Union County General 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 the number and severity of the deficiency cited herein, the Condition: Successful [Proficiency Testing] Participation was not met. The laboratory failed to achieve an overall testing score of satisfactory performance (80% or greater) for the analyte blood gas pH for two out of three consecutive events in 2024 resulting in unsuccessful proficiency testing performance (See D2096). D2096 ROUTINE CHEMISTRY CFR(s): 493.841(f) Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 7 -- 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 American Proficiency Institute (API) proficiency testing record review and interview with the laboratory manager on September 17, 2024 at 10:00 am, the laboratory failed to achieve satisfactory performance (80% or greater) for the analyte blood gas pH for two out of three consecutive proficiency testing events in 2024 resulting in unsuccessful proficiency testing performance. Findings included: a, A review of the laboratory's 2024 API proficiency testing scores indicated the following unsatisfactory proficiency testing events for the analyte blood gas pH: - 2024 Proficiency Testing Event 1 = 60% - 2024 Proficiency Testing Event 2 = 40% b. An interview on 09/17/2024 at 10:00 am with the laboratory manager confirmed the above findings. D5026 IMMUNOHEMATOLOGY CFR(s): 493.1217 If the laboratory provides services in the specialty of Immunohematology, the laboratory must meet the requirements specified in 493.1230 through 493.1256, 493. 1271, and 493.1281 through 493.1299. This CONDITION is not met as evidenced by: Based on the number and severity of the deficiency cited herein, the Condition: Immunohematology was not met. The laboratory failed to review all immunohematology policies and procedures to assure they are adequate to ensure the safety of individuals being transfused (See D5559). D5311 SPECIMEN SUBMISSION, HANDLING, AND REFERRAL CFR(s): 493.1242(a) The laboratory must establish and follow written policies and procedures for each of the following, if applicable: (1) Patient preparation. (2) Specimen collection. (3) Specimen labeling, including patient name or unique patient identifier and, when appropriate, specimen source. (4) Specimen storage and preservation. (5) Conditions for specimen transportation. (6) Specimen processing. (7) Specimen acceptability and rejection. (8) Specimen referral. This STANDARD is not met as evidenced by: Based on laboratory manager interview and preanalytic systems policies and procedures record review on September 17, 2024 at 10:30 am, the laboratory failed to establish written policies and procedures for the laboratory informations system (LIS) used to process patient specimens. Findings included: a. According to the laboratory manager and referenced in the laboratory's written protocol, the laboratory used an electronic laboratory informations system (LIS) to process patient specimens. The laboratory used the LIS to record and document the collection, receipt, and testing of patient specimens, and reporting of patient test results. b. The laboratory manager -- 2 of 7 -- confirmed that the laboratory did not maintain a written policy and procedures for the laboratory's LIS. c. According to laboratory CLIA records, the laboratory performed approximately 99,999 patient test annually. 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 direct observation and interview with the laboratory manager on September 17, 2024 at 11:00 am, the laboratory failed to ensure microbiology culture media were not in use past the expiration date for three of three packages of Columbia Nalidixic Acid (CNA) culture media. Findings included: a. During a tour of the laboratory on 09 /17/2024 at 11:00 am, three packages of CNA culture media, lot number 140221, expiration 8/31/2024, were found in use for patient testing. b. Additional observations determined that the following patient specimens were cultured using this expired CNA culture media: 907036 and 907016. c. Interview on 09/17/2024 at 11:00 am with the laboratory manager confirmed the above findings. D5559 IMMUNOHEMATOLOGY CFR(s): 493.1271(e)(f) (e) Investigation of transfusion reactions. (e)(1) According to its established procedures, the laboratory that performs compatibility testing, or issues blood or blood products, must promptly investigate all transfusion reactions occurring in facilities for which it has investigational responsibility and make recommendations to the medical staff regarding improvements in transfusion procedures. (e)(2) The laboratory must document, as applicable, that all necessary remedial actions are taken to prevent recurrences of transfusion reactions and that all policies and procedures are reviewed to assure they are adequate to ensure the safety of individuals being transfused. (f) Documentation. The laboratory must document all control procedures performed, as specified in this section. This STANDARD is not met as evidenced by: Based on hospital administrator and laboratory manager interviews and immunohematology record review on September 17, 2024 at 09:00 am, the laboratory, which issues fresh frozen plasma (FFP) for patient transfusion, failed to review all immunohematology policies and procedures to assure that they are adequate to ensure the safety of individuals being transfused with FFP. Findings included: a. On May 28, 2024, for patient #904678, a type and screen, and two units of packed red blood cells (pRBC) and two units of FFP were ordered by the patient's physician. i. Laboratory records indicated that the type and screen testing results showed that patient #904678 was AB positive with a negative antibody screen. ii. Laboratory records indicated that laboratory testing personnel set up two units of compatible A positive pRBC that were fully crossmatched for transfusion to patient #904678. That is, laboratory testing personnel compatibly crossmatched the two pRBC units using immediate spin and anti-human globulin (AHG) techniques. iii. Laboratory records indicated that laboratory testing personnel set up to units of O positive FFP for transfusion to patient -- 3 of 7 -- #904678. NOTE: O positive FFP is incompatible for transfusion to AB positive patients. b. On May 28, 2024 at 19:10, laboratory records indicated that the laboratory issued the first unit of compatible A positive pRBC to nursing staff. This first unit of A positive pRBC unit was transfused to patient #904678 without incident. c. On May 28, 2024 at 20:34, laboratory records indicated that nursing staff #1, per laboratory written protocol, issued the second unit of compatible A positive pRBC to nursing staff #2. This second unit of A positive pRBC was transfused to patient #904678 without incident. Typically, it was the practice of the hospital to staff the laboratory with laboratory testing personnel from 06:00 to 18:00 daily. When laboratory personnel were not available, nursing staff were permitted to enter the laboratory using two nurses to issue blood products set up by laboratory testing personnel to themselves. d. On May 28, 2024 at 21:53, laboratory records indicated that nursing staff #2, per laboratory written protocol, issued the first unit of incompatible O positive FFP to nursing staff #1. This first unit of O positive FFP was transfused to patient #904678 without incident. e. On May 28, 2024 at 22:12, laboratory records indicated that nursing staff #2, per laboratory written protocol, issued the second unit of incompatible O positive FFP to nursing staff #1. This second unit of O positive FFP was transfused to patient #904678 without incident. f. On June 3, 2024, the laboratory manager was reviewing blood product transfusion records from the previous seven days and discovered that on May 28, 2024 two units of incompatible FFP was set up by laboratory testing personnel for transfusion to patient #904678. These two incompatible FFP units were issued on May 28, 2024, and transfused to patient #904678 without incident. g. Hospital records indicate that patient #904678 was transfer to a different facility on May 30, 2024. h. Although the laboratory maintained written policies and procedures for the issuance of blood products to nursing staff, these policies and procedures were not adequately reviewed and revised to ensure that hospital patients were transfused when blood products, including FFP, were compatible. D6076 LABORATORY DIRECTOR CFR(s): 493.1441 The laboratory must have a director who meets the qualification requirements of 493. 1443 of this subpart and provides overall management and direction in accordance with 493.1445 of this subpart. This CONDITION is not met as evidenced by: Based on the number and severity of the deficiencies cited herein, the Condition: Laboratories Performing High Complexity Testing, Laboratory Director was not met. The laboratory director, high complexity testing, failed to ensure that: - methodologies selected have the capability of providing the quality of results required for patient care (see D6085); - laboratory personnel were following the laboratory's written protocols as required (see D6087); - proficiency testing samples are tested as required under subpart H of this part (see D6089); - all proficiency testing reports received are reviewed by the appropriate staff to evaluate the laboratory's performance and to identify any problems that require

Summary Statement of Deficiencies D0000 The New Mexico Department of Health completed a validation survey on 02/04/2019 at Union County General Hospital for 42 CFR Part 493, Laboratory Requirements. The laboratory was found out of compliance with the following condition: 42 CFR Part 493.1403 Laboratory director, moderate complexity D5411 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(a) Test systems must be selected by the laboratory. The testing must be performed following the manufacturer's instructions and in a manner that provides test results within the laboratory's stated performance specifications for each test system as determined under 493.1253. This STANDARD is not met as evidenced by: Based on the review of the coagulation analyzer installation records and interview with the laboratory manager, the laboratory failed to ensure that donors/study participants met the manufacturer's requirements for the Prothrombin Time mean patient normal range used in the calculation of the INR (International Normalized Ratio which is used to monitor anticoagulation therapy). The laboratory reported performing 317 tests per year. Findings are: A. Record review of the installation records for the Sysmex CA-620 coagulation analyzer in June 2017 revealed no documentation of the process used to establish the mean patient normal range. The only current record available was the "MVP Reference Range Verification" which only listed the values for each test run and the calculations used to verify the reference range. B. There was no documentation found in the installation/validation records of medical questionnaires, sex or age of the participants that volunteered to participate in the mean patient normal range study . Review of the manufacturer's instructions "Verification of Reference Interval" indicated the following requirements for the study: "Donors must be from a healthy population (no known pathological condition; no pre-surgical or hospitalized patients) Donors should not take any medications, 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 -- including aspirin. A minimum of 20 donors with a reasonably even distribution of males and females should be included. Donors should span the adult age range." C. During interview on 01/17/19 at 1:45 pm, the laboratory manager stated she could not find the questionnaires. She also stated that the laboratory had drawn 20 samples, "maybe more," and that the donors did not take hormones. D. Review of the reagent lot rollover study performed on the Sysmex CA-560 coagulation in August 2015 also revealed no documentation of medical questionnaires, sex or age of the donors. D5477 CONTROL PROCEDURES CFR(s): 493.1256(e)(4)(g) (e) For reagent, media, and supply checks, the laboratory must do the following: (e) (4) Before, or concurrent with the initial use-- (e)(4)(i) Check each batch of media for sterility if sterility is required for testing; (e)(4)(ii) Check each batch of media for its ability to support growth and, as appropriate, select or inhibit specific organisms or produce a biochemical response; and (e)(4)(iii) Document the physical characteristics of the media when compromised and report any deterioration in the media to the manufacturer. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on the review of quality control records, laboratory procedure manual and interview with the laboratory manager, the laboratory failed to perform and document the use of quality control organisms for each lot/shipment of microbiology media received. The laboratory reported performing 347 urine, 11 throat, 88 wound, 180 blood, 15 body fluid, 14 sputum, and 74 vaginal cultures and 348 antibiotic sensitivities per year. Findings are: A. Review of 2018 microbiology media quality control records revealed no documentation of the use of quality controls organisms for each lot/shipment of media received. B. Review of the laboratory's microbiology manual, signed by the laboratory director on 09/12/16, did not require the laboratory to perform quality control organisms for each lot/shipment of "Exempt Culture Media" such as Blood, Columbia, Hektoen, Salmonella-Shigella, MacConkey, Brucella Agar and GN (Gram Negative) broth. C. During interview on 01/17/19 at 3: 39 pm, the laboratory manager confirmed that the laboratory had not developed an Individualized Quality Control Plan (IQCP) for the "Exempt" media since quality control regulations were updated as of 01/01/16. D5481 CONTROL PROCEDURES CFR(s): 493.1256(f)(g) (f) Results of control materials must meet the laboratory's and, as applicable, the manufacturer's 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 the review of quality control records, manufacturer instructions, individualized quality control plan (IQCP), and interview with the laboratory manager, the laboratory failed to maintain records used to support the laboratory's (QCP) Quality Control Plans. The laboratory reported performing 187 D-Dimer, 47 C. diff, and 34 serum hCG tests per year. Findings are: A. The laboratory failed to maintain all records used in the development of the IQCP for each of the following analytes:Serum hCG (human chorionic gonadotropin), clostridium difficile (C. diff), -- 2 of 5 -- and D-Dimer. B. Review of the laboratory's IQCP records for Serum hCG, C. diff, and D-Dimer revealed no documentation that the laboratory had reviewed historical data or performed studies to support the Quality Control Plan (QCP) approved by the laboratory director on 12/14/16. C. During interview on 01/15/19 at 4 pm, the laboratory manager stated that she did not keep the records used to support the development of the IQCP. D5793 ANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1289(b)(c) (b) The analytic systems quality assessment must include a review of the effectiveness of