b)The laboratory must examine or test, as applicable, the proficiency testing samples it receives from the proficiency testing program in the same manner as it tests patient specimens. This testing must be conducted in conformance with paragraph (b)(4) of this section. If the laboratory's patient specimen testing procedures would normally require reflex, distributive, or confirmatory testing at another laboratory, the laboratory should test the proficiency testing sample as it would a patient specimen up until the point it would refer a patient specimen to a second laboratory for any form of further testing. This STANDARD is not met as evidenced by: Based on record review, staff interview, and policy review, the laboratory failed to report the results from the Laboratory Information System (LIS) or testing personnel worksheets to American Proficiency Institute (API) for 3 of 3 Immunology /Immunohematology events (3rd Event 2024,1st Event 2025, and 2nd Event 2025) reviewed from 2024 and 2025. Findings include: 1. Review of API proficiency testing records on the afternoon of 11/24/25 showed the 3rd Event 2024, 1st Event 2025, and 2nd Event 2025 Immunology/Immunohematology proficiency testing records lacked evidence of testing personnel worksheets showing agglutination results for ABO, Rh, Compatibility Testing, and Unexpected Antibodies. 2. During interview at 5:30 p.m. on 11/24/25, a Technical Supervisor (Personnel #1) confirmed testing personnel do not document proficiency testing agglutination results on a blood bank log or into the LIS. 3. Review of 2nd Event 2025 Immunology/Immunohematology proficiency testing records on the afternoon of 11/24/25 showed the following: - Testing personnel marked "Group O" for ABO sample RED-10 on the API report form - API Comparative Evaluation report showed "Group A" was reported to API 4. During interview at 5:30 p.m. on 11/24/25, a Technical Supervisor (Personnel #1) confirmed the results documented for the 2nd Event 2025 was not the result reported to API. 5. 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 -- Reviewed the afternoon of 11/25/25, the policy "Blood Band Identification System," last revised 11/25/25, stated, "CHI Lisbon Health is subscribed to the API Proficiency Testing program. All samples are treated like patient samples. . . ." D2009 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) (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 record review, staff interview, and policy review, the laboratory failed to ensure testing personnel signed the attestation statement for 1 of 15 (2nd Event 2025 Chemistry Core) American Proficiency Institute (API) proficiency testing events reviewed from 2024 and 2025. Findings include: 1. Reviewed at 2:26 p.m. on 11/24 /25, the 2nd Event 2025 Chemistry Core API proficiency testing records failed to include attestation statements signed by the Testing Personnel. 2. During interview the afternoon of 11/24/25, a Technical Supervisor (Personnel #1) confirmed testing personnel had not signed the attestation statements for the 2nd Event 2025 Chemistry Core API proficiency testing. 3. Reviewed the afternoon of 11/24/25, the policy "Proficiency Testing," effective 08/27/24, stated, "After submission of the results online, the Testing Personnel must sign the attestation form." D3037 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(4) (a)(4) Proficiency testing records. Retain all proficiency testing records for at least 2 years. This STANDARD is not met as evidenced by: Based on record review, staff interview, and policy review, the laboratory failed to retain instrument printouts for 1 of 3 American Proficiency Institute (API) proficiency Chemistry Core events (1st Event 2025) reviewed from 2024 and 2025. Findings include: 1. Reviewed at 2:57 p.m. on 11/24/25, the 1st Event 2025 Chemistry Core proficiency testing records lacked evidence of Siemens Dimension EXL 200 analyzer printouts. 2. During interview at 3:18 p.m. on 11/24/25, a Technical Supervisor (Personnel #1) confirmed the chemistry proficiency testing results were not interfaced with the laboratory information system (LIS) and the Siemens Dimension EXL 200 (Dimension EXL) analyzer printouts were not available. 3. The laboratory failed to provide Dimension EXL analyzer printouts or LIS results for 1st Event 2025 Chemistry Core proficiency testing. 4. Reviewed on 11/24/25, the policy "Proficiency Testing" effective 08/27/24, stated, "Results are recorded on report forms, all instrument printouts are saved along with a copy of completed report form." D5215 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(b)(2) The laboratory must verify the accuracy of any analyte, specialty or subspecialty assigned a proficiency testing score that does not reflect laboratory test performance (that is, when the proficiency testing program does not obtain the agreement required -- 2 of 4 -- for scoring as specified in subpart I of this part, or the laboratory receives a zero score for nonparticipation, or late return or results). This STANDARD is not met as evidenced by: Based on record review, staff interview, and policy review, the laboratory failed to verify the accuracy of results for 2 of 2 regulated analytes (Total Bilirubin and Gram Stain Morphology) the American Proficiency Institute (API) assigned as not graded. The laboratory performed 1465 Total Bilirubin patient tests and 16 Gram Stain patient tests over the past year. Findings include: 1. Reviewed on 11/24/25, the 2nd Event 2025 Chemistry Core proficiency testing showed Total Bilirubin samples CH-07, CH- 09, and CH-10 as not graded and 3rd Event 2025 Chemistry Core proficiency testing showed Total Bilirubin samples CH-12 and CH-15 as not graded. The laboratory failed to evaluate the not graded results. 2. Reviewed on 11/24/25, the 2nd Event 2025 Microbiology proficiency testing showed Gram Stain Morphology sample GS-09 as not graded. The laboratory failed to evaluate the not graded results. 3. During interview the afternoon of 11/24/25, a Technical Supervisor (Personnel #1) confirmed the laboratory failed to evaluate the 2nd Event 2025 Total Bilirubin, 3rd Event 2025 Total Bilirubin, and 2nd Event 2025 Gram Stain Morphology not graded results. 4. Reviewed on 11/24/25, the policy "Proficiency Testing " effective 08/27/24, stated, ". . . Ungraded or educational ungraded results will be self-graded with follow up as needed . . ." D5221 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(d) All proficiency testing evaluation and verification activities must be documented. This STANDARD is not met as evidenced by: Based on record review and staff interview, the laboratory failed to verify the accuracy of results for 3 of 3 (1st Event 2025, 2nd Event 2025, and 3rd Event 2025) American Proficiency Institute (API) serum HCG proficiency testing verification events reviewed in 2025. The laboratory performed 24 serum HCG patient tests over the past year. Findings include: 1. Reviewed on 11/24/25, the 1st Event 2025, 2nd Event 2025, and 3rd Event 2025 proficiency testing serum HCG records failed to show the laboratory documented verification of accuracy of serum HCG. 2. During interview the afternoon of 11/24/25, a Technical Supervisor (Personnel #1) confirmed the laboratory did not document review of the 2025 serum HCG proficiency testing verification events. 3. The laboratory failed to provide a policy regarding verification proficiency testing. D6127 TECHNICAL SUPERVISOR RESPONSIBILITIES CFR(s): 493.1451(b)(9) (b)(9) Evaluating and documenting the performance of individuals responsible for high complexity testing at least semiannually during the first year the individual tests patient specimens. This STANDARD is not met as evidenced by: Based on record review, staff interviews, and policy review, the Technical Supervisor failed to evaluate and document the competency at least semiannually for 1 of 1 new -- 3 of 4 -- testing personnel (Testing Personnel #4) hired in March 2025. Findings include: 1. Reviewed at 11:35 a.m. on 11/24/25, Testing Personnel #4's competency evaluation records lacked evidence of six-month competency evaluations for serum Human Chorionic Gonadotropin (HCG) and manual differential in September 2025. 2. During interview at 11:48 a.m. on 11/24/25, a Technical Supervisor (Personnel #1) confirmed Testing Personnel #4 was hired in March 2025 and did not have six-month competency evaluations completed for the serum HCG and manual differential. 3. During interview at 11:52 a.m. on 11/24/25, Testing Personnel #4 confirmed she has reported patient serum HCG and manual differential test results. 4. Reviewed the afternoon of 11/24/25, the policy "Competency Assessment," effective 02/12/18, stated, "Assessment Determination . . . Six Month Assessment This follows the initial assessment." D6128 TECHNICAL SUPERVISOR RESPONSIBILITIES CFR(s): 493.1451(b)(9) (b)(9) Thereafter, evaluations must be performed at least annually unless test methodology or instrumentation changes, in which case, prior to reporting patient test results, the individuals performance must be reevaluated to include the use of the new test methodology or instrumentation. This STANDARD is not met as evidenced by: Based on record review, staff interview, and policy review, the Technical Supervisor failed to evaluate and document the competency for 4 of 4 testing personnel (Testing Personnel #1, #2, #3, and #5) requiring annual competency evaluations in 2024. Findings include: 1. Reviewed at 10:47 a.m. on 11/24/25, the competency evaluation records lacked evidence of annual competency evaluations in 2024 as follows: - Testing Personnel #1 - K-Check Ketone testing (Ketones), blood culture identification and sensitivities, sedimentation rate MiniiSED analyzer (MiniiSED), gram stain procedure (gram stain), and manual differential procedure (manual differential) - Testing Personnel #2 - Ketones, MiniiSED, gram stain, and manual differential - Testing Personnel #3 - Ketones, gram stain, and manual differential - Testing Personnel #5 - Ketones, MiniiSED, blood bank procedure, gram stain, and manual differential 2. During interview at 1:15 p.m. on 11/24/25, a Technical Supervisor (Personnel #1) confirmed Testing Personnel #1, #2, #3, and #5 did not have all annual competency evaluations completed in 2024. 3. Reviewed the afternoon of 11/24/25, the policy "Competency Assessment," effective 02/12/18, stated, "Assessment Determination . . . Annual Competency . . . This is performed after 6-Month Assessment and annually for all staff." -- 4 of 4 --

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 record review, staff interview, and policy review, the laboratory director failed to sign the attestation statements for 3 of 3 (3-2020, 1-2021, and 2-2021) immunohematology proficiency testing events reviewed. Findings include: 1. Reviewed at 1:15 p.m. on 11/30/21, the 2020-2021 proficiency testing records lacked evidence the laboratory director signed the proficiency testing attestation statements for 3-2020, 1-2021, and 2-2021 immunohematology proficiency testing events. 2. During interview at 3:45 p.m. on 11/30/21, a technical supervisor (Personnel #1) confirmed the laboratory director had not signed the attestation statements for 3-2020, 1-2021, and 2-2021 immunohematology proficiency testing events. 3. Reviewed at 11: 00 a.m. on 12/01/21, the undated policy "Proficiency Testing," stated, ". . . Procedure: . . . - After submission of the results online, the Testing Personnel must sign the attestation form. Lab director . . . must also sign the attestation form. . . ." 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 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 -- the laboratory's patient population. This STANDARD is not met as evidenced by: Based on record review, staff interview, and policy review, the laboratory failed to verify the accuracy, precision, and reportable range for 1 of 2 new test methods (D- dimer) on the Quidel Triage Meter Pro in October 2019 before reporting patient results. The laboratory performed approximately 800 patient D-dimer tests on the Quidel Triage Meter Pro analyzer since implementation. Findings include: 1. Reviewed at 8:25 a.m. on 12/01/21, the laboratory's 2019 performance specification verification records for the Quidel Triage Meter Pro analyzer lacked evidence the laboratory verified performance specifications for accuracy, precision, and reportable range for D-dimer. 2. During interview at 8:50 a.m. on 12/01/21, a technical supervisor (Personnel #1) confirmed the laboratory began patient testing on the Quidel Triage Meter Pro analyzer for D-dimer in October 2019, and the laboratory did not have evidence the laboratory director and/or technical supervisor had verified the performance specifications for accuracy, precision, and reportable range. 3. Reviewed at 11:00 a.m. on 12/01/21, the policy "Clinical Laboratory Improvement Amendments (CLIA) Laboratory Director Responsibilities and Delegations," effective 08/2018, stated, "Responsibility . . . Test method verification. Approval of new instrument and /or test method validation . . . Title . . . Medical Director Technical supervisor Clinical Lab . . ." 4. Upon request on 12/01/21, the laboratory failed to provide a policy requiring verification of performance specifications for accuracy, precision, and reportable range for new test systems. D6087 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(3)(iii) The laboratory director must ensure that laboratory personnel are performing the test methods as required for accurate and reliable results. This STANDARD is not met as evidenced by: Based on record review, observation, staff interview, manufacturer's instructions review, and policy review, the laboratory failed to use the correct mean normal protime (PT) value for calculating International Normalized Ratios (INRs) for 4 of 4 weeks (October 28 through November 30, 2021) since the laboratory began using a new lot number of Innovin (thromboplastin) reagent on the Sysmex CA600 coagulation analyzer. The laboratory performed approximately 50 tests during this timeframe. Findings include: 1. Reviewed at 9:55 a.m. on 12/01/21, the 2021 coagulation lot number change records showed the mean normal PT value as 10.4 for Innovin lot number 549788. 2. Observation of the Sysmex CA600 coagulation analyzer at 10:00 a.m. on 12/01/21 revealed a mean normal PT value of 10.1 used to calculate patient INRs. 3. During interview at 10:05 a.m. on 12/01/21, a technical supervisor (Personnel #1) confirmed the laboratory did not enter the new mean normal PT value of 10.4 when the laboratory began using the new lot number of Innovin on 10/28/21. 4. Reviewed on 12/01/21, the Siemens Dade Innovin package insert, dated 05/2008, stated, ". . . Determination of INR (International Normalized Ratio) . . . 1. . . . the PT results for patients on oral anticoagulants should be recorded as INR values. . . The INR is determined according to the following equation: INR = R [powered to the ISI value], where R = Patient PT [divided by] Mean normal PT** ISI is the International Sensitivity Index of the reagent/instrument combination. . . . ** The mean normal PT is defined as the mean value of the normal range. It must be -- 2 of 3 -- determined specifically for each thromboplastin lot using the method used to analyze the patient samples . . ." 5. Reviewed on 12/01/21, the undated policy "Protime/INR" failed to include instructions for changing lot numbers of Innovin. -- 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: Based on American Proficiency Institute proficiency testing record review and staff interview, the laboratory failed to achieve satisfactory performance in proficiency testing for the analyte blood alcohol for two of three consecutive events in 2020 (Events 1 and 3), resulting in unsuccessful performance. (Refer to D2096) D2096 ROUTINE CHEMISTRY CFR(s): 493.841(f) Failure to achieve satisfactory performance for the same analyte or test in two 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 -- consecutive testing events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on proficiency testing record review and staff interview, the laboratory failed to achieve satisfactory performance in proficiency testing for the analyte blood alcohol in two of three consecutive events in 2020 (Events 1 and 3), resulting in unsuccessful performance. Findings include: 1. Review of 2020 American Proficiency Institute (API) proficiency testing reports on 10/19/20 for the analyte blood alcohol revealed the following results: Event 1-2020 - 20% Sample Lab Results Acceptable Range #01 207 262 - 438 #02 47 54 - 92 #03 73 85 - 144 #04 5 0 - 18 #05 127 155 - 260 Event 3- 2020 - 0% Sample Lab Results Acceptable Range #11 13 93 - 156 #12 7 50 - 85 #13 17 123 - 206 Sample Lab Results Acceptable Range #14 13 94 - 159 #15 2 9 - 30 The specialty of chemistry requires a score of 80% or greater for satisfactory performance. 2. During a telephone interview at 2:35 p.m. on 10/19/20, the laboratory manager (#1) confirmed the laboratory had scored less than 80% in Events 1 and 3 in 2020 for blood alcohol. -- 2 of 2 --

Summary Statement of Deficiencies D5451 CONTROL PROCEDURES CFR(s): 493.1256(d)(3)(iii)(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-- At least once a day patient specimens are assayed or examined perform the following for-- Test procedures producing graded or titered results include a negative control material and a control material with graded or titered reactivity, respectively; 493.1256 (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on record review, staff interview, and policy review, the laboratory failed to perform quality control (QC) testing each day of immunohematologic (blood type) patient testing for 1 of 6 patient testing days in August 2019 (08/21/19). Findings include: 1. Reviewed at approximately 8:25 a.m. on 09/11/19, the August 2019 patient testing and QC records indicated the laboratory did not perform QC for Anti-A1 and Anti-B reagent cells used for blood type testing for the following: 08/21/19 Patient #109270 - Blood type testing. 2. During interview at approximately 9:45 a.m. on 09/11 /19, a general supervisor (#1) confirmed the laboratory did not document the Anti-A1 and Anti-B QC results on 08/21/19, and the laboratory performed one patient blood type test. 3. Review of the policy "Blood Bank Policy Manual," version #1.1, revised 02/10/19 occurred at 9:55 a.m. on 09/11/19. The policy, revised 02/10/19, stated, ". . . Quality Control Log Quality control of blood banking reagents is performed day of testing. . . . Documentation of quality control results . . . is kept in the quality control log book in blood bank. . . ." 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 No Tags No deficiency details available. 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 --