Bullock County Hospital

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 review of the American Proficiency Institute (API) Proficiency Testing (PT) records, and an interview with the new Technical Consultant, the Laboratory failed to ensure successful participation in a proficiency testing program, for each specialty, subspecialty, and analyte or test in which the laboratory is certified under CLIA. The laboratory did not successfully participate in the specialty of Immunohematology for Compatibility Testing. (Refer to D2181). . D2181 COMPATIBILITY TESTING CFR(s): 493.863(e) 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 -- (e) Failure to achieve an overall testing event score of satisfactory for two consecutive testing events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on a review of the American Proficiency Institute (API) Proficiency Testing (PT) records, and an interview with the new Technical consultant (TC), the laboratory failed to successfully participate in proficiency testing for Compatibility testing, resulting in initial unsuccessful performance. The findings include: 1. A review of the API PT records revealed the laboratory received the following failing scores, resulting in unsatisfactory performances for two consecutive events, as follows: A. Immunohematology 2024-Event #2: Compatibility testing: 0% "Failure to Participate" B. Immunohematology 2025-Event #1: Compatibility testing: 80% 2. During an interview on 5/28/2025 at 1:15 pm, the new Technical Consultant confirmed the above findings. . D3031 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(3) Analytic systems records. Retain quality control and patient test records (including instrument printouts, if applicable) and records documenting all analytic systems activities specified in 493.1252 through 493.1289 for at least 2 years. In addition, retain the following: This STANDARD is not met as evidenced by: Based on a review of Hematology records, Coagulation records, Chemistry /Immunoassay records, D-dimer records and an interview with the new Laboratory Manager (LM) and the new Technical Consultant (TC), the previous laboratory manager failed to retain documentation of daily Hematology quality control (QC), Coagulation QC, Chemistry maintenance, and Ddimer QC. This was noted during review of 2023 through 2025. The findings include: 1. A review of QC and maintenance documentation revealed no evidence of the following documentation : a) Sysmex XS-1000i Hematology QC records 2/5/2024 through 11/15/2024. b) Sysmex CA-600 Coagulation QC records for January, February, August, and September 2024. c) Siemens Dimension EXL 200 Chemistry/Immunoassay weekly and monthly maintenance records June 2023 through December 2024. d) Quidel Triage Meter QC records July through November 2024 and January through March 2025. 2. During an interview on 5/28/2025 at 3:05 PM, the new LM and TC were unable to locate the documentation requested above when they were hired February 2025. D5417 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(d) (d) Reagents, solutions, culture media, control materials, calibration materials, and other supplies must not be used when they have exceeded their expiration date, have deteriorated, or are of substandard quality. This STANDARD is not met as evidenced by: Based on a review of the Blood Bank reagent records and an interview with the new -- 2 of 4 -- Laboratory Manager (LM) and new Technical Consultant (TC), the laboratory used expired Blood Bank reagent for QC prior to patient testing. This was noted for two days of two years reviewed in 2023 through 2024. The findings include: 1. A review of the Blood Bank reagent records revealed the following days expired reagent was utilized: a) Check Cells Lot # V262364 expired 8/28/23; 1 patient affected 9/13/2023, b) Rh Controls Lot # V220888 expired 5/11/24; 1 patient affected 5/12/2024. 2. During an interview on 5/29/2025, at 3:13 PM, the new LM and new TC confirmed the above findings. D5439 CALIBRATION AND CALIBRATION VERIFICATION CFR(s): 493.1255(b) (b)(1) Following the manufacturer's calibration verification instructions; (b)(2) Using the criteria verified or established by the laboratory under 493.1253(b)(3)-- (b)(2)(i) Including the number, type, and concentration of the materials, as well as acceptable limits for calibration verification; and (b)(2)(ii) Including at least a minimal (or zero) value, a mid-point value, and a maximum value near the upper limit of the range to verify the laboratory's reportable range of test results for the test system; and (b)(3) At least once every 6 months and whenever any of the following occur: (b)(3)(i) A complete change of reagents for a procedure is introduced, unless the laboratory can demonstrate that changing reagent lot numbers does not affect the range used to report patient test results, and control values are not adversely affected by reagent lot number changes. (b)(3)(ii) There is major preventive maintenance or replacement of critical parts that may influence test performance. (b)(3)(iii) Control materials reflect an unusual trend or shift, or are outside of the laboratory's acceptable limits, and other means of assessing and correcting unacceptable control values fail to identify and correct the problem. (b)(3)(iv) The laboratory's established schedule for verifying the reportable range for patient test results requires more frequent calibration verification. This STANDARD is not met as evidenced by: Based on a review of the D-dimer calibration verification (C-V) records and an interview with the new Laboratory Manager (LM) and new Technical Consultant (TC), the laboratory failed to ensure C-V was performed and documented on the Quidel Triage D-dimer analyzer the second half of 2023 and all of 2024 (three of five 2023-2025 C-V's missed). The findings include: 1. A review of the records for the Quidel Triage D-dimer revealed documentation of C-V performed on 4/27/2023 and 4 /22/2025 only. No evidence of October 2023 and all of 2024 C-V performed and documented. 2. During an interview on 5/29/2025 at 1:05 PM, the new LM and the new TC confirmed the above findings. D5481 CONTROL PROCEDURES CFR(s): 493.1256(f)(g) (f) Results of control materials must meet the laboratorys and, as applicable, the manufacturers test system criteria for acceptability before reporting patient test results. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on a review of the 2023 D-dimer quality control (QC) records, the D-dimer patient results log, Blood Bank QC records and Blood Bank patient log, and an interview with the new Laboratory Manager (LM) and the new Technical Consultant -- 3 of 4 -- (TC), the laboratory failed to ensure at least two levels of quality control were run and acceptable for D-dimer, and failed to ensure QC was performed for Blood Bank, prior to analyzing patient specimens and reporting the results. This was noted three days out of 6 months reviewed in 2023 for D-dimer and four days out of 2 years reviewed for Blood Bank. The findings include: 1. A review of the QC records for the Quidel Triage D-dimer analyzer revealed the following dates QC was out prior to patient testing: a) Level 1 out on 7/16/2023; 6 patients affected, b) Level 1 out on 8/18/2023; 4 patients affected, c) Level 1 out on 10/19/2023; 6 patients affected. 2. A review of the Blood Bank QC records revealed no evidence of QC performed and documented prior to patient testing for the following days: a) 8/11/2024; 1 patient affected, b) 9/16 /2024; 1 patient affected, c) 10/2/2024; 1 patient affected, d) 3/12/2025; 1 patient affected. 3. During an interview on 5/29/2025 at 1:12 PM, the new LM and new TC confirmed the above findings for D-dimer and confirmed the previous LM's ran patient's prior to performing Blood Bank QC. -- 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 laboratory's proficiency testing provider, American Proficiency Institute (API). The laboratory was found to be out of compliance with CONDITION LEVEL DEFICIENCIES, as follows: D2016 - 42 C.F.R. 493.803 Condition: Successful participation [proficiency testing] D6000 - 42 C.F.R. 493.1403 Condition: Laboratories performing moderate complexity testing; laboratory director . D2016 SUCCESSFUL PARTICIPATION CFR(s): 493.803(a)(b)(c) (a) Each laboratory performing nonwaived testing must successfully participate in a proficiency testing program approved by CMS, if applicable, as described in subpart I of this part for each specialty, subspecialty, and analyte or test in which the laboratory is certified under CLIA. (b) Except as specified in paragraph (c) of this section, if a laboratory fails to participate successfully in proficiency testing for a given specialty, subspecialty, analyte or test, as defined in this section, or fails to take remedial action when an individual fails gynecologic cytology, CMS imposes sanctions, as specified in subpart R of this part. (c) If a laboratory fails to perform successfully in a CMS- approved proficiency testing program, for the initial unsuccessful performance, CMS may direct the laboratory to undertake training of its personnel or to obtain technical assistance, or both, rather than imposing alternative or principle sanctions except when one or more of the following conditions exists: (1) There is immediate jeopardy to patient health and safety. (2) The laboratory fails to provide CMS or a CMS agent with satisfactory evidence that it has taken steps to correct the problem identified by the unsuccessful proficiency testing performance. (3) The laboratory has a poor compliance history. This CONDITION is not met as evidenced by: Based on off-site proficiency testing (PT) desk reviews of the CASPER Reports 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 -- 0153D and 0155D (Individual Laboratory Profiles from the Centers of Medicare and Medicaid Services [CMS]), and PT evaluation reports from the American Proficiency Institute (API), the laboratory failed to successfully participate (achieve scores of 80% or greater) in proficiency testing for Creatine Kinase, isoenzyme (CK-MB), an analyte in the specialty of Chemistry. The laboratory failed two consecutive 2024-2025 PT events, resulting in initial unsuccessful proficiency testing performance. Refer to D2096. . D2096 ROUTINE CHEMISTRY CFR(s): 493.841(f) (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 off-site proficiency testing (PT) desk reviews of the CASPER Reports 0153D and 0155D (Individual Laboratory Profiles from the Centers of Medicare and Medicaid Services [CMS]), and PT evaluation reports from the American Proficiency Institute (API), the laboratory failed to successfully participate (achieve scores of 80% or greater) in proficiency testing for Creatine Kinase, isoenzyme (CK-MB). The laboratory failed two consecutive 2024-2025 PT events, resulting in initial unsuccessful proficiency testing performance. The findings include: 1. A review of the CASPER Reports revealed the laboratory received failing scores for CK-MB in two consecutive API PT events, as follows: A) 2024 Core Chemistry Event #3: 0% B) 2025 Core Chemistry Event #1: 20% 2. A review of the laboratory's proficiency testing evaluation reports from the API website confirmed these findings. . 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 off-site proficiency testing (PT) desk reviews of the CASPER Reports 0153D and 0155D (Individual Laboratory Profiles from the Centers of Medicare and Medicaid Services [CMS]), and proficiency testing evaluation reports from the American Proficiency Institute (API), the laboratory director failed to ensure successful participation in an HHS approved proficiency testing program. Refer to D6016. . D6016 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(i) (e)(4)(i) The proficiency testing samples are tested as required under Subpart H of this part; This STANDARD is not met as evidenced by: -- 2 of 3 -- Based on off-site proficiency testing (PT) desk reviews of the CASPER Reports 0153D and 0155D (Individual Laboratory Profiles from the Centers of Medicare and Medicaid Services [CMS]), and PT evaluation reports from the American Proficiency Institute (API), the laboratory director failed to ensure the laboratory had successful participation in an HHS approved proficiency testing program for Creatine Kinase, isoenzyme (CK-MB) for two consecutive 2024-2025 PT events. Refer to D2096. SURVEYOR ID #32558 Licensure and Certification Surveyor -- 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 in an interview with the Laboratory Manager on 3/27/2024. The laboratory was found to be out of compliance with CONDITION LEVEL DEFICIENCIES, as follows: D2016 - 42 C.F.R. 493.803 Condition: Successful participation [proficiency testing] D6000 - 42 C.F.R. 493.1403 Condition: Laboratories performing moderate complexity testing; laboratory director . D2016 SUCCESSFUL PARTICIPATION CFR(s): 493.803(a)(b)(c) (a) Each laboratory performing nonwaived testing must successfully participate in a proficiency testing program approved by CMS, if applicable, as described in subpart I of this part for each specialty, subspecialty, and analyte or test in which the laboratory is certified under CLIA. (b) Except as specified in paragraph (c) of this section, if a laboratory fails to participate successfully in proficiency testing for a given specialty, subspecialty, analyte or test, as defined in this section, or fails to take remedial action when an individual fails gynecologic cytology, CMS imposes sanctions, as specified in subpart R of this part. (c) If a laboratory fails to perform successfully in a CMS- approved proficiency testing program, for the initial unsuccessful performance, CMS may direct the laboratory to undertake training of its personnel or to obtain technical assistance, or both, rather than imposing alternative or principle sanctions except when one or more of the following conditions exists: (1) There is immediate jeopardy to patient health and safety. (2) The laboratory fails to provide CMS or a CMS agent with satisfactory evidence that it has taken steps to correct the problem identified by the unsuccessful proficiency testing performance. (3) The laboratory has a poor compliance history. This CONDITION is not met as evidenced by: Based on a review of the CASPER Reports 0153D and 155D, and a telephone interview with the Laboratory Manager, the surveyor determined the laboratory failed 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 -- to successfully participate in proficiency testing for the Subspecialty of Endocrinology and the analyte TSH (Thyroid Stimulating Hormone) for two out of three testing events, 2023-Event #2 and 2024-Event #1; these failures resulted in initial unsuccessful proficiency testing performance. The findings include: 1. A review of the CASPER Reports revealed the laboratory received failing scores for two out of three testing events, resulting in initial unsuccessful proficiency testing performance, as follows: A) 2023-Event #2: TSH-20%, resulting in a failing score of 73% in the Subspecialty of Endocrinology; and B) 2024-Event #1: TSH-20%, Free Thyroxin (Free T4)-20%, and Thyroxin (T4)-40%, resulting in a failing score of 45% in the subspecialty of Endocrinology. 2. During a telephone interview on 3/27/2024 at 12:50 PM, the Laboratory Manager confirmed the above failing proficiency testing scores. 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 proficiency testing desk review of the CASPER Report 0155D (Individual Laboratory Profile) and an interview with the Laboratory Manager, the laboratory failed to achieve satisfactory performance (80% or greater) for two out of three testing events for Endocrinology, a Subspecialty of the Specialty of Chemistry. The findings included: 1. A review of the CASPER Report 0155D report revealed the following API (American Proficiency Institute) proficiency testing score failures in the subspecialty of Endocrinology: A) 2023-Event #2: TSH-20%, resulting in a failing score of 73% in the Subspecialty of Endocrinology B) 2024-Event #1: TSH-20%, Free Thyroxin (Free T4)-20%, and Thyroxin (T4)-40%, resulting in a failing score of 45% in the Subspecialty of Endocrinology. 2. During a telephone interview on 3/27 /2024 at 12:50 PM, the Laboratory Manager confirmed the above failing proficiency testing scores. D2107 ENDOCRINOLOGY CFR(s): 493.843(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 proficiency testing desk review of the CASPER Report 0155D (Individual Laboratory Profile) and an interview with the Laboratory Manager, the laboratory failed to achieve satisfactory performance (80% or greater) for two out of three testing events for TSH (Thyroid Stimulating Hormone. The findings included: 1. A review of the CASPER Report 0155D revealed the following API (American Proficiency Institute) proficiency testing scores: A) Chemistry 2023-Event #2: TSH with a failing score of 20% B) Chemistry 2024-Event #1: TSH with a failing score of 20% 2. During a telephone interview on 3/27/2024 at 12:50 PM, the Laboratory Manager confirmed the above failing proficiency testing scores. . -- 2 of 3 -- 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 proficiency testing desk review of the CASPER Report 0155D (Individual Laboratory Profile) and and an interview with the Laboratory Manager on 3/27/2024, the Laboratory Director failed to provide overall management and direction of the laboratory services. (Refer to D6016.) D6016 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(i) The laboratory director is responsible for the overall operation and administration of the laboratory, including the employment of personnel who are competent to perform test procedures, and record and report test results promptly, accurate, and proficiently and for assuring compliance with the applicable regulations. (e) The laboratory director must-- (e)(4)(i) Ensure that the proficiency testing samples are tested as required under Subpart H of this part; This STANDARD is not met as evidenced by: Based on a proficiency testing desk review of the CASPER Report 0155D (Individual Laboratory Profile) and an interview with the Laboratory Manager on 3/27/2024, the Laboratory Director failed to ensure successful participation in an HHS (Health and Human Services) approved proficiency testing program. The laboratory failed to successfully participate in proficiency testing for the subspecialty of Endocrinology and the analyte TSH (Thyroid Stimulating Hormone) for two out of three testing events, 2023-Event #2 and 2024-Event #1; these failures resulted in initial unsuccessful proficiency testing performance. (Refer to D2096 and D2107.) Surveyor ID# 32558 Licensure and Certification Surveyor -- 3 of 3 --

Summary Statement of Deficiencies D2009 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) The individual testing or examining the samples and the laboratory director must attest to the routine integration of the samples into the patient workload using the laboratory's routine methods. This STANDARD is not met as evidenced by: Based on a review of the American Proficiency Institute (API) proficiency testing (PT) records and an interview with Testing Personnel #1 and #3, the surveyor determined the Laboratory Director (or Designee) failed to sign the attestation statements for fifteen out of sixteen 2021-2023 survey events, and the personnel performing moderate-complexity testing failed to sign the attestation statements for two of sixteen survey events. The findings include: 1. A review of the 2021-2023 API records revealed the Laboratory Director failed to sign the attestation statements for 15 out of 16 survey events; only the 2022 Event-1 Immunohematology/Immunology statement was signed by the Director. The surveyor also noted Testing Personnel #5 had signed one attestation as the Director, however there was no record documenting this individual was the Laboratory Director's Designee. 2. A further review of the 2021-2023 API records revealed the attestation statements for Chemistry /Endocrinology surveys, Events 2021 Event-3 and 2022 Event-1 were not signed by the moderate-complexity testing personnel. Only Testing Personnel #1 had signed as a waived testing personnel (for Urine Drug Screening) on the latter event. 3. A review of the API Attestation Statement page revealed the following instructions: "SIGNATURES REQUIRED-Testing personnel and the laboratory director must physically sign an attestation statement for all PT results. ...". The surveyor noted the words "physically sign" were underlined. 4. During an interview on 5/31/2023 at 2:15 PM, Testing Personnel #1 and #3 confirmed the above findings. . D5291 GENERAL LABORATORY SYSTEMS QUALITY ASSESSMENT Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 7 -- CFR(s): 493.1239(a) The laboratory must establish and follow written policies and procedures for an ongoing mechanism to monitor, assess, and, when indicated, correct problems identified in the general laboratory systems requirements specified at 493.1231 through 493.1236. This STANDARD is not met as evidenced by: Based on a review of the API (American Proficiency Institute) proficiency testing (PT) records, and an interview with Testing Personnel #1 and #3, the surveyor determined the laboratory failed to perform effective Quality Assurance (QA) reviews of the PT records to ensure: (I) All attestation statements were signed by the Laboratory Director (or designee) and the testing personnel; (II)

Summary Statement of Deficiencies D5213 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(b)(1) The laboratory must verify the accuracy of any analyte or subspecialty without analytes listed in subpart I of this part that is not evaluated or scored by a CMS- approved proficiency testing program. This STANDARD is not met as evidenced by: Based on a review of American Proficiency Institute (API) Proficiency Testing records and an interview with the General Supervisor, the Laboratory failed to verify the accuracy of Antibody Screen, Urine Sediment, and Blood Cell Identification that were not evaluated by American Proficiency Institute (API). This was noted on eight out of thirteen 2019 - 2021 Immunology/Immunohematology and Hematology /Coagulation proficiency testing events. The findings include: 1. A review of Proficiency Testing records revealed the following: a.) 2019 2nd Hematology /Coagulation Event - Blood Cell Identification (all samples) was not graded due to educational samples b.) 2019 3rd Hematology/Coagulation Event - Blood Cell Identification (all samples) was not graded due to educational samples c.) 2020 1st Hematology/Coagulation Event - Blood Cell Identification (all samples) was not graded due to educational samples d.) 2020 2nd Hematology/Coagulation Event - Blood Cell Identification (all samples) was not graded due to educational samples e.) 2020 3rd Hematology/Coagulation Event - Blood Cell Identification (all samples) was not graded due to educational samples and Urine Sediment (US-06) was not graded due to no consensus f.) 2020 3rd Immunology/Immunohematology Event - Antibody Screen (SER-11) was not graded due to no consensus g.) 2021 1st Hematology /Coagulation Event - Blood Cell Identification (all samples) was not graded due to educational samples h.) 2021 2nd Hematology/Coagulation Event - Blood Cell Identification (all samples) was not graded due to educational samples 2. During an interview on 09/07/2021 at 4:45 PM, the General Supervisor confirmed the above events were not graded by API and the results were not internally evaluated. 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 -- 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 a review of American Proficiency Institute (API) proficiency testing records and an interview with the General Supervisor, the laboratory failed to verify the accuracy of Microalbumin (a moderate complexity Chemistry test performed on the Siemens Dimension EXL200) at least twice annually. This was noted from 2019 to 2021. The findings include: 1. A review of the proficiency testing records revealed a lack of accuracy verification being performed at least twice annually for Microalbumin. 2. During an interview on 09/07/2021 at 5:00 PM, the General Supervisor confirmed proficiency testing or accuracy verifications were not being performed for Microalbumin at least twice annually. 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 specimens, accurate and reliable test system operation, and test result reporting. The criteria must be consistent with the manufacturer's instructions, if provided. These conditions must be monitored and documented and, if applicable, include the following: (1) Water quality. (2) Temperature. (3) Humidity. (4) Protection of equipment and instruments from fluctuations and interruptions in electrical current that adversely affect patient test results and test reports. This STANDARD is not met as evidenced by: Based on a review of the temperature records, a review of the Quidel Triage Total 5 Control Product Insert, and an interview with the General Supervisor, the laboratory failed to ensure the criteria (acceptable ranges) for freezer temperatures were consistent with the manufacturer's instructions. The laboratory further failed to ensure Triage Total 5 Controls were stored as per manufacturer's instructions from January 2020 to August 2021. The findings include: 1. A review of temperature records revealed the acceptable range for the freezer (where Quidel Triage Total 5 Controls were stored) was -15 to -25 degrees Celsius. The temperature records also revealed the temperatures recorded were between -15 to -20 degrees Celsius from January 2020 to August 2021. 2. A review of the Quidel Triage Total 5 Control Product Insert revealed "...Store frozen at -20 degrees Celsius or colder in a non-defrosting freezer..." 3. During interview on 09/08/2021 at 4:45 PM, the General Supervisor 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 -- 2 of 3 -- 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 laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on a review of the IQCP (Individualized Quality Control Plan), the Quality Control (QC) records, the patient logs for the Quidel Triage Meter (D-Dimer), and an interview with the General Supervisor, the laboratory failed to ensure two levels of quality control (QC) were performed and documented every 30 days of patient testing as per the IQCP. This was noted one time from July 2019 to August 2021. The findings include: 1. A review of the IQCP for the Triage Meter (D-Dimer) revealed a QC Plan which specified two levels of QC should be performed and documented every 30 days of patient testing, or with each new lot number. 2. A review of the July 2019 to August 2021 Triage Meter QC data log revealed QC was performed on 07/27 /2020, next QC run was 09/22/2020. So, QC being performed every 30 days lapsed from 08/27/2020 to 09/21/2020, 25 patients were performed during this time period. 3. During an interview on 08/08/2021 at 2:33 PM, the General Supervisor confirmed the laboratory failed to follow their IQCP and performed QC at least every 30 days. 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 a review of the personnel records and an interview with the General Supervisor, the Technical Supervisor failed to evaluate and document the performance of individuals at least semiannually during the first year of patient testing. This was noted on one of two new testing personnel records reviewed by the surveyor. The finding include: 1. A review of the personnel records revealed Testing Personnel #7's semiannual evaluation was not performed. Testing Personnel #7's initial training was documented on 08/18/2019, and annual evaluation in August 2020 (this evaluation was redone on 05/16/2021 due to missing elements). 2. During an interview on 09/07 /2021 at 2:00 PM, the General Supervisor confirmed the semiannual evaluation was not performed for Testing Personnel #7. -- 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 a review of the CASPER reports (#153/#155), a review of API (American Proficiency Institute) proficiency testing records, and a telephone interview with the laboratory manager on January 31, 2020, the surveyor determined the laboratory failed to successfully participate in proficiency testing for the White Blood Cell Differential (WBC differential) for two consecutive testing events, Event #2 and #3 of 2019. These failures resulted in the laboratory's initial unsuccessful proficiency testing occurrence for the WBC differential. The findings include: 1. A review of the CASPER reports revealed the laboratory scored zero percent (0 %) for the WBC differential (Hematology testing) for Events #2 and #3 of 2019. These two Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 2 -- consecutive failures resulted in the laboratory's initial unsuccessful proficiency testing participation for the WBC differential. 2. A review of the API proficiency testing records confirmed the above noted consecutive failures for the WBC differential. 3. In a telephone interview on January 31, 2020 at 3:22 PM, the laboratory manager stated the failures were due to clerical errors with data entry. 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 review of the CASPER reports (#153/#155), a review of API (American Proficiency Institute) proficiency testing records, and a telephone interview with the laboratory manager on January 31, 2020, the surveyor determined the laboratory failed to satisfactorily perform in proficiency testing for the White Blood Cell Differential (WBC differential) for two consecutive testing events, Event #2 and #3 of 2019. These failures resulted in the laboratory's initial unsuccessful proficiency testing occurrence for the WBC differential. The findings include: 1. Refer to D2016. -- 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 a review of the Casper reports (#153/#155), a review of API (American Proficiency Institute) proficiency testing records, and a telephone interview with the laboratory manager, the surveyor determined the laboratory failed to successfully participate in proficiency testing for Digoxin (Chemistry) for two consecutive testing events, Event #2 and #3 of 2018. These failures resulted in the laboratory's initial proficiency testing occurrence. The findings include: 1. A review of the Casper reports (#153 and #155) revealed the laboratory failed Digoxin testing for Events #2 and #3 of 2018, two consecutive testing events. 2. The laboratory scored 40 % (percent) for Event #2 and 0 % for Event #3 of 2018. 3. In a telephone interview on 10 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 -- /29/18 at 2:54 PM, the laboratory manager stated the results for Event #3, 2018 had been returned from API, though not yet reviewed. The manager could not remember the exact circumstances for the failure, which occurred on Event #2, 2018. D2118 TOXICOLOGY CFR(s): 493.845(f) Failure to achieve satisfactory performance for the same analyte or test in two consecutive testing events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on a review of the Casper reports (#153/#155), a review of API (American Proficiency Institute) proficiency testing records, and a telephone interview with the laboratory manager, the surveyor determined the laboratory failed to satisfactorily perform in proficiency testing for Digoxin (Chemistry) for two consecutive testing events, Event #2 and #3 of 2018. These failures resulted in the laboratory's initial proficiency testing occurrence. The findings include: 1. Refer to D2016 (493.803 Unsuccessful Participation). Patricia Watson, BS, MT (ASCP) Licensure and Certification Supervisor -- 2 of 2 --