Magnolia Regional Health System Inc

Summary Statement of Deficiencies 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: Based on observation and interview with laboratory staff it was determined that the laboratory had supplies available for use after their expiration date. Findings follow: A) During a tour of the laboratory on 12/12/24 at 1:16 pm, one (of three) BD Bactec Plus Aneorobic Culture Tube, (REF 442023, lot 4038374, expiration 11/15/2024) was observed in the laboratory, available for use beyond the expiraton date. B) During a tour of the laboratory on 12/12/24 at 1:18 pm, two (of six) Finntip 250 Universals, (REF 9400260, lot 19156PO, expirations 06/2024 and 01/2022) were observed in the laboratory, available for use beyond the expiraton date. D) In an interview on 12/12 /24 at 1:20 pm Technical Supervisor #1 (as listed on the CMS-209 form) , confirmed that the items, identified above, had exceeded the expiration date and were available in the laboratory. D5783

Summary Statement of Deficiencies 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: Through review of laboratory policy and procedure, observation and interview it was determined that the laboratory failed to label four of ten specimen collection containers with patient name or unique patient identifier. Findings follow: A) During a tour of the laboratory on 3/24/23 at 8:45 am, ten urine specimen containers were observed in the laboratory specimen storage refrigerator; four labeled on the specimen lid only. B) Review of the laboratory policy and procedure revealed that "patient specimen containers must be labeled with the patient's name and unique identifier". . C) In an interview on 3/24/23 at 8:55 am , the laboratory staff member (#2 on the CMS 209 form) confirmed that the specimens identified above had been analyzed and lacked proper patient identification on the containers as required by policy and procedure. 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 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 -- 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: Through observation, review of temperature records, lack of documentation and interview it was determined that the laboratory failed to monitor the temperature of two of five rooms in which supplies with storage temperature requirements were stored on each day of operation. Findings follow: A) During a tour of the laboratory on 3/22/23 at 11:35 am six rooms containing items with a temperature storage requirement , the office, Phlebotomy room #1, Phlebotomy room #2, the main laboratory, storage room and respiratory therapy ABG testing area all separated by a closable door, were observed. B) During a review of the laboratory's temperature records it was noted that temperature records for the main laboratory, the blood bank (an alcove of the main laboratory), the microbiology area (an alcove of the main laboratory) ,the storage room, and the respiratory therapy ABG testing area were presented and no temperature measurements for phlebotomy room #1 or phlebotomy room #2 were presented. C) During a tour of the laboratory on 3/24/23 at 8:45 am, 10 BD Na Citrate blood collection tubes lot# 2200057 expiration date 2023-04-30 and 3 Vacuette Na Citrate blood collection tubes lot# 8230133Y expiration date 2024-01-01 all with a storage temperature requirement of 4 degrees C. to 25 degrees C. were observed in phlebotomy room #1. D) During a tour of the laboratory on 3/24/23 at 8: 55 am, 5 BD Na Citrate blood collection tubes lot# 2200057 expiration date 2023-04- 30 , 10 Vacuette Na Citrate blood collection tubes lot# 8230133Y expiration date 2024-01-01 and 10 Vacuette Na Citrate blood collection tubes lot# 8220938W expiration date 2023-09-04 all with a storage temperature requirement of 4 degrees C. to 25 degrees C. were observed in phlebotomy room #2. E) Upon request, the laboratory could not present the temperature records for phlebotomy rooms #1 and #2 in which the supplies identified above were stored,. F) In an interview on 3/24/23 at 9: 15 am the laboratory staff member ( number 2 on the CMS 209 form) confirmed that the daily temperature of the two rooms, in which the supplies identified above were stored, had not been monitored and recorded.. D5415 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(c) Reagents, solutions, culture media, control materials, calibration materials, and other supplies, as appropriate, must be labeled to indicate the following: (1) Identity and when significant, titer, strength or concentration. (2) Storage requirements. (3) Preparation and expiration dates. (4) Other pertinent information required for proper use. This STANDARD is not met as evidenced by: Through review of package inserts, observation, and interview it was determined that the laboratory did not change expiration dates on control materials after opening as required by manufacturer. Finding follow: A) Review of the package insert for Eightcheck 3 WP Hematology Controls revealed that the product expires in 14 days after vial is opened and put into use and the expiration dates should be changed as required after opening. B) During a tour of the laboratory on 3/24/23 at 09:15 am the surveyor observed a plastic container in which were three vials of Eightcheck 3 WP hematology controls , lot #'s 23620710, 23620711 and 2360713 with an expiration -- 2 of 4 -- date of 2023-04-05. The vials did not have new expiration dates or dates put into use indicated on the testing materials or the container and were identified as the controls currently in use. C) In an interview on 3/24/23 at 9:15 am laboratory staff member (number 2 on form CMS 209) confirmed that no amended expiration date or date when put into use were written on the vials or container. 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 review is required prior to reporting patient test results. This STANDARD is not met as evidenced by: Through a review of Personnel Records for three of five testing personnel listed on the form CMS-209, lack of documentation and through interviews with hospital staff, it was determined the laboratory director failed to give written authorization to one of three testing personnel who perform moderately complex arterial blood gas (ABG) procedures. Survey findings include: A) The surveyor reviewed personnel records for three testing personnel (listed as #'s 13, 15 and 18 on the form CMS-209) who perform moderately complex ABG procedures and no authorization to perform testing was present for employee (# 18 on the CMS 209 form). B) Upon request, the laboratory was unable to provide authorization to perform moderately complex ABG testing for employee (#18 on the CMS 209 form). C) In an interview, at 9:20 am on 3 /23/23, hospital staff member (#1 on a separate employee identification list) confirmed that employee # 18 performs ABG testing and that there is no authorization to perform testing signed by the laboratory director. . D6053 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(9) The technical consultant is responsible for evaluating and documenting the performance of individuals responsible for moderate complexity testing at least semiannually during the first year the individual tests patient specimens. This STANDARD is not met as evidenced by: Through review of personnel competency records for seven testing personnel listed on the CMS 209 form, authorizations to perform tests, and interview, it was determined that the laboratory did not assess the competency of one of one testing personnel semi- annually during the first year of employment. Findings follow: A) Review of personnel records of testing personnel ( number 15 on the CMS 209 form) indicated that the employee was hired on 2/22/21 and authorized by the laboratory director to perform moderately complex testing without direct supervision. B) Upon review of personnel records of testing personnel (number 15 on the CMS 209 form) competency -- 3 of 4 -- evaluations were dated as performed on 4/29/21 and 6/22/22 which do not document competencies performed semi-annually during the first year of employment which was 2/22/21 to 2/22/22 for this personnel. C) In an interview on 3/23/23 at 9:20 am, the hopital staff member (number one on the separate personnel identification list) verified that competency evaluations were not performed semi-annually during the first year of employment for the testing personnel identified as number 15 on the CMS 209 form.. -- 4 of 4 --

Summary Statement of Deficiencies 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 the manufacturer's instructions for Bio-Rad Multiqual chemistry controls, chemistry policies and procedures, Monthly Levey-Jennings Charts for chemistry tests, and Bio-Rad Unity Laboratory Comparison Reports, and through interviews with laboratory staff, it was determined the laboratory failed to follow manufacturer's instructions which required establishing quality control ranges for chemistry tests. Survey findings include: A. The laboratory policy titled "Chemistry DXC 700 AU Analyzer and QC" states, "All QC data is checked daily by the testing personnel and QC out of range >2 SD (standard deviation) is logged in the Daily QC log and

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 2019 and 2020 CMS Casper Reports 0155D, 0153D, and the American Proficiency Institute (API) proficiency testing results, it was determined the laboratory failed to have non-initial unsuccessful participation in proficiency testing for the test of Blood Cell Identification (Cell I.D.). Survey findings follow: Failure to achieve satisfactory performance for two consecutive testing events or two out of three consecutive testing events is unsuccessful performance as cited at D2130. D2017 REINSTATEMENT OF NONWAIVED LABORATORIES CFR(s): 493.807(a)(b) 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 -- (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 review of 2019 and 2020 CMS Casper Reports 155D, 153D and American Proficiency Institute (API) testing results, it was determined the laboratory had a subsequent unsuccessful performance for the test of Blood Cell Identification (Cell I. D.). Failure to achieve satisfactory performance for the test Blood Cell ID in three of four proficiency testing events. A. A review of the proficiency testing results revealed the laboratory received a score of 0% for the test of Cell ID in the first proficiency testing event of 2019. B. A review of the proficiency testing results revealed the laboratory recieved a score of 60% for the test of Cell ID in the third proficiency testing event of 2019. C. A review of the proficiency testing results revealed the laboratory recieved a score of 0% for the test of Cell ID in the first proficiency testing event of 2020. 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 review of the 2019 and 2020 CMS Casper Reports 155D, 153D and American Proficiency Institute (API) proficiency testing results, it was determined the laboratory failed three of four proficiency testing events which constitutes non-initial unsuccessful performance for the test of Blood Cell Identification (Cell ID). Survey findings follow: A. A review of the proficiency testing results revealed the laboratory received a score of 0% for the test of Cell ID in the first proficiency testing event of 2019. B. A review of the proficiency testing results revealed the laboratory recieved a score of 60% for the test of Cell ID in the third proficiency testing event of 2019. C. A review of the proficiency testing results revealed the laboratory recieved a score of 0% for the test of Cell ID in the first proficiency testing event of 2020. 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 -- 2 of 3 -- with 493.1407 of this subpart. This CONDITION is not met as evidenced by: . Based on a review of the 2019 and 2020 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. 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 review of 2019 and 2020 proficiency testing event results, it was determined the laboratory director failed to ensure the laboratory successfully participated in proficiency testing for the analyte Blood Cell Identification. Refer to D2130 -- 3 of 3 --

Summary Statement of Deficiencies D2016 SUCCESSFUL PARTICIPATION CFR(s): 493.803(a)(b)(c) (a) Each laboratory performing nonwaived testing must successfully participate in a proficiency testing program approved by CMS, if applicable, as described in subpart I of this part for each specialty, subspecialty, and analyte or test in which the laboratory is certified under CLIA. (b) Except as specified in paragraph (c) of this section, if a laboratory fails to participate successfully in proficiency testing for a given specialty, subspecialty, analyte or test, as defined in this section, or fails to take remedial action when an individual fails gynecologic cytology, CMS imposes sanctions, as specified in subpart R of this part. (c) If a laboratory fails to perform successfully in a CMS- approved proficiency testing program, for the initial unsuccessful performance, CMS may direct the laboratory to undertake training of its personnel or to obtain technical assistance, or both, rather than imposing alternative or principle sanctions except when one or more of the following conditions exists: (1) There is immediate jeopardy to patient health and safety. (2) The laboratory fails to provide CMS or a CMS agent with satisfactory evidence that it has taken steps to correct the problem identified by the unsuccessful proficiency testing performance. (3) The laboratory has a poor compliance history. This CONDITION is not met as evidenced by: . Based on review of 2018 and 2019 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 analytes Troponin (TNI) and Creatine Kinase Muscle/Brain (CKMB). As evidenced by: 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 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 -- 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 review of 2018 and 2019 CMS Casper Reports 0155D and 0153D and API proficiency testing results, it was determined the laboratory failed to have satisfactory participation in proficiency testing for the analyte TNI and CKMB as evidenced by: A. The laboratory received a sore of 60 % in the first and second proficiency testing event of 2019 for the analyte TNI. B. The laboratory received a sore of 60% in first and second proficiency testing event of 2019 for the analyte CKMB. D6019 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(iv) 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)(iv) Ensure that an approved

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 Respiratory policy and procedure manual, personnel files, a review of proficiency test documentation for 2017 and 2018, as well as interviews with staff, it was determined proficiency testing samples were not tested by all personnel who routinely perform Blood Gas patient testing.. As evidenced by: A. A review of the Respiratory policy and procedure manual revealed the Arterial Blood Gas Proficiency testing policy which states; "The analysis of all proficiency tests samples shall be performed, as closely as practical, in the same manner as regular patient samples." B. A review of eleven of eleven Respiratory personnel records revealed, testing personnel #2, #6,#7, #8, #9, #10 and # 11 ( as listed on form CMS- 209) were authorized by the Laboratory Director to perform Blood Gas testing. C. A review of 2017 and 2018 Proficiency testing attestation (six of six events) statements revealed Respiratory had no documentation that seven of eleven testing personnel (#2, #6, #7, #8, #9, #10 and #11 as listed on form CMS-209) had not performed proficiency testing in 2017 and 2018. D. A review of six of six Proficiency testing events attestation statements of 2017 and 2018 revealed Respiratory personnel #1(as listed on form CMS 209) participated in all six events. E. In an interview at 14:00 on 10/17/2018, Respiratory personnel #1 (as listed on form CMS -209) confirmed that testing personnel #2, #6, #7, #8, #9, #10 and #11 (as listed on form CMS-209) perform Blood Gas patient testing and had not participated in proficiency testing in 2017 and 2018. D5413 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT 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 -- 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: . Through a review of Gem Premier 3500 Blood Gas analyzer user manual, lack of documentation, as well as interviews with staff, it was determined the Respiratory laboratory failed to document humidity conditions that are essential for the operation of the Gem Premier 3500 analyzer. As evidenced by: A. A review of the user manual ( Section 11.3 "Specifications") for the Gem Premier 3500 Blood Gas analyzer revealed the Ambient Environmental requirements for the analyzer operations: Relative Humidity 5% to 90%; External Ambient Temperatures 15 to 35 degrees Celsius. B. The surveyor requested daily documentation of humidity. None was provided. C. In an interview on 10/18/2018 at 1330, Respiratory personnel #1 (as listed on form CMS 209) confirmed the Respiratory laboratory has no documentation of humidity on days of testing. 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. The 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 -- 2 of 3 -- 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 (65-101). C. The surveyor requested documentation of established ranges for ESR quality controls. None was provided. D. In an interview on 10/16/2018 at 10:00, general supervisor (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. -- 3 of 3 --