Little River Memorial 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 review of the 2025 CMS Casper Reports 0153D, 096D, and the American Proficiency Institute (API) proficiency testing results, it was determined the laboratory failed to have initial successful participation in proficiency testing for the analyte Uric Acid. 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 as cited at 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 -- (f) Failure to achieve satisfactory performance for the same analyte or test in two consecutive testing events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on review of the 2025 CMS Casper Reports 0153D, 096D, and API proficiency testing results, it was determined the laboratory failed to have satisfactory participation in proficiency testing for the analyte Uric Acid. Survey Findings follow: A. A review of the proficiency testing results revealed the laboratory received a score of 60% for the analyte Uric Acid in the second proficiency testing event of 2025. B. A review of the proficiency testing results revealed the laboratory received a score of 60% for the analyte Uric Acid in the third proficiency testing event of 2025. 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 2025 proficiency testing results, the laboratory director failed to ensure that the proficiency testing samples are tested as required under Subpart H of this part. 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: Based on the 2025 proficiency testing event results, the laboratory director failed to ensure the laboratory successfully participated in proficiency testing for the Chemistry test uric acid. Refer to D2096. -- 2 of 2 --

Summary Statement of Deficiencies D5401 PROCEDURE MANUAL CFR(s): 493.1251(a) (a) A written procedures manual for all tests, assays, and examinations performed by the laboratory must be available to, and followed by, laboratory personnel. Textbooks may supplement but not replace the laboratory's written procedures for testing or examining specimens. This STANDARD is not met as evidenced by: Bases on through review of Laboratory policy and procedure manual, lack of documentation and interview with staff, it was determined the laboratory failed to have a written procedure for Blood Bank. Survey findings follow: A) Upon request, the laboratory was unable to provide policy and procedure for blood banking. The only policy provided was for Emergency Release. No policy was provieded for how, what, when, and who is responsible for maintaining the blood banking refrigerator. B) In an interview on 01/31/2025 at 09:20 am, Testing Personnel (TP-1 on form CMS 209), confirmed there was no written procedure for blood banking. 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 observation and interview with laboratory staff determined that the laboratory had supplies available for use after their expiration date. Findings follow: A) During a tour of the laboratory on 1/31/2025 at 11:58 am, one of two phlebotomy 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 -- trays containing 4 Sodium Citrate (Blue Top) blood collection tubes lot 4045036, expiration date 11/30/2024 was observed in the phlebotomy area, available for use beyond the expiration date. B) In an interview on 1/31/2025 at 12:18 pm the testing personnel (TP - 1 on form CMS 209), confirmed that the items, identified above, had exceeded the expiration date and were available for use. D5555 IMMUNOHEMATOLOGY CFR(s): 493.1271(c)(f) (c) Blood shall be stored in a clean and orderly environment in a manner to prevent mix-ups. Expired blood must not be in the routine inventory. Unacceptable units must be segregated from routine inventory. (c)(1) An audible alarm system must monitor proper blood and blood product storage temperature over a 24-hour period. (c)(2) Inspections of the alarm system must be documented. This STANDARD is not met as evidenced by: Based on review of the laboratory's policy and procedure for Blood Bank showed only one procedure titled, "Emergency Release". No procedures were provided for the continuous monitoring systems currently used for the blood bank refrigerator. No procedure were provided for the blood bank refrigerator storage alarm checks, lack of documentation function checks, and interview demonstrated that the laboratory failed to perform periodic alarm checks for the blood bank blood storage refrigerator for the calendar year 2023 through 2025. Findings follow: A) Review of the laboratory's policy and procedure for Blood Bank revealed no procedures on how the laboratory is conducting daily monitoring, temperature verification of the temperature alarms, notification of system checks, and the results recorded on the appropriate log. B) Review of the laboratory documentation for blood bank refrigerator alarm check revealed that no alarm check was documented in 2023 through 2025 for the Blood Bank refrigerator. C) Upon request, the laboratory was unable to provide documentation of blood bank refrigerator alarm checks performed for 2023 through 2025. D) In an interview on January 31, 2025, at 12:10 pm, the testing personnel (TP- 1 on form CMS 209), stated that the laboratory had not performed alarm checks on the blood storage refrigerator. D6032 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(14) (e)(14) Specify, in writing, the responsibilities and duties of each consultant and each person, engaged in the performance of the preanalytic, analytic, and postanalytic phases of testing, that identifies which examinations and procedures each individual is authorized to perform, whether supervision is required for specimen processing, test performance or results reporting, and whether consultant or director review is required prior to reporting patient test results. This STANDARD is not met as evidenced by: Based on review of personnel files for fourteen testing personnel listed on the form CMS-209, lack of documentation, and interviews with laboratory staff, determined the laboratory director failed to authorize one of fourteen testing personnel to perform testing without direct supervision. Survey findings include: A) During a review of personnel files for fourteen testing personnel (TP), TP- 10 (as listed on the form CMS- 209) failed to have written authorization from the laboratory director, to perform -- 2 of 3 -- moderate complexity testing without direct supervision. B) In an interview on 1/31 /2025 at 12:01 pm, the testing personnel (TP-1 on form CMS 209) confirmed the lack of written authorization to TP-10 on form CMS 209. D6106 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(14) (e)(14) 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 lack of laboratory policies and procedures and interviews it was determined that the Laboratory Director failed to ensure that an approved procedure manual was available to all personnel. Cross refers to D5401 -- 3 of 3 --

Summary Statement of Deficiencies D5783

Summary Statement of Deficiencies D2007 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) The samples must be examined or tested with the laboratory's regular patient workload by personnel who routinely perform the testing in the laboratory, using the laboratory's routine methods This STANDARD is not met as evidenced by: Through a review of the form CMS-209 and blood gas proficiency test records, lack of documentation, and interviews with staff, it was determined the blood gas samples were not tested by all of the personnel who routinely perform patient testing. Survey findings include: A. Five testing personnel (laboratory employees #7, #8, #9, #10, and #11) who perform blood gas testing were listed on the form CMS-209. B. A review of blood gas proficiency test records for three events in 2020 and one event in 2021 revealed that laboratory employee #7 (as listed on the form CMS-209) had signed the attestation stating she had performed testing on three of four events (First and Second Chemistry Core Events in 2020 and the First Chemistry Core Event in 2021) and laboratory employee #8 had signed the attestation for the Third Chemistry Core Event of 2020. There was no documentation that laboratory employees #9, #10, or #11 (three of five) had performed blood gas proficiency testing in 2020 or 2021. C. In an interview, at 10:23 a.m. on 4/14/2021, the technical consultant (as listed on the form CMS-209) confirmed that three of five personnel who routinely run patient blood gas tests have not performed proficiency testing in 2020 or 2021. D2128 HEMATOLOGY CFR(s): 493.851(e) (1) For any unsatisfactory analyte or test performance or testing event for reasons other than a failure to participate, the laboratory must undertake appropriate training and employ the technical assistance necessary to correct problems associated with a Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 8 -- proficiency testing failure. (2) For any unacceptable analyte or testing event score, remedial action must be taken and documented, and the documentation must be maintained by the laboratory for two years from the date of participation in the proficiency testing event. This STANDARD is not met as evidenced by: Through a review of proficiency test documentation for the Third Hematology Event 2019 through the First Hematology Event 2021 (five events), a review of

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 2020 and 2021 CMS Casper Reports 0155D, 0153D, and the American Proficiency Institute (API) proficiency testing results, it was determined the laboratory failed to have initial successful participation in proficiency testing for the analyte Total Bilirubin (TB). Failure to achieve satisfactory performance for the same analyte or test in two consecutive testing events or two out of three proficiency testing events is unsuccessful performance as cited at 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 2020 and 2021 CMS Casper Reports 0155D and 0153D and American Proficiency Institute (API) proficiency testing results, it was determined the laboratory failed to have satisfactory participation in proficiency testing for the analyte Total Bilirubin (TB). Survey Findings follow: A. A review of the proficiency testing results revealed the laboratory recieved a score of 0% for the analyte TB in the second proficiency testing event of 2020. B. . A review of the proficiency testing results revealed the laboratory recieved a score of 60% for the analyte TB in the first proficiency testing event of 2021. 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 2020 and 2021 proficiency testing results, it was determined the laboratory director failed to ensure that the proficiency testing samples are tested as required under Subpart H of this part. As cited at 6016 D6016 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(i) The laboratory director is responsible for the overall operation and administration of the laboratory, including the employment of personnel who are competent to perform test procedures, and record and report test results promptly, accurate, and proficiently and for assuring compliance with the applicable regulations. (e) The laboratory director must-- (e)(4)(i) Ensure that the proficiency testing samples are tested as required under Subpart H of this part; This STANDARD is not met as evidenced by: . Based on review of 2020 and 2021 proficiency testing event , it was determined the laboratory director failed to ensure the laboratory successfully participated in proficiency testing for the Analyte Total Bilirubin. As cited at D2096 -- 2 of 2 --

Summary Statement of Deficiencies D2015 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(5)(6) (5) The laboratory must document the handling, preparation, processing, examination, and each step in the testing and reporting of results for all proficiency testing samples. The laboratory must maintain a copy of all records, including a copy of the proficiency testing program report forms used by the laboratory to record proficiency testing results including the attestation statement provided by the PT program, signed by the analyst and the laboratory director, documenting that proficiency testing samples were tested in the same manner as patient specimens, for a minimum of two years from the date of the proficiency testing event. (6) PT is required for only the test system, assay, or examination used as the primary method for patient testing during the PT event. This STANDARD is not met as evidenced by: . 1. Through a review of the first, second and third Proficiency testing events of 2018 and 2017, lack of documentation, and interviews with laboratory staff, it was determined the laboratory failed to maintain copies of Proficiency test records for at least two years. As evidenced by: A. During a review of three of three Chemistry Proficiency testing events of 2018, it was determined the laboratory failed to maintain the attestation forms for the second Chemistry event of 2018 (1 of 3 events). B. During a review of two of two Hematology Proficiency testing events of 2018, it was determined the laboratory failed to maintain the attestation forms for the first Hematology event of 2018 (1 of 2 events). C. In an interview at 13:00 on 10/3/2018, technical consultant (as listed on the form CMS-209) confirmed the laboratory failed to retain copies of the attestation forms for at least two years ( 2 of 3 events). 2. Through a review of the first, second and third Proficiency testing event of 2018 and 2017, it was determined the Respiratory Laboratory failed to maintain copies of Proficiency test records for at least two years. As evidenced by: A. During a review of three of three Proficiency testing events of 2017, it was determined the Respiratory 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 maintain the attestations forms for the second and third Proficiency event of 2017. C. In an interview at 13:00 on 10/3/2018, technical consultant (as listed on the form CMS-209) confirmed the Respiratory laboratory failed to retain copies of the attestation forms for at least two years. 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: . 1. Through a review of the Laboratory policies and procedures, a review of personnel files for all staff, lack of documentation, and interviews with staff, it was determined the laboratory failed to follow written procedures for competency assessment. As evidenced by: A. A review of the Laboratory Policy and Procedure Manual revealed the Competency Assessment Policy which states: "Evaluating and documenting competency of personnel responsible for testing is performed at least semiannually during the first year the individual test patients. Thereafter competency assessments are performed at least annually." B. Through a review of the personnel files for employees #3, #6, and #7 ( as listed on form CMS 209), it was determined that there was no documentation of competency assessment in 2017 for three of six laboratory employees. C. In an interview on 10/3/2018 at 1315, the technical consultant (as listed on form CMS-209) stated that the 2017 competency assessments were not available. 2. Through a review of the Respiratory Laboratory policies and procedures, a review of personnel files for all staff, lack of documentation, and interviews with staff, it was determined the Respiratory Laboratory failed to follow written procedures for competency assessment. As evidenced by: A. A review of the Respiratory Policy and Procedure Manual revealed the Competency Assessment Policy which states: "Evaluating and documenting the performance of individuals responsible for testing Human specimens is done semiannually during the first year of employment and annually thereafter." B. Through a review of personnel files for employees #1, #2, #3, #4, #5 and #6 (as listed on form CMS 209), it was determined that there was no documentation of competency assessment in 2017 for six of six Respiratory personnel. C. In an interview on 10/3/2018 at 1400, the technical consultant (as listed on form CMS-209) stated that the 2017 competency assessments were not available. D5417 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(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: . Through observations made during a tour of the laboratory, it was determined the laboratory had Becton-Dickinson ( BD) Vacutainer collection tubes available for use when they had exceeded their expiration date. As evidenced by: A. During a tour of the laboratory on 10/05/2018 at 10:30, the Surveyor observed 22 of 22 BD Dark Blue -- 2 of 5 -- top (used for Heavy Metals) (lot # 7256520 expiration date 9/30/2018); 16 of 16 BD red top tubes (lot # 7157861 expiration date 0630//2018) and 2 of 2 BD gray top collection tubes (lot # 7100990 expiration date 08/03/2018) located in the laboratory available for use when they had exceeded their expiration date. B. On 10/05/2018, at 1030, the technical consultant (as listed on CMS-209) confirmed the vacutainer tubes were available for use after they had exceed their expiration date. D5469 CONTROL PROCEDURES CFR(s): 493.1256(d)(10)(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-- Establish or verify the criteria for acceptability of all control materials. (i) When control materials providing quantitative results are used, statistical parameters (for example, mean and standard deviation) for each batch and lot number of control materials must be defined and available. (ii) The laboratory may use the stated value of a commercially assayed control material provided the stated value is for the methodology and instrumentation employed by the laboratory and is verified by the laboratory. (iii) Statistical parameters for unassayed control materials must be established over time by the laboratory through concurrent testing of control materials having previously determined statistical parameters. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: . Through a review of Streck Erythrocyte Sedimentation Rate (ESR) Chex package inserts, ESR quality control, lack of documentation, as well as interviews with laboratory staff, it was determined the laboratory failed to establish the criteria for acceptability of ESR control. As evidenced by: A. Streck Auto Plus analyzer is utilized by the laboratory to perform ESR assay. A review of package insert for ESR- CHEX for automated Sedimentation Rate states: "The assay values are derived from replicate analysis on both automated and manual methods. Upon receipt of a new control lot, it is recommended that an individual laboratory establish its own mean and limits. However, the control means established by the laboratory should fall within the Expected range specified for the control." B. In a review of ESR quality control data, it was determined the mean and acceptable range in three of three months (April, July and September 2018) reviewed matched the expected range as listed on the ESR-Chex package insert. Level I control range (1-17) and Level II control range (64-110). C. The surveyor requested documentation of established ranges for ESR quality controls. None was provided. D. In an interview on 10/4/2018 at 10:00, technical consultant (as listed on CMS-209) confirmed that the laboratory has not established their own mean and range for ESR quality controls. The laboratory uses the manufactures ranges for the ESR control. D5775 COMPARISON OF TEST RESULTS CFR(s): 493.1281(a)(c) (a) If a laboratory performs the same test using different methodologies or instruments, or performs the same test at multiple testing sites, the laboratory must have a system that twice a year evaluates and defines the relationship between test results using the different methodologies, instruments, or testing sites. (c) The laboratory must document all test result comparison activities. -- 3 of 5 -- This STANDARD is not met as evidenced by: . Through observations made during a tour of the laboratory, lack of documentation, and interviews with staff, it was determined the laboratory failed to document semi- annual test comparison for testing performed on the Beckman Coulter AU680 Chemistry Analyzer and the Alere Triage Analyzer. As evidenced by: A. During an initial tour of the laboratory at 1130 on 10/3/2018, the surveyor observed Beckman Coulter AU680 Chemistry analyzer and the Alere Triage Analyzer in the Chemistry section of the laboratory. B. At the time of the tour (10/3/2018 at 1130), the technical consultant (as listed form CMS-209) stated that the Alere Triage serves as a secondary analyzer for the analytes Troponin (TNI) and Creatine Kinase Muscle/Brain (CK: MB). C. The surveyor requested documentation of semi-annual comparison of TNI and CKMB tests performed on both the Beckman Coulter Au680 and the Alere Triage. None was provided. D. In an interview at 11:40 on 10/3/2018 the Technical Consultant ( as listed form CMS-209) stated the semi-annual comparisons were not performed by the Laboratory. D6013 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(3)(ii) 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)(ii) Verification procedures used are adequate to determine the accuracy, precision, and other pertinent performance characteristics of the method; This STANDARD is not met as evidenced by: . Through a review of the new instrument validation documentation for the Sysmex XN-450 Hematology Analyzer, lack of documentation, as well as interviews with staff, it was determined the Laboratory failed to have the director approve verification procedures to ensure they are adequate to determine the accuracy, precision, and other pertinent performance characteristics as evidenced by: A. A review of the verification documentation for the Sysmex Hematology Analyzer which was performed on 7/31 /2018 revealed the verification procedures were not approved and signed by the Laboratory Director. B. In an interview on 10/4/2018 at 1330, technical consultant (as listed on CMS form 209) confirm the verification procedure for the Hematology Analyzer were not approved or signed by the Laboratory Director. D6032 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(14) 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)(14) Specify, in writing, the responsibilities and duties of each consultant and each person, engaged in the performance of the preanalytic, analytic, and postanalytic phases of testing, that identifies which examinations and procedures each individual is authorized to perform, whether supervision is required for specimen processing, test performance or results reporting, and whether consultant or director -- 4 of 5 -- review is required prior to reporting patient test results. This STANDARD is not met as evidenced by: . Through a review of Laboratory personnel files, lack of documentation, and interviews with staff, it was determined the Laboratory Director failed to specify, in writing, which examinations and procedures each individual is authorized to perform and whether supervision is required. As evidence by: A. A review of personnel records for six of six testing personnel revealed laboratory testing personnel #4, and #5 (as listed on the form CMS-209) failed to include the Laboratory Director's written authorization to perform moderate complexity testing. B. In an interview at 14:00, on 10/3/2018, technical consultant (as listed on the form CMS-209) confirmed there were no written authorizations from the Laboratory Director stating the tests that each individual is authorized to perform. -- 5 of 5 --

Summary Statement of Deficiencies D0000 On 04/03/18 at 1:00 PM, an entrance conference was conducted with Facility Representatives. The facility was informed the purpose of the visit was to conduct a complaint investgation. On 04/04/18 at 2:45 PM, an exit conference was conducted with Facility Representatives. The findings of the survey were discussed. The Representatives were given an opportunity to present additional information. No additional information was presented. The following conditions were not met: 493.1250 - Analytic Systems 493.1403 - Moderate Complexity Laboratory Director 493.1409 - Technical Consultant 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 review of the Quality Assurance Policy, review of the Westgard Rules for Evaluating Out-of Control Situations, review of the Quality Control Design policy, review of documents titled "QC Review" for January, February, and March 2018, review of quality control documentation for January, February, and March 2018, and interviews with laboratory staff, it was determined the laboratory failed to meet the Condition of analytic systems as evidenced by: D5441 - the laboratory quality control procedures failed to monitor accuracy of test performance D5783 - the laboratory failed to take and document