Midwest Institute For Minimally Invasive Therapies

Summary Statement of Deficiencies D5016 ROUTINE CHEMISTRY CFR(s): 493.1210 If the laboratory provides services in the subspecialty of Routine Chemistry, the laboratory must meet the requirements specified in 493.1230 through 493.1256, 493. 1267, and 493.1281 through 493.1299. This CONDITION is not met as evidenced by: Based on direct observation, review of the CMS-209 (Laboratory Personnel Report), laboratory policies and procedures, Individual Quality Control Plan (IQCP), laboratory records, lack of documentation, and interviews with the technical consultant (TC); the laboratory failed to have a competency assessment policy and procedure in place to assess employee competency for one of one TC (See D5209), failed to have policy and procedure manuals reviewed, approved, signed, and dated by the current laboratory director (See D5407), failed to have IQCP's for three of three cartridge types utilized on the i-Stat analyzer (See D5445a) and failed to perform quality control procedures as specified by the i-Stat IQCP for one of two hematology tests performed on the i-Stat analyzer (See D5445b), failed to include all the required components of a laboratory test report, including the facility's address, on eight of eight patient test reports (See D5805), and failed to have pertinent reference ranges correlate between the i-Stat analyzer's standard operating procedure and patient test reports (See D5807). D5024 HEMATOLOGY CFR(s): 493.1215 If the laboratory provides services in the specialty of Hematology, the laboratory must meet the requirements specified in 493.1230 through 493.1256, 493.1269, and 493. 1281 through 493.1299. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 6 -- This CONDITION is not met as evidenced by: Based on direct observation, review of the CMS-209 (Laboratory Personnel Report), laboratory policies and procedures, Individual Quality Control Plan (IQCP), laboratory records, lack of documentation, and interviews with the technical consultant (TC); the laboratory failed to have a competency assessment policy and procedure in place to assess employee competency for one of one TC (See D5209), failed to have policy and procedure manuals reviewed, approved, signed, and dated by the current laboratory director (See D5407), failed to have IQCP's for three of three cartridge types utilized on the i-Stat analyzer (See D5445a) and failed to perform quality control procedures as specified by the i-Stat IQCP for one of two hematology tests performed on the i-Stat analyzer (See D5445b), failed to include all the required components of a laboratory test report, including the facility's address, on eight of eight patient test reports (See D5805), and failed to have pertinent reference ranges correlate between the i-Stat analyzer's standard operating procedure and patient test reports (See D5807). D5209 PERSONNEL COMPETENCY ASSESSMENT POLICIES CFR(s): 493.1235 As specified in the personnel requirements in subpart M, the laboratory must establish 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 the CMS-209 (Laboratory Personnel Report), laboratory policies and procedures, lack of documentation, and interview with the technical consultant (TC); the laboratory failed to have a competency assessment policy and procedure in place to assess employee competency for one of one technical consultant. Findings include: 1. Review of the CMS-209 (Laboratory Personnel Report) revealed one technical consultant. 2. Review of laboratory policies and procedures revealed the laboratory lacked a competency assessment policy and procedure to assess the competency of one of one TC. 3. Interview with the TC on 07/24/2025, at 9:41 am, confirmed the laboratory failed to have a competency assessment policy and procedure in place to assess employee competency for one of one technical consultant. D5407 PROCEDURE MANUAL CFR(s): 493.1251(d) (d) Procedures and changes in procedures must be approved, signed, and dated by the current laboratory director before use. This STANDARD is not met as evidenced by: Based on review of laboratory policies and procedures, lack of documentation, and interview with the technical consultant (TC); the laboratory failed to have one of one i- Stat policy and procedure manual reviewed, approved, signed, and dated by the current laboratory director (as noted on the CMS-209 Laboratory Personnel Report) for the specialties of chemistry and hematology. Findings include: 1. Review of laboratory policy and procedure manuals revealed no laboratory director (LD) approval, including signature and date, by the current LD for the procedure, "i-Stat 1" -- 2 of 6 -- used for Chem-8+, Protime, and Activated Clotting Time testing. 2. Interview with the laboratory representative on 07/24/2025, at 11:04 am, confirmed the LD had not signed or dated the procedure relating to chemistry and hematology testing. 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: a) Based on direct observation, review of the laboratory's policies and procedures, lack of documentation, and interview with the technical consultant (TC); the laboratory failed to have IQCP's for three of three cartridge types utilized on the i-Stat analyzer in the specialties of chemistry and hematology. Findings include: 1. Direct observation upon a tour of the laboratory on 07/24/2025, at 9:45 am, revealed three cartridge types utilized for patient testing on the i-Stat analyzer (Serial Number: 401381). a) Chem 8+ cartridges utilized for chemistry (sodium, potassium, chloride, calcium, glucose, blood urea nitrogen, and creatinine) and hematology (Hematocrit) testing; b) Activated Clotting Time (ACT) cartridges utilized for hematology testing; and c) Protime / International Normalized Ratio (PT/INR) cartridges utilized for hematology testing. 2. Review of the laboratory's policies and procedures for i-Stat testing revealed a lack of IQCP's for each of the individual cartridge types that performed patient testing. 3. Interview with the TC on 07/24/2025, at 9:53 am, confirmed the laboratory failed to have IQCP's for three of three cartridge types utilized on the i-Stat analyzer in the specialties of chemistry and hematology. b) Based on review of the laboratory's Individual Quality Control Plan (IQCP) for the i-Stat analyzer, laboratory records, lack of documentation, and interview with the technical consultant (TC); the laboratory failed to perform quality control (QC) procedures as specified by the i-Stat IQCP for one of two Protime/International Normalized Ratio (PT/INR) tests performed on the i-Stat analyzer in the years of 2023 through 2025 in the specialty of hematology. Findings include: 1. Review of the laboratory's IQCP for the i-Stat analyzer (Serial Number: 401381), utilized for PT/INR testing, stated, under "Liquid QC", "1. Frequency: All new shipments will be QC'd upon arrival with 2 levels of controls and monthly." 2. Review of laboratory records revealed one of two patients tested for PT/INR in the years of 2023 through 2025 failed to have PT/INR controls performed within one month prior of patient testing. Patient: 1954 Date of testing: 02/12/2024 Date QC performed: 12/27/2023 3. Interview with the TC on 07/24 /2025, at 1:00 pm, confirmed the laboratory failed to perform QC procedures as specified by the IQCP for one of two PT/INR tests performed on the i-Stat analyzer in the years of 2023 through 2025 in the specialty of hematology. D5805 TEST REPORT CFR(s): 493.1291(c) -- 3 of 6 -- (c) The test report must indicate the following: (c)(1) For positive patient identification, either the patient's name and identification number, or a unique patient identifier and identification number. (c)(2) The name and address of the laboratory location where the test was performed. (c)(3) The test report date. (c)(4) The test performed. (c)(5) Specimen source, when appropriate. (c)(6) The test result and, if applicable, the units of measurement or interpretation, or both. (c)(7) Any information regarding the condition and disposition of specimens that do not meet the laboratory's criteria for acceptability. This STANDARD is not met as evidenced by: Based on review of laboratory records and interview with the technical consultant (TC); the laboratory failed to include all the required components of a laboratory test report, including the facility's address, for six of six i-Stat Chem 8+ and two of two i- Stat Protime / International Normalized Ratio (PT/INR) test reports reviewed from 2023 through the date of survey, 07/24/2025. Findings include: 1. Review of six of six i-Stat Chem 8+ patient test reports found the laboratory failed to indicate the testing facility's address on the laboratory's patient test report. Patient: Date of Testing: 2755 07/31/2023 3127 11/13/2023 3858 04/29/2024 5480 11/01/2024 5238 01/27/2025 6618 06/09/2025 2. Review of two of two i-Stat PT/INR patient test reports found the laboratory failed to indicate the testing facility's address on the laboratory's patient test report. Patient: Date of Testing: 1956 10/09/2023 1954 02/12/2024 3. Interview with the TC on 07/24/2025, at 1:00 pm, confirmed the laboratory failed to include all the required components of a laboratory test report, including the facility's address, for six of six i-Stat Chem 8+ and two of two i-Stat PT/INR test reports reviewed from 2023 through the date of survey, 07/24/2025. D5807 TEST REPORT CFR(s): 493.1291(d) (d) Pertinent "reference intervals" or "normal" values, as determined by the laboratory performing the tests, must be available to the authorized person who ordered the tests and, if applicable, the individual responsible for using the test results. This STANDARD is not met as evidenced by: Based on review of laboratory policies and procedures, patient test reports, and interview with the technical consultant (TC); the laboratory failed to have pertinent reference ranges correlate between the i-Stat analyzer's standard operating procedure (SOP) and patient test reports, including six of six Chem 8+ patient test reports and two of two Protime/International Normalized Ratio (PT/INR) patient test reports, in the specialties of chemistry and hematology. Findings include: 1. Review of laboratory policies and procedures revealed the procedure titled "Procedure Manual for the i-Stat System", which stated the following reference ranges for the analytes of the Chem 8+ cartridge: Analyte: Reference Range: Sodium 135 - 145 mmol/L** Potassium 3.5 - 5.0 mmol/L Chloride 100 - 109 mmol/L Calcium 1.12 - 1.32 mmol/L Glucose 70 - 105 mg/dL*** BUN* 6 - 20 mg/dL Creatinine 0.5 - 1.1 mg/dL Hematocrit Female: 34 - 47 %PCV**** Male: 40 - 52 %PCV *BUN = Blood Urea Nitrogen **mmol/L = millimoles per liter ***mg/dL - milligrams per deciliter ****% PCV = % packed cell volume 2. Review of laboratory policies and procedures revealed the procedure titled "Procedure Manual for the i-Stat System", which failed to provide a reference range for the results of the PT/INR cartridge. 3. Review of laboratory policies and procedures revealed the procedure titled "Procedure Manual -- 4 of 6 -- for the i-Stat System" failed to be reviewed, approved, signed, and dated by the current laboratory director (as noted on the CMS-209 Laboratory Personnel Report) for the specialties of chemistry and hematology (See D5407). 4. Review of six of six i- Stat Chem 8+ patient test reports (2755, 3127, 3858, 5238, 5480, and 6618) revealed the following reference ranges for the analytes of the Chem 8+ cartridges: Analyte: Reference Range: Sodium 138 - 146 mmol/L Potassium 3.5 - 4.9 mmol/L Chloride 98 - 109 mmol/L Calcium 1.2 - 1.32 mmol/L Glucose 70 - 105 mg/dL BUN 8 - 26 mg/dL Creatinine 0.6 - 1.3 mg/dL Hematocrit Female: 38 - 46 %PCV Male: 43 - 51 %PCV 5. Review of two of two i-Stat PT/INR patient test reports (1954 and 1956) revealed the following reference ranges for the analytes of the PT/INR cartridges: Analyte: Reference Range: PT 11 to 13.5 seconds INR 0.8 - 1.1 6. Interview with the TC on 07 /24/2025, at 11:04 am, confirmed the laboratory failed to have pertinent reference ranges correlate between the i-Stat analyzer's SOP and patient test reports, including six of six Chem 8+ patient test reports and two of two PT/INR patient test reports, in the specialties of chemistry and hematology. D6026 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(8) (e)(8) Ensure that reports of test results include pertinent information required for interpretation; This STANDARD is not met as evidenced by: Based on review of laboratory policies and procedures, patient test reports, and interview with the technical consultant (TC); the laboratory director failed to ensure all the required components of a laboratory test report, including the facility's address, were present on eight of eight patient test reports reviewed (See D5805) and failed to ensure pertinent reference ranges correlate between the i-Stat analyzer's standard operating procedure and patient test reports (See D5807) and in the specialties of chemistry and hematology. D6031 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(13) (e)(13) Ensure that an approved procedure manual is available to all personnel responsible for any aspect of the testing process; and This STANDARD is not met as evidenced by: Based on review of laboratory policies and procedures, lack of documentation, and interview with the technical consultant (TC); the laboratory director failed to ensure policy and procedure manuals were reviewed, approved, signed, and dated by the current laboratory director (as noted on the CMS-209 Laboratory Personnel Report) for the specialties of chemistry and hematology (See D5407). D6042 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(4) (b)(4) Establishing a quality control program appropriate for the testing performed and establishing the parameters for acceptable levels of analytic performance and ensuring that these levels are maintained throughout the entire testing process from the initial receipt of the specimen, through sample analysis and reporting of test -- 5 of 6 -- results; This STANDARD is not met as evidenced by: Based on direct observation, review of the laboratory's Individual Quality Control Plan (IQCP), lack of documentation, and interview with the technical consultant (TC); the TC failed to ensure IQCP's were available for three of three cartridge types utilized on the i-Stat analyzer and failed to ensure quality control procedures were performed as specified by the i-Stat IQCP in the specialties of chemistry and hematology (See D5445a and D5445b). -- 6 of 6 --

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 a desk review of the Certification and Survey Provider Enhanced Reporting (CASPER) Report 0155D - Individual Laboratory Profile and American Proficiency Institute (API) proficiency testing (PT) reports, the laboratory failed to participate in the API Core Chemistry PT events two and three of 2024 (See D2089 and D2123); the laboratory failed to successfully participate in PT for the subspeciality of routine chemistry (See D2097) and the routine chemistry analytes Chloride (Cl, Analyte #0355), Creatinine (Analyte # 0405), Glucose (Analyte #0415), Potassium (K, Analyte #0465), Sodium (Na, Analyte #0475), and Blood Urea Nitrogen (BUN, Analyte #0505) (See D2096) during PT events two and three of 2024; and 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 5 -- laboratory failed to successfully participate in PT for the specialty of hematology (See D2131) and the hematology analytes Hematocrit (HCT, Analyte #0785) and Hemoglobin (HGB, Analyte #0795) (See D2130) during PT events two and three of 2024. D2089 ROUTINE CHEMISTRY CFR(s): 493.841(c) Failure to participate in a testing event is unsatisfactory performance and results in a score of 0 for the testing event. Consideration may be given to those laboratories failing to participate in a testing event only if-- (1) Patient testing was suspended during the time frame allotted for testing and reporting proficiency testing results; (2) The laboratory notifies the inspecting agency and the proficiency testing program within the time frame for submitting proficiency testing results of the suspension of patient testing and the circumstances associated with failure to perform tests on proficiency testing samples; and (3)The laboratory participated in the previous two proficiency testing events. This STANDARD is not met as evidenced by: Based on a desk review of the Certification and Survey Provider Enhanced Reporting (CASPER) Report 0155D - Individual Laboratory Profile and American Proficiency Institute (API) proficiency testing (PT) reports, the laboratory failed to participate in the API Core Chemistry PT events two and three of 2024 for the routine chemistry analytes Calcium, Ionized (non-regulated), Chloride (Cl), Creatinine, Glucose, Potassium (K), Sodium (Na), and Blood Urea Nitrogen (BUN). Findings Include: 1. Review of the CASPER Report 0155D, ran on 11-01-2024, identified the 0% scores for the regulated chemistry analytes Chloride (Cl), Creatinine, Glucose, Potassium (K), Sodium (Na), and Blood Urea Nitrogen (BUN) in events two and three of 2024. 2. Review of API Core Chemistry PT event summaries confirmed the laboratory failed to participate, resulting in a score of 0% for Calcium, Ionized (non-regulated), Chloride (Cl), Creatinine, Glucose, Potassium (K), Sodium (Na), and Blood Urea Nitrogen (BUN) in PT events two and three of 2024. 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 desk review of the Certification and Survey Provider Enhanced Reporting (CASPER) Report 0155D - Individual Laboratory Profile and American Proficiency Institute (API) proficiency testing (PT) reports, the laboratory failed to successfully participate PT for the routine chemistry analytes Chloride (Cl, Analyte #0355), Creatinine (Analyte # 0405), Glucose (Analyte #0415), Potassium (K, Analyte #0465), Sodium (Na, Analyte #0475), and Blood Urea Nitrogen (BUN, Analyte #0505) during events two and three of 2024, resulting in the initial unsuccessful PT performance. Findings Include: 1. Review of the CASPER Report 0155D, ran on 11- 01-2024, identified the initial unsuccessful PT performance for the routine chemistry analytes: Chloride (Cl, Analyte #0355), Creatinine (Analyte # 0405), Glucose -- 2 of 5 -- (Analyte #0415), Potassium (K, Analyte #0465), Sodium (Na, Analyte #0475), and Blood Urea Nitrogen (BUN, Analyte #0505). ROUTINE CHEMISTRY Cl - EVENT- 2, 2024 = 0% - Unsatisfactory Cl - EVENT-3, 2024 = 0% - Unsatisfactory Creatinine - EVENT-2, 2024 = 0% - Unsatisfactory Creatinine - EVENT-3, 2024 = 0% - Unsatisfactory K - EVENT-2, 2024 = 0% - Unsatisfactory K - EVENT-3, 2024 = 0% - Unsatisfactory Na - EVENT-2, 2024 = 0% - Unsatisfactory Na - EVENT-3, 2024 = 0% - Unsatisfactory BUN - EVENT-2, 2024 = 0% - Unsatisfactory BUN - EVENT-3, 2024 = 0% - Unsatisfactory 2. Review of API Core Chemistry PT event summaries confirmed the laboratory failed to participate, resulting in a score of 0% for Cl, Creatinine, Glucose, K, Na, and BUN in PT events two and three of 2024. 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 desk review of the Certification and Survey Provider Enhanced Reporting (CASPER) Report 0155D - Individual Laboratory Profile and American Proficiency Institute (API) proficiency testing (PT) reports, the laboratory failed to successfully participate PT for the subspecialty of routine chemistry (Analyte #0245) during events two and three of 2024, resulting in the initial unsuccessful PT performance for the subspecialty. Findings Include: 1. Review of the CASPER Report 0155D, ran on 11- 01-2024, identified the initial unsuccessful PT performance for the subspecialty of routine chemistry. CHEMISTRY Routine Chemistry - EVENT-2, 2024 = 0% - Unsatisfactory Routine Chemistry - EVENT-3, 2024 = 0% - Unsatisfactory 2. Review of API Core Chemistry PT event summaries confirmed the laboratory failed to participate, resulting in a score of 0% for the subspecialty of Routine Chemistry in PT events two and three of 2024. D2123 HEMATOLOGY CFR(s): 493.851(c) Failure to participate in a testing event is unsatisfactory performance and results in a score of 0 for the testing event. Consideration may be given to those laboratories failing to participate in a testing event only if-- (1) Patient testing was suspended during the time frame allotted for testing and reporting proficiency testing results; (2) The laboratory notifies the inspecting agency and the proficiency testing program within the time frame for submitting proficiency testing results of the suspension of patient testing and the circumstances associated with failure to perform tests on proficiency testing samples; and (3) The laboratory participated in the previous two proficiency testing events. This STANDARD is not met as evidenced by: Based on a desk review of the Certification and Survey Provider Enhanced Reporting (CASPER) Report 0155D - Individual Laboratory Profile and American Proficiency Institute (API) proficiency testing (PT) reports, the laboratory failed to participate in the API Core Chemistry PT events two and three of 2024 for the hematology analytes Hematocrit (HCT) and Hemoglobin (HGB). Findings Include: 1. Review of the -- 3 of 5 -- CASPER Report 0155D, ran on 11-01-2024, identified the 0% scores for the regulated hematology analytes Hematocrit (HCT) and Hemoglobin (HGB) in events two and three of 2024. 2. Review of API Core Chemistry PT event summaries confirmed the laboratory failed to participate, resulting in a score of 0% for Hematocrit (HCT) and Hemoglobin (HGB) in PT events two and three of 2024. 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 a desk review of the Certification and Survey Provider Enhanced Reporting (CASPER) Report 0155D - Individual Laboratory Profile and American Proficiency Institute (API) proficiency testing (PT) reports, the laboratory failed to successfully participate PT for the hematology analytes Hematocrit (HCT, Analyte #0785) and Hemoglobin (HGB, Analyte #0795) during events two and three of 2024, resulting in the initial unsuccessful PT performance. Findings Include: 1. Review of the CASPER Report 0155D, ran on 11-01-2024, identified the initial unsuccessful PT performance for the hematology analytes Hematocrit (HCT, Analyte #0785) and Hemoglobin (HGB, Analyte #0795). HEMATOLOGY HCT - EVENT-2, 2024 = 0% - Unsatisfactory HCT - EVENT-3, 2024 = 0% - Unsatisfactory HGB - EVENT-2, 2024 = 0% - Unsatisfactory HGB - EVENT-3, 2024 = 0% - Unsatisfactory 2. Review of API Core Chemistry PT event summaries confirmed the laboratory failed to participate, resulting in a score of 0% for HCT and HGB in PT events two and three of 2024. 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 a desk review of the Certification and Survey Provider Enhanced Reporting (CASPER) Report 0155D - Individual Laboratory Profile and American Proficiency Institute (API) proficiency testing (PT) reports, the laboratory failed to successfully participate PT for the specialty of hematology (Analyte #0760) during events two and three of 2024, resulting in the initial unsuccessful PT performance for the subspecialty. Findings Include: 1. Review of the CASPER Report 0155D, ran on 11- 01-2024, identified the initial unsuccessful PT performance for the specialty of hematology. HEMATOLOGY Hematology - EVENT-2, 2024 = 33% - Unsatisfactory Hematology - EVENT-3, 2024 = 0% - Unsatisfactory 2. Review of API Core Chemistry PT event summaries confirmed the laboratory failed to participate in PT events two and three of 2024, resulting in the unsatisfactory scores for the specialty of hematology. D6000 MODERATE COMPLEXITY LABORATORY DIRECTOR CFR(s): 493.1403 -- 4 of 5 -- 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 the Certification and Survey Provider Enhanced Reporting (CASPER) Report 0155D - Individual Laboratory Profile and American Proficiency Institute (API) proficiency testing (PT) reports, the laboratory director failed to ensure successful participation in an Health and Human Services (HHS) approved PT program for the specialties of chemistry and hematology resulting in the laboratory's initial unsuccessful PT performance for the specialty of hematology, subspecialty of routine chemistry and the following chemistry and hematology analytes: Chloride (Cl, Analyte #0355), Creatinine (Analyte # 0405), Glucose (Analyte #0415), Potassium (K, Analyte #0465), Sodium (Na, Analyte #0475), Blood Urea Nitrogen (BUN, Analyte #0505), Hematocrit (HCT, Analyte #0785) and Hemoglobin (HGB, Analyte #0795) (See 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 the Certification and Survey Provider Enhanced Reporting (CASPER) Report 0155D - Individual Laboratory Profile and American Proficiency Institute (API) proficiency testing (PT) reports, the laboratory director to ensure PT samples were tested as required. The laboratory failed participated in the API Core Chemistry PT events two and three of 2024 (See D2089 and D2123); the laboratory failed to successfully participate in PT for the subspeciality of routine chemistry (See D2097) and the routine chemistry analytes Chloride (Cl, Analyte #0355), Creatinine (Analyte # 0405), Glucose (Analyte #0415), Potassium (K, Analyte #0465), Sodium (Na, Analyte #0475), and Blood Urea Nitrogen (BUN, Analyte #0505) (See D2096) during PT events two and three of 2024; and the laboratory failed to successfully participate in PT for the specialty of hematology (See D2131) and the hematology analytes Hematocrit (HCT, Analyte #0785) and Hemoglobin (HGB, Analyte #0795) (See D2130) during PT events two and three of 2024. -- 5 of 5 --

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 review of the CASPER Report 0155D and review of College of American Pathologists (CAP) analyte scorecard, and interview with a laboratory representative (IM) the laboratory failed to successfully participate in proficiency testing (PT) for the hematology analyte prothrombin time during events one, two, and three of 2022, resulting in the subsequent unsuccessful performance for prothrombin time. See D2130. D2130 HEMATOLOGY CFR(s): 493.851(f) Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 3 -- Failure to 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 review of the CASPER Report 0155D and review of College of American Pathologists (CAP) analyte scorecard and interview with a laboratory representative (IM) found the laboratory failed to successfully participate in proficiency testing (PT) for the hematology analyte prothrombin time during events one, two, and three of 2022, resulting in the subsequent unsuccessful performance. Findings include: 1. Review of the CASPER Report 0155D revealed that the subsequent unsuccessful PT performance occurred during CAP PT events one, two, and three of 2022, as listed below. Hematology EVENT -1, 2022 - Prothrombin Time - 40% Unsatisfactory EVENT -2, 2022 - Prothrombin Time - 60% Unsatisfactory EVENT -3, 2022 - Prothrombin Time - 60% Unsatisfactory 2. Review of CAP PT analyte scorecard for prothrombin time PT in 2022 confirmed the subsequent unsuccessful PT performance for the analyte prothrombin time for events one, two, and three of 2022. 3. A phone interview on 11-4-2022, at 10:24 am, with a laboratory representative (IM) confirmed the subsequent unsuccessful PT performance for the analyte prothrombin time for events one, two, and three of 2022. 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 review of the CASPER Report 0155D and review of College of American Pathologists (CAP) analyte scorecard the laboratory director failed to ensure laboratory personnel are performing prothrombin time testing as required to ensure accurate and reliable results in 2022 due to subsequent unsuccessful proficiency testing performance. See D6014. D6014 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(3)(iii) 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)(3) Ensure that-- (e)(3)(iii) Laboratory personnel are performing the test methods as required for accurate and reliable results. This STANDARD is not met as evidenced by: Based on review of the CASPER Report 0155D and review of College of American Pathologists (CAP) analyte scorecard the laboratory director failed to ensure laboratory personnel are performing prothrombin time testing as required to ensure accurate and reliable results in 2022 due to unsuccessful proficiency testing -- 2 of 3 -- performance. Findings Include: 1. The laboratory has failed to successfully participate in proficiency testing for prothrombin time testing for three of three PT events in 2022 resulting in subsequent unsuccessful proficiency testing performance. See D2130. -- 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 review of the CASPER Report 0155D and interview with a College of American Pathologists (CAP) representative the laboratory failed to successfully participate in proficiency testing (PT) for the routine chemistry analyte partial pressure of carbon dioxide (PCO2) blood gas during PT events one and two of 2022. See D2096. D2096 ROUTINE CHEMISTRY CFR(s): 493.841(f) 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 -- 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 CASPER Report 0155D and interview with a College of American Pathologists (CAP) representative; the laboratory failed to successfully participate in proficiency testing (PT) for the routine chemistry analyte partial pressure of carbon dioxide (PCO2) blood gas during PT events one and two of 2022. Findings include: 1. Review of the CASPER Report 0155D ran on 8-1-2022 identified the initial unsuccessful PT performance for the specialty of chemistry for PCO2 Blood Gas. ROUTINE CHEMISTRY PCO2 Blood Gas - EVENT-1, 2022 = 0% - Unsatisfactory PCO2 Blood Gas - EVENT-2, 2022 = 0% - Unsatisfactory 2. A phone interview with the CAP PT representative on 08/01/2022, at 10:03 AM, confirmed the unsuccessful PT performance for PCO2 blood gas during PT events one and two of 2022. -- 2 of 2 --

Summary Statement of Deficiencies D2016 SUCCESSFUL PARTICIPATION CFR(s): 493.803(a)(b)(c) (a) Each laboratory performing nonwaived testing must successfully participate in a proficiency testing program approved by CMS, if applicable, as described in subpart I of this part for each specialty, subspecialty, and analyte or test in which the laboratory is certified under CLIA. (b) Except as specified in paragraph (c) of this section, if a laboratory fails to participate successfully in proficiency testing for a given specialty, subspecialty, analyte or test, as defined in this section, or fails to take remedial action when an individual fails gynecologic cytology, CMS imposes sanctions, as specified in subpart R of this part. (c) If a laboratory fails to perform successfully in a CMS- approved proficiency testing program, for the initial unsuccessful performance, CMS may direct the laboratory to undertake training of its personnel or to obtain technical assistance, or both, rather than imposing alternative or principle sanctions except when one or more of the following conditions exists: (1) There is immediate jeopardy to patient health and safety. (2) The laboratory fails to provide CMS or a CMS agent with satisfactory evidence that it has taken steps to correct the problem identified by the unsuccessful proficiency testing performance. (3) The laboratory has a poor compliance history. This CONDITION is not met as evidenced by: Based on review of the CASPER Report 0155D and interview with a College of American Pathologists (CAP) representative the laboratory failed to successfully participate in proficiency testing (PT) for the hematology analyte prothrombin time during events one and two of 2022 resulting in the initial unsuccessful performance for prothrombin time. See D2130. D2130 HEMATOLOGY CFR(s): 493.851(f) 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 -- 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 review of the CASPER Report 0155D and interview with a College of American Pathologists (CAP) representative the laboratory failed to successfully participate in proficiency testing (PT) for the hematology analyte prothrombin time during events one and two of 2022, resulting in the initial unsuccessful performance for prothrombin time. Findings include: 1. Review of the CASPER Report 0155D revealed that the initial unsuccessful PT performance occurred during CAP PT events one and two of 2022, as listed below. Hematology EVENT -1, 2022 - Prothrombin Time - 40% Unsatisfactory EVENT -2, 2022 - Prothrombin Time - 60% Unsatisfactory 2. A phone interview with the CAP PT representative on 7-1-2022 at 11:15 am confirmed the initial unsuccessful PT performance for the analyte prothrombin time for events one and two of 2022. -- 2 of 2 --

Summary Statement of Deficiencies D5400 ANALYTIC SYSTEMS CFR(s): 493.1250 Each laboratory that performs nonwaived testing must meet the applicable analytic systems requirements in 493.1251 through 493.1283, unless HHS approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub.7), that provides equivalent quality testing. The laboratory must monitor and evaluate the overall quality of the analytic systems and correct identified problems as specified in 493.1289 for each specialty and subspecialty of testing performed. This CONDITION is not met as evidenced by: Based on record and manual review, manufacturer's instructions, and interview with the technical consultant (TC), the laboratory failed to meet the applicable analytic systems requirements in 493.1251 through 493.1283 for performing Chemistry and Hematology testing in the laboratory. Findings Include: 1. The laboratory failed to meet the following analytic systems requirements: *Failed to establish manufacturer's performance specifications for Routine Chemistry testing. See D5421. *Failed to follow manufacturer's requirements and perform function checks necessary for accurate and reliable test results and test result reporting. D5431. *Failed to establish control procedures for Routine Chemistry testing. See D5441. *Failed to perform control procedures for Hematology testing. See D5445. 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) 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 -- 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 record review, the Food and Drug Administration (FDA), and interview with the technical consultant (TC), the laboratory failed to demonstrate that it could obtain performance specifications comparable to those established by the manufacturer before reporting patient test results in the subspecialty of Routine Chemistry, affecting 20 patients. Findings: 1. The Abbott i-STAT operator's and procedures manual, FDA website, quality control (QC) documents, and patients test results were reviewed. 2. The laboratory used the i-STAT handheld analyzer CHEM8+ test system for Routine Chemistry testing of the following analytes: Sodium (Na); Potassium (K); Calcium (Ca); Chloride (Cl); Creatine (Crea); Glucose (Glu); and Urea (BUN) in the surgery center laboratory. 3. The FDA changed the categorization of the i-STAT CHEM8+ test system from "Waived" to "Moderate" on 02/07/2020 for the testing of the analytes listed in findings #2. 4. The manufacturer's instructions were provided for verifying the reportable range of the analytes in the CHEM8+ panel by performing calibration verification. 5. The laboratory failed to perform the calibration procedure to ensure the i-STAT analyzer met the manufacturer's specification for Routine Chemistry testing, prior to testing patients. 6. The laboratory reported 20 patient test result during the time period of 02/072020 through 07/16/2021. 7. On a Recertification survey conducted on 07/16/2021 at 3:45 PM, the TC confirmed the above findings. D5431 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(a)(2) For unmodified manufacturer's equipment, instruments, or test systems, the laboratory must perform and document function checks as defined by the manufacturer and with at least the frequency specified by the manufacturer. Function checks must be within the manufacturer's established limits before patient testing is conducted. This STANDARD is not met as evidenced by: Based on record review and interview with the technical consultant (TC); the laboratory failed to perform and document the maintenance protocols as defined by the manufacturer with at least the frequency specified by the manufacturer, to ensure equipment, instrument, and test system performances are accurate and reliable, affecting 40 patients. Findings: 1. The Abbott i-STAT manufacturer's manual, maintenance documents, and the laboratory individual quality control plan (IQCP) were reviewed. 2. The laboratory used the Abbott i-STAT analyzer to test for the following analytes: *Activated Clotting Time - Celite (ACT-C), *Protime /International Normalized Ratio (PT/INR); *Sodium (Na); *Potassium (K); *Calcium (Ca); . *Chloride (Cl); *Creatine (Crea); *Glucose (Glu); and *Urea (BUN) in the surgery center. 2. The manufacturer's instructions in Section 14: Quality Control (QC) states " Check each Handheld reader with the Electronic Simulator, using either the internal or external simulator, once on each day of use.". 3. The patients' results log book showed patient tests were performed 36 day during the period of 09/30/2019 through 07/15/2021. 4. The i-STAT System: Electronic Simulator log revealed the following documented test dates: 06/12/2019; 12/20/2019; 08/27/2020; and 12/01 /2020; and 07/16/2021. 5. Further review of the log revealed the Electronic Simulator check of either internal or external or both were not performed for 36 out of 36 days -- 2 of 5 -- patients were tested. 6. The laboratory failed to follow it's IQCP to perform and document the electronic check each day of testing. 7. On a Recertification survey conducted on 07/16/2021 at 3:45 PM, the TC confirmed the above findings. D5441 CONTROL PROCEDURES CFR(s): 493.1256(a)(b)(c)(g) (a) For each test system, the laboratory is responsible for having control procedures that monitor the accuracy and precision of the complete analytic process. (b) The laboratory must establish the number, type, and frequency of testing control materials using, if applicable, the performance specifications verified or established by the laboratory as specified in 493.1253(b)(3). (c) The control procedures must-- (c)(1) Detect immediate errors that occur due to test system failure, adverse environmental conditions, and operator performance. (c)(2) Monitor over time the accuracy and precision of test performance that may be influenced by changes in test system performance and environmental conditions, and variance in operator performance. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on record review, the Food and Drug Administration (FDA), lack of documentation, and interview with the technical consultant (TC), the laboratory failed to establish control procedures that monitor the accuracy and precision of the complete analytic process for testing performed in the subspecialty of Routine Chemistry, affecting 20 patients. Findings: 1. The i-STAT operator's and procedures manual, quality control (QC) logs and data sheets, and patients' results were reviewed. 2. The laboratory used the i-STAT handheld analyzer CHEM8+ test system for Routine Chemistry testing of the following analytes: Sodium (Na); Potassium (K); Calcium (Ca); Chloride (Cl); Creatine (Crea); Glucose (Glu); and Urea (BUN) in the surgery center laboratory. 3. The FDA changed the categorization of the i-STAT CHEM8+ test system from "Waived" to "Moderate" on 02/07/2020 for the testing of the analytes listed in findings #2. 4. Review of the laboratory manual, QC documents and patients' results revealed the following: *The laboratory failed to establish quality control procedures when the CHEM8+ test system complexity was changed to moderate. *The CHEM8+ tests were performed 17 days during the period of 02/07 /2020 through 07/15/2021. *The laboratory failed to perform electronic QC check procedures and test 2 levels of control material each day of patient testing for 16 out of 17 test dates. *Twenty (20) patients were tested since 02/07/2020. 5. The laboratory failed to establish and implement QC procedures for Routing Chemistry testing when the i-STAT test system's level of complexity changed, prior to testing patients. 6. On a Recertification survey conducted on 07/16/2021 at 3:45 PM, the TC confirmed the above findings. 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 -- 3 of 5 -- laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on record review, manufacturer's instructions, and interview with the technical consultant (TC); the laboratory failed to perform control procedures using the number and frequency established by the laboratory for Hematology, affecting 18 out of 18 patients. Findings Include: 1. The laboratory's individual quality control plan (IQCP), the manufacturer's instructions, quality control (QC) logs from the month of October of 2019 through July of 2021, and patient test printout results were reviewed. 2. The laboratory used the Abbott i-STAT analyzer to test for Activated Clotting Time - Celite (ACT-C) and Protime/International Normalized Ratio (PT/INR) in the surgery center. 3. The ACT-C and PT/INR IQCP revealed the following: *The laboratory must document and perform two levels of controls monthly and with each new shipment. *The laboratory must perform and document the electronic function checks each day of use. 4. Review of the QC, manual, and maintenance logs showed the laboratory failed to print the i-Stat manual for their analyzer, failed to perform and document monthly QC procedures for 8 out 21 months; and failed to perform and document electronic function checks each day of use for 36 out of 36 test dates. 5. The Quality Assessment (QA) plan failed to ensure that QC procedures were followed by testing personnel, and failed to monitor, assess, and when indicated, make adjustments when needed, due to changes in the manufacturer's instructions or the laboratory's QC plan. 6. The laboratory failed to establish and follow an IQCP that ensures the i-STAT test system performances are accurate and reliable for Hematology testing and in accordance to the manufacturer's instructions. 7. On a Recertification survey conducted on 07/16/2021 at 3:45 PM, the TC confirmed the above findings. D5807 TEST REPORT CFR(s): 493.1291(d) Pertinent "reference intervals" or "normal" values, as determined by the laboratory performing the tests, must be available to the authorized person who ordered the tests and, if applicable, the individual responsible for using the test results. This STANDARD is not met as evidenced by: Based on record review and interview with the technical consultant (TC); the laboratory failed to ensure reference ranges or normal values are included in the final test report, affecting 8 out of 8 patients. Findings: 1. The patients' final report of 8 randomly selected patients were reviewed. 2. The laboratory failed to include the "reference intervals" or "normal" values for the following reported analytes: *Activated Clotting Time - Celite (ACT-C), *Protime/International Normalized Ratio (PT/INR); *Sodium (Na); *Potassium (K); *Calcium (Ca); . *Chloride (Cl); *Creatine (Crea); *Glucose (Glu); and *Urea (BUN). 3. On a Recertification survey conducted on 07/16/2021 at 3:45 PM, the TC confirmed the above findings. D6063 LABORATORY TESTING PERSONNEL CFR(s): 493.1421 The laboratory must have a sufficient number of individuals who meet the qualification requirements of 493.1423, to perform the functions specified in 493. 1425 for the volume and complexity of tests performed. -- 4 of 5 -- This CONDITION is not met as evidenced by: Based on record review and an interview with the technical consultant (TC), the laboratory failed to ensure individuals meet the qualification requirements of 493. 1423, to perform the functions specified in 493.1425 for the complexity of tests performed in the specialties of Hematology and Chenisry for 1 out of 5 testing personnel (TP). Findings: 1. The laboratory failed to ensure that laboratory personnel meet the education requirement for moderately complex testing, prior to testing patients. See D6065. D6065 TESTING PERSONNEL QUALIFICATIONS CFR(s): 493.1423(b)(1)(2)(3)(4)(i) (b) Meet one of the following requirements: (b)(1) Be a doctor of medicine or doctor of osteopathy licensed to practice medicine or osteopathy in the State in which the laboratory is located or have earned a doctoral, master's, or bachelor's degree in a chemical, physical, biological or clinical laboratory science, or medical technology from an accredited institution; or (b)(2) Have earned an associate degree in a chemical, physical or biological science or medical laboratory technology from an accredited institution; or (b)(3) Be a high school graduate or equivalent and have successfully completed an official military medical laboratory procedures course of at least 50 weeks duration and have held the military enlisted occupational specialty of Medical Laboratory Specialist (Laboratory Technician); or (b)(4)(i) Have earned a high school diploma or equivalent; and This STANDARD is not met as evidenced by: Based on record review, the Laboratory Personnel Report (CMS-209) and interview with the technical consultant (TC); the laboratory failed to ensure laboratory employees meet the qualification requirements for performing moderately complex testing in the specialty of Hematology and Chemistry for 1 out of 4 testing personnel (TP). Findings: 1. The CMS 209, employee files, and manuals were reviewed. 2. The CMS 209 lists 4 TP (TP1, TP2, TP3, and TP4) performing Hematology and Routine Chemistry tests. 3. The personnel education credentials revealed that TP3 had education documentation from a foreign country. These documents had not been evaluated for United States equivalency. 4. The laboratory failed to ensure the foreign documents of TP3 met the education requirements for moderately complex testing, prior to testing patients. 5. On a Recertification survey conducted on 07/16/2021 at 3: 45 PM, the TC confirmed the above findings. -- 5 of 5 --