Baltimore City Health Dept Druid Sexual Health Cli

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: Based on review of proficiency testing (PT) records, review of patient testing logbooks, and interview with the technical consultant (TC), the laboratory failed to document Gram stain and rapid plasma reagin (RPR) PT results in the same manner as patient results in three of six PT events reviewed. Findings: 1. The laboratory documented patient results for Gram stain and RPR testing in patient logbooks. 2. Records for RPR PT were reviewed for four events from 2024-2025. Results for RPR PT samples were not documented in the patient result logbook for two of four PT events. 3. Records for Gram stain PT were reviewed for two events in 2024. Results for Gram stain samples were not documented in the patient result logbook for one of two PT events. 4. During the exit interview on 09/18/2025 at 12:50 PM, the TC confirmed that PT results were not consistently documented in the Gram stain and RPR patient results logbooks. D2009 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) (b)(1) The individual testing or examining the samples and the laboratory director must attest to the routine integration of the samples into the patient workload using the laboratory's routine methods. This STANDARD is not met as evidenced by: 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 -- Based on review of proficiency testing (PT) records and interview with the technical consultant (TC), the laboratory failed to ensure that the testing personnel (TP) and laboratory director (LD) or designee consistently attested to the routine integration of PT samples into the patient workload using the laboratory's routine methods in three of six PT events reviewed. Findings: 1. Records for rapid plasma reagin PT were reviewed for four events from 2024-2025. The attestation form was not signed by the LD or designee in two of the four PT events. 2. Records for Gram stain PT were reviewed for two events in 2024. The attestation form was not signed by the TP or the LD or designee in one of two events 3. During the exit interview on 09/18/2025 at 12: 50 PM, the TC confirmed that the TP and LD or designee did not consistently attest to the routine integration of PT samples into the patient workload using the laboratory's routine methods. D5211 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(a) The laboratory must review and evaluate the results obtained on proficiency testing performed as specified in subpart H of this part. This STANDARD is not met as evidenced by: Based on review of proficiency testing (PT) records and interview with the technical consultant (TC), the laboratory failed to ensure all unacceptable PT results were evaluated and potential patient impact was assessed. Findings: 1. The laboratory received an 80% for the D5-A 2024 Gram stain PT event. The investigation stated that "it appeared that staff may have decolorized the slides for too long resulting in the incorrect response." Retraining for Gram stain testing was documented on 07/11 /2024. The investigation did not address whether patient results were potentially affected by over-decolorizing the slides. 2. The laboratory received a 60% for Gram stain and morphology results for the D5-B 2024 Gram stain PT event. The PT records did not include an investigation into the unacceptable results. 3. During the exit interview on 09/18/2025 at 12:50 PM, the TC confirmed that the PT investigation for D5-A 2024 did not include an assessment of potential patient impact and there was no PT investigation for the unacceptable results from D5-B 2024 included with the PT records. D5215 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(b)(2) The laboratory must verify the accuracy of any analyte, specialty or subspecialty assigned a proficiency testing score that does not reflect laboratory test performance (that is, when the proficiency testing program does not obtain the agreement required for scoring as specified in subpart I of this part, or the laboratory receives a zero score for nonparticipation, or late return or results). This STANDARD is not met as evidenced by: Based on review of proficiency testing (PT) records and interview with the technical consultant (TC), the laboratory failed to perform a self-evaluation of scores that were ungraded by the PT provider. Findings: 1. The laboratory was enrolled in PT for Gram stains with College of American Pathologists (CAP). 2. The following codes were used when a PT sample was not graded by CAP with the following instructions from the "Actions Laboratories Should Take when a PT Result is Not Graded" section -- 2 of 3 -- included in CAP's participant summary: a. "[26] Educational Challenge:" "Review participant summary for comparative results and document performance accordingly. Evaluation criteria are not established for educational challenges. Laboratories should determine their own evaluation criteria approved by their laboratory director for self- evaluation." b. "[27] Lack of participant or referee consensus:" "Document that the laboratory performed a self-evaluation and compared its results to the intended response when provided in the participant summary. If comparison is not available, perform and document alternative assessment (ie, split samples) for the period that commercial PT reached non-consensus to the same level and extent that would have been tested." 3. The 2024 1st PT event included two morphology results not graded due to code [27] and four "PMN Leukocytes" results not graded due to code [26]. The laboratory investigation only included an assessment for one of the four results coded [26]. 4. The 2024 2nd PT event included one morphology result not graded due to code [27] and five "PMN Leukocytes" results not graded due to code [26]. There was no documentation that the laboratory self-evaluated the ungraded PT results. 5. During the exit interview on 09/18/2025 at 12:50 PM, the TC confirmed that there was no consistent documentation that the laboratory self-evaluated ungraded Gram stain PT results. -- 3 of 3 --

Summary Statement of Deficiencies 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. 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 02/23/2024 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. 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 -- (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 Gram stain identification and 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: 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 -- Based on remote record review of proficiency testing (PT) records and interview with 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 Gram stain identification and 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 D2015 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(5)(6) (5) The laboratory must document the handling, preparation, processing, examination, and each step in the testing and reporting of results for all proficiency testing samples. The laboratory must maintain a copy of all records, including a copy of the proficiency testing program report forms used by the laboratory to record proficiency testing results including the attestation statement provided by the PT program, signed by the analyst and the laboratory director, documenting that proficiency testing samples were tested in the same manner as patient specimens, for a minimum of two years from the date of the proficiency testing event. (6) PT is required for only the test system, assay, or examination used as the primary method for patient testing during the PT event. This STANDARD is not met as evidenced by: Based on record review, the lab director did not sign attestation statements to document proficiency testing samples were tested in the same manner as patient specimens. Findings: 1. The lab director did not sign the attestation for event D5-A 2016 (Gram stain); 2. The lab director did not sign the attestation for event RHCVW- A 2016; 3. The lab director did not sign the attestation for event RHCVW-B 2016; 4. The lab director did not sign the attestation for event D5-A 2017 and the lab did not have handling, preparation, processing, examination, and reporting records for this event; 5. The lab director did not sign the attestation for event VM-A 2017; 6. The lab director did not sign the attestation for event VM-B 2017; and 7. The lab director did not sign the attestation for event RHCVW-B 2017 and the lab did not have handling, preparation, processing, examination, and reporting records for this event. D3011 FACILITIES CFR(s): 493.1101(d) Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 5 -- Safety procedures must be established, accessible, and observed to ensure protection from physical, chemical, biochemical, and electrical hazards, and biohazardous materials. This STANDARD is not met as evidenced by: Based on record review and interview with lab staff on the day of survey, the lab manager and lab director did not review and sign the "MSDS Acknowledgement Roster" in the written procedure, to show that this training was conducted. D5211 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(a) The laboratory must review and evaluate the results obtained on proficiency testing performed as specified in subpart H of this part. This STANDARD is not met as evidenced by: Based on record review and interview with lab staff, the lab did not review and provide documentation to show that it evaluated proficiency test performance for RPR titers. Findings: 1. In 2017 all three events (identified as events A, B and C) were given a code 11 by the proficiency test provider. The code means the lab was unable to perform the RPR titer and the proficiency test provider states that the lab will provide documentation to show that it was unable to perform the tests; 2. The lab did not prepare a statement or provide documentation showing why the lab failed to participate in each event; and 3. Lab staff stated, during interview on the day of survey, that the lab discontinued RPR titers. The labs written procedure for performing RPR titers was not retired and still in the procedure manual. 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 record review and interview with lab staff, the lab did not update the written procedures to ensure they were current. Findings: 1. The lab has a chart (procedure) to document temperatures of a bacteriology incubator. Lab staff stated, during interview on the day of survey, that the incubator procedures are no longer performed by the lab; 2. The RPR worksheet (procedure) used by the lab is not labeled with the labs identification information (name, address); and 3. The daily gram stain quality control record (procedure) is not labeled with the labs identification information (name, address). 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, -- 2 of 5 -- 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)