Cairo Diagnostic Center

Summary Statement of Deficiencies D5012 SYPHILIS SEROLOGY CFR(s): 493.1207 If the laboratory provides services in the subspecialty of Syphilis serology, the laboratory must meet the requirements specified in 493.1230 through 493.1256, and 493.1281 through 493.1299. This CONDITION is not met as evidenced by: Based on review of laboratory records, patient test results, manufacturer's package inserts, lack of documentation, and interview with the laboratory technical consultant (as listed on the CMS-209 - Laboratory Personnel Form on 12/13/2023); the laboratory failed to ensure two levels of qualitative quality control materials were run each day of patient testing for Syphilis Rapid Plasma Reagin (RPR) Card Testing prior to reporting of patient results (see D5449). In addition, the laboratory failed to follow their RPR Card Test procedure regarding the frequency of a) verifying rocker rotations; b) frequency of verifying the needle weekly for proper volumetric delivery; and c) the frequency of which to run controls (see 5401). The laboratory also failed to follow the manufacturer's package insert for RPR regarding allowing all reagents and samples to warm to the provided room temperature prior to use (see D5411). Lastly, the laboratory failed to document a patient RPR test result for one of nine patients (see D5789). D5024 HEMATOLOGY CFR(s): 493.1215 If the laboratory provides services in the specialty of Hematology, the laboratory must meet the requirements specified in 493.1230 through 493.1256, 493.1269, and 493. 1281 through 493.1299. 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 -- This CONDITION is not met as evidenced by: Based on record review, lack of documentation, and interview with the technical consultant (TC), the laboratory failed to meet the criteria for acceptability of quality control (QC) results prior to reporting patient test results for one of six patients reviewed for prothrombin time (PT) testing (see D5481). 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 procedures and records, and interview with the laboratory's technical consultant (TC); the laboratory failed to follow their Syphilis Rapid Plasma Reagin (RPR) procedure regarding a) the frequency of verifying the rocker rotations; b) the frequency of verifying the needle weekly for proper volumetric delivery; and c) the frequency of which to run controls as required by 493. 1251. Findings include: 1. Review of the "Rapid Plasma Reagin" (RPR) Procedure Manual revealed the procedure stated: a) "The rotator should be checked daily to see that it rotates at 100 +/- 3 rpm [rotations per minute]; adjust as needed. Record the observed rate on speed." Upon review of patient log sheets, six of nine patients tested for RPR from 12/17/2021 to the survey date of 12/13/2023 did not have documentation of rotator speed correlating with their date of testing recorded on the patient log sheet. Patient Identification: Date of testing: 133390 12/17/2021 135778 06 /28/2022 7734 08/18/2022 59136 10/24/2022 4321 03/13/2023 7894 03/20/2023 b) "Check needle weekly for volumetric delivery (60drips/ml [milliliter]) and record on the A.C. worksheet." Upon review of patient log sheets, six of nine patients tested for RPR from 12/17/2021 to the survey date of 12/13/2023 did not have documentation of needle volume dispenses within one week of their date of testing recorded on the log sheet. Patient Identification: Date of testing: 133390 12/17/2021 135778 06/28/2022 7734 08/18/2022 59136 10/24/2022 4321 03/13/2023 7894 03/20/2023 c) "Reactive and non-reactive, minimally reactive and reactive control is tested with each batch of patient specimens." Upon review of patient log sheets, three of nine patients tested for RPR from 12/17/2021 to the survey date of 12/13/2023 had no quality control testing documented for the dates testing was performed. Patient Identification: Date of testing: 135778 06/28/2022 7734 08/18/2022 7894 03/20/2023 2. Interview with the laboratory's TC on 12/13/2023 at 04:26 pm confirmed the above findings. 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 review of laboratory procedures and records, the manufacturer's package -- 2 of 4 -- insert, and interview with the laboratory's technical consultant (TC); laboratory failed to follow the manufacturer's package insert for the Syphilis Rapid Plasma Reagin (RPR) Card Test in regard to allowing all reagents and samples to warm to the provided room temperature prior to use, as required by 493.1252. Findings include: 1. Review of the Arlington Scientific, Inc. (ASI) RPR Card Test manufacturer's package insert, under Preparation For The Assay, stated, "Allow all reagents and samples to warm to room temperature (20-30 C) before use." Upon review of a) patient logs sheets, the documented range of acceptable temperature was recorded as 20-25 C and b) the laboratory's procedure manual's documented range of acceptable temperature was recorded as 23-30 C. 2. Upon review of patient log sheets, five of nine patients tested for RPR from 12/17/2021 to the survey date of 12/13/2023 did not have documentation of provided room temperature correlating with their date of testing recorded on the patient log sheet. Patient Identification: Date of testing: 133390 12/17 /2021 135778 06/28/2022 7734 08/18/2022 59136 10/24/2022 4321 03/13/2023 7894 03/20/2023 3. Interview with the laboratory's TC on 12/13/2023 at 04:26 pm confirmed the above findings. D5449 CONTROL PROCEDURES CFR(s): 493.1256(d)(3)(ii)(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-- At least once a day patient specimens are assayed or examined perform the following for-- Each qualitative procedure, include a negative and positive control material; (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on review of patient test results, laboratory quality control (QC) records, and interview with the laboratory technical consultant (TC); the laboratory failed to ensure two levels of quality control (QC) materials were ran each day for Rapid Plasma Reagin (RPR) serology testing on three out of nine patients before reporting patient test results, as required per 493.1256. Findings include: 1. RPR serology testing reports logs were reviewed from 12/17/2021 to the date of the survey (12/13/2023). 2. Review of three of nine patient test reports for RPR serology testing found no quality control testing was documented for the test dates performed. Medical Record Number: Test Date: 135778 06/28/2022 7734 08/18/2022 7894 03/20/2023 3. During survey date 12/13/2023, at 02:41 pm, the TC confirmed the surveyors' findings. 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 record review, lack of documentation, and interview with the technical consultant (TC), the laboratory failed to meet the criteria for acceptability of quality control (QC) results prior to reporting patient test results for one of six patients reviewed for prothrombin time (PT) testing using the Sysmex CA-600 (serial Number: 12733), as required per 493.1256. Findings include: 1. Review of quality -- 3 of 4 -- control results on the dates of six patients was performed. Medical Record Number (MRN): Date of Testing: 1011 11/01/2023 37962 08/04/2023 7490 10/10/2022 63307 03/16/2023 1011 02/23/2022 6851 10/14/2022 2. Review of MRN 6851, patient test report date of 10/14/2022, found the following: a. Patient was tested for PT, result 16.6 seconds. b. Review of QC data for patient test report date of 10/14/2022 shows PT Ci-Trol Level 1 (lot number: 564813) QC did not meet the limits of acceptability and was outside the acceptable range. There was no documentation of

Summary Statement of Deficiencies D5219 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(c)(2) At least twice annually, the laboratory must verify the accuracy of any test or procedure listed in subpart I of this part for which compatible proficiency testing samples are not offered by a CMS-approved proficiency testing program. This STANDARD is not met as evidenced by: Based on review of laboratory records and interview with the laboratory technical supervisor (TS); the laboratory failed to perform bi-annual method accuracy evaluations for pinworm examinations in 2018 and 2019. Findings Include: 1. Review of the laboratory's test menu identified the test "Pinworm Exam". 2. Review of proficiency testing documentation found no evidence of bi-annual method accuracy evaluation for pinworm examinations in 2018 and 2019. 3. Interview with the TS on 02-27-2020, at 2:30 pm, confirmed that the laboratory failed to perform bi-annual method accuracy verifications for pinworm examinations in 2018 through 2019. 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)

Summary Statement of Deficiencies 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: A. Based on review of laboratory records and personnel interviews; the laboratory failed to enroll and maintain enrolment in proficiency testing (PT) for the regulated analytes; infectious mononucleosis, syphilis serology and hCG. Findings Include: 1. Review of American Proficiency Institute (API) PT records revealed that the laboratory failed to enroll in PT for the regulated analytes; infectious mononucleosis and syphilis serology when the laboratory switched PT providers after event 1 of 2017. 2. Interview with testing personnel (TP) #1 confirmed on 7-26-2018, at 10:30 am, the laboratory performs infectious mononucleosis testing using the Clearview Mono test kit with serum and syphilis serology with ASI rapid plasma reagin card test kit. 3. On survey date 7-27-2018, at 2:00 pm, it was confirm that that the lab had not enroll in PT testing for infectious mono and syphilis serology since 1st quarter 2017. B. Based on review of laboratory records, direct observations, and personnel interviews; the laboratory failed to maintain enrollment for the regulated analyte serum human chorionic gonadotropin (hCG). 1. Review of API PT records found the laboratory discontinued enrollment for qualitative serum hCG in the second event of 2018. 2. Review of the qualitative serum hCG testing log found testing was still being performed by the laboratory, as recent as 07-12-2018. 3. Review of the API 2018 PT Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 14 -- event schedule for qualitative serum pregnancy (Chemistry-Core) states PT results were due June 8, 2018 when the laboratory was still performing patient testing. 4. Direct observation during a tour of the laboratory facility on 7-26-2018, at 10:30am, with TP #1, identified Clearview qualitative serum hCG kits used for qualitative serum pregnancy testing. 5. TP#1 confirmed on 7-26-2018, at 1:30pm, the laboratory is still performing qualitative serum hCG till the kits expire. 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: Based on review of laboratory records and personnel interviews; the laboratory failed to test American Proficiency Institute (API) proficiency testing (PT) samples by personnel who routinely perform testing in 2017 through 2018. Findings Include: 1. Review of the laboratory's policy and procedure manual identified the policy, "Proficiency Testing Policy", which states, "All personnel will be involved in the testing of the proficiency samples. Testing is to be performed with the laboratory's regular workload, by personnel who routinely perform the testing, using the methods of testing normally used for patient testing." 2. Review of API PT records found no documentation of testing personnel (TP) #1 performing core chemistry, hematology /coagulation, or immunology proficiency testing from event 2 of 2017 through event 2 of 2018. 3. On survey date 07-26-2018, at 1:00 pm, TP #1 confirmed 1 of 3 TP who were authorized to perform laboratory testing failed to participate in API PT in 2017 through 2018. 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 laboratory records and personnel interviews; the laboratory failed -- 2 of 14 -- to successfully participate in proficiency testing (PT) for calcium and PO2 in the specialty of chemistry. Findings include: 1. Review of the CASPER Report 0096D, American Association of Bioanalysts (AAB) and American Proficiency Institute (API) PT records, and interview with testing personnel (TP) #1, on 7-26-2018 2016, at 1:00 pm, confirmed that the initial unsuccessful PT performance for calcium occurred during chemistry 3, 2016 and event 2 of 2017. See D2096. 2. Review of the CASPER Report 0096D, American Proficiency Institute (API) PT records, and interview with testing personnel (TP) #1, on 7-26-2018 2016, at 1:00 pm, confirmed that the initial unsuccessful PT performance for PO2 blood gas occurred during chemistry event 1 of 2018 and event 2 of 2018. See D2096. D2094 ROUTINE CHEMISTRY CFR(s): 493.841(e) (1) For any unsatisfactory analyte or test performance or testing event for reasons other than a failure to participate, the laboratory must undertake appropriate training and employ the technical assistance necessary to correct problems associated with a proficiency testing failure. (2) For any unacceptable analyte or testing event score, remedial action must be taken and documented, and the documentation must be maintained by the laboratory for two years from the date of participation in the proficiency testing event. This STANDARD is not met as evidenced by: Based on review of laboratory records and interview with testing personnel (TP) #1; the laboratory failed to perform and document a