Palmetto Adult And Children's Urology, Pa

Summary Statement of Deficiencies D0000 A focus survey was completed on November 3, 2023. It was determined that Immediate Jeopardy (IJ) existed for the following condition-level deficiencies: Cytology-42 C.F.R. 493-1221 Laboratory Director-42 C.F.R. 493.1441 D5032 CYTOLOGY CFR(s): 493.1221 If the laboratory provides services in the subspecialty of Cytology, the laboratory must meet the requirements specified in 493.1230 through 493.1256, 493.1274, and 493.1281 through 493.1299. This CONDITION is not met as evidenced by: Based on review of laboratory policies and procedures, laboratory records, cytology specimen slide preparations, and interviews the laboratory failed to follow written policies and procedures to document the competency of the Technical Supervisor (refer to D5209); failed to refer nongynecologic cytology tests to a CLIA-certified laboratory (refer to D5315); failed to establish written policies and procedures for three laboratory test processes (refer to D5403); failed to test staining materials for intended reactivity of the Papanicolaou stain (refer to D5473); failed to follow written policies and procedures for an annual statistical comparison of three of three required nongynecologic statistics (refer to D5629); failed to follow written policies and procedures for the establishment, reassessment and documentation of individual workload limits (refer to D5633, D5637 and D5647); failed to follow written policies and procedures to ensure the laboratory maintained records of the total number of slides examined and the total number of hours spent examining slides per 24-hour period (refer to D5645); and failed to ensure cytology specimen slides were retrieveable upon request (refer to D5663). D5205 COMPLAINT INVESTIGATIONS CFR(s): 493.1233 Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 15 -- The laboratory must have a system in place to ensure that it documents all complaints and problems reported to the laboratory. The laboratory must conduct investigations of complaints, when appropriate. This STANDARD is not met as evidenced by: Based on review of laboratory policies and procedures, lack of laboratory records and interview with Staff A, the laboratory failed to establish written policies and procedures for the documentation of complaints and problems reported to the laboratory for 2021, 2022 and January 2023 to the date of the survey in 2023. Findings include: 1. The Survey Team requested and the laboratory failed to provide written policies and procedures for investigating and documenting complaints and problems reported to the laboratory. 2. The Survey Team requested and the laboratory failed to provide documentation of complaints and problems reported to the laboratory. 3. During an interview on September 11, 2023 at 3:37 PM, Staff A confirmed these findings. 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: Based on review of laboratory policies and procedures, competency assessment records and interview with Staff A, the laboratory failed to follow written policies and procedures to assess the competency of one of one Technical Supervisor in 2022 and January 2023 to the date of the survey in 2023. Findings include: 1. The laboratory failed to follow the procedure TECHNICAL SUPERVISOR COMPETENCY ASSESSMENT POLICY, which stated: "Competency of the Technical Supervisor must be assessed annually." 2. The Survey Team requested and the laboratory failed to provide competency records for the one of one Technical Supervisor in 2022 and January 2023 to the date of the survey in 2023. Technical Supervisor includes: - Laboratory Director/Technical Supervisor A 3. During an interview on September 12, 2023 at 4:32 PM, the Survey Team requested the competency assessment records for Laboratory Director/Technical Supervisor A. Staff A stated: "I only have 2021." D5315 SPECIMEN SUBMISSION, HANDLING, AND REFERRAL CFR(s): 493.1242(c) The laboratory must refer a specimen for testing only to a CLIA-certified laboratory or a laboratory meeting equivalent requirements as determined by CMS. This STANDARD is not met as evidenced by: Based on interviews and review of nongynecologic final test reports, the Laboratory Director/Technical Supervisor A failed to refer 106 nongynecologic cytology tests to a CLIA-certified laboratory from May 12, 2023 to October 17, 2023. Findings include: 1. During an interview on September 11, 2023 at 10:10 AM, the Practice Administrator stated: "The slides are not screened onsite at Facility A." "Specimens -- 2 of 15 -- are sent to Facility B to be processed." "The slides are then sent to the Laboratory Director/Technical Supervisor A at Facility C to be read." 2. During a phone interview on September 11, 2023 at 10:50 AM, the Laboratory Director/Technical Supervisor A stated: "I do not screen on site at Facility A." "The slides are screened at Facility C." "I haven't screened on-site at Facility A since March 2020." 3. During an interview on September 11, 2023 at 12:14 PM, when asked if there is a CLIA certificate for Facility C, the Practice Administrator stated: "There is no CLIA certificate for the Laboratory Director/Technical Supervisor A at Facility C." "Laboratory Director /Technical Supervisor A is working under our CLIA number." 4. During an interview on October 30, 2023 at 9:13 AM, when asked if the Laboratory Director/Technical Supervisor A is screening at Facility C, the Practice Administrator stated: "Laboratory Director/Supervisor A previews the cases at Facility C and comes down to Facility A on the weekend to screen and sign out." 5. During an interview on October 30, 2023 at 11:51 AM, when asked if the Laboratory Director is screening at Facility C, Staff A stated: "Laboratory Director/Technical Supervisor A is screening at Facility C and comes down every other weekend to screen them again and sign them out." 6. During an interview on November 1, 2023, Staff A provided a list of 106 nongynecologic cytology tests with corresponding report dates referred to Facility C from May 12, 2023 to October 17, 2023. Cytology tests and report dates include: -UH3211344 05/18 /23 -UH3211345 05/18/23 -UH3211346 05/17/23 -UH3211474 05/18/23 - UH3211635 05/18/23 -UH3211636 05/18/23 -UH3211637 05/15/23 -UH3211922 05 /21/23 -UH3212056 05/21/23 -UH3212164 05/21/23 -UH3212165 05/21/23 - UH3212166 05/21/23 -UH3212167 05/21/23 -UH3212333 05/21/23 -UH3212459 05 /21/23 -UH3212769 05/28/23 -UH3212868 05/30/23 -UH3212869 05/30/23 - UH3213158 05/30/23 -UH3213159 05/30/23 -UH3213412 06/19/23 -UH3214105 06 /19/23 -UH3214106 06/19/23 -UH3214107 06/19/23 -UH3214199 06/19/23 - UH3214355 06/19/23 -UH3214356 06/19/23 -UH3214966 06/25/23 -UH3215072 06 /25/23 -UH3216392 06/30/23 -UH3216923 07/13/23 -UH3217303 07/25/23 - UH3217304 07/25/23 -UH3217533 07/25/23 -UH3217671 07/25/23 -UH3217672 07 /25/23 -UH3217673 07/25/23 -UH3217674 07/25/23 -UH3218355 07/31/23 - UH3218356 07/31/23 -UH3218357 07/31/23 -UH3218645 08/07/23 -UH3218863 08 /07/23 -UH3218864 08/07/23 -UH3218865 08/07/23 -UH3218866 08/07/23 - UH3218867 08/07/23 -UH3218868 08/07/23 -UH3218869 08/07/23 -UH3218993 08 /07/23 -UH3218994 08/07/23 -UH3219095 08/07/23 -UH3219096 08/07/23 - UH3219214 08/14/23 -UH3219302 08/09/23 -UH3219303 08/14/23 -UH3219304 08 /14/23 -UH3219409 08/14/23 -UH3219410 08/14/23 -UH3219411 08/14/23 - UH3219507 08/14/23 -UH3219508 08/14/23 -UH3219509 08/14/23 -UH3219740 08 /15/23 -UH3219741 08/15/23 -UH3219915 08/15/23 -UH3219916 08/15/23 - UH3220170 08/20/23 -UH3220171 08/20/23 -UH3220172 08/20/23 -UH3220671 08 /27/23 -UH3220786 08/27/23 -UH3220787 08/27/23 -UH3220888 08/27/23 - UH3221259 09/04/23 -UH3221589 09/04/23 -UH3222662 09/25/23 -UH3222663 09 /25/23 -UH3222952 09/25/23 -UH3223263 09/25/23 -UH3223478 09/27/23 - UH3223479 09/27/23 -UH3223692 10/08/23 -UH3223693 10/03/23 -UH3223873 10 /08/23 -UH3223874 10/05/23 -UH3223996 10/05/23 -UH3224137 10/08/23 - UH3224348 10/15/23 -UH3224349 10/09/23 -UH3224647 10/15/23 -UH3224785 10 /15/23 -UH3224786 10/15/23 -UH3224966 10/17/23 -UH3225032 10/16/23 - UH3225033 10/17/23 -UH3225180 10/17/23 -UH3225283 10/17/23 -UH3225411 10 /17/23 -UH3225412 10/17/23 -UH3225515 10/17/23 -UH3225516 10/17/23 - UH3225517 10/17/23 -UH3225776 10/17/23 -UH3225777 10/17/23 -UH3225778 10 /17/23 D5403 PROCEDURE MANUAL CFR(s): 493.1251(b) -- 3 of 15 -- 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 D0000 A Recertification Survey was initiated on 10/09/2023 and concluded on 10/09/2023. The facility was found not to be in compliance with the laboratory requirements of 42 CFR Part 493 with deficiencies cited. 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 document review, policy review, and interview, the laboratory failed to review and sign graded proficiency testing (PT) results for 1 (2023 Microbiology - 2nd Event) of 5 PT events reviewed. Findings included: Review of the policy titled, "PCR [polymerase chain reaction] Proficiency testing and ordering," with a revision date of 09/06/2023, revealed "Completed Results 1. Check the report when returned and correct any errors. 2. Ensure signatures are on the form." Review of the "American Proficiency Institute Performance Summary" for the "2023 Microbiology - 2nd Event," revealed the report was not signed and dated by the Laboratory Director (LD) or designee to indicate the report was reviewed. During an interview on 10/09 /2023 at 10:30 AM, the Testing Personnel stated she forgot to mark the document for the LD's review and signature during the LD's recent onsite visit. D6121 TECHNICAL SUPERVISOR RESPONSIBILITIES CFR(s): 493.1451(b)(8)(i) The procedures for evaluation of the competency of the staff must include, but are not limited to direct observations of routine patient test performance, including patient preparation, if applicable, specimen handling, processing and 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 2 -- This STANDARD is not met as evidenced by: Based on document reviews, policy review, and interview, the laboratory failed to ensure the semiannual and annual competency evaluation for 1 of 1 testing personnel (TP) reviewed indicated the results of the competency evaluation. Findings included: Review of the "Laboratory Personnel Report," signed by the Laboratory Director (LD) and dated 10/09/2023, indicated the LD held the position of director, clinical consultant, and technical supervisor. The Laboratory Personnel Report further indicated the laboratory had one employee that held the position of Testing Personnel. Review of the laboratory policy titled, "Technical Supervisor Responsibilities," with a revision date of 09/06/2023, revealed "(9) Evaluating and documenting the performance of individuals responsible for high complexity testing at least semiannually during the first year the individual tests patient specimens. Thereafter, evaluations must be performed at least annually." A review of the "[laboratory name] PCR [polymerase chain reaction] Competency," for the TP's "6-Month [semiannually]" competency with an evaluation date of 02/28/2023, revealed the LD signed the semiannual competency on 03/01/2023; however, the competency did not specify whether the TP was competent to perform the required skills. A review of the "[laboratory name] PCR Competency," for the TP's "Annual" competency with an evaluation date of 09/16/2023, revealed the LD signed the annual competency on 10 /08/2023; however, the competency did not specify whether the TP was competent to perform the required skills. During an interview on 10/09/2023 at 12:25 PM, the TP stated the LD assessed their competency by direct observation as they performed laboratory testing but did document the results of their performance on the form. -- 2 of 2 --