Summary:
Summary Statement of Deficiencies D0000 An initial certification survey was completed on 08/20/2024. It was determined that Immediate Jeopardy (IJ) existed for the following condition level deficiencies: 42 C.F. R 493.801 - Condition: Enrollment and testing of proficiency samples 42 C.F.R 493.1217 - Condition: Immunohematology 42 C.F.R 493.1403 - Condition: Laboratory Director 42 C.F.R 493.1409 - Condition: Technical Consultant 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 review of the federal Casper report 0096D, laboratory proficiency testing (PT) records, lack of documentation, and interview with the laboratory representative; the laboratory failed to enroll in approved Health and Human Services (HHS) proficiency testing (PT) challenges for Rhesus (Rh) factor testing from the beginning of patient testing, 05/01/2023, through the date the surveyors were on site, 08/14 /2024, for the specialty of immunohematology. Findings include: 1. Review of laboratory PT records revealed that the laboratory failed to enroll in testing for the analyte Rhesus (Rh) factor from the beginning of patient testing, 05/01/2023, through the date the surveyors were on site, 08/14/2024, for the specialty of immunohematology. 2. Interview with the laboratory representative on 08/14/2024, at 11:21 am, confirmed no enrollment in an approved HHS PT program. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 13 -- 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 review of the federal Casper report 0096D, laboratory proficiency testing (PT) records, laboratory records, policy and procedure manuals, manufacturer's package insert, patient test reports, direct observation lack of documentation, and interview with the laboratory representative, the laboratory failed to establish and follow written policies and procedures to assess testing personnel and technical consultant competencies (See D5209); establish and follow written policies and procedures for monitoring, assessing, and correcting problems (See D5291); outline all components of test procedure (See D5403); have policy and procedure manuals reviewed, approved, signed, and dated by the current laboratory director (See D5407); demonstrate it can obtain performance specifications (See D5421); ensure negative and positive control materials were tested each day of testing (See D5449); and perform testing as outlined by the manufacturer for Rhesus (Rh) factor testing in the specialty of immunohematology (See D5551). 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: a) Based on review of laboratory policy and procedure manuals, lack of documentation, and interview with the laboratory representative; the laboratory failed to establish and follow written policies and procedures to assess testing personnel (TP) competency for two of two TP performing Rhesus (Rh) factor testing in the specialty of immunohematology. Findings include: 1. Review of the laboratory policy and procedure manuals found no policy / procedure in place used to monitor TP competency. 2. Review of laboratory competency assessment records showed the laboratory failed to assess competency for two of two TP. 3. Interview with the laboratory representative on 08/14/2024, at 11:41 am, confirmed the above findings. b) Based on review of laboratory policy and procedure manuals, lack of documentation, and interview with the laboratory representative; the laboratory failed to establish and follow written policies and procedures to assess technical consultant (TC) competency for one of one TC overseeing Rhesus (Rh) factor testing in the specialty of immunohematology. Findings include: 1. Review of the laboratory policy and procedure manuals found no policy / procedure in place used to monitor TC competency. 2. Review of laboratory competency assessment records showed the laboratory failed to assess competency for one of one TC. 3. Interview with the laboratory representative on 08/14/2024, at 11:41 am, confirmed the above findings. D5291 GENERAL LABORATORY SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1239(a) -- 2 of 13 -- 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 review of laboratory policy and procedure manuals, lack of documentation, and interview with the laboratory representative; the laboratory failed to establish and follow written policies and procedures for monitoring, assessing, and correcting problems in the specialty of immunohematology. Findings Include: 1. Review of laboratory policy and procedure manuals revealed no documentation of a written quality assessment plan was available. 2. Interview with the laboratory representative on 08/14/2024, at 1:20 pm, confirmed no written quality assessment plan had been established. 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)