Summary:
Summary Statement of Deficiencies D0000 An announced initial survey was conducted on 12/06/2023 at Chelsea Urgent Care, a clinical laboratory in Chelsea, AL. The laboratory was not in compliance with 42 CFR Part 493, Requirements for Clinical Laboratories. Based on survey findings, an Immediate Jeopardy situation was identified, and the laboratory was notified at 12:07 PM on 12/06/2023. The following Conditions were not met: D2000 - Enrollment and Testing of Samples 493.801 D5400 - Analytic Systems 493.1250 D6000 - Moderate Complexity Laboratory Director 493.1403 D6033 - Technical Consultant Moderate Complexity 493.1409 D2000 ENROLLMENT AND TESTING OF SAMPLES CFR(s): 493.801 Each laboratory must enroll in a proficiency testing (PT) program that meets the criteria in subpart I of this part and is approved by HHS. The laboratory must enroll in an approved program or programs for each of the specialties and subspecialties for which it seeks certification. The laboratory must test the samples in the same manner as patients' specimens. For laboratories subject to 42 CFR part 493 published on March 14, 1990 (55 FR 9538) prior to September 1, 1992, the rules of this subpart are effective on September 1, 1992. For all other laboratories, the rules of this subpart are effective January 1, 1994. This CONDITION is not met as evidenced by: Based on surveyor review of proficiency testing (PT) records, a lack of any PT records, and interview with Testing Personnel #1, the laboratory failed to enroll in PT in the specialty of Hematology for the Diatron Abacus-3CP Complete Blood Count (CBC) test, for 2 of 2 events in 2023. The findings include: 1) A lack of records revealed no evidence of enrollment in PT for Hematology from date testing began to survey date of 12/06/2023.. 2) Interview of laboratory director conducted on 12/06 /2023 at 11:30AM, confirmed the laboratory was not performing any PT testing. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 12 -- 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. This STANDARD is not met as evidenced by: Based on surveyor review, a lack of any hematology testing records, and interview with laboratory staff, the laboratory failed to retain any Diatron Abacus-3CP hematology analyzer records for testing performed on date patient testing started on 7 /12/2023 through 12/06/2023. The findings include: 1. The surveyor review revealed the laboratory lacked any records for the hematology analyzer. The laboratory failed to print quality control documents and retain them after testing started on 7/12/2023. 2. During an interview on 12/06/2023 at 12:07 PM, Testing Personnel #1 confirmed the laboratory was not keeping records for 2 years. D5291 GENERAL LABORATORY SYSTEMS QUALITY ASSESSMENT 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 surveyor review, a lack of procedure manuals, and an interview with the Laboratory Director, the laboratory failed to establish written procedures to monitor general laboratory requirements. This was noted from the date patient testing started on 7/12/2023 through to the current survey on 12/6/2023. The findings include 1. Record review revealed no evidence of established policies and procedures for the testing personnel to follow and correct the failures within the laboratory such as: a) Patient confidentiality; b) Specimen identification and integrity; c) Complaint investigations; d) Communications; e) Personnel competency; f) Proficiency testing performance. 2. The laboratory was asked to provide documentation of policies and procedures, no documentation was provided. 3. During an interview on 12/6/2023 at 12:07 PM, the Laboratory Director confirmed the above findings. 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 surveyor review of laboratory policies and procedures, a lack of any -- 2 of 12 -- policies, procedures, manufacturer manuals and interview with the laboratory staff the laboratory failed to: 1) Ensure a written procedure was available to the laboratory personnel for Complete Blood Counts (CBC), a Hematology test. (Refer to D5401.) 2) Establish written procedures to monitor analytical laboratory requirements. (Refer to D5403). 3) Document temperatures for the refrigerator in which Hematology QC was stored. (Refer to D5413.) 4) Monitor and document room temperatures and humidity. (Refer to D5413.) 5) Ensure testing personnel checked expiration dates and did not use expired QC material. (Refer to D5417.) 6) Document the laboratory director approval of the validation procedure for new CBC test before testing began on 7/12 /2023. (Refer to D5421.) 7) Document weekly maintenance on the Abacus-3CP Hematology analyzer as per the manufacturer's requirements for five of five months in 2023. (Refer to D5429.) 8) Have a procedure in place that monitors the accuracy and precision of test performance over time. (Refer to D5441.) 9) Ensure daily Hematology quality control was documented prior to analyzing patient specimens and reporting the results. (Refer to D5481.) 10) Establish and maintain a Quality Assurance (QA) program to assure the quality of laboratory services provided. (Refer to D5791.) Due to the evidence of this condition, an Immediate Jeopardy (IJ) was called on 12/6/2023 at 12:07 PM. 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 surveyor review and an interview with Testing Personnel #1, the laboratory failed to have a written procedure for Diatron Abacus-3CP Complete Blood Counts (CBC) Hematology analyzer. The findings include: 1. Surveyor review revealed no documentation of a written procedure for CBC hematology test, this was noted for the day patient testing began on 7/12/2023 through current survey on 12/6/2023. 2. The laboratory did not have a copy of the Diatron Abacus-3CP manufacturer manual. 3. During an interview on 12/6/23 at 12:07 PM, Testing Personnel #1 confirmed the laboratory did not have a written procedure for the test above. D5403 PROCEDURE MANUAL CFR(s): 493.1251(b) The procedure manual must include the following when applicable to the test procedure: (1) Requirements for patient preparation; specimen collection, labeling, storage, preservation, transportation, processing, and referral; and criteria for specimen acceptability and rejection as described in 493.1242. (2) Microscopic examination, including the detection of inadequately prepared slides. (3) Step-by-step performance of the procedure, including test calculations and interpretation of results. (4) Preparation of slides, solutions, calibrators, controls, reagents, stains, and other materials used in testing. (5) Calibration and calibration verification procedures. (6) The reportable range for test results for the test system as established or verified in 493.1253. (7) Control procedures. (8)