St Petersburg Womans Health Center

Summary Statement of Deficiencies D0000 An on-site announced CLIA recertification survey was conducted at St Petersburg Woman's Health Center on 02/15/2024. The laboratory is not in compliance with 42 CFR Part 493, Requirement for Laboratories. The following Conditions were cited: D5400 - 493.1250 Condition: Analytic systems D6033 - 493.1409 Condition: Laboratories performing moderate complexity testing; technical consultant 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 review and interview with the Laboratory Director, the laboratory failed to verify the performance specifications of the i-STAT1 instrument prior to reporting patient test results (See D5421) and failed to run two levels of external quality controls each day of patient testing for 6 out of 6 months (05/19/23 - 11/29/23) for Beta (B) Human Chorionic Gonadotropin (HCG) (See D5447). D5421 ESTABLISHMENT AND VERIFICATION OF PERFORMANCE CFR(s): 493.1253(b)(1) Each laboratory that introduces an unmodified, FDA-cleared or approved test system must do the following before reporting patient test results: (1)(i) Demonstrate that it can obtain performance specifications comparable to those established by the manufacturer for the following performance characteristics: (1)(i)(A) Accuracy. (1)(i) 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 -- (B) Precision. (1)(i)(C) Reportable range of test results for the test system. (1)(ii) Verify that the manufacturer's reference intervals (normal values) are appropriate for the laboratory's patient population. This STANDARD is not met as evidenced by: Based on record review and interview with Testing Personnel #B (laboratory owner) and the Laboratory Director, the laboratory failed to verify the performance specifications of the i-STAT1 instrument prior to reporting 29 of 29 patient test results from 05/19/2023 to 11/29/2023 for Beta (B) Human Chorionic Gonadotropin (HCG). Findings included: Record review confirmed that the laboratory failed to verify the performance specifications of the i-STAT1 instrument prior to reporting patient test results on 05/19/2023. Record review of the "i-STAT1 System Manual" revised 10/18 /2021 revealed "It is important to validate the performance of the i-STAT System and the recommended quality control regimen..." On 02/15/2023 at 1:05 PM, Testing Personnel #B confirmed the laboratory had not verified the performance specifications of the i-STAT1 instrument. On 02/15/2023 at 4:00 PM, the Laboratory Director stated he was unaware the laboratory had not verified performance specifications for the i- STAT1 Instrument. D5447 CONTROL PROCEDURES CFR(s): 493.1256(d)(3)(i)(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 quantitative procedure, include two control materials of different concentrations; (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on lack of record review and interview with Testing Personnel #B (laboratory owner) and the Laboratory Director, the laboratory failed to run two levels of external quality controls each day of testing for 6 out of 6 months (05/19/23 - 11/29/23) reviewed for Beta (B) Human Chorionic Gonadotropin (HCG) tested on the i-STAT1 instrument. Findings included: Record review revealed no Quality Control (QC) records for two levels of external quality controls were available for review. Record review of the "STAT Beta Cartridge" log revealed 29 patients had been tested from 05 /19/23 - 11/29/23. On 02/15/2023 at 2:00 PM, Testing Personnel #B confirmed two levels of external QC had not been run on the instrument before patient testing. On 02 /15/2023 at 4:05 PM, the Laboratory Director stated he did not know two levels of external quality controls had not been run before testing patients. D6033 TECHNICAL CONSULTANT-MODERATE COMPEXITY CFR(s): 493.1409 The laboratory must have a technical consultant who meets the qualification requirements of 493.1411 of this subpart and provides technical oversight in accordance with 493.1413 of this subpart. This CONDITION is not met as evidenced by: Based on record review and interview, the Technical Consultant (who is also the -- 2 of 3 -- Laboratory Director) failed to verify the Total Beta (B) Human Chorionic Gonadotropin procedure and establish of the laboratory's test performance characteristics before patient testing (See D6040) and establish a quality control program including the parameters for acceptable levels of analytic performance for the Total B HCG procedure (See D6042). D6040 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(2) The technical consultant is responsible for-- (b)(2) Verification of the test procedures performed and the establishment of the laboratory's test performance characteristics, including the precision and accuracy of each test and test system. This STANDARD is not met as evidenced by: Based on record review and interview with the Technical Consultant, the Technical Consultant failed to verify the Total Beta (B) Human Chorionic Gonadotropin (HCG) procedure that was performed on the i-STAT1 instrument before testing 29 patients from 05/19/23 - 11/29/23. Findings included: Record review of the CMS 209, Laboratory Personnel Report signed by the Laboratory Director and dated 02/13/2024, revealed the Laboratory Director was also the Technical Consultant. Record review of the "STAT Beta Cartridge" logs revealed the laboratory performed Total B HCG testing for 29 patients on the i-STAT1 instrument from 05/19/2023 through 11/29 /2023. Record review revealed no performance verification records were present for the i-STAT1. On 02/15/2023 at 4:00 PM, the Technical Consultant stated he did not know performance of verification had not been completed for Total B HCG test procedure on the i-STAT1 prior to testing and reporting patient results. D6042 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(4) (b) The technical consultant is responsible for-- (b)(4) Establishing a quality control program appropriate for the testing performed and establishing the parameters for acceptable levels of analytic performance and ensuring that these levels are maintained throughout the entire testing process from the initial receipt of the specimen, through sample analysis and reporting of test results; This STANDARD is not met as evidenced by: Based on record review and interview, the Technical Consultant failed to ensure acceptable levels of analytic performance were established and maintained from 05/19 /2023 - 11/29/2023 for the Total Beta (B) Human Gonadotropin (HCG) test that was performed on the i-STAT1 . Finding included: Record review of the CMS 209, Laboratory Personnel Report signed by the Laboratory Director and dated 02/13/2024, revealed the Laboratory Director was also the Technical Consultant. Record review revealed the laboratory did not have two levels of external quality control records for the Total B HCG from 05/19/2023 - 11/29/2023. On 02/15/2023 at 04:05 PM, the Technical Consultant stated he did not know two levels of external quality control records for Total B HCG were not being tested before reporting patients. -- 3 of 3 --

Summary Statement of Deficiencies D0000 An announced CLIA recertification survey was conducted at St Petersburg Woman's Health Center on 02/07/22. The laboratory is not in compliance with 42 CFR Part 493, Requirements for Laboratories. The following is a description of the standard level deficiencies: D5413 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(b) The laboratory must define criteria for those conditions that are essential for proper storage of reagents and specimens, accurate and reliable test system operation, and test result reporting. The criteria must be consistent with the manufacturer's instructions, if provided. These conditions must be monitored and documented and, if applicable, include the following: (1) Water quality. (2) Temperature. (3) Humidity. (4) Protection of equipment and instruments from fluctuations and interruptions in electrical current that adversely affect patient test results and test reports. This STANDARD is not met as evidenced by: Based on observation, record review, and interview with the Director of Personnel, the laboratory failed to perform patient testing at the required temperature for 155 days out of 185 days (10/25/2019 - 02/04/2022) that temperatures were recorded. Findings Included: Observation on 02/07/2022 at 09:55 am, revealed an Insignia RVB - BL Rh view box. This device is a blood typing tool used in Rh determination. Record review of the manufacturer's instructions for the Blood Grouping Reagent Anti-D (Monoclonal Blend) Gamma Clone revealed "Place 1 drop of Gamma-clone Anti-D (Monoclonal Blend) on a warm (approximately 45 degrees Celsius) slide on a lighted view box." Record review of the laboratory's procedure titled "RH Control" revised on 11/27/2005 revealed the Rh view box temperature was to be 40-50 degree Celsius (C). Record review of the "Daily Laboratory Log Sheet" revealed the following Rh view box out of range temperatures that were documented: 1. 01/15/20: 35 degrees C 2. 01/17/20: 35 degrees C 3. 01/22/20: 35 degrees C 4. 01/24/20: 35 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 -- degrees C 5. 01/29/20: 35 degrees C 6. 01/31/20: 35 degrees C 7. 02/05/20: 35 degrees C 8. 02/07/20: 35 degrees C 9. 02/12/20: 35 degrees C 10. 02/14/20: 35 degrees C 11. 02/19/20: 35 degrees C 12. 02/21/20: 35 degrees C 13. 02/26/20: 35 degrees C 14. 02/28/20: 35 degrees C 15. 03/04/20: 35 degrees C 16. 05/22/20: 35 degrees C 17. 05/27/20: 35 degrees C 18. 05/29/20: 35 degrees C 19. 06/03/20: 35 degrees C 20. 06/05/20: 35 degrees C 21. 06/10/20: 35 degrees C 22. 06/12/20: 35 degrees C 23. 06/17/20: 35 degrees C 24. 06/19/20: 35 degrees C 25. 06/24/20: 35 degrees C 26. 06/26/20: 35 degrees C 27. 07/01/20: 35 degrees C 28. 07/03/20: 35 degrees C 29. 07/08/20: 35 degrees C 30. 07/10/20: 35 degrees C 31. 07/15/20: 35 degrees C 32. 07/17/20: 35 degrees C 33. 07/22/20: 35 degrees C 34. 07/24/20: 35 degrees C 35. 07/29/20: 39 degrees C 36. 07/31/20: 35 degrees C 37. 08/05/20: 35 degrees C 38. 08/07/20: 35 degrees C 39. 09/16/20: 35 degrees C 40. 09/18/20: 35 degrees C 41. 09/23/20: 35 degrees C 42. 09/25/20: 35 degrees C 43. 10/01/20: 35 degrees C 44. 10/02/20: 35 degrees C 45. 10/07/20: 35 degrees C 46. 10/09/20: 35 degrees C 47. 10/14/20: 35 degrees C 48. 10/21/20: 35 degrees C 49. 10/23/20: 35 degrees C 50. 10/28/20: 35 degrees C 51. 10/29/20: 35 degrees C 52. 10/30/20: 35 degrees C 53. 11/04/20: 35 degrees C 54. 11/06/20: 35 degrees C 55. 11/11/20: 35 degrees C 56. 11/13/20: 35 degrees C 57. 11/18/20: 35 degrees C 58. 11/20/20: 35 degrees C 59. 11/25/20: 35 degrees C 60. 12/02/20: 35 degrees C 61. 12/04/20: 35 degrees C 62. 12/09/20: 35 degrees C 63. 12/11/20: 35 degrees C 64. 12/18/20: 35 degrees C 65. 12/23/20: 35 degrees C 66. 12/30/20: 35 degrees C 67. 01/06/21: 35 degrees C 68. 01/08/21: 35 degrees C 69. 01/13/21: 35 degrees C 70. 01/15/21: 35 degrees C 71. 01/20/21: 35 degrees C 72. 01/22/21: 35 degrees C 73. 01/27/21: 35 degrees C 74. 01/29/21: 35 degrees C 75. 02/05/21: 35 degrees C 76. 02/10/21: 35 degrees C 77. 02/12/21: 37 degrees C 78. 02/13/21: 35 degrees C 79. 02/17/21: 38 degrees C 80. 02/19/21: 35 degrees C 81. 02/24/21: 35 degrees C 82. 02/26/21: 35 degrees C 83. 03/03/21: 35 degrees C 84. 03/05/21: 35 degrees C 85. 03/10/21: 35 degrees C 86. 03/12/21: 35 degrees C 87. 03/17/21: 35 degrees C 88. 03/19/21: 35 degrees C 89. 03/24/21: 35 degrees C 90. 04/16/21: 37 degrees C 91. 04/21/21: 38 degrees C 92. 04/23/21: 37 degrees C 93. 04/28/21: 38 degrees C 94. 04/30/21: 37 degrees C 95. 05/05/21: 38 degrees C 96. 05/07/21: 39 degrees C 97. 05/12/21: 39 degrees C 98. 05/14/21: 37 degrees C 99. 05/19/21: 37 degrees C 100. 05/21/21: 37 degrees C 101. 05/26/21: 38 degrees C 102. 05/28/21: 37 degrees C 103. 06/02/21: 37 degrees C 104. 06/04/21: 37 degrees C 105. 06/25/21: 37 degrees C 106. 06/30/21: 37 degrees C 107. 07/02/21: 38 degrees C 108. 07/09/21: 38 degrees C 109. 07/14/21: 37 degrees C 110. 07/16/21: 37 degrees C 111. 07/21/21: 37 degrees C 112. 07/23/21: 38 degrees C 113. 07/28/21: 38 degrees C 114. 07/30/21: 38 degrees C 115. 08/04/21: 37 degrees C 116. 08/06/21: 37 degrees C 117. 08/11/21: 38 degrees C 118. 08/13/21: 37 degrees C 119. 08/18/21: 37 degrees C 120. 08/20/21: 38 degrees C 121. 08/25/21: 38 degrees C 122. 08/27/21: 38 degrees C 123 09/01/21: 37 degrees C 124. 09/03/21: 38 degrees C 125. 09/08/21: 37 degrees C 126. 09/10/21: 38 degrees C 127. 09/15/21: 37 degrees C 128. 09/17/21: 37 degrees C 129. 09/22/21: 38 degrees C 130. 09/24/21: 37 degrees C 131. 09/29/21: 37 degrees C 132. 10/01/21: 37 degrees C 133. 10/06/21: 38 degrees C 134. 10/08/21: 38 degrees C 135. 10/13/21: 37 degrees C 136. 10/15/21: 38 degrees C 137. 10/20/21: 37 degrees C 138. 10/22/21: 38 degrees C 139. 10/27/21: 37 degrees C 140. 10/29/21: 37 degrees C 141. 11/03/21: 37 degrees C 142. 11/05/21: 38 degrees C 143. 11/10/21: 37 degrees C 144. 12/29/21: 35 degrees C 145. 12/31/21: 38 degrees C 146. 01/05/22: 37 degrees C 147. 01/07/22: 38 degrees C 148. 01/12/22: 35 degrees C 149. 01/14/22: 37 degrees C 150. 01/19/22: 37 degrees C 151. 01/21/22: 37 degrees C 152. 01/26/22: 37 degrees C 153. 01/28/22: 38 degrees C 154. 02/02/22: 38 degrees C 155. 02/04/22: 37 degrees C On 02/07/22 at 12:00 pm, the Director of Personnel stated when the laboratory got the new Rh view box, the Insignia Rh View Box User's & Service Manual stated "Rh slides reaches temperature of 37 degrees (+/- -- 2 of 3 -- 2 degrees ) in 5 to 10 minutes, eliminating wasteful heat up time." The Director of Personnel reported that he was told by the Laboratory Director to follow the temperature range for the view box and not the reagent. -- 3 of 3 --

Summary Statement of Deficiencies D0000 An announced CLIA recertification survey was conducted at St. Petersburg Womans Health Center on 10/03/2019. The laboratory is not in compliance with 42 CFR Part 493, Requirements for Laboratories. The following is a description of the standard level deficiencies: D5407 PROCEDURE MANUAL CFR(s): 493.1251(d) Procedures and changes in procedures must be approved, signed, and dated by the current laboratory director before use. This STANDARD is not met as evidenced by: Based on review of the policy and procedure manual and phone interview with Testing Personnel #C, the Laboratory Director failed to sign the Policy and Procedure manual. Findings Included: Record review of the procedure manual revised 11/23 /2005 revealed "The Laboratory Director should: 1. Review the entire procedure manual annually and initial and date each procedure." Continued review of the procedure manual revealed that there was a form titled "Test Procedures Form." The form was blank. No Laboratory Director signature was present to indicate procedures had been reviewed. Telephone interview on 10/03/19 at 12:45 PM with Testing Personnel #C revealed the signature page was in front of the policy and procedure manual and if not someone had removed the signature page. No signature page could be located. 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. 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 record review and staff interview, the laboratory failed to ensure the Rh (D antigen) positive quality control was documented from 02/16/18 to 10/02/19. Findings included: Record review of the package insert, "Blood Grouping Reagent Anti - D (Monoclonal Blend) Gamma-Clone By Slide, Tube, or Microwell Test" from Immunocor, revealed that "the reactivity of blood grouping reagents should be confirmed on each day of use by testing with red blood cells known to be negative and positive for the relevant antigen." Record review of the "Daily Laboratory Log Sheet" showed that the laboratory had not documented the Rh (D antigen) positive control from 02/16/18, when a revised "Daily Laboratory Log Sheet" had been implemented, to 10/02/19. Phone interview on 10/03/19 at 10:30 AM with the Office Manager revealed she did not know the "Daily Laboratory Log Sheet" had been revised and did not include documentation of the Rh (D antigen) positive control. She stated that every day of testing, staff performed positive and negative controls, and they did document the negative control on the "Daily Laboratory Log Sheet." D5781