Comprehensive Urologic Care Sc

Summary Statement of Deficiencies D5203 SPECIMEN IDENTIFICATION AND INTEGRITY CFR(s): 493.1232 The laboratory must establish and follow written policies and procedures that ensure positive identification and optimum integrity of a patient's specimen from the time of collection or receipt of the specimen through completion of testing and reporting of results. This STANDARD is not met as evidenced by: Based on review of laboratory policies and procedures, observation and interview the laboratory failed to follow written policies and procedures to ensure positive patient identification of patient specimens during nongynecologic specimen processing. Findings include: 1. The laboratory failed to follow the procedure SPECIMEN ACCESSIONING AND HANDLING, which stated: "Cytology specimen accession numbers begin with the prefix "C" followed by the last two digits of the year, i.e. 2006, "06", a dash and then the next sequential numerical number." "This accession number is written on the requisition and on the specimen container." "Write the accession number on a 50ml centrifuge tube." 2. The laboratory failed to follow the procedure COLLECTION AND PREPARATION OF NON-GYNECOLOGICAL SPECIMENS, which stated: "Number requisition and specimen container with next available accession number." "Number centrifuge tube with accession number and pour 50 ml or total volume of specimen in centrifuge tube." 3. During an observation of nongynecologic specimen processing on January 14, 2025 at 9:00 AM, Staff B failed to write C and the year on the specimen containers and centrifuge tubes for five of five specimens. Specimens include: Accession number Number on container/tube: - C25-49 49 -C25-50 50 -C25-51 51 -C25-52 52 -C25-53 53 4. During an interview on January 15, 2025 at 9:40 AM, these findings were confirmed with the Laboratory Director/Technical Supervisor A, Technical Supervisor B, Cytotechnologist, Practice Manager and Regulatory Affairs Officer. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 11 -- D5305 TEST REQUEST CFR(s): 493.1241(c) (c) The laboratory must ensure the test requisition solicits the following information: (c)(1) The name and address or other suitable identifiers of the authorized person requesting the test and, if appropriate, the individual responsible for using the test results, or the name and address of the laboratory submitting the specimen, including, as applicable, a contact person to enable the reporting of imminently life threatening laboratory results or panic or alert values. (c)(2) The patient's name or unique patient identifier. (c)(3) The sex and age or date of birth of the patient. (c)(4) The test(s) to be performed. (c)(5) The source of the specimen, when appropriate. (c)(6) The date and, if appropriate, time of specimen collection. (c)(7) For Pap smears, the patient's last menstrual period, and indication of whether the patient had a previous abnormal report, treatment, or biopsy. (c)(8) Any additional information relevant and necessary for a specific test to ensure accurate and timely testing and reporting of results, including interpretation, if applicable. This STANDARD is not met as evidenced by: Based on review of laboratory test requisitions and interview the laboratory failed to ensure test requisitions solicited the sex of the patient for 20 of 20 test requisitions from November 2024. Findings include: 1. The Survey Team reviewed 20 consecutive test requisitions from November 2024. Twenty of 20 test requisitions failed to solicit the sex of the patient. Test requisitions include: -C24-1340 -C24-1341 -C24-1342 -C24-1343 -C24-1344 -C24-1345 -C24-1346 -C24-1347 -C24-1348 -C24- 1349 -C24-1350 -C24-1351 -C24-1352 -C24-1353 -C24-1354 -C24-1355 -C24-1356 - C24-1357 -C24-1358 -C24-1359 2. During an interview on January 15, 2025 at 9:40 AM, these findings were confirmed with the Laboratory Director/Technical Supervisor A, Technical Supervisor B, Cytotechnologist, Practice Manager and Regulatory Affairs Officer. D5401 PROCEDURE MANUAL CFR(s): 493.1251(a) (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 22 laboratory policies and procedures, interviews and laboratory records the laboratory failed to follow two written policies and procedures. Findings include: 1. The laboratory failed to follow the procedure PREVENTING CROSS CONTAMINATION OF CYTOLOGY AND TISSUE, which stated: "All stains and solutions are covered when not in use, and changed or filtered as needed to remove any sediment or cellular debris, and after known malignant or highly cellular cases are stained. In addition stains will be changed weekly." a. During an interview on January 14, 2025 at 9:00 AM, the Cytotechnologist stated all stains and solutions were changed weekly. b. The Survey Team reviewed records titled CYTOLOGY STAIINING DAILY LOG from January 1, 2024 through January 10, 2025. The laboratory failed to change the stains and solutions for 23 of 53 weeks. Weeks include: -01/01/24 through 01/05/24 -01/29/24 through 02/02/24 -02/05/24 through 02 -- 2 of 11 -- /09/24 -02/19/24 through 02/23/24 -02/26/24 through 03/01/24 -03/04/24 through 03 /08/24 -03/25/24 through 03/29/24 -04/08/24 through 04/12/24 -04/15/24 through 04 /19/24 -05/06/24 through 05/10/24 -05/20/24 through 05/24/24 -06/10/24 through 06 /14/24 -07/01/24 through 07/05/24 -07/22/24 through 07/26/24 -08/19/24 through 08 /23/24 -09/02/24 through 09/06/24 -09/30/24 through 10/04/24 -10/14/24 through 10 /18/24 -11/04/24 through 11/08/24 -11/25/24 through 11/29/24 -12/02/24 through 12 /06/24 -12/16/24 through 12/20/24 -12/30/24 through 01/03/25 2. The laboratory failed to follow the procedure CYTOCENTRIFUGE MAINTENANCE IN CYTOLOGY, which stated: "Monthly Maintenance Lubricate center piece (head bearings) and locking ball bearing of the cytospin and the centrifuge used lithium grease sparingly so that it does not get on the inside of the bowl liner during centrifuging. Trunnion lubrication on the Thermo IEC CL30 Centrifuge. This operation is necessary to allow the buckets to swing freely. Clean the trunnions with a dry wipe (as well as the part of the bucket that rotates on the trunnions). Then, put a very small quantity of grease on the curved face of the trunnion. Do not apply too much grease because it will eventually coat the bowl liner of the centrifuge as centrifugal force pulls the grease from the trunnions. If the centrifuge is having imbalance problems, try this operation before calling for service." "Log monthly maintenance by initialing the CYTOSPIN 2 / CENTRIFUGE MAINTENANCE LOG." a. During an interview on January 14, 2025 at 9:00 AM, the Cytotechnologist stated the Shandon Cytospin 4 was lubricated quarterly and documented on the laboratory record titled INSTRUMENT RECORD for the Shandon Cytospin 4. The Cytotechnologist further stated the monthly maintenance performed and documented on the laboratory record titled CYTOSPIN 2 / CENTRIFUGE MAINTENANCE LOG did not include lubricating the Cytospin. b. During an interview on January 14, 2025 at 9:00 AM, the Cytotechnologist stated the Thermo IEC CL30 Centrifuge was lubricated quarterly and documented on the laboratory record titled INSTRUMENT RECORD for the Thermo IEC CL30 Centrifuge. The Cytotechnologist further stated the monthly maintenance performed and documented on the laboratory record titled CYTOSPIN 2 / CENTRIFUGE MAINTENANCE LOG did not include lubricating the Centrifuge. 3. During an interview on January 15, 2025 at 9:40 AM, these findings were confirmed with the Laboratory Director/Technical Supervisor A, Technical Supervisor B, Cytotechnologist, Practice Manager and Regulatory Affairs Officer. D5403 PROCEDURE MANUAL CFR(s): 493.1251(b) (b) The procedure manual must include the following when applicable to the test procedure: (b)(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. (b)(2) Microscopic examination, including the detection of inadequately prepared slides. (b)(3) Step-by- step performance of the procedure, including test calculations and interpretation of results. (b)(4) Preparation of slides, solutions, calibrators, controls, reagents, stains, and other materials used in testing. (b)(5) Calibration and calibration verification procedures. (b)(6) The reportable range for test results for the test system as established or verified in 493.1253. (b)(7) Control procedures. (b)(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: Based on record review, the Food and Drug Administration (FDA), and an interview with the radiology manager, the laboratory failed to enroll in an HHS approved proficiency testing (PT) program for the subspecialty of Routine Chemistry during the year of 2020. Findings include: 1. The laboratory's manuals, FDA website, and the i- STAT manufacturer's logs and package inserts were reviewed. 2. The laboratory was using the Abbott i-STAT Crea and EC8+ cassette kits (cartridges) in the radiology laboratory. 3. Review of the i-STAT logs and package inserts showed the cartridges tested for the following Blood Chemistry analytes: BLUE CARTRIDGE: Sodium (Na); Potassium (K); Chloride (CL); Glucose (Glu); Blood Urea Nitrogen (BUN /Urea); Hematocrit (Hct); pH; and Carbon Dioxide Partial Pressure (PCO2); PINK CARTRIDGE: Creatinine (Crea) 4. The FDA categorized the i-STAT test system as "Moderate" (on 02/07/2020) when the Blue and Pink cartridges are used to test the analytes listed in findings #3. 5. The laboratory failed to enrolled in an approved PT program for the subspecialty of Routine Chemistry when it's iSTAT test system was categorized from "Waived" to "Moderate" by the FDA on 02/07/2020. 6. On a 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 -- Recertification survey conducted on 11/23/2020 at 12:30 PM, the Radiology manager confirmed the above findings and stated he was unaware of the i-STAT category change and thought the test system was waived and did not require PT enrollment. 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 record review, the Laboratory Personnel Report (CMS 209), and an interview with the radiology manager; the laboratory failed to establish written procedures to include the assessment of employees performing Routine Chemistry testing, affecting 1 out of 1 testing personnel (TP). Findings: 1. The CMS 209, personnel records, and procedures manual were reviewed. 2. The laboratory failed to have a written competency procedure to evaluate the TP performing Routine Chemistry testing. 3. TP3 was listed on the CMS 209 for performing Routine Chemistry testing using the i-STAT test system. 4. The personnel documents for TP3 did not include test performance training and evaluation. 5. On a Recertification survey conducted on 11/23/2020 at 12:50 PM, the radiology manager confirmed the above findings. D5400 ANALYTIC SYSTEMS CFR(s): 493.1250 Each laboratory that performs nonwaived testing must meet the applicable analytic systems requirements in 493.1251 through 493.1283, unless HHS approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub.7), that provides equivalent quality testing. The laboratory must monitor and evaluate the overall quality of the analytic systems and correct identified problems as specified in 493.1289 for each specialty and subspecialty of testing performed. This CONDITION is not met as evidenced by: Based on record and manual review, manufacturer's instructions, and an interview with the radiology manager, the laboratory failed to meet the applicable analytic systems requirements in 493.1251 through 493.1283 for performing Routine Chemistry testing in the laboratory. Findings Include: 1. The laboratory failed to meet the following analytic systems requirements: *Failed to have written procedures for all assays and tests. See D5401. *Failed to establish control procedures. See D5441. 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. -- 2 of 5 -- This STANDARD is not met as evidenced by: Based on review of the laboratory records and interview with the radiology manager, the laboratory failed to have written procedures for the Routine Chemistry testing performed in Radiology. Findings Include: 1. The laboratory's procedures manual was reviewed. 2. The laboratory performs Routine Chemistry testing using the i-STAT test system. 3. The procedures manual failed to include the following written policies and procedures for its blood chemistry testing: * Requirements for patient preparation; specimen collection, labeling, storage, preservation, transportation, processing, and referral, as applicable. *Step-by-step performance of the procedure, including test calculations and interpretation of results, if applicable. *Preparation of solutions, calibrators, controls, reagents, and other materials used in testing; * Calibration or calibration verification procedures. * The established or verified reportable range for test results for the test system. * The Control procedures. *