First Surgical Hospital

Summary Statement of Deficiencies D0000 The laboratory was found to be in compliance with the Conditions of the CLIA regulations found at 42 CFR 493.1 through 493.1780, CLIA requirements for laboratories as a result of a recertification survey completed on 09/16/2025 and recertification is recommended. Standard level deficiencies were cited. 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 the review of instructions on Proficiency Testing Performance Evaluation from American Proficiency Institute (API), the laboratory's proficiency testing results from 2024 to 2025, and confirmed in an interview, the laboratory failed to have review documentation of self-evaluation of "Not Graded" results for 3 of 9 events reviewed. The findings were: 1. Review of the instructions from American Proficiency Institute (API) revealed "Laboratories are responsible for documenting and performing

Summary Statement of Deficiencies D0000 The following deficiencies are a result of a desk review of proficiency testing scores obtained from the national database and verified with the proficiency testing company. The facility was found to be out of compliance with the conditions of participation of the CLIA program The following CONDITION LEVEL DEFICIENCIES were found to be out of compliance: 493.803 D2016 Condition: Successful participation [proficiency testing] 493.1403 D6000 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 a desk review of proficiency testing records obtained from the CMS (Center 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 -- for Medicare Services) national database and verified with the proficiency testing company American Proficiency Institute (API), the laboratory failed to successfully participate in a proficiency testing program approved by CMS, for each specialty, subspecialty, and analyte or test in which the laboratory is certified under CLIA. The laboratory did not successfully participate in the specialty of hematology for the analyte CELL ID OR WBC DIFF. Refer to D2130. D2121 HEMATOLOGY CFR(s): 493.851(a) Failure to attain a score of at least 80 percent of acceptable responses for each analyte in each testing event is unsatisfactory analyte performance for the testing event. This STANDARD is not met as evidenced by: Based on a desk review of proficiency testing records obtained from the CMS (Center for Medicare Services) national database and verified with the laboratory's American Proficiency Institute (API) proficiency test results, the laboratory failed to achieve an overall testing event score of at least 80% for the analyte CELL ID OR WBC DIFF for 2 of 3 events reviewed. Findings included: 1. API 2022-3rd event the laboratory received the following unsatisfactory score: CELL ID OR WBC DIFF 76% 2. API 2023-1st event the laboratory received the following unsatisfactory score: CELL ID OR WBC DIFF 44% 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 proficiency testing records obtained from the CMS (Center for Medicare Services) national database and verified with the proficiency testing company American Proficiency Institute (API), the laboratory failed to achieve a satisfactory performance (80 % or greater) for the analyte CELL ID OR WBC DIFF for two out of three consecutive testing events in 2022 and 2023. Two out of three unsatisfactory scores result in unsuccessful PT performance. Findings included: 1. API 2022-3rd event the laboratory received the following unsatisfactory score: CELL ID OR WBC DIFF 76% 2. API 2023-1st event the laboratory received the following unsatisfactory score: CELL ID OR WBC DIFF 44% D6000 MODERATE COMPLEXITY LABORATORY DIRECTOR CFR(s): 493.1403 The laboratory must have a director who meets the qualification requirements of 493. 1405 of this subpart and provides overall management and direction in accordance with 493.1407 of this subpart. This CONDITION is not met as evidenced by: Based on a desk review of proficiency testing records obtained from the CMS (Center for Medicare Services) national database and verified with the laboratory's American -- 2 of 3 -- Proficiency Institute (API) proficiency test results, it was revealed that the laboratory director failed to provide overall management and direction of the laboratory services. Refer to D6016. D6016 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(i) The laboratory director is responsible for the overall operation and administration of the laboratory, including the employment of personnel who are competent to perform test procedures, and record and report test results promptly, accurate, and proficiently and for assuring compliance with the applicable regulations. (e) The laboratory director must-- (e)(4)(i) Ensure that the proficiency testing samples are tested as required under Subpart H of this part; This STANDARD is not met as evidenced by: Based on a desk review of proficiency testing records obtained from the CMS (Center for Medicare Services) national database and verified with the proficiency testing company American Proficiency Institute (API) the laboratory director failed to ensure successful participation in a CMS-approved proficiency testing program. Refer to D2121 and D2130. -- 3 of 3 --

Summary Statement of Deficiencies D0000 The following deficiencies are a result of a desk review of proficiency testing scores obtained from the national database and verified with the proficiency testing company. The facility was found to be out of compliance with the conditions of participation of the CLIA program The following CONDITION LEVEL DEFICIENCIES were found to be out of compliance: 493.803 D2016 Condition: Successful participation [proficiency testing] 493.807 D2017 Reinstatement After Failure 493.1403 D6000 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: Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 3 -- Based on a desk review of proficiency testing records obtained from the CMS (Center for Medicare Services) national database and verified with the proficiency testing company American Proficiency Institute (API) and the facility, it was determined the laboratory had not successfully participated in a proficiency testing program approved by CMS, for each specialty, subspecialty, and analyte or test in which the laboratory is certified under CLIA. The laboratory did not successfully participate in the specialty of Routine Chemistry for the analyte Chloride. (Refer to D2096) D2017 REINSTATEMENT OF NONWAIVED LABORATORIES CFR(s): 493.807(a)(b) (a) If a laboratory's certificate is suspended or limited or its Medicare or Medicaid approval is cancelled or its Medicare or Medicaid payments are suspended because it fails to participate successfully in proficiency testing for one or more specialties, subspecialties, analyte or test, or voluntarily withdraws its certification under CLIA for the failed specialty, subspecialty, or analyte, the laboratory must then demonstrate sustained satisfactory performance on two consecutive proficiency testing events, one of which may be on site, before CMS will consider it for reinstatement for certification and Medicare or Medicaid approval in that specialty, subspecialty, analyte or test. (b) The cancellation period for Medicare and Medicaid approval or period for suspension of Medicare or Medicaid payments or suspension or limitation of certification under CLIA for the failed specialty, subspecialty, or analyte or test is for a period of not less than six months from the date of cancellation, limitation or suspension of the CLIA certificate. This CONDITION is not met as evidenced by: Based on a desk review of proficiency testing records obtained from the CMS (Center for Medicare Services) national database (Report 153 and Report 155), and verified with the proficiency testing records from American Proficiency Institute (API) and the facility, it was determined the laboratory had not successfully participated in proficiency testing for the analyte Chloride under the specialty of Routine Chemistry for 4 of 6 testing events and has not demonstrated sustained satisfactory performance on two consecutive proficiency events since the unsuccessful scores. Findings included: 1. 2020 Chemistry - Core - second event the laboratory received an unsatisfactory score of 0% for the analyte Chloride. 2. 2020 Chemistry - Core - third event the laboratory received an unsatisfactory score of 60% for the analyte Chloride. * The 2020 second event and 2020 third event resulted in initial unsuccessful proficiency testing performance. 3. 2021 Chemistry - Core - second event the laboratory received an unsatisfactory score of 20% for the analyte Chloride. * The 2021 second event constituted non-initial unsuccessful proficiency testing performance. 4. 2022 Chemistry - Core - first event the laboratory received an unsatisfactory score of 60% for the analyte Chloride. * The 2022 first event constituted an additional non-initial unsuccessful proficiency testing performance. Note: The laboratory has voluntarily ceased testing Chloride on their primary instrument, The Horiba Pentra C400 on 02/23/2022. 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. -- 2 of 3 -- This STANDARD is not met as evidenced by: Based on a desk review of proficiency testing records obtained from the CMS (Center for Medicare Services) national database Report 153 and Report 155, and verified with the proficiency testing records from American Proficiency Institute (API), it was revealed the laboratory failed to achieve satisfactory performance for the analyte Chloride for 4 of 6 testing events in 2020, 2021 and 2022. Findings included: 1. 2020 Chemistry - Core - second event the laboratory received an unsatisfactory score of 0% for the analyte Chloride. 2. 2020 Chemistry - Core - third event the laboratory received an unsatisfactory score of 60% for the analyte Chloride. 3. 2021 Chemistry - Core - second event the laboratory received an unsatisfactory score of 20% for the analyte Chloride. 4. 2022 Chemistry - Core - first event the laboratory received an unsatisfactory score of 60% for the analyte Chloride. Four out of six unsatisfactory scores results in non- initial unsuccessful proficiency testing performance. D6000 MODERATE COMPLEXITY LABORATORY DIRECTOR CFR(s): 493.1403 The laboratory must have a director who meets the qualification requirements of 493. 1405 of this subpart and provides overall management and direction in accordance with 493.1407 of this subpart. This CONDITION is not met as evidenced by: Based on a desk review of proficiency testing records obtained from the CMS (Center for Medicare Services) national database and verified with the laboratory's American Proficiency Institute (API) proficiency test results, it was revealed that the laboratory director failed to provide overall management and direction of the laboratory services. (Refer to D6016) D6016 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(i) The laboratory director is responsible for the overall operation and administration of the laboratory, including the employment of personnel who are competent to perform test procedures, and record and report test results promptly, accurate, and proficiently and for assuring compliance with the applicable regulations. (e) The laboratory director must-- (e)(4)(i) Ensure that the proficiency testing samples are tested as required under Subpart H of this part; This STANDARD is not met as evidenced by: Based on a desk review of proficiency testing records obtained from the CMS (Center for Medicare Services) national database and verified with the laboratory's American Proficiency Institute (API) proficiency test results, it was revealed the laboratory director failed to ensure the overall quality of the laboratory services provided. The laboratory director failed to ensure successful participation in a CMS approved proficiency testing program. (Refer to D2096) -- 3 of 3 --

Summary Statement of Deficiencies D0000 Noted deficiencies and plans of correction were discussed with the laboratory representative(s) at the exit conference. The facility was found to be in compliance with applicable Conditions of Participation in the CLIA program, and recertification is recommended. . D2006 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(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 review of the American Proficiency Institute (API) proficiency testing for 2020 and 2021, laboratory policies and confirmed with interview, the laboratory failed to test proficiency testing samples it received from the proficiency testing program in the same manner as it tested patient specimens for one of twenty tests reviewed (serum hCG). Findings included: 1. A review of API proficiency testing events from 2020 and 2021 revealed that on three of six events (API 1st event 2021; API 2nd event 2021; API 2nd event 2020) the testing person ran the positive result proficiency specimens in duplicate using their Sure-Vue hCG test cartridges. 2021 API 1st event API-02 - Positive API-03 - Positive API-04 - Positive 2021 API 2nd event API-06 - Positive API-08 - Positive API-10 - Positive 2020 API 2nd event API-06 - Positive API-09 - Positive API-10 - Positive 2. Review of the laboratory policy Critical Values List (policy #01.12) revealed no documentation of a serum hCG as a critical lab result. 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 -- Review of the hCG policy revealed no documentation of a repeat analysis for positive results. 3. An interview with the laboratory manager on 3/1/22 at 1425 hours in the conference room confirmed the above findings. She stated that it's the lab policy to confirm all positive hCG results. However, the laboratory does NOT repeat the testing on their test cartridge, the laboratory sends out for confirmation. 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 American Proficiency Institute (API) proficiency testing records from 2020 and 2021; laboratory policy and records; and confirmed with interview, the laboratory failed to verify the accuracy of all testing twice annually for one of twenty tests reviewed (urine microscopic) in 2020 and 2021. Findings included: 1. Review of the API test records from 2020 to 2021 revealed no documentation of the laboratory being enrolled in proficiency testing for urine microscopic. 2. Review of the laboratory records available revealed no documentation of a twice annual accuracy assessment for urine microscopic for 2020 or 2021. 3. Review of the laboratory records available revealed no documentation of a policy to determine the accuracy assessment for urine microscopic. 4. Review of the laboratory worksheet Annual Test Volume and Proficiency Testing Programs Worksheet signed by the laboratory director on 1/31/22 revealed an annual volume of 206 for urinalysis. 5. An interview with the laboratory manager on 2/1/22 at 1420 hours in the conference room confirmed the above findings. D5311 SPECIMEN SUBMISSION, HANDLING, AND REFERRAL CFR(s): 493.1242(a) The laboratory must establish and follow written policies and procedures for each of the following, if applicable: (1) Patient preparation. (2) Specimen collection. (3) Specimen labeling, including patient name or unique patient identifier and, when appropriate, specimen source. (4) Specimen storage and preservation. (5) Conditions for specimen transportation. (6) Specimen processing. (7) Specimen acceptability and rejection. (8) Specimen referral. This STANDARD is not met as evidenced by: Based on direct observation by surveyor, review of laboratory policies, manufacturer's instructions, and confirmed in interview, the laboratory failed to follow its policy for specimen rejection for one of five specimens observed in the laboratory. The findings included: 1. Surveyor observation on 2/1/22 at 1535 hours in the laboratory revealed one of five purple top tubes for the Pentra 60 C+ hematology analyzer with a short sample (patient ID 9797). 2. An interview with the laboratory manager on 2/1/22 at 1540 hours in the laboratory and after her review of the specimen, she acknowledged that the specimen was 1/4 full and below the fill line for the tube. She stated that the patient was a "hard stick." 3. Review of the laboratory's policy Specimen Rejection revealed under Specimen Rejection Criteria "Improper specimen collection: improper or inadequate venipuncture technique may result in hemolyzed specimens. Inadequate volume of specimen may also inhibit testing." 4. Review of the instructions for use for -- 2 of 4 -- the BD Vacutainer Evacuated Blood Collection System (500030670, 03/2018) under Caution revealed "Overfilling or under filling of tubes will result in an incorrect blood- to-additive ratio and may lead to incorrect analytic results or poor product performance." 5. Review of the patient final reports for 2/1/22 revealed the laboratory analyzed and reported the above purple top (Patient ID 9797) for CBC (complete blood count). 6. An interview with the laboratory manager on 2/1/22 at 1540 hours confirmed the above findings. D5473 CONTROL PROCEDURES CFR(s): 493.1256(e)(2)(g) (e) For reagent, media, and supply checks, the laboratory must do the following: (e) (2) Each day of use (unless otherwise specified in this subpart), test staining materials for intended reactivity to ensure predictable staining characteristics. Control materials for both positive and negative reactivity must be included, as appropriate. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on review of the laboratory and patient test records from 2021 and confirmed in interview, the laboratory failed to verify manual differential stain quality each day of use for six of ten days reviewed. The findings were: 1. Random review of laboratory patient final reports from March, July, and September of 2021 revealed the laboratory performed manual CBC (complete blood count) differential for the following six patients. 3/11/21: Accession 2103110009 3/16/21: Accession 210316028 9/29/21: Accession 2109290011 9/22/21: Accession 2109220047 7/27/21: Accession 2107270009 7/06/21: Accession 2107060001 2. Review of the laboratory records available for the above days revealed no documentation of the stain quality. 3. An interview with the laboratory manager on 2/1/22 at 1505 hours in the conference room confirmed the above findings. D5805 TEST REPORT CFR(s): 493.1291(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 the laboratory verification records, patient final reports, and confirmed in interview, the laboratory failed to ensure the accuracy and reliability of data for Troponin testing on the iSTAT analyzer for seven of ten patients reviewed. Findings were: 1. Review of the verification studies from 2018 for Troponin on the iSTAT analyzer revealed the lowest reportable range as 0.29 ng/mL. 2. Random review of patient final reports from 2021 revealed seven of ten patient final reports with Troponin results reported outside of its reportable range. Date Patient ID Trop Result (ng/mL) 7/06/21 6315 0.00 9/16/21 8331 0.00 8/16/21 7948 0.00 10/121 7912 -- 3 of 4 -- 0.00 6/15/21 7158 0.00 9/24/21 7291 0.00 3. An interview with the laboratory manager on 2/2/22 at 1505 hours in the conference room confirmed the above findings. D6127 TECHNICAL SUPERVISOR RESPONSIBILITIES CFR(s): 493.1451(b)(9) The technical supervisor is responsible for 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 review of the laboratory personnel files, and confirmed in interview, the technical supervisor failed to perform semi-annual competency for five of eight testing person (TP) during the first year of testing patient specimens for high complexity testing in immunohematology. Findings were: 1. A review of the facility's personnel files revealed documentation of the initial and second competency within the first year for four of eight testing personnel (TP#16, hire date 10/13/21; TP# 5, hire date 4/22/21; TP #3, hire date 3/29/21; TP #2, hire date 6/7/21) for blood bank testing by the TC #1 who did not meet the requirements as a technical supervisor for immunohematology. The technical consultant has a bachelor's degree. 2. A review of the facility's personnel files revealed documentation of the initial competency of one of eight testing personnel (TP#1, hire date 11/30/20) for blood bank testing by the TP#7 who did not meet the requirements as a technical supervisor for immunohematology. Testing person #7 has a bachelor's degree. 3. An interview with the laboratory manager on 2/1/22 at 1148 hours in the conference room confirmed the above findings. -- 4 of 4 --

Summary Statement of Deficiencies D0000 The following deficiencies are a result of a desk review of proficiency testing scores obtained from the national database and verified with the proficiency testing company. The facility was found to be out of compliance with the conditions of participation of the CLIA program The following CONDITION LEVEL DEFICIENCIES were found to be out of compliance: 493.803 D2016 Condition: Successful participation [proficiency testing 493.807 D2017 Reinstatement After Failure 493.1403 D6000 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: 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 -- Based on a desk review of proficiency testing records obtained from the CMS (Center for Medicare Services) national database and verified with the proficiency testing company American Proficiency Institute (API), it was determined the laboratory had not successfully participated in a proficiency testing program approved by HHS, for each specialty, subspecialty, and analyte or test in which the laboratory is certified under CLIA. The laboratory did not successfully participate in the specialty of Routine Chemistry for the analyte Chloride. (Refer to D2096) D2017 REINSTATEMENT OF NONWAIVED LABORATORIES CFR(s): 493.807(a)(b) (a) If a laboratory's certificate is suspended or limited or its Medicare or Medicaid approval is cancelled or its Medicare or Medicaid payments are suspended because it fails to participate successfully in proficiency testing for one or more specialties, subspecialties, analyte or test, or voluntarily withdraws its certification under CLIA for the failed specialty, subspecialty, or analyte, the laboratory must then demonstrate sustained satisfactory performance on two consecutive proficiency testing events, one of which may be on site, before CMS will consider it for reinstatement for certification and Medicare or Medicaid approval in that specialty, subspecialty, analyte or test. (b) The cancellation period for Medicare and Medicaid approval or period for suspension of Medicare or Medicaid payments or suspension or limitation of certification under CLIA for the failed specialty, subspecialty, or analyte or test is for a period of not less than six months from the date of cancellation, limitation or suspension of the CLIA certificate. This CONDITION is not met as evidenced by: Based on a desk review of proficiency testing records obtained from the CMS (Center for Medicare Services) national database and verified with the proficiency testing records from American Proficiency Institute (API), it was determined the laboratory had not successfully participated in proficiency testing for the analyte Chloride under the specialty of Routine Chemistry for 3 of 4 testing events and has not demonstrated sustained satisfactory performance on two consecutive proficiency events since the unsuccessful scores. Findings include: 1. 2020 Chemistry - Core - second event the laboratory received an unsatisfactory score of 0% for the analyte Chloride. 2. 2020 Chemistry - Core - third event the laboratory received an unsatisfactory score of 60% for the analyte Chloride. * The 2020 second event and 2020 third event resulted in intial unsuccessful proficiency testing performance. 3. 2021 Chemistry - Core - second event the laboratory received an unsatisfactory score of 20% for the analyte Chloride. * The 2021 second event constituted non-initial unsuccessful proficiency testing performance. 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 a desk review of proficiency testing records obtained from the CMS (Center for Medicare Services) national database and verified with the laboratory's American Proficiency Institute (API) proficiency test results, it was revealed the laboratory -- 2 of 4 -- failed to attain a score of at least 80% for the analyte Chloride in 2020 and 2021. Findings include: 1. 2020 Chemistry - Core - second event the laboratory received an unsatisfactory score of 0% for the analyte Chloride. 2. 2020 Chemistry - Core - third event the laboratory received an unsatisfactory score of 60% for the analyte Chloride. 3. 2021 Chemistry - Core - second event the laboratory received an unsatisfactory score of 20% for the analyte Chloride. . 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 proficiency testing records obtained from the CMS (Center for Medicare Services) national database and verified with the proficiency testing records from American Proficiency Institute (API), it was revealed the laboratory failed to achieve satisfactory performance for the analyte Chloride for 3 of 4 testing events in 2020 and 2021. Findings include: 1. 2020 Chemistry - Core - second event the laboratory received an unsatisfactory score of 0% for the analyte Chloride. 2. 2020 Chemistry - Core - third event the laboratory received an unsatisfactory score of 60% for the analyte Chloride. 3. 2021 Chemistry - Core - second event the laboratory received an unsatisfactory score of 20% for the analyte Chloride. Three out of four unsatisfactory scores results in non- intial unsuccessful proficiency testing performance. D6000 MODERATE COMPLEXITY LABORATORY DIRECTOR CFR(s): 493.1403 The laboratory must have a director who meets the qualification requirements of 493. 1405 of this subpart and provides overall management and direction in accordance with 493.1407 of this subpart. This CONDITION is not met as evidenced by: Based on a desk review of proficiency testing records obtained from the CMS (Center for Medicare Services) national database and verified with the laboratory's American Proficiency Institute (API) proficiency test results, it was revealed that the laboratory director failed to provide overall management and direction of the laboratory services. (Refer to D6016) D6016 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(i) The laboratory director is responsible for the overall operation and administration of the laboratory, including the employment of personnel who are competent to perform test procedures, and record and report test results promptly, accurate, and proficiently and for assuring compliance with the applicable regulations. (e) The laboratory director must-- (e)(4)(i) Ensure that the proficiency testing samples are tested as required under Subpart H of this part; -- 3 of 4 -- This STANDARD is not met as evidenced by: Based on a desk review of proficiency testing records obtained from the CMS (Center for Medicare Services) national database and verified with the laboratory's American Proficiency Institute (API) proficiency test results, it was revealed the laboratory director failed to ensure the overall quality of the laboratory services provided. The laboratory director failed to ensure successful participation in a HHS approved proficiency testing program. (Refer to D2096) -- 4 of 4 --

Summary Statement of Deficiencies D5413 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(b) The laboratory must define criteria for those conditions that are essential for proper storage of reagents and sp accurate and reliable test system operation, and test result reporting. The criteria must be consistent with the m instructions, if provided. These conditions must be monitored and documented and, if applicable, include the Water quality. (2) Temperature. (3) Humidity. (4) Protection of equipment and instruments from fluctuations interruptions in electrical current that adversely affect patient test results and test reports. This STANDARD is not met as evidenced by: An unannounced revisit was performed on 10/12/20 to 10/14/20. I. Based on review of manufacturer's instruc temperature charts, patient reports, and interview, the laboratory failed to ensure the Main Laboratory's define Temperature met the manufacturer's requirements for PT (Prothrombin time) and APTT (activated Partial Th Time) performed on the Sysmex CA-600. A. Review of the Sysmex CA-600 Installation Package Rev 1.2 un Coagulation Specimen Handling under Specimen Storage stated, "PT *uncentrifuged or centrifuged *unopen degrees C (Celsius)... APTT *uncentrifuged or centrifuged *unopened tube *18-24 degrees C". B. Review of laboratory's Main Laboratory temperature chart showed the laboratory's defined room temperature range was C. Review of temperatures from January 2020 - September 2020 showed temperatures exceeded 24 degrees C 28 days in January 2020: 1. Jan 9 (24.1 degrees C), 2. Jan 11 (24.1 degrees C), 3. Jan 13 (24.5 degrees C), 4. degrees C), 5. Jan 15 (24.7 degrees C), 6. Jan 16 (24.7 degrees C), 7. Jan 17 (24.8 degrees C), 8. Jan 18 (25.0 Jan 19 (24.9 degrees C), 10. Jan 21 (25.0 degrees C), 11. Jan 23 (24.5 degrees C), 12. Jan 24 (24.5 degrees C (24.1 degrees C), and 14. Jan 27 (24.1 degrees C). C. Random review of patient reports for PT and APTT sho following patients were tested: patient IDs 1401-0001 on 1/14/20, 1219-0001 on 1/17/20 and 1301-0003 on 1 Interview with the technical consultant on 10/14/2020 at 1535 hours via phone call from the conference room she could update that to 20-24. II. Based on review of manufacturer's instructions, temperature charts, patient interview, the laboratory failed to ensure the Main Laboratory's established Room Temperature acceptable ra manufacturer's requirements for the controls for pH, pCO2 (partial Carbon dioxide), pO2 (partial Oxygen), N (Potassium), Ca (Calcium), Cl (Chloride), TCO2 (total Carbon dioxide), Glu (Glucose), Lac (Lactate) and BU 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 -- nitrogen) quality control performed on the epoc Blood Analysis System analyzer. A .Review of the Eurotrol G Metabolites control package insert used for the analysis of pH, pCO2 (partial Carbon dioxide), pO2 (partial O (Sodium), K (Potassium), Ca (Calcium), Cl (Chloride), TCO2 (total Carbon dioxide), Glu (Glucose), Lac (La BUN (Blood urea nitrogen) on the epoc Blood Analysis System analyzer under Procedures stated, "1...Equili ampule(s) for a minimum of 1 hour to a temperature to as close to 22 degrees C (Celsius)... as possible." B. R epoc System Procedure Manual, 51008148 Rev 07, under "Supplies and Storage Requirements for Quality C stated, "Follow the Manufacturer's storage and handling instructions. If ampules are taken from cool storage, ampules to Room Temperature (20-25 degrees C)." C. Review of the epoc Procedure Manual, 51012382 Rev Aqueous Fluid Handling at 9.4.2 Before Use, stated "If ampoules are taken from cool storage, equilibrate the Room Temperature (20 - 25 degrees C)." D. Review of the laboratory's temperature chart showed the laborato room temperature range was 16-25 degrees C. Review of temperatures from January 2020 - September 2020 temperatures for 9 of 9 months with the unacceptable room temperature range of 16-25 degrees Celsius. E. In the technical consultant on 10/14/2020 at 1535 hours via phone call from the conference room acknowledged update that to 20 to 24. III. Based on observation and interview, the laboratory failed to ensure the temperatur manager's office was established and monitored for the storage of laboratory reagents and test kits per manuf instructions. A. Surveyor observation on 10/13/2020 at 1445 in the manager's office revealed no means of mo temperatures. B. Further observation on 10/13/20 at 1445 revealed the following test kits, reagents, and blood tubes: 1. 2 Boxes of Ca Clean II, Lot A0013, exp 2021-05-27 with a manufacturer storage requirement of 5-3 printed on the box. 2. 10 Boxes of Sure-Vue Serum/Urine hCG-STAT kits, Lot HCG0022039, exp 2022-02-2 manufacturer storage requirement of 2-30 degrees C printed on the boxes. 3. 1 Box of NERL Reagent Grade 959427, exp 2021-06 with a manufacturer storage requirement of 15-30 degrees C printed on the box. 4. 1 Ca Vacutainer Buffered Sodium Citrate Blood Collection Tubes, Lot 0167175, exp 2021-03-31 with a manufactu requirement of 4 - 25 degrees C printed on the box. C. Interview with testing personnel #2 listed on the CMS /13/2020 at 1455 hours in the laboratory confirmed temperatures were not documented in the manager's offic aware that reagents or test kits were stored in the office. *************************************************************************************** D5821 TEST REPORT CFR(s): 493.1291(k) When errors in the reported patient test results are detected, the laboratory must do the following: (k)(1) Prom authorized person ordering the test and, if applicable, the individual using the test results of reporting errors. corrected reports promptly to the authorized person ordering the test and, if applicable, the individual using th (k)(3) Maintain duplicates of the original report, as well as the corrected report. This STANDARD is not met as evidenced by: An unannounced revisit was performed on 10/12/20 to 10/24/20. Based on review of laboratory policy, patien and confirmed in interview, the laboratory failed to follow its policy to promptly notify the authorized person test when errors in EPOC patient results are detected. Findings were: 1. Review of the laboratory policy Erro with an effective date of 10/4/2016 revealed "once an error has been discovered or a complaint made, the foll is initiated by the lab employee in charge at the time..notify ordering physician and/or RN that an error occur the date, time the person was notified, and who is performing the notification on EHR, to the ordering physic 2. Review of the patient final report of the blood gas specimen observed on 10/12/20 revealed a final report w following results and corresponding reference ranges. Patient MR 4297 i-STAT Lactate - 2.87 mg/dL (refere 11.30) iSTAT pH - 7.37 (reference range 7.35-7.45) iSTAT pCO2 - 43 mmHg (reference range 35-45) iSTAT mmHg (reference range 80-105) iSTAT TCO2 - 24 3. After an interview with the RN Quality Manager for cl the Patient MR4297 final report on 10/13/20 at 1000 hours in the conference room, he provided the surveyor final report for the same specimen. Patient MR 4297 EPOC Lac - 2.87 mmol/L (reference range 0.36-0.75) E (reference range 7.35-7.45) EPOC pCO2 - 42.5 mmHg (reference range 35-48) EPOC pO2 - 64 mmHg (refer 108) EPOC TCO2 - 24 mmol/L (reference range 22-29) 4. Review of the above corrected report revealed no of the notification to the ordering physician and/or RN that an error occurred. 5. Review of the electronic hea /14/20 at 1430 in the laboratory revealed the laboratory canceled the initial order and results for iSTAT. An o -- 2 of 3 -- was entered with the corresponding results. 6. An interview with the technical consultant on 10/14/20 at 1415 phone confirmed the above findings. **************************************************************************************** D5891 POSTANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1299(a) The laboratory must establish and follow written policies and procedures for an ongoing mechanism to monit when indicated, correct problems identified in the postanalytic systems specified in 493.1291. This STANDARD is not met as evidenced by: An unannounced revisit was performed on 10/12/20 to 10/14/20. Based on review of the laboratory's records interview, it was revealed the laboratory's quality assessment plan failed to identify and correct issues in post systems. The findings were: 1. The laboratory failed to have documentation of the providing the correct date final patient test reports (refer to D5801). 2. The laboratory failed to have documentation of providing the cor identifier on patient reports (refer to D5805). -- 3 of 3 --