Baltimore City Hlth Dept Eastern Sexual Hlth Clini

Summary Statement of Deficiencies D2007 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) (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: *This is a repeat deficiency. The laboratory was cited during the initial survey completed on 02/26/2024 for not documenting proficiency testing (PT) results in the patient testing logbooks. The laboratory's

Summary Statement of Deficiencies 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 the patient logbooks for syphilis serology and gram stain, proficiency testing (PT) records, and interview with the testing person (TP), the laboratory failed to document the PT samples along with the regular patient workload. Findings: 1. The syphilis serology and gram stain PT records from 2021 through 2023 were reviewed for a total of eight events for each speciality. 2. Review of the patient logbooks from 2021 through 2023 showed that the PT samples for all 16 events were not documented in the logbook in the same manner as the patients. The original test results were not documented and maintained in the same manner as the patients. 3. During the survey on 02/26/2024 at 11:45 AM, the TP confirmed that the PT results were not being documented in the patient logbooks in the same manner as the patients. 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. 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 STANDARD is not met as evidenced by: Based on review of the specimen collection procedure and interview with the technical consultant (TC), the laboratory failed to ensure that the policy included instructions for the collection and labeling of specimens for gram stain analysis. Findings: 1. The specimen collection procedure failed to include instructions for the collection and labeling of specimens for gram stain analysis collected by the clinicians. 2. The TC stated that the specimens are collected and processed by the clinicians and brought to the laboratory for staining and analysis. 3. During the survey on 02/26/2024 at 12:30 PM, the TC confirmed that the specimen collection procedure failed to include collection and labeling procedures of specimens for gram staining. 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: The laboratory failed to enroll in an approved proficiency testing (PT) program for rapid plasma reagin (RPR) testing during 2019 while testing was being performed (D2001). The cumulative effect of this deficiency has the potential to result in the laboratory's inability to ensure the accuracy and reliability of patient test results. D2001 ENROLLMENT CFR(s): 493.801(a)(1)(2)(i) The laboratory must-- (1) Notify HHS of the approved program or programs in which it chooses to participate to meet proficiency testing requirements of this subpart. (2)(i) Designate the program(s) to be used for each specialty, subspecialty, and analyte or test to determine compliance with this subpart if the laboratory participates in more than one proficiency testing program approved by CMS; This STANDARD is not met as evidenced by: Based on remote record review of proficiency testing (PT) records and interview with 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 -- the technical consultant and laboratory director (LD), the laboratory failed to enroll in an approved PT program during 2019 to verify the accuracy of the rapid plasma reagin (RPR) testing performed at the laboratory. Findings: 1. To meet the PT requirements, the laboratory is required to be enrolled in an approved PT program when performing patient testing. 2. The PT records that were submitted failed to include documentation for 2019. 3. During the remote survey phone interview on 03 /19/2021 at 3:00 PM, the LD confirmed that the laboratory was unable to procure the funds to purchase the PT modules and reagents necessary for testing during 2019 and failed to ensure the accuracy and reliability of patient test results during 2019. D6000 MODERATE COMPLEXITY LABORATORY DIRECTOR CFR(s): 493.1403 The laboratory must have a director who meets the qualification requirements of 493. 1405 of this subpart and provides overall management and direction in accordance with 493.1407 of this subpart. This CONDITION is not met as evidenced by: Based on record review and interview, the laboratory director failed to ensure that the quality assurance program for the laboratory had been maintained and documented (D6021). D6021 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(5) The laboratory director is responsible for the overall operation and administration of the laboratory, including the employment of personnel who are competent to perform test procedures, and record and report test results promptly, accurate, and proficiently and for assuring compliance with the applicable regulations. (e) The laboratory director must-- (e)(5) Ensure that quality assessment programs are established and maintained to assure the quality of laboratory services provided. This STANDARD is not met as evidenced by: Based on remote survey record review and phone interview with the laboratory director (LD), the LD failed to ensure that "STAT Laboratory Surveys" records were performed and maintained, and that the "STAT Laboratory Surveys" failed to be performed after August 2019 as part of the quality assurance (QA) program. Findings: 1. The "STAT Laboratory Surveys" records from June 2018 through August 2019 were reviewed remotely. The records included a documented onsite review performed by the technical consultant (TC) at the Druid and Eastern STD clinics. 2. There were no monthly QA reports for August 2018, November 2018, March 2019, June 2019, and July 2019. The "STAT Laboratory Surveys" and investigation worksheets had not been completed since August 2019. 3. During the remote survey phone interview on 03/19/2021 at 3:00 PM, the LD stated that the missing "STAT Laboratory Surveys" records were due to the fact that the TC was not being paid and therefore did not come to the office and perform the required monthly reviews. According to the LD, since August 2019 no monthly reviews were performed and documented. -- 2 of 2 --

Summary Statement of Deficiencies 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)