Lake City Community Hospital

Summary Statement of Deficiencies D3023 REQUIREMENTS FOR TRANSFUSION SERVICES CFR(s): 493.1103(c)(2) The facility must establish and follow policies to ensure positive identification of a blood or blood product recipient. This STANDARD is not met as evidenced by: During an onsite recertification on 7/20/22, review of policy and procedure manual, personnel interview, and observation, the lab failed to follow the policy that ensures positive identification for blood and blood products. Findings include: 1. Review of blood bank Quality Assurance (QA) manual (Amended on 01/20/2004) reveals that that the chart of the patient must be brought to the lab by nursing before blood or blood products can be signed out. Title "Signing out a unit of blood or blood product". Under subject "Blood bank signing out a unit of blood or blood product". Approved 11 /20/1997. The procedure states "The chart of the patient shall be brought to the laboratory by nursing personnel, ward secretaries, or nursing assistants. The chart shall be checked against the sign out book and the blood bank requisitions for the medical record number of the patient and the type of product ordered by the physician and the consent form. Any discrepency must be cleared up before the blood unit can be issued. " 2. Demonstration by testing personnel # 13 on CMS form 209 showed that only blood product requisition form and patient consent form were reviewed for identification.When asked, the testing person stated that patient charts are not used for positive identification but requisitions and patient consent forms are now used. 3. During an interview with lab supervisor at 12:30pm, it was confirmed that the lab no longer follows its procedure of reviewing patient charts to confirm patient identity before signing out blood and blood products. Only an order for blood products and patient consent is reviewed. Review of the blood issuance log from May to July 2022 revealed 11 units of blood were issued. D5311 SPECIMEN SUBMISSION, HANDLING, AND REFERRAL 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): 493.1242(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 a lab tour, personnel interview, and lack of documentation, the lab failed to have a policy for outside submissions. Findings Include: 1. During a lab tour at 11am (7/20/22) , the question was asked if specimens were recieved from outside the facility and the response from lab supervisor was yes. A request was made for the procedure and it was revealed that the facility did not have a policy for it. 2.In an interview with the lab supervisor at 1:18pm (7/20/22) in the break room confirmed the findings. D5401 PROCEDURE MANUAL CFR(s): 493.1251(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: Based on review of Laboratory Quality Assurance (QA) manual, record review of Quality Control (QC) results, and confirmed with interview with lab personnel, the lab failed to follow its own policy for documenting

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: During a proficiency testing desk review performed on 03/11/2021, based on review of CASPER report 155D and graded reports from American Proficiency Institute (API), it was determined that the laboratory failed to successfully participate in proficiency testing for the specialty of chemistry, the analyte partial pressure of carbon dioxide (PC02) for two consecutive proficiency testing events reviewed (2020, Events 1 and 2). See D2087 and D2096. D2087 ROUTINE CHEMISTRY CFR(s): 493.841(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 2 -- Failure to attain a score of at least 80 percent of acceptable responses for each analyte in each testing event is unsatisfactory analyte performance for the testing event. This STANDARD is not met as evidenced by: During an onsite recertification survey performed on 03/11/2021, based on the CASPER 155D report review and onsite proficiency testing results review from American Proficiency Institute (API) proficiency testing, the laboratory failed to attain a satisfactory score of at least 80% for PCO2 for two of three consecutive proficiency testing events. Findings include: 1. The CASPER 155D report revealed the following scores for your laboratory's PCO2: a. 2020, Event 1: 60% b. 2020, Event 2: 40% 2. The scores were confirmed by review of the graded API results. Scores less than 80% for this analyte indicates unsatisfactory performance. A failure of this analyte for two consecutive or two out of three consecutive testing events is scored as unsuccessful. 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: During a proficiency testing desk review performed on 03/11/2021, based on review of the CASPER 155D report and graded report from API, it was determined that the laboratory failed to achieve satisfactory performance for PCO2 in two consecutive testing events (2020, Events 1 and 2). See D2087. -- 2 of 2 --